[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and Cosmetic Act; Draft Guidance for Industry; Availability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availability of a draft guidance entitled ``Guidance for Entities 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 20, 2015.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    FDA is announcing the availability of a draft guidance for industry 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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