Who Enforces USP800? Why Upgrade Hospital Pharmacies?

USP 800 Modular Clean Room
USP 800 Modular Clean Room

When it comes to enforcement, agencies could be different in each state. It could be:
• Federal Government for federally owned facilities;
• State Board of Pharmacy;
• State Board of Medicine;
• State Public Health Department;
• OSHA (Occupational Safety and Health Administration) (because it relates to employee health);
Creating the very tight tolerance for negative pressure & dedicated exhausting 100% of the HD Buffer Room air outdoors is typically very difficult because many Compounding Pharmacies are built in the basement or lower floors of multi-story hospitals with no way to direct vent the air outside. Odulair could not find even one “off-the-shelf” HVAC system that would meet the required specifications. The company had to design their own HVAC system and find a company to build it for them.



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What is USP?

Modular Clean Room for Sale by Odulair
Modular Clean Room for Sale by Odulair

The United States Pharmacopeia organization, also known as USP, is the only independent, not-for-profit, non-governmental pharmacopeia in the world. It is a volunteer organization that was founded in 1820. USP is global and has offices in China, India, Brazil, Ethiopia, Ghana and Switzerland. It provides a global compendium of over 4,500 monographs for prescription and OTC drugs, dietary supplements, and medical devices. The USP also establishes standards for the production of drugs and supplements. One of those newly established standards is USP <800>. The USP <800> was published to help ensure a quality environment and protect pharmacists and technicians compounding Hazardous Drugs. There exists a growing evidence highlights acute and chronic health effects can occur due to occupational exposure to over 200 Hazardous Drugs. The standard was published 9/29/17 to become official on 7/1/18. Deadline has been extended multiple times, with current deadline for hospitals to be compliant is 12/1/19.

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