Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Issuing agencies

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry (GFI) #256B entitled "Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities." This draft guidance, when finalized, will describe FDA's current thinking regarding the circumstances under which we generally do not intend to take action against the compounding of animal drug products from bulk drug substances (BDS) when done in accordance with Current Good Manufacturing Practice (CGMP) at drug production facilities that are registered with FDA.

Full Text

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<title>Federal Register, Volume 91 Issue 166 (Friday, August 28, 2026)</title>
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[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
[Notices]
[Pages 55602-55606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4533]


Compounding Animal Drugs From Bulk Drug Substances: Compounding 
Under CGMP in Federally-Registered Facilities; Draft Guidance for 
Industry; Availability; Agency Information Collection Activities; 
Proposed Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft guidance for industry (GFI) 
#256B entitled ``Compounding Animal Drugs from Bulk Drug Substances: 
Compounding under CGMP in Federally-Registered Facilities.'' This draft 
guidance, when finalized, will describe FDA's current thinking 
regarding the circumstances under which we generally do not intend to 
take action against the compounding of animal drug products from bulk 
drug substances (BDS) when done in accordance with Current Good 
Manufacturing Practice (CGMP) at drug production facilities that are 
registered with FDA.

DATES: Submit either electronic or written comments on the draft 
guidance by November 27, 2026 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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 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-2018-D-4533 for ``Compounding Animal Drugs from Bulk Drug 
Substances: Compounding under CGMP in Federally-Registered 
Facilities.'' Received comments 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

[[Page 55603]]

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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff, Center for Veterinary Medicine, Food and 
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Cindy L. Burnsteel, Center for 
Veterinary Medicine, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-0817, <a href="/cdn-cgi/l/email-protection#33705a5d574a1d7146415d404756565f735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="8dcee4e3e9f4a3cff8ffe3fef9e8e8e1cdebe9eca3e5e5fea3eae2fb">[email&#160;protected]</span></a>.
    With regard to the collection of information: Kelly Covington, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-
5661, <a href="/cdn-cgi/l/email-protection#e5b5b7a4b691848383a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="eebebcafbd9a8f8888ae888a8fc086869dc0898198">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
#256B entitled ``Compounding Animal Drugs from Bulk Drug Substances: 
Compounding under CGMP in Federally-Registered Facilities.''
    FDA has generally exercised enforcement discretion with regard to 
animal drug compounding from BDS under certain circumstances when no 
other medically appropriate treatment options exist. In the Federal 
Register of April 14, 2022 (87 FR 22212), we announced the availability 
of final GFI #256, entitled ``Compounding Animal Drugs from Bulk Drug 
Substances.'' GFI #256 describes circumstances under which FDA 
generally does not intend to take enforcement action for violations of 
the FD&C Act against either veterinarians or pharmacists who compound 
certain types of animal drugs from BDS in either State-licensed 
pharmacies or Federal facilities. The enforcement discretion in GFI 
#256 applies to State-licensed pharmacies as well as federal government 
facilities.
    GFI #256B is intended to provide recommendations for an additional 
type of compounder, federally-registered facilities that operate in 
compliance with state laws and regulations governing drugs, pharmacy, 
and veterinary medicine but that may not be State-licensed pharmacies 
(e.g., the state has a different license for outsourcing facilities). 
``Federally-registered facilities'' are defined in draft GFI #256B as 
facilities that are registered with FDA under section 503B(b) (21 
U.S.C. 353b(b)) or section 510(b) (21 U.S.C. 360(b)) of the FD&C Act.
    Draft GFI #256B, when finalized, will describe the circumstances 
with respect to federally-registered facilities under which FDA does 
not intend to take enforcement action against the compounding of animal 
drug products from BDS for nonfood-producing animals, either with or 
without patient-specific prescriptions, and for the use of certain BDS 
for compounding animal drugs for use as antidotes for food-producing 
animals or as sedatives and anesthetics for free-ranging wildlife 
species, provided that certain circumstances are present. We will 
combine this draft guidance, when finalized, with our final GFI #256, 
``Compounding Animal Drugs from Bulk Drug Substances.'' In draft GFI 
#256B, we have made minor changes and clarifications to recommendations 
that were originally in GFI #256. If any of these are adopted when GFI 
#256B is finalized, we consider them level 2 changes to GFI #256, and 
we will make conforming changes as appropriate.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Compounding 
Animal Drugs from Bulk Drug Substances: Compounding under CGMP in 
Federally-Registered Facilities.'' 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.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, relevant 
for Executive Order 14192.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that 
are subject to review by the OMB under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3521). A description of these provisions is given 
in the Description section of this document with an estimate of the 
annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
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.
    Title: Compounding Animal Drugs from Bulk Substances; OMB control 
number 0910-0904-Revision.
    Description of Respondents: The respondents are pharmacists in 
State-licensed pharmacies, pharmacists in Federal government 
facilities, veterinarians, and pharmacists at federally-registered 
facilities who compound animal drugs from BDS.
    Description: This information collection supports recommendations 
discussed in Food and Drug Administration guidance. In the Federal 
Register of April 14, 2022 (87 FR 22212), we announced the availability 
of final GFI #256, entitled ``Compounding Animal Drugs from Bulk Drug 
Substances.'' GFI #256 describes circumstances under which FDA 
generally does not intend to take enforcement action against 
veterinarians or pharmacists who compound certain types of animal drugs 
from BDS in either State-licensed pharmacies or Federal facilities for 
violations of the FD&C Act.

