83 FR 2786 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 13 (January 19, 2018)

Page Range		2786-2787
FR Document		2018-00914

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.

Federal Register, Volume 83 Issue 13 (Friday, January 19, 2018)

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2786-2787]
From the Federal Register Online [www.thefederalregister.org]
[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.thefederalregister.org/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

Federal Register / Vol. 83, No. 13 / Friday, January 19, 2018 / Notices 2787

• Section 505 (21 U.S.C. 355) policies for the preparation of Guidances/default.htm or https://
(concerning the approval of drugs under compounded drugs used in in-patient www.regulations.gov.
new drug applications or abbreviated settings. The final guidance notes that Dated: January 16, 2018.
new drug applications); and FDA is considering the applicability of Leslie Kux,
• Section 582 (21 U.S.C. 360eee–1) the policies described in this guidance
(concerning drug supply chain security Associate Commissioner for Policy.
to hospitals and health systems. We
requirements). recognize that this issue is of interest to [FR Doc. 2018–00914 Filed 1–18–18; 8:45 am]
One of the conditions that must be many stakeholders and will publicly BILLING CODE 4164–01–P
met for a compounded drug product to convey our further thinking on the
qualify for the exemptions under section applicability of these policies to
503B of the FD&C Act is that the drug hospitals and health systems with an DEPARTMENT OF HEALTH AND
is not essentially a copy of one or more opportunity for comment. HUMAN SERVICES
approved drugs (section 503B(a)(5)). This guidance is being issued
Section 503B(d)(2) defines essentially Food and Drug Administration
consistent with FDA’s good guidance
a copy of an approved drug as: practices regulation (21 CFR 10.115). [Docket No. FDA–2014–D–1525]
• A drug that is identical or nearly This guidance represents the current
identical to an approved drug, or a thinking of FDA on ‘‘Compounded Drug Mixing, Diluting, or Repackaging
marketed drug not subject to section Products That Are Essentially Copies of Biological Products Outside the Scope
503(b) and not subject to approval in an Approved Drug Products Under Section of an Approved Biologics License
application submitted under section 503B of the Federal Food, Drug, and Application; Guidance for Industry;
505, unless, in the case of an approved Cosmetic Act.’’ It does not establish any Availability
drug, the drug appears on the drug rights for any person and is not binding
shortage list in effect under section 506E AGENCY: Food and Drug Administration,
on FDA or the public. You can use an HHS.
at the time of compounding, alternative approach if it satisfies the
distribution, and dispensing (section requirements of the applicable statutes ACTION: Notice of availability.
503B(d)(2)(A)) or and regulations. This guidance is not
• a drug, a component of which is a SUMMARY: The Food and Drug
subject to Executive Order 12866. Administration (FDA or the Agency) is
bulk drug substance that is a component
of an approved drug or a marketed drug II. Paperwork Reduction Act of 1995 announcing the availability of a final
that is not subject to section 503(b) and guidance for industry entitled ‘‘Mixing,
This guidance contains collections of
not subject to approval in an application Diluting, or Repackaging Biological
information that are subject to review by
submitted under section 505, unless Products Outside the Scope of an
OMB under the PRA (44 U.S.C. 3501–
there is a change that produces for an Approved Biologics License
3520). Under the PRA, Federal Agencies
individual patient a clinical difference, Application.’’ This final guidance
must obtain approval from OMB for
as determined by the prescribing describes the conditions under which
each collection of information they
practitioner, between the compounded FDA does not intend to take action
conduct or sponsor. ‘‘Collection of
drug and the comparable approved drug against a State-licensed pharmacy, a
information’’ is defined in 44 U.S.C.
(section 503B(d)(2)(B)). Federal facility, or an outsourcing
3502(3) and 5 CFR 1320.3 and includes
This guidance sets forth FDA’s facility that mixes, dilutes, or
Agency requests or requirements that
policies concerning the ‘‘essentially a repackages certain biological products
members of the public submit reports,
copy’’ provision of section 503B of the outside the scope of an approved
keep records, or provide information to
FD&C Act. biologics license application (BLA). It
a third party. Section 3506(c)(2)(A) of
In the Federal Register of July 11, also describes the conditions under
the PRA (44 U.S.C. 3506(c)(2)(A))
2016 (81 FR 44879), FDA issued a notice which FDA does not intend to take
requires Federal Agencies to provide a
announcing the availability of the draft action when a State-licensed pharmacy,
60-day notice in the Federal Register
version of this guidance. The comment a Federal facility, an outsourcing
concerning each proposed collection of
period on the draft guidance ended on facility, or a physician prepares
information before submitting the
October 11, 2016. FDA received 29 prescription sets of allergenic extracts
collection to OMB for approval. To
comments on the draft guidance. In for subcutaneous immunotherapy.
comply with this requirement, in the
response to received comments or on its Federal Register of July 11, 2016, we DATES: The announcement of the
own initiative, FDA made several gave interested persons 60 days to guidance is published in the Federal
changes. For example, in response to comment on the information collection Register on January 19, 2018.
requests in comments for direction on provisions in the draft guidance. ADDRESSES: You may submit electronic
records retention, FDA added a The information collection provisions or written comments on Agency
recommendation that compounders in this guidance have been submitted to guidances at any time as follows:
maintain the records described in the OMB for review as required by section
guidance for at least 3 years. In addition, Electronic Submissions
3507(d) of the PRA. These provisions
to address questions raised in are not in effect until they display a Submit electronic comments in the
comments, FDA clarified that the currently valid OMB control number. following way:
Agency does not intend to take action FDA will publish a notice in the Federal • Federal eRulemaking Portal:
against an outsourcing facility for failing Register announcing OMB’s decision https://www.regulations.gov. Follow the
to compound in accordance with regarding the information collection instructions for submitting comments.
daltland on DSKBBV9HB2PROD with NOTICES

section 503B(a)(5) if it fills orders for a provisions in this guidance. Comments submitted electronically,
compounded drug that is essentially a including attachments, to https://
copy of an approved drug that has been III. Electronic Access www.regulations.gov will be posted to
discontinued and is no longer marketed. Persons with access to the internet the docket unchanged. Because your
FDA received comments from may obtain the guidance at either comment will be made public, you are
hospital organizations regarding the https://www.fda.gov/Drugs/Guidance solely responsible for ensuring that your
potential implications of proposed ComplianceRegulatoryInformation/ comment does not include any

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Document Created: 2018-01-19 02:42:33
Document Modified: 2018-01-19 02:42:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		The announcement of the guidance is published in the Federal Register on January 19, 2018.
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.
FR Citation		83 FR 2786

83 FR 2786 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 13 (January 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration