USP General Chapter <797> pertains to the compounding of both hazardous and nonhazardous drugs. USP <800> serves as a new standard to guide the handling of hazardous drugs in order to protect patients, health care personnel, and the environment.
DHHS (NIOSH) Publication No.The format for the 2014 list was revised to include three groups of hazardous drugs: (1) Antineoplastic drugs; (2) Non-antineoplastic hazardous drugs; and (3) Drugs with reproductive effects.
The most common routes of exposure are skin contact with hazardous drug-contaminated workplace surfaces and inhalation of drug aerosols generated during compounding or administration of hazardous drugs.
The law defines an outsourcing facility as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B.
Specifically, the chapter is designed to "prevent patient harm and fatality from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs." The Joint Commission actively enforces USP Chapter 797 compliance as
The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
1For nonsterile preparations, a ventilated engineering control, such as a fume hood or Class I BSC can be used. A containment ventilated enclosure (CVE), such as a powder hood, also may provide adequate protection.
Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and nonsterile HDs. Two pairs of chemotherapy gloves are required for administering antineoplastic HDs. Gowns shown to resist permeability by HDs are required when administering injectable antineoplastic HDs.
U.S. Food and Drug Administration (FDA)
USP <800> affects all types of pharmacy operations: Retail pharmacy, LTC pharmacy, compounding pharmacy, and every other facility with the word pharmacy associated with it.
USP's mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.” Standards for an article recognized in a USP compendium are expressed in the article's monograph, the General Notices, and applicable general chapters (such
Who does USP <800> apply to? USP <800> applies to all healthcare personnel who handle HD preparations including pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, veterinarians, and veterinary technicians.
USP 797 requirements affect all disciplines involved in sterile compounding, including physicians, nurses, pharmacists, and pharmacy technicians.
Hazardous drugs include those used for can- cer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscella- neous drugs.
United States Pharmacopeia
USP <800> states that a medical surveillance program should include the following: Completion of an exit examination when a worker' s employment ends, documenting the information on the employee' s exposure, medical, and reproductive history.
USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter <795> provides standards for compounding quality nonsterile preparations.
Although USP is a scientific nonprofit organization, its standards—such as USP <800>—are enforced by a variety of local, state, and federal regulatory agencies and are also followed worldwide. Accrediting bodies such as The Joint Commission survey for compliance with USP compounding standards.
Isolators provide primary environmental controls and must provide at least ISO Class 5 quality of air to which sterile ingredients and CSP's are directly exposed. First air is defined as the undisrupted air coming directly from a HEPA filtration source. i.e. Laminar Flow.
USP <800> recommends use of CSTDs during hazardous drug (HD) compounding and requires use during administration of antineoplastic HDs. An exception is permissible if the dosage form does not allow for a CSTD or if the agent is physically or chemically incompatible with the CSTD.
The objective of the USP 797 Guidelines is to describe conditions and practices to prevent harm, including death, to patients resulting from a contaminated or improperly made compounded sterile preparations (CSPs).
To meet the definition of an outsourcing facility, the facility must be engaged in the compounding of sterile human drugs (section 503B(d)(4)(A)(i)). Entities that do not compound sterile human drugs should not register as outsourcing facilities.
Exposure to hazardous drugs can occur through4: skin absorption. inhalation of aerosols and drug particles. ingestion from contaminated food or drink or other hand to mouth contact.
Personal Protective EquipmentPPE is important for the health professional to protect against occupational hazards of HDs. PPE includes gloves; gowns; head, hair, shoe, and sleeve covers; eye and face protection; and respiratory protection. PPE as defined by pharmacy policy must be worn when handling HDs at all times.
Segregating inventory by drug categories helps to prevent potentially harmful errors. The Joint Commission (TJC), formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), requires that internal and external medications must be stored separately.
