USP <800> clean-room.
NIOSH-listed hazardous drugs require more than a standard compounding bench. USP Chapter 800 defines how pharmacies contain, handle, and clean up HD compounds to protect staff, patients, and the environment. TFC operates a dedicated HD containment suite for qualifying prescriptions.
Suite
A separate standard for hazardous drugs.
USP <800> applies to drugs on the NIOSH List of Hazardous Drugs — including many hormones, certain antineoplastics, and other agents with documented occupational exposure risks. The chapter sits alongside USP <795> (non-sterile) and USP <797> (sterile): HD work must follow <800> containment whether the final preparation is a cream, capsule, or injection.
For prescribers, the practical question is not whether a pharmacy “does compounding” but whether it has the facility, training, and documentation to handle your HD compound safely. For facility administrators, the same capability supports LTC residents who receive HD preparations prepared to order.
Read our prescriber guide on sterile standards: What we mean when we say USP <797>.
Negative-pressure HD room
Dedicated hazardous-drug compounding area with engineering controls designed to prevent cross-contamination into non-HD spaces.
Closed-system devices
CSTDs and HD-specific handling protocols for receiving, manipulating, and dispensing NIOSH-listed ingredients.
Surface wipe testing
Routine residue testing on high-touch surfaces in the HD suite, with documented action limits and remediation procedures.
Training & PPE
Documented HD garbing, spill response, and waste segregation training for staff who enter the containment area.
PCAB oversight
Compounding operations reviewed under Pharmacy Compounding Accreditation Board standards, including HD handling policies.
Third-party testing
Independent potency and stability testing through Eagle Analytical when a prescription or facility contract requires documented verification.
Two contexts, one clean-room.
Specialty compounding
Prescriber-directed HD preparations — including hormone therapy and oncology-supportive dosage forms — compounded under USP <795>, <797>, and <800> as applicable. See our BHRT page and compounding hub.
Long-term care pharmacy
ACHC LTC-accredited services for SNFs, ALFs, group homes, and hospice partners who need HD preparations in bubble-pack or unit-dose workflows. See For Facilities and Long-Term Care.
Questions to ask before you send an HD Rx.
- Is this drug on the current NIOSH HD list, and does your pharmacy classify it as Category 1, 2, or 3?
- Will my patient’s preparation be compounded in a USP <800>-designed containment area?
- Do you perform surface wipe testing in the HD suite, and how often?
- If the preparation is sterile, does your <797> room meet ISO classifications independent of <800>?
- Can you provide third-party potency verification when the prescription requires it?
- How do you assign beyond-use dates for HD preparations?
Send a prescription or ask a question.
Call the compounding desk at (323) 348-4205, fax (323) 348-4213, or visit For Prescribers.