USP <795>: What It Means for Compounded Medications and Patient Safety

When a pharmacist mixes a custom dose of medicine for a patient who can’t swallow a pill, or creates a dye-free version of a drug for someone with allergies, they’re doing USP <795>, a set of standards that define how nonsterile compounded medications must be prepared to ensure safety, accuracy, and consistency. Also known as USP Chapter <795>, it’s the rulebook that keeps compounding from becoming guesswork. This isn’t about fancy labs or high-tech machines—it’s about clean surfaces, proper labeling, accurate measurements, and trained staff. If you’ve ever gotten a custom cream, liquid, or capsule from a pharmacy, USP <795> is why you can trust it won’t make you sick.

USP <795> doesn’t just cover the final product—it controls the whole process. From how ingredients are stored and weighed, to how the workspace is cleaned between batches, to how long the final mix stays stable, every step has a requirement. It’s closely tied to pharmacy compounding, the practice of preparing customized medications not commercially available, which is used daily for kids, seniors, and people with rare allergies or swallowing issues. Without USP <795>, one pharmacy’s vanilla-flavored liquid antibiotic might be twice as strong as another’s, or contain contaminants from dirty tools. That’s why state boards and the FDA look to USP <795> when investigating bad outcomes.

It also connects to sterile compounding, a stricter standard (USP <797>) for injectables and IV solutions. While sterile compounding deals with life-or-death risks like infections from IV bags, nonsterile compounding under USP <795> handles more common but still dangerous errors—like wrong doses, cross-contamination, or unstable mixtures that break down over time. Think of it this way: USP <795> is the foundation. If the foundation cracks, even the best sterile procedures won’t save you.

You’ll find posts here that dig into real cases where compounding went wrong, how pharmacies are adapting to new inspections, and why some generic drugs aren’t interchangeable with custom mixes. You’ll also see how patient safety ties into medication storage, labeling mistakes, and caregiver confusion—all things USP <795> tries to prevent. Whether you’re a pharmacist, a caregiver, or just someone who’s been prescribed a compounded medicine, understanding this standard helps you ask the right questions. The posts below aren’t just technical guides—they’re real stories about what happens when rules are followed… or ignored.