USP <800> Hazardous Drugs – Handling in Healthcare Settings was posted as a proposed new USP General Chapter on March 28, 2014. The purpose of <800> is to protect health care personnel and the environment when handling hazardous drugs (HDs). The chapter builds on the components of two USP compounding General Chapters: <795> Pharmaceutical Compounding – Nonsterile Preparations and <797> Pharmaceutical Compounding – Sterile Preparations. Similar to <795> and <797>, it applies to all personnel who prepare, compound, or dispense these preparations, and additionally applies to all health care personnel who are involved in the transit of HDs throughout any health care setting, such as those who receive and transport the medications as well as those who administer any HD.
List of Hazardous Drugs
The proposed chapter does not list specific HDs, but refers to the most current NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Currently, that is the 2012 list (NIOSH Publication Number 2012-150– see Table 1), but entities need to be aware of any future updates.
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, low-risk compounded sterile preparations (CSPs) can be compounded in a segregated compounding area (SCA). If an entity prepares only low- or medium-risk HD CSPs and finds a limit of a 12-hour beyond-use time acceptable, a BSC can be placed in the C-SCA.
The chapter describes the three possible facility designs for sterile compounding (see Table 2).
Dispensing Oral and Topical Hazardous Drugs
HDs in unit-dose or unit-of-use packaging that do not require any further alteration before delivery to the patient may be dispensed without any further requirements for containment unless required by the manufacturer. If the entity’s policies permit, non-antineoplastic HDs that require only transfers from the manufacturer’s package to a prescription container may be dispensed without any further requirement for containment unless required by the manufacturer. Equipment such as counting trays and spatulas should be dedicated for use with these drugs.
Administration of Hazardous Drugs
Those familiar with <797> requirements are aware of the primary and secondary engineering controls used to contain HDs for storage and compounding. Since <800> is designed to apply to all personnel in health care settings, consideration must be given to containment protection during administration of these agents. Closed-system drug transfer devices (CSTDs) are supplemental engineering controls that are available to contain HDs during administration. USP <800> recommends use of CSTDs during compounding, and requires use for administration, when the dosage form allows.
Public Comment Period for Proposed USP <800>
Proposed chapter <800> is available in its entirety at ttps://www.usp.org/usp-nf/notices/compounding-notice. Additionally, a recorded Webinar and supporting slides are available. Public comments are being accepted until July 31, 2014, and comments can be sent to CompoundingSL@USP.org using the information listed on the USP Web page.
The final version of <800> will be published in United States Pharmacopeia – National Formulary (USP-NF) and will become official and enforceable six months after the publication date. Once <800> is finalized, <797> will be harmonized with the HD issues that currently differ in that chapter.
See PP&P’s June 2014 issue for continuing coverage of New Proposed USP General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings.
Patricia C. Kienle, RPh, MPA, FASHP, is Director, Accreditation and Medication Safety, for Cardinal Health Innovative Delivery Solutions. She can be reached at email@example.com.
Disclaimer: Although Patti is a member of the USP Compounding Expert Committee, the information presented in this article is her opinion alone and should not be construed as official USP guidance.
What Is Included in Proposed USP <800>?
- Facility requirements
- Storage under negative pressure
- Elimination of low-volume exemption currently in <797>
- Allowance for containment segregated compounding area
- List of hazardous drugs
- Current NIOSH hazardous drug list
- Supplemental engineering controls for administering hazardous drugs
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
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