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FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

Pharmacy Checkers

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. It’s legal to import those drugs.

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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

Pharmacy Checkers

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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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 ?

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Trump Administration Opens Door to Drug Importation Programs

Pharmacy Checkers

This week, the Trump administration formally announced support for not only state prescription drug importation programs, but also HHS Secretary Alex Azar’s own importation plan. These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here.

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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.

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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.

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