80 FR 65768 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 207 (October 27, 2015)

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance.

[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65768-65769]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3539]


Interim Policy on Compounding Using Bulk Drug Substances 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Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability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announcing the availability of a draft guidance entitled ``Interim 
Policy on Compounding Using Bulk Drug Substances Under Section 503B of 
the Federal Food, Drug, and Cosmetic Act.'' The draft guidance 
describes FDA's interim regulatory policy regarding outsourcing 
facilities that compound human drug products using bulk drug substances 
while FDA develops the list of bulk drug substances that can be used in 
compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act). When final, the guidance will reflect the Agency's current 
thinking on the issues addressed by the guidance.

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draft guidance before it begins work on the final version of the 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 December 28, 2015.

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

[[Page 65769]]

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-2015-D-3539 for ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503B of the Federal Food, Drug, and Cosmetic 
Act; Draft Guidance for Industry; 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 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 20993-0002, 301-
796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' A new 
section 503B (21 U.S.C. 353b), added to the FD&C Act by the Drug 
Quality and Security Act (Pub. L. 113-54) 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: (1) It appears on a list 
established by the Secretary identifying bulk drug substances for which 
there is a clinical need (see section 503B(a)(2)(A)(i) of the FD&C Act) 
or (2) the drug product 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 describes the conditions under which FDA does not 
intend to take action against an outsourcing facility for compounding a 
drug product from a bulk drug substance that does not appear on a list 
of bulk drug substances that may be used in compounding and is not used 
to compound a drug product that appears on the FDA drug shortage list 
at the time of compounding, distribution, and dispensing, while FDA 
develops the list of bulk drug substances that can be used in 
compounding under section 503B(a)(2)(A)(i) of the FD&C Act.
    Elsewhere in this issue of the Federal Register, the Agency is 
making available for public comment a draft guidance entitled ``Interim 
Policy on Compounding Using Bulk Drug Substances Under Section 503A of 
the Federal Food, Drug, and Cosmetic Act,'' which describes the 
conditions under which FDA does not intend to take action against a 
licensed pharmacist at a State-licensed pharmacy or a Federal facility 
for compounding a drug product from a bulk drug substance that cannot 
otherwise be used in compounding under section 503A of the FD&C Act 
while FDA develops the list of bulk drug substances that can be used in 
compounding under section 503A(b)(1)(A)(i)(III).

II. Electronic Access

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

    Dated: October 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27268 Filed 10-26-15; 8:45 am]
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