Pharmacy question list for compounded GLP-1 products

The FDA's own description is the place to start: compounded drugs are not FDA approved, which means the agency does not verify their safety, effectiveness or quality before they are marketed. That is not a reason never to use one; it is a reason to do, yourself, some of the checking the agency does for an approved product. These thirteen questions are that checking.

Licence and type

The first question is the state licence: which state, what number, and whether the pharmacy is licensed to ship into yours. Every state board publishes a licence lookup; a pharmacy that will not give you the number has answered a different question. The Compounding Explained site in this network links every state board's lookup page.

The second question is whether the pharmacy operates under section 503A or 503B of the Food, Drug and Cosmetic Act. The FDA's questions-and-answers page draws the line: a 503A pharmacy compounds for individual patients on a prescription and is overseen day to day by its state board, with FDA doing surveillance and for-cause inspections; a 503B outsourcing facility registers with FDA, is inspected by FDA on a risk-based schedule, and must follow current good manufacturing practice, which 503A pharmacies are not required to do. Neither is "better" for every purpose, but you should know which you are dealing with, and if the answer is 503B, the facility should appear on the FDA's registered outsourcing facility list.

The third is the prescriber of record and whether the product was made for your named prescription. A vial made in advance for whoever orders is a different regulatory object from one compounded for you.

The product

Where does the active ingredient come from, and can they show its supplier certificate? Can you see the certificate of analysis for your lot, with potency, sterility and endotoxin results and the name of the testing lab? What is the exact concentration on your label and in which units will your dose instructions be written? Concentration is where dosing errors are born; the dose log has a header line for it, and the calculators site's dose unit converter shows the arithmetic so you can check what you were told. What else is in the vial, and why? Some compounded products include a second ingredient or an additive; you are entitled to know what it is and what it is for. And what is the beyond-use date, how was it assigned, and does it change once the vial is opened?

Shipping, storage and problems

How is it kept cold in transit, and what should the box look like on arrival? What should you do if it arrives warm, cloudy or with particles (the shot-day checklist says: do not use it, call)? Who answers dose questions, and when? How do they handle a suspected adverse event, and do they report to FDA MedWatch? What does the price include, and what happens to your prescription if you stop?

Writing the answers down

The sheet has a header for the pharmacy, the date and the person you spoke to, and answer lines under each question. Keep it with the supply and refill tracker; if a lot ever needs reporting, the two sheets together are the record. If you want to see how FormBlends answers these questions for its own compounded semaglutide and tirzepatide, the product pages are where to look, and the questions still apply.