On May 11, 1972, the U.S. Food and Drug Administration (FDA) established  Over-the-Counter (OTC) Drug Review began to enhance the safety, effectiveness and appropriate labeling of drugs sold without prescriptions.

The final regulations in part 330 (21 CFR part 330) providing for the OTC drug review under 21 CFR 130.301 (recodified as § 330.10) were published and made effective in the Federal Register of May 11, 1972 (37 FR 9464). Since that time, FDA has published various calls for data inviting interested parties to submit data and information for the advisory review panels to review. 

During the course of the OTC drug review, advisory review panels reviewed many of the categories of OTC drug products included in prior call-for-data notices but did not review every category because of resource limitations.

In order for a product to be eligible for the OTC drug review, the product or similarly formulated and labeled products had to be marketed as OTC drugs at the inception of the OTC drug review, which date was later extended to on or before December 4, 1975.

Prescription drug products were also eligible for the review, as long as they continued to be marketed on a prescription basis while FDA evaluated data to ascertain whether the ingredient or combination of ingredients in the product could be proposed as GRAS/E for OTC use.