[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Notices]
[Pages 37742-37743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1444]


Final Guidance; Pharmacy Compounding of Human Drug Products Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a guidance entitled ``Pharmacy 
Compounding of Human Drug Products Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act.'' The guidance announces the Agency's 
intention with regard to enforcement of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, 
now that the FD&C Act has been amended by the Drug Quality and Security 
Act (DQSA). The guidance reflects the Agency's current thinking on the 
issues addressed by the guidance.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communications, 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. 
Send one self-addressed adhesive label to assist that office in 
processing your request. 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: Marissa Chaet Brykman, 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

    FDA is announcing the availability of a guidance entitled 
``Pharmacy Compounding of Human Drug Products Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act.'' The guidance provides 
information to compounders of human drug products on the Agency's 
application of section 503A of the FD&C Act (21 U.S.C. 353a) and 
current enforcement policies relating to the compounding of human drug 
products.
    Section 503A of the FD&C Act describes the conditions that must be 
satisfied for drug products compounded by a licensed pharmacist or 
licensed physician to be exempt from the following three 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); (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). All other applicable provisions of the FD&C Act 
remain in effect for compounded drugs, however, even if the conditions 
in section 503A are met.
    Previously, the conditions of section 503A of the FD&C Act also 
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.\1\ In 2013, the DQSA amended section 503A 
of the FD&C Act to remove the unconstitutional advertising, promotion, 
and solicitation provisions. As a result, it is necessary to explain 
FDA's current thinking with regard to section 503A of the FD&C Act. 
Several provisions of section 503A of the FD&C Act require rulemaking 
and consultation with a Pharmacy Compounding Advisory Committee to 
implement. In the guidance, FDA explains how those provisions will be 
applied pending those consultations and rulemaking.
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    \1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357 
(2002).
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    Among other things, the guidance restates the provisions in section 
503A of the FD&C Act that remain in effect, describes FDA's interim 
policies with respect to specific provisions in section 503A that 
require implementing regulations or other actions, and contains a non-
exhaustive list of potential enforcement actions against individuals or 
firms that compound human drug products that do not meet the conditions 
of section 503A.
    In the Federal Register of December 4, 2013 (78 FR 72901), FDA 
issued a document announcing the availability of the draft version of 
this guidance and the withdrawal of both the May 2002 Compliance Policy 
Guide entitled ``Pharmacy Compounding'' and the November 1998 guidance 
for industry entitled ``Enforcement Policy During Implementation of 
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The comment 
period on the draft guidance ended on February 3, 2014. Many of the 
received comments raise issues that the Agency intends to address in 
other policy documents and were not directly pertinent to the topics 
addressed in this guidance. These comments will be further considered 
if relevant to another policy document developed by the Agency.
    FDA made the following changes in the final guidance: (1) Inserted 
references to the Federal Register documents seeking nominations for 
the bulk drug substances and difficult-to-compound lists under section 
503A (78 FR 72841, December 4, 2013, and 78 FR 72840, December 4, 2013, 
respectively); (2) modified the language that discusses the time period 
during which the MOU will be made available to the States for their 
consideration and signature and the time period with regard to the 
enforcement of the 5 percent limit if a State chooses not to sign the 
MOU; and (3) made grammatical and other minor editorial changes for 
clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking regarding section 503A of the FD&C Act and 
human drug compounding. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. 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

[[Page 37743]]

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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15372 Filed 7-1-14; 8:45 am]
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