Top 8 Dispenser Webinar Questions: Asked and Answered
On Monday’s DSCSA dispenser webinar, we received many questions around which scenarios require the exchange of Transaction History, Transaction Statement, and Transaction Information (T3) documentation. We’ve rounded up the most common ones and provided answers. Read what your peers are asking and what you’ll need to think about when July 1 arrives.
#1: My medical foundation stores product at a central site then distributes it to practice sites. Is that product distribution subject to DSCSA regulations?
A medical foundation or larger organization may buy
#2: What constitutes being under the same ownership? Does “same ownership” mean one organization across the country? Or one health system within a large organization?
DSCSA does not explicitly define the parameters of common ownership. One popular interpretation is that the affiliated group extends up to the highest level of majority common ownership without regard to geography, which plays no role here. Scale and scope are typically irrelevant, as well.
Consider a pharmacy chain that owns 100% of their stores. That chain is 25% owned by a larger health care organization. Common ownership of the stores extends only to the pharmacy chain and not the larger health
#3: How are product returns back to the wholesaler handled? What about out of date products?
According to the 2015 DSCSA compliance requirements, dispensers do not need to provide T3 documentation for either saleable returns back to the original supplier or for non-saleable returns. If you send
Out of date products are considered a non-saleable return so you do not need to provide T3.
#4: What about supplying a health care provider with drugs? Do you have to include T3 documentation?
This comes down to whether or not a change of ownership occurs between the supplier and the health care provider. If the health care provider is actually buying drugs from the supplier and not owned by that supplier, that constitutes a change of ownership and requires T3 to be passed between them. In contrast, a doctor in an office owned by and receiving drugs from a larger organization would not be required to receive T3 from that organization.
#5: Does a hospital supplying medications to an ambulance service need to pass along compliance documentation?
This scenario is similar to a hospital and clinic; the ambulance just happens to be a mobile caregiving organization that is dispensing medications to patients. If the ambulance service is buying drugs from the supplier, then there is a change of ownership and T3 must be provided. If the service is owned by the hospital, then there is no need to pass along T3.
#6: What if I am loaning a pharmaceutical drug to another pharmacy and not receiving cash, but getting repaid with other drugs that my pharmacy needs?
If the loan is a change of ownership between two separately owned pharmacies, then this scenario would be considered a trackable transaction for DSCSA compliance and would require T3. DSCSA does not specify that a cash transaction is required to constitute a change of ownership. This makes sense if you consider that you cannot just substitute one physical product for another within a Transaction History. Even if they are the same product type, they may have come from separate sources or have been produced in different lots.
The one exception would be for a drug loaned to fulfill a prescription for a specifically identified patient. DSCSA stipulates that when an emergency shipment of product is made to another pharmacy to fulfill a “specific patient need”, then it is an exempt transaction.
#7: If my supplier ships product directly to one of my
stores, do I need to send the T3 to the store?
While most of your product may typically ship to a distribution center, some percentage will likely go directly to your stores. The law doesn’t require T3 to go to the location that receives the physical product; it just requires that the T3 be sent to the purchaser. The documentation can stay in the compliance document central repository at the larger pharmacy chain or hospital.
You may choose to provide access to T3 to your individual
#8: Our hospital has many outlying clinics to which we provide medication. Will I need to supply the traceability information to the clinics, which we own, for each drug we give them?
As long as you are supplying product to clinics that are owned by your hospital, then you do not have to provide T3. Your hospital needs to have the compliance documentation for the products but you do not need to pass it onto your clinics. You may want to consider providing access to the documentation compliance repository to your clinics for situations like verification requests.
The same is true if your hospital and clinics are under common ownership and both owned by a larger organization.