The U.S. Pharmaceutical & Life Sciences market accounts for over 40% of global pharmaceutical sales and is expected to grow to over 680 billion by 2023. 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.
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 completes in 2023, full unit-level traceability, including aggregation, will be required.
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.
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.
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.
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.
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).
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.
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 on November 27, 2023, including the requirement to trace products electronically down to the package level.
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:
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.
