Who is responsible for following DSCSA, and what are they responsible for?

The most significant evolution in the DSCSA framework, now actively being enforced, is the move from lot-level tracing to package-level tracing.

For a decade, the industry worked with a system where transaction data was exchanged for large batches (lots) of product. While helpful, a lot can contain hundreds of thousands of individual packages. If a single illegitimate package entered the supply chain, locating it was like finding a needle in a vast haystack, often requiring the quarantine or recall of the entire lot.

The final DSCSA phase requires:

• Serialization: Every individual prescription drug package must be marked with a unique Product Identifier (PI) in both human- and machine-readable form (a 2D DataMatrix barcode). The PI includes the National Drug Code (NDC), Serial Number, Lot Number, and Expiration Date.
• Interoperable Electronic Tracing: The transaction information (TI) and transaction statement (TS), collectively known as T3 data, must be exchanged securely and electronically for each individual saleable unit at the package level. This electronic system, often using EPCIS (Electronic Product Code Information Services), allows for immediate, digital verification.

This digital marriage of the physical drug package and its electronic data record is what empowers trading partners and regulators to instantly trace a drug’s lineage, verify its authenticity, and, most importantly, isolate and remove a suspect product in hours, not weeks. This efficiency saves lives.

Who Needs to Be DSCSA Compliant?

The DSCSA defines four core entities as Authorized Trading Partners (ATPs): Manufacturers, Repackagers, Wholesale Distributors, and Dispensers. All transactions involving prescription drugs must only occur between ATPs. Engaging with an unauthorized entity is a violation that immediately compromises supply chain security.

Here is a breakdown of the core responsibilities for each ATP under the enhanced security requirements.

I. Manufacturers & Repackagers

Manufacturers are at the top of the supply chain and bear the initial, foundational responsibility for serialization and data creation. Repackagers, who take a finished drug product and change its packaging for distribution (e.g., bottling large containers into smaller ones), have a similar role for the products they handle.

The responsibilities for these trading partners and their respective impacts on patient safety include:  

• Product Serialization: Affixing the unique Product Identifier (PI) to every saleable unit and homogenous case. This PI includes the serial number, which makes each package unique.
  • Patient Safety Impact: Creates the digital passport for the drug, making it impossible to pass a counterfeit (without the correct, unique serial number) through the secure system.
• Electronic Data Exchange: Providing the full electronic Transaction Information (TI) and Transaction Statement (TS) for each package in a secure, interoperable format (typically EPCIS) to the receiving trading partner (e.g., the Wholesale Distributor) prior to or at the time of the transaction.
  • Patient Safety Impact: Ensures downstream partners have the necessary data to perform package-level tracing and verification immediately upon receipt.
• Verification Response: Maintaining a secure, electronic system to quickly respond to a verification request from any downstream trading partner, state, or federal official. Response time is generally mandated to be within 24 hours.
  • Patient Safety Impact: Facilitates rapid investigation of suspect products by confirming if the serial number on a package matches the original data created by the manufacturer.
• ATP Status: Must have a current, valid registration with the FDA under section 510 of the FD&C Act.
  • Patient Safety Impact: Proves the product originates from a legitimate, government-registered source.

II. Wholesale Drug Distributors (WDDs)

Wholesale distributors are the critical link between manufacturers and dispensers. They manage massive volumes of product and are responsible for ensuring the security of the inventory they hold and distribute. Their responsibilities and those impacts to the safety of patients include:

• Receive & Store Serialized Data: Receiving the electronic, package-level TI and TS from the manufacturer or repackager and storing this information for at least six years.
  • Patient Safety Impact: Provides the historical data trail needed for regulators or other ATPs to investigate a product at any point during its lifecycle.
• Outbound Data Exchange: Providing the electronic, package-level TI and TS to the downstream trading partner (e.g., the Dispenser) prior to or at the time of the transaction.
  • Patient Safety Impact: Passes the digital passport forward, allowing the pharmacy to verify the drug before dispensing it to the patient.
• Saleable Returns Verification: Before accepting a returned product back into saleable inventory, the WDD must verify the Product Identifier with the manufacturer to ensure the product is legitimate.
  • Patient Safety Impact: Closes a major historical loophole used by criminals: preventing counterfeit or diverted product from being re-introduced into the supply chain via the returns process.
• ATP Status: Must have a valid state or federal license and comply with federal reporting requirements.
  • Patient Safety Impact: Ensures that entities handling the drug are licensed, inspected, and adhering to strict federal operating standards.

