Document ID: FDA-2018-D-1067-0001
Agency: fda
Document Type: Notice
Title: Evaluation of Bulk Drug Substances Nominated for Use in Compounding
Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability
Posted Date: 2018-03-26T04:00Z

[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Pages 12952-12953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1067]

Evaluation of Bulk Drug Substances Nominated for Use in 
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act; Draft Guidance for Industry; Availability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 the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Evaluation of Bulk Drug Substances Nominated for Use in Compounding 
Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This 
draft guidance describes policies that FDA proposes to use in 
evaluating bulk drug substances nominated for use in compounding under 
section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for 
inclusion on the list of bulk drug substances that can be used in 
compounding under section 503B.

DATES: Submit either electronic or written comments on the draft 
guidance by May 25, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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

[[Page 12953]]

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 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-2018-D-1067 for ``Evaluation of Bulk Drug Substances Nominated for 
Use in Compounding 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 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 and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20903, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Evaluation of Bulk Drug Substances Nominated for Use in 
Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act.'' Section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug 
Quality and Security Act in 2013, describes the conditions that must be 
satisfied for human drug products compounded by an outsourcing facility 
to be exempt from the following three sections of the FD&C Act: section 
505 (21 U.S.C. 355) (concerning the approval of drugs under new drug 
applications or abbreviated new drug applications); section 502(f)(1) 
(21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate 
directions for use); and section 582 (21 U.S.C. 360eee-1) (concerning 
drug supply chain security requirements). One of the conditions that 
must be met for a drug product compounded by an outsourcing facility to 
qualify for these exemptions is that the outsourcing facility does not 
compound drug products using a bulk drug substance unless either: (1) 
It appears on a list established by the Secretary of Health and Human 
Services identifying bulk drug substances for which there is a clinical 
need (see section 503B(a)(2)(A)(i) of the FD&C Act) (503B Bulks List) 
or (2) the drug compounded from such bulk drug substances appears on 
the drug shortage list in effect under section 506E of the FD&C Act (21 
U.S.C. 356e) at the time of compounding, distribution, and dispensing 
(see section 503B(a)(2)(A)(ii) of the FD&C Act).
    This draft guidance addresses FDA policies for developing the 503B 
Bulks List, including the Agency's interpretation of the phrase ``bulk 
drug substances for which there is a clinical need,'' as it is used in 
section 503B of the FD&C Act. The draft guidance also addresses the 
factors and processes by which the Agency intends to evaluate and list 
bulk drug substances.
    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 ``Evaluation 
of Bulk Drug Substances Nominated for Use in Compounding 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 draft 
guidance is not subject to Executive Order 12866.

II. Electronic Access

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

    Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06046 Filed 3-23-18; 8:45 am]
 BILLING CODE 4164-01-P