Compounding pharmacies require tight temperature, relative humidity, and pressurization control to operate in compliance with the current standards. Those standards are set to change in the coming months, and we’ve put together a series of articles to help navigate the new requirements.
Balancing and actively controlling the airflow to achieve the correct pressure relationships in compounding pharmacy spaces can be challenging. The HVAC systems must maintain accurate relationships and the differentials between the pharmacy and adjacent areas under everyday use, which can be problematic. These stringent requirements come from the many regulations governing compounding pharmacies’ construction, operation, and certification.
Besides the building codes in the specific jurisdiction, such as the International Building Codes (IBC), other organizations, like the Facility Guidelines Institute (FGI), United States Pharmacopeia (USP), and the Controlled Environment Testing Association (CETA), have requirements that must be adhered to for compliance. FGI regulates all types of licensed healthcare buildings but references USP for additional requirements for compounding pharmacies. The USP is a non-profit organization comprising pharmacists who convene to review the requirements related to drugs and the protection of patients. From that convention, regulatory chapters are revised and distributed in the USP Compounding Compendium, a collection of documents to serve as a resource for compounding practitioners. Portions of two chapters, particularly, relate to facility control for the building HVAC system, <797> and <800>. CETA governs the testing methods for maintaining the standards outlined in USP for sterile compounding facilities and the requirements for certification.
USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations was initially issued in 2019 but has been recalled and since revised, with an official date for enforcement on November 1, 2023. USP General Chapter <800> Hazardous Drugs – Handling in Healthcare Settings was issued in 2019 but is informational only and not enforceable until USP <797> is officially adopted.
The current enforceable USP <797> is the 2008 version. Since USP <800> was not started until 2016, it is not referenced in the current official version of UPS <797>. Note that facilities will have a six-month grace period from when USP <797> is official to when UPS <800> will be enforceable.
USP <800> concerns handling hazardous drugs, so it is a protection measure for the pharmacists and health care staff, which makes it different from the USP <797>, which centers around the protection of the patients. These two chapters work hand in hand where the sterile compounding of hazardous drugs is concerned. In many jurisdictions, USP <800> will become effective this fall.
In this series of articles, we will be discussing several different topics, including the requirements of USP, what makes them challenging to address, HVAC-focused design, redundancy of equipment, what equipment you might want on emergency power, and finally, lessons learned from the dozens of pharmacies we have designed in the last seven years.
Feel free to contact Douglas Barnhart, PE, with any questions related to pharmacy design, construction, and operation at dcb@ba-inc.com or 717-845-7654.
Organization history and helpful links:
– History of USP
– FAQ from USP for 797 and 800
– USP 800