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Why ImprimisRx? 503A Quality Standards

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 and potency testing for all sterile formulations
  • Required to meet US Pharmacopeia (USP) <795> & <797> guidelines
  • PCAB Accredited

ImprimisRx 503A facilities are licensed to ship to all 50 states.

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Standards

ImprimisRx is committed to delivering high-quality formulations that are required to meet

U.S. PHARMACOPEIA (USP) <795> and <797> guidelines & PCAB Requirements

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.