Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for Industry; Availability, 55847-55851 [2021-21970]
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55847
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0271]
Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act; Revised Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Hospital and
Health System Compounding Under
Section 503A of the Federal Food, Drug,
and Cosmetic Act’’ (‘‘revised draft
guidance’’). This revised draft guidance,
when finalized, will describe how FDA
intends to apply certain provisions of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to human drug products
compounded by State-licensed
pharmacies that are not outsourcing
facilities and distributed for use within
a hospital or health system. First, it
addresses the requirement that
compounding be based on the receipt of
a valid prescription order for an
identified individual patient. Second, it
addresses the provision concerning
compounded drug products that are
essentially copies of a commercially
available drug product. This draft
guidance revises the draft guidance
issued in 2016 entitled, ‘‘Hospital and
Health System Compounding Under the
Federal Food, Drug, and Cosmetic Act’’
(‘‘draft guidance’’). FDA is revising the
draft guidance to address stakeholder
feedback and provide further
clarification on policies regarding
hospital and health system
compounding. This revised draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the revised draft
guidance by December 6, 2021 to ensure
that the Agency considers your
comment on this revised draft guidance
before it begins work on the final
version of the guidance. Submit
electronic or written comments on the
proposed collection of information in
the revised draft guidance by December
6, 2021.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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–0271 for ‘‘Hospital and Health
System Compounding 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, 240–402–7500.
• 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
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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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 revised 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 request or include a fax number to
which the revised draft guidance may be
sent. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the revised draft
guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the revised draft
guidance: Tracy Rupp, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring,
MD 20993, 301–796–3100.
With regard to the proposed collection
of information: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act.’’ Pharmacies located within a
hospital, or standalone pharmacies that
are part of a health system, frequently
provide compounded drug products for
administration within the hospital or
health system. Some of these
compounders seek to compound under
section 503A of the FD&C Act (21 U.S.C.
353a) and others have registered with
FDA as outsourcing facilities and are
subject to section 503B of the FD&C Act
(21 U.S.C. 353b).
Section 503A of the FD&C Act
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 (CGMP)
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 or abbreviated
new drug applications).
This revised draft guidance proposes
policies for FDA’s application of certain
provisions of section 503A of the FD&C
Act to human drug products
compounded by State-licensed
pharmacies that are not outsourcing
facilities and distributed for use within
a hospital or health system. First, the
revised draft guidance addresses the
requirement that compounding be based
on the receipt of a valid prescription
order for an identified individual
patient. Second, it addresses the
provision concerning compounded drug
products that are essentially copies of a
commercially available drug product.
This revised draft guidance does not
apply to human drug products
compounded by outsourcing facilities
under section 503B of the FD&C Act,
compounded drug products that are not
distributed for use within a hospital or
health system, or drug products
compounded for use in animals.
In the Federal Register of April 18,
2016 (81 FR 22610), FDA announced the
availability of a draft guidance for
industry entitled, ‘‘Hospital and Health
System Compounding Under the
Federal Food, Drug, and Cosmetic Act’’
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(‘‘draft guidance’’). The draft guidance
proposed new policies for the
application of section 503A of the FD&C
Act to drug products compounded by
licensed pharmacists or physicians in
State-licensed hospital or health system
pharmacies. In particular, the draft
guidance described certain
circumstances under which FDA
generally would not intend to take
action if a hospital or health system
pharmacy distributed compounded drug
products without first receiving a
patient-specific prescription or order.
The comment period on the initial
draft guidance ended on July 18, 2016.
FDA received approximately 76
comments on the draft guidance. FDA is
issuing a revised draft guidance with
certain changes made in response to
received comments or on its own
initiative. For example, the prescription
requirement enforcement policy
described in the revised draft guidance
does not consider whether the drug
products are distributed only to
healthcare facilities that are located
within a 1-mile radius of the
compounding pharmacy (‘‘1-mile radius
policy’’). Instead, the Agency is
proposing a two-part, risk-based
compliance policy.
In addition, the revised draft guidance
proposes new policies for hospital and
health system pharmacies regarding the
provision in section 503A of the FD&C
Act which states that to qualify for the
exemptions under section 503A of the
FD&C Act, among other conditions, 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.
