Does Re-Dispensing to Patients Require DSCSA Documentation?

We operate a pharmacy in Georgia that services residents of assisted living facilities. A number of residents acquire their medications via a mail-order pharmacy mandated by their insurance plan. They then bring those Rx bottles from the mail-order pharmacy to our pharmacy, where we store their medications and re-dispense those drugs to the residents/patients. In that case, we have an order, vis-à-vis a prescription, from the physician and we take the drugs from the mail order pharmacy’s Rx bottle and put the meds in our dispensing containers. We attach our pharmacy’s label with our Rx number on the container and then send it back to the resident.

We have no lot numbers, no identification of the generics’ manufactures, no way to track backwards. We don’t know if those drugs even came from an American pharmacy since all we have is the Rx bottle and label.

This re-packing practice is presently allowed under Georgia law, but it appears to violate at least the spirit of track-and-trace. Any thoughts?

Answer

The Drug Supply Chain Security Act (DSCSA) is federal legislation that mandates full supply chain traceability from pharmaceutical manufacturer to pharmacy dispenser of prescription drug products being distributed in the United States. As such, it only covers transactions between parties in the supply chain, not between the dispenser and the patient.

In your situation, once the mail-order pharmacy dispenses medications to the assisted living resident, those meds fall out of the supply chain. Now the patient owns the product. Even when the patient drops off those medications to your facility and your facility stores and re-dispenses the product back to the patient, the patient still owns the product. Therefore, in this case, DSCSA does not apply.

Now, if your pharmacy purchased the medications from the resident and then resold that product to another pharmacy, then DSCSA regulations would apply and the Transaction History, Information and Statement (T3) for that product would need to be provided to the purchaser. Since you would not have received a T3 for this product from the patient, as the patient would not have received a T3, it would be impossible to absolutely determine the original trace history and applicable compliance documentation for this product. Thus, you likely would be unable to resell the drug product with the appropriate DSCSA documentation.

To reiterate, T3 documentation is not a concern at point of dispense, as long as that product is never a part of another supply chain transaction (i.e., a saleable return or a loan/borrow operation with another dispenser). So, if the focus of your current operations is really providing a service to an existing patient whereby you are taking possession of their own medicines and helping them to manage the dispensation of those medicines as part of their therapy medicine regimen, then DSCSA will not apply. 

If your pharmacy or hospital has a question on DSCSA requirements, send it along to questions@tracelink.com. We’ll feature it in an upcoming article.