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"Regulation of Medication Compounding by State Boards of Pharmacy"

American Society for Dermatologic Surgery Association

Contact: Kristin A. Hellquist, Director of Advocacy & Practice Affairs,

Poster Authors
Kelly A Reynolds, BA (1); Sarah A Ibrahim, BA (2); Kristin Hellquist, MS, CAE (3); Emily Poon, PhD (2); Murad Alam, MD, MSCI, MBA (2,4,5)

(1) University of Cincinnati College of Medicine, Cincinnati, OH
(2) Department of Dermatology, Northwestern University, Feinberg School of Medicine, Chicago, IL
(3) American Society for Dermatologic Surgery Association, Rolling Meadows, IL
(4) Department of Otolaryngology, Northwestern University, Feinberg School of Medicine, Chicago, IL
(5) Department of Surgery, Northwestern University, Feinberg School of Medicine, Chicago, IL.

Corresponding Author:
Murad Alam, MD, MSCI, MBA
676 N St Clair St, Ste 1600
Chicago, IL 60611
(312) 695-6647
(312) 695-4541 fax

Background: State boards of pharmacy are charged with the regulation of all “compounding” - i.e. the customization of pharmaceuticals to meet to meet the unique needs of individual patients – that takes place in community-based pharmacies, physicians’ offices, and specialized compounding pharmacies. The United States Pharmacopeia (USP) Convention is an independent agency that has developed quality standards for compounded pharmaceuticals (General Chapters <795>, <797>, <800>), but these may or may not be implemented into state board of pharmacy regulations. The objective of this questionnaire-based study was to assess the extent to which state boards of pharmacy enforce USP standards in their regulation of compounded preparations.

Methods and Findings: Surveys comprised of six open-ended questions regarding the selection and implementation of USP compounding standards were distributed to state board of pharmacy directors across all 50 states and Washington DC. Free text responses were analyzed using thematic content analysis methods and summary statistics were calculated.

Responses were received from 71% of invited participants (36/51), and nearly all respondents (35/36, 97%) indicated that their board references USP compounding standards in their regulations. The majority of state boards (18/28, 64%) require compliance with ‘some, but not all standards’ - most frequently General Chapters <795> and <797>, but not <800> (9/28, 32%) - whereas a third of respondents (10/28, 36%) stated ‘all’ USP compounding standards are enforced. Finalized USP chapters are most commonly implemented (18/21, 86%), although some boards also consider newly proposed standards (3/21, 14%). More than half of respondents (22/36, 61%) incorporate USP standards into their guidance via a committee and/or standard rulemaking process.

Conclusions: The results of this study indicate that almost all state boards of pharmacy incorporate USP standards into their compounding regulations, although selective implementation of certain standards or parts of standards is more common than requiring total compliance with USP. USP chapters <795> and <797> are more commonly enforced than <800>, which may be due to the fact that <800> was only recently finalized.

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