FDA is issuing this revised draft
guidance to address stakeholders’
feedback, reflect additional Agency
consideration of the proposed policies,
and enable the public to further review
and comment before finalization.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The revised draft guidance,
when finalized, will represent the
current thinking of FDA on ‘‘Hospital
and Health System Compounding 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3521),
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Federal Agencies must obtain approval
from the Office of Management and
Budget (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(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.
We are consolidating the information
collection in the revised draft guidance
with the information collections and
approvals under OMB control number
0910–0800.
With respect to the following
collection of information, FDA invites
comments on these 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.
Human Drug Compounding Under
Sections 503A and 503B the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910–0800—
Revision
This notice solicits comments on
certain information collections found in
the revised draft guidance entitled
‘‘Hospital and Health System
Compounding Under Section 503A of
the Federal Food, Drug, and Cosmetic
Act’’ (‘‘revised draft guidance’’). This
guidance, when finalized, will support
implementation of the copies provisions
of the 1997 Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115) discussed
in section 503A of the FD&C Act, which
were maintained by the 2013 Drug
Quality and Security Act (DQSA) (Title
I of Pub. L. 113–54).
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For efficiency of Agency operations,
we are revising OMB control number
0910–0800 to include information
collections relating to the copies
policies for hospital and health system
pharmacies that are not outsourcing
facilities, as proposed in the revised
draft guidance document.
As proposed in section III.B of the
revised draft guidance, among other
conditions, we generally would not
intend to take action against a hospital
or health system pharmacy that is not an
outsourcing facility for compounding a
drug product regularly or in inordinate
amounts that is essentially a copy of a
commercially available drug product, if
the compounded drug product is
administered only to patients within the
hospital or health system and the
pharmacy obtains from the prescriber a
statement that: (1) Specifies a change
between the compounded drug product
and the commercially available drug
product; (2) indicates that the
compounded drug product will be
administered only to patients for whom
the change produces a significant
difference from the commercially
available drug product; and (3)
describes the intended patient
population for the compounded drug
product. In addition, the revised draft
guidance specifies that the statement
would be maintained in the hospital or
health system pharmacy to address
routine orders for patients for whom the
change produces a significant
difference, and a statement would be on
file for each prescriber that covers each
drug product that is compounded.
As provided in section III.B of the
revised draft guidance, except for the
policy proposed above regarding the
documentation of a prescriber’s
determination of significant difference,
we propose to apply the policies
described in the guidance,
‘‘Compounded Drug Products That Are
Essentially Copies of a Commercially
Available Drug Product Under Section
503A of the Federal Food, Drug, and
Cosmetic Act’’ (‘‘503A copies
guidance’’) to drug products
compounded by hospital and health
system pharmacies that are not
outsourcing facilities.
As described in section III.B.2 of the
503A copies guidance, and proposed in
the revised draft guidance to apply to
hospital and health system pharmacies,
if a compounder intends to rely on a
prescriber determination of significant
difference to establish that a
compounded drug is not essentially a
copy of a commercially available drug
product, the compounder should ensure
that the determination is documented
on the prescription. If a prescription
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does not make clear that the prescriber
made the determination required by
section 503A(b)(2) of the FD&C Act, or
a compounded drug is substituted for
the commercially available drug
product, the compounder can contact
the prescriber and if the prescriber
confirms it, make a notation on the
prescription that the compounded drug
product contains a change that makes a
significant difference for the patient.
The notations should be as specific as
those described in the 503A copies
guidance, and the date of the
conversation with the prescriber should
be included on the prescription.
With respect to the determination of
significant difference described above,
we estimate that, annually, a total of
approximately 3,075 hospital or health
system pharmacies (table 1) will obtain
a prescriber determination of significant
difference. This estimate represents
approximately half of the hospitals in
the United States, including those that
are in health systems. Of these, we
estimate that approximately half (1,538)
will have hospital or health system
pharmacies that will follow the policy
in the revised draft guidance, obtaining
a statement of significant difference for
the intended patient population, and
approximately half (1,537) will have
hospital or health system pharmacies
that will follow the policy with respect
to prescriber determination of
significant difference in the 503A copies
guidance, documenting the notation on
the individual patient prescription. This
estimate assumes that most pharmacies
in smaller hospitals and health systems
will follow the policy in the 503A
copies guidance because a prescriber
determination of significant difference
will not be routinely needed and can be
most efficiently managed on a patientby-patient basis. On the other hand, this
estimate assumes that most pharmacies
in larger hospitals and health systems
will follow the policy in the revised
draft guidance because the need for a
prescriber determination of significant
difference is more routinely necessary
and, therefore, most efficiently managed
with a statement of significant
difference that is maintained in the
hospital or health system pharmacy to
address routine orders for patients for
whom the change produces a significant
difference.
