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86–394 2014

REFORMING THE DRUG COMPOUNDING 

REGULATORY FRAMEWORK 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

JULY 16, 2013 

Serial No. 113–70 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 16 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 17 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 18 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, prepared statement ................................................................. 140 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

prepared statement .............................................................................................. 143 

WITNESSES

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, 

Food and Drug Administration ........................................................................... 20 

Prepared statement .......................................................................................... 22 

Answers to submitted questions ...................................................................... 155 

B. Douglas Hoey, Chief Executive Officer, National Community Pharmacists 

Association ............................................................................................................ 57 

Prepared statement .......................................................................................... 60 

Answers to submitted questions ...................................................................... 165 

Kasey Thompson, Vice President, American Society of Health-System Pharmacists .................................................................................................................. 67 

Prepared statement .......................................................................................... 69 

Answers to submitted questions ...................................................................... 173 

Jeffrey Francer, Assistant General Counsel, Pharmaceutical Research and 

Manufacturers of America ................................................................................... 74 

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

Answers to submitted questions ...................................................................... 177 

David Gaugh, Senior Vice President for Sciences and Regulatory Affairs, 

Generic Pharmaceutical Association .................................................................. 88 

Prepared statement .......................................................................................... 90 

Answers to submitted questions ...................................................................... 181 

Allan Coukell, Senior Director, Drug and Medical Devices, The Pew Charitable Trusts .......................................................................................................... 102 

Prepared statement .......................................................................................... 104 

Answers to submitted questions ...................................................................... 185 

David G. Miller, Executive Vice President and CEO, International Academy 

of Compounding Pharmacists .............................................................................. 109 

Prepared statement .......................................................................................... 60 

Answers to submitted questions *

Carmen Catizone, Executive Director, National Association of Boards of Pharmacy ...................................................................................................................... 123 

Prepared statement .......................................................................................... 125 

Answers to submitted questions ...................................................................... 189 

* Mr. Miller did not respond to submitted questions. 

SUBMITTED MATERIAL

Discussion draft ....................................................................................................... 3 

Statement of Express Scripts, submitted by Mr. Griffith .................................... 145 

Statement of the National Association of Chain Drug Stores, submitted by 

Mr. Griffith ........................................................................................................... 147 

Page

VI 

Statement of Public Citizen, submitted by Mr. Griffith ....................................... 152 

(1) 

REFORMING THE DRUG COMPOUNDING 

REGULATORY FRAMEWORK 

TUESDAY, JULY 16, 2013 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 3:05 p.m., in room 

2322, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Present: Representatives Pitts, Burgess, Shimkus, Murphy, 

Blackburn, Lance, Griffith, Bilirakis, Ellmers, Dingell, 

Schakowsky, Green, Barrow, Christensen, Castor, and Waxman (ex 

officio). 

Staff Present: Clay Alspach, Chief Counsel, Health; Sean 

Bonyun, Communications Director; Noelle Clemente, Press Secretary; Paul Edattel, Professional Staff Member, Health; Julie 

Goon, Health Policy Advisor; Sydne Harwick, Legislative Clerk; 

Carly McWilliams, Professional Staff Member, Health; Andrew 

Powaleny, Deputy Press Secretary; Chris Sarley, Policy Coordinator, Environment and Economy; Heidi Stirrup, Health Policy Coordinator; John Stone, Counsel, Oversight; Alli Corr, Minority Policy Analyst; Eric Flamm, Minority FDA Detailee; Elizabeth Letter, 

Minority Assistant Press Secretary; Karen Lightfoot, Minority 

Communications Director and Senior Policy Advisor; Karen Nelson, 

Minority Deputy Committee Staff Director for Health; and Rachel 

Sher, Minority Senior Counsel. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. The time of 3 o’clock having arrived, we will call the 

meeting of the subcommittee to order. 

The chair will recognize himself for an opening statement. 

As we all know, in the summer and fall of 2012, a Massachusetts 

company, the New England Compounding Center, NECC, shipped 

over 17,000 vials of an injectable steroid solution from three contaminated lots to healthcare facilities across the country. And after 

receiving injections of NECC’s contaminated steroid, over 50 people 

died from complications associated with fungal meningitis and 700 

others were stricken with meningitis and other persistent fungal 

infections. The outbreak ranks as one of the worst public health 

crises associated with contaminated drugs in the history of the 

United States. 

2 

Shortly after the contamination came to light, the committee 

began an investigation into the matter, requesting documents from 

the Food and Drug Administration and the Massachusetts Department of Public Health, examining whether the outbreak could have 

been prevented and reviewing existing Federal and State regulatory authority over compounding pharmacies acting as manufacturers. 

Both this subcommittee and the Oversight and Investigations 

Subcommittee have held multiple hearings on the issues surrounding compounded drugs. Today’s witnesses are here to discuss 

three legislative proposals released since the outbreak, including a 

discussion draft authored by my colleague, Morgan Griffith. 

[The discussion draft follows:] 

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Mr. PITTS. The Griffith draft includes targeted provisions that 

both clarify FDA’s authority as it relates to Section 503 of the 

Food, Drug, and Cosmetics Act, while ensuring that traditional 

compounding remains within the purview of State boards of pharmacy. 

I would like to welcome our witnesses. 

And I will yield the balance of my time to Representative Griffith. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

As we all know, in the summer and fall of 2012, a Massachusetts company, the 

New England Compounding Center (NECC), shipped over 17,000 vials of an 

injectable steroid solution from three contaminated lots to health care facilities 

across the country. 

After receiving injections of NECC’s contaminated steroid, over 50 people died 

from complications associated with fungal meningitis, and 700 others were stricken 

with meningitis or other persistent fungal infections. 

The outbreak ranks as one of the worst public health crises associated with contaminated drugs in the history of the United States. 

Shortly after the contamination came to light, the Committee began an investigation into the matter, requesting documents from the Food and Drug Administration 

(FDA) and the Massachusetts Department of Public Health; examining whether the 

outbreak could have prevented; and reviewing existing federal and state regulatory 

authority over compounding pharmacies acting as manufacturers. 

Both this subcommittee and the Oversight and Investigations Subcommittee have 

held multiple hearings on the issues surrounding compounded drugs. 

Today’s witnesses are here to discuss three legislative proposals released since the 

outbreak, including a discussion draft authored by my colleague, Morgan Griffith. 

The Griffith draft includes targeted provisions that both clarify FDA’s authority 

as it relates to Section 503 of the Food, Drug and Cosmetics Act while ensuring that 

traditional compounding remains within the purview of state boards of pharmacy. 

I would like to welcome our witnesses, and I would yield the remainder of my 

time to Rep. Griffith. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate that very 

much. 

The fungal meningitis outbreak that was associated with the 

tainted sterile compounded drugs from the NECC is something 

that I have followed since the beginning. Obviously, you are always 

concerned when something affects anybody in the United States 

but particularly when it has the impact that it had in my district 

and in the areas immediately around my district, where we had 2 

deaths, 50 confirmed cases, approximately 1,400 patients that were 

notified that they had gotten the tainted injects, creating great concern. 

Now, I do acknowledge, and we have had hearings on it—and, 

Dr. Woodcock, you have been very good about answering my questions, and I appreciate that—where we looked into it and found 

that the split in the circuits was caused by the issue on the advertising portions of the original bill. And as we previously discussed, 

it is a shame that this issue wasn’t taken up sometime ago, but it 

wasn’t. And we are here now, and we are going to try to clarify the 

law to make sure that we don’t have this problem again. And I appreciate the fact that you are going to help us work on that. 

You know, we have been following this. And what we want to do 

is make sure that we do, as the chairman said, protect public 

17 

health and ensure that small businesses, like the 130 legitimate 

community pharmacists that are located in my area, are not subject to unnecessary and burdensome Federal regulations. I also recognize the importance, as a former State legislator, that we continue to have the States be primary over the true local 

compounding pharmacies. 

We have before us a draft. We are still working on it. We want 

to clarify the FDA’s authority in this realm, particularly in regard 

to compounders who try to pretend that they are not manufacturers. And that is sometimes difficult, and I understand that, but we 

think that we have a bill that will help on that. 

There are still questions that we are trying to get answered from 

stakeholders to complete the legislation. That is why in the draft 

you will see a couple of places where we have some blanks. I am 

proud to be trying to work out those differences with my colleagues 

across the aisle, Congressman Green and Congresswoman DeGette, 

to see if we can reach a bipartisan consensus and something that 

works to protect the health of Americans and protect the interests 

of small compounding pharmacies, which provide a great service to 

our public. 

My goal has always been to draw a clear line on defining what 

a traditional compounding pharmacy is, and that should be regulated by the States, and what a manufacturer, a drug manufacturer is, which properly should be regulated by the FDA. 

I look forward to today’s hearing and from hearing from all of 

our witnesses as we continue this process to clarify FDA’s authority 

when it comes to compounding pharmacies. 

And I thank you, Mr. Chairman, for this opportunity and yield 

back my time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the ranking member of the full committee, Mr. Waxman, for 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Mr. Chairman. 

It has been 10 months since we saw the tragic fungal meningitis 

outbreak caused by the New England Compounding Center in Massachusetts. More than 60 people have died, over 740 people were 

sickened, and more than 13,000 others in 20 States are still waiting to see whether they will get meningitis. This is the largest outbreak of healthcare-associated infections in U.S. history and one of 

the Nation’s worst public health disasters in recent memory. 

We have learned a lot through our investigation, especially that 

FDA’s authorities over compounding pharmacies are broken and inadequate. And I am glad we have finally begun the process of repairing them. 

FDA has repeatedly testified that the agency desperately needs 

new authority to protect the public from another contamination incident. The agency has described how circuit court decisions have 

forced FDA to cobble together a piecemeal approach to regulating 

compounding pharmacies that are different in some parts of the 

country that in others. This has created loopholes that companies, 

18 

like the New England Compounding Center, have been able to exploit. 

FDA has also described the fact that the pharmacy compounding 

industry has changed dramatically since 1997, when Congress last 

legislated. Hospitals have grown dependent on so-called 

outsourcers, which are very large compounding pharmacies that 

mix batches of customized drugs for a particular hospital. 

FDA says it is not enough to simply fix the defect in the current 

statute. We need a new paradigm to handle this new state of affairs. The reason we need a new paradigm is that the new class 

of outsourcers does not fit neatly within the binary structure that 

exists in the current statute. They are neither traditional 

compounders nor drug manufacturers, so we need to tailor FDA’s 

authorities to fit the reality that the agency faces. 

But we also need to ensure that we properly circumscribe what 

these outsourcers can make so that they cannot become an avenue 

for undercutting FDA’s gold-standard drug approval process. FDA 

needs strong records-inspection authority to be able to determine 

whether a compounding pharmacy is performing only a traditional 

compounding or has crossed the line into becoming an outsourcer 

or even a drug manufacturer. 

In addition, these nontraditional compounders or outsourcers 

need to register with the FDA and tell FDA what drugs they are 

producing. They should be required to follow good manufacturing 

practices as set by the FDA and label their products as compounded so that healthcare providers and patients know that the 

products are not FDA-approved drugs. 

As illustrated by the recent tragedy, these entities should also be 

required to promptly report adverse events to FDA so that FDA 

and the States can work together to identify dangerous compounded drugs and prevent them from reaching consumers. 

In order for FDA to be successful at carrying out these new authorities, we need to ensure that FDA has a steady stream of resources. We will not have accomplished much if we enact a new 

statutory scheme but deny the FDA the dollars it needs to use its 

new authorities. 

We have learned that there is a gaping hole in our drug safety 

laws. American families expect us to work together to develop an 

effective legislative response, and we need to do this as quickly as 

possible. We know that, otherwise, it will not be if another dangerous catastrophe occurs with compounded medicines, but when. 

Thank you, Mr. Chairman. I yield back the balance of—unless 

any of my colleagues on the Democratic side would like the 

minute? 

OK. I yield back the time. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

vice chairman of the committee, Dr. Burgess, for 5 minutes for an 

opening statement. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. 

You and the ranking member have said it very well. This is a 

continuation in this committee’s examination of the meningitis outVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
19 

break that was caused by contaminated methylprednisolone acetate 

prepared in a preservative-free fashion that killed 53 Americans 

and harmed over 700, many of whom will suffer for the remainder 

of their lives with significant medical complications. 

So 53 Americans are no longer here because the Food and Drug 

Administration refused to use their statutory authority to enforce 

existing regulations. I am willing to update the authority that the 

FDA already has. I don’t know that I am willing to vest the FDA 

with new authority. 

Besides refusing to use their existing statutory authority, the 

Food and Drug Administration is stalling the process to clarify existing regulations. We have been meeting for weeks now, both this 

subcommittee and the Oversight and Investigations Subcommittee, 

trying to determine how best to clarify existing regulations. 

The Food and Drug Administration refuses to give an inch. They 

say they want clarity. Well, when we ask what kind of clarity, 

there is no answer. When we suggest a volume limitation by which 

to define a manufacturer, they say it is not workable. When we 

suggest a time period to determine whether an entity is a manufacturer, we get back, ‘‘It is not workable.’’ 

So my ask to the FDA is: Stop telling us it is not workable, and 

start helping us with a practical solution. If you are holding out for 

a power grab for a vast, new, unfunded authority, I am not going 

to help you get there. 

So far, the only thing I have heard from the Food and Drug Administration are complaints about sequestration. I get it. They 

complain that user fees don’t address their financial needs, especially under sequestration. I really get it. But to have the Food and 

Drug Administration come to Congress, seeking completely new 

user fees and authorizations to inspect facilities, when existing regulations clearly give the authority to inspect anyone who is a manufacturer, I have to tell you, I just don’t get it. 

The fact that the Food and Drug Administration has continued 

to inspect facilities—they have closed facilities. How are they inspecting these facilities if they have no authority to do so? 

Representative Griffith’s bill represents the best effort to date to 

address some of the FDA concerns while adhering to the spirit of 

the law. And I am comfortable supporting that bill. But, honestly, 

all the laws in the world are not going to save a single patient if 

there is no one enforcing the law. 

We read the chain of emails from two administrations of the 

Food and Drug Administration. It was painful to read those emails. 

They would come right up to the edge, right up to the point where 

they might close someone down, and then say, well, we can’t send 

another warning letter because we have already sent too many, so 

we don’t know what to do. Well, I know what to do: Close the place 

down. It was the right answer, and it still is today. 

Who at the Food and Drug Administration has been fired over 

this incident? Again, 53 Americans died, 700 are living with a disability. Who has been fired in this exercise? 

So I would say enough is enough. Let’s put pen to paper and 

make sure the bad actors are not able to hide from clear enforcement authority, but let’s make sure the enforcement authority is 

actually going to be enforced. 

20 

Mr. Chairman, I thank you for the time, and I yield back to you. 

Mr. PITTS. The chair thanks the gentleman. 

I would like to thank all of our witnesses for coming. 

On our first panel today, we have Dr. Janet Woodcock, director 

of the Center for Drug Evaluation Research of the U.S. Food and 

Drug Administration. 

Thank you very much for coming, Dr. Woodcock. You will have 

5 minutes to summarize your testimony. Your written testimony 

will be entered into the record. So, at this time, you are recognized 

for 5 minutes for your opening statement. 

STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER 

FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG 

ADMINISTRATION 

Dr. WOODCOCK. Thank you. 

Since the last hearing before this subcommittee, which was just 

7 weeks ago, we have had another multi-State outbreak involving 

contaminated methylprednisolone acetate, preservative-free. Even 

with all the publicity and attention surrounding this problem, we 

are still seeing multiple contaminated compounded products on the 

market. 

We really appreciate the committee’s interest in exploring legislative options to try to help prevent future tragedies. And I would 

like to start with what I think are the common legislative goals I 

hope we all share. 

Any legislation that is passed should provide clarity so that people know who is on first—FDA, the States, compounders, and 

healthcare providers all know their roles and responsibilities and 

obligations under the law. 

We feel that there should be a legal framework that is a better 

fit for the industry that has now evolved and is well beyond 

compounding by a corner pharmacy for a single patient, by prescription, in response to a practitioner from a medical need. It has 

gone well beyond that. We have outsourcers who supply large 

amounts of sterile products to hospitals across the country. 

Enforceability: We need legislation that we can implement on the 

ground, that we can actually make work, and is resourced to be 

successful. 

We need to preserve the benefits of traditional compounding. We 

have always recognized these benefits, where there is a medical 

need not met by the products that are FDA-approved. And we need 

to preserve the ability of pharmacists to compound and physicians 

and other prescribers to order compounded products to meet those 

medical needs. 

And, most importantly, we need better protection of the public by 

bringing the highest-risk practices under Federal oversight. This 

includes really focusing on prevention rather than reaction when 

outbreaks are occurring. 

We want to work with you to achieve those goals. We believe 

that for the highest-risk compounding pharmacies we do need legislation that requires Federal registration so we know who they are 

and where they are, that holds them to Federal quality standards, 

which we call the GMPs, for production, that also requires the 

compounders to tell us when serious adverse events related to their 

21 

products are reported to them so that we can intervene before 

these problems get out of hand. 

And we think for all pharmacy compounding, certain basic protections should be in place, including clear authority for us to inspect records so we can determine the cause of an outbreak or decide whether a compounder actually fits into the highest-risk category; restrictions on compounding complex products that even conventional drug manufacturers, who test their products, find difficult to produce safely; and a requirement to start with safe and 

high-quality ingredients when you are compounding. 

And, finally, we feel that clear labels on compounded drugs to 

allow prescribers and patients to make informed choices are important. 

We appreciate the leadership of Mr. Griffith, Mr. Markey, and 

the Senate HELP Committee in drafting legislation to try and tackle these issues. It is not easy. While the administration has not 

taken a position on any of these bills, I am happy to provide my 

views on the extent to which they address the goals that we have 

for any new compounding legislation. 

The fungal meningitis outbreak has been a nightmare that continues for over 700 people sickened by these drugs and their families. And it is just the worst of a long series of outbreaks over the 

past 2 decades that include deaths, blindness, and hospitalizations. 

