[Federal Register Volume 80, Number 155 (Wednesday, August 12, 2015)]
[Notices]
[Pages 48324-48325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19740]
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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; 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 entitled ``Guidance for Entities
Considering Whether to Register as Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is
intended to inform entities that are considering registering as
outsourcing facilities under section 503B of the Federal Food, 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: Submit either electronic or written comments on Agency guidances
at any time.
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 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the 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 final 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 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.
In the Federal Register of February 19, 2015 (80 FR 8871), FDA
issued a notice announcing the availability of the draft version of
this guidance. The comment period on the draft guidance ended on May
20, 2015. FDA received eleven comments on the draft guidance. Some of
the 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) Removed the
reference to a separate guidance document that explains how outsourcing
facilities should report the products they compound to FDA because that
guidance is not directly related to the issue of entities considering
whether to register as outsourcing facilities; (2) noted that FDA has
issued separate guidance documents addressing some of the conditions of
section 503B and that it intends to publish additional guidance
addressing other conditions; (3) added a reference to FDA's draft
guidance regarding compounding animal drug products from bulk drug
substances, which addresses outsourcing facilities engaging in this
activity; and (4) 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 on registering as an outsourcing facility
under section 503B of the FD&C Act. It does not create any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it 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
[[Page 48325]]
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: August 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19740 Filed 8-11-15; 8:45 am]
BILLING CODE 4164-01-P