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The FDA quietly dropped BPC-157, TB-500 and CJC-1295 from its safety-concern category

In April, the FDA removed BPC-157, TB-500 and CJC-1295 from Category 2 of its bulk substances list, the category indicating agency safety concerns, after the nominations for those substances were withdrawn. It did not move them to Category 1, the list of substances permitted for compounding, and none has an approved drug containing it or a recognised pharmacopoeia monograph.

What this actually means

This is the story that made July's advisory committee vote possible, and it was widely misreported at the time as the FDA softening its position.

Coming off a safety-concern list is not the same as going onto an approved list. These compounds moved from explicitly flagged to simply unaddressed, which is a legal grey zone rather than a green light. Vendor sites reported it as vindication anyway.

For a UK reader it changed nothing then and changes nothing now. None of the three has ever had an MHRA authorisation, and US category listings have no bearing on UK law.

Sources

What this is. A dated, sourced note on something that changed. Peptide Register is an independent reference: it sells nothing, carries no advertising, and takes no money from any company selling any compound it covers. This is not medical advice. If a change affects a medicine you are prescribed, speak to your doctor or pharmacist rather than acting on something you read here.

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