503A and 503B

It takes both to meet your compounding needs

What is the difference between 503A and 503B compounding?
503A compounding complies with USP <797> standards and focuses on customized patient-specific compounding dispensed only with a prescription. CAPS is the market leader in customized Parenteral Nutrition and has the largest network of 503A regional facilities (22) in the industry.  CAPS also offers patient-specific chemotherapy and hydration from our regional 503A pharmacies for daily delivery. 

503B compounding is essentially batch compounding with required compliance to the federal cGMP regulations including 100% release testing quality assurance. These facilities comply with GMP level standards. 

503A 503B
Follows quality standards for USP <797>  Complies with cGMP regulations. Conducts 100% release testing on drug batches
Customized services with local delivery for patient-specific needs  Non-patient specific, with beyond use dating
Patient-specific labels with barcoding, ISMP-safe labeling features  503B label standards with barcoding, ISMP-safe labeling features 
Easy online ordering with CAPSlink  Easy online ordering with CAPSlink 
Over two decades of experience  Transparent reporting on quality and customer service 
Delivering solutions every day  Delivering confidence every day 

CAPS offers 22 503A regional pharmacies registered to dispense your customized, patient-specific compounding needs.

  • Parenteral Nutrition (PN)
  • Chemotherapy    
  • Patient-Specific drug doses
  • (IVPB, Syringe, CRRT)

 CAPS offers two 503B outsourcing facilities registered with the FDA to dispense non-patient-specific CSPs.

  • Cardioplegia
  • Anesthesia Syringes
  • Drug delivery
  • Neonatal PN Starter Bags
  • Controlled Substances
  • CRRT