DSCSA Requirements and Implementation Readiness: Why It Is Crucial to Be Prepared

In November 2013, a landmark decision was taken by Congress to strengthen the U.S. pharmaceutical supply chain. The Drug Supply Chain Security Act (DSCSA) became law, establishing regulations designed to address the issues of counterfeit, contaminated, stolen, or otherwise harmful drugs endangering public health. It was created to keep these illicit and counterfeit drugs out of the U.S. drug supply chain, protecting end users. The act outlines steps for electronically tracking and tracing prescription drugs at the packaging level. 

Key DSCSA Requirements  

DSCSA requirements mandate manufacturers, wholesalers, healthcare providers and pharmacies to maintain and securely share certain prescription drug data. It aims to maximize patient and public safety by preventing the distribution of incorrect or harmful drugs and to enhance the security of our country’s drug supply with a more seamless flow of data between supply chain partners. This is achieved by marrying the physical with its digital counterpart. This dual representation includes a digital version manifested though barcodes and transaction event data, coupled with the physical version bearing product identifier data in a human-readable format on the label. The primary goal of these DSCSA requirements is to support the pharmaceutical industry with inventory accuracy and establish other operational proficiencies. 

Expectations for Trading Partners and Health Systems 

In the dynamic healthcare supply chain management landscape, understanding the DSCSA requirements and developing a solid implementation plan is crucial for both trading partners and healthcare systems, whether in a consolidated pharmacy service center, warehouse or a hospital. With the November 2023 DSCSA compliance requirements now in effect and a one-year stabilization period extending to November 2024, there is a real urgency to ensure traceability and transparency in the pharmaceutical supply chain. The need for efficient and streamlined pharmacy operations and an exhaustive understanding of requirements for trading partners and health systems has never been more critical given shifting regulations and compliance requirements. Although there are some basic similarities in expectations for both, specific requirements exist separately for each distinct group and sub-groups.  

Both trading partners and health systems must become familiar with the law working with their respective teams to ensure understanding occurs and communications take place both ways to confirm knowledge to build confidence in their partnership and plans. Manufacturers, repackagers, wholesale distributors and dispensers (which could include a health system) must provide product tracing information and must know how to handle suspect and illegitimate products. As authorized trading partners, health systems should confirm their counterparts’ authorization by checking the state licensure website; third-party logistics providers and wholesale distributors must report licensure annually.   

Manufacturers, repackagers, wholesale distributors and dispensers must also adhere to these DSCSA requirements: 

1. Transaction Information: Provide, capture and maintain information about transactions involving products distributed within the United States as well as the trading partners who engaged in these transactions.  
2. Systems and Investigations: Establish systems and processes to conduct investigations into the legitimacy of products upon determining that a product is suspect.  
3. Verification of Suspect Products: Upon receiving a request for verification from the Food and Drug Administration (FDA), they must quarantine any suspect product because it may be counterfeit, unfit for distribution or potentially dangerous.  
4. FDA Notification: Prompt notification to the FDA is mandatory when the suspect product is confirmed as legitimate. Conversely, if an illegitimate product is discovered, or a product is deemed to have a high risk of illegitimacy, they must alert the FDA and relevant stakeholders, quarantine and manage the disposition of the illegitimate product, and respond to any requests for verification of product identifiers on specific packages or homogenous cases (except for dispensers).  
5. Product Identification: Affix a product identifier with standardized graphics, including National Drug Code (NDC), serial and lot number and expiration date in both human- and machine-readable forms (a 2D data matrix barcode for packages and linear or a 2D data matrix barcode for homogenous cases). This does not apply to wholesale distributors and dispensers. 

Why DSCSA Regulations Compliance is Non-negotiable 

DSCSA compliance and a solid plan for all involved will soon be non-negotiable and there are numerous reasons why health systems will want to ensure every partner along the pharmaceutical supply chain is fully DSCSA ready, such as: 

1. Patient Safety: If pharmaceutical companies and their distributors are not DSCSA compliant, it could compromise the safety and efficacy of the drugs that pharmacies dispense to patients, causing illegitimate products to enter the market.
2. Supply Chain Integrity: Pharmacies rely on the DSCSA mandated enhanced drug traceability and serialization throughout the supply chain to confirm they are receiving legitimate products. Without compliance by pharmaceutical companies or distributors, the integrity of the entire supply chain could be disrupted.
3. Operational Effectiveness: Delays or uncertainties in verifying the authenticity of drugs can disrupt pharmacy operations, leading to potential delays in patient care and erosion of trust around the source of their products.
4. Regulatory Compliance: Partnering with DSCSA-compliant pharmaceutical companies and distributors makes it easier for pharmacies to meet their own upstream and downstream compliance obligations.
5. Financial and Legal Implications: As a trading partner, non-compliance with DSCSA requirements can result in significant penalties and fines or potential legal risks for pharmaceutical companies and distributors, which could potentially affect their downstream business relationships and pricing structures with health system pharmacies.
6. Reputation and Trust: Non-compliant or ill-prepared trading partners could raise questions about their overall commitment to quality, safety and regulatory adherence. This could erode the trust with the health system and their downstream patients and customers.
7. Future Preparedness: Pharmacies want to align themselves with forward-thinking pharmaceutical companies and distributors that are both compliant now and prepared for future regulations after a ten-year preparation period.

These interdependent expectations and requirements for DSCSA trading partners and health systems alike highlight the significant imperative for alignment in this supply chain industry evolution. It is crucial to recognize that DSCSA readiness is not just a regulatory obligation, but an essential responsibility to patient safety, the integrity of the pharmacy supply chain and the advancement of healthcare.