Compounding Pharmacy
Compliance Glossary

A traditional compounding pharmacy operating under Section 503A of the Federal Food, Drug, and Cosmetic Act. 503A pharmacies prepare patient-specific compounds in response to a valid prescription, are licensed by state Boards of Pharmacy, and follow USP 795, 797, and 800.

The number of times the entire volume of air in a room is replaced per hour. USP 797 requires at least 30 ACPH in ISO Class 7 rooms and at least 20 ACPH in ISO Class 8 rooms. USP 800 requires at least 12 ACPH in non-sterile HD compounding rooms and at least 30 ACPH in sterile HD buffer rooms.

The substance in a compounded preparation that produces the intended pharmacological effect. APIs used in compounding must comply with the USP-NF monograph criteria when one exists, be accompanied by a Certificate of Analysis (COA), and be manufactured by an FDA-registered facility in the United States.

Personnel competency demonstrated via media fill, gloved fingertip and thumb sampling on both hands, and surface sampling of the direct compounding area. USP 797 §2.3 requires this initially and at least every 6 months for personnel compounding Category 1 or Category 2 CSPs, and at least every 3 months for personnel compounding Category 3 CSPs.

The date or hour-and-date after which a compounded preparation must not be used and must be discarded. BUDs are determined from the date and time compounding is initiated. For sterile preparations, the maximum BUD depends on the CSP Category (USP 797 Tables 12, 13, 14). For non-sterile preparations, the BUD depends on water activity (a_w) and storage conditions (USP 795 Table 4). See also: USP 797 Revised — BUD tables explained.

A ventilated cabinet that provides personnel, environmental, and product protection. Class II BSCs are commonly used as Primary Engineering Controls (PECs) for sterile compounding. Per USP 800, BSCs used for HD compounding must be externally vented.

An isolator designed for compounding sterile hazardous drugs. Provides worker protection from airborne drug exposure plus an aseptic environment for sterile compounding. Per USP 800, CACIs used for HD compounding must be externally vented.

An isolator designed for compounding sterile non-hazardous preparations. Maintains an aseptic environment throughout compounding and material transfer. Per USP 797, a CAI must not be used for preparation of antineoplastic or API HDs.

A CSP assigned a BUD of no more than 12 hours at controlled room temperature or 24 hours refrigerated (USP 797 Table 12). May be compounded in an unclassified Segregated Compounding Area (SCA); sterility testing is not required.

A CSP assigned a BUD beyond the Category 1 limits, up to the ceilings in USP 797 Table 13. Requires a full ISO 5/7/8 cleanroom suite, formal environmental monitoring, and documented personnel competency. Specific BUDs depend on whether starting components are sterile, whether the CSP is aseptically processed or terminally sterilized, and whether a passing sterility test was performed.

A CSP assigned the longest BUDs available under USP 797 (Table 14) — up to 180 days frozen for terminally sterilized preparations. Requires all Category 2 controls plus sterility testing every batch, weekly sporicidal disinfection, increased EM frequency, quarterly (every 3 months) personnel competency, sterile garbing, and a stability determination.

A unit of measurement for viable microbial colonies on sample media after incubation. USP 797 uses CFU thresholds as action levels for environmental monitoring (Tables 7 and 8) — for example, an ISO 5 PEC has a surface action level of >3 CFU per media device and an air action level of >1 CFU per cubic meter. See: Environmental Monitoring — full action level tables.

Per USP 800, the process of removing soil (organic and inorganic material) from objects and surfaces, normally by manual or mechanical means using water with detergents or enzymatic products. Distinct from disinfection, decontamination, and deactivation — each is a separate step in HD handling areas.

A preparation not intended to be sterile, created by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug product or bulk drug substance. Governed by USP 795.

A record documenting the compounding of each CSP or CNSP. Required content per USP 795 §7 and USP 797 §11 includes date and time of preparation, lot numbers and expiration dates of all components, weights and volumes used, total quantity compounded, BUD assigned, results of QC procedures, and the names or identifiers of personnel involved in preparing and verifying the preparation.

