25 Mar 2025
💊Implications of New Nonprescription Drug Regulations for Businesses
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Summary
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulatory text outlines compliance requirements for nonprescription drug products with an additional condition for use, impacting businesses involved in drug manufacturing and marketing. These businesses will need to adapt to new application, labeling, and reporting requirements set by the FDA.