The T3 document, contains 3 specific parts. T3 documents can be paper-generated or electronic. Below, we have broken down the essentials of the T3 document, as prescribed in DSCSA regulations. You can also view a sample document by clicking the button below.
Detailed Information about the product such as identifier and to and from addresses.
Transaction information must include:
(A) the proprietary or established name or names of the product;
(B) the strength and dosage form of the product;
(C) the National Drug Code number of the product;
(D) the container size;
(E) the number of containers;
(F) the lot number of the product;
(G) the date of the transaction;
(H) the date of the shipment, if more than 24 hours after the date of the transaction;
(I) the business name and address of the person from whom ownership is being transferred; and
(J) the business name and address of the person to whom ownership is being transferred.
…means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.
So this is the same as the above information, but for each change in ownership
The `transaction statement’ is a statement, in paper or electronic form, that the entity transferring ownership in a transaction complies with all DSCSA requirements.
The statement must included:
(A) is authorized as required under the Drug Supply Chain Security Act;
(B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act;
(C) received transaction information and a transaction statement from the prior owner of the product, as required under section 582;
(D) did not knowingly ship a suspect or illegitimate product;
(E) had systems and processes in place to comply with verification requirements under section 582;
(F) did not knowingly provide false transaction information; and
(G) did not knowingly alter the transaction history.