The Old vs. New OTC System
For decades, FDA regulated OTC drugs through a lengthy notice-and-comment rulemaking process known as the OTC Drug Review. The CARES Act (March 2020) replaced this with a more efficient administrative order process.
Key Changes Under the CARES Act
Administrative Orders Replace Rulemaking
FDA can now issue, revise, or revoke OTC monograph orders through a streamlined administrative process instead of formal rulemaking.
User Fee Program (OMUFA)
The act established the Over-the-Counter Monograph User Fee Act, requiring OTC drug manufacturers to pay user fees to support FDA review activities.
Innovation Pathway
New active ingredients can now be added to OTC monographs through a dedicated innovation pathway, encouraging development of new OTC treatments.
Exclusivity Provisions
Companies that invest in developing new OTC conditions of use may receive a period of market exclusivity.
Impact on Manufacturers
- Faster regulatory changes — FDA can update monograph requirements more quickly
- User fee obligations — manufacturers must register and pay annual fees
- Opportunity for innovation — new pathway to bring novel OTC ingredients to market
- Enhanced compliance requirements — more active FDA oversight
Compliance Action Items
- Ensure all OTC products comply with current monograph conditions
- Register for OMUFA user fee payments
- Review product formulations against latest administrative orders
- Update Drug Facts labels as monograph requirements evolve
- Monitor FDA announcements for new administrative orders
Get Expert OTC Compliance Support
United Regulatory helps OTC drug manufacturers navigate the new regulatory landscape. Contact us for a compliance assessment.