80 FR 65781 - Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (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 65781-65783]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3517]


Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance; Availability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the availability of a draft guidance entitled ``Interim Policy on 
Compounding Using Bulk Drug Substances Under Section 503A of the 
Federal Food, Drug, and Cosmetic Act.'' The draft guidance describes 
FDA's interim regulatory policy regarding the use of bulk drug 
substances by licensed pharmacists in State-licensed pharmacies or 
Federal facilities and by licensed physicians to compound human drug 
products while FDA develops the list of bulk drug substances that can 
be used in compounding under the Federal Food, Drug, and Cosmetic Act 
(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

[[Page 65782]]

considers your comment on the 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 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-3517 for ``Interim Policy on Compounding Using Bulk Drug 
Substances Under Section 503A of the Federal Food, Drug, and Cosmetic 
Act; Draft Guidance; 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 
Sections 503A of the Federal Food, Drug, and Cosmetic Act.'' Section 
503A of the FD&C Act describes the conditions that must be satisfied 
for human drug products compounded by a licensed pharmacist in a State-
licensed pharmacy or Federal facility, or by a licensed physician, to 
be exempt from the following three sections of the FD&C Act: Section 
505 (concerning the approval of drugs under new drug applications or 
abbreviated new drug applications); section 502(f)(1) (concerning the 
labeling of drugs with adequate directions for use); and section 
501(a)(2)(B) (concerning current good manufacturing practice 
requirements).
    One of the conditions that must be met for a compounded drug 
product to qualify for these exemptions is that a licensed pharmacist 
or licensed physician compounds the drug product using bulk drug 
substances that: (1) Comply with the standards of an applicable United 
States Pharmacopeia (USP) or National Formulary (NF) monograph, if a 
monograph exists, and the USP chapter on pharmacy compounding; (2) if 
such a monograph does not exist, are drug substances that are 
components of drugs approved by the Secretary; or (3) if such a 
monograph does not exist and the drug substance is not a component of a 
drug approved by the Secretary, appears on a list developed by the 
Secretary through regulations issued by the Secretary under subsection 
(c) of section 503A. (See section 503A(b)(1)(A)(i) of the FD&C Act).
    This guidance describes the conditions under which FDA does not 
intend to take action against a licensed pharmacist or licensed 
physician for compounding a drug product from a bulk drug substance 
that is not the subject of an applicable USP or NF monograph, is not a 
component of an FDA-approved drug, or does not appear on the list of 
bulk drug substances that can be used in compounding under section 
503A(b)(1)(A)(i)(III) of the FD&C Act by a licensed pharmacist or 
licensed physician while FDA is developing the list.
    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 503B of 
the Federal Food, Drug, and Cosmetic Act,'' which describes conditions 
under

[[Page 65783]]

which FDA does not intend to object to the compounding of a drug 
product from certain bulk drug substances by an outsourcing facility 
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.
    The final guidance ``Pharmacy Compounding of Human Drug Products 
Under Section 503A of the FD&C Act,'' (503A Final Guidance) published 
in 2014 (79 FR 37742; July 2, 2014), states, ``Until a bulk drug 
substances list is published in the Federal Register as a final rule, 
human drug products should be compounded using only bulk drug 
substances that are components of drugs approved under section 505 of 
the FD&C Act, or are the subject of USP or NF monographs.'' Because 
this draft interim guidance proposes to change the Agency's policy 
relating to compounding with bulk drug substances while FDA develops a 
list of bulk drug substances that can be used in compounding, FDA is 
adding a footnote to the 503A Final Guidance referencing this draft 
interim guidance. Once this draft interim guidance is finalized, FDA 
intends to remove that footnote from the 503A Final Guidance and cross-
reference the final interim guidance as establishing the policy for 
compounding with bulk drug substances during the development of the 
503A bulks list. The footnote is being added to the 503A Final Guidance 
as a Level 2 change under 21 CFR 10.115 because the final interim 
guidance, rather than the footnote to the 503A Final Guidance, will set 
forth the actual change in policy. Accordingly, comments on the 
proposed change in policy are being solicited as part of this Notice of 
Availability on the draft interim guidance.

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. 2015-27269 Filed 10-26-15; 8:45 am]
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