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S. HRG. 112–934 

PHARMACY COMPOUNDING: IMPLICATIONS OF 

THE 2012 MENINGITIS OUTBREAK 

HEARING 

OF THE

COMMITTEE ON HEALTH, EDUCATION, 

LABOR, AND PENSIONS 

UNITED STATES SENATE 

ONE HUNDRED TWELFTH CONGRESS 

SECOND SESSION 

ON

EXAMINING PHARMACY COMPOUNDING, FOCUSING ON IMPLICATIONS 

OF THE 2012 MENINGITIS OUTBREAK 

NOVEMBER 15, 2012 

Printed for the use of the Committee on Health, Education, Labor, and Pensions 

( 

Available via the World Wide Web: http://www.gpo.gov/fdsys/ 
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS 

TOM HARKIN, Iowa, Chairman 

BARBARA A. MIKULSKI, Maryland 

JEFF BINGAMAN, New Mexico 

PATTY MURRAY, Washington 

BERNARD SANDERS (I), Vermont 

ROBERT P. CASEY, JR., Pennsylvania 

KAY R. HAGAN, North Carolina 

JEFF MERKLEY, Oregon 

AL FRANKEN, Minnesota 

MICHAEL F. BENNET, Colorado 

SHELDON WHITEHOUSE, Rhode Island 

RICHARD BLUMENTHAL, Connecticut 

MICHAEL B. ENZI, Wyoming 

LAMAR ALEXANDER, Tennessee 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

RAND PAUL, Kentucky 

ORRIN G. HATCH, Utah 

JOHN MCCAIN, Arizona 

PAT ROBERTS, Kansas 

LISA MURKOWSKI, Alaska 

MARK KIRK, Illinois 

PAMELA J. SMITH, Staff Director, Chief Counsel 

LAUREN MCFERRAN, Deputy Staff Director 

FRANK MACCHIAROLA, Republican Staff Director 

(II) 
C O N T E N T S 

STATEMENTS 

THURSDAY, NOVEMBER 15, 2012 

Page 

COMMITTEE MEMBERS

Harkin, Hon. Tom, Chairman, Committee on Health, Education, Labor, and 

Pensions, opening statement ............................................................................... 1 

Prepared statement .......................................................................................... 2 

Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming, opening 

statement .............................................................................................................. 4 

Roberts, Hon. Pat, a U.S. Senator from the State of Kansas .............................. 6 

Mikulski, Hon. Barbara A., a U.S. Senator from the State of Maryland ............ 34 

Alexander, Hon. Lamar, a U.S. Senator from the State of Tennessee ................ 36 

Hagan, Hon. Kay R., a U.S. Senator from the State of North Carolina ............. 39 

Blumenthal, Hon. Richard, a U.S. Senator from the State of Connecticut ........ 41 

Bennet, Hon. Michael F., a U.S. Senator from the State of Colorado ................. 43 

WITNESSES—PANEL I 

Bell, Beth, M.D., MPH, Director, National Center for Emerging and Zoonotic 

Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, 

GA .......................................................................................................................... 8 

Prepared statement .......................................................................................... 10 

Hamburg, Margaret A., M.D., Commissioner, Food and Drug Administration, 

Washington, DC ................................................................................................... 16 

Prepared statement .......................................................................................... 18 

Smith, Lauren, M.D., MPH, Interim Commissioner, Department of Public 

Health, Boston, MA .............................................................................................. 23 

Prepared statement .......................................................................................... 25 

WITNESS—PANEL II 

Cadden, Barry, Owner and Director of Pharmacy, New England Compunding 

Center, Framingham, MA—(Mr. Cadden declined to appear) 

WITNESSES—PANEL III 

Kainer, Marion, M.D., MPH, FRACP, Director, Healthcare Associated Infections & Antimicrobial Resistance Program, Tennessee Department of 

Health, Nashville, TN .......................................................................................... 55 

Prepared statement .......................................................................................... 57 

Miller, David G., R.Ph., Executive Vice President and CEO, International 

Academy of Compounding Pharmacists, Missouri City, TX ............................. 65 

Prepared statement .......................................................................................... 66 

Thompson, Kasey K., Pharm.D., M.S., B.S., Vice President, Office of Policy, 

Planning and Communications, American Society of Health-System Pharmacists, Bethesda, MD ........................................................................................ 74 

Prepared statement .......................................................................................... 76 

ADDITIONAL MATERIAL 

Statements, articles, publications, letters, etc.: 

Senator Casey ................................................................................................... 87 

(III) 
(IV) 

John J. Dreyzehner, M.D., MPH, FACOEM, Commissioner, Tennessee 

Department of Health, Nashville, TN ......................................................... 88 

Andrew C. Holt, Pharm.D. Executive Director, Tennessee Board of Pharmacy, Nashville, TN ..................................................................................... 90 

Craig Becker, President, Tennessee Hospital Association, Nashville, TN .. 92 

Baeteena M. Black, D.Ph., Executive Director, Tennessee Pharmacists 

Association (TPA), Nashville, TN ................................................................ 94 

Wiley Robinson, M.D., FHM, President, Tennessee Medical Association 

(TMA), Nashville, TN ................................................................................... 97 

Response by Lauren A. Smith, M.D., MPH, to questions of the HELP 

Committee ..................................................................................................... 98 

Response by Marion Kainer to question of Senator Whitehouse .................. 109 

Response by David G. Miller, R.Ph., to questions of: 

Senator Enzi .............................................................................................. 110 

Senator Casey ............................................................................................ 110 

Senator Franken ........................................................................................ 112 

Response by Kasey K. Thompson to questions of: 

Senator Enzi .............................................................................................. 117 

Senator Casey ............................................................................................ 119 

Senator Franken ........................................................................................ 120 
(1) 

PHARMACY COMPOUNDING: IMPLICATIONS 

OF THE 2012 MENINGITIS OUTBREAK 

THURSDAY, NOVEMBER 15, 2012 

U.S. SENATE, 

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS, 

Washington, DC. 

The committee met, pursuant to notice, at 9:53 a.m., in room 

SD–106, Dirksen Senate Office Building, Hon. Tom Harkin, chairman of the committee, presiding. 

Present: Senators Harkin, Enzi, Mikulski, Casey, Hagan, 

Merkley, Franken, Bennet, Blumenthal, Alexander, and Roberts. 

OPENING STATEMENT OF SENATOR HARKIN

The CHAIRMAN. The Senate Committee on Health, Education, 

Labor, and Pensions will please come to order. 

We’re meeting here today to better understand what caused one 

of the worst public health crises this country has experienced in recent years, the meningitis outbreak that has claimed the lives of 

32 Americans and sickened at least 461 people. While those affected grapple with side effects and complications related to treatment, thousands more are waiting to see if they become ill. This 

outbreak has been traced back to pharmaceuticals produced at the 

New England Compounding Center in Framingham, MA, where it 

is now clear the owners and managers demonstrated a complete 

disregard for basic procedures to ensure that the products they 

were manufacturing were sterile. 

The real question we will seek to answer today is: How could this 

have happened? How could 17,000 doses of a product so contaminated that, upon recall, black particles were visible to the naked 

eye in some of the samples, have been shipped to 23 States? How 

could a pharmacy that the FDA had described in 2003 as posing, 

and I quote, 

‘‘ . . . the potential for serious public health consequences if 

the compounding practices, in particular, those relating to specific sterile products, are not improved . . . ’’ 

How could they have been then licensed to ship drugs to 45 different States? 

As we have learned over the course of our committee inquiry, 

NECC’s shortcomings were well-documented. The FDA and the 

Massachusetts Board of Pharmacy repeatedly found significant deficiencies in their operations, including the suspected destruction of 

documents and contaminated lots; findings of bacterial contamination in compounded medications; findings of sterile injectable prod-
2 

ucts that were both too weak or too strong in potency; and repeated 

complaints about the sale of compounded drugs without a patientspecific prescription in direct violation of State and Federal law. 

Yet, despite the abundance of documentation, neither the Massachusetts Board nor the FDA appears to have taken the necessary 

steps to protect the public from these products. 

I will dispense with the rest of my statement, and I will submit 

it in its entirety for the record. 

[The prepared statement of Senator Harkin follows:] 

PREPARED STATEMENT OF SENATOR HARKIN

The committee will come to order. We are meeting here today to 

better understand what caused one of the worst public health crises this country has experienced in recent years: the meningitis 

outbreak that has claimed the lives of 32 Americans and sickened 

at least 461 people. 

While those affected grapple with side effects and complications 

related to treatment, thousands more are waiting to see if they become ill. This outbreak has been traced back to pharmaceuticals 

produced at the New England Compounding Company in Framingham, Massachusetts, where owners and managers demonstrated a complete disregard for basic procedures to ensure that 

the products they were manufacturing were sterile. 

The question we will seek to answer today is: how could this 

have happened? How could 17,000 doses of a product so contaminated that upon recall, black particles were visible to the naked 

eye, have been shipped to 23 States? How could a pharmacy that 

the FDA had described in 2003 as posing, 

‘‘ . . . the potential for serious public health consequences if 

[the] compounding practices, in particular those relating to 

specific sterile products are not improved, . . . ’’ 

have been licensed to ship drugs to 45 different States? 

As we have learned over the course of our committee inquiry, 

NECC’s shortcomings were well-documented. The FDA and the 

Massachusetts Board of Pharmacy repeatedly found significant deficiencies in NECC’s operations, including the suspected destruction of documents and contaminated lots; findings of bacterial contamination in compounded medications; findings of sterile 

injectable products that were both too weak or too strong in potency; and repeated complaints about the sale of compounded drugs 

without a patient-specific prescription, in direct violation of State 

and Federal law. And yet, despite the abundance of documentation, 

neither the Massachusetts Board nor the FDA appears to have 

taken the necessary steps to protect the public from these products. 

Equally troubling is that fact that, when the owners and managers of NECC sought a license for a separate company, 

Ameridose, to compound drugs on scale perhaps 10 times the size 

of NECC, these same State and Federal regulators granted that license. They did so without referencing the checkered history of 

NECC, even though Ameridose would supply hospitals across the 

country under contract with the largest group purchasing organization in the United States. How could that history not been deemed 

relevant? How could NECC’s owners have been allowed to expand 
3 

their operations, in light of their history? These are questions I am 

hoping to answer today. 

In the face of such a tragedy it is natural to want to take action. 

And we will. This committee has a demonstrated ability to work to 

find bipartisan solutions that will take into consideration the needs 

of all stakeholders. The hearing today will explore not just what 

happened, but it will begin to help us determine how to prevent 

similar outbreaks in the future. 

What is important to remember, however, is that drug 

compounding is essential and that most pharmacies that compound 

do so on a vastly smaller scale than NECC. We need to ensure that 

these pharmacists can continue to compound without a drastic increase in overhead. 

We also know that to address drug shortages, compounding is occurring both in hospitals and in pharmacies to replenish supply of 

previously available drugs. Indeed, in the case of 

methylprednisolone acetate, the drug at issue in the outbreak, two 

manufacturers had ceased producing the drug in the last 2 years. 

We know compounding is critical, and that the need for large 

scale compounding is increasing. But we do not know where or how 

much large-scale drug compounding is being conducted, or if these 

companies are compounding drugs in accordance with best practice 

standards. More importantly, we have no way of knowing which facilities are not in compliance. This is a problem and indicates to me 

the need for better Federal regulation in this area. 

As a committee, we will work together to identify and plug any 

gaps in our regulators’ authority. We want to ensure that any 

pharmacy that takes the kinds of risks with patient lives that 

NECC did will be shut down long before more patients get hurt. 

The only good that can come from a tragic situation like this outbreak is the momentum to make changes to prevent it from ever 

happening again. I look forward to hearing the thoughts of the 

panel on this topic and I promise the other members of this committee who I know have a history on this issue to working together 

with you to ensure that a problem like this cannot occur again. 

In our first panel, we’ll hear from Dr. Beth Bell of the Centers 

for Disease Control and Prevention about the public health impact 

of the meningitis outbreak and CDC’s role in responding to it. Dr. 

Peggy Hamburg of FDA and Dr. Lauren Smith of the Massachusetts Department of Public Health will talk to us about the role of 

their agencies in regulating compounding pharmacies in general 

and in investigating NECC specifically. And we’ll ask them about 

their views on what we can do to prevent future crises. 

We invited the manager and co-owner of the New England 

Compounding Center, Mr. Barry Cadden, to appear on our second 

panel. We were informed by Mr. Cadden’s attorney that he would 

decline to voluntarily appear, and if compelled to appear, would invoke his Fifth Amendment right against self-incrimination and 

refuse to answer our questions. I am disappointed by his failure to 

appear, but frankly, I believe this committee has amply demonstrated the extensive failures of Mr. Cadden and NECC, as the 

record of this hearing will make clear. 

On our third panel, we will talk to the physician whose critical 

work led to the initial identification of the outbreak and who ably 
4 

worked with CDC to isolate NECC products as the source of the 

meningitis infections, Dr. Marion Kainer of the Tennessee Department of Health. We’ll also talk with David Miller from the International Academy of Compounding Pharmacists and Dr. Kasey 

Thompson of the American Society of Health-System Pharmacists 

about the use of compounding in medical care, and the measures 

needed to ensure that compounded drugs are safe. 

Before we begin, I’d like to submit to the record the documents 

that we have received from NECC, FDA, and Massachusetts in response to our investigatory letters. 

The CHAIRMAN. But before we begin, I’d like to submit for the 

record the documents that we have received from NECC, the FDA, 

and Massachusetts in response to our investigatory letters. Without objection, they’ll be submitted for the record. 

[Editor’s Note: Due to the large volume of documents and the 

high cost of printing, the information referred to is maintained in 

the committee file.] 

And with that, I’ll yield to Senator Enzi. 

OPENING STATEMENT OF SENATOR ENZI

Senator ENZI. Thank you, Mr. Chairman. 

Thirty-two Americans have died, out of 461 total, sickened after 

receiving contaminated steroid injections produced by the New 

England Compounding Center, or NECC. Additionally, approximately 14,000 patients in 23 States have been exposed to potentially contaminated injections produced by the same pharmacy. 

This case represents a catastrophic failure by the regulatory 

agencies that are charged with protecting patients from unsafe 

drugs. Such a failure is unacceptable, and we’re going to examine 

what happened in order to determine what needs to be done to prevent it from reoccurring. 

The compounding pharmacy that caused these patients’ deaths 

and illnesses has a long history of problems with product safety 

and compliance with State regulations. These problems began almost as soon as NECC first received its pharmacy license in the 

late 1990’s, when complaints began to be made about the sterility 

of the products and its practices around the requirement for individual patient prescriptions. 

Both the FDA and Massachusetts Board of Pharmacy became 

aware of the problems with NECC over a decade ago. They jointly 

inspected NECC’s facility and held multiple meetings about the 

problems they discovered. The Massachusetts Board entered into a 

consent decree with NECC in 2006. Later that year, FDA also 

issued a warning letter to NECC. 

Despite the multiple warnings, State and Federal regulators 

failed to continue to monitor NECC and take the steps that could 

have prevented the current situation. In particular, the Massachusetts Board should have known from its numerous inspections of 

NECC’s facility that it was operating a large-scale drug manufacturing operation. That information, coupled with repeated complaints highlighting NECC’s pattern of failing to require valid prescriptions for specific patients, clearly contravened Massachusetts 

regulatory requirements for compounding pharmacies. 
5 

Even after receiving multiple complaints about the sterility and 

safety of drugs compounded by NECC, there is no evidence that the 

Board made any effort to even followup and inspect NECC’s facility 

from 2006 until 2011. State boards of pharmacy have explicit authority over the practice of pharmacy, including compounding products for individual patients. States like Massachusetts also have 

clear and unequivocal authority to inspect, suspend, and revoke 

pharmacy licenses. 

While there have been litigation and conflicting court decisions 

around Federal legislation enacted in 1997 to differentiate between 

compounded and manufactured products, this ambiguity alone cannot be blamed for this tragedy. FDA can inspect any facility that 

manufactures, processes, packs, or holds products for interstate 

commerce and has authority over unapproved new drugs in interstate commerce. FDA also has the ability to take action against 

misbranded or adulterated products. 

NECC was clearly operating outside its pharmacy license in violating State laws requiring individual prescriptions. NECC also 

looked like it was operating as a large-scale drug manufacturer, 

pretending to be a pharmacy in order to avoid FDA regulation. In 

every warning letter and legal brief the Food and Drug Administration has ever issued concerning this very type of conduct, including 

a 2006 warning letter to NECC, the agency said it had clear authority to regulate this very type of conduct. 

I hope today we can find out why these State and Federal authorities were not used to prevent this tragedy. The committee is 

and will continue to investigate NECC’s conduct and the oversight 

of both FDA and the Massachusetts Board of Pharmacy. We’ve sent 

letters to FDA, the Massachusetts Board, and NECC. We’ve received over 10,000 pages of documents, which show NECC has a 

history of not complying with State and Federal law. We expect to 

receive more documents in the coming weeks and will leave no 

stone unturned. 

I want to take a moment to recognize the longstanding interest 

of my colleagues, Senators Roberts and Burr, regarding pharmacy 

compounding. They’ve been leaders in this area since the late 

1990s and released a draft of pharmacy compounding legislation 

with former HELP Committee Chairman Kennedy in 2007. 

Many other members of the HELP Committee also have a strong 

interest in this matter. Senator Alexander’s home State of Tennessee has been hit particularly hard by the current outbreak. I 

know that Senators Franken and Blumenthal have strong views. 

Numerous members of the HELP Committee signed oversight letters requesting the information from the Food and Drug Administration, the Massachusetts Board of Pharmacy, and the New England Compounding Center. 

The HELP Committee worked very effectively and in a bipartisan manner to reauthorize the FDA user fee legislation earlier 

this year. I am confident we can all work together to arrive at a 

common understanding of this problem and its solution. 

I’m also interested in hearing from Dr. Kasey Thompson of the 

American Society of Health-System Pharmacists on our third 

panel. Many patient populations and specialties require compounded products, including pediatrics and hospice. Some State 
6 

pharmacy boards, like Wyoming’s, also do their jobs effectively. I 

hope he can comment on the benefits of traditional pharmacy 

compounding and the strengths and weaknesses of pharmacy regulation by the States. 

Last, I want to thank Dr. Bell from the CDC and Dr. Kainer for 

attending today. Without your hard work, I understand this could 

have been much worse. Patients all over the country owe you 

thanks for immediately acting upon hearing about only one case. 

Thank you, Chairman Harkin, for holding this important hearing, and I look forward to learning more about how this tragedy occurred in order to see that it’s not repeated in the future. 

The CHAIRMAN. Thank you very much, Senator Enzi. 

It has been a longstanding procedure of this committee that only 

the chair and the ranking member give opening statements. The 

chair, with the concurrence of the ranking member, would diverge 

from that for this hearing because of the long-time interest in and 

leadership by Senator Roberts on this issue and because he had 

been a leader on a bill that came up about 5 or 6 years ago. I would 

yield for no more than 5 minutes for an opening statement by Senator Roberts. 

STATEMENT OF SENATOR ROBERTS

Senator ROBERTS. Thank you, Mr. Chairman, and Ranking Member Enzi. The reason I’m making this statement is very simple. I’ve 

been involved in this for 12 years. This is not a new story. I just 

appreciate you allowing me to make a short statement. I believe it’s 

important to outline some of the previous actions that members of 

this committee and the Senate have taken in the past to review 

and take action on issues relating to compounding pharmacy. 

I want to begin by thanking the Chairman and the Ranking 

Member for holding this hearing on a crisis that has gained significance and deserves attention over the past few weeks but is also 

an issue that many of us on the committee have worked on for 

many years and for some over a decade. 

First and foremost, I want to start out by reiterating my support 

for pharmacy compounding. I know that compounding serves a very 

important role for patients, such as patients who are allergic to certain ingredients found in approved drugs or for children who need 

a pediatric dosage of a drug. 

Legitimate pharmacy compounding occurs when a patient has a 

special medical need that cannot be met by an FDA-approved drug. 

Their physician writes a specific prescription for the patient, and 

then the individual pharmacist makes the medication for the individual patient. This type of compounding should continue. I want 

to work to ensure that we don’t do anything to alter that practice. 

However, and unfortunately, the more traditional pharmacy 

compounding is not why we are here today. We are here today because there have been bad actors who are using the good name of 

pharmacy compounding to mass produce products not approved by 

the FDA and provide them to patients. Compounding products are 

made for the individual patient and are, therefore, not FDA-approved. 

However, under the guise of traditional compounding, some manufacturers have been mass producing and providing products with-
7 

out the knowledge of the patient or their doctor. Regrettably, this 

is not a new issue. There have been many examples of injuries and 

deaths from unsafe compounded drugs that stretch across the country. In fact, it goes back over a decade or more. Throughout that 

time, I’ve had the privilege of working with many members on this 

committee, more especially Senator Burr, on issues relating to 

pharmacy compounding. 

This is an issue that hit far too close to home in Kansas. Several 

years ago, a pharmacist in Kansas City was found to be diluting 

cancer drugs for his patients. Unfortunately, over 4,000 patients 

were affected before authorities could stop him. Senator Kit Bond 

and I worked together at that time to hold the first HELP Committee hearing on pharmacy compounding. We requested a GAO 

report on the status of pharmacy compounding to try to get some 

answers. 

We sponsored what I always thought was a very simple amendment to the Medicare Modernization Act to have the FDA establish 

a committee to look into pharmacy compounding and make any recommendations to improve and protect patient safety. This committee was to terminate after 1 year. It was an amendment supported in the Senate. Unfortunately, it was stripped during the 

conference because some folks incorrectly thought that the States 

were adequately regulating such pharmacies and that additional 

Federal regulation would be an undue burden. 

I must say I think every member here on this committee time 

and again has fought against additional Federal regulation and 

placing undue burdens on any constituent, including my local community pharmacists. I was amazed. Fast forward a few years later. 

With Chairman Kennedy and Senator Burr, we once again tried to 

take a closer look at the regulation and enforcement of pharmacy 

compounding. In an effort to be open and transparent, we produced 

a discussion draft along with Ranking Member Enzi and Senator 

Reed and requested comments and feedback. 

While I don’t think that discussion draft is anything that I would 

recommend signing into law today, the intent was to garner stakeholder feedback and apply it to our policymaking. Instead, rather 

than working with us, we were faced with a full grassroots effort 

to stop the discussion draft from moving forward. I said then, and 

I would repeat now, that my intent, and I believe the intent of others, was never to do away with pharmacy compounding. What we 

needed were answers. What we got was pushback. 

Now, while it was ultimately Chairman Kennedy’s decision not 

to move forward with the discussion draft, I had hoped then and 

continue to believe it is important today to revisit the regulation, 

oversight, and enforcement of pharmacy compounding at the Federal and State levels. There are obviously very serious patient safety concerns. I have my own opinions on where the cracks may be 

and ways to address these safety concerns. To that end, I am working with my colleagues on the HELP Committee to discover the appropriate measures we need to put in place to protect patient safety. 

Let me be clear. I have not and will not introduce any sort of legislation to ban pharmacy compounding. However, the recent and 

repeated loss of life has reiterated the need for appropriate meas-
8 

ures to be put in place to ensure that bad actors can no longer take 

advantage of patients. Patients have a right to know when they are 

receiving a product that is not FDA-approved and the risk that 

may come with using it. As I said during the last hearing we had 

on this subject, I fully recognize the benefits of compounding pharmacy and that they fill an important niche in the healthcare delivery system. 

However, many questions need to be answered. How do we define 

manufacturing versus compounding? What are we doing at the 

State level to enforce regulations currently on the books? How can 

we get States that do not have adequate regulations on the books 

to improve? Are those who are inspecting properly trained? Should 

we have a means to test products once they have been compounded 

to ensure they are safe and accurate doses? Are schools of pharmacy properly training individuals to compound and what steps 

they should take to make sure they do so safely? Why is there not 

a system of adverse event reporting? 

These questions were important a decade ago and, unfortunately, 

they continue to remain relevant today. My expectation from today’s hearing is to answer some of these questions, learn more 

about the current state of regulation of pharmacy compounding, 

and I anticipate that all of our witnesses will commit to working 

fully with this committee to address any potential gaps in the regulatory structure that would potentially affect patient safety. 

I thank the chair and my colleagues for their indulgence. 

The CHAIRMAN. Thank you very much, Senator Roberts. 

Now we’ll turn to our first panel. We’ll hear from Dr. Beth Bell 

of the Centers for Disease Control and Prevention about the public 

health impact of this outbreak and the CDC’s role in responding to 

it. Second, we’ll turn to Dr. Peggy Hamburg, Commissioner of the 

FDA, and then Dr. Lauren Smith of the Massachusetts Department 

of Public Health to tell us about the role of their agencies in regulating compounding pharmacies in general and in investigating 

NECC, specifically. We’ll ask them about their views on what we 

can do to prevent future crises. 

With that, all your statements will be made a part of the record 

in their entirety. I’d ask that you limit your opening statements to 

5 to 7 minutes, and then we’ll open it for questions. Welcome, all 

of you. Thank you for being here. 

Dr. Bell, we’ll start with you. Please proceed. 

STATEMENT OF BETH BELL, M.D., MPH, DIRECTOR, NATIONAL 

CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND PREVENTION, 

ATLANTA, GA 

Dr. BELL. Chairman Harkin, Ranking Member Enzi, members of 

the committee, thank you for the opportunity to speak to you today 

about CDC’s response and ongoing activities in the multistate outbreak of fungal meningitis and other infections. CDC disease detectives work 24/7 to save lives and protect Americans from harm. 

The fungal meningitis outbreak is a reminder of the importance of 

CDC’s ability to rapidly respond to, to characterize, and to stop outbreaks of unexplained illness and death. 
9 

My remarks today will focus specifically on the public health response to the outbreak associated with injections of contaminated 

preservative-free methylprednisolone acetate produced by the New 

England Compounding Center, NECC. To begin, I want to give particular credit to Dr. April Pettit, an infectious disease doctor at 

Vanderbilt University, who identified the first meningitis case and 

notified the State health department. If Dr. Pettit had not acted, 

it is likely that many more patients would have been exposed. 

We are also fortunate that Dr. Pettit reached out to Dr. Marion 

Kainer of the Tennessee Department of Health, who quickly identified similar cases, reached out to CDC for support, and identified 

the common exposures: three lots of methylprednisolone acetate 

produced by NECC. Dr. Kainer’s quick response resulted in a voluntary national recall of the suspected NECC lots within days of 

the first case being reported. CDC then reached out to other State 

health departments to marshal an enormous nationwide effort, including rapidly contacting approximately 14,000 patients at risk. 

The efforts of Dr. Kainer and the hundreds of other State public 

health officials who responded to this outbreak did not happen by 

chance. Despite trying economic times, we have worked hard to 

build and sustain a network of trained public health professionals 

that can rapidly detect and respond to outbreaks. As State budget 

cuts have forced public health personnel losses, we are fortunate to 

have been able to make a real difference with CDC’s direct financial and in-kind support. 

Many of the outbreak responders are directly supported through 

CDC’s Epidemiology and Laboratory Capacity Cooperative Agreement. Dr. Kainer is a graduate of CDC’s Epidemic Intelligence 

Service Training Program, and Tennessee is one of CDC’s 10 

emerging infections program sites that receive additional resources 

which supported their response in this outbreak. The resources 

available through the Prevention and Public Health Fund authored 

by this committee also made a tangible difference in detecting and 

responding to the outbreak. 

I would also like to share information about some of the patients 

affected by the outbreak and what CDC has done to try to help 

them. As of November 14, a total of 461 cases, including 32 deaths, 

have been reported in 19 States. The approximately 14,000 people 

across the country who received the contaminated medication include people like Diana Reed and George and Lillian Cary. 

Diana Reed of Brentwood, TN, was the primary caretaker of her 

wheelchair-bound husband, Wayne, who suffers from Lou Gehrig’s 

Disease. Diana was healthy and physically active, but after a neck 

injury, she turned to steroid injections to help with her pain. Tragically, Diana received a contaminated injection and became the 

third Tennessean to die of fungal meningitis. 

George Cary of Howell, MI, is husband of Lillian. Both received 

contaminated steroid injections in September. Lillian was the first 

to show symptoms and, tragically, lost her battle to fungal meningitis. While grieving the loss of his wife, George was also diagnosed 

with fungal meningitis himself and is in the process of undergoing 

the long and difficult treatment. These are just a few of the personal stories associated with this tragic event. 
10 

Because this infection is so rare and few doctors have ever treated it, CDC stepped in to ensure that patients were getting the best 

possible care. We convened a panel of the Nation’s leading clinical 

fungal disease experts to work with CDC scientists to help develop 

diagnostic and treatment guidance. Even with treatment, we are 

seeing many patients return with new symptoms and new conditions. We also fear that more exposed patients will become ill before the outbreak is over. 

Our focus going forward should be on preventing these outbreaks 

in the future and ensuring that all products, materials, and procedures used in healthcare are safe. We are fortunate in this case for 

the clinical and public health heroes like Drs. Pettit and Kainer in 

Tennessee. 

I will end by again noting the thousands of patients and families 

who have been directly affected by this event. Diana, George, Lillian, and countless others put their faith in our healthcare system. 

Patients deserve to be safe whenever they receive their medical 

care. 

Thank you. 

[The prepared statement of Dr. Bell follows:] 

PREPARED STATEMENT OF BETH BELL, M.D., MPH 

Chairman Harkin, Ranking Member Enzi, members of the committee, thank you 

for the opportunity to speak to you today about CDC’s response and ongoing activities related to the multistate outbreak of fungal meningitis and other infections. 

CDC works 24–7 to save lives and protect people from harm and this outbreak illustrates the power of public health in action both to identify serious health problems 

and to coordinate a targeted response that protects our Nation and its citizens from 

infectious disease threats. 

I want to extend my sympathies to the patients affected by this outbreak. Our 

hearts go out to the patients and families impacted by the debilitation and death 

from these infections. 

My remarks today will focus specifically on the identification of, and subsequent 

public health response to the outbreak associated with injections of contaminated 

preservative-free methylprednisolone acetate (MPA), an injectable steroid produced 

by the New England Compounding Center (NECC). Specifically, I will cover three 

critical areas related to the outbreak: 

• a summary of the response by CDC and our partners in State public health 

agencies; 

• a description of the fungal infections involved in this outbreak and how these 

infections are affecting patients; and 

• a discussion of several early lessons learned. 

As of November 14 at noon (EST), a total of 461 cases, including 32 deaths, have 

been reported in 19 States. The cases include fungal meningitis, stroke, or other 

central nervous system-related infections plus 10 peripheral joint infections (i.e., 

knee, hip, shoulder, elbow). CDC and our partners at State and local health departments marshaled an enormous effort nationwide to determine the source and scope 

of the outbreak, rapidly contact patients at risk, and enlist the individual input of 

leading experts to help us develop novel diagnostic and treatment guidance to 

achieve the best possible patient outcomes. In this outbreak, local infectious disease 

officials, including State epidemiologists, healthcare associated infection (HAI) prevention coordinators, and others whose positions are directly supported through 

CDC’s Epidemiology and Laboratory Capacity (ELC) cooperative agreement and 

CDC’s Emerging Infections Program (EIP) were pivotal in the original identification 

of the outbreak and the substantial patient notification that followed. Their efforts 

at the State and local level have been extraordinary and in many cases undoubtedly 

contributed directly to saving the lives of exposed patients. 

I would like to highlight some specific efforts by CDC and State health agencies: 

• The Tennessee Department of Health (TN DOH) identified and sounded the 

alarm on the initial cluster of cases. The TN DOH official who alerted others about 

these cases serves as the State’s HAI Program Director and is a graduate of CDC’s 
11 

1www.cdc.gov/mmwr/preview/mmwrhtml/mm61e1012a1.htm?slcid=mm61e1012a1lw. 

Epidemic Intelligence Service (EIS) program. Tennessee also is one of CDC’s 10 

Emerging Infections Program (EIP) sites and as such receives additional resources 

that helped support their response in this outbreak. 

• The Virginia Department of Health laboratory, whose staff had been trained by 

CDC in identifying fungi, was the first to identify the very rare fungal pathogen, 

Exserohilum. This discovery saved valuable time and provided the Nation with a 

critical piece of information to guide diagnostic and treatment recommendations. 

• The Michigan Department of Community Health identified the first case of a 

joint infection associated with these products. 

• Over 250 Federal disease control specialists have been working out of CDC’s 

Emergency Operations Center to coordinate the multistate fungal outbreak response 

efforts with Federal, State, local, tribal, and territorial public health partners. CDC 

coordination was helpful to ensure patient notification, development and dissemination of treatment guidance, and rapid communication to the public and the health 

professions community. 

• State and local public health departments, health care facilities, and CDC 

tracked down and contacted over 14,000 exposed patients in 23 States with 

facilities which received the implicated medication. 

• CDC engaged the Nation’s leading clinical fungal disease experts to receive 

their individual input on the development of diagnostic and treatment guidance appropriate for identifying and treating patients that develop infections. 

This panel has met repeatedly as the outbreak has evolved to adjust clinical 

advice to very complex and rare infections. CDC has educated over 4,200 clinicians through our clinician conference calls (COCA calls) on the interim diagnostic and treatment guidance. 

• CDC has prioritized transparent and rapid communication with the public in 

this outbreak. To date, CDC’s meningitis outbreak and fungal diseases web 

pages have been accessed over 1 million times and have sourced media outlets 

with direct links and resources to ensure accurate reporting and broad dissemination of health messages. CDC has used the Health Alert Network 

(HAN) to release multiple health advisories as the outbreak has unfolded. 

HANs are directly distributed to health care providers nationwide. CDC has 

also responded to over 4,500 calls to our public inquiry line (CDC–INFO). 

• CDC’s mutually reinforcing laboratory and surveillance systems have been critical in confirming the cause of the outbreak: 

• CDC’s fungus laboratory is the national reference laboratory and in this outbreak has served as an indispensable resource to public health and FDA laboratories to identify and confirm the variety of fungal species recovered from 

patient, product, and environmental samples. Because there were no available 

rapid diagnostic tests to identify the fungal organism(s) associated with this 

outbreak, CDC scientists developed and refined a real-time polymerase chain 

reaction (PCR) to detect fungal ribosomal DNA, and then performed DNA sequencing to identify the specific fungus by its DNA barcode. 

• CDC’s HAI laboratory is working with FDA to identify other microorganisms 

from sealed medication vials. Few laboratories nationwide have the technical 

expertise and capacity to perform such complicated and exact testing to assess the presence of any bacterial contamination. 

• CDC’s Infectious Diseases Pathology laboratory has been testing biopsy and 

autopsy samples from the outbreak. Information from these analyses provides 

vital clinical information on how this rare disease is affecting patients, and 

such information is used to inform development of CDC’s interim clinical 

guidance. 

EVOLUTION OF THE OUTBREAK

On September 18, an astute clinician alerts the Tennessee Department of Health 

(TN DOH) of a patient with culture-confirmed Aspergillus fumigatus meningitis 

after epidural steroid injection at an ambulatory surgical center (ASC).1 The patient 

received an epidural steroid injection on July 30 and was admitted to the hospital 

in late August. 

This type of infection is exceedingly rare, and we are extremely fortunate that the 

clinician chose to test the patient’s cerebrospinal fluid (CSF) for a possible fungal 

infection (which is not a routine test ordered by clinicians) and then notify the State 

health department when those results came back positive. After further consultation 

with the clinician in Tennessee, the TN DOH contacts CDC on September 20 to ask 
12 

2Kainer, M., et al. Outbreak of Neuroinvasive Fungal Infections Associated with Epidural 

Steroid Injections, Tennessee, 2012. 3Kainer, M., et al. Outbreak of Neuroinvasive Fungal Infections Associated with Epidural 

Steroid Injections, Tennessee, 2012. 4Lot #05212012@68, BUD 11/17/2012; Lot #06292012@26, BUD 12/26/2012; Lot #08102012 

@51, BUD 2/6/2013. 5www.cdc.gov/mmwr/preview/mmwrhtml/mm61e1012a1.htm’slcid=mm61e1012a1lw. 6MA DPH NECC Preliminary Investigation Findings: ‘‘. . . investigators found NECC employees cleaning sterile compounding areas and conducting environmental testing. MA DPH investigators also detected signs of bleach decontamination in the compounding areas.’’ 7MA DPH NECC Preliminary Investigation Findings. 

if CDC has received similar reports of unexplained fungal meningitis infections. 

CDC relays that it had not received reports of unexplained fungal meningitis infections and recommends that the TN DOH conduct a site visit to the ambulatory surgical center where the epidural injection was administered. 

On Friday, September 21, the TN DOH follows up with CDC about the results 

of the site visit. TN DOH relays that multiple products and exposures could be the 

source of the infection, including epidural injection tray kits, preservative-free contrast media, povidone-iodine, lidocaine, and preservative-free MPA from NECC.2 External contamination of supplies in a common storage area at the ASC was also considered as a possible source of infection. CDC recommends that TN DOH continue 

to gather detailed information, including lot numbers on all of the products and 

sources of exposure, to facilitate further investigation. Over the weekend, the TN 

DOH works with the ASC and area hospitals to gather additional information and 

checks if there are any other Aspergillus or unexplained meningitis cases. 

On Monday, September 24, CDC and TN DOH discuss the investigation. The discussion focuses on additional patients with meningitis from the same ASC with 

similar procedures and product exposures uncovered by the TN DOH over the weekend. CSF cultures from the additional patients with meningitis were negative, but 

all presented with a clinical picture similar to the index patient. CDC and TN DOH 

coordinate on next steps of the investigation. The TN DOH contacts the Massachusetts Department of Public Health (MA DPH) in an effort to obtain more information about NECC and its products. TN DOH notifies MA DPH about its cluster of 

meningitis cases following epidural steroid injections 3 and that use of MPA distributed by NECC is one of the common exposures under investigation. 

On Tuesday, September 25, CDC notifies FDA that CDC and the TN DOH are 

investigating a cluster of meningitis cases in a single ASC in Tennessee that may 

be related to product contamination. CDC notes that they are investigating several 

product exposures as possible sources of infection. Also on Tuesday, the MA DPH 

and the MA Board of Pharmacy organize a call with NECC, the TN DOH, and CDC 

to inform NECC of the ongoing investigation and inquire about product information 

and adverse event reporting. Public health authorities learn about how the MPA 

steroid is prepared, request distribution lists for the three lots 4 identified by the TN 

DOH and inquire about any reports of illnesses related to MPA.5 NECC states that 

it has not received reports of illnesses and that sterility testing, as well as environmental monitoring, has not demonstrated any concerning results. The MA Board of 

Pharmacy asks if NECC has a voluntary recall process in place if the investigation 

confirms contamination. NECC affirms that it does have a voluntary recall process 

in place. 

The following day (September 26), the MA Board of Pharmacy initiates an inspection of NECC 6 and NECC issues a voluntary recall of the three lots of MPA identified by the TN DOH. Approximately 3,000 doses of MPA are quarantined or returned.7 CDC is provided an invoice list of all facilities that received possibly contaminated lots and begins work with TN DOH and other State health departments 

to contact other clinics from the NECC distribution list to see if they are aware of 

any meningitis cases of unknown etiology. CDC also provides an update to FDA 

about the NECC call and informs FDA that NECC initiated a voluntary recall of 

the three lots of MPA though there was no specific evidence of product contamination. CDC asks FDA to query MedWatch reports for any related cases; the 

MedWatch query ultimately identifies the previously known cases from the Tennessee ASC. During this time, CDC continues to pursue other possible sources of 

the outbreak and contacts the New York Department of Health for assistance in 

contacting the company that produced the epidural injection trays used at the Tennessee ASC. 
13 

8MA DPH NECC Preliminary Investigation Findings. 

9http://www.cdc.gov/mmwr/preview/mmwrhtml/mm61e1012a1.htm?slcid=mm61e1012a1 lw. 10http://www.cdc.gov/media/releases/2012/t1004lmeningitisloutbreak.html. 11MA DPH NECC Preliminary Investigation Findings—Investigators found that methylprednisolone products labeled as patient specific were not individual prescriptions but lists of 

patients generated by a clinic and provided to NECC to obtain the product which is a violation 

of MA pharmacy regulations. 12MA DPH NECC Preliminary Investigation Findings—‘‘The Notice directed that all 

methylprednisolone acetate raw materials (chemicals), all non-sterile products located at NECC 

used in the compounding of methylprednisolone acetate, and all inventory on the premises prepared for dispensing and stored at the pharmacy, or received by recall should be quarantined 

and not disposed of without the express approval of the DPH.’’ 

On September 27, FDA and MA DPH begin coordination for a collaborative investigation of NECC.8 A case is identified in another State 9 as North Carolina reports 

its first patient with meningitis of unknown etiology following epidural spinal injection to CDC late that evening. This is significant because it is the first evidence that 

the exposure may not be isolated to the TN ASC. CDC begins working with the TN 

DOH and NC DOH to identify common exposures in new cases from both States 

which include MPA from NECC as well as the same brands of povidone iodine and 

lidocaine. Of the patients identified thus far, only one has a culture-confirmed Aspergillus fungal meningitis infection. The additional patients have a similar clinical 

presentation of meningitis as the index case with Aspergillus, but no microbiological 

data yet link them together. The microbiological key comes later in the outbreak 

when the Virginia Department of Health (VA DOH) in consultation with CDC’s infectious disease pathology laboratory links an unexplained death to the outbreak 

and identifies Exserohilium as the fungal pathogen related to that case. 

On Friday, September 28, CDC requests all 23 States with clinics that received 

the three MPA lots from NECC begin contacting patients who received epidural injections to see if there are any other meningitis cases of unknown etiology. Through 

the weekend of September 29–September 30, CDC posts outbreak information to 

ClinMicroNet (a network of clinical labs) and the Emerging Infections Network 

(EIN, a network of infectious disease physicians) to help identify any additional Aspergillus meningitis cases or meningitis cases of unknown etiology. 

On Monday, October 1, FDA and MA Board of Pharmacy initiate a joint inspection of NECC.10 Investigators find violations of MA pharmacy regulations 11 and the 

MA DPH issues a formal quarantine notice.12

The following day, CDC initiates a call with the 23 States that received the three 

NECC lots of MPA to provide updates on the investigation and share information 

on meningitis cases of unknown etiology as well as common exposures. While NECC 

products are considered the likely source of the outbreak, the investigation does not 

find conclusive evidence of NECC product contamination until October 4 when FDA 

announces it has identified by microscopy visible fungal contamination of previously 

sealed vials of MPA from NECC from one of the three lots identified by TN DOH. 

With conclusive identification of fungal contamination, CDC activates its Emergency Operations Center on October 4 and intensifies outreach to patients and clinicians to ensure appropriate patient diagnosis and treatment. CDC also launches a 

fungal meningitis outbreak Web site to provide continual updates to patients, clinicians, and the public, and by October 5, CDC posts the lists of the clinics that had 

received the three implicated lots of MPA to facilitate patient followup. Additionally, 

CDC and FDA laboratories work on pathogen identification in patient, product, and 

environmental samples. This combined laboratory effort ultimately recovers multiple 

bacterial and fungal contaminants from sealed NECC products labeled as sterile. 

THE PATIENT EXPERIENCE WITH FUNGAL MENINGITIS AND RELATED INFECTIONS

We do not yet have a full picture of the extent of the impact of this tragic outbreak, which clearly has devastating impacts on patients and their families. Contaminated medication was administered by injection to thousands of people, resulting in an outbreak of fungal meningitis and other infections. Exserohilum rostratum, the predominant fungal species in this outbreak, is a common brown-black mold 

found in soil and on plants, especially grasses, that thrives in warm and humid climates. Fungal infection caused by Exserohilum rostratum is rare and when it does 

occur it has generally been documented as a cause of sinus and skin infections. Diagnosis of fungal meningitis, particularly with molds, is extremely difficult because 

traditional diagnostic methods such as culture have limited yield. 

