FDA Rule Would Facilitate Prescription-to-OTC Switches But Nix a Third Class of Drugs

July 12, 2022

(STAT News) – Under the proposed rule, an OTC drug could have the same active ingredient, dosage form, strength, route of administration, and indication as its prescription-only counterpart. What the rule does not do is create a third class of drugs that would not require a prescription yet, instead of being available over the counter, would be “behind-the-counter” and could be purchased only after consulting with a pharmacist. The possibility of this third class has been in play since 2012. (Read More)