What Is A Pharmacy Line Of Demarcation?

The pharmacy line of demarcation separates the non-hazardous drug sterile compounding area (SGA) from the hazardous drug compounding section.

What Is The Requirement For A Pharmacy Line Of Demarcation?

USP does not define the pharmacy line of demarcation or required perimeter around the SCA, nor does TJC.  In some states, the Board of Pharmacy does define the perimeter.  For example, in California the code requires three (3) feet of perimeter space. Otherwise, the USP and TJC have said that the SCA must be either a room or a demarcated area within a room.  You cannot have non-essential activity occurring in that area, but they do not specify how big that space needs to be.

“Segregated Compounding Area—A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device (i.e., a PEC) that provides unidirectional airflow of ISO Class 5 … air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding.”

The following are additional required characteristics for a segregated compounding area per USP 797:

• The compounding process must be Low Risk only and a 12-hour BUD must be utilized.  
• The SCA shall not be in a location that has unsealed windows or doors that connect to the outdoors or high traffic flow, or that is adjacent to construction sites, warehouses, or food preparation. The SCA should be separated from activities not essential to the preparation of CSPs. Placement of devices (e.g., computers, printers) and objects (e.g., carts, cabinets) that are not essential to compounding should be restricted or limited, depending on their effect on air quality in the compounding environment. Note that this list is not intended to be all inclusive.
• Sinks should not be located adjacent to the PEC, however, there may be an eyewash station in the SCA.

The plan for a 1-foot perimeter on the sides with a 3-foot perimeter in front of the PEC is sufficient, but we would also advise checking with your state board of pharmacy to verify whether they have any minimum pharmacy line of demarcation separation requirements.

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