Oct 15 -- The Food and Drug Administration (FDA or the Agency) is announcing a virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to system attributes necessary to enable secure tracing of product at the package level. The public meeting will be held on November 16, 2021, from 9 a.m. to 4 p.m., and will take place virtually. Submit either electronic or written comments on this public meeting by January 18, 2022.
On November 27, 2013, the DSCSA (Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. This system will enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain. Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(g)(1)) imposed requirements for the enhanced drug distribution security that go into effect on November 27, 2023. Additionally, section 582(i) of the FD&C Act directs FDA to hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from members of the pharmaceutical distribution supply chain and other interested stakeholders. Section 582(h)(3) of the FD&C Act directs FDA to conduct a public meeting and issue guidance addressing the system attributes necessary to enable secure tracing of product at the package level.
FDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below:
How is implementation of the 2023 enhanced system requirements progressing for your organization?
What challenges are your organization facing?
Are the proposed recommendations in FDA's draft guidance entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act” (June 2021) helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
Are there areas in which FDA could provide more clarity?
1. Enhanced Drug Distribution Security -- System Attributes; Aggregation, Inference, and Physical Security Features
2. System Structure -- Data Architecture; Adoption of Data and System Security; Protecting Confidential Commercial Information and Trade Secrets; System Access and Data Retrieval
3. Enhanced Product Tracing -- Serialized Transaction Information and Data Exchange (Incorporation of the Product Identifier into Product Tracing Information); Responsibilities of the Selling and Buying Trading Partners in Regard to the Product Tracing Information; Handling Aggregation Errors and Other Discrepancies
4. Gathering of Relevant Product Tracing Information
5. Enhanced Verification -- Verification of Distributed Product; Verification of Saleable Return Product; Alerts for Illegitimate Product
6. Trading Partner Readiness -- Your organization's Overall Readiness for Implementation of the Enhanced Drug Distribution Security Provisions of the DSCSA That Go into Effect in 2023; Components That Your Organization Is Furthest Along in Developing, Including the Components Being Prioritized and the Components That Are Easier or More Challenging to Implement: i. Technical Components, ii. Technical Infrastructure, iii. Business Processes, iv. Employee Training
Public Meeting on Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA), November 16, 2021 https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-
FR notice of Nov 16 meeting with opportunity to present: https://www.federalregister.gov/documents/2021/10/15/2021-22474/enhanced-drug-distribution-security-at-the-package-level-under-the-drug-supply-chain-security-act
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act: Guidance for Industry (draft) https://www.fda.gov/media/149704/download