作者Amy Shank, PCCA政府关系主任
本文已更新:2020年9月1日
2019年11月，FDA发布了从原药中配制动物药物指南草案:工业指南(GFI) #256。该指南将严重限制动物患者获得复合药物，与2015年发布的FDA后来撤回的机构指南类似。FDA没有法定权力来监管从散装成分中提取动物制剂，国会此前曾警告该机构，任何新的指导文件都应以法规为依据。如书面所述，提案草案:
- 要求由fda批准的产品制成用于个体动物患者的化合物，除非临床需要证明为什么必须由原料药制成。FDA没有证明已批准产品的活性成分质量更高，也没有证明由FDA批准产品制备的最终化合物质量更高。如果需要的话，药房通常也无法获得fda批准的动物药物产品进行复方
- 将为办公室使用的复方药物创建一个原料药成分的正面清单和负面清单，这将限制动物患者的治疗选择
- 将兽医作为唯一需要证明患者接受复合药物的临床需要的从业者
- 要求具有USP复合成品各论的配方必须遵循该各论，这将使一些动物暴露于不适当的成分，并取消为动物患者定制的选项
- 为动物患者配制药物建立了一个明显比人类更严格的框架，因为《药品质量与安全法》授权从原料药中配制用于人类患者的药物
Want to Learn More? PCCA members can watch our
informational webinar on GFI #256 in PCCA Play, our educational media library. It features Matt Martin, PharmD, PCCA Clinical Services Manager, and Chris Simmons, RPh, PCCA Vice President of Creative Development. They can also visit the
PCCA Public Affairs page on our Members-Only Website or email us at publicaffairs@pccarx.com.
Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group (CHCG), where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip Office as a policy advisor.