The new draft guidance outlines situations where FDA intends to exercise enforcement discretion to not take action.

On November 19, 2019, the U.S. Food and Drug Administration (FDA) released revised guidance concerning the compounding of animal drugs from bulk drug substances—in particular, the circumstances under which the FDA would not plan to take enforcement action for certain violations of the Federal Food, Drug, and Cosmetic Act (FDCA) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. The guidance is intended to replace a withdrawn draft guidance concerning the compounding of animal drugs initially released in May 2015.

The process of animal drug compounding typically involves a licensed pharmacist or veterinarian who “combines, mixes, or alters ingredients of a drug to create a medication” specially designed to meet the needs of a particular patient. The FDCA, among other things, prohibits the marketing of unapproved drugs. While new animal drugs undergo a review and approval process by the FDA, compounded animal drugs do not and, as such, they would ordinarily be deemed “unsafe” or “adulterated” drugs under the FDCA. FDA does not, however, regulate the practice of medicine. Recognizing the importance of compounded medications to animal health, for several years FDA has exercised enforcement discretion concerning animal medications compounded from bulk ingredients. The new draft guidance outlines situations where FDA intends to exercise enforcement discretion to not take action against pharmacies or veterinarians compounding medications from bulk ingredients for use in animals.

The guidance, in its current form, provides that the “FDA does not intend to take enforcement action for violations of the FDCA requirements for approval, adequate directions for use, and cGMP requirements” with respect to the compounding of animal drugs from bulk drug substances under the following certain circumstances:

• When animal drugs are compounded from bulk drug substances for nonfood-producing animals, provided that certain requirements are met, including that:
  1. The drug compounding is directly supervised by a veterinarian or pharmacist in a state-licensed or federal facility;
  2. The drug is compounded in accordance with USP-NF standards;
  3. The drug is dispensed in accordance with a prescription or pursuant to certain other guidelines;
  4. The compounded drug is not a copy of an FDA-approved drug and, if it shares certain properties with an FDA-approved drug, there are sufficient clinical differences; and
  5. The drug is properly labeled as set forth in the draft guidance.
• When animal drugs are compounded without patient-specific prescriptions for nonfood-producing animals, provided that certain requirements are met, including that:
  1. The drug compounding is directly supervised by a veterinarian or pharmacist in a state-licensed or federal facility;
  2. The drug is compounded from a bulk drug substance on the FDA’s recognized list;
  3. The veterinarian establishes and documents scientifically based withdrawal times that ensure that residue or resulting toxins do not enter the food supply chain; and
  4. The drug is properly labeled as set forth in the draft guidance.

Importantly, the draft guidance reserves the right of the FDA to take enforcement action when, for instance, animal drugs compounded from bulk drug substances either present specific human or animal safety concerns or fail to meet other manufacturing, product quality, labeling or packaging requirements of the FDCA.

At this stage in the notice and comment period, the FDA has released the revised guidance to solicit public comments, which will be accepted until February 18, 2020, with the expectation that the guidance may be revised before being issued in final form.

For More Information

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