[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7390-7391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03807]


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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; 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 final 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 
guidance describes policies that FDA intends 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: The announcement of the guidance is published in the Federal 
Register on March 4, 2019.

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 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

[[Page 7391]]

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 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 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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 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 guidance also addresses the factors 
and processes by which the Agency intends to evaluate and list bulk 
drug substances.
    In the Federal Register of March 26, 2018 (83 FR 12952), FDA issued 
a notice announcing the availability of the draft version of this 
guidance. The comment period ended on May 25, 2018. FDA received 
approximately 60 comments on the draft guidance. In response to 
received comments or on its own initiative, FDA made certain changes to 
the guidance. For example, FDA has further explained how Congress' 
limitation on bulk drug substances that can be used in compounding 
under section 503B helps to preserve the integrity of the new drug 
approval process and identified the process to request that FDA add or 
remove a bulk drug substance from the 503B Bulks List after the Agency 
has made a final determination with respect to that substance in the 
Federal Register.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents 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 guidance is not subject to Executive 
Order 12866.

II. Electronic Access

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

    Dated: February 26, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03807 Filed 3-1-19; 8:45 am]
BILLING CODE 4164-01-P