Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these facilities are governed by the Veteran Administration.
The purpose of this publication by the VA is to make sure that these facilities make the right choices and adjustments in order to meet the necessary USP Compliance. The Article refers to the USP 795 Pharmaceutical Compounding – Non-sterile Preparations, USP 797 Pharmaceutical compounding – Sterile Preparations and USP 800 Hazardous Drugs – Handling in Healthcare Settings.
The VA made a great effort to break down and better explain the proposed USP chapters by describing specific scenarios that can be referred to as the minimum requirements. They did a great overview of the facility’s architecture like for example defining the minimum Ceiling, floor and walls capacities.
The VA in this publication also turns their attention to the interior finishes and provides some benchmarks regarding maintenance, durability and life cycle spread of materials. In addition to this publication, the VA has also bolstered their generic HVAC setup guide for all VA healthcare participants.
This is considered to be a giant leap forward for the VA since they finally decided to the most common cleanroom setup as shown in the figure below:
Sterile compounding rooms used for hazardous and non-hazardous drug compounding and intravenous admixtures shall follow the current version of the VA HVAC Design Manual (DM). The Design Manual includes information on air handling unit and room requirements for these rooms such as room air changes, room design temperatures, relative humidity ranges, noise levels, and space pressure relationships.
Pharmacy support spaces shall follow the current version of the VA HVAC DM unless noted otherwise. The room data sheets provided in the Room Templates chapter of this document refers the user to specific room types shown in the VA HVAC DM unless noted otherwise.
We must add that such comprehensive HVAC upgrades targeting most areas of your facility can take a long time to be completed. But in terms of keeping your pharmacy production going during the renovation process we can surely help out with our USP 797 – USP 800 Compliant Mobile Compounding Centers.
A huge improvement in personnel safety protocol by the VA is their anticipation for shipping and receiving HDs, something that we feel was overseen with the new USP Hazardous Drugs – Handling in Healthcare Settings chapter, even though there are clarifications on the delivery, handling and storage of hazardous drugs.
For this purpose we’ve developed a product that guarantees the safest and efficient environment for incoming and outgoing hazardous materials named the StageThru 800, that also comes pre attached to our USP 800 compliant engineering controls the XLTC 800.
The VA did an amazing job in deciding and visually setting up the room templates that should be used as reference when designing an USP compliant pharmacy.
We are pleased to announce that many of our stances and opinions were adopted by the VA in this publication. We rest assured that all of our VA compliance Pharmacy Planning and Design projects meet the appropriate USP requirements as well as are compliant with the VA Pharmacy Design Guides.
Our company is SAM registered and we have performed several hundred USP compliance jobs for the VA since our launch in 2005.
Give us a call at 800.418.9289 and we are sure that we can help!
Typically by us getting involved in jobs early, we can save facilities a tremendous amount of professional fees, overall project cost and long-term operational costs.