July 17, 1981

Patient Package Insert Regulations Stayed

JAMA. 1981;246(3):252. doi:10.1001/jama.1981.03320030044029

On April 28, 1981, a notice from the Food and Drug Administration published in the Federal Register stayed the effective date of final regulations that would mandate patient package inserts for ampicillin, amoxicillin, hetacillin, cimetidine, clofibrate, phenytoin, and propoxyphene drugs. This stay does not affect requirements for patient package inserts for the oral contraceptive estrogen, and progestational drugs codified earlier in the Federal Register. This stay is welcome, even though it may defer action only until July 1, 1981, for it gives more time to explore the necessity for, and the cost and potential usefulness of, patient package inserts.

Under ideal circumstances, government agencies should not intervene between patient and physician, with mandates concerning diagnosis or treatment. Unfortunately, circumstances are not always ideal; and some patients receive prescriptions from their physician for medications about which the patient has no knowledge and has received no instruction. Some physicians do not put