USP 800 Acronyms

Active Pharmaceutical Ingredient
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.

Alternative Duty
Performance of other tasks that do not include the direct handling of HDs.

Ante-room
An ISO Class 7 or cleaner room where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels are performed. The ante-room is the transition room between the unclassified area of the facility and the buffer room.

Assessment of risk
Evaluation of risk to determine alternative containment strategies and/or work practices.

Biological Safety Cabinet
A ventilated cabinet often used for preparation of hazardous drugs. These cabinets are divided into three general classes (Class I, Class II, and Class III). Class II BSCs are further divided into types (Type A1, Type A2, Type B1, and Type B2). See Appendix 3 for details.

Beyond-use Date
The date or time beyond which a compounded preparation cannot not be used and must be
discarded (see 795 and 797). The date or time is determined from the date or time when the preparation was
compounded.

Buffer Room
A type of C-SEC under negative pressure that meets ISO Class 7 or better air quality where the C-PEC that generates and maintains an ISO Class 5 environment is physically located. Activities that occur in this area are limited to the preparation and staging of components and supplies used when compounding HDs.

Chemotherapy Glove
A medical glove that meets the ASTM Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (D6978) or its successor.

Classified Space
An area that maintains an air cleanliness classification based on the International Organization for Standardization (ISO).

Cleaning
The process of removing soil (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products.

Compounding Aseptic Containment Isolator
A specific type of CAI that is designed for the compounding of sterile HDs. The CACI is designed to provide worker protection from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer processes and to provide an aseptic environment with unidirectional airflow for compounding sterile preparations.

Compounding Aseptic Isolator
An isolator specifically designed for compounding sterile, non-hazardous pharmaceutical ingredients or preparations. The CAI is designed to maintain an aseptic compounding environment throughout the compounding and material transfer processes.

Compounding Personnel
Individuals who participate in the compounding process.

Compounding Preparation
A nonsterile or sterile drug or nutrient preparation that is compounded in a licensed pharmacy or other healthcare-related facility in response to or anticipation of a prescription or a medication order from a licensed prescriber.

Containment Primary Engineering Control
A ventilated device designed and operated to minimize worker and environmental exposures to HDs by controlling emissions of airborne contaminants through the following:
• The full or partial enclosure of a potential contaminant source
• The use of airflow capture velocities to trap and remove airborne contaminants near their point of generation
• The use of air pressure relationships that define the direction of airflow into the cabinet
• The use of HEPA filtration on all potentially contaminated exhaust streams

Containment Segregated Compounding Area
A type of C-SEC with nominal requirements for airflow and room pressurization as they pertain to HD compounding.

Containment Secondary Engineering Control
The room with fixed walls in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room.

Closed-system Drug-transfer Device
A drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system.

Containment Ventilated Enclosure
A full or partial enclosure that uses ventilation principles to capture, contain, and remove airborne contaminants through HEPA filtration and prevent their release into the work environment.

Deactivation
Treatment of an HD contaminant on surfaces with a chemical, heat, ultraviolet light, or another agent to transform the HD into a less hazardous agent.

Decontamination
Inactivation, neutralization, or removal of HD contaminants on surfaces, usually by chemical means.

Disinfection
The process of inhibiting or destroying microorganisms

Doff
To remove PPE

Don
To put on PPE

Engineering Controls
Primary, secondary, and supplemental devices designed to eliminate or reduce worker exposure to HDs.

EPA Registered Disinfectant
Antimicrobial products registered with the Environmental Protection Agency (EPA) for healthcare use against pathogens specified in the product labeling.

Externally Vented
Exhausted to the Outside

Final Dosage Form
Any form of a medication that requires no further manipulation before administration

Globally Harmonized System of Classification and Labeling of Chemicals
A system for standardizing and harmonizing the classification and labeling of chemicals

Goggles
Tight-fitting eye protection that completely covers the eyes, eye sockets, and facial area that immediately surrounds the eyes. Goggles provide protection from impact, dust, and splashes. Some goggles fit over corrective lenses.

Hazardous Drug
Any drug identified by at least one of the following criteria:
• Carcinogenicity, teratogenicity, or developmental toxicity
• Reproductive toxicity in humans
• Organ toxicity at low dose in humans or animals
• Genotoxicity or new drugs that mimic existing HDs in structure or toxicity

High-efficiency Particulate Air
An extended-medium, dry-type filter in a rigid frame, having a minimum particle collection efficiency of 99.97% for particles with a mass median diameter of 0.3 µm when tested at a rated airflow in accordance with MIL STD 282 using IEST Recommended Standard RP-CC001.5.

Negative Pressure Room
A room that is maintained at a lower pressure than the adjacent areas; therefore the net flow of air is into the room.

Pass Through
An enclosure with interlocking doors that is positioned between two spaces for the purpose of reducing particulate transfer while moving materials from one space to another. A pass-through serving negative-pressure rooms needs to be equipped with sealed doors.

Positive Pressure Room
A room that is maintained at a higher pressure than the adjacent areas; therefore, the net flow of air is out of the room.

Personal Protective Equipment
Items such as gloves, gowns, respirators, goggles, faceshields, and others that protect individual workers from hazardous physical or chemical exposures.

Repackaging
The act of removing a product from its original primary container and placing it into another primary container, usually of smaller size.

Safety Data Sheet
An informational document that provides written or printed material concerning a hazardous chemical. The SDS is prepared in accordance with the HCS [previously known as a Material Safety Data Sheet (MSDS)].

Spill Kit
A container of supplies, warning signage, and related materials used to contain the spill of an HD.

Standard Operating Procedure
Written procedures describing operations, testing, sampling, interpretation of results, and corrective actions that relate to the operations that are taking place.

Supplemental Engineering Controls
An adjunct control (e.g., CSTD) that may be used concurrently with primary and secondary engineering controls. Supplemental engineering controls offer additional levels of protection and may facilitate enhanced occupational protection, especially when handling HDs outside of primary and secondary engineering controls (e.g., during administering)

Unclassified Space
A space not required to meet any air cleanliness classification based on the International Organization for Standardization (ISO).