USP <797>

USP <797> is the United States Pharmacopeia’s chapter of standards for compounding sterile preparations — anything that will be injected, infused or put in an eye. It covers air quality in the compounding room, garbing and hand hygiene, how long a preparation may be used before it must be discarded, and the training and testing staff must complete.

It matters for GLP-1 patients because compounded semaglutide and tirzepatide are sterile injectables, and the federal floor beneath them is lower than most people assume. FDA states that drugs compounded under section 503A in a state-licensed pharmacy are not subject to current good manufacturing practice requirements, while drugs compounded in a 503B outsourcing facility are. Between those two tiers, USP standards and state adoption of them carry much of the weight.

Two limits are worth understanding. First, USP is a standards-setting organization, not a regulator — the chapter becomes enforceable when a state board of pharmacy or an accreditor adopts it, and adoption varies by state. Second, FDA notes that regardless of where compounding occurs, federal provisions on insanitary conditions apply, and compounding under insanitary conditions can lead to widespread patient harm.

The practical connection to your vial is beyond-use dating. A sterile preparation carries a limited window from the moment it is made, and FDA separately recommends discarding a multi-dose vial within 28 days after first use, even if medication remains, and even if the compounder’s instructions say otherwise. Stretching a vial beyond that is where the standards and real-world usage collide most often.

Ask which pharmacy compounds your medication, whether it holds PCAB accreditation, what beyond-use date is printed on the vial, and how it is shipped and stored. Our expiration and beyond-use tracker and beyond-use date review go further.