[[Page 55604]]

    Draft GFI #256B, when finalized, will describe the circumstances 
with respect to federally-registered facilities under which FDA does 
not intend to take enforcement action against the compounding of animal 
drugs from BDS for nonfood-producing animals, either with or without 
patient-specific prescriptions, and for the use of certain BDS for 
compounding animal drugs for use as antidotes for food-producing 
animals or as sedatives and anesthetics for free-ranging wildlife 
species, provided that certain conditions are met. We will incorporate 
this draft guidance, when finalized, into our final GFI #256, 
``Compounding Animal Drugs from Bulk Drug Substances.''
    We note also related reporting, recordkeeping, and disclosure 
requirements applicable under the Controlled Substances Act, for which 
currently active information collection approvals are maintained by the 
Department of Justice's Drug Enforcement Administration. For purposes 
of this information collection request, however, we have characterized 
the burden that may be associated with recommendations discussed in the 
guidance document as recordkeeping burden.
    Our exercise of discretion depends on our ability to assess whether 
the circumstances under which FDA would intend to exercise such 
discretion, as described in this draft guidance, exist. FDA staff may 
use pharmacy and veterinary records, among other things, to determine 
the circumstances surrounding the compounding activity. Except with 
regard to one proposed item, the routine business records kept by 
pharmacists who compound animal drugs from BDS who compound animal 
drugs from BDS, as well as veterinarians prescribing compounded animal 
drugs within a valid veterinarian-client-patient relationship, should 
be adequate to ascertain if the circumstances described in the draft 
guidance exist.
    The draft guidance provides recommendations for the compounding of 
animal drugs from bulk drug substances at ``federally-registered 
facilities,'' that is, facilities that are registered with FDA under 
section 503B(b) (21 U.S.C. 353b(b)) or section 510(b) (21 U.S.C. 
360(b)) of the FD&C Act. Section III.A.4 of the draft guidance explains 
that when the compounded drug is a copy of a marketed FDA-approved, 
conditionally approved, or indexed animal drug or an FDA-approved human 
drug, there should be a difference between the compounded drug and the 
FDA-approved, conditionally approved, or indexed animal drug or the 
FDA-approved human drug that will produce a clinical difference in the 
identified patient. We tentatively conclude that it is usual and 
customary for veterinarians to document their medical rationale for 
using such a compounded product as a matter of maintaining an adequate 
medical record in routine practice; therefore, no burden has been 
estimated for the time it would take for a veterinarian to make this 
record.
    Section III.A.5 of the draft guidance explains that when the 
compounded drug contains the same active moiety as a marketed FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug (which includes drugs containing the same active 
ingredient and those with a different salt, ester, or other noncovalent 
derivative), there should be a difference between the compounded drug 
and the marketed FDA-approved, conditionally approved, or indexed 
animal drug or FDA-approved human drug that will produce a clinical 
difference in the identified patient. In such a case, the medical 
rationale is documented in the prescription or noted in the patient's 
medical record. We tentatively conclude that it is usual and customary 
for veterinarians to document their medical rationale for using such a 
compounded product as a matter of maintaining an adequate medical 
record in routine practice; therefore, no burden has been estimated for 
the time it would take for a veterinarian to make this record.
    Sections III.A.5 and III.A.6 of the draft guidance describe 
circumstances under which FDA recommends pharmacist compounders 
document the prescribing veterinarian's medical rationale and the 
reason that a BDS is being used as the source of the active ingredient. 
Based on our evaluation, we believe it is usual and customary business 
practice for veterinarians to document the medical rationale, as 
recommended in the guidance. However, we believe pharmacist compounders 
may not document the information recommended in the guidance as a usual 
and customary business practice.
    FDA estimates the burden of this collection of information as 
follows:

