The Drug Supply Chain Security Act (DSCSA) requires physician practices that purchase or dispense medication to implement electronic, interoperable systems to track prescription drugs at the package level, ensuring only authorized, non-counterfeit products are used. Practices must verify suppliers, manage digital transaction data (EPCIS), and comply with strict quarantine rules for suspicious products.

Key impacts on physician practices include:

• Authorized Trading Partner Verification: Practices must confirm that suppliers (wholesalers, manufacturers) are licensed, which should be documented.
• Electronic Data Requirements: As of November 2024,, practices must exchange data via Electronic Product Code Information Services (EPCIS) to trace products, moving away from manual, paper-based tracking.
• In-Office Dispensing Rules: Practices that dispense medication must maintain, store, and be able to produce transaction information, history, and statements for 6 years.
• Handling Suspect Products: If a medication is suspected to be counterfeit or stolen, the practice must quarantine it and notify the FDA and trading partners.
• Operational Changes: Practices must implement barcode scanning solutions to verify product identifiers (NDC, serial number, lot, expiration date) upon receipt.

While some smaller practices might rely on upstream partners for compliance data, they are still responsible for ensuring the drugs they buy are verified.

If you have any questions regarding traceability with products distributed by Clint Pharmaceuticals, please reach out to us at 1-800-677-5022.