The clinical syndromes of these infections are rare and thus lack clinical trials or 

other experience that provide evidence for optimal treatment. Available treatments 

are not straight-forward because of potential adverse events and variability among 
14 

patients. With little literature describing these types of infections and limited clinical experience available, CDC solicited the individual input of outside mycology experts to help develop novel diagnostic and treatment guidance for patients at risk 

for these fungal infections. CDC has worked with these experts throughout the outbreak to update our interim guidance as more information has become available 

about the clinical experience of patients. Adequate duration of antifungal treatment 

is unknown although we expect a minimum of 3 months’ treatment be considered. 

CDC has sent staff to States and worked with State and local health departments 

to abstract medical charts and gather information on patients’ ongoing clinical experiences. CDC has disseminated our treatment guidance through web postings, blast 

e-mails to professional societies, and multiple clinician-specific conference calls. 

As of November 13, the median age of the patients is 65 years (range: 16–92 

years) and over 60 percent are female. While most of the cases have presented with 

meningitis, we have also seen cases of stroke, epidural abscess (infection between 

the outer covering of the brain and spinal cord and the bones of the skull or spine), 

osteomyelitis (bone infection), and septic arthritis (joint infection). Many patients 

with meningitis had only a few mild symptoms, such as headache and/or nausea or 

vomiting. 

The incubation period has ranged from 0 to 120 days with a median of 20 days. 

Based on current data, the highest risk is likely to be in the first 42 days (6 weeks) 

after last injection. Maximum incubation period for infection is not known, and the 

incubation period could be longer for some patients. Thus, asymptomatic but exposed patients should remain vigilant for symptoms and seek medical attention 

should symptoms develop. The clinical situation is still evolving. Even with treatment, we are seeing many patients return after being discharged from the hospital 

with new symptoms and other conditions such as arachnoiditis (inflammation of the 

membranes that surround nerves) and abscesses at the original injection sites. This 

suggests that there may be long-term complications for patients that have not yet 

become apparent. 

To support ongoing clinical efforts, CDC has developed a Clinicians Consultation 

group consisting of a network of leading clinical infectious disease and fungal disease experts nationwide who have volunteered to provide consultation with clinicians providing direct patient care. CDC is also planning to continue to follow cases 

to help track the course of treatment and provide ongoing information on patient 

outcomes. 

EARLY LESSONS LEARNED

Outbreak responses require skilled, trained public health personnel in State and 

local agencies. In this outbreak, we were fortunate that trained individuals were already ‘‘on the ground’’ in key positions, reinforced by already-established surveillance and laboratory capacity. Personnel cuts at the State and local levels have 

made CDC support to State infectious disease programs key to these efforts. CDC’s 

Epidemiology and Laboratory Capacity (ELC) cooperative agreement and the 

Emerging Infections Program (EIP) support this critical infectious disease capacity 

and networking. 

This outbreak is also a reminder of the importance of CDC’s infectious disease 

epidemiologists and laboratories to rapidly respond to and characterize outbreaks of 

unexplained death and illness. This outbreak exemplifies the work of CDC’s disease 

detectives to track down and solve public health problems. CDC’s laboratory capacity for infectious diseases has been a critical element in the response, identifying 

rare or obscure pathogens and providing added capacity as a backstop to States. 

With declining local resources, many States have cut back on maintaining fungal 

testing and instead rely upon CDC’s fungus laboratory. During the peak of laboratory testing, CDC’s fungus laboratory was operating 7 days a week to test the hundreds of outbreak-related samples. This outbreak has also underscored the importance of bioinformatics and genomics technologies that can help CDC and States 

more rapidly and decisively detect, respond to, and control large outbreaks like this 

one. 

CDC plays a vital role not only in responding to these outbreaks but in preventing 

them as well. For years, CDC and its State public health partners have been the 

first-responders to multiple outbreaks stemming from suboptimal practices in handling sterile medications in clinics and in pharmacies. We are learning that many 

of these outbreaks are the result of a widespread lack of knowledge of or adherence 

to well-recognized regulatory and professional standards for properly handling sterile medications. 
15 

CONCLUDING REMARKS

This outbreak demonstrates the essential role that public health plays in identifying and responding to infectious disease outbreaks large or small. Our national 

public health capacity is disseminated to State and local responders who work on 

a daily basis to keep our country safe from infectious diseases—whether they are 

from naturally emerging threats such as a new influenza pandemic or from humanmade problems such as contaminated medicines. CDC will continue to work with 

State partners, national experts, front-line clinicians and others to respond to the 

critical public health needs related to this outbreak. 

The CHAIRMAN. Thank you very much, Dr. Bell. 

Now we’ll turn to Dr. Peggy Hamburg, the Commissioner of the 

Food and Drug Administration. Dr. Hamburg and Dr. Smith, I 
16 

know you were both at the House hearing yesterday. I hate to have 

you do double duty, but that’s the way this system works. We 

wanted you over here also to be able to speak with us, so we could 

also engage you in questions about the role of both the FDA and 

the Massachusetts inspections. 

Dr. Hamburg, please proceed. 

STATEMENT OF MARGARET A. HAMBURG, M.D., COMMISSIONER, FOOD AND DRUG ADMINISTRATION, WASHINGTON, 

DC 

Dr. HAMBURG. Thank you very much, Mr. Chairman and members of the committee. I appreciate the opportunity to testify about 

this tragic fungal meningitis outbreak associated with an injectable 

steroid product distributed by NECC as well as to focus on the 

safety concerns related to compounding and legislation that is 

needed to prevent such incidents from happening again. 

I want to, of course, begin by offering my sympathies to the patients affected by this outbreak and their families. This event has 

had devastating effects on patients across the country, many of 

whom were likely unaware that they were receiving a drug that 

was compounded, not reviewed or approved by the FDA. 

Our foremost goal is the protection of the public health. Since the 

onset of this outbreak, we’ve targeted FDA resources, from experts 

in our headquarters to inspectors and scientists in district offices 

and labs across the country, to do everything we can to stem the 

toll of this terrible event. 

Together, with CDC and the States, we’ve sought to identify potentially contaminated products and ensure that they are removed 

from market and don’t reach patients. We’ve collected and analyzed 

hundreds of samples from the relevant firms, as well as from medical facilities and State and local agencies, to isolate the cause and 

determine the extent of the contamination. We’re working daily to 

ensure that timely, clear, and accurate information is disseminated 

about the findings of our investigation, what products are affected, 

and what providers should do with any product still on their 

shelves. We’re working to alleviate existing drug shortages that 

could be exacerbated by product recalls. 

We’ve also been reviewing actions taken in the past with regard 

to NECC. In a tragedy of this magnitude, you always look back to 

see what more could have been done. Certainly, we should have 

sent the warning letter more swiftly and done the inspection originally planned. From our review thus far, we have no reason to believe that any of those specific actions in question, more timely 

issuance of the 2006 warning letter or inspectional follow-up, would 

have prevented this recent tragedy. 

What we do know is that stronger, clearer authority would enable more effective regulation of the drug compounding industry, 

especially when it’s been evolving so significantly. As it is, our authority over compounding is limited, unclear, and contested. In the 

face of differing views in Congress and the courts about FDA’s authority and continuing challenges by industry, the agency has 

struggled with how to chart an effective course to protect the public 

health. 
17 

Like Senator Roberts, we recognize that traditional compounding 

provides an important service for patients who, for example, can’t 

swallow a pill or are allergic to an ingredient in a drug product. 

The industry has evolved well beyond a neighborhood pharmacist. 

In particular, the movement by many hospitals to outsource pharmacy compounding has created a market for compounding operations that produce drugs that reach far larger numbers of patients. 

When these facilities operate well, they may serve an important 

function in terms of safety and efficiency. However, when they fail 

to follow safety and quality standards, many patients may be 

harmed. Our best information is that there are thousands of other 

compounders out there producing what should be sterile products 

made to exacting standards, and thus many other firms with the 

potential to generate a tragedy like this. 

The current oversight framework, in attempting to draw a bright 

line between compounders and manufacturers, fails to address the 

complex issues raised by the changing nature of the industry. Additionally, gaps and ambiguities in the law have hampered our ability to act to protect patients and to prevent rather than to react 

to safety problems. 

I am committed to working with Congress and other stakeholders 

to design a system of rational, risk-based regulation that takes into 

account both the Federal and State rules. As I outlined in my testimony, we have developed a proposed framework that would tier the 

degree of oversight to the risk posed by the type of product and 

practices. Traditional compounding would remain the purview of 

the States. 

The higher risk posed by nontraditional compounding would be 

addressed by Federal standards, including standards for quality 

control. Under this framework, certain products carrying the highest risk could not be compounded. They could only be produced by 

entities willing to meet the standards currently required of drug 

manufacturers. 

We would also like to explore with you authorities that would be 

important to support this new regulatory paradigm, including clear 

authority to access records, mandatory reporting of adverse events, 

additional registration requirements to facilitate appropriate oversight and coordination with State regulators, clear label statements 

to allow prescribers and consumers the opportunity to make informed judgments, and adequate funding to support the inspections 

and oversight activities outlined in the framework. 

Because a key piece of any plan involving oversight of pharmacy 

compounders will continue to be performed at the State level, we 

must work closely with our State partners as we develop the 

framework for new authorities. FDA will be inviting representatives from all 50 States to participate in a full-day meeting on December 19 to facilitate these important discussions and to strengthen our working relationship with the States. 

We have a collective opportunity and responsibility to help prevent future tragedies. If we fail to act, this type of incident will 

happen again. It is a matter of when, not if, I’m afraid. If we fail 

to act now, it will only be a matter of time until we’re all back in 
18 

1Four-hundred and twenty-eight cases of fungal meningitis, stroke due to presumed fungal 

meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus 10 peripheral joint infections (e.g., knee, hip, shoulder, elbow). 2 ‘‘CDC and FDA Joint Telebriefing on Investigation of Meningitis Outbreak’’ (October 4, 

2012); transcript available at http://www.cdc.gov/media/releases/2012/t1004lmeningitisl 

outbreak.html. 

this room asking why more people have died and what could have 

been done to prevent it. 

I am happy to answer any questions you have and look forward 

to working with you on this very important public health issue. 

[The prepared statement of Dr. Hamburg follows:] 

PREPARED STATEMENT OF MARGARET A. HAMBURG, M.D. 

INTRODUCTION

Mr. Chairman and members of the committee, I am Dr. Margaret Hamburg, Commissioner of Food and Drugs at the Food and Drug Administration (FDA or the 

Agency), which is part of the Department of Health and Human Services (HHS). 

Thank you for the opportunity to be here today to discuss important issues related 

to the tragic fungal meningitis outbreak associated with compounded methylprednisolone acetate (MPA), a steroid injectable product distributed by the New 

England Compounding Center (NECC), and to discuss more broadly safety issues 

related to pharmacy compounding. 

I want to begin by offering my deepest sympathies to the patients affected by this 

outbreak and their families. This outbreak has had devastating effects on individuals and families across the country. The Centers for Disease Control and Prevention (CDC) has reported 32 deaths among 438 individual cases (428 cases of fungal 

meningitis and 10 cases of peripheral joint infections) 1 across 19 States. Approximately 14,000 patients may have received injections with MPA from three implicated lots. In addition, two other NECC products have been found to be contaminated with different bacteria. We have found no adverse health effects to date from 

these additional products, but continue to investigate the public health implications 

of this contamination. 

Although the investigation is ongoing, we want to provide you with an update on 

the actions that FDA has taken, and is continuing to respond to this outbreak. We 

also want to suggest steps that Congress can take to strengthen FDA’s authority 

to help prevent tragedies like this from happening in the future. 

FDA’S RESPONSE TO THE CURRENT OUTBREAK

FDA’s primary goal since the onset of this outbreak has been to protect the public 

health. With the State and Federal partners, we are conducting thorough investigations of the relevant facilities, monitoring the voluntary recalls associated with 

these products to ensure that contaminated and potentially contaminated product 

is off of the shelves, and ensuring that information is communicated promptly and 

clearly to health care professionals and patients. 

Let me briefly summarize the sequence of key events regarding the outbreak. On 

September 25, 2012, CDC notified FDA that it was working with the Tennessee Department of Health to investigate a cluster of meningitis cases at a single clinic, 

which might be associated with product contamination. When we learned of the potential contamination, we joined CDC in investigating. On September 26, NECC 

began a voluntary recall of three implicated lots of MPA and voluntarily ceased 

manufacturing of MPA. The Massachusetts Board of Registration in Pharmacy, 

which has primary oversight responsibility for pharmacies in its State, oversaw the 

recall, and initiated a 1-day inspection of NECC’s Framingham, MA, facility. FDA 

also began to coordinate with the Massachusetts Board of Registration in Pharmacy 

to plan for inspection of NECC. We coordinated closely with the State on this adverse event inspection, because the State has authority to compel certain actions 

where our authority is more limited. 

FDA and the Massachusetts Board of Registration in Pharmacy initiated a joint 

inspection of NECC on October 1, 2012. On October 4, FDA and CDC held a joint 

press conference announcing the investigation of the meningitis outbreak.2 On October 5, after FDA had observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of MPA collected from NECC, FDA 

issued a MedWatch Safety Alert to 220,000 health professionals to notify them of 

the fungal contamination. Out of an abundance of caution, the Safety Alert took the 
19 

3 ‘‘CDC, FDA, Massachusetts Department of Public Health: Joint Telebriefing Updating Investigation of Meningitis Outbreak’’ (Oct. 11, 2012); transcript available at http://www.cdc.gov/ 

media/releases/2012/t1011lmeningitisloutbreak.html. 

additional step of recommending that health care professionals and consumers not 

use any product produced by NECC. FDA also requested that health care professionals retain and secure all remaining products purchased from NECC until FDA 

provided further instructions about how to dispose of these products. In addition, 

the Safety Alert encouraged health care professionals and patients to report to the 

Agency’s MedWatch Safety Information and Adverse Event Reporting Program any 

adverse events or side effects related to the use of these products. On October 6, 

at FDA’s recommendation, NECC agreed to recall all products. 

As our investigation continued, on October 11, we announced our findings showing the presence of a fungal contaminant in multiple sealed vials of MPA injection, 

made at the NECC’s Framingham, MA site. CDC confirmed the specific type of fungus related to the patient disease—Exserohilum—in this briefing as well.3 On October 15, based on FDA’s ongoing investigation and out of an abundance of caution, 

we further advised health care professionals to followup with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery or a 

cardioplegic solution. After working closely with the State on October 22, the Agency 

made available two lists of customers (consignees) who received products that were 

shipped on or after May 21, 2012, from NECC’s Framingham, MA facility, advising 

those customers to check their stocks to identify whether they had any products 

from NECC, and if so, to immediately isolate any identified product from their drug 

supplies and contact NECC to obtain instructions on how to return products. 

On October 26, FDA released a copy of the FDA Form 483 (list of observations 

made during the on-site inspection) issued to NECC. FDA observed, and has since 

confirmed, that contaminated products were made at NECC’s Framingham, MA facility, and listed a number of observations made during the course of the inspection 

regarding conditions in the clean room at this facility. 

Most recently, on November 1, FDA and CDC laboratories announced that bacteria had been identified as present in three separate lots (batches) of NECC-supplied, preservative-free injectable betamethasone, with each lot producing different 

culture results (identifying different contaminants), and in a single lot of NECC 

cardioplegia solution. FDA stated that although final laboratory results on additional samples were still pending, the previous finding of fungal contamination of 

MPA and recent finding of bacterial contamination of injectable betamethasone and 

cardioplegia solution reinforced the Agency’s concern about the lack of sterility in 

products produced at NECC’s compounding facility and served to underscore that 

hospitals, clinics, and health care professionals should not use any NECC-supplied 

products. 

The Agency has been working closely with CDC, numerous State health departments, and the Massachusetts Board of Registration in Pharmacy to investigate the 

outbreak of fungal meningitis. This is a far-ranging investigation across the United 

States. FDA, in conjunction with our State partners, is in the process of inspecting 

several facilities associated with this outbreak. This includes compounders, wholesale distributors, active pharmaceutical ingredient (API) suppliers, contract laboratories, and others. The Agency’s first priority has been to detect any contaminated 

or potentially contaminated products, to prevent them from reaching U.S. consumers by ensuring they are effectively recalled and removed from the market, and, 

as discussed more fully below, to communicate key information about these products 

to the providers and patients who need it. In connection with this investigation, 

FDA has collected and analyzed hundreds of samples from firms associated with 

this outbreak, as well as from medical facilities and State and local agencies. In addition to staff at FDA headquarters, staff in FDA district offices in New England, 

New York, Dallas, Seattle, Chicago, Los Angeles, Detroit, Cincinnati, Kansas City, 

and Florida, and laboratory personnel in Denver, San Francisco, Atlanta, New York, 

and Boston, are assisting in this investigation. 

FDA also inspected Ameridose LLC’s facility in Westborough, MA as part of the 

Agency’s ongoing fungal meningitis outbreak investigation. Ameridose and NECC 

share some of the same management. Ameridose entered into a voluntary agreement with the Massachusetts Board of Registration in Pharmacy to temporarily 

cease all pharmacy and manufacturing operations starting on October 10, 2012. 

After FDA’s preliminary inspectional findings raised concerns about a lack of sterility assurance for products produced at and distributed by Ameridose’s 

Westborough facility, the company voluntarily recalled all of its unexpired products 

in circulation. FDA completed its inspection on November 9, 2012. 
20 

4 Inspection Report for April 2002 inspection, at PP. 2, 3, 5; Establishment Inspection Report 

for 2002/2003 inspection, at p. 11; Inspection Memorandum for 2004 inspection, at p. 3; Warning 

Letter Response, at PP. 3–4. 5 A copy of MABRP’s May 24, 2011, Inspection Report for NECC is available on MABRP’s Web 

site at http://www.mass.gov/eohhs/docs/dph/quality/boards/necc/03-new-england-compound 

ing-pharmacy-incnew-england-compounding-center-inspection-report.pdf. 6See MABRP’s May 24, 2011 Inspection Report for NECC, id., at p. 10. 

FDA is currently conducting recall audit checks of NECC’s customers. In an audit 

check, FDA contacts a subset of the firm’s customers, which in this case were health 

care facilities, to confirm that they received notice of the recall and took the action 

requested in the recall notice. 

In this case, the facilities were instructed to immediately segregate and quarantine the material and to work with NECC to coordinate return of the products. 

As of November 5, 2012, FDA had completed 587 audit checks of NECC’s health 

care facility customers. FDA found no product remaining for use at any of the 

NECC customers that it audited, and all customers had knowledge of the recall. 

Ameridose commenced its product recall on October 31, 2012; FDA initiated its 

audit check process for the Ameridose recall on November 5, 2012. 

FDA has identified six Ameridose products that were on the FDA drug shortage 

list prior to the recall (sodium bicarbonate injection; succinylcholine injection; atropine sulfate injection; bupivacaine hydrochloride injection; lidocaine hydrochloride 

injection and furosemide injection). 

These six drugs were in shortage before the Ameridose shutdown due to manufacturing problems, delays, and discontinuations by commercial manufacturers. FDA’s 

Drug Shortage Program is using every tool available to work with manufacturers 

to address these shortages. For five of the drugs, we expect the shortages to decrease based on all of the ongoing efforts of FDA and the manufacturers to address 

these shortages and do not anticipate the Ameridose shutdown to create additional 

issues. For sodium bicarbonate injection, we are continuing all efforts to address the 

shortage, including exploring temporary importation to assist with supplies until demand is being met by the U.S. manufacturers. 

FDA has communicated throughout this investigation with the media, Congress, 

State health officials, health care professionals, and the public to keep them apprised of important findings and developments as we move forward in our investigation. FDA’s Web site is updated on a frequent basis to provide broad access to any 

new public information. This information is being further disseminated through the 

Agency’s electronic listserves and through Twitter and Facebook. Along with CDC, 

FDA is providing health care professionals with information they need on an ongoing basis, and as new information comes to light, to advise and treat patients affected by this situation. 

Targeted alerts have been sent to 150 health care professional organizations, including the national specialty-specific societies that work with spinal injections, 

such as the American Society of Anesthesiologists, the American Academy of Physical Medicine and Rehabilitation, and the North American Spine Society, and also 

to all State medical, pharmacist, nursing, and physicians’ assistant societies, as well 

as all State boards of pharmacy. Regular phone updates are provided to State 

health departments, in collaboration with CDC, and written updates are also distributed to national pharmacy and ophthalmology professional organizations. FDA 

also contacted patient and health care professional groups and consumer groups and 

worked with the American Hospital Association as part of our response. 

FDA pharmacists are fielding calls from the public and we have extended their 

hours of availability for the last several weeks to help respond to the public’s concerns. We also continue to respond to calls and e-mails from health care professionals, hospitals and clinics, and others with questions about the NECC and 

Ameridose recalls. 

The far-ranging investigation is ongoing and FDA will continue to update stakeholders as quickly as possible as information becomes publicly available. 

FDA’s past activities with respect to NECC include: a 2002 inspection in response 

to adverse event reports (followed by a State inspection and action under Massachusetts’ authority) and a 2006 Warning Letter focused on lower risk issues associated 

with copying approved drugs, marketing and packaging. Throughout this time, 

NECC has repeatedly disputed FDA’s jurisdiction over its facility.4 The Massachusetts Board of Pharmacy re-inspected NECC in 2011 in response to a letter from 

the firm indicating that NECC was ‘‘updating its facility and moving into adjacent 

space’’; that inspection included a tour of the facility, security review, licensing review, and inspection of NECC’s sterile and non-sterile processing areas.5 The Massachusetts Board of Pharmacy inspection found the facility to be ‘‘Satisfactory.’’ 6
21 

7 H.R. 5256, Pharmacy Compounding Preservation Act of 1994, introduced Oct. 7, 1994, 1 cosponsor; H.R. 598, Pharmacy Compounding Preservation Act of 1994, introduced Jan. 20, 1995, 

141 co-sponsors; H.R. 3199, Drug and Biological Products Reform Act of 1996, introduced March 

29, 1996, 205 co-sponsors; H.R. 1060, Pharmacy Compounding Act, introduced March 13, 1997, 

152 co-sponsors; H.R. 1411, Drug and Biological Products Modernization Act of 1997, introduced 

April 23, 1997, 16 co-sponsors. 8Statement by David A. Kessler, M.D., Commissioner of Food and Drugs, Dept. of Health and 

Human Services, before the Subcommittee on Health and Environment, Committee on Commerce, House of Representatives (May 1, 1996). 9Public Law 105–115, FDAMA, 111 Stat. 2296 (Nov. 21, 1997), available at http://www.gpo 

.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf. 10 Id. 

FDA’S LEGAL AUTHORITY OVER COMPOUNDED DRUGS

FDA regards traditional pharmacy compounding as the combining or altering of 

ingredients by a licensed pharmacist, in response to a licensed practitioner’s prescription for an individual patient, which produces a medication tailored to that patient’s special medical needs. In its simplest form, traditional compounding may involve reformulating a drug, for example, by removing a dye or preservative in response to a patient allergy. Or it may involve making a suspension or suppository 

dosage form for a child or elderly patient who has difficulty swallowing a tablet. 

FDA believes that pharmacists engaging in traditional compounding provide a valuable medical service that is an important component of our health care system. 

However, by the early 1990s, some pharmacies had begun producing drugs beyond 

what had historically been done within traditional compounding. 

After receiving reports of adverse events associated with compounded medications, 

FDA became concerned about the lack of a policy statement on what constituted appropriate pharmacy compounding. In March 1992, the Agency issued a Compliance 

Policy Guide (CPG), section 7132.16 (later renumbered as 460.200) to delineate 

FDA’s enforcement policy on pharmacy compounding. It described certain factors 

that the Agency would consider in its regulatory approach to pharmacies that were 

producing drugs. 

The compounding industry objected to this approach and several bills were introduced, some with significant support, to limit the Agency’s oversight of 

compounding.7 In May 1996, in a House Commerce Committee hearing on FDA reform legislation, FDA Commissioner David Kessler testified that the compounding 

provision being considered by the committee was likely to encourage large-scale 

manufacturing under the guise of pharmacy compounding, and could allow for potentially dangerous compounding of sterile products, leading to serious safety problems or death.8

In November 1997, S. 830, the Food and Drug Administration Modernization Act 

of 1997 (FDAMA) was signed into law as Public Law 105–115.9 FDAMA added to 

the FD&C Act’s Section 503A, which addresses FDA’s authority over compounded 

drugs.10 Section 503A exempts compounded drugs from three critical provisions of 

the FDCA: the premarket approval requirement for ‘‘new drugs’’; the requirement 

that a drug be made in compliance with current good manufacturing practice 

(cGMP); and the requirement that the drug bear adequate directions for use, providing certain conditions are met. These conditions include, among other things, 

that the compounding be performed by a licensed pharmacist or physician, that 

there be a prescription for the compounded product for an individual patient, and 

that the compounded product be necessary for an identified patient. It allows FDA 

to restrict the compounding of certain categories of drugs (after notice-and-comment 

rulemaking), and limits the quantity of compounded drugs that a pharmacy could 

ship out of State to 5 percent of the total prescription orders, unless the State enters 

into a Memorandum of Understanding with FDA that addresses the distribution of 

‘‘inordinate amounts’’ of compounded drugs out of the State, and the handling of 

complaints about compounded products shipped out of the State. Section 503A also 

contains restrictions on the advertising or promotion of the compounding of any particular drug, class of drug, or type of drug, and on the solicitation of prescriptions 

for compounded drugs from prescribers. These provisions were the subject of subsequent court challenges, which have produced conflicting case law and amplified the 

perceived gaps and ambiguity associated with FDA’s authority over compounding 

pharmacies. We look forward to working with Congress to address these issues. 

Looking Ahead 

FDA believes that there is a legitimate role for traditional compounding to provide 

needed drugs to patients that, for example, need a drug that is allergen free or have 

a medical need that cannot be met with an approved FDA product. However, we 

have grown increasingly concerned about certain compounding practices, and we 
22 

have seen an increasing number of incidents related to compounded drugs. The 

NECC/meningitis situation is the latest, and most serious, incident. As described 

above, FDA’s ability to take action against compounding, that exceeds the bounds 

of traditional pharmacy compounding and poses risks to patients, has been hampered by gaps and ambiguities in the law, which have led to legal challenges to 

FDA’s authority to inspect pharmacies and take appropriate enforcement actions. 

The Administration is committed to working with Congress to address the threat 

to public health from gaps in authorities for effective oversight of certain 

compounding practices. To that end, FDA has developed a framework that could 

serve as the basis for the development of a risk-based program to protect the public 

health. 

Risk-based Framework 

Recognizing the history of compounding practice, FDA supports the long-standing 

policy that all compounding should be performed in a licensed pharmacy by a licensed pharmacist (or a licensed physician), and that there must be a prescription 

or order for an individual patient who has a documented medical need for the compounded drug. 

Further, we recommend that the statute recognize two categories of compounding: 

traditional and non-traditional. ‘‘Traditional compounding’’ would include the combining, mixing, or altering of ingredients to create a customized medication for an 

individual patient with an individualized medical need for the compounded product, 

in response to a valid patient-specific prescription or order from a licensed practitioner documenting such medical need. Traditional compounding plays an important 

role in the health system and should remain the subject of State regulation of the 

practice of pharmacy. 

‘‘Non-traditional compounding’’ would include certain types of compounding for 

which there is a medical need, but that pose higher risks based on one or more of 

the factors identified below. Non-traditional compounding would be subject to Federal standards adequate to ensure that the compounding could be performed without putting patients at undue risk. For example, enforcement could be by the FDA 

or by a State willing to effectively oversee the compounding activities, as determined 

by FDA. 

Factors that could place a product into the ‘‘non-traditional compounding’’ category might include some statutorily specified combination of: the type of product/ 

activity (e.g., sterile compounding); the amount of product being made; whether the 

production is being done before the receipt of a prescription or order for a particular 

patient (so-called ‘‘anticipatory compounding’’); whether the compounded drug is 

being shipped interstate; or whether the drug is being dispensed to someone other 

than the ultimate user when it leaves the facility where it was produced. 

Non-traditional compounding should, because of the higher risk presented, be subject to a greater degree of oversight, with the riskiest products subject to the highest 

level of controls, such as appropriate current good manufacturing practice (‘‘cGMP’’) 

standards established by FDA. In addition, FDA believes that with noted exceptions, 

certain products are not appropriate for compounding under any circumstances. 

These products would include: (1) what are essentially copies of FDA-approved 

drugs, absent a shortage justification based on the drug appearing on FDA’s shortage list; and (2) complex dosage forms such as extended release products; 

transdermal patches; liposomal products; most biologics; and other products as designated by FDA. Producing complex dosage forms would require an approved application and compliance with cGMPs, along with other requirements applicable to 

manufactured drug products. We would seek to permit the Secretary to have sufficient flexibility in this area to make these exceptions necessary to address issues 

of public health. 

FDA would like to explore with Congress other authorities that would be important to support this new regulatory paradigm. For example, FDA should be given 

clear, full authority to collect and test samples of compounded drugs and to examine 

and collect records in a compounding pharmacy, just as the agency does when inspecting other manufacturers. FDA should have clear statutory authority to examine records such as records of prescriptions received, products shipped, volume of 

operations, and operational records such as batch records, product quality test results, and stability testing results. Such inspections are necessary to determine 

when a pharmacy exceeds the bounds of traditional compounding, to respond to public health threats, and to enforce Federal standards. 

FDA also believes that pharmacies engaged in non-traditional compounding 

should register with FDA so that FDA can maintain an accurate inventory of such 

pharmacies to facilitate appropriate oversight and coordination with State regulators. In addition, FDA would like to explore with Congress several other ideas 
23 

such as clear label statements identifying the nature and source of the non-traditionally compounded product, and requiring non-traditional compounders to report 

adverse events. The labeling statements would provide prescribers and consumers 

with valuable information about the products they are using or taking so that they 

can make informed judgments about their use. Requiring non-traditional 

compounders to report adverse events, as drug manufacturers are required to do, 

would allow FDA and the States to identify trends and to proactively take steps to 

curtail dangerous compounding practices. Other appropriate regulatory and enforcement tools might also be useful. Funding will be necessary to support the inspections and other oversight activities outlined in this framework. We look forward to 

working with Congress to explore the appropriate funding mechanisms to support 

this work, which could include registration or other fees, as Congress has authorized 

and FDA has implemented in other settings. 

In light of growing evidence of threats to the public health, the Administration 

urges Congress to strengthen Federal standards for non-traditional compounding. 

Such legislation should appropriately balance legitimate compounding that meets a 

genuine medical need with the reality that compounded drugs pose greater risks 

than those that are evaluated by FDA for safety and efficacy and subject to manufacturing controls to ensure consistently high product quality. We recommend that 

it recognize the appropriate State role in regulation of traditional compounding, 

while authorizing Federal standards and oversight for non-traditional compounders 

that produce riskier products. We look forward to working with Congress in striking 

the right balance. 

CONCLUSION

Protecting Americans from unsafe and contaminated drugs is not just an important responsibility of FDA—it is part of our core mission. To fulfill our mission, we 

must be able to proactively identify dangerous practices before they result in actual 

harm, and when necessary, intervene to minimize the damage and to prevent future 

similar events. Tragically, there have been 32 deaths to date associated with this 

outbreak. However, we are hopeful that our actions thus far and the ongoing investigation are preventing unknown numbers of further deaths, which might have occurred had we and our partners not acted aggressively after we became aware of 

the outbreak. 

We look forward to working with Congress on legislation that will balance the 

need to allow legitimate forms of traditional pharmacy compounding with the need 

for adequate Federal oversight of higher risk pharmacy compounding practices. 

I am happy to answer any questions you may have. 

The CHAIRMAN. Thank you, Dr. Hamburg. 

Dr. Smith, welcome. Again, as I said, your statements will be 

made a part of the record in their entirety. If you could sum it up, 

I’d appreciate it. 

STATEMENT OF LAUREN SMITH, M.D., MPH, INTERIM COMMISSIONER, DEPARTMENT OF PUBLIC HEALTH, BOSTON, MA 

Dr. SMITH. Good morning, Senator Harkin and Ranking Member 

Enzi and members of the committee. Thank you for having me here 

today. My name is Dr. Lauren Smith, and I’m the Interim Commissioner for the Massachusetts Department of Public Health. 

I must begin by saying that my thoughts are with the victims 

and their families of this tragic outbreak—some of the poignant 

stories described by Dr. Bell. I know that the numbers that represent those made ill and those who lost their lives actually represent real people with real stories. That only strengthens my resolve to ensure that no other families have to suffer the heartbreak 

that these have. 

As a mother, a pediatrician, and a public health leader, I have 

devoted my life and career to protecting the health of others. These 

events invoke in me the same outrage that you and the rest of the 

public feel. For many of you, I know this hits very close to home. 
24 

For nearly 2 months, our department, along with the FDA, has 

conducted a joint investigation of the New England Compounding 

Center, the source of the devastating fungal meningitis outbreak. 

We have also investigated and shut down NECC’s sister companies. NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions, and violated their pharmacy license, 

which endangered thousands of lives as a result. NECC bears the 

primary responsibility for the harm that they have caused with 

these actions. 

I was given the responsibility as interim commissioner less than 

3 weeks ago to lead my department through this crisis. And like 

you, I have been trying to put together the pieces of the puzzle. 

First licensed by Massachusetts in 1998, NECC and its owner, 

Barry Cadden, have been the subject of numerous complaints resulting in a series of investigations by the State and the FDA. 

These investigations led the Board of Pharmacy to propose reprimand and probation in 2004. This proposal was inexplicably 

weakened in 2006, allowing NECC to continue to operate without 

any disciplinary actions pending an independent evaluation of its 

progress under a consent agreement. The Board of Pharmacy’s failure to take decisive disciplinary action in 2006 on these complaints 

contributed to these tragic events. 

In addition, in April 2006, the Board of Pharmacy staff learned 

that the principal of PSI, the evaluator for NECC, had been convicted of Federal crimes that resulted in 18 people being blinded. 

However, the staff did not share this information with the Board 

members before they accepted the report from PSI indicating that 

NECC’s compliance with the consent agreement had been completed. These same staff members failed to act on a July 2012 report from a Colorado Board of Pharmacy that NECC had violated 

both Colorado and Massachusetts pharmacy regulations. These 

staff members have been removed from their jobs. 

Poor judgment, missed opportunities, and lack of action have allowed NECC to continue on this troubling path. We acknowledge 

that some of these lapses were preventable, but, clearly, all are unacceptable. 

From the early days of this outbreak, the department has acted 

swiftly and decisively. We secured a surrender of NECC’s license, 

shut down its operations, and secured a total recall of NECC products. We moved to permanently revoke NECC’s license, as well as 

the licenses of the three principal pharmacists who oversaw their 

operations. We also secured the suspension of operations of 

Ameridose and Alaunus, which are two other drug manufacturers 

also owned by Barry Cadden, which, as I’m sure you know, have 

been found to have substandard practices. 

While taking these strong and necessary actions, we have reexamined our own State regulations regarding compounding pharmacies. Although our regulations are comparable to those in most 

States, they clearly need to be strengthened to address the realities 

of this evolving industry. On November 1, Massachusetts enacted 

a series of emergency regulations to bring greater scrutiny to this 

industry and require sterile compounding pharmacies to report 

both volume and distribution information to us. 
25 

In addition, licensed pharmacies will also have to report when 

they are the subject of either a State or a Federal investigation. We 

have also begun unannounced inspections of all sterile 

compounding pharmacies. Teams are conducting those inspections 

even as we speak. 

To further strengthen our oversight over sterile compounding 

pharmacies, we must also explore changes in State law. We have 

created a special commission to review best practices in other 

States and to identify stronger mechanisms of oversight of pharmacies such as these in Massachusetts. 

As we work to raise our standards in Massachusetts, we urge 

Congress to act to strengthen the Federal oversight. Congressman 

Markey’s leadership on this issue is laudable, and we hope this will 

address the regulatory black hole that exists currently between 

State and Federal oversight. 

As a pediatrician who has cared for acutely ill children and their 

families for close to 20 years, I understand that patients place a 

significant amount of trust in our healthcare system. We must use 

these terrible events as an impetus to work together as public 

health leaders and legislators to institute reforms to restore this 

trust and ensure that something like this never happens again. I 

know that we will keep the victims and their families always in our 

thoughts as we work to identify responsibility and to implement 

policies and practices that will be both effective and lasting. 

Thank you. I appreciate this committee’s interest in this matter, 

and I commend you for moving so swiftly to bring us together to 

discuss it. 

[The prepared statement of Dr. Smith follows:] 

PREPARED STATEMENT OF LAUREN SMITH, M.D., MPH 

SUMMARY

• For nearly 2 months, the Massachusetts Department of Public Health has conducted a joint investigation of New England Compounding Center (NECC) with our 

Federal partners at the Food and Drug Administration (FDA) to determine what 

caused the devastating fungal meningitis outbreak that has sickened hundreds and 

led to dozens of deaths across the country. DPH has also been jointly investigating 

sister companies Ameridose and Alaunus, Westborough, MA-based drug manufacturers. 

• NECC knowingly disregarded sterility tests, prepared medicine in unsanitary 

conditions and unlawfully engaged in manufacturing, endangering thousands of 

lives as a result. 

• This testimony provides a chronology of events based upon documents, reports, 

and e-mails recently reviewed, beginning with NECC’s licensure in July 1998. It is 

a troubling history. 

• The Massachusetts Department of Public Health has taken swift and decisive 

actions since we became aware of the outbreak. 

• DPH secured a surrender of NECC’s license, shut down its operations and 

issued a total recall of NECC products. 

• Massachusetts sterile compounding pharmacies have been required to attest 

under penalty of perjury that they are meeting all State laws and regulations. 

• The Massachusetts Board of Pharmacy approved emergency regulations to enhance oversight of compounding pharmacies. 

• We have begun unannounced inspections of the State’s 25 sterile 

compounding pharmacies to review how they function when they are not 

aware that an inspection is scheduled. 

• We have named Christian A. Hartman, an expert in pharmacy practice and 

patient safety, to chair a Special Commission on compounding pharmacies. 

We will look at best practices in other States, explore new ideas, and consider 

the interplay between State and Federal authority. 
26 

• We have removed three key employees from their jobs due to their failures 

to act at key junctures. 

• Massachusetts will continue to do whatever we can, make any changes, and 

identify any areas of new law to make sure something like this never happens 

again. 

Good morning, Chairman Harkin, Ranking Member Enzi, members of the committee, thank you for having me here today. My name is Dr. Lauren Smith, I am 

the Interim Commissioner of the Massachusetts Department of Public Health and 

I welcome the opportunity to have this discussion. 

I want to say from the outset that my thoughts are with the victims and families 

affected by this tragic outbreak. As a mother, a pediatrician, and a public health 

leader, I have devoted my life and career to protecting the health of others. Have 

no doubt that these events invoke in me the same outrage that you and the rest 

of the public feel. The natural first question we all ask is ‘‘How could this possibly 

have happened?’’ The necessary second question is ‘‘What can we do to ensure that 

this terrible situation does not happen again?’’ 

For nearly 2 months, our Department has conducted a joint investigation of New 

England Compounding Center (NECC), alongside our Federal partners at the Food 

and Drug Administration (FDA), to answer these questions. 

NECC is a Framingham, MA-based pharmacy that compounds sterile medications. It was identified as the source of the devastating fungal meningitis outbreak 

that has sickened hundreds and led to dozens of deaths across the country. For 

many of you, and for those with cases among your constituents in particular, I know 

these losses hit close to home. 

NECC knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and unlawfully engaged in manufacturing, endangering thousands of lives 

as a result. NECC bears the primary responsibility for the harm they have caused 

with these actions. 

I was given the responsibility as interim commissioner less than 3 weeks ago, to 

lead my department during this crisis. And like you, I have spent the last several 

weeks trying to put together the pieces of this troubling puzzle. 

Although the majority of these events happened in the previous administration 

and well before I came to the Department, I offer the following chronology based 

on a review of documents and reports from the time. 

Let me begin by noting that by statute, the Massachusetts Board of Registration 

in Pharmacy, supported by the Department of Public Health’s Division of Health 

Professions Licensure, has primary responsibility for oversight of the practice of 

pharmacy in the Commonwealth. 

The Board of Pharmacy is an independent body, with 11 members appointed by 

the Governor. The Board has the responsibility and legal authority to license and 

regulate pharmacies and pharmacists. DPH staff investigators, lawyers, administrators, and an executive director support the Board’s operations. 

The Massachusetts Board of Registration in Pharmacy’s interaction with NECC 

began on July 16, 1998, when it obtained its initial license. On February 2, 1999, 

the Board received the first complaint against NECC, which alleged that the pharmacy had provided a prescriber with pre-printed prescriptions that specifically listed 

NECC medications. State law prohibits pre-printed prescriptions. Prescriptions are 

required to be patient-specific, and based upon the patient’s diagnosis, medical history, allergies, tolerance, and the specific constellation of symptoms that the patient 

is presenting. This complaint was resolved in October 1999 with an informal reprimand letter, a non-disciplinary action. 

In April 2002, working with the FDA, the Board visited NECC and obtained 

records related to a recent MedWatch report concerning betamethasone, a compounded steroid suppository. The FDA investigator met with Barry Cadden, owner 

of NECC, and conducted an inspection on April 9, concerning procedures, sterility 

and recordkeeping. 

In October 2002, the Board initiated a joint investigation with the FDA at NECC 

related to the April 2002 betamethasone complaints as well as MedWatch reports 

associated with the use of methylprednisolone acetate, the injectable steroid medication implicated in this current outbreak. The MedWatch reports pertained to two 

patients who received the steroid and experienced pain and headaches and were 

hospitalized with meningitis-like symptoms. Laboratory tests from these investigations identified subpotency of betamethasone and superpotency of methylprednisolone acetate. The FDA also noted contamination of one lot of methylprednisolone 

acetate with bacteria. These investigations continued into 2003. 
27 

Also in 2002, Board of Pharmacy member Karen Ryle convened a Task Force to 

study Board oversight of the compounding pharmacy industry. Barry Cadden served 

on this Task Force, which met for nearly 2 years. The Task Force discussed proposals to change regulations around compounding, but records do not show whether 

formal recommendations were made, and the Board did not adopt new regulations. 

In February 2004, the Board conducted a followup inspection of NECC and noted 

that all deficiencies surrounding sterility, safety, quality and procedures from the 

2002–3 investigations had been resolved. Just weeks later, however, the Board received a complaint, from a pharmacist in Wisconsin, expressing concerns with the 

safety of a topical anesthetic product. The complaint alleged that NECC advised the 

pharmacy to unlawfully use a staff member’s name rather than an individual patient’s name in filling a prescription. The Board then in place resolved this complaint with a disciplinary warning letter on September 30, 2004. 

Based on this series of investigations, in September 2004, the Board voted unanimously to sanction NECC with a reprimand, a 3-year probation, and a requirement 

that Barry Cadden obtain additional training in sterile compounding. NECC objected to these sanctions, but the Board reaffirmed this approach through an additional unanimous vote on November 23, 2004. 

More than a year later, on January 10, 2006, NECC entered into a non-disciplinary consent agreement with the Board that was significantly weaker than the earlier version. The signed consent agreement stipulated a 1-year probation to be 

stayed with the condition that NECC hire an independent evaluator. The Board’s 

staff identified Pharmaceutical Systems, Inc. (PSI) as the evaluator to conduct inspections of NECC’s compounding practices. 

