Time is running out to nominate bulk drug substances to the FDA

Published on October 20, 2015
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Veterinarians have until Nov. 16 to submit nominations of bulk drug substances to the Food and Drug Administration (FDA). This is part of the agency’s draft compounding guidance, released earlier this summer, which would consider the ingredients that outsourcing facilities would be allowed to use to prepare compounded medications for veterinary office stock.PharmaDrugs

The FDA’s draft guidance for industry #230, “Compounding Animal Drugs from Bulk Drug Substances,” describes the conditions under which the FDA generally does not intend to initiate enforcement action against state-licensed pharmacies, licensed veterinarians, and facilities registered as “outsourcing facilities” (which do not currently compound for animal patients) that compound animal drugs from bulk drug substances (i.e., the active pharmaceutical ingredients). This draft guidance would not change the regulations related to compounding from an FDA-approved drug product.

As part of the guidance, the FDA is developing a list of bulk drug substances (or, Appendix A) when all of the following criteria are met:

  • there is no marketed approved, conditionally approved, or index-listed animal drug that can be used as labeled to treat the condition;
  • there is no marketed approved animal or human drug that could be used by extra-label-drug-use rules to treat the condition;
  • the drug cannot be compounded from an approved animal or human drug;
  • immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and
  • the FDA has not identified a significant safety concern specific to the use of the bulk drug substance to compound animal drugs.

To determine if a bulk drug substance should be included in Appendix A, the FDA needs information from veterinarians about the bulk drug substances being nominated, including:

  • A statement identifying the species and condition(s) that the drug product to be compounded with the nominated bulk drug substance is intended to treat;
  • A bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available, including any relevant peer-reviewed veterinary literature;
  • If there are FDA-approved drug products that address the same conditions in the same species, an explanation, supported by relevant veterinary literature, of why a compounded drug product is necessary (i.e., why the approved drug product is not suitable for a particular patient population);
  • A review of the veterinary literature to determine whether there are FDA-approved animal or human drugs that could be prescribed as an extra-label use to treat the condition(s) in the species that the drug compounded with the nominated substance is intended to address;
  • If the bulk drug substance is an active ingredient in an approved animal or human drug, an explanation, supported by appropriate scientific data, of why the animal drug product cannot be compounded from the approved drug
  • An explanation, supported by relevant veterinary literature, of why the animal drug product to be compounded with the nominated bulk drug substance must be available to the veterinarian for immediate treatment to avoid animal suffering or death.

Generic statements or nominations without supporting information will not be accepted by the FDA.

Submit your comments to the FDA directly for the official record; feel free to also share your thoughts with us at regulatorycommentsatavma [dot] org.

Read more about the AVMA’s compounding efforts, including our formal response to the FDA’s draft guidance, on our website.


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