Food and Drug Administration--Prescription drug products; patient package inserts requirements. Final rule.

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.