As 2019 comes to an end, the United States Food & Drug Administration’s (“FDA” or the “Agency”) Center for Veterinary Medicine has published a new draft Guidance for Industry #256, “Compounding Animal Drugs from Bulk Drug Substances” (the “Draft Guidance”).  The Draft Guidance addresses FDA’s regulatory approach to compounding animal drugs from bulk drug substances.  Many in the industry may recall that FDA previously published draft Guidance for Industry #230, similarly titled, “Compounding Animal Drugs from Bulk Drug Substances,” in 2015.  However, after receiving comments from more than 150 stakeholders, including from Rachael Pontikes on behalf of certain stakeholders, FDA withdrew this draft guidance in 2017.  FDA went back to the drawing board in an attempt to publish a more workable framework.  The Draft Guidance appears to be the result of those deliberations.

What does the Draft Guidance cover?

Like draft Guidance for Industry #230, FDA again asserts, in the absence of any governing statutory authority from Congress, that the Agency can regulate the compounding of animal drugs—specifically, that FDA has the authority to set forth parameters around compounding animal drugs from bulk substances.  In this new Draft Guidance, FDA proceeds to set out its thinking for compounding animal drugs from bulk drug substances under three different scenarios: (1) compounding pursuant to a patient-specific prescription for nonfood-producing animals; (2) compounding for office stock for nonfood-producing animals; and (3) compounding for use as antidotes for food-producing animals.

For example, if compounding with bulk substances pursuant to patient-specific prescriptions for nonfood-producing animals, FDA is stating that the drug should be compounded in accordance with applicable United States Pharmacopeia and National Formulary (“USP-NF”) Chapters and monographs and is asserting the drug cannot be a copy of an FDA-approved, conditionally approved, or indexed animal drug, or an FDA-approved human drug.  If compounding without patient-specific prescriptions (“office stock”) for nonfood-producing animals, FDA is creating via this Draft Guidance an Animal Bulks List.  That is, FDA is asserting, in order to compound animal drugs for office stock from bulk, the bulk drug substance must be listed on FDA’s List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals.

FDA is accepting nominations for bulk drug substances to evaluate for inclusion on its Animal Bulks List

In conjunction with the publication of the Draft Guidance, FDA issued a notice to establish a public docket for the nominations of bulk drug substances for inclusion on the Animal Bulks List.  According to the Draft Guidance, FDA will include a nominated bulk drug substance on the Animal Bulks List only if the substance meets certain criteria.  The status of the previously nominated bulk substances is in flux.  Currently, FDA intends to include eight bulk drug substances on the Animal Bulks List that the Agency previously determined met its criteria that was set out in the now withdrawn 2015 draft guidance.  However, these substances will be included on the Animal Bulks List only to the extent they meet the approach of the final guidance.

What’s next?

The issuance of this Draft Guidance and the establishment of the public docket are further indications that FDA continues to take an active interest in the regulation and oversight of drug compounding.  FDA is accepting comments to the Draft Guidance, which must be submitted by February 18, 2020.  As stated above, FDA is also accepting nominations of bulk drug substances for FDA’s evaluation and inclusion on the Animal Bulks List.

Should you have any questions regarding the Draft Guidance or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, Emily Hussey, David Hartmann, or Kelly Kearney for further discussion.