Document ID: FDA-2016-D-1267-0032
Agency: fda
Document Type: Notice
Title: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Posted Date: 2018-01-19T05:00Z

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2786-2787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00914]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1267]

Compounded Drug Products That Are Essentially Copies of Approved 
Drug Products 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 Agency) is announcing 
the availability of a guidance for industry entitled ``Compounded Drug 
Products That Are Essentially Copies of Approved Drug Products Under 
Section 503B of the Federal Food, Drug, and Cosmetic Act.'' For a drug 
product compounded by an outsourcing facility to qualify for the 
exemptions under section 503B of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), it must not be essentially a copy of one or more 
approved drug products and must meet other conditions in section 503B. 
This guidance sets forth FDA's policies concerning the ``essentially a 
copy'' provision of section 503B of the FD&C Act.

DATES: The announcement of the guidance is published in the Federal 
Register on January 19, 2018.

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-2016-D-1267 for ``Compounded Drug Products That Are Essentially 
Copies of Approved Drug Products 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 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 ``Compounded Drug Products That Are Essentially Copies of 
Approved Drug Products Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.'' In 2013, the Drug Quality and Security Act, created 
new section 503B of the FD&C Act (21 U.S.C. 353b), which describes a 
new category of compounders called outsourcing facilities. Section 503B 
of the FD&C Act describes the conditions that must be satisfied for 
human drug products compounded by or under the direct supervision of a 
licensed pharmacist in an outsourcing facility to qualify for 
exemptions from the following three sections of the FD&C Act:
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning 
labeling of drugs with adequate directions for use);

[[Page 2787]]

     Section 505 (21 U.S.C. 355) (concerning the approval of 
drugs under new drug applications or abbreviated new drug 
applications); 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 compounded drug 
product to qualify for the exemptions under section 503B of the FD&C 
Act is that the drug is not essentially a copy of one or more approved 
drugs (section 503B(a)(5)).
    Section 503B(d)(2) defines essentially a copy of an approved drug 
as:
     A drug that is identical or nearly identical to an 
approved drug, or a marketed drug not subject to section 503(b) and not 
subject to approval in an application submitted under section 505, 
unless, in the case of an approved drug, the drug appears on the drug 
shortage list in effect under section 506E at the time of compounding, 
distribution, and dispensing (section 503B(d)(2)(A)) or
     a drug, a component of which is a bulk drug substance that 
is a component of an approved drug or a marketed drug that is not 
subject to section 503(b) and not subject to approval in an application 
submitted under section 505, unless there is a change that produces for 
an individual patient a clinical difference, as determined by the 
prescribing practitioner, between the compounded drug and the 
comparable approved drug (section 503B(d)(2)(B)).
    This guidance sets forth FDA's policies concerning the 
``essentially a copy'' provision of section 503B of the FD&C Act.
    In the Federal Register of July 11, 2016 (81 FR 44879), FDA issued 
a notice announcing the availability of the draft version of this 
guidance. The comment period on the draft guidance ended on October 11, 
2016. FDA received 29 comments on the draft guidance. In response to 
received comments or on its own initiative, FDA made several changes. 
For example, in response to requests in comments for direction on 
records retention, FDA added a recommendation that compounders maintain 
the records described in the guidance for at least 3 years. In 
addition, to address questions raised in comments, FDA clarified that 
the Agency does not intend to take action against an outsourcing 
facility for failing to compound in accordance with section 503B(a)(5) 
if it fills orders for a compounded drug that is essentially a copy of 
an approved drug that has been discontinued and is no longer marketed.
    FDA received comments from hospital organizations regarding the 
potential implications of proposed policies for the preparation of 
compounded drugs used in in-patient settings. The final guidance notes 
that FDA is considering the applicability of the policies described in 
this guidance to hospitals and health systems. We recognize that this 
issue is of interest to many stakeholders and will publicly convey our 
further thinking on the applicability of these policies to hospitals 
and health systems with an opportunity for comment.
    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 ``Compounded Drug Products That Are 
Essentially Copies of Approved Drug Products 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. Paperwork Reduction Act of 1995

    This guidance contains collections of information that are subject 
to review by OMB under the PRA (44 U.S.C. 3501-3520). Under the PRA, 
Federal Agencies must obtain approval from OMB for each collection of 
information they conduct or sponsor. ``Collection of information'' is 
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency 
requests or requirements that members of the public submit reports, 
keep records, or provide information to a third party. Section 
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal 
Agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, in the 
Federal Register of July 11, 2016, we gave interested persons 60 days 
to comment on the information collection provisions in the draft 
guidance.
    The information collection provisions in this guidance have been 
submitted to OMB for review as required by section 3507(d) of the PRA. 
These provisions are not in effect until they display a currently valid 
OMB control number. FDA will publish a notice in the Federal Register 
announcing OMB's decision regarding the information collection 
provisions in this guidance.

III. 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: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00914 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P