Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule.
The Food and Drug Administration(FDA) is amending its patient package insert regulations to make the distribution requirements for patient package inserts for drug products in unit-of-use containers the same as the requirements for products in bulk containers. The agency is also amending its antibiotic drug regulations to permit manufacturers and distributors of antibiotics to make changes in labeling to comply with the patient package insert regulations without advance approval by FDA. This action will conform the requirements for implementing FDA's patient package insert regulations for antibiotics to the requirements currently applicable to the other drugs in the program.
D004348:Drug Labeling / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration