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.
NOWOctober 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.
| 
