Veterinarians have until Aug. 17 to weigh in on the U.S. Food and Drug Administration’s proposed policy on the compounding of animal drugs from bulk active ingredients.
Released in May, “Guidance for Industry No. 230” acknowledges that the compounding of animal drugs from bulk substances is currently illegal but may be an appropriate treatment option in some cases.
“This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug approval process or jeopardizing the safety of the food supply,” said Bernadette Dunham, DVM, Ph.D., director of FDA’s Center for Veterinary Medicine.
The agency also is asking veterinarians to suggest bulk substances that compounders could use to create medications “for an individual animal patient or veterinarian office use under specified conditions.”
The agency stated that drugs compounded from bulk ingredients should be medications of last resort in many cases.
“FDA is concerned about the use of [these] animal drugs … especially when approved alternatives exist that can be used as labeled or in an extralabel manner,” the document states.
“Compounded drugs have not undergone premarket FDA review of safety, effectiveness or manufacturing quality,” the document adds. “The unrestricted compounding of animal drugs from bulk drug substances has the potential to compromise food safety, place animals or humans at undue risk from unsafe or ineffective treatment, and undermine the incentives to develop and submit new animal drug applications.”
Veterinary compounders such as Diamondback Drugs of Phoenix and Stokes Pharmacy of Mount Laurel, N.J., are wary of the draft document. They warned in a statement released Monday that the proposed guidance “recommends eliminating office use of compounded medications from compounding pharmacies.”
Diamondback, Stokes and a handful of other compounders commissioned a survey of nearly 2,400 veterinarians after the government document was released. Nearly all the practitioners who participated agreed that “having access to compounded medications when they are necessary in their medical judgment is important.”
“If published, the FDA proposed guidance will have [a negative] impact on virtually all veterinary practices,” the companies stated.
“The FDA has no authority to regulate the practice of medicine,” they added. “Yet, the guidance calls for a state-licensed prescriber to include a detailed explanation on each prescription about why the veterinarian did not prescribe an FDA-approved manufactured drug.”
The American Veterinary Medical Association has asked FDA to extend the comment period by 90 days.
“Many areas of veterinary medicine rely on compounded preparations to maintain animal health and welfare, treat diseases and prevent animal suffering,” wrote AVMA’s executive vice president and CEO, Ron DeHaven, DVM, MBA. “[To] coordinate with the many interested parties to provide the most constructive, substantive comments will require a substantial amount of time and resources.”
FDA is accepting comments on “Guidance for Industry No. 230” at www.1.usa.gov/1ImZiQq.
Nominations of bulk drug substances may be made at www.1.usa.gov/1PZBIxn.