The Food and Drug Administration (FDA) issued a rule regarding nonprescription drugs that require additional conditions for safe use. Originally set to take effect on January 27, 2025, the rule has been delayed twice and is now effective on May 27, 2025, due to a review process triggered by a presidential memorandum. The new rule establishes specific requirements for drug applications, labeling, and reporting related to these nonprescription drugs. The FDA intends to use this extra time for a thorough review, as immediate public input was deemed impractical and potentially against public interests, to ensure that entities affected by the rule have sufficient time to adjust their compliance strategies.
Simple Explanation
The FDA made a rule about how some over-the-counter drugs need special conditions to be used safely, but they decided to wait a little longer before starting the new rule, so everyone has more time to get ready.