Understanding 340B Program Compliance Issues: DSCSA Answers for Dispensers

If your business participates in the 340B Program as a contract pharmacy, you likely have questions about how you will handle DSCSA compliance requirements for 340B products. Because DSCSA does not address the 340B Program at all, there is a lack of clarity around contract pharmacy 340B product responsibilities. The key question is, what are the DSCSA compliance concerns for a contract pharmacy who is receiving medications that they do not own?

Industry associations are reviewing the issue and encouraging the FDA to shed some light on it. There is hope that clarification may, at some point, be written into the law or published through official FDA guidance. Until that time, though, here is some background on the issue and approaches to consider.

The 340B Program and Product Flow

The federal 340B Program facilitates the provision of outpatient medications to eligible health care organizations at reduced prices, easing costs to providers who service government program enrollees.

Typically, the health system administering the program purchases the drugs, which are then shipped by the wholesale distributor to a local contract pharmacy that will dispense them to patients. So the compliance documentation goes one place – to the administering health system that takes ownership of the product – but the product goes elsewhere, to the local contracting pharmacy. These two business entities are typically not under the same ownership.

How will 340B product fit into your overall compliance approach?

Beginning July 1, your pharmacy will follow certain procedures to insure you have the correct compliance documentation for all prescription drugs that you purchase. As a contracting pharmacy receiving 340B product but not the associated compliance documentation, you must think through how you might adapt your receiving process for products that you receive possession of but for which you do not take ownership. You have a decision to make, along with several possible next steps:

Do you want to attempt to verify that the proper DSCSA compliance documentation exists before you accept possession of 340B product?

While verifying the existence of T3 (Transaction History, Information, and Statement) documentation for 340B product is not completely within your control, making the decision that you will attempt to do so may add consistency to your overall compliance approach and business processes, since you will likely be checking for DSCSA documentation received for other product from the same supplier.

It may also minimize potential liability or patient safety concerns. While DSCSA, as commonly interpreted, does not currently hold you accountable for checking the documentation, no pharmacy or clinic wants to dispense product that turns out to be suspect when a documentation check could have helped prevent it.

Can the purchasing health system help with T3 access?

If you decide that your pharmacy will attempt to check for compliance documentation, talk to the purchasing health system. Can they provide access for you? They may enable you to login to their compliance system, allowing you to view T3 for just your specific set of products. Or, they may be willing to accept queries from you, asking if they have received the appropriate T3 for the physical products that you have received.

What about the wholesale distributor?

If the purchasing health system cannot provide access, you can reach out to the wholesale distributor. Some have expressly said that they will not provide compliance documentation access to contract pharmacies that are not legally entitled to it, but others may be willing to work with you.

As industry and FDA conversations develop, TraceLink will provide updates. For now, decide your compliance approach to 340B product, explore T3 access options with your business partners, and talk to your compliance system partner about how they might help once consensus on contract pharmacy requirements emerges.