One week to DSCSA

With just days before the deadline, it's time for a recap of the DSCSA provisions that are already in effect, and those that start in November 27. Read on for a quick overview!

At present, all pharmaceutical trading partners must:

• Ensure that they're only doing business with Authorized Trading Partners.
• Have systems in place for verification, with the ability to Identify, quarantine, and investigate suspect products; notify the FDA and trading partners of illegitimate products; and dispose of illegitimate products.
• Include a product identifier for all drug packages and homogenous cases, unless dealing with product that is subject to grandfathering, waivers, exceptions, or exemptions by the FDA.
• Provide, receive, and maintain lot-level transaction data.
• Include transaction data with each product exchange, delivered via Advanced Shipping Notice (ASN) or through an online portal. (This is known as 3Ts: Transaction Information, Transaction History, and Transaction Statement)
• Respond to government requests for information by providing lot-level transaction data.
• Retain transaction data related to suspect/illegitimate products for six years.

These will be enforced by FDA and state regulators, with violations incurring seizure, injunction, criminal fines and penalties, and other measures. Trading partners may also set their own penalties or incentives around compliance; regardless, noncompliance  can cause serious damage to a company's reputation.

Incoming DSCSA Requirements

Soon, the set of requirements known as “Section 582(g)(1)”, “package-level”, or “enhanced security" go into effect.

As of November 27, 2023, all pharmaceutical trading partners must:

• Exchange TI and TS securely, electronically, and interoperably.
• Include in Transaction Information the unique identifier of each package in the transaction (referred to as “serialized data”).​
• Have systems and processes for verification of product identifiers at the package level.​
• Be able to respond to appropriate tracing requests and trace products at the package level. ​
• Associate a saleable return with the Transaction Information (TI) and Transaction Statement (TS) associated with that product

As the FDA has noted, these requirements can be satisfied by Electronic Product Code Information Services (EPCIS) files with accurate product identifiers for each package. Exchanging serialized data in EPCIS enables package-level tracing.

Keep moving forward

It's important to note that the FDA has clarified an often misunderstood statement on the stabilization period.

In August, the administration announced that it “does not intend to take action to enforce” 582(g)(1) until November 27, 2024. However, it then detailed its intentions in a statement, uncharacteristically underlined for emphasis in the original:

"This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements."

The FDA’s stabilization period is not enforcement discretion, meaning that businesses are at risk of regulatory enforcement actions if they aren't complying with current requirements, or if they're stopping or slowing their compliance with 582 (g)(1).

Trading partners are expected to continue using current methods to handle transaction data while they begin to stabilize and make their systems fully interoperable for “accurate, secure, and timely electronic data exchange.”

In short, FDA still expects trading partners to have systems and processes in place to meet their requirements as of November 27, 2023. If you're not there yet, now's the time to ask for help!