[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69859-69860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1429]


Registration of Human Drug Compounding Outsourcing Facilities 
Under Section 503B of the FD&C Act; Final Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry entitled ``Registration 
of Human Drug Compounding Outsourcing Facilities Under Section 503B of 
the FD&C Act.'' The guidance addresses new provisions in the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug 
Quality and Security Act (DQSA). The guidance is intended to assist 
human drug compounders that elect to register as outsourcing facilities 
in registering, re-registering, or de-registering with FDA. The 
guidance provides information on how an outsourcing facility should 
submit facility registration information electronically in structured 
product labeling (SPL) format using FDA's electronic submission system. 
This 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 the final 
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. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the final guidance document. Submit electronic comments on 
the final 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: Soo Jin Park, Drug Registration and 
Listing Team, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3100.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Registration of Human Drug Compounding Outsourcing 
Facilities Under Section 503B of the FD&C Act.'' This guidance is being 
issued consistent with the new authority conferred to FDA in the DQSA 
(Pub. L. 113-54). In that legislation, Congress created a new category 
for certain facilities that

[[Page 69860]]

compound human drugs called ``outsourcing facilities.'' Section 
503B(d)(4) of the FD&C Act (21 U.S.C. 353B(d)(4)) defines an 
outsourcing facility, in part, as a facility that complies with all of 
the requirements of section 503B, including registering with FDA as an 
outsourcing facility and paying associated fees. If the conditions 
outlined in section 503B(a) of the FD&C Act are satisfied, a drug 
compounded by or under the direct supervision of a licensed pharmacist 
in an outsourcing facility is exempt from certain sections of the FD&C 
Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the 
labeling of drugs with adequate directions for use) and section 505 (21 
U.S.C. 355) (concerning the approval of human drug products under new 
drug applications (NDAs) or abbreviated new drug applications (ANDAs)). 
Drugs compounded in outsourcing facilities are not exempt from the 
requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 
351(a)(2)(B)) (concerning current good manufacturing practice for 
drugs). This guidance is intended to assist compounding facilities that 
wish to register as outsourcing facilities to register with FDA and 
discusses the process for registering, re-registering, and de-
registering.
    In the Federal Register of December 4, 2013 (78 FR 72899), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. That draft guidance set forth an interim and electronic 
submission method for human drug compounders that elect to register as 
outsourcing facilities. The comment period on the draft guidance ended 
on February 3, 2014. FDA received nine comments on the draft guidance. 
Some of the received comments raised issues that were not directly 
pertinent to the topics addressed in this guidance. FDA intends to 
consider those comments as they relate to issues being addressed in 
other policy documents being developed by the Agency.
    In response to received comments or on its own initiative, FDA made 
the following changes as it finalized this guidance: (1) We included a 
phone number for a point of contact; (2) we deleted reference to an 
alternative interim registration method; (3) we added information on 
how a registered outsourcing facility can de-register; (4) we clarified 
what registration information will be made public; (5) we clarified the 
standard to be used to grant a waiver of the electronic submission 
requirements; and (6) we made grammatical and other minor editorial 
changes to improve 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 on this topic. 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. Paperwork Reduction Act

    This guidance contains collections of information that are subject 
to review by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information have been approved under OMB control number 0910-0777.

III. Comments

    Interested persons can 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27693 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P