Section 804’s Conflicting Standards for Personal vs. Wholesale Drug Importation and Why it Matters
Pharmacy Checkers
JANUARY 4, 2020
The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. Importation from Canada is legal under this section of U.S. law, but only if the Secretary of Health and Human Services (HHS) certifies, as stated in Part L , that such importation would pose “no additional risk” to the public and would help save the American consumer money.
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