Clinical

Prescription length is set by the product, not the calendar. A compounded GLP-1 is limited by its beyond-use date. A manufactured testosterone vial is limited by its size and the controlled-substance rules.

Two phase 3 papers, two company toplines and a filing date. The data are strong. The drug is still not something you can lawfully prescribe.

Six peptides won a nonbinding vote in July. FDA’s own reviewers found controlled human data for none of them, and no human data at all for three.

A vitamin in the vial does not make a copy into something else. A prescriber’s reason, written for one patient, does. FDA has now said which one it is looking at.

Section 503A is built around a prescription for a named patient. Stock on your shelf is not that, which is why the other category exists and why the states diverge from here.

This is an operational readiness question, not a clinical technique question. The things that decide the outcome are settled weeks earlier, in a document and a stock cupboard.

Epinephrine is first line. The operational question is whether the person standing next to the patient can reach it and is permitted to use it, and that is settled in a document.

The rule everyone cites against naming the drug was struck from the statute in 2013. The real constraints are somewhere else, and they are stricter about a different thing.

Oral semaglutide reaches about 0.8% bioavailability with a purpose-built absorption enhancer. That number tells you what a peptide powder in a capsule is achieving.

The FDA signaled movement on BPC-157 and a dozen other peptides, and the market read it as permission. Removal from the do-not-compound list is not the same as approval to compound.

The FDA approved label changes removing cardiovascular, breast cancer and dementia risk statements from the boxed warning. The endometrial cancer warning stayed, and compounded products were not addressed.

Exosome and stem cell products marketed for regeneration are generally regulated as biological drugs, and none is FDA approved for those uses. The claims are usually what triggers enforcement.