Product Returns and Compliance Documentation: DSCSA Answers for Dispensers
As dispensers acclimate to DSCSA requirements, many are wondering how the law impacts product returns. What are the different types of returns and when do you need to provide Transaction History, Information, and Statement (T3) documentation?
Types of Returns
There are two types of returns: saleable and non-saleable.
Non-saleable returns include expired product, short shelf life product unlikely to be sold and consumed by expiry date, and damaged product. Non-saleable product may be returned to the original supplier, to the manufacturer, or to a returns processor or reverse distributor that focuses on secure disposal of non-saleable pharmaceuticals. Any of these parties will usually return some value for
What the Law Says
For dispensers, there is no DSCSA compliance documentation requirement for either saleable or non-saleable product returns.
Management of returns in general and specifically under DSCSA may impact several operations, so there are a few scenarios and best business practices that you will want to keep in mind:
- As long as you are returning
saleableproduct to the supplier from whom you purchased it, DSCSA does not require you to provide T3 documentation to that supplier as part of any return authorization process you may follow. However, some dispensers pass excess product along to a different party – like a broker who buys saleable returned product - and still thinkof it as a return. If you “return” product to a different party, you have in fact sold the product and need to provide the appropriate compliance documentation. By DSCSA regulations, that sale is a wholesale distribution transaction.
- You can return
non-saleableproduct to the manufacturer, repackager, wholesale distributor, or any other party without having to provide T3 documentation.
- Given that you do not need T3 for non-saleable returns, the law also does not mandate that you notate the return transaction within your compliance documentation. But from a business best practices perspective, you may want a record of the fact that you did return the product to a given partner on a given date. That way, if there is ever a patient incident and an associated product recall, you can demonstrate that you returned the product in
question,and that the drugs that caused the issue originated from somewhere else and not from your business.
- “Saleable returns” are often defined in slightly different ways between trade partners which may have DSCSA implications. For example, an
overagein an ordered shipment leaves the dispenser with excess product. Should the dispenser mark this as an exception, requiring some level of void/reissue of their received DSCSA compliance documentation for the affected product or should they mark it as a saleable return and ship back the excess physical product even though their DSCSA T3 records will be at odds with their physical inventory? Issues like these need to be considered across all of your trade relationships for return scenarios.