Well what do we do now? FDA Enforcement Update

 

Pharma Information Update Stay on top of the latest requirements 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 are offering our pharma update webinar and blast emails.  Well it's been a year - how have things changed?  Not Much it would seem...  THEN November 2019: 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.  NOW October 2020: FDA Announcement Regarding Certain Wholesale Distributor and Dispenser Verification Requirements Under DSCSA Today, the Food and Drug Administration announced a final guidance regarding enforcement of the Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributor verification of saleable returned products and dispenser verification of the product identifier for suspect and illegitimate product. FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify a product identifier prior to further distributing returned product as required under the DSCSA. This provides wholesale distributors three additional years to comply with this requirement. FDA also does not intend to take action against dispensers who do not, prior to November 27, 2023, verify the product identifier for suspect or illegitimate product in the dispenser’s possession or control. This provides dispensers three additional years to comply with this requirement. Please contact drugtrackandtrace@fda.hhs.gov with questions about this announcement. Having said that, We still need to address the issue, we just have a little more time. So to all our clients or potential clients facing a growing list of vendors telling them how they need a solution right now, you have some breathing room. And perhaps some time to properly evaluate your best path forward.  If an integrated solution from a trusted source seems like it might be a better option, feel free to join our mailing list, or reach out to us for a discussion on how to make sure your systems are compliant and Future Proof, with a software partner dedicated to your industry.  Subscribe to our list Pharma Email Blast Monthly Features Addl blasts as needed Dates TBA $200 No charge as part of  maintenance SIGN UP NOW Pharma Webinars Coming Soon 1-2 hrs Dates TBA $300 No charge as part of maintenance SIGN UP NOW Feel free to suggest topics or email sales@tshinc.com Please sign up so we can reserve your spots today.