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Importation of Pharmaceuticals From Canada Under the Section 804 Importation Program


On September 24, 2020, the Food and Drug Administration (FDA) finalized regulations that will allow for the importation of certain pharmaceutical products from Canada. The new regulations are part of the FDA's implementation of an executive order from July that is intended to reduce the cost of certain pharmaceuticals through the importation of less expensive versions of those products. The regulations modify 21 Code of Federal Regulations § 1.74, and add a new section at 21 CFR § 251.

The new program will permit the importation of foreign approved drugs from Canada where those drugs are the same as FDA-approved drugs, but are originally manufactured for foreign markets. The regulations have detailed requirements that must be met before the start of any importation. Some of the key requirements are:

  • Only drugs imported from Canada are permitted
  • The importation must be sponsored by a state or Indian Tribe (this requirement may be dropped in the future)
  • The drug must be manufactured at an FDA-registered drug establishment
  • The drug must be the same as a drug that is covered by a valid FDA drug approval, and that is actively marketed in the United States
  • The importer is subject to record-keeping, drug tracking, and adverse event reporting requirements.
  • The importer must relabel the drugs with United States-compliant labeling
  • The drug must be tested for authenticity and quality
  • FDA must determine that the importation is safe, and that it will likely result in cost savings to the American public

To take advantage of this new program, the sponsor must submit a Special 804 Importation (SIP) request. FDA has a great deal of discretion on whether or not to approve the request. Certain categories of drugs—including drugs that contain controlled substances, injectable or infused drugs, and inhalation drugs—are excluded from the program.

This new program offers a mechanism to provide safe and effective alternatives to expensive pharmaceutics in the United States. States, Tribal governments, and companies partnering with those entities will need to be prepared to navigate the significant regulatory complexities that accompany this promising opportunity. Quarles & Brady LLP would be happy to assist in addressing any questions you might have regarding Section 804 Importation.


The Executive Order on Increasing Drug Importation to Lower Prices for American Patients

FDA's Final Regulation on Importation of Prescription Drugs

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