A new guidance from the Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) went into effect on April 1, 2023. This guidance focuses on the compounding of animal drugs utilizing bulk drug substances.
As a guidance this represents the FDA’s current thinking on the topic, though they do not recommend taking enforcement action against those compounding animal drugs from bulk substances when there is no other medically appropriate treatment available.
The reasoning behind this guidance is that compounded animal drugs are not FDA-approved. Unlike approved drugs, those compounding medications in 503(a) settings do not have to submit data to the FDA regarding the safety and effectiveness of the product.
The FDA is attempting to encourage more individual prescriptions of compounded medications as opposed to “office stock.”
They are also addressing the present concerns of these drugs when they present animal or human safety concerns, are intended for use in food-producing animals, are copies of a marketed FDA-approved or indexed drug and are sold as office stock.
What are the key takeaways?
- Guidance for Industry (GFI) #256 is applicable to veterinarians as well as pharmacists in state-licensed pharmacies or federal facilities.
- Compounding using FDA-approved medications (e.g., crushing tablets of an FDA-approved medication to compound into a suspension) is not affected by this GFI.
- When a drug is compounded from bulk substances using the same active ingredient that is in an approved drug, it is not considered to be equivalent to the FDA-approved product or generic and cannot be presumed to have the same effect.
- The FDA recognizes that there are instances in which there are no FDA-approved or indexed drugs that can be used to treat an animal with a specific condition and in those limited circumstances an animal drug compounded from bulk drug substances may be a medically appropriate treatment.
- The FDA does not intend to act against certain antidotes, sedatives, and anesthetics that are utilized or food-producing animals and free-ranging wildlife, respectively.
- The FDA does not intend to question prescriber determinations that are documented in a prescription or notation but instead will consider whether a prescription or notation relied upon by a compounder both documents that the determination was made and contains a medical rationale describing the clinical difference (e.g., [Ingredient] in approved product is toxic to this species).
- The labeling of a compounded drug must include all the following in addition to any other information required by state law:
- Name of drug
- Strength of drug
- Species of patient
- Patient identification (name or identifier)
- Name, address, and contact information for the compounding pharmacy or veterinarian and name of prescribing veterinarian
- A beyond use date
- The statements:
- “Report suspected adverse reactions to the [pharmacist or veterinarian who compounded the drug] and to FDA using online Form FDA 1932a.”
- “This is a compounded drug. Not an FDA approved or indexed drug.”
- “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
By Alex Gochenauer, PharmD, DICVP, FSVHP, FACA
