Containment hoods for powders
Hazardous drug powders are weighed and handled inside ventilated containment hoods. The hood draws airborne particles away from the person working, so they are not breathed in or carried into the room.
HAZARDOUS DRUG COMPOUNDING · USP <800>
How we compound hazardous drugs
under USP <800>.
Many of the hormones clinics prescribe are classed as hazardous drugs. Here is what USP <800> asks of a compounding pharmacy, how our lab meets it, and the questions to ask any pharmacy that compounds for your patients.
PCAB accredited · licensed in all 50 states + DC
Containment hoodsNegative pressure roomFit-tested masksPCAB accredited
THE STANDARD
What makes
a drug hazardous.
The National Institute for Occupational Safety and Health (NIOSH) keeps a list of drugs that can harm the people who handle them, through skin contact or breathing in dust, even when the drug is safe for the patient it was prescribed for. Hormones such as estradiol, progesterone and testosterone are on that list.
USP General Chapter <800> sets out how a pharmacy should handle those drugs: how they are received and stored, where they are compounded, what the room and equipment must do, what staff wear, and how everything is cleaned. A pharmacy compounding hormones every day handles hazardous drug powders every day, so these controls are part of the daily work rather than an occasional precaution.
IN OUR LAB
How our equipment and procedures contain hazardous drugs.
We buy professional equipment for this work because it protects our team. Containment is only as good as the hood, the room and the habits around them.
A negative pressure compounding room
Hazardous drugs are compounded in a dedicated room kept at negative pressure, so air flows into the room rather than out of it. Residue stays in the space built to contain it instead of drifting into the rest of the pharmacy.
Personal protective equipment and fit-tested masks
Staff wear protective equipment chosen for hazardous drug handling, and masks are fit tested to the person wearing them. A mask that does not seal does not protect.
Deactivation, decontamination and cleaning
Work surfaces and equipment go through written deactivation, decontamination and cleaning procedures, so residue from one preparation is removed before the next.
Surface and exposure testing
We test work surfaces for hazardous drug contamination and run exposure testing for staff, so the controls are checked rather than assumed.
Training and a written risk assessment
Everyone who handles hazardous drugs is trained for it before they start. A hazardous drug risk assessment sets out how each drug we handle is received, stored, compounded and cleaned up.
These controls sit inside our wider quality program: PCAB accreditation, competency-tested staff, precision balances and electronic mixing systems, and periodic third-party potency testing depending on the preparation. See how we manage quality.
TALK WITH OUR TEAM
Ask us how we handle
your prescriptions.
Tell us what your program prescribes. We will tell you plainly what we can prepare, what we cannot, and how each one is handled in our lab.
- Review which of your preparations are hazardous drugs
- Walk through our containment and cleaning procedures
- Schedule a visit to our Johnson City lab
Already ready to set up your clinic?Start in the Clinic Onboarding app
WHY IT MATTERS TO YOUR PROGRAM
What hazardous drug handling means for a clinic.
Your hormone prescriptions are covered
If your program prescribes compounded estradiol, progesterone or testosterone, the pharmacy filling it is handling hazardous drugs. It is fair to ask how. See our hormone therapy fulfillment page.
Containment protects other preparations
Keeping hazardous drug residue in the room built for it, and cleaning it away afterwards, is how it stays out of the preparations made elsewhere in the pharmacy.
Accreditation looks at it
PCAB accreditation reviews a pharmacy's facilities, engineering controls and equipment practices, and hazardous drug handling standards incorporate USP <800>. Read about our PCAB accreditation.
THE CHECKLIST
Six questions to ask
any pharmacy, including us.
Run this list on us. Our pharmacists will walk your team through each answer, and you are welcome to visit the lab.
- 01
Which of the drugs you prepare for us are on the NIOSH hazardous drug list?
- 02
Where are hazardous drugs compounded, and is that room under negative pressure?
- 03
What equipment contains powders while they are weighed and handled?
- 04
How are staff trained and protected, and are masks fit tested?
- 05
Do you test surfaces for hazardous drug residue?
- 06
How do you keep hazardous drug residue out of non-hazardous preparations?
FREQUENTLY ASKED QUESTIONS
The details
worth asking about.
What is USP <800>?
USP General Chapter <800> is the United States Pharmacopeia's standard for handling hazardous drugs in healthcare settings. It covers how hazardous drugs are received, stored, compounded, cleaned up after and disposed of, with the goal of protecting the people who handle them, patients and the environment.
Are compounded hormones hazardous drugs?
Several are. The National Institute for Occupational Safety and Health (NIOSH) lists drugs that can harm the people who handle them, and the list includes hormones such as estradiol, progesterone and testosterone. That is why hormone compounding falls under USP <800> handling standards.
Is USP <800> about the patient or the pharmacy staff?
Both, with a strong focus on the people who handle the drugs. Pharmacy staff work with hazardous drug powders every day, so containment equipment, ventilation, protective equipment and cleaning are what keep repeated exposure down.
How is USP <800> different from USP <795>?
USP <795> sets standards for non-sterile compounding in general, such as creams, capsules and troches. USP <800> adds requirements for handling drugs classed as hazardous. A non-sterile pharmacy that compounds hormones follows both. ProCompounding is a non-sterile 503A pharmacy and complies with USP <795> and USP <800>.
Does following USP <800> change the preparation my patient receives?
The preparation is compounded to the prescriber's order either way. What the controls change is containment: hazardous drug residue stays where it is handled and is cleaned away, rather than reaching other preparations or the people in the pharmacy.
Can we see your hazardous drug compounding room?
Clinics and partners can schedule a visit to see our compounding operation in Johnson City, Tennessee. Ask through the form on this page or call 423-975-0597.
Compounded preparations are not reviewed or approved by the FDA for safety or efficacy.