Despite interviews with Board and staff members involved with these decisions 

and a thorough review of the limited records retained from this period, troubling 

questions remain about what influenced the more lenient consent agreement resolution, given NECC’s track record. I will not be satisfied until we know the full story 

behind this decision. 

What we know now is that from January to April 2006, the independent evaluator 

PSI conducted an assessment of NECC’s compliance with United States Pharmacopeia Standards, and oversaw development of policies and procedures. PSI also 

issued recommendations for process improvement and provided training for NECC 

staff. An April 7, 2006 report from PSI described NECC’s compliance with the evaluation. 

Our investigation has revealed that in late April 2006, some Board of Pharmacy 

and Health Professions Licensure staff, including the Board’s executive director and 

legal counsel, learned that PSI executives were convicted of Federal crimes related 

to defrauding the FDA and selling unapproved sterilization equipment to hospitals. 

However, we have found no evidence to indicate that the executive director or staff 

attorney of the Board provided this crucial information to the Board. Nor did they 

see fit to send inspectors back to NECC in 2006 to determine if they were fulfilling 

the requirements of the corrective action plan. 

In May 2006, the Board voted to affirm that NECC was in compliance with the 

terms of the consent agreement, thus accepting PSI’s findings in overseeing NECC’s 

compliance. 

Consistent with Board policy at the time, which was to inspect pharmacies only 

upon a change in licensure status or upon receipt of a complaint, the next time a 

Board investigator returned to the pharmacy was 5 years later on May 24, 2011 to 

inspect NECC following its renovation and expansion. This inspection included a 

full review of the facility space, operations, sterility protocols, and compliance with 

United States Pharmacopeia among other factors. The inspector found no evidence 

to suggest that NECC was violating patient-specific prescription requirements, and 

no deficiencies were cited. 

In March 2012, the Board received a complaint pertaining to an insufficiently potent eye anesthetic distributed by NECC. This complaint focused on the potency of 

the medication but did not reference sterility concerns. This investigation continues. 

In July 2012, some of the same staff members who failed to inform the Board of 

the issues surrounding PSI received a report from the Colorado Board of Pharmacy 

documenting violations of Colorado and Massachusetts pharmacy laws. The information provided to the Board executive director and legal counsel by Colorado showed 

that NECC had distributed bulk shipments of drugs to many hospitals in that State 

between 2010 and 2012 without patient/specific prescriptions, in violation of NECC’s 

Colorado and Massachusetts licenses. The Colorado Board of Pharmacy issued a 

cease and desist order to stop NECC from engaging in the unlawful distribution of 

prescription drugs in the State in April 2011. Colorado informed the FDA of the adverse action, and provided them with the report, supporting evidence, and copy of 
28 

the order. However, there is no record of Colorado providing similar notice to the 

Board or DPH. 

Colorado contacted Board staff in July 2012 because NECC was violating the 

April 2011 cease and desist order by continuing to prepare and dispense bulk shipments without patient-specific prescriptions. However, after receiving the July report, both the executive director and legal counsel failed to order an investigation, 

inform the Board of the complaint, or take any other action on the Colorado complaint. 

The first two lots of contaminated methylprednisolone acetate linked to the meningitis outbreak were prepared in May and June 2012. The Colorado report was received 2 weeks prior to the production and shipping of the third lot of contaminated 

vials, which were prepared in August. Though issues of contamination with NECC 

products were not included in the Colorado report, given NECC’s history and the 

evidence from Colorado that the company was violating Massachusetts pharmacy 

regulations, prompt action was warranted. 

The individuals responsible for this failure to act have been removed from their 

jobs. These steps are consistent with the swift and decisive actions of DPH since 

we became aware of the outbreak. 

Late in the evening of September 24, the Tennessee Department of Health notified our Department about a cluster of six exceedingly rare fungal meningitis cases. 

All six cases shared common risk factors, including an epidural injection of a steroid 

prepared by NECC. The Massachusetts DPH secured a list of medical facilities in 

23 States that had received shipments of the steroids from three suspect lots identified by the Centers for Disease Control and Prevention. A day later, we secured a 

recall of those three lots, totaling 17,676 vials, and began our on-site investigation 

at NECC. 

On October 1, we were joined on-site at NECC by the FDA and commenced our 

joint investigation. Among a list of troubling findings, investigators observed visible 

black particulate matter in sealed vials that had been returned to NECC through 

the recall. Several batches of the drugs had been shipped by NECC prior to the completion of internal sterilization tests. Investigators also found evidence that NECC 

had been dispensing medication in bulk shipments rather than filling a patient-specific prescription for each dose dispensed. 

We secured a surrender of NECC’s license, shut down its operations and issued 

a total recall of NECC products. 

Our aggressive investigation not only focused on NECC, but also companies with 

shared ownership. On October 10, we secured the voluntary suspension of operations of Ameridose, a Westborough, MA drug manufacturer also owned by Barry 

Cadden. This closure allowed for a full investigation by DPH and the FDA, and 

eventually led to a total recall of Ameridose products. Ameridose remains closed as 

the investigation continues. 

The Board of Registration in Pharmacy moved to permanently revoke NECC’s license, as well as the individual licenses of the three principal pharmacists who ran 

NECC so they may never practice pharmacy in Massachusetts again. The Board 

also issued a cease and desist order to all pharmacy staff at NECC to bar them from 

any compounding activities. 

While taking these forceful and necessary actions, we have also reexamined our 

own approach to regulating this industry. 

It is clear that the compounding pharmacy industry has changed drastically from 

the days of neighborhood businesses that served a local clientele. We recognized 

that our State regulations needed to be strengthened to address the realities of this 

industry, which has evolved over time, and again we took action. 

On November 1, Massachusetts enacted a series of emergency regulations to bring 

greater scrutiny to the industry and ensure that we have the tools to prevent such 

a tragedy from happening again. 

Our new regulations stem from the lessons learned from this tragedy and require 

sterile compounding pharmacies in Massachusetts to report volume and distribution 

figures to the State, for the first time. This will alert us to any pharmacy that is 

acting like a manufacturer by producing medication on an industrial scale, which 

requires an FDA license and the additional scrutiny and adherence to high manufacturing standards for safety and quality that FDA oversight requires. We are also 

requiring all licensed pharmacies to report to the State when they are the subject 

of investigations by any other States or the Federal Government. This will allow us 

to know when other entities have identified issues with pharmacies in Massachusetts, including other States that issue non-resident licenses to pharmacies in Massachusetts. 

The Board of Pharmacy’s prior approach to inspecting pharmacies when they first 

apply for a license, and then again only if they move or if there is a complaint, 
29 

though not out of line with the approach used by most States, is no longer sufficient 

to keep pace with the changing nature of the industry. Since the outbreak we have 

begun unannounced inspections of the State’s 25 sterile compounding pharmacies to 

review how they function when they are not aware that an inspection is scheduled. 

Teams are in the process of conducting additional inspections as we speak. 

Massachusetts sterile compounding pharmacies have also been required to attest 

under penalty of perjury that they are meeting all State laws and regulations. 

To further strengthen our oversight over sterile compounding pharmacies, we 

need to explore changes to State law. We created a Special Commission, and named 

Christian Hartman, an expert in pharmacy practice and patient safety, as its chairman. The Commission will include members of the Massachusetts’ Legislature and 

experts in pharmacy practice, regulatory affairs, and patient safety. We will look at 

best practices in other States, explore new ideas, and consider the interplay between 

State and Federal authority. The first meeting of the Commission is scheduled for 

this month and this body will report its findings to the Governor by December 31. 

As we work to raise standards in Massachusetts, we urge Congress to act to 

strengthen Federal oversight. It is clear that the patchwork of disparate State regulations is not enough to keep the public safe. 

Congressman Markey’s leadership in putting forward legislation is laudable and 

would help fill what he has aptly called a ‘‘regulatory black hole’’ that exists between State and Federal oversight. Congressman Markey’s report also shows that 

at least 34 States have had deaths or illnesses stemming from violations at 

compounding pharmacies nationwide before this current meningitis outbreak. We 

join Congressman Markey in supporting immediate Federal action. 

As a pediatrician who has looked into the faces of children and families at their 

most vulnerable moments, I understand the faith and trust that patients place in 

our health care system. I would never have contemplated that a medicine I might 

prescribe to my patients could actually be the source of such harm. We must use 

these terrible events as an impetus to work together, as public health officials and 

legislators, to reaffirm the trust that has been broken by the circumstances surrounding this outbreak. 

I pledge to you that Massachusetts will continue to do whatever we can, make 

any changes, and identify any areas of new law to make sure something like this 

never happens again. We intend to identify responsibility but also focus on reforms 

that will be effective and lasting. 

As the victims and their families remain always in our thoughts, we accept the 

challenge of reform that lies ahead. 

Thank you. I am happy to take your questions. 

The CHAIRMAN. Thank you, Dr. Smith, and thank you all. We’ll 

start a round of 5-minute questions. 

I wanted to have Dr. Bell here today. I know you weren’t at the 

hearing in the House yesterday. I thought it was extremely important for us and for the public to know just how important the intervention of CDC was in this. I’m going to read your concluding remarks which I read last night. 

‘‘The outbreak demonstrates the essential role that public 

health plays in identifying and responding to infectious disease 

outbreaks, large or small. Our national public health capacity 

is disseminated to State and local responders who work on a 

daily basis to keep our country safe from infectious diseases, 

whether they are from naturally emerging threats such as a 

new influenza pandemic or from human made problems such 

as contaminated medicines. CDC will continue to work with 

State partners, national experts, frontline clinicians and others 

to respond to the critical public health needs related to this 

outbreak.’’ 

Again, I think the public needs to be aware that we have an infrastructure in this country with CDC, with our State departments 

of public health, with our field epidemiologists who instantaneously 

can intervene, track these threats down, keep our public safe. 

That’s why I thought it was so important for CDC to be here today, 
30 

both to outline—and I know we have another witness from Tennessee who will be here. You mentioned this person, Dr. Kainer— 

to let the public know that things happen, and we’re never going 

to be 100 percent safe, either from human-made problems or infectious diseases, as you mentioned, like influenza pandemics. 

I think it’s also important for us to know that the more we constrain the budgets of the Center for Disease Control and Prevention and the budgets of our public health entities around the 

United States, the more we put the public at risk. We have for too 

long treated public health as sort of a stepchild of healthcare in 

America, something that, well, we just don’t have to pay attention 

to. It’s to our detriment, and people die, and people get sick if we 

don’t continue our support for public health in the United States. 

Senator Mikulski and I worked very closely in the Affordable 

Care Act to make sure that we had a strong component of public 

health in that bill. I just hope that my colleagues and others who 

are watching the proceedings will, again, note what has happened 

to public health funding in America. I know this is not an Appropriations Committee meeting, but I wear two hats, and I’m sorry, 

but I’m going to wear that one here right now. 

In fiscal year 2009, CDC funding was $6.239 billion. Got that? 

In 2009, $6.239 billion. In fiscal year 2012, it’s down to $5.644 billion, and yet we have more emerging diseases. We have more people. We have people moving more rapidly around the country. We 

have people moving from this country to other countries, back and 

forth, through commerce, through travel. Yet we continue to turn 

a blind eye to the need for public health infrastructure in this 

country. 

Dr. Bell, thank you, and I look forward to our witness from the 

State of Tennessee also and what they did to intercede in this. 

Dr. Hamburg, when I see the history of this and I read the history of this and I see the two court cases, Fifth Circuit and Ninth 

Circuit—I’m not going to go into all that. You understand it. I have 

some sympathy for the FDA not knowing exactly what its role is 

going to be. But that’s OK. That’s the past. We have to do something now. And, of course, I’m going to look to Senator Roberts and 

others who have been more involved in this in the past for some 

guidance and direction. 

Why don’t we just have a demarcation line? If a compounding 

pharmacy makes anything that goes outside the State boundaries, 

that’s FDA jurisdiction—anything. If it stays within a State, it can 

be State or it can be dual, depending. But anything that goes beyond State borders, that must be under FDA purview. 

Dr. HAMBURG. That isn’t the way the law is currently written. 

You’re asking a larger question of why don’t we do that. The problem is—— 

The CHAIRMAN. I know that’s not the way the law is, but I’m saying why don’t we do that? 

Dr. HAMBURG. The problem is that there is not a clear distinction 

between what is a compounder and what is a manufacturer, either 

in law or in practice. The industry is evolving in ways that can be 

very, very important to the healthcare system and the needs of patients. 
31 

For example, it used to be in a hospital that the hospital pharmacy in the basement would make up intravenous bags with potassium chloride or other substances added in to be used on the floor. 

Because of volume and because of concerns about making sure that 

this is actually done under the best and most safe and most efficient circumstances, hospitals have started outsourcing some of 

those kinds of activities where they’re repackaging a drug or a 

medical product, and that can have real benefits. 

If we treat all of those individuals as manufacturers, we’ll have 

to have them submit drug applications for every one of those products. They’ll be subject to user fees. We could hold them to stronger 

standards of compliance to good manufacturing practice, et cetera, 

and that would really have benefits. I think the challenge is we 

have to think about how to address this. 

The CHAIRMAN. Dr. Hamburg, I understand. I get all that. But, 

really, the essential thing is what is in the best interest of protecting the public health. 

Dr. HAMBURG. I think—— 

The CHAIRMAN. That’s the essential question. 

Dr. HAMBURG. Yes. 

The CHAIRMAN. Now, if some people can’t protect the public 

health by making things in their basement, maybe they shouldn’t 

be making things in their basement. 

Dr. HAMBURG. I guess what I would really propose is that we 

have an antiquated system, trying to fit a square peg into a round 

hole. What we have proposed in terms of a tiered system, I think, 

could get at these issues in a very responsible way. Traditional 

compounding on a small scale would remain under the purview of 

the States. 

Nontraditional compounding that gets us into this area would be 

addressed in a different way. For one thing, they’d have to register 

with us, so we’d know who they were and what they were making. 

We would have Federal standards that they could be held to, either 

enforced by the States or by the FDA. We would have to, in statute, through a combination of factors, define what puts you into 

this category; what kinds of products you’re making, like sterile 

products; what volume of products; are you shipping interstate; 

other issues about shipping directly to the user or through a third 

party. We can do that together. 

Then there’s some products that clearly should only be under the 

purview of a full-fledged manufacturer and that simply should not 

be compounded because of the nature of those products, biologics 

and transdermal patches, extended release, and other things. Then 

copying an FDA-approved drug is also clearly not appropriate. 

The CHAIRMAN. OK. Thank you. I’m over my time. I will hold for 

Senator Enzi when he returns. 

Next I would recognize—oh, he’s not coming back? Then I would 

yield to Senator Roberts or Senator Alexander. This is in terms of 

how people appear on the committee. Senator Roberts appeared—— 

Senator ROBERTS. It looks like I have appeared first. 

Dr. Hamburg, your past interactions with NECC, the New England Compounding Center, prior to the current crisis, which 

spanned over 6 to 10 years, depending on how you look at it—we 
32 

were taking a look at your testimony before the House. Were you 

Dingellized over there or, did you get around all that? 

Dr. HAMBURG. That’s a term I’m not familiar with. 

Senator ROBERTS. There are a lot of us that are very much familiar with it. 

[Laughter.] 

You said that NECC has repeatedly disputed FDA’s jurisdiction 

over its facility. You cited a number of times during your interactions that NECC had done so. Isn’t it also true that each time 

the NECC disputed the FDA authority, the FDA responded, reasserting its authority to regulate the NECC? Now, that culminated in the final communication between the FDA and the 

NECC in 2008 prior to the current crisis. 

The FDA wrote to the NECC to outline in no less than four 

pages—and we don’t need to get into reading the four pages, I 

hope—the numerous reasons why the FDA did have the authority 

to regulate and, furthermore, use its enforcement authorities with 

the NECC. I think that’s correct. 

Now, in fact, that letter went on to tell the NECC not only to 

clean up its act or there would be specific consequences, but also 

to confirm future inspections would occur to ensure the firm’s 

compounding practices are consistent with the policies articulated 

in the compounding guidelines. If this is correct, then I think we 

need a yes or no answer from you. That didn’t come in the House. 

One more time, did the FDA actually have the authority to regulate and engage in enforcement actions against the NECC? Can 

you give us a yes or no? 

Dr. HAMBURG. I’ll make you mad the same way I made Dingell 

mad in terms of it’s not a yes or no question, per se. We have authority, but it’s limited and—— 

Senator ROBERTS. I think you said it was a gray area. I don’t 

want a gray area. I want a black or white answer. Do you have 

that authority? Did you have that authority? 

Dr. HAMBURG. We have limited—we have authority, but it is limited and unclear and contested. 

Senator ROBERTS. That’s a hell of an authority. In May 2011, 

from the Colorado Board of Pharmacy, the FDA was informed of a 

cease and desist letter and related report accusing the NECC of illegal distribution of compounded drugs. FDA officials, including 

Bruce Ota, the signatory to the 2008 FDA letter I was referring to, 

to the NECC threatening enforcement for such conduct and asserting jurisdiction over NECC, was individually notified according to 

the May 2011 email that was introduced into the record. 

The FDA then waited until July 2012, over a year, to suggest to 

Colorado they contact the Massachusetts Board of Pharmacy. I 

don’t know how you can explain this, with over a year. The State 

of Massachusetts fired and suspended the individuals who ignored 

the Colorado complaint about the NECC. By the time the FDA suggested in July 2012 that Colorado contact the Massachusetts Board 

for action, the NECC had already compounded some of the drugs 

that led to this tragedy. 

Indeed, if the FDA had acted in 2011, according to their letter, 

either to investigate or to notify Massachusetts of the NECC’s continued violation, 30 lives could have been saved. Did the FDA take 
33 

any action against the FDA personnel who ignored this problem for 

over a year? 

Dr. HAMBURG. Obviously, in the context of the situation, looking 

at that, questions are raised. When the communication came from 

Colorado, it was around an issue of NECC acting out of compliance 

with the Colorado Board of Pharmacy Registration and Licensure 

and the question of whether they were, in fact, registered with us 

as a manufacturer. 

I wish, in retrospect, that we had alerted the Massachusetts 

Board of Pharmacy at that time. It’s also important to underscore 

that that communication really was not about the kinds of sterility 

concerns and safety quality issues that underlie this ongoing outbreak. 

Senator ROBERTS. OK. I appreciate that. My time is almost up. 

If you had inspected upon receipt of the Colorado complaint in the 

summer of 2011 and found the unsanitary conditions and the scale 

of production that existed at NECC, is it your position that you 

could not have shut the operation down despite a decade of evidence that NECC was a bad actor? That’s the first part. 

Last part: If that is the case, why do you assert the authority to 

cease, enjoin, or otherwise prosecute the recipients of your warning 

letters? Why in the hell send the warning letters if you can’t act 

on them? That’s just an empty threat. Why do we even have an 

FDA and why do you have a job if the FDA can’t stop back-alley, 

large-scale drug manufacturing that it knows about and writes letters about? 

Dr. HAMBURG. If we had gone in in 2011, as you had suggested, 

and found unsanitary conditions and contaminated product, we 

could have acted with the full force of FDA authority as we have 

acted in other cases of compounding failures that have resulted in 

contaminated products. However, in terms of our routine oversight 

responsibility of NECC, that does rest with the State board of 

pharmacy if they are behaving as a compounder. 

Massachusetts was actually in that facility in 2011 and found 

that the conditions were satisfactory. It speaks to the fact that inspections are only one piece of what can make a difference. What 

we are really trying to seek is a legislative framework that would 

enable us to hold these kinds of large-scale, nontraditional 

compounders to a set of standards, proactively in a preventive way, 

rather than using authority—— 

Senator ROBERTS. That’s what you want us to provide, a legislative framework to really define that you do have the authority to 

act on your own letters? 

Dr. HAMBURG. At the present time, our authority, because it is 

limited and unclear and contested, really forces us into a position 

of being reactive rather than proactive. With drug manufacturers, 

we can require and hold them to a different set of standards in 

terms of compliance with good manufacturing practice and the requirement of preapproval review for safety, quality, and manufacturing controls. 

Senator ROBERTS. Thank you. I’m done. 

The CHAIRMAN. We’ve got to go around. Thank you. 

Senator Mikulski. 
34 

STATEMENT OF SENATOR MIKULSKI

Senator MIKULSKI. Mr. Chairman, thank you very much for holding this hearing. I, too, wish to express my condolences to the families who have passed away—one in Maryland. Today, their Sun 

paper reports a constituent whose name I can use because it’s already in a public domain—Mr. Gerald Cohen, 71, retiree, filling his 

free time with gardening, enjoying the company of his grandchildren, and being active in the community. Treated with steroids, 

he now is so sick from nausea, fever, and he eventually had a 

stroke. He told his wife, ‘‘I thought I was dying.’’ 

This is why we are here today, to look for the right regulation. 

Also, at the same time, regulation without resources is a hollow exercise, and then resources without a workforce—the fact that we 

have to recruit people in science and train them to enforce these 

also needs to be part of this discussion. 

Mr. Chairman and colleagues, I hope this is the first of a series 

of hearings on not only regulatory reform but also on resource need 

and also on workforce need. I would hope today, too, we would look 

at not only what is not working but what did work. Obviously, Tennessee was really doing their public health job. Obviously, Colorado 

was really doing their job, because they sent an alert. So, we need 

to do those lessons learned. 

In the area of regulation, I’m very interested in the black hole 

of when do we go from the traditional role of compounding—with 

Senator Roberts we all agree exists—to where they’re now manufacturers. Even when they do do traditional compounding, when 

are they just sloppy, dilatory, or dangerous? How do we get to that? 

The other is then the resources that Senator Harkin talked about 

and referenced. 

Dr. Hamburg, I’d like to come back to you. Do you feel that what 

you are suggesting with your two-tiered system would get us to the 

problem, or would you also think that there needs to be—that this 

would be a down payment on getting to this? As the market is 

evolving, market forces are evolving on compounding, and then our 

tendency in Congress is to be anti-regulatory, dump everything on 

the States, until there is a problem. Then we pound our chests and 

want the Federal Government to be involved. 

We’ve got a lot of convergent forces, even within this institution. 

Do you think your framework would get us to this, or do you think 

also we need additional work, say, through a commission, as suggested by Senator Roberts, or through the Institute of Medicine to 

go for an even more deep dive in this? 

Dr. HAMBURG. I think that the tiered approach that we are proposing would make an enormous difference. Right now, really, 

what is a compounder versus a manufacturer is very unclear. 503A 

was Congress’ attempt to really clarify it, but it doesn’t define 

compounding anywhere. It doesn’t set an absolute limit on volume. 

It doesn’t set an absolute prohibition on compounding in advance 

of getting a prescription. 

Senator MIKULSKI. That’s the methodology. What would be the 

outcome achieved? 

Dr. HAMBURG. What would be the outcome achieved? 

Senator MIKULSKI. In other words, if we go your way, yes. 
35 

Dr. HAMBURG. Oh, I think there would be many, many benefits. 

We would, No. 1, be able to really know what the landscape looks 

like, who’s out there doing what. We would have a set of Federal 

standards that would be strong and really support quality. We 

would have authorities for adverse event reporting and an ability 

to have labels so people would know whether the product was compounded or not. We would clarify the issue around inspections so 

that when we went in, we’d be able to get access to the records that 

we need. 

Senator MIKULSKI. OK. Thank you. I want to go to Dr. Bell and 

Dr. Smith for my next set of questions. 

Dr. Bell, you referred consistently in your testimony about something called the Epidemic Intelligence Service, and then how also 

those people trained in that service are working in a variety of 

States, one of which was Tennessee that, again, did such a superb 

job. 

Senator Alexander, we’d like to compliment the public health 

people in Tennessee. 

Could you, then, talk about the role of CDC, not only in this, but 

this Epidemic Intelligence Service, and how it would be of use in 

terms of ultimately bio surveillance at the local level which acted 

so quickly, because we can’t be in every place, everywhere, all the 

time? And it must go through the States. 

Dr. BELL. Yes. Thank you, Senator. The Epidemic Intelligence 

Service is a training program that CDC has had in place for actually many decades. Many of us—and I hazard to say maybe most 

of us, even me with the gray hair—who have been at CDC for decades started our careers in CDC in the Epidemic Intelligence Service. There is a very, very large cohort of epidemiologists in the 

State and local health departments who also trained at CDC. 

This is an extremely important resource that we have. There are 

other aspects—— 

Senator MIKULSKI. Just tell me what it does. 

Dr. BELL. Basically, it’s a training program, so—— 

Senator MIKULSKI. What do you train them to do? 

Dr. BELL. We train them to do field epidemiology. We train them 

to investigate outbreaks. We train them in how to work with the 

laboratories. We train them in how public health works. 

Senator MIKULSKI. Then they don’t stay at CDC. Some do. 

Dr. BELL. That’s correct. 

Senator MIKULSKI. Like the ones who were so pioneering in the 

work on early detection of Legionnaire’s Disease and others. But 

then they go to States. 

Dr. BELL. That’s right. 

Senator MIKULSKI. Then they work in State health departments 

or in a variety of other areas of the public health human infrastructure. 

Dr. BELL. That’s right. In fact, we have some Epidemic Intelligence Service officers that are assigned to State health departments during their training. For example, this outbreak is a good 

example of how this EIS program works. 

Senator MIKULSKI. I have limited time, Dr. Bell. 

Dr. BELL. OK. Just to say that we have done what we call EpiAids. These are, in outbreaks, assistants that we provide. In this 
36 

situation, we’ve sent EIS officers out five or six times to help quickly—including to Tennessee very early on in the outbreak—to help 

the State health departments quickly identify the problem. 

Senator MIKULSKI. Now, tell me how much these people get paid, 

and what is their education? 

Dr. BELL. I can’t tell you how much they get paid. They generally—— 

Senator MIKULSKI. Are they GS–15s? Do they get paid $180,000 a year? Do they get paid $45,000 a year? 

Dr. BELL. I think it depends on their level of training. They have 

to have an advanced degree. It could be a Ph.D., an M.D., or they 

could be a nurse with a master’s degree. They could be a veterinarian. They could be a pharmacist. They have many different 

ways of entering CDC. 

Senator MIKULSKI. Thank you. My time is up. 

I would like to say to my colleague, Mr. Chairman, with your indulgence—to my colleague from Kansas, Senator Roberts—I would 

like, really, Mr. Chairman, to work with you to—we have the FDA 

recommendations. We have the Roberts Commission. I remember 

when you did that during the Affordable Care Act, and it was an 

impressive piece of work. 

We’re possibly going to IOM, the Institute of Medicine, where we 

have the appropriate regulation, where we don’t over-regulate so 

we strangulate. But at the same time, we have to really move on 

it. While we’re working to pass legislation, perhaps we need a process to get us to the right legislation and maybe a down payment 

on what we need to do, while we also look at the resources, which 

you identified, Mr. Chairman, and then these workforce needs, because if you have the right roles without the right people, you don’t 

have anything. 

Thank you, and I appreciate this hearing. 

The CHAIRMAN. I want to reassure you, Senator Mikulski, and 

others on this committee that I have asked my staff to work with 

Senator Enzi’s staff and other staff on this committee to get a good 

bipartisan process going, to work together to achieve exactly the 

end that you say. That is ongoing right now. I want to reassure you 

of that. 

Senator Alexander. 

STATEMENT OF SENATOR ALEXANDER

Senator ALEXANDER. Thanks, Mr. Chairman, for the hearing, and 

thanks to Senator Roberts for your leadership in the area. I certainly intend to work with Senator Harkin and Senator Roberts, 

Senator Mikulski and others. 

I hope it’s our first order of business to answer these questions, 

not just whose job was it to prevent this tragedy, but whose job will 

it be to make sure it doesn’t happen again. That’s our job here 

today. This has been a nightmare for Tennesseans, as it has been 

for any Americans affected. We’ve had 32—13 Tennesseans died, 81 

Tennesseans are sick, and 1,000 more exposed. 

All of us are shaken, because we live in this country where we 

have this miracle that we walk into one of our 60,000 drug stores 

or pharmacies or go to our doctor or our pain clinic, and we get 

medicine, and we don’t think about it. We just assume it’s safe. 
37 

And then to suddenly go home and find that you’ve got fungal meningitis and you may die or be permanently disabled is a nightmare, 

not just for the families involved, especially them, but for all of us. 

I want to do everything I can to help solve this problem. 

Now, my experience as Governor, Mr. Chairman, was that whenever I gave a job to more than one person, sometimes it came back 

not done. When I put somebody on the flagpole, it was surprising 

to see how fixing that responsibility got it done. Let’s start on what 

went right. 

Obviously, we had incompetence in the Massachusetts State 

Board of Pharmacy. We had confusion at the FDA. We had a textbook case of A-plus excellence at the CDC, the Centers for Disease 

Control, and at the State of Tennessee and at Vanderbilt University, their partner, where they uncovered this within literally a 

matter of a couple of days, and in a few more days were able to 

alert everybody about it. 

Dr. Bell, whose job is it? Is it your job at CDC, once something 

like this is discovered, to let the world know about it? Is that your 

job, or is that the job of a lot of different people? 

Dr. BELL. Senator, that’s our job. 

Senator ALEXANDER. So it’s clear. If that hadn’t been done, that 

would have been your responsibility, really. Right? 

Dr. BELL. Yes, sir. It’s our responsibility to let the world know 

about public health threats. 

Senator ALEXANDER. Right. And you did a superb job. Let’s go 

back. What we’re hearing from the FDA is they had some authority, but it was confusing. We hear from Massachusetts—or I’ll just 

say it. Massachusetts—well, let me ask Dr. Smith. 

Massachusetts clearly had the authority to regulate this 

compounding pharmacy. Correct? 

Dr. SMITH. That’s correct. 

Senator ALEXANDER. So Massachusetts clearly had the authority. 

FDA had some authority, but there was confusion. It seems to me 

that one guiding principle in terms of working this out is let’s stop 

this dual responsibility. Let’s put either the State board of pharmacy on the flagpole or the FDA on the flagpole and get the other 

one out of it. 

Now, I’ll give you an example of that. In surface mining, we have 

a procedure in the State where the EPA and the Department of Interior may delegate to States the whole responsibility for regulating surface mining, or they may take it back. If something bad 

goes wrong, and Tennessee has that responsibility, it’s Tennessee’s 

fault. If Tennessee gave it back to the Federal Government, it’s the 

Federal Government’s fault. At least everybody knows who’s on the 

flagpole for that. 

Dr. Hamburg, would you be in favor of a system that would say 

to a State like Massachusetts that for 10 years has been incompetent in managing a compounding facility like this that it should 

take over completely compounding of pharmaceutical drugs? 

Dr. HAMBURG. There are many different models that—— 

Senator ALEXANDER. No. I’m asking you would you be in favor 

of that model? Do you think it makes sense to have a model where 

you may delegate to Massachusetts or any State, for example, the 
38 

responsibilities for even sterile compounding or advanced compounding, or you may keep it? 

Dr. HAMBURG. I think first—— 

Senator ALEXANDER. But if you kept it, it would be your responsibility, and you couldn’t say you were confused about it. 

Dr. HAMBURG. Traditional compounding on the local level should 

remain the responsibility of States. Nontraditional compounding—— 

Senator ALEXANDER. How much of that goes on? Traditional 

compounding, as I understand it, happens in most pharmacies. Is 

that right? 

Dr. HAMBURG. Most pharmacies. We don’t know the numbers because they don’t register with us. There are many, many, many, 

many thousands. 

Senator ALEXANDER. I’ve heard an estimate of 60,000 pharmacies 

or drug stores. 

Dr. HAMBURG. Yes. 

Senator ALEXANDER. That’s traditional compounding. Advanced 

compounding—how much of that is there? 

Dr. HAMBURG. We think there are about 7,500 pharmacies doing 

so-called advanced compounding, and then about 3,000 that are 

doing sterile processing. For those, we should have Federal standards that could be enforced by the State or by the Federal Government. 

Senator ALEXANDER. Now, that’s my problem. Why would you 

say ‘‘or by the Federal Government?’’ Then we have a hearing 5 

years from now, and we have another tragedy, and the State says, 

‘‘Well, we could have done it,’’ and you say, ‘‘We could have done 

it.’’ I’d like to see one of you say, ‘‘It was our job,’’ just like Dr. Bell 

said. 

Dr. HAMBURG. I guess I’m saying that’s a subject for discussion. 

Some States are very strong in terms of their boards of pharmacy. 

Others are much weaker. 

Senator ALEXANDER. How do we pick and choose? If I’m sitting 

down in Gainesboro, TN, I don’t care which one it is. Whether it’s 

the Federal Government or the State government, I want the one 

that’s going to do the job. How do you decide that? 

Dr. HAMBURG. I think it should be made explicit. 

Senator ALEXANDER. So you agree that one person should 

have—— 

Dr. HAMBURG. I do think we should make it explicit. 

Senator ALEXANDER. With advanced compounding, either Federal 

or State should be in charge. Is that right? 

Dr. HAMBURG. For nontraditional compounding, there should be 

Federal standards that apply to certain types of practices that go 

to issues of quality and safety. 

Senator ALEXANDER. Instead of telling somebody else what to do, 

why don’t you just do it? Is it too big a job to put all here? 

Dr. HAMBURG. It would certainly enormously expand what we do 

presently. We’ve got about 5,600 drug manufacturers and facilities 

that we routinely are responsible for oversight of and inspection. 

Senator ALEXANDER. Let me answer my own question and say 

it’s too big a job to put it all here. Would you then certify State 
39 

agencies as adequate to do sterile compounding or inadequate to do 

it? And what if they fail to do it? 

Dr. HAMBURG. We need to discuss the range of options. That 

would certainly be one model that could work. I would like to see, 

though, some consistency of the standards applied, and I think a 

Federal standard would enable us to do that. 

Senator ALEXANDER. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you. I just want to say we will have a second round here for this panel. 

Senator Hagan. 

STATEMENT OF SENATOR HAGAN

Senator HAGAN. Thank you, Mr. Chairman, and thank you and 

Senator Enzi for holding this hearing today and the continued bipartisan leadership of this committee. I also want to thank our witnesses for coming today, and I certainly have heartfelt and sympathy condolences to all of the families and individuals who have 

gotten sick from this, ultimately have died, and then all of the 

other people who are very worried about what might happen. 

Confronting this outbreak is a pressing national concern. Over 

451 people in 19 different States have developed fungal meningitis, 

and 32 people have died, one of those individuals in my State, a 

woman, Elwina Shaw. I actually had an opportunity to speak with 

her son and with her husband. She was 77 years old. She was very 

active. Her husband said you couldn’t slow her down. She was busy 

from the morning until she went to bed—active. She loved to garden. She had back pain this summer. She went to get treated and 

had three steroid injection shots. When she ended up getting a migraine headache, she just didn’t know what to do. She had nausea, 

and she really just wanted to stay in bed. 

She went to the hospital, and they treated her for migraines. The 

headaches returned. Her family took her back, and that’s when 

they diagnosed the fungal meningitis. She stayed at the hospital 

for over a month. She then had two strokes. She was left without 

speech and motor functions. Her son, Scott, said this was a horrible 

death, that she had black fungus that had to be swabbed from her 

mouth and suctioned, and it was just a horrible situation. 

Fifty-two days after the injection to relieve her back pain, she 

passed away. What is really ironic about today—today would have 

been her 78th birthday. We all know that these are terrible situations, and we are committed to acting to be sure that something 

like this never happens again in the United States. 

Dr. Hamburg, what I’m trying to understand is—if you can help 

give some thought and guidance to—why in February 2003 the 

FDA designated the New England Compounding Center a pharmacy rather than a manufacturer? The investigation then was into 

the same pharmacy compounding the same drug that led to the 

same result of fungal meningitis. I’m just wondering if this scenario could have been avoided 10 years ago. 

Dr. HAMBURG. We were actively involved in the investigation beginning in 2002 of the contaminated products, working to get the 

products off the shelves and limit the damage. In terms of the ongoing efforts to remediate the sterility concerns, we were working 

with the State board of pharmacy. Together we determined that 
40 

NECC—as I understand it. I, of course, wasn’t commissioner at the 

time, so I’m relying on records and what I’ve been told. 

As I understand it—and I’ve looked at the notes, the minutes of 

the meeting—there was a determination that NECC was behaving 

as a compounding pharmacy, and under the existing legal framework, that is the appropriate authority of the State board of pharmacy for regulatory oversight. They took the lead and began a series of steps with NECC to address the sterility concerns. We tried 

to be as helpful as we could be. It was clearly determined that it 

was the Massachusetts Board of Pharmacy’s responsibility to work 

with NECC on this important issue. 

Senator HAGAN. We certainly see what has happened in the interim. That’s why we’re obviously holding this hearing and looking 

at the actions that we need to take. And I know we’re on a short 

timeframe today. 

Dr. Smith, I wanted to also thank you for coming. I know you 

recently became the interim commissioner. Given the integral role 

that the Massachusetts Board of Pharmacy has played in the current outbreak, I want you to shed some light on its failure to properly discipline the New England Compounding Center over a longer 

period of time. 

Yesterday, when I spoke to Elwina Shaw’s son, Scott, he said, 

‘‘These companies are allowed to make drugs in the back end of a 

recycling facility?’’ The disturbing thing is—and this is his quote— 

is that ‘‘someone in this Nation thought that was a good idea. It 

makes no sense.’’ 

I have to ask you, Dr. Smith, why in April 2011 did the NECC 

receive a permit to expand its facilities when the FDA later found 

out that its building was 100 feet from the mattress and plastics 

recycling plant, and that black particulate matter near the HVAC 

system was contaminating sealed vials of the steroid now causing 

this current meningitis outbreak? When the Board granted that request, did it know that the same family that owns NECC also owns 

that recycling plant? Any comments? 

Dr. SMITH. Certainly. When the board of pharmacy did the onsite inspection that you’re referring to, it was in the situation of 

NECC requesting an expansion or a change in its physical plant. 

The inspector at the time did the on-site inspection, looked at about 

10 or 12 different areas, including sterility, quality assurance, staff 

training, among a number of others. At that time, the inspector’s 

report, which I know we’ve shared with this committee, indicated 

that there were no issues. 

Now, it is not a specific aspect of the report to look at the broader outside environment and the siting of the facility. However, 

going forward, that is certainly something that we can look at. 

Senator HAGAN. But in the FDA report, it did show that this 

black particulate matter was close by and, obviously, could have 

tainted some of the medicine. 

Dr. SMITH. There were a number of substandard practices that 

NECC had, including the interior contamination that you’re discussing, as well as a disregard for their own policies and procedures regarding sterility, and, obviously, their disregard of Massachusetts pharmacy law. 
41 

Senator HAGAN. Obviously, there are many issues that we have 

to determine, and I appreciate you holding this hearing. Thank 

you. 

The CHAIRMAN. Thank you, Senator Hagan. As I said, we’ll have 

an extra round for Senators to followup on. 

Senator Blumenthal. 

STATEMENT OF SENATOR BLUMENTHAL

Senator BLUMENTHAL. Thank you, Mr. Chairman. I want to join 

in my thanks to you and Senator Enzi for holding this hearing as 

I suggested and urged that you do in the wake of this tragedy and 

express my sympathy to the families and individuals who have 

been affected by it, and also my respect for Commissioner Hamburg 

and the excellent institution that you lead. 

Unfortunately, having reviewed many of these documents, having spoken to experts in the field, having reviewed the history here, 

the conclusion is inescapable that this tragedy could and should 

have been prevented by more effective enforcement of existing 

laws. NECC was a known risk to both Federal and State regulators, but both failed to take any dispositive and effective action 

to stop this kind of tragedy, action that could have been taken 

against both NECC and Ameridose. In effect, they were disasters 

waiting to happen. In fact, they waited to happen for about a decade. 

Going through the history, I understand your view that the 

FDA’s authority was, as you have said—and I think you’ve used 

this formulaic expression a number of times—contested, limited, 

and unclear. But so is a lot of Federal authority and State authority, and it’s used effectively to prevent wrongdoing and law breaking by companies like NECC that cannot only imperil the health 

of people but actually kill them, as this company did through its 

contaminated product. 

I think that a lot of the questioning that you’re seeing here reflects a skepticism on the part of Congress and the public about 

whether the FDA will use this enhanced authority more effectively 

than it has used the authority that it has had to date. I think that 

the assurance that the FDA now has to give is that it will be vigorous and zealous in using new authority, if it’s given that authority, and I think that that is a challenge for the agency at this point. 

It’s a challenge for the Federal Government and certainly for 

State authorities as well. We don’t have jurisdiction over them. I 

would suggest to you that the jurisdictional question ought to be 

resolved very simply and starkly. If a company manufactures 

drugs, you regulate them now, do you not? 

Dr. HAMBURG. Drug manufacturers we regulate, yes. 

Senator BLUMENTHAL. Correct. In other words, if a company produces pharmaceutical drugs without a specific patient prescription, 

they are regulated by the Federal Government. That ought to be 

the rule. 

Dr. HAMBURG. As I understand it, that is not currently, in fact, 

in the law. 

Senator BLUMENTHAL. It certainly was the intent of Congress. 

Those decisions that so swayed the FDA to avoid asserting its authority and jurisdiction were also unclear, limited, and contested. 
42 

An enforcer knows, in that situation, the only way to protect the 

public is to use what authority he or she has. 

Dr. HAMBURG. Yes. 

Senator BLUMENTHAL. In this instance, whether it’s in 2004, the 

inspection report that involved the FDA; 2006, where a warning 

letter was issued and NECC never responded until 2007 and then 

the FDA never got back to them until 2008, the FDA failed to use 

its existing authority. I’m suggesting to you that the jurisdiction 

ought to be asserted as widely and effectively as possible and that 

there be no ambiguity in the law as there is now. 

To the extent you use a multi-tiered, complicated, differentiated 

approach, you will embark on the same kind of perilous voyage 

that you have in the past. 

Dr. HAMBURG. If I can make two quick points, one is I completely 

agree with what you’re saying. Frankly, I wasn’t there, but I wish 

that the responses had been more timely, there had been better 

communication with the States, and that the outcome had been different. As far as using our existing authorities, during my tenure, 

we have tried to be proactive or aggressive in responding to problems that come before us. 

There have been a series of incidents where we’ve had problems 

with contaminated products for intraocular injection or problems 

with other compounded products, and we have moved in quickly, 

as soon as we heard about the cases, done the inspections, gotten 

the companies to recall the products. In some cases—in most of the 

cases, in fact, they’ve stopped compounding sterile products. 

In one instance that was actually a veterinary case that occurred 

right before I became commissioner, we decided to go after the 

compounding pharmacy after 21 horses were killed because of 

super potent medication that they were provided with by a 

compounding pharmacy. We lost in court. Later, we had a problem 

with that same compounding pharmacy for an important human 

medical product, and there was serious injury as a result. We went 

back in, we recalled the product, we got them to stop practices, and 

they’re not compounding now. 

We have tried to use the authority that we have, but it is reactive. What I would like would be to have a system in place that 

was statutorily defined, that would assign roles and responsibilities, that would define standards of quality practice, that would 

help us to prevent problems from happening in the first place. Just 

looking at the map in terms of how the statute governing our oversight of compounding pharmacies currently exists, it applies in 

some parts of the country and it doesn’t in others, and there’s a big 

gray area. That can’t be good for anyone. 

What I’m saying is that—as Senator Roberts said, this is certainly the most tragic of the events that we’ve seen. For more than 

a decade, there have been problems in this area, and there will be 

more problems unless we really work together, to make sure that 

we have the overriding, legal authorities that are strong and clear 

and explicit. I just think we can do better. 

Senator BLUMENTHAL. I agree. 

