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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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The Medical Metaverse Digest for June 30

Intouch Solutions

47% of those had made in-game purchases, and 37% had purchased virtual cosmetic items. CVS aims to be first pharmacy in the metaverse (Pymnts.com) – CVS has filed a patent to sell goods and provide healthcare services in the virtual world. And 79% of their 3,000 survey respondents said that they had already – not someday!

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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

Suitability Petitions permit the submission of an ANDA that differs from an NDA-approved listed drug in strength, dosage form, route of administration, or active ingredient (in a combination drug). But until FDA approves a Suitability Petition, an ANDA cannot be submitted to the Agency for the proposed change. That’s right!

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The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

Suitability Petitions permit the submission of an ANDA that differs from an NDA-approved listed drug in strength, dosage form, route of administration, or active ingredient (in a combination drug). But until FDA approves a Suitability Petition, an ANDA cannot be submitted to the Agency for the proposed change. That’s right!

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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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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(2) stipulates that the FDA can permit personal imports with specific waivers or by general regulation. Those pharmacies aren’t rogue. 15 and 16).

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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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