And this continues. As we proceed with our inspections—we have 

had 61 and counting—of the industry, we continue to see a pattern 

of profoundly disturbing lapses in basic sterile practices that 

should be in place to assure the sterile drugs—the drugs that are 

injected in the blood, the spine, the eye, and so forth—are actually 

sterile. 

So I reiterate my statement from the hearing you held 7 weeks 

ago. It is a matter of when this is going to occur, not whether it 

is going to occur. We owe it to the public and the victims of this 

incident and the numerous other outbreaks over the years to enact 

legislation that provides better protection in the future. 

I look forward to answering your questions. 

[The prepared statement of Dr. Woodcock follows:] 

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Mr. PITTS. The chair thanks the gentlelady. 

And I will begin the questioning and recognize myself for 5 minutes for that purpose. 

Dr. Woodcock, isn’t it true that, assuming the circuit split ambiguity is resolved, FDA now has the authority to regulate nontraditional compounders as manufacturers? 

Dr. WOODCOCK. Yes, that is true. 

Mr. PITTS. Doesn’t that mean that FDA could already require 

that such compounders pay user fees and submit applications to 

show that they can produce drugs under GMP conditions? 

Dr. WOODCOCK. That is a possible outcome. We would have to 

find out who they are, because they don’t register, and where they 

operate. And it is possible even if we close one entity down, another 

could quickly grow up. 

There is no real preventive structure here; this is a reactive 

structure that would rely upon us finding these folks and taking 

action. And it isn’t clear in the judiciary if we would prevail because of still-remaining ambiguities in the law. 

Mr. PITTS. In your testimony, you note that there is need for appropriate and effective oversight of the pharmacy compounding industry. According to the FDA, this industry and the healthcare industry have evolved and outgrown the law. 

How do you recommend we draft this legislation to ensure that 

this industry does not outgrow this legislation? 

Dr. WOODCOCK. Well, I think one of the keys—and I recognize it 

is very hard—is making that distinction between traditional pharmacy compounding, which was for a single patient, medical need, 

prescription for that compounded product, and the kind of practices 

that are going on now. And those practices involve making large 

batches often, small to large batches, and of course shipping them 

many places, often without a prescription. 

Mr. PITTS. Now, are large-scale compounders, compounding manufacturers we would call them, more similar to pharmacies or manufacturers? What qualities do they share with manufacturers? 

Dr. WOODCOCK. They share with manufacturers the fact that 

they are manipulating drug products and making them in batches, 

large to small batches, and shipping them to various places. 

They share with pharmacies that many of the practices that they 

are doing used to be done in the hospital pharmacy, and the hospital pharmacies have outsourced much of these operations because 

they don’t have the appropriate facilities. But, frankly, no one is 

looking to see if these new outsourcers have the appropriate facilities and practices. 

Mr. PITTS. Considering that they are more similar in function to 

manufacturers, should they be regulated within the manufacturing 

framework? 

Dr. WOODCOCK. They are similar but not identical. Most of them 

make large numbers of different products in much smaller amounts 

than a pharmaceutical manufacturer would make. Many of them 

are starting from FDA-approved products and putting them in syringes or little IV bags and all sorts of things for the particular doctor or practice or hospital and what their needs are, all right? 

So if you wish to have NDAs and the entire panoply of the FDA 

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ers, this industry could probably not exist, all right? So that is a 

choice that you have to make. Do you create a new framework that 

encompasses this, or do you want to stick to the current binary 

structure that we have? 

Mr. PITTS. Would it be better to regulate large-scale 

compounders under the manufacturing standards rather than establishing a new category? 

Dr. WOODCOCK. We believe that the main issue with these largescale, especially sterile, compounders is that they are not following 

what we call aseptic processing practices that are appropriate, 

which are part of our good manufacturing processes, OK, and practices. 

And we feel that if that was required, to use appropriate sterile 

processing and certain other aspects of the good manufacturing 

practices, that they could make quality products that would be 

safe. 

Mr. PITTS. Under the proposed Senate framework, FDA would be 

barred from requiring compounding manufacturers to submit NDAs 

and ANDAs pre-inspection and labeling requirements before these 

drugs reach patients. 

Would any of these tools be available to FDA as it relates to 

compounding manufacturers, even if agency regulators identified 

high-risk compounding manufacturers where they, upon inspection, 

thought such tools were appropriate to utilize in order to protect 

public health? 

Dr. WOODCOCK. Well, we need to have tools that prevent this industry in general from subverting the new drug review process and 

the generic drug review processes that were established by Congress a long time ago and have served us very well. So there have 

to be provisions that make a distinction between what constitutes 

manufacturing a new drug or a generic drug and these practices. 

And that is not easy or straightforward to do. 

But we have proposed that for all compounding pharmacies that 

there be certain things that they would not be doing. They would 

not be making copies of FDA-approved drugs, for example. Why 

would you need a higher-risk product if there were approved drugs 

available? 

We have also proposed that medical need might be a criterion. 

That is really the reason you use a compounded drug, is because 

there isn’t an FDA-approved drug available for that medical need. 

And so that is the reason that compounding exists, to meet that 

need. 

Mr. PITTS. Thank you. My time has expired. 

The chair recognizes, filling in for Ranking Member Pallone, Mr. 

Green of Texas, for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

Dr. Woodcock, thank you for continuing your willingness to advise the subcommittee on this subject. The question that has been 

at the forefront of our policymaking is how to establish a bright 

line between State and Federal jurisdiction between the traditional 

compounders and those operating closer to manufacturers. No approach is without its challenges, and certainly none are perfect. 

I understand that a lot of the FDA answers are premised on the 

fact that you cannot know what you don’t know before you know 

36 

it. However, under the assumption that you get the records inspection authority necessary to look at the records of the suspect entities, that there are other factors that Congress gives you to establish risk, such as sterility, interstate commerce, and the existence 

or not of a prescription. 

With that in mind, how can we go about setting a production volume level threshold as a proxy for assessing risk? Other than the 

options that are on the table from the Markey, Griffith, and Senate 

drafts, how else can we go about targeting our regulations toward 

the highest-risk entities? 

Dr. WOODCOCK. Well, one thing we don’t want to do, in talking 

about volume or those types of things, is create a large loophole so 

that manufacturers can actually circumvent the entire legislation. 

The problem with volume is that the traditional compounding 

volume unit is one. It is one compounded product that is made in 

response to one patient’s medical need—— 

Mr. GREEN. Which is currently regulated under State law. 

Dr. WOODCOCK. Yes. And that is the way it should be, we feel. 

That is a traditional pharmacy practice. 

The risk of that is limited by many things. If you make one sterile product, one transfer, you have less personnel, you have less 

manipulations. Obviously, the exposure, if you make a lot, 17,000 

or 7,000, then the risk is spread across many people. But the actual 

risk as you go from 1 to 10 to 100 increases, and so it is hard to 

make a bright line on—— 

Mr. GREEN. OK. There is other criteria other than volume. 

Length of time. I have seen 7 days, we have seen 10 days. Because 

if you are warehousing this product on a shelf, it can deteriorate 

and bacteria can grow, which is, I assume, what happened up in 

Massachusetts. So we are looking at, also, some kind of timeframe 

for the use of that drug; is that correct? 

Dr. WOODCOCK. Timeframe could be a criterion that could be 

used. You know, we have put forth criteria—— 

Mr. GREEN. Well, we are looking at multiple criteria, I hope. 

Dr. WOODCOCK. Certainly, the longer any sterile drug product is 

stored, or any drug product for that matter, the riskier it becomes. 

And one of the reasons the hospitals gave the IG, when they did 

their survey, of why they outsourced the products is they say that 

compounded products have a longer beyond-use date. They might 

have up to 6 months. But, in our inspections, what we found is 

they didn’t establish that by testing. They just maybe looked in a 

compendium or something and said, well, 6 months looks like a 

good beyond-use date. They had no data to back it up. 

Mr. GREEN. OK. 

Dr. Woodcock, the National Association of Boards of Pharmacy 

are testifying on our second panel, and they suggest a revision of 

the FDA’s proposed statutory framework for traditional 

compounders. Their goal is to allow patients to access limited 

amounts of compounding products made by traditional 

compounders in advance of a prescription when they are in clinics, 

doctors’ offices, or other healthcare settings. And I would use the 

example of a hospital, for example, made by from a compounder because of, you know, the volume. 

37 

Specifically, one of the limitations they suggest is to limit the 

total quantity provided to a healthcare provider to a 10-day patient 

supply. What are your views on that? 

Dr. WOODCOCK. Well, my understanding is that 10 days would 

be the amount that that entity, healthcare entity or clinic, whatever, needed for 10 days. Right? And so, say they needed 50 vials; 

they used up 50 vials in 10 days. And then the clinic shifted to 100 

providers. That would be 5,000, right? 

So I don’t know that that is a very good—and then you would 

make a batch of 5,000 and that would be OK. So I am not sure that 

is OK. 

Mr. GREEN. Well, the other concern from your earlier testimony 

is that we want to make sure that that longevity, the efficiency of 

that compounding substance is actually 10 days instead of whatever you guess it is. Other pharmaceuticals have to show that their 

shelf life—— 

Dr. WOODCOCK. Yes. Under the GMPs, if we had Federal regulation of a sector, we would require that stability be demonstrated. 

Mr. GREEN. Well, again, I am out of time, but I appreciate you 

working with both Congressman Griffith Congresswoman DeGette 

and I and our ranking members to see how we can get this right. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the vice chairman, Dr. Burgess, for 5 minutes for questions. 

Mr. BURGESS. I thank the chairman. 

So, Dr. Woodcock, you know, we have these large outsourcers. 

And is that part of the problem, you don’t know who they are? 

Dr. WOODCOCK. We have large outsourcers; we don’t know who 

they are. They are doing a variety of things, including making a 

lot of convenience dosage forms for hospitals and clinics. They are 

also compounding from bulk for shortages, making 

hyperalimentation and so forth—— 

Mr. BURGESS. Let me ask you a question about that then. Are 

they not already required to register with the Food and Drug Administration under Section 510 of the act? 

Dr. WOODCOCK. Not according to them. 

Mr. BURGESS. But according to you. I mean, you are the enforcer. 

Dr. WOODCOCK. If we can find them and we can conclude that 

they are, you know, violating—that they are required to register. 

But, according to them, they are registered pharmacies in their— 

whatever State, doing pharmacy operations. 

Mr. BURGESS. Those small pharmacies that compound as a result 

of receipt of a prescription, I mean, they are exempt under the law. 

Dr. WOODCOCK. Yes. 

Mr. BURGESS. And there is value in that. I mean, we all get it, 

that if a kid needs Tamiflu and there is no pediatric formulation 

available, someone needs to be able to crush up the tablet and mix 

it with the cherry favoring so that the kid gets it. We all want that. 

But this is not that situation. These are companies that make a 

large volume, and they make it not on receipt of a prescription. 

They make it well in advance of anyone ordering it. So, for all the 

world, they look like a manufacturer to anyone else. 

Dr. WOODCOCK. Well, I wish the distinction were that simple. 

However, as I just stated, if you have a pharmacy that is making 

38 

office stock and they are going to give that clinic 50 vials a week, 

all right, in response to a usual need, which is a practice in many 

States that is allowed, all right, and they have 100 customers, then 

they are going to be making a batch every week or perhaps every 

2 weeks of 5,000 to 10,000 vials. 

Mr. BURGESS. But—— 

Dr. WOODCOCK. And is that different? I mean, they are allowed 

under the State pharmacy laws to have anticipatory compounding. 

Mr. BURGESS. So they would be regulated by the State boards of 

pharmacy, would they not? 

Dr. WOODCOCK. Yes. They have to have a pharmacy license, uhhuh. 

Mr. BURGESS. So they are licensed and regulated. Now, when 

they engage in interstate sales, that seems like it would come 

under your jurisdiction, would it not? 

Dr. WOODCOCK. My understanding is there are reciprocal licensing agreements amongst the various boards of pharmacy in all the 

different States. 

Mr. BURGESS. I just have to tell you, it doesn’t sound like a gap 

in the statute, it sounds like an enforcement issue. And from everything that we received on the events leading up to the New England Compounding Center disaster, I mean, there were people 

within your agency over and over again that said, ‘‘Well, we can’t 

just send them another warning letter. We have to actually do 

something.’’ And then they would get to the point of doing something, and no one would do it. 

Let me just ask you again. I mean, I assume there has been 

some sort of internal look at the breakdowns in the system as they 

existed in the Food and Drug Administration; am I correct? 

Dr. WOODCOCK. Yes. 

Mr. BURGESS. And have there been disciplinary actions taken 

against any individuals? 

Dr. WOODCOCK. Well, this is more a collective failure than an individual failure. We are now using our authorities very aggressively—— 

Mr. BURGESS. OK, let me stop you for a second. A collective failure, and we want to give you new authority? I mean, honestly, do 

you see the problem with that logic? 

Dr. WOODCOCK. I understand your problem. However, we are 

right now being very aggressive in using our existing authority. 

Mr. BURGESS. Correct. And you are using that existing authority, 

and you are using it to the end that you are inspecting people, and 

you have closed some people down, have you not? I mean, before 

Main Street Pharmacy, you had closed other entities down. When 

either you or Dr. Hamburg came here earlier this year, you probably told us about some people you had closed down. 

Dr. WOODCOCK. We have taken actions. You know, basically, the 

State boards of pharmacy have closed a number of entities down. 

We have taken other judicial actions. It remains to be seen if these 

are contested. 

Mr. BURGESS. Right. But the Food and Drug Administration 

has—I mean, they have shown up with their official FDA jackets 

and seized records and seized product and closed facilities down, 

did you not? 

39 

Dr. WOODCOCK. We have done 61 inspections, and we found 

many serious violations of sterile practices and many products that 

are posing risk to the public. 

Mr. BURGESS. So this is what I just don’t get. You have the authority, since October of 2012 or whenever it was that we decided 

to do this, but you didn’t have it the year before. And nothing has 

changed in statute over that time. So you had the authority in 

2006, 2007, 2008, 2009, did you not? 

Dr. WOODCOCK. We had the authority we have now. We feel—— 

Mr. BURGESS. Yes. 

Dr. WOODCOCK [continuing]. Our authority is limited. But we can 

do the things that you say, and we are doing those. 

Mr. BURGESS. It doesn’t look limited to somebody looking from 

the outside. It looks like you are exercising your authority and it 

is working. 

Dr. WOODCOCK. Well, for example, we have received reports of 

contaminated products and injuries of people from pharmacies we 

have never heard of. Now, it is hard for me to imagine—you know, 

I am somebody who is an executive. OK, manage things. How am 

I going to find these and anticipate that they are going to cause 

problems and shut them down if I have never even heard of them? 

Mr. BURGESS. Well, Mr. Chairman, I know my time has expired. 

I may ask you this question in writing. I would just really like 

to know how you expect to do that under the new authority that 

the Senate bill is proposing or that Mr. Markey has proposed. 

But I will yield back my time, Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the ranking member of the full committee, Mr. Waxman, for 5 minutes for questions. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

There was a provision, Dr. Woodcock, in the bill that Mr. Griffith 

introduced that I want to ask you about. It says that so long as 

a company holds a valid State pharmacy license and receives assurances from the healthcare providers to whom they are sending 

compounded drugs that the providers will send back prescriptions 

within 7 days after administering the compounded drug, that the 

company is considered to be doing traditional pharmacy 

compounding within the scope of State law. 

In other words, regardless of the quantity of compounded medicines a company is making and whether the company is shipping 

those medicines all over the country, so long as that company receives prescriptions from their customers within 7 days after the 

medicines are actually given to the patient—who knows when that 

will be—there will be no Federal oversight of that company. 

This seems like a particularly dangerous structure to me. It 

would allow a company like NECC, which caused the fungal meningitis outbreak, to operate freely without FDA oversight so long as 

it made a relatively minor change in its business practice: keeping 

copies of prescriptions sent to it after the fact. 

Now, I am sure that wasn’t the intent of the provision. And, actually, this provision is based on FDA’s unreleased compliance policy guide, which was part of the documents that FDA provided in 

the context of the Oversight and Investigations Subcommittee investigation. FDA has indicated that this guidance was never reVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
40 

leased because the NECC meningitis outbreak made the agency 

rethink its approach. 

Can you describe why FDA included this provision in the draft 

policy guidance? Do you still believe there is some merit in this 

provision, in the wake of the NECC outbreak? 

Dr. WOODCOCK. Well, like the Members here and in the Senate, 

we are struggling to put some type of quantitative limits on what 

can be done. And we are working within the framework that existed at the time and still exists. 

We have learned a lot since then. And one of the things we have 

learned is that this approach can be worked around, as you said. 

And you can do the math on that and see that you can get up to 

a very large volume of shipping if you are able to receive names 

back, similar to if you have a 10-day limit or whatever, you are 

able to get up to a very large volume if you have enough customers. 

And then that raises the risk up very high. 

I don’t think we have, you know, the magic answer about how 

to identify those highest-risk facilities and what characteristics 

they should have. And we want to work with the Congress on this 

because it is a difficult line to draw. 

But I feel that the 7-day—there is a loophole there that would 

allow a proliferation, a very large volume of shipping as long as 

there was receipt of those names. And that would be very difficult 

for us to enforce. So we go into a pharmacy, we look, there are lists 

of names. You know, what are we going to do then? 

It really puts the onus, actually, the way I think the bill is drafted, on whoever receives the stuff to send it back, to kind of promise 

to send the names back in 7 days. 

Mr. WAXMAN. It appears to me that you are operating within the 

confines of the current statutory framework and doing the best you 

could under that regime. Now, you have suggested that Congress 

should enact an updated statutory framework that would be better 

tailored to this new class of large compounding companies. 

If we adopt a framework like the one you have described, do you 

think this 7-day reconciliation provision is still necessary or useful 

in some way? 

Dr. WOODCOCK. It depends on probably how the definition of 

‘‘traditional compounding’’ is taken forward. Because we feel that 

for the large-volume outsourcers, they are really not getting prescriptions. That is not the business they are in. As I said, much of 

their business is doing what the hospital pharmacies did in their 

pharmacy years ago. And that has been outsourced—that is why 

we call them outsourcers—to larger facilities. 

