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STAT+: FDA and large compound pharmacies settle a long-running dispute over a key list for ingredients

STAT

Food and Drug Administration and a trade group that represents large compound pharmacies have resolved a long-running dispute over the use of bulk ingredients, clearing the way for some compounded medicines to become available more quickly. Continue to STAT+ to read the full story…

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Opinion: Compounding pharmacies offer a fix for shortages of essential drugs

STAT

Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations. Read the rest…

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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

In a review on fungal-contaminated compounded pharmaceuticals and medical devices, researchers have described how the contamination of these products can be due to breaches in sterile compounding procedures. Ahmed et al. One case of drug contamination from 2021 was highlighted in the paper.

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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Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance).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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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use. This has been demonstrated recently with PLUVICTO ® , which was the first US Food and Drug Administration (FDA)-approved targeted radioligand therapy for eligible patients with prostate cancer.

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. This places a continued reliance upon plate reading and the limitations of human vision.

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9 foods high in estrogen

The Checkup by Singlecare

Foods high in estrogen Phytoestrogens are estrogen-like plant-based compounds and are the form of dietary estrogen obtained from foods we consume. Food and Drug Administration (FDA). Functions and action mechanisms of flavonoids genistein and icariin in regulating bone remodeling , Journal of Cellular Physiology (2013).