Notice2026-03448
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Primary source
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Published
February 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 35 (Monday, February 23, 2026)</title>
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[Federal Register Volume 91, Number 35 (Monday, February 23, 2026)]
[Notices]
[Pages 8495-8496]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03448]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-4348]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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: Submit written comments (including recommendations) on the
collection of information by March 25, 2026.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0800. Also include the FDA docket
number found in brackets in the heading of this document.
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#a0f0f2e1f3d4c1c6c6e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="0c5c5e4d5f786d6a6a4c6a686d2264647f226b637a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 certain 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 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 (AER) for Outsourcing Facilities
Under Section 503B of the Federal Food, Drug, and Cosmetic Act''
(October 8, 2015), available at Adverse Event Reporting for Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act [verbar] FDA The guidance document is intended for firms that have
registered with FDA under section 503B of the FD&C Act as human drug
compounding outsourcing facilities (outsourcing facilities). Under
section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit
adverse event reports to FDA ``in accordance with 21 CFR
310.305(e)(1).'' The guidance document explains that, under 21 CFR
310.305(c)(1), manufacturers, packers, and distributors of marketed
prescription drug products that are not the subject of an approved new
drug or abbreviated new drug application submit to FDA adverse event
reports within 15 calendar days of receiving the information and must
submit follow-up reports within 15 calendar days of receipt of new
information about the adverse event, or as requested by FDA. Also,
under Sec. 310.305(f), entities must maintain for 10 years the records
of all adverse events required to be reported under Sec. 310.305. The
guidance document also explains that, in accordance with regulatory
requirements, adverse event reports must be submitted in an electronic
format that FDA can process, review, and archive (collection of
information is submitted via Form FDA 3500A (MedWatch), approved under
OMB control number 0910-0291). A copy of the current labeling of the
compounded drug product must be provided in the report.
We maintain a searchable database on our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> that
includes other topical guidance pertaining to human drug compounding.
Guidance documents are issued consistent with FDA's good guidance
practice regulations in 21 CFR 10.115, which provide for public comment
at any time. Please see 21 CFR 10.115(f) for instruction on how to
participate in the development and issuance of FDA guidance documents.
In the Federal Register of November 24, 2025 (90 FR 52965), we
published a 60-day notice soliciting comment on the proposed collection
of information. Five comments have been posted to the docket, which we
have subsequently evaluated. All commenters appear to recognize the
practical utility of the collection activities in supporting FDA's
public health protection goals, but asked for increased transparency
regarding specific elements. We appreciate this
[[Page 8496]]
feedback and remind interested readers that FDA published its 60-day
notice in compliance with requirements of the PRA, as administered by
OMB, and uses the notice as way to help us with the ongoing evaluation
of our existing collection inventory. Toward that end, we have updated
explanatory text that accompanies our burden estimate figures. At the
same time, we have made no adjustments to our estimated annualized
burden.
With regard to comments pertaining to certain AER follow-up
information, it is our understanding that provision in 5 CFR
1320.3(h)(5) excepts this collection activity from what an Agency must
consider in its calculation of burden to respondents. For the benefit
of our stakeholders, however, we note that the majority of burden
attributable to information collection activities associated with AER
and FDA's MedWatch program is currently approved in OMB control number
0910-0291. Also, other postmarketing AER information collection
activity for drugs is accounted for in OMB control number 0910-0230. We
have therefore confined our calculation of burden for this information
collection to those activities we believe may be attributable to tasks
recommended in specific FDA guidance. Established in 2015 to account
for burden associated with guidance pertaining to AER for certain
facilities as referenced above in this notice, the information
collection has evolved to include burden that may be attributable to
FDA guidance pertaining to the electronic submission of information,
previously approved and included in OMB control number 0910-0827.
Relatedly, we note three other currently approved information
collections that account for burden attributable to statutory
requirements in sections 503A and 503B: (1) OMB control number 0910-
0776, Registration of Human Drug Compounding Outsourcing Facilities
under section 503B of the FFDCA and Associated fees under section 744K,
established in 2014 to account for burden that may be attributable to
FDA guidance discussing applicable fees; (2) OMB control number 0910-
0858, Human Drug Compounding, Repackaging, and Related Activities
Regarding Sections 503A and 503B of the Federal Food, Drug, and
Cosmetic Act, established in 2018 to account for burden that may be
attributable to FDA guidance discussing various respective compounding
activities; and (3) OMB control number 0910-0883, Obtaining Information
to Understand and Challenges and Opportunities Encountered by
Compounding Outsourcing Facilities, established in 2020 to account for
burden that may be attributable to FDA efforts undertaken to help
inform us how best to utilize our limited resources toward ensuring the
safety of human drug compounding. We note, also, comment on the latter
collection, currently pending OMB review and approval under the PRA.
With regard to comments on burden estimates associated with States
entering into memoranda of understanding with the Secretary, as
described in section 503A(b)(3) of the FD&C Act, we again remind
readers our 60-day notice was published in compliance with requirements
of the PRA. Acknowledging no current activity in this regard, the
figure of ``1'' is proffered in accordance with FDA's understanding of
requirements in 5 CFR 1320.5(a), as a minimum placeholder for potential
activity and in acknowledgement of any burden associated with informal
inquiry, as described in 5 CFR 1320.3(b)(1)(5).
With regard to comments pertaining to the accuracy of FDA's
estimate of both the number of respondents and amount of effort for
requisite tasks, we appreciate the need for greater clarity. As FDA has
communicated in previous notices, there are challenges in determining
the precise number of respondents to the various information collection
tasks, as well as in determining what specific activities are subject
to review and approval by OMB under the PRA. Some activities may be
considered usual and customary (5 CFR 1320.3(b)(2)) and therefore not
subject to such review and approval. For this reason we have retained
our currently approved estimates, but continue to consider public
comment regarding the number of potential respondents to the collection
activities as well as the corresponding annualized burden.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
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Information collection activity Number of
in Sections 503a and 503b of the Number of responses per Total annual Average burden Total hours
FD&C Act 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 reporting 75 ~108 8,111 0.2 214
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.
While we have retained our currently approved burden estimates, we
have corrected an inadvertent omission from our 60-day notice in row 6
of Table 1 reflecting the number of estimated responses and average
burden per response.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-03448 Filed 2-20-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on February 23, 2026.
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