And I apologize, Mr. Chairman, because my time has long expired. 
43 

Overriding is the key word, overriding local authorities that may 

be reluctant to enforce. Your job—and it is uniquely and always the 

job of the Federal Government to establish standards that protect 

the public health and safety where there is a national impact, and, 

clearly, there is a national impact here. When a drug compounding 

pharmacy—whatever terminology you want to use, traditional, nontraditional, big, small—if they manufacture a drug, if they make it 

without a specific individual prescription, that’s manufacturing. 

You do that now. Why not for these as well? 

Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you very much, Senator Blumenthal. 

I will, for the record, say that the first phone call I received after 

this outbreak occurred was from Senator Blumenthal, urging us 

and urging this committee to really engage in this. Based on that, 

we got our committee staff involved in it immediately. 

I thank you for your diligence and being on top of this, Senator 

Blumenthal. 

Senator BLUMENTHAL. Thank you, Mr. Chairman. 

The CHAIRMAN. Senator Bennet. 

STATEMENT OF SENATOR BENNET

Senator BENNET. Thank you, Mr. Chairman. I want to thank you 

and the Ranking Member for holding this hearing. 

This may be the most needless tragedy that I’ve seen since I’ve 

been here. I’ve appreciated the work that we’ve done over the last 

several years with the FDA to try to figure out how we get a drug 

supply in this country that’s actually safe. When I learned, for example, that 80 percent of the active ingredients in our pharmaceuticals are coming from abroad and there was no regulatory 

framework in place, we all went to work on that. We’re working together, and I appreciate the chairman’s leadership on a track-andtrace system in this country. 

This was an event that never had to happen. I wanted to ask a 

question to Dr. Smith and Dr. Hamburg about this. 

Thank you for being here today. Thank you all for your testimony. 

Dr. Smith, as you relayed in your testimony, the Colorado Board 

of Pharmacy issued a cease and desist letter to the New England 

Compounding Center in both April 2011 and July 2012, twice, because NECC had continued to violate its licensure in both Colorado 

and Massachusetts by issuing numerous compounded drugs without patient-specific prescriptions. Both times, our board of pharmacy in Colorado also informed the Massachusetts Board of Pharmacy, as well as the local Denver office of the FDA. 

I’ve been informed that upon receipt of both complaints, the executive director of the Massachusetts Board failed to assign an investigator to this complaint. After the outbreak, they also failed to 

alert the Massachusetts Department of Public Health officials of 

this complaint. Obviously, our State had the diligence and resources to be on the lookout for NECC products. Others, for some 

reason, did not and as a result this tragedy occurred all over the 

United States of America. 
44 

Dr. Smith, I want to know whether you felt the response to the 

Colorado Board of Pharmacy was adequate, and, if not, how you’re 

going to fix this problem going forward. 

And, Dr. Hamburg, I’d like to ask you about when a State board 

of pharmacy serves in its good actor role by issuing these cease and 

desist letters and notifies the Massachusetts Board and their local 

FDA office, how we can better prioritize this at the Federal level. 

As Senator Alexander said, how can we better strengthen the role 

of either the States or the Federal Government to take responsibility in a circumstance like this one? 

Dr. Smith, I’ll turn it to you. 

Dr. SMITH. Thank you. Just to be clear, while the executive director of the Board of Pharmacy did receive notification from the Colorado Board of Pharmacy regarding the cease and desist that was 

done in April 2011, we have not found any record that there was 

any communication from the Colorado Board of Pharmacy at that 

time back in 2011. 

Now, that said, clearly, when we got the information from the 

Colorado Board of Pharmacy in July—— 

Senator BENNET. I don’t think I understood what you just said. 

Can you say that again? 

Dr. SMITH. I’m sorry. If I heard you correctly, you indicated that 

back in 2011 and then again in 2012, the Colorado Board of Pharmacy communicated with the Massachusetts Board of Pharmacy. 

What I was saying is that we haven’t found any record of a communication between Colorado and the Massachusetts Board until July 

2012. 

Now, that said, it is clear that it was a serious and, grave lapse 

of judgment executed by the board’s executive director not to followup on what Colorado sent. The report was clear. It indicated 

with sufficient detail that NECC was clearly operating outside of 

Massachusetts pharmacy laws. The board certainly knew of NECC 

at that time and that it had issues. It should have been a red flag 

that was followed up on, and it wasn’t. That clearly was, frankly, 

a mistake, a grave one, and we have acted since then to remove 

that employee. 

Senator BENNET. It’s one of those things where it doesn’t even 

feel like it’s a gray area. It feels to us like it was a flashing red 

light. 

Dr. SMITH. I agree. What I can say is when I learned of this 

email exchange and the fact that we, the board of pharmacy, knew 

this in July 2012, I was astounded, baffled, and incredibly angry, 

because that was something we should have acted on. 

Senator BENNET. Dr. Hamburg. 

Dr. HAMBURG. In retrospect, clearly, I would have hoped that 

there would have been greater communication. That speaks to the 

issue that was raised about ensuring the appropriate level of back 

and forth communication and coordination with our State partners. 

When this email was received, it was in the context of a violation 

of State pharmacy registration and licensure. While there was an 

indication that they had sent product in the absence of specific patient prescriptions, there was no indication of a safety or quality 

concern that was being raised. 
45 

We really felt that it was—as I understand, those kinds of issues 

are often handled by the State board of pharmacy. We should have 

made sure that Massachusetts was aware, and it underscores the 

need for greatly enhanced communication and coordination. The 

other aspect speaks to the larger question that we really need to 

work on clarifying and trying to figure out how to address this 

issue of compounding versus manufacturing and when does one authority kick in and when does the other apply. 

Senator BENNET. I think Senator Alexander hit the nail on the 

head. It’s a question of clarity, of what the roles and responsibilities here really are, so that what, at the best, is bureaucratic in 

difference—and it’s probably worse than that, I suspect—causes 

this kind of thing. 

Mr. Chairman, thank you for holding this hearing. 

The CHAIRMAN. Thank you, Senator Bennet. 

I’m starting another round. I don’t know how many Senators 

would like to have more questions. I just have a couple. 

Dr. Hamburg, unlike NECC, where there is a lack of clarity, as 

we now know, regarding the FDA’s authority, there’s another company called Ameridose. 

Dr. HAMBURG. Yes. 

The CHAIRMAN. Owned by the same people, run by the same people, closely aligned. Ameridose is registered with the FDA. Although it is essentially a large-scale compounder—it is a largescale compounder—it provides products to hundreds of hospitals all 

over the country. Now, given that the two companies are owned 

and run by the same people, that the FDA inspectors documented 

many similar serious problems at Ameridose and NECC, could the 

contamination just have easily occurred at Ameridose? 

For example, in 2008, the regional inspector for the FDA recommended a warning letter to be issued to Ameridose, but it never 

got sent. I’m wondering whether what you’re recommending is 

clarifying enough, that compounders like NECC are subject to 

FDA’s authority. Is that really enough, if FDA already had the authority with regard to Ameridose? 

Dr. HAMBURG. I can’t speak to the specifics of Ameridose because 

it is the subject of an ongoing investigation. It speaks to this issue 

of these hybrids of compounding pharmacies that are merging more 

into manufacturing, and the fact that we do need a system that is 

clearer. 

Registration with the FDA does not necessarily mean that they 

become a drug manufacturer. People register with us for all kinds 

of reasons and never even are putting anything into commerce. It 

means, we get their name and address. We never got listings of 

products that Ameridose was manufacturing, but we were engaged 

with them in terms of inspections and responding to some specific 

complaints and concerns. 

I really think we need to work together to figure out how to address this evolving field of nontraditional compounding, because it 

can serve an important need. We need to be able to define it more 

and be able to really apply the right enforcement approaches. 

The CHAIRMAN. I got it. I got that. I just keep saying that FDA 

had authority over Ameridose but didn’t exercise that authority. 

This was clear. 
46 

Dr. HAMBURG. We were in Ameridose and took some actions related to some specific concerns in the facility. In 2010, I think it 

was, we were in there around an issue with a particular product, 

nicardipine, I believe. 

The CHAIRMAN. I will take a look at that. I just know that in 

2008—— 

Dr. HAMBURG. There was a—my colleague was just reminding 

me—a recall of a super potent—— 

The CHAIRMAN. Oh, this. 

Dr. HAMBURG [continuing]. Fentanyl product. 

The CHAIRMAN. That’s very true. One was super potent and one 

was subpotent. 

Dr. HAMBURG. There was one that was dramatically super potent 

and one that was less potent. We were in there and we did take 

actions. Again, I can’t speak to all the specifics because we’re still 

investigating, looking at that internally as to what we should have 

done, and it’s part of a broader investigation. 

The CHAIRMAN. OK. I got that. I’ll look at Ameridose, but it 

seems to me that that was a clear cut case but we still weren’t exercising authority. 

I did have one more question, Dr. Smith. You know, I look at this 

history, and I’m pointing it out not just to point a finger at something and to chastise, but to understand that certain structures 

don’t accomplish what people think they accomplish. In 2003, staff 

from the FDA met with the staff from the Massachusetts Board of 

Pharmacy to discuss, 

‘‘ . . . the potential for serious public health consequences if 

NECC’s compounding practices, in particular, those relating to 

sterile products, are not improved.’’ 

That was in 2003. 

At that meeting, consensus was reached that primary jurisdiction 

over NECC rested with the board, Massachusetts. The board then 

took 1 year to get a staff investigator to recommend censure, 6 

months to actually issue a censure in the form of a draft consent 

decree, another whole year to arrive at a signed consent decree 

which then lasted for all of 6 months. 

In all, it took the board 4 years from the time MPA-caused meningitis was reported to make NECC hire a third party to review 

and improve its sterility procedures. Again, this is not effective 

oversight. 

Maybe I’m making a statement more than a question. I’m saying 

that sometimes we set up these structures, and we people them 

with the very people that they’re supposed to be policing. In this 

case, I’m informed that a member of this board is a person who actually works for Ameridose, and his or her paycheck—I forget the 

gender of the person—their paycheck comes from the very company 

that they’re supposed to be overseeing. 

We see this happening in a lot of different States, where boards 

are set up but they’re peopled with the very people that they’re 

supposed to be policing. They’re all friends. They go to the same 

clubs. They belong to the same this and the same that, and it’s sort 

of a wink and a nod and a pat on the back. Sometimes that’s why 

I think that for effective oversight, you need the expertise of people 
47 

in the field, but only to inform a board, not to actually exercise that 

kind of jurisdiction. 

Dr. SMITH. You bring up very important points. The Board of 

Pharmacy in Massachusetts, by statute, indicates who is allowed to 

be on the board. Certainly, in evaluating as part of this review the 

function of the board, that’s something that’s also going to be taken 

up by the special commission that we’ve established to be able to 

really provide us with best practices about what kind of board 

makeup might be better suited or better balanced to be able to perform the oversight function that is so crucial. 

If I could just say one other thing about the lapses that you 

clearly point out, I would say that the emergency regulations that 

we issued on November 1st include two that I think are very important. One would be to require pharmacies in Massachusetts who 

are the subject of State or Federal investigations to disclose that 

and make that known to us. That would get at the issue that Senator Bennet raised of Massachusetts not being aware at the time 

that Colorado issued a cease and desist letter. That would be very 

important. 

The other would be that sterile compounding pharmacies must 

supply information about volume and distribution patterns to the 

State board. Right now, that is not required. And, clearly, 

compounding pharmacies like NECC who are acting in a de facto 

manufacturing-like role would then have to tell us information 

about how much they’re making, what they’re making, and where 

they’re shipping it to. 

That would allow us to identify pharmacies that are doing that 

kind of practice, as opposed to the neighborhood compounder that’s 

doing that necessary compounding or the ones that are doing it 

within State law, which is one prescription at a time. NECC was 

violating that as well. 

The CHAIRMAN. Got it. Thank you. 

Senator Roberts. 

Senator ROBERTS. Thank you, Mr. Chairman, and thank you for 

citing the timeframe that is most frustrating to this. 

Doctor, you said that if there were sterility issues, you could 

have shut the manufacturer down. I’m having a lot of trouble here 

with this. On 4/16/2002, FDA report cited sterility issues and lack 

of accountability by NECC and Mr. Cadden as the former CEO or 

director, he took the Fifth over in the House yesterday, we asked 

him to appear and he did not. 

I might add that this timeline was prepared by our staff, the 

committee staff, the chairman’s staff. We asked for a timeline from 

you in regards to any actions that you have taken against any 

compounding manufacturer. We have yet to receive that, and I 

would hope that we could get it. 

But this is 2002. Mr. Chairman, we go through 2002—a complaint, 2002 adverse event, FDA inspections, FDA 483. By the way, 

the 483 is like a 1099 in regards to your taxes. You don’t want to 

get a 483. That says you’re in trouble, and you’ve got to answer. 

I have the answer by the New England Compounding Center. Then 

I have the warning letter back. 

I could go down all of the things that have happened here—investigation, complaint, board action, board action, inspection. We 
48 

go clear down here, another whole page of it—letter, board action, 

board consent, board compliance, compliance, other licensing, advisory letters, licensing. Finally, in 2006, a warning letter. Finally, 

we get something done. 

Here’s the warning letter. In the warning letter—and here, by 

the way, is the 483 that says you’re in trouble—2002. Finally, after 

all of these things happen, in 2006, we have a warning letter. All 

right. What happens with a warning letter? And then New England Compounding Centers respond, and then you respond to them 

about the warning letter. So this is a warning letter after the response to the warning letter. 

And you say, 

‘‘Your firm must promptly correct the violations noted in December 4, 2006, warning letter and establish procedures to assure that such violations do not reoccur. Its failure to do so will 

result in enforcement action, including seizure of the firm’s 

products and an injunction against the firm and its principals. 

In a future inspection, we will confirm the commitments that 

you made in your response and verify that your firm’s 

compounding practices are consistent with the policy articulated,’’ 

et cetera, et cetera, et cetera. 

That’s a pretty strong response. What happened? Actually, nothing happened until 2008, and then there was another 483. I’m not 

going to go through all that. We went through that. That involved 

Colorado. And, finally, we get to a 483 of October 26, 2012, finding 

multiple sources of contamination and air sampling showing contaminants 6 months prior to compounding of MPA. This has been 

going on since 2002. This is amazing. 

These are steroid injections, by the way, that when there was an 

inspection, there were vials of the product and there was black fungus in the vials. Who on earth would put an injection needle into 

a vial with black fungus to put into somebody’s knee or shoulder 

or whatever? Maybe that’s the problem I have with my knees. Hell, 

I don’t know. 

I’m just saying it took all that time, Mr. Chairman, and nobody 

did anything. You say that you have the ability to shut down somebody if they have sterility issues. I have two or three 483s here and 

letters back and forth from 2002 until now, and the thing that shut 

the manufacturer down was 30 lives. Holy mackerel. 

Senator Alexander is precisely correct. I don’t know whether you 

need a State flagpole or a Federal flagpole or something to get us 

off the dime here so that if somebody gets into this kind of a problem and you feel that you have to issue a 483, you can shut them 

down. Now, what am I missing here, other than I’m over time and 

I made a long statement and I didn’t allow you to have a question. 

By the way, thank you for wearing purple because Kansas State 

is rated No. 1 in the BCS poll. 

Dr. HAMBURG. Obviously, it’s a very long answer and we’re out 

of time. Just quickly, the 2002 contaminated product issues were 

responded to very swiftly in terms of going in and inspecting. We 

worked with the Massachusetts Board of Pharmacy. The products, 

in fact, were taken off the shelves. A decision was made, as we discussed earlier, that because this was a compounding pharmacy, it 
49 

was under the purview of the Massachusetts Board of Pharmacy 

who licenses and oversees the day-to-day operations. 

They took on that responsibility of working with the company to 

resolve the sterility issues, including the consent decree in 2006, 

which turned out to have serious flaws, as Dr. Smith indicated. 

The belief was that the company had made progress, working with 

the Massachusetts Board of Pharmacy, to address the sterility 

issues. 

The 2006 warning letter from the FDA actually concerned a completely different set of issues at the facility. It had to do with three 

specific products where we did have very real concerns with the 

practices at NECC. It didn’t have to do with sterility failures. It 

had to do with basically copying FDA-approved drugs or making 

unapproved drugs. They were things that were taken seriously. 

As I said earlier, I wish that we had been much prompter in the 

followup on that, and perhaps we should have been more aggressive. The response to those warning letters—and had we taken the 

legal action that you indicated that we were citing authority to 

take, it would have been on a set of issues involving these specific 

products, and it probably—maybe we would have been successful 

and it would have made a difference. Maybe we wouldn’t have 

been. 

I wasn’t at the agency at the time. I know that there was a lot 

of internal debate about how to proceed. That’s why it was slowed, 

because of the ambiguity in the law and the fact that there was 

ongoing litigation and differing opinions about the scope of our authority coming in. I think that doesn’t fully answer your question, 

and I think we all wish that we had done more. It is complicated. 

Senator ROBERTS. OK. I’ve gone over and it’s my fault, not your 

fault—3 minutes. You’re just saying basically that your statement 

was erroneous. You do not have the authority to shut people down 

if there’s a sterility issue because you don’t know whether it’s 

State, whether it’s Federal, or whether it’s specific to this product 

or that product, and all of the laundry list of things that went on 

here with staff and everything else. Then you have a crisis on your 

hands, and that’s what happened. 

It’s a pretty sad situation, Mr. Chairman. 

Can we get your timeline? 

Dr. HAMBURG. We will get you the timeline. We are still collecting information, going through documents. This did happen at 

a time when many of the people involved are no longer at the agency. We’re working hard to respond to the ongoing public health crisis, and many of the same people that we need to pull the documents are involved in that. 

We are very focused on it. We recognize the work that you need 

to do. We want to work with you, and we appreciate your patience. 

The CHAIRMAN. Thank you, Senator Roberts. 

Senator Blumenthal. 

Senator BLUMENTHAL. Thank you, Mr. Chairman. I’d like to pursue, Mr. Chairman, your questions at the very outset here about 

the Ameridose matter, which, for me, in many respects, is more serious even than the NECC from a Federal enforcement standpoint. 

I have reviewed all the documents, 483s, and inspection reports. 

Clearly, serious, egregious violations of basic standards were found 
50 

by your inspectors in 2008 and then again in 2010. Now, I take it 

that the recommendation was made for a warning letter to be 

issued. There is no evidence in the documents submitted to this 

committee that any warning letter was ever sent. Do you disagree? 

Dr. HAMBURG. That is my understanding. 

Senator BLUMENTHAL. There was no warning letter ever sent. 

Dr. HAMBURG. No. 

Senator BLUMENTHAL. Despite findings about the lack of potency 

in the drugs, the lack of proper sterility standards, the basic cleanliness, and other kinds of minimal standards in a company that is 

many times the size of NECC manufacturing hundreds of different 

kinds of products sent across the Nation, no warning letter was 

issued. Is that correct? 

Dr. HAMBURG. The product was recalled, however. My understanding is no warning letter was sent. 

Senator BLUMENTHAL. Why was no warning letter issued? 

Dr. HAMBURG. We are looking into that. As I said, some of the 

specifics are part of an ongoing investigation internally and more 

broadly. 

Senator BLUMENTHAL. There’s no question in your mind, is 

there—because there wasn’t in any of the inspectors who did these 

reports—that FDA had full and complete authority over 

Ameridose? 

Dr. HAMBURG. As I said, it was something of a hybrid in terms 

of being a repackager-pharmacy. It wasn’t a drug manufacturer, 

like Merck or Pfizer, but—— 

Senator BLUMENTHAL. You’re telling the committee it was not a 

drug manufacturer? 

Dr. HAMBURG. It was not a drug manufacturer in the sense of 

a drug manufacturer that we have the oversight of in terms of new 

products that undergo product review and approval before licensure, that are subject to all that that entails. 

Senator BLUMENTHAL. Your inspector in the jurisdiction section 

of the report in 2010 said the firm currently repacks and manufactures prescription drug products which are FDA-regulated drug 

products. 

Dr. HAMBURG. As I said at the outset, Ameridose is actually the 

subject of an ongoing investigation, and you understand what that 

entails. I have been asked not to try to characterize Ameridose at 

this time as we’re looking into those very questions that you’re asking. 

Senator BLUMENTHAL. Let me ask you a broader question which 

looks to the future rather than the past. I want to reiterate that 

much of the documents and issues that have been brought to the 

committee relate to a time before you took over the position that 

you have now, and we’re asking both you and Dr. Smith to answer 

questions about institutional performance well before your responsibility. 

Looking to the future, if there is an NECC and an Ameridose 

continuing to operate out there, do you know who they are? In 

other words, if you had that authority today, do you know where 

you would go in terms of where the problems are, the future tragedies waiting to happen? 
51 

Dr. HAMBURG. We do not know the universe of compounding 

pharmacies that might fit into this category of activity because 

they are not required to register. 

Senator BLUMENTHAL. Shouldn’t you know? 

Dr. HAMBURG. I do think that we should know, and I would like 

to see that as part of new legislation if we would do it. 

Senator BLUMENTHAL. You can begin that task right now, can’t 

you? 

Dr. HAMBURG. We are beginning to reach out to our colleagues 

at the State level to learn more information. We are enhancing our 

activities around some of the large compounding facilities that we 

know about to really make sure that we have as much information 

about what they’re doing and how they’re doing it. 

Senator BLUMENTHAL. Let me just suggest—and I don’t mean to 

sound simplistic, because I know your task is resource challenged 

and we haven’t really discussed the resource issue. I know it’s one 

that is very much a challenge for the FDA at this point. 

Dr. HAMBURG. Absolutely. 

Senator BLUMENTHAL. The Congress really should be meeting its 

obligation to provide those resources that are necessary for the 

tasks that we’re all implying you should have been carrying out. 

I would suggest very respectfully that the FDA ought to make it 

a priority to scrutinize the 3,000 compounding pharmacies, the documents that are public—and most of these documents are public 

right now, as we’ve seen from the media. They’re available to folks 

who want to go into the records to find them—and where are the 

next tragedies going to occur; who will cause them; what kind of 

standards are they failing to meet—so that when you’re provided 

with that authority that is not as limited, unclear, and contested, 

as you say it is now, you can swoop down on them and shut them 

down or at least require that they correct the problems that exist. 

Dr. HAMBURG. I really appreciate your observations, including 

the one on resources, because that is a huge challenge. We have 

enormous responsibilities for the protection of the public health 

across a huge domain of areas of activity. I hope that I can work 

with you to address the crazy quilt of regulatory oversight that we 

currently have, because that will enable us to act in a much more 

efficient and targeted way. 

I also do think that the more we can be preventive, as you say, 

rather than reactive, using our authorities that are clearly in the 

law to address a contaminated product—but we don’t want to have 

to wait until there’s a contaminated product. We want to be able 

to make sure that these facilities are operating with the kind of 

preventive controls and standards of quality that the American 

people expect and deserve. 

Senator BLUMENTHAL. I would just suggest that you be preventive with a capital P, and that you regard these renegade, outlier 

drug manufacturers as the threat to public health which, clearly, 

they are. 

Dr. HAMBURG. Yes. 

Senator BLUMENTHAL. Thank you, Mr. Chairman. 

The CHAIRMAN. Thank you, Senator Blumenthal. 

Senator Alexander. 
52 

Senator ALEXANDER. Mr. Chairman, I’d like to ask to place in the 

record statements from the Tennessee Department of Health, the 

Tennessee Board of Pharmacy, the Tennessee Hospital Association, 

the Tennessee Pharmacists Association, and the Tennessee Medical 

Association, all of which I asked for this hearing. 

[The information referred to may be found in Additional Material.] 

Senator ALEXANDER. As much as I would like to focus my time 

on whose fault it was, I think the families of those who were hurt 

in Tennessee would like me to find out how we can make sure this 

doesn’t happen again. I’d like to pursue the line of questioning that 

Senator Blumenthal and I and others have asked about, for lack 

of a better word, the flagpole theory. 

As I listen to this—and the reason I haven’t asked Dr. Smith 

many questions is she said, and we know, that the Massachusetts 

State Board of Pharmacy had the clear authority to deal with this 

problem. They just were incompetent in dealing with it. And if anybody’s going to be shut down, I think they should be shut down. 

That would be where I would go. 

Now, as we move over to the FDA, thinking about looking ahead, 

I’m not sure—listening to the FDA’s confusion and reading their 

record about this, I wouldn’t trust the FDA more than I would 

trust the Tennessee Department of Public Health to keep our medicines safe. In fact, the evidence that we’ve heard already and that 

we’re going to hear from the second panel is that an example of 

doing things well in part of this area came because of the alliance 

between Vanderbilt University and the Tennessee Department of 

Health. 

It leads me back to this solution, Mr. Chairman, to how we fix 

accountability here. I’m trying to think through different ways we 

do things in the Federal Government. I’m thinking of our nuclear 

program. Admiral Rickover in the 1950s set up our nuclear submarines, and he had a very novel idea. He interviewed every single 

captain, and he told them their career depended upon whether or 

not there was ever an accident on the reactors on their submarines. 

Since the 1950s, there’s never been a death in connection with 

any activity on a nuclear submarine, and I’m pretty sure the reason is because if there’s an accident on a nuclear submarine, that 

captain’s career is basically over or seriously diminished. There’s 

clear responsibility. It’s the captain’s responsibility. 

I’d like to be able to come back to a testimony 6 months from 

now, after we’ve worked together to pass a law, and hear representatives of State boards of pharmacy say, ‘‘This is my responsibility, and this is what we’re doing about it,’’ and hear the FDA 

say, ‘‘This is our responsibility.’’ I don’t want to hear this joint responsibility that ‘‘they were supposed to do it, and we could have 

done it, but nobody did it.’’ 

Let me narrow it down a little bit. As I understand it, Senator 

Blumenthal was focusing in on manufacturing, and the estimate I 

have is that there are about 5,600 manufacturers of drugs. Is that 

about right? 

Dr. HAMBURG. There are about 6,500 facilities that are manufacturing active pharmaceutical ingredients or drugs. 
53 

Senator ALEXANDER. You have the total responsibility for that. 

Right? 

Dr. HAMBURG. We do provide ongoing oversight, yes. 

Senator ALEXANDER. That’s your job. That’s not the Massachusetts Board of Pharmacy—— 

Dr. HAMBURG. Yes, absolutely. 

Senator ALEXANDER. You’re on the flagpole for them. And then 

you’ve said and others have said that the compounding actually 

goes on, traditional compounding, in thousands of pharmacies 

across the country, and we’re not talking about that. That’s under 

State boards of pharmacy. 

What we’re really talking about—and the estimates I have may 

or may not be right—is that there are about 7,500 pharmacies that 

specialize in advanced compounding services and about 3,000 in 

sterile compounding. It’s somewhere within those facilities, where 

State boards of pharmacy have responsibility, and you have some 

responsibility. Is that right? 

Dr. HAMBURG. Yes. That’s the area that in our proposed framework we’d really like to focus on as needing clarification. 

Senator ALEXANDER. Would you like to take over the responsibility, the total responsibility, for a certain number of those pharmacies? 

Dr. HAMBURG. That might well be the best outcome. 

Senator ALEXANDER. How many of those would that be? Is that 

a few hundred, or is that a few thousand, or do you know? 

Dr. HAMBURG. We don’t know, because at the present time, many 

of those facilities are not reporting information to us or are not registered with us. We need to understand—and those numbers are 

not our numbers because they don’t—— 

Senator ALEXANDER. No, they’re my numbers, and I’m not sure 

they’re right. I’m just trying to get a rough idea. If you already 

have 6,500 manufacturers, if you were to take over several thousand more or several hundred more, it would make a difference. 

Maybe you don’t have the capacity to do that. 

Dr. HAMBURG. It would be a real challenge. Of course, for our 

other inspectional activities over drug manufacturers, we have user 

fees that help to support our budget. Senator Harkin well knows, 

as we just worked so hard—— 

Senator ALEXANDER. Right. I’m trying to get to a point. Would 

it be conceivable that there could be a system where you have the 

responsibility, but you’re able to delegate that responsibility to 

some States that are willing to meet standards, and your job would 

be more like, say, the Nuclear Regulatory Commission? You’d go 

around and check and make sure that—it wouldn’t be your job to 

regulate—you wouldn’t regulate the facilities, but you would basically be regulating the States who took on that function in addition 

to their supervision of traditional pharmacies. 

Dr. HAMBURG. That would be one model, and we could—— 

Senator ALEXANDER. Is that a possibility? 

Dr. HAMBURG. Also lay out clear Federal standards for practice. 

Senator ALEXANDER. Could that be done in a way that made it 

clear that while you were—what that might mean, for example, in 

a case like this, is that you would go to Massachusetts—you’d have 

the authority to go to Massachusetts and take away their authority 
54 

completely to deal with sterile manufacturing or sterile 

compounding because of incompetence or failure to meet Federal 

standards, under that model. 

Dr. HAMBURG. That would be a possible model. It’s well worth 

exploring all the different ways that we could improve the system 

and make sure that it is fully coordinated and provides a safety net 

to protect health. 

Senator ALEXANDER. Mr. Chairman, as you can tell, my general 

drift here is that looking to the future, if the definition already is 

not for these advanced compounding units—if they’re not already 

manufacturing—and Senator Blumenthal was suggesting they may 

already be—if they already are, then they’re under the FDA. 

If they’re not, I would suggest we make it clear that either the 

Federal Government or the State government through a set of certification from the Federal Government be on the flagpole, have the 

full accountability and responsibility for doing it. If they fail to do 

it, they lose their opportunity to do that. That’s one model that I 

would suggest. 

The CHAIRMAN. Thank you very much, Senator Alexander. I 

would just say that as part of this ongoing effort, Senator Enzi and 

I and the committee will be sending a letter to each State board 

of pharmacy to learn more about their oversight practices in this 

area, including just how many large-scale sterile compounders are 

operating today and who they are. We don’t know. We are preparing a letter, and I hope that I can get all of the signatures on 

both sides of the aisle here to send that letter out. It’s being prepared by our staffs right now. 

I will close this panel where I started with Dr. Bell. I talked 

about the need for public health and the funding. We’ve heard a 

lot about FDA and about the necessity for FDA to take more oversight responsibility here. Again, I remind you of what Dr. Hamburg 

just said. This comes down to resources. 

We continually ask the Food and Drug Administration to do 

more and more and more. We ask them to do more in healthcare. 

We ask them to do more in food inspections, more for imports coming from overseas, and, to a certain point, the resources are going 

to have to be there. So, I hope that when appropriations time 

comes around—and we’re looking at funding for both of these, both 

for CDC and for the FDA—that we can meet our obligations in 

making sure that they’re adequately funded to carry out the responsibilities we keep asking them to do. 

Thank you all very much. 

Now we’ll turn to our second panel. I guess we won’t turn to our 

second panel. The second panel was Barry Cadden, the manager 

and co-owner of the New England Compounding Center. He declined our invitation. We decided not to issue a subpoena. He was 

subpoenaed by the House committee yesterday and showed up and 

continually took the Fifth Amendment. There was no reason to go 

through that charade here today with him. 

On our third panel, we have—and I’ll ask them to come up— 

David G. Miller, the executive vice president and CEO of the International Academy of Compounding Pharmacists, an association 

which represents individual pharmacists involved in the compounding industry. 
55 

Then we have Dr. Kasey Thompson, who serves as the vice president of the Office of Policy, Planning, and Communications at the 

American Society of Health-System Pharmacies, an organization 

which advises its members on the responsible use of compounded 

medications. Dr. Thompson has extensive knowledge regarding the 

safe use of compounded drugs, as he previously served as ASHP’s 

director of the Center of Patient Safety and director of the Practice 

Standards and Quality Divisions. 

Our third witness is one who has been referenced earlier, Dr. 

Marion Kainer. I will yield to my distinguished friend and Senator 

from Tennessee for purposes of introducing Dr. Kainer from Tennessee. 

Senator ALEXANDER. Thank you, Mr. Chairman. 

I’d like to welcome Dr. Marion Kainer. Our previous witness 

from the Centers for Disease Control mentioned her. She’ll tell 

more about this, and we’ll talk about it at the time. An astute clinician at Vanderbilt University, who has a partnership with the 

State of Tennessee where Dr. Kainer is director of Healthcare Associated Infections and Antimicrobial Resistance Program, reported 

something suspicious to Dr. Kainer. Within a matter of a few days, 

this report led to a recall of the material that was being spread 

around the United States from this New England facility, undoubtedly saving many lives and helping many others. 

It was called by the executive director of the Association of State 

and Territorial Health Officials, who said this, Mr. Chairman: 

‘‘By the time we learned this was a problem around the 

country, the information from Tennessee had already narrowed 

it down to what the problem was. It was a textbook case of 

how to do it right.’’ 

Dr. Kainer obtained her medical degree and master of public 

health in Melbourne. She’s had a distinguished career in Australia 

and the United States, with over 20 years of experience in infection 

control. I compliment her for her astuteness, her leadership, and 

welcome her to the panel, and I thank the chairman for inviting 

her. 

The CHAIRMAN. Thank you, Senator Alexander. 

We welcome you all. All of your statements will be made a part 

of the record in their entirety. We’ll proceed in reverse order of the 

introductions. We’ll start with Dr. Kainer. 

Dr. Kainer, I’m sure I speak for all the committee. You have our 

highest praise, and we thank you for your diligence—for being on 

top of this immediately and for doing exactly what needed to be 

done in getting it to the Center for Disease Control. I’ll just echo 

what Senator Alexander said. Your timely action and professionalism undoubtedly saved many lives. 

Thank you very much and please proceed. Welcome to the committee. 

STATEMENT OF MARION KAINER, M.D., MPH, FRACP, DIRECTOR, HEALTHCARE ASSOCIATED INFECTIONS & ANTIMICROBIAL RESISTANCE PROGRAM, TENNESSEE DEPARTMENT OF HEALTH, NASHVILLE, TN 

Dr. KAINER. Thank you. On behalf of the Tennessee Department 

of Health, I would like to thank Senator Alexander for the oppor-
56 

tunity to comment on the fungal meningitis outbreak. I’m the director of the Healthcare Associated Infections and Antimicrobial 

Resistance Program. 

In Tennessee, we now report 81 cases and 13 deaths. Our concerns and prayers for patients, families, and loved ones affected by 

this preventable tragedy are ongoing. There are many heartbreaking stories. Some have been reported in the media. Diana 

Reed’s death devastated her family. Her husband has Lou Gehrig’s 

Disease and Diana was her husband’s arms, legs, and voice and 

kept his accounting business going. 

Fungal meningitis is extremely rare. One of our greatest challenges was knowing just what we were dealing with as more and 

more patients fell ill. Even though we were looking for fungus, because the initial patient reported to us had been diagnosed with 

fungal meningitis, none of the diagnostic tests yielded confirmed 

results until October 3d, 15 days after we initiated our investigation of the first case. My written remarks include a detailed chronology. 

I would like to direct your attention to some early lessons 

learned from this outbreak. First, compounding of medications 

must be performed safely. Patients and healthcare providers should 

expect safe and effective medications. Compounding pharmacies do 

provide a needed service. If compounded products are unavailable 

to meet the unique needs of some patients, providers may perform 

compounding or repackaging themselves at the bedside and may 

also put patients at risk. 

Second, recent investments in public health infrastructure 

through cooperative agreements from the CDC have supported 

building public health capacity. This capacity was critical in identifying and responding to this outbreak, determining the cause resulting in product recall only 8 days after initial notification, saving lives and limiting the number of patients exposed. 

Six members of our Healthcare Associated Infections or HAI 

team are funded through the Prevention and Public Health Fund 

Epidemiology and Laboratory Capacity grant and the Emerging Infections Program. In addition, the team has a CDC/CSTE fellow. I 

am the only person on the HAI team not funded by the CDC. 

Our HAI team had the expertise to conduct on-site visits, to ask 

the right questions, create a database, and enter and analyze the 

data swiftly to determine the cause of the outbreak and those at 

highest risk of getting sick. We did an analysis to assess the potential impact if there had been a delay in the recall from NECC by 

9 days. In Tennessee alone, we estimate by now, we would have 

seen an additional 59 cases and at least five additional deaths. 

To prevent healthcare associated infections, our team has built 

close relationships with infection preventionists. These relationships are built on mutual trust and have been invaluable in promoting open communication. Surge capacity was provided by staff 

funded under the Epidemiology and Laboratory Capacity and the 

Public Health Emergency Preparedness grants. 

These staff reviewed clinical information and helped track down 

over 1,000 exposed patients. Contact by phone or in person was 

made by local public health staff funded by the State of Tennessee. 

Outreach included frequent telephone calls and knocking on doors. 
57 

Our nurses tracked down one patient by contacting a tour operator 

in Yellowstone Park. 

Third, this outbreak illustrates the tremendous importance of 

inter-facility communication when patients may seek medical services in multiple facilities for complications that arise from treatment at another facility. It also illustrates the critical importance 

of astute clinicians in alerting public health. 

In conclusion, this has been a devastating outbreak for patients, 

their families and friends, healthcare providers and clinics. In Tennessee, we still have many patients hospitalized and suffering from 

complications and others who are exposed and frightened that they 

may become affected. 

Sustained commitment to funding from CDC for emergency preparedness and reduction of healthcare associated infections has 

supported our productive relationships with partners and 

healthcare providers across the State. These preexisting relationships allowed us to respond quickly because we trusted each other. 

We all need to work together to do our best to prevent such a tragedy from occurring again and to ensure that we have a public 

health capacity to detect and rapidly respond to any future outbreaks. 

Thank you for your time and attention. 

[The prepared statement of Dr. Kainer follows:] 

PREPARED STATEMENT OF MARION KAINER, M.D., MPH, FRACP 

SUMMARY

Communication and coordination among healthcare providers and public health in 

Tennessee was unusually strong thanks to major Federal grants to the State that 

have supported tracking and improving rates of hospital-acquired infections. Years 

of close collaboration between public health staff in the federally funded healthcare 

associated infection program and hospital-based infection preventionists in the State 

resulted in relationships and mutual trust that permitted easy collaboration during 

the investigation and response to this crisis. 

Despite this close relationship, cracking this investigation was difficult because of 

the significant technical challenges in definitively diagnosing fungal meningitis. We 

had to take actions days in advance of being able to confirm that we were definitely 

dealing with a fungus. With CDC’s help, we have been able to diagnose people much 

more easily since the early days of the outbreak. A timeline of the major events in 

this investigation is provided in the attached written testimony. 

Recent investments in public health infrastructure through cooperative agreements from the CDC have built public health capacity at the TDH. This capacity 

was invaluable in identifying and responding to the outbreak, determining the cause 

resulting in product recall only 8 days after initial notification, saving lives and limiting the number of patients administered the contaminated injections. In Tennessee, if the recall from NECC had been delayed by 9 days, we estimate that at 

this time we would have seen an additional 59 cases and at least 5 additional 

deaths. If treatment guidance from CDC had been delayed, the number of deaths 

would be even higher. Of the 33 Tennessee patients who sought medical care before 

October 3, 9 (27.3 percent) died. Of the 48 patients who sought medical care on, or 

after October 3, when the first CDC treatment guidance was issued, four (8.3 percent) died. 

Six members of the Healthcare Associated Infections (HAI) team are funded 

through the Prevention and Public Health Fund Epidemiology and Laboratory Capacity Cooperative agreement and the Emerging Infections Program. In addition, 

the team has a CDC/Council of State and Territorial Epidemiologists (CSTE) fellow. 

The only person not funded by CDC is the director of the HAI program, Dr. Kainer. 

The team had the expertise to ask the right questions, conduct on-site visits, create 

relevant standardized investigation forms, create a data base, enter and analyze the 

data swiftly to determine the cause of the outbreak and those at highest risk of getting sick. Surge capacity was provided by staff funded under the Epidemiology and 

Laboratory Capacity (ELC) grant and the Public Health Emergency Preparedness 
58 

(PHEP) cooperative agreements as well as an additional CDC/CSTE fellow and an 

Epidemic Intelligence Service (EIS) officer assigned to Tennessee. State-funded public health nurses in the field were mobilized to contact hard to reach patients, going 

door to door when necessary, and maintaining regular phone and in person contact 

with patients for weeks. 

This has been a devastating outbreak for patients, their families and friends, 

healthcare providers and clinics. In Tennessee we still have many patients hospitalized and suffering from complications and others who are exposed and frightened 

that they may become infected. Sustained commitment to funding for emergency 

preparedness and reduction of healthcare associated infections through cooperative 

agreements from the CDC has supported our productive relationships with our partners and healthcare providers across the State. These pre-existing relationships allowed us to respond quickly because we trusted each other. We all need to work 

together to do our best to prevent such a tragedy from occurring again and to ensure 

that we have the public health capacity to detect and rapidly respond to any future 

outbreaks. 

On behalf of the Tennessee Department of Health, I would like to thank Senator 

Alexander for the opportunity to comment on the recent fungal meningitis outbreak. 

I hope to provide some insights from this tragic outbreak to the Health, Education, 

Labor, and Pensions (HELP) Committee which I hope will assist the committee to 

gain an understanding of potential opportunities to prevent and respond to such 

devastating outbreaks in the future. 

As of November 13, Tennessee reported 81 cases and 13 deaths. Behind each one 

of these numbers is a lot of suffering of the patients affected, their loved ones and 

the communities in which they participated. One example: The death of Diana Reed 

who, according to her brother, was her husband’s arms, legs and voice, has been 

devastating. Her husband has Lou Gehrig’s Disease and Diana was instrumental in 

keeping his accounting business going and in helping her husband get in and out 

of bed, the shower and his wheelchair. The family is trying to figure out how they 

will carry on and enable her husband the ability to maintain his dignity and to keep 

his work without her; they shared their story with the New York Times. 

Fungal meningitis is extremely rare. One of our great challenges was knowing 

just what we were dealing with as more and more patients fell ill. Even though we 

were looking for a fungus because the initial patient reported to us had been diagnosed with a fungal meningitis, none of the diagnostic tests yielded confirmed results until October 3, 15 days after we initiated our investigation of the first case. 

Below is an outline of the timeline of major events of this outbreak and the role 

of the Tennessee Department of Health in this investigation. I will also discuss lessons learned in the context of this investigation. 

Timeline of Major Events 

Date Major events Case count as known at that time 

Day 1: Tuesday, Sept. 18 ..... Dr. Marion Kainer, Director of the Tennessee Department 

of Health (TDH) Healthcare Associated Infections and 

Antimicrobial Resistance Program, receives an email 

sent by Dr. April Pettit, Infectious Diseases Physician, 

Vanderbilt University Medical Center (VUMC) about a 

patient with meningitis caused by a fungus, Aspergillus fumigatus, who had a recent epidural injection 

at a pain clinic.

Dr. Kainer and Dr Pettit discuss the case ........................

Dr. Kainer speaks with Ms. Candace Smith, infection 

preventionist (IP) at St Thomas Hospital (STH), which 

is organizationally affiliated with the St Thomas Outpatient Neurosurgical Center (STONC) where the patient received the injection. Dr. Kainer requests details of the procedure, states that the infection is a 

sentinel event of concern, which deserves a careful 

investigation and requests that Ms. Smith commence 

an inspection of the pain clinic (e.g., evidence of any 

construction, water damage) and to inquire about any 

potential additional cases.

1 case of Aspergillus meningitis 
59 

Timeline of Major Events—Continued 

Date Major events Case count as known at that time 

Day 3: Thursday, Sept 20 .... IP from STH contacts Dr. Kainer and confirms that index 

case had an epidural steroid injection (ESI) at 

STONC; provides details of the procedure. Because 

the facility manager of STONC is on vacation, the IP 

at STH continues to help in the investigation.

