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
The Drug Supply Chain Security Act was enacted in 2013 to put protocols into place for the serialization and traceability of pharmaceuticals that move through the drug supply chain – from manufacturer through to the distributors until they reach the hands of the patient. The goal being to ensure the safety and purity of each … Continue reading Does the DSCSA Affect How the Medical Marijuana Industry Is Regulated?
Before the pandemic struck, the pharma industry was working feverishly to implement and enforce all the requirements of the DSCSA, especially the Phase II requirements scheduled for November of 2023. When COVID-19 dramatically changed the business landscape, the implementation became even more of an uphill battle, with both time and the pandemic acting as a … Continue reading Impact of COVID-19 on DSCSA Implementation
Last week the FDA posted new guidance called “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that directly addresses everything I talked about in my last essay, “DSCSA Exemption For Public Health Emergencies” and more. This new guidance was “fast-tracked” and went direct to … Continue reading FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE
On March 10, 2020, Alex M. Azar II, Secretary of Health and Human Services of the US government, declared a public health emergency (PHE) under Section 319F of the Public Health Service Act “…to provide liability immunity for activities related to medical countermeasures against COVID-19.” This action immediately opened an exemption embedded in the Drug … Continue reading DSCSA Exemption For Public Health Emergencies
There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just … Continue reading How The DSCSA Is Designed To Work
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
Industry moves forward on two fronts toward meeting the 2023 requirements of the DSCSA. Where is the FDA?