Mr. WAXMAN. Are you worried, though, that this 7-day provision 

might become a loophole? 

Dr. WOODCOCK. Well, it could be a loophole. It absolutely could 

be a loophole. And so I think, collectively, we have to think very 

clearly about how we draw those lines so that something like 

NECC does not happen again. 

Mr. WAXMAN. Yes. OK. Thank you. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Virginia, Mr. Griffith, for 5 minutes for questions. 

41 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate that very 

much. 

Let’s talk about this 7-day issue and related to the volume. One 

of the frustrations that we have had with some other folks is that 

we have actually been asking—and you will see some blanks in the 

bill, because we are trying to sort that out, which is why sometimes 

it is nice to have hearings and you can ask these questions in public. 

We are trying to figure out at what volume do you all consider 

them to be large enough that they ought to be considered manufacturers, no matter what they call themselves, that they are, in fact, 

manufacturers. 

And what I have heard from your testimony today is, you said 

that under the bill, you know, there could be 5,000 to 10,000 vials 

a week being sent out, and that is too much. So now we have a 

number at least of 250,000 a year. I multiplied it by 50 instead of 

52, figuring there might be a little break in there somewhere. But 

we have that minimum of 250,000. 

So the question is, we are not trying to just say the 7 days; we 

are looking for something else that we can identify? 

Dr. WOODCOCK. Yes. 

Mr. GRIFFITH. Crossing States lines doesn’t do it, because in my 

district, I have two cities that are shared, Bristol, Virginia/Tennessee, Bluefield, Virginia/West Virginia, and all kinds of places 

where the lines—you know, you can get from West Virginia, Kentucky, Tennessee, and North Carolina all in the span of about an 

hour and a half if you drive the right routes. And so, you know, 

saying that just crossing the State line won’t do it. 

So we are looking for some help from you all as the experts. And 

you indicated that is a difficult line to draw. And I understand 

that, but we have to draw it. And I think it is our responsibility, 

with your help, to draw that line. 

So I would say to you, do you have an answer to that question 

today? And if not today, can you give me one? 

Because if the right number is, if you produce more than 20,000 

vials, then I think we have something we can work with and we 

can discuss. And I understand you may not be able to give me an 

exact answer today, but I think that is part of what we need. 

Because Congressman Waxman is absolutely right; I don’t think 

7 days, acting alone, works. With a volume or some other qualifier 

and the 7 days—the 7 days is to make sure we don’t put everybody 

out of business who is trying to do it right. But the volume number 

would really help us a lot. 

Or if you have some other fix that works besides, you know, just 

crossing over State lines when you have small-town pharmacies 

that could be hit when they are in a split city. What do you say 

to that, and what can you help us on? 

Dr. WOODCOCK. Well, we—— 

Mr. GRIFFITH. We are just trying to get this thing worked out 

and do it right. 

Dr. WOODCOCK. Yes. We would really like to work with you. Any 

number that we come up with, any set of limits, have challenges, 

right, as far as how they are defined. The existing—— 

42 

Mr. GRIFFITH. But here is the problem: We are not going to get 

it perfect. We—— 

Dr. WOODCOCK. Right. 

Mr. GRIFFITH [continuing]. Are never going to get it perfect. But, 

you know, in that football field analogy, let’s get it 80, 90 yards 

down the field. Then we can start worrying about how we get the 

last 10 yards. Right now we don’t have any yards on that. 

And I am just trying to, you know, solve a problem. And let’s not 

throw out the really good, trying to get to the perfect. 

Dr. WOODCOCK. Well, the traditional definition of ‘‘compounding,’’ 

the number is one. I would just like to make that very clear. It is 

a pharmacist compounding in response to a prescription for an individual patient need. 

So, as we get above one, we start going into practices that are 

batch manufacturing, basically. And what your pharmacy community will probably say is, well, we like to do that because we have 

multiple—— 

Mr. GRIFFITH. It is not just the pharmacies. It is the docs and 

some of the hospitals. 

Dr. WOODCOCK. Yes. 

Mr. GRIFFITH. Because if you are an ophthalmologist and you 

need those drugs, if you have an emergency eye surgery going on 

and you need something right away, you can’t wait for it to be compounded up, so you do want to have a supply. 

Now, in that regard, as well, you know, we are looking for some 

help on that number. If 120 days is just picked out of the air and 

it is the wrong number, help us find the right number for how long, 

you know, these drugs have a shelf life, or give us some guidelines 

on how we figure that out. 

Because, again, we are not trying to make it hard on anybody. 

We want the ophthalmologist to be able to provide emergency services. We want the hospitals to be able to have what they need 

there. But we also want the safeguards that the American public 

expects and it has a right to expect when we are doing something 

this complicated. 

Dr. WOODCOCK. Well, with regard to the stability numbers or the 

shelf-life numbers, all right, for pharmaceuticals, those are generated using the actual product and doing actual testing. So then 

we have a hard number; we know how long it is stable, whether 

it deteriorates with the stopper that is used and, you know, the degree of the bacterial contamination and so forth, which is not supposed to be in there anyway. 

So, other than doing testing like that, you are going to need a 

very short shelf life to retain confidence that the products are still 

good. 

Mr. GRIFFITH. And I think that is something that we can work 

out, is a short shelf life. If you can give us some help on what that 

should be, whether it is 10 days or 20 days. As long as the hospitals and the people doing those emergency surgeries know, then 

they can adapt to that. But, you know, that is one of those issues 

that we are trying to figure out. 

You know, I know this is difficult, and I really appreciate the 

work that you have done and the fact that you have given us what 

43 

I believe to be very clear and honest answers. But sometimes we 

have to pull the trigger and figure out what the numbers are. 

Dr. WOODCOCK. Yes, we do have to act. 

Mr. GRIFFITH. So if you could help us with that, I would greatly 

appreciate it. 

This is not, as you know, a Republican or a Democrat issue. This 

is just trying to get it right. 

But I do agree with Dr. Burgess that we can clarify but I don’t 

think that there is new authority that is needed. But clarifying the 

authority that we believe exists will help you, will it not? And we 

only have time for a ‘‘yes’’ or ‘‘no.’’ 

Dr. WOODCOCK. Yes. 

Mr. GRIFFITH. All right. I appreciate that and yield back. 

Thank you, Mr. Chairman. 

Mr. WAXMAN. Mr. Chairman, may I ask unanimous consent—— 

Dr. WOODCOCK. Without objection, so ordered. 

Mr. WAXMAN [continuing]. To submit a statement? 

Mr. GRIFFITH. And, Mr. Chairman, I did, likewise, forget to do 

a unanimous consent on a couple of documents, if I might. 

Mr. PITTS. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. WAXMAN. And I have a document also. And I also wanted to 

thank Mr. Griffith for his willingness to talk this through and work 

it out. 

Mr. PITTS. All right. At this time, the chair recognizes the ranking member emeritus, Mr. Dingell, for 5 minutes for questions. 

Mr. DINGELL. Mr. Chairman, thank you. I commend you for holding this hearing. 

Dr. Woodcock, welcome. My questions will require ‘‘yes’’ or ‘‘no’’ 

answers. 

Nearly 9 months after the initial outbreak of fungal meningitis 

from contaminated steroid injections at New England 

Compounding Center, it is clear to me that Food and Drug needs 

strong and clear authority over compounding pharmacies, which it 

now lacks. 

My home State of Michigan has been especially hard-hit. To date, 

there have been 264 cases related to NECC and 17 deaths in 

Michigan alone, the most in the Nation. 

I am confident we can come together in a bipartisan manner to 

clarify and strengthen the authority of FDA over compounding 

pharmacies. 

Today we have three bills before us which take different responses and answers to solving the problem. Each has its strengths 

and weaknesses. I am going to focus my questions on important authorities that I believe should be included. 

Question one: Does FDA believe that classifying an entity according to the existing statutory scheme of either a traditional 

compounding pharmacy or a conventional drug manufacturer could 

cause disruptions in our healthcare system, yes or no? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Does FDA have the authority to require all 

compounding pharmacies to register with the agency, yes or no? 

Dr. WOODCOCK. No. 

Mr. DINGELL. No? 

44 

Dr. WOODCOCK. No. 

Mr. DINGELL. Would you submit for the record what authority 

you need? 

Dr. WOODCOCK. Certainly. 

Mr. DINGELL. Does FDA have authority to require all 

compounding pharmacies to report adverse events, yes or no? 

Dr. WOODCOCK. No. 

Mr. DINGELL. Does it need that authority? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Submit to us, please, what you think you need, for 

the purposes of the record. 

Does the FDA have the authority to require all compounding 

pharmacies to follow good manufacturing practices, yes or no? 

Dr. WOODCOCK. No. 

Mr. DINGELL. Do you need it, yes or no? 

Dr. WOODCOCK. ‘‘All’’ might be an overstatement. Yes, for some. 

Mr. DINGELL. All right. I would like to have you define what it 

is you happen to feel you have need of. 

Does FDA believe nontraditional compounders should be subject 

to appropriate good manufacturing practices like manufacturers 

are, yes or no? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Please elaborate for the record. 

Dr. WOODCOCK. Certainly. 

Mr. DINGELL. Does FDA believe a risk-based inspection schedule 

is appropriate for nontraditional compounders, yes or no? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Tell us why for the record, if you please. 

Next question: Does FDA have full authority to see all records 

when inspecting any compounding pharmacy, yes or no? 

Dr. WOODCOCK. No. 

Mr. DINGELL. Does it need it? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Please define for the record what you think you 

have need of. 

Has FDA faced litigation regarding its ability to inspect records 

in pharmacies, yes or no? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Please describe for the record what you feel you 

have need of. 

Now, do you need this authority to effectively regulate 

compounding pharmacies, yes or no? 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Please state why for the record. 

I have long believed that we must provide agencies like FDA 

with the necessary authorities and researchers and resources to 

properly protect public health. FDA has a user-fee system for the 

approval of pharmaceuticals and medical devices, amongst others. 

If we give FDA increased authority in this area, which I believe we 

should, then I believe we should also have a stronger user-fee program. 

Now, would the user-fee provisions contained in the Senate bill 

provide FDA with the necessary resources to carry out these authorities, yes or no? 

45 

Dr. WOODCOCK. Yes. 

Mr. DINGELL. Would you discuss for the record, please? 

Now, the American people deserve a response to the NECC outbreak so that we can ensure that this never happens again. I am 

committed, like most of my colleagues here, to seeing to it that we 

work towards a proper bipartisan solution to the problem. And I 

plan on continuing my discussions with my friends on both sides 

of the aisle until we reach agreement on the best way forward. 

I would like to have you discuss a little further some of the comments that you made in response to Mr. Griffith’s rather excellent 

questions. 

I have a curiosity. Is the number of shipments by the 

compounder as important as to whom they are shipped and what 

the compounding might happen to be and who the individual is 

that is making the shipments? 

Dr. WOODCOCK. We feel that the highest risk relates to sterile 

products. So that is number one. Things are going to be injected 

into your body, right? And the contamination, that—— 

Mr. DINGELL. So you need authority to define those things, don’t 

they? 

Dr. WOODCOCK. That is one. 

We propose using interstate commerce as a proxy for risk, because if you are shipping all over the country, you are making 

more, it is taking longer, right? So the shelf life is going to be 

longer, and there is time for bacteria or fungi to grow and so forth. 

And your batches are probably larger, and that increases the risk 

of errors, and, also, it just simply increases the number of people 

who could be harmed. 

Mr. DINGELL. I am running out of time. And out of respect for 

my colleagues, would you please submit for the record a statement 

on this particular point? 

Dr. WOODCOCK. Certainly. 

Mr. DINGELL. Thank you. 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from Tennessee, Ms. Blackburn, for 5 minutes for 

questions. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And thank you for being with us. We appreciate your time and 

coming back. I know that you probably and your staff probably 

feels like we have talked about this issue nonstop, but it is of tremendous concern to us. For those of us in Tennessee, it is especially concerning. We have 14 individuals that lost their lives and 

so many who are still suffering. 

And I will just associate myself with Mr. Burgess’s remarks in 

regard to it being a collective failure. We do realize that there were 

actions that you all should have and could have taken, and it is of 

concern to us. 

A couple of things I just want to ask you about. Looking at drug 

shortages, are there any instances where FDA is permitting 

compounding pharmacies to make products on that drug-shortage 

list without having those facilities go through the inspections and 

qualifications? 

46 

And, then, are there people that are on the ANDA list that have 

submitted those applications where you have not gotten around to 

approving those applications? 

Dr. WOODCOCK. Well, first of all, we prioritize any generic drug 

application that is related to a shortage and try to get it through 

the process as quickly as possible. 

As far as compounding pharmacies, yes, they are making drugs 

to address shortage issues, but, no, we have no real oversight of 

that right now. That is not the scheme that is in place. That is regulated primarily by the State boards of pharmacy. 

Mrs. BLACKBURN. OK. On the ANDAs, you said you prioritize 

those applications. How long does it take to get one of those 

through the process? 

Dr. WOODCOCK. Well, it varies tremendously, whether or not the 

application is in good shape. If there are multiple foreign facilities 

involved in production of the drug that we haven’t inspected before, 

we may have to go to other countries and inspect those facilities. 

So that sometimes can be a rate limiting step. 

Mrs. BLACKBURN. On average. 

Dr. WOODCOCK. I could get back to you on that. I don’t have it. 

Mrs. BLACKBURN. OK. I would love that. I think that it would be 

instructive to us. 

Mr. Griffith mentioned something about limitations. I understand that many States have used some form of volume limitation 

for anticipatory compounding to determine whether an entity is 

acting within the scope of their license. 

So do you think that a volume limitation in conjunction with 

other factors from 503(a) could help distinguish between entities 

that are engaged in large-scale compounding similar to manufacturing or in traditional compounding? 

Dr. WOODCOCK. It is possible. The States have a patchwork of 

laws which are different. Some allow anticipatory compounding; 

some allow office stock. So there are a variety of interpretations or 

laws across the different States. 

Clearly, volume is another proxy for risk. And the larger the volume of the batch or lot you are making, the higher the risk that 

is imposed if you are not using good manufacturing practices. 

So that is possible, but we have struggled with this, and we have 

had a very difficult time coming up with a coherent scheme that 

would use volume. And then that would have to be usually enforced by the States, because it would apply to all the compounding 

pharmacies. It wouldn’t be a uniform Federal standard, or it would 

be very difficult for us to enforce it even if it were, because, as the 

testimony shows, there may be 23,000 pharmacies or something 

that are doing compounding of different types. 

Mrs. BLACKBURN. OK. Thank you for that. I would think that 

volume could be one of those indicators that may be a bit more illuminating as you try to work through this process. It would seem 

it would be a key indicator. 

With that, I will yield back. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentlelady from the Virgin Islands, Dr. Christensen, for 5 minutes for her questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

47 

And welcome back, Dr. Woodcock. 

Dr. WOODCOCK. Thank you. 

Mrs. CHRISTENSEN. Some of these questions have been asked one 

way or another, but I want to just to be clear. And I would like 

to talk about one of the concerns we have been hearing a lot about, 

having to do with the proposed statutory framework. 

As has been said, FDA has suggested that Congress should revise its statute to clearly delineate which compounding entities 

should be subject to Federal oversight and which ones should remain the purview of States. Specifically, you have recommended 

that facilities be subject to FDA oversight if they conduct sterile 

compounding, which you said is the highest risk; second, whether 

they compound medicines in advance of or without a prescription, 

which I don’t understand; or if they ship compound medicines 

across State lines. 

One of the problems, according to some of the stakeholders, is 

that this construct would prevent doctors’ offices from obtaining 

limited amounts of compounded medication without a prescription 

that would be kept as office stock. So they feel that these medicines 

need to be in their office so that they can be given to a patient who 

needs them right then. 

It is my understanding from your answers that FDA doesn’t support this. So could you explain the rationale for not allowing some 

limited amount of office stock to be exempt from the triad of requirements? 

Dr. WOODCOCK. Certainly. 

We are not—we aren’t wedded to anything. We need to find a 

workable scheme, right? Each doctor’s office or clinic may say, as 

I said, they may say, we only use 25 of these vials a week. OK? 

But if the compounding pharmacy has 1,000 customers, right, then 

that is 25,000 vials. And would you say that is too many? 

So if you simply use that and allow a certain amount of anticipatory office stock, that is what you could end up with. And so you 

just have to kind of play out this scenario in your mind and what 

this would look like. And I don’t know, maybe you think that them 

making 25,000 sterile vials is OK, is not manufacturing, right? 

Mrs. CHRISTENSEN. I think that anything that goes beyond a specific compound for a specific patient is too much, trust me. And—— 

Dr. WOODCOCK. Could I say one more thing? 

Mrs. CHRISTENSEN. Sure. 

Dr. WOODCOCK. We are not proposing that this be prohibited. We 

are saying that it should go into a category that involves good manufacturing practices so that there would be oversight of the aseptic 

processing so that we would be assured it would be done correctly 

and at least these products would not be contaminated. 

Mrs. CHRISTENSEN. Got it. And are there certain types of compounded drugs for which some limited amount would not be subject 

to the limitation? Are there specific drugs that you could conceive 

of that could be compounded without—for which some limited 

amount should not be subject to the extra oversight? 

Dr. WOODCOCK. Well, we have proposed that the category of federally regulated would be, you know, interstate commerce without 

a prescription of sterile drugs, right? And that leaves a large variety of other things to the States, including intrastate sterile drugs, 

48 

which still, arguably, can be of high risk, and all other compounded 

products, which would be the oral, the creams, the lotions, all those 

sorts of things. 

Now we have proposed that there be a floor that you should not 

be able to compound drugs, say, that FDA pulled off the market because they weren’t safe, OK, and that you shouldn’t compound 

drugs from a monograph, you know, from a appropriate source OK, 

and so forth. So we had certain criteria we think should apply to 

all pharmacies who compound. However that vast majority of nonsterile, non-injectables so we really are not proposing to have under 

this broad scheme, this new scheme that we were talking about. 

