Countdown to DSCSA Compliance: What You Need to Know

The DSCSA deadline is quickly approaching, and many manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics (3PL) providers are scrambling to meet FDA requirements. So what do you need to know in order to be compliant? In this blog post, we will look into the details of the DSCSA act, why it was enacted, and the steps manufacturers, distributors, and 3PLs should take for compliance.

What is the Drug Supply Chain Security Act (DSCSA)?

Congress enacted the Drug Quality and Security Act (DQSA) on November 27, 2013. The Drug Supply Chain Security Act (DSCSA) sets forth new definitions and requirements to ensure the enhanced drug distribution security of the U.S. pharmaceutical industry supply by creating an electronic, interoperable system for tracking and tracing prescription drugs from manufacturers to dispensers at the individual and lot package level.

An amendment to the DSCSA was enacted in 2013, requiring companies throughout the prescription drug supply chain to take specific steps to improve safety and traceability. For example, manufacturers must abide by item-level traceability by affixing a product identifier on each package or homogenous case of products they ship. Repackagers must then track any changes made to the product and wholesale distributors must verify the pedigree of the products they receive. Lastly, dispensers must report any suspect product to the food and drug administration for analysis and to combat drug counterfeiting.

1. What is the Drug Supply Chain Security Act (DSCSA)?
2. Why Was the Security Act Adopted by Congress?
3. What Products are Subject to the Act?
4. When is the Deadline to Meet DSCSA Requirements?
5. What is Interoperable Tracing?
6. When Does Transaction Statement Reporting Go Into Effect?
7. Tips for Pharmaceutical Manufacturers, Wholesale Distributors, and 3PLs
8. Helpful Links for Drug Supply Chain Security and Safety
9. The Role of WMS Software in the Pharmaceutical Supply Chain

Why Was the Security Act Adopted by Congress?

The DSCSA was enacted in response to the growing problem of counterfeit, adulterated, and mislabeled drugs entering the U.S. that are identified by the FDA or have unfortunately made their way through the drug supply chain. The goal of the act is to create an electronic system of traceability that will identify potentially dangerous drugs and prevent them from reaching patients through the pharmaceutical distribution supply chain.

What Products are Subject to the Act?

The act applies to most prescription medicines distributed and dispensed in the U.S., with the exception of certain compounded, over-the-counter (OTC), and veterinary drugs. The act also requires that companies keep records of all transaction history, including sales, returns, recalls, and destruction related to these products.

When is the Deadline to Meet DSCSA Requirements?

The implementation phase has been in place since 2015, with the deadline for full implementation compliance being November 27, 2023. This deadline applies to all manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers in the U.S.

What is Interoperable Tracing?

Interoperable electronic tracing is a key component of the DSCSA. It requires that all entities in the drug supply chain use electronic systems to track and trace drugs with product identifiers, so they can be pinpointed and traced throughout their entire pharmaceutical supply chain journey – from manufacturer to patient.

There are three main components to interoperable electronic tracing as itemized below by the Pharmaceutical Distribution Security Alliance:

• “Interoperable Exchange. Trading partners must exchange required transaction information (TI) and transaction statements (TS) in a secure, electronic, interoperable manner, and the TI must include the product identifier at the package level.
• Interoperable Verification. Trading partners must be able to verify product identifiers on each package or sealed homogenous case in a secure, electronic, interoperable manner.”
• Interoperable Tracing. Trading partners must maintain secure, electronic, interoperable systems and processes to provide TI and TS in response to a request for it and to promptly facilitate gathering the information necessary to produce the TI for each transaction going back to the manufacturer.”

This method of product tracing and access to transaction information will provide unit-level traceability to protect consumers from any contaminated or suspicious product at the individual package level.

When Does Transaction Statement Reporting Go Into Effect?

While those in the pharmaceutical distribution supply chain have been required to report their state license, contact information, and any disciplinary action taken by the state or federal government, the final phase which includes the transaction statement reporting requirement goes into effect on November 27, 2023. Trading partners in the drug supply chain must exchange transaction information (TI) and a transaction statement (TS) for each sale or transfer of products that are subject to the DSCSA. The TI must include the product identifier at the package level.

Tips for Pharmaceutical Manufacturers, Wholesale Distributors, and 3PLs

There’s no way around it, if your company is in the pharmaceutical industry as defined above, it is imperative that you implement processes and achieve interoperable tracing as required by the supply chain security act by the deadline.

• Familiarize Yourself with the Law: Read the security act details. Note that there are some specific tracing and verification requirements that manufacturers need to meet, and others for wholesale distributors and 3PLs (also referred to as trading partners).
• Always Provide Product Transaction Information: This should include serialized transaction information, transaction history, and transaction statements.
• Learn to Identify Suspect and Illegitimate Products: Once such products are identified, be sure to secure the items and notify the FDA.
• Make Sure Each Trading Partner is Authorized: Confirm that all companies in your supply chain are authorized and properly licensed.
• Report Appropriate Licensure: Distributors and 3PLs are required to report their licenses to the FDA.

For pharmaceutical manufacturers, the most important step is to affix a standardized numerical identifier on each package and homogenous case of prescription medications they ship. This will allow FDA to track and trace each drug along its entire journey from manufacturer to patient. In addition, manufacturers must also ensure that their systems are compliant with the necessary standards and regulations laid out in the DSCSA to enable secure tracing.

Wholesale distributors and 3PLs must also take steps to meet DSCSA requirements. Distributors must verify the pedigree of all drugs they receive, while 3PLs must ensure that their systems are compliant with the necessary standards and regulations laid out in the DSCSA traceability requirements.

Related: Pharmaceutical Warehouse Challenges: Enhancing Productivity And Safety With Innovative Solutions

Helpful Links for Drug Supply Chain Security and Safety

Drug Supply Chain Security Act (DSCSA) | FDA

Drug Establishments Registration Site

Partnership for DSCSA Governance

Good Warehouse Practices in the Pharmaceutical Industry | iGPS

The Role of WMS Software in the Pharmaceutical Supply Chain

In order to comply with the DSCSA, many companies throughout the pharmaceutical supply chain rely on warehouse management system (WMS) software. WMS systems can help companies automate processes such as tracking and tracing prescription drugs, verifying pedigrees, and identifying illegitimate products. By automating these processes, WMS software can help companies save time and money while ensuring DSCSA compliance.

It’s important to know that ASC Software has been dedicated to supporting all DSCSA verification requirements since the act’s passage with a multitude of pharmaceutical companies. ASCTrac WMS software was made for the drug industry, providing innovative features and tools for interoperable data exchange, verification, and tracing. Users can utilize software modules for easy identification, packaging, and shipping under FDA guidelines.

To learn how ASC can help your company, whether you are a manufacturer, distributor, 3PL, or trading partner, contact us today.