[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