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State Drug Importation Bills Just Got More Personal in California

Pharmacy Checkers

Simple summary: Canada’s brand drugs are priced much lower and states want access to them. The bill not only calls for wholesale importation from Canada – but also personal drug importation from Canada and other countries, subject to Section 804 of the Food, Drug, and Cosmetic Act. It’s about time! There’s no gray in that statement.

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Trump Administration Opens Door to Drug Importation Programs

Pharmacy Checkers

These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. This recognition of equivalent brand drug safety is a step in the right direction. The first proposed channel of prescription drug importation is already codified in law: Section 804 of the Food, Drug and Cosmetic Act.

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

Pharmacy Checkers

The proposed rule provides specifics so that states contemplating or already formulating wholesale drug importation programs have a shot at gaining approval for those programs, per Section 804 of the Food, Drug and Cosmetic Act. Then pharmacy benefit managers (PBMs) negotiate a lower price with the drug company. Here’s Politico.

Drugs 73
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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

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts.

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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. J(3) is specific to Canada and basically tells the FDA to permit personal importation from licensed pharmacies that require a valid prescription. 15 and 16).

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. As a subset of biosimilars, interchangeable biological products can be substituted for the reference product at the pharmacy level, without the input of the prescribing physician.