Source: VIN News

The FDA’s recent approval of Vetmedin Solution, a liquid version of the Veterinary heart drug pimobendan, was followed by the removal of pimobendan solution from a list of drugs allowed to be compounded for Veterinary clinics. This signals a vigorous enforcement of the FDA’s new approach to Veterinary compounding. While some, like Veterinary pharmacologist Dr. Dawn Boothe, appreciate the FDA’s balancing act between patient needs and safety, major compounder Wedgewood Pharmacy criticizes the restrictive approach, claiming it impedes veterinarians’ access to necessary medications.

Compounding, the practice of customizing medications, is crucial in Veterinary medicine due to diverse patient needs. However, compounded drugs bypass FDA approval, raising safety concerns. The FDA’s guidance outlines conditions for enforcement discretion, creating lists of allowed, under review, and disallowed substances. Advocates argue that delays in obtaining compounded drugs hinder patient care, especially in remote or mobile Veterinary practices. The FDA’s response to drug shortages and its handling of newly approved drugs raise questions about flexibility in enforcement.

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