The DSCSA was passed in 2013, to be phased in over 10 years, and is intended to strengthen the US supply chain by preventing counterfeit and 'gray market' medications from being introduced.
In order to do that, DSCSA requires 'trading partners' to have a verification system in place for medications to be tracked from the moment they are manufactured to the moment they are received at the dispensing site (in our case, the community pharmacy).
If you don't have your verification system policies and procedures, you need them. Last year the FDA issued its first fine for violations of DSCSA to McKesson, and it totaled $150 million.
Don't leave your pharmacy open to this risk. Check out the PharmCompliance P and P for download here. It offers a complete DSCSA template to get you up and running fast!
OK, enough said about that. Here are my top things to know about DSCSA in the community pharmacy:
#1: How to get the drug pedigrees from your distributor
Do you know where to go on your distributor's website to print the drug pedigrees?
DSCSA requires that medications are tracked through the use of a 'drug pedigree,' which essentially is documentation to pass ownership of the drugs over from one company to the next. For the big distributors, these papers can be downloaded off their website in .pdf format. There's no need really to print them off with every order (DSCSA allows them to be stored electronically), but you should know how to get them in case you are asked for them.
The most common reason is the rare case a pharmacy needs to supply a drug pedigree to another trading partner (see #2), but actually the FDA has legal authority to request them too.
Once you are asked for the drug pedigree, you have 2 business days to cough it up, so be prepared!