When a pharmacy compounds a medication, the FDA does not approve the result. What stands between a patient and a poorly made preparation is the pharmacy’s licence, its inspections and a set of detailed standards published by the United States Pharmacopeia, known as USP.
Three chapters matter most. You will see them cited as USP 795, 797 and 800.
Who writes the rules
USP is an independent, non-profit organisation that sets public standards for medicines. State boards of pharmacy adopt and enforce its compounding chapters, and inspectors use them to judge whether a pharmacy’s practices are safe. The FDA also references USP standards in its compounding policies.
USP 795: non-sterile compounding
Chapter 795 covers preparations that do not need to be sterile, such as capsules, creams, ointments, oral liquids and suppositories. It sets requirements for the compounding area, ingredient quality, equipment, documentation and how long a preparation can safely be used, known as its beyond-use date.
USP 797: sterile compounding
Chapter 797 covers sterile preparations, including injectables and eye drops. Because these bypass the body’s natural defences, contamination can be dangerous, as the 2012 fungal meningitis outbreak linked to the New England Compounding Center showed. The Centers for Disease Control and Prevention recorded 753 cases and 64 deaths.
Chapter 797 sets rules for clean rooms and air quality, garbing and hand hygiene, staff training and competency testing, environmental monitoring, and beyond-use dates based on how and where a preparation is made. USP’s revised chapters 795 and 797 became official on 1 November 2023.
USP 800: hazardous drugs
Chapter 800 protects pharmacy staff, patients and the environment from hazardous drugs, such as certain hormones and chemotherapy agents. It covers containment, ventilation, protective equipment, cleaning and handling from receipt to disposal.
How inspections use the standards
State boards inspect pharmacies against these chapters. NABP’s Verified Pharmacy Program, a multistate inspection programme used by boards of pharmacy, evaluates compliance with USP 795, 797 and 800, along with licensing, records and staff training, according to NABP.
What this looks like at a telehealth pharmacy
Pharmacies that ship compounded medications to patients in many states have to meet these standards and every state’s licensing rules at once. Precision Medicine, a 503A pharmacy based in Bellmore, New York, that fills prescriptions for telehealth companies, says it complies with USP 795, 797 and 800 and runs sterile and non-sterile compounding with multiple quality control checkpoints.
Questions patients can ask
- Is my medication sterile or non-sterile?
- What is its beyond-use date, and how should I store it?
- Does the pharmacy follow USP 795, 797 and, where relevant, 800?
- When was the pharmacy last inspected?
Most patients will never see inside a clean room. Knowing the standards that govern it helps you ask the questions that matter.