Source: The Food and Drug Law Institute
The Drug Quality and Security Act (the DQSA), enacted on November 27, 2013, enhances the security of the pharmaceutical supply chain by establishing a national system for traceability and serialization… Read More →
Source: U.S. House of Representatives Energy and Commerce Committee
Background: This hearing will focus on the importance of securing the downstream pharmaceutical supply chain, which includes manufacturers, wholesale distributors, pharmacies, repackagers and third-party logistics providers. In order to ensure… Read More →
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: 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: The Food and Drug Law Institute
For at least the past decade, federal and state regulators have been concerned about potential threats to supply chain security and patient safety, which may arise from gaps in the… Read More →
Source: PDSA
Initially convened to address threat of CA pedigree system, PDSA worked closely with Congress, FDA and other stakeholders to propose and pass the DSCSA. After the DSCSA law was signed… 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
The DSCSA establishes a national system for the traceability of certain prescription pharmaceutical products through the distribution chain. A cornerstone of that system is the identification and disposition of “illegitimate… Read More →
Source: PDSA
The national uniformity of the DSCSA is achieved through preemption of certain state requirements, as set out in Section 585 of the Food, Drug, and Cosmetic Act (FDCA). PDSA appreciates the FDA’s efforts… 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 →
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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