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 “maximum batch size for all preparations requiring sterility testing” to 750 final‑yield units. Several commenters urged a lower cap for manual processes and higher allowances for validated automated systems. Jules (Jules D'Souza) D’Souza of Empower Pharmacy told the board that modern semi‑automated filling lines can fill dozens of vials per minute and that strict low caps on final yields could increase manual handling and contamination risk. Commenters proposed treating fully automated fills differently from manual operations.

- Beyond‑use dating (BUD): The draft assigns specific BUDs tied to category (1/2/3) and whether preparations are aseptically processed or terminally sterilized. Jonathan Head and others argued the proposal’s fixed BUDs for aqueous category‑3 preparations remove pharmacists’ ability to extend BUDs using validated stability and sterility data. Head said his pharmacy spent “just over … $120,000” on stability testing for formulations and asked the board to allow evidence‑based extensions analogous to what the draft permits for non‑aqueous products.

- Sterility testing and sample counts: The draft requires sterility testing equal to 5% of the number of compounded sterile preparations produced. Commenters noted that USP <71> sample plans often require fewer vials (for example, a fixed cap such as 20 vials for many batch sizes), and that applying 5% to large batches would substantially increase laboratory costs. Head said the proposed 5% rule would nearly double the number of test vials for larger batches compared with USP tables.

- Small‑batch carve‑outs and economic impact: Many speakers, including attorneys and trade groups, urged carve‑outs for small, patient‑specific batches (commonly described as ≤24 units) to prevent disproportionate cost burdens on small pharmacies. Steven Snow, a compounding regulatory attorney, cited figures from economic analyses showing preliminary testing costs could range in the low thousands per formulation and escalate into the hundreds of thousands for pharmacies with many formulations, calling those ‘‘staggering figures’’ for small and mid‑sized compounders.

- Environmental monitoring, container‑closure and preservative testing: The draft adds more frequent surface and viable‑air sampling, and it requires container‑closure integrity testing and antimicrobial‑effectiveness testing for multi‑dose compounded preparations unless acceptable supporting data exist. Commenters asked the board to allow use of validated third‑party or manufacturer data, USP monographs or previously conducted studies in lieu of requiring each pharmacy to commission new tests for every formulation and vial size.

Board discussion and staff directions

Board members and staff discussed several specific edits and clarifications to send back in the reproposal, including requests that staff: clarify who is covered by ‘‘personnel who have direct oversight of compounding personnel but do not compound’’ and how competency evaluations (glove fingertip sampling, media‑fill testing) apply; provide clearer wording for media‑fill testing to require simulation of the ‘‘most challenging or stressful’’ conditions; remove an unused definition for “designated person”; and address humidity/temperature excursion language for pharmacies in humid climates.

The board also discussed whether to allow common ownership data sharing for media‑fill testing and how to treat category‑2 pharmacies that use non‑sterile starting components. Staff were asked to draft specific language for: (a) how automation will be defined for any higher maximum final‑yield allowance, (b) acceptable external sources of container‑closure and preservative efficacy data (for example, USP monographs, manufacturer data or previously contracted testing), and (c) limits or guardrails for repeated small batches to prevent circumvention of testing requirements.

Formal action

The board voted to repropose the amendments with the edits and clarifications discussed and return them for a new public comment period. (Motion: not specified in the transcript; outcome: approved.) The reproposal will be returned to the Texas Register for an additional comment period and will reflect the staff drafting requests above.

Background and next steps

Board staff noted the draft amendments were originally proposed at the Nov. 5, 2024 board meeting and published in the Texas Register on Dec. 27, 2024. The Office of the Governor Regulatory Compliance Division issued a letter on May 2, 2025 finding the proposed amendments a reasonable exercise of the board’s authority to protect public health. The board will accept additional public comment on the reproposed language before final adoption. Board staff indicated they will provide revised text implementing the changes discussed and will return to the board at a future meeting for consideration of final adoption.

Quotes and attributions in this article come from Texas State Board of Pharmacy meeting speakers who addressed sterile compounding rules during the May 2 meeting.