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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.
503B compounding is essentially batch compounding with required compliance to the federal cGMP regulations including 100% release testing quality assurance. These facilities comply with cGMP 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)
- Patient-Specific drug doses
- (IVPB, Syringe)
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