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We estimate that, annually,
approximately 1,538 hospital or health
system pharmacies following the policy
in the revised draft guidance will obtain
approximately 30 statements of
significant difference for compounded
drug products, for a total of
approximately 46,140 statements (table
1, row 1). We estimate that the
consultation between the hospital or
health system pharmacy and the
prescriber to obtain the statement of
significant difference will require
approximately 5 minutes per statement
(table 1, row 1).
We estimate that, annually,
approximately 1,537 hospital or health
pharmacies following the policy in the
503A copies guidance will consult a
prescriber to determine whether the
prescriber has made a determination
that the compounded drug product has
a change that produces a significant
difference for a patient as compared to
the comparable commercially available
drug and that the compounders will
document this determination on
approximately 76,850 prescription
orders for compounded drug products
(table 1, row 2). We estimate that the
consultation between the compounder
and the prescriber and adding a notation
to each prescription that does not
already document this determination
will take approximately 3 minutes per
prescription order (table 1, row 2). The
average burden per consultation and
notation for pharmacies following the
significant difference policy in the 503A
copies guidance, compared to
pharmacies following the significant
difference policy in the revised draft
guidance, is estimated to be less (3
minutes) because the significant
difference determination described in
the 503A copies policy is specific to one
patient, whereas the statement of
significant difference in the revised
draft guidance describes the intended
patient population.
In addition, as described in section
III.B.3 of the 503A copies guidance, and
proposed in the revised draft guidance
to apply to hospital and health system
pharmacies, if the drug product was
compounded because the approved drug
product was not commercially available
because it was on the FDA drug shortage
list, the prescription or a notation on the
prescription should note that it was on
the drug shortage list and note the date
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the list was checked. We estimate that
a total of approximately 4,613 hospital
or health system pharmacies will
document this information on
approximately 922,600 prescription
orders for compounded drug products
(table 1, row 3). We estimate that
checking FDA’s drug shortage list and
documenting this information will
require approximately 2 minutes per
prescription order (table 1, row 3).
With respect to maintaining records of
the statement of significant difference
proposed in section III.B of the revised
draft guidance, we estimate that a total
of approximately 1,538 hospital or
health system pharmacies will maintain
approximately 46,140 statements of
significant difference (table 2, row 1).
We estimate that maintaining the
records will require approximately 2
minutes per record (table 2, row 1).
With respect to maintaining records of
the significant difference determination,
as provided in section III.B.5 of the
503A copies guidance, we estimate that
a total of approximately 1,537 hospital
or health system pharmacies will
maintain approximately 76,850 records
(table 2, row 2). We estimate that
maintaining records will require
approximately 2 minutes per record
(table 2, row 2).
Also with respect to maintenance of
records, as described in section III.B.5 of
the 503A copies guidance, and proposed
in the revised draft guidance to apply to
hospital and health system pharmacies,
compounders under section 503A
should maintain records of (1) the
frequency in which they have
compounded drug products that are
essentially copies of commercially
available drug products and (2) the
number of prescriptions that they have
filled for compounded drug products
that are essentially copies of
commercially available drug products.
We estimate that a total of
approximately 3,075 hospital or health
system pharmacies will maintain
approximately 61,500 records of
prescriptions that they have filled for
compounded drug products that are
essentially copies of commercially
available drug products (table 2, row 3).
We estimate that maintaining the
records will require approximately 2
minutes per record (table 2, row 3).
We estimate the burden of this
collection of information as follows:
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55851
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
Consultation between the hospital or health system pharmacy and the prescriber
to document the statement of significant difference (revised draft guidance).
Consultation between the hospital or health system pharmacy and prescriber and
the notation on the prescription documenting the prescriber’s determination of
significant difference (503A copies guidance).
Hospital or health system pharmacy checking FDA’s drug shortage list and documenting on the prescription that the drug is in shortage (503A copies guidance).
1,538
30
46,140
.08 (5 minutes) .....
3,691
1,537
50
76,850
.05 (3 minutes) .....
3,843
4,613
200
922,600
.03 (2 minutes) .....
