Notice2025-20773
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
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Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection relating to human drug compounding.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52965-52967]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20773]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4348]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Drug Compounding Under Sections 503A and 503B of
the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection relating to human
drug compounding.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 23, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 23, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 52966]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-4348 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Drug Compounding Under
Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: 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,
<a href="/cdn-cgi/l/email-protection#b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="beeeecffedcadfd8d8fed8dadf90d6d6cd90d9d1c8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the 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, including
each proposed extension of an existing 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 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 of the Federal
Food, Drug, and Cosmetic Act
OMB Control Number 0910-0800--Extension
This information collection helps support the implementation of
sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 353a and 353b); Pharmacy Compounding and
Outsourcing Facilities. Compounding is generally a practice in which a
licensed pharmacist, a licensed physician, or, in the case of an
outsourcing facility, a person under the supervision of a licensed
pharmacist, combines, mixes, or alters ingredients of a drug to create
a medication tailored to the needs of an individual patient. Although
compounded drugs can serve an important medical need for certain
patients, they also present risk. Our compounding program aims to
protect patients from unsafe, ineffective, and poor quality compounded
drugs, while preserving access to lawfully-marketed compounded drugs
for patients who have a medical need for them.
Respondents to the information collection are those engaged in the
practice of pharmacy compounding. The information collection is
intended to account for burden attributable to activities pertaining to
the registration of outsourcing facilities and reporting of drugs, as
established in sections 503B(b)(1) through 503B(b)(3) of the FD&C Act.
Additionally, the information collection is intended to account for
burden attributable to activities associated with the submission of
adverse event reports, as required under section 503B(b)(5) of the FD&C
Act. Finally, the information collection is intended to account for
burden attributable to activities associated with States entering into
memoranda of understanding with the Secretary, as described in section
503A(b)(3) of the FD&C Act.
To help respondents understand statutory requirements applicable to
compounding activities governed by the
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FD&C Act, we have developed the following topical guidance documents:
<bullet> ``Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act'' (January 3, 2017), available on our
website at <a href="https://www.fda.gov/media/90173/download">https://www.fda.gov/media/90173/download</a>. The guidance is
intended for entities that compound human drugs and elect to register
as outsourcing facilities under section 503B of the FD&C Act. Once an
entity has elected to register as an outsourcing facility, it must
submit reports identifying the drugs compounded by the outsourcing
facility. The guidance describes who must report, the format of the
report, the content to include in each report, when to report, how
outsourcing facilities may submit reports to FDA, and the consequences
of outsourcing facilities' failure to submit reports.
<bullet> ``Adverse Event Reporting for Outsourcing Facilities Under
Section 503B of the Federal Food, Drug, and Cosmetic Act'' (October 8,
2015), available at <a href="https://www.fda.gov/media/90997/download">https://www.fda.gov/media/90997/download</a>.
The guidance documents were issued consistent with FDA's good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Section 503B of the FD&C Act Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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503B AERs....................... 55 1 55 1.10 61
503B Recordkeeping AERs......... 55 1 55 16 880
503A Reporting.................. 45 ~197 8,879 0.87 7,968
503A Recordkeeping.............. 45 2 90 1 90
503A Disclosure (MOU)........... 1 1 1 1 1
Outsourcing facility .............. .............. 8,111 .............. 214
registration & reporting under
503B(b)........................
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Total....................... .............. .............. 17,191 .............. 9,214
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based upon our evaluation of the information collection, we have
retained our currently approved burden estimate.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20773 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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