Nonprescription Drugs for Additional Condition Use Get FDA Rule

The FDA is establishing requirements for manufacturers seeking to market drugs that don’t need a prescription, finalizing a rule that would expand the development of such products and increase consumer access to safe and effective medicines.

A final rule released Monday by the Food and Drug Administration outlines industry provisions for the marketing of nonprescription drugs with an additional condition for nonprescription use (ACNU). The products can be marketed without a prescription if a manufacturer implements “an additional condition to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a practitioner licensed by law ...