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§251.12. Importer responsibilities. — Inbound Citations

21 C.F.R. § 251.12

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 251.12 as a whole

  • (a) A SIP Sponsor must submit a report to FDA each quarter in electronic format via the ESG or to an alternative transmission point identified by FDA containing the information set forth in this section, beginning after the SIP Sponsor files an electronic import entry for consumption for its first shipment of drugs under the SIP. If the SIP Sponsor specifies in such report that the information contained in the report is being transmitted on behalf of the Importer and in order to fulfill the Importer's obligation under § 251.12, the Importer need not separately submit such information to FDA.