Fed Regist. 2003 Jun 24;68(121):37405-11.
DEA is finalizing a Notice of Proposed Rulemaking (NPRM) defining central fill pharmacy activities and permitting central fill pharmacies to prepare controlled substances prescriptions on behalf of retail pharmacies with which the central fill pharmacies have a contractual agreement to provide such services or with which the pharmacies share a common owner. When one retail pharmacy receives a prescription and a second pharmacy prepares and subsequently delivers the controlled substance medication to the first retail pharmacy for dispensing to the patient, the second pharmacy is engaging in a "central fill activity". Records must be maintained by both the central fill pharmacy and the retail pharmacy that completely and accurately reflect the disposition of all controlled substance prescriptions dispensed. With respect to security, central fill pharmacies would be required to comply with the same security requirements applicable to retail pharmacies including the general requirement to maintain effective controls and procedures to guard against theft and diversion of controlled substances. DEA is creating an allowance for retail pharmacies that also perform central fill activities to do so without separate DEA registration, separate inventories, or separate records. This rulemaking is sought by the regulated industry and will allow for more efficient delivery of controlled substance prescriptions to patients.
美国药品执法管理局（DEA）正在敲定一项拟议规则制定通知（NPRM），该通知将界定集中配药药房的活动，并允许集中配药药房代表与之签订提供此类服务的合同协议或与之拥有共同所有者的零售药房，制备管制物质处方。当一家零售药房收到处方，而另一家药房制备并随后将管制物质药物交付给第一家零售药房以供向患者配药时，第二家药房即从事“集中配药活动”。集中配药药房和零售药房均必须保存记录，这些记录要完整、准确地反映所有已配药的管制物质处方的处置情况。在安全方面，集中配药药房将被要求遵守适用于零售药房的相同安全要求，包括维持有效控制和程序以防止管制物质被盗和转移的一般要求。DEA正在为同时开展集中配药活动的零售药房提供一项许可，使其无需单独的DEA注册、单独的库存或单独的记录即可开展此类活动。这项规则制定是受监管行业所寻求的，将有助于更高效地向患者提供管制物质处方。
