Reference

Pharmaceutical compliance glossary

Key terms and definitions every compounding pharmacy professional should know : from USP standards to FDA regulations.

#
21 CFR Part 11 →
FDA regulation for electronic records and electronic signatures. Requires password re-authentication at signing, complete audit trails, signature hash verification, and ALCOA+ data integrity principles.
503A Pharmacy →
Compounding pharmacy that compounds pursuant to individual patient prescriptions under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA). Typically state-regulated.
503B Outsourcing Facility →
FDA-registered compounding facility that can produce larger quantities without patient-specific prescriptions. Subject to cGMP requirements and FDA oversight.
A
ALCOA+ →
Data integrity principle: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available. The gold standard for pharmaceutical data integrity.
B
BUD (Beyond-Use Date) →
Date and time after which a compounded preparation shall not be used. Determined by sterility testing, container type, storage conditions, and USP <797> guidelines.
C
CAPA →
Corrective and Preventive Action: a systematic approach to identifying, investigating, and addressing quality issues. Follows an open, investigate, resolve, close lifecycle.
cGMP →
Current Good Manufacturing Practice: FDA regulations (21 CFR Parts 210/211) ensuring pharmaceutical products are consistently produced and controlled according to quality standards.
CFU →
Colony Forming Unit: a measure of viable bacterial or fungal numbers used in microbial monitoring. Action levels vary by ISO classification zone.
C-PEC →
Containment Primary Engineering Control: an engineering control such as a biological safety cabinet (BSC) used for handling hazardous drugs, providing both product and operator protection.
G
GFI #256 →
FDA Guidance for Industry #256 regarding compounding animal drugs from bulk drug substances. Requires documentation of veterinarian-client-patient relationships (VCPR) and compliance with the FDA Bulk Drug Substance (BDS) list.
H
HEPA Filter →
High-Efficiency Particulate Air filter: removes at least 99.97% of airborne particles 0.3 microns or larger. Essential for maintaining ISO classified cleanroom environments.
I
ISO 5/7/8 →
Cleanroom classifications per ISO 14644-1, specifying maximum allowable particle counts per cubic meter of air. ISO 5 is the cleanest (used in PECs), ISO 7 for buffer rooms, and ISO 8 for ante rooms.
L
Laminar Flow →
Unidirectional airflow at uniform velocity used in ISO 5 environments. Provides first-air protection by sweeping contaminants away from the critical compounding zone.
M
Media Fill →
Aseptic technique competency test using growth media to simulate compounding conditions. Personnel must pass media fill testing before compounding sterile preparations and at defined intervals thereafter.
N
NAPRA →
National Association of Pharmacy Regulatory Authorities: the Canadian body whose Model Standards for Pharmacy Compounding of Sterile and Non-sterile Preparations govern compounding practice across Canada, paralleling USP <795>/<797>/<800> in the United States.
P
PEC →
Primary Engineering Control: a device or zone that provides an ISO 5 environment for compounding, such as a laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI).
R
RLS →
Row-Level Security: a database-level access control mechanism that ensures strict data isolation between tenants. Policies are enforced at the database layer, preventing cross-organization data leakage.
S
SEC →
Secondary Engineering Control: the room in which the PEC is placed, such as a buffer room or ante room. Provides ISO 7 or ISO 8 background air quality to support the PEC.
SOP →
Standard Operating Procedure: documented, version-controlled instructions for carrying out routine operations. SOPs in compounding require author, reviewer, and approver signatures per 21 CFR Part 11.
U
USP <795> →
United States Pharmacopeia chapter for nonsterile compounding. Covers quality standards, master formulation records, compounding procedures, and beyond-use dating for non-sterile preparations.
USP <797> →
United States Pharmacopeia chapter for sterile compounding: the primary standard for cleanroom operations. Covers environmental monitoring, personnel training, garbing, cleaning, and beyond-use dating for sterile preparations.
USP <800> →
United States Pharmacopeia chapter for handling hazardous drugs. Requires negative pressure HD rooms, containment primary engineering controls (C-PECs), exposure monitoring, and separate HVAC systems.
V
VCPR →
Veterinarian-Client-Patient Relationship: a documented relationship required before a veterinary compounding pharmacy can prepare medications for an animal patient. Required under GFI #256.

See these standards in action

CompliRx helps compounding pharmacies meet USP <797>, USP <800>, and 21 CFR Part 11 requirements with automated monitoring and digital documentation.