503A COMPOUNDING PHARMACY VS.

503B OUTSOURCING FACILITY

What is a 503A Compounding Pharmacy? 

Regulated and inspected by State Boards of Pharmacy, our traditional compounding pharmacy focuses on compounding patient-specific preparations pursuant to a prescription for individual patient use. In addition to being regulated by all State Boards of Pharmacy, we are also compliant with USP Chapters <795> & <797> and provide independent third-party validation on all compounded preparations. 

  • Patient-Specific Preparations 

  • Regulated/Inspected by State Boards of Pharmacy 

  • Independent Third-Party Validation 

  • USP Chapters <795> & <797> Compliant 

 

What is a 503B Outsourcing Facility? 

Regulated and inspected by the FDA as well as most State Boards of Pharmacy, our FDA-Registered Outsourcing Facility focuses on offering greater flexibility and access to Office Use medication for your facilities with the production of larger batches of medication. Our Outsourcing Facility operates pursuant to current Good Manufacturing Practices (cGMP). 

  • Office Use Medication 

  • Regulated/Inspected by FDA as well as most State Boards of Pharmacy

  • cGMP Facility

  • Independent Third-Party Validation