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.