Mrs. CHRISTENSEN. And are there any exemptions to the across 

State line borders for pharmacies that are close to State borders or 

that routinely operate across State borders today? 

Dr. WOODCOCK. Right, well that is, I think, the question that we 

just heard that that creates some unfairness like any scheme we 

are going to apply there would be some disparities. We weren’t proposing that there would be that exemption for States that were 

close by or four corners or whatever. 

Mrs. CHRISTENSEN. The question has been raised that you all 

had a lot of authority that you hadn’t exercised before so, and you 

said that FDA took some aggressive action and when you have 

taken that aggressive action, is it that FDA has gone over out on 

a limb in the interests of public health risking court challenges? Or 

did you find some authority that you didn’t think you had before? 

Dr. WOODCOCK. Well, as I said, we, I think we may get court 

challenges. I think in some cases, the States have taken action because we have brought this to their attention, and they are the 

holders of the, you know, they issue the pharmacy licenses. And so 

although we have even inspected 61 pharmacies, now if you think 

of the universe that we are talking about, it is a much larger universe, and new ones can grow up all the time. 

So although we are taking aggressive action, the fact that we do 

have to think through the judicial consequences and so forth meaning each of these actions, as I would call them pretty lawyer intensive, all right, and we don’t have unlimited legal resources. 

Mrs. CHRISTENSEN. I have gone over my time, thank you. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentlelady from North Carolina, Mrs. Ellmers, for 5 minutes for 

questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you, Dr. 

Woodcock, for being with us again. 

To the best of my knowledge this is about the fourth hearing that 

we have had in the subcommittee on this issue, especially in relation to the New England Compounding Center, and I think there 

are still some questions out there that many of us have about how 

that process is moving forward. 

It seems to me, after looking at all the information that the FDA 

did have some authority at that point to shut down NECC, and of 

course, that is not the possess that went forward and we obviously 

need to clarify, of course, the FDA authority as been discussed 

many times here already today. 

Dr. Woodcock, in your opinion, would you agree with my statement and might you have anything to add? What can we do to 

49 

bridge this? Because as we are having this conversation, there are 

many times that you say that we did have authority, we did not 

have authority, but we have got to fix this problem. So what is 

your solution? What do you want to see done? 

Dr. WOODCOCK. Well, what FDA has proposed is that we have 

different legislation, I won’t say it is quote, that the large scale industry that has grown up especially that is making sterile products 

be subject to Federal regulation. It is basically a new type of industry, the scale, the fact that it is sterile and so forth, and it is not 

the traditional corner drugstore making—— 

Mrs. ELLMERS. And that, I guess at that point is now where we 

have the question of the amount that is being compounded, meaning each individual vial, or, you know, sterile unit, I know I have 

heard shelf life be discussed, and of course, I think that does have 

more to do with the actual make-up of the compounded prescription, which leads me again to the question, I know when we have 

a traditional pharmacy, we have a prescription, and that is filled 

for the patient. Then we, as you pointed, out have this situation 

where we have hospitals and different, you know, maybe outpatient 

surgery clinics that use those compounded products as well. 

Why can’t—I guess my question is rather than concentrating so 

much on the number, obviously there is a safety issue there, we 

want to make sure we are producing a sterile product, but when 

it comes to going to a hospital or an outpatient surgery center, why 

can it not stay under the same category that it is right now rather 

than moving into a larger manufacturing label or status? 

Dr. WOODCOCK. Because they make—the people who supply 

these outpatient clinics like NECC, OK, make large scale volume, 

which Dr. Burgess has said, well, that clearly is manufacturing, we 

know it when we see it, right, the question is how do you distinguish that. 

Mrs. ELLMERS. Well, and that leads me to my next thought, and 

I realize that we are talking about legislation that is already being 

proposed, but if we know that an outpatient clinic does a number, 

a particularly an average number of cases every month, and they 

were to receive that compounding product for that amount, would 

that not essentially be kind of a large-scale prescription when you 

think about it? Is there not another avenue we can take here rather than just add more regulation and more costs, but at the same 

time, continue to produce a very safe product? 

Dr. WOODCOCK. Well, that is the issue, continuing to produce a 

safe product. As I said, we have had another outbreak since the 

last time this body had a hearing, all right. 

Mrs. ELLMERS. I am going to stop you there, thank you, I do 

have about 50 seconds which leads me to my next question. At the 

time of the outbreak, the NECC outbreak, there was a compliance 

policy guide that the FDA was preparing, but I think that had been 

put on hold. 

Has that now been, has that policy been evaluated? And what is 

the FDA doing? 

Dr. WOODCOCK. We have learned since then, and as I told Dr. 

Burgess we are aggressively applying our existing authorities 

under the law to these pharmacies. Existing authorities require 

prescriptions. 

50 

Mrs. ELLMERS. So the question, again, is has the agency evaluated the compliance policy guide? Has that been—— 

Dr. WOODCOCK. Yes. 

Mrs. ELLMERS. Is that being implemented now as this authority? 

Dr. WOODCOCK. No, we feel that parts of that are actually 

unfeasible based on what we have learned. We have learnt a lot 

since the NECC outbreak all right and we have revised our approach to be more practical. 

Mrs. ELLMERS. Thank you and my time has run out thank you. 

Mr. PITTS. The chair thanks the gentlelady. I recognize the 

gentlelady from Illinois, Ms. Schakowsky 5 minutes for questions. 

Ms. SCHAKOWSKY. I am over here, Dr. Woodcock. 

Dr. WOODCOCK. I am sorry. 

Ms. SCHAKOWSKY. Did I hear you at some point say that there 

ought to be labels of dates certain and information for the consumer on compounded products? 

Dr. WOODCOCK. Yes, after this NECC outbreak, many of the FDA 

staff who had to go in the hospital they said, well, we don’t even 

know what products we are getting that are compounded when 

they are having a procedure or something. There is no label that 

is required now that identifies a product as a compounded product. 

Ms. SCHAKOWSKY. Here is my question problem, that I began my 

activism decades ago to get expiration dates on products sold in the 

supermarket. I am for consumer information. But when it comes to 

prescription drug, particularly if you are in the hospital, are you 

suggesting that in some way, we leave this up to an informed consumer to be able to make decisions on whether or not they want 

that or that it be suitable for them? 

Dr. WOODCOCK. Not really. We think that this simply raises 

awareness about the use of compounded drugs. The use of, there 

are beyond use dates on compounded products now. Our issue with 

them is that they aren’t based on evidence, based on experiments 

that are done on that compounded product from what we have seen 

in our inspection. 

Ms. SCHAKOWSKY. Well, let me ask you about all the prescriptions that we get. They all now have a date on them and I regularly go through my shelf and dispose of—— 

Dr. WOODCOCK. Excellent. 

Ms. SCHAKOWSKY. Outdated drugs. Are all of those, do we know 

that those are accurate? 

Dr. WOODCOCK. Absolutely. They have to perform experiments on 

stability and dating period and submit all that information to FDA 

and we have to agree with it. 

Ms. SCHAKOWSKY. OK, so that is not part of the requirement and 

something that you would need the authority to require that? 

Dr. WOODCOCK. Performing stability testing, so forth, on products is part of good manufacturing practices. 

Ms. SCHAKOWSKY. And so that would, under your new categories, 

would be required of these compounders? 

Dr. WOODCOCK. We are proposing that for the highest risk facilities that make sterile drug products and ship them inter State. 

Ms. SCHAKOWSKY. So if we are not doing it by quantity, what are 

we doing it by? What do you recommend we do it by? 

51 

Dr. WOODCOCK. We propose by risk and simply pulling off the 

highest risk class of products which is the sterile products that are 

shipped inter State so they are going, causing multi State outbreaks, and that are without a prescription and the prescription— 

without a prescription is a proxy for mass production, OK, because 

it is not one pharmacy making one sterile product for a person, say, 

in another State. They are making large batches and then shipping 

them all around. 

Ms. SCHAKOWSKY. So the FDA has talked a lot about medical 

need as a condition for compounding a product. So how should we 

incorporate this concept into legislation? 

Dr. WOODCOCK. We feel that is a fundamental concept for 

compounding. It is the reason—why else would you give people 

products that didn’t go through the system that Congress has established for drugs, right, which is they are tested for safety and 

efficacy, and they have applications and everything, and the reason 

is there is a medical need that is not met by existing products. And 

so we feel to raise practitioners’ awareness that they would indicate that there was a medical need for this product, and why are 

we doing this? Because when we talk to people who bought products from NECC, the practitioners, what they said, well, there was 

just the order form online, and we just ordered like any other order 

that you would make. And so there was no awareness, there was 

no practitioner awareness that this was a higher risk product. 

Ms. SCHAKOWSKY. I see. In your testimony, you explain that certain products with limited exceptions are not appropriate for 

compounding under any circumstances. Would you include this situation that we are just talking about, that, you know, the practitioner just went online, found this to be available? Should those 

products not have been compounded under any circumstances? 

Dr. WOODCOCK. No, we have very specific criteria for what we 

think shouldn’t be compounded under any circumstances, and that 

would be, for example, the drugs that FDA has pulled off the market because they dangerous. We don’t think they should be compounded. Very complex dosage forms, our, the pharmaceutical manufacturers have trouble making certain dosage forms right. For example, extended release may cause dose dumping and get all the 

dose in the body at once and could kill you, for example, and they 

have to do extensive testing on their products to make sure they 

have been manufactured correctly. So we don’t think some of these 

very risky products should be compounded either. 

Ms. SCHAKOWSKY. Thank you. I appreciate it. I yield back. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentleman from Florida, Mr. Bilirakis, 5 minutes for questioning. 

Mr. BILIRAKIS. Thank you, Mr. Chairman I appreciate it very 

much. Thank you for your testimony. Dr. Woodcock, you mentioned 

that copies of FDA-approved drugs should never be compounded. 

What about the drug progesterone, which, for years, was compounded by pharmacists for pregnant women to prevent premature 

births? In 2011, FDA approved Makena, which is a manufactured 

form of progesterone. The manufacturer sent a cease and desist letter to compound pharmacies, and FDA weighed in and said pharVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
52 

macies could continue to compound this drug even though a more 

expensive manufactured drug is available. 

If we explicitly prevent compound pharmacies from making copies of FDA-approved drugs, what will happen to pregnant women’s 

access to achieve drugs, affordable medication to prevent premature births? 

Dr. WOODCOCK. You know, I can’t comment specifically on that 

instance because of ongoing litigation issues. However, I think in 

general, Congress set up a system that required new drugs to go 

through the FDA review process, and that was because of the many 

abuses and many deaths and many problems there were long ago 

when there wasn’t a system to make sure drugs are safe and effective. So there were many outbreaks in the past as well as like the 

thalidomide crisis and so forth, all of which led Congress to do this. 

Now, if we feel, in general, if there is a safe and effective drug 

available to the public, people should not be exposed to drugs that 

are of lower quality unless there is a medical need for that other 

product. 

Mr. BILIRAKIS. Next question, you mentioned needing the power 

to access pharmacy records. Are you looking for the authority over 

pharmacy records in general, or just the nontraditional compound 

pharmacies? 

Dr. WOODCOCK. Well, we would like to, so to speak, be able to 

distinguish, more or less, the sheep from the goats. We need to 

know, people have said, well, why don’t you act on this or that or 

other, haven’t we acted if we can’t demonstrate that a pharmacy 

is shipping large quantities of drugs that violate whatever scheme 

Congress comes up with, right, then we won’t have the power to 

use our authorities. And the way we do that, you look at their shipping records and say if there is a requirement for names or prescriptions, we would need to be able to verify that, otherwise we— 

there are bad actors out there and there are people who say oh get 

all that stuff or we don’t do this, and if we can’t verify that then 

it really ties our hands. 

Mr. BILIRAKIS. How about, you mentioned using the administrative warrants to compel access to records. 

Can you explain what this process is and how do you go about 

getting the records, the warrants? 

Dr. WOODCOCK. Well, I am not a lawyer, all right. But my understanding, I have asked the lawyers and we have to go to a court 

and we have to ask the court. And sometimes it can be done rapidly, but often it averages about 2 weeks. And we are concerned, 

first of all, of course, if there is an outbreak, that is too long because lives are at stake. 

Another thing, a problem we can have is that people can clean 

up and destroy their records in the time that it takes for us, and, 

of course, we don’t have evidence that they have destroyed records 

because they may be destroyed, but when our investigators are in 

some of these firms, they have had a very strong smell of bleach 

which we think means that the mold has been bleached off of the 

counters and so forth, and that there was a lot of cleanup during 

the time we went and tried to get a warrant to get in. 

Mr. BILIRAKIS. Thank you. We all, of course, want to ensure the 

safety and sterility of compounded drugs. We must also not lose the 

53 

sight of the important role that compounded drugs play in patient 

care. Some physicians keep a supply of compounded drugs available for anticipatory office use because in waiting for the drug to 

get compounded for the patient, that waiting period could endanger 

the patient’s health. I know we touched about upon this, but some 

of the bills we are reviewing today include patient specific prescription requirements for certain compounded drugs. 

Do these prescription requirements really address and improve 

the safety and sterility of compounded drugs? Are there other 

measures that can be taken to improve the safety of these products 

that also ensure physician and patient access to compounded drugs 

for use in the office setting? 

Dr. WOODCOCK. Well, our proposal doesn’t preclude lack of prescriptions in the anticipatory compounding. What we are saying is 

when you do that for sterile products, you should make the products under good manufacturing practices, proper aseptic processing 

so you don’t contaminate them. Now, that is one way to deal with 

this. That is what we are proposing is if you wish to ship products, 

sterile products around and not get prescriptions, then you should 

make them under good manufacturing practices because you are 

likely to be making batches of sterile products, and that really 

doesn’t look like compounding, it looks more like manufacturing 

when you are making batches. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from Florida, Ms. Castor, 5 minutes for questions. 

Ms. CASTOR. Thank you, Mr. Chairman, and thank you Dr. 

Woodcock for being here. The last time you were here you were 

kind of to allow me to change the subject and ask you about one 

of the serious drug shortages facing our country, and that involves 

the injectables, injectable nutrition that primarily affects premature infants and our children’s hospitals continue to raise the 

issue and practitioners and scared parents across the country. I 

know at the end of May, FDA acted to allow some imports of those 

nutrition elements. 

Can you give us an update on how it is going? Is the situation 

improving? Have you hit any roadblocks. 

Dr. WOODCOCK. It took longer than we had hoped and when I 

talk to you last, I thought it was imminent and it took longer than 

what we hoped to get those products in. We believe we are alleviating these shortages, but we are not out of the woods yet. We 

do not have a U.S. manufacturer online to my knowledge that can 

give us a stable supply but we are working on that. 

Ms. CASTOR. Are there prospects for U.S. manufacturers to come 

online? 

Dr. WOODCOCK. That is what we believe, yes. 

Ms. CASTOR. And what would that time frame would be? 

Dr. WOODCOCK. Pardon me. 

Ms. CASTOR. What do you think the time frame would be? 

Dr. WOODCOCK. I don’t know. We can get back to you with details if you would like. 

Ms. CASTOR. Good. I look forward to that, thank you very much. 

And you really have clarified over the number of hearings that we 

have had back on this topic on reforming drug compounding, we 

54 

have had a series of hearings, and your message is sinking in, I 

believe. We now have three bills that are out there, you have got 

a Senate bill by Senator Harkin, you have got one that is kind of 

on the other end of the spectrum by former Representative Markey, 

you have Mr. Griffith’s bill now that he is working on. 

When you look at the three bills that have been drafted, can you 

point to a section of any of those bills that you say boy, that is really the most important thing that could be accomplished here or 

that would be one of our priorities going forward for FDA and protection of the public health? 

Dr. WOODCOCK. Well, we do feel the Senate bill has the right 

framework. There is still issues about, but you know it does provide registration so we can find out who the people are, it provides 

reporting of adverse events so that if any compounding pharmacy 

starts getting into trouble, we can react quickly. It does have a 

user fee program, it does carve out a section of a sterile manufacturers who would be subject to higher standards and it does provide some other Federal standards. So we feel that is a good start, 

but all—this is a very difficult issue to draw these lines correctly 

and they are trade-offs that have to be made, and we recognize 

that everyone is struggling with this and we want to work with you 

all. 

Ms. CASTOR. In that Senate bill, is it clear to you when you read 

it that the traditional neighborhood pharmacist that are not in the, 

not making thousands of batches or even hundreds of batches are 

clearly exempt. 

Dr. WOODCOCK. Yes, the Senate bill has State law prevail on the 

traditional pharmacy compounding, and we feel, unfortunately, 

there is a bit of a patchwork there because each State has a different set of laws, so your two pharmacies are 20 miles apart in 

different States may be operating under totally different frameworks, and we think that will be difficult for us to enforce, pending 

one might be regulated by us, and the other on the other State regulated by the State, and that is very difficult. 

Ms. CASTOR. Well, thank you very much. I was thinking about 

this earlier today reading over the testimonies and I think if we 

just put ourselves in the shoes of the average American consumer, 

I think what they want most of all is to be assured that especially 

the highest-risk drugs, the ones that are being injected, like you 

said, are being manufactured in a way that is safe and that the 

government at least has the authority to know who they are, where 

they are, so that we can ensure that no one is harmed to the extent 

of what happened with NECC. So thank you very much. I yield 

back. 

Dr. WOODCOCK. Thank you. 

Mr. PITTS. The chair thanks the gentlelady and recognizes the 

gentleman from New Jersey, Mr. Lance, for 5 minutes for questions. 

Mr. LANCE. Thank you, Mr. Chairman. 

Dr. Woodcock, your opinion should entities making nonsterile 

products in advance of prescription shipping interstate be regulated 

by the FDA as traditional manufacturers or by States as traditional compounders? 

55 

Dr. WOODCOCK. So should traditional, should manufacturers who 

are making nonsterile products and shipping them interstate. 

Mr. LANCE. Interstate? 

Dr. WOODCOCK. Interstate, perhaps in very large quantities be 

regulated as manufacturers or. 

Mr. LANCE. Or as traditional compounders. 

