New Draft Guidance “Allows” Compounding of Animal Drugs from Bulk Drug Substances

On May 20, 2015, the Food and Drug Administration (FDA) issued a draft document for a new Guidance for Industry Compounding Animal Drugs from Bulk Drug Substances (“Draft Guidance”). This Draft Guidance sets the FDA’s new policy regarding compounding animal drugs from bulk drug substances by state-licensed pharmacies, licensed veterinarians, and facilities that register with the FDA as outsourcing facilities. By its terms, it is meant to supersede the Compliance Policy Guide entitled “Compounding of Drugs for Use in Animals”, which was issued in 1996 and updated in 2003. Among the many components of the Draft Guidance, the most significant development is that it creates a limited permissibility for pharmacies or outsourcing facilities to compound animal drugs using certain bulk drug substances if certain conditions are met. Prior to this Draft Guidance, according to the FDA, compounding animal drugs using bulk drug substances in large part was not permitted.

In the Draft Guidance, the FDA states (in somewhat of a departure from prior FDA pronouncements) that it “recognizes that there are circumstances where there is no drug available to treat a particular animal with a particular condition, because either no drug is approved for a specific animal species or no drug is available under the extra-label drug use provisions. In those limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option.” The FDA goes on to state that it generally does not intend to take action if a state-licensed pharmacy or outsourcing facility compounds according to certain specific conditions, described below. 

Some notable conditions required for state licensed pharmacies include, but are not limited to:

  1. The drug is dispensed after the receipt of a valid prescription from a veterinarian for an individually identified animal patient that comes directly from the prescribing veterinarian or from the patient’s owner or caretaker to the compounding pharmacy. Drugs may be compounded in advance of receipt of a prescription, based on a history of patient-specific prescriptions for that drug product over a consecutive 14-day period within the previous six months.
  2. The drug may not be intended for food producing animal, and must include the words “This patient is not a food-producing animal.”
  3. If the drug contains a bulk drug substance that is a component of any marketed FDA-approved animal or human drug, there must be a change between the FDA-approved drug and the compounded drug that produces a clinical difference.
  4. The pharmacy must receive from the veterinarian, in addition to any other information required by state law, the following information, which can be documented on the prescription or documentation accompanying the prescription:
    1. Identification of the species of animal for which the drug is prescribed
    2. The statement “There are no FDA-approved animal or human drugs that can be used as labeled or in an extra-label manner under section 512(a)(4) or (5) and 21 CFR part 530 to appropriately treat the disease, symptom, or condition for which this drug is being prescribed.”
  5. The bulk drug substances used to compound the drugs must be manufactured by an establishment that is registered under Section 510 of the Food, Drug, and Cosmetic Act and be accompanied by a valid certificate of analysis.
  6. The drug is not sold or transferred by an entity other than the entity that compounded such drug. For purposes of this condition, a sale or transfer does not include administration of a compounded drug by a veterinarian to a patient under his or her care.
  7. The label of the drug must indicate the species and name of the animal patient, and the name of the owner or caretaker of the animal patient.

If the animal drug is compounded by an outsourcing facility, numbers 2, 5, and 6 from above will apply. However, the FDA is imposing additional conditions on drugs compounded by registered outsourcing facilities:

  1. The drugs are compounded only from bulk drug substances appearing on a list to be developed and maintained by the FDA of bulk drug substances that may be used by an outsourcing facility in compounding for animal drugs
  2. The drug must be compounded in accordance with current good manufacturing practice requirements
  3. The veterinarian’s prescription or order states that the drug is intended to treat the species and condition(s) for which the substance is found on the FDA’s list
  4. The drug complies with a detailed list of labeling requirements included in the Draft Guidance

In addition, in the Appendix to the Draft Guidance, the FDA has stated that it intends to limit outsourcing facility use of bulk drug substances to address situations where all of the following additional 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 marked approved animal or human drug that could be used under section 512(a)(4) or (a)(5) and 21 CFR Part 530 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
  • FDA has not identified a significant safety concern specific to the use of the bulk drug substance to compound animal drugs

Importantly, for registered outsourcing facilities (unlike licensed pharmacies or veterinarians), the Draft Guidance would give them the explicit ability to compound for “office use” and in quantities exceeding a 14-day anticipatory supply.

Thus, through this Draft Guidance, the FDA has created distinctions among licensed pharmacies, veterinarians and outsourcing facilities, even though (as the FDA acknowledges) both Section 503A and 503B of the Food, Drug and Cosmetic Act provide certain statutory exemptions for compounded human drugs only, and make no mention of rights with respect to drugs compounded for animal use. Essentially, the FDA is creating a standard applicable to certain classes of facilities, even though their enabling statutes remain completely silent on compounding for animal drugs.

The Draft Guidance has come to the end of the comment period for the actual guidance language (although the comment period for nominating drugs to bulk drug lists – described below – was recently extended until November 16, 2015). Importantly, this Draft Guidance also renews the debate and discussion over the FDA’s statutory ability to regulate animal drug compounding, when such practice has traditionally and historically been relegated to the regulation and oversight by the various State Boards of Pharmacy or of Veterinary Medicine.

Frier Levitt routinely represents pharmacies, veterinarians and outsourcing facilities who compound for animal drugs. For more information about this Draft Guidance and how your business may be affected, contact Frier Levitt today.