Health and Human Services Department Docket FDA-2020-N-1819 Proposed Rule

2022-01927: Certain Requirements Regarding Prescription Drug Marketing

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Summary

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from enactment of the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA). This action, if finalized, will remove or revise outdated and conflicting regulatory requirements to align with changes to affected provisions of the FD&C Act following enactment of the DSCSA.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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