27,678
Total ....................................................................................................................
....................
........................
....................
...............................
35,212
Total annual
records
Average burden
per recordkeeping
Total hours
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
recordkeepers
Activity
Records of the statement of significant difference (revised draft guidance) .............
Records of documentation of significant difference (503A copies guidance) ...........
Records of frequency and number of prescriptions filled for compounded drug
products that are essentially a copy (503A copies guidance).
1,538
1,537
3,075
30
50
20
46,140
76,850
61,500
.03 (2 minutes) .....
.03 (2 minutes) .....
.03 (2 minutes) .....
1,384
2,306
1,845
Total ....................................................................................................................
....................
........................
....................
...............................
5,535
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
IV. Electronic Access
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–21970 Filed 10–6–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Request for comments on the draft
Department Strategic Plan for FY
2022–2026
Office of the Secretary, Office
of the Assistant Secretary for Planning
and Evaluation, Health and Human
Services.
ACTION: Request for comments on the
draft HHS Strategic Plan FY 2022–2026.
AGENCY:
The Department of Health and
Human Services (HHS) is seeking public
comment on its draft Strategic Plan for
Fiscal Years 2022–2026 through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/.
DATES: Submit comments on or before
November 7, 2021.
SUMMARY:
VerDate Sep<11>2014
23:02 Oct 06, 2021
Written comments can be
provided by email, Fax, or U.S. mail.
Email: HHSPlan@hhs.gov.
Fax: (202) 690–5882.
Mail: U.S. Department of Health and
Human Services, Office of the Assistant
Secretary for Planning and Evaluation,
Division of Strategic Planning, Attn:
Strategic Plan Comments, 200
Independence Avenue SW, Room 434E,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Margo Bailey, (202) 730–8504.
SUPPLEMENTARY INFORMATION: The draft
Department of Health and Human
Services Strategic Plan FY 2022–2026 is
provided as part of the strategic
planning process under the Government
Performance and Results Modernization
Act of 2010 (GPRA–MA)(Pub. L. 111–
352) to ensure that Agency stakeholders
are given an opportunity to comment on
this plan.
This document articulates how the
Department will achieve its mission
through five strategic goals. These five
strategic goals are (1) Protect and
Strengthen Equitable Access to High
Quality and Affordable Health Care, (2)
Safeguard and Improve National and
Global Health Conditions and
Outcomes, (3) Strengthen Social Wellbeing, Equity, and Economic Resilience,
(4) Restore Trust and Accelerate
Advancements in Science and Research
for All, and (5) Advance Strategic
Management to Build Trust,
Transparency, and Accountability. Each
goal is supported by objectives and
strategies.
ADDRESSES:
Persons with access to the internet
may obtain an electronic version of the
revised draft guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
lotter on DSK11XQN23PROD with NOTICES1
Number of
records per
recordkeeper
Jkt 256001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
The strategic planning consultation
process is an opportunity for the
Department to refine and strengthen the
HHS Strategic Plan FY 2022–2026. We
look forward to receiving your
comments by November 7, 2021. The
text of the draft HHS Strategic Plan FY
2022–2026 is available through the
Department of Health and Human
Services website at www.hhs.gov/about/
draft-strategic-plan/. For
comparison purposes, the current HHS
Strategic Plan FY 2018–2022 can be
viewed at https://www.hhs.gov/about/
strategic-plan/.
For those who may not have internet
access, a hard copy can be requested
from the contact point, Margo Bailey,
(202) 730–8504.
Dated: September 29, 2021.
Rebecca Haffajee,
Acting Assistant Secretary for Planning and
Evaluation (ASPE), Principal Deputy, ASPE.
[FR Doc. 2021–21939 Filed 10–5–21; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Request for Public Comments on the
Development of the 2021–2022 IACC
Strategic Plan for Autism Spectrum
Disorder (ASD)
On behalf of the Interagency
Autism Coordinating Committee (IACC),
the National Institute of Mental Health
(NIMH) Office of Autism Research
SUMMARY:
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 86, Number 192 (Thursday, October 7, 2021)]
[Notices]
[Pages 55847-55851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0271]
Hospital and Health System Compounding Under Section 503A of the
Federal Food, Drug, and Cosmetic Act; Revised Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Hospital and Health System Compounding Under Section 503A of the
Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance'').
