处方药；最终指南患者用药指导说明书的撤销及指南患者用药指导说明书草案的撤回——美国食品药品监督管理局。通知。
Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.
出版信息
Fed Regist. 1982 Sep 7;47(173):39249-50.
The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.
美国食品药品监督管理局（FDA）正在撤销5类药品的最终指南患者用药指导，并撤回另外5类药品的指南患者用药指导草案。在本期《联邦公报》的其他地方，该机构正在撤销为处方药产品的患者用药指导的编制和分发制定一般要求的规定。这些规定曾设立了一个将适用于10类药品、为期3年的试点项目。本通知撤销了描述制造商如何就受影响药品类别遵守相关规定的草案和最终指南。
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