What public records (state boards, FDA inspections, PCAB/ACHC directories) are best for verifying a compounding pharmacy’s sterile compounding credentials?
Executive summary
The most reliable public records to verify a compounding pharmacy’s sterile-compounding credentials are state board of pharmacy license and inspection records, PCAB/ACHC accreditation directories and documentation, and—where available—federal inspection records or public FDA communications; each source plays a distinct role and has limits that must be understood [1] [2] [3]. State boards are the primary regulators of compounding pharmacies, PCAB/ACHC accreditation adds an independent, standards-based layer tied to USP chapters, and FDA materials are supplemental because federal oversight of routine compounding is constrained [3] [4] [5].
1. State board licenses and inspection reports are the basal public record
State Boards of Pharmacy issue licenses, set classifications for sterile compounding facilities, and often post inspection reports or require inspection documentation for nonresident pharmacies; for example, Texas explicitly requires a recent inspection report conducted by an approved vendor and notes that proof of ACHC/PCAB accreditation alone does not replace a state-specific inspection [1]. Because compounding pharmacy regulation is predominantly a state responsibility, a pharmacy’s license status, board disciplinary actions, and inspection history on the state board website are the first, authoritative documents to consult [3].
2. PCAB/ACHC accreditation directories show voluntary compliance with USP-based standards
The Pharmacy Compounding Accreditation Board (PCAB), administered by the Accreditation Commission for Health Care (ACHC), maintains accreditation records demonstrating a pharmacy’s voluntary adherence to PCAB standards, which reference USP <797> for sterile compounding and USP <795>/<800> where applicable; ACHC/PCAB accreditation requires documented policies, onsite surveys, and recurring reviews—annual verifications and triennial physical inspections are part of that regime as described by PCAB/ACHC materials [2] [6] [5] [3]. PCAB/ACHC directories or the pharmacy’s published accreditations provide clear evidence a provider has submitted to independent surveyors and follows PCAB’s principles, but accreditation is voluntary and does not substitute for state licensure or a state-specific inspection requirement [6] [1] [7].
3. Understand what ACHC inspection services are—and when they matter
ACHC offers both PCAB accreditation and discrete Pharmacy Inspection Services; those inspection services are not identical to PCAB accreditation and are sometimes used to satisfy state nonresident inspection requirements when a state authorizes specific vendors—ACHC materials make that distinction explicit, and some boards accept ACHC-conducted inspections while others maintain state-specific audit rules [7] [1]. Therefore, an inspection report from ACHC may be persuasive but its sufficiency depends on the particular state board’s rules; public records should be checked against the state’s list of approved inspectors or required report formats [1] [7].
4. FDA documents are useful but limited for routine sterile compounding verification
FDA inspection reports, warning letters, and inspectional observations provide federal-level visibility into serious problems when FDA asserts jurisdiction, but PCAB and NABP materials note that the FDA’s resources and role differ from state boards and that most compounding oversight traditionally rests with states—thus an absence of an FDA action is not proof of compliance, and FDA records should be used as supplemental confirmation rather than the primary verification tool [3] [8]. Where an FDA inspection or public communication exists, it is a strong signal and should be cross-referenced with state and accreditation records.
5. Practical verification workflow and caveats
The clearest public-verification workflow is to (a) confirm current licensure and review state inspection reports and disciplinary history via the state board website, (b) check the PCAB/ACHC accreditation directory and request the pharmacy’s current certificate or survey report to confirm scope (sterile vs non-sterile and any hazardous drug handling distinctions), and (c) search for FDA public inspectional materials or warning letters for additional context—bearing in mind accreditation is voluntary and ACHC inspection services may or may not satisfy a specific state’s nonresident inspection requirements [1] [2] [7] [4]. Public records will show different aspects: licensure/enforcement (state), standards-based quality and onsite survey history (PCAB/ACHC), and federal enforcement actions (FDA) —none alone gives the full picture, so triangulation across these sources is necessary [6] [5] [3].