GDP in the US: Update on DSCSA Implementation

In the US, there has been a lot going on in the area of Good Distribution Practice (GDP) in the last weeks and months. In this article, you will find a summary of recent developments.

FDA Stakeholder Call

The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. The U.S. Food and Drug Administration (FDA) has organized a stakeholder call to discuss the DSCSA implementation, which took place on 29 November 2023.

Topics included:

• 10-year anniversary of DSCSA implementation
• Stabilization period and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level
• Recent key guidances for industry related to supply chain security requirements
• Looking ahead

DSCSA Portal

End of November 2023, the FDA announced that the CDER NextGen Portal (CDER NextGen) now includes a DSCSA portal that enables the FDA and trading partners to communicate when the FDA requests information related to investigations of suspect or illegitimate products or during a recall.

The portal is used to:

• Confirm basic information and points of contact for trading partners
• Notify trading partners when they have messages from FDA
• Enable trading partners to respond to FDA messages and upload documents

Request for Information and Comments

On 20 November 2023, the FDA published a request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act).

Interested persons are invited to provide detailed information and comments on the progress of their enhanced drug distribution security implementation.

Summary Article

On 27 November 2023, the FDA Voices "FDA Protects Patients from Harmful Drugs Through the Drug Supply Chain Security Act" were published. Jaqueline Corrigan-Curay and Jill Furman from the Center for Drug Evaluation and Research (CDER) give an overview how FDA, industry members and other stakeholders have collaborated to implement the requirements over the past 10 years.

The following topics are covered:

• Implementing the DSCSA
• Stabilization period for industry
• Collaboration to implement supply chain interoperability

Webinar

The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research (CDER) has provided a webinar "Implementing DSCSA: Stabilization Period and Expectations"

Topics covered are:

• DSCSA implementation timeline
• Provisions of section 582(g)(1) of the FD&C Act
• Establishment of a stabilization period from November 2023 - November 2024 for trading partners to continue to build and validate interoperable systems and processes
• Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the FD&C Act—Compliance Policies
• Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
• Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act
• Addition key final guidances
• What is next and agency expectations

Overview of DSCSA Law and Policies

Since the DSCSA was enacted in 2013, the FDA has issued a couple of guidance and policy documents - as the overview "Drug Supply Chain Security Act Law and Policies" shows.

Key Requirements

The FDA also compiled an overview "What do I need to know about supply chain security requirements under the Drug Supply Chain Security Act (DSCSA)? on key supply chain requirements to help regulated firms navigate requirements and meeting their compliance obligations under the law.