Dr. WOODCOCK. I think that is a policy call. There are trade-offs 

there; there are is far more of that. These are lower risk products, 

and what we have proposed is other restrictions like not copying 

FDA-approved product and only working from certain bulk product, 

API’s and so forth, that would put some boundaries on these practices but I think there is some danger of folks going into business 

as a kind of shadow generic company without FDA oversight, if 

they could ship broadly. 

Mr. LANCE. If they were regulated under the FDA what would 

the proposed framework be? As opposed to being regulated by the 

States. 

Dr. WOODCOCK. Well, we haven’t proposed anything for that 

group. Generally speaking, doing those practices, you would have 

to, right now under the current law, which we have been talking 

about, you have to file an application for every single form that you 

are shipping, and often, of course, these are customized to different 

doctors’ preferences and so forth, and these groups make thousands 

of different dosage forms, they would have to file an application for 

each one with extensive documentation and pay user fees. 

Mr. LANCE. Thank you. I know that you have recently conducted 

a series of inspections compounding pharmacies and as I understand it, you have done that in conjunction with State officials; is 

that accurate, Dr. Woodcock? 

Dr. WOODCOCK. Yes, in almost all cases, we have gone in with 

the State. 

Mr. LANCE. And you have stated that the agency needs full 

record inspections authority for every pharmacy in the country and 

in that, if you are conducting these inspections with State Pharmacy Board officials, do you believe as well that you need independent authority independent from the State boards? 

Dr. WOODCOCK. We have had some cases where the State officials, due to resource constraints, have not been able to go in with 

us and we are concerned that might be even more happen more 

often in emergency where we feel that we really need the ability 

to get in there. We do always try to have the State officials come 

with us because they have we have joint authorities. 

Mr. LANCE. Are some States better at this than others traditionally, or does it just vary based upon State resources at the moment. 

Dr. WOODCOCK. I don’t think we have a large enough sample size 

to say which States, you know, we know some States as the Board 

of Pharmacy Association has testified, some States are better 

staffed and so forth than others for their board of pharmacy operations. 

Mr. LANCE. Thank you. I would be happy to yield to any other 

member who wishes to speak. 

Mr. GREEN. If I could, we are looking, and I think I share it with 

my colleague, Congressman Griffith, we are looking at multiple 

things that gives the FDA the authority to do it, because we don’t 

56 

want this to happen again, and I have to admit having served 

there a good while, that first hearing we had neither the FDA nor 

the compounders nor the State agencies showed that they were actually do the doing the job, so we want to make sure you have the 

tools, so it will be multiple and I would be glad to my colleague 

from New Jersey to yield to my colleague, Mr. Griffith. 

Mr. GRIFFITH. If I could have a minute of that time I would appreciate it, and one of the things we are also working on in the bill 

that I think is helpful and I think you would agree is that we set 

up a facilitating process where there are complaints from the State 

where they can work a little more efficiently with the FDA, and 

likewise, if you hear something go on from State A that the FDA 

can then communicate that it to that to State B and C, that this 

particular group may be having a problem. 

Dr. WOODCOCK. Yes, we would like to have, perhaps, a message 

board or something but we don’t want to turn into the telephone 

operator. 

Mr. GRIFFITH. I understand that, but anything we can do to facilitate, because one of the problems is those who were here for the 

hearings know is that we had a couple of States that were blowing 

the whistle, and no action was taken, so we want to try to make 

sure we facilitate in making sure that the next time when Colorado 

or Ohio or some other State is, in fact, raising red flags that that 

message is getting through, and I do appreciate and yield back 

to—— 

Mr. LANCE. Thank you very much. 

Mr. PITTS. The chair thanks the gentlemen. That concludes questions from the members. I am sure they will have written questions. We ask that you please respond promptly. Dr. Woodcock, as 

always, you have been a very excellent witness. Thank you for your 

testimony. 

Dr. WOODCOCK. Thank you. I am pleased to respond. 

Mr. PITTS. Thank you. I will call the second panel up at this time 

and introduce them as they come forward. In this order they will 

testify: Dr. Doug Hoey, chief executive officer, National Community 

Pharmacists Association; Dr. Kasey Thompson, vice president, 

American Society of Health-System Pharmacists; Mr. Jeffrey 

Francer, assistant general counsel, Pharmaceutical Research and 

Manufacturers of America; Dr. David Gaugh, Senior Vice President 

for Sciences and Regulatory Affairs, Generic Pharmaceutical Association; Mr. Allan Coukell, Senior Director Medical Programs, the 

Pew Charitable Trust; Dr. David Miller, Executive Vice President 

and CEO, International Academy of Compounding Pharmacists; 

and, finally, Dr. Carmen Catizone, Executive Director, National Association of Boards of Pharmacy. 

Thank you all for coming. 

You will each have 5 minutes to summarize your testimony. Your 

written testimony will be placed in the record. 

Dr. Hoey, we will start with you for an opening statement. 

57 

STATEMENTS OF B. DOUGLAS HOEY, CHIEF EXECUTIVE OFFICER, NATIONAL COMMUNITY PHARMACISTS ASSOCIATION; 

KASEY THOMPSON, VICE PRESIDENT, AMERICAN SOCIETY 

OF HEALTH-SYSTEM PHARMACISTS; JEFFREY FRANCER, ASSISTANT GENERAL COUNSEL, PHARMACEUTICAL RESEARCH 

AND MANUFACTURERS OF AMERICA; DAVID GAUGH, SENIOR 

VICE PRESIDENT FOR SCIENCES AND REGULATORY AFFAIRS, GENERIC PHARMACEUTICAL ASSOCIATION; ALLAN 

COUKELL, SENIOR DIRECTOR, DRUG AND MEDICAL DEVICES, THE PEW CHARITABLE TRUSTS; DAVID G. MILLER, 

EXECUTIVE VICE PRESIDENT AND CEO, INTERNATIONAL 

ACADEMY OF COMPOUNDING PHARMACISTS; AND CARMEN 

CATIZONE, EXECUTIVE DIRECTOR, NATIONAL ASSOCIATION 

OF BOARDS OF PHARMACY 

STATEMENT OF B. DOUGLAS HOEY 

Mr. HOEY. Thank you and good afternoon, Chairman Pitts and 

Vice Chairman Burgess and Ranking Member Pallone, members of 

the subcommittee, the National Community Pharmacists Association greatly appreciates the opportunity to testify today and share 

the community pharmacy perspective on legislation addressing 

pharmacy compounding. 

NCPA represents the interests of America’s community pharmacists, including the small business owners of more than 23,000 

independent community pharmacies. 

Almost 86 percent of independent community pharmacies compound medications. Our members perform a wide variety of 

compounding services, including working with physicians to create 

medications to help patients needing hormone replacement medications, help pediatric patients, and those with severe nausea and 

vomiting where commercially available medications are unresponsive or unavailable to give just a few examples. 

NCPA commends members of this committee for taking a closer 

look at what actions and inactions led to the tragic NECC event. 

We believe this committee has taken the proper steps by focusing 

on investigations into clarifying existing oversight to ensure that 

the appropriate regulatory bodies are exercising their full authority. 

NCPA is also grateful to Congressman Griffith for the tireless efforts to prevent a tragedy like NECC from occurring again. NCPA 

supports the approach of Representative Griffith’s discussion draft 

as it is not a broad expansion of FDA power over historically State 

regulated pharmaceutical compounding. To the contrary, the draft 

strikes the proper balance of making certain that future tragedies 

are avoided while also preserving patients’ access to vital compounds. 

In addition, NCPA fully supports the discussion draft to preserve 

State Board of Pharmacy oversight of pharmacy compounding. 

NCPA has historically, and continues to advocate that pharmacy 

compounding is best regulated by the State Boards of Pharmacy. 

Conversely, manufacturing is overseen by the FDA. If the FDA has 

a concern about an appropriately licensed pharmacy, then the FDA 

currently has the authority to ask the State Board of Pharmacy to 

work with them to address the issue. NCPA also strongly supports 

58 

efforts by Representative Griffith’s discussion draft to preserve office use and anticipatory compounding where State laws allow such 

practices. 

In order to preserve access to compounds, the discussion draft acknowledges that pharmacies should not be hindered in their ability 

to engage in anticipatory compounding as long as it is reasonable 

and based on a historical pattern of prescriptions, or for specific patients served by that pharmacy. 

Furthermore, NCPA strongly supports the efforts of the discussion draft in recognizing that strengthening communication between FDA and State Boards of Pharmacy is essential. 

NCPA believes one of the leading contributors to the NECC tragedy was the failure of the FDA to exert its existing authority to 

oversee entities going beyond pharmacy compounding. Communication and coordination between State Boards of Pharmacy and the 

FDA is imperative. 

While NCPA appreciates all efforts on this very important issue, 

we do have strong concerns with other legislative proposals, including granting FDA additional authority to create ‘‘do not compound’’ 

lists. 

Contrary to the discussion draft, other legislative proposals grant 

the FDA unrestricted authority to designate drugs or specific categories of drugs to a ‘‘do not compound’’ list. This would be an unnecessary expansion of FDA authority over the practice of pharmaceutical compounding while doing nothing to prevent another tragedy like NECC. 

A second concern is requiring community pharmacies to notify 

FDA when compounding short supply medications. While the discussion draft adequately addresses the concern that shortages of 

prescription drugs have tripled during the last 5 years, other legislative proposals place burdensome FDA notification requirements 

on compounding pharmacies. 

Mandating all compounding pharmacies to bypass their State 

Board of Pharmacy does nothing to prevent another NECC. 

And, third, exempting pharmacies within health systems from 

compounding standards, while the discussion draft holds all 

compounding pharmacies to the same compounding standards, 

other legislative proposals exempt all pharmacies within health 

systems from the proposed compounding requirements. 

A recent OIG report found that almost half of hospitals stated 

that cost and space limitations would be major challenges to 

achieve USP 797 compliance. Thus, as Congress addresses this 

very important issue, the intent should be to ensure all patients receive safe and quality compounded medications. 

In conclusion, NCPA is committed to working with Members of 

Congress in order to make certain that a tragedy such as the New 

England Compounding Center does not occur in the future, while 

also preserving patients’ access to customized and safe compounded 

medications. 

Thank you for inviting NCPA to testify and to share the view 

points of independent community pharmacy owners and operators 

across the country on compounding. I look forward to answering 

any questions you may have. Thank you. 

Mr. PITTS. Thank you, Dr. Hoey. 

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[The prepared statement of Mr. Hoey follows:] 

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Mr. PITTS. Dr. Thompson, you are recognized for 5 minutes for 

an opening statement. 

STATEMENT OF KASEY THOMPSON 

Mr. THOMPSON. Good afternoon, and thank you, Chairman Pitts 

and distinguished members of the committee for holding this hearing. I am here today to provide ASHP’s perspective as a professional society that represents over 42,000 pharmacists who practice 

in hospitals, health systems and ambulatory clinics, and has been 

a recognized leader for over 20 years in the development of guidelines on sterile compounding, nonsterile compounding and guidelines on working with outsourcers. The event caused by the New 

England Compounding Center resulted in 61 unnecessary deaths 

and more than 700 meningitis cases. 

ASHP strongly believes that the authority and accountability between the FDA and State Boards of Pharmacy needs to be clarified. 

We believe that compounding outsourcers that prepare customized 

sterile preparations that are not commercially available should be 

held to the highest standards for quality, including relevant current good manufacturing practices and should be required to be 

registered with and routinely inspected by the FDA. 

Further, we believe that these entities should not copy commercially available products except in the cases of drug shortages or 

to make a medically necessary variation that meets patient specific 

needs. The drug approval process in the United States is the gold 

standard and should be maintained as such. However, it is important to recognize that there are many legitimate and medically necessary compounded sterile preparations that simply are not available from a brand or generic manufacturer in the strength or dosage forms that patients need. 

U.S. hospitals prepare a vast array of compounded sterile preparations from FDA-approved products every day in order to meet 

patient-specific needs. The compounded medications that hospitalized patients need range from simple intravenous admixtures to 

complex customized medications that are not available off the shelf, 

such as multi-ingredient cardioplegia solutions for heart surgery, 

epidural pain medications for women in labor and delivery, concentrated pain medications for cancer patients, and adult medications prepared in concentrations that can be safely administered to 

babies and children. 

Where necessary, hospitals enlist the services of qualified 

compounding outsourcers for some preparations for several reasons. For example, some hospitals may not have the necessary 

equipment or facilities to prepare some high risk sterile preparations, which is sometimes the case in small and rural hospitals. Or 

they may face medication shortages for commercial products that 

can only be replicated by outside suppliers that provide customized 

compounded sterile preparations. They may also enlist the help of 

outsourcers to prepare FDA-approved sterile products in ready-toadminister packages in the strength and dosage forms they need. 

The evolution of the compounding outsourcing industry over the 

past decade has outpaced the ability of State and Federal laws to 

68 

keep up, creating legal and regulatory gray areas between State 

and Federal Government. 

Unfortunately, it just isn’t as simple as calling these large scale 

anticipatory compounding entities a pharmacy, a repackager or a 

pharmaceutical manufacturer. They are something in between each 

of these but no one category fits them perfectly. 

Recent bipartisan Senate legislation addresses the need for clarity and distinguishing between compounding by a pharmacy and 

the activities of a compounding outsourcer. It assigns responsibility 

and accountability to the FDA for regulating compounding manufacturers while preserving the accountability for pharmacy 

compounding to State Boards of Pharmacy. It also establishes a 

user fee program to help ensure that the FDA has the resources 

it needs to effectively regulate compounding manufacturers. 

Because of the potential nationwide scale of these operations, we 

are concerned that State Boards of Pharmacy may not be able to 

provide adequate oversight of these facilities. Many State boards 

may not have the resources or expertise to evaluate whether a 

pharmacy has crossed the line and become a manufacturer. 

With respect to the regulatory framework proposed in the draft 

legislation by Representative Griffith, ASHP is concerned that the 

regulatory environment that allowed the New England 

Compounding Center to operate as a pharmacy would remain intact. In other words, if authority between State Boards of Pharmacy and FDA is unclear due to lack of accountability, we would 

be concerned that neither FDA nor State boards could be held accountable if an entity were licensed as a pharmacy, but was also 

preparing sterile compounded preparations without a prescription 

and selling across State lines. 

In addition, our understanding of the draft legislation is that 

FDA would only be permitted to inspect a pharmacy that may be 

operating as a large scale compounding entity if FDA has received 

a submission from the State Board of Pharmacy. 

This ability for FDA to have the necessary access to records and 

inspect a compounding entity would be contingent upon State 

boards being properly equipped with trained personnel to determine if an activity appears to approach manufacturing. We are concerned that FDA may not be fully accountable if the State board 

does not notify the agency. 

Further, this approach would imply that State boards would inspect all prescription records and sales transactions of each licensed pharmacy in their State to identify those entities that may 

be acting outside the scope of traditional pharmacy compounding. 

Therefore, it would be referred to the FDA. We do not see that as 

realistic for many State boards, and therefore believe that these 

types of compounding outsourcers would be more appropriately regulated by FDA. 

In conclusion, ASHP remains completely committed to working 

with Congress, the FDA and other stakeholders in developing a reformed regulatory framework for pharmacy compounding. Thank 

you, Chairman Pitts, for holding this hearing on this very important public health topic. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Thompson follows:] 

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Mr. PITTS. Mr. Francer, you are recognized 5 minutes for an 

opening statement. 

STATEMENT OF JEFFREY FRANCER 

Mr. FRANCER. Thank you, Mr. Chairman and members of the 

subcommittee. I am Jeff Francer, I serve as assistant general counsel of the Pharmaceutical Research and Manufacturers of America. 

Thank you for the opportunity to present our views this afternoon. 

PhRMA is a voluntary, nonprofit association that represents the 

country’s leading pharmaceutical research and biotechnology companies. In 2012, PhRMA’s members alone invested nearly $50 billion in discovering and developing new medicines. PhRMA shares 

the committee’s goal of advancing public health and protecting patient safety by ensuring that FDA’s statutory authority and safety 

standards for pharmacy compounding are strong enough to protect 

patients against the risks demonstrated over the past year. 

There is no higher priority for biopharmaceutical companies than 

patient safety. We commend the committee’s diligence in investigating the causes of the recent tragedies and examining potential 

solutions. 

PhRMA believes that medicines manufactured by our member 

companies as well as those manufactured by nontraditional pharmacies and manufacturers should be regulated by FDA using a 

consistent, risk-based approach. This approach best serves public 

health because products that present similar risks should be regulated in a similar manner. 

In light of the incidents surrounding the New England 

Compounding Center, it is clearly appropriate for Congress to revisit the FDA’s authority to regulate compounding of prescription 

drugs. And consistent with the goals of clarifying FDA’s authority 

and protecting patient safety, PhRMA would support legislation 

that would include the following seven attributes: 

First, clarify that FDA retains its strong existing authority to 

regulate as a new drug any medicine that is compounded outside 

of traditional compounding. Large-scale, commercial manufacturing 

of prescription medicine should be governed by the same high 

standards, whether the commercial producer is designated as a 

pharmacy or as a manufacturer. 

Second, the legislation would provide express inspection and registration authority for nontraditional compounders as manufacturers, including to the extent that such authority is not clear the 

ability to inspect records to determine whether pharmacies are actually engaging in nontraditional compounding. 

Third, provide user fee authority which we believe already exists, 

to ensure that FDA has adequate resources to regulate nontraditional compounders as manufacturers. 

Fourth, ensure that nontraditional compounders may not compound copies of marketed drugs and thus subvert FDA’s generic 

and bio similar approval processes. 

Fifth, prohibit the compounding of specific drugs or drug categories for safety reasons. 

75 

Sixth, appropriately limit the channels of distribution of compounded drugs, including through a prohibition on wholesale distribution. 

And finally, any new legislation should resolve any ambiguity in 

FDA’s current authority by deleting the section of the Federal 

Food, Drug, and Cosmetic Act at issue in the Western States case. 

