8874 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of recordkeeping Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

(hours) 

Total hours 

Records of adverse events, including records of efforts to 

obtain the data elements for each adverse event report 50 1 50 16 800 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments can be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm or http://

www.regulations.gov. 

Dated: February 11, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03419 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1459] 

Memorandum of Understanding 

Addressing Certain Distributions of 

Compounded Human Drug Products 

Between the States and the Food and 

Drug Administration; New Proposed 

Draft; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; 

withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability for public 

comment of a draft standard 

memorandum of understanding (MOU) 

entitled ‘‘Memorandum of 

Understanding Addressing Certain 

Distributions of Compounded Human 

Drug Products Between the State of 

[insert State] and the U.S. Food and 

Drug Administration.’’ The draft 

standard MOU describes the 

responsibilities of the State that chooses 

to sign the MOU in investigating and 

responding to complaints related to 

compounded human drug products 

distributed outside the State and in 

addressing the interstate distribution of 

inordinate amounts of compounded 

human drug products. 

FDA is also announcing the 

withdrawal of an earlier draft standard 

MOU entitled ‘‘Memorandum of 

Understanding on Interstate Distribution 

of Compounded Drug Products,’’ which 

was issued in January 1999. The January 

1999 draft standard MOU is superseded 

by the new draft standard MOU. 

DATES: FDA is withdrawing its draft 

standard MOU that published on 

January 21, 1999 (64 FR 3301), as of 

February 19, 2015. Submit either 

electronic or written comments on the 

new draft standard MOU by June 19, 

2015. Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by June 19, 2015 

(see the ‘‘Paperwork Reduction Act of 

1995’’ section of this document). 

ADDRESSES: Submit written requests for 

single copies of the MOU to Edisa 

Gozun, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Suite 5100, Silver 

Spring, MD 20993–0002. Send one selfaddressed label to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the new draft 

standard MOU. 

Submit electronic comments on the 

new draft standard MOU or on the 

collection of information to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Edisa Gozun, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Suite 5100, Silver 

Spring, MD 20993–0002, 301–796–3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 503A of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 353a) describes the 

conditions that must be satisfied for 

drug products compounded by a 

licensed pharmacist or licensed 

physician to be exempt from the 

following sections of the FD&C Act: (1) 

Section 501(a)(2)(B) (21 U.S.C. 

351(a)(2)(B)) (concerning current good 

manufacturing practice (CGMP) 

requirements), (2) section 502(f)(1) (21 

U.S.C. 352(f)(1)) (concerning the 

labeling of drugs with adequate 

directions for use), and (3) section 505 

(21 U.S.C. 355) (concerning the approval 

of drugs under new drug applications or 

abbreviated new drug applications). 

One of the conditions to qualify for 

the exemptions listed in section 503A of 

the FD&C Act is that (1) the drug 

product is compounded in a State that 

has entered into an MOU with FDA that 

addresses the distribution of inordinate 

amounts of compounded drug products 

interstate and provides for appropriate 

investigation by a State agency of 

complaints relating to compounded 

drug products distributed outside such 

State; or (2) if the drug product is 

compounded in a State that has not 

entered into such an MOU, the licensed 

pharmacist, pharmacy, or physician 

does not distribute, or cause to be 

distributed, compounded drug products 

out of the State in which they are 

compounded in quantities that exceed 5 

percent of the total prescription orders 

dispensed or distributed by such 

pharmacy or physician (see section 

503A(b)(3)(B)(i) and (b)(3)(B)(ii) of the 

FD&C Act). 

Section 503A(b)(3)(B) of the FD&C Act 

directs FDA to develop, in consultation 

with the National Association of Boards 

of Pharmacy (NABP), a standard MOU 

for use by the States in complying with 

section 503A(b)(3)(B)(i). 

II. Previous Efforts To Develop a 

Standard MOU 

In the Federal Register of January 21, 

1999 (64 FR 3301), FDA announced the 

availability for public comment of a 

draft standard MOU, developed in 

consultation with NABP (1999 draft 


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1The conditions of section 503A of the FD&C Act 

originally included restrictions on the advertising 

or promotion of the compounding of any particular 

drug, class of drug, or type of drug and the 

solicitation of prescriptions for compounded drugs. 

These provisions were challenged in court and held 

unconstitutional by the U.S. Supreme Court in 

2002. See Thompson v. Western States Med. Ctr., 

535 U.S. 357 (2002). 

standard MOU). Over 6,000 commenters 

submitted comments on the 1999 draft 

standard MOU. Because of litigation 

over the constitutionality of the 

advertising, promotion, and solicitation 

provisions in section 503A,1 the draft 

standard MOU was never completed. In 

2013, section 503A of the FD&C Act was 

amended by the Drug Quality and 

Security Act (DQSA) (Pub. L. 113–54) to 

remove the advertising, promotion, and 

solicitation provisions that were held 

unconstitutional, and FDA is 

implementing section 503A, including 

the provisions on the MOU. By this 

notice, FDA is withdrawing the 1999 

draft standard MOU, and the new draft 

standard MOU made available today 

supersedes that draft standard MOU. 

