[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44879-44881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16362]



[[Page 44879]]

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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Cosmetic Act; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Compounded 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 the other conditions in section 
503B. This guidance sets forth FDA's policies concerning the 
``essentially a copy'' provision of section 503B.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work to finalize the guidance, submit 
either electronic or written comments on this draft guidance by October 
11, 2016. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by August 10, 2016.

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-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 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 comments on information collection issues to the Office of 
Management and Budget in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to 
[email protected]. All comments should be identified with the 
title, ``Compounded Drug Products That Are Essentially Copies of 
Approved Drug Products Under Section 503B of the Federal Food, Drug, 
and Cosmetic Act.''
    Submit written requests for single copies of the draft 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 draft 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, 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft 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 
a new section 503B of the Act, which describes a new category of

[[Page 44880]]

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);
     Section 505 (21 U.S.C. 355) (concerning the approval of 
drugs under new drug applications (NDAs) or abbreviated new drug 
applications (ANDAs)); 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 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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on the 
``essentially a copy'' provision of section 503B of the FD&C 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.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information that 
they conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) 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, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
document, FDA invites comments on the following topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Under the draft guidance, pursuant to section 503B(d)(2)(B) of the 
FD&C Act, if an outsourcing facility compounds a drug, the component of 
which is a bulk drug substance that is a component of an approved drug, 
there must be a change that produces a clinical difference for an 
individual patient as determined by the prescribing practitioner. If an 
outsourcing facility intends to rely on such a determination to 
establish that a compounded drug is not essentially a copy of an 
approved drug, the outsourcing facility should ensure that the 
determination is documented on the prescription or order (which may be 
a patient-specific prescription or a non-patient specific order) for 
the compounded drug.
    If a prescription or order does not make clear that the 
determination required by section 503B(d)(2)(B) has been made, the 
outsourcing facility may contact the prescriber or healthcare facility, 
and if the prescriber or healthcare facility confirms it, make a 
notation on the prescription or order that the prescriber has 
determined that the compounded product contains a change that produces 
a clinical difference for patient(s). The date of the conversation with 
the healthcare facility or prescriber should be included on the 
prescription or order.
    We estimate that annually a total of approximately 40 outsourcing 
facilities (``number of respondents'' in table 1, line 1) will consult 
a prescriber to determine whether he or she has made a determination 
that the compounded drug has a change that produces a clinical 
difference for an individual patient as compared to the comparable 
approved drug and that outsourcing facilities will document this 
determination on approximately 4,000 prescriptions or orders for 
compounded drugs (``total annual disclosures'' in table 1, line 1). We 
estimate that the consultation between the outsourcing facility and the 
prescriber or health care facility and adding a notation to each 
prescription or order that does not already document this determination 
will take approximately 3 minutes per prescription or order.
    In addition, if the outsourcing facility compounded a drug that is 
identical or nearly identical to an approved drug product that appeared 
on FDA's drug shortage list, the outsourcing facility should maintain 
documentation (e.g., a notation on the order for the compounded drug) 
regarding the status of the drug on FDA's drug shortage list at the 
time of compounding, distribution and dispensing. We estimate that a 
total of approximately 30 outsourcing facilities (``number of 
respondents'' in table 1, line 2) will document this information on 
approximately 3,000 prescriptions or orders for compounded drugs 
(``total annual disclosures'' in table 1, line 2). We estimate that 
checking FDA's drug shortage list and documenting this information will 
take approximately 2 minutes per prescription or order.
    An outsourcing facility should also maintain records of 
prescriptions or orders including notations that a prescriber has 
determined that the compounded drug has a change that produces a 
clinical difference for an individual patient. Because the time, 
effort, and financial resources necessary to comply with this 
collection of information would be incurred by licensed pharmacists and 
licensed physicians in the normal course of their activities, it is 
excluded from the definition of ``burden'' under 5 CFR 1320.3(b)(2).

[[Page 44881]]

    FDA estimates the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                 Number of
      Type of reporting          Number of      disclosures    Total annual   Average burden per    Total hours
                                respondents   per respondent    disclosures       disclosure
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Consultation between the                  40             100           4,000  3 minutes.........             200
 outsourcing facility and
 prescriber or health care
 facility, and the notation
 on the prescription or
 order documenting the
 prescriber's determination
 of clinical difference.
Checking FDA's drug shortage              30             100           3,000  2 minutes.........             100
 list and documenting on the
 prescription that the drug
 is in shortage.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Electronic Access

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

    Dated: July 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16362 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P