Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability, 22617-22619 [2016-08877]
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Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 58 have been approved
under OMB control number 0910–0119;
the collections of information in 21 CFR
parts 801 and 809 have been approved
under OMB control number 0910–0485;
the collections of information in 21 CFR
part 807, subpart E, have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231; the
collections of information in the
guidance document entitled ‘‘Informed
Consent For In Vitro Diagnostic Device
Studies Using Leftover Human
Specimens That Are Not Individually
Identifiable’’ have been approved under
OMB control number 0910–0582; the
collections of information in the
guidance document entitled ‘‘Guidance
for Industry and FDA Staff:
Administrative Procedures for CLIA
Categorization’’ have been approved
under OMB control number 0910–0607;
and the collections of information in the
guidance document entitled ‘‘Requests
for Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756.
Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08899 Filed 4–15–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[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Drug, and Cosmetic Act; Draft
Guidance for Industry; Availability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.
The Food and Drug
Administration (FDA or the Agency) is
SUMMARY:
VerDate Sep<11>2014
17:54 Apr 15, 2016
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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: 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): Division of
PO 00000
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22617
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
https://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
https://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: https://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 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
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Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
I. Background
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.
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
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;
mstockstill on DSK4VPTVN1PROD with NOTICES
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 oira_submission@omb.eop.gov.
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:
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(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
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Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
‘‘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
22619
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
Number of
respondents
Type of reporting
Consultation between the 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.
1 There
Number of
disclosures per
respondent
3,444
50
Total annual
disclosures
172,200
Average
burden per
disclosure
0.083 (5 minutes).
Total hours
14,350
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of reporting
Records of calculations performed to determine ‘‘limited
quantities’’.
1 There
Number of
records per
recordkeeper
10,332
10
Total annual
records
103,320
Average
burden per
recordkeeping
Total hours
0.083 (5 minutes).
8,610
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Electronic Access
ACTION:
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Notice.
SUMMARY:
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
[FR Doc. 2016–08877 Filed 4–15–16; 8:45 am]
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 18,
2016.
BILLING CODE 4164–01–P
ADDRESSES:
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—OMB Control Number 0910–
0510—Extension
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Pub. L. 107–250) was signed into law
on October 26, 2002. Section 201 of
MDUFMA added a new paragraph (g) to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (21 U.S.C. 374),
directing FDA to accredit third parties
(accredited persons) to conduct
inspections of eligible manufacturers of
class II or class III devices. FDA’s
guidance document entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–N–0427]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Inspection by Accredited Persons
Program
AGENCY:
Food and Drug Administration,
HHS.
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17:54 Apr 15, 2016
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0510. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
PO 00000
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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): 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 https://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 https://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: https://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 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
[[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
oira_submission@omb.eop.gov. 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
----------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of disclosures per Total annual Average burden per Total hours
respondents respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of calculations 10,332 10 103,320 0.083 (5 minutes)... 8,610
performed to determine
``limited quantities''.
----------------------------------------------------------------------------------------------------------------
\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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://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