III. New 503A Guidance 

Immediately after the enactment of 

the DQSA, in December 2013, the 

Agency published a draft guidance on 

section 503A of the FD&C Act entitled 

‘‘Pharmacy Compounding of Human 

Drug Products Under Section 503A of 

the Federal Food, Drug, and Cosmetic 

Act’’ (2013 draft 503A guidance) (see 78 

FR 72901 (December 4, 2013) 

announcing the availability of the draft 

guidance). That draft guidance 

described FDA’s proposed policy with 

regard to specific provisions of section 

503A of the FD&C Act that require 

rulemaking or other action by FDA, 

such as the MOU provisions. Thirty-one 

commenters on the 2013 draft 503A 

guidance offered FDA their views on the 

MOU provisions of section 503A. FDA 

considered these comments in 

developing the new draft standard 

MOU. The final 503A guidance, 

published July 2, 2014 (see 79 FR 37742 

announcing the availability of the final 

503A guidance), states that FDA does 

not intend to enforce the 5 percent limit 

on distribution of compounded drug 

products out of the State in which they 

are compounded until after FDA has 

finalized an MOU and made it available 

to the States for their consideration and 

signature. After considering any 

comments on the new draft standard 

MOU submitted to this docket, FDA 

intends to finalize the standard MOU 

and make it available for signature by 

individual States. FDA will determine at 

the time of publication of the final MOU 

how long it will allow States to consider 

whether to sign the MOU before FDA 

begins to enforce the 5 percent limit in 

those States that have not signed an 

MOU. 

IV. New Draft Standard MOU 

FDA has now developed a new draft 

standard MOU on which it is soliciting 

public comment. FDA has consulted 

with NABP in developing this new draft 

standard MOU. FDA also considered the 

comments submitted in 1999 on the 

previous draft standard MOU, as well as 

comments on the MOU provisions it 

received in connection with the 

published 2013 draft 503A guidance. 

Key provisions of the new draft 

standard MOU are summarized and 

discussed in this section of the 

document and, where appropriate, 

compared to the provisions in the 1999 

draft standard MOU. 

A. Investigation of Complaints 

The new draft standard MOU 

provides that States that enter into the 

MOU will agree to: 

• Investigate complaints relating to 

human drug products compounded in 

the State and distributed outside the 

State, including complaints about 

adverse drug experiences or certain 

product quality issues to, among other 

things, determine whether there is a 

potential public health risk or safety 

concern, and confirm that any risk or 

safety concern is adequately contained; 

• As appropriate, take action to 

ensure that the relevant compounding 

pharmacy, pharmacist, or physician 

determines the root cause of the 

problem and eliminates any public 

health risk identified in relation to the 

complaint; 

• Notify FDA within 72 hours of any 

complaints relating to a compounded 

human drug product distributed outside 

the State involving a potential public 

health risk or immediate safety concern, 

such as a report of a serious adverse 

drug experience or serious product 

quality issue, the State’s initial 

assessment of the validity of the 

complaint, and any actions the State has 

taken or plans to take to address such 

complaints; 

• Provide FDA with certain 

information about the complaint, 

including the following: 

Æ Name and contact information of 

the complainant; 

Æ name and address of the 

pharmacist/pharmacy/physician that is 

the subject of the complaint; 

Æ a description of the complaint, 

including a description of any 

compounded drug product that is the 

subject of the complaint; 

Æ the State’s initial assessment of the 

validity of the complaint relating to a 

compounded human drug product 

distributed outside the State; and 

Æ a description and date of any 

actions the State has taken to address 

the complaint; and 

• Maintain records of the complaints 

it receives, the investigation of each 

complaint, and any response to or 

action taken as a result of a complaint, 

beginning when the State receives 

notice of the complaint. The draft 

standard MOU says that the State agrees 

to maintain these records for at least 3 

years, beginning on the date of final 

action or the date of a decision that the 

complaint requires no action. 

The new draft standard MOU, as 

compared to the 1999 draft standard 

MOU, clarifies that the types of 

complaints of compounded human drug 

products that should be investigated 

include any adverse drug experience 

(not just serious adverse drug 

experiences, which were identified as 

an example of the types of complaints 

to be investigated in the 1999 draft 

standard MOU) and product quality 

issues that, if left uncorrected, could 

lead to potential public health risks or 

safety concerns. Even nonserious 

adverse drug experiences and product 

quality issues can be indicative of 

problems at a compounding facility that 

could result in product quality defects 

leading to serious adverse drug 

experiences if not corrected. For 

example, inflammation around the site 

of an injection can indicate product 

contamination from inadequate sterile 

practices at the compounding 

pharmacy. If the pharmacy has 

inadequate sterile practices, other more 

serious contamination could result in 

serious adverse events. 

FDA is clarifying that the complaints 

that States agree to investigate under the 

MOU are only those complaints that are 

made about compounded human drug 

products distributed outside the State. 

In contrast to the 1999 draft standard 

MOU, the new draft standard MOU does 

not contain a provision that would 

require the States entering into the MOU 

with FDA to agree to investigate alleged 

violations of the FD&C Act. Upon 

further reflection, FDA has tentatively 

concluded that it would be more 

appropriate for FDA to determine 

whether a particular action is a violation 

of Federal law. Of course, if any State 

identifies a potential violation of 

Federal law, it is encouraged to report 

it to FDA. 

Furthermore, the new draft standard 

MOU does not include specific 

directions to the States relating to how 

to conduct their investigation of 


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8876 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

2FDA is currently considering whether to 

propose regulations or issue guidance documents to 

further its implementation of section 503A(b)(3)(B) 

of the FD&C Act. Notice of any such action will be 

provided in the Federal Register. 

3 Drugs that a patient takes across state lines in 

this manner are distributed interstate. However, for 

reasons explained in this notice, FDA’s draft 

standard MOU does not count them toward the 

limit on distributing inordinate amounts of 

compounded drug products interstate. 

complaints. Rather, as recommended by 

comments previously submitted on the 

1999 draft standard MOU, the details of 

such investigations are left to the States’ 

discretion. 

