As many of you may be getting questions or have concerns about your compliance and changing rules to the DSCSA and Pharma specific issues,
We have created this list to outline how the MDS system will help you address these challenges.
FDA Announces Enforcement Discretion Guidance for DSCSA Verification Requirement
FDA has announced
that, given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, it does not intend to act against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier before distributing a returned product as required under the DSCSA.
Having said that, We still need to address the issue , we just have a little more time.
The goal of this email list is to point out our suggested best (business) practices.
While we do not enforce or force you to follow these rules, this list is intended more as a guide to allow you to decide internally how you might want to update your practices and systems.
Please note this is a combination of information collected from various conferences and Industry Groups HDA, NCPA, HIDA, FDA, etc.
However since the FDA is the current enforcement agency in charge we have used their site as the model for compliance.
In addition we plan on highlighting and partnering with industry experts such as Sumeet Singh President & Senior Consultant with https://fiveriversrx.com
If you are not familiar with five rivers, they have some excellent training courses available online
and are available for consulting and information. They regularly contribute to our knowledge and we work with them on both existing and new clients to assist in many different areas.