Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022
Author:
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmaceutical Science
Link
https://link.springer.com/content/pdf/10.1007/s12247-022-09692-4.pdf
Reference25 articles.
1. Gudeman J, Jozwiakowski M, Chollet J, et al. Potential risks of pharmacy compounding. Drugs R&D. 2013;13(1):1–8. https://doi.org/10.1007/s40268-013-0005-9.
2. Watson CJ, Whitledge JD, Siani AM, Burns MM. Pharmaceutical compounding: a history, regulatory overview, and systematic review of compounding errors. J Med Toxicol. 2021;17(2):197–217. https://doi.org/10.1007/s13181-020-00814-3. Epub 2020 Nov 2. PMID: 33140232; PMCID: PMC7605468.
3. Taylor S, Hays C, Glass B. Compounding medications in a rural setting: an interprofessional perspective. J Multidiscip Healthc. 2018;20(11):197–204. https://doi.org/10.2147/JMDH.S156161. PMID: 29719402; PMCID: PMC5916384.
4. Mohiuddin AK. Extemporaneous compounding: selective pharmacists with separate skill. Innov Pharm. 2019;10(4). https://doi.org/10.24926/iip.v10i4.1660. Retraction in: Innov Pharm. 2020 Feb 25;11(1): PMID: 34007590; PMCID: PMC8051898.
5. Rathore, A.S., Li, Y., Chhabra, H. et al. FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020. J Pharm Innov (2022). https://doi.org/10.1007/s12247-022-09678-2.
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