APHIS clarifies rules on biologics production

Published on June 30, 2015
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Federal rules now clarify that, while veterinarians can make custom biologics for patients, that allowance does not extend to contract work through unlicensed commercial laboratories.

The changes to Department of Agriculture regulations, which took effect July 10, state that veterinarians can continue making vaccines and other biologics for administration to their own patients under an exemption to the licensing requirements that apply to veterinary biologics manufacturers. But the regulations now state that those veterinarians can make such products only in the same facilities they use for daily practice.

Veterinary assistants also can prepare biologics when the licensed veterinarians responsible for the products are available on the premises during preparation.

“Such preparation may not be consigned to any other party or sub-contracted to a commercial laboratory/manufacturing facility,” the regulations state.

Officials with the USDA Animal and Plant Health Inspection Service had proposed the clarification to the Virus-Serum-Toxin Act regulations in July 2012.

A Federal Register notice published in May 2015 indicates some comments sent in response to the proposal had included arguments that the changes would restrict access to custom vaccines and slow veterinarians’ responses to mutating viruses.

“We do not intend to hinder innovation and the development of valuable new technologies, nor do we anticipate that this rule will have such an effect,” APHIS officials wrote in response. “Any manufacturing establishment wishing to provide its technology and expertise to veterinarians has several licensing options that will allow it to market its products.”

 Despite the concerns raised in comments, the notice predicts little or no effect of the rules on veterinary practitioners.

“Veterinary practitioners who are in compliance with the regulations do not need to alter the way they conduct their veterinarian-client-patient relationships,” it states.

“This final rule will not change the nature of the exemption, the number of veterinary practitioners eligible to take advantage of the exemption, or the criteria that must be satisfied in order to establish the existence of a veterinarian-client-patient relationship.”

In a September 2012 letter, AVMA CEO Ron DeHaven wrote that the AVMA appreciated the proposed clarification, which aligns with the AVMA Guidelines for Use of Autogenous Biologics. More information is available here. The AVMA’s response to the proposal is available here.