80 FR 12504 - Compounding of Human Drug Products Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 45 (March 9, 2015)

The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets.

[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12504-12505]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0030]


Compounding of Human Drug Products Under the Federal Food, Drug, 
and Cosmetic Act; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of public docket.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
establishing a public docket to receive information, recommendations, 
and comments on matters related to the Agency's regulation of 
compounding of human drug products under sections 503A and 503B of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is 
intended for general comments related to human drug compounding that 
are not specific to documents or issues that are the subject of other 
dockets.

DATES: Comments may be submitted to this docket at any time.

ADDRESSES: You may submit comments, identified by Docket No. [FDA-2015-
N-0030], by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written comments in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. [FDA-2015-N-0030]. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Philantha Bowen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg.51, Rm. 5175, Silver Spring, MD 20993-0002, 301-
796-2466.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 503A of the FD&C Act (21 U.S.C. 353a) describes the 
conditions that must be satisfied for human 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). 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\
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    \1\ See Thompson v. Western States Med. Ctr., 535 U.S. 357 
(2002).
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    On November 27, 2013, President Obama signed the Drug Quality and 
Security Act (DQSA) (Pub. L. 113-54), which contains important 
provisions relating to the oversight of human drug compounding. This 
new law removes from section 503A of the FD&C Act the provisions that 
had been held unconstitutional by the U.S. Supreme Court in 2002. By 
removing these provisions, the new law clarifies that section 503A of 
the FD&C Act applies nationwide. In addition, the DQSA adds a new 
section, 503B, to the FD&C Act (21 U.S.C. 353b) that creates a new 
category of ``outsourcing facilities''. Outsourcing facilities, as 
defined in section 503B of the FD&C Act, are facilities that meet 
certain conditions described in section 503B, including registration 
with FDA as an outsourcing facility. If these conditions are satisfied, 
a drug compounded for human use by or under the direct supervision of a 
licensed pharmacist in an outsourcing facility is exempt from three 
sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and 
(3) section 582 (21 U.S.C. 360eee), but not section 501(a)(2)(B).
    Since enactment of the DQSA, FDA has sought public comment on a 
number of specific human drug compounding issues and has published 
several Federal Register notices seeking public input. These have 
included notices inviting comment on the registration process and 
product reporting requirements for human drug compounding outsourcing 
facilities (78 FR 72899 and 78 FR 72897), requesting nominations for 
the list of drugs that present demonstrable difficulties for 
compounding (78 FR 72840), and seeking input on other specific matters. 
A complete list of the human drug compounding policy documents issued 
by the Agency for public comment can be found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm166743.htm. The Agency will continue to seek public comment on 
specific documents and issues through future Federal Register notices. 
The Agency recognizes, however, that it would be useful to have a 
docket available for submissions of any information related to human 
drug compounding that may be unrelated to the specific issues and 
documents published for public comment.

II. Establishment of a Docket

    FDA is establishing a public docket so that anyone can share 
information, research, and ideas on any matters related to human drug 
compounding that are not specific to the documents or issues addressed 
in other dockets. This information will give the Agency insight into 
stakeholders' experiences and views regarding human drug compounding as 
the Agency works to implement sections 503A and 503B of the FD&C Act.
    This docket will be open for comment simultaneously with a number 
of other dockets that are specific to particular human drug compounding 
documents or issues (see http://www.fda.gov/drugs/

[[Page 12505]]

guidancecomplianceregulatoryinformation/pharmacycompounding/default.htm 
for a list of specific human drug compounding policy documents open for 
public comment). Please do not submit comments to this general docket 
that have already been submitted to specific dockets. Such submissions 
are duplicative and not helpful to the Agency. If comments on 
particular documents or issues are submitted to this docket rather than 
the docket specifically opened for the particular document or issue, 
the comment might not be considered as the specific documents are being 
finalized and issues considered. FDA will not respond to questions or 
requests submitted to this docket but will consider any information 
submitted in its work to implement the law.
    Information in the docket will be publicly available. Therefore, we 
remind commenters not to submit personal or confidential information.
    Interested persons may submit either electronic comments 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 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.

    Dated: March 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05376 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P