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Electronic Code of Federal Regulations

e-CFR data is current as of May 21, 2020

Title 21Chapter IIPart 1305Subpart C → §1305.25


Title 21: Food and Drugs
PART 1305—ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
Subpart C—Electronic Orders


§1305.25   Unaccepted and defective electronic orders.

(a) No electronic order may be filled if:

(1) The required data fields have not been completed.

(2) The order is not signed using a digital certificate issued by DEA.

(3) The digital certificate used had expired or had been revoked prior to signature.

(4) The purchaser's public key will not validate the digital signature.

(5) The validation of the order shows that the order is invalid for any reason.

(b) If an order cannot be filled for any reason under this section, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph.

(c) When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original order and the statement must be retained in accordance with §1305.27.

(d) Neither a purchaser nor a supplier may correct a defective order; the purchaser must issue a new order for the order to be filled.

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