Within this framework, FDA could and should take a risk-based 

approach to the regulation of nontraditional compounding using the 

same approach that FDA now takes to pharmaceutical manufacturing. However, complex legislation that creates a whole new classification of compounder, so-called compounding manufacturers, is 

unnecessary. Such an approach could result in regulatory confusion 

and the application of different regulatory standards for similar 

types of manufacturing. In fact, such a third class would actually 

decrease FDA’s current statutory standards for regulating nontraditional compounders. 

Finally, PhRMA is concerned about risks to patient safety that 

could result from proposals to allow compounding of copies of marketed pharmaceuticals in the event of a drug shortage. This potential exception could expose patients to unsafe drugs because the 

compounder need not establish that the compounded version has a 

safety and efficacy profile equivalent to the FDA-approved product. 

In conclusion, Mr. Chairman, PhRMA thanks the subcommittee 

for the opportunity to provide testimony this afternoon regarding 

how to clarify FDA’s existing authority to regulate nontraditional 

compounding. Biopharmaceutical companies are committed to patient safety. The same safety standards that govern pharmaceutical 

manufacturing should also protect patients who are treated with 

medicines manufactured by large-scale compounders. And we look 

forward to continuing the work with the subcommittee as it continues this important task. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Francer follows:] 

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Mr. PITTS. Dr. Gaugh, you are recognized for 5 minutes for opening statement. 

STATEMENT OF DAVID GAUGH 

Mr. GAUGH. Thank you, Chairman Pitts and members of the 

House Energy Subcommittee on Health, and thank you for inviting 

me to testify before the subcommittee on this very important topic 

of drug compounding. 

My name is David Gaugh. I am senior vice president for Sciences 

and Regulatory Affairs at the Generic Pharmaceutical Association 

and a licensed pharmacist. 

GPhA represents the manufacturers and distributors of finished 

dose generic pharmaceuticals, bulk pharmaceuticals and suppliers 

of other goods and services to the generic industry. 

The quality and affordability of generic medicines is vital to the 

public health and sustainability to the health care system. Prior to 

joining GPhA, I was general manager of a generic injectable manufacturing company. I also served a leadership role in a major group 

purchasing organization and was assistant director of pharmacy in 

a hospital system in the Midwest where one of my responsibilities 

was oversight of traditional compounding performed by my staff. 

GPhA supports the goal of clarifying the FDA’s authority over 

compounding in order to protect patient safety and prevent another 

health care crisis like the fungal meningitis outbreak that was 

caused by the substandard compounded drugs. 

Traditional compounding plays a vital role for patients and any 

new regulation should maintain that role. GPhA firmly believes 

that pharmacy compounding should adhere to the standard of one 

patient, one prescription, one drug. Patient safety is the highest 

priority for approved pharmaceutical manufacturers who comply 

with quality and sterile manufacturing processes and procedures as 

defined by the current good manufacturing practices, or cGMP. 

These regulations and associated guidances apply to all prescription drugs approved by the FDA for sale in the U.S. 

The FDA’s regulations and guidance are based on the fundamental principles that quality cannot be inspected or tested into a 

finished product, but quality must be designed into the product and 

the manufacturing process. 

The large-scale manufacturing of sterile medicines, no matter 

who performs the functions, must involve similar activities as they 

have similar potential risks. In order to ensure the safety of the 

American public, the large-scale manufacturer of these sterile 

medicines should be regulated by the FDA in a consistent riskbased manner at the same high standards, including submitting 

documentation to the FDA and submitting to both preapproval and 

routine risk-based cGMP inspections. 

A sterile injectable drug should not be the object of compounding 

unless these aforementioned regulations and guidances are enforced by the FDA or if the product is compounded for an individual patient by an individual prescriber. 

GPhA strongly supports established standards for the quality of 

bulk substances used in compounding. We believe it is critical that 

these standards should include a requirement to the bulk substance used in compounding be from FDA inspected cGMP-compliVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00094 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
89 

ant facilities, and that should be done prior to the compounding. 

GPhA recognizes that many in Congress believe that there should 

be an exemption to these requirements for certain medically necessary sterile products and shortage. We believe that the requirements for any category of large-scale compounding of sterile products should be the same FDA standards that apply to pharmaceutical manufacturers. 

To solve a drug shortage of sterile injectable marketed drugs by 

lowering oversight, safety and quality standards is not in the best 

interests of the American public. 

GPhA believes any drug substance exemption should include explicit language clarifying that the large scale compounder that is 

compounding marketable products on the FDA drug shortage list 

must immediately stop both the compounding and the distribution 

once notified by the FDA through established processes that the 

shortage has ended. 

GPhA strongly supports the requirement for large scale 

compounding pharmacies or compounding manufacturers that plan 

to compound a marketed drug on the official FDA drug shortage 

list notify the FDA prior to starting that compounding. 

We do not believe it is appropriate for notification only after initial large scale compounding has started. Additionally, the FDA 

should be given the authority to deny the request for compounding 

of a drug on the drug shortage list. 

GPhA strongly supports providing the FDA with the additional 

resources needed to conduct inspections and do effective oversight 

through the fees on large-scale compounders. These fees should be 

sufficient to ensure that resources are not diverted from other 

areas within the agency. 

In the interest of providing health care professionals and patients with complete information, any product compounded outside 

of the institution in which it is administered should be appropriately labeled as determined by the FDA and identified as a compounded product. 

GPhA believes large-scale compounding pharmacies should be 

held to same adverse events reporting requirements as pharmaceutical manufacturers to allow the FDA ability to earlier identify 

and prevent any future health crisis. 

In conclusion, Mr. Chairman, GPhA and our member companies 

are committed to ensuring both the role of the traditional 

compounders for patients, that need these patients are used and 

are safe for the patients and we look forward to working with the 

committee on this very important factor. Thank you. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Gaugh follows:] 

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Mr. PITTS. Mr. Coukell, you are recognized for 5 minutes for an 

opening statement. 

STATEMENT OF ALLAN COUKELL 

Mr. COUKELL. Chairman Pitts and members of the subcommittee, thank you for the opportunity to testify on pharmacy 

compounding and the need for legislation to protect patients. 

My name is Allan Coukell. I am a pharmacist and director of 

drug and medical device work at the Pew Charitable Trust, independent research and policy organization with a longstanding focus 

on drug quality issues. 

This subcommittee has heard previously about the risks of substandard compounded medicines and I won’t reiterate those today, 

except to say that the recent fungal meningitis outbreak was far 

from an isolated incident, and even now, FDA inspections reveal 

alarming ongoing quality problems. 

Today, I would like to propose ways for Congress to reduce these 

risks, and at the same time, ensure that patients have access to 

the medicines they need. Current law is inadequate for this purpose both because the courts have created uncertainty about the 

status of section 503A of the FDCA and because 503A does not recognize the emergence ofa large scale compounding industry that is 

far removed from traditional pharmacy practice. 

So let me begin with two points that I think all stakeholders 

should endorse. First, patients, doctors and pharmacists should 

prefer FDA-approved drugs over compounded medicines whenever 

possible. Only FDA-approved drugs have demonstrated their safety, efficacy and bioequivalence and have preapproved manufacturing facilities and methods. New legislation must not encourage 

compounding at the expense of traditional manufacturing. 

Second, the preparation of customized medicines in response to 

a prescription for an individual patient is an established part of 

State-regulated pharmacy practice. But now let me make a third 

point, which is that there is a large-scale compounding sector that 

fits neither of the above categories. Instead, it does batch production of products, often high risk sterile products and admixtures of 

FDA-approved drugs for use in hospitals and clinics. 

And the Inspector General recently reported that 85 percent of 

hospitals, hospitals of all sizes, large and small, purchased some intravenous drugs from outside pharmacies, sometimes thousands of 

doses a day. Together with the American Hospital Association and 

ASHP, Pew recently convened a pharmacy sterile compounding 

summit that brought together hospitals, purchasing organizations, 

compounders, regulators and pharmacy associations. 

It also included experts on pharmacy and manufacturing who 

emphasized the enormous differences between the standards developed for pharmacy practice and the good manufacturing practices 

that apply to manufacturing. These experts stressed that only 

GMPs are adequate to ensure the safety of large scale, standardized production. 

Oversight of such standards is a role for the FDA and not for 

State boards of pharmacy. Section 503A already recognizes FDA’s 

responsibility to oversee some compounding, but merely reinstating 

the section would leave a lack of clarity about which facilities were 

103 

subject to FDA oversight, and it would not clearly give FDA the 

ability to ensure that large-scale compounders comply with applicable GMPs. And shutting down a facility or requiring the filing of 

an NDA may not always be in the public interest. 

So which facilities should be subject to FDA oversight? There is 

no single ideal solution, but a potential framework could include 

some of the following: Volume of production. Clearly larger scale 

operations expose more patients to risks. Those risks are not mitigated by an after the fact prescription. Large-scale operations 

should be subject to GMP. The nature of the products, manipulating a sterile product is a high-risk activity. Sterile drugs made 

from nonsterile raw ingredients are especially high risk. 

Expiration dates. The longer a product sits before use, the more 

likely it is to degrade or sustain bacterial or fungal growth. Longer 

beyond use dating calls for higher quality standards and may also 

serve as a mechanism to distinguish between traditional pharmacy 

and this new compounding sector. 

My written testimony contains additional recommendations for a 

practical and enforceable framework. In particular, facilities under 

FDA oversight must be required to register and to avoid an unfunded mandate to pay a fee. Compounded drugs should be clearly 

labeled as such and wholesale distribution prohibited. Current law 

gives FDA the authority to create a list of drugs that may not be 

compounded and to inspect pharmacies as necessary, and these authorities must be maintained. 

I thank you for your leadership on this important issue. It is 

time to update the FDCA to remove ambiguities and create a clear, 

workable framework for patient safety. And I welcome your questions. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Coukell follows:] 

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Mr. PITTS. Dr. Miller, you are recognized for 5 minutes for your 

opening statement. 

STATEMENT OF DAVID G. MILLER 

Mr. MILLER. Good afternoon, Chairman Pitts, ladies and gentlemen of the committee, it is a pleasure on behalf of the International Academy of Compounding Pharmacists to appear before 

you today to talk about a situation that started with one pharmacy 

in Framingham, Massachusetts, but fundamentally has uncovered 

a real gap in our laws. 

Now, I have been listening this afternoon to testimony, and you 

have the written testimony of my colleagues and myself, but I have 

heard six different terms used to define this thing that we are attempting to address and regulate. 

Members of the International Academy of Compounding Pharmacists are pharmacists. We work in small drug stores, we work 

in large chain drug stores, at CVS, at a Publix grocery store in 

Florida, in hospitals. 

Compounding is an essential core component of the filling and 

care of prescription medications for patients throughout this country. One of the challenges that we have found ourselves in is that 

the core concept of filling a prescription ordered by a physician either for the treatment of that patient in his or her home, or the 

use of that medication in the doctor’s office for administration and 

treatment of a patient on site has somehow been clouded by the 

evolution of this other thing. 

Tonight, this afternoon, we have heard that thing referred to as 

repackagers, traditional compounders, nontraditional compounders, 

outsourcing pharmacies, outsourcing admixture pharmacies, manufacturers, compounding manufacturers, batch production. 

Now, again, I am a pharmacist. I look at this relatively simple. 

I get a prescription from a physician to take care of an individual 

patient, or I get a prescription to send a medication to a doctor’s 

office so he or she can take care of that patient. IACP believes that 

currently section 503A is very clear that the Food and Drug Administration does have authority over the distribution of drugs in 

the United States, either through manufacturing or wholesaler distribution, and that our States have authority over the practice of 

pharmacy. 

We believe at IACP that a great deal of confusion over this other 

entity that appears to not want to be regulated either by the FDA 

or falls within the gap of the regulation of the States, that is a separate group from pharmacy. And one of the things that we have 

seen as we have looked and worked with the Senate HELP committee on S. 959 is the core concept of preserving the integrity of 

the drug distribution system under FDA oversight, and on that 

side of the body it has been deemed a compounding manufacturer, 

unfortunately has gotten into the day-to-day practice of pharmacy 

and practice of medicine. 

For example, on the Senate side, we now know that one of the 

things that we must have to ensure the protection, the safety and 

access of medications for patients is quality assurance. There is no 

language in S. 959 requiring all pharmacies or these other things 

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to adhere by the nationally published standards of the United 

States pharmacopeia. There is no quality assurance. 

There are specific language that intrudes on the practice of medicine and the practice of pharmacy. Most recently, the version of S. 

959 that was distributed now includes a requirement that a pharmacist who fills a medication that may be a medication that is in 

drug shortage must inform the Food and Drug Administration 

within 3 days of filling that prescription. And we believe that is a 

significantly troublesome precedent. 

There are also questions about whether or not all pharmacies 

would be actually required to participate and be overseen under 

this process and indeed within Senate 959 as my colleague from 

NCPA said previously, all hospitals and health system pharmacists 

are actually exempted from the Senate’s new approach to regulating this issue. 

Fortunately, Congressman Griffith has introduced a draft piece 

of legislation that we believe is really the closest solution to solving 

the questions that arose because of NECC’s activities. We look forward to continuing to work with him and with this body on helping 

craft legislation that does a few most critical things: One, preserve 

patient access to medication; two, assure the American public of 

the safety of the medicines that they receive, that there are swift 

and accountable actions by our regulators at both the State and the 

Federal level to carry those laws out. 

Thank you very much. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Miller follows:] 

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Mr. PITTS. Dr. Catizone, you are recognized for 5 minutes for 

your opening statement. 

STATEMENT OF CARMEN CATIZONE 

Mr. CATIZONE. Good afternoon, Chairman Pitts and members of 

the subcommittee. On behalf of the National Association of Boards 

of Pharmacy and the State boards across the country, thank you 

for the opportunity to be here today. 

NABP believes that the three legislative proposals provide the 

regulatory framework for us to address the issue of compounding 

manufacturing and to protect the public health. We support the 

Senate HELP bill and support the provisions that clearly distinguish traditional compounding, which should be regulated by the 

States and remain the purview of the States, and manufacturing, 

which should be the purview and remain the purview of the FDA. 

And we support the new category of compounding manufacturer 

that should fall within the purview and under the regulation of the 

FDA. 

We commend Mr. Griffith and the other authors of the House 

bills for their diligence and concern for patient safety. However, we 

must also caution that there are provisions in the House bills that 

may not be intended to but could take us in the wrong direction, 

in a direction different from the legislative intent and a direction 

that could lead us to another NECC tragedy. 

In regard to a primary issue identified by the House bill, NABP 

agrees that there is a bona fide but narrow need for pharmacists 

to compound a limited amount of products for administration to patients. The creation of the previously referenced third category, 

compounding manufacturer, seems to address the needs of the majority of patients. However, we are also sensitive to the fact that 

some stakeholders do not believe this is an appropriate category for 

this activity and would like to place this activity under the domain 

of traditional compounding and the purview of the State boards of 

pharmacy. 

To respond to these concerns, specifically those of patient need, 

limiting the amounts of compounded products for direct administration in order to avoid any masking of manufacturing for 

compounding, we would support such an allowance provided there 

are limitations and qualifiers to those activities. 

Those qualifiers include: First, the State has to allow such activity. Once that is allowed, the other limitations follow. There must 

be a demonstrated medical need for the compounded product. A 

non-patient-specific order must be written by the practitioner who 

will be administering or is directly responsible for administering 

the compounded product. 

The total quantity provided at the clinic office or healthcare setting per patient cannot exceed a 10-day supply. The compounded 

medication cannot be resold. The compounded medication must be 

prepared in accordance with applicable USP standards or GMPs, 

depending upon the product, as determined by the FDA. 

There must be a limitation on the total quantity of compounded 

products that the pharmacy can prepare. Such quantity cannot exceed a certain percentage of or some other measure of the pharVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00129 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
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macy’s total number of prescriptions dispensed, dosage units, patient supply, or some other measurable and comparable factor. 

The pharmacy must notify the applicable State board or boards 

of pharmacy and FDA of their involvement in this area in accordance with an appropriate process and frame times to be determined. And the FDA must have full legal access to all records of 

the pharmacy engaged in this activity. And equally as important, 

there can be no prohibitions on the sharing of information between 

the States and the FDA on these activities, as presently exists. 

We want to note that these limitations and qualifiers for this activity does not erode the distinction between compounding manufacturing and compounding manufacturers created by the Senate 

HELP bill. They simply allow for an exemption with additional 

oversight under the category of traditional compounder. 

Generalizing to a large extent, if the Senate HELP bill is used 

as a framework and modification from the House bills are employed, we would have three broad categories for compounding and 

manufacturing. 

Traditional compounding: Per patient, patient-specific, regulated 

by the States, and all requirements of the States and USP standards in place. The FDA’s current enforcement authority and responsibilities would remain. And the FDA could act, as they have 

been able to act, in the recent past. 

Manufacturing and compound manufacturing: regulated by the 

FDA, complete access to all of those records, all of the requirements of the FDA, including GMPs. 

And then this exemption, under traditional compounding: for 

those activities for administration within a clinic, healthcare setting, or hospital, shared authority between the FDA and the 

States, access to those records, and communication between the 

FDA and the States. 

In closing, we appreciate the opportunity to be here today. We 

respectfully request that action be taken to develop and pass Federal legislation. We think it is important. We don’t want to lose the 

opportunity. 

Thank you. 

Mr. PITTS. The chair thanks the gentleman. 

[The prepared statement of Mr. Catizone follows:] 

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Mr. PITTS. Thanks to all the witnesses for your opening statements. 

We will now begin questioning. I will recognize myself for 5 minutes for that purpose. 

Mr. Hoey, the meningitis outbreak was a clear example of a communication breakdown between the FDA and the boards of pharmacy. How does Mr. Griffith’s draft address strong lines of communication between boards of pharmacy and the FDA? 

Mr. HOEY. Thank you, Chairman Pitts. 

I think one of the key things that it does is that it requires the 

FDA to respond within 60 days when the board of pharmacy has 

sent a complaint or sent some kind of a warning to the FDA. 

Clearly, that did not happen in the NECC tragedy. Despite numerous heads-up, numerous warning signs sent to the FDA, there 

was not appropriate action taken. Representative Griffith’s bill 

would require that action be taken within that 60-day period. 

