Notice2025-14226
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
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 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35693-35694]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0082]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Compounding Animal
Drugs From Bulk Drug Substances
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 August 28, 2025.
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 0910-0904. 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
[[Page 35694]]
20852, 301-796-5733, <a href="/cdn-cgi/l/email-protection#57070516042336313117313336793f3f2479303821"><span class="__cf_email__" data-cfemail="4d1d1f0c1e392c2b2b0d2b292c6325253e632a223b">[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.
Compounding Animal Drugs From Bulk Substances
OMB Control Number 0910-0904--Extension
This information collection helps support recommendations discussed
in FDA guidance. Animal drugs compounded from bulk drug substances by
pharmacists and veterinarians do not meet certain important
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). To
be legally marketed in accordance with animal drug approval
requirements of the FD&C Act, an approval, conditional approval, or
listing on the Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species \1\ is required, and compounded drugs do not go
through any of these pre-market review processes. (Information
collection associated with new animal drug applications is approved
under OMB control no. 0910-0032; information collection pertaining to
index of legally marketed unapproved new animal drugs for minor species
is approved under OMB control no. 0910-0605.) Further, all animal drugs
are required to, among other things, be made in accordance with current
good manufacturing practice (CGMP) requirements and have adequate
directions for use, requirements not met by compounded drugs.\2\ Thus,
drugs compounded from bulk drug substances violate the FD&C Act because
they are not approved or indexed, are not made according to CGMP, and
cannot satisfy the FD&C Act's adequate directions for use provision
(which requires, among other things, that a prescription drug have FDA-
approved labeling). However, FDA has generally refrained from taking
enforcement action against animal drugs compounded from bulk drug
substances under certain circumstances when no other medically
appropriate treatment options exist.
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\1\ Sections 512, 571, and 572 of the FD&C Act (21 U.S.C. 360b,
360ccc, 360ccc-1).
\2\ Section 501(a)(2)(B) of the FD&C Act (21 U.S.C.
351(a)(2)(B)), 21 CFR parts 210 and 211, and section 502(f)(1) of
the FD&C Act (21 U.S.C. 352(f)(1)).
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To assist respondents in understanding FDA's current thinking about
animal drug compounding from bulk substances, our Center for Veterinary
Medicine developed GFI #256 entitled ``Compounding Animal Drugs from
Bulk Drug Substances'' (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances</a>). The guidance describes circumstances under which
FDA generally does not intend to take enforcement action against
pharmacists and veterinarians who compound animal drugs from bulk drug
substances.
In the Federal Register of May 1, 2025 (90 FR 18665), we published
a 60-day notice soliciting comment on the proposed collection of
information. Three comments were submitted to the docket by various
trade associations, however the first two were not responsive to the
information collection topics solicited under 5 CFR 1320.8(d). Rather,
the comments appeared to be proffered in accordance with our Good
Guidance Practice regulations in 21 CFR 10.115 and we therefore refer
the commenters to 21 CFR 10.115(f) regarding how the public may
participate in the development of FDA guidance documents. The third
comment suggested improvements to increase the utility of Form FDA
1932a, Veterinary Adverse Drug Reaction, Lack of Effectiveness, Or
Product Defect Report, approved for use in OMB control no. 0910-0291,
currently pending OMB review. We appreciate this comment and continue
to make technological enhancements to our collection instruments as our
limited resources allow. At the same, none of the comments offered an
alternative estimate, and we therefore retain the estimate of burden
for the information collection as communicated in our 60-day notice,
which is as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per Total
respondents respondent responses response hours
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Documenting rationales by 7,500 1,134 8,505,000 0.017 (1 minute) 144,585
licensed veterinarian/
pharmacist compounders in state-
licensed pharmacies or Federal
facilities.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We base our estimate on our experience with the regulation of
compounded animal drugs. Based on a review of the information
collection since our last request for OMB approval, we have made no
adjustments to our burden estimate.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14226 Filed 7-28-25; 8:45 am]
BILLING CODE 4164-01-P
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