A ventilated device designed to minimize worker and environmental exposures to hazardous drugs. Required by USP 800 §5.3 for any HD compounding (sterile or non-sterile), with a final-dosage-form exception (counting/repackaging of intact tablets or capsules). Examples: Class I and II BSCs, CVEs, CACIs.

An unclassified C-SEC with at least 12 ACPH, externally vented, and 0.01–0.03 inches water column negative pressure relative to adjacent areas. May be used to house a C-PEC for sterile HD compounding, but BUDs are then limited to those USP 797 assigns to a segregated compounding area.

The room with fixed walls in which a C-PEC is placed. Required by USP 800 for all HD compounding. For non-sterile HD: externally vented, ≥12 ACPH, 0.01–0.03 in WC negative pressure. For sterile HD: either an ISO 7 buffer room with an ISO 7 ante-room (preferred, ≥30 ACPH) or an unclassified C-SCA.

A sterile preparation made by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance. Governed by USP 797 and classified as Category 1, 2, or 3.

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. Per USP 800, CSTDs must be used when administering antineoplastic HDs when the dosage form allows, and should be used during compounding when the dosage form allows.

Per USP 800 §15, treatment of an HD contaminant on surfaces with a chemical, heat, UV light, or another agent to transform the HD into a less hazardous agent. The first of four distinct cleaning steps for HD handling: deactivation → decontamination → cleaning → disinfection.

Per USP 800, the inactivation, neutralization, or removal of HD contaminants on surfaces — usually by chemical means. Distinct from deactivation, cleaning, and disinfection.

One or more individuals identified in a compounding facility's SOPs who are responsible for and accountable to the performance and operation of the facility, personnel, and the preparation of CSPs or CNSPs. Required by USP 795, 797, and 800.

Per USP 800, the process of inhibiting or destroying microorganisms. Performed after cleaning, in areas intended to be sterile.

A program of routine sampling designed to verify that a cleanroom meets defined microbiological and particulate standards. USP 797 §6 requires viable impact volumetric airborne particulate sampling and surface sampling in all classified areas. Frequencies: surface monthly + air every 6 months for Cat 1/2; surface weekly + air monthly for Cat 3. See: Environmental Monitoring — full program design.

A test that measures bacterial endotoxin in injectable CSPs. Required by USP 797 §12.3 for Category 1 injectable CSPs prepared from nonsterile components that require sterility testing, for Category 2 injectable CSPs where sterility testing is required per Table 13, and for Category 3 injectable CSPs when endotoxin testing is required.

Personnel competency demonstrated via visual observation plus gloved fingertip and thumb sampling after garbing. USP 797 §2.2 requires three successful initial evaluations on three separate occasions; ongoing evaluation at least every 6 months for personnel compounding Cat 1/2 CSPs and at least every 3 months for personnel compounding Cat 3 CSPs.

Sampling of gloved fingertips and thumbs to detect microbial contamination on personnel after garbing or aseptic manipulation. USP 797 Table 1 action levels: >0 CFU total from both hands after garbing; >3 CFU after media-fill testing.

Per USP 800, any drug identified by at least one of: 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. The NIOSH List of Antineoplastic and Other Hazardous Drugs is the authoritative source.

An extended-medium, dry-type filter with a minimum particle collection efficiency of 99.97% for particles with a mass median diameter of 0.3 μm. Used in PECs and supplied to ISO-classified rooms in sterile compounding facilities.

An air cleanliness classification (ISO 14644-1) requiring no more than 3,520 particles ≥0.5 μm per cubic meter under dynamic operating conditions. USP 797 requires every Primary Engineering Control (PEC) for any CSP to meet ISO Class 5 or better.

An air cleanliness classification requiring no more than 352,000 particles ≥0.5 μm per cubic meter. USP 797 requires buffer rooms and HD ante-rooms to meet ISO 7 (minimum 30 ACPH).

