Which option is an exemption from DSCSA transaction data requirements?

Which option is an exemption from DSCSA transaction data requirements?

• A. Intracompany distribution of products
• B. Direct sale to a consumer
• C. Sale to a non-affiliate wholesaler
• D. Pharmacist counseling of a patient

Answer: (A)

Under DSCSA, most transfers of prescription drugs between trading partners require specific transaction data. There is a clear exemption for intracompany distributions—transfers of products within the same corporate structure. Since ownership and control don’t pass between separate entities in an intracompany move, there’s no need to generate or transmit transaction data for those internal transfers. Direct sales to a consumer involve moving product to a non-affiliated party or end user in a way that isn’t an internal corporate transfer, so they don’t qualify for that exemption. A sale to a non-affiliate wholesaler is a transfer between separate entities and would require transaction data. Pharmacist counseling of a patient doesn’t involve a product transfer at all, so it isn’t about transaction data. So the intracompany distribution is the exemption.

Under DSCSA, most transfers of prescription drugs between trading partners require specific transaction data. There is a clear exemption for intracompany distributions—transfers of products within the same corporate structure. Since ownership and control don’t pass between separate entities in an intracompany move, there’s no need to generate or transmit transaction data for those internal transfers.

Direct sales to a consumer involve moving product to a non-affiliated party or end user in a way that isn’t an internal corporate transfer, so they don’t qualify for that exemption. A sale to a non-affiliate wholesaler is a transfer between separate entities and would require transaction data. Pharmacist counseling of a patient doesn’t involve a product transfer at all, so it isn’t about transaction data.

So the intracompany distribution is the exemption.