This revised draft guidance, when finalized, will describe how FDA
intends to apply certain provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to human drug products compounded by State-
licensed pharmacies that are not outsourcing facilities and distributed
for use within a hospital or health system. First, it addresses the
requirement that compounding be based on the receipt of a valid
prescription order for an identified individual patient. Second, it
addresses the provision concerning compounded drug products that are
essentially copies of a commercially available drug product. This draft
guidance revises the draft guidance issued in 2016 entitled, ``Hospital
and Health System Compounding Under the Federal Food, Drug, and
Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance
to address stakeholder feedback and provide further clarification on
policies regarding hospital and health system compounding. This revised
draft guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the revised
draft guidance by December 6, 2021 to ensure that the Agency considers
your comment on this revised draft guidance before it begins work on
the final version of the guidance. Submit electronic or written
comments on the proposed collection of information in the revised draft
guidance by December 6, 2021.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 55848]]
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-0271 for ``Hospital and Health System Compounding 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 revised 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 request or include a fax number to which the
revised draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the revised draft
guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the revised draft guidance: Tracy Rupp, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993, 301-796-3100.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Hospital and Health System Compounding Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' Pharmacies
located within a hospital, or standalone pharmacies that are part of a
health system, frequently provide compounded drug products for
administration within the hospital or health system. Some of these
compounders seek to compound under section 503A of the FD&C Act (21
U.S.C. 353a) and others have registered with FDA as outsourcing
facilities and are subject to section 503B of the FD&C Act (21 U.S.C.
353b).
Section 503A of the FD&C Act 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 (CGMP) 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 or abbreviated new drug
applications).
This revised draft guidance proposes policies for FDA's application
of certain provisions of section 503A of the FD&C Act to human drug
products compounded by State-licensed pharmacies that are not
outsourcing facilities and distributed for use within a hospital or
health system. First, the revised draft guidance addresses the
requirement that compounding be based on the receipt of a valid
prescription order for an identified individual patient. Second, it
addresses the provision concerning compounded drug products that are
essentially copies of a commercially available drug product. This
revised draft guidance does not apply to human drug products compounded
by outsourcing facilities under section 503B of the FD&C Act,
compounded drug products that are not distributed for use within a
hospital or health system, or drug products compounded for use in
animals.
In the Federal Register of April 18, 2016 (81 FR 22610), FDA
announced the availability of a draft guidance for industry entitled,
``Hospital and Health System Compounding Under the Federal Food, Drug,
and Cosmetic Act''
[[Page 55849]]
(``draft guidance''). The draft guidance proposed new policies for the
application of section 503A of the FD&C Act to drug products compounded
by licensed pharmacists or physicians in State-licensed hospital or
health system pharmacies. In particular, the draft guidance described
certain circumstances under which FDA generally would not intend to
take action if a hospital or health system pharmacy distributed
compounded drug products without first receiving a patient-specific
prescription or order.
The comment period on the initial draft guidance ended on July 18,
2016. FDA received approximately 76 comments on the draft guidance. FDA
is issuing a revised draft guidance with certain changes made in
response to received comments or on its own initiative. For example,
the prescription requirement enforcement policy described in the
revised draft guidance does not consider whether the drug products are
distributed only to healthcare facilities that are located within a 1-
mile radius of the compounding pharmacy (``1-mile radius policy'').
Instead, the Agency is proposing a two-part, risk-based compliance
policy.
In addition, the revised draft guidance proposes new policies for
hospital and health system pharmacies regarding the provision in
section 503A of the FD&C Act which states that to qualify for the
exemptions under section 503A of the FD&C Act, among other conditions,
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.
FDA is issuing this revised draft guidance to address stakeholders'
feedback, reflect additional Agency consideration of the proposed
policies, and enable the public to further review and comment before
finalization.
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Hospital and Health System Compounding 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (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(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. We
are consolidating the information collection in the revised draft
guidance with the information collections and approvals under OMB
control number 0910-0800.
With respect to the following collection of information, FDA
invites comments on these 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.
Human Drug Compounding Under Sections 503A and 503B the Federal Food,
Drug, and Cosmetic Act
OMB Control Number 0910-0800--Revision
This notice solicits comments on certain information collections
found in the revised draft guidance entitled ``Hospital and Health
System Compounding Under Section 503A of the Federal Food, Drug, and
Cosmetic Act'' (``revised draft guidance''). This guidance, when
finalized, will support implementation of the copies provisions of the
1997 Food and Drug Administration Modernization Act (FDAMA) (Pub. L.
105-115) discussed in section 503A of the FD&C Act, which were
maintained by the 2013 Drug Quality and Security Act (DQSA) (Title I of
Pub. L. 113-54).
