USP 800

Responsibilities of Organizations per USP <800>

Assign a Compounding Supervisor

The proposed chapter uses the term entity to describe any health care organization that uses HDs. USP <800> requires that each entity assign a specific person as the compounding supervisor, who is responsible for developing and implementing appropriate procedures, overseeing facility compliance and monitoring, ensuring competency of personnel, and ensuring environmental control of the compounding areas.

Storage of Hazardous Drugs

HDs must be stored separately from non-HDs (as currently required in <797>), with one possible exception. Those HDs on the NIOSH list that are not listed as antineoplastic agents, are available in final-manufactured dosage forms, and not manipulated other than counting for dispensing, may be co-mingled with non-HD stock if the entity’s policy allows. Unless the HDs are received in their final unit-dose or unit-of-use packaging, the storage of HDs must be stored in a room that is separate from non-HD storage.

The restricted-access room must be under negative pressure, externally vented, and have at least 12 air changes per hour. Injectable HDs may be stored in the negative-pressure buffer room used for sterile preparations if there is sufficient room available and all particle-generating external packaging (such as coarse cardboard) has been removed prior to placement in the buffer room. If refrigerated antineoplastics are stocked, a refrigerator dedicated to storage of HDs is required in the HD storage area.

Compounding Hazardous Drugs

Compounding and other manipulation of HDs must be performed in a containment primary engineering control (C-PEC) within a separate room that provides personnel protection. The restricted-access room must be under negative pressure, externally vented, and have the appropriate number of air changes per hour. (The number of air changes required differs based on the type of compounding and the C-PEC in which it is being done.)

For those sites compounding nonsterile HDs, a C-PEC is required. Most organizations will use a containment ventilated enclosure (commonly called a powder hood) or a Class I biological safety cabinet (BSC) for this, although a Class II BSC also can be used if it is specifically dedicated to use for nonsterile compounding. The proposed chapter also makes allowances for occasional use of the C-PEC designed for use for sterile compounding, provided mitigating steps are taken to safely return the use of the BSC or compounding aseptic containment isolator (CACI) for sterile compounding.

There is a significant change in the proposed chapter for those sites that have a BSC or CACI in a positive pressure room, under the exemption currently allowed for low-volume sterile compounding. Proposed USP <800> would remove this exemption. However, <800> provides a new option: a containment segregated compounding area (C-SCA) can be created. Currently, this is not allowed by <797>, as only non-hazardous, Category 1 compounded sterile preparations (CSPs) can be compounded in a segregated compounding area (SCA). If an entity prepares only Category 1 or Category 2 HD CSPs and finds a limit of a 12-hour beyond-use time acceptable, a BSC can be placed in the C-SCA.