What is DSCSA?
DSCSA stands for the Drug Supply Chain Security Act. Under this regulation, drugs you use in your clinic, hospital, or pharmacy are subject to new tracking requirements by the FDA. This in part is in response to the NECC meningitis outbreak in 2012. DSCSA is a part of a larger regulation signed into law in 2013, the Drug Quality and Security Act (DQSA).
Who does this apply to?
DSCSA touches pretty much everyone. DSCSA regulations apply to clinics, pharmacies, hospitals, suppliers, wholesalers and manufacturers.
So what are the requirements exactly?
For those who buy and sell prescription drugs, there are 3 fundamental requirements: 1) Government-approved documentation (“Track and Trace paperwork”) must be shipped with the product every time it is bought or sold; 2) You must store this documentation for a period of no less than 6 years; 3) As the recipient or seller of the product, you must be able to provide government investigators detailed reporting data regarding everything you have bought or sold, e.g. you must be able to report from your 6 years of stored documentation.
How do I know if I am meeting the requirements?
First of all, we would suggest you check out our DSCSA Compliance Checklist. This should get you thinking about where you receive product from, how you track the product you have, what your processes are for receiving or transferring inventory.
So how does RxTrail work?
RxTrail is a “giant data hub” for all of your Track and Trace paperwork. RxTrail works with your suppliers, wholesalers, other clinics, drug manufacturers etc. to collect all of the information you need to meet DSCSA requirements. RxTrail stores this data for 6 years or longer at your request. We provide you tools for reporting, i.e. “getting the data out”, that is required if you are subject to a government investigation. Finally, we provide consultative services all along the way.
How can I sign up for RxTrail
Please reach out to us on our contact page. We can show you a demo of the RxTrail software. If you decide to sign up with RxTrail, we can typically get you live on our platform within 5 business days.