States signing the new standard MOU 

would agree to notify FDA about certain 

complaints and provide FDA with 

certain information about the complaint 

so FDA could investigate the complaint 

itself, or take other appropriate action.2

B. Inordinate Amounts 

The new draft standard MOU 

provides that States that enter into the 

MOU will agree to: 

• Review compounding records 

during inspections of compounding 

pharmacies to identify whether the 

compounding pharmacy, or the 

compounding pharmacist or physician, 

is distributing inordinate amounts of 

compounded human drug products 

interstate; 

• Notify FDA if the State identifies 

any pharmacy, pharmacist, or physician 

within its jurisdiction that has 

distributed inordinate amounts of 

compounded human drug products 

interstate; 

• Take action regarding any 

pharmacy, pharmacist, or physician that 

distributes inordinate amounts of 

compounded human drug products 

interstate; and 

• Provide FDA with certain 

information, including the following: 

Æ The name and address of the 

pharmacy/pharmacist/physician; 

Æ a description of the evidence 

indicating that the pharmacy/

pharmacist/physician has distributed 

inordinate amounts of compounded 

human drug products interstate, 

including a description of any 

compounded drug product that was 

distributed in inordinate amounts; and 

Æ a description and date of any 

actions the State has taken to address 

the distribution of inordinate amounts 

of compounded human drug product 

interstate. 

In the new draft standard MOU, a 

pharmacist, pharmacy, or physician is 

considered to have distributed an 

inordinate amount of compounded 

human drug products interstate if the 

number of units of compounded human 

drug products distributed interstate 

during any calendar month is equal to 

or greater than 30 percent of the number 

of units of compounded and noncompounded drug products distributed 

or dispensed both intrastate and 

interstate by such pharmacist, 

pharmacy, or physician during that 

calendar month. FDA does not intend to 

include in the consideration of 

inordinate amounts those prescriptions 

dispensed to a patient (or patient’s 

agent), where the patient (or patient’s 

agent) to whom the drug is dispensed 

carries the drug across State lines after 

it has been dispensed to the patient (or 

the patient’s agent) at the facility in 

which the drug was compounded.3 This 

concept would be called the 30 percent 

limit. 

The 1999 draft standard MOU defined 

‘‘inordinate amounts’’ as the number of 

compounded prescriptions dispensed or 

distributed interstate annually by a 

pharmacy or physician that is equal to 

or greater than 20 percent of the total 

number of prescriptions dispensed or 

distributed (including both intrastate 

and interstate) by such pharmacy or 

physician; or the number of 

compounded prescriptions dispensed or 

distributed interstate annually by a 

pharmacy or physician that is less than 

20 percent of the total number of 

prescriptions dispensed or distributed 

(including both intrastate and interstate) 

by such pharmacy or physician, but 

prescriptions for one or more individual 

compounded drug products (including 

various strengths of the same active 

ingredient) dispensed or distributed 

interstate constitute more than 5 percent 

of the total number of prescriptions 

dispensed or distributed. The 1999 draft 

standard MOU also included an 

exclusion from calculations to 

determine inordinate amounts for 

‘‘local’’ interstate distribution to 

patients within 50 miles of the 

compounding pharmacy, and for 

interstate distribution in response to a 

public health emergency or catastrophic 

event. 

Many comments on the 1999 draft 

standard MOU opposed the percentage 

limits it contained, and some comments 

on the 2013 draft 503A guidance 

opposed any definition of inordinate 

amounts that would significantly 

restrict interstate distributions under 

section 503A of the FD&C Act. Other 

comments suggested not defining 

‘‘inordinate amounts,’’ leaving the 

definition up to the States, or defining 

the term as ‘‘the amount that would be 

considered conventional 

manufacturing.’’ FDA is proposing the 

30 percent limit as the definition of 

‘‘inordinate amounts’’ for the following 

reasons. 

Section 503A of the FD&C Act reflects 

Congress’ recognition that human drug 

compounding may be appropriate when 

it is based on receiving a valid 

prescription or notation for an identified 

individual patient. However, drug 

products compounded under this 

section of the FD&C Act are not required 

to demonstrate that they are safe or 

effective, bear adequate directions for 

use, or conform to CGMP. Congress, 

therefore, imposed strict limits on the 

distribution of drug products 

compounded under this section to 

protect the public health and the 

integrity of the drug approval process. 

In particular, Congress did not intend 

for compounders operating under these 

statutory provisions to grow into 

conventional manufacturing operations 

making unapproved drugs, operating a 

substantial proportion of their business 

interstate. Although other provisions of 

the FD&C Act apply to state-licensed 

pharmacies and physicians that may 

qualify for the exemptions under section 

503A of the FD&C Act (e.g., the 

adulteration provisions for making 

drugs under insanitary conditions), and 

although FDA may take action in 

appropriate cases against compounders 

that violate these provisions or that 

operate outside of the conditions in 

section 503A, Congress recognized that 

these compounders are primarily 

overseen by the States. If a substantial 

proportion of a compounder’s drugs are 

distributed outside a State’s borders, 

adequate regulation of those drugs poses 

significant challenges to State 

regulators. States face logistical, 

regulatory, and financial challenges 

inspecting compounders located outside 

of their jurisdiction. In addition, 

particularly if a compounder distributes 

drugs to multiple States, it can be very 

difficult to gather the scattered 

information about possible adverse 

events associated with those drugs, 

connect them to the compounder, and 

undertake coordinated action to address 

a potentially serious public health 

problem. 

