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 Q&A Document on Dispenser Requirements under DSCSA
PDSA has developed a resource document for dispensing organizations looking to successfully implement the requirements of the Drug Supply Chain Security Act (DSCSA). Specifically, the resource document discusses the requirements… 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
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 →
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 →
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: 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 →
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 →