TFC  /  Compounding  /  USP <800>
Hazardous-drug containment

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.

Accreditation PCAB
Sterile USP <797>
Non-sterile USP <795>
Testing Eagle Analytical
What <800> is

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>.

Facility & workflow

What our <800> setup includes.

Capability summary — PIC verification required before live publish.

Containment

Negative-pressure HD room

Dedicated hazardous-drug compounding area with engineering controls designed to prevent cross-contamination into non-HD spaces.

Transfer

Closed-system devices

CSTDs and HD-specific handling protocols for receiving, manipulating, and dispensing NIOSH-listed ingredients.

Monitoring

Surface wipe testing

Routine residue testing on high-touch surfaces in the HD suite, with documented action limits and remediation procedures.

Personnel

Training & PPE

Documented HD garbing, spill response, and waste segregation training for staff who enter the containment area.

Quality

PCAB oversight

Compounding operations reviewed under Pharmacy Compounding Accreditation Board standards, including HD handling policies.

Verification

Third-party testing

Independent potency and stability testing through Eagle Analytical when a prescription or facility contract requires documented verification.

Where it shows up

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.

For prescribers

Questions to ask before you send an HD Rx.

Compounded medications are prepared from individual prescriptions and are not FDA-approved drug products. This page describes pharmacy capability only — not clinical outcomes.

Send a prescription or ask a question.

Call the compounding desk at (323) 348-4205, fax (323) 348-4213, or visit For Prescribers.