Mandl F L, Greenberg R B
Am J Hosp Pharm. 1976 Aug;33(8):814-6.
The legal issues surrounding the potential liability of a pharmacist for dispensing or preparing drugs under conditions not contained in the official labeling of a product are examined. Although the specific issue of liability of a pharmacist for preparing a drug in a nonapproved manner or dispensing a drug for a nonapproved use has not been adjudicated, based on evolving legal principles it appears that the pharmacist will be held responsible for the drugs so prepared or dispensed. Preparation of a drug which is adulterated under the federal Food, Drug and Cosmetic Act appears to be negligent, although its precise effect will be dependent upon state law. Liability for dispensing for nonapproved uses may be minimized if the pharmacist, in the exercise of sound professional judgment, concludes that the use is rational, safe and reasonable.
围绕药剂师在产品官方标签未涵盖的条件下调配或制备药品的潜在责任的法律问题进行了研究。尽管药剂师以未经批准的方式制备药品或为未经批准的用途调配药品的具体责任问题尚未裁决，但根据不断发展的法律原则，药剂师似乎将对如此制备或调配的药品负责。根据联邦《食品、药品和化妆品法案》，制备掺假药品似乎构成疏忽，尽管其确切影响将取决于州法律。如果药剂师在运用合理的专业判断后得出结论认为该用途合理、安全且合理，那么为未经批准的用途调配药品的责任可能会降至最低。
