Document ID: FDA-2016-D-0238-0027
Agency: fda
Document Type: Notice
Title: Facility Definition Under Section 503B of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry; Availability
Posted Date: 2018-05-11T04:00Z

[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22083-22085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10046]

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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; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final 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 guidance to provide the 
Agency's current thinking on these questions and related issues 
regarding how to ensure that the compounding of drugs in an outsourcing 
facility occurs only in accordance with section 503B.

DATES: The announcement of the guidance is published in the Federal 
Register on May 11, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal. https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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

[[Page 22084]]

identifies you in the body of your comments, that information will be 
posted on https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Facility Definition Under Section 503B of the Federal Food, 
Drug, and Cosmetic Act.'' Section 503B (21 U.S.C. 353b), added to the 
Federal Food, Drug, and Cosmetic Act (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) (21 U.S.C. 352(f)(1)) (concerning 
labeling requirements);
     Section 505 (21 U.S.C. 355) (concerning drug approval 
requirements); and
     Section 582 (21 U.S.C. 360eee-1) (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 (21 U.S.C. 351(a)(2)(B)), outsourcing 
facilities are subject to current good manufacturing practice 
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 guidance to provide its 
current thinking on these questions and related issues regarding how to 
ensure that the compounding of drugs in an outsourcing facility occurs 
only in accordance with section 503B.
    In the Federal Register of April 18, 2016 (81 FR 22611), FDA issued 
a notice announcing the availability of the draft version of this 
guidance. The comment period on the draft guidance ended on July 18, 
2016. FDA received 19 comments on the draft guidance. In response to 
received comments, FDA made certain changes. In particular, FDA revised 
the guidance to provide for a compounder seeking to operate under 
section 503A of the FD&C Act (21 U.S.C. 353a) to be located next to an 
outsourcing facility provided that there is complete segregation 
between the outsourcing facility and the 503A compounder.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Facility Definition Under Section 503B of 
the Federal Food, Drug, and Cosmetic 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. This guidance is not subject to 
Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either

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https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10046 Filed 5-10-18; 8:45 am]
 BILLING CODE 4164-01-P