NYSVMS legal counsel advises that while most compounding restrictions are federal, some New York State restrictions may also apply.
Under federal regulations, a veterinarian can order a compounded drug from a pharmacy under the following conditions:
- There is no FDA-approved, commercially available drug available for the patient's condition;
- The drug must be ordered from a pharmacy that offers compounding services by pharmacists trained in compounding;
- The compounded drug must be ordered for a specific patient;
- The compounded drug must be entirely administered to the patient; the veterinarian is not permitted to keep any compounded drug in stock in the practice.
The AVMA provides the following guidelines on veterinarians’ use of compounded medications:
Guidelines for compounding of approved new animal and approved human drugs in all animals
Compounding from FDA-approved drugs is considered extra-label drug use under FDA rules.
Compounding is the customized manipulation of an approved drug(s) by either a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding.
Compounding is not allowed unless there is no approved new animal or approved new human drug that, when used per label or in an extra label fashion, can appropriately treat the condition diagnosed.
- Compounding must done by or under the order of a veterinarian.
- Compounded drugs must not be used for production or performance purposes.
- A compounded human drug cannot be used in a food-producing animal if a legally compounded animal drug can instead be used.
- Compounded drugs must be prepared from FDA-approved drugs
- The volume of compounded drug must be commensurate with the anticipated need for use in individual patients.
- State laws on compounding must also be followed.
- A veterinarian must be cognizant of the need to maintain a safe food supply. Specifically, veterinarians must not allow entry of a treated animal into the food chain, if there is insufficient scientific evidence indicating a proper withdrawal interval after treatment.
Additional information on the federal compounding restrictions that apply to animal drugs is available at:http://ebusiness.avma.org/EBusiness50/files/productdownloads/2011_Compounding_Brochure.pdf.
When a veterinarian orders a compounded drug, New York State law (and the laws of many other states) prohibits the veterinarian from reselling the compounded drug to a client/patient. Compounding pharmacies are advising NYSVMS that a veterinarian can order a compounded drug for a particular patient and administer it to the patient in-house, but may not charge the client/patient specifically for the drug. The veterinarian can treat the cost of the drug, including the cost of having the drug shipped to the veterinary practice and any additional recordkeeping costs associated with the ordering and shipping, as part of the cost of providing the veterinary service to the patient and include this cost within the overall charge for veterinary treatment. However, there should not be any itemized charge for this drug on the bill, which can be viewed as "reselling” the drug.
Alternatively, the veterinarian can write a prescription for the drug and direct the client to order it from a compounding pharmacy that will sell it directly to the client. This alternative may not be desirable if the drug is an injectable or administered in some other way that makes it preferable that the veterinarian administer it.
Any out-of-state pharmacy physically located outside New York State that ships, mails, delivers, invoices or provides samples of prescription drugs or prescription devices into New York State must be registered with the NYS Education Department as a nonresident, out of state pharmacy establishment.
None of these regulations are new, but NYSVMS has become aware that there may be a new drug enforcement initiative that is forcing pharmacies to comply with these existing laws. NYSVMS is working with AVMA to provide comprehensive guidelines for veterinarians in New York State on the prescribing, ordering and recordkeeping of compounded drugs.
quoted here