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USP 800 Compliance For Hazardous Drug Compounding

Everything You Need For USP 800 Compliance

USP 800 updates the current USP 797 regulations regarding the handling of hazardous drugs in compounding pharmacies, hospital pharmacies, and medical centers. These new regulations and guidelines will offer more protection to pharmacists and workers to ensure safe handling of chemotherapy and other hazardous drugs. USP 800 compliance, as well as USP 797 compliance, is our specialty here at Cleanroom Connection. We work with industry leaders in the pharmaceutical compounding world to make sure we are carrying the best cleanroom supplies and personal protective equipment.

 

Sterile Chemo Gowns

image representing impervious chemo gowns for usp 800 compliance

Impervious chemo gowns are ASTM chemo tested and approved for use in USP 800 compliant facilities. Polyethylene coated polypropylene gowns and coats for safe handling of chemo. Chemo apparel available from Covidien and TrueCare.

Chemo & HD Gloves

chemobloc gloves

Chemo gloves and sterile chemo-safe cleanroom gloves in latex and latex-free nitrile material. Multiple thicknesses. USP 800 requires ASTM chemo-rated gloves be used when handling hazardous drugs. Our chemo gloves all come with ASTM test results.

Sterile Chemo Mats

image representing sterile chemo prep mats

Sterile chemotherapy preparation mats are individually packaged, sterile, ISO5 compliant and come in two convenient sizes. These sterile chemo mats are made of 3 layers and impervious. They will absorb and protect workers from small spills as well as keep surfaces dry.

 

Sterile Chemo Goggles

sterile cleanroom goggles

High-quality cleanroom goggles and sterile-single use goggles will protect your eyes from hazardous drugs. These goggles are to be used in conjunction with the appropriate face mask. Choose from autoclavable or single-use disposable goggles.

Chemo Handling

image representing chemo spill kit products from covidien

Chemo products include our complete offering of protective apparel, spill kits, gowns, gloves, IVA seals, prep mats and more. USP 800 compliance is easy with our guidance and selection of personal protective equipment. Call for free samples on all items.

Sterile Chemo Sleeves

image representing sterile chemo sleeves for protection against chemotherapy

Sterile chemotherapy sleeves offer adequate protection for your arms, whether these sleeves are used over existing sleeves or to bridge a gap between your wrist and your gown cuff. Impervious sleeves offer protection to your arm when handling HDs.

 

Let Us Help You With USP 800 Compliance, Read More Below

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Some Changes Come With USP 800

Compounding Supervisor

With the introduction of USP Chapter 800, pharmacy staff and administration have new responsibilities. USP 800 requires the assignment of a specific person as the compounding supervisor. The compounding supervisor is responsible for developing and implementing appropriate procedures as well as overseeing facility compliance and monitoring. This new position also ensures competency of personnel and environmental control of the compounding areas.

Separation of Hazardous Drugs

Another change is that compounding and other manipulation of hazardous drugs must be performed in a containment primary engineering control (C-PEC) within a separate room. The goal is additional personnel protection. The C-PEC’s room must be under negative pressure, externally vented, and have the appropriate number of air changes per hour.

Co-Mingling of Non-Antineoplastic Hazardous Drugs

USP 800 allows for non-antineoplastic hazardous drugs that are available in final-manufactured dosage forms and on the NIOSH list may be co-mingled with non-hazardous drugs stock if the pharmacy policy allows. Note that an additional stipulation is that the permitted co-mingled drug must not be manipulated other than counting for dispensing.

On-Site Training and USP 800 Implementation

Cleanroom Connection offers the below on-site services to help your facility implement USP 800 compliance whether you are a an independent compounding pharmacy, hospital compounding pharmacy, oncology pharmacy, pharmaceutical manufacturer or healthcare facility.

We offer a wealth of resources to ensure USP 800 compliance in your hospital, compounding pharmacy, or medical center. Our training partners offer a comprehensive training program and demonstrations on gowning, cleaning, and creation of standard operating procedures (SOP) for compliance with USP Chapter 800.

Our cleanroom consultants can help you with USP 800 implementation. From answering your questions about protocols to helping you order chemo-rated apparel, gloves, wipes, masks and other cleanroom apparel that’s made for use in the handling of hazardous drugs. We also offer a complete selection of lint free and sterile cleanroom apparel and disinfectants to ensure a contamination free environment. Cleanroom Connection offers a complete solution for compliance with USP including the proper protective apparel, cleanroom cleaning supplies, on-site training, SOP creation, and guidance to ensure complete understanding and compliance. We specialize in working with hospital pharmacies and helping them implement USP 800 protocol. Click on one of the below to learn more about our USP 800 compliance services.