Dr. Kainer contacts Dr. Perz at the Division of 

Healthcare Quality Promotion (DHQP), Centers for Disease Control and Prevention (CDC) to ask whether 

any cases of Aspergillus meningitis had been reported to CDC from any other ambulatory surgery 

centers (ASC) or pain clinics. Fungal meningitis is 

rare, but is not required to be reported to the CDC. 

Even without any requirement, clinicians or States 

often contact CDC about unusual infections; however, 

no one had recently contacted the Mycotics Branch at 

CDC to report any cases of Aspergillus meningitis.

STH reports two additional patients with meningitis with 

high levels of white blood cells but no known cause. 

Both had undergone ESIs at STONC. Diagnoses were 

complicated because the patients appeared to be 

getting better and the cause of their meningitis was 

unknown. Dr. Kainer worked with clinicians to request 

exhaustive diagnostic tests. They also had ESI performed by same anesthesiologist at STONC. The preservative-free methylprednisolone acetate used in 

their ESIs was obtained from New England 

Compounding Center (NECC).

Arrange for one on Dr Kainer’s staff to visit STONC the 

next morning, with the IP and the ID physician from 

STH..

On this day, STONC closes voluntarily, 

sequesters supplies and orders new 

supplies from other distributors.

1 case of Aspergillus meningitis 

2 cases of meningitis, unknown 

cause, both seeming to be 

improving 

No national reports of Aspergillus meningitis 

Day 4: Friday, Sept 21 ......... Visit to STONC by TDH staff for a careful review of all 

procedures and the physical environment: no evidence 

observed of environmental conditions that would have 

led to fungal contamination of procedures.

TDH contacts CDC and describes findings of site visit. 

TDH asks CDC to help with laboratory testing of patients with meningitis of unknown cause (because 

fungus is very hard to diagnose) and also for testing 

of environmental samples from the clinic, if needed.

Another patient with meningitis and stroke with a history of ESI at STONC is identified, while VUMC also 

reports yet another patient who had a stroke and had 

an epidural injection, but at the time it was not clear 

where the ESI was done (it was confirmed as STONC 

on Day 7).

TDH sent out a Health Alert using our TN Health Alert 

Network (THAN), asking clinicians to look for and report any cases of meningitis following epidural injection to the TDH.

At this time, the leading suspected causes of meningitis 

were the contrast media and methylprednisolone acetate (MPA) from NECC because both were used in 

each patient (and are commonly given together for an 

ESI). Other less likely possibilities included local anesthetic, local skin preparation and needles used for 

the injection.

1 case of Aspergillus meningitis 

2 cases of meningitis of unknown cause 

1 case of stroke and meningitis, 

unknown cause 

1 case of stroke, no spinal tap 

was done 

Day 6: Sunday, Sept 23 ....... IP at STH contacts Dr. Kainer about one new patient 

and one patient re-admitted with meningitis; both 

had ESI at STONC.
60 

Timeline of Major Events—Continued 

Date Major events Case count as known at that time 

Day 7: Monday, Sept 24 ....... Facility manager from STONC has returned from vacation and provides additional information on the facility practices. TDH staff arrange to begin collecting 

data on patients to try to find out what distinguishes 

the case patients from those who did not get sick. 

TDH and CDC communicating closely.

Dr. Kainer contacts State epidemiologist at Massachusetts Department of Health, Dr. Al DeMaria, to request a conference call with TDH, CDC, MA staff and 

NECC to obtain distribution list of clinics that got 

MPA from NECC in order to look for other cases of 

meningitis among patients who received ESI with 

MPA compounded by NECC.

1 case Aspergillus meningitis 

4 cases of meningitis unknown 

cause 

1 case of stroke, but no spinal 

tap done 

Day 8: Tuesday, Sept 25 ...... 2 new cases of meningitis reported to TDH. Both had 

ESI using MPA from NECC at STONC; however, one of 

the patients did not receive the suspected contrast 

and the procedure was done by a different anesthesiologist.

Conference call with TDH, CDC, Massachusetts Department of Health and Board of Registration in Pharmacy (MABRP) and NECC. NECC stated no adverse 

events reported, no new suppliers of ingredients or 

changes in procedures. TDH described severity of 

cases and that preservative free MPA was leading hypothesis. TDH requested distribution list and verified 

that voluntary recall procedures were in place.

TDH staff begin collecting all the medical information 

needed to conduct their epidemiologic studies.

STONC starts contacting potentially exposed patients .....

A new patient who had an ESI at STONC was admitted 

to STH with numbness and bowel/bladder control 

problems, but no headache or fever. Her spinal tap 

shows signs of meningitis of unknown cause, but 

with a much lower white blood cell count than the 

other cases of meningitis.

1 case Aspergillus meningitis 

6 cases of meningitis unknown 

cause 

1 case of stroke, but no spinal 

tap done 

1 case of other neurologic problems and abnormal spinal tap 

(unknown cause) 

Day 9: Wednesday, Sept. 26 NECC issues voluntary recall for three lots of preservative free MPA and provides distribution list of consignees to MABORP and FDA.

TDH and CDC draft an Epi-X Alert (national emergency 

alert system for public health professionals) to report 

cases of meningitis related to epidural injections.

TDH continues to followup on patients who received ESI 

at STONC to look for any other unusual illnesses or 

complications.

CDC helps TDH by making available a medical doctor 

with expertise in treating fungus to assist TN clinicians in caring for patients.

Day 10: Thursday, Sept. 27 TDH staff complete first round of epidemiologic studies; 

preliminary findings supports that MPA is a likely 

source..

TDH asks STONC to contact all patients who had procedures since July 30.

Analysis of the NECC distribution list shows two other 

clinics in TN received MPA. These clinics are contacted and all MPA is sequestered. Both clinics cease 

performing ESIs.

The first clear evidence that the meningitis cause is not 

related to the STONC clinic: North Carolina (NC) reports a patient with meningitis exposed to MPA from 

NECC.
61 

Timeline of Major Events—Continued 

Date Major events Case count as known at that time 

Day 11: Friday, Sept. 28 ...... It is still not absolutely clear that the MPA from NECC 

is the only possible source of contamination: the NC 

case patient had also received lidocaine and 

povidone iodine from the same manufacturers used 

by STONC. The lidocaine was the same lot number.

CDC notifies all State Health Departments of situation 

and urges them to contact clinics who do ESIs to ask 

them to contact and check on the health of recipients 

of MPA using a script prepared by CDC. They ask 

that this be done immediately, not waiting until after 

the weekend.

CDC issues another national Epi-X alert indicating that 

this now is a multistate outbreak and requesting reports of meningitis, other neurological infections, and 

stroke. TDH sends its own alert through THAN to clinicians and hospitals in TN to look for and report 

meningitis, stroke and focal infections in patients 

who have had epidural injections.

Still, all diagnostic tests on these cases remain negative. The only patient with a confirmed diagnosis remains the first case patient reported. This highlights 

the difficulty of diagnosing a fungal infection, even 

when one is looking very hard to find it.

TDH continues to work on epidemiologic studies to learn 

more about these patients, despite not yet having a 

confirmed diagnosis. TDH requests assistance from 

CDC to abstract clinical data from patient records 

(help arrives on Day 14).

Day 13: Sunday, Sept 30 ..... TDH and STONC staff continue to abstract data on patients who had procedures since July 1.

Day 14: Monday, Oct 1 ........ TDH holds its first press conference and initiates a daily 

scheduled press briefing.

TDH partners with the State Poison Control Center to assist in responding to questions from the general public.

Other TN clinics continue to contact patients exposed to 

MPA from NECC. CDC and TDH staff work on gathering patient data to continue studies.

TDH participates on call with expert fungal clinical 

panel convened by CDC, discuss need for CDC to provide interim suggestions/advice to clinicians on diagnosis and treatment.

11 cases, 2 deaths 

Day 15: Wednesday, Oct 3 ... CDC issues interim guidance on diagnostics and clinical 

management using input from an expert fungal clinical panel convened by CDC.

For the first time since the initial report, a tissue biopsy from a case patient shows a fungus. However, 

the fungus looks different than Aspergillus. More 

tests must be done to identify it.

TDH issues another alert through THAN to clinicians to 

help them identify, diagnose and treat ill persons exposed to MPA from NECC.

TDH analysis of STONC patients suggests that one particular lot of the three NECC MPA lots present at 

STONC is the most likely to make patients sick: Lot 

06292012.

18 cases, 2 deaths 
62 

Timeline of Major Events—Continued 

Date Major events Case count as known at that time 

Day 16: Thursday, Oct 4 ...... A final identification of the fungus causing illness is 

still not made, but a specimen from another patient 

who died shows a fungus that is not Aspergillus.

FDA announces fungus was seen on microscopic examination of an unopened vial of MPA from Lot 

08102012. This now is very strong evidence that MPA 

is the cause of the outbreak.

TDH alerts TN healthcare facilities using THAN to cease 

use of all medications and products from NECC.

Day 17: Friday, Oct 5 ........... TDH opens State health operations center to assist in 

case tracking, active surveillance (contacting, reaching out to all persons who received MPA from NECC 

at any of the three Tennessee clinics—a total of 

1,009 persons). Mobilize regional health operations 

centers and use public health nurses to contact hard 

to reach patients, going door to door when necessary. 

Public health nurses maintained regular phone and in 

person contact with affected patients for weeks, 

changing messaging as required to adjust to a fluid 

and constantly changing scientific understanding and 

related patient needs.

The CDC has another meeting of its expert fungal panel 

29 cases, 3 deaths 

Day 18: Saturday, Oct 6 ...... NECC announces voluntary recall of all NECC products ..

FDA issues Medwatch alert asking providers to stop 

using any NECC products.

29 cases, 3 deaths 

Day 24: Friday, Oct 12 ......... MMWR (CDC publication) is published on clinical presentation of cases.50 cases, 6 deaths 

Day 26: Sunday, Oct 14 ....... FDA call with States and CDC on concerns about sterility of any product from NECC.53 cases, 6 deaths 

Day 27: Monday, Oct 15 ...... FDA issues Medwatch alert ...............................................

TDH works with the Tennessee Hospital Association 

(THA), the TN medical association (TMA), the ambulatory surgery center association and the TN pharmacist 

association to assist in alerting hospitals, providers 

and clinics to identify and notify patients who received NECC products.

53 cases, 6 deaths 

Day 29: Wednesday, Oct 17 TDH identifies that patients who received older vials are 

much more likely to get sick. Questions begin about 

whether or not to test these patients even if they are 

not sick, if testing might prevent serious illness such 

as stroke.

61 cases, 8 deaths 

Day 30: Thursday, Oct 18 .... TDH works with CDC experts to develop a mathematical 

model used for decision analysis by CDC about what 

to do for high risk patients.

For the first time, CDC and FDA confirm presence of 

Exserohilum rostratum in unopened vials 

from Lot 0810210@51.

This is now definitive evidence that contaminated MPA 

is the cause of the outbreak.

63 cases, 8 deaths 

Day 35: Tuesday, Oct 23 ...... MA Board of Registration in Pharmacy issues report of 

initial preliminary findings.

70 cases, 9 deaths 

Day 38: Friday, Oct 26 ......... FDA releases copy of FDA form 483. All 50 vials of MPA 

tested showed contamination (likely fungal).

74 cases, 10 deaths 

Day 48: Tuesday, Nov 6 ....... The New England Journal of Medicine publishes an article written by TDH and CDC investigators on this outbreak: http://www.nejm.org/doi/full/ 

10.1056/NEJMoa1212972.

78 cases, 13 deaths 

Day 51: Friday, Nov 9 .......... TDH invited to provide testimony to the Senate HELP 

committee.

TDH requests on-site assistance again from CDC to describe later complications of fungal infection, such as 

epidural abscess, arachnoiditis and risk factors. Two 

EIS officers will arrive on-site on Nov 13.

81 cases, 13 deaths 
63 

LESSONS LEARNED

1. Compounding and/or repackaging of medications must be performed safely. Patients and healthcare providers should expect safe and effective medications. 

Compounding pharmacies provide a needed service. If compounded products are unavailable to meet the unique needs of some patients, providers may perform 

compounding or repackaging themselves at the bedside and may also put patients 

at risk. 

2. Recent investments in public health infrastructure through cooperative agreements from the CDC have supported building public health capacity at the TDH. 

This capacity was invaluable in identifying and responding to the outbreak, determining the cause resulting in product recall only 8 days after initial notification saving lives and limiting the number of patients administered the contaminated injections. Specific examples are provided below: 

a. Six members of the Healthcare Associated Infections (HAI) team are funded 

through the Prevention and Public Health Fund Epidemiology and Laboratory Capacity Cooperative agreement and the Emerging Infections Program. 

In addition, the team has a CDC/Council of State and Territorial Epidemiologists (CSTE) fellow. The only person not funded by CDC is the director of 

the HAI program, Dr. Kainer. 

i. The team had the expertise to ask the right questions, conduct on-site 

visits, create relevant standardized investigation forms, create a database, enter and analyze the data swiftly to determine the cause of the 

outbreak and those at highest risk of getting sick. 

ii. In Tennessee, if the recall had been delayed by 9 days, we estimate 

that at this time we would have seen an additional 59 cases and at 

least 5 additional deaths. If treatment guidance from CDC had been 

delayed, the number of deaths would be even higher. 

iii. To prevent healthcare associated infections, the team has built very 

close relationships with infection preventionists at hospitals, the Tennessee Hospital Association and is building relationships with the ambulatory surgery center community. These relationships are built on 

mutual trust and have been invaluable in promoting open communication. 

b. Surge capacity was provided by staff funded under the Epidemiology and 

Laboratory Capacity (ELC) grant and the Public Health Emergency Preparedness (PHEP) cooperative agreements as well as an additional CDC/ 

CSTE fellow and an Epidemic Intelligence Service (EIS) officer assigned to 

Tennessee. 

i. These staff-funded provided assistance in reviewing clinical information 

on suspect and confirmed cases, and in tracking down 1,009 exposed 

patients. Contact by phone or in person was made by local public 

health department staff, funded by the State of Tennessee, sometimes 

with assistance from law enforcement. Outreach included frequent telephone calls and door to door tracking, including home visits whenever 

necessary. Some exposed patients were living in or traveling in other 

States or were overseas when they developed symptoms. 

ii. The State Health Operations Center provided the necessary infrastructure to coordinate activities among the 170 public health staff in Tennessee. 

iii. The alert network (THAN) connecting TDH with clinicians and staff 

at hospitals was invaluable in rapidly getting information out. 

iv. We were able to use a database designed for tracking persons in shelters to track patients who were exposed. 

3. Relationships with Federal partners were critical in the response to this outbreak. 

a. CDC provided invaluable assistance throughout the outbreak including 

weeknights and weekends. Some examples include: 

i. Laboratory support: CDC developed a diagnostic test to assist in the 

outbreak investigation and provided laboratory support for confirming 

the identities of fungal isolates. The infectious diseases pathology 

branch has been providing valuable insights on how this fungus behaves and the type of damage it does to tissues. This has greatly assisted the clinicians on the fungal expert working group. 

ii. Clinical support: TDH was fortunate to have CDC Epidemic Intelligence Service Officers on-site to assist in clinical data abstraction. 

CDC regularly convenes the expert fungal panel to develop diagnostic 
64 

and management guidance that has been constantly updated with the 

latest clinical information. This has been very helpful to clinicians, 

many of whom have never treated fungal meningitis before, and this 

guidance without a doubt saved a lot of lives. Of the 33 Tennessee patients who sought medical care before October 3, 9 (27.3 percent) died. 

Of the 48 patients who sought medical care on, or after October 3, 

when the first CDC treatment guidance was issued, four (8.3 percent) 

died. 

iii. Communications: CDC has provided relevant, up-to-date information 

on case counts, diagnostic and treatment guidance, case definitions, 

etc, . . . on their Web site, through EPI–X alerts and the Health Alert 

Network. They have hosted regular conference calls with State partners and other Federal partners to ensure accurate dissemination of 

information. 

iv. Epidemiologic support: CDC has provided technical support (e.g., reviewing logistic regression models, running survival analyses) as well 

as coordinated the aggregation of data across multiple States to provide a complete national picture. Examples of critical information include distribution of incubation periods. CDC provided expertise in 

mathematical modeling to review whether guidance needed to be 

changed for asymptomatic patients at high risk of infection in order 

to prevent strokes or death. 

v. Coordination: CDC has coordinated the national response with other 

States and the FDA. 

vi. Funding through cooperative agreements—please see above note #2 on 

how these funds were used to build capacity at the TDH. 

b. FDA provided valuable information on local inspection findings, as well as 

laboratory testing of products 

i. The information provided by FDA was extremely helpful. It also would 

have been helpful if FDA had shared interim findings with TDH and 

other State health departments to allow them a better understanding 

of the extent of the problem at the compounding pharmacy. This type 

of information is very helpful as State health departments attempt to 

gauge the level of risk and consider surveillance strategies. 

4. Relationships and Infrastructure 

a. By focusing on emergency preparedness and on reducing healthcare associated infections, we have made much progress in enabling rapid communication between public health and hospitals; however challenges remain, especially with providers who do not work in hospitals (e.g., ambulatory surgery 

centers) and with medical specialists who are not traditional emergency response partners. 

b. Use of electronic health records allowed tremendous savings in time in allowing us to monitor the clinical progress of patients and saved time and resources at the affected hospitals. 

c. This outbreak illustrated the tremendous importance of inter-facility communication when patients may seek medical services in multiple facilities for 

complications that arise from treatment at another facility. Reporting to public health is critical, as Dr. Pettit’s email illustrated. 

d. Communication with exposed patients during periods of great uncertainty 

was very important. Public health played a vital role in finding exposed patients that were difficult to reach and when clinic staff were overwhelmed 

with the task at hand. 

e. Communication with media: Frequent press-briefings allowed TDH to effectively communicate important public health messages in a dynamic and rapidly evolving outbreak while allowing staff to continue to do critical work. 

CONCLUSION

This has been a devastating outbreak for patients, their families and friends, 

healthcare providers and clinics. In Tennessee we still have many patients hospitalized and suffering from complications and others who are exposed and frightened 

that they may become infected. Sustained commitment to funding for emergency 

preparedness and reduction of healthcare associated infections through cooperative 

agreements from the CDC has supported our productive relationships with our partners and healthcare providers across the State. These pre-existing relationships allowed us to respond quickly because we trusted each other. We all need to work 

together to do our best to prevent such a tragedy from occurring again and to ensure 
65 

that we have the public health capacity to detect and rapidly respond to any future 

outbreaks. 

Thank you for your time and attention. 

The CHAIRMAN. Thank you, Dr. Kainer. 

Now we’ll turn to you, Mr. Miller, for your statement. 

STATEMENT OF DAVID G. MILLER, R.Ph., EXECUTIVE VICE 

PRESIDENT AND CEO, INTERNATIONAL ACADEMY OF COMPOUNDING PHARMACISTS, MISSOURI CITY, TX 

Mr. MILLER. Thank you, Chairman Harkin. I also thank the 

members of the committee. My name is David Miller. I am the executive vice president and I am proud to serve also as the CEO of 

the International Academy of Compounding Pharmacists. 

We are a professional association that represents pharmacists in 

a wide variety of practices, local community pharmacies, hospitals, 

nursing homes, hospice centers. Each one of those pharmacists and 

the pharmacy technicians and the student pharmacists that belong 

to our organization actually specialize in the development of customized medication solutions that patients need in order to meet 

their particular health needs. 

The tragedy of New England Compounding Center, NECC, is 

quite simple to us as an organization. They were a pharmacy that 

was essentially hiding behind that license and, in reality, acting as 

an illegal drug manufacturer. Plain and simple, what NECC did 

was to violate the trust that every member of the public has, specifically, in their local pharmacist, but even more so tainted the 

reputation of pharmacists in every practice setting throughout the 

country and placed their trust in jeopardy. 

We know that NECC now acted with impunity. They failed to adhere to the quality standards that our organization, our profession, 

and our government require of us at both the State and Federal 

level. We know also that NECC ignored State laws and Federal 

laws as they manufactured illegally and distributed bulk quantities 

of prescription drugs throughout the country. 

We know what NECC did. We do not yet know fully the extent 

of what allowed them to do that. It is clear that the State Board 

of Pharmacy of Massachusetts failed to do their job. They failed to 

protect the citizens of Massachusetts and, most importantly, because other States relied upon their action, their inspections, and 

their follow-through, permitted NECC to continue its illegal activities and distribute tainted medications into States throughout the 

United States. 

More importantly, we also know that the FDA knew, as we heard 

on the previous panel, of the problems with NECC. One of the 

things that we find particularly appalling, not only as a profession 

but, specifically, a professional association, is that there is no question whether or not the Food and Drug Administration had regulatory authority over this particular business. They were engaged 

in illegal manufacturing of drugs. The FDA is empowered through 

the FDCA and this Congress to stop illegal manufacturing. 

I have heard for 2 days and have seen a map that actually was 

created by IACP being referred to by the agency as a crazy quilt. 

There are questionable overlaps in the regulation of compounding 

pharmacy. Let me reiterate that there is no question who has the 
66 

* The Summary was provided by the International Academy of Compounding Pharmacists, of 

which, David G. Miller, R.Ph., is Executive Vice President and CEO. 

authority to immediately shut down an illegal prescription drug 

manufacturer. That rests with the FDA. 

That is something that we find particularly disturbing, that the 

agency, who knew that NECC was distributing drugs without patient-specific prescriptions throughout the United States, did nothing to stop them. 

Last, one of the things that we have to ask ourselves as a 

healthcare system is what prompted clinicians, hospitals, facilities 

throughout the United States to obtain medications from a pharmacy. We know in this particular case of methylprednisolone acetate, the medication at issue, and others that NECC produced was 

a product that was manufactured and available in the marketplace. 

What prompted, what allowed, and what permitted physicians, 

hospitals, et cetera, to purchase from an illegal manufacturer? As 

one of the members from the State of Tennessee asked me when 

this first issue came to light, why did a hospital in Tennessee buy 

medicine from a pharmacy outside of Boston? Why did they not 

turn to a local accredited sterile compounding pharmacy? Why did 

they do that? 

That’s a question, Mr. Chairman and members of the committee, 

we don’t yet know. There’s much we don’t know. What I can tell 

you is this, as an organization representing and comprised of pharmacists and pharmacy technicians, we are absolutely committed to 

making sure this never happens again. No compounding pharmacist should be able to hide behind their license as a pharmacy 

or a pharmacist when, in reality, their actions are illegal drug 

manufacturing. We have to stop that. 

I thank the committee, and I look forward to working with you 

as we attempt to solve this problem as expeditiously as possible. 

Thank you, sir. 

[The prepared statement of Mr. Miller follows:] 

PREPARED STATEMENT OF DAVID G. MILLER, R.PH. 

SUMMARY* 

IACP Vice President of Government Affairs Sarah Dodge said, 

‘‘IACP appreciates the opportunity to provide input as the U.S. Senate HELP 

Committee seeks to better understand current Federal and State oversight of 

pharmacy compounding and explore the possibilities for a legislative solution to 

the tragedy surrounding New England Compounding Center (NECC) business 

practices.’’ 

‘‘We believe we share similar goals: an understanding of how this tragedy 

happened, what can be done to prevent it from ever happening again, and ultimately how do we assure that compounding pharmacists are able to practice 

their professional expertise without overly burdensome regulations which inhibit quality patient care.’’ 

The State and Federal regulatory scheme for pharmacy compounding is complex— 

IACP members have valuable experience and technical understanding of the laws 

that govern our industry. IACP stands ready to help legislators and regulators to 

assist in conducting a thorough and complete assessment of State and Federal laws 

governing the practice of pharmacy. We believe this assessment must also examine 

how regulators exercise their jurisdiction and discretion in enforcement. IACP 

strongly believes that, in Massachusetts as well as other States, many laws and regulations exist that—if they had been followed and compliance had been enforced— 

would have severely mitigated the potential for the tragic meningitis infections and 

the needless deaths that have occurred. 
67 

The apparent and tragic results of NECC’s alleged behavior undermine the fundamental principal of pharmacists’ practice—preserve patient health by doing no 

harm. We are determined to help find the gaps in the practice, regulatory, and enforcement system which permitted this problem to happen and produce real solutions to prevent it from occurring in the future. Our profession stands ready to work 

with leaders from across the Federal and State governments to make sure that what 

happened at NECC never happens again. 

Not only does Massachusetts have State sterility requirements and United States 

Pharmacopeia (USP) Standard compliance requirements, but it retains the right to 

pull a pharmacy’s license, if that pharmacy is practicing outside the scope of its licensing requirements. 

By all current indications, the operations of NECC were clearly outside of the 

scope of their own and other States’ licensure requirements and their license should 

have been pulled long ago. The Massachusetts Board of Pharmacy had the authority 

to do so. The FDA also had the authority to do so once they identified NECC as 

engaging in the illegal manufacturing and distribution of a prescription drug. 

At a minimum, knowing what they did, both the State and the FDA should have 

worked together to force the pharmacy to register as a manufacturer and to comply 

with Current Good Manufacturing Practice Guidelines (cGMP). Unfortunately, 

NECC showed a blatant disregard for existing rules and regulations (no matter 

what the law was or might have been, their behavior suggests that they would not 

have followed it). 

Additionally, and still to be answered by both regulatory agencies, is this fundamental question: If both the State and the FDA knew of problems at NECC—and 

we know that they did, based on publicly disclosed documents—why did they fail 

to followup or take action? New regulations or new laws are meaningless if the regulatory agencies charged with upholding them simply turn a blind eye to problems 

and fail to do their job. 

IACP supports the following State actions, at a minimum, to help mitigate further 

problems with sterility and other potential patient hazards: 

• All Boards of Pharmacy must be adequately funded by State legislatures in a 

manner sufficient to hire trained/educated pharmacists to conduct regular inspections of all pharmacies. Too many Boards have been ‘‘de-funded’’ by legislatures that 

have funneled revenue from the Boards into the States’ general funds leaving administrative gaps; 

• Board inspectors conducting compounding pharmacy inspections in both community and institution settings must receive training in both the State regulations 

pertaining to compounding as well as the practice itself; 

• All States must adopt mandatory compliance with USP <795> and <797> standards. Only 17 currently mandate that in their laws. All pharmacies providing 

compounding services—regardless of practice setting—must be held accountable to 

those standards; 

• State Boards must ‘‘police’’ themselves and provide the necessary assurances to 

other State Boards which depend upon them for conducting inspections for non-resident pharmacies in a regular and consistent manner. Massachusetts’s Board obviously failed to execute its responsibilities both to its citizens as well as patients in 

other States in which NECC was licensed by not conducting regular inspections. 

IACP looks forward to the opportunity to testify before the Senate HELP Committee on November 15, 2012 to further address these critical issues. 

The International Academy of Compounding Pharmacists (IACP) appreciates the 

opportunity to provide input to the Senate HELP Committee as the committee and 

legislators seek to better understand current Federal and State oversight of pharmacy compounding and explore the possibilities for a legislative solution to the tragedy surrounding New England Compounding Center (NECC) business practices. 

IACP is an international, professional association established in 1991 to protect, 

promote and advance the art and science of pharmacy compounding. IACP provides 

support to more than 2,700 members through programs and services including reimbursement/third-party advocacy, government representation, regulatory analysis, 

public relations support, referral services and a fellowship program. IACP also represents more than 164,000 patient and practitioner advocates as part of our P2C2 

grassroots network. 

IACP members are individuals; IACP does not represent or advocate on behalf of 

specific pharmacies, businesses or companies. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians 

to create customized medication solutions for patients and animals whose health 
68 

care needs cannot be met by standardized medications manufactured by the pharmaceutical industry. 

IACP believes we share similar goals: an understanding of how this tragedy could 

happen, and how to ensure the safest possible practice of compounding in the future. 

The State and Federal regulatory scheme for pharmacy compounding is complex— 

IACP members have valuable experience and technical understanding of the laws 

that govern our industry. IACP stands ready to help legislators and regulators to 

assist you in conducting a thorough and complete assessment of State and Federal 

laws governing the practice of pharmacy. We believe this assessment should also examine how regulators exercise their jurisdiction and discretion in enforcement. 

The apparent and tragic results of NECC’s alleged behavior undermine the fundamentals of pharmacy, which include doing no harm. We are determined to help 

find the problem and solve it. Our profession stands ready to work with you and 

leaders from across the Federal and State governments to make sure that what happened at NECC never happens again. 

IACP strongly believes that, in Massachusetts and other States, laws and regulations currently exist that—if they had been followed and compliance had been enforced—would have severely mitigated the potential for the tragic meningitis infections that have occurred. Not only does Massachusetts have State sterility requirements and United States Pharmacopeia (USP) Standard compliance requirements, 

but it retains the right to pull a pharmacy’s license, if that pharmacy is practicing 

outside the scope of its licensing requirements. 

By all current indications, the operations of NECC were clearly outside of the 

scope of the State’s licensure requirements and their license should have been 

pulled long ago. The State and the FDA should have worked together to force the 

pharmacy to register as a manufacturer, but also to comply with Current Good 

Manufacturing Practice Guidelines (CGMP). Unfortunately, NECC showed a blatant 

disregard for existing rules and regulations (no matter what the law was, their behavior indicates that they would not have followed it). 

Millions of Americans have unique health needs that off-the-shelf prescription 

medicines cannot meet. For them, customized medicines—prescribed or ordered by 

licensed prescribers and mixed safely by trained, licensed compounding pharmacists—are the only way to better health. 

By definition, compounded medicines are different than commercial pharmaceuticals; they are prepared at the direction of licensed prescribers to meet patients’ 

individual needs that are not met by manufactured pharmaceuticals. As a result, 

Federal requirements designed for large-scale manufacture of uniformly dosed drugs 

do not apply to compounding pharmacies. 

Many patients depend on compounded medicines, including children, those with 

allergies, cancer patients, children with autism, senior citizens, menopausal women, 

hospice patients and those who rely upon discontinued drugs. For patients who are 

unable to take medications orally or as injections—the traditional dosage forms for 

manufactured drugs—compounding pharmacists can create alternate methods of delivery, like ointments, solutions or suppositories, to fit their unique health needs. 

Many, if not most, of the lifesaving intravenous drugs given in hospitals and clinics are compounded. Because hospital patients are often on multiple medications, 

compounding them into one treatment saves the hospital personnel time and the patient multiple injections or administrations. 

Additionally, compounded medications are often used by veterinarians and pet 

owners for the care of their pets. Animals come in all shapes and sizes, so one-sizefits-all pharmaceuticals do not always meet their needs. In many cases, a compounded medication may be necessary for a non-food animal to be satisfactorily 

treated. 

In 2003, IACP established a 501(c)(3) foundation to further research and educational initiatives for the advancement of pharmacy compounding. Its mission is 

to conduct and publish research studies, establish academic alliances, and institute 

educational programs and issue forums. 

In 2004, IACP joined a coalition of eight leading pharmacy professional and regulatory organizations in the creation of a voluntary accreditation program for pharmacy compounding. The Pharmacy Compounding Accreditation Board (PCAB) helps 

to assure quality and raise awareness of the profession. 

To begin with, IACP would support the following State actions to help mitigate 

further problems with sterility and other potential patient hazards: 

• All Boards of Pharmacy must be adequately funded by State legislatures in a 

manner sufficient to hire trained/educated pharmacists to conduct regular inspections of all pharmacies. Too many Boards have been ‘‘de-funded’’ by legislatures that 
69 

have funneled revenue from the Boards into the States’ general funds leaving administrative gaps; • Board inspectors conducting compounding pharmacy inspections in both community and institutional settings must receive training in both the State regulations 

pertaining to compounding as well as the practice itself; • All States must adopt mandatory compliance with USP <795> AND <797> 

standards. Only 17 currently have that on their books; and State Boards must ‘‘police’’ themselves and provide the necessary assurances to other State Boards which 

depend upon them for conducting inspections for non-resident pharmacies in a regular and consistent manner. 

Massachusetts’s Board obviously failed to execute its responsibilities both to its 

citizens as well as patients in other States in which NECC was licensed by not conducting regular inspections. 

Many States address specific compounding standards either through existing 

State laws and regulations and/or through the State’s adoption of USP standards 

for compounding pharmacy practices. IACP has submitted this information to the 

committee as part of its responses to committee questions issued to stakeholders 

prior to this hearing. 

Uncertainty about the application of section 503A does not affect oversight of 

pharmacy compounding. As mentioned, the States do address compounding, specifically, and provide appropriate governing compounding standards. Moreover, some 

States already (and all should) require mandatory compliance with USP <795> AND 

<797> standards. To reiterate, IACP supports adoption of mandatory compliance 

with USP 795/595 by all States. 

From the Federal standpoint, the FDCA’s existing inspection provision, section 

704, allows FDA oversight when a pharmacy is not operating in conformity with 

governing State laws, or akin to a drug manufacturer. FDCA section 704 contains 

two very important components: 

1. Pursuant to the first sentence of section 704(a), FDA is permitted to inspect 

‘‘all pertinent equipment, finished and unfinished materials, containers, and labeling therein’’ of any pharmacy. FDA can glean the information it needs to determine 

whether a pharmacy is engaged in manufacturing through its inspection of these 

items. 

2. FDA gains enhanced inspection authority to inspect a pharmacy that is operating as if it were a manufacturer. This authority exists whenever a pharmacy: 

(a) is not operating in conformity with State laws regulating the practice of pharmacy; 

(b) is not regularly engaged in dispensing prescription drugs upon the prescriptions of licensed practitioners; and 

(c) is compounding drugs for sale other than in the regular course of its business 

at retail. See section 704(a)(2)(A). 

Notably, the enhanced authority granted to FDA under these circumstances is the 

same inspection authority FDA possesses with regard to drug manufacturers. Thus, 

existing FDCA section 704 allows FDA to inspect a noncompliant pharmacy such 

as NECC as a manufacturer, subjecting it to inspection for ‘‘all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether 

prescription drugs . . . which are adulterated or misbranded within the meaning of 

[the FDCA] . . . have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of [the FDCA]. 

(Section 704(a) (sentence three). 

IACP strongly believes that the States have laws and regulations in place that 

regulate the professional practice of pharmacy, and they have for hundreds of years. 

State laws, for example, govern anticipatory compounding (appropriately based on 

a history between the pharmacy and the physician or patient to ensure adequate 

supply) and beyond-use dates for drugs, both of which necessarily limit how much 

of a drug may be compounded in advance. 

Anticipatory compounding is also a required component of most States’ laws to ensure timely patient access to drugs and thereby prevent wait-time and/or unavailability that may be harmful to the patient’s health. States similarly regulate such 

things as standards for active pharmaceutical ingredients (APIs) used in 

compounding; ability to compound commercial copies; and percentage of compounded preparations that may be shipped out of State, i.e., many of the things existing section 503A simply attempts to reiterate. 

Notably, when a pharmacy operates outside the scope of its State laws and regulations governing the professional practice of pharmacy, that pharmacy subjects 

itself to FDA inspection and oversight, and full FDCA application to the same extent as a drug manufacturer. NECC serves as a prime example of a pharmacy that 
70 

both breached State pharmacy regulatory laws and that should have been held accountable as a manufacturer by FDA. Such a non-State law compliant pharmacy no 

longer operates within the professional practice of pharmacy, which has always been 

effectively and traditionally regulated by the States through statutes and regulations developed over the course of more than a century. 

IACP believes that, since the practice of pharmacy (much like the practice of medicine, veterinary medicine, nursing, etc.) is already regulated at the State level, the 

majority of policy and oversight is best if implemented/addressed/enforced at the licensure level. States have the ability to remove a pharmacy’s license if that pharmacy is not operating within its licensure requirements. 

States also already have in place levels of licensure, depending on the function 

and scope of practice. The Federal Government has clear oversight and jurisdiction 

if that pharmacy is acting as a manufacturer. Should a pharmacy be acting in a 

manufacturing fashion, they should be licensed as a manufacturer and subject to 

CGMP, as are all other manufacturers. 

Again, IACP believes that all States must adopt mandatory compliance with USP 

<795> AND <797> standards. Only 17 States currently have adopted USP standards. 

With regard to ‘‘manufacturing,’’ IACP has long maintained and continues to 

maintain, that volume, percentage of sales, use of ‘‘commercial’’ equipment, or interstate sales should not be the determining factor in what constitutes a manufacturing practice. A pharmacy that focuses much of its practice upon compounding 

gains even greater experience with the activity, and thus has heightened expertise 

and experience that benefit, rather than harm, recipient patients. By analogy, an 

experienced heart surgeon is far more preferable than a surgeon who performs heart 

surgery only sporadically. IACP thus believes that rather than indicators such as 

volume, percentage of sales, interstate shipment, etc., it is the activity of the pharmacy with regard to what they do with medicines they dispense that must be scrutinized to determine whether or not they are engaged in manufacturing. 

IACP strongly believes that the current statutory definition of manufacturing (as 

it reads in the Controlled Substances Act) (CSA) sufficiently defines, and distinguishes manufacturing from the practice of pharmacy compounding (see citation) 

Notably, the CSA definition dovetails nicely with existing FDCA section 704, as described above. Both hinge on the status of ‘‘pharmacy’’ or, conversely, ‘‘manufacturer,’’ of whether the company preparing the drug operates in conformity with applicable State laws governing the practice of pharmacy and as an incident to dispensing such drug in the course of professional pharmacy practice. 

Should Congress believe it is appropriate, it may be helpful to reiterate (mirror) 

the CSA definition in the Federal Food, Drug and Cosmetic Act (FDCA) as an appropriate standard for distinguishing between drug manufacturing and the medical 

practice of pharmacy compounding. Such inclusion also promotes uniformity between the two Federal acts. The CSA, (21 U.S.C. Sec. 802 (112–90) TITLE 21— 

FOOD AND DRUGS, SUBCHAPTER I—CONTROL AND ENFORCEMENT Part A 

(15) states: 

‘‘(15) The term ‘‘manufacture’’ means the production, preparation, propagation, 

compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by 

means of chemical synthesis or by a combination of extraction and chemical 

synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the 

preparation, compounding, packaging, or labeling of a drug or other substance 

in conformity with applicable State or local law by a practitioner as an incident 

to his administration or dispensing of such drug or substance in the course of 

his professional practice. The term ‘‘manufacturer’’ means a person who manufactures a drug or other substance.’’ 

Additionally, the CSA States the following in terms of differentiating between 

interstate and intrastate commerce (21 USC Sec. 801 (112–90), TITLE 21—FOOD 

AND DRUGS. SUBCHAPTER I—CONTROL AND ENFORCEMENT Part A (5): 

‘‘(5) Controlled substances manufactured and distributed intrastate cannot be 

differentiated from controlled substances manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of controls, between controlled substances manufactured and distributed interstate and controlled substances manufactured and distributed intrastate.’’ 

Any changes to the statutory definitions of ‘‘manufacture’’ in either the CSA or 

the FDCA, or any changes to related regulations and/or agency policies, should be 

consistent as they apply to compounding pharmacies. For example, under either the 

FDCA or the CSA, a pharmacist should, with a prescription from a licensed physi-
71 

cian, be able to compound patient-specific medications, controlled substance or not, 

sterile or unsterile, and deliver them directly to the prescribing physician for office 

administration when medically necessary as determined by the physician. 

This alone should not trigger a requirement that the pharmacist register with either the DEA or the FDA as a ‘‘manufacturer.’’ However, under current DEA policy, 

based on the agency’s interpretation of the CSA, unless the drug (controlled substance) is delivered directly to the ‘‘end user,’’ (i.e. the patient), registration as a 

‘‘manufacturer’’ is required, even when the pharmacist is compounding the drug 

pursuant to a valid prescription and delivering the drug to the prescribing physician 

for medically necessary office administration. 

This is a particularly troubling policy by the DEA as it relates to sterile, injectable 

compounds, which often must be surgically implanted and delivered via intrathecal 

pain pump. As the recent tragedy involving the NECC has shown, maintaining sterility throughout the compounding process and the administration of injectable compounded drugs is critical to patient safety. 

DEA’s current policy runs counter to both their stated goal of preventing diversion 

of controlled substances, and to standard medical practices intended to maintain 

sterility of the drugs. This has put compounding pharmacists in the untenable position of following universally accepted medical practice and risking enforcement action by the DEA; or, undergoing an expensive and burdensome manufacturer registration process that does not accurately reflect the status of their traditional pharmacy practice. 

Alternatively, they could refuse to fill prescriptions for controlled substances for 

office administration, which could jeopardize patient access to critical medications. 

Again, changes to the FDCA or CSA should be consistent in what actions trigger 

manufacturer licensing requirements and should not impede traditional pharmacists 

from compounding patient-specific medications for office administration when medically necessary. 

With regard to standards for sterile and non-sterile compounding, IACP feels that 

these issues are sufficiently addressed by State laws and regulations. Where it is 

not, IACP strongly urges that States adopt rules and regulations similar to those 

in Iowa (Iowa regulations are attached). IACP again encourages that the USP 

<795> and <797> standards and practices be adopted by every State, as further 

safeguard. 

State Boards must ‘‘police’’ themselves and provide the necessary assurances to 

other State Boards which depend upon them for conducting inspections for non-resident pharmacies in a regular and consistent manner. Massachusetts Board obviously failed to execute its responsibilities both to its citizens as well as patients in 

other States in which NECC was licensed by not conducting regular inspections. 

Additionally, virtually every State requires an out-of-state pharmacy to register 

as such with the recipient State (with one notable exception being Massachusetts). 

In this regard, the pharmacy dispensing compounds across State lines is subject to 

heightened (not diluted) oversight and regulation because it must abide by the laws 

of both its home State and the out-of-state recipient. 

With regard to the Active Pharmaceutical Ingredients (APIs) used in the profession of compounding, there already exists in Federal statute language that requires 

all drugs compounded in the United States to use only active pharmaceutical ingredients (APIs) from FDA registered facilities. (See section 510). IACP regularly reminds its members to require a bill of lading. This provision was included in the 

PDUFA reauthorization legislation signed into law this year. Please see below for 

statutory language: 

P.L. 112–144, Section 713, The ‘‘Food and Drug Administration Safety and Innovation Act’’. 

SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS. 

Section 801 (21 U.S.C. 381) is amended— 

(1) in subsection (o), by striking ‘‘drug or’’; and 

(2) by adding at the end the following: 

(r)(1) The Secretary may require, pursuant to the regulations promulgated 

under paragraph (4)(A), as a condition of granting admission to a drug imported or offered for import into the United States, that the importer electronically submit information demonstrating that the drug complies with applicable requirements of this Act. 

(2) The information described under paragraph (1) may include— 

(A) information demonstrating the regulatory status of the drug, such as 

the new drug application, abbreviated new drug application, or investigational new drug or drug master file number; 
72 

(B) facility information, such as proof of registration and the unique facility 

identifier; 

(C) indication of compliance with current good manufacturing practice, testing results, certifications relating to satisfactory inspections, and compliance with the country of export regulations; and 

(D) any other information deemed necessary and appropriate by the Secretary to assess compliance of the article being offered for import. 

(B) PROCEDURE.—In promulgating a regulation under subparagraph (A), 

the Secretary shall— 

(i) issue a notice of proposed rulemaking that includes the proposed regulation; 

(ii) provide a period of not less than 60 days for comments on the proposed 

regulation; and 

(iii) publish the final regulation not less than 30 days before the regulation’s effective date. 

(C) RESTRICTIONS.—Notwithstanding any other provision of Federal law, in 

implementing this subsection, the Secretary shall only promulgate regulations 

as described in subparagraph (B). 

(3) DISCONTINUANCE OF REGISTRATION.—The Secretary shall discontinue 

the registration of any commercial importer of drugs that fails to comply with the 

regulations promulgated under this subsection. 

(4) UNIQUE FACILITY IDENTIFIER.—The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The 

requirement to include a unique facility identifier in a registration under paragraph 

(1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence. 

