The following regulation has been amended and will become effective April 12, 2024:
Article XXXI: Compounding Guidelines
This is an amendment to a current regulation. As stated in proposed rule posting on October 3, 2023, current USP Chapters 795 and USP 797 are enforceable per the last effective updates on November 1, 2023. For USP 800 related elements, compliance plans that include action items and timelines will be acceptable but must be fully implemented by 1/1/2025 to avoid potential enforcement actions. Noncompliant USP 800 activities without a substantial compliance plan in place will be subject to enforcement actions.