Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances, 18665-18667 [2025-07578]
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Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
industry, each containing one or more
comments on the proposed collection of
information.
(Comment 1) Several comments
expressed appreciation for FDA’s efforts
in developing a comprehensive
understanding of the outsourcing
facility sector, its challenges, and
opportunities for advancement. Other
comments expressed appreciation for
FDA’s efforts to ensure that the survey
questions capture the most important
information from compounding
outsourcing facilities and that the
survey not place an undue burden on
respondents.
(Response 1) We agree that the
information being collected has utility
for understanding of the outsourcing
facility sector, its challenges, and
opportunities for advancement and that
we are making an effort to not place an
undue burden on respondents.
(Comment 2) One comment suggested
that certain questions focus on financial
considerations and economic
consequences and argued that they are
not necessary for FDA’s oversight of
outsourcing facilities and are unrelated
to FDA’s public health mission and the
quality and safety of compounded
drugs.
(Response 2) We have considered the
comments and disagree. As stated
previously, the Center of Excellence is
conducting this research to better
understand outsourcing facilities’
challenges and opportunities in
different areas to help guide decisions
regarding future training and other
engagement. We think that an important
component to understanding the
18665
challenges and opportunities that
outsourcing facilities face includes
gaining insight into the financial
considerations that impact outsourcing
facilities’ operations and business
models.
(Comment 3) Several comments
proposed changes to existing questions
or the inclusion of new questions.
(Response 3) We have considered the
comments requesting that the Agency
update the questionnaire and disagree
that certain questions should be
modified or added. We believe that the
information sought from the proposed
questions will be captured within the
existing questions or elsewhere in our
research.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Total hours
Survey Invitation ......................................................
Survey Questionnaire ..............................................
250
250
1
1
250
250
0.0833 (5 mins) .........
0.50 (30 mins) ...........
21
125
Total ..................................................................
........................
........................
500
....................................
146
1 There
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Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
The universe of registered outsourcing
facilities and related human
prescription drug compounding
businesses known to the Center of
Excellence will be sent a survey
invitation. We reduced our estimate of
the number of respondents from 300 to
250. We estimate that approximately
250 respondents will receive an
invitation to participate in the survey
and will spend 5 minutes reading the
invitation and considering whether to
take the survey, for a total of 20.825
burden hours per year, rounded to 21
hours. Based on our historical
experience, we anticipate that all those
invited to participate in the survey will
complete the survey. We estimate that
respondents will spend 15 to 30
minutes to complete the revised survey.
Using the upper-bound estimate, we
report a reduction in burden hours to 30
minutes (0.50 hour) per survey response
from our previous estimate of 1 hour per
response. We estimate that
approximately 250 respondents will
spend 30 minutes completing the
survey, for a total of 146 burden hours
per year.
Based on a review of the information
collection since our last request for
OMB approval, we have made
adjustments to our burden estimate. Our
estimated burden for the information
collection reflects an overall decrease of
VerDate Sep<11>2014
17:24 Apr 30, 2025
Jkt 265001
454 hours and a corresponding decrease
of 100 responses. We have also reduced
our estimated burden per survey
response from 1 hour to 30 minutes.
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–07557 Filed 4–30–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2025–N–0082]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Compounding
Animal Drugs From Bulk Drug
Substances
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
PO 00000
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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 the recordkeeping
provisions set forth in Guidance for
Industry, GFI #256—Compounding
Animal Drugs from Bulk Substances.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
30, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 30, 2025. 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:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2025–N–0082 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Compounding Animal Drugs from Bulk
Drug Substances.’’ 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 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
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17:24 Apr 30, 2025
Jkt 265001
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.
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, PRAStaff@
fda.hhs.gov.
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
PO 00000
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Fmt 4703
Sfmt 4703
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.
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
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)).
E:\FR\FM\01MYN1.SGM
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18667
Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
compounded from bulk drug substances
under certain circumstances when no
other medically appropriate treatment
options exist.
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’’
(https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-256-compoundinganimal-drugs-bulk-drug-substances).
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
Activity
Documenting rationales by licensed veterinarian/pharmacist
compounders in state-licensed pharmacies or Federal facilities
1 There
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–07578 Filed 4–30–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2025–N–0414]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Reagents for Detection of Specific
Novel Influenza A Viruses
Food and Drug Administration,
HHS.
Notice.
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 the information
collection associated with Agency
guidance on reagents for detection of
specific novel influenza A viruses.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:24 Apr 30, 2025
Jkt 265001
Either electronic or written
comments on the collection of
information must be submitted by June
30, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 30, 2025. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Food and Drug Administration
ACTION:
1,134
Total
annual
responses
8,505,000
Average
burden per
response
(1 minute)
0.017
Total hours
144,585
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates 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.
AGENCY:
7,500
Number of
responses per
respondent
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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–
2025–N–0414 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
on Reagents for Detection of Specific
Novel Influenza A Viruses.’’ 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
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
E:\FR\FM\01MYN1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18665-18667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07578]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0082]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Compounding Animal Drugs From Bulk Drug Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 the recordkeeping provisions set forth in
Guidance for Industry, GFI #256--Compounding Animal Drugs from Bulk
Substances.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 30, 2025. 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:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
[[Page 18666]]
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-2025-N-0082 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Compounding Animal Drugs from
Bulk Drug Substances.'' 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
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.
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,
[email protected].
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.
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
[[Page 18667]]
compounded from bulk drug substances under certain circumstances when
no other medically appropriate treatment options exist.
---------------------------------------------------------------------------
\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)).
---------------------------------------------------------------------------
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'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances). 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average burden
Activity Number of responses per annual per response Total hours
respondents respondent responses (1 minute)
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Documenting rationales by licensed 7,500 1,134 8,505,000 0.017 144,585
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 estimates 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: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07578 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
