[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22617-22619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0269]


Prescription Requirement Under Section 503A 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Drug, and Cosmetic Act; Draft Guidance for Industry; Availability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 the Agency) is 
announcing the availability of a draft guidance for industry entitled 
``Prescription Requirement Under Section 503A of the Federal Food, 
Drug, and Cosmetic Act.'' This guidance sets forth FDA's policy 
concerning certain prescription requirements for compounding human drug 
products for identified individual patients under section 503A of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses 
compounding after the receipt of a prescription for an identified 
individual patient, compounding before the receipt of a prescription 
for an identified individual patient (anticipatory compounding), and 
compounding for office use.

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draft guidance before it begins work to finalize the guidance, submit 
either electronic or written comments on this draft guidance by July 
18, 2016. Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 by May 18, 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-0269 for ``Prescription Requirement 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 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

[[Page 22618]]

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, ``Prescription Requirement Under Section 503A of the Federal 
Food, Drug, and Cosmetic Act; Collection of Information.''
    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, Room 5197, Silver Spring, MD, 301-796-3110.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Prescription Requirement 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:
     Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning 
current good manufacturing practice requirements);
     section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the 
labeling of drugs with adequate directions for use); and
     section 505 (21 U.S.C. 355) (concerning the approval of 
drugs under new drug applications (NDAs) or abbreviated new drug 
applications (ANDAs)).
    A compounded drug product may be eligible for the exemptions under 
section 503A of the FD&C Act only if it is, among other things, 
compounded for an identified individual patient based on the receipt of 
a valid prescription order or a notation, approved by the prescribing 
practitioner, on the prescription order that a compounded product is 
necessary for the identified patient. Among other conditions, to 
qualify for the exemptions under section 503A of the FD&C Act, the drug 
product must be compounded by a licensed pharmacist in a State-licensed 
pharmacy or a Federal facility, or by a licensed physician (section 
503A(a)).
    This guidance sets forth FDA's policy concerning certain 
prescription requirements for compounding human drug products for 
identified individual patients under section 503A of the FD&C Act. It 
addresses compounding after the receipt of a prescription for an 
identified individual patient, compounding before the receipt of a 
prescription for an identified individual patient (anticipatory 
compounding), and compounding for office use.
    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 
prescription requirement under section 503A 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

    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, if it is not obvious from a prescription 
order that the prescription is for a compounded drug product, a 
compounder may consult with the prescriber to determine whether the 
patient needs a compounded drug and make an appropriate notation on the 
prescription order. To serve as a basis for compounding under section 
503A of the FD&C Act, a notation must document the prescriber's 
determination that a compounded drug is necessary for the identified 
patient. FDA recommends using the following statement:
    Per [type of communication] with [name of prescriber] on [date], 
[name of prescriber] has advised that compounded [name of drug] is 
necessary for the treatment of [name of patient].
    We estimate that annually a total of approximately 3,444 licensed 
pharmacists and licensed physicians (``number of respondents'' in table 
1) will make a notation with this statement on approximately 172,200 
prescription orders (``total annual disclosures'' in table 1). We 
estimate that the consultation between the compounder and the 
prescriber and adding the written statement to each prescription will 
take approximately 5 minutes per prescription order.
    In addition, the licensed pharmacist or licensed physician seeking 
to compound a drug product under section 503A should maintain records 
of valid prescription orders received for compounded drug products to 
demonstrate compliance with the prescription requirement in section 
503A(a)(1) of the FD&C Act. For example, this includes records of valid 
prescription orders and of prescription orders bearing notations that 
the compounded drug product is necessary for the identified individual 
patient as described in section III.A of this guidance and section 
503A(a) of the FD&C Act. 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

[[Page 22619]]

``burden'' under 5 CFR 1320.3(b)(2). FDA understands that maintaining 
records of prescriptions for compounded drug products is part of the 
usual course of the practice of compounding and selling drugs and is 
required by States' pharmacy laws and other State laws governing record 
keeping by health care professionals and health care facilities.
    Under the guidance, licensed pharmacists and licensed physicians 
should also maintain records of the calculations performed to determine 
the limited quantities of drug products compounded before the receipt 
of valid prescription orders under the enforcement policy described in 
section III.B.2 of this guidance and section 503A(a)(2) of the FD&C 
Act. These records should clearly reflect the quantity of a particular 
drug product compounded in advance of receiving prescription orders for 
identified individual patients that the compounder has kept on hand as 
stock for distribution, and the basis for the quantity the compounder 
kept in stock. Under the enforcement policy described in section 
III.B.2 of this guidance, this would include the quantity of the drug 
product distributed under prescription orders for identified individual 
patients during the reference period that the licensed pharmacist or 
licensed physician selected (i.e., a 30-day period within the last 
year).
    We estimate that annually a total of approximately 10,332 licensed 
pharmacists and licensed physicians (``number of recordkeepers'' in 
table 2) will maintain approximately 103,320 records (``total annual 
records'' in table 2). We estimate that maintaining the records will 
take approximately 5 minutes per record.
    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 per  Total annual   Average burden per    Total hours
                                  respondents     respondent     disclosures       disclosure
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Consultation between the                3,444               50       172,200  0.083 (5 minutes)...        14,350
 licensed pharmacist or
 licensed physician and the
 prescriber and adding a
 notation to document the
 prescriber's determination
 that a compounded drug is
 necessary for an identified
 patient.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                Table 2--Estimated Annual Recordkeeping Burden 1
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                                                  Number of
       Type of reporting          Number of      records per    Total annual   Average burden per    Total hours
                                recordkeepers    recordkeeper      records        recordkeeping
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Records of calculations                10,332               10       103,320  0.083 (5 minutes)...         8,610
 performed to determine
 ``limited quantities''.
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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: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08877 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P