The U.S. Food and Drug Administration (FDA) has unveiled a significant development in pharmaceutical compliance with the immediate implementation of new guidelines. This guidance, titled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies,” outlines the FDA’s stance on enforcing requirements related to electronic, package-level product tracing. These enhanced drug distribution security requirements, mandated by section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), have been introduced primarily to ensure the integrity of the pharmaceutical supply chain.

 

 

 

 

 

 

 

 

Key points of the guidance

 

• Who’s affected: The guidance applies to a range of stakeholders, with a primary focus on manufacturers, wholesale distributors, dispensers, and repackagers. These trading partners must adhere to the enhanced drug distribution security requirements.

 

• Effective date: The requirements come into force on November 27, 2023.

 

• Stabilization period: To facilitate the transition and implementation of these critical measures, the FDA has instituted a 1-year stabilization period. During this period, the industry will have additional time to fine-tune its systems and processes while ensuring that patients continue to have access to essential pharmaceutical products.

 

• No delay justification: It’s important to note that the stabilization period should not be interpreted as a justification for delaying compliance efforts. Trading partners must still make every effort to implement the enhanced drug distribution security requirements within the stipulated time frame.

 

• Enforcement timeline: The FDA will not actively enforce the enhanced drug distribution security requirements until November 27, 2024. Additionally, enforcement of section 582(g)(1)(B) of the FD&C Act will not apply to products introduced into commerce by manufacturers or repackagers before November 27, 2024, and for subsequent transactions involving such products until their expiry.

 

 

Insights of the guidance

 

The FDA’s guidelines enhance pharmaceutical supply chain security and traceability.

 

All trading partners are obliged to meet several key requirements under section 582(g)(1) of the FD&C Act:

 

  Electronic data exchange

Secure, interoperable, electronic methods must be employed to exchange transaction information and transaction statements. This should include package-level product identifiers for each package involved in the transaction.

 

  Product verification

Systems and processes must be in place to verify products at the package level.

 

  Prompt response

Trading partners must be equipped with systems and processes to swiftly respond with transaction information and transaction statements upon request by regulatory authorities, particularly in cases of recalls or investigations involving suspect or illegitimate products.

 

  Information gathering

Systems and processes should facilitate the collection of necessary information for producing transaction information, including tracing back to the manufacturer, as needed.

 

  Saleable returns

Trading partners accepting saleable returns must establish processes for accepting these returns and associating them with the respective transaction information and transaction statement.

 

 

 

FDA prioritizes interoperability and EPCIS for Pharma security

 

The impending shift to electronic-based methods highlights the crucial role of interoperability in ensuring secure and efficient transaction information exchange among trading partners.

 

The FDA recommends adopting the globally recognized Electronic Product Code Information Services (EPCIS) standard, enabling seamless data sharing and compliance with DSCSA requirements. While various technological approaches are available, EPCIS stands out as a highly recommended choice due to its potential to facilitate compliance.

 

Protecting confidential information is paramount, necessitating robust systems and practices. These recommendations set the stage for enhanced drug distribution security, providing a foundation. They aim for successful implementation and compliance as the pharmaceutical industry evolves towards a more secure supply chain.

 

 

Source: https://www.fda.gov/