USP <800>: What To Expect (Free Webinar)
Join Baker for a free webinar on February 4 to learn about what the pharmaceutical compounding industry can expect from the soon-to-be-released USP <800> Hazardous Drugs – Handling in Healthcare Settings
Update: The recorded webinar and presentation slides are now available.
By Aaron Johnson and Cheri GaudetJoin Baker for a free webinar on February 4 to learn about what the pharmaceutical compounding industry can expect from the soon-to-be-released USP <800> Hazardous Drugs – Handling in Healthcare Settings. Presenters Aaron Johnson (Engineering Test Supervisor) and Deborah Thibodeaux (Applications Specialist) will provide an overview of the expected changes involving primary and secondary engineering controls (e.g., biological safety cabinets, clean rooms, etc.). Attendees will be able to use what they learn to prepare to implement the proposed guidelines, which are available for public review and comment over the next few months.
Once it is finalized (publication is expected this coming June), USP <800> will provide new guidelines on how hazardous drugs are received, stored, compounded, dispensed and administered to humans and animals. The document clarifies and revises guidelines on hazardous drug handling that were originally given in USP <795> and <797>, which more generally addressed non-sterile and sterile preparations (respectively). Meanwhile, the latest revision of USP <800> is available for public review, and comments will be accepted until May 31.
Following the publication of USP <800>, both <795> and <797> will be revised to conform with the new hazardous drug handling guidelines given in <800>. Clearly the proposed chapter will have longstanding implications for the pharmaceutical compounding industry.
Get Ready for USP <800> “Alphabet Soup”
The proposed chapter includes a number of new terms (and their abbreviations) that you’ll want to become familiar with, including:
Containment Primary Engineering Control (C-PEC): A ventilated enclosure designed to minimize worker and environmental exposure to hazardous drugs during handling. For example, a Class II Type A2 biological safety cabinet (like SterilGARD®) or a compounding aseptic containment isolator (or CACI, like ChemoSHIELD®).Containment Secondary Engineering Control (C-SEC): The room in which the ventilated enclosure (C-PEC) is located. As its name suggests, the purpose of the C-SEC is to be a “backup” or “secondary” containment mechanism, to contain within the room any potential hazard that could escape the C-PEC. The C-SEC must either be an ISO Class 7 buffer room (preferred) or an unclassified C-CSA (see below).
Containment Segregated Compounding Area (C-SCA): This is a type of C-SEC that contains specific room pressurization and nominal airflow values related to hazardous drug compounding.
Containment Ventilated Enclosure (C-VE): A full or partial enclosure that uses ventilation principles to capture, contain and remove airborne contaminations through HEPA filtration and prevent their release into the work environment.
A full list of terms is available in the glossary of the USP <800> document.
What To Expect From USP <800>
Chapter <800> provides specific guidance related to handling hazardous drugs; it is not intended to replace either <795> or <797>. Here is a quick summary of the three most important changes related to primary and secondary engineering controls:
- Elimination of the current allowance in USP <797> permitting facilities to prepare low volumes of sterile hazardous drugs in a non-negative pressure room. This means that all sterile hazardous drug compounding regardless of volume must be conducted in a controlled, negative pressure space that is designated for hazardous drug compounding.
- An allowance permitting facilities to prepare sterile hazardous drugs within an unclassified C-SCA (rather than an ISO Class 7 buffer room) under certain conditions.
- For non-sterile compounding, an allowance for either external venting (preferred) or redundant HEPA filtration of the C-PEC (double exhaust HEPA). Activities must be conducted in a controlled, negative pressure space that is designed for hazardous drug compounding.
FMI: USP <800> Webinar
For more details about the proposed changes and what they will mean for your facility, please join us for our February 4th webinar. Submit a question for our presenters during registration, or ask your own questions during our live Q&A.
Update: Although the live presentation has already occurred, the webinar recording and a copy of the presentation slides are now available.
