All AASV members in the United States should have received a mailing recently reminding you about the regulations governing extra-label drug use and compounding. We sent this out to raise awareness of the regulations pertaining to compounding coccidiostats from bulk ingredients.
As you are probably aware, there are no US Food and Drug Administration (FDA) approved coccidiostats for use in swine. Therefore, it becomes necessary to use a product (such as Marquis), which is FDA approved in other species, in an extra-label manner. This is perfectly legal under the 1994 Animal Medicinal Drug Use Clarification Act (AMDUCA) which allows for the use of FDA approved animal and human drugs in food-producing animals under certain circumstances. The AMDUCA makes it legal to use approved products or to compound those approved products to make them more useful in swine.
The challenge we currently have is that the FDA-approved coccidiostats are in short supply and back ordered. From what I have been told, it will likely be at least the first quarter of 2023 before significant quantities of coccidiostats are available. Therefore, there is no approved product available to use in an extra-label manner and it is illegal to manufacture (compound) a product for use in food-producing animals from a bulk ingredient. Compounding, however, can be a very confusing process with some subtleties that veterinarians and pharmacists do not always think to consider.
According to the FDA website (fda.gov/animal-veterinary/unapproved-animal-drugs/animal-drug-compounding), compounding is generally considered to be the process of combining, mixing, or altering ingredients to create a medication specifically tailored to meet the needs of an individual patient or group of patients. Compounding includes the combining of 2 or more drugs. Compounded drugs are not FDA approved. This means that FDA does not verify the safety or effectiveness of compounded drugs. Further, when the compounded drug is for a food-producing animal, FDA has not reviewed evidence supporting conditions of use to protect against harmful drug residues in edible tissues (ie, meat, milk, eggs, etc.)
The Federal Food, Drug, and Cosmetic Act permits the compounding of drugs from 2 or more FDA approved final products but not from bulk ingredients. A bulk drug ingredient is a substance used to make a drug that becomes an active ingredient in the finished dosage form of the drug. In other words, although you may be able to purchase the raw ingredient ponazuril from a chemical supply house or a pharmacy, it is not an FDA- approved final product and may not be used to compound drugs for food- producing animals. I have been asked about using United States Pharmacopeia (USP)-approved ponazuril purchased from a reliable source. The USP designation denotes that a chemical is pharmaceutical-grade but has nothing to do with FDA or an FDA approval.
The FDA recently released Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances (fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances) to describe their interpretation and enforcement strategy concerning animal drug compounding. Unfortunately, GFI #256 does not allow for compounding of drugs for food-producing animals except to produce antidotes or sedatives.
In addition to being illegal, there have been concerns expressed by harvest facilities regarding the use of unapproved products in food-producing animals. Foods derived from animals receiving unapproved products could be determined to be adulterated and, thus, unacceptable for human consumption.
This puts veterinarians in the untenable position of not having effective tools to treat coccidiosis while following FDA regulations. The AASV has been in discussion with FDA for weeks to try to obtain some sort of guidance or legal relief to allow veterinarians to effectively treat pigs and prevent the mortality, morbidity, production loss, and welfare challenges associated with coccidiosis. Unfortunately, while they are aware of our concerns, the FDA has not provided any such relief at the time of this writing. We will continue to push and interact with the FDA but felt it was important that we make you aware of the legalities and challenges associated with compounding in food-producing animals. You can see a reprint of the compounding article sent to US members in the Advocacy in Action column in this issue of the journal. The AASV staff will keep you apprised of any changes.
Harry Snelson, DVM
Executive Director