Source: FDA
The DSCSA requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing… Read More →
Source: Public Law 113–54
On November 27, 2013, President Obama signed into law the Drug Quality and Security Act (DQSA), P.L. 113-54 (27 Stat. 587). P.L. 113-54 contains two separate titles: Title I addresses… Read More →
Source: GS1 Healthcare
The vision of GS1 Healthcare is to be recognised, open and neutral source for regulatory agencies, trade organisations and other similar stakeholders seeking input and direction for global standards in… Read More →
Source: PDSA
National uniformity is established through the DSCSA by preempting certain state requirements related to product tracing, licensure of wholesale distributors, and licensure of 3PLs. The DSCSA requires a common understanding and approach from… Read More →
Source: PDSA
PDSA and its members have considered and evaluated what we believe to be the most appropriate approaches to exceptions and grandfathering. PDSA offered these comments and suggestions to FDA to assist the… Read More →
Source: PDSA
PDSA and its members have considered and evaluated what we believe to be the most appropriate approaches to exemptions and waivers. PDSA offered these initial comments and suggestions to FDA to assist the… Read More →
Source: Rx-360
With the quickening pace of global pharmaceutical regulatory drug serialization and traceability mandates, the RX360 Traceability Data Exchange and Architecture Workgroup (TDEA) began its activities in August of 2014 hosting… Read More →
Source: PDSA
Consistent State adherence to the uniform national requirements of the DSCSA is critical to the successful implementation of the statute. PDSA is concerned that the lack of uniformity among State approaches will… Read More →
Source: PDSA
The DSCSA establishes national standards for the licensure of wholesale distributors and third-party logistics providers (3PLs). As part of that licensure scheme, wholesale distributors and 3PLs are required to annually report to… Read More →
Source: PDSA
Given the interconnected nature of the supply chain, we are encountering a large degree of uncertainty and challenge regarding January 1, 2015 implementation across all sectors of the supply chain. As with… Read More →
We are a coalition of more than 30 stakeholders spanning the supply chain spectrum – including biologic and pharmaceutical manufacturers, distributors, pharmacies, and logistics providers.
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