On October 14 FDA sent something to the White House. It's called the Interim Access Policy for Compounding Using Certain Peptides, it's sitting at the Office of Management and Budget right now, and nobody outside government has read it.
Here's what's been reported. It tells 503A compounding pharmacies, the ones that fill a prescription for one patient at a time, that FDA won't come after them for compounding a short list of peptides. Every report names BPC-157. The list itself isn't public.
That sounds like the thing people have been waiting two years for. Read it closer, because it's the same mistake most peptide news gets read with.
Enforcement discretion leaves the law exactly where it was.
When FDA changes a rule, it goes through notice-and-comment rulemaking. It publishes a proposal, takes public comment, answers that comment and publishes a final rule. That final rule carries the force of law, and undoing it means running the whole process again.
Enforcement discretion skips all of that. It's FDA putting in writing where it plans to point its enforcement budget right now. A compounded peptide is still an unapproved drug the day after this publishes. FDA has just said it won't spend money on that fight for the moment.
The difference shows up the day somebody changes their mind. A rule takes months to unwind. A discretion policy can be pulled in an afternoon, with no comment period and nothing anyone can appeal.
It also only speaks for FDA. A state board of pharmacy makes its own calls. So does a payment processor. So does a drug company with a legal department, which eleven defendants have found out since August.
And research-use-only isn't in it at all.
This is the part to remember. The policy is written for 503A pharmacies compounding against a prescription for a real patient. Holland & Knight's read says it plainly: research-use-only and supplement channels aren't covered.
So if you buy research-grade, nothing about your situation changed on the 14th.
If anything it got a little worse, and the reason surprises people. Until now this whole category has been one big grey area, which is uncomfortable but also hard to enforce against. A policy like this draws a line through the middle of it. On one side, a pharmacy with a license, a prescription and a written promise from FDA. On the other side, everyone else. A line like that makes the far side easier to act on, because the agency can point at the approved path and ask why you didn't take it.
What I'm reading the day it lands.
There's no legal deadline on this, so it publishes whenever OMB finishes with it. Could be next week. Two things matter the minute it's out: the covered peptide list and the conditions. The headline will say BPC-157. The conditions will say who, for whom, and under what rules.
I put all of this on the tracker, next to where each of the twelve peptides stands. When the policy publishes, the covered list goes there the same day.