An air cleanliness classification requiring no more than 3,520,000 particles ≥0.5 μm per cubic meter. USP 797 requires ante-rooms providing access only to positive-pressure buffer rooms to meet ISO 8 minimum (at least 20 ACPH).

An open-front device providing ISO Class 5 or better unidirectional HEPA-filtered airflow for sterile compounding. Per USP 797, a LAFW must not be used for preparation of antineoplastic or API HDs.

An aseptic process simulation in which microbial growth media (typically soybean-casein digest media, SCDM) is used in place of a CSP to evaluate whether the aseptic process could potentially introduce contamination. Required as part of aseptic manipulation competency per USP 797 §2.3; the media fill must simulate the most difficult and challenging compounding procedures the person actually performs.

A detailed record of procedures describing how a CSP or CNSP is prepared. Required by USP 795 §7 for every unique CNSP formulation; required by USP 797 §11 for every CSP prepared from nonsterile ingredients or prepared for more than one patient. Required content includes ingredients, container closure system, compounding instructions, BUD and storage requirements, QC procedures, and a reference source supporting the BUD.

The U.S. federal agency that maintains the List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings. USP 800 requires entities to maintain a list of HDs they handle that includes any items on the current NIOSH list, reviewed at least every 12 months.

A device or zone that provides an ISO Class 5 or better environment for the exposure of critical sites during sterile compounding. Examples include LAFWs, BSCs, CAIs, CACIs, pharmaceutical isolators, and RABS. Per USP 797 §4, every Category 1, 2, or 3 CSP must be compounded in an ISO 5 or better PEC.

The probability that a unit is nonsterile after terminal sterilization. USP 797 §10 specifies that CSPs prepared by terminal sterilization must achieve a PNSU of 10⁻⁶ — equivalent to one nonsterile unit in a million.

Items such as gloves, gowns, respirators, goggles, and face shields that protect individual workers from hazardous physical or chemical exposures. USP 800 §7 specifies PPE requirements for HD handling, including two pairs of ASTM D6978 chemotherapy gloves and a disposable, back-closing, permeation-resistant gown for HD compounding.

An enclosure providing HEPA-filtered ISO Class 5 unidirectional air, with defined openings allowing ingress and egress of materials. CAIs and CACIs are types of RABS. Generally not opened during compounding operations.

A designated space, area, or room with a defined perimeter that contains a PEC. May be unclassified (i.e., not ISO-classified). Per USP 797, only Category 1 CSPs may be compounded in an unclassified SCA.

A written procedure describing how a specific task is performed. Required by USP 795 §11, USP 797 §17, and USP 800 §17. All three chapters require SOPs to be reviewed at least every 12 months by the designated person(s), with revisions documented and communicated to affected personnel.

A chemical or physical agent that destroys bacterial and fungal spores at sufficient concentration for a specified contact time, expected to kill all vegetative microorganisms. Per USP 797 Table 10, sporicidal disinfectant must be applied at least monthly in PECs and on surfaces outside the PEC for Cat 1/2 operations, and at least weekly for Cat 3 operations.

A test performed per USP 〈71〉 or a validated alternative to confirm a sterile preparation is free of microbial contamination. Required for Category 2 CSPs assigned a BUD that requires sterility testing per Table 13, and for every batch of Category 3 CSPs.

A sterilization process applied to a CSP in its final, sealed container closure system (e.g., steam, dry heat, irradiation). The preferred sterilization method per USP 797 §10 unless the specific CSP or container cannot tolerate it. Must achieve a PNSU of 10⁻⁶.

A measure of the fraction of total water in a preparation that is unbound and freely available to support microbial growth or chemical reactions. USP 795 §10 uses water activity to classify CNSPs as aqueous (a_w ≥ 0.6) or nonaqueous (a_w < 0.6) for BUD assignment.