On August 27, 2026, FDA’s Center for Veterinary Medicine (CVM) issued Draft Guidance for Industry No. 256B, “Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities” (Draft Guidance). The Draft Guidance describes circumstances under which FDA generally would not take enforcement action for certain violations arising from compounding animal drugs from bulk drug substances (BDS) in federally-registered facilities. When finalized, it will be combined with existing CVM GFI #256, “Compounding Animal Drugs from Bulk Drug Substances,” which addresses FDA’s enforcement priorities for animal drugs compounded from BDS but does not cover such compounding in federally-registered facilities that are not licensed as pharmacies. The comment period ends on November 27, 2026.
Finalized in August 2022, GFI #256 limits its scope to animal drugs compounded from BDS by or under the direct supervision of veterinarians, or pharmacists in State-licensed pharmacies or Federal facilities. In issuing the Draft Guidance four years later, FDA explains that it has since received questions regarding the applicability of GFI #256 to animal drug compounding in other types of facilities. In addition, FDA notes that the Draft Guidance responds to congressional interest, as outlined in the Senate Report for the FY26 Agriculture Appropriations, which encouraged FDA “to provide public clarification on the role of Animal Drug Compounding in outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act” (FDCA).[1]
If finalized, the Draft Guidance would extend FDA’s enforcement discretion policy in GFI #256 to compounding animal drugs from BDS in “federally-registered facilities,” provided the drugs are compounded in accordance with current good manufacturing practice (CGMP) and subject to other conditions described further below. “Federally-registered facilities” are facilities 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 FDCA, which include outsourcing facilities and other FDA-registered manufacturing establishments that comply with state laws governing drugs, pharmacy, and veterinary medicine but may not be State-licensed pharmacies. For details on the regulatory framework, see our previous alert published when CVM issued Draft GFI #256.
Like GFI #256, the Draft Guidance describes conditions for three scenarios under which CVM intends to exercise enforcement discretion for violations of new animal drug approval[2] and labeling requirements[3] applicable to compounded animal drugs produced from BDS in federally-registered facilities operating under CGMP:
- Compounding for non-food-producing animals pursuant to patient-specific prescriptions;
- Compounding for non-food-producing animals without patient-specific prescriptions (“office stock”); and
- Compounding certain drugs for food-producing animals—specifically antidotes for toxicoses and sedatives or anesthetics for free-ranging wildlife.
The Draft Guidance does not cover animal drugs compounded for investigational use, drugs compounded by non-federally-registered pharmacies, or drugs compounded from FDA-approved animal or human drugs.
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Difference
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GFI #256
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Draft Guidance
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Scope
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Compounding by or under the direct supervision of veterinarians, or pharmacists in State-licensed pharmacies or Federal facilities.
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Compounding in federally-registered facilities, including outsourcing facilities (section 503B(b)) and facilities registered under section 510(b) of the FDCA.
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CGMP Requirement
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Enforcement discretion applies to violations of new animal drug approval, adequate directions for use, and CGMP requirements when guidance conditions are met.
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Enforcement discretion applies only to new animal drug approval and adequate directions for use violations. CGMP compliance is a condition of eligibility.
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Facility Registration and Drug Listing Requirements
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Does not require drug registration or listing with FDA.
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Requires registration and listing as follows:
- Patient-specific prescriptions: Facility must be registered as an animal drug producer; drug must be listed if produced in multi-patient batches more than once.
- Office stock: Facility must be registered as an animal drug producer; drug must be listed (with NDC per 21 CFR Part 207).
- Food-producing animals/wildlife: Facility must be registered as an animal drug producer; drug must be listed if produced in multi-patient batches more than once.
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Labeling Requirements for Patient-Specific Prescriptions
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Requires patient identification, among other things, but does not expressly require it on the product label.
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Requires patient identification on the product label and the following on product labeling:
- Indication(s) for the prescribed drug.
- Patient-specific dosing information.
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Patient-Specific Prescription Definition
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A prescription “includes the species of the animal patient, and identifying information about the animal patient . . . and otherwise complies with applicable State law. A patient may be a single animal or a group of animals in a specific, identified location.”
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A patient-specific prescription “identifies the specific animal patient to be treated. . . . A patient may be a single animal or an identifiable group of animals of the same species consisting of a specific number of animals in an identified location.” The group and location must be adequately described so an objective observer can ascertain whether an animal is part of the group at prescribing. FDA generally considers drugs compounded for a group to be “office stock” if, based on the number of animals, indication, quantity, and other circumstances, it is implausible that only the identified group will be treated.
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Distribution of Office Stock Drugs and Drugs for Food-Producing Animals
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Veterinarians stocking office stock drugs may dispense or transfer them only to the animal’s owner/caretaker or another veterinarian in the same practice.
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Office stock, antidotes for food-producing animals, and sedatives/anesthetics for wildlife may be distributed only directly from the compounder to a veterinarian or health care facility for patient administration or dispensing to the caretaker.
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Dual Registration Facilities
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Not addressed.
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Federally-registered outsourcing facilities that are also State-licensed pharmacies must ensure complete segregation of CGMP and non-CGMP operations to follow either GFI #256 or the Draft Guidance. Because outsourcing facilities are widely understood to produce drugs under CGMP, such facilities should label any non-CGMP drugs in a manner that is not false or misleading.
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If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.
[1] S. Rep. No. 119-37, at 130 (2025).
[2] FDCA sections 512 and 501(a)(5) (21 U.S.C. §§ 360b and 351(a)(5)).
[3] FDCA section 502(f)(1) (21 U.S.C. § 352(f)(1)).
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