Search Results for: interoperability

DSCSA, HDA, PDG

2 Organizations You Need to Join to Get Ready for the DSCSA Phase II

If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.  The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements … Continue reading 2 Organizations You Need to Join to Get Ready for the DSCSA Phase II →

DSCSA, FDA, Saleable Returns Verification

Why the FDA Extended The Saleable Returns Verification from 2020 to 2023

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In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability. One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to … Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023 →

DSCSA, EDDS, EPCIS

Drug Supply Chain Security Act, Phase II: Here’s what you MUST know

As 2020 transitioned to 2021, we took another step closer toward the implementation of 2023 Drug Supply Chain Security Act, Phase II. From manufacturers to wholesalers, pharmacies and other stakeholders, many uncertainties are swirling around the subject, so today we are writing to try to dispel some of the concern. Let’s start with an overview … Continue reading Drug Supply Chain Security Act, Phase II: Here’s what you MUST know →

Anti-counterfeiting, Traceability

WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020.  The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates.  That pool of countries shrinks each year as more and more new mandates are … Continue reading WHO Publishes Draft Policy Brief for Medicines Traceability Regulations →

PDG

The Partnership for DSCSA Governance Is Up and Running

The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing…” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II … Continue reading The Partnership for DSCSA Governance Is Up and Running →