Mr. PITTS. Mr. Francer, the Senate bill establishes a third category: compounding manufacturers. Do you think establishing a 

new category would provide clarity or confusion? 

Mr. FRANCER. Chairman Pitts, we believe that a new provision 

like that would provide confusion and that it is not necessary. We 

believe that traditional compounding as it is now should be regulated by the States. And when there is not a prescription and we 

have a large-scale-type facility, it is manufacturing. And the FDA 

is quite good at regulating manufacturers. 

Mr. PITTS. Mr. Gaugh, supporters of creating a compounding 

manufacturing category argue that the growing market from hospitals for outsourcers necessitates a need to exempt them from the 

new drug requirements of the FDCA. 

Wouldn’t this change permanently preclude the FDA from requiring pre-inspection of some facilities engaged in large-scale manufacturing from bulk API? 

Mr. GAUGH. It very well could. So it is not totally clear, but, to 

your point, yes, it could blur those lines. 

And even if you do outsource the product from a hospital to another provider, you still have that capability in 21st-century electronics to provide that prescription for the patient to the 

compounding pharmacy to compound that product one by one, patient to prescription. 

Mr. PITTS. Now, in your testimony, you write about the importance of the drug manufacturing control processes written into the 

ANDA applications. Can you outline why this process between FDA 

and an applicant is critical to ensure the safety and efficacy of the 

product that will be ultimately marketed to the public? 

Mr. GAUGH. Yes. As I said earlier in my statement, the fundamental principles of quality can’t be inspected and tested with the 

finished product. They need to be designed into that product and 

into the manufacturing process. And so the NDA and ANDA holders, as they develop these products, are designing that in for both 

the product and for the manufacturing process. That is not being 

done in compounding. 

Additionally, the ANDAs and NDAs that are filed contain specific 

specifications around stability, around impurities, around container 

131 

closure, other manufacturing processes that, again, are not addressed by the compounding pharmacies. 

Mr. PITTS. Dr. Miller, a couple of questions for you. Can you explain the importance of traditional compounding in our Nation’s 

healthcare system? And then would you explain your thoughts on 

the creation of an expanded do-not-compound authority list for the 

FDA? 

Mr. MILLER. Yes. Thank you, Mr. Chairman. 

I think the easiest way to understand why we need compounded 

medications is just to look at all of us in the room. We are all different sizes, we are all different ages, we are all different sexes, 

and each one of us metabolizes and uses drugs in different ways. 

One of the advantages of having trained pharmacists and physicians who understand the use of having medications customized to 

each one of us, it helps us get the therapy that we need. 

The U.S. drug system is phenomenal. The vast majority of the 

products manufactured by my colleagues at PhRMA and the Generic Pharmaceutical Association meet most of our needs. But some 

of us require tweaks. So compounding pharmacists use techniques, 

tools, skills, and training to prepare medicines that are unique to 

a particular individual. Or, in some instances, as we have heard repeatedly this afternoon and I know that you will hear over and 

over again, compounding pharmacists in the short term can step in 

to fulfill drug-shortage or backorder situations. That is first and 

foremost why we need compounds. 

Your question was, the second one? 

Mr. PITTS. Your thoughts on the creation of an expanded do-notcompound authority list for the FDA. 

Mr. MILLER. IACP’s position on this has been fairly consistent, 

sir. The FDA has had the authority to create a do-not-compound 

list based on a concern of safety or efficacy, and that we would 

leave in and strongly support. 

Unfortunately, the agency has not updated that list in more than 

10 years, and the provision of expanded authority to say, well, we 

can add a drug based on that it is hard to compound, or, you know, 

we think that you shouldn’t use this particular active pharmaceutical ingredient—there are some other clauses on the Senate 

side—IACP strongly disagrees with that. 

Because the fundamental reason for having a do-not-compound 

list is the agency should simply say, this medication is not safe, 

should not be used, is ineffective, it goes on the list. 

Mr. PITTS. My time has expired. 

The chair recognizes Mr. Green for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

Dr. Thompson, in your testimony, you note that none of the classifications of ‘‘repackage’’ or ‘‘pharmacy’’ or ‘‘manufacturer’’ fits 

neatly with the regulatory needs of the large-scale compound or 

outsourcer. 

Do you believe that asking the FDA to regulate these operations 

as manufacturers but leaving these specifics on how they are regulated up to the enforcement discretion of the FDA is a good policy? 

Mr. THOMPSON. Sir, you know, reflecting on the Senate bill and 

how they have defined a compounding manufacturer, they defined 

132 

it as an entity that is not preparing product in response to a prescription, is engaged in interstate commerce, as a proxy for risk. 

We think as this industry has evolved over the last decade to 

provide necessary service to hospitals and clinics and others that 

it has really created this gray area that there isn’t Federal legislation or regulation for. So we do think it is necessary to help clarify 

what those entities do, which provide very helpful services to 

healthcare organizations and patients. 

Mr. GREEN. Have you looked at the enforcement discretion that 

is in Congressman Griffith’s bill? 

Mr. THOMPSON. Well, we don’t think enforcement discretion is a 

good policy. And that is the thing now, that there are these companies out there that are selling products for anticipatory use that, 

under the law, really isn’t allowed. But they do fill a need. They 

are doing it under, you know, under good standards in many cases, 

but those need to be clarified. 

What we think in the Griffith draft, that, you know, in some 

ways, it creates a third category without calling it that. It still allows entities to prepare large-scale products without Federal oversight. It leaves it to State boards of pharmacy—really, the same environment that exists now, that caused NECC—it leaves it to the 

State boards to call the FDA and identify something. The State 

boards are under-resourced, they don’t have the expertise, and they 

are not manufacturing-level inspectors. 

Mr. GREEN. And I agree, although I think the Griffith bill also 

has some enforcement at FDA to respond to those State boards 

when they just send a letter. Because we had a number of letters 

in this situation that was done. 

Mr. Miller, do you believe that using interstate commerce of sterile compounds in advance of a prescription is an adequate proxy to 

assess the highest-risk products? 

Mr. MILLER. We have to be very careful with that, because as 

Congressman Griffith has pointed out in his own State and even 

here within the Washington, D.C., metro area, where I grew up in 

northern Maryland, the concept of interstate commerce as the endall-be-all definition of when something goes over that line, we have 

to recognize that health care in the United States is not limited to 

within State borders. So I would challenge our thinking that just 

the movement of a medication across a State line should be the 

trigger for FDA oversight. 

Mr. GREEN. OK. 

Mr. MILLER. The other portion—— 

Mr. GREEN. I only have 2 minutes left. But I understand that, 

because, you know, people in Beaumont, Texas, people come from 

southeast Louisiana to buy from a pharmacy. But me, as an individual, I can do it. But if you are selling across, there may be an 

issue. 

But let me go on to another question. Of your members, how 

many are unquestionably small operations that would be caught up 

in a regulatory net created by establishing a proxy of interstate 

sterile and anticipatory compounding? 

Mr. MILLER. Quite honestly, sir, we don’t know. And we don’t 

know because there is very little data on the amount of prescription compounding that occurs not only in compounding specialty 

133 

pharmacies but hospitals, home infusion, long-term care, others. 

That data is unknown. This could have significant impact on practice. 

Mr. GREEN. The goal of this legislation would be primarily to 

protect the health and safety of our people and to also respect the 

various State laws in providing regulatory certainty to those who 

are regulated and to those who are purchasing regulated products. 

And I agree—some of us, I know the chairman has experience in 

State legislature. And we dealt with ours in Texas just like they 

dealt with in Pennsylvania. To me, our boards of pharmacy are certainly best equipped to regulate State agencies and the State-level 

activities. 

However, don’t you agree that engaging in interstate commerce 

creates a regulatory gray area that justifies a Federal response? 

Mr. MILLER. Well, you have to look at the model that has already 

been created by my colleague at the National Association of Boards 

of Pharmacy for the transfer of licenses between pharmacists 

across State lines. There is certainly a public-private partnership 

that can exist that currently shares information back and forth as 

pharmacies, say, in Texas wish to be licensed in the State of Louisiana. 

We don’t necessarily believe that a Federal response is the only 

workable solution. 

Mr. GREEN. Well, and I think you are right, that it has to be a 

combination of State and Federal. But, you know, the problem we 

had in Massachusetts wasn’t going across into Connecticut, necessarily. It was actually going across the country. And, again, traditional compounding is something we want to protect. 

I know I am out of time, Mr. Chairman. Thank you. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Virginia, Mr. Griffith, for 5 minutes for questions. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. 

I would say up front that I don’t believe that our bill would have 

allowed the NECC situation to have occurred. I think the increased 

communications and the aspects that this bill has in it would have 

prevented that. 

I do think that there are some things that we left holes in there 

and we are trying to sort out, and I think that is important. I also 

want to make it clear that if there is any indication, we can always 

tweak the language. That is why it is a draft bill. We are not trying 

to take anything away from the current FDA authority. If there is 

something that they currently have, we are not trying to take anything away. But we are trying to clarify, without going too far, 

what their authority is and try to sort these things out. 

Mr. Coukell, I think you have it; we just have to figure out the 

combination. You listed in your testimony drawing the line, and 

you said some of the things we could look at were volume of production, nature of the products, percentage of sales, expiration 

dates, and interstate commerce. 

As you heard previously when I testified, I don’t think that interstate commerce alone necessarily does it, because it creates problems in those border areas or where the States are very close toVerDate Nov 24 2008 15:01 Aug 01, 2014 Jkt 037690 PO 00000 Frm 00139 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-70 CHRIS
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gether or smaller. But some combination thereof is probably the 

answer. 

What I would ask each of you to think about—and you can always get back to me later—is, what combination or which number 

of those factors do you think might be most important in figuring 

out that trigger to make that distinction? Because I think we all 

recognize, that is one of the issues we are trying to resolve. 

And if we could start with you, Mr. Catizone, if you have 

thoughts now, or just say, I will send them to you later. 

Mr. CATIZONE. Sure. Distinctions we make are: patient-specific, 

whether it is interstate or intrastate, it is compounding. Non-patient-specific, inter- or intra-, quantity, volume doesn’t matter, it is 

manufacturing. 

Mr. GRIFFITH. Manufacturing. OK. 

Mr. MILLER. Congressman, our perspective is, you have to be so 

careful with the issue of volume. It is an easy checkbox, you know, 

very easy to define. But, unfortunately, in health care, you can’t 

usually rely upon easy—— 

Mr. GRIFFITH. Let me ask you this, though. If we had volume, 

plus maybe a percentage of the business crossing State lines, if you 

threw two or three of them together, do you think that gets us closer to where we need to be? 

Mr. MILLER. Yes. And I think you have some precedence already 

in the Prescription Drug Marketing Act of 1987. That actually sets 

limits on retail pharmacies of 5 percent of sales to physician offices, 

hospitals, and clinics before they must register as a wholesaler— 

precedent. 

Mr. GRIFFITH. All right. Let me keep moving down the line so 

that we don’t use up all the time. 

Yes, sir? 

Mr. COUKELL. Congressman, first, thank you for your leadership 

on that bill. We were heartened to see the placeholder language 

and would like to work with you on that. 

A couple of points just now. One is, you know, just to emphasize, 

I think everybody agrees that if somebody is filling a prescription 

for a patient, that is a traditional pharmacy practice, and nobody 

is talking about that. So the question is, how much product should 

people be able to make on spec ahead of time? 

And, you know, I mentioned the summit we held with ASHP and 

AHA. One of the quality experts there said, if somebody is starting 

with a non-sterile bulk ingredient, they are buying a bottle of 

methylprednisolone over the Internet and making a sterile product, 

that ought to be under GMP, no matter what. So his threshold 

there was zero for that particular type of product. For something 

that starts with a sterile precursor, you would set a higher threshold. 

So I think it would be—I will finish. 

Mr. GRIFFITH. Yes, I hate to—we are running out of time. 

Mr. COUKELL. I think it would be impossible to say, basically, 

from a public health point of view, what is the limit at which we 

would not want people putting product out there. 

Mr. GRIFFITH. OK. And if we could, I hate to limit the folks at 

the other end of the table, but we are running out of time. 

135 

Mr. GAUGH. We would leave it at two categories: traditional 

compounding and—— 

Mr. GRIFFITH. Manufacturing. 

Mr. GAUGH [continuing]. Pharmaceutical manufacturing, yes. 

Pharmacists are trained to compound. They are not trained to 

manufacture. It doesn’t mean they can’t learn, but they are not 

trained to do that. 

Mr. GRIFFITH. Right. 

Yes, sir? 

Mr. FRANCER. Yes, Congressman Griffith, the touchstone clearly 

is whether there is a prescription or not. However, the FDA’s current guidance in terms of its compliance lists a number of criteria, 

including compounding finished drugs from bulk active ingredients, 

using commercial-scale equipment. And the FDA actually has a 

multiple-factor test that they use. 

Mr. GRIFFITH. All right. 

Yes, sir? 

Mr. THOMPSON. Sir, we appreciate that the bill is a working 

draft, and we look forward to working with you to clarify key aspects. 

You know, the notion of percent of business might be a way to 

look at it. You know, volume, as mentioned by others, is a moving 

target. Risk level is a really key one, too. You know, high-risk-level 

compounding, compounding from API, nonsterile to sterile, is a 

very important area to focus on 

Mr. GRIFFITH. OK. 

Mr. THOMPSON. And I will leave it at that, and we will provide 

more—— 

Mr. GRIFFITH. I appreciate that. Thank you. 

Mr. HOEY. Thank you, Congressman. 

A valid prescription, individual valid prescription, is key. That is 

the starting point and possibly the ending point, as well. 

As far as interstate and percentage of prescriptions, percentage 

of volumes, those are possible, but they can be a slippery slope. 

And it is hard to have a one-size-fits-all in those categories. 

Mr. GRIFFITH. Right. 

Thank you all very much. And I look forward to working with all 

of you in trying to sort this out at some point. We are going to have 

to make the difficult decision and draw that line somewhere. And 

I do appreciate it. 

I yield back, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the ranking member emeritus, Mr. Dingell, for 5 minutes for questions. 

Mr. DINGELL. Mr. Chairman, thank you for your courtesy. 

One main reason for the NECC outbreak was much confusion regarding FDA’s authorities and the proper role of the States. This 

question is for all of the witnesses, ‘‘yes’’ or ‘‘no.’’ Do you believe 

that it is important to have clear lines of division between FDA 

and State boards of pharmacy when it comes to regulating 

compounding pharmacies, yes or no? 

Starting with you, Dr. Hoey. 

Mr. HOEY. Yes. 

Mr. DINGELL. Next witness? 

136 

Mr. THOMPSON. Yes, sir. 

Mr. FRANCER. Absolutely, yes. 

Mr. GAUGH. Yes. 

Mr. DINGELL. Next witness? 

Mr. COUKELL. Yes. 

Mr. MILLER. Yes. 

Mr. CATIZONE. Yes. 

Mr. DINGELL. Gentlemen, thank you. 

Would you each submit, if you please, to the record how that division of responsibility should be created in the legislation. 

Now, Section 503(a) of FDA Modernization Act of 1997 has been 

subject to court challenges which have limited its effectiveness. 

Since that time, our medical system has changed drastically. 

This question is for Kasey Thompson of the American Society of 

Health-System Pharmacists. 

Do you believe that our healthcare system has come to rely on 

what you call compounding outsourcers, yes or no? 

Mr. THOMPSON. To a greater extent, yes. 

Mr. DINGELL. Now, in your testimony, you mention that your 

members also use compounded sterile preparations which are not 

available in an appropriate form from a manufacturer. Is that correct, yes or no? 

Mr. THOMPSON. Yes. 

Mr. DINGELL. Now, can you please submit to the committee for 

the record a list of examples of these kinds of products? 

Mr. THOMPSON. Yes, sir. 

Mr. DINGELL. Now, do you believe that these compounding 

outsourcers should be subject to current good manufacturing practices and risk-based inspections by FDA, yes or no? 

Mr. THOMPSON. Yes. 

Mr. DINGELL. Do you believe that State boards of pharmacy 

could adequately regulate these compounding outsourcers, yes or 

no? 

Mr. THOMPSON. No. 

Mr. DINGELL. Now, these new compounding outsourcers are now 

routinely used by hospitals across the country. Any legislation 

must ensure that there are no unintended consequences which 

could have a negative impact on patient care. 

Now, these questions are for you, Mr. Coukell of Pew. How is it 

correct that a recent study by the Inspector General at HHS found 

that 85 percent of hospitals which administer IV drugs purchased 

some of the products from outside the pharmacies? Is that so, yes 

or no? 

Mr. COUKELL. Yes. 

Mr. DINGELL. Now, Mr. Coukell, does Section 503(a), as currently 

drafted and interpreted, recognize the existence of these 

compounding outsourcers and our reliance on them, yes or no? 

Mr. COUKELL. It does not, not as such. 

Mr. DINGELL. Would you submit to us your thoughts on how that 

matter should be addressed? 

And if the other members of the panel would do the same thing, 

it would be appreciated. 

137 

Now, do you believe that simply reinstating Section 503(a) would 

result in sufficient clarity regarding FDA’s authority over 

compounding pharmacies, yes or no? 

Mr. COUKELL. No. 

Mr. DINGELL. Would you give us some comments for the purpose 

of the record on that particular point, if you please? 

Now, I want to thank you all. 

It is clear that we need to update and to significantly enhance 

FDA’s authority in this area. I know there is bipartisan support for 

this issue. And we need, I know, to clearly define roles for the 

States and FDA concerning compounding pharmacies. 

This committee has done good bipartisan work on public health 

in the past, and I believe that we can do it again. And I am looking 

forward to continue working on this issue with my colleagues on 

both sides of the aisle. 

I want to commend each member of the panel for your excellent 

testimony. Gentlemen, you have done a superb job, and I want you 

to know how much I appreciate it. 

And to you, Mr. Chairman, I thank you and yield back the balance of my time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentlelady from North Carolina, Mrs. Ellmers, for 5 minutes for 

questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

Dr. Thompson, a moment ago, one of my colleagues had asked 

you about whether or not you felt that State boards could actually 

continue to regulate any of the basically nontraditional 

compounders. What is your reason? I mean, keeping in mind, of 

course, safety and sterility and best practices. Do you not feel that 

they have the capacity to do so? 

