PDSA Letter Re: DSCSA Licensing Standards
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 →
PDSA Comments Re: FDA Importation Proposed Rule
Source: PDSA
PDSA formally submitted comments on the Food and Drug Administration’s proposed rule on the importation of pharmaceutical products. In short, PDSA has significant concerns that the proposed rule would undermine… Read More →
PDSA Vision for DSCSA Governance: Whitepaper & Webinar Recording
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 →
PDSA & DSCSA: Prior Work and Future Directions
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 →
The Healthcare Distribution Management Association
Source: HDMA
HDMA is the national association representing primary pharmaceutical distributors, the vital link between the nation’s pharmaceutical manufacturers and healthcare providers. HDMA reviews key priority issues and advocates on behalf of… Read More →
Food and Drug Administration
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 →
The Drug Supply Chain Security Act
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 →
GS1 Healthcare
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 →
PDSA FAQs on Preemptive Effect of the DSCSA
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 →
PDSA Letter Re: DSCSA Guidance and Process for Exceptions and Grandfathering
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 →