                                                 Table 1--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
 Recommended information collection activity      Number of       records per     Total annual        Average burden per recordkeeping       Total hours
                                                recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documenting rationales by licensed                       7,500              741       5,556,306  0.02 (1 minute)...........................      111,126
 veterinarian/pharmacist compounders in state-
 licensed pharmacies or Federal Facilities.
Documenting rationales by facilities                         8              741           5,928  0.02 (1 minute)...........................          119
 registered under section 503B(b) or section
 510(b) (21 U.S.C. 360(b)(2) of the FD&C Act.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................            7,508  ...............       5,562,234  ..........................................      111,245
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sums may not total due to rounding.

    Our estimated burden for the information collection reflects an 
overall decrease of 58,855 hours and a corresponding decrease of 393 
records/recordkeeper. We attribute this adjustment to a decrease in our 
estimate of the percentage of prescriptions that are subject to the 
recommendation related to medical rationale, plus the inclusion of 
federally-registered facilities. Of the approximately 98 federally-
registered facilities that perform any compounding in the United 
States, about 8 specialize in both human and animal compounding. We do 
not have data on the number of patient-specific prescriptions filled at 
these facilities and therefore use the same assumptions we use for 
other compounders. We seek information about percentage of patient 
specific animal drug prescriptions sold by these facilities, and the 
percentage of those prescriptions that meet the guidance's definition 
of copy. GFI 256B makes recommendations that apply not only to 
outsourcing facilities registered under

[[Page 55605]]

section 503B(b), but also to ``traditional'' animal drug manufacturers 
registered under section 510(b). At present, to our knowledge, no 
facilities registered under section 510(b) compound patient-specific 
prescriptions. Therefore, we do not count them in our estimated number 
of recordkeepers and estimate 0 recordkeeping burden for those firms at 
this time.
    At the time of its initial publication, we originally assumed the 
guidance's recommendations regarding medical rationales would apply to 
50 to 75 percent of all prescriptions. However, since the publication 
of GFI 256, FDA has conducted additional inspections of animal drug 
compounders and has a better understanding of current industry 
practices. Based on our additional experience with the regulation of 
compounded animal drugs, we now estimate that 49% of all prescriptions 
for compounded animal drugs would fall within the medical rationale 
recommendation. We note that our medical rationale recommendation does 
not apply to several significant categories of compounded animal drugs, 
namely, all drugs not compounded from BDS, all drugs sold as office 
stock, and all drugs which do not meet the guidance's definition of a 
copy (such as compounded drugs with a different active moiety and/or 
route of administration). We do not have additional information about 
our other estimates (e.g., the estimated number of recordkeepers) and 
therefore continue to use our original estimates for those values. 
Therefore, recalculating using 49% as the number of prescriptions that 
fall within the medical rationale recommendation, we estimate the total 
number of recordkeeping hours for veterinarians, pharmacies and federal 
government facilities under GFI 256 to be 111,126.
    With respect to draft GFI #256B, we estimate it will take 1 minute 
(0.02 hours) per record for federally-registered facilities to document 
the rationales described in the draft guidance, for a total of 119 
hours attributable to the new respondents in draft GFI 256B, as 
reported in Table 1.
    Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources 
to comply with a collection of information are excluded from the burden 
estimate if the reporting, recordkeeping, or disclosure activities are 
usual and customary because they would occur in the normal course of 
activities. If the compounded drug is compounded for use as an antidote 
for food-producing animals or for use as a sedative or anesthetic for 
free-ranging wildlife species, section III.C.3 of the guidance 
recommends that the veterinarian establishes and documents a 
scientifically based withdrawal time that ensures residues of the: (1) 
Antidote and the underlying toxin or (2) sedative or anesthetic are not 
present in the animal at the time of slaughter or harvest or the 
veterinarian ensures the animal does not enter the food supply. We 
believe that it is usual and customary for veterinarians to establish 
and document a scientifically based withdrawal time as a matter of 
maintaining an adequate medical record in routine practice and, 
therefore, estimate no burden for the time it would take for a 
veterinarian to make this record. See 5 CFR 1320.3(b)(2).
    We believe any information collection pertaining to enforcement 
activities would involve administrative actions to which the Federal 
government is a party or that occur after an administrative case file 
has been opened regarding a particular individual or entity and would 
be exempt from OMB review and approval under the PRA. See 44 U.S.C. 
3518(c)(1)(B); 5 CFR 1320.4(a)(2), (c).
    In addition, the guidance makes a number of recommendations 
regarding the labeling of animal drugs compounded from bulk drug 
substances. In sections III.A.8, III.B.6, and III.C.8, the guidance 
recommends basic information that pharmacists should include on the 
label of the compounded drug, such as the name and strength of the 
drug, species, directions for use, and the name, address, and contact 
information for the compounder. We believe that it is usual and 
customary for pharmacists to include such information on the labels of 
compounded animal drugs in the normal course of their activities, and 
therefore, estimate no burden for the time it would take to prepare 
such labeling. See 5 CFR 1320.3(b)(2). Sections III.A.8, III.B.6, and 
III.C.6 of GFI #256 and III.A.9, III.B.7, and III.C.9 of GFI #256 also 
recommend compounders include several specific statements on the label 
of animal drugs compounded from bulk drug substances (e.g., ``This is a 
compounded drug. Not an FDA approved or indexed drug''). Because these 
recommended labeling statements are public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public (5 CFR 1320.3(c)(2)), they are 
exempt from OMB review and approval under the PRA.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

