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Increased regulation of medication compounding by state boards of pharmacy

Authors :
Kristin Hellquist
Sarah A. Ibrahim
Murad Alam
Emily Poon
Kelly A. Reynolds
Source :
Archives of Dermatological Research. 314:787-790
Publication Year :
2021
Publisher :
Springer Science and Business Media LLC, 2021.

Abstract

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.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.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.

Details

ISSN :
1432069X
Volume :
314
Database :
OpenAIRE
Journal :
Archives of Dermatological Research
Accession number :
edsair.doi.dedup.....8b178e133b56be4b625a9b03a26cd958
Full Text :
https://doi.org/10.1007/s00403-021-02290-3