GDP in the US: FDA gives One-Year Reprieve on DSCSA enhanced Drug Distribution Security Requirements

On 28 August 2023, the U.S. Food and Drug Administration (FDA) has published a final guidance for industry entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies".

The guidance addresses all trading partners, in particular manufacturers, wholesale distributors, dispensers, and repackagers, who are subject to requirements under section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024."FDA is issuing this guidance to address industry readiness to comply with these requirements."

Section 582(g)(1) of the FD&C Act

According to section 582(g)(1) of the FD&C Act, on 27 November 2023 the following interoperable, electronic tracing of product at the package level requirements shall go into effect:

• "(A) The transaction information and the transaction statements [...] shall be exchanged in a secure, interoperable, electronic manner [...]
• (B) The transaction information [...] shall include the product identifier at the package level for each package included in the transaction. [...]
• (C) Systems and processes for verification of product at the package level, including the standardized numerical identifier, shall be required. [...]
• (D) The systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the Secretary (or other appropriate Federal or State official) in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required.
• (E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer, as applicable, shall be required. [...]
• (F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product."

Content of the New Guidance

The seven-page document starts with an introduction. It gives a brief overview of the Drug Supply Chain Security Act (DSCSA). The DSCSA was signed into law on 27 November 2013. It outlines critical steps for building an electronic, interoperable system by 27 November 2023 to identify and trace certain prescription drugs through the pharmaceutical distribution supply chain in the US.

The authority writes that it "believes the compliance policies provided in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the DSCSA while helping ensure continued patient access to prescription drugs."

The following background chapter provides an overview of the requirements under the DSCSA and the critical steps. The guidance states that "trading partners are continuing to put in place the necessary systems and processes in order to electronically exchange product tracing information." However, "FDA has heard from stakeholders, including a broad representation of trading partners, about concerns regarding trading partner readiness and the need for clarity and flexibility to ensure trading partners can continue to move product through the supply chain when the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act take effect. While FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023, we recognize that some technical and operational issues, including issues involving trading partners and other affected stakeholders, may not be fully resolved by that time."

In order to take account of this fact, the guidance is intended to provide clarity and flexibility to trading partners. Nevertheless, the authority makes clear that the 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."

Chapter III of the guideline refers to the product identifier as required by 582(g)(1)(B) of the FD&C. The FDA grants a one-year extension, as it does not intend to take action to enforce this requirement until 27 November 2024. The same applies for the "requirement under section 582(g)(1)(B) of the FD&C Act with respect to product that is introduced in a transaction into commerce by the product’s manufacturer or repackager".

In Chapter IV the authority informs about the compliance policies with respect to the other requirements according to sections 582(g)(1)(A), 582(g)(1)(C), 582(g)(1)(D), 582(g)(1)(E), and 582(g)(1)(F). Again, until 27 November 2024, FDA does not intend to take action to enforce these requirements.

The FDA concludes that these compliance policies "balance the development of robust interoperable, electronic tracing of product at the package level through the pharmaceutical distribution supply chain with the technical and operational complexities associated with the implementation of the enhanced drug distribution security requirements established by the DSCSA."

Download

The guidance document is available for download on the FDA website.