IV. Other Issues for Consideration

    Although this draft guidance proposes to extend a similar 
enforcement policy to all federally-registered facilities as is 
currently applicable to State licensed pharmacies and Federal 
government facilities, FDA is interested in which, if any, alterations 
should be made to better tailor this policy to account for the quality 
advantages of drugs that are produced in accordance with CGMP, as 
opposed to those compounded under the enforcement discretion policy of 
GFI #256, which are not made under CGMP conditions. FDA therefore 
requests the following additional information and comments on the 
options. FDA may adopt any of these changes in the final document 
without reissuance of a new draft guidance. For all data provided in 
response to these questions, we request the respondent do its best to 
identify the source of the data (e.g., data from 503B facilities vs. 
data from other non-federally registered compounders vs. combined 
data).
    1. FDA seeks comment on whether it should expand the 
recommendations in this guidance to additional drugs that are not 
currently on ``The List of Bulk Drug Substances for Compounding Office 
Stock Drugs for Use in Nonfood-Producing Animals'' (available at 
<a href="https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals">https://www.fda.gov/animal-veterinary/animal-drug-compounding/list-bulk-drug-substances-compounding-office-stock-drugs-use-nonfood-producing-animals</a>). FDA remains concerned that compounded office stock 
potentially exposes large numbers of animals to drugs of unproven 
safety and effectiveness but notes that production in accordance with 
CGMP would present fewer quality concerns than drugs compounding under 
non-CGMP conditions per GFI #256. Unapproved drugs made in accordance 
with CGMP can still present additional quality risks compared to 
approved products because, while both are made according to CGMP, the 
latter undergo a product-specific Chemistry Manufacturing and Controls 
review during their application review. FDA is interested in the 
effects of extending the enforcement discretion policy related to 
office stock made in federally-registered establishments to additional 
categories of drugs, such as all office stock that does not meet the 
definition of a copy (i.e., the enforcement discretion policy would 
include compounding office stock on ``The List of Bulk Drug Substances 
for

[[Page 55606]]

