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Everything you need to compound a prescription Conveniently, Consistently and in Compliance with compounding regulations is in the FI℞ST® kit.
• API sourced from FDA-registered facility
• API certificate of analysis (COA) verified by independent analytical laboratory testing
• API precisely weighed using state of the art, cGMP-compliant filling process
• API stability in container closure system established by CutisPharma analytical testing
• Diluent formulated to optimize taste-masking, pH, and viscosity of compounded formulation
• Diluent excipients meet requirements under Section 503A of the Food, Drug and Cosmetic Act
• Diluent stability established by analytical testing
• Compounded product stability (Beyond Use Date) verified by analytical testing
Compounding Unit-of-Use Kits: White Paper. Compounding is defined by the USP as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug- delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient pharmacist/compounder relationship in the course of professional practice.” Click Here To Read More
Learn more about how FI℞ST® Kits help facilitate compliance with Section 503A and USP <795> procedures and guidelines to make compounding easy
FI℞ST® Unit-of-Use Kits address many of the unmet needs in compounding by providing a standardized, high quality alternative to traditional pharmacy compounding. The elegance of the FI℞ST® kit concept is in its simplicity: everything a pharmacist needs to compound a prescription is contained in a single box, with pre-weighted, pre-measured components manufactured by an FDA-registered, cGMP pharmaceutical company. Our FI℞ST® Unit-of-Use Kit portfolio covers three categories of commonly compounded preparations: oral solutions and suspensions, topicals, and suppositories:
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