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Compounding Update
by Jan Ginsky, VMD, CVPP, MVMA President

In Other News


The practice of compounding medications has come under increased scrutiny by the Food and Drug Administration (FDA) and state boards of pharmacy largely due to recent human illnesses and deaths caused by contamination of ostensibly “sterile” injectable, compounded medications. Existing regulations are now being reviewed and enforced.

FDA regulations on extra-label drug use define compounding as the “customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient.” Appropriately compounded products must be prepared from FDA-approved drugs. Compounds made from bulk chemicals or raw pharmaceutical ingredients are considered unapproved new animal drugs and have always been prohibited by federal drug laws.

Many veterinarians keep compounded medications on hand to administer to patients, and to send home with patients, when situations and need demand. However, it isn’t legal for compounded preparations to be developed in large quantities and sold to third parties, or for resale to individual patients.

The AVMA recognizes the importance of the continued availability of compounded medications for veterinarians and their patients. Accordingly the Executive Board established three policies regarding veterinary compounding to present to the Senate Healthcare Committee as congressional members consider legislation addressing drug compounding for human use. These policies can be found on the NOAH posting or by clicking the links below: 

Veterinary Compounding, Compounding from Unapproved [Bulk] Substances in Non-Food Animals

Compounding from Unapproved [Bulk] Substances in Food Animals

The Maryland State Board of Veterinary Medical Examiners shares this statement about their position:

“The Maryland State Board of Veterinary Medical Examiners is working closely with the Maryland State Board of Pharmacy to give veterinarians the flexibility they need to best serve their clients and patients with the use of compounded drugs. Both Boards are in agreement that veterinarians are unique in their need for compounded drugs and in their therapeutic application. We are confident that a regulation can be drafted that will protect the public from poor quality medicine, yet allow [veterinarians] to conveniently access the medicine they need to do their job of successfully treating disease.”

Veterinarians are encouraged to familiarize themselves with current regulations on compounding and policies on enforcement as prescribers may be held responsible for adverse drug events, as well as sanctioned for apparent misuse or misdirection of compounded products. The MVMA will provide updates on the progress of compounding legislation as they become available through issues of this newsletter, the News Bites, and/or e-mail notifications.



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