Compounding Office Stock Drugs for Use in Nonfood-Producing Animals'' 
and any other animal drug from a bulk drug substance, provided there is 
no marketed approved/indexed human or animals drugs with the same 
active moiety and route of administration). We invite comment on this 
or other options.
    2. FDA seeks information on the relative percentages of drugs being 
compounded from bulk drug substances that meet the definition of a copy 
under this guidance (same active moiety and route of administration as 
FDA-approved/indexed drug) compared with those that do not meet the 
definition of a copy.
    3. FDA seeks general comment on whether any parts of GFI #256 
negatively affect the market incentives to produce these same drugs 
under CGMP as described in this guidance.
    4. FDA seeks information on how many/which of the drugs on ``The 
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use 
in Nonfood-Producing Animals'' are presently being produced according 
to CGMP. We are specifically interested in understanding whether 
federally-registered facilities are able to meet veterinarians' needs 
with respect to these drugs.
    5. FDA seeks information from conventional animal drug 
manufacturers (federally-registered facilities under FD&C Act section 
510) as to whether they are likely to compound under this guidance and 
which, if any, barriers exist (e.g., pharmacist supervision).
    6. FDA seeks comment from conventional animal drug manufacturers 
who make approved products whether any aspects of this guidance should 
be specifically tailored to better accommodate manufacturers who wish 
to compound copies of their own approved products (i.e., to meet the 
medical needs of individual animal patients who are not suitable 
candidates for the approved version). We recognize these registered 
facilities have particular expertise in these BDS, as well as access to 
various stages of in-process materials for the approved product, and 
request comment on how this should be addressed in GFI #256B.
    7. FDA seeks comment/information as to the impact of recent United 
States Pharmacopeia (USP) changes to chapters <795> and <797> for 
State-licensed compounding pharmacies and whether animal patients would 
benefit from state-licensed pharmacies (e.g., non-compounding, retail/
dispensing-only pharmacies) being able to obtain compounded animal 
drugs made under CGMP in federally-registered facilities under GFI 
#256B, which they would dispense. FDA has preliminarily considered this 
change, but FDA has concerns about our ability to control the 
inappropriate distribution of copies if the compounding of animal drugs 
from BDS is conducted in a separate facility and/or by parties who are 
unrelated to the pharmacist/facility who obtains and maintains the 
medical rationale, particularly given there are tens of thousands of 
non-compounding retail/dispensing pharmacies that could distribute 
these drugs. We seek comment on any challenges posed by this option, 
such as:
    <bullet> Difficulties in taking action against a federally-
registered facility if adequate medical rationale is not collected by 
3rd party pharmacies that distribute the federally-registered 
facility's drugs;
    <bullet> Ability to assess medical rationale (including asking 
standard inspectional questions about a firm's process for collecting 
rationale) if a single compounder's drugs are distributed by (and 
medical rationale collected by) numerous, potentially unrelated 
pharmacies; and
    <bullet> Ability to assess a federally-registered facility's 
decision to use BDS as opposed to approved products as the source of 
active ingredients when some of the justifications for using BDS are 
inherently patient or species specific (e.g., patient or species 
allergic to specific ingredient) and the federally-registered facility 
may not know the identity or needs of the animal patient to whom a 
state licensed pharmacy may subsequently dispense a drug;
    <bullet> Practical and legal limitations on FDA's ability to 
conduct a full inspection and review all records recommended by this 
guidance (including reviewing original records of medical rationale for 
patient-specific prescriptions) if they are created and maintained by a 
pharmacy that did not manufacture, produce, or otherwise compound the 
drug (i.e., a non-compounding retail pharmacy that only fills patient-
specific prescriptions from drugs it obtained from a federally-
registered facility);
    <bullet> Changes that might mitigate the practical and legal 
constraints related to inspecting countless retail/dispensing-only 
pharmacies, including:
    [cir] recommending the federally-registered facility maintain 
copies of all medical rationale (even the medical rationale obtained 
elsewhere);
    [cir] limiting the recommendation to a federally-registered 
facility that distributes to pharmacies under common ownership and 
control; and/or
    [cir] limiting the recommendation only to drugs that do not meet 
the definition of a copy.
    8. FDA seeks information from federally-licensed facilities, 
particularly outsourcing facilities, as to their current practices and 
future ability/willingness to dispense patient-specific prescriptions. 
We note that the guidance treats prescriptions for groups of animals as 
patient-specific in certain circumstances.
    9. FDA seeks information about the impact any changes or proposals 
above in this guidance have on zoos, as well as any unique factors that 
distinguish zoos from other consumers of, or markets for, animal drugs.
    10. FDA is concerned that ``groups of animals,'' as described in 
GFI #256, is being misused as a means of dispensing office stock. We 
have made minor changes and clarifications in draft GFI #256B to 
address this issue (e.g., clarifying what constitutes a group and how 
groups should be described), but we seek comment on whether it is 
appropriate to further revise our recommendations on prescribing to 
groups of animals, such as treating prescriptions for groups of animals 
as patient-specific only when every animal in the group is treated 
simultaneously for the same indication (e.g., contagious disease 
threatening entire group due to its presence in a specific, identified 
location, or entire group exposed to toxin) or where it is impractical 
to not treat all animals simultaneously. FDA requests comment on both 
specific situations (``contagious disease,'' ``toxic exposure,'' etc.) 
and general recommendations (``when necessary to treat 
simultaneously'') where prescriptions should be written for groups of 
animals.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17580 Filed 8-27-26; 8:45 am]
BILLING CODE 4164-01-P


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