What quality control, sterility, and testing standards (USP <797>, <71>, lot testing) apply to pharmacies compounding injectable tirzepatide?
Executive summary
Pharmacies compounding injectable tirzepatide must follow USP General Chapter <797> for sterile preparations, which sets requirements for personnel, facilities, environmental monitoring, storage, and testing of finished preparations [1]. Where sterility testing is required, USP Sterility Tests (〈71〉) and related lot-testing expectations inform how many units or batches must be tested and how testing is performed; state boards and accreditation programs enforce or interpret these standards and may impose limits such as maximum batch sizes [2] [3] [4].
1. Which core USP standards govern injectable tirzepatide compounding
Injectable tirzepatide is a compounded sterile preparation and therefore falls squarely under USP General Chapter <797>, which governs sterile compounding across pharmacy settings and addresses responsibilities of compounding personnel, training, facility and ventilation requirements, environmental monitoring, and storage and testing of finished sterile preparations [1] [5]. The 2022–2023 revisions to <797> were promulgated after long stakeholder review and became official in late 2023; those revisions introduced new categories for compounded sterile preparations and updated quality‑control expectations relevant to injectables [6] [7].
2. Sterility testing standards: USP 〈71〉 and how testing is described
When sterility testing is required, USP 〈71〉 (“Sterility Tests”) provides the microbiological methods and sample handling approaches used to assess sterility; practical protocols such as aseptic transfer of aliquots into sterile vials, incubation and observation steps are described in compendial guidance and referenced in USP <797> implementation materials [2]. Guidance and regulatory documents commonly tie the decision to sterility‑test to the product category and batch size: some categories of CSPs require routine sterility testing while others do not, per the new <797> category framework and cross‑references to 〈71〉 [3] [7].
3. Lot testing, batch size, and beyond‑use dating (BUD) implications
USP <797> and implementing guidance discuss lot/batch testing expectations and how they intersect with maximum batch sizes and BUD determinations; some advisory groups and state recommendations have urged limits (for example proposals around 250 final‑yield units) for CSPs requiring sterility testing, and state boards may adopt or modify such limits during implementation [3]. The chapter revision process and state adoption timelines have left some variability in enforcement, and USP materials and accreditation entities (e.g., NABP) have updated accreditation and inspection programs to reflect the 2023 changes including master formulation records and QC updates specific to injectables [8] [4].
4. Facility, personnel, and environmental monitoring obligations tied to QC
Quality control under <797> extends beyond end‑product testing to prescriptive requirements for compounding environment and personnel competency: cleanroom and IV room ventilation standards, garbing, hand hygiene, PEC handling, gloved fingertip/thumb sampling, and routine environmental monitoring are integral parts of assuring sterility and are spelled out in USP guidance and implementation resources [1] [9] [10]. These process controls are considered essential because compendial text permits equivalent technologies only when they are demonstrably as effective as the described methods [2].
5. Regulatory caveats: state enforcement and commercial product restrictions
Implementation and enforcement of USP <797> vary by state and over time; some jurisdictions delayed full adoption of the 2022/2023 revisions and continue to enforce earlier versions until specific dates, while boards warn that compounding commercially available products like brand tirzepatide or semaglutide is allowed only in narrow circumstances and may trigger FDA or state board action if done improperly [11] [4]. Accreditation bodies and state pharmacy boards use USP <797> as the baseline for inspections and may reference additional standards or limits when overseeing lot testing and sterility programs [5] [4].
6. Bottom line — what pharmacies must do in practice
Pharmacies compounding injectable tirzepatide must build a quality program that implements USP <797> process and environmental controls, applies USP 〈71〉 methods when sterility testing is required, and documents lot/batch testing and BUD decisions consistent with the chapter and any state or accreditation requirements; they must also monitor evolving state adoption timelines and legal restrictions around compounding commercially available GLP‑1 products [1] [2] [3] [11] [4]. Where source material or local law is silent or variable, pharmacies should consult the official USP compendium, state board guidance, and accredited laboratory procedures to define specific lot‑sampling plans and sterility test execution [8] [5].