导航活性药品成分的直接进口:复合药房的合规考虑
Bradley S Byars1, Brad Howard2
1Brown & Fortunato, P.C. bbyars@bf-law.com.
International journal of pharmaceutical compounding
|February 8, 2025
概括
复合药房可以通过直接进口活性药物成分 (API) 来降低成本. 然而,在采购外国API时,仔细关注联邦和州法规对于遵守和保持实践完整性至关重要.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 供应链管理 供应链管理
背景情况:
- 直接进口活性药物成分 (API) 为复合药房提供了节省成本和扩展服务的机会.
- 从国际制造商,特别是来自中国的API采购,存在重大监管障碍和合规风险.
- 现有的框架可能无法完全解决用于复合目的API进口的复杂性.
研究的目的:
- 检查联邦监管格局,管理用于药房配合药剂的API的进口.
- 概述外国API采购药店的必要尽职调查程序.
- 为导航API进口的州级监管考虑提供指导.
主要方法:
- 审查有关药品成分进口的联邦法规.
- 分析与国际API采购相关的供应链风险.
- 合并药房业务的尽职调查和合规性最佳实践的汇编.
主要成果:
- 确定影响API进口的关键联邦法规.
- 在对外国API供应商进行审查时,制定药房尽职调查框架.
- 强调国家特定法规在进口过程中的重要性.
结论:
- 遵守联邦和州的指导方针对于复合药房进口API至关重要.
- 实施强有力的尽职调查措施可以减轻与外国API采购相关的风险.
- 合规性确保了复合实践的完整性和患者安全.
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