{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T04:00:41Z","timestamp":1765857641555,"version":"3.48.0"},"reference-count":17,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T00:00:00Z","timestamp":1749772800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,12,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Compounded preparations are essential for meeting unique patient needs, especially during drug shortages. The United States Pharmacopeia (USP) identifies candidates for developing compounded preparation monographs (CPMs) using the American Society of Health-System Pharmacists (ASHP) Drug Shortages List, created by ASHP and the University of Utah Drug Information Service (UUDIS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>The ASHP Drug Shortages List, covering January 1, 2021, to December 31, 2023, was analyzed to target drugs in chronic shortage (540 days or more). Exclusion criteria were applied to filter out capsule\/tablet forms, diagnostic agents, \u03b2-lactams, hazardous drugs, and those deemed unfeasible for compounding per US Food and Drug Administration (FDA) guidance. Drugs without a USP Reference Standard for the active ingredient were also excluded. After initial exclusions, a focused review by the USP Compounding Expert Committee (CMP EC) further refined the list by removing drugs with readily available alternatives and those unsuitable for compounding. From the initial list of 3,361 drugs, 883 were identified as chronically in shortage; of these, 135 were actively in shortage. Following exclusions, 42 drugs were recommended as candidates for CPM development to assist in managing shortages and ensuring patient access to essential medications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This structured, collaborative approach demonstrates how USP can effectively utilize the ASHP Drug Shortages List to prioritize CPM candidates, addressing drug shortages and supporting continuity of care across the US healthcare system.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajhp\/zxaf118","type":"journal-article","created":{"date-parts":[[2025,5,8]],"date-time":"2025-05-08T07:36:27Z","timestamp":1746689787000},"page":"e71-e79","source":"Crossref","is-referenced-by-count":0,"title":["Identifying candidates for USP Compounded Preparation Monograph studies from ASHP and University of Utah Drug Shortages List"],"prefix":"10.1093","volume":"83","author":[{"given":"Marin Vander","family":"Schaaf","sequence":"first","affiliation":[{"name":"Medical University of South Carolina , Charleston, SC ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Domenick","family":"Francis","sequence":"additional","affiliation":[{"name":"Medical Affairs, Pfizer Inc , New York, NY"},{"name":"University of Pittsburgh School of Pharmacy , Pittsburgh, PA ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lauren","family":"Pearson","sequence":"additional","affiliation":[{"name":"USP Healthcare Quality and Safety Center of Excellence , Rockville, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Ganio","sequence":"additional","affiliation":[{"name":"ASHP Office of Practice Advancement , Bethesda, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erin","family":"Fox","sequence":"additional","affiliation":[{"name":"University of Utah Health , Salt Lake City, UT ,","place":["USA"]},{"name":"USP Compounding Expert Committee, USP , Rockville, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Serumaga","sequence":"additional","affiliation":[{"name":"USP Healthcare Quality and Safety Center of Excellence , Rockville, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Blaine","family":"Groat","sequence":"additional","affiliation":[{"name":"USP Healthcare Quality and Safety Center of Excellence , Rockville, MD ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,6,13]]},"reference":[{"key":"2025121522565029200_CIT0001","article-title":"The history of compounding","volume-title":"Pharmaceutical Compounding and Dispensing","author":"Marriott","year":"2010"},{"volume-title":"The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use","year":"2020","author":"National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy","key":"2025121522565029200_CIT0002"},{"issue":"1","key":"2025121522565029200_CIT0003","first-page":"1742","article-title":"ASHP guidelines on managing drug product shortages","volume":"75","author":"American Society of Health-System Pharmacists","year":"2018","journal-title":"Am J Health-Syst Pharm"},{"author":"American Society of Health-System Pharmacists","key":"2025121522565029200_CIT0004"},{"year":"2024","author":"Electronic Code of Federal Regulations","key":"2025121522565029200_CIT0005"},{"year":"2019","author":"US Food and Drug Administration","key":"2025121522565029200_CIT0006"},{"key":"2025121522565029200_CIT0007","article-title":"Drug, supply, and equipment shortages continue to compromise patient care","author":"Institute for Safe Medication Practices","year":"2023","journal-title":"ISMP Medication Safety Alert! 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Not so fast: interpreting data from the FDA and University of Utah Drug Information Service","author":"Wosi\u0144ska","year":"2024","journal-title":"Health Affairs Forefront"}],"container-title":["American Journal of Health-System Pharmacy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajhp\/advance-article-pdf\/doi\/10.1093\/ajhp\/zxaf118\/63484496\/zxaf118.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajhp\/article-pdf\/83\/1\/e71\/63484496\/zxaf118.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajhp\/article-pdf\/83\/1\/e71\/63484496\/zxaf118.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T03:56:57Z","timestamp":1765857417000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajhp\/article\/83\/1\/e71\/8161581"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,13]]},"references-count":17,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,6,13]]},"published-print":{"date-parts":[[2025,12,16]]}},"URL":"https:\/\/doi.org\/10.1093\/ajhp\/zxaf118","relation":{},"ISSN":["1079-2082","1535-2900"],"issn-type":[{"type":"print","value":"1079-2082"},{"type":"electronic","value":"1535-2900"}],"subject":[],"published-other":{"date-parts":[[2026,1,1]]},"published":{"date-parts":[[2025,6,13]]}}}