USP <800> hazardous-drug 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.

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> for non-sterile preparations: HD work must follow <800> containment whether the final preparation is a cream, capsule, or oral liquid.

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.

New to compounding standards? See what is compounding.

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 an accredited third-party lab when a prescription or facility contract requires documented verification.

Specialty compounding

Prescriber-directed HD preparations — including hormone therapy and oncology-supportive dosage forms — compounded under USP <795> and <800> as applicable. See our BHRT page and compounding hub.

Long-term care pharmacy

Long-term-care 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.