Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration. Notice.
The Food and Drug Administration (FDA) is revoking the final guideline patient package inserts for 5 classes of drugs and is withdrawing the draft guideline patient package inserts for 5 other classes of drugs. Elsewhere in this issue of the Federal Register, the agency is revoking the regulations that established general requirements for the preparation and distribution of patient package inserts for prescription drug products. Those regulations had established a pilot program that would have been applied to 10 classes of drugs for 3 years. This notice revokes the draft and final guidelines which described how manufactures might comply with the regulations with respect to affected classes of drug.
D004348:Drug Labeling / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration