Proposed Rule: Article XXXI

Currently, Article XXXI states that USP Chapters 795 and 797 are enforceable. These chapters have updates scheduled effective 11/1/2023.  Compliance with non-USP 800 related components of these chapter updates are expected on 11/1/2023.  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 after 11/1/2023 will be subject to enforcement actions. For those that do not intend to become compliant with provisions of USP 800, related activity should cease as soon as possible.

Proposed rule for Compounding Guidelines now posted for comment.

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