[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2790-2792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1309]


Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A 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 a Commercially Available Drug 
Product Under Section 503A of the Federal Food, Drug, and Cosmetic 
Act.'' One of the conditions to qualify for exemptions under section 
503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is 
that a drug product must be compounded by a licensed pharmacist or 
physician who does not compound regularly or in inordinate amounts any 
drug products that are essentially copies of a commercially available 
drug product. This guidance sets forth FDA policies regarding this 
provision of section 503A, including the terms ``commercially 
available,'' ``essentially a copy of a commercially available drug

[[Page 2791]]

product,'' and ``regularly or in inordinate amounts.''

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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-1309 for ``Compounded Drug Products That Are Essentially 
Copies of a Commercially Available Drug Product Under Section 503A 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.
    <bullet> 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 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, 301-796-
3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Compounded Drug Products That Are Essentially Copies of a 
Commercially Available Drug Product Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act.'' Section 503A (21 U.S.C. 353a), added to 
the FD&C Act by the Food and Drug Administration Modernization Act of 
1997, 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:
    <bullet> Section 501(a)(2)(B) (21 U.S.C. 351 (a)(2)(B)) (concerning 
current good manufacturing practice requirements);
    <bullet> Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the 
labeling of drugs with adequate directions for use); and
    <bullet> Section 505 (21 U.S.C. 355) (concerning the approval of 
drugs under new drug applications (NDAs) or abbreviated new drug 
applications (ANDAs)).
    One of the conditions that must be met for a compounded drug 
product to qualify for the exemptions under section 503A of the FD&C 
Act is that it must be compounded by a licensed pharmacist or a 
licensed physician that does not compound regularly or in inordinate 
amounts (as defined by the Secretary of Health and Human Services) any 
drug products that are essentially copies of a commercially available 
drug product (section 503A(b)(1)(D)).
    The statute further states that the term ``essentially a copy of a 
commercially available drug product'' does not include a drug product 
in which there is a change, made for an identified individual patient, 
which produces for that patient a significant difference, as determined 
by the prescribing practitioner, between the compounded drug and the 
comparable commercially available drug product (section 503A(b)(2) of 
the FD&C Act).
    This guidance sets forth FDA's policies concerning the 
``essentially a copy'' provision under section 503A of the FD&C Act, 
including the terms ``commercially available,'' ``essentially a copy of 
a commercially available drug product,'' and ``regularly or in 
inordinate amounts.''

[[Page 2792]]

    In the Federal Register of July 11, 2016 (81 FR 44881), 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 approximately 88 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 a period 
of at least 3 years. In addition, to address questions raised in 
comments, FDA clarified that the policies in this guidance apply to a 
compounded drug product without regard to the source(s) of the active 
pharmaceutical ingredient (API) in that product, for example, the 
policies would apply regardless of whether the compounder used an API 
that was purchased as an isolate, or if the compounder modified a 
finished drug product containing an API.
    FDA received comments on the draft guidance from hospital 
organizations regarding the potential implications of the proposed 
policies in the draft guidance 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 convey our further 
thinking on the applicability of these policies to hospitals and health 
systems publicly 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 a Commercially Available Drug Product Under 
Section 503A 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 the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA) of 1995 (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 (81 FR 44881).
    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. 2018-00915 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P