The 340B program, presents a unique set of questions and workflow considerations. 340B inventory in the contract pharmacy scenario is purchased by a covered entity such as a hospital or FQHC, and shipped to a 340B contract pharmacy. There are several considerations regarding DSCSA that you should consider.
First, DSCSA does not make any exemptions at this time for 340B program participants or inventory purchased on 340B contracts. That being said the same rules apply, regarding providing a system to:
- enable verification of the legitimacy of the drug product identifier down to the package level;
- enhance detection and notification of illegitimate products in the drug supply chain; and
- facilitate more efficient recalls of drug products.
So the main issue here, is to whom does responsibility reside? At this point, responsibility is shared by both parties.
First of all, 340B inventory is shipped to the contract pharmacy. Per DSCSA, the contract pharmacy cannot accept such inventory, unless it includes DSCSA transaction information, historical documents and the legal statement indicated DSCSA regulations are being met. In this way, the contract pharmacy is responsible for verification of product. In addition to these, the contract pharmacy will be responsible for pulling inventory in the event of detection and notification of illegitimate or recalled product, so they are clearly in active participant in this portion of the DSCSA process.
Ownership of the inventory places certain responsibility with the covered entity as well. The covered entity which maintains ownership of the inventory shipped to the contract pharmacy is responsible for the disposition of that inventory. They have purchased the inventory and therefore their responsibility may involve reporting and response to investigation, and also data storage of DSCSA data for 6 years.
DSCSA System and Process
340B illustrates the importance of having a system, accessible by both the covered entity and the contract pharmacy, as they both have roles in ensuring DSCSA compliance regulations are being met. The RxTrail system, provides both covered entities and their contract pharmacies with the tools to comply with DSCSA.