A Comparison of 503A & 503B Compounding Pharmacies
The Optimal Scripts brand is comprised of several 503A and 503B compounding pharmacies. Each plays a specific role in our manufacturing, logistical, and sales processes. Understanding the differences between the two will empower the sales force to explain why Optimal Scripts, made in America, is simply the best choice on the market.
Designations
503A: Compound Pharmacies
503B: Outsourcing Facilities
Regulatory Oversight
503A: Primarily regulated by state boards of pharmacy
503B: Regulated by the U.S. Food and Drug Administration (FDA)
Bulk Compounding
503A: Limited to small-scale compounding for individual patient prescriptions
503B: Permitted to produce large batches of compounded medications not for specific patient prescriptions
Quality Standards
503A: Subject to USP <795> and <797> standards for compounding practices
503B: Required to adhere to Current Good Manufacturing Practices (CGMP) standards
Drug Testing
503A: May perform in-house testing of compounded medications
503B: Required to conduct rigorous testing and quality assurance protocols
Labeling
503A: Must include patient-specific information and directions for use
503B: Labels must comply with FDA regulations for commercial drug products
Prescription Requirements
503A: Requires patient-specific prescriptions for each compounded medication
503B: Can compound medications without patient-specific prescriptions for office use