The FDA has digitized and publicly posted more than 960 historical documents related to over-the-counter drug monographs, allowing users to search records that previously required individual email requests.
The collection, which includes documents dating to 1972, is freely available through the OTC Monographs@FDA database. It contains information about nonprescription drug ingredients and their regulatory review.
The FDA’s Office of Nonprescription Drugs completed the project more than a year before the October 31, 2027, deadline established under the second authorization of the OTC Monograph User Fee Program, known as OMUFA II.
The digitization commitment formed part of negotiations with industry in 2025. It required the office to engage an independent contractor to scan historical paper documents catalogued during the program’s first authorization and place them in a searchable online collection.
OMUFA provides resources for FDA activities supporting the modernized OTC drug monograph system. That regulatory framework supports the marketing of thousands of nonprescription drug products each year.
The newly accessible records cover the historical monograph process and provide material for pharmaceutical companies, researchers and members of the public examining ingredient reviews and regulatory decisions.
Previously, people seeking these documents had to request them separately by email. The online catalog removes that requirement for the scanned collection, giving users direct access without submitting individual requests to the agency.
The project makes the historical regulatory record available in one searchable resource rather than through case-by-case correspondence.
Users can access the full catalog of scanned historical documents directly through the OTC Monographs@FDA website.
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