Drug Supply Chain Security Act (DSCSA) Unpacked
Challenges of Pharmaceutical Traceability
The U.S. Pharmaceutical & Life Sciences market accounts for over 40% of global pharmaceutical sales and is expected to grow to over 680 billion. This rise is driven by a growing, aging population with higher disposable income. Although the vast majority of pharmaceuticals sold in the U.S. are safe, this large and growing market is an attractive target for theft and counterfeiting. A long-standing estimate by the World Health Organization (WHO) suggests that between five and eight percent of pharmaceuticals sold worldwide is counterfeit; many experts consider this estimate low.
Counterfeit or falsified medical products can contain the wrong active ingredients, no active ingredients or toxic ingredients, and are often produced in unsanitary conditions by untrained personnel. Furthermore, they are carefully produced to look identical to genuine products, making them difficult to detect. These fraudulent products can either fail to treat a patient's condition or cause a dangerous and possibly fatal reaction. There have been numerous high-profile cases where illegitimate pharmaceuticals have caused illness and death.
To protect patients from these dangers, the safety of the life sciences supply chain is essential. Many countries worldwide have already enacted and enforced product serialization and Track & Trace requirements. The Food & Drug Administration's Drug Supply Chain Security Act (DSCSA) is designed as a tool to help combat illegitimate pharmaceutical products in the U.S.
About the Drug Supply Chain Security Act (DSCSA)
Enacted in 2013, the DSCSA is a U.S. federal law designed to secure the life sciences value chain and protect patient safety by providing a single standard for tracking and tracing certain prescription drugs throughout the supply chain. The law replaces an assortment of state requirements. In response to the growing number of substandard or counterfeit pharmaceutical products, the DSCSA system verifies pharmaceuticals at all stages from the manufacturer to the pharmacist to the consumer. As the phased implementation completed, full unit-level traceability, including aggregation, is required.
Benefits of the Drug Supply Chain Security Act (DSCSA)
- Improved patient safety as counterfeit drugs are prevented from entering the supply chain
- New and faster ways to identify illegitimate products in the supply chain
- Safer and more efficient supply chains
- Clearer regulations with a single source of truth
- Stronger distributor licensure standards
Requirements of the Drug Supply Chain Security Act (DSCSA)
The DSCSA requires trading partners in the pharmaceutical supply chain - manufacturers, wholesale distributors, re-packagers, third-party logistics firms and dispensers (mainly pharmacies) - to track, trace and verify prescription drugs, ensuring that only proper, safe medicines reach patients.
1. Product Identification
Manufacturers and repackagers are required to serialize products, which is accomplished by attaching a standardized product identifier that includes the product’s standardized numerical identifier (SNI), unique to each package or case, lot number, and expiration date, in both humanand machine-readable format. The product identifier data will be included in a 2-dimensional data matrix code on each package; and linear or 2-dimensional matrix bar code on each homogenous case. Manufacturers and repackagers must maintain product identifier records for at least 6 years.
2. Product Verification
Manufacturers, wholesale drug distributors, repackagers and some dispensers must provide information that verifies a product is legitimate and must quarantine and investigate a product that might be illegitimate—in other words, a product that is suspected of being counterfeit, diverted or stolen. There must be a process to notify trading partners and the FDA of suspected illegitimate products in a timely manner, and a process for responding to notifications of illegitimate products.
3. Product Serialization
Manufacturers must serialize prescription drugs, including a serial number, lot number, expiration date and product identifier (GTIN® or NDC). Manufacturers must verify products at the package level and must provide 3T documents electronically. Repackagers must ensure serialization for repackaged medicines and must be able to generate their own serial numbers. Repackagers must keep track of the relationship between the original and repurposed products. Repackagers can only transact certain pharmaceuticals if they are properly serialized and must verify products at the package level.
4. Saleable Returns
Wholesale distributors must verify the serialized product identifiers of any saleable returned pharmaceuticals before they can be resold. The wholesaler initiates a verification request to the manufacturer, who must respond within 24 hours with a verification response. Verification includes ensuring the product identifier is correct and true, including the serial number, lot number, expiration date and Global Trade Item Number (GTIN).
5. Authorized Trading Partner (ATP)
As a key part of DSCSA requirements, pharmaceutical dispensers, distributors and manufacturers must only engage with other authorized trading partners. Movilitas.Cloud became an early adopter of this initiative, proving to be a trusted solution partner for fast implementation and credentialing.
6. Product Tracing
Trading partners must provide information about a drug and who handled it for every transaction in the U.S. pharmaceutical market. Manufacturers, wholesale distributors and re-packagers, prior to or at the time of the transaction, must provide trading partners with transaction information, transaction history and a transaction statement. Product tracing standards currently require traceability at the lot level, but additional changes will take effect when the DSCSA enters the Enhanced Drug Distribution Security (EDDS) phase including the requirement to trace products electronically down to the package level.
What You Need to Do to Comply with DSCSA
As a manufacturer, wholesale distributor, re-packager, third-party logistics firm or dispenser, you have strict responsibilities to your customers and other trading partners, as well as licensing and record-keeping requirements and a duty to report to the FDA:
1. Trade with Properly Licensed Partners
- Manufacturers and re-packagers must have valid FDA registration
- Distributors and 3PLs must have valid state or federal licenses and must comply with reporting requirements
- Check the FDA’s drug establishment current registration site database (DECRS) to verify the licensure of your trading partners
- Use form FDA-3911 to notify the FDA within 24 hours if you believe you possess an illegitimate product
- Notify trading partners within 24 hours
- Quarantine and investigate products you believe might be illegitimate
- Take steps to ensure patients do not receive illegitimate product
2. Standardize Operating Procedures to Identify Products that Might be Falsified
- Use form FDA-3911 to notify the FDA within 24 hours if you believe you possess an illegitimate product
- Notify trading partners within 24 hours
- Quarantine and investigate products you believe might be illegitimate
- Take steps to ensure patients do not receive illegitimate product
3. Share the 3Ts During All Transactions
- Transaction Information (TI)
- Transaction History (TH)
- Transaction Statements (TS)
4. Track and Trace Pharmaceuticals
- Only accept products with complete tracking information, including the 3Ts
- Generate and provide complete product tracing information when dealing with trading partners
- Respond to requests by trading partners within two business days in the case of a recall or other investigation
- Store tracing information for at least six years
5. Prepare to Respond to Information Requests
- Respond to requests by trading partners within two business days in the case of a recall or other investigation
- Store tracing information for at least six years
6. Check for Proper Product Identifiers
- A product identifier that contains an NDC, serial number, lot number and expiration date in human- and machine-readable format
- Manufacturers and re-packagers must place a product identifier on prescription pharmaceutical packages
- Dispensers can only buy or sell properly identified and serialized pharmaceuticals
How Engineering Industries eXcellence Can Help
The DSCSA and other pharmaceutical regulations require strict drug serialization and reporting to both governmental databases and supply chain partners. To achieve compliance, pharmaceutical companies need a serialization solution that scales to high data volume, effectively integrates with master and transactional data, connects the supply chain network and provides compliant reporting. Look no further than Movilitas.Cloud, the easy-to-use, highly configurable, Software-as-a-Service solution offered by the Industries eXcellence division of the Engineering Group. The application's Serialized Manufacturing and Serialized Logistics enable businesses to make serialization and compliance easy.
