Hazardous Compounding and USP <800>

General Chapter <800> Hazardous Drugs–Handling in Healthcare Settings was formally published February 1, 2016 in the First Supplement to USP 39-NF 34. USP <800> is established in concert with USP General Chapters <795> for non-sterile compounding and USP <797> for sterile compounding. The purpose of the chapter is to provide standards and define processes to protect personnel, patients, and the environment when handling hazardous drugs in a healthcare setting. Building on existing standards and guidelines, General Chapter <800> provides a comprehensive approach for handling hazardous drugs with the ultimate goal of preventing and/or minimizing exposure to hazardous drugs.

Yes – USP <800> is established in concert with USP General Chapters <795> for non-sterile compounding and USP <797> for sterile compounding.

The chapter applies to healthcare personnel and entities that handle hazardous drugs; this list includes pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.

The chapter does not list specific hazardous drugs, but refers to the current National Institute for Occupational Safety and Health (NIOSH) list of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. Drugs identified on this list are considered hazardous or potentially hazardous with respect to at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity.

View a full list of hazardous drugs

In an effort to provide an adequate timeframe to implement USP <800> standards, the chapter has a delayed official implementation date of July 1, 2018¹. It is important to note that this implementation date is when entities must be compliant with USP <800>; waiting too long to begin the process could negatively impact your practice.

¹On September 29th, 2017 USP released a notification of intent to revise the official implementation date of USP General Chapter <800> to December 1, 2019.

Segregation is an important aspect of exposure control and there must be designated equipment for hazardous drug compounding as this will minimize the likelihood of cross-contamination. Hazardous compounding equipment that requires segregation from non-hazardous compounding equipment may include balances, mortars, pestles, spatulas, stir bars, beakers, cylinders, and counting trays.

C-PECs used for non-sterile hazardous drug compounding must be externally vented through HEPA filtration (preferred) or internally vented through at least two HEPA filters in series. For sterile hazardous drug compounding, the C-PEC must be externally vented through HEPA filtration.

C-PECs for both sterile and non-sterile compounding must be housed within a room segregated from non-hazardous compounding rooms. This room is called the Containment-Secondary Engineering Control (C-SEC) and must maintain negative pressure with respect to the adjacent rooms and maintain the minimum Air Changes Per Hour (ACPH) as described by USP <800>. Furthermore, the room must be externally exhausted through HEPA filtration to the outside of the building. For sterile compounding, the C-SEC must also maintain compliance with the required ISO quality air as described in USP <797>.

When not properly protected through the use of personal protective equipment and engineering controls, occupational exposure has been shown to be associated with health effects such as skin rashes, decreased fertility, spontaneous abortions, congenital malformations, and possibly leukemia and other cancers.

CSTDs are a supplemental engineering control that should be used as an adjunct to primary and secondary engineering controls. The use of CSTDs has been shown to effectively reduce surface contamination and worker exposure, but does not totally eliminate the risk.

Yes, gloves worn for hazardous compounding are required to meet the American Society for Testing and Materials (ASTM) standard D6978 (or its successor). Double gloving is required when working with hazardous substances.

Even if the right controls (e.g., personal protective equipment, engineering controls) are in place, occupational exposure can occur if these controls are not being used properly or if personnel are inappropriately handling hazardous drugs. Personnel training and verification of competency is imperative to risk minimization in the workplace, making it one of the most important aspects of a hazardous drug exposure control program. Pharmacy personnel must be educated and trained in all aspects of working with hazardous substances. Any personnel expected to handle or come in contact with a hazardous substance, either directly or indirectly, should complete a thorough training program on working with hazardous drugs as well as risk mitigation techniques.

Facilities that handle hazardous drugs must have a hazardous communication program in place. As such, each employee who may be exposed to hazardous chemicals when working shall be provided with information regarding the occupational risks associated with the facility-specific hazardous drugs and training on proper handling procedures, prior to their initial assignment to work with a hazardous chemical.

The only hazardous drugs that are exempt from USP <800> requirements are final dosage forms of hazardous compounded preparations and conventionally manufactured hazardous drug products which includes antineoplastic dosage forms that do not require any further manipulation other than counting or repackaging.

Active pharmaceutical ingredients (APIs) in the form of creams, liquids, or low-aerosol formulations still fall under USP’s definition of an API (i.e. “Any substance or mixture of substances intended to be used in the compounding of a drug preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.”) As such, entities must still use the containment strategies outlined in USP <800> when compounding with these types of hazardous drugs.