With their first DSCSA deadline just days away, many dispensing organizations are trying to clarify situations in which the regulations apply. Are the common practices of loaning, bartering, and donating drugs subject to the law, or do DSCSA requirements only come into play when product is purchased and cash changes hands? Read on to understand what scenarios require compliance documentation and the impact for your business.

What does the law say?

When dispensers hear that DSCSA focuses on change of ownership, they often assume that it pertains only to traditional buying and selling of product. The law is literal, though, and applies to any change of ownership regardless of financial flow unless explicitly exempt.

When a change of ownership occurs, Transaction History, Information, and Statement (T3) compliance documentation must be exchanged unless the transaction is made in the context of an exemption – such as dispensation for a specific patient need – or you are providing product to a facility under common ownership.

What are some typical change of ownership scenarios and associated considerations?

In speaking with thousands of pharmacies, clinics, and hospitals, there are three change of ownership situations they most commonly describe:

Product is sold in exchange for a payment

When you resell product as a dispenser, the law explicitly states that you need to provide compliance documentation. That also means you need to understand – or have a compliance system that understands – what additions need to be made to the T3 on the outbound side based on product origin. For instance, if you purchased from a primary wholesaler, they may not have sent lot number and transaction date but you will be required to provide that information as part of the complete T3 with your outgoing product. If you do resell product or anticipate doing so, you will want to make sure you always enter lot number upon product receipt, whether or not your supplier has provided it.

When you resell product as a dispenser, the law explicitly states that you need to provide compliance documentation. That also means you need to understand—or have a compliance system that understands—what additions need to be made to the T3 on the outbound side based on product origin. For instance, if you purchased from a primary wholesaler, they may not have sent lot number and transaction date but you will be required to provide that information as part of the complete T3 with your outgoing product. If you do resell product or anticipate doing so, you will want to make sure you always enter lot number upon product receipt, whether or not your supplier has provided it. Dispensers sometimes also sell

Dispensers sometimes also sell excess product, potentially at a discounted price, when they know they will not use it during its shelf life. Selling it to another dispenser rather than letting it expire and become a non-saleable return with a limited refund value is all part of good inventory management. But regardless of the exact cost structure, change of ownership occurs in this situation, also, so you must send T3 with your outbound product.

Product is loaned or bartered, often in exchange for a payment in kind of other drugs

Loaning or bartering occurs most frequently in hospital or clinic settings. When you trade one product in exchange for another, you need to provide the same type of T3 you would if it were a standard sale.

It’s also important to remember that you need to send and receive T3 during changes of ownership so the product that you receive in a loan or barter relationship must also be accompanied by the appropriate compliance documentation. Otherwise, you cannot legally accept and dispense that product.

With the advent of DSCSA, it’s a good idea to evaluate all the barter relationships you have and the context in which they occur. Do your barter partners have a solid compliance approach and understanding of the regulations?This is an opportunity to evaluate some of your own business processes, too. When

This is an opportunity to evaluate some of your own business processes, too. When product is sent to fulfill a specific patient need, you are exempt from sending T3. But now that you are faced with the prospect of official inquiries and inspections, you will likely want to create an internal record of where that product went.

Product is donated

Under certain circumstances, you may either receive donated product from a wholesale distributor or your business may donate product. In either case, DSCSA requirements must be followed unless a relevant exemption is in place. There are two that pertain to donations that you will want to explore: one related to the distribution of product samples by manufacturers and licensed wholesale distributors; and one charitable exemption that applies when product is going to a non-profit affiliate of the organization.

The bottom line

The issue of whether or not cash changed hands, and how much, is irrelevant when it comes to DSCSA compliance documentation requirements. If a change of ownership took place – by sale, loan, barter, or donation – then T3 must be exchanged.

Check back next week to learn about a related topic, consignment inventory and DSCSA. And if you missed our three-part DSCSA Answers for Dispensers, it’s not too late to read about lot number, 340B compliance, or managing T3 access.