Prescription drug products; revocation of patient package insert requirements--Food and Drug Administration. Final rule.
The Food and Drug Administration (FDA) is revoking its final rule establishing requirements for the preparation and distribution of patient package inserts (PPI's) for prescription drug products for human use. This action is taken because the agency has determined that a mandatory pilot PPI program is unjustifiable, and that it is now preferable to encourage alternative patient information efforts. The agency believes that cooperation with health professionals and others in both the public and private sectors and reliance upon expanding privately sponsored initiatives in patient education should serve to provide patients with needed information about prescription drugs.
D004348:Drug Labeling / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration