Last month the US Department of Health and Human Services (HHS) published a new notice of proposed rulemaking (NPRM) related to the importation of finished drugs from foreign supply chains–initially, only Canada but expandable in the future to other countries. The proposal is the result of President Trump’s initiative to lower the price of some … Continue reading The HHS Importation Proposed Rule
Could the FDA delay enforcement of the wholesaler’s 2019 DSCSA requirements?
Get to know GS1 Digital Link and GS1 Web URI syntax now. It’s already here!
Here are some resources for meeting wholesaler requests for their DSCSA obligations.
In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act (DSCSA). It’s already been a long journey, but this is only the beginning. Companies can’t even take a break. In just one year the wholesale distributor saleable returns requirement will … Continue reading Sponsored: From Serialization to Full Traceability: 2018 Outlook On Compliance
Finally, FDA explains how to apply for a waiver, exception or exemption from the DSCSA…in draft form.
Once again, HDA schools FDA in the proper interpretation of the DSCSA.
Dr. Ilisa Bernstein of the FDA spoke about the DSCSA at the HDA Traceability Seminar
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