What must a Transaction Statement convey?

What must a Transaction Statement convey?

• A. A binding contract between buyer and seller
• B. That the entity transferring ownership received product, received transaction information and a transaction statement from prior owner, did not knowingly ship a suspect product, had systems to comply with verification, and did not knowingly provide false transaction information or alter transaction history
• C. That the product is stored at correct temperature
• D. That the product is within expiration

Answer: (B)

A Transaction Statement must certify the integrity and continuity of the pharmaceutical supply chain under DSCSA. It confirms that the entity transferring ownership received the product along with the transaction information and a transaction statement from the previous owner, and that the transferring entity did not knowingly ship a suspect product. It also states that the entity has systems in place to verify information and that it did not knowingly provide false transaction information or alter the transaction history. This attestation is what links each handoff in the chain of custody and supports traceability and accountability. Other options don’t fit because a transaction statement isn’t a binding contract, nor does it guarantee storage temperature or expiration status. Those details relate to product quality or terms of sale, not the certification about chain-of-custody and verification that the DSCSA transaction statement provides.

A Transaction Statement must certify the integrity and continuity of the pharmaceutical supply chain under DSCSA. It confirms that the entity transferring ownership received the product along with the transaction information and a transaction statement from the previous owner, and that the transferring entity did not knowingly ship a suspect product. It also states that the entity has systems in place to verify information and that it did not knowingly provide false transaction information or alter the transaction history. This attestation is what links each handoff in the chain of custody and supports traceability and accountability.

Other options don’t fit because a transaction statement isn’t a binding contract, nor does it guarantee storage temperature or expiration status. Those details relate to product quality or terms of sale, not the certification about chain-of-custody and verification that the DSCSA transaction statement provides.