340B Contract Pharmacy

Contract pharmacies provide prescription drug dispensing services to 340B program eligible patients for 340B covered entities. Most covered entity/contract pharmacy relationships rely on a replenishment model where the contract pharmacy dispenses drug to a 340B eligible patient from their own stock; in essence the covered entity borrows the drug from the contract pharmacy to dispense to the patient. The covered entity then buys the drug from their wholesaler on their 340B account and ships the drug to the contract pharmacy under a “bill to/ship” to arrangement in order to replenish the drug to the contract pharmacy.

Drug Supply Chain Security Act (DSCSA)

DSCSA regulations come into play whenever direct ownership of drug product changes. When ownership changes, the previous owner “prior to or at the time of, each transaction" must supply the subsequent owner with transaction documents including the transaction history (TH), transaction information (TI), and transaction statement (TS) otherwise known as the 3Ts. Furthermore, the subsequent owner “shall not accept ownership of product unless the previous owner prior to, or at the time of, the transaction” unless the previous owner provides the same trans-action documents.

DSCSA does allow for transfer of drug product from one trading partner to another without the need for sending the transaction documents in one exception which is for a “specific patient need.” This is defined “the transfer of a product from one pharmacy to another to fill a prescription for an identified patient.” Therefore, it is our understanding that when a covered entity borrows drug from the contract pharmacy to dispense to a 340B eligible patient this transaction is exempt but the definition of specific patient need goes on to say that it “does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock.” When the covered entity ships drug to the contract pharmacy to replenish the drug dis-pensed to the patient the transaction is not exempt under DSCSA regulation and the transaction documents must be provided to the contract pharmacy. We also strongly believe that to be completely compliant with DSCSA regulation the transaction history must include entries for both the covered entity and the contract pharmacy to indicate the ownership change.

Solution

Our solution is simple, all contract pharmacy accounts appear on the login for the covered entity. Each contract pharmacy is also given their own login in order to view their specific transaction reports. A complete Transaction History (TH) is associated with each drug product from manufacturer to wholesaler to dispenser. Our tool automatically add a transaction between the covered entity and contract pharmacy showing a complete Transaction History (TH) and custom Transaction Statement (TS) is added for the covered entity to ensrue complete compliance with DSCSA.