Applied DNA Sciences Inc (BNBX)

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Two FDA Notices published in the Federal Register yesterday.

Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments
The Proposed DSCSA Pilot Project Program
FDA will be seeking pilot project participants from the pharmaceutical distribution supply chain (authorized manufacturers, repackagers, wholesale distributors, and dispensers) and other stakeholders. FDA expects that participants will propose the design and execution of their pilot project in their submission to FDA; however, FDA intends to meet with all pilot project participants to ensure that the learnings from the pilot project(s) will be complementary in informing the direction of the development of the electronic, interoperable system that will go into effect in 2023. FDA encourages supply chain members to focus their proposed pilot project(s) on the DSCSA requirements related to the interoperable, electronic tracing of products at the package level. Specifically, the pilot project(s) should focus on the requirements for package-level tracing and verification that go into effect in 2023. Such pilot projects will be more useful than pilot projects dedicated to lot-level tracing. If there are adequate pilot project submissions, FDA may establish more than one pilot project to accomplish the goals of the DSCSA Pilot Project Program.

https://www.federalregister.gov/documents/2017/07/20/2017-15203/pilot-project-program-under-the-drug-supply-chain-security-act-request-for-comments

Also

Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments

FDA will hold public meetings on August 23, 2017, December 5 and 6, 2017, and February 28, 2018, on enhanced drug distribution security. The purpose of these public meetings is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. These public meetings will focus on the following topics for discussion:

What supply chain security should look like in 2023
What is needed for enhanced drug distribution security
What is needed for electronic interoperability
Standards for product tracing
Data architecture options for an electronic interoperable system
The management and maintenance of product tracing data
The use of aggregation and inference for enhanced product tracing and verification
Building capacity for a unit-level system for product tracing and verification

https://www.federalregister.gov/documents/2017/07/20/2017-15204/enhanced-drug-distribution-security-under-the-drug-supply-chain-security-act-public-meetings-request