27 Jan 2025

📜FDA Delays Effective Date for Nonprescription Drug Regulation

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) is delayed until March 21, 2025.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

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The regulatory delay affects compliance requirements for businesses involved in nonprescription drug products, necessitating adjustments in their application processes and marketing strategies due to the new requirements outlined for products with an Additional Condition for Nonprescription Use, delaying the rule's implementation until March 21, 2025.

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