Therefore, as a baseline measure, 

section 503A(b)(3)(B) of the FD&C Act 

limits the distribution of compounded 

human drug products outside of the 

State in which they are compounded 

under section 503A(a) to 5 percent of 

the total prescription orders dispensed 

or distributed by a licensed pharmacist, 

pharmacy, or physician. It then directs 

FDA, in consultation with NABP, to 

develop a standard MOU that addresses 

the distribution of inordinate amounts 

of compounded human drug products 

interstate and provides for appropriate 


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4The DQSA adds new section 503B to the FD&C 

Act (21 U.S.C. 353b). Under section 503B(b) of the 

FD&C Act, a compounder may elect to become an 

outsourcing facility by registering with FDA. 

Products compounded in a registered outsourcing 

facility can qualify for exemptions from the FDA 

approval requirements in section 505 of the FD&C 

Act and the requirement to label products with 

adequate directions for use under section 502(f)(1) 

of the FD&C Act if the requirements in section 503B 

are met. Outsourcing facilities will be inspected by 

FDA and must comply with other provisions of the 

FD&C Act, such as CGMP requirements. 

5 In different contexts, where it would further a 

regulatory purpose, Congress and the Agency have 

specifically defined distribute to exclude 

Continued 

investigation by a State agency of 

complaints relating to compounded 

human drug products distributed 

outside such State. Implementation of 

this provision requires FDA to 

determine whether a limit higher than 5 

percent would be appropriate, provided 

the States make certain agreements: A 

State agrees to appropriately investigate 

complaints relating to compounded 

human drug products distributed out of 

the State and agrees to address the 

distribution of amounts that would be 

inordinate. 

FDA tentatively concludes that if a 

State agrees to meet the conditions set 

forth in this MOU, distribution 

interstate up to the 30 percent limit 

would not be inordinate. This 

conclusion is based on FDA’s 

expectation that States signing the MOU 

would appropriately investigate 

complaints about compounded human 

drug products distributed out of State, 

and address compounders distributing 

an inordinate amount of compounded 

drug products out of the state in which 

they are compounded. FDA’s current 

view is that its proposed limit would 

appropriately balance the benefits of 

access to compounded human drug 

products with the need to protect the 

public health and the drug approval 

system. We do not believe that an 

additional limit is necessary for the 

distribution of an individual 

compounded drug product such as that 

contained in the 1999 draft standard 

MOU. 

In developing the new draft standard 

MOU, we considered that patients can 

now obtain compounded human drug 

products from outsourcing facilities,4

which are not subject to volume 

restrictions on interstate distribution. 

This could mitigate the access concerns 

noted in some comments FDA received 

on the definition of ‘‘inordinate 

amounts’’ in the 1999 draft standard 

MOU, and in more recent comments 

expressing concerns about access if 

‘‘inordinate amounts’’ is defined 

restrictively or the 5 percent limit is 

enforced. 

It is appropriate to provide a bright 

line test for when compounding 

pharmacies located in States that sign 

the MOU cross the line to conventional 

manufacturing that should be subject to 

all of the requirements of the FD&C Act, 

including the new drug approval and 

CGMP requirements. Congress provided 

such a bright line test, the 5 percent 

limit, for compounders located in States 

that do not sign the MOU. 

Some commenters in response to the 

1999 draft MOU and the 2013 draft 

503A guidance were concerned with 

limitations on interstate distribution of 

compounded human drug products to 

contiguous States. In the 1999 draft 

MOU, the calculation of ‘‘inordinate 

amounts’’ excluded compounded 

human drug products that were 

distributed interstate but within 50 

miles of the pharmacy or physician’s 

office. After considering the provision 

in the 1999 draft MOU and the 

comments, FDA believes that the 30 

percent limit on inordinate amounts 

provided in this new draft standard 

MOU is high enough that special 

calculations to address interstate 

distribution between contiguous States 

or over short distances are not needed. 

Moreover, the new draft standard MOU 

includes consideration of inordinate 

amounts of prescriptions dispensed to a 

patient (or patient’s agent), if the patient 

(or patient’s agent) to whom the drug is 

dispensed carries the drug across State 

lines after it has been dispensed to the 

patient (or patient’s agent) at the facility 

in which the drug was compounded. We 

also do not intend to count as part of the 

5 percent limit on distribution out of the 

State prescriptions dispensed to a 

patient (or patient’s agent), if the patient 

(or patient’s agent) to whom the drug is 

dispensed carries the drug across State 

lines after it has been dispensed to the 

patient (or patient’s agent) at the facility 

in which the drug was compounded. We 

believe this treatment of these 

transactions where there are direct 

relationships among the patient, the 

prescriber, and the pharmacist or 

physician compounding the drug is 

consistent with section 503A of the 

FD&C Act. 

Finally, the new draft standard MOU 

does not exclude from the calculation of 

‘‘inordinate amounts’’ interstate 

distributions in response to a public 

health emergency or catastrophic event. 

We believe the 30 percent limit affords 

adequate opportunity for interstate 

distributions and note that outsourcing 

facilities may be able to compound 

drugs in an emergency and drugs on 

FDA’s drug shortage list, further 

mitigating access concerns. 

C. Definitions 

The Appendix to the new draft 

standard MOU defines key terms used 

in the MOU, including ‘‘adverse drug 

experience,’’ ‘‘serious adverse drug 

experience,’’ ‘‘product quality issue,’’ 

‘‘serious product quality issue,’’ and 

‘‘distribution.’’ The definitions of 

‘‘adverse drug experience,’’ ‘‘serious 

adverse drug experience,’’ ‘‘product 

quality issue,’’ and ‘‘serious product 

quality issue’’ are taken from relevant 

sections of FDA’s regulations (see 21 

CFR 310.305 and 314.81). For purposes 

of the new draft standard MOU, a 

‘‘distribution’’ occurs when a 

compounded human drug product 

leaves the facility in which the drug was 

compounded. Distribution includes 

delivery or shipment to a physician’s 

office, hospital, or other health care 

setting for administration and 

dispensing to an agent of a patient or to 

a patient for his or her own use. 

