Remove new-section-804-drug-import-rule-does-not-allow-foreign-versions-of-fda-approved-drugs
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New Section 804 Drug Import Rule Does Not Allow Foreign Versions of FDA-Approved Drugs

Pharmacy Checkers

The new federal rule on drug importation from Canada , drafted pursuant to Section 804 of the FDCA, does not allow for the importation of foreign versions of FDA-approved drugs. It only allows for the importation of FDA-approved drugs.

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Trump Administration Announces FDA-Proposed Rule and Guidance to Allow Prescription Drug Importation

Pharmacy Checkers

The FDA has done something that prescription drug importation advocates had possibly given up on. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices.

Drugs 73
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FDA opens door to expressly permit personal drug importation, and yet…

Pharmacy Checkers

Americans have been personally importing medications for decades. In most cases, the reason is that the same drugs sold in the U.S. million Americans import drugs to save money each year. This, despite the fact that, under most circumstances, such imports are prohibited. are much cheaper elsewhere.

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Section 804’s Conflicting Standards for Personal vs. Wholesale Drug Importation and Why it Matters

Pharmacy Checkers

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. What about personal drug importation ?

Drugs 58
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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Pharmacy Checkers

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed.