Gibbs Jeffrey N
Hyman, Phelps and McNamara, PC, Washington, DC.
Int J Pharm Compd. 2008 May-Jun;12(3):238-41.
The question of whether all compounded drugs are "new drugs" has been disputed in the United states for over 15 years. The Federal Food, Drug, and Cosmetic Act generally requires that "new drugs" obtain U.S. Food and Drug Administration approval before being sold in the U.S. Between 1938 and the late 1980s, the U.S. Food and Drug Adminsitration did not asert that compounded drugs are subject to the drug provisions. Then the U.S.Food and Drug Administration developed and advanced a new theory. As articulated in a 1989 memorandum by a U.S. Food and Drug Administration attorney, the U.S. Food and Drug Administration could take the position that compounded drugs were new drugs and therefore subject to new drug approval requirements. Although the memorandum acknowledged that this represented a significant change in policy, the U.S.Food and Drug Administration adopted this legal theory. Their position that compounded drugs are new drugs led to a clash between the agency and compounding pharmacies. Congress appeared to settle this dispute in 1997 when it passed the Food and Drug Administration Modernization Act. This law contained a provision expempting pharmacies from the new drug approval requirements (and two other requirements) if they met certain critieria. Although the U.S. Food and Drug Administration has continued to maintain that is will not assert the "unapproved new drug" theory against the traditional compounding of drugs, it has invoked the "new drug" theory in many warning letters to pharmacies, including a series of heavily publicized warning letters issued the day before oral argument in the Medical Center Pharmacy case to the validity of the U.S. Food and Drug Administration's interpretation. The Fifth Circuit decision in the Medical Center Pharmcy case will provide an answer. It may not, however, be the final answer.
在美国，关于所有复方制剂是否属于“新药”的问题已争论了15年多。《联邦食品、药品和化妆品法案》通常要求“新药”在在美国销售之前需获得美国食品药品监督管理局的批准。在1938年至20世纪80年代末期间，美国食品药品监督管理局并未声称复方制剂受药品条款的约束。随后，美国食品药品监督管理局提出并推进了一种新理论。正如美国食品药品监督管理局一名律师在1989年的一份备忘录中所阐述的那样，美国食品药品监督管理局可能会认为复方制剂是新药，因此应遵循新药批准要求。尽管该备忘录承认这代表了政策上的重大变化，但美国食品药品监督管理局还是采纳了这一法律理论。他们认为复方制剂是新药的立场导致了该机构与配药药房之间的冲突。1997年国会通过《食品药品管理局现代化法案》时，似乎解决了这一争端。该法律包含一项条款，即如果药房符合某些标准，则可免于新药批准要求（以及其他两项要求）。尽管美国食品药品监督管理局继续坚称不会针对传统的药品调配主张“未经批准的新药”理论，但它在许多给药房的警告信中援引了“新药”理论，包括在医疗中心药房案口头辩论前一天发出的一系列广受关注的警告信，以质疑美国食品药品监督管理局解释的有效性。第五巡回上诉法院在医疗中心药房案中的裁决将给出答案。然而，这可能不是最终答案。
