High-Quality Compounded Drugs From 503A FDA-Inspected Facilities
ImprimisRx® is committed to delivering high-quality patient-specific formulations governed by U.S. Pharmacopeia (USP) <795> & <797> requirements. Our pharmacies are accredited by the Pharmacy Compounding Accreditation Board (PCAB). We operate under the regulatory framework of the Drug Quality & Security Act (2013) and state pharmacy laws.
Quality Assurance From an ImprimisRx®Pharmacy
- Comprehensive quality monitoring program
- Sterility testing for all sterile formulations
- PCAB Accredited
ImprimisRx® 503A facilities are licensed to ship to all 50 states.
Click on each Quality Commitment to reveal the how our standards compare to the requirements from USP and PCAB.
ImprimisRx®
SteriCheckTM process for all sterile lots
USP
Sterile lots per USP <71>
PCAB
Comply with USP
ImprimisRx®
Provided for all sterile injectable lots
USP
Sterile Injectable lots
per USP <85>
PCAB
Comply with USP
ImprimisRx®
14 Days for Sterility Result
USP
Not required, but recommended
PCAB
Comply with USP
ImprimisRx®
Daily monitoring
USP
Every 6 months
PCAB
Every 6 months
ImprimisRx®
Sterility Results
Endotoxin Results**
USP
No requirement
PCAB
No requirement
ImprimisRx®
Stability study data on batched products
USP
Literature and experience based stability study recommended
PCAB
Comply with USP
ImprimisRx®
Initial Aseptic Training Semi-Annual Evaluation
USP
Initial Aseptic training Annual Aseptic Evaluation
PCAB
Comply with USP
ImprimisRx®
All aseptic in ISO5 Disinfectant Rotation
USP
Aseptic in ISO5 Disinfectant Rotation
PCAB
Aseptic in ISO5 Disinfectant Rotation
ImprimisRx®
Written SOPs:
- Equipment monitoring and calibration;
- Compounding filling and labeling;
- Equipment and supplies; Training of staff;
- Procedure for handling hazardous drugs;
- Quality assurance program; Record keeping
requirements; - Recall procedures
USP
Written SOPs:
- Equipment monitoring and calibration;
- Compounding filling and labeling;
- Equipment and supplies; Training of staff;
- Procedure for handling hazardous drugs;
- Quality assurance program; Record keeping
requirements; - Recall procedures
PCAB
Written SOPs:
- Equipment monitoring and calibration;
- Compounding filling and labeling;
- Equipment and supplies; Training of staff;
- Procedure for handling hazardous drugs;
- Quality assurance program; Record keeping
requirements; - Recall procedures
All batches of our sterile compounded formulations are tested for sterility and our injectables are tested for bacterial endotoxins prior to distribution. For every order, a cleared report is included along with the shipment.
Our compounding pharmacy is monitored and inspected on a quarterly basis to ensure maintained compliance with U.S. Pharmacopeia (USP) requirements.