(5) EXEMPTIONS.—The Secretary, by notice in the Federal Register, may establish exemptions from the requirements of this subsection. 

(c) MISBRANDING.—Section 502(o) (21 U.S.C. 352) is amended by inserting ‘‘if 

it is a drug and was imported or offered for import by a commercial importer of 

drugs not duly registered under section 801(s),’’ after ‘‘not duly registered under section 510.’’ 

(d) REGULATIONS.— 

(1) IN GENERAL.—Not later than 36 months after the date of the enactment of 

this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security acting through U.S. Customs and Border Protection, 

shall promulgate the regulations required to carry out section 801(s) of the Federal 

Food, Drug, and Cosmetic Act, as added by subsection (b). 

(2) PROCEDURES FOR PROMULGATING REGULATIONS.— 

(A) IN GENERAL.—In promulgating a regulation under paragraph (1), the Secretary shall— 

(i) issue a notice of proposed rulemaking that includes the proposed regulation; 

(ii) provide a period of not less than 60 days for comments on the proposed regulation; and 

(iii) publish the final regulation not less than 30 days before the regulation’s effective date. 

(B) RESTRICTIONS.—Notwithstanding any other provision of Federal law, in implementing section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added 

by subsection (b), the Secretary shall promulgate regulations only as described in 

subparagraph (A). 

On the issue of where and with whom a pharmacy should be registered, pharmacies are already required to register with their State Board of Pharmacy and the 

Drug Enforcement Administration (DEA). Adding an additional registration requirement for pharmacies would do nothing to further the goal of keeping patients safe— 

it would amount to a paperwork requirement/administrative step that would 

produce no particular positive outcome due to an already overstrained FDA budget 

and the existing broad categories of oversight the agency has to prioritize. 

The FDA may inspect an establishment—including pharmacies—to ensure that 

drugs are appropriately handled and stored. In other words . . . they can look at 

what’s on the shelf, in the refrigerator, in the inventory, etc. 

The FDA may not inspect records and files (e.g., prescriptions, compounding formulas, etc.) unless either (a) the pharmacy in noncompliant with its State laws, see 

supra section 704 discussion, or (b) FDA has an administrative warrant that demonstrates a sufficient cause to do so. A pharmacy may decline such an inspection 

if it believes it is operating in full compliance with the State law unless there is 

some sort of court document authorizing the FDA to do so. 
73 

However, if the pharmacy is registered as a manufacturer, the FDA has much 

broader authority to inspect and cite such a manufacturing entity. As a manufacturer, they would also have to comply with CGMP and the FDA has clear injunctive 

authority over them, should they not remedy violations. In short, a pharmacy engaged in manufacturing is subject to the same laws, inspections, restrictions, and 

penalties as a commercial drug manufacturer. 

There are many patients (both human and animal) needing products in various 

medical scenarios requiring physician input and judgment based upon the needs of 

their patient. States already have limitations to this in their regulations and laws 

as necessary for their particular State for citizens/citizens’ pets. Pharmacists are required, by State law, to have sufficient drugs and preparations on their shelves to 

enable them to service their clients in a timely manner. Any requirement that a 

pharmacist must wait on each and every prescription thus works counter to public 

interest and patient health and safety. 

Regarding the prescription, moreover, there is no need for a physician to explicitly 

order a compounded drug. If a physician orders a name brand commercial product, 

the pharmacy will fill the prescription with it. If, however, the physician’s prescription is specific as to active ingredient, dosage, and/or delivery format, it enables the 

pharmacy to create the medication as needed for the particular patient, and as a 

prescribed physician, without need of express direction to compound by the physician. 

IACP acknowledges that many States have already addressed this issue through 

‘‘office use’’ specifications in their laws and regulations (IACP has supplied the committee with a state-by-state office use regulation guide). Should a State NOT have 

such standards in place, IACP would urge the State to adopt clear and concise guidance for the compounding of medications for ‘‘office use.’’ IACP adds that compounds 

prepared for office stock are no different than a singular compounded drug prescription in terms of pharmacy preparation. The same State law remains applicable to 

each and every one of these compounds. Finally, regarding labeling, please see the 

enclosed IACP statement regarding suggested labeling for office use. 

Ultimately, the decisionmaking with regard to what a script requires is left to the 

medical practitioner who writes the scripts in the first place. The doctor or veterinarian is best educated and best suited to make these determinations on medicines 

to be used and in what dose and dosage form. IACP does not believe the volume 

of prescriptions involved necessarily is the issue. Instead, the issue is one of (a) drug 

preparation—which is the same regardless of number, and (b) fulfilling the medical 

judgments of the practitioner by following the practitioner’s directions, as determined for the practitioner’s patient. 

IACP believes that the FDCA’s existing inspection provision, section 704, which 

was outlined supra, allows FDA the necessary authority and oversight it needs to 

determine whether a pharmacy is operating as a pharmacy or, instead, akin to a 

drug manufacturer, thus subjecting it to full inspection and FDCA application. 

By way of further example, FDA may inspect the equipment, drug materials, containers and labeling of any pharmacy. See section 704(a) (sentence one). State law 

requires pharmacy labeling to include, inter alia, the name and strength of the active ingredient, the lot number, the beyond-use date, the quantity or amount in the 

container, the pharmacy’s name, and the physician’s name. 

Through this information, FDA can assess the professionals’ licensure, the exact 

prescription for the patient, and exactly what the patient will receive. Moreover, all 

this information must be included on the label or the pharmacy violates its State’s 

law, thus triggering the FDCA section 704 enhanced inspection (sentence three) that 

applies to drug manufacturers. (See section 704(a)(2)(A)). 

It has not been IACP’s experience that the FDA has had difficulty collaborating 

with the States. The opposite appears to be true. FDA often collaborates with both 

the State boards of pharmacy and the DEA, both of which have full inspection authority over pharmacies. See e.g., Wedgewood Village Pharmacy, Inc. v. U.S., 421 

F.3d 263, 271 (2005) (noting FDA collected all the evidence it needed regarding 

whether a pharmacy was operating as a pharmacy or more akin to a manufacturer 

through collaboration with the State board and DEA); and Medical Center Pharmacy 

v. Mukasey, 451 F.Supp.2d 854 (W.D.Tex. 2006) (noting same). 

IACP stresses the importance of communicating important health information to 

patients whenever any medication is dispensed through labeling on the medication. 

IACP supports State regulations that require information on labeling that informs 

the patient that the medication has been compounded. 

With regard to adverse event reporting, IACP argues that MedWatch is the Food 

and Drug Administration’s reporting system for an adverse event or sentinel event, 

founded in 1993. This system should also be used for compounded medication. 
74 

An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality 

problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas). 

Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500). Reporting can be conducted online, by phone 1–800–FDA–1088, or by submitting the MedWatch 3500 

form by mail or fax 1–800–FDA–0178. 

Rather than replicating The MedWatch system, IACP contends that there already 

exists a reporting system for all in the Triad of care. MedWatch is intended to detect 

safety hazard signals for medical products. If a signal is detected, the FDA can issue 

medical product safety alerts or order product recalls, withdrawals, or labeling 

changes to protect the public health. Important safety information is disseminated 

to the medical community and the general public via the MedWatch Web site and 

the MedWatch E-list. 

On the issue of communication between agencies, IACP would support a notification system that requires States to notify the FDA (within 14 days of such action) 

when a pharmacy’s license has been revoked. Additionally, the FDA should notify 

States when they believe a pharmacy is acting as a manufacturer and may be operating outside of its registration status allowances. 

Additionally, Congress might want to consider assessing civil penalties when a 

pharmacy owner/operator has willfully misled authorities as to the nature of their 

business. 

IACP appreciates this opportunity to provide input on this critical outbreak to the 

committee and looks forward to further discussing this issue. IACP will be happy 

to respond to any additional questions the committee may have. 

The CHAIRMAN. Thank you, Mr. Miller. 

Now we’ll turn to Dr. Thompson. 

Dr. Thompson, please proceed. 

STATEMENT OF KASEY K. THOMPSON, PHARM.D., M.S., B.S., 

VICE PRESIDENT, OFFICE OF POLICY, PLANNING AND COMMUNICATIONS, AMERICAN SOCIETY OF HEALTH-SYSTEM 

PHARMACISTS, BETHESDA, MD 

Mr. THOMPSON. Thank you, Chairman Harkin and distinguished 

members of the committee, for holding this hearing. My name is 

Kasey Thompson. I am vice president for Policy, Planning, and 

Communications with the American Society of Health-System 

Pharmacists. I am here today to provide ASHP’s perspective on the 

recent meningitis outbreak and to explore potential policy options 

to help prevent similar events from occurring ever again in the future. 

First and foremost, on behalf of ASHP and our more than 40,000 

members practicing in hospitals, health systems, and ambulatory 

clinics, I want to express our sympathy for the victims and their 

families who were harmed by this terrible tragedy. The patients 

who relied on these medications deserved much better. 

Unfortunately, the New England Compounding Center appeared 

to have been operating in a manner that falls far short of standards for compounding sterile preparations. Further, the scale and 

scope of NECC’s operations more nearly resembles pharmaceutical 

manufacturing than traditional pharmacy compounding. 

U.S. hospitals prepare a vast array of compounded sterile preparations every day in order to meet the needs of patients. In fact, 

the majority of compounded medications hospitals utilize are prepared in-house by pharmacy departments. The compounded medications that hospitalized patients need include simple intravenous 

admixtures to complex customized medications that are not avail-
75 

able off the shelf, such as multi-ingredient solutions for heart surgery, epidural pain medication, and adult medications prepared 

with concentrations that can be safely administered to babies and 

children. 

However, hospitals also enlist the help of qualified compounding 

pharmacies for some compounded preparations for several reasons. 

For example, they may not have the necessary equipment or facilities to prepare some high-risk preparations, or they may face medication shortages from commercial products. 

Hospitals prepare or purchase compounded medications based on 

specific patient needs and individual medication orders or in anticipation of needs for patients under their care. Importantly, medications that are purchased from outside compounding pharmacies are 

not commercially available from brand or generic manufacturers in 

the individualized form needed for specific patients. 

ASHP has dedicated itself to developing the highest standards 

for compounding sterile products in hospitals. We began publishing 

guidelines on sterile and non-sterile compounding in the early 

1990s. In 2010, ASHP published the ASHP Guidelines on Outsourcing Sterile Compounding Services to advise pharmacy departments on how to conduct due diligence when selecting outsourcing 

vendors. All of our guidelines have always been available as a free 

public service to the healthcare community and to others. 

However, even with the availability of these useful resources, we 

cannot rely solely on the diligence of purchasers to take the place 

of proper licensing, inspection, and oversight of entities producing 

compounded medications, especially those entities that are manufacturing in large quantities and shipping across the country. Pharmacists and other healthcare providers should not be expected to 

perform the jobs of regulators by visiting and inspecting pharmacies and manufacturers that they do business with. 

The distinction between traditional pharmacy compounding and 

manufacturing appears to be a regulatory gray area between State 

boards of pharmacy and the FDA. As we have seen, however, the 

implications of this gray area are serious. 

We recognize the regulatory challenges of defining the activities 

in this gray area. We firmly believe that specific definitions are essential so that mass production of the scope and scale done by 

NECC falls clearly within the regulatory jurisdiction of FDA rather 

than State boards of pharmacy. To this end, we have developed policy recommendations for the committee, FDA, and other stakeholders to consider as we explore ways to address this gap in oversight. 

A number of variables make distinguishing between compounding and manufacturing difficult. Therefore, both functions might be 

better viewed as a continuum of activities stratified by the potential risk for patient harm, each requiring defined procedures, 

equipment, training, and quality controls. At one end of the continuum, oversight of traditional compounding is clearly within the 

purview of States and the oversight of pharmaceutical manufacturing within the purview of the FDA. 

Once compounding activities advance along the continuum to 

manufacturing, the risk to patient safety and public health increases. There may be a need for a special category of FDA over-
76 

sight that falls between compounding and manufacturing but does 

not require a drug approval. 

For example, if a compounding pharmacy sells to other organizations and not directly to patients, there may be a need to be regulated by the FDA. Doing so would allow hospitals, clinics, and physician offices to purchase sufficient quantities of compounded product as is necessary to meet patient needs, while doing so under the 

assurance that they are making those purchases from appropriately regulated entities. 

ASHP recommends stronger communication and collaboration between State boards of pharmacy and the FDA to accomplish this 

goal. We also believe that State boards of pharmacy should be able 

to work with FDA to inspect an entity suspected of engaging in 

large-scale drug production beyond the scope of traditional pharmacy compounding. 

Finally, we strongly believe the FDA must be provided with the 

resources it needs to perform oversight of compounding entities 

that are potentially engaged in manufacturing. 

Thank you for the opportunity to provide the perspectives of the 

pharmacists who practice in hospitals and health systems. ASHP 

remains committed to working with Congress, the FDA, and other 

stakeholders to ensure that an event like this never occurs again. 

[The prepared statement of Mr. Thompson follows:] 

PREPARED STATEMENT OF KASEY K. THOMPSON, PHARM.D., M.S., B.S. 

SUMMARY

U.S. hospitals prepare a vast array of compounded sterile preparations every day 

in order to meet the needs of patients. However, hospitals also enlist the help of 

qualified compounding pharmacies for some compounded preparations for several 

reasons. 

ASHP has dedicated itself to being a leader in developing the highest standards 

for compounding and sterile product preparation in hospitals. We have developed an 

assessment tool based on our guidelines that helps pharmacists in hospitals and 

health systems comprehensively evaluate sterile compounding service providers and 

use comparative date for their vendor selection process. 

However, we cannot solely rely on the due diligence of purchasers to take the 

place of proper licensing, inspections and oversight of entities producing compounded medications. The distinction between traditional pharmacy compounding 

and manufacturing appears to be a regulatory gray area between State boards of 

pharmacy and FDA. As we have seen, however, the implications of this gray area 

are serious. 

ASHP recommends stronger communication and collaboration between State 

boards of pharmacy and the FDA. We also believe that it may be necessary to revisit previous attempts to further define pharmacy compounding from large scale, 

mass-produced medications. Finally, we strongly believe that FDA must be provided 

the resources it needs to perform serious and meaningful regulatory oversight. 

Good morning and thank you Chairman Harkin, Ranking Member Enzi, and distinguished members of the committee, for holding this hearing. My name is Kasey 

Thompson and I am vice president of Policy, Planning and Communications for the 

American Society of Health-System Pharmacists (ASHP). I am here today to provide 

ASHP’s perspective on the recent meningitis outbreak, and to explore potential policy options to help prevent similar events from occurring in the future. 

First and foremost, on behalf of ASHP and our more than 40,000 members practicing in hospitals, health systems, and ambulatory clinics, I want to express our 

sympathy for the victims and their families who were harmed by this tragedy. The 

patients who relied on these medications deserved much better. Unfortunately, the 

New England Compounding Center appeared to have been operating in a manner 

that falls far short of standards for compounding sterile preparations. Further, the 
77 

scale and scope of NECC’s operation more nearly resembles pharmaceutical manufacturing rather than pharmacy compounding. 

U.S. hospitals prepare a vast array of compounded sterile preparations every day 

in order to meet the needs of patients. In fact, the majority of compounded medications hospitals utilize are prepared in-house by pharmacy departments. The compounded medications that hospitalized patients need span from simple intravenous 

admixtures to complex customized medications that are not available off the shelf, 

such as multi-ingredient cardioplegia solutions for heart surgery, precisely measured combinations of epidural pain medication and adult medications prepared in 

concentrations that can be safely administered to babies and children. 

However, hospitals also enlist the help of qualified compounding pharmacies for 

some compounded preparations for several reasons. For example, they may not have 

necessary equipment or facilities to prepare some high-risk preparations, or they 

may face medication shortages for commercial products that can only be replicated 

by a compounding pharmacy. 

Hospitals prepare or purchase compounded medications based on specific patient 

needs and individual medication orders or in anticipation of needs for patients 

under their direct care. Importantly, medications that are purchased from outside 

compounding pharmacies are not commercially available from brand or generic 

manufacturers in the individualized form needed for a specific patient or patients, 

unless manufacturers cannot supply them. 

ASHP has dedicated itself to developing the highest standards for compounding 

and sterile product preparation in hospitals. Through our peer-reviewed publication, 

the American Journal of Health-System Pharmacy, we began publishing guidelines 

on sterile and non-sterile compounding in the early 1990s. In 1993 we published the 

ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared 

Sterile Products. This was revised in 2000, and is currently in the final stages of 

revision. 

These guidelines formed the basis for the three-tier risk assessment structure 

later incorporated by the United States Pharmacopeia into Chapter 797, its standards for compounding sterile products. In 2010, ASHP published the ASHP Guidelines on Outsourcing Sterile Compounding Services to advise pharmacy departments 

on how to conduct due diligence when selecting outsourcing vendors. In addition, we 

have developed an assessment tool based on our guidelines that helps pharmacists 

in hospitals and health systems comprehensively evaluate sterile compounding service providers and use comparative data for their vendor selection process. Our 

guidelines and assessment tool are and have been available free as a public service 

to the health care community and others. 

POLICY OPTIONS

We cannot rely solely on the due diligence of purchasers to take the place of proper licensing, inspections and oversight of entities producing compounded medications, especially for those entities that are manufacturing in large quantities and 

shipping across the country. Pharmacists and other health care providers should not 

be expected to perform the jobs of regulators by visiting and inspecting pharmacies 

or manufacturers that they do business with. 

The distinction between traditional pharmacy compounding and manufacturing 

appears to be a regulatory gray area between State boards of pharmacy and FDA. 

As we have seen, however, the implications of this gray area are serious. 

We recognize the regulatory challenges of defining the activities in this gray area, 

but we firmly believe that specific definitions are essential so that mass production 

of the scope and scale done by NECC falls within the regulatory jurisdiction of FDA, 

rather than State boards of pharmacy. To this end, we have developed policy recommendations for the committee, FDA and other stakeholders to consider as we explore ways to address this gap in oversight. 

Previous attempts to define compounding in Federal law contained certain elements that should be examined in light of practice changes since 1997. Recent legislative proposals merit further discussion and exploration, since they may reflect 

those practice changes and allow for the regulatory flexibility among State boards 

of pharmacy and the FDA that would ensure that hospitals continue to be allowed 

to obtain compounded medications in anticipation of patient need. 

Compounding pharmacies range from small pharmacy operations that compound 

medications for individual patients directly under their care to large-scale operations that prepare compounded medications in the volumes required to serve the 

needs of patients under the care of health systems or physician offices. A number 

of variables make distinguishing between compounding and manufacturing difficult. 

Therefore, both functions might be better viewed as a continuum of activities strati-
78 

fied by the potential for risk of patient harm, each requiring defined procedures, 

equipment, training, and quality controls. At one end of the continuum, oversight 

of traditional compounding is clearly within the purview of States, as is FDA regulation at the other end of the continuum with pharmaceutical manufacturing. As legislative proposals are considered, it will be important to reaffirm the role of State 

boards of pharmacy to license and regulate traditional compounding while recognizing that large-scale compounding of sterile products may require oversight by the 

FDA in cooperation with State boards of pharmacy. 

Once compounding activities advance along the continuum to manufacturing and 

the risk to patient safety and public health increases, there may be a need for a 

special category of FDA oversight that falls between compounding and manufacturing but does not require a drug approval (e.g., an NDA). For example, if a 

compounding pharmacy sells to other organizations and not directly to patients, 

then they may need to be regulated by the FDA. Doing so would allow hospitals, 

clinics, and physician offices to purchase sufficient quantities of compounded product as is necessary to meet patient needs, while doing so under the assurance that 

they are making those purchases from appropriately regulated sources. 

ASHP recommends stronger communication and collaboration between State 

boards of pharmacy and the FDA to accomplish this goal. We also believe that State 

boards of pharmacy should be able to work with FDA to inspect an entity suspected 

of engaging in large-scale production beyond the scope of pharmacy compounding. 

Previous court rulings have made FDA’s authority to inspect these facilities unclear 

and subject to legal action. 

Finally, we strongly believe that FDA must be provided the resources it needs to 

perform serious and meaningful regulatory oversight of entities that are potentially 

engaged in manufacturing. Not to do so now will only hinder the agency in implementing legislation. 

CONCLUSION

To summarize, we are profoundly saddened by what we believe should have been 

an avoidable tragedy. ASHP remains committed to working with Congress, FDA and 

other stakeholders to address these regulatory gaps and reduce the likelihood of 

similar outbreaks from compounded sterile products in the future. 

The CHAIRMAN. Thank you very much, Dr. Thompson. We’ll 

begin a round of 5-minute questions. 

Mr. Miller, do you believe Congress should clarify the legal status of section 503A given the current split between the Ninth and 

Fifth Circuits? 

Mr. MILLER. Mr. Chairman, there is definitely clear confusion 

about authority based upon the judicial decisions in the Fifth and 

the Ninth. We also know based upon the Medical Center v. Thompson decision in the Supreme Court that actually struck down sections of the original FDA FDAMA law as being unconstitutional. 

So, yes, we need to go back and revisit this, especially in light of 

this tragedy. 

The CHAIRMAN. Let me ask that question one more time. Do you 

believe Congress should clarify the legal status of section 503A? 

Mr. MILLER. Yes. 

The CHAIRMAN. Thank you. That’s all I wanted to hear. We know 

the background and stuff. We’re trying to get a clarification of this. 

So you think that we should give that kind of clarification whether 

it’s the flagpole type or some kind of clarification on section 503A? 

Let me ask this. I may tend to disagree with you a little bit on 

your sort of absolute statement that FDA had jurisdiction in this. 

I still think that’s sort of a gray area. But let’s assume that they 

did. 

Mr. MILLER. Yes, sir. 

The CHAIRMAN. Assuming we agree that they should have jurisdiction when a pharmacy like NECC operates in a manner and 

scale that is essentially a manufacturer, shouldn’t the FDA have 
79 

access to records such as prescription records to help it determine 

whether the operation is really a compounder or a manufacturer? 

Mr. MILLER. That’s a complex question, and the answer is it 

does. The FDA has the ability to obtain a court order, subpoena, 

or administrative warrant to obtain any records within a pharmacy. They also have the ability to work in collaboration with a 

board of pharmacy. The board of pharmacy in every State has the 

ability to look at all documentation and materials in any of its licensed sites. 

If the FDA felt compelled, in addition to its Form 482 on-site inspection of materials, that it needed additional information, that’s 

a simple collaboration with a State board of pharmacy. We know 

based on testimony that occurred between the FDA and the Massachusetts Board of Pharmacy, and yet that system still failed. Does 

the FDA—should they—actually, Senator, although it’s not specific, 

they do have that ability currently. 

The CHAIRMAN. They do have to go through a lot of hoops. 

They’ve got to go to court. They’ve got to get all kinds of things before they do that. That takes, obviously, a lot of resources. It takes 

a lot of time. I’m just saying that if we agree that FDA should have 

this jurisdiction, shouldn’t they have access to records to help them 

determine whether it’s a compounder or a manufacturer, because 

sometimes—as Dr. Hamburg kept saying, sometimes they don’t 

know. 

Mr. MILLER. Yes. One of the things that also has to be addressed—and it’s very important—is that as we distinguish between a pharmacy engaged in compounding, which more than 50 

percent of all pharmacies in the country do, versus manufacturing, 

we have to look at what they are doing, not necessarily how, but 

what are they doing. 

The CHAIRMAN. I know you were here for the first panel. You 

may have heard me say something about State lines. 

Mr. MILLER. Yes. 

The CHAIRMAN. I don’t know if that’s right or not. What are the 

features that distinguish NECC from what you would view as a legitimate large-scale compounding pharmacy? Again, we heard 

about volume. I mentioned interstate shipment, prescription 

records. Again, do we have some guidelines? What features would 

distinguish that as a legitimate large-scale compounding pharmacy? 

Mr. MILLER. Mr. Chairman, I am a pharmacist. I tend to think 

black and white. The answer is pretty simple. When I receive a 

prescription, regardless of whether it’s a compound or an off-theshelf commercially manufactured drug, that is coming from an authorized prescriber in my State. I’m empowered to fill it for a patient, or, depending upon the order, I may be filling it for a clinic 

associated with a hospital down the street. I fill prescriptions. 

The difference between NECC and a compounding pharmacy was 

they weren’t filling prescriptions. They were bulk manufacturing 

and selling. A company like Pfizer creates and sells medications. 

They don’t fill prescriptions. A company like Ameridose, associated 

with NECC, creates and sells medications. Pharmacies fill prescriptions. 
80 

One of the things that we’ve heard from conversations with many 

boards of pharmacy is how do I distinguish this? It’s relatively simple. Any pharmacy inspector, specifically one who is a pharmacist 

and trained, can tell you, based on the paperwork in that pharmacy, is this pharmacy filling a prescription, or are they essentially 

creating bulk quantities? And those bulk quantities, whether 

they’re 100 or 100,000—are they being sold as opposed to being dispensed? 

It’s a function of what we do as pharmacists that really differentiates between pharmacy practice and manufacturing. That’s where 

I think we really went awry here with NECC, because it was quite 

apparent that they were not filling prescriptions. They were selling 

stuff, and that’s what manufacturers do. 

The CHAIRMAN. OK. I’ll try to absorb all that. 

Senator Roberts. 

Senator ROBERTS. I want to be a little insistent here, and I apologize for that. In the first place, in my opening statement, I said 

that I hoped that the witnesses today would offer their commitment to work with us—and I think you’ve done that—and to do so 

in good faith—and I know you’ll do that—with the intent to be 

transparent and forthcoming with your thoughts and your suggestions and your concerns. That came from my opening remarks. 

Is this something that you are both willing to do, remembering 

that during the early days of trying to get something done, we 

wanted answers and all we got was pushback. Could you speak to 

that, please? 

Mr. MILLER. Senator Roberts, as a pharmacist and as an organization representing pharmacists, the worst possible thing has happened. We have more than 30 people dead. We have 461 people ill. 

Right now, the focus must be on working collaboratively—professional associations, regulators, legislators—to prevent this from 

ever happening again. IACP and all the other pharmacy associations, State and national, will be working with you, this committee, 

and everyone else to make sure that we protect the public from organizations, businesses, entities like an NECC. You have my commitment on that, Senator. 

Senator ROBERTS. I appreciate that. 

Dr. Thompson, I know that you are providing a legislative blueprint to be of help to us, which I appreciate. Is that criteria voluntary, or is that mandatory? 

Mr. THOMPSON. The blueprint that we suggested? 

Senator ROBERTS. Yes. 

Mr. THOMPSON. We think that’s mandatory. Basically, it’s to clarify the jurisdiction of the FDA over manufacturing of these 

compounding entities. I call them entities for a reason, because it 

is a gray area—and I’m speaking as a practitioner and for our 

members—in trying to understand who they’re doing business with 

out there. And we do believe there are some gray areas. 

We think that this is something that would give the FDA the authority it needs to regulate these entities that fall between the 

Pfizers and the Mercks and the large-scale manufacturers that are 

manufacturing under approved drug applications and abbreviated 

new drug applications for generic drugs and these entities that are 

compounding medications in large amounts. 
81 

Senator ROBERTS. In your opinion, either one of you, do you 

think that NECC is a manufacturer? If you do, do you believe that 

FDA has the current oversight and enforcement authority to appropriately regulate manufacturers? 

Mr. THOMPSON. I believe that they were behaving as a manufacturer, without question. It’s become clear to me, or perhaps unclear, whether FDA had the authority or not. This registration that 

compounding pharmacies do with the FDA is not the same as what 

a commercial manufacturer that is manufacturing under a new 

drug application and is licensed to manufacture under that application. I do believe it’s a regulatory gray area that must be confirmed 

by Congress. 

Mr. MILLER. No question, Senator. NECC was engaged in illegal 

manufacturing. They did not have a license in the State of Massachusetts as a manufacturer. All States oversee that, in addition to 

the FDA. They were not registered with the FDA. They were shipping products nationwide without prescriptions, without official authorized orders from prescribers. Bottom line, that’s manufacturing. 

Senator ROBERTS. I appreciate that. I have no further questions, 

Mr. Chairman. 

The CHAIRMAN. Senator Alexander. 

Senator ALEXANDER. Thanks, Mr. Chairman. 

Thank you for being here and for your testimony. You make the 

solution sound pretty simple, that you just take these large facilities that are in the gray area, and some of them are manufacturers 

and they’re regulated by the FDA, and the rest of them aren’t. 

They’re filling prescriptions and they’re regulated by State boards 

of pharmacy. Am I hearing you right? 

Mr. MILLER. From—go ahead, Kasey. 

Mr. THOMPSON. I’m sorry. Yes, you are hearing me correctly in 

that respect. We do believe that traditional pharmacy compounding 

is the filling of a prescription and dispensing that to a patient. 

These entities that are preparing large amounts of medications and 

not necessarily dispensing those to patients but selling those to 

various entities, whether it’s hospitals, physician offices or others, 

are manufacturing. 

Senator ALEXANDER. There are some—let’s take Tennessee. 

Maybe we’ve got 1,000 to 1,200 pharmacies. Let me just guess at 

it. And based upon your testimony, maybe 500 of them do 

compounding. 

Mr. MILLER. That’s correct. 

Senator ALEXANDER. Now, apparently, there must be a number 

of other larger compounding pharmacy facilities in Tennessee, for 

example. Would that be true? Anybody know? I have some suggestions here that there may be 7,500 pharmacies that specialize in 

advanced compounding, 3,000 that provide sterile compounding. 

Are these just large drug stores that we’re talking about, or are 

these large entities or companies that fill prescriptions, that do advanced sterile compounding and still fill prescriptions? How many 

are we talking about here? 

Mr. MILLER. Senator, thank you. I can answer that. Those statistics actually come from the International Academy of Compounding 
82 

Pharmacists. The 7,500 and 3,000 you’ve heard mentioned are actually our statistics. 

There are compounding pharmacies, sterile compounding pharmacies, in the State of Tennessee, actually, quite a few of them. 

Some are large. Some are relatively small. One of the things I don’t 

want us to get too hung up on is the issue of size, because size does 

not necessarily mean that you’re a manufacturer. It’s actually what 

you do—Senator Harkin, to what I was saying before. 

Senator ALEXANDER. There might be 40 or 50 in Tennessee, 

roughly. We’re usually 2 percent of everything, so if there are 3,000 

sterile manufacturers, there might be 40, 50 or 60 of varying sizes. 

Is that right? 

Mr. MILLER. Sterile compounding pharmacies, not manufacturers. 

Senator ALEXANDER. Sterile compounding pharmacies. 

Mr. MILLER. Yes, sir. What we have to recognize is they may be 

part of a hospital. They may be part of a home infusion company 

that specializes in outpatient, a nursing home, long-term care, or 

it could be affiliated with one of our major chains. It could be a 

standalone, community-based pharmacy. 

Senator ALEXANDER. These are the ones we’re talking about here. 

We’re not talking about the 1,000 pharmacies that are doing traditional compounding, or we’re not talking about manufacturers who 

are selling in bulk. We’re talking about, in my State, maybe 40, 50, 

or 60 entities of various sizes which are compounding pharmacies, 

some of them doing sterile work. 

Mr. MILLER. Actually, you have more than that in terms of 

compounding, in general. That estimate for sterile compounding in 

your State—I would say that’s extremely accurate. Those are the 

pharmacies we would want to make sure are identified by your 

State. 

Senator ALEXANDER. That’s where the potential trouble is, insofar as this incident is concerned. Is that right? 

Mr. MILLER. My hesitation isn’t because I don’t agree. I’m concerned that that may be too narrow of an interpretation. 

Senator ALEXANDER. Let me ask it this way, then. The trouble 

is the lack of clarity about who’s on the flagpole. 

Mr. MILLER. Yes, sir. 

Senator ALEXANDER. If I can understand—let’s just narrow it 

down to these, let’s say, 50 advanced compounding facilities in Tennessee. That gets rid of most of the drug stores in Tennessee, and 

it gets rid of all the manufacturers. We’re talking about 50. How 

do we decide who regulates those 50? Does the State board of pharmacy do it, or does the FDA do it? 

Mr. MILLER. Right now? 

Senator ALEXANDER. Well, no. How should it be? How should it 

be going forward? 

Mr. MILLER. To identify them, I would send the State board of 

pharmacy in to inspect all of them. That State board inspector 

should be able to determine is this pharmacy a pharmacy, or is this 

pharmacy actually engaged in manufacturing. 

Senator ALEXANDER. What if they’re as incompetent as the State 

Board of Pharmacy of Massachusetts seemed to be over the last 10 

years? 
83 

Mr. MILLER. Then we have a very significant problem. Fortunately, that doesn’t seem to be the case in most States. One of the 

recommendations our organization has at the State level is we need 

to adequately fund our boards and provide them with inspectors 

who are trained and kept up-to-date so they can go in and review 

a pharmacy so that we can identify and prevent an NECC—— 

Senator ALEXANDER. I interrupted you. You were saying you 

would send the State board of pharmacy in to decide, first, are they 

pharmacies, or are they manufacturers? 

Mr. MILLER. That’s correct. 

Senator ALEXANDER. Then what? 

Mr. MILLER. If they are identified as being a manufacturer outside of the practice of pharmacy and the rules and regulations 

within the State, the State board has the ability to shut them 

down, discipline them, revoke their license, suspend it, if they believe—the State board, just as Colorado did with NECC—if they 

identify that pharmacy as a manufacturer, they can cross-file that 

complaint, specifically, with the FDA, who has the ability to shut 

down an illegal manufacturer. 

Senator ALEXANDER. Yes. 

Mr. MILLER. So it’s a combination of both—— 

Senator ALEXANDER. Well, this is helping me. Sometimes when 

we get these large, difficult questions, getting it down to a quantifiable level helps. We’re really talking about, in a State like ours, 

what to do about 30, 40 or 50 institutions. How do we identify 

them, and then how do we regulate them. If we don’t trust the 

State in every case, or don’t trust the FDA in every case—I would 

trust the Tennessee Board more than I’d trust the FDA to identify 

them, to tell you the truth, based on what I’ve heard today. But 

not Massachusetts. 

So there we have the dilemma. I suppose with that smaller number, you could allow the FDA to go in and make its own judgment 

about whether they’re manufacturers or not. If they are, regulate 

them. You’re saying have the State board go in and decide it. 

Mr. MILLER. Senator, first off, the FDA can go into those facilities, those pharmacies, at any time. No question about that. If we 

wish to, from a policy standpoint, require that the FDA inspect all 

potentially identified sterile compounding pharmacies, that’s a decision we could make as a policy. 

Senator ALEXANDER. That wouldn’t be so many that it would be 

an overwhelming number, would it? Or would it? 

Mr. MILLER. I can’t answer that for the FDA. My biggest concern 

would be—— 

Senator ALEXANDER. We’re just talking about identification. 

Mr. MILLER. Yes. The agency would need to not only identify 

them, but also then deal with the fact that each State has conflicting compounding guidelines. For example, in the State of Tennessee, your board of pharmacy said clearly to all licensees in January, ‘‘No non-patient-specific prescriptions in our State.’’ Other 

States do permit that. 

Senator ALEXANDER. Why is that? 

Mr. MILLER. Why is that? Because the individual State board of 

pharmacy makes a decision as to what is needed and how it needs 

to be regulated to protect the citizens within their State. 
84 

Senator ALEXANDER. Well, I’m running a little bit over my time 

here, Senator Harkin. It helps us, in terms of developing a policy 

to solve the problem looking forward, to narrow it down to the 

number of entities we’re talking about. Perhaps we could agree to 

exclude manufacturers and people who are illegally manufacturing. 

They’re just illegally manufacturing. And then traditional 

compounding, we understand, exists. 

To identify the number of entities that fall into this gray area, 

how do we identify them, and then how do we regulate them? One 

of the things I’m experimenting with in my mind is an idea for 

these areas, such as sterile compounding, that sort of area, where 

the FDA may have standards, and actually certify a State to handle that narrow area of compounding and be able to take it away. 

For example, in the case of Massachusetts, had there been such 

a structure existing, based upon what we’ve heard today, I would 

say if the FDA had the authority, it should jerk the ability of Massachusetts to deal with these sorts of entities at least until Massachusetts cleaned up its act. On the other hand, it should give Tennessee an award for working with the CDC to move quickly to 

eliminate the spread. 

Anything you could submit to the committee, to the chairman, 

Senator Enzi, Senator Roberts, those of us who are interested, 

identifying exactly the number of entities we’re dealing with and 

a practical way for identifying, with the end result being that we 

have some agency clearly on the flagpole, so when we come up here 

6 months from now, we don’t have one saying, ‘‘Yes, I had responsibility,’’ and the other one saying, ‘‘Well, I had some, too’’—I want 

one to say, ‘‘It was my fault, my job, my responsibility,’’ or the 

other one saying, ‘‘No, that’s my fault,’’ just as the head of the CDC 

said when I asked her—I said, ‘‘Whose job was it to let the world 

know what happened?’’ She said, ‘‘That was my job.’’ 

The CHAIRMAN. Thank you, Senator Alexander. We’re preparing 

this letter, as I mentioned earlier, to go out to all the State boards 

of pharmacy. Please take a good look at that, and if you’ve got 

some suggestions for other things that you might want to go into 

that letter, please let us know. I’d like to get it out as soon as possible. 

Senator ALEXANDER. Good. I’ll look at it today. 

The CHAIRMAN. Some of the things you brought up may not be 

in there, and I want to have you take a look at that to see if we 

need to put—— 

Senator ALEXANDER. Thank you. Good. 

The CHAIRMAN. I appreciate that very much. 

I just wanted to ask Dr. Thompson—I read through your testimony yesterday, and I’ll just refer to it again, just reviewing it. I 

know you’re saying that hospitals and large entities like that can’t 

really ensure the inspections to make sure that they’re getting the 

right kind of products that are sterile and everything like that. 

It seems to me if hospitals are outsourcing compounding, can’t 

they take steps to ensure that they’re buying from suppliers who 

utilize sterile practices? It seems like—don’t take this wrong, but 

it seems like in your testimony you’re shoving it all off on the 

compounding pharmacies. Don’t the hospitals also, especially large 

entities, have a responsibility? Can’t they take steps to ensure who 
85 

they’re buying from and that they’re meeting good manufacturing 

practices? 

Mr. THOMPSON. Yes, sir, and I believe that many of them do. 

They verify that they’re licensed by the State board of pharmacy. 

They look to see whether or not they’re registered with the FDA 

as a manufacturer, which is a regulatory gray area. I’ve spoken 

with many pharmacists that do go out and visit facilities. 

As you can imagine, Senator Harkin, a small hospital in Iowa 

with 25 beds or less—— 

The CHAIRMAN. Can’t do that, no. 

Mr. THOMPSON [continuing]. You know, flying to Massachusetts. 

That’s where the challenge comes in. I think many do that. But, 

at the end of the day, they have to be able to count on the regulatory apparatus, whether it be the State or the FDA, to do their 

part. We don’t inspect Pfizer to make sure that their products—so 

that’s sort of the point I was trying to make. 

The CHAIRMAN. I understand a small hospital in Tennessee or 

Iowa can’t do that. There are some big hospital chains, and they 

buy a lot of product. A lot of the smaller hospitals would rely upon 

their ability to make sure that from whom they’re buying is practicing good manufacturing practices. 

Mr. THOMPSON. Oh, sure, absolutely. Many of them do that. I’ve 

spoken with many hospital pharmacists that go out and look at 

compounding pharmacies. It gets a little difficult when they go into 

these manufacturing operations, because that’s sort of a different 

type of expertise—that somebody needs to inspect a manufacturer. 

But many of them do that, to your point. 

The CHAIRMAN. I also want to again say forthrightly about 

compounding products that we think a lot about it as meeting specific needs of individuals. It has to be prescription-based, rather 

than just producing mass products. Compounding pharmacies also 

fill a real niche in our society for meeting a drug shortage that 

might happen at some time. They can step in and do things right 

away and help us meet certain drug shortages. That’s just another 

valuable service that they provide. 

Dr. Kainer, I didn’t ask you any questions, but, again, more than 

anything, you illustrate the diligence and the professionalism of 

our public health professionals in the United States and the close 

cooperation between the State departments of health and the CDC. 

To me—and I have looked at different health systems around the 

world—our public health system in this country, in terms of prevention and in terms of immediate diagnosis—that’s the wrong 

word—immediately finding things that are happening—detection 

and response, beats anything anywhere in the world. 

We have to make sure that we continue to have adequate funding so that we employ and hire the best possible epidemiologists 

and other professionals. You exemplify that, and I appreciate it 

very, very much. 

Mr. Miller, thank you very much. The two responses that I liked 

hearing from you today were, No. 1, on the clarification on 503A, 

and in response to Senator Roberts that your association will, indeed, work with us as opposed to what happened a few years ago. 

Mr. MILLER. Absolutely, Senator. 

The CHAIRMAN. That’s good news. 
86 

Senator ALEXANDER. Mr. Chairman. 

The CHAIRMAN. Yes. 

Senator ALEXANDER. Mr. Chairman, something you said, might 

provide an opportunity for Dr. Kainer to respond. I thought you 

made a very good point. The hospitals and the clinics and the physicians, particularly after this, who buy compounded medicines will 

be on alert. Maybe there’s something else that the CDC or its associates could do to create a warning system. 

For example, was there anything that went on over the last 10 

years that we’ve heard about in Massachusetts with the New England Compounding Center that could have been put up as a yellow 

flag that a hospital, like the Saint Thomas pain clinic might have 

known about before they bought that, just by checking the internet? 

Is there a system like that, Dr. Kainer? I thought Senator Harkin’s question was a very good one. 

The CHAIRMAN. That’s interesting. 

Dr. KAINER. I’m not specifically aware of such a system that occurs right now that is in the public, specifically on identifying or 

having a warning signal for a hospital. They have the 483 inspection reports that people can do. It’s not necessarily user-friendly or 

easy for hospitals. 

If I may add, many of the physicians who ordered these medications did not realize that they were ordering from a compounding 

pharmacy. They actually thought that they were purchasing things 

from a manufacturer. Alerting clinicians as to what is the difference between a compounding pharmacy and a drug manufacturer, what’s the difference between a generic medication versus a 

brand name medication, and compounded products are not the 

same. 

There’s a lot of confusion among those providers. Perhaps there’s 

an opportunity here to educate the providers that there is a difference between compounded products and manufactured products. 

The CHAIRMAN. That’s very interesting. We should pursue that, 

too. I was just told by my staff that many of the documents that 

came out of the board in Massachusetts were not public. There was 

no way for anybody out there, a hospital or someone, to know that 

there were these indications. Maybe that’s something else we 

should look at. 

Is there anything else that any of you want to impart to the committee at all before we close it down? No? 

Thank you all very, very much, each of you, for your diligence, 

for being here, for adding to our deliberations. You can sense that 

this is truly a bipartisan effort. This committee will forge ahead in 

developing legislation, and, toward that end, we again seek your 

input and your advice and work with you to develop this legislation. Hopefully, we’ll have something soon next year that we’ll be 

able to move ahead on and put this sad chapter behind us. 

Thank you all very much. I request that the record stay open for 

10 days to allow Senators to submit statements and questions for 

the record. 

With that, the committee will stand adjourned. Thank you all 

very much. 

[Additional material follows.] 
87 

ADDITIONAL MATERIAL 

PREPARED STATEMENT OF SENATOR CASEY

Chairman Harkin, Ranking Member Enzi, I would like to thank 

you for convening this investigative hearing. As members of the 

Health, Education, Labor, and Pensions Committee, many from 

States affected by this terrible tragedy, I believe we have a duty 

to exercise our investigative and oversight authority, and to make 

sure that we take every step possible to ensure that a tragedy like 

the ongoing meningitis outbreak does not happen again. 

