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FDA presses peptide enforcement while rulemaking stays stalled

Pharmaceutical Executive reports the agency is leaning on enforcement tools as formal policy on compounded peptides remains unfinished.

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By Daniel Okafor · Regulatory Correspondent
Sep 29 06:23 ETSource: Pharmaceutical Executive

The wire

  1. 01Pharmaceutical Executive reports that formal FDA rulemaking on peptides has stalled even as the agency continues enforcement activity in the space.
  2. 02Compounders, clinics and telehealth prescribers dispensing peptides are operating without settled federal rules while still facing enforcement exposure.
  3. 03No timeline for completed rulemaking is given, so the practical boundaries will continue to be set case by case through agency action.

From the source

As Peptide Rulemaking Stalls, FDA Enforcement Moves Forward

Read at pharmexec.com
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