Last week, FDA issued a final rule regarding the importation of certain prescription drugs from Canada. This action was taken by the agency as part of the Safe Important Action Plan, and was done in an attempt to provide safe, effective, and more affordable drugs to Americans.
The final rule was published alongside a final guidance document and outlines all requirements that Sponsors must include in their importation plan.
Here are 10 things you need to know about the new regulation:
- The final rule, which was issued on October 1st, will take effect on Monday, November 30, 2020.
- When it takes effect, the final rule will allow states, American Indian Tribes, and, in certain future circumstances, pharmacists and wholesalers, to submit importation program proposals to FDA for review and approval. If authorized by FDA, certain prescription drugs will be able to be imported from Canada.
- In order for their plans to be approved, Sponsors must demonstrate that their importation of a particular drug will “pose no additional risk to the public’s health and safety” and “result in a significant reduction in the cost of covered products to the American consumer.”
- Importation authorization automatically terminates after two years, “or a shorter period of time if a shorter period of time is specified in the authorization.”
- Before the end of the authorization period, FDA may extend a product’s authorization period. However, FDA can also terminate a product’s importation authorization at any time for reasons outlined in the final rule.
- The eligible prescription drugs that will be included in the Section 804 Importation Program (SIP) must be specified by the Sponsor. Furthermore, FDA states that, to be eligible, a drug must be able to be sold legally in either Canada or the US with appropriate labeling. Prescription drugs that are already authorized by Health Canada must be re-labeled with required US information, as outlined in the Federal Food, Drug, & Cosmetic (FD&C) Act.
- The Sponsor must identify the Foreign Seller in Canada that will purchase the eligible prescription drug directly from its manufacturer, as well as the importer in the US that will buy the drug directly from the Foreign Seller. Both the Foreign Seller and the Importer will be subject to the supply chain requirements outlined in the final rule as well as under the FD&C Act. The Foreign Seller must be licensed to wholesale drugs by Health Canada and be registered with FDA as a Foreign Seller. Furthermore, the Importer must be a wholesale distributor or pharmacist licensed to operate in the United States.
- After the Agency has authorized the proposal, “the Importer must re-submit a Pre-Import Request to FDA at least 30 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.”
- The product(s) being imported must be tested for authenticity, degradation, and to ensure that they are in compliance with established specifications and standards (Statutory Testing). If the Statutory Testing is not completed by the manufacturer, the Importer must arrange for it to be completed by a qualifying laboratory in the US. Furthermore, the Importer must also ensure that the drug is in compliance with all labeling requirements under the FD&C Act.
- If testing is done by the Importer, the manufacturer must supply the necessary information to authenticate the drug and confirm that its labeling complies with all requirements under the FD&C Act.
- After the product has been imported, there are a number of post-importation requirements that must be followed, including:
- Sponsor must provide the FDA with data and information about the SIP, “including the SIP’s cost savings to the American consumer."
- Importer must submit adverse event, field alert, and other reports to the FDA and the drug’s manufacturer.
- If the FDA or any participant in the SIP determines that a recall is warranted, the Sponsor is responsible for effectuating the recall. Each SIP must have a written recall plan that describes how the recall will be performed and outlines who will be responsible for conducting the associated activities.
Are you interested in importing an approved product to the United States from Canada? We can assist you throughout the entire process, using science to help you achieve successful interactions with FDA. To learn more about our services and how we can help you, contact us today.
