What Does the DSCSA Mean For You?

The DSCSA Adds Another Layer of Complexity To Running A Pharmacy

Running a pharmacy requires a huge amount of coordination already. Suppliers, Vendors, Customers, Doctors, Insurance, Not to mention payroll, staffing, DEA, board of pharmacy, inspections, the list goes on and on.

It’s time to add to that list the Drug Supply Chain Security Act (DSCSA). Signed into law in 2013, the DSCSA gave the FDA power to regulate the medication supply chain in the United States. The law requires a number of things from manufacturers, wholesalers and dispensers (pharmacies).

You may have noticed over the last few years as medication labels have been reworked with the addition of the GTIN, a serial number in addition to the lot number, and 2D barcodes. All of these were in preparation for the full implementation of the provisions of the DSCSA. This law requires medications to be electronically tracked and validated by the manufacturer at each sale or transfer.

Dispensers are required to adhere to a number of provisions and also to perform certain functions as well. First, dispensers are required to ensure that all of their trading partners (anyone you are buying from or selling to that isn’t a patient) are authorized by the FDA. Second, dispensers must ensure they only receive products with serialization data. The big requirement, though, is that dispensers must operate an interconnected database for their purchase history that allows them to send and receive data with their trading partners and the original manufacturers of the medications.

This database must be able to receive notifications about products that are suspected to be illegitimate and be able to transmit reports and notifications about products they identify that they suspect are illegitimate. This data must be kept in a secure, online database and retained for a minimum of 6 years.

These are some big requirements. Developing a database network that every manufacturer and wholesaler would participate in is no small task. Building one with secure transmissions, a variety of users, an ever-expanding amount of memory with a system of backups and redundancies to ensure not one medication’s information is lost is even more difficult. MedTrax is here to help.

We heard from pharmacies around the country. You needed answers to the DSCSA compliance so we responded. We have used our connections and resources to build the database we would want if we were in the pharmacy. We’ve met the requirements of the DSCSA and at the same time simplified recalls, improved outdates, added hazardous material information and created some great reports that can help you make more informed decisions.

MedTrax is here to help you solve your DSCSA problems. Give us a call today and get started now.