Search Results for keywords:"Additional Condition for Nonprescription Use"

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has delayed the effective date of a rule regarding nonprescription drug products with an additional condition for nonprescription use (ACNU). Originally set to take effect on January 27, 2025, the rule is postponed to March 21, 2025, due to a memorandum from the President calling for a "Regulatory Freeze Pending Review." This delay is intended to allow further examination of the rule and its implications, ensuring it aligns with legal and policy considerations. The rule outlines requirements for nonprescription drugs involving applications, labeling, and postmarketing reporting, differentiating them from prescription drugs based on these additional conditions.

The Food and Drug Administration (FDA) has issued a final rule establishing new guidelines for nonprescription drugs that require an "Additional Condition for Nonprescription Use" (ACNU). This rule allows drugs that can't be safely used with labeling alone to be sold without a prescription if the manufacturer implements an approved ACNU to ensure proper use. It aims to expand consumer access to certain drugs that would otherwise need a prescription and outlines specific requirements for drug application, labeling, and reporting failures of the ACNU process. The rule will take effect on January 27, 2025, and is intended to improve public health by making more medications safely available as nonprescription options.