Texas pharmacy board reopens sterile-compounding rules after industry objections over batch sizes, BUDs and testing costs

The Texas State Board of Pharmacy on May 2 reproposed amendments to its sterile compounding rules after hearing public comment from compounding pharmacists, trade groups and attorneys who warned the changes could raise costs, reduce access and disadvantage small or rural pharmacies.

Board staff presented the draft amendments — published in the Texas Register on Dec. 27, 2024 and proposed by the board at its Nov. 5, 2024 meeting — which would reorganize definitions and personnel standards and add new operational requirements for environmental monitoring, personnel competency and batch controls for compounded sterile preparations. The Office of the Governor’s Regulatory Compliance Division issued a determination on May 2, 2025 that the proposed amendments were a reasonable exercise of the board’s authority to protect public health, staff said.

Why it matters: The changes would set new limits and testing requirements that commenters said could increase preliminary validation and per‑batch sterility and container‑closure testing costs, potentially driving up prices for patients and forcing some independent compounding pharmacies to scale back or close.

Industry speakers urged the board to limit mandatory testing, allow evidence‑based flexibility for beyond‑use dates and recognize automation when setting batch‑size caps. ‘‘If adopted as written, these proposed rules risk creating significant financial burdens that could cripple small and rural compounding pharmacies or be passed on to patients,’’ Jonathan Head, a compounding pharmacist and co‑owner of Las Colinas Pharmacy, told the board.

What was discussed

- Batch size and automation: The draft limits…