USP <800> Compliance FAQs

USP<800> Frequently Asked QuestionsUSP<800> Frequently Asked Questions

Are you prepared for USP<800>? We can help.

Spectrum is prepared for USP Chapter <800> and can help you prepare as well. From a complete line of USP<800> compliant primary engineering controls; to deactivation, decontamination, cleaning and disinfection solutions; to personal protective equipment; Spectrum has everything you need. We can also help you fill in the knowledge gaps for understanding and complying with the chapter through our ACPE accredited 1-day and 2-day training programs. Below are a few frequently asked questions about USP<800>, and about the related products and programs that Spectrum offers.

What is USP<800>?

The United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs - Handling in Healthcare Settings was formally published February 1, 2016 in the First Supplement to USP 39-NF 34. The purpose of the chapter is to provide standards and defined processes to protect personnel, patients and the environment when handling hazardous drugs in a healthcare setting. This guidance includes handling of materials from receipt, to storage, compounding, administration and disposal. The chapter applies to both non-sterile and sterile compounding and to all settings where hazardous drugs are handled.

When does USP<800> go into effect?

The official date of implementation for USP General Chapter <800> was December 1, 2019. If you have not yet taken any actions, you may currently be out of compliance with this new chapter. The time is now to ensure the safety of hazardous drug compounders.

What chemical solutions are required for Deactivation, Decontamination, Cleaning, Disifection or Sporicide treatments per USP<800> guidelines?

Spectrum has compiled a USP<800> Solutions Guide to identify Spectrum Pharmacy products that can be used for each step in the process.

What garb and Personal Protective Equipment (PPE) are required by USP<800> guidelines?

Spectrum has compiled a USP<800> PPE Guide to identify Spectrum Pharmacy products that can be used for various applications.

Where must HDs be stored?

HDs must be stored in a negative pressure room with -0.01 to -0.03 inches water column and may be stored in the same space where HD compounding occurs.

Does the hood (C-PEC) have to be vented to the outside?

C-PECs used for sterile compounding must be vented to the outside. C-PECs for non-sterile HD compounding may be vented to the outside or must have a double-HEPA filter in series that recirculates air into the room.

How do I determine which drugs are considered hazardous?

Review the current NIOSH list of hazardous drugs published by CDC, also posted on our Industry Links page.

What training is required for personnel before they begin compounding hazardous drugs?

Personnel must be trained on donning and doffing PPE, spill procedures, proper HD handling, deactivation, decontamination, cleaning and disinfection (for sterile), waste disposal and dispensing procedures.

Is an ante-room required for a non-sterile hazardous room (C-SEC)? for a sterile C-SEC? what ISO class?

No ante-room is required for non-sterile HD compounding. An ante-room with ISO class 7 air quality is required for sterile compounding.

Does USP<800> involve only supplies and personal protective equipment?

In order to prepare for the new USP<800> guidance, healthcare professionals must pay attention to receipt of hazardous drugs, facility requirements, personnel training, and obtaining the proper supplies and equipment.

How do I find products that help me become USP<800> compliant?

Spectrum has put together a USP <795><797><800> catalog of consumables, equipment and supplies that are intended to help pharmacies and laboratories with non-sterile (795), sterile (797) and hazardous drug (800) compliance.

What do Spectrum’s USP<800> classes cover?

Spectrum’s USP<800> class, USP <800> Compliance – Improving the Safety of Compounded Preparations, was developed with Ernest Mario School of Pharmacy/Rutgers University. This 1-day or 2-day program concentrates not only on the compounding of HD’s, but the receipt, storage, dispensing, administration and disposal as well. Instruction will highlight the principles of protecting personnel, patients and the environment from exposure. Instruction can be tailored to the student audience, addressing state-specific standards as needed. Browse Spectrum’s education page for Spectrum Pharmacy Institute (SPI) USP800 classes in New Brunswick, NJ, which include both classroom and laboratory training in a state-of-the-art facility. Alternatively, check out our Roadshow USP800 classes in several US cities (TBD).

Does Spectrum’s USP<800> class include hands-on training?

USP800 classes held at Spectrum Pharmacy Institute (SPI) in New Brunswick, NJ include both classroom and laboratory training in a state-of-the-art facility, with hands-on simulation focusing on the critical aspects in HD safety and preparation. Roadshow USP<800> classes are seminar instruction only and do not include a laboratory portion.

Can I earn CEU’s for Spectrum’s USP<800> class?

Yes! Our 2-day hands-on class provides 1.07 CEU’s (10.7 credit hours) for pharmacists and pharmacy technicians, and the 1-day seminar-only class provides 0.625 CEU’s (6.25 credit hours).

How is Spectrum’s USP<800> class accredited?

Spectrum’s USP<800> training program, USP <800> Compliance – Improving the Safety of Compounded Preparations, is written and presented by subject matter experts, reviewed by faculty of Rutgers University's Ernest Mario School of Pharmacy and jointly accredited with Spectrum Pharmacy Institute.

Where is Spectrum’s USP<800> class held?

The course is conveniently offered at multiple locations, including at Spectrum Pharmacy Institute in New Brunswick, NJ, and at Grifols, USA in Los Angeles, CA, or other cities across the US (coming soon).

Who teaches Spectrum’s USP<800> class?

This course is instructed by Lou Diorio, RPh, FAPhA Principal LDT Health Solutions; and Richard Dilzer, RPh, FACA, FIACP Director of Pharmacy Technical Services, Spectrum Pharmacy Products.

When are classes held?

Spectrum Pharmacy Institute (SPI) offers compounding training classes on a number of subjects, typically each subject being repeated every 2-3 months. See the complete calendar of SPI classes.

How can I learn more about Spectrum’s USP<800> class?

For questions about the 2-day accredited training program, visit any of Spectrum's USP<800> class web pages.

Where do I register for Spectrum’s USP<800> class?

Please visit any of Spectrum's USP<800> class web pages for registration and all other information.

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