[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72901-72902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance; Pharmacy Compounding of Human Drug Products Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act; Withdrawal of 
Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the availability of a draft guidance entitled ``Pharmacy 
Compounding of Human Drug Products Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act''. The draft guidance announces the 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. When final, the guidance will reflect the 
Agency's current thinking on the issues addressed by the guidance.
    The Agency is also announcing the withdrawal of a guidance 
entitled, ``Enforcement Policy During Implementation of Section 503A of 
the Federal Food, Drug, and Cosmetic Act,'' which was issued in 
November 1998, and the withdrawal of CPG Section 460.200 of the 
Compliance Program Guidance (CPG) Manual entitled, ``Pharmacy 
Compounding,'' which was issued in May 2002. These guidances are being 
withdrawn because they are no longer consistent with the Agency's 
current thinking on the issues they address.

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 the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 3, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Policy, Office of Enforcement, 
Food and Drug Administration, rm. 4025, 12420 Parklawn Dr., Rockville, 
MD 20857. Send one self-addressed adhesive label to assist that office 
in processing your request. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance.

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. Announcement of Draft Guidance

    FDA is announcing the availability of a draft guidance entitled 
``Pharmacy Compounding of Human Drug Products Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act.'' The draft guidance provides 
information to compounders of human drug products and to FDA staff 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

[[Page 72902]]

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.
    The conditions of section 503A of the FD&C Act 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 struck down as unconstitutional by the U.S. Supreme Court 
in 2002.\1\ Now that section 503A has been amended by the Drug Quality 
and Security Act to remove the unconstitutional advertising, promotion, 
and solicitation provisions, it is necessary to explain FDA's current 
thinking with regard to section 503A. Several provisions of section 
503A require rulemaking and consultation with a Pharmacy Compounding 
Advisory Committee to implement. In the draft guidance, we explain 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 draft guidance restates the provisions in 
section 503A 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.
    FDA is issuing the draft guidance as level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance, when finalized, will represent FDA'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. Withdrawal of 1998 Guidance and 2002 CPG

    In a notice published in the Federal Register of November 23, 1998 
(63 FR 64723), FDA announced the availability of a guidance entitled 
``Enforcement Policy During Implementation of Section 503A of the 
Federal Food, Drug, and Cosmetic Act,'' which is now being withdrawn. 
In a notice published in the Federal Register of June 7, 2002 (67 FR 
39409), FDA announced the availability of CPG Section 460.200 of the 
Compliance Program Guidance Manual entitled ``Pharmacy Compounding,'' 
which is also now being withdrawn. These two documents are being 
withdrawn because they are no longer consistent with FDA's current 
thinking on the issues they address.

III. Request for Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or by 
FAX: 301-827-6870. It is only necessary to send one set of comments. 
Identify comments with the docket number found in the 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.

IV. Electronic Access

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

    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
 [FR Doc. 2013-28963 Filed 12-2-13; 11:15 am]
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