Kennedy and Senator Marshall press FDA for compounded peptide access
Marshall asked FDA to use enforcement discretion with conditions including cGMP-registered API sources and prescriptions for identified patients.
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By Daniel Okafor · Regulatory Correspondent
Oct 23 09:41 ETSource: Alliance for Pharmacy Compounding
The wire
- 01HHS Secretary Robert F. Kennedy Jr. said on October 20 the administration wants a state-regulated marketplace for certain unapproved peptides with 503A pharmacies at the center; Sen. Roger Marshall wrote to FDA the next day.
- 02Marshall's letter to Acting Commissioner Kyle Diamantas asks for interim compounding under conditions: FDA-registered cGMP API, 503A or outsourcing facilities only, patient-specific prescriptions, and ongoing PCAC safety review.
- 03The Alliance for Pharmacy Compounding is calling for guardrails in any peptide policy; neither statement is a rule, and FDA has not said whether it will exercise the requested discretion.
From the source
Read at a4pc.orgTwo calls for peptide access in two days
HHS Secretary Robert F. Kennedy Jr. said on October 20 that the administration wants a state regulated marketplace for certain unapproved peptides, with 503A pharmacies at the center. In an interview, Kennedy argued that Americans are buying peptides anyway, and products should be inspected and match their labels. He also said that FDA should generally step in when there is a safety signal, and ot
