(b) The report in paragraph (a) of this section must contain the following information:

1. (1) The name, address, telephone number, and professional license number (if any) of the Importer;
2. (2) The name and quantity of the active ingredient of the imported eligible prescription drug(s);
3. (3) A description of the dosage form of the eligible prescription drug(s);
4. (4) The date(s) on which the eligible prescription drug(s) were shipped;
5. (5) The quantity of the eligible prescription drug(s) that was shipped;
6. (6) The lot or control number assigned to the eligible prescription drug(s) by the manufacturer of the eligible prescription drug(s);
7. (7) The point of origin (i.e., the manufacturer) and the destination (i.e., the wholesaler, pharmacy, or patient to whom the Importer sells the drug) of the eligible prescription drug(s);
8. (8) The per unit price paid by the Importer for the prescription drug(s) in U.S. dollars; and
9. (9) Any other information that FDA determines is necessary for the protection of the public health.

(d) The report in paragraph (a) of this section must include the following documentation:

1. (1) Documentation from the Foreign Seller specifying the manufacturer of each eligible prescription drug and the quantity of each lot of the eligible prescription drug(s) received by the Foreign Seller from that manufacturer;
2. (2) Documentation demonstrating that the eligible prescription drug was received by the Foreign Seller from the manufacturer and subsequently shipped by the Foreign Seller to the Importer;
3. (3) Documentation of the quantity of each lot of the eligible prescription drug(s) received by the Foreign Seller, demonstrating that the quantity being imported into the United States is not more than the quantity that was received by the Foreign Seller; and
4. (4) Documentation demonstrating that the sampling and testing requirements described in section 804(d)(1)(J)(i)(III) of the Federal Food, Drug, and Cosmetic Act were met for each shipment of each eligible prescription drug.

(e) The report in paragraph (a) of this section must include certifications from the Importer for each shipment of each eligible prescription drug that the drug is approved for marketing in the United States and is not adulterated or misbranded and meets all labeling requirements under the Federal Food, Drug, and Cosmetic Act. This certification must include:

1. (1) That there is an authorized SIP;
2. (2) That the imported drug is covered by the authorized SIP;
3. (3) That the drug is an eligible prescription drug as defined in this part;
4. (4) That the FDA-approved counterpart of the drug is currently commercially marketed in the United States;
5. (5) That the drug is approved for marketing in Canada; and
6. (6) That the drug is not adulterated or misbranded and meets all labeling requirements under the Federal Food, Drug, and Cosmetic Act.