Fed Regist. 2007 Apr 23;72(77):20039-47.
This rulemaking controls the chemical N-phenethyl-4-piperidone (NPP) as a List I chemical under the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.). Clandestine laboratories are using this chemical to illicitly manufacture the schedule II controlled substance fentanyl. The recent distribution of illicitly manufactured fentanyl has caused an unprecedented outbreak of hundreds of suspected fentanyl-related overdoses, at least 972 confirmed fentanyl-related deaths, and 162 suspected fentanyl-related deaths occurring mostly in Delaware, Illinois, Maryland, Michigan, Missouri, New Jersey, and Pennsylvania. NPP has been identified as the starting material in several seized fentanyl clandestine laboratories. In addition to DEA's concern regarding the deaths associated with illicitly manufactured fentanyl, DEA is extremely concerned about the safety of law enforcement officers encountering these clandestine laboratories. Therefore, DEA is regulating NPP as a List I chemical through this Interim Rulemaking. DEA is soliciting comments on this Interim Rule. This rulemaking will subject handlers of NPP to the chemical regulatory provisions of the CSA and its implementing regulations, including 21 CFR Parts 1309, 1310, 1313, and 1316. This rulemaking does not establish a threshold for domestic and international transactions of NPP. As such, all transactions involving NPP, regardless of size, shall be regulated. This rulemaking also specifies that chemical mixtures containing NPP will not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of NPP will be regulated and will be subject to control under the CSA.
本规则制定将化学物质N-苯乙基-4-哌啶酮(NPP)作为《受控物质法案》(CSA)(美国法典第21编第801节及后续章节)下的第一类化学品进行管控。秘密实验室正使用这种化学物质非法制造附表II受控物质芬太尼。近期非法制造的芬太尼的流通已导致前所未有的数百起疑似与芬太尼相关的过量用药事件爆发,至少972例经确认的与芬太尼相关的死亡,以及162例疑似与芬太尼相关的死亡,这些事件大多发生在特拉华州、伊利诺伊州、马里兰州、密歇根州、密苏里州、新泽西州和宾夕法尼亚州。NPP已被确定为多个查获的芬太尼秘密实验室中的起始原料。除了美国缉毒局对与非法制造的芬太尼相关的死亡事件的关注外,美国缉毒局还极其担心执法人员在遇到这些秘密实验室时的安全。因此,美国缉毒局通过本临时规则制定将NPP作为第一类化学品进行监管。美国缉毒局正在就本临时规则征求意见。本规则制定将使NPP的处理者受CSA及其实施条例的化学监管规定约束,包括《联邦法规汇编》第21编第1309、1310、1313和1316部分。本规则制定未为NPP的国内和国际交易设定阈值。因此,所有涉及NPP的交易,无论规模大小,均应受到监管。本规则制定还规定,含有NPP的化学混合物在任何浓度下都不会免于监管要求。因此,所有含有任何数量NPP的化学混合物的交易都将受到监管,并将根据CSA进行管控。