However, the definition notes that, to 

qualify for the exemptions under section 

503A of the FD&C Act, a compounder 

must obtain a prescription for an 

individually identified patient (section 

503A(a)), and the draft standard MOU 

would not alter this condition. Interstate 

distributions of compounded drug 

products would count toward the 30 

percent limit whether or not the 

compounded drug products satisfied the 

prescription condition, or other 

conditions, in section 503A of the FD&C 

Act. 

Some comments on the 2013 draft 

503A guidance state that provisions in 

the standard MOU relating to drug 

distribution should not apply to 

dispensed drugs. Although the 

comments do not share a single 

definition of dispensing, or offer a 

detailed definition, they generally take 

the position that a drug is dispensed 

when it is provided pursuant to a 

prescription or doctor’s order, and that 

dispensing is not a form of distribution. 

We have not adopted this approach, and 

propose a definition of distribution that 

we believe is consistent with the text 

and purpose of section 503A of the 

FD&C Act. Under our draft standard 

MOU, a distribution occurs when a 

compounded drug leaves the facility 

where it was made, regardless of 

whether the drug is also deemed to be 

dispensed. 

Section 503A(b)(3)(B) of the FD&C Act 

directs FDA to include provisions in the 

MOU regarding the distribution of 

compounded drugs. The section does 

not define distribution to exclude 

dispensing, which Congress has done 

elsewhere when that was its intention.5


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dispensing. See, for example, section 581(5) of the 

FD&C Act, which applies to Title II of the DQSA, 

and 21 CFR 208.3, which applies to 21 CFR part 208 

of our regulations. Section 503A of the FD&C Act 

does not contain a similar definition, or specific 

direction to exclude dispensing from the meaning 

of distribution. We also note that these definitions 

were adopted for provisions that focus on 

conventionally manufactured drug products, which 

assign different obligations to dispensers than to 

wholesalers, packagers, or other intermediaries in 

light of the different role that dispensers play with 

respect to product labeling and the drug 

distribution chain. In contrast, section 503A of the 

FD&C Act focuses on compounded drugs, and the 

reasons for defining distribution to exclude 

dispensing in Title II of the DQSA or part 208 do 

not apply. 

6See discussion of the purposes of section 503A 

of the FD&C Act in section IV.B, supra. 

Our proposed definition implements the 

purpose of section 503A(b)(3)(B) of the 

FD&C Act, which is to limit and regulate 

compounded drugs that are sent out of 

the state in which they are made.6 Our 

definition is also consistent with the 

ordinary meaning of distribute; it is 

natural to say that an entity 

compounding under section 503A of the 

FD&C Act distributes the drugs it makes 

to patients and health care providers, 

just as the manufacturers of other 

regulated articles are said to distribute 

their products to their customers. The 

definition proposed by comments, on 

the other hand, would write an 

exclusion for dispensing into the statute 

where Congress did not. It would also 

mean that drug products compounded 

under section 503A of the FD&C Act are 

excluded from the MOU and the 5 

percent limit, because, in order to 

qualify for the exemptions under section 

503A, a compounder must obtain a 

valid prescription order for an 

individually identified patient. For the 

reasons stated previously in section IV.B 

of this document, we believe this would 

achieve the opposite of what Congress 

intended. 

In support of their alternative 

approach, commenters note that in 

section 503A(b)(3)(B)(ii) of the FD&C 

Act, Congress directed FDA to calculate 

the quantity of ‘‘prescription orders 

dispensed and distributed’’ when the 

Agency applies the 5 percent limit to 

compounders in states that do not sign 

the MOU. This language, however, 

supports FDA’s proposed approach, 

because it makes clear that Congress 

understood the word distribute in this 

section to refer to filling prescription 

orders; otherwise it would not have 

directed the Agency to count the 

number of prescription orders that 

pharmacists and prescribers 

‘‘distributed.’’ Nor is there anything to 

suggest that Congress understood 

distributed and dispensed to be 

mutually exclusive categories rather 

than overlapping categories. Given the 

statutory text and purpose, we believe 

that Congress referred to drugs 

dispensed or distributed in section 

503A(b)(3)(B) of the FD&C Act to make 

clear that the Agency must not limit its 

calculation of total prescription orders 

to compounded drugs that the pharmacy 

or prescriber makes, but also include 

any other prescription orders, such as 

conventionally manufactured drugs, for 

which the pharmacist or prescriber 

serves solely as the dispenser. 

V. Other Issues 

A. Development of a Standard MOU 

A number of commenters on both the 

1999 draft MOU and on the 2013 draft 

503A guidance suggested that FDA 

specifically negotiate MOUs with 

individual States, rather than develop a 

standard MOU. Section 503A of the 

FD&C Act requires the Agency to 

develop a standard MOU for use by the 

States. Furthermore, it would be 

impractical to develop an 

individualized MOU with every State, 

and creating individualized MOUs 

would create a patchwork of regulation 

of interstate distribution from 

compounders seeking to qualify for the 

exemptions under section 503A of the 

FD&C Act. This would be confusing to 

the health care community, as well as 

regulators. 

