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Regulatoryfdacompounding503aenforcement discretion

Law firm analyzes FDA enforcement reprieve on compounded peptides

Buchanan Ingersoll & Rooney examines what a temporary enforcement posture would mean for pharmacies compounding peptide preparations.

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By Daniel Okafor · Regulatory Correspondent
Oct 14 16:16 ETSource: Buchanan Ingersoll & Rooney PC

The wire

  1. 01A client alert from Buchanan Ingersoll & Rooney discusses FDA peptide compounding policy and the implications of a temporary enforcement reprieve for pharmacies.
  2. 02503A and 503B operators weighing whether to continue peptide preparations need to understand that enforcement discretion is not the same as approval.
  3. 03The piece is law-firm commentary, not an FDA notice; the underlying agency position and its duration remain the governing facts.

From the source

FDA Peptide Compounding Policy: What a Temporary Enforcement Reprieve Could Mean for Pharmacies

Read at bipc.com
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