Food and Drug Administration announced a new policy that could make six experimental peptides more readily available. According to a document released by the HHS, the government will not penalize specialized pharmacies for making and supplying these popular substances to patients with a prescription. The peptides: BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500.
This does not mean these particular peptides have been approved for use by the FDA. In fact, none of them have gone through the rigorous human testing required for FDA drug approval. And the new policy is not intended to be permanent.
Instead, it allows temporary access as the FDA decides on a longer-term plan for the six peptides. It also includes the caveat that compounders report “serious adverse events, and product quality issues to FDA and to the States where the products are compounded,” according to the document. This topic has been red-hot since July, when the FDA held an advisory committee meeting to consider whether to add these peptides to a list of substances that U.S. compounding pharmacies are allowed to manufacture and supply.
These substances are already widely used and obtained on the gray market. If people are going to use them, advocates have argued, it would be safest if those substances came from licensed pharmacies and are used with physician oversight. Critics, on the other hand—including FDA scientists—are concerned that the government may be opening the floodgates to under-studied and potentially harmful drugs.
These substances, they note, have not been fully vetted for safety and effectiveness. And some of these peptides are already being promoted and sold on the basis of scientific claims that experts say are unsupported or questionable. Here's what could come next, if you're thinking about taking one of these six compounded peptides.
Some parts of the current conversation played out at last month’s PepMed conference in Washington, D.C. A sign pointing guests to the registration table featured a stylized gold peptide overlaid on the white dome of the U.S. PepMed’s organizer, the American Academy of Peptide Medicine (AAPM), founded just last year, has already become a major voice in this debate.
Extract — continue reading at the source.
