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The recent Food and Drug Administration hearing as to whether present prescription requirements should be removed from hydrocortisone preparations for topical use warrants mention of the regulations concerning this matter. Many do not understand how drugs are released for over-the-counter sale. Current legislation (the Food, Drug and Cosmetic Act of 1938 and the Durham-Humphrey amendment of 1952) implies that any drug potentially unsafe when not used under proper medical supervision shall be restricted to sale by prescription only. At any time that a manufacturer, or even an interested person, believes the prescription restriction is no longer necessary to protect the public, and has evidence to support this contention of the drug's safety, he may petition the Food and Drug Administration to allow over-the-counter sales, provided, of course, labeling includes what is deemed by the FDA to be adequate directions for use and necessary warnings.
Over-the-counter sales are tantamount to self-medication.
OVER-THE-COUNTER MEDICAMENTS. JAMA. 1956;162(7):661. doi:10.1001/jama.1956.02970240043013
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