We recommend that all compounding professionals read and fully understand USP General Chapter <800> to be compliant, both to protect pharmacy employees and patients.
To help, we've developed a general overview to clarify the main points to consider.
WHAT IS USP <800>?
USP General Chapter <800> provides best practice standards for workplace safety for handling hazardous drugs as determined by the National Institute of Occupational Safety and Health (NIOSH). It is in effect as of December 1, 2019.
WHICH REGULATORY AGENCIES REFER TO OR USE USP <800> FOR GUIDANCE?
OSHA, the FDA, state workplace safety agencies, and many state boards of pharmacy. Failure to comply with USP <800> standards exposes owners and/or facility managers to fines and liability, and may expose personnel to harmful drug handling effects. The chapter has been moved to “informational status” by USP pending the appeal of USP <795> and <797> revisions.
WHAT DO WE NEED TO PAY SPECIAL ATTENTION TO?
USP <800> compliance requires several strategies including:
- Containment Primary Engineering Control (C-PEC): The powder hood, glove box, or similar device where compounding takes place must vent through a HEPA filter, and may require direct venting to outside the building.
- Containment Secondary Engineering Control (C-SEC): All C-PEC devices must be located inside a negative pressure room (C-SEC). This room must be physically separated from other preparation areas and vented outside the building.
- Personal Protective Equipment (PPE): Certain PPE, such as gloves, must meet specific standards for use with hazardous drugs — refer to USP <800> and the NIOSH Hazardous Drug List for detailed requirements.
CAN WE USE ANY OF OUR EXISTING EQUIPMENT FOR ALL COMPOUNDING PREPARATIONS, HAZARDOUS AND NON-HAZARDOUS?
Disposable or clean equipment that comes in direct contact with hazardous drugs (HDs) must be dedicated for use with HDs only, and must be operated in the C-SEC unless it is operated as a closed system (e.g. certain mixers, terminal sterilization using an autoclave, or convection oven). Equipment that doesn’t come into direct contact with HDs may be shared between HD and non-HD compounding areas provided it is deactivated, decontaminated, and cleaned before it is removed from the HD area.
The full list NIOSH list of hazardous drugs, including over 200 APIs, can be found on the CDC’s website. If you work with any of the following commonly compounded drugs, your facility will need to store, handle, and compound under USP <800> guidelines.
- Antineoplastics include: Fluorouracil, methotrexate, mitotane
- Non-antineoplastics include: Cyclosporine, estradiol (and other estrogens), methimazole, phenytoin, progesterone, tacrolimus
- Non-antineoplastics that primarily have adverse reproductive effects include: HCG, colchicine, fluconazole, oxytocin, testosterone, tretinoin
Letco ships all drugs found on the NIOSH list in special packaging to make it easier for your pharmacy to ensure proper receiving and handling. Learn more >
USP <800>-compliant PPE
Let us help you cover your bases — and your compounding staff — with USP <800>-compliant personal protective equipment. Ask your Account Manager about sizes and options available for the following PPE products:
On-Demand WebinarWatch a presentation from Letco's Erik Tosh on USP <800>'s status and what pharmacists need to know in light of appeals to compounding chapters as of November 2019.
Verify Workplace Safety
Let us help with savings on USP <800> Surface Wipe Sampling Tests from ARL Bio Pharmacy. Learn more about our Quality Savings Program and unique partnership with ARL.