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# Contrast Agent, Radioactive Drug, OTC Drug Status Clarified
- URL: https://www.fdaweb.com/contrast-agent-radioactive-drug-otc-drug-status-clarified/
- Published: 2023-01-19T12:00:00.000Z
- Updated: 2026-09-14T18:12:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153578

Attorneys **James Bolani** and **Bonnie Odom** (Epstein Becker Green) say a small section buried in the Consolidated Appropriations Act of 2023 clarified the regulatory status of contrast agents, radioactive drugs, and over-the-counter monograph drugs. “The new law brings to an end the uncertainty regarding the regulatory status of these product classes following the court case *Genus Medical Technologies v. FDA* and the subsequent Request for Information issued by FDA in 8/2021 that offered the notion of reclassifying products that had been regulated as drugs for several decades as medical devices,” the attorneys write in an online [post](https://www.ebglaw.com/insights/congress-clarifies-the-regulatory-classification-of-contrast-agents-radioactive-drugs-and-otc-monograph-drugs/?utm%5Fcampaign=Insights&utm%5Fcontent=235160483&utm%5Fmedium=social&utm%5Fsource=twitter&hss%5Fchannel=tw-92367412).

They say that although FDA was not compelled to make such reclassifications as a result of *Genus* and could classify products as drugs, even if they lack chemical action, the clarification of the law brings a level of certainty to the regulatory status of the three classes of products that could provide substantial benefits to innovation. They also say FDA has an opportunity to build on the regulatory clarity through its user fee waiver policies that should help clear, and not hinder, the path for small pharmaceutical companies to pursue innovative drug development efforts.

The post outlines the products that are deemed drugs and not deemed drugs and looks ahead to possible future actions affecting product jurisdiction and incentivizing drug development.