The Department of Health and Human Services issued a policy allowing licensed pharmacies and doctors to temporarily compound six experimental peptides without the threat of federal enforcement. This regulatory measure includes popular injury-recovery compounds such as TB-500 and BPC-157. However, the action was pushed through despite explicit objections from career Food and Drug Administration scientists. These internal experts warned that there is little evidence showing the treatments are safe or effective.
Key points
Licensed doctors and pharmacies can temporarily compound six specific peptides free from…: Licensed doctors and pharmacies can temporarily compound six specific peptides free from the risk of federal penalties.
Internal scientific staff warned that scant evidence exists to prove the compounded pepti…: Internal scientific staff warned that scant evidence exists to prove the compounded peptides are safe or effective.
The policy was enacted under the Trump administration despite pushback from career regula…: The policy was enacted under the Trump administration despite pushback from career regulators within the Food and Drug Administration.
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HHS opens peptide floodgates, despite concerns from FDA scientists
The Trump administration is giving the peptide craze a regulatory boost. HHS issued a policy allowing licensed pharmacies and physicians to temporarily compound six experimental peptides, including the popular injury-recovery duo BPC-157 and TB-500, without fear of federal enforcement, STAT’s Margaret Manto writes. This comes despite objections from FDA career scientists who say there’s scant evidence the substances are safe or effective.
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