< div class = " PCCABlogPost " > < p > < em >艾米柄,PCCA政府关系总监< / em > < / p > < p > <你> <我>本文更新:9月1日,2020年< / i > < / u > < / p > < p > < br / > 2019年11月,美国食品药品监督管理局公布的草案指导复合动物药物大部分毒品物质:指导行业(-)# 256。本指南将严重限制复合动物患者,药物,它类似于机构2015年发布的指导,FDA后来撤回了。< / p > < p > FDA没有法定权力调节动物复合散装原料,和国会此前该机构警告说,任何新的指导文件应该基于法令。写,建议草案:< / p > < ul类= " PCCABlogBullets " > <李>需要化合物为个体动物患者是由fda批准的产品,除非临床需要说明为什么它必须是由大部分药物的物质。FDA并没有证明,批准产品的活性成分高质量或最终化合物由FDA批准的产品都是高质量的。药店也不普遍获得fda批准的动物药品化合物与他们是否被要求这样做,李< / > <李>创建一个积极的和消极的列表的大部分药物成分对药物复合办公室使用,这将限制动物患者治疗选择< /李> <李>指出兽医作为唯一从业者需要演示临床病人需要接受复合药物< /李> <李>要求配方有USP复合成品专著必须遵循专著,这将使一些动物不合适的原料和删除的选项定制动物病人李< / > <李>建立一个更严格的框架复合药物动物比人类患者,由于药品质量和安全法案授权从大部分药物复合物质对人类患者李< / > < / ul > < div >公众评论期< a href = " http://bit。ly / - - 256“目标= "平等" > FDA指南草案兽医复合< / >最初将结束在2月18日,2020年,为了应对来自众多利益相关者的反馈组织中,FDA已经把评论时间延长至10月15日,2020年。这使混合者更多的时间来表达他们的担忧这个问题。< / div > < div > < / div > < div > <跨风格= "字体大小:16 px;" > <强>如何支持兽医复合< /强> < / span > < br / >为你提供你的反馈很重要,FDA在10月15日,2020年,为了保护您的兽医病人的访问复合药物。为了帮助实现这一目的,我们准备了一个< a href = " http://bit。ly / GFI - 256 -信-模板“目标= "平等" >定制- # 256信模板< / >,您可以下载。 You can share it with your local veterinarians, too.
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.