Requirements for Sterile Compounding Pharmacies

July 29, 2026

When a pharmacy compounds medications that are considered hazardous, the risk isn't only to the patient, it extends to the personnel preparing the drug and to everyone in the facility. USP General Chapter <800> exists to manage exactly that risk. For any practice that relies on a compounding partner, understanding what <800> requires is a practical way to gauge whether a pharmacy is operating at the standard patient safety demands.


Here's a plain-language breakdown of what USP <800> asks of a sterile compounding pharmacy.


What USP <800> Is


USP <800> is the United States Pharmacopeia standard governing the safe handling of hazardous drugs (HDs) in healthcare settings. Its purpose is protective: to minimize the exposure of pharmacy staff, patients, and the environment to drugs that can cause harm through unintended contact. It sits alongside the broader discipline of sterile compounding, adding a layer of containment requirements specifically for hazardous materials.


Whereas general sterile compounding focuses on keeping the preparation free of contamination, <800> focuses on keeping people safe from the preparation. Both matter, and a well-run pharmacy treats them as complementary, see our overview of what sterile compounding involves for the foundation.


Which Drugs Are Considered Hazardous


The definition of a hazardous drug is not arbitrary. It follows the list maintained by the National Institute for Occupational Safety and Health (NIOSH), which identifies drugs with properties such as carcinogenicity, teratogenicity, reproductive toxicity, or organ toxicity at low doses. A pharmacy is expected to maintain an assessment of the hazardous drugs it handles and to apply the appropriate controls to each.


Facility & Engineering Controls


The most visible requirement of <800> is physical. Hazardous compounding must take place within containment engineering controls:


  • A Containment Primary Engineering Control (C-PEC), the hood or cabinet where compounding occurs, designed to protect both the preparation and the compounder.
  • A Containment Secondary Engineering Control (C-SEC), the room housing the C-PEC, which is typically kept under negative pressure relative to adjacent spaces and externally vented, so that any airborne contamination is contained and removed rather than allowed to escape.


These controls, along with restricted access and dedicated storage, keep hazardous materials separated from the rest of the pharmacy's workflow.


Personal Protective Equipment (PPE)


<800> specifies PPE appropriate to the task, including chemotherapy-rated gloves (often double-gloved), protective gowns, and, depending on the activity, eye and respiratory protection. PPE requirements are matched to the risk of the specific operation, from receiving and storage through compounding and cleaning.


Personnel Training & Competency


Equipment alone doesn't create safety, trained people do. <800> requires that personnel who handle hazardous drugs be trained on safe practices before they begin and reassessed for competency on an ongoing basis. This includes proper technique, spill response, and the correct use of PPE and containment controls.


Handling, Transport, Deactivation & Waste


The standard extends across the full lifecycle of a hazardous drug: receiving and unpacking, labeling and storage, transport within and outside the facility, deactivation and decontamination of surfaces, and the correct disposal of hazardous waste. Each step has defined procedures intended to prevent exposure at every point.


How USP <800> Works with USP <797>


USP <800> doesn't replace the sterility requirements of USP <797>, it layers on top of them. A sterile hazardous preparation must satisfy both: the aseptic, contamination-control requirements of <797> and the containment requirements of <800>. A pharmacy that understands how the two interact is far better positioned to keep both patients and staff safe. For the safety rationale behind both chapters, see our guide to USP <797> and <800> safety standards.


What This Means When You Choose a Compounding Partner


For a referring practice, <800> compliance is a useful signal. A pharmacy that maintains a compliant facility, trains its staff, and documents its hazardous-drug controls is demonstrating a safety culture that carries through to everything it prepares. It's a reasonable question to ask any potential compounding partner: how do you comply with USP <800>?


Pharmko maintains a USP <800>-compliant facility, so that any preparation requiring hazardous-drug handling is managed under the appropriate containment and safety protocols, never improvised. The same rigor that protects our team is what protects the patients who receive our preparations. Learn more about our sterile compounding pharmacy.


Talk to Our Pharmacy Team   · [1 (877) 540-2003]

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