Like you, I am deeply disturbed by the long history of problems 

at the New England Compounding Center, and concerned that it 

took an event of this magnitude, with over 400 people infected with 

a potentially lethal strain of meningitis and over 30 having succumbed to its effects, to alert us to the dangers of this company’s 

practices. 

In the face of this crisis, Pennsylvania has seen only one case, 

compared to dozens of cases in the home States of some of my colleagues on the committee. This outbreak has alerted us all to the 

dangers to public health posed by bad actors in the pharmacy 

compounding arena. 

I know there are many good compounding pharmacists, and I 

recognize the important role they play in ensuring that patients 

have access to the drugs they need, when they need them, and in 

the right form. Something went wrong at NECC, and now over 30 

people are dead as a result. We are here to learn what led to this 

situation, and what we need to do to ensure it never happens 

again. 

There are many questions we have yet to answer, and we are not 

sure what the best path forward will be. It is clear that NECC was 

operating outside the bounds of Federal and State law. Do we need 

greater Federal oversight of compounding pharmacies? Do we need 

to require the FDA to work more closely with State boards of pharmacy, and improve their communication? How have the split district court decisions affected the FDA’s ability to take action with 

regard to compounding pharmacies? 

There appears to be a lot of confusion surrounding the regulation 

and oversight of these larger compounding pharmacies that operate 

in the middle ground between traditional, small-scale compounding 

pharmacies and large manufacturers. I believe that everyone would 

benefit by reexamining current Federal law and reevaluating 

whether our existing regulatory system is appropriate for an industry that is changing and addressing new challenges in our health 

care system. I know that this issue has been contentious in the 

past, and I hope that all of the interested parties will come together in good faith to protect the public from future tragedies. 

I look forward to hearing from our witnesses, I thank them for 

sharing their expertise, and I thank Chairman Harkin and Ranking Member Enzi for their commitment to protecting the public 

from harm. I look forward to working with the other members of 

the committee to clarify the law as it pertains to compounding 

pharmacists. 
88 

PREPARED STATEMENT OF JOHN J. DREYZEHNER, M.D., MPH, FACOEM, 

COMMISSIONER, TENNESSEE DEPARTMENT OF HEALTH, NASHVILLE, TN 

Please accept my sincere appreciation for your investigation into a matter that 

has, regrettably, impacted thousands of Americans. Our concerns and prayers for 

the patients, families and loved ones affected by this preventable tragedy are continuing. On behalf of those who have died or suffered physical and mental anguish, 

and their families and friends who have also endured loss and anxiety, I thank you 

for your work and assure you the Tennessee Department of Health is firmly committed to working with you, our State legislators, the healthcare community and 

other stakeholders to take this clear opportunity to do all we can to assure this 

never occurs again. 

As you know, healthcare and public health professionals in Tennessee were the 

first in the Nation to detect, investigate and understand what had gone horribly 

wrong in our clinics as a result of a compounding pharmacy that now appears to 

have been acting as a manufacturer in another State. Our investigation began Tuesday, September 18, when an astute clinician provided the first indication of something unusual in a patient’s presentation and subsequent laboratory evaluation. The 

finding of fungal meningitis launched a rapid investigation that soon identified contaminated methylprednisolone acetate (MPA) from the New England Compounding 

Center in Massachusetts as the cause of an outbreak of meningitis, stroke and 

death for patients who had received epidural steroid injections with the egregiously 

tainted product at three facilities in our State. 

I am proud of the work done in Tennessee to expeditiously identify the contaminated medication which within 8 days of that first report September 18th sparked 

a national recall of the three contaminated lots of MPA. I am equally proud of work 

by the Tennessee Department of Health, our central and local health department 

teams and our many healthcare partners to rapidly find, reach out and provide close 

assistance and regular contacts to more than 1,000 at risk individuals and their 

families. I’m also proud of the cooperation among many States in addressing this 

most serious outbreak. None the less, because this whole tragic episode was preventable, I am not just saddened by the occurrence, I am angered. 

This does not appear merely to have been an unfortunate lapse or error in pharmacy judgment or practice. It appears to have been a cascade of increasingly serious 

and obvious omissions and commissions that were persistently not addressed for 

reasons currently unknown. The people who compounded these medications knew 

they were being relied upon to be sterile by patients and clinicians—real people who 

trusted them. This was a blatant disregard for health and safety by pharmacists 

who should understand the potential consequences of the final catastrophic failure 

that ultimately occurred. This was, at root, a fundamental breach of an ethical duty 

and sacred obligation by the New England Compounding Center to first, do no 

harm. 

As a physician, my colleagues and I rely on a long-standing foundation of trust 

and confidence in the drugs we administer to patients, believing these materials are 

safe and effective and will help, not hurt, an individual. I’ve talked with doctors who 

unknowingly administered contaminated NECC products to the people they were 

trying to help, and the impact to them is devastating. The men and women in the 

medical community who trusted NECC products are among the victims in this tragedy. We are angered by a few who failed to uphold the integrity of critical processes, 

protocols and procedures, resulting in harm to those we have pledged not to harm. 

I turn now to the committee’s specific questions. It is important to retain the ability to compound medication. Compounding pharmacies play a vital role in the practice of medicine. While the national attention has focused on major compounding operations, most family pharmacists across America are occasional compounding pharmacists, attested to by the mortar and pestle that are symbols of pharmacy practice. 

These pharmacists help patients who need smaller doses or different forms or formulations of medications than may be readily available from manufacturers. Children may need medication in a different form to use it. If a child cannot swallow 

a pill, for example, he or she may need a liquid. Similar considerations apply to hospice patients who may be unable to receive medication by its traditional route. Dermatologists often prescribe compounded products because of the unavailability of 

certain drug combinations; others are allergic to dyes and preservatives used in 

medications they need. 

It is vital to preserve this traditional compounding, maintaining the value provided to patients, but we must make sure manufacturing of pharmaceuticals is not 

done under the guise of drug compounding. 

Tennessee’s laws and regulations, as do most States, provide that the practice of 

pharmacy includes compounding. In Tennessee, there is not a separate license for 
89 

pharmacies who do drug compounding; therefore Tennessee regulates pharmacies 

under its general pharmacy laws and regulations. It is important to note Tennessee 

also has a similar license category that encompasses and regulates manufacturers/ 

wholesalers/ distributors of drugs. The same regulations apply to out-of-state pharmacies, although we necessarily must rely upon the pharmacy’s home State and/or 

Federal entities to inspect and provide ‘‘on the ground’’ regulation. There is always 

room for improvement. Attention to both regulatory and industry standards are necessary, complimented by a robust and adequately resourced regulatory effort to 

achieve these improvements. We are actively reviewing our own processes—and in 

partnership with our Boards, including our Board of Pharmacy, professional associations and other stakeholders—we are considering how we can improve our own regulatory posture, efficiency and effectiveness in Tennessee to assure the safety of patients and the confidence of our public, as well of the people outside our borders 

who rely on us to regulate their suppliers. 

We understand in this situation we can be vulnerable to over-reacting but at the 

same time we do not want to do too little. Clearly the status quo is not acceptable. 

While our State is also a victim of these bad actors in another jurisdiction, that does 

not relieve us of our responsibility to look at our own processes with a critical eye 

and make them better. When events like this contaminated medication tragedy 

occur or when we identify a ‘‘near miss’’ we must take the opportunity to see how 

we can prevent a similar event from occurring again. We are committed to doing 

just that. In my 15 months as Commissioner of Health in Tennessee and more than 

two decades in public health, the need to do so has never been more clear. 

As an example, we acquire information about non-resident compounding pharmacies from the pharmacy’s home State through reciprocity. We could require more 

information be provided with respect to a pharmacy’s operation, so we can more 

readily identify issues which require investigation or action by State regulators. We 

also believe information can be collected that will help draw a distinction between 

traditional compounding and mass-compounding pharmacies. Our review of these 

issues has led us to believe the factors which the FDA stated it would consider in 

determining when it would take enforcement action are generally appropriate. We 

believe a regulating body should: 

• Determine whether the pharmacy is compounding drugs in response to or anticipation of receiving prescriptions for individual patients. 

• Determine whether the pharmacy is compounding drugs that were withdrawn 

or removed from the market for safety reasons; 

• Determine whether the pharmacy is compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs; 

• Determine whether the pharmacy is receiving, storing, or using drug substances 

without first obtaining written assurance from the supplier that each lot of the drug 

substance was made in an FDA-registered facility; and for substances intended for 

sterile compounding, is sterile upon receipt. 

• Determine whether the pharmacy is receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements; 

• Determine whether the pharmacy is using commercial scale manufacturing or 

testing equipment for compounding drug products; 

• Determine whether the pharmacy is compounding drugs for third parties who 

resell to individual patients or offering compounded drug products at wholesale to 

other State licensed persons or commercial entities for resale; and 

• Determine whether the pharmacy is compounding drug products that are commercially available or that are essentially copies of commercially available FDA-approved drug products. 

We don’t believe any adverse event reporting requirement that exists will capture 

every occurrence that could lead to harm. Additionally, some errors are not easily 

detected and therefore not likely to be identified or reported. In the subject outbreak, the fungal meningitis, was not a reportable disease and may have gone undetected as an adverse medication event had we not had robust and trusting relationships with healthcare professionals through our CDC funded healthcare associated 

infection team and the astute clinicians and scientists that identified a concerning 

occurrence. In this same case, strokes occurred that were not initially recognized as 

being linked to the injection of tainted epidural steroids. 

We believe it is important for the Federal Government to respond to this issue 

because many drugs are introduced into interstate commerce, and it is the proper 

role of the Federal oversight agencies to regulate these drugs and those producing 

the drugs. In addition to appropriate Federal regulation, however, the Tennessee 

Department of Health would like to take this opportunity to stress the importance 
90 

of our State-Federal partnerships. The capacity building funding for emergency preparedness and training has ensured our ability to marshal resources, particularly 

people and expertise, to respond correctly and rapidly and to be able to mount a 

surge of effort in an emergency situation. The prior existence and availability of 

those resources and excellent communication with Federal partners in this outbreak 

made a significant difference in the speed and thoroughness of our response. It is 

crucial these resources remain available to the States for any such future event of 

public health significance. 

In summation, the Tennessee Department of Health is supportive of strengthening the regulatory process for compounding pharmacies through fact-based initiatives that ensure what happened at New England Compounding Center will not 

happen again. Compounding pharmacies have provided safe, reliable medications for 

many years, and we shouldn’t allow the aberration of a few to negate the value of 

many who serve admirably. We would also note that regulation is necessary but not 

sufficient to ensure safe and effective medications. We must also rely on the professionals who do the work every day to keep their sacred obligations to the patients 

and clinicians they serve in the forefront at all times. We encourage the committee 

to make sure existing laws and regulatory practices are rigorously enforced, and to 

consider any additional authorities deemed necessary to ensure all Americans that 

the drugs they receive through interstate commerce meet all applicable quality 

standards including safety and effectiveness. 

Thank you for your work in this critical area. 

STATE OF TENNESSEE, DEPARTMENT OF HEALTH, 

BUREAU OF HEALTH LICENSURE AND REGULATION, 

DIVISION OF HEALTH RELATED BOARDS, 

NASHVILLE, TN 37243. 

Hon. LAMAR ALEXANDER, 

U.S. Senate, 

Washington, DC 20510. 

SENATOR ALEXANDER: I wanted to thank you for the opportunity to submit testimony for the upcoming hearings related to compounding pharmacy. The magnitude 

of the fungal meningitis outbreak has reinforced the need to improve regulation of 

facilities performing high volume sterile product preparation, both pharmacies and 

manufacturers. My answers to the questions posed are delineated below. 

Question 1. What is the appropriate role of compounding pharmacies in providing 

medicines to patients? 

Answer 1. Compounding is a cornerstone of the practice of pharmacy. 

Compounding pharmacists prepare custom medicines for patients who may be allergic to a particular ingredient, require a smaller (or larger) dose, or need specialized 

or rare pharmaceuticals. Compounding has traditionally been limited to these sorts 

of activities. Compounding requires a high level of pharmacological expertise, as 

well as close coordination with other health care providers and patients. However, 

in recent years the practice of compounding has been expanded to include the largescale repackaging, mixing, and fabrication of drugs. This practice, which under certain circumstances could be considered ‘‘drug manufacturing,’’ varies from the traditional practice of compounding. A complex set of factors has led to the rise of this 

practice, and it is therefore difficult to lay the blame at the feet of any party. While 

these sorts of organizations have played a valuable role in ensuring the stability of 

our drug supply, steps should be taken to ensure the continued existence of traditional pharmacy compounding. 

Question 2. What is Tennessee’s experience with licensing, regulating, and overseeing in-state compounding pharmacies operating within Tennessee’s borders? Outof-state compounding pharmacies? Are there areas that need improvement? 

Answer 2. Tennessee law recognizes that compounding is an integral part of the 

practice of pharmacy. Compounding pharmacies in Tennessee are regulated under 

the same standards applied to retail pharmacies; there are not distinct licenses for 

each type of practice. Periodic inspections are carried out by pharmacist investigators to ensure compliance in all areas of pharmacy practice, including compounding. 

Out-of-state compounders are judged by the same standards as out-of-state retail 

pharmacies. The same regulations apply to each, but we have to rely upon regulators in each pharmacy’s home State to inspect and ensure that out-of-state pharmacies comply with the law. It would not be practical to inspect all out-of-state 
91 

pharmacies that hold Tennessee licenses, nor would it be practical to inspect all 

drug products shipped into the State from out-of-state pharmacies. 

Specific legislation targeted at sterile compounding practices, as well as legislation or regulation that makes a distinction between traditional compounders and 

manufacturers are two areas to consider. Additional resources could also be helpful. 

Question 3. Where do you obtain information about non-resident compounding 

pharmacies? What solutions would you recommend to improve the availability and 

understanding of that information? 

Answer 3. We acquire information about non-resident compounding pharmacies 

from regulators in each pharmacy’s home State. We could require that more information be provided with respect to a pharmacy’s operation, so that we could readily 

see if there are issues which require investigation or action by State regulators. We 

could also increase our cooperation and information sharing with Federal entities 

such as FDA and DEA when the regulatory boundaries blend or crossover. 

Question 4. Is there a way to draw a distinction between traditional compounding 

pharmacies and mass-compounding pharmacies similar to what NECC was doing? 

Answer 4. The FDA uses several factors to differentiate between traditional 

compounding and NECC-type operations. These factors are very helpful in drawing 

this distinction, and are set out below: 

• Determine whether the pharmacy is compounding drugs in anticipation of receiving prescriptions, except in limited quantities; 

• Determine whether the pharmacy is compounding drugs that were withdrawn 

or removed from the market for safety reasons; 

• Determine whether the pharmacy is compounding finished drugs from bulk active ingredients that are not components of FDA approved drugs; 

• Determine whether the pharmacy is receiving, storing, or using drug substances 

without first obtaining written assurance from the supplier that each lot of the drug 

substance was made in an FDA-registered facility; 

• Determine whether the pharmacy is receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements; 

• Determine whether the pharmacy is using commercial scale manufacturing or 

testing equipment for compounding drug products; 

• Determine whether the pharmacy is compounding drugs for third parties who 

resell to individual patients or offering compounded drug products at wholesale to 

other State licensed persons or commercial entities for resale; and 

• Determine whether the pharmacy is compounding drug products that are commercially available or that are essentially copies of commercially available FDA-approved drug products. 

Question 5. How do Tennessee providers using an out-of-state compounding pharmacy evaluate and determine to use that pharmacy? 

Answer 5. This aspect is part of the practice of medicine in Tennessee. It is the 

facility or provider’s ultimate choice to pick a supplier. 

Question 6. Do you believe that existing adverse event reporting is adequate to 

capture any event that may occur as the result of a compounded prescription drug? 

Answer 6. It is difficult to determine what sort of adverse event reporting structure could have prevented this tragedy. It is hard to develop event reporting requirements that cover enough ground, but aren’t overly burdensome to our health 

care providers. Given the rapidly changing nature of the healthcare and pharmaceutical industries, event reporting criteria would likely need to be constantly updated. While it is important that health care providers report adverse events to the 

appropriate bodies, it also ensures that the regulators have the necessary tools to 

work with the private sector in the event of an emergency. 

Question 7. Do you think there should be a Federal response to clarify how 

compounding pharmacies are regulated in light of the actions of NECC? 

Answer 7. Yes, clarification is highly important as it pertains to the differentiation between manufacturing and compounding pharmacy and the resulting 

variances in regulation. Federal leadership would also be beneficial to develop communication channels that will increase transparency and facilitate interstate and 

interagency information exchange, resulting in more informed regulation by individual States or regulating bodies. 
92 

Thank you for your willingness to take on the daunting task of regulatory reform. 

With thoughtful input from a variety of sources, we are more likely to find a fitting 

solution to the challenges that we face. 

Sincerely, 

ANDREW C. HOLT, Pharm.D., 

EXECUTIVE DIRECTOR, 

Tennessee Board of Pharmacy. 

PREPARED STATEMENT OF CRAIG BECKER, PRESIDENT, TENNESSEE HOSPITAL

ASSOCIATION (THA), NASHVILLE, TN 

On behalf of the Tennessee Hospital Association and its member hospitals, I 

would like to thank Senator Alexander for the opportunity to comment on the recent 

meningitis outbreak in Tennessee and the impact on the patients we serve. It is my 

intention to provide the Health, Education, Labor, and Pensions (HELP) Committee 

with a chronological description of events, the role of THA and finally with lessons 

learned from this tragedy. 

First and foremost, THA and its members’ primary concern is over the health of 

the patients impacted by this tragedy. Once the problem had been identified by the 

Tennessee Department of Health (TDH) and the Center for Disease Control (CDC), 

THA members stopped using the tainted product. Once the cause of the outbreak 

and a course of action had been determined, THA and its members took every appropriate action to deal with this unprecedented crisis. 

We hope and pray that there never will be another incident like this, but we feel 

the systems in place to notify members, pull the tainted product off the shelves and 

treat the infected patients, worked. We cannot thank enough the TDH, Commissioner John Dreyzehner, M.D., MPH, Marion Kainer, M.D., MPH, Director, 

Healthcare Associated Infections and Antimicrobial Resistance program and the rest 

of the TDH staff for its prompt actions and for its succinct directions to the provider 

community. 

THA’s role in this event was primarily to act as a conduit for information to our 

members and non-members alike, as it was made available from the TDH and other 

Federal agencies. THA has a data base of all key administrative and clinical people 

in Tennessee’s hospitals. At various times, at the direction of the TDH, THA provided hospitals, both members and non-members, with critical information about 

the crisis and more important, actionable directions on how to treat, or not treat 

those affected patients. 

CHRONOLOGY

I believe it would be instructional for the committee to know the chronology of 

events THA has developed from our combined notes and calendars. It should be understood this is based on THA material and not others, who may differ with our 

view. 

September 18, 2012—Dr. April Pettit, an infectious disease specialist at Vanderbilt University Medical Center, treats the first (index) case, realizing this type of 

spinal meningitis was extremely rare. Dr. Pettit alerted TDH to the potential problem. Dr. Kainer immediately implements surveillance procedures to determine if 

there were other cases. 

September 20, 2012—TDH identifies two other possible cases. Dr. Kainer notifies CDC. 

September 24, 2012—After surveying the clinic where the outbreak had occurred, TDH traces tainted product back to New England Compounding Center 

(NECC) and requests from Massachusetts Department of Health (MDH) a distribution list of all products shipped to Tennessee. 

September 25, 2012—Tracing records back, TDH determines ‘‘Clinic A’’ as the 

likely location for several of the patients. It should be noted that the provider community acted immediately, closing the suspected clinic and totally supported the 

TDH investigation. The clinic identified and gave all patient information to TDH 

and provided full access to clinical records. 

September 26, 2012—NECC issues a voluntary recall of steroid products. 

September 28, 2012—CDC declares the problem a multi-state outbreak. 

October 30, 2012—At the direction of Commissioner Dreyzehner, THA began acting as a conduit of information to get information to all key staff in hospitals and 

clinics, noting the clear connection to NECC. 
93 

October 5, 2012—Federal Drug Administration (FDA) confirms a sealed vial is 

contaminated and issues a national recall and order to cease using NECC products. 

October 8–10, 2012—THA and TDH work together providing constant timely information to providers on findings and treatment recommendations. 

October 15, 2012—THA hosts a conference call with TDH and key hospital staff. 

October 16, 2012—THA staff follows up with personal calls to same key staff of 

all hospitals and clinics that received NECC product to be sure the product has been 

pulled from all clinical areas, including crash carts, ambulatory units, etc. 

October 17, 2012—THA briefs FDA on the situation and requests guidance on 

who our providers should contact, what they should say, what patient prioritization 

(surgery, topical, etc.) should providers use, and guidance on how to deal with the 

pediatric population. FDA took our request under advisement. 

October 18, 2012—THA, working with TDH, sends out sample notification letters, which includes guidance from FDA and CDC. Again, THA personally contacts 

those impacted hospitals and clinics. 

October 19, 2012—THA provides additional information received from TDH on 

media responses, patient letters. This became a burden for hospitals not NECC. 

Also, a flood of ‘‘worried well’’ patients began showing up in hospital ERs. Hospitals 

had to take critical staff away from patient care to staff call centers to field calls 

from the ‘‘worried well.’’ 

October 20, 2012—To present TDH determines 42 days is the critical time for 

incubation of the disease, and flood of patients begins to ease. THA and TDH continue to be in constant contact and alerts are sent as needed. 

LESSONS LEARNED

As in any crisis, it is always important to review lessons learned to be prepared 

for the future disaster. The following represent the significant findings from THA’s 

perspective. 

1. The Tennessee Health Alert Network, (THAN), developed after 9/11 was invaluable. Even with THA having an extensive list of key staff, THAN alerted providers 

about the problem much faster than we could have otherwise. 

2. Having a transparent and open line of communication with TDH, THA and the 

provider community was the most important element of dealing with the crisis. Drs. 

Dreyzehner and Kainer are to be commended for keeping in constant contact and 

for being willing to utilize a non-government entity such as THA to transmit accurate and timely information. We found it discouraging that Federal agencies weren’t 

aware of the role non-governmental entities could play in such an emergency. 

3. There needs to be a better system of contacting smaller ambulatory care and 

physician office settings. Getting the information to them was mostly through the 

media. 

4. Better and timelier guidance from Federal agencies is critical. There were many 

questions around whether or not products such as eye drops should be given priority 

status and what providers should tell patients. It appeared to those of us in the field 

that coordination among agencies was lacking. One suggestion would be to designate a lead agency in a crisis like this and to empower the appropriate staffs to 

give out information to providers and their representatives instead of having to ‘‘run 

it up the flag pole.’’ 

5. As a follow up to No. 4, a national spokesperson speaking out on the crisis 

would have been very helpful. In Tennessee, Dr. Dreyzehner was the very effective 

face of the crisis. He was transparent, open and didn’t avoid the tough questions. 

6. This was a supplier issue, not a provider issue. Hospitals, doctors and nurses 

worked on the assumption these drugs were safe; however when the crisis erupted, 

it became their problem, not NECC’s. It would have been helpful for a Federal agency to make it clear to the public that it was NECC’s problem, not the provider community. In some ways, our doctors and nurses feel as much a victim as our patients. 

CONCLUSION

This was a tragedy to our patients, to the trust in the safety of our drugs from 

both the provider and patient perspective and to the providers who injected what 

they thought was safe product. I have personally talked with doctors and nurses 

who have said they are devastated by what happened. 

Again, I cannot express enough appreciation to Drs. Dreyzehner and Kainer and 

the entire TDH staff for its support, quick action and openness, all of which no 

doubt saved lives. We have learned from this tragedy and will be better prepared 
94 

for the next one. It is our greatest hope that hospitals, doctors and nurses can be 

assured we have safe and adequate medications, to serve the American people. 

Thank you for your time and for allowing me to thank those who acted so courageously in dealing with this outbreak. 

TENNESSEE PHARMACISTS ASSOCIATION (TPA), 

NASHVILLE, TN 37219, 

November 15, 2012. 

Hon. LAMAR ALEXANDER, 

U.S. Senate, 

455 Dirksen Senate Office Building, 

Washington, DC 20510. 

Re: Response to Request for Testimony Regarding Pharmacy Compounding in Ten- nessee 

DEAR SENATOR ALEXANDER: The Tennessee Pharmacists Association appreciates 

the opportunity to submit testimony for the record to the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee for your November 15, 2012, hearing entitled ‘‘Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.’’ We thank you for your service to the citizens of Tennessee and our country. 

The Tennessee Pharmacists Association (TPA) is a professional organization representing pharmacists, student pharmacists, pharmacy technicians and others interested in improving medication use and patient care in Tennessee. TPA members 

provide care in all practice settings, including community pharmacies, hospitals, 

long-term care facilities and other settings. TPA and its members are deeply concerned about the tragic situation that has occurred as a result of what appears to 

be large-scale manufacturing by a pharmacy in Massachusetts, and we are prepared 

to work with legislators and regulators to assure public safety and access to quality 

medications that meet patients’ needs. We extend our deepest sympathy to patients 

and families affected by this tragic event. 

RESPONSES TO SPECIFIC QUESTIONS

The questions you posed demonstrate a sincere desire to understand the complexities of the issue, and Tennessee’s pharmacists appreciate your commitment. Our responses are provided after surveying TPA member pharmacists and reviewing their 

responses to the questions. In some instances, responses are provided that are specific to hospital/health-system pharmacy practice settings and are so noted. 

To assure a clear understanding of the answers below, we are providing the definitions for ‘‘compounding’’ and ‘‘manufacturer’’ found in the Tennessee Pharmacy 

Practice Act, §TCA 63–10–204: 

Compounding 

(4) ‘‘Compounding’’ means the preparation, mixing, assembling, packaging or labeling of a drug or device: 

(A) As the result of a prescription order or initiative based on the prescriberpatient-pharmacist relationship in the course of professional practice, 

(B) In anticipation of prescription orders based on routine, regularly observed 

prescribing patterns; or 

(C) For the purpose of, or as an incident to, research, teaching or chemical 

analysis and not for sale or dispensing; 

Manufacturer 

(21) ‘‘Manufacturer’’ means any person, except a pharmacist compounding in the 

normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion or processing of a drug, either directly or indirectly, 

by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the 

labeling or relabeling of its container and the promotion and marketing of such 

drugs or devices; 

Question 1. What is the appropriate role of compounding pharmacies in providing 

medicines to patients? 

Answer 1. Compounding has been and continues to be an essential and integral 

part of the profession of pharmacy and was the major component of pharmacy practice for many years prior to large-scale pharmaceutical manufacturing. 

Compounding allows pharmacists to meet specific patient medication needs, including veterinary needs. Pharmacists are educated, trained and qualified to provide 

these services for their patients. 
95 

Generally speaking, compounding of a pharmaceutical product occurs when a particular patient has a specific need and the medication dosage form or concentration 

required to treat that need is not available from a commercial manufacturer, or is 

not available due to a shortage. Many patient populations require medications that 

may not be available for a variety of reasons. For example: 

1. Pediatric patients, particularly neonates, may require small dosages or customized dosage forms that aren’t manufactured by an FDA-approved manufacturer. 

2. Geriatric patients may need a dose in an oral liquid that can be administered 

via nasogastric tubes. 

3. Patients undergoing anesthesia, such as women in labor, require medications 

that must be sterile and free of preservatives in order to be safely administered 

through an epidural injection. 

Increasingly, compounded pharmacy products are also purchased to fulfill patient 

needs for prescription drugs that are not available due to manufacturers’ shortages 

or back-order situations. When certain drug products cannot be purchased through 

the routine inventory chains, the critical product may only be available through 

compounding pharmacies. Critical shortages continue to contribute to medication 

safety issues, and compounding pharmacies are often the only source of these 

agents. 

Compounding is a necessary component of the professional practice of all pharmacies. Many community pharmacies routinely engage in preparation of non-sterile 

pharmaceuticals. The simple mixing of two commercially manufactured products 

into a new product—such as adding a customized flavoring agent—is compounding, 

as is mixing two creams together. Preparing of any intravenous admixture or creating specialty pediatric or geriatric dose formulations is also compounding, in that 

a manufactured product is altered for specific patient needs. All pharmacists must 

have the right to compound and prepare a product for an individual patient need. 

Additional Comments From the Health-System/Hospital Pharmacy Community 

While not every community pharmacy is equipped for sterile compounding, it is 

a necessary component in the daily routine of every hospital pharmacy. 

Compounding pharmacies provide a significant service to hospital patients. They 

formulate therapeutic and diagnostic products, make noncommercial formulations, 

customized preservative-free and dye-free formulations, and are essential to meet 

the needs created by national pharmaceutical shortages. Compounding pharmacies 

fill a niche with high-risk compounding, such as non-sterile to sterile IV admixtures 

like cardioplegia solutions or IV Continuous Renal Replacement Therapy solutions. 

Most inpatient hospital pharmacies in Tennessee do not have IV rooms that meet 

structural USP 797 regulations, nor the equipment, expertise, or testing processes 

to perform this level of compounding safely. Compounding pharmacies can provide 

this service at an extremely high quality. With the critical shortages of sterile 

injectibles, especially medications that are used in code or emergency situations, 

compounding pharmacies also perform sterile transfer from larger size injectibles to 

the size and dosage form that is readily available. This prevents serious medication 

errors from occurring and prevents delays in emergency therapy. 

Question 2. What is Tennessee’s experience with licensing, regulating, and overseeing in-state compounding pharmacies operating within Tennessee’s borders? Outof-state compounding pharmacies? Are there areas that need improvement? 

Answer 2. The Tennessee Board of Pharmacy has successfully regulated all pharmacies providing patient care services in Tennessee, including both hospital- and 

community-based pharmacies that compound. Additionally, the Board of Pharmacy 

regulates manufacturers, wholesalers and distributors located in Tennessee. State 

law requires all Tennessee Board of Pharmacy investigators to be pharmacists licensed in Tennessee. The Tennessee Board of Pharmacy routinely inspects all licensees located in-state to verify compliance with laws, rules and standards of practice. 

Tennessee law requires any pharmacy, regardless of whether located in-state or 

out-of-state, providing services to a Tennessee resident to be licensed by the Tennessee Board of Pharmacy. Regarding out-of-state pharmacies, the Tennessee Board 

of Pharmacy relies on the Boards of Pharmacy in other States for regulation of the 

pharmacies in their respective States. The Tennessee Board does not and cannot 

conduct on-site inspections of out-of-state pharmacies to verify compliance with Tennessee law and Board regulations. Inspections by out-of-state agencies, if conducted 

at all, may vary widely from State to State, as do State rules and regulations. The 

qualifications of the inspectors in other States may vary as well. 

Inspections of pharmacies by qualified personnel are critical. Visual, on-site inspection of the premises, the culture of the pharmacy staff, and operations are im-
96 

portant in assessing the appropriate actions of the pharmacy being inspected. We 

believe all States must have requirements for routine and thorough inspections of 

pharmacies. It is imperative that all Boards of Pharmacy be provided sufficient resources to employ optimal numbers of pharmacists as inspectors and to provide the 

ongoing training needed by those pharmacist inspectors. 

Question 3. Where do you obtain information about non-resident compounding 

pharmacies? What solutions would you recommend to improve the availability and 

understanding of that information? 

Answer 3. From a regulatory perspective, information on non-resident 

compounding pharmacies comes from the Tennessee Board of Pharmacy or, if information is shared, from the Board of Pharmacy in the State where the pharmacy is 

originally licensed. 

Most information regarding sources of compounded products comes either from 

hospital pharmacy buying groups or as ‘‘word of mouth’’ or recommendations from 

colleagues. Marketing materials or advertisements may also be a source of information. Small hospitals would rely heavily on such materials, while larger institutions 

with greater resources at their disposal may conduct on-site visits at out-of-state 

pharmacies. 

Question 4. Is there a way to draw a distinction between traditional compounding 

pharmacies and mass-compounding pharmacies similar to what NECC allegedly was 

doing? 

Answer 4. It is very difficult to definitively differentiate between compounding 

and manufacturing in all circumstances. While it is easy to determine that a traditional pharmacy practice providing patient-specific, small-volume services as described in the definition of compounding is ‘‘compounding,’’ the provision of compounded medications may be of significant volumes and still be compounding as opposed to manufacturing. Manufacturing occurs when individual patient needs are 

not part of the process. Altering drug products in large quantities for resale that 

are not prepared and labeled for specific patient use in the final State is manufacturing. Current State and national laws need to be enforced to protect our citizens. 

Whatever proposals are considered, we believe it is important that State Boards 

of Pharmacy continue to license and regulate traditional compounding, while recognizing that large-scale production of sterile products that are not for specific patients may require oversight by the Food and Drug Administration (FDA) in cooperation with State Boards of Pharmacy. A process for better collaboration and cooperation between State Boards of Pharmacy and the FDA would be a step forward. 

Question 5. How do Tennessee providers using an out-of-state compounding pharmacy evaluate and determine to use that pharmacy? 

Answer 5. The Tennessee Department of Health has an on-line resource that allows healthcare providers to research the licensure of all entities through a web portal: http://health.state.tn.us/HCF/FacilitieslListings/facilities.htm. 

Pharmacists also use an evaluation tool published by the American Society of 

Health-System Pharmacists. This tool can be located at: http://www.ashpfoundation 

.org/sterileproductstool. 

In addition, pharmacists receive information through hospital buying groups and 

from marketing information received. Again, word of mouth or positive recommendations by colleagues can have a major influence on selection of out-of-state 

compounding pharmacies. 

Availability and pricing may be considered in these decisions. 

Question 6. Do you believe that existing adverse event reporting is adequate to 

capture any that may occur as the result of a compounded prescription drug? 

Answer 6. The Tennessee Board of Pharmacy rule 1140–03–.14(14) states: 

‘‘The designated pharmacist in charge shall report to the board any situation 

in which a medical or prescription order has caused serious personal injury or 

death.’’ 

In Tennessee, reporting of adverse events that occur at this level is not an option 

but a requirement. 

The current national system of voluntary reporting adverse medication reactions 

is probably underutilized for both compounded and manufactured medications. 

While pharmacists support the concept of actively reporting adverse reactions to 

compounded and commercially available preparations, the existing system—FDA 

MedWatch program—is designed in such a manner as to actually impede pharmacists’ participation. There needs to be additional collaboration between the FDA 

and compounding pharmacists, so this system can be widely and meaningfully used. 
97 

Additional Comments From the Health-System/Hospital Pharmacy Community 

The existing FDA adverse event reporting mechanism commonly referred to as 

MedWatch (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm) 

is cumbersome and time-consuming. Furthermore, it is an entirely voluntary process. We believe that the vast majority of providers/prescribers are unaware of this 

reporting process. We also believe that many reports are never made due to a fear 

of reprisal. 

Question 7. Do you think there should be a Federal response to clarify how 

compounding pharmacies are regulated in light of other actions of NECC? 

Answer 7. We believe that if NECC had been properly categorized as a manufacturer (instead of a compounding pharmacy), existing regulations as enforced by the 

FDA would have been adequate to prevent this tragedy from taking place. We believe there is a need for more stringent oversight and a clearer distinction between 

compounding and manufacturing. The FDA does require clear authority, adequate 

funding and staffing in order to properly inspect and oversee manufacturers of pharmaceuticals. 

Unfortunately, there are no laws that will absolutely prevent unethical behavior 

or operations that fall short of recognized standards. Thorough and routine inspections by qualified and trained individuals and stringent oversight by regulatory personnel are the best approaches to prevent these types of situations. 

TPA remains committed to working with Congress, State legislators, national and 

State regulators, and other stakeholders to address any regulatory gaps that may 

exist and reduce the likelihood of any problems from compounded products in the 

future. 

Please contact me if you have questions or need additional information regarding 

the comments that TPA has submitted. Again, thank you for requesting input from 

pharmacists and other health care professionals in Tennessee. 

Sincerely, 

BAETEENA M. BLACK, D.PH., 

Executive Director. 

TENNESSEE MEDICAL ASSOCIATION (TMA), 

NASHVILLE, TN 37212, 

November 14, 2012. 

Hon. LAMAR ALEXANDER, 

U.S. Senate, 

455 Dirksen Senate Office Building, 

Washington DC 20510. 

Re: Meningitis Outbreak 

DEAR SENATOR ALEXANDER: Thank you for the opportunity to make comments on 

the recent nationwide meningitis outbreak. First and foremost, our hearts go out to 

the thousands of patients who sought care from physicians for chronic back pain, 

only to later learn that the medication administered was contaminated. Whether the 

patients were diagnosed with fungal meningitis or were fortunate enough not to be 

affected, they all were placed in an unfortunate position that was probably preventable had there been more oversight of the Massachusetts compounding pharmacy. 

For background purposes, members of the Senate Health, Education, Labor, and 

Pensions Committee should be aware that chronic pain and its treatment has become an increasingly visible part of medical treatment over the last 20 years. Welleducated and appropriately trained physicians will almost always initiate other, less 

aggressive forms of treatment, such as pharmaceutical or physical therapy, before 

initiating spinal injections or even more invasive surgical procedures. A provider 

treating chronic back pain should be somewhat passive when starting spinal injections and, if the patient does not get relief, stop the treatment regimen. 

Compounding pharmacies, both local to the State of Tennessee and those that are 

external to the State of Tennessee doing business in our State, are overseen and 

licensed by the Tennessee Board of Pharmacy. Tennessee physicians believe that 

our Pharmacy Board performs these duties with great care and diligence. We have 

no reason to believe that any patient seen and cared for at any of the three centers 

which received the tainted medication here in Tennessee was provided anything but 

the appropriate standard of care. Our pain physicians in the State tell us that they 

do use compounded drugs for those hard to get drugs or for repackaging. Prior to 

this outbreak, the prevailing perception among the physician community in Tennessee was that compounding pharmacies were as regulated as manufacturing phar-
98 

macies and that generally the products they marketed met the necessary quality 

control standards for safety and efficacy. 

We now know differently and believe that Congress can assure the development 

of a transparent and accountable regulatory system, whether that be Federal or on 

a State level, over the production and distribution of compounded drugs. It is our 

understanding that, if the company had been licensed as a manufacturer, they 

would have come under the aegis of the FDA. Regulatory gaps should be filled so 

physicians can once again feel safe about the compounded drugs they order. Should 

Congress determine that the Food and Drug Administration is the proper entity to 

oversee this facet of the health care system, we would ask you to provide the agency 

with the necessary authority and resources to effectively regulate the industry. 

In terms of the adverse event reporting, existing mechanisms are in place to report adverse outcomes. The elusive component of any reporting system is ‘‘recognizing’’ an event as adverse and related to a medication, compounded or not. Fortunately, a very perceptive Vanderbilt physician was able to identify the cause of a 

very bad outcome and reported it immediately to State officials. Once recognized, 

capturing and reporting is reasonably straight-forward. 

Since the outbreak was publicized, we have heard from some individual physicians specializing in pain care that patients have expressed a real reluctance to undertake spinal injections. For some, other treatment options may be available but 

for many the injections represent the best long-term hope for relief of their pain. 

Although their reluctance is certainly understandable, such a response limits the options available to the treating physician and ultimately will mean less-than-acceptable care to the patient. Whatever Congress can do to assure consumers that this 

outbreak represents an opportunity to make real change that will minimize the possibility of future reoccurrences would be a significant step forward. 

Thank you again for the opportunity to make comments on this issue. 

Sincerely, 

WILEY ROBINSON, M.D., FHM, 

President. 

THE COMMONWEALTH OF MASSACHUSETTS, 

BOSTON, MA 02108–4619, 

January 23, 2013. 

U.S. SENATE, 

Committee on Health, Education, Labor, and Pensions, 

Attn: Pamela J. Smith, Staff Director; and 

Frank J. Macchiarola, Republican Staff Director, 

428 Senate Dirksen Office Building, 

Washington, DC 20510–6300. 

DEAR MS. SMITH AND MR. MACCHIAROLA: Thank you for the opportunity to respond to your member’s inquiries regarding compounding pharmacy oversight and 

the New England Compounding Center (NECC)—the company primarily responsible 

for the meningitis outbreak that has claimed dozens of lives across the country. As 

the Massachusetts Department of Public Health continues to take aggressive actions 

to protect public safety, our ongoing collaboration with your committee is important 

to ensure that this type of tragedy never happens again. 

In Massachusetts, we have taken significant actions to enhance our regulations, 

increase inspection schedules and hold pharmacies accountable following this tragic 

outbreak. And this month, Governor Patrick filed strong legislation to further increase oversight of pharmacies, including regulation of out-of-state pharmacies and 

reconstitution of our Board of Pharmacy. As we work to raise standards in Massachusetts, we urge Congress to act to strengthen Federal oversight to address the 

regulatory grey areas that exist between State and Federal regulation. 

The Department is committed to our continued and close collaboration with the 

committee, the Centers for Disease Control and Prevention (CDC), the U.S. Food 

and Drug Administration (FDA), and other States’ public health officials to investigate the exact cause of an outbreak to take the necessary actions to enhance policies and adopt best practices both here and across the Nation. 

I welcome the opportunity to continue this work with you, your fellow committee 

members, and the U.S. House Energy and Commerce Committee to address these 

critical needs. 
99 

1Please note that the Massachusetts Board of Pharmacy voted on final regulations as described on January 8, 2013. These regulations will become final once published within the Massachusetts Register on February 1, 2013. 

Below you will find answers to your specific questions. Please do not hesitate to 

be in touch with me or my staff. We thank you for your continued leadership. 

Sincerely, 

LAUREN A. SMITH, M.D., MPH, 

Interim Commissioner. 

Question 1. Why did the Massachusetts Board of Pharmacy enter into a weakened 

consent agreement with NECC, even after forwarding the original, stronger consent 

agreement (which included a public reprimand) to the prosecuting attorneys within 

the Department of Public Health? 

Answer 1. These actions were taken in 2006 during a previous Administration 

and are deeply troubling. An extensive file-by-file and e-mail review conducted by 

staff has yet to uncover any documentation, information or communications that 

clearly describe what transpired between the initial consent decree in 2004 and the 

final actions taken by the Board in 2006. 

While NECC bears the primary responsibility for this tragic outbreak, it is apparent that Board staff displayed poor judgment, missed opportunities and failed to 

take appropriate action to hold NECC accountable. Those individuals who were responsible have been removed from their jobs. 

Question 2. Did the Department of Public Health ever consider legal action as an 

alternative to either of the consent agreements? 

Answer 2. As stated above, the lack of documentation related to these decisions 

is troubling. In the absence of such information, we cannot clearly establish the 

array of options that may have been considered. 

Question 3. What steps are you currently undertaking to improve oversight of 

compounding pharmacies in Massachusetts? 

Answer 3. Following my testimony before the committee on November 15, 2012, 

the Commonwealth has taken significant actions to this effect, which I am happy 

to share with you. 

We advanced emergency regulations that went into effect immediately on November 1, 2012, to enhance our ability to monitor the sterile compounding industry. The 

new regulations require sterile compounding pharmacies in Massachusetts to report, 

for the first time, volume and distribution figures to the State, which will alert the 

Board of any pharmacy that is acting like a manufacturer, which requires an FDA 

license. 

The regulations also require all licensed pharmacies and pharmacists to report to 

the Board when they are the subject of any disciplinary action by any State or Federal agency. This will allow the Board to know when other entities have identified 

issues with Massachusetts-licensed pharmacies.1

Nearly 40 pharmacies have been inspected since Governor Patrick directed the 

Board of Pharmacy to begin checks of compounding pharmacies that produce sterile 

injectable medications. These inspections identified problems in several pharmacies 

for which new cease and desist orders have been issued and corrective plans have 

been put into place. 

