DSCSA Quick FactsR
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 trackingrequirements by the FDA. This in part is in response to the NECC meningitisoutbreak 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 in healthcare. 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 Does RxTrail help Pharmacies with DSCSA?
We partner with you to answer your questions and help get you started with running a compliant pharmacy and clinic. We provide self-auditing tools and you can also secure our services for an on site assessment. We believe that these “mock” audits are the best option, to ensure you are covering all of your bases and prepare you for the future.