{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T00:26:54Z","timestamp":1790296014183,"version":"4.1.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"24","license":[{"start":{"date-parts":[[2020,11,12]],"date-time":"2020-11-12T00:00:00Z","timestamp":1605139200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,12,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This article is one of the 5 articles describing steps taken to enhance sterile compounding compliance at a large, multisite academic medical center. This article focuses on the development of a comprehensive personnel training and assessment program for sterile compounding.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>Increased regulatory oversight and the release of new United States Pharmacopeia chapters motivated the reenvisioning of the medical center\u2019s sterile compounding personnel training and assessment program. The main challenges facing any entity undertaking sterile compounding include identification of compounding staff, development of policies and procedures, and baseline and ongoing training including observational competency assessments and record keeping. These challenges are exacerbated by high work volumes and variation in compounding practices encountered within a large multisite institution. Our organization developed a team of specialized pharmacists and pharmacy technicians to implement and enforce changes promoting the safe production and use of compounded sterile products and meet rising regulatory requirements. This team worked within various operational areas to customize purchased policies and procedures and group compounding staff based on training needs. The team performs ongoing personnel monitoring and training of new compounders in a shared training space. Challenges encountered and future considerations for program enhancement are described.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Implementation of standards and enforcement of staff behaviors in a large academic medical center is perhaps best completed by a team of highly trained experts working in collaboration with supervisors and using a dedicated training and testing space, as evidenced by the success of the described program in overecoming past challenges.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajhp\/zxaa326","type":"journal-article","created":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T22:02:49Z","timestamp":1605132169000},"page":"2089-2100","source":"Crossref","is-referenced-by-count":8,"title":["Development of a sterile compounding training and competency program at a large academic medical center"],"prefix":"10.1093","volume":"77","author":[{"given":"Carrie E","family":"Penzien","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"},{"name":"College of Pharmacy, University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jamie C","family":"Tharp","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"},{"name":"College of Pharmacy, University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Mulzer","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig","family":"Rurka","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chadi","family":"Abbas","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce W","family":"Chaffee","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Michigan Medicine, Ann Arbor, MI"},{"name":"College of Pharmacy, University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,11,12]]},"reference":[{"key":"2020120403575601300_CIT0001","first-page":"361","article-title":"Education, training, and evaluation of hospital compounding personnel","volume":"10","author":"McElhiney","year":"2006","journal-title":"Int J Pharm Compd."},{"key":"2020120403575601300_CIT0002","first-page":"307","article-title":"Basics of sterile compounding: Personnel requirements for sterile compounding","volume":"20","author":"Akers","year":"2016","journal-title":"Int J Pharm Compd."},{"key":"2020120403575601300_CIT0003","first-page":"95","article-title":"U.S. Food and Drug Administration inspections: guide to a successful outcome for 503A sterile compounding pharmacies","volume":"21","author":"Yoch","year":"2017","journal-title":"Int J Pharm Compd."},{"key":"2020120403575601300_CIT0004","doi-asserted-by":"crossref","first-page":"1598","DOI":"10.1056\/NEJMoa1213978","article-title":"Fungal infections associated with contaminated methylprednisolone injections","volume":"369","author":"Smith","year":"2013","journal-title":"New Engl J Med."},{"key":"2020120403575601300_CIT0005"},{"key":"2020120403575601300_CIT0006","article-title":"Compounding facilities assessment and planning: a focus on USP &lt;797&gt; and USP &lt;800&gt;","author":"Clark","journal-title":"Am J Health-Syst Pharm."},{"key":"2020120403575601300_CIT0007","first-page":"626","article-title":"USP general chapter &lt;797&gt; Pharmaceutical compounding\u2014sterile preparations. USP physical tests","volume-title":"United States Pharmacopoeia.","year":"2008"},{"key":"2020120403575601300_CIT0008","first-page":"41","article-title":"USP general chapter &lt;797&gt; Pharmaceutical compounding\u2014sterile preparations. Pharmacopeial Forum","volume-title":"United States Pharmacopoeia.","year":"2015"},{"key":"2020120403575601300_CIT0009","first-page":"44","article-title":"USP General Chapter &lt;797&gt; Pharmaceutical compounding\u2014sterile preparations. Pharmacopeial Forum","volume-title":"United States Pharmacopoeia.","year":"2018"},{"key":"2020120403575601300_CIT0010","article-title":"USP general chapter &lt;797&gt; Pharmaceutical compounding\u2014sterile preparations. 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