August 01, 2013

 

 Compounding policies updated in anticipation of federal action

Posted July 17, 2013 

The AVMA Executive Board has approved several policy-related proposals by the Council on Biologic and Therapeutic Agents meant to help the Association advocate for the inclusion of veterinary compounding needs in upcoming legislation.  

Earlier this year, COBTA and the AVMA Clinical Practitioners Advisory Committee learned that Congress is expected to pass compounding legislation during the current session. This spurred the two AVMA entities into preparing updated AVMA policies that could be used to advocate for inclusion of veterinarians’ compounding needs and appropriate compounding standards. The process included consulting with veterinary species and specialty organizations along with AVMA entities and members.

The revised AVMA policy “Veterinary Compounding“ approved by the Executive Board incorporates language from the former policy and specifically indicates rules currently in place allowing for legal compounding, gives recommendations on how to compound in a way that is consistent with minimizing the risk of adverse events, and advocates for additional compounding needs, such as allowing veterinarians to maintain sufficient quantities of preparations for emergency situations and providing for proper labeling of compounded preparations to reflect that they are not approved by the Food and Drug Administration.

The board also approved adopting the following policies concerning compounding of products from bulk, raw, active ingredients for use in food and nonfood animals:  
 
Compounding from Unapproved (Bulk) Substances in Food Animals
Compounding of drugs from unapproved (bulk) substances for use in animals is currently illegal under the Federal Food, Drug, and Cosmetic Act and the Animal Medicinal Drug Use Clarification Act. Unapproved bulk substances are the raw active pharmaceutical ingredients (APIs) that are used to make final drug products, and as such, they are not commercially available as FDA-approved finished drug products. Veterinarians cannot guarantee the potency, purity, or safety of these unapproved bulk substances in a compounded product. The AVMA recognizes specific circumstances wherein bulk compounds might be medically necessary in food animals, specifically poison antidotes and compounds for euthanasia or depopulation that are not approved or commercially available. These actions should take place only within the context of a veterinarian-client-patient relationship.

The AVMA recommends that there be a publically available, current list of unapproved bulk substances that can be legally compounded within a veterinarian-client-patient relationship specific and limited to euthanasia, depopulation, and poison antidote compounds, for food animal species.

If adequate scientific information is not available to determine a withdrawal time, the compound cannot be used in a food animal or the treated animal cannot enter the food supply. 

 

Compounding from Unapproved (Bulk) Substances in Non-Food Animals
Compounding of drugs from unapproved (bulk) substances for use in animals is currently illegal under the Federal Food, Drug, and Cosmetic Act and the Animal Medicinal Drug Use Clarification Act. Unapproved bulk substances are the raw active pharmaceutical ingredients (APIs) that are used to make final drug products, and as such, they are not commercially available as FDA-approved finished drug products. Veterinarians cannot guarantee the potency, purity, or safety of these unapproved bulk substances in a compounded product.
 
The AVMA believes there are three general sets of circumstances in which compounding from bulk pharmaceutical ingredients may be medically necessary: the approved product is not commercially available, the needed compounded preparation cannot be made from the approved product, or there is no approved product from which to compound the needed preparation. The AVMA recognizes that compounding of drugs from unapproved bulk substances for use in animals not intended for food (eg, major and minor non–food animal species) is medically necessary in certain situations and should be allowed in those circumstances as specifically indicated above. These actions should take place only within the context of a veterinarian-client-patient relationship. 
 
Compounding from Unapproved (Bulk) Substances in Non-Food Animals
Compounding of drugs from unapproved (bulk) substances for use in animals is currently illegal under the Federal Food, Drug, and Cosmetic Act and the Animal Medicinal Drug Use Clarification Act. Unapproved bulk substances are the raw active pharmaceutical ingredients (APIs) that are used to make final drug products, and as such, they are not commercially available as FDA-approved finished drug products. Veterinarians cannot guarantee the potency, purity, or safety of these unapproved bulk substances in a compounded product.
 
The AVMA believes there are three general sets of circumstances in which compounding from bulk pharmaceutical ingredients may be medically necessary: the approved product is not commercially available, the needed compounded preparation cannot be made from the approved product, or there is no approved product from which to compound the needed preparation. The AVMA recognizes that compounding of drugs from unapproved bulk substances for use in animals not intended for food (eg, major and minor non–food animal species) is medically necessary in certain situations and should be allowed in those circumstances as specifically indicated above. These actions should take place only within the context of a veterinarian-client-patient relationship.
 

To learn more about veterinary compounding, click here.