Increased regulation of medication compounding by state boards of pharmacy

Background: Medications may be specially prepared, or “compounded,” to meet the needs of patients who cannot use standard formulation. The United States Pharmacopeia (USP) Convention is a private, nongovernmental organization which independently develops guidelines for pharmaceuticals. The purpose of this survey study is to better understand the extent to which state boards of pharmacy currently incorporate relevant USP guidelines into their compounding regulations. Methods and findings: Executive directors or other administrative representatives of each state board of pharmacy were invited to respond to six open-ended questions. Their free text responses were analyzed by two reviewers (KR, SI) using qualitative research techniques. The response rate was 71% (36/51). Almost all (35/36, 97%) indicated that they implement USP compounding standards at least in part. Eighteen boards (18/28, 64%) reported that ‘some, but not all standards’ are enforced, most commonly < 795 > and < 797 > , but not < 800 > (9/28, 32%). Ten (10/28, 36%) indicated that ‘all’ USP compounding standards are enforced. Eighteen (18/21, 86%) only implement finalized USP standards, whereas three consider newly proposed chapters (3/21, 14%). Over half (22/36, 61%) employ a committee or similar process to select standards. Conclusions: Almost all responding state boards of pharmacy incorporate finalized USP compounding standards into their regulations, usually via a formal rulemaking process, with boards commonly implementing some standards but not all. Chapters < 795 > and < 797 > are implemented more commonly than < 800 >. Since Congress passed the Drug Quality and Security Act (DQSA), pharmacy boards are becoming increasingly observant of USP compounding standards.