Be Sure With Advasur
U.S. Dispensers Subject to Federal and State DSCSA Compliance Audits
Deadline for DSCSA Compliance
In One Year
Potential Prison Term for Pharmacist's Noncompliance
For Six Years
Storage Term by Pharmacy for Electronic Advance Shipment Notices (ASNs)
DSCSA COMPLIANCE Explained
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This system will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
The Drug Supply Chain Security Act will require the development of an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they move through the U.S. supply chain.
The System will:
What Is Serialization
and What Does It Mean to the Pharma Industry?
Serialization is the affixing of unique serial numbers (Unique Product Identifier) to each saleable package unit of product.
Aggregation is the linking of all package levels in a parent/child relationship (i.e. bundle, case, pallet).
Track and Trace is the tracing of a product through the supply chain to the end consumer or point of dispensation.
In the U.S., the Unique Product Identifier (UPI) consists of:
- A National Drug Code (NDC) or a Global Trade Item Number (GTIN)
- A Serial Number (alphanumeric up to 20 characters)
- A Lot Number
- An Expiration Date
Counterfeit medicines have become a serious threat to public health.
10% of medicines sold worldwide are counterfeit (source: WHO)
Counterfeit medicines are 20% more profitable than heroin (source: WHO)
Counterfeit medicines cause 700,000 deaths / year (malaria & tuberculosis treatment only; source: OECD)
Counterfeit medicines produce $200 billion in annual revenue (source: WCO)
Serialization Challenges For Dispensers
Timeliness: If you cannot achieve serialization compliance in time, you put your whole business at risk
Productivity: Central configuration and prequalification reduce impact on OEE and speed up deployment
Connectivity: Serial numbers, master data and event information need to be exchanged among supply chain parties and also reported in a compliant way.
Communication: Serialization implementation requires the coordination of numerous internal and external stakeholders. Don’t underestimate the scope of your project!
Serialization and Beyond: when choosing your serialization solution, don’t forget to consider future compliance and regulatory requirements. Beyond compliance, think of the business potential of your serialization data.
Are You Ready For The DSCSA?
FDA has developed materials for state officials, including overviews of the requirements and standards for licensure, a summary of the 2015 Intergovernmental Meeting, and two Long-Term Information-Sharing Agreements to facilitate the exchange of information about DSCSA between FDA and the states.
- Overview of Product Tracing Requirements
- Overview of Wholesale Distributor and Third-party Logistics Provider Requirements and Standards for Licensure (PDF – 338KB)
- FDA’s Guidance on Uniform National Policy (Section 585 of the FDCA) (PDF – 155KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting
- Intergovernmental Working Meeting on the DSCSA, November 17, 2015: Summary and Action Items (PDF – 98KB)External Link Disclaimer
- DSCSA Long-Term 21 CFR §20.88 Information-Sharing Agreement Template: DSCSA only (PDF – 166KB)
- DSCSA Long-Term 21 CFR §20.88 Information-Sharing Agreement Template: Combined DSCSA and Compounding Agreement (PDF – 165KB)
The FDA webpage will be updated as new information becomes available. FDA encourages state officials to explore this webpage and the DSCSA to learn more about the law