FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act

July 5, 2022

FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act

FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security Act (DSCSA). These documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on November 27, 2023. We invite interested stakeholders to comment through the dockets linked below.

The DSCSA outlines steps to achieve electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. This will improve FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, Revised Draft Guidance

  • This draft guidance recommends that trading partners use GS1’s Electronic Product Code Information Services (EPCIS) standard to provide and maintain the electronic data associated with transaction information and transaction statements.
  • The revisions enable the interoperable exchange of DSCSA-related information in a uniform manner and reflect the enhanced drug distribution security requirements that will go into effect on November 27, 2023, including only electronic methods and product tracing and verification of product at the package level.
  • Please see Docket FDA-2014-D-1981 for more information.

Identifying Trading Partners Under the Drug Supply Chain Security Act, Revised Draft Guidance

  • This draft guidance will help industry and state and local governments categorize the entities in the drug supply chain in accordance with the DSCSA.
  • Specifically, this guidance addresses the status of some entities as DSCSA trading partners, including private-label distributors, salvagers, and returns processors and reverse logistics providers.
  • The revisions also discuss the applicability of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act related to third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards.
  • Please see Docket FDA-2017-D-1956 for more information.

More Information

Interested in learning more? Contact us today to find out how we can help with your global regulatory needs.

 




Agency Alerts General Regulatory

July 5, 2022

FDA Gains Ground in Development of Pilot Program Required Under Drug Supply Chain Security Act

The Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013, “outlines critical steps to build an electronic, interoperable system” to identify and trace prescription drugs...

Read More
Agency Alerts General Regulatory

July 5, 2022

FDA Releases Interim Policy for the Regulation of Bulk Drug Substances Used in Compounding

On October 26, 2015, FDA released two draft guidances with interim regulations regarding the use of bulk drug substances in compounding under sections 503A and 503B of the Federal Food, Drug, and...

Read More
ANDA FDA

July 5, 2022

FDA publishes product-specific guidances to facilitate generic drug development

Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...

Read More