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 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: PDSA
PDSA and its members have submitted a letter request the FDA to issue formal clarification of 3PL licensure status, as stated in the DSCSA, in written form through guidance, press… 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: 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 Position Statement on Administration's Importation Final Rule
The Pharmaceutical Distribution Security Alliance (PDSA) released the following statement on the Department of Health and Human Services’ (HHS) final rule permitting the establishment of programs to import prescription drugs… Read More →
Source: PDSA
PDSA developed a series of Questions and Answers to help stakeholders understand industry perspectives on key open questions related to interoperability and DSCSA implementation. These Q&As supplement previous Q&As published… Read More →
Source: PDSA
The Pharmaceutical Distribution Security Alliance (PDSA) has released “A Proposal: Governance for DSCSA Phase II Interoperability,” the first in a series of White Papers. Through this series of papers, PDSA… 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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