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# OTC Drug Proposal to Offer New Class of Products
- URL: https://www.fdaweb.com/otc-drug-proposal-to-offer-new-class-of-products/
- Published: 2022-06-27T12:00:00.000Z
- Updated: 2026-09-14T17:50:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152169

FDA has released a proposed rule that broadens options for drug companies seeking to market a nonprescription drug product. The agency is proposing use of an “additional condition” for potential nonprescription products when labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a drug product. Any proposed additional conditions require consumers to first successfully fulfill these to obtain the nonprescription drug product, the agency says.

“For example, an applicant could propose an additional condition for nonprescription use that requires a consumer to respond with specific answers to a set of questions on a self-selection test available by either a phone ‘app’ or an automated telephone response system in order to purchase the nonprescription drug product,” an [agency notice](https://www.fda.gov/news-events/press-announcements/fda-introduces-innovative-proposal-advance-consumer-access-nonprescription-drugs?ref=fdaweb.com) says. If the agency “finds that the additional condition for nonprescription use will permit appropriate self-selection and/or appropriate actual use of the product, and consumers can use the product safely and effectively without the supervision of a healthcare practitioner, it may approve the product for nonprescription use with the additional condition for nonprescription use,” it says.

The [proposed rule](http://secure-web.cisco.com/1uiPpYoAjEndL80QWuov300ijOtrG734Iewa%5FSH1xCdleuuAtu--B6K16A2A06d6ZZG5WCz0D1NcPyLzmrSDxN3M0NCxuxE0HE%5F32mGqxGJnG9iF-Rw804%5FIp5tcajAbbb-daIHvySnT69ojq7rZLO1a0GvYZurgFzNRi5FNbzx65%5F8o69%5FtxLqlApTHhccnSj1qh90sSQVJunxvqaj-m0Q/http%3A%2F%2Femail.prnewswire.com%2Fls%2Fclick%3Fupn%3D3slWLw94I3jq-2B-2FedjFNgZNHfup2C1EvAshY0BqdE-2FtHytXyVmCYgPRpUg3N8VlWi1hM-2Bxd6ALrv5fnYEsjhPAMsLreg1qNNs7GUMSUVSptS30HGbkwObdOc7wgso5BxnCm76cUfJNC7EZ42BL5ZOzqwvxs7HCXYyBQ9qFzm-2Bsx-2FBmdm4ZAYuLZ9Cj1P4smnowNCO-2BEoOntphSpb0ZFLt6A-3D-3DDYPu%5FxCGFIN3nMOPWun4BAdUrZI6NUVIWPuhGNPih1t9UspWUawZ-2BSsLNM-2FdqNsHgZvBOv2VEdnfOT6D3LQf9YiTWMRYwyRIUxHE2FUIAK378qD8xNVK-2B-2FaeXwDLd565JxaSEHup-2ByQM-2FwvmTaTJlmh7nzqYEZ5vzHFUkFuw1jfS8M3pLwSEz009oSEQBq4qetMkxamqFEjFtnklF9-2F0iymQ4Jy49qzStpkDnvEMCKad-2Fw5EpEY-2Fj31vH-2FgXE-2Fwqw4QqJAgSCHHcZatrpRPe-2F0K9wj1kp-2FhiOuoKRIGlEY0-2B8QZmKnmheULZedJ8VSh-2Bc-2BesxofWNmJY4c-2BJ842uEcv2GN6CbUGU4DbGLKT67MGaVE0t1rkli-2FBsb6eMhwCM2LDMZ?ref=fdaweb.com) is open for comments for 120 days.