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Quality Standards

Highest Standards, Period.

Quality over profits is our primary directive. Our sterile facility was custom-built to exceed USP new <795>, <797> and USP <800> compounding standards. We invite you to learn more about what makes us part of the 1% of all 503A pharmacies in the country.

Our Quality Standards

USP <795> Non-Sterile Compounding

  • Establishes guidelines to minimize errors

  • Provides requirements for final product quality

  • Packaging & labeling requirement for final products

USP <797> Sterile Compounding

  • Specifically addresses sterile compounding

  • Establishes positive & negative pressure cleanrooms

  • New requirements for sterility testing 

  • Training & competency requirements for staff

USP <800> Handling of Hazardous Drugs

  • Improved safety for pharmacy staff

  • Requires separation of hazardous and non-hazardous products 

  • Specifically addresses handling of hazardous materials

About the U.S. Pharmacopeia (USP)

USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. 
 
For over 200 years, USP has worked to build trust where it matters most: in the world's medicines, dietary supplements and foods. Through our rigorous science and the public quality standards we set, USP helps protect patient safety and improve the health of people around the world.
 
Learn more ​

Science Lab

Testing  & Verification

We believe in continually monitoring the quality of the products we produce. We use third-party, ISO 17025:2017 accredited labs to verify the sterility and potency of our products.

Sterility Testing

  • Batch testing of high-volume products

  • Daily staff glove and fingertip testing  

  • USP<71> sterility testing

  • USP<85> endotoxin testing

Potency  & Beyond Use Date (BUD)

  • Incoming verification of all raw material 

  • Testing and certification of each new formulation

  • Specialized temperature and humidity studies to ensure our products meet or exceed our label claims

Regulatory & Compliance

Quality is not an endpoint, it’s a process that takes constant monitoring to ensure. We have dedicated staff that are constantly monitoring and challenging our pharmacy team to excel.

  • Dedicated QA Officer and Facilities Manager

  • Monthly QA Meetings to Review and Address Quality

  • Electronic Monitoring of Cleanroom Systems

  • Regular Training for Pharmacy Staff

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