Compounded GLP-1 medications

What compounding means

Compounding

The preparation of a medication by a pharmacy to meet a need not met by an approved product — for example an alternative strength or an excluded ingredient. Compounded preparations are not FDA-approved: they are not reviewed for safety, efficacy or manufacturing quality in the way an approved drug is.

US law permits compounding of a drug that is on the official shortage list, which is what enabled widespread compounded semaglutide and tirzepatide during the shortages of recent years. When a shortage is declared resolved, that basis narrows, and the FDA has taken enforcement positions accordingly. Availability has therefore changed more than once, and any summary — including this one — can date quickly.

Salt forms and why they are not equivalent

Some compounded products have used semaglutide sodium or semaglutide acetate rather than the semaglutide base used in approved products. The FDA has stated that these salt forms are different active ingredients, not alternative names for the same one.

Multi-dose vials change the logging problem

Approved GLP-1 products largely arrive as pens where the device controls the amount. Compounded product typically arrives as a multi-dose vial with syringes, which means you draw a volume yourself, from a concentration stated by the pharmacy.

• The pharmacy's stated concentration (e.g. mg per mL) is the number everything depends on — record it exactly.
• The syringe type matters, because what you read off the barrel is a volume. See reading an insulin syringe.
• A multi-dose vial has a beyond-use date assigned by the pharmacy, which is not the same as a manufacturer expiry.
• A new vial can have a different concentration from the last one. Never assume continuity — start a new vial record every time.

This is one of the few GLP-1 situations where volume arithmetic legitimately applies, because you are drawing from a stated concentration. Our syringe unit converter handles that conversion — using the pharmacy's concentration and the amount your prescriber specified, never a number you chose.

The record to keep

1. Full ingredient name as printed, including any salt form.
2. Pharmacy name and, where given, the compounding facility.
3. Stated concentration and total vial volume.
4. Beyond-use date and the date you first punctured the vial.
5. Prescriber name and the amount they specified.
6. Every injection: date, time, amount, volume drawn, syringe type and site.
7. Side effects with timestamps, and any change in product or pharmacy as its own dated event.

This is more record-keeping than a branded pen requires, and that asymmetry is the point: the less standardised the product, the more the log has to carry. PepCycle stores concentration, beyond-use date and first-use date per vial, so switching between vials leaves a clean audit trail.

A note on sourcing

There is a real distinction between a licensed compounding pharmacy operating on a valid prescription, and grey-market "research" semaglutide sold without one. This page describes record-keeping for the former. For the latter, no record-keeping practice compensates for an unverified product, and that is a conversation for a clinician rather than a tracker.