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Veterinary groups ask Texas board to clarify rule on compounded multiuse vials
Summary
Veterinarians and industry groups urged the Texas State Board of Veterinary Medical Examiners to clarify whether Administrative Code rule 573.44 prohibits compounded multiuse vials of controlled substances, and asked the board to consider guidance on 503B outsourcing facilities; board agreed to place the item on a future agenda.
Veterinarians and industry representatives urged the Texas State Board of Veterinary Medical Examiners on Feb. 20 to clarify whether Texas Administrative Code rule 573.44 prohibits veterinarians from obtaining compounded multiuse vials of controlled substances for office use.
The request came during the board’s public-comment period from Aaron Lopez of Political Capital and Michael Giuliano, both of whom said they had heard a de facto board position circulating among practitioners that the rule prevents veterinarians from using compounded multiuse vials such as buprenorphine. “We are seeking clarification to confirm that compounded multiuse vials prepared by 503bs are permissible for use in Texas,” Aaron Lopez said, using the shorthand for FDA-regulated outsourcing facilities known as 503B.
Lopez and Giuliano asked the board to acknowledge that 503B outsourcing facilities follow current good manufacturing practices (cGMP) under federal oversight and, they said, can provide multiuse vials with sterility assurances and expiration dating that support safe, multi-patient use. Giuliano said practitioners are hearing conflicting guidance and that, if pharmacies cannot supply controlled substances for office use, veterinarians should be advised that properly licensed outsourcing facilities are a compliant source.
Troy Alexander, executive director of the Texas Veterinary Medical Association, reiterated the request for clarity and told the board the association would welcome guidance on the rule’s application to multiuse vials.
Board members did not adopt a rule change or issue a formal interpretation at the meeting. Chair Dr. Gola acknowledged the concerns and said staff will place the compounding rule 573.44 on an upcoming agenda for further consideration; the director later confirmed the item will be considered at a future meeting. No vote or formal amendment to 573.44 was taken at the Feb. 20 session.
Why it matters: Practitioners said the unclear interpretation has operational impact, particularly for clinics trying to maintain ready supplies of pain medications and anesthetics. The commenters framed their request around harmonizing state rule interpretation with federal standards for outsourcing facilities and DEA requirements for controlled substances.
What the board can do next: The board’s staff and legal division may draft guidance or a proposed rule amendment to clarify how 573.44 applies to compounded multiuse preparations and the role of outsourcing facilities; commenters offered to serve as technical resources during that process.
Board speakers: In addition to public commenters, Chair Dr. Gola and staff received written comments and said the board will consider the item at a later date. No formal action was taken at this meeting.
