[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8871-8872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03416]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1399]
Guidance for Entities Considering Whether To Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act; Draft Guidance for Industry; Availability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availability of a draft guidance entitled ``Guidance for Entities
Considering Whether to Register as Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance
is intended to inform entities that are considering registering as
outsourcing facilities under section 503B of the Federal Food,
[[Page 8872]]
Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and
Security Act (DQSA), of the regulatory implications of registration as
an outsourcing facility.
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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 20, 2015.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, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993. 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: Sara Rothman, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Guidance for Entities Considering Whether to Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' On November 27, 2013, President Obama signed the
DQSA (Pub. L. 113-54) into law. The DQSA added a new section 503B to
the FD&C Act that created a category of entities 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).
FDA has received questions about whether entities engaged in
various types of activities (e.g., a facility that is compounding only
non-sterile drugs or only repackaging biological products) should
register as an outsourcing facility. Because entities that register as
outsourcing facilities in fiscal year 2015 (beginning October 1, 2014)
must pay a registration fee and FDA has determined that fees paid
pursuant to sections 503B and 744K of the FD&C Act will not be
refunded, FDA is issuing this guidance to answer some of these
questions and to provide potential registrants additional information
about the regulatory impact of registering as an outsourcing facility.
Elsewhere in this volume of the Federal Register, FDA is announcing
the availability of separate FDA guidance documents on (1) mixing,
diluting, or repackaging biological products outside the scope of an
approved biologics license application, and (2) repackaging certain
human drug products by pharmacies and outsourcing facilities. These
guidance documents describe FDA's compliance policies with respect to
biological products that are mixed, diluted, or repackaged outside the
scope of an approved biologics license application and repackaged human
drugs.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on registering
as an outsourcing facility under section 503B of the FD&C Act. 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 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: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03416 Filed 2-18-15; 8:45 am]
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