Restore Health Consulting LLC, Laguna Beach, California.
Int J Pharm Compd. 2023 Nov-Dec;27(6):461-466.
The impending updates to United States Pharmacopeia Chapter <797> and Chapter <795> specify that compounders must obtain active pharmaceutical ingredients and should obtain excipients from FDA-registered facilities. Additionally, the U.S. Food and Drug Administration cautions compounders to know their bulk active pharmaceutical ingredients and excipients suppliers. While the U.S. Food and Drug Administration expects 503B outsourcing facilities to qualify their critical suppliers, pharmacy boards and accrediting bodies are beginning to ask 503A compounders for their list of approved suppliers and how they qualify them. As such, pharmacies should become comfortable in qualifying suppliers as part of their quality assurance program. This article discusses how pharmacies can apply the elements of supplier qualification to their practice to ensure that critical supplies and services meet company specifications for quality and compliance.
即将更新的《美国药典》第 <797> 章和第 <795> 章规定，制剂商必须从 FDA 注册设施获取原料药，并应从 FDA 注册设施获取辅料。此外，美国食品和药物管理局警告制剂商要了解其原料药和辅料供应商的情况。虽然美国食品和药物管理局预计 503B 外包设施将对其关键供应商进行资格认证，但药房委员会和认证机构已开始要求 503A 制剂商提供其批准供应商的名单及其对他们的资质认证情况。因此，药房应该在其质量保证计划中对供应商进行资格认证。本文讨论了药房如何将供应商资格认证的要素应用于其实践，以确保关键用品和服务符合公司对质量和合规性的要求。
