Fed Regist. 2003 May 1;68(84):23195-206.
On September 16, 1998, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) to implement provisions of the Controlled Substances Act (CSA) pertaining to the regulation of chemical mixtures which contain any of 34 listed chemicals. The NPRM was published to implement CSA requirements that only those chemical mixtures identified by regulation be exempt from applicable regulatory controls. The NPRM proposed criteria for the determination of whether a chemical mixture shall qualify for automatic exemption from CSA regulatory controls. Additionally, the NPRM defined an application process by which manufacturers may apply for an exemption for chemical mixtures that do not qualify for automatic exemption. Due to concerns regarding the potential illicit use of chemical mixtures which contain ephedrine, N-methylephedrine, N- methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine (as precursor material for the production of methamphetamine and related amphetamines), DEA is hereby finalizing the portion of the NPRM pertaining to these six chemicals. Final regulations for all remaining listed chemicals will be published under separate rulemaking, upon completion of a thorough review of applicable comments.
1998年9月16日,美国药品执法管理局(DEA)发布了一项拟议规则制定通知(NPRM),以实施《受控物质法》(CSA)中有关管制含有34种所列化学物质中任何一种的化学混合物的条款。发布该NPRM是为了实施CSA的要求,即只有那些通过法规确定的化学混合物才可免于适用的监管控制。NPRM提出了用于确定化学混合物是否应自动免于CSA监管控制的标准。此外,NPRM还定义了一个申请程序,制造商可通过该程序为不符合自动豁免条件的化学混合物申请豁免。由于担心含有麻黄碱、N - 甲基麻黄碱、N - 甲基伪麻黄碱、去甲伪麻黄碱、苯丙醇胺和/或伪麻黄碱的化学混合物(作为生产甲基苯丙胺及相关安非他命的前体材料)可能被非法使用,DEA特此确定NPRM中与这六种化学物质相关的部分内容。对于所有其余所列化学物质的最终法规将在完成对适用评论的全面审查后,在单独的规则制定中发布。