81 FR 22611 - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 74 (April 18, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Section 503B defines an outsourcing facility, in part, as ``a facility at one geographic location or address.'' FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.

[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22611-22612]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08878]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0238]


Facility Definition Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Facility 
Definition Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' Section 503B defines an outsourcing facility, in part, as ``a 
facility at one geographic location or address.'' FDA has received 
questions from outsourcing facilities and other stakeholders about the 
meaning of this term, such as whether multiple suites used for 
compounding human drugs at a single street address constitute one or 
multiple facilities, or whether a single location where human drugs are 
compounded can be subdivided into separate operations compounding under 
different standards. FDA is issuing this draft guidance to answer these 
questions.

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draft guidance before it begins work on the final version of the 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 July 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-0238 for ``Facility Definition Under Section 503B of the 
Federal Food, Drug, and Cosmetic Act; Availability.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug 
Evaluation

[[Page 22612]]

and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Facility Definition Under Section 503B of the Federal Food, 
Drug, and Cosmetic Act.''
    Section 503B, added to the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) by the Drug Quality and Security Act in 2013, created a 
new category of compounders called outsourcing facilities. Section 503B 
describes the conditions that must be satisfied for human drug products 
compounded by or under the direct supervision of a licensed pharmacist 
in an outsourcing facility to qualify for exemptions from three 
sections of the FD&C Act:
     Section 502(f)(1) (concerning labeling requirements);
     Section 505 (concerning drug approval requirements); and
     Section 582 (concerning Drug Supply Chain Security Act 
requirements).
    Section 503B(d)(4) of the FD&C Act defines an outsourcing facility 
as a facility at one geographic location or address that: (1) Is 
engaged in the compounding of sterile drugs; (2) has elected to 
register as an outsourcing facility; and (3) complies with all of the 
requirements of this section. In addition, an outsourcing facility is 
not required to be a licensed pharmacy, and it may or may not obtain 
prescriptions for identified individual patients. Because drugs 
compounded by outsourcing facilities are not exempt from section 
501(a)(2)(B) of the FD&C Act, outsourcing facilities are subject to 
current good manufacturing practice (CGMP) requirements.
    FDA has received questions from outsourcing facilities and other 
stakeholders about the meaning of the term ``facility at one geographic 
location or address,'' such as whether multiple suites used for 
compounding human drugs at a single street address constitute one or 
multiple facilities, or whether a single location where human drugs are 
compounded can be subdivided into separate operations compounding under 
different standards. FDA is issuing this draft guidance to answer these 
questions.
    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 current thinking of FDA on the meaning of 
the term ``facility at one geographic location or address'' under 
section 503B of the FD&C Act. It does not establish 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. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08878 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P