B. Exemptions From the Interstate 

Distribution Provisions 

Some comments on the 2013 draft 

503A guidance requested that we 

consider exempting certain drug 

products or types of compounding 

entities from the limits in the MOU and 

the 5 percent limit. For example, some 

comments recommended that we 

exempt nonsterile products or home 

infusion pharmacies. 

Congress did not exempt any 

particular drug products or 

compounding entities from the 5 

percent limit. Furthermore, FDA 

believes that the 5 percent limit and the 

MOU limit on inordinate amount 

provisions are important to distinguish 

pharmacy compounding from 

conventional manufacturing in the guise 

of compounding, and to protect 

consumers and the integrity of the drug 

approval process. American consumers 

rely on the FDA drug approval process 

to ensure that medications have been 

evaluated for safety and effectiveness 

before they are marketed in the United 

States. Drugs made by compounders, 

including those made at human drug 

compounding outsourcing facilities, are 

not FDA-approved. This means that 

they have not undergone premarket 

review of safety, effectiveness, or 

manufacturing quality. Therefore, when 

an FDA-approved drug is commercially 

available, FDA recommends that 

practitioners prescribe the FDAapproved drug rather than a 

compounded drug unless the 

prescribing practitioner has determined 

that a compounded product is necessary 

for the particular patient and would 

provide a significant difference for the 

patient as compared to the FDAapproved commercially available drug 

product. 

In section 503A of the FD&C Act, 

Congress enacted several conditions to 

differentiate compounders from 

manufacturers and provided that only if 

they meet those conditions can they 

qualify for the exemptions from the drug 

approval requirements in section 505 of 

the FD&C Act. One of those conditions 

relates to limitations on the interstate 

distribution of compounded human 

drug products, and FDA intends to 

enforce those provisions to differentiate 

compounding that qualifies for the 

exemptions from conventional 

manufacturing in the guise of 

compounding that does not, and will 

apply the conditions to all types of 

drugs and all categories of 

compounding. 

C. Information Sharing Between States 

and FDA 

Several commenters on the 1999 draft 

MOU proposed that signatories to the 

MOU would agree to share information 

on a variety of subjects. The new draft 

standard MOU provides that States will 

agree to notify FDA of any complaint 

relating to a compounded human drug 

product distributed outside the State 

involving a potential public health risk 

or immediate safety concern, such as a 

report of a serious adverse drug 

experience or serious product quality 

issue, and provide information about 

those events and issues. The new draft 

standard MOU also provides that States 

will notify FDA if they identify a 

pharmacist, pharmacy, or physician 

within their jurisdiction that has 

distributed inordinate amounts of 

compounded human drug products 

interstate. In addition, FDA regularly 

posts on its compounding Web site 

information about enforcement and 

other actions related to compounders 

that violate the FD&C Act, and it is 

obligated to share certain information 

with States under section 105 of the 

DQSA. 


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Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8879 

7 ‘‘[U]ntil the State . . . enters into a 

memorandum of understanding (MOU) with the 

Secretary or 180 days after the development of the 

standard MOU, whichever comes first, the [section 

503A] exemption shall not apply if inordinate 

quantities of compounded products are distributed 

outside of the State in which the compounding 

pharmacy or physician is located.’’ (U.S. Senate 

Committee Report, see note 2.) 

D. Enforcement of the 5 Percent Limit on 

Distribution of Compounded Drug 

Products Out of the State in Which They 

Are Compounded 

In the 2013 draft 503A guidance, FDA 

stated that it does not intend to enforce 

the 5 percent limit on distribution of 

compounded drug products outside of 

the State in which they are compounded 

until 90 days after FDA has finalized a 

standard MOU and made it available to 

the States for their consideration and 

signature. Most commenters on the 2013 

draft 503A guidance said this period 

was too short, but did not recommend 

a specific alternative. A few commenters 

recommended a different timeframe, 

one recommending 120 days and 

another recommending 365 days. The 

1997 Senate Committee Report for the 

Food and Drug Administration 

Modernization Act suggests that a 180- 

day period for States to decide whether 

to sign might be appropriate.7 The 

Agency proposes a 180-day period after 

the final standard MOU is made 

available for signature before FDA will 

enforce the 5 percent limit in States that 

have not signed the MOU, and invites 

public comment on whether this is the 

appropriate timeframe. FDA will 

announce at the time it publishes the 

final standard MOU and makes it 

available for signature when it intends 

to begin enforcing the 5 percent limit in 

States that do not sign. 

VI. Paperwork Reduction Act 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal Agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)), requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register for each proposed 

collection of information before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information collected; and (4) ways to 

minimize the burden of the collection of 

information on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Section 503A of the FD&C Act 

describes, among other things, the 

circumstances under which certain 

human drug products compounded by a 

licensed pharmacist or licensed 

physician are exempt from certain 

sections of the FD&C Act. One of the 

conditions to qualify for the exemptions 

listed in section 503A of the FD&C Act 

is that: (1) The human drug product is 

compounded in a State that has entered 

into an MOU with FDA that addresses 

the distribution of inordinate amounts 

of compounded human drug products 

interstate and provides for appropriate 

investigation by a State agency of 

complaints relating to compounded 

human drug products distributed 

outside such a State; or (2) if the human 

drug product is compounded in a State 

that has not entered into such an MOU, 

the licensed pharmacist, pharmacy, or 

physician does not distribute, or cause 

to be distributed, compounded human 

drug products out of the State in which 

they are compounded, more than 5 

percent of the total prescription orders 

dispensed or distributed by such 

pharmacy or physician (see section 

503A(b)(3)(B)(i) and (b)(3)(B)(ii). 

