Quality Assurance

We are committed to providing high-quality formulations to you and your patients

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.



Standards

ImprimisRx® is committed to delivering high-quality formulations.

Click on each Quality Commitment to reveal the how our standards compare to the requirements from USP and PCAB.

STERILITY TESTING

ImprimisRx®

SteriCheckTM process for all sterile lots

USP

Sterile lots per USP <71>

PCAB

Comply with USP

ENDOTOXIN TESTING

ImprimisRx®

Provided for all sterile injectable lots

USP

Sterile Injectable lots
per USP <85>

PCAB

Comply with USP

PRE-SHIPMENT QUARANTINE

ImprimisRx®

14 Days for Sterility Result

USP

Not required, but recommended

PCAB

Comply with USP

ENVIRONMENTAL TESTING

ImprimisRx®

Daily monitoring

USP

Every 6 months

PCAB

Every 6 months

TEST RESULTS INCLUDED WITH ORDER

ImprimisRx®

Sterility Results
Endotoxin Results**

USP

No requirement

PCAB

No requirement

BEYOND USE DATING

ImprimisRx®

Stability study data on batched products

USP

Literature and experience based stability study recommended

PCAB

Comply with USP

PERSONNEL

ImprimisRx®

Initial Aseptic Training Semi-Annual Evaluation

USP

Initial Aseptic training Annual Aseptic Evaluation

PCAB

Comply with USP

COMPOUNDING ENVIRONMENT

ImprimisRx®

All aseptic in ISO5 Disinfectant Rotation

USP

Aseptic in ISO5 Disinfectant Rotation

PCAB

Aseptic in ISO5 Disinfectant Rotation

QA PROGRAM DOCUMENTATION AND POLICIES

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

Testing

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.