Possible Ramifications of USP <800>

By David Wasescha, Director of Biosafety Products

On November 10, 2015 in Case Studies

If you’ve recently visited a hospital or compounding pharmacy, you may have heard discussion about USP <800>, a new chapter - currently in draft form - by the United States Pharmacopeia.  The chapter details new regulations for the handling of hazardous drugs and is an expansion on USP <795> and USP <797>, which cover non-sterile and sterile drug compounding.

One of the more significant topics that the new chapter addresses is the safe handling of hazardous drugs during the compounding process. Compounding, which is the practice of creating a unique pharmaceutical product such as a cream, tablet, or injection, often requires the use of active drug ingredients that come in the form of powders.

In its current draft state, USP <800> outlines that handling hazardous active drug ingredients intended for non-sterile compounding must take place in an enclosure that allows for both personal protection and safe containment of powders generated during preparation.

While all non-sterile hazardous compounding must take place in a negative pressure room, some flexibility exists in the way that exhaust is removed from an enclosure used for compounding.

The two options are as follows:

• Option 1: The enclosure must be HEPA filtered and vented externally.
• Option 2: The enclosure must be double HEPA filtered before returning exhaust to the room.

Labconco’s well known XPert line, and recently available RXPert Single HEPA Filtered line, are ideally suited to handle Option 1. Paired with ductwork, the XPert System (w/ external venting), XPert Station and RXPert models meet the requirements of USP <800>.

Labconco’s solution to Option 2 is the RXPert Double Filtered Balance System. This Class I enclosure includes all of the industry-leading features offered by the XPert and Single Filtered RXPert lines such as bag-in/bag-out HEPA filter replacement, sturdy metal and glass construction, and excellent powder containment ability, but features a second HEPA filter on the unit.

The double HEPA filtered system, which returns exhaust directly to the room, gives added flexibility to the way in which a compounding pharmacy can successfully comply with USP <800> by reducing the need for expensive ductwork. Additionally, the double HEPA filtered RXPert is the only enclosure on the market that gives certifiers the ability to 100% scan each HEPA filter.

The first HEPA filter is accessed through an easy-to-remove panel that allows for ample space during scanning. Once returned, the panel serves as a multi-point delivery mechanism for aerosols when testing the second HEPA filter. 

New RXPert Filtered Balance Systems offer uncompromised safety while providng high performance and flexibility in an easy-to-install package for any compounder looking to comply with USP <800>.