Greenberg R B
Corporate Affairs Office, American Society of Hospital Pharmacists, Bethesda, MD 20814.
Am J Hosp Pharm. 1988 Oct;45(10):2118-26.
The Prescription Drug Marketing Act of 1987 is described, and its implications for hospitals and other health-care entities are discussed. The act, which became effective on July 21, 1988, is intended to reduce public health risks from adulterated, misbranded, and counterfeit drug products that enter the marketplace through drug diversion. The law provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Other distribution channels for samples specified in the law are permissible, provided records are maintained. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also identified. According to FDA's advisory guidelines on the statute, the law will permit hospitals to return drug products, provided the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (for manufacturers) or the goods were destroyed or returned to the manufacturer (for wholesalers). The final chapter on drug diversion must await issuance of final FDA regulations.
本文介绍了1987年的《处方药销售法案》，并讨论了该法案对医院和其他医疗保健机构的影响。该法案于1988年7月21日生效，旨在降低因药品转移而进入市场的掺假、标签错误和假冒药品给公众健康带来的风险。该法律规定，在美国生产并出口的处方药产品，除产品制造商外，不得再进口。它还对处方药产品和样品的销售设定了限制。只有在有执照的开处方者提出要求时，处方药产品的样品才可以分发。只要保存记录，法律规定的样品其他分销渠道也是允许的。根据该法律，批发分销商必须获得州政府的许可并符合统一标准。还确定了违反该法律的处罚措施。根据美国食品药品监督管理局（FDA）关于该法规的咨询指南，该法律将允许医院退回药品，前提是退还给制造商或批发商，并获得书面通知证明货物已被接收（对于制造商）或货物已被销毁或退回给制造商（对于批发商）。关于药品转移的最后一章必须等待FDA最终法规的发布。