III. Dispensers (Pharmacies, Hospitals, Clinics)

Dispensers—the final step before the patient—have a paramount role in protecting the consumer. While they don’t generate the serialized data, they must be able to receive, store, and utilize it. Their core responsibilities and the direct impact to patient safety include:

• Accept Electronic T3 Data: Must receive and maintain the electronic Transaction Information (TI) and Transaction Statement (TS) for every package for at least six years.
  • Empowers the pharmacist to confirm the drug’s legitimacy. They can be held accountable for any suspect product if they cannot produce the corresponding electronic data record.
• Suspect Product Management: Developing and implementing systems to quarantine any product suspected of being counterfeit, stolen, or otherwise illegitimate. The dispenser must then conduct an investigation, using the serialized data to verify the product’s authenticity.
  • Patient Safety Impact: The last line of defense before the patient. A robust system ensures a suspect drug is removed from inventory and not accidentally dispensed.
• FDA Reporting: If a product is determined to be illegitimate, the dispenser must immediately notify the FDA using Form 3911 and notify immediate trading partners within 24 hours.
  • Patient Safety Impact: Triggers a rapid, system-wide alert to prevent other dispensers from receiving the same dangerous product.
• ATP Status: Must have a valid state license to dispense prescription drugs.
  • Patient Safety Impact: Confirms the entity providing medication to the public is licensed and regulated by state authorities.

DSCSA: Beyond the Ledger, a Public Health Mandate

The true significance of DSCSA compliance extends far beyond the technical requirements of scanning barcodes and exchanging electronic files. It’s about creating a national ecosystem of accountability and trust.

1. Protecting the Most Vulnerable

The victims of a compromised supply chain are often the most vulnerable: patients relying on life-saving medications. A contaminated cancer drug, a stolen vaccine, or a counterfeit opioid could have devastating, even fatal, consequences. DSCSA’s serialized tracking and verification capabilities mean that the moment a product is identified as illegitimate, every trading partner with that product in stock can be notified and the inventory can be located and removed with unprecedented speed.

2. Supply Chain Resilience and Stability

Before DSCSA, a single report of a suspect product could lead to widespread panic and recalls that disrupted the legitimate supply of medicine. With unit-level traceability, trading partners can perform surgical quarantines and tracebacks. They can confirm, with high certainty, which specific packages are compromised, allowing the remaining, legitimate inventory to continue flowing to patients. This supply stability is vital, preventing artificial shortages and maintaining patient access to care.

3. The Digital Transformation of Pharmacy

The DSCSA transition forces the pharmaceutical industry to embrace digital interoperability. Paper-based systems, PDFs, and manual processes are no longer compliant. This digital transformation streamlines operations, improves inventory management, and allows for much faster communication between partners—all necessary elements for a modern, efficient, and safe healthcare system.

The Road Ahead: No More Extensions

The initial November 27, 2023, deadline for the enhanced, electronic tracing requirements saw the FDA grant a stabilization period to allow the industry to mature its systems. However, the FDA has been clear that enforcement is now a reality. The final phase deadlines for the various ATPs are firm.

Compliance is not a one-time project; it’s an ongoing operational state. Every trading partner must:

• Audit their systems for true, package-level EPCIS data exchange capabilities.
• Validate their ATP network to ensure they are only transacting with licensed partners.
• Establish robust SOPs for exception handling (e.g., missing data, damaged barcodes) and for investigating suspect products.

For the pharmaceutical supply chain, DSCSA is the standard of care. Full compliance is a non-negotiable duty to the patients who depend on its integrity. It’s the promise that the medicine they receive is safe, effective, and exactly what the doctor ordered. The health of the nation relies on it.