Mr. THOMPSON. I think it really comes down, ma’am, to resources 

and expertise. You know, just like pharmacists, we are not inspectors of pharmaceutical manufacturers, and—— 

Mrs. ELLMERS. Right. 

Mr. THOMPSON [continuing]. I don’t think State boards tend to 

have that capacity either. 

Mrs. ELLMERS. Right. I guess this gets to the—there again, we 

seem to get hung up on volume, and, you know, it seems to get 

back to the same things. 

And, you know, to Dr. Woodcock I had posed a question of, if the 

nontraditional compounder were to be providing to a hospital or an 

outpatient surgery clinic, where the drugs would be administered 

under the supervision, obviously, of a physician to a patient within 

a reasonable timeframe and even possibly with, you know, some 

certain guidelines, like on a monthly basis, is it that they would 

be providing that to multiple entities and the volume there would 

be too much to be enforced? 

Mr. THOMPSON. Well, I think the reason we think that some 

version of CGMPs is important is because it would really get into 

the specifics of sterility and stability tests in this per FDA and 

compendial standards. And that would really determine whether it 

had a 30-, 60-, 90-day, or 12-month beyond-use date associated 

with it. And that would really determine the storage conditions and 

when it needs to be administered. 

138 

But I think without, you know, a clearer process, whether it is 

CGMPs or some other process, that you just don’t have that assurance in the current environment. 

Mrs. ELLMERS. Dr. Gaugh, shouldn’t large-scale compounders be 

required to prove that they can manufacture under GMP conditions 

before patients are put at risk? 

Mr. GAUGH. Yes, they should be. 

Mrs. ELLMERS. OK. In your testimony, you write about the importance of the drug manufacturing control process. Can you outline why this process between the FDA and applicant is critical to 

ensure the safety and efficacy of the product that will be ultimately 

marketed? 

Mr. GAUGH. Again, it is all about the CGMP requirements that 

exist between the FDA and the manufacturer. And those requirements don’t exist between the State boards of pharmacy and the 

compounders to the same degree and the same level. And, as Dr. 

Thompson stated, they are not typically trained to inspect to that, 

whereas the FDA is. So it needs to fall into that same category. 

Mrs. ELLMERS. So can you explain, the similar scope of risk between ANDA holders manufacturing drugs and large-scale 

compounders in relation to, you know, explaining and creating two 

regulatory regimes for large-scale compounders and manufacturers. 

So I am concerned I don’t understand that process. 

Mr. GAUGH. So if I understand the question correctly, when you 

look at what the ANDA and the NDA holders are required to do, 

they have specifications they must meet around the potency of the 

product, around potential impurities and impurity growth around 

microbe growth. That doesn’t exist currently in the compounding 

structure, in the compounding review. It would under CGMP requirements, but it doesn’t under current requirements. 

Mrs. ELLMERS. So it would under—OK, again—— 

Mr. GAUGH. It could, I should say. 

Mrs. ELLMERS. It could. 

Mr. GAUGH. Yes. 

Mrs. ELLMERS. But it does not at this time? 

Mr. GAUGH. It does not. 

Mrs. ELLMERS. OK. And so, again, expanding on that, do you see 

risk in creating two more regulatory regimes? I mean, essentially, 

would there be two separate regulatory processes here or—— 

Mr. GAUGH. In our opinion, that would be creating two different 

regulatory processes at the FDA, if they were the ones controlling 

this. They would be controlling a manufacturer process for 

CGMP—— 

Mrs. ELLMERS. For compounding and manufacturing. 

Mr. GAUGH [continuing]. To be different. And we don’t see the 

manufacturing processes being different, so, therefore, the structure of control should not be different. 

Mrs. ELLMERS. OK. 

I only have about 40 seconds left. 

To Dr. Miller, again, getting back to just the importance of the 

physician role in this, why is the anticipatory compounding important to physicians? 

Mr. MILLER. Having medicine available. When the patient comes 

to you, you don’t want to send that patient—give them a piece of 

139 

paper, send them down to the compounding pharmacy, where it 

may take 2 to 14 days to prepare and test that, then come back 

to be treated. 

Mrs. ELLMERS. Yes. 

Mr. MILLER. Physicians want to treat you today. Pharmacists 

want to treat you today. We have to be able to prepare medicines 

in advance. 

Mrs. ELLMERS. Very good. 

And I see that my time has run out, so thank you, Mr. Chairman. 

Thank you to the panel. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentlelady from the Virgin Islands, Dr. Christensen, for 5 minutes for questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

Mr. Catizone, in your testimony, one of the limitations you suggest on compounding in advance of a prescription for traditional 

compounders is that the total quantity provided to a healthcare 

provider not exceed a 10-day patient supply. 

I am interested in NABP’s views on an alternative or additional 

approach to a limitation on compounding in advance of or without 

a prescription, of something like a 10- or 14-day expiration date 

from time of manufacture. 

As I understand it, one of the aspects of traditional pharmacy 

compounding that contributes to safety is that it ordinarily is performed for an individual patient at a time the patient needs and 

will use the drug. One of the problems with allowing traditional 

compounders to make drugs in advance or without a prescription 

is that the drugs can be made in unlimited quantities and allowed 

to sit on a shelf, either in the compounder’s warehouse or in the 

healthcare provider’s offices, for extended periods of time. During 

that time, any bacterial, fungal, or other biological contaminants 

have time to grow and make the product more dangerous. 

A relatively short expiration date from the time of manufacture 

would presumably limit the amount of drug that would be compounded in advance of an order, limit the size of orders that 

healthcare providers would request, and limit the amount of time 

any contaminants could grow. 

So what are your thoughts about such an approach? 

Mr. CATIZONE. Under the limitations we propose, there were two 

factors: one, the patient supply, as well as the total quantity the 

pharmacy would provide. 

The 10- to 14-day expiration date is another variable that we 

could support, provided that that expiration date coincides with 

what the beyond-use dates are with the product so that we didn’t 

put a 10-day or a 14-day expiration when the product was only 

good for 2 or 3 days. So coinciding those two factors makes that another very viable factor to look at in this process. 

Mrs. CHRISTENSEN. Does anyone else have an opinion or want to 

comment on it? 

Mr. HOEY. The USP requirement for a USP 797 standards would 

also help to address some of the issues that you are talking about. 

I would also mention an example of the importance of anticipatory compounding. There was a situation where there was a 

140 

shortage of injectable atropine for crash carts, for emergency crash 

carts. And because that drug wasn’t available, a compounding 

pharmacy was able to make that. Well, if a patient is crashing, you 

don’t want to have to write a prescription at that moment while 

your patient is coding. When that patient has had the proper treatment from the nurses and the physicians and the pharmacists, 

then you can write the prescription. But not having that prescription available at the time could cause someone to die. 

So that is a situation where there is a shortage of the drug, and 

because compounding pharmacists have made that drug, it is available when the patient needs it immediately. 

Mrs. CHRISTENSEN. Yes. I think in a situation like that, as I understood it from Dr. Woodcock’s testimony, because it is an emergency drug not available, that that would be something that they 

would allow. 

Mr. HOEY. And there would have to be a stock on those crash 

carts that are on—— 

Mrs. CHRISTENSEN. Absolutely. 

Mr. HOEY [continuing]. Certain floors in the hospital. 

Mrs. CHRISTENSEN. Absolutely. 

Mr. HOEY. And it wouldn’t be just that drug. There would be several drugs that are on those crash carts. 

Mrs. CHRISTENSEN. If there are no other comments, Mr. Chairman, I don’t have another question. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the gentleman from Pennsylvania, Dr. Murphy, for 5 minutes for 

questions. 

Mr. MURPHY. Thank you, Mr. Chairman. Thank the panel. 

By the way, Mr. Chairman, I have an opening statement I would 

like to submit for the record, too. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Thank you, Chairman Pitts, for holding this hearing to further the discussion 

about FDA’s authority over drug compounding. 

Soon after the fungal meningitis outbreak began in the fall of 2012, the Oversight 

and Investigations Subcommittee initiated a thorough investigation to determine 

whether this tragic outbreak—which has now claimed the lives of over 60 people 

and sickened nearly 750 others—could have been prevented. 

The Subcommittee found that the New England Compounding Center was not operating in the shadows; in fact, they were operating right under FDA’s investigative 

nose for a decade. Our investigation highlighted several opportunities where the 

agency confronted a choice in dealing with NECC and its sister company, 

Ameridose. FDA repeatedly decided not to act. Furthermore, as FDA has recently 

confirmed to the Committee, not a single complaint the agency had independently 

received about these companies over the past decade was forwarded to the state 

pharmacy board. 

It is very hard to legislate cultural change into a large federal agency. However, 

Mr. Griffith’s discussion draft makes important changes to address the breakdowns 

that occurred at FDA in the NECC case. His legislation is grounded in the facts 

uncovered by our investigation and makes it clear when FDA can—and must—put 

patients before process. I commend him for his efforts, and look forward to continue 

working with my colleagues to reform drug compounding rules so patients receive 

safe and effective medications. 

Mr. MURPHY. All right. I am also the chairman of Oversight and 

Investigations, and we had a number of hearings on this to try and 

141 

get the FDA to give us a straight answer. We didn’t get it from Dr. 

Hamburg. I am going to try and ask you folks. 

If the FDA has reason to believe that a compounding pharmacist 

is acting like a manufacturer, do you believe the FDA should have 

the authority to inspect a facility to the extent necessary to determine if that is the case? 

Let’s go down the panel. Dr. Hoey? 

Mr. HOEY. In cooperation with the State board of pharmacy, yes. 

Mr. MURPHY. Dr. Thompson? 

Mr. THOMPSON. If they are truly acting as a manufacturer, yes. 

Mr. MURPHY. Mr. Francer? 

Mr. FRANCER. Yes. 

Mr. GAUGH. Yes. 

Mr. MURPHY. Mr. Coukell? 

Mr. COUKELL. Yes, but of course they have to know that that facility is out there. 

Mr. MURPHY. OK. 

Dr. Miller? 

Mr. MILLER. Yes. And it already has that authority under 704(a). 

Mr. MURPHY. Thank you. 

Mr. CATIZONE. Yes. 

Mr. MURPHY. OK. 

So when we had our hearing before, I could not get an answer 

from Dr. Hamburg on that, because what it appeared was that they 

had, like, a 1-year moratorium against doing inspections without 

cause, it was said, that had made the medication that infected so 

many with meningitis. 

And I asked several times, six or seven times, about this, and her 

responses were—I said, ‘‘For example, in terms of dealing with the 

definition of a compounding pharmacy, who is responsible for 

that?’’ She said, ‘‘Well, it is not the FDA, it is Congress.’’ I said, 

‘‘But who keeps that definition?’’ She said, ‘‘Our chief counsel.’’ ‘‘So 

have you reviewed this definition with your chief counsel?’’ She 

said, ‘‘I think everyone agrees.’’ And I said, ‘‘I didn’t ask you if you 

agree.’’ She said, ‘‘The law is clear.’’ And I said, ‘‘I want to know, 

have you reviewed with someone the definition of ’compounding’ 

versus ’drug manufacturing’? Have you reviewed that with someone? When did that take place?’’ She said, ‘‘You know, we have had 

a lot of discussions.’’ I frustratingly said, ‘‘So has someone reviewed 

with you the definition of ’manufacturer’ versus ’compounding’?’’ 

She says, ‘‘You know, that is unfortunate. It is not clear.’’ 

It went on. I said, ‘‘Well, wait a minute. If you are telling me you 

don’t have the authority to inspect based upon whether or not 

someone is a compounder versus a manufacturer, someone must be 

advising the FDA on where you have jurisdiction and where you 

do not.’’ At that point, she said it was too complex and we couldn’t 

understand. 

Now, all of you answered that question pretty straightforward. 

You thought that there was authority with regard to this. But this 

is a key part of this issue and one that I want to find out. I mean, 

clearly, if we need more jurisdiction, we need to review that, in 

terms of the safety of patients and make sure people understand 

what is to be done here. But the way you all responded to me, it 

sounds like it already is there. 

142 

So I am going to go into a little more detail with this. Do you 

all believe, yes or no, is there a clear definition of ‘‘manufacturing’’ 

that defines when the FDA can come in and not? 

Dr. Hoey? 

Mr. HOEY. Yes, there is a clear definition of ‘‘manufacturing.’’ 

And the FDA, as my colleague from PhRMA mentioned, the FDA 

does a good job of monitoring CGMP, and they do a good job of regulating manufacturers. 

Mr. MURPHY. Dr. Thompson? 

Mr. THOMPSON. I think there is, yes. But these large-scale entities aren’t behaving like manufacturers that have an NDA or an 

ANDA. 

Mr. MURPHY. When you say a large-scale entity, meaning what? 

Mr. THOMPSON. Well, like the compounding-manufacturer-type 

entities. I mean, they are really big compounding pharmacies. They 

are registered as pharmacies in all 50 States. There are nonresident license agreements. 

Mr. MURPHY. OK, so this is not a mom-and-pop. This is someone 

who makes a lot of—— 

Mr. THOMPSON. Yes, but they are essentially compounding at a 

very—— 

Mr. MURPHY. On a large scale. 

Mr. THOMPSON [continuing]. Large scale. They are not, often, 

commercially available products, unless there is a shortage, that 

are customized dosage forms. They are just doing—— 

Mr. MURPHY. I see. And the FDA has the authority to go into 

those? 

Mr. THOMPSON. I think they fall under the jurisdiction of the 

State boards under the current construct. And I think that is concerning for us, because these look more like manufacturing entities, 

but they are not. And I don’t think the State boards have the capability to regulate them. 

Mr. MURPHY. Mr. Francer? 

Mr. FRANCER. Congressman, I believe the FDA knows manufacturing when the agency sees it and that, as a matter of patient 

safety, they should be using their authority to the maximum extent 

possible. 

Mr. MURPHY. Dr. Gaugh? 

Mr. GAUGH. Yes. Once identified, I think they have the authority 

to step in. 

Mr. MURPHY. Mr. Coukell? 

Mr. COUKELL. I think the authority to investigate after a problem has been identified is not the same as having the authority 

and the tools to proactively ensure quality. And that is what we are 

missing. 

Mr. MURPHY. Yes, what we found in this case with NECC is that 

they complaints from everybody—patients, doctors, whistleblowers—who were all saying, there is a problem here, and the 

FDA didn’t act. So that is a question, and I still think that is one 

of my concerns with this whole issue. Is it that we need a bill or 

do we need an FDA that takes action within that? 

Dr. Miller? 

Mr. MILLER. I am going to answer backwards. 

Mr. MURPHY. Yes. 

143 

Mr. MILLER. Yes, we believe they have adequate authority and 

a definition. 

However, the approach and the answers that you received from 

Commissioner Hamburg implies that any one of us could go into 

our garage, start an illegal drug company, put that medication out 

into the marketplace, and the FDA would not be able to shut me 

down? If that is indeed the case and that is the confusion, when 

we address this legislation, we have to make it very clear that illegal, inappropriate manufacturing falls under the jurisdictional authority of the FDA. 

Mr. MURPHY. Thank you. 

Mr. CATIZONE. There is not a clear definition. 

Mr. MURPHY. I see my time is up, and I am still seeking an answer. 

Thank you very much. 

Mr. PITTS. The chair thanks the gentleman. 

That concludes the questions from the Members who are here. 

We will have follow-up questions. I am sure other Members will 

have questions. We ask that you please respond promptly when we 

submit them to you. 

I will remind Members that they have 10 business days to submit questions for the record. And so Members should submit their 

questions by the close of business on Tuesday, July 30th. 

Superb hearing. Excellent testimony. Thank you all so much for 

coming. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 5:45 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

This legislative hearing is the product of the thorough, thoughtful, and bipartisan 

investigation that the committee launched in the wake of last fall’s tragic meningitis 

outbreak. We were deliberate in our efforts as we wanted to know what went wrong 

and why before the committee acted legislatively. Sadly, Michigan has been hit 

hardest by the outbreak—according to CDC data last updated July 1, 2013, 264 of 

the 749 illnesses caused by the outbreak were in Michigan and we have endured 

17 of the 61 fatalities, including three from my own district. 

During our committee’s investigation, under the leadership of Oversight and Investigations Subcommittee Chairman Tim Murphy, we found that the meningitis 

outbreak and the loss of innocent lives could have been prevented. The New England Compounding Center was operating in an unacceptable and unlawful manner 

for years. Yet, it took this outbreak and its tragic consequences for the Food and 

Drug Administration (FDA) to act. Although the facts demonstrate that the FDA 

had the authority to regulate the bad actors who harmed patients with unsafe products, we believe that clarifying FDA’s regulatory authority in this area through legislation is a prudent step toward improving the safety of all Americans. 

In May, this subcommittee held a hearing on the drug compounding industry to 

understand its evolution and the current role it plays in our health care system. We 

learned that compounding is an integral part of our health care system that helps 

patients receive the treatments necessary for their unique medical needs. As we 

look to legislate in this area, we want to ensure that patients can continue to receive compounded drugs that are safe. I believe that everyone here today shares 

that goal. 

We also want to ensure that bad actors can no longer use the good name of pharmacies to hide activity that is essentially large-scale drug manufacturing. The FDA 

gold standard for approval should give patients the assurance that the drugs they 

use are safe and effective. Activities akin to large-scale manufacturing must be regulated as such in order to uphold the integrity of our nation’s drug supply. 

144 

Our hearing today is a result of thorough and collaborative investigative and policy work. While all of the bills before us today include ideas that we should consider 

carefully, I would like to thank Morgan Griffith for his dedication and leadership 

throughout both the committee’s investigative and legislative process. The Griffith 

discussion draft before us today includes key provisions that serve the important 

goals of clarifying FDA’s authority and protecting the role of traditional 

compounding. As we continue to work in a bipartisan manner, it is my belief that 

we will find common ground to advance legislation that achieves these goals. 

Thank you, Mr. Chairman. I yield my remaining time to 

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