For efficiency of Agency operations, we are revising OMB control
number 0910-0800 to include information collections relating to the
copies policies for hospital and health system pharmacies that are not
outsourcing facilities, as proposed in the revised draft guidance
document.
As proposed in section III.B of the revised draft guidance, among
other conditions, we generally would not intend to take action against
a hospital or health system pharmacy that is not an outsourcing
facility for compounding a drug product regularly or in inordinate
amounts that is essentially a copy of a commercially available drug
product, if the compounded drug product is administered only to
patients within the hospital or health system and the pharmacy obtains
from the prescriber a statement that: (1) Specifies a change between
the compounded drug product and the commercially available drug
product; (2) indicates that the compounded drug product will be
administered only to patients for whom the change produces a
significant difference from the commercially available drug product;
and (3) describes the intended patient population for the compounded
drug product. In addition, the revised draft guidance specifies that
the statement would be maintained in the hospital or health system
pharmacy to address routine orders for patients for whom the change
produces a significant difference, and a statement would be on file for
each prescriber that covers each drug product that is compounded.
As provided in section III.B of the revised draft guidance, except
for the policy proposed above regarding the documentation of a
prescriber's determination of significant difference, we propose to
apply the policies described in the guidance, ``Compounded Drug
Products That Are Essentially Copies of a Commercially Available Drug
Product Under Section 503A of the Federal Food, Drug, and Cosmetic
Act'' (``503A copies guidance'') to drug products compounded by
hospital and health system pharmacies that are not outsourcing
facilities.
As described in section III.B.2 of the 503A copies guidance, and
proposed in the revised draft guidance to apply to hospital and health
system pharmacies, if a compounder intends to rely on a prescriber
determination of significant difference to establish that a compounded
drug is not essentially a copy of a commercially available drug
product, the compounder should ensure that the determination is
documented on the prescription. If a prescription
[[Page 55850]]
does not make clear that the prescriber made the determination required
by section 503A(b)(2) of the FD&C Act, or a compounded drug is
substituted for the commercially available drug product, the compounder
can contact the prescriber and if the prescriber confirms it, make a
notation on the prescription that the compounded drug product contains
a change that makes a significant difference for the patient. The
notations should be as specific as those described in the 503A copies
guidance, and the date of the conversation with the prescriber should
be included on the prescription.
With respect to the determination of significant difference
described above, we estimate that, annually, a total of approximately
3,075 hospital or health system pharmacies (table 1) will obtain a
prescriber determination of significant difference. This estimate
represents approximately half of the hospitals in the United States,
including those that are in health systems. Of these, we estimate that
approximately half (1,538) will have hospital or health system
pharmacies that will follow the policy in the revised draft guidance,
obtaining a statement of significant difference for the intended
patient population, and approximately half (1,537) will have hospital
or health system pharmacies that will follow the policy with respect to
prescriber determination of significant difference in the 503A copies
guidance, documenting the notation on the individual patient
prescription. This estimate assumes that most pharmacies in smaller
hospitals and health systems will follow the policy in the 503A copies
guidance because a prescriber determination of significant difference
will not be routinely needed and can be most efficiently managed on a
patient-by-patient basis. On the other hand, this estimate assumes that
most pharmacies in larger hospitals and health systems will follow the
policy in the revised draft guidance because the need for a prescriber
determination of significant difference is more routinely necessary
and, therefore, most efficiently managed with a statement of
significant difference that is maintained in the hospital or health
system pharmacy to address routine orders for patients for whom the
change produces a significant difference.
We estimate that, annually, approximately 1,538 hospital or health
system pharmacies following the policy in the revised draft guidance
will obtain approximately 30 statements of significant difference for
compounded drug products, for a total of approximately 46,140
statements (table 1, row 1). We estimate that the consultation between
the hospital or health system pharmacy and the prescriber to obtain the
statement of significant difference will require approximately 5
minutes per statement (table 1, row 1).
