Unit Dose Relabeling
HealthFirst is a licensed pharmaceutical repackager and wholesaler for single unit repackaging, compliant relabeling and meets all tracking and tracing criteria for serialization, registration and distribution of unit dose and Low Unit of Measure (LUM) medications in accordance with the Drug Supply Chain Security Act (DSCSA).
Requirements for Serialized Numerical Identifiers (SNI) and Unique Product Identifiers (UPI)
The Drug Supply Chain Security Act (DSCSA) requires that manufacturers apply a unique product identifier on specific prescription drug products. The DSCSA compliant product identifier is defined as a standardized graphic including both human and machine-readable data that contains the standardized numerical identifier, lot number, and expiration date of the product. Trading partners are also required to exchange product tracing information when transacting prescription drugs.
DSCSA Compliant Distribution Services
Implementing serialization of single or LUM items in compliance with the phases of the DSCSA regulation is complex, costly, and labor-intensive. Considerations include State and Federal licensing and regulatory compliance, new NDC registration for each unit dose, production process investments, label and packaging design, inventory management, pedigree pass through, and tracking and tracing each product transaction at the unit dose level. Let HealthFirst do the work for you.
HealthFirst offers two options for unit dose serialized distribution:
Serialized medications can be drop shipped on your behalf directly to your end customer, including pedigree passthrough and the required tracking and tracing documentation. HealthFirst is licensed to distribute product in all 50 States and US Territories – we can expand your distribution area via our drop ship program.
HealthFirst can also ship single serialized product in bulk to your warehouse for your distribution. Each unit is individually serialized and packaged with the drug insert so it’s ready to ship to your customer.
Contact us to discuss your DSCSA compliant distribution needs.