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What is a Compounding Pharmacy?

BuzzRx

If your doctor’s office has given you a prescription with instructions to fill it at a compounding pharmacy, you might be wondering what exactly this means. Only around 7,500 are compounding pharmacies, of which only 3,000 perform sterile compounding. What does it mean when a pharmacy is compounding?

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FDA accepts Outlook Therapeutics’ BLA for wet AMD treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA.

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Wegovy backorder: Why it happens and what to do about it

The Checkup by Singlecare

Unlike Ozempic, which is FDA approved to treat Type 2 diabetes, Wegovy is approved for weight loss in patients with a body mass index (BMI) of 30 or higher and in patients with a BMI of 27 or higher who also have a weight-related medical condition like Type 2 diabetes, high blood pressure, or high cholesterol.

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STAT+: Pharmalittle: We’re reading about fake Ozempic, the FTC policing pharma, and more

STAT

 One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Ozempic and similar diabetes medicines have been increasingly used off label for weight loss.

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Pharma á la carte – 4/25/23

The Honest Apothecary

CALIFORNIA CONSIDERS CLASSIFYING FLAVORING AS “COMPOUNDING “ In a nearly unprecedented move, the state of California is considering treating “flavoring” of a prescription (such as a child’s antibiotic) as “compounding”, thus making the process more difficult and burdensome to pharmacies.

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The Wholesaling Prohibition (Potentially) Demystified? FDA’s Take on Supply Chains for Section 503B Outsourcing Facilities

The FDA Law Blog

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). Richardson & Karla L. See 21 U.S.C. 353b(a)(8). Section II at 2.

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Is Mounjaro covered by Medicaid?

The Checkup by Singlecare

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Mounjaro’s only on-label use is for diabetes, so Medicaid likely won’t cover it for obesity. Look into compounded options (but be careful).