FDA Issues Final Rule on Importation of Prescription Drugs From Canada

FDA is issuing new regulations that allow importation of prescription drugs from Canada. Under the final rule, FDA may approve “Section 804 Importation Programs” (SIPs) sponsored by a state, tribal or territorial governmental entity. The registered wholesaler or pharmacy identified by the SIP as the importer could then import the specified drug from an FDA-registered, Health Canada-licensed wholesaler that buys the drug directly from its manufacturer. The final rule is set for publication in the Oct. 1 Federal Register, and takes effect Nov. 30.

FDA is concurrently publishing a guidance document that outlines procedures for drug manufacturers to import FDA-approved drugs originally authorized for sale in a foreign market. The proposed rule and guidance document form a two-pronged approach announced by FDA in 2019 that aims to make prescription drugs cheaper (see 1907310018).

SIPs Must Reduce Cost, Pose No Additional Safety Risks

The final rule says FDA may approve a SIP if the sponsor’s application demonstrates that its proposed importation would pose no additional risk to public health and safety, and that it would “result in a significant reduction of cost to the American consumer.” Even if it meets these requirements, FDA may still reject the application “in its sound discretion,” for example if it has safety concerns, thinks the SIP won’t result in significant enough cost savings, or wants to limit the number of SIPs in light of resource demands. Approval of a SIP will last for two years, at which point the SIP may be extended for additional two-year periods.

Eligible drugs. Drugs imported under a SIP must be approved by Health Canada to be eligible, and meet the conditions of an FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA). Controlled substances, biological products, infused drugs (including a peritoneal dialysis solution), intravenously injected drugs, and drugs that are inhaled during surgery are excluded from the programs.

Wholesaler or pharmacy may co-sponsor. While the sponsor must be a non-federal governmental entity, a pharmacist, wholesaler or another governmental entity is able to co-sponsor the plan. “Co-sponsorship could introduce valuable flexibility (for example, multiple States could co-sponsor a plan with a large wholesaler) and allow SIPs to benefit from the experience of pharmacists and wholesalers, while preserving the advantages that accrue from sponsorship by at least one State or other governmental entity,” FDA said.

No state, tribal or territorial sponsor may be required after two years. In a change from its proposed rule, FDA will consider approving SIPs that do not have a state, tribal or territorial co-sponsor if, after an initial two-year period beginning on the date of the first import entry under any SIP, it determines that there is a sufficient likelihood that such a proposal could provide the same level of assurance of safety as a proposal that does include such a sponsor.

Supply Chain for Each Drug Must Have One Manufacturer, Seller and Importer

The SIP proposal must have to identify the foreign seller in Canada that will purchase the eligible prescription drug directly from its manufacturer, and the importer in the U.S. that will buy the drug directly from the foreign seller. The supply chain for each drug under a SIP must be limited to three entities, i.e. one manufacturer, one foreign seller and one importer, FDA said. The initial SIP must be limited to a single foreign seller and a single importer, though additional sellers and importers could be added to a SIP after the program begins and FDA is satisfied with its compliance with statutory and regulatory requirements.

No transshipment through Canada. If an eligible drug is manufactured outside of Canada, it must be exported commercially into Canada by the manufacturer and labeled for the Canadian market. It may not be transshipped through Canada for sale in another country, FDA said.

Sale directly to seller. Eligible prescription drugs must be sold directly by the manufacturer to the foreign seller in Canada.

Special Labeling Requirements for Canadian Seller, U.S. Importer

Under the proposed rule, the foreign seller must ensure that a Section 804 serial identifier (SSI), which is an alphanumeric serial number unique to each package or homogenous case, is affixed or imprinted to each package and homogenous case of the drugs, FDA said. The importer must ensure that the product identifier is affixed or imprinted to each package or homogenous case of the drugs. That identifier must include a product identifier that includes a National Drug Code, unique alphanumeric serial number of up to 20 characters, lot number, and expiration date, in both human- and machine-readable format. The importer must also maintain records linking the product identifier affixed or imprinted on a package or homogenous case to the SSI that the foreign seller assigned.

Additional Labeling, Testing Requirements for Importers

The importer also has other responsibilities, including screening eligible prescription drugs for evidence regarding whether or not they are adulterated, counterfeit, damaged, tampered with, or expired; arranging for each shipment of eligible prescription drugs to be tested by a qualifying laboratory; and arranging for them to be relabeled with the FDA-approved labeling, including the carton and container labels, prescribing information, and any patient labeling, such as medication guides, instruction for use documents, and patient package inserts. The Importer is also responsible for facilitating the affixation or imprinting of a product identifier at the same time that the eligible prescription drugs are relabeled with the FDA-approved labeling.

In a change from the proposed rule, the final rule sets a 30-day deadline for manufacturers to supply an importer with the required attestation and information statement, batch records, transaction information, statutory testing information, and authorization to use the FDA-approved labeling for the manufacturer’s drug. The 30-day deadline aligns with the timeline for the importer to submit a Pre-Import Request, which must be submitted 30 days prior to the entry or arrival of a shipment of eligible prescription drugs into the U.S., FDA said.

Pre-Import Request Required 30 Days Before Entry at FDA-Specified Port

At least 30 days prior to “the scheduled date of arrival or entry for consumption of a shipment containing an eligible prescription drug covered by the SIP, whichever is earlier,” the importer must submit a pre-import request to FDA. Entry is limited to only the CBP port of entry authorized by FDA.

Formal entry required. Under the final rule, the importer, or authorized customs broker, is required to electronically file a formal entry for consumption in ACE “for each eligible prescription drug imported or offered for import into the United States,” FDA said.

Testing and relabeling performed post-entry or in FTZ. The importer may admit the drug into an FTZ to conduct required testing and labeling, or can make an entry for consumption and request to recondition the drug. The drug must be relabeled and the testing accepted by FDA before the drug could be distributed in the U.S.