title: Patient package inserts and the pharmacist's responsibility.
abstract: Patient package insert regulations by the Food and Drug Administration are discussed, emphasizing the pharmacist's responsibility. The possible criminal and civil liability problems the pharmacist may face under the regulations are considered. Legal implications of alternatives to using PPIs provided by the manufacturer are presented. The prudent pharmacist will examine the alternatives, weighing the administrative, clinical and legal implications of the various approaches.
mesh_terms: D007880:Legislation, Drug; D007885:Legislation, Pharmacy; D010595:Pharmacists / Q000331:legislation & jurisprudence*; D011356:Product Labeling; D014481:United States; D014486:United States Food and Drug Administration