Attention Pharmacy Owners: Important Update on the Upcoming November DSCSA Requirements!

Dear Customers,

The FDA has issued a small business exemption for small dispensers (Pharmacies) with less than 25 full-time Pharmacists and Pharm Technicians. These small dispensers have until November 27th, 2026, to comply with the enhanced drug supply chain security requirements.

If you are a Small Dispenser that qualifies for the exemption, you may not have to

• Collect and receive Serialized data (EPCIS)
• Conduct a Product verification on the Suspect product (VRS)
• Conduct a Product Tracing on a suspect product.

However, the rest of the DSCSA regulations will still be enforced by November 27th, 2024.
Those requirements include:

• Collecting and saving all Transactional (T3) data
• Reconciling all Drugs with your Transactional (T3) data
• Saving Transactional (T3) data for at least six years
• Verifying Trading Partners
• Require Procedures and Policy documentation
• Identifying and investigating any suspect product
• Reporting Illegitimate Products to the FDA with Form 3911
• Obtaining GLNs
• Confirming all smallest salable products have Product Identifiers

Overall, pharmacies must be prepared for the complex regulations and strive for full compliance by the November 27th, 2024, deadline.

InfiniTrak is already providing complete compliance for the DSCSA, including the final interoperable phase of the law, and pharmacies can get fully compliant with the platform. By complying with the law, pharmacies ensure the highest level of patient safety and benefit from the additional functionality provided by InfiniTrak.

If you are interested, you can sign up for InfiniTrak HERE to ensure compliance with the DSCSA regulations.

Sincerely yours,
Sam Pizzo
Vice President of Data Analytics and Partnerships