[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Rules and Regulations]
[Pages 37500-37502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[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; 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 guidance for industry entitled 
``Interim Policy on Compounding Using Bulk Drug Substances Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The 
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).

DATES: Submit electronic or written comments on Agency guidances at any 
time.

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

[[Page 37501]]

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''. 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 guidance for industry 
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 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: 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 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 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 can 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 pursuant to section 503B(a)(2)(A)(i) of the FD&C Act (503B 
bulks list).\1\
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    \1\ Elsewhere in this issue of the Federal Register, the Agency 
is making available a 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 in a State-licensed pharmacy or Federal 
facility, or a licensed physician, 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).
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    The guidance also describes FDA's process to establish the 503B 
bulks list, and it describes categories of substances that were 
nominated for inclusion on the 503B bulks list. These categories 
include:
     503B Category 1--Bulk Drug Substances Under Evaluation: 
These bulk drug substances may be eligible for inclusion on the 503B 
bulks list, were nominated with sufficient supporting information for 
FDA to evaluate them, and do not appear on any other list.
     503B Category 2--Bulk Drug Substances That Raise 
Significant Safety Risks: These bulk drug substances were nominated 
with sufficient supporting information to permit FDA to evaluate them 
and they may be eligible for inclusion on the 503B bulks list. However, 
FDA has identified significant safety risks relating to the use of 
these bulk substances in compounding, and therefore does not intend to 
adopt the policy described for the bulk substances in Category 1.
     503B Category 3--Bulk Drug Substances Nominated Without 
Adequate Support: These bulk drug substances may be eligible for 
inclusion on the 503B bulks list but were nominated with insufficient 
supporting information for FDA to evaluate them. These substances can 
be re-nominated with sufficient supporting information

[[Page 37502]]

through a docket that FDA has established.
    In the Federal Register of October 27, 2015 (80 FR 65768), FDA 
issued a notice announcing the availability of the draft version of 
this guidance. The comment period on the draft guidance ended on 
December 28, 2015. FDA received 11 comments on the draft guidance. In 
response to received comments or on its own initiative, FDA made 
several changes to the guidance to clarify particular points. In 
addition, FDA has made the following updates to the lists on its Web 
site of bulk drug substances that were nominated for inclusion on the 
503A bulks list: \2\
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    \2\ In the future, if FDA makes changes to the categories of 
bulk drug substances on its Web site, we intend to follow the 
procedure identified in the guidance.
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     503B Category 2: FDA has added one bulk drug substances to 
Category 2, germanium sesquioxide, because FDA identified significant 
safety risks relating to the use of this bulk drug substance in 
compounding.
     503B Category 4: The draft interim guidance included a 
fourth category of bulk drug substances that would have identified 
substances that FDA evaluated for inclusion on the 503B bulks list but, 
after obtaining and considering public comments, decided not to place 
on the 503B bulks list. In the final interim guidance, FDA removed this 
fourth category because the Agency intends to identify the bulk drug 
substances that will not be placed on the 503B bulks list in the 
Federal Register notice that establishes the 503B bulks list. 
Therefore, we do not believe it is necessary to also include them in 
the categories identified in this guidance.

II. Electronic Access

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

    Dated: June 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13798 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P