Texas Board of Pharmacy adopts stricter sterile‑compounding standards after debate over batch size, testing and costs

The Texas State Board of Pharmacy on Feb. 12 adopted a package of amendments to state sterile compounding rules that change definitions, operational standards, batch‑size limits and sterility testing requirements for compounding pharmacies.

Board members approved the final rules after staff summarized provisions that replace ‘risk‑level’ language with category‑based standards, set a default maximum batch yield of 250 final units with an exception allowing up to 1,000 final yield units when preparations are fully packaged using an automated compounding device, allow certain temperature exceptions for radiopharmaceutical compounding, and add specific requirements for records and recall procedures.

Why it matters: The changes affect pharmacies that compound sterile preparations used in hospitals, clinics and outpatient care. Several compounding operators told the board that expanded testing and preliminary validation could impose large compliance costs on small and mid‑size pharmacies and potentially reduce access for patients who rely on customized preparations.

Public commenters pressed the board on cost and technical standards. "If we apply the board's unit‑cost estimates across the typical 100 to 200 formulations many compounding pharmacies maintain, the first year compliance cost can be in the hundreds of thousands to over $1 million," said Steven Snow of Bridal, Summerall & Ladner. He presented spreadsheets estimating a multi‑billion‑dollar statewide impact over five years if each of Texas's licensed sterile compounding pharmacies must repeat testing independently.

Compounding pharmacists and industry representatives urged the board to recognize membrane filtration and validated, formulation‑specific stability testing as acceptable pathways to extended dating for aqueous products. "Membrane filtration is a widely recognized, FDA‑regulated sterilization method for heat‑sensitive products," said Jonathan Head, a compounding pharmacist and co‑owner of Las Colinas Pharmacy. He asked the board to allow evidence‑based BUD extensions supported by validated data.

Board members debated several technical points in public session, including whether the rule should list examples of automated equipment (one member proposed adding "for example, repeater pump") and whether to alter a proposed allowance for short temperature or humidity excursions. The board discussed retaining a 5% sterility‑testing requirement as a simple standard versus reverting to the variable USP 71 sampling chart used by testing laboratories.

During discussion, board member Megan recommended removing language that would reference British, European, and Japanese pharmacopoeias where that could create a conflict with federal law; the board adopted that change and approved minor grammatical edits noted by another member. President Spear cast the vote to adopt the package after motions and seconds; the motion carried.

What the rule does not do: The adopted rule package keeps explicit sampling and testing requirements in place; it does not automatically permit blanket year‑long BUDs without validated, formulation‑specific evidence. The board and staff repeatedly said the changes aim to align practices with public‑health protection while incorporating national standards where appropriate.

Next steps: The board approved the final amendments for implementation. Staff noted the rulemaking file had been reviewed by the governor's regulatory compliance office, which on Jan. 26 issued a determination that the board's proposed amendments were a reasonable exercise of authority to protect public health. The board indicated it may revisit specific numeric details (such as excursion timeframes or testing percentages) later if operational issues emerge during implementation.

Board actions and provenance: The rule discussion and public comments began in the staff presentation at the start of the sterile‑compounding item and continued through multiple public comments and board deliberations; staff recommended adoption and the board voted to adopt the amendments (motion and vote recorded on the agenda).