What Is USP <800> And Its Key Requirements for Pharmacies

Hazardous drugs pose a serious threat to the healthcare professionals who handle, transport, and administer these drugs. Each year, about 8 million U.S. healthcare workers are potentially exposed to hazardous drugs, including pharmacy personnel. Guidelines like USP 800 provide standardized regulation to help ensure the safety of healthcare workers and patients.

Developed by the United States Pharmacopeia (USP), the USP 800 sets standards for handling hazardous drugs safely. Following these guidelines helps keep everyone safe, including your pharmacists and patients.

In this post, we will discuss what USP 800 is, its key requirements, and the top products from Total Pharmacy Supply that can help your pharmacy comply with its guidelines.

What is USP 800?

USP 800 provides guidelines for handling hazardous drugs safely.

Hazardous drugs are used in healthcare facilities to treat different diseases, including cancer. Exposure to these drugs can lead to both acute and chronic effects, such as skin rashes, hair loss, infertility, miscarriage, birth defects, and possibly leukemia and other cancers. The health risk depends on how long the healthcare workers were exposed to these drugs.

However, following the USP 800 guidelines can significantly reduce the risk of exposure. These guidelines cover everything from receiving and storing the drugs to administering and disposing of them. Although most of these requirements were recommended by agencies like NIOSH and OSHA, USP 800 formalized them, establishing a standard. It became effective on December 1, 2019.

Key Requirements of USP 800

When it comes to pharmacies, the key requirements of USP 800 include:

1. Proper Utilization of Personal Protective Equipment (PPE)

Your pharmacy staff must wear PPE when handling hazardous drugs.

• Gloves: Gloves required for handling hazardous drugs should comply with ASTM standard D-6978-(05)-13 and be made with materials like nitrile. Your pharmacists should double gloves and change them every 30 minutes or if they become contaminated.
• Gowns: Your staff should use disposable gowns when handling hazardous drugs. These gowns must be closed in the back, long-sleeved, and should have elastic or knit cuffs.
• Respirators: The pharmacists must wear N95 disposable respirators because there is a risk of inhaling drug particles or vapors.
• Eye and Face Protection: The pharmacy staff should wear face shields or goggles to protect their eyes and face.

2. Training

Training is a must for all those who handle hazardous drugs, and it should include learning:

• The health risks associated with exposure to these drugs.
• How to use and dispose of PPE.
• How to use Closed-System Drug-Transfer Devices (CSTDs).
• Proper waste disposal.
• How to handle and clean up spills safely.

3. Engineering Controls

Engineering controls help your staff minimize exposure to hazardous drugs, especially when handling compounding supplies. Your pharmacy will need to:

• Use devices like Biological Safety Cabinets (BSCs) and Compounding Aseptic Containment Isolators (CACIs) for compounding hazardous drugs.
• Maintain negative pressure in the room where compounding takes place to prevent the risk of contamination.
• Use proper ventilation and air filtration systems to maintain a clean and safe environment in your pharmacy.

Top Products from TPS to Ensure USP 800 Compliance

Total Pharmacy Supply knows how critical it is to maintain safety when handling hazardous drugs. We have several products, from prep mats to containment hoods, which can help pharmacies handle these drugs safely and comply with USP 800.

1. ChemoplusTM Chemotherapy Prep Mats

ChemoplusTM Chemotherapy Prep Mats are designed to keep your workbench clean when compounding or handling chemotherapy drugs. With three layers of protection, including a non-permeating plastic backing, these mats can efficiently absorb spills and help prevent contamination. These prep mats are easy to use and dispose of, making them a practical choice for every pharmacy.

2. Cobalt Blue® Validated Sterile Wipes

These USP 800-compliant Cobalt Blue® Validated Sterile Wipes are perfect for cleaning workbenches where you handle or compound hazardous drugs. These wipes are soft, abrasion-resistant, and virtually free of particle generation, making them ideal for cleaning counters, equipment, and other surfaces where hazardous drugs are handled. They are packed in resealable pouches, making it easy to use and dispose of one wipe at a time.

3. N95 Disposable Respirators

N95 Disposable Respirators are highly recommended for handling hazardous drugs. These single-use masks have an adjustable nose clip, which fits them snugly over the nose and mouth. They have a smooth inner lining, cushioning foam, or stretchable headband, making them comfortable.

4. 70% IPA Spray Alcohol, Sterile

This Virtu-CleanTM Sterile Alcohol Spray is perfect for ensuring USP 800 compliance. It’s 70% by volume isopropanol and 30% purified water. The spray evaporates quickly and leaves extremely low residue, making it ideal for cleaning and disinfecting counters and equipment used for compounding hazardous chemicals.

5. Virtu-CleanTM Class 100 Nitrile Cleanroom Gloves

Virtu-CleanTM Class 100 Nitrile Cleanroom Gloves are ambidextrous gloves made from high-quality nitrile. They are latex and powder-free and have a 12" cuff, providing an effective barrier against hazardous drugs. They are also comfortable to wear and offer excellent dexterity, making compounding effortless.

6. Ductless Containment Hoods

Ductless Containment Hoods are designed to protect your pharmacy staff from hazardous airborne drug fumes and particles. They provide a continuous airflow, which keeps the harmful fumes out and recirculates the clean air back into the hood. In a pharmacy, these hoods are suitable for light grinding, compounding, and pharmaceutical powder filling.

Conclusion

USP 800 provides guidelines to help your pharmacy staff handle hazardous drugs safely. It includes training your staff to handle these drugs properly, using the right PPE, and maintaining strict engineering controls when handling or compounding such drugs.

Using the right products can make USP 800 compliance easier for your pharmacy. Our products like ChemoplusTM Chemotherapy Prep Mats, Cobalt Blue® Validated Sterile Wipes, N95 Disposable Respirators, 70% IPA Spray Alcohol, Virtu-CleanTM Class 100 Nitrile Cleanroom Gloves, and Ductless Containment Hoods are all designed to help you comply with USP 800 standards.

Total Pharmacy Supply offers these products and more to help you stay safe and compliant. To learn more about these supplies, start browsing our inventory or call (800) 878-2822 now.