21 CFR 1314.110 - Reports for mail-order sales.

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§ 1314.110 Reports for mail-order sales.

(a) Each regulated person required to report under § 1310.03(c) of this chapter must either:

(1) Submit a written report, containing the information set forth in paragraph (b) of this section, on or before the 15th day of each month following the month in which the distributions took place. The report must be submitted under company letterhead, signed by the person authorized to sign on behalf of the regulated seller, to the Import/Export Unit, Drug Enforcement Administration (see the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address); or

(2) Upon request to and approval by the Administration, submit the report in electronic form, either via computer disk or direct electronic data transmission, in such form as the Administration shall direct. Requests to submit reports in electronic form should be submitted to the Import/Export Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.

(b) Each monthly report must provide the following information for each distribution:

(1) Supplier name and registration number;

(2) Purchaser's name and address;

(3) Name/address shipped to (if different from purchaser's name/address);

(4) Method used to verify the identity of the purchaser and, where applicable, person to whom product is shipped;

(5) Name of the chemical contained in the scheduled listed chemical product and total quantity shipped (e.g. pseudoephedrine, 3 grams);

(6) Date of shipment;

(7) Product name;

(8) Dosage form (e.g., tablet, liquid);

(9) Dosage strength (e.g., 30mg, 60mg, per dose etc.);

(10) Number of dosage units (e.g., 100 doses per package);

(11) Package type (blister pack, etc.);

(12) Number of packages;

(13) Lot number.

[71 FR 56024, Sept. 26, 2006, as amended at 75 FR 10684, Mar. 9, 2010]

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