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Drugs are compounded in precise concentrations for extended durations, sometimes involving complex formulations. A significant challenge in this context is the off-label use of short-term plastic primary packaging for long-term storage of compounded DPs, which could be due to a lack of awareness, financial constraints and inadequate regulation. Without proper risk assessments, such packaging can release potentially harmful leachable compounds, posing a serious threat to patient safety. Evaluating hospital pharmacy compounding procedures to mitigate this risk is essential. While off-label drug use is a well-known concept in hospitals, off-label use of plastic primary packaging is an entirely different practice. In both the United States and Europe, healthcare professionals, including pharmacists, are allowed to use medical devices, including primary packaging, in ways that are not explicitly approved by regulators based on their clinical judgement and best practices, taking into account the patient\u2019s best interest. However, this off-label use could bring about unique risks and challenges, especially in the highly controlled environment of hospital pharmacy compounding, where patient safety is crucial. Therefore, the current review explores the historical context and the current landscape of hospital pharmacies, investigates the potential root causes of container closure integrity issues in pharmaceutical compounding, discusses the materials of construction as well as their physical\u2013chemical properties influencing their roles in most popular primary packaging and finally presents expert opinions aimed at identifying long-term solutions to the existing challenges regarding their off-label uses in hospital pharmacy compounding.<\/jats:p>","DOI":"10.1177\/20420986251317424","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T02:41:31Z","timestamp":1739500891000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["A critical opinion-based review of hospital pharmacy compounding with respect to the risk of leachable substances due to the off-label use of plastic primary packaging"],"prefix":"10.1177","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8704-130X","authenticated-orcid":false,"given":"William","family":"Bello","sequence":"first","affiliation":[{"name":"Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland"},{"name":"Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland"},{"name":"School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland"},{"name":"Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3329-8240","authenticated-orcid":false,"given":"Julian","family":"Pezzatti","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6659-0790","authenticated-orcid":false,"given":"Camille","family":"Stampfli","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6546-8128","authenticated-orcid":false,"given":"Laurent","family":"Carrez","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4180-5417","authenticated-orcid":false,"given":"Serge","family":"Rudaz","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland"},{"name":"Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland"},{"name":"Swiss Center of Applied Human Toxicology (SCATH), Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0817-5393","authenticated-orcid":false,"given":"Farshid","family":"Sadeghipour","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Lausanne University Hospital, Lausanne, Switzerland"},{"name":"Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland"},{"name":"School of Pharmaceutical Sciences, University of Geneva, CMU-Rue Michel Servet 1, 1211 Geneva 4, Switzerland"},{"name":"Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,2,13]]},"reference":[{"key":"bibr1-20420986251317424","unstructured":"Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC. 2017 O.J. 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