14 terms that change the meaning of a claim. Most disputes about GLP-1 pricing and evidence turn on one of them — whether a figure is a starter dose or a maintenance dose, whether a comparator was placebo or another active drug, whether a substance may legally be compounded at all.
A traditional compounding pharmacy preparing a medicine for a named individual patient under state board oversight. Since February 2025 this is the surviving route for compounded GLP-1s, and it requires a prescriber to document a clinical reason.
An FDA-registered outsourcing facility compounding in batches to cGMP standards. Mass compounding of GLP-1s under shortage discretion ended when the shortages were resolved.
How the FDA signals whether a substance may be used in 503A compounding. Category 2 has been identified as raising significant safety risks and may not be used. BPC-157 is Category 2.
Semaglutide sodium and semaglutide acetate. The FDA has said these are not the same active ingredient as the base form used in approved products.
The scheduled step-up from an initiation dose to a maintenance dose. Gastrointestinal effects cluster around each step rather than spreading evenly.
The dose a patient stays on after titration, and the dose every published efficacy figure was collected at. A price quoted at a starter dose is not the price of treatment.
A dose below the range studied in the pivotal trials. No published efficacy figure applies to a microdose at any price.
A prepaid multi-month plan divided by its months, so plans with different terms can be compared on the same basis.
Major adverse cardiovascular events — a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. The primary endpoint of the SELECT trial.
The analytical approach a trial uses to handle participants who stop treatment. The same trial can report two figures under two estimands, and marketing usually quotes the higher.
A trial design comparing a drug against another active drug rather than placebo. It supports a weaker claim — 'not worse than' rather than 'reduces events'.
Labelling stating a product is not for human use. A legal position, not a safety finding, and an admission that no approval exists.
The standard an approved generic must meet against its reference product. A compounded preparation has no such demonstration, which is why it is not a generic.
The FDA's strongest labelling warning. GLP-1 labelling carries one on thyroid C-cell tumours based on rodent studies, underlying the contraindication for medullary thyroid carcinoma and MEN 2 history.