By Rebecca Mayo, J.D.
A new draft guidance provides information and clarity to veterinarians and pharmacists about FDA enforcement of approval requirements for animal drugs compounded from bulk drug substances.
Although compounded animal drugs are subject to drug approval requirements under the Federal Food, Drug, and Cosmetic Act (FDC Act), the FDA has generally exercised enforcement discretion when no other medically appropriate treatment options exist. To protect human and animal health, the FDA has issued a new draft guidance intended to limit and clarify the circumstances in which it will not take enforcement action for compounded animal drug products. If the drug products meet certain requirements, the FDA will not take enforcement action for violations of the FDC Act and will defer to State licensing boards for day-to-day oversight of compounding (Notice, 84 FR 64085, November 20, 2019).
Compounding. The compounding of an animal drug from bulk drug substances results in a "new animal drug," which would be subject to approval, conditional approval, or indexing requirements as well as the cGMP requirements. The law permits compounding of animal drugs when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance. However, the FDA recognizes that while there are numerous drugs that are FDA-approved, conditionally approved, or indexed for use in animals, there are many different species of animals, each with a variety of diseases and conditions for which there are no FDA-approved, conditionally approved, or indexed drugs. When there is no approved drug that can be used to treat an animal with a particular conditions, an animal drug compounded from bulk drug substances may be a medically appropriate treatment.
Basic requirements. The drug must be compounded by or under the direct supervisions of a veterinarian or a pharmacist in a state-licensed pharmacy or federal facility. The label of the drug must include the name and strength of the drug, identifying information about the patient or the species of animal the drug will be used on, information for the compounding pharmacy or veterinarian, a beyond use date, and specific warning statements. Any adverse events or product defects associated with the drug must be reported within 15 days.
Nonfood-producing animals. In addition to the basic requirements, patient-specific prescriptions must be compounded in accordance with the current United States Pharmacopeia and National Formulary (USP-NF) compounding requirements and comply with the standards of applicable USP-NF monographs. The drug must be dispensed by a pharmacy directly to the prescribing veterinarian or the patient’s owner or caretaker or must be dispensed by the veterinarian to the owner or caretaker of a patient. The compounded drug must not be a copy of a marketed FDA-approved, conditionally approved, or indexed animal drug or an FDA-approved human drug. If the compounded drug contains the same active moiety as an approved drug but a different salt, ester, or noncovalent derivative that will produce a clinical difference, the compounder must document the medical rationale. If the compounded drug as any of the same active ingredient moiety(ies) as one or more approved drugs, the compounder must document the reasons why the approved drug cannot be used as the source of the active ingredient.
Office stock drugs must be intended for use in a nonfood-producing species and be compounded from a bulk drug substance listed by the FDA. The drug must be compounded in accordance with the current USP-NF compounding requirements and comply with standards of all applicable USP-NF monographs. The drug must only be dispensed to the owner or caretaker of an animal patient or to another veterinarian in the same practice located in the same physical location.
Food-producing animals. Bulk drug substances may be compounded for use as antidotes for treating toxicosis in food-producing animals. In addition to the basic requirements, the drug must also be compounded from a bulk drug substance on the FDA list. The veterinarian must document a scientifically based withdrawal time that ensures residue of the antidote and the underlying toxin are not present in the animal at the time of slaughter or the veterinarian must ensure the animal does not enter the food supply.
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