Health Secretary Robert F. Kennedy has implemented a rule that permits specialty pharmacies to sell six specific peptide drugs, despite previous FDA concerns regarding their safety and effectiveness. This rule, titled 'Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,' allows pharmacies to produce these peptides without fear of enforcement actions from the Department of Health and Human Services. The FDA had previously removed these peptides from a list of drugs that could be compounded due to safety issues.
Key facts
- Robert F. Kennedy issued a rule allowing the sale of six peptide drugs by specialty pharmacies.
- The FDA previously removed these peptides from a compounding list due to safety concerns.
- The rule states HHS will not enforce actions against pharmacies producing these peptides.
- Kennedy has expressed personal support for the peptides, calling himself a 'big fan.'
- The rule was published in the Federal Register with a final publication date of October 30.
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