Section 503A(b)(3) directs FDA, in 

consultation with the NABP, to develop 

a standard MOU for use by states in 

complying with the provisions 

concerning the interstate distribution of 

inordinate amounts of compounded 

human drug products interstate and 

appropriate investigation by a State 

agency of complaints relating to 

compounded human drug products 

distributed outside such State. 

The new draft standard MOU contains 

the information collections that must be 

approved by OMB under the PRA. 

These information collections are 

described in this section of the 

document. For purposes of this analysis, 

FDA assumes that 25 States will sign the 

standard MOU with FDA. 

Under section III.a. of the new draft 

standard MOU, the State will notify 

FDA by email at StateMOU@fda.hhs.gov 

within 72 hours of receiving any 

complaint relating to a compounded 

human drug product distributed outside 

the State involving a potential public 

health risk or immediate safety concern, 

such as a report of a serious adverse 

drug experience or serious product 

quality issue. The notification will 

include the following information: (1) 

The name and contact information of 

the complainant, in the case of a 

complaint; (2) the name and address of 

the pharmacist, pharmacy, and/or 

physician that is the subject of the 

complaint; (3) a description of the 

complaint, including a description of 

any compounded drug product that is 

the subject of the complaint; (4) the 

State’s initial assessment of the validity 

of the complaint relating to a 

compounded human drug product 

distributed outside the State; and (5) a 

description and date of any actions the 

State has taken to address the 

complaint. In addition, the States will 

maintain records of the complaints they 

receive, the investigation of each 

complaint, and any response to or 

action taken as a result of a complaint, 

beginning when the State receives 

notice of the complaint. The States will 

maintain these records for at least 3 

years, beginning on the date of final 

action or the date of a decision that the 

complaint requires no action. 

Based on our knowledge of State 

regulation of compounding practices 

and related complaints, we estimate that 

annually a total of approximately 25 

States (‘‘no. of respondents’’ in table 1, 

row 1) will notify FDA within 72 hours 

of receiving any complaint relating to a 

compounded human drug product 

distributed outside the State involving a 

potential public health risk or 

immediate safety concern. We estimate 

that each State will notify FDA annually 

of approximately 3 complaints it 

receives (‘‘no. of responses per 

respondent’’ in table 1, row 1), for a 

total of 75 notifications of complaints 

sent to FDA (‘‘total annual responses’’ in 

table 1, row 1). We estimate that 

preparing and submitting this 

information to us as described in the 

MOU will take approximately 0.5 hours 

per response (‘‘average burden per 

response’’ in table 1, row 1), for a total 

of 37.5 hours (‘‘total hours’’ in table 1, 

row 1). 

We also estimate that a total of 

approximately 25 States (‘‘no. of 

recordkeepers’’ in table 2) will prepare 

and maintain records for 3 years of the 

complaints they receive, investigations 

of complaints, and on any State action 


emcdonald on DSK67QTVN1PROD with NOTICES
8880 Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 

taken or replies to complaints. We 

estimate that each State will receive 

approximately 3 complaints annually 

and will prepare and maintain 

approximately 5 records per each 

complaint the State receives, for a total 

of 15 records per State (‘‘no. of records 

per recordkeeper’’ in table 2), and a total 

of 375 records annually across all States 

(‘‘total annual records’’ in table 2). We 

further estimate that preparing and 

maintaining these records will take 

approximately 1 hour per record 

(‘‘average burden per recordkeeping (in 

hours)’’ in table 2), for a total of 375 

hours (‘‘total hours’’ in table 2). 

Under section III.a. of the new draft 

standard MOU, investigations 

performed by the State under this MOU 

will ensure that (1) the root cause of the 

problem that is the subject of the 

complaint is determined, (2) any risk or 

safety concern associated with the 

compounded human drug product is 

adequately contained (i.e., there is no 

ongoing risk to the public), and (3) 

sufficient corrective action has been 

taken to eliminate any future public 

health risk. 

Under section III.b of the new draft 

standard MOU, the States will notify 

FDA by email at StateMOU@fda.hhs.gov 

within 7 days of determining that a 

pharmacist, pharmacy, or physician 

within their jurisdiction has distributed 

inordinate amounts of compounded 

human drug products interstate, as 

described in the MOU. The notification 

should include the following 

information: (1) The name and address 

of the pharmacist/pharmacy/physician; 

(2) a description of the evidence 

indicating that the pharmacist/

pharmacy/physician has distributed 

inordinate amounts of compounded 

human drug products interstate, 

including a description of any 

compounded drug product that was 

distributed in inordinate amounts; and 

(3) a description and date of any actions 

the State has taken to address the 

distribution of inordinate amounts of 

compounded human drug products 

interstate. 

We estimate that annually a total of 

approximately 25 States (‘‘no. of 

respondents’’ in table 1, row 2) will 

notify FDA of their determination that a 

pharmacist, pharmacy, or physician has 

distributed inordinate amounts of 

compounded human drug products 

interstate. We estimate that each State 

will notify FDA annually of 

approximately 2 determinations it 

makes (‘‘no. of responses per 

respondent’’ in table 1, row 2), for a 

total of 50 determinations (‘‘total annual 

responses’’ in table 1, row 2). We 

estimate that preparing and submitting 

this information to FDA as described in 

the MOU will take approximately 0.5 

hours per response (‘‘average burden per 

response’’ in table 1, row 2), for a total 

of 25 hours (‘‘total hours’’ in table 1, 

row 2). 

Under section V of the current draft 

standard MOU, a State may designate a 

new liaison to the MOU by notifying 

FDA’s administrative liaison in writing. 

If a State’s liaison becomes unavailable 

to fulfill its functions under the MOU, 

the State will name a new liaison within 

2 weeks and notify FDA. 

