Fed Regist. 1980 Sep 12;45(179 Pt 2):60754-84.
The Food and Drug Administration [FDA] adopts final regulations establishing requirements and procedures for the preparation and distribution of patient package inserts for prescription drugs for human use. The package inserts will inform the patient about the drug product. This action is intended to promote the safe and effective use of prescription drug products by patients and to ensure that patients have the opportunity to be informed of the benefits and risks involved in the use of prescription drug products. The agency intends to apply the regulations to 10 drugs or drug classes during an initial implementation program. Further evaluation of the costs and benefits of the program will guide the agency in deciding whether to extend, revise, or defer these requirements.
美国食品药品监督管理局（FDA）通过了最终法规，确立了供人类使用的处方药患者用药指导手册的编制和分发要求及程序。这些用药指导手册将向患者介绍药品情况。此举旨在促进患者安全、有效地使用处方药，并确保患者有机会了解使用处方药所涉及的益处和风险。该机构打算在初始实施计划期间将这些法规应用于10种药品或药品类别。对该计划成本效益的进一步评估将指导该机构决定是否扩展、修订或推迟这些要求。
