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 →
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
PDSA respectfully asks that the FDA provide further direction and clarity consistent with the following supplemental question and answer: If a dispenser is not required to be licensed under applicable state law, how… Read More →
Source: PDSA
PDSA respectfully asks that the FDA provide further direction and clarity with regard to, and consistent with, the following additional question and answer: If an entity constitutes a “manufacturer” under… 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: 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: PDSA
PDSA respectfully asks that the FDA expressly acknowledge the acceptability and appropriateness of using an abbreviated transaction statement and specifically asks that the FDA acknowledge the acceptability and appropriateness of… Read More →
Source: PDSA
Since the enactment of the DSCSA members of PDSA have identified a number of questions that are not clearly answered by the plain language of the DSCSA and create operational… 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: 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 →
We are a coalition of more than 30 stakeholders spanning the supply chain spectrum – including biologic and pharmaceutical manufacturers, distributors, pharmacies, and logistics providers.
Learn More →