We estimate that, annually, approximately 1,537 hospital or health
pharmacies following the policy in the 503A copies guidance will
consult a prescriber to determine whether the prescriber has made a
determination that the compounded drug product has a change that
produces a significant difference for a patient as compared to the
comparable commercially available drug and that the compounders will
document this determination on approximately 76,850 prescription orders
for compounded drug products (table 1, row 2). We estimate that the
consultation between the compounder and the prescriber and adding a
notation to each prescription that does not already document this
determination will take approximately 3 minutes per prescription order
(table 1, row 2). The average burden per consultation and notation for
pharmacies following the significant difference policy in the 503A
copies guidance, compared to pharmacies following the significant
difference policy in the revised draft guidance, is estimated to be
less (3 minutes) because the significant difference determination
described in the 503A copies policy is specific to one patient, whereas
the statement of significant difference in the revised draft guidance
describes the intended patient population.
In addition, as described in section III.B.3 of the 503A copies
guidance, and proposed in the revised draft guidance to apply to
hospital and health system pharmacies, if the drug product was
compounded because the approved drug product was not commercially
available because it was on the FDA drug shortage list, the
prescription or a notation on the prescription should note that it was
on the drug shortage list and note the date the list was checked. We
estimate that a total of approximately 4,613 hospital or health system
pharmacies will document this information on approximately 922,600
prescription orders for compounded drug products (table 1, row 3). We
estimate that checking FDA's drug shortage list and documenting this
information will require approximately 2 minutes per prescription order
(table 1, row 3).
With respect to maintaining records of the statement of significant
difference proposed in section III.B of the revised draft guidance, we
estimate that a total of approximately 1,538 hospital or health system
pharmacies will maintain approximately 46,140 statements of significant
difference (table 2, row 1). We estimate that maintaining the records
will require approximately 2 minutes per record (table 2, row 1). With
respect to maintaining records of the significant difference
determination, as provided in section III.B.5 of the 503A copies
guidance, we estimate that a total of approximately 1,537 hospital or
health system pharmacies will maintain approximately 76,850 records
(table 2, row 2). We estimate that maintaining records will require
approximately 2 minutes per record (table 2, row 2).
Also with respect to maintenance of records, as described in
section III.B.5 of the 503A copies guidance, and proposed in the
revised draft guidance to apply to hospital and health system
pharmacies, compounders under section 503A should maintain records of
(1) the frequency in which they have compounded drug products that are
essentially copies of commercially available drug products and (2) the
number of prescriptions that they have filled for compounded drug
products that are essentially copies of commercially available drug
products. We estimate that a total of approximately 3,075 hospital or
health system pharmacies will maintain approximately 61,500 records of
prescriptions that they have filled for compounded drug products that
are essentially copies of commercially available drug products (table
2, row 3). We estimate that maintaining the records will require
approximately 2 minutes per record (table 2, row 3).
We estimate the burden of this collection of information as
follows:
[[Page 55851]]
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
Activity Number of disclosures annual Average burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Consultation between the 1,538 30 46,140 .08 (5 minutes)........ 3,691
hospital or health system
pharmacy and the prescriber to
document the statement of
significant difference (revised
draft guidance).
Consultation between the 1,537 50 76,850 .05 (3 minutes)........ 3,843
hospital or health system
pharmacy and prescriber and the
notation on the prescription
documenting the prescriber's
determination of significant
difference (503A copies
guidance).
Hospital or health system 4,613 200 922,600 .03 (2 minutes)........ 27,678
pharmacy checking FDA's drug
shortage list and documenting
on the prescription that the
drug is in shortage (503A
copies guidance).
-------------------------------------------------------------------------------
Total....................... ........... .............. ........... ....................... 35,212
----------------------------------------------------------------------------------------------------------------
\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 Total
Activity Number of records per annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of the statement of 1,538 30 46,140 .03 (2 minutes)....... 1,384
significant difference
(revised draft guidance).
Records of documentation of 1,537 50 76,850 .03 (2 minutes)....... 2,306
significant difference (503A
copies guidance).
Records of frequency and number 3,075 20 61,500 .03 (2 minutes)....... 1,845
of prescriptions filled for
compounded drug products that
are essentially a copy (503A
copies guidance).
--------------------------------------------------------------------------------
Total...................... ............. .............. ........... ...................... 5,535
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
IV. Electronic Access
Persons with access to the internet may obtain an electronic
version of the revised draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-21970 Filed 10-6-21; 8:45 am]
BILLING CODE 4164-01-P
