FDA发布有关不能配药药品的最终规定
出自识林
FDA发布有关不能配药药品的最终规定
笔记 2016-10-07 Lachman CONSULTANTS “FDA正在修订其法规修正已经从市场上撤销或移除的药品清单，因为药品或这些药品的成分被发现是不安全的或无效的（简称“已撤销或已移除清单”或“清单”）（§ 216.24 (21 CFR 216.24)）。出现在已撤销或已移除清单上的药品不得根据《联邦食品、药品和化妆品法案》（FD&C法案）503A和503B节提供的豁免进行配药。” FDA已经决定通过评议和规则制定条款继续从清单中添加或移除条目，因为FDA的行动可能对配药界产生重大影响。在本最终规定 FD&C法案503A对药房配药商以及503B对外包设施分别做出了规定。根据FD&C法案这些部分的规定符合豁免的一个条件是配药商不使用已经在卫生部长确定的因安全性或有效性原因已撤销或移除的产品清单上的成分。最终规定实施法案的这些规定。 预期对清单的更新会以更为正式的方式，因为FDA将聘请配药咨询委员会，并将通过评议和规则制定程序作出最终决定。FDA指出，“目前，FDA尚未完成在拟议规定中对于含有盐酸羟考酮的所有缓释药品的条目，这类药品尚未被FDA确定具有滥用遏制属性。关于盐酸羟考酮已撤销或移除清单中一个条目的添加仍在FDA的审议之中。” 这是一个有趣的发展，因为FDA已经认为羟考酮不含有滥用抑制属性，不再被认为是安全的。似乎FDA还没有准备好对所有潜在的缓释剂型的羟考酮单一实体产品实现飞跃。 在最终规定中，FDA概述了提交到拟议规定中的16条评议，并提供了答复。还讨论了从列表中添加或删除药物的过程。最终清单正在考虑中。 Lachman CONSULTANTS - Bob Pollock先生 FDA Issues Final Rule on Drugs that Cannot Be Compounded “FDA is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective (referred to as ‘the withdrawn or removed list’ or ‘the list’) (§ 216.24 (21 CFR 216.24)). Drugs appearing on the withdrawn or removed list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act.” FDA has decided to continue to make additions or removals from the list through comments and rulemaking provisions, since FDA’s action could have a significant impact on the compounding community. In this Final Rule, the FDA is adding 24 entries to the list, modifies the list to permit one product to be compounded under certain circumstances, and “modifies the title of part 216 the introductory test to §216.24” (where the list is published). There are pharmacy compounders under section 503A of the Act and outsourcing facilities identified under section 503B of the Act. One condition to qualify for the exemptions under those sections of the Act is that the compounder does not use an ingredient identified on the list of products that the Secretary has determined have been withdrawn or removed for safety or efficacy reasons. This Final Rule (here Expect updates to the list, but in a more formal manner, as FDA will employ both their Compounding Advisory Committee and will make its final decisions through its comment and rule-making procedures. FDA notes that “[A]t this time, FDA is not finalizing the entry in the proposed rule for all extended-release drug products containing oxycodone hydrochloride that have not been determined by FDA to have abuse-deterrent properties. The addition of an entry to the withdrawn or removed list for oxycodone hydrochloride remains under consideration by FDA.” This is an interesting development since FDA has taken the position that OxyContin that does not contain abuse-deterrent properties is no longer considered safe. It appears that FDA is not ready to make the leap to all potential oxycodone single-entity products in extended-release form. In the Final Rule, the FDA outlines 16 comments that were submitted to the proposed rule and provides their responses. The process for adding or deleting drugs from the list is also discussed. The final list is also presented. |
中，FDA将24条条目添加入清单，修改清单以允许一个产品在某些情况下配药，并“修改216部分的标题和§216.24介绍性内容”。