The U.S. Food and Drug Administration has proposed a rule that, if implemented, would allow states to import certain prescription drugs from Canada.
“The purpose of the proposed rule is to lower prices and reduce out of pocket costs for American patients,” the FDA said in a Federal Register notice expected to be published on Dec. 23.
Under the rule, the program would be implemented through the Federal Food, Drug, and Cosmetic (FD&C) Act’s Section 804 Importation Programs (SIPs) and managed by states or certain non-federal entities. A pharmacist or wholesaler could co-sponsor a SIP.
Each eligible prescription drug import must be approved for use in both Canada and the U.S. and include appropriate labeling.
“The supply chain for each drug under a SIP would be limited to three entities, i.e. one manufacturer, one foreign seller, and one importer,” FDA said.
After the FDA approves a SIP, the U.S. importer must submit a “pre-import request” to the agency at least 30 days before the scheduled date of the prescription drug’s delivery. FDA will dictate at which Customs and Border Protection (CBP) port of entry the drug will arrive in the U.S.
The U.S. importer or its customs broker would be required to electronically file a formal import entry in the CBP’s Automated Commercial Environment (ACE).
“As drug distributors realize savings in acquiring imported drugs and pass some of these savings to consumers and other parties in the drug supply chain, it is possible that U.S. drug manufacturers may experience a transfer in U.S. sales revenues to these parties,” FDA said.
FDA will accept public comments regarding the proposed rulemaking for 75 days after publication in the Federal Register.
Canadians are concerned that the implementation of the FDA regulation will exacerbate a domestic shortage of certain prescription drugs.
FreightWaves Canadian correspondent Nate Tabak reported in August that a 2018 survey found 67% of Canadian pharmacists dealt with daily shortages of certain prescription medicines.
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