State medical board regulation of compounding in physician offices

Abstract

Background: After Congress passed the Drug Quality and Security Act (DQSA) in 2013, new rules led to increased oversight of compounding pharmacies and also draft guidance relating to compounding in physicians' offices.

Objective: To gather information from state medical board directors about the nature and frequency of reported adverse events associated with compounding in physicians' offices, and board policies regarding the regulation of such compounding.

Design: Cross-sectional survey study. Participants were surveyed regarding: (1) the number of compounding-associated adverse events in physician offices; and (2) the extent to which their board implements United States Pharmacopeia (USP) standards on physician office compounding.

Setting: Remote data collection at an academic medical center.

Participants: Executive directors or comparable executives of state medical and osteopathic boards.

Measurements: Adverse event reports associated with medications compounded in physician offices. State board rules consistent with USP compounding standards for physician offices.

Results: Seventy percent of state boards (47/67) responded, with 42 complete responses analyzed. The majority (71%) of boards able to provide information on compounding errors had received no reports of these. None of the reported errors were known to have resulted in patient harm. Ninety percent of respondents had not incorporated any USP compounding standards into their regulations.

Conclusion: These findings suggest that the incidence of adverse events associated with in-office compounding is low, and that this may be limiting the propensity of state medical and osteopathic boards to implement strict regulations, such as USP compounding standards, that would further restrict such compounding. Therefore, regulatory agencies and legislators would better serve their mission by reallocating resources to ensure the integrity of other aspects of the drug supply chain.

Keywords: Board; Compounding; Medical; Offices; Physician; Regulation; State.