Snapshot

The Importation Program under Section 804 of the FD&C Act pathway has been developed by the of United States.

This pathway can be used where Prescription drugs that are approved in Canada and meet specific USFDA requirements..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is - FDA may use a phased review process to review a SIP Proposal that does not identify a Foreign Seller in an initial submission but the SIP cannot be authorized by FDA without an identified Foreign Seller. Under section 251.4 of the final rule, there is the possibility that a SIP Proposal would not be authorized if a Foreign Seller is not identified within 6 months of the initial submission date of the SIP Proposal. - After FDA has authorized a SIP Proposal, the Importer must submit a Pre-Import Request to FDA at least 30 calendar days before the scheduled date of arrival or entry for consumption of a shipment containing an eligible prescription drug covered by the SIP, whichever is earlier. “Entered for consumption,” as defined in 19 CFR 141.0a(f), is the most common entry type for FDA-regulated products and is used when products are imported for use in the United States and go directly into United States commerce without any restrictions of time or use placed on them. Once the shipment arrives or is entered at a port of entry, it may be examined by a government agency. - Entry and arrival of a shipment containing an eligible prescription drug is limited under the final rule to the U.S. Customs and Border Protection (CBP) port of entry authorized by FDA. The Importer or its authorized customs broker is required to electronically file an entry for consumption in the Automated Commercial Environment (ACE) or other electronic data interchange system authorized by CBP for each eligible prescription drug imported or offered for import into the United States. These entries must be filed as formal entries. If an eligible prescription drug that is imported or offered for import does not comply with section 804 of the FD&C Act and the provisions of this final rule, that drug will be subject to refusal under section 801 of the FD&C Act (21 U.S.C. 381). - FDA’s evaluation of SIP proposals may include requests for additional information necessary to ensure the proposal meets the requirements in the statute and final rule. .