IV rooms, often used in hospital and pharmacy applications, are a place for the sterile preparation of IV medications. Under the revised USP <797> regulations, compounded sterile preparations (CSPs) are requiring stricter adherence to federal regulations and protocols.
Maintaining strict adherence to FDA regulations and other governing institutions is important to pharmacists and all compounding personnel in:
Physician practice facilities
Other facilities in which CSPs are prepared, stored, and dispensed
The challenge with compounded preparations is ensuring that the solutions or drugs to be administered are made in sterile conditions that conform to current Good Manufacturing Practices (cGMP's). This requires the utilization of specific equipment and protocol including specialized air filtration, properly garmented workers and regimented QC testing. Aside from the equipment and validation processes, one must also stay familiar with current regulations and standards.
It is essential that newly constructed clean rooms and enclosures maintain a strict adherence to these and other requirements through in-depth knowledge and an understanding of current regulations and protocols, as well as the ability to provide the level of certification required for a particular application.