FDA draft guidance allows for an animal drug to be compounded from bulk drug substances in limited circumstances for which there is no FDA-approved treatment.
The FDA today issued a draft guidance that addresses instances in which the agency does not intend to take action for violations by pharmacists and veterinarians compounding or overseeing the compounding of animal drugs from bulk drug substances. Under the Federal Food, Drug and Cosmetic Act (FD&C Act), compounding an animal drug from bulk drug substances results in a new medication that must comply with the FD&C Act’s approval. In addition, all animal drugs are required to be made in accordance with current good manufacturing practice (cGMP) requirements and have adequate directions for use, according to the FDA.
The new guideline is intended to provide additional information and clarity for veterinarians and pharmacists regarding the FDA’s current enforcement actions that address animal drug compounding from bulk drug substances. If passed, the policies in the proposed guidance would define situations in which veterinarians are acting within a valid veterinarian-client-patient relationship (VCPR) and for which there is no medically appropriate drug that is FDA-approved to treat the animal.
This policy would also address the FDA’s concerns with compounding animal drugs from bulk drug substances, including significant concerns with these medications when they present particular human or animal safety concerns; are intended for use in food-producing animals; are copies of marketed FDA-approved, conditionally approved, or indexed drugs; or are compounded without a patient-specific prescription.
In order to be legally marketed currently, animal drugs, with few exceptions, must be approved by the FDA under section 512 of the FD&C Act, conditionally approved by the FDA under section 571 of the FD&C Act, or indexed under section 572 of the FD&C Act. The FDA-approved animal drugs are subject to requirements once they are on the market, in addition to a pre-market review. Reports of adverse events and manufacturing quality throughout the lifetime of the product allow the FDA to continue to monitor the safety and efficacy of the drug after approval.
The guidance provisions will require the FDA to review the data regarding the safety and efficacy of a product before it qualifies for a conditional approval or indexing process.
For more information the guidance, click here.
Compounding animal drugs from bulk drug substances-guidance for industry. FDA website. https://www.fda.gov/media/132567/download. Published November 2019. Accessed November 19, 2019.