We estimate that annually a total of 

approximately 13 States (‘‘no. of 

respondents’’ in table 1, row 3) will 

notify FDA of a new liaison to the MOU. 

We estimate that each State will submit 

to FDA annually approximately 1 

notification of a new liaison (‘‘no. of 

responses per respondent’’ in table 1, 

row 3), for a total of 13 notifications of 

a new liaison (‘‘total annual responses’’ 

in table 1, row 3). We estimate that 

preparing and submitting each 

notification as described in the MOU 

will take approximately 0.2 hours per 

response (‘‘average burden per 

response’’ in table 1, row 3), for a total 

of 2.6 hours (‘‘total hours’’ in table 1, 

row 3). 

Under section VI of the new draft 

standard MOU, a State may terminate its 

participation in the MOU by submitting 

to FDA a 30-day notice of termination. 

We estimate that annually a total of 

approximately 1 State (‘‘no. of 

respondents’’ in table 1, row 4) will 

notify FDA that it intends to terminate 

its participation in the MOU. We 

estimate that this State will submit to 

FDA annually approximately 1 

notification of termination (‘‘no. of 

responses per respondent’’ in table 1, 

row 4), for a total of 1 notification 

(‘‘total annual responses’’ in table 1, row 

4). We estimate that preparing and 

submitting the notification as described 

in the MOU will take approximately 0.2 

hours per notification (‘‘average burden 

per response’’ in table 1, row 4), for a 

total of 0.2 hours (‘‘total hours’’ in table 

1, row 4). 

Under section VI of the new draft 

standard MOU, if a State does not 

adhere to the provisions of the MOU, 

FDA may post a 30-day notice of 

termination on its Web site. As a result 

of this action by FDA, the State will 

notify all pharmacists, pharmacies, and 

physicians within the State of the 

termination and advise them that 

compounded human drug products may 

be distributed (or caused to be 

distributed) out of the State only in 

quantities that do not exceed 5 percent 

of the total prescription orders 

dispensed or distributed by the 

pharmacist, pharmacy, or physician. 

We estimate that annually a total of 

approximately 1 State (‘‘no. of 

respondents’’ in table 3) will submit 1 

notification of termination as described 

in the MOU (‘‘no. of disclosures per 

respondent’’ in table 3) to the 

pharmacists, pharmacies, and 

physicians in its State for a total of 1 

notification of termination (‘‘total 

annual disclosures’’ in table 3). We 

estimate that preparing and submitting 

each notification will take 

approximately 1 hour per notification 

(‘‘average burden per disclosure (in 

hours)’’ in table 3), for a total of 1 hour 

(‘‘total hours’’ in table 3). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Compounding MOU between FDA and States Number of 

respondents 

Number o 

esponses per 

respondent 

Total annual 

responses 

Average burden per response 

Total hours 

State notifies FDA of compounding complaints it receives 25 3 75 0.5 37 .5 

State notifies FDA of the distribution of inordinate 

amounts of compounded drug products ........................ 25 2 50 0.5 25 

State notifies FDA of a new liaison to the MOU ............... 13 1 13 0.2 2 .6 

State notifies FDA of its intent to terminate participation 

in the MOU ..................................................................... 1 1 1 0.2 0 .2 

Total ............................................................................ 64 7 139 N/A 65 .3 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


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Federal Register / Vol. 80, No. 33 / Thursday, February 19, 2015 / Notices 8881 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Compounding MOU between FDA and States Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

(in Hours) 

Total Hours 

State recordkeeping for 3 years of compounding complaints ............................................................................. 25 15 375 1 375 

Total ............................................................................ 25 15 375 1 375 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Compounding MOU between FDA and States Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden per disclosure 

(in Hours) 

Total hours 

State notification to pharmacists, pharmacies, and physicians that its participation in the MOU has been terminated by FDA ................................................................... 1 1 1 1 1 

Total .............................................................................. 1 1 1 1 1 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

VII. Request for Comments 

FDA invites comments from 

interested persons on the new draft 

standard MOU that would establish an 

agreement between the signatory States 

and FDA regarding the appropriate 

investigation by such States of 

complaints relating to compounded 

human drug products distributed 

outside the State, and the distribution of 

inordinate amounts of compounded 

human drug products interstate. The 

Agency is providing a 120-day comment 

period. 

After considering any comments on 

the new draft standard MOU submitted 

to this docket, FDA intends to finalize 

the standard MOU and make it available 

for signature by individual States. FDA 

will determine at the time of publication 

of the final MOU how long it will allow 

States to consider whether to sign the 

MOU before FDA begins to enforce the 

5 percent limit in those States that have 

not signed an MOU. 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

VIII. Electronic Access 

Persons with access to the Internet 

may obtain the draft standard MOU at 

http://www.regulations.gov. 

Dated: February 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03420 Filed 2–18–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1525] 

Mixing, Diluting, or Repackaging 

Biological Products Outside the Scope 

of an Approved Biologics License 

Application; Draft Guidance for 

Industry; Availability 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Mixing, 

Diluting, or Repackaging Biological 

Products Outside the Scope of an 

Approved Biologics License 

Application.’’ This draft guidance 

describes the conditions under which 

FDA does not intend to take action 

against a state-licensed pharmacy, a 

Federal facility, or outsourcing facility 

that mixes, dilutes, or repackages 

certain biological products without 

obtaining an approved biologics license 

application (BLA). 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 20, 2015. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002; or the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Avenue, Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Leah Christl, Center for Drugs 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6426, 

Silver Spring, MD 20903, 301–796– 

0869; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 


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