Other pharmacies that have been inspected have come back with minor deficiencies that have since been corrected, or are currently being addressed. Unannounced inspections of compounding pharmacies that produce sterile injectable 

medications will continue until all have been inspected. 

We also announced changes at the Massachusetts Board of Pharmacy, with three 

new members who work across diverse health care settings filling seats on the 

Board. 

In October 2012, the Governor established a Special Commission on Pharmacy 

Compounding as part of the Administration’s comprehensive response to the outbreak. The Commission met regularly, looking at best practices in other States and 

exploring changes to the law to help address the regulatory gray area surrounding 

compounding pharmacies. A final report was issued on January 4, 2013. 

Building on the recommendations identified by the Commission, on January 4, 

2013 Governor Patrick also announced the filing of legislation to reform the Board 

of Pharmacy and strengthen the Commonwealth’s oversight of the compounding 

pharmacy industry in Massachusetts. Specifically, the legislation: 
100 

1. Requires a special license for sterile compounding that will enable regulators 

to better track and hold pharmacies accountable for their practices; 

2. For the first time, authorizes the Board to assess fines against Massachusettslicensed pharmacies that violate Board of Pharmacy policies, regulations, or statute; 

and establishes whistleblower protections for pharmacists and pharmacy staff; 

3. Requires licensure for out-of-state pharmacies that deliver and dispense medications in the Commonwealth; 

4. Establishes a clear process to restructure and reorganize the composition of the 

Board of Pharmacy, ensuring more balanced representation of background of Board 

members to improve oversight of the industry. The Board will include more members not practicing in the industry they are responsible for regulating. Under the 

legislation, the eleven (11) member Board would be comprised of four pharmacists, 

one pharmacy technician, one nurse, one physician, one quality improvement expert, 

and three public members who have experience in healthcare delivery or consumer 

advocacy. 

Question 4. FDA inspectors released recently a report last week from their recent 

investigation of Ameridose—a company owned and managed by the same families 

as the New England Compounding Center. This report included the following description of the conditions they found—I quote: 

‘‘ . . . insects were observed to be located in the unclassified area where finished sterile product is packaged and stored. The insects were also located within approximately 3 to 10 feet of the controlled area where sterile products are 

manufactured. At least one bird was observed flying in the unclassified area 

where sterile finished product is packaged and stored.’’ 

How do you explain the fact that Ameridose was shipping products all over the 

country that had been manufactured under these circumstances, given the years of 

complaints about both the New England Compounding Center and Ameridose? 

Answer 4. In the course of its licensure in Massachusetts, Ameridose had been 

subject to one complaint, pertaining to potential patent infringement. This issue was 

settled between Ameridose and the complainant. 

During previous licensure inspections, Board staff did not identify any findings 

similar as those witnessed during the joint inspection with the FDA. As soon as we 

learned of these issues, we took action to suspend operations at Ameridose and 

NECC’s other sister companies. The FDA secured a recall of all Ameridose products 

and the company remains closed. 

These events have clearly indicated that the complaints-driven inspection policies 

that were used by Massachusetts and continue to be used by many States are insufficient to provide comprehensive oversight to compounding pharmacies. It is important to know how a pharmacy is operating when they are not scheduled for an inspection. That is why Massachusetts now has unannounced inspections of all pharmacies compounding sterile injectable substances and we have advanced new regulations to enhance our inspection schedules. 

Question 5. Many State Boards of Pharmacy rely on the Board of Pharmacy in 

the State where a pharmacy is physically located to conduct inspections, since most 

Boards of Pharmacy do not have the capacity to inspect pharmacies across the country. Given the current crisis, how do you think Minnesota’s Board of Pharmacy can 

make sure that a pharmacy in Massachusetts is shipping safe products into Minnesota? Does the current system work? 

Answer 5. As you have pointed out, limited, geographic-bound resources require 

greater, more consistent and streamlined communications between States, as well 

as our Federal partners. Although we have taken great strides to increase oversight 

in Massachusetts, similar progress is needed at the Federal level. The Federal Government’s role in oversight of interstate commerce is essential to our shared success. 

Likewise, the FDA must fulfill its obligation to ensure that manufacturers declare 

themselves as such and abide by all Federal laws and regulations. In Massachusetts, our Board of Pharmacy has adopted emergency regulations that require every 

pharmacy to report within 7 business days all adverse events relating to the preparation of medications in that pharmacy. Additionally, pharmacies in Massachusetts 

are now required to share all disciplinary actions taken by other States and the 

FDA on receipt. While this does not substitute for clear, regular and streamlined 

communications between all parties, I believe these to be important steps forward 

to ensure this never is allowed to happen again. 

As outlined in the Department’s response to Question 3, through the Governor’s 

filed legislative reform, the Board will now have the authority to regulate out-ofstate compounding pharmacies that ship medications into Massachusetts through 

the development of an out-of-state oversight process. The Board will also gain the 
101 

authority to create an alternate licensure category for pharmacies that pose a higher 

risk to the public, and to levy fines against these licensees where appropriate. Additionally, Massachusetts is working with our Commission on compounding pharmacies as well as the National Association of Boards of Pharmacy (NABP) to further 

address these issues and make enhancements where necessary. 

Question 6a. In addition to the report from the FDA of infestations of insects, 

vermin, and even a bird in Ameridose’s facility, according to the FDA’s inspection 

report, Ameridose did not adequately test sterility or log complaints from patients 

and reports of adverse events. Can you clarify the requirements of a compounding 

pharmacy in the Commonwealth of Massachusetts regarding sterility testing and 

the reporting of complaints and adverse health events? 

Answer 6a. The Massachusetts Board of Pharmacy regulation 247 CMR 9.01(3) 

requires that ‘‘a pharmacist shall observe the standards of the current United States 

Pharmacopoeia.’’ Briefly, United States Pharmacopoeia (‘‘USP’’) requires the following testing: 

• Viable particle testing must be done every 6 months at a minimum and when 

certifying new equipment, following any servicing of facilities or equipment, and in 

response to issues of compounded sterile preparations (CSPs). 

• Sampling of compounding personnel glove fingertips, at least annually. 

• Media fill test, at least annually. 

• All high-risk level CSPs that are prepared in groups of more than 25 identical 

single dose packages or multi-dose vials must meet sterility tests before they are 

dispensed/administered. (They also have to be tested for bacterial; endotoxins 

(pyrogens)). 

Additionally, the emergency regulation, 247 CMR 6.15(5), adopted on November 

1, 2012 requires pharmacies to attest to compliance with USP <797>. In the Spring 

of 2012, the Board began requiring new pharmacies that engage in sterile 

compounding to complete a USP <797> Gap Analysis. Presently, inspections of pharmacies engaged in sterile compounding focus on compliance with USP <797>. 

The emergency regulation, 247 CMR 6.15(6), adopted on November 1, 2012, requires every pharmacy to report within 7 business days all errors that occur during 

the preparation of medications in that pharmacy, building on previously established 

reporting requirements for medication errors that led to patient harm. 

Question 6b. Had these requirements been fully implemented, would they have 

been sufficient? Does the State have the capacity to enforce these requirements? 

Answer 6b. Massachusetts has the authority to enforce its regulations, which require compliance with USP <797> and reporting of adverse events, and to impose 

disciplinary action for any violation of its regulations. 247 CMR 6.15(5);247 CMR 

9.01(3); 247 CMR 10.03. 

Question 6c. Does the State have the capacity to enforce these requirements for 

compounding pharmacies located in other States that are shipping into Massachusetts—for example, the statewide requirement that Minnesota also has on the books 

that sterile products be compounded according to the United States Pharmacopea? 

Answer 6c. The Governor’s proposed legislation introduces an out-of-state licensure category, currently not in existence in Massachusetts. Through comprehensive 

requirements on all pharmacies that seek to ship medications to the Commonwealth, we will gain the authority to enforce requirements in the quality and safety 

of compounding processes. 

Question 7. After reviewing the documents and looking at the timeline, it is clear 

that NECC had multiple violations of Massachusetts pharmacy law. What, in addition to the multiple violations and inspection reports, would prompt the Board to 

suspend or revoke a pharmacy license? 

Answer 7. Under my leadership, the Board and DPH will continue to act swiftly 

to hold pharmacies and pharmacists sufficiently responsible for their actions. While 

I was not at the Department during the deliberations around NECC’s 2006 consent 

agreement, it is my position that the action was insufficient given the severity and 

volume of deficiencies from their initial licensure in 1998 through 2004. Since we 

learned of this crisis, we secured suspension of operations at NECC and its sister 

companies and launched unannounced inspections of all pharmacies compounding 

sterile injectible substances, which have also resulted in additional cease and desist 

orders and corrective plans. 

Question 8. How often do you suspend or revoke licenses, and what factors are 

considered when deciding between different disciplinary actions? What is the proc-
102 

ess to suspend or revoke a license, both when you have the consent of the company 

and you do not? 

Answer 8. Inspections and resulting disciplinary actions by the Board, including 

but not limited to suspensions and revocations of a pharmacy’s retail license, constitute a complaint-driven process. As defined with the Board of Pharmacy, a ‘‘complaint’’ is a formal proceeding and does not refer to the colloquial use of the word. 

The Board receives approximately 300 complaints per year. The Board opens a 

‘‘complaint’’ after receiving information about issues with a licensee, and establishing that an investigation is warranted. 

Complaints that warrant disciplinary action are often a result of identified deficiencies found in the course of an inspection. Historical data is readily available for 

the 6 years of the Patrick-Murray Administration (January 2007 through December 

2012). During this time period, the Board identified deficiencies during its inspections of the self-identified sterile compounding pharmacies on eight occasions. In 

seven of these instances, the deficiencies were resolved without the need for further 

Board action; however, Board action was required in one case. (See CIVAS complaint history, appended and referenced as Attachment A.) While Attachment A 

provides a thorough summary of the history, below are examples of types of deficiencies noted: 

• Failures to maintain required documentation (e.g., perpetual inventory for controlled substances); 

• Unregistered technician observed working in control room; 

• Failure to maintain appropriate supervisory ratios; 

• Equipment lacking and having outdated seals and/or certification (e.g., balance); 

• Broken equipment (e.g., thermometer in ante room); 

• General concerns regarding cleanliness; 

• Refrigeration concerns (e.g., refrigeration logs with temperature readings below 

recommended level); 

• Expired drugs on shelves; and 

• Inadequate security (e.g., door left ajar). 

Should a complaint warrant Board action, the Board can choose to take either a 

disciplinary or non-disciplinary action. The Massachusetts General Laws grant the 

Board the authority to take various disciplinary and non-disciplinary actions. Disciplinary actions are intended for those described in our regulations that result in 

a permanent mark on a licensee’s record that is publicly reported and available to 

consumers on our Web site. Disciplinary actions may include: suspension, revocation 

of personal registration, pharmacy permit, license or controlled substance registration, reprimand or censure of the registrant or licensee, cease and desist notice, consent agreement or probation. Non-disciplinary actions may include a non-disciplinary warning letter, advisory letter, a consent agreement with non-disciplinary actions, or dismissal of the complaint. The actions available to the Board are summarized with the corresponding statutory authority (See Attachment B). It should be 

noted that Governor Patrick’s recently filed legislation authorizes the Board to assess fines against Massachusetts-licensed pharmacies that violate Board of Pharmacy policies, regulations, or statute. 

From 2002–12, the Board recorded sixty-eight (68) disciplinary actions taken 

against Massachusetts retail pharmacies: 

Year 2002—No. of Disciplinary Actions: 1 

Year 2003—No. of Disciplinary Actions: 4 

Year 2004—No. of Disciplinary Actions: 2 

Year 2005—No. of Disciplinary Actions: 4 

Year 2006—No. of Disciplinary Actions: 2 

Year 2007—No. of Disciplinary Actions: 4 

Year 2008—No. of Disciplinary Actions: 9 

Year 2009—No. of Disciplinary Actions: 9 

Year 2010—No. of Disciplinary Actions: 11 

Year 2011—No. of Disciplinary Actions: 17 

Year 2012—No. of Disciplinary Actions: 5 

Question 9. Please briefly discuss past situations in which the Board has revoked 

a license. What violations were evident in those facilities? Was the revocation communicated to other State boards or the FDA? 

Specifically, were any revoked for violations of the patient-specific prescription 

rule? What were the circumstances? 

Answer 9. Since January 1, 2000, the Massachusetts Board of Pharmacy has 

taken action against 14 pharmacies, to revoke, suspend, or summarily suspend licensure, or enter into a consent agreement for surrender of licensure. None of the 
103 

14 instances involved violation of the patient-specific prescription rule. The circumstances varied, and include: Medicaid fraud (false claims to MassHealth), improper storage or handling of drugs; failure to maintain proper sanitation; repackaging and redispensing medications that had been returned; issues involving sample 

medications; sale of drugs to an unlicensed entity; and failing to keep medications 

properly labeled leading to dispensing errors. 

Staff formerly employed to support the Board of Pharmacy did not maintain sufficient records to clearly delineate when actions were shared with either the FDA or 

other relevant State Boards. Going forward, the Department is conducting an extensive audit of all operational policies and procedures in all nine (9) health professions 

licensure boards supported by DPH staff. These efforts will facilitate alignment of 

these entities, ensuring uniformity and enhanced quality control of these critical 

functions. 

Question 10. Please describe any standard operating procedures that were put in 

place since September 25 to facilitate communication and coordination with other 

boards of pharmacy. How is any disagreement with another board of pharmacy resolved? 

Answer 10. See response to Questions 3 and 5. 

Question 11. How often do you contact other State boards of pharmacy? Do you 

know which of your pharmacies ship out-of-state, and do you ever get requests to 

inspect those facilities? How do you respond to such requests? 

Answer 11. On November 1, 2012, the Massachusetts Board of Registration in 

Pharmacy adopted emergency regulations that include the following provision: 

‘‘Every pharmacy licensed pursuant to M.G.L. c. 112, §39, that performs central intravenous admixture services (CIVAS), or engages in sterile 

compounding, shall report to the Board every 6 months, or upon request by the 

Board, at a minimum, the following information: 

(a) total number of prescriptions dispensed, distribution data identifying the 

States in which the prescriptions were distributed, status of any non-resident 

licenses issued by other States, hood certifications required by 247 CMR 

6.01(5)(c) 5, status of CIVAS approval is) where applicable, and any other information required by the Board. 

(b) All such report shall be accurate and comply with the Board’s reporting 

requirements. 

(c) All reports shall be accompanied by an affidavit attesting compliance with 

all laws and regulations pertinent to sterile compounding. This attestation shall 

be made under pains and penalties of perjury, and include attestation to the 

following: ‘‘this registrant/licensee only prepares and dispenses medication pursuant to a valid prescription as defined in M.G.L. 

c. 94C for a single patient, regardless of whether the medication is prepared 

for a Massachusetts or out-of-state patient.’’—247 CMR 6.15(5). 

Prior to enactment of these regulations, there was no formal mechanism for designating which pharmacies shipped their products to other States. 

Question 12. I am concerned that if a State board wants to know the history of 

a facility, not all the information is reported and it is hard to know the full compliance history. I understand the National Association of the Boards of Pharmacy 

keeps a database with this information. Could you describe which of the numerous 

actions against NECC in the past 14 years were reported to NABP, or how the actions were made known to other State boards of pharmacy? 

Answer 12. All of the dispositions taken against NECC were non-disciplinary. As 

a result, none of the Board actions would have likely been reported to the 

Healthcare Integrity Protection Data Bank (HIPDB) and the National Practitioner 

Data Bank (NDBP). These actions included the 1999 informal reprimand (against 

both NECC and Barry Cadden, the co-owner and head pharmacist of NECC, as an 

individual), the September 30, 2004 advisory letters to NECC, the January 2006 

consent agreement (specifically agreed not to report), and the 2010 Ameridose complaints. 

This highlights what I have said before: that poor judgment, missed opportunities 

and a lack of appropriate action allowed NECC to continue on this troubling path. 

The Division of Health Professional Licensure (DHPL) reports disciplinary actions 

against its licensees in several ways. First, the Board reports disciplinary actions 

with respect to pharmacists and pharmacy technicians to the HIPDB. The Board 

also reports disciplinary actions with respect to pharmacies to the NPDB. In both 

instances, Board staff prepares an internal report that Division staff use to enter 

into the Federal databases within a day of action. The reported disciplinary actions 
104 

include not only the initial discipline imposed (e.g., suspension of license), but also 

subsequent changes (e.g., reinstatement of licensure, with probationary status). 

In addition to the foregoing, the Board maintains a spreadsheet, listing the disciplinary licensing actions reported to HIPDB and NPDB. As I mentioned before, 

under previous Board policy, non-disciplinary actions were not reported publicly, 

something both the Board and the Commission are actively reexamining. This 

spreadsheet is cumulative for the period beginning in calendar year 2005 (fiscal year 

2006) to the present. During the first week of each month, Board staff updates this 

spreadsheet with the NPDB and HIPDB reports made during the preceding months. 

The spreadsheet is then emailed to individuals or entities on a distribution list. The 

distribution list includes the National Association of Boards of Pharmacy (NABP), 

specifically, clearinghouse@nabp.net. DPH cannot comment on NABP policy as to 

how this information is then reviewed and shared more broadly. 

Question 13. In general, what actions do you report to NABP regarding pharmacies in Massachusetts? Could you describe the line between what you must report, and what is not reported? 

Answer 13. These tragic events have made one thing clear: timely information 

and communication, acted on swiftly is critical in ensuring public health and safety. 

As I have described in answering Question 12, there are clear policies in place for 

Board staff to report these incidents to NPDB and HIPDB. 

ATTACHMENTS 
105 
106 
107 
108 
109 

* A summary of the findings mentioned may be found at www.nejm.org/doi/full/10.1056/ 

NEJMoa1212972. 

RESPONSE OF MARION KAINER TO QUESTION OF SENATOR WHITEHOUSE

Question. Dr. Kainer, your testimony notes that electronic health records allowed 

‘‘tremendous’’ savings in time and resources. How were electronic health records 

used by health care providers and the Tennessee Department of Health? Are there 

best practices you would recommend for other State health departments regarding 

the use of electronic health records during a public health crisis? 

Answer. All of the hospital systems caring for patients in Tennessee used an electronic health record to record most of their health information when they were inpatients. At the beginning of our investigation and response, as in past responses to 

other outbreaks, we sent staff to the facilities to review key records on site and requested faxed copies of other records. This approach provides access to the needed 

records, but it is slow and involves many staff to process all the requests. In general, these are the same hospital staff who are needed at the healthcare facility as 

part of their response, so their availability is limited. 

In the context of an evolving outbreak, when the number of cases is increasing 

rapidly and our understanding is evolving quickly, the questions being asked are 

also rapidly changing. This leads to repeated requests for additional records on both 

old and new patients. The process of obtaining vital information can become very 

slow. 

Early in this outbreak response, the Tennessee Department of Health worked 

with all five hospital facilities caring for case patients to obtain remote electronic 

access to inpatient medical records from Health Department computers. This allowed our staff to quickly gather additional information on existing patients and to 

initially review new patient records, without having to visit the facilities or take the 

time of medical staff to assist with access. This provided more immediate and complete access to information than ever before. 

As a result, we reduced the time to completing our analyses substantially, leading 

to better information for patients and clinicians in Tennessee, and the CDC. Rapid 

access to source data also allowed us to quickly compose a detailed summary of our 

findings, which was published in the New England Journal of Medicine * much 

more quickly than if we had not had access to electronic records. This allowed a 
110 

broader audience to receive detailed information about the outbreak they could use 

to guide patient evaluation and care. 

RESPONSE OF DAVID G. MILLER, R.PH., TO QUESTIONS OF SENATOR ENZI, 

SENATOR CASEY, AND SENATOR FRANKEN

SENATOR ENZI

Question 1. How do you define traditional compounding? What, if any, additional 

regulations should be placed on pharmacies that ship large quantities of products 

interstate? Is there a larger Federal role? 

Answer 1. IACP does not have a definition of ‘‘traditional’’ compounding nor does 

one exist within our profession. We are very concerned that this term has been referenced by numerous individuals, organizations, and agencies and is both broad and 

subject to significantly variable interpretation depending upon who is referencing 

‘‘traditional.’’

We believe the focus should not be on the creation of a definition of traditional 

vs. non-traditional but a more close examination of what constitutes compounding— 

the preparation and issuance of a medication upon receipt of a valid prescription 

from an authorized prescriber—and what constitutes manufacturing—the preparation, promotion, selling and distribution of a medication when no authorized prescriber is involved.

The manufacture of a medication cannot be judged, therefore, on the basis of 

quantity. It is not the amount or even the process of compounded medicine that is 

produced. Rather, it is an examination of the transaction in and of itself. A very 

busy, very large pharmacy can legitimately and appropriately compound and dispense medications intra- or interstate based upon the receipt of valid prescriptions 

from authorized prescriber and still remain a pharmacy. On the other hand, a small 

pharmacy can be engaged in manufacturing if the preparation and issuance of a 

compounded medication is done without a prescription or medical order from an authorized prescriber.

We believe that an immediate area to be addressed is the communication link between the State Boards of Pharmacy and the Food and Drug Administration. State 

Boards are in the best position to determine whether their license or permit holding 

pharmacies are exceeding the scope of pharmacy practice and engaging in manufacturing-like activities. In those instances, the State Board should have a liaison or 

communication channel to the FDA for followup inspection and action as the Federal agency has jurisdictional authority over manufacturing including illegal manufacturing by pharmacies or other entities. 

Question 2. Are there basic standards that all sterile compounding facilities 

should be held to, such as USP 797? How would that be enforced? 

Answer 2. IACP supports enactment of legislation or regulations which mandates 

the compliance with USP <797> standards by any practitioner or practice site involved in the preparation of sterile compounds. That includes all pharmacists as 

well as physicians, veterinarians or any other health care practitioner who compounds sterile preparations. Additionally, all settings including hospitals, home infusion companies, long-term care facilities, hospices, etc., should be held to the same 

accountability of adherence to these industry-wide standards. 

IACP also supports enactment of legislation or regulations which mandates compliance with USP <795> standards by any practitioner or practice site involved in 

the preparation of non-sterile compounds as well.

Since States issue the licenses and permit for operation to a pharmacy, they are 

the first enforcement agency that should be responsible for conducting regular, unannounced inspections of all sterile compounding facilities. 

Should you have any further questions or wish clarification on our responses, 

please do not hesitate to contact us. In the meantime, please accept our best wishes 

for a wonderful holiday season. 

SENATOR CASEY

Question 1. How many prescriptions are filled annually by compounding pharmacists, and of those, how many are filled in a non-hospital/outpatient setting? 

Answer 1. Unfortunately, no database exists which tracks all prescriptions filled 

in the United States—compounded preparations included. It has been estimated by 

the International Journal of Pharmaceutical Compounding that 1–3 percent of all 

outpatient prescriptions are compounded on an annual basis.
111 

Question 2. When a compounding pharmacist ships drugs interstate in response 

to a valid prescription, are the products shipped directly to the patient or to the patient’s provider? Does it depend on the type of product? 

Answer 2. It depends upon the prescription itself (the actual order from the authorized prescriber), the type of medication ordered, the directions given by the prescriber, and the express request of the patient.

Some patient-specific medications can be delivered directly to the patient or, if requested to do so by either the patient or the prescriber, be delivered to the prescriber. In the latter case, that is often done when the administration of the medication is done by the prescriber him/herself. An example of that would be intrathecally 

administered medicines. Because those drugs are infusions, the integrity and stability of the medicine must be maintained. Minimizing steps in transport (e.g., pharmacy to patient then patient to physician) and controlling such things as temperature or security is one means of assuring that integrity. 

Question 3. How many of your members are accredited by the Pharmacy 

Compounding Accreditation Board? Have these numbers been increasing? 

Answer 3. As a professional society, IACP’s membership is comprised of individuals: pharmacists, pharmacy technicians, student pharmacists and others involved 

in the specialty practice of compounding. The Pharmacy Compounding Accreditation 

Board accredits pharmacies—the physical business in which pharmacists practice. 

PCAB does not accredit individual practitioners; therefore, no IACP member is accredited by PCAB. As of December 1, 2012, PCAB currently accredits 168 

pharmacies. According to their staff, there are approximately 40 additional pharmacies in various stages of the accreditation process. Since the NECC crisis, PCAB 

has seen a 400 percent increase in applications by pharmacies to begin the accreditation process. 

Question 4. What is IACP doing to encourage its membership to pursue accreditation and take other steps to ensure their compounded products are safe? 

Answer 4. IACP is a founding member of the Pharmacy Compounding Accreditation Board (PCAB) and has many members serving on its standing committees as 

well as providing a representative to its eight-person board of directors. IACP provides PCAB with complimentary exhibits at its national meetings and advertising 

space in its publications to raise awareness of the Board. All new members of IACP 

also receive PCAB information upon joining the Academy. Our most recent issue of 

our electronic magazine—Custom Rx Connection—featured an extensive article for 

the PCAB executive director. Additionally, our bi-weekly electronic newsletter also 

announces all newly accredited and re-accredited PCAB pharmacies as part of our 

efforts to promote accreditation. 

IACP conducts both live and web-based accredited continuing education programs 

for its members and non-members on compounding standards and safety. The Academy began a collaboration with the United States Pharmacopeia (USP) earlier in 

2012 which brings their seminars on standards and safety to all pharmacists 

through our educational portal. 

Question 5. Dr. Hamburg discussed a possible risk-based framework for the regulation of compounding, recognizing that certain compounded products inherently 

pose a greater potential risk to patients should they be handled improperly. Could 

you share your comments on FDA’s proposed framework? 

Answer 5. Neither IACP nor its colleague professional associations have been provided sufficient details to determine whether or not the FDA’s concept of a ‘‘riskbased framework’’ will lead to a meaningful change in their enforcement of regulatory authority. We continue to have a dialog with the agency to find solutions that 

will prevent a future NECC-like catastrophe; however, as outlined by Commissioner 

Hamburg, the proposed framework raises significant questions about scope and intent. 

Question 6. Do you feel that taking risk into account is inappropriate? If so, what 

alternatives would you suggest? 

Answer 6. IACP does not believe that the proposed framework from the FDA fully 

defines the concept of ‘‘risk’’ as it is understood in the professional practice community. Healthcare professionals are trained to assess risk of therapy but the agency’s 

definition is not consistent with that commonly understood definition. Some medicines are technically difficult to compound because of the nature of the drug chemical or procedures necessary to obtain a finished preparation while others are clinically risky and inappropriate because they are known to have significant side effects 

and may cause harm to patients. Our Academy believes that developing a consensus-based definition between the pharmacy and medical practice communities in 
112 

conjunction with State and Federal regulatory authorities must be undertaken before any framework can be addressed. 

Question 7. How do you propose drawing a clear line between traditional 

compounding for individual patients and large-scale compounding that much more 

closely resembles manufacturing? Clearly, there is confusion as to where this line 

is currently and where it should be. 

Answer 7. IACP’s position is that there is a clear demarcation between 

compounding and manufacturing. The issue is not whether a pharmacy is 

compounding in ‘‘large-scale’’ amounts—a term that is nearly indefinable—but 

whether they are compounding pursuant to a valid prescription or medical order 

from an authorized prescriber. Pharmacists dispense prescription drugs only when 

instructed to do so through the form of a prescription or medical order. Manufacturing is substantially different. A manufacturer is permitted to sell medications to 

a facility, hospital, wholesaler, pharmacy or directly to a prescriber without a prescription or medical order. Compounding and dispensing is driven by prescriber decisionmaking. Manufacturing is a purchase decision made without any prescriber 

input. All States define what constitutes a ‘‘valid prescription’’ and also designate 

which persons are considered ‘‘authorized prescribers.’’ IACP believes that existing 

Federal statutory and regulatory language defines what constitutes a manufacturer 

and that the Food and Drug Administration has clear oversight authority in that 

arena. 

SENATOR FRANKEN

Question 1. In a report on meningitis in 2002, the Centers for Disease Control and 

Prevention reported that ‘‘some health-system pharmacists might not realize that 

they are purchasing injectables prepared through compounding.’’ The CDC report 

continues by stating that ‘‘purchasers of pharmaceuticals should determine if supplies are provided from a compounding pharmacy that is licensed in their State and 

that follows appropriate measures to ensure that injectable products are free of contamination.’’ What responsibility do you believe that purchasers of compounded 

products should have to make sure that the products they’re giving to their patients 

are safe? 

Answer 1. IACP believes that all purchasers of compounded preparations are as 

equally responsible for assuring the quality and safety of the medications they obtain as they are for products purchased from pharmaceutical manufacturers. That 

is a responsibility which all pharmacists in the medication supply chain have been 

trained to do and should do.

When it comes to compounded preparations, the responsibility is even greater. 

Last year and in light of the ongoing drug shortage situation, IACP developed a tool 

to assist physicians and pharmacists in making informed decisions about professional partnerships with compounding pharmacies. This tool includes a step-wise 

checklist that includes such things as verification of licensure status, accreditation 

status, standards and processes for regular testing and validation, as well as recommendations to conduct an on-site interview and inspection. Called the 

Compounding Pharmacy Assessment Questionnaire (CPAQTM), IACP distributed 

that tool to State and national medical, hospital, and pharmacy associations upon 

its release in October 2011. A copy of the CPAQTM is included for your review and 

is also available for download at the Academy’s Web site http://www.iacprx.org. 

ATTACHMENTS 

[International Academy of Compounding Pharmacists (IACPTM), October 5, 2011] 

IACP PROVIDES MEANINGFUL SOLUTION WITH COMPOUNDING PHARMACY

ASSESSMENT QUESTIONNAIRE

RISING MEDICATION SHORTAGES AFFECT PATIENT HEALTH—NEW IACP TOOL HELPS

EVALUATE PHARMACIES FOR NEEDED COMPOUNDED MEDICATION SERVICES

HOUSTON.—As hospital medication shortages continue to increase by the day 

within the North American healthcare system, the International Academy of 

Compounding Pharmacists (IACP) has developed a new assessment questionnaire to 

assist hospitals, practitioners and non-compounding pharmacies identify and evaluate compounding pharmacies as they seek alternative sources for medications that 

currently are in limited to complete shortage status. 
113 

IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQTM) provides a 

comprehensive checklist of what to look for in a compounding pharmacy practice 

and is based upon United States Pharmacopeia (USP) standards which 

compounding pharmacists are obligated to follow according to State board of pharmacy regulations or standards of practice. Collaboration between licensed 

compounding pharmacists and their colleagues in hospitals and institutions is a 

long-standing solution to back-orders and shortages but the current shortage situation is at a crisis point for many health-systems. The expertise of a compounder 

with access to APIs (Active Pharmaceutical Ingredients—the pure, raw drug ingredient) can mean the difference between continued or initiation of much-needed 

medicines or an unnecessary delay in patient care. 

IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQTM) includes 

evaluation points in the following areas: 

• Regulatory compliance 

• Licensing—permits 

• Internal controls and quality assurance 

• Testing & verification 

• Site visits 

Linda F. McElhiney, PharmD, R.Ph., FIACP, FASHP, compounding pharmacy operations coordinator, Indiana University Health, says, 

‘‘Drug shortages have been an ongoing problem for healthcare facilities and 

the number of drug products that are unavailable due to manufacturer 

backorders and discontinuation is on the rise. These facilities are often trying 

to find substitutions for the drug products or alternative treatments and there 

is often a delay in the patients’ treatment. Compounding pharmacies may be 

able to prepare these medications using bulk active pharmaceutical ingredients; 

however, it may be difficult for the healthcare pharmacy administrators to know 

if the compounding pharmacy can provide quality compounded medications to 

meet their facilities’ needs because they are unfamiliar with the USP standards 

for compounding sterile and non-sterile preparations. The International Academy of Compounding Pharmacists (IACP) has developed a checklist of standards and criteria to assist the administrators in finding a suitable compounding 

pharmacy to meet these needs.’’ 

Scott Karolchyk, R.Ph., FIACP, IACP president-elect, says, 

‘‘IACP leadership recently participated in FDA’s conference on prescription 

drug shortages. While there were many good intentions expressed during the 

conference, there were no real solutions for now. Each day, pharmacists and 

physicians are grappling with making sure our patients get the medicines they 

need. What was clearly overlooked was how compounding pharmacists are providing solutions today as they work with U.S. hospitals, surgery centers, and 

practitioners to make those medicines available.’’ 

John Herr, R.Ph., IACP president, asked, ‘‘What better solution to this problem than pharmacists working intraprofessionally to take care of patients?’’ 

‘‘The CPAQ tool is compounding pharmacy’s way of stimulating that relationship. Given that compounders have an outstanding track record for preparing 

quality medications on a per-prescription basis, we know that working together 

will lessen the need to use the so-called ‘gray market’ of suppliers, distributors 

and others which are taking advantage of people in need.’’ 

ABOUT IACP

The International Academy of Compounding Pharmacists (IACP) is a professional 

association founded in 1991 to protect, promote and advance personalized medication solutions. The association represents more than 2,100 pharmacists and pharmacist technicians licensed and regulated by their individual State boards of pharmacy and located throughout North America, South America, Europe, Australia and 

Asia. In addition, IACP represents more than 154,800 patients, physicians, nurse 

practitioners and veterinarians through its ally grassroots organization, Patients & 

Professionals for Customized Care (P2C2). IACP is committed to ensuring the rights 

of physicians to prescribe, of pharmacists to prepare, and of patients to take personalized medication solutions that meet their unique, individual health needs. 

IACP offers a free Compounding Pharmacy Locator Service which can be accessed 

toll free at (800) 927–4227 or via IACP’s Web site at www.iacprx.org. 
114 
115 
116 
117 

RESPONSE BY KASEY K. THOMPSON TO QUESTIONS OF SENATOR ENZI, 

SENATOR CASEY AND SENATOR FRANKEN

SENATOR ENZI

Question 1. USP updated their standards for sterile compounding 5–10 years ago. 

Since then, have you seen an increase in outsourcing of sterile compounding? 

Answer 1. USP 797 became official in 2004 and underwent a major revision in 

2008 that included additional requirements. 

Below are results from ASHP’s May 2011 survey demonstrating increased outsourcing: 

• In 2011, 70.9 percent of hospitals reported partially or completely outsourcing 

some drug preparation activities. A greater percentage of larger hospitals outsource 

some preparation activities compared with smaller hospitals. For example, 96.9 percent of hospitals with 600 or more staffed beds out-sourced some part of preparation 

activities, compared with 49 percent of hospitals with fewer than 50 staffed beds. 

The outsourcing of some preparation activities has increased over time, from 21 percent of hospitals in 2002 to 31 percent in 2005 and 42 percent in 2008. 

• Of hospitals that out-sourced some part of preparation activities, 73 percent 

out-sourced patient-controlled analgesia (PCA) and epidural analgesia preparations, 

65 percent out-sourced oxytocin preparations, and 38 percent out-sourced some i.v. 

admixtures and minibags (Table 10). About 25 percent of hospitals out-sourced syringe-based anesthesia medications, total parenteral nutrition (TPN) preparations, 

and flushes. Hospitals less frequently out-sourced cardioplegia preparations, unit 

dose drug repackaging, and unit dose repackaging for bar coding. The percentages 

of hospitals outsourcing PCA and epidural analgesia preparations, i.v. admixtures 

or minibags, and flushes have increased during the past 9 years, while the outsourcing of TPN preparations has declined. 
118 

Table 10.—Preparation Activities That Are Either Partially or Completely Outsourced, Excluding Services Through a Contract Pharmacy Services Provider 

Characteristic n 

Patientcontrolled 

analgesia and 

epidural 

analgesia 

preparations 

Oxytocin 

I.V. 

Admixtures 

and smallvolume I.V. 

solutions 

Syringe-based 

anesthesia 

medications 

Total 

parenteral 

nutrient 

solutions 

Flushes Cardioplegia solutions 

Unit dose 

repackaging (drug 

only) 

Unit dose 

repackaging for 

bar coding 

No. Staffed Beds:.

<50 .......................................................................................................................... 51 70.6 52.9 27.5 11.8 21.6 25.5 3.9 11.8 3.9 50–99 ...................................................................................................................... 56 73.2 60.7 42.9 16.1 16.1 21.4 3.6 16.1 10.7 100–199 .................................................................................................................. 63 68.3 66.7 42.9 23.8 17.5 22.2 15.9 12.7 6.3 200–299 .................................................................................................................. 69 76.8 76.8 39.1 30.4 29.0 21.7 23.2 15.9 11.6 300–399 .................................................................................................................. 54 77.8 63.0 40.7 38.9 31.5 16.7 37.0 22.2 24.1 400–599 .................................................................................................................. 86 79.1 81.4 44.2 38.4 32.6 18.6 41.9 20.9 19.8 ≥600 ........................................................................................................................ 62 88.7 72.6 40.3 41.9 45.2 25.8 64.5 40.3 22.6 

All hospitals—2011 .................................................................................................... 441 73.3 65.21 38.3 24.12 23.6 22.2 18.33 16.0 10.44All hospitals—20083 .................................................................................................. 270 64.0 5 37.3 32.8 13.9 13.4 14.6 All hospitals—20056 .................................................................................................. 186 40.2 31.4 39.8 12.8 11.6 9.6 All hospitals—20029 .................................................................................................. 137 16.7 15.7 52.4 9.1 12.1 8.9 

1 Uncorrected x2 = 16.4578, df = 6, designed-based F(4.17, 1810.24) = 3.0517, p = 0.0147. 2 Uncorrected x2 = 24.0577, df = 6, designed-based F(4.19, 1817.03) = 4.2945, p = 0.0015. 3 Uncorrected x2 = 71.3848, df = 6, designed-based F(4.21, 1825.56) = 12.4305, p = 0.0001. 4 Uncorrected x2 = 20.8045, df = 6, designed-based F(4.20, 1824.14) = 3.5927, p = 0.0055. 5 Not surveyed. 
119 

In April 2012, Pharmacy Purchasing and Products published its own survey. 

In general these results demonstrate a gradual increase (from 56 percent to 65 

percent) in outsourcing since the establishment of USP 797 standards for 

compounding sterile products in 2008. While 76 percent of respondents reported outsourcing in response to a drug shortage, safety and the ability to provide a ready 

to administer dosing form were equally significant reasons as demonstrated by outsourced patient controlled analgesia (67 percent), epidural injections (48 percent), 

controlled substances (35 percent) and pre-filled OR medications (34 percent). (See 

graphs below.) 

SENATOR CASEY

Question 1. Do you believe that hospitals and health systems that outsource their 

compounding to external compounding pharmacies are sufficiently able to determine 

whether those pharmacies are producing safe products? 

Answer 1. Pharmacists have the expertise to help evaluate if compounding is 

being conducted in accordance with Federal and State definitions and standards established by the U.S. Pharmacopeia in Chapter 797. However, the ability of hospitals to conduct routine inspections of compounding entities is limited by resources, 

which is why it is important to have a Federal and State oversight system that en-
120 

*Aseptic processing uses sterile components to make a sterile final product. Sterility must be 

maintained through multiple manipulations which introduces more variables than formulation 

of products that are terminally sterilized. 

sures that these entities are capable of producing safe products in accordance with 

Federal and State laws. The American Society of Health-System Pharmacists also 

has guidelines and assessment tools available to help hospitals evaluate outside entities that provide compounded formulations. ASHP Guidelines on Outsourcing Sterile Compounding Services http://www.ashp.org/DocLibrary/Bestpractices/Mgmt 

GdlOutsourcingSterileComp.aspx; ASHP Foundation: Outsourcing Sterile Products 

Preparation Contractor Assessment Tool http://www.ashpfoundation.org/Main 

MenuCategories/PracticeTools/SterileProductsTool/SterileProductsAssessmentTool. 

aspx. Most pharmacists are not trained to evaluate manufacturing-level facilities where 

Current Good Manufacturing Practices (cGMPs) are applicable. Examples are bulk 

compounding of sterile preparations from (1) nonsterile ingredients or (2) from sterile ingredients using aseptic processing * and storing these medications for periods 

beyond those associated with compounding. 

Question 2. Do you think that the compounded products typically used in a hospital or in-patient setting are different from other products typically used in outpatient settings, and if so, do you think that they should be subject to additional 

or different regulation? 

Answer 2. The environment in which these medications are used is less important 

than the environment in which they must be prepared. The difference is whether 

the compounded product is a sterile preparation, such as an injectable, or ophthalmic medication. The preparation area is highly controlled to prevent contamination using methods that include in-process and final product quality assurance procedures. The applicable standards, USP 797, are adequate for compounding sterile 

preparations in hospitals. 

Question 3. Under the current patchwork system of State and Federal regulation, 

do you think products compounded in a hospital pharmacy are safer or less safe 

than products compounded at freestanding compounding pharmacies? 

Answer 3. Compounded sterile products from pharmacies that are made pursuant 

to or in anticipation of a medication order or prescription and according to USP 797 

standards are equally safe, whether the pharmacy is in a hospital or community setting. 

However, a sterile compounding business entity that does not fill prescriptions for 

individual patients is not a pharmacy. Regulatory oversight of these entities should 

be dependent on the scope and scale of their operations, which may range from patient-specific small batches to large-scale production of commonly used drugs or dose 

forms based on historical demand. The beyond use date (BUD) or shelf life these 

entities assign to final products as well as the risk level (low, medium, high) of the 

compounding activity are also factors. 

These entities are neither a pharmacy nor a manufacturer, but fall somewhere in 

between into a regulatory gray area. An intermediate category of drug establishment with criteria for inclusion and clarification of regulatory oversight should be 

developed. 

SENATOR FRANKEN

Question 1. In a report on meningitis in 2002, the Centers for Disease Control and 

Prevention reported that ‘‘some health-system pharmacists might not realize that 

they are purchasing injectables prepared through compounding.’’ In your experience, 

is this sometimes the case? If so, what responsibility do you believe that purchasers—including health systems—have to ensure that they are providing their patients with safe medicines? 

Answer 1. Lack of clarity regarding the nature of drug establishments that register with the FDA may in fact mislead pharmacists to believing they are purchasing products from a legitimate manufacturer, rather than a compounding pharmacy. Compounding businesses advertise that they are ‘‘registered with FDA,’’ and 

are listed on FDA’s Web site, however, their registration categories are not disclosed. Thus, pharmacists may not be aware they are contracting with a retail pharmacy, a regional admixture pharmacy, or a manufacturing pharmacy, rather than 

an entity with FDA oversight. 

Pharmacists are accountable for the safety and quality of the products they dispense, including those obtained from contracted services. It should be recognized, 

however, that pharmacists have little control over how these businesses are oper-
121 

ated. Regardless of State or Federal oversight, a licensed business subject to statutory and regulatory requirements and offering products or services for sale should 

not be allowed to shift liability for its products to the end users. 

Question 2. In your written testimony, you state, ‘‘Previous court rulings have 

made FDA’s authority to inspect these facilities unclear and subject to legal action.’’ 

Would you expand on this statement? 

In order to determine whether a pharmacy is acting like a manufacturer, should 

FDA have the authority to inspect the records and processes of pharmacies that 

they believe may be acting improperly? 

Answer 2. It is our understanding that FDA has limited authority to inspect large 

scale compounding entities since most are essentially operating as pharmacies. We 

believe that FDA’s authority needs to be clarified or new authorities given to FDA 

to regulate compounding businesses that produce large amounts of compounded 

products, and sell those products to entities other than the end user. We believe 

that FDA and State boards of pharmacy will need to work together more closely to 

determine when a compounding pharmacy should be placed into a new or clarified 

category of FDA oversight. 

[Whereupon, at 12:51 p.m., the hearing was adjourned.] 

Æ