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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.

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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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ACMT Toxicology Visual Pearl: The Bark with Some Bite

ALiEM - Pharm Pearls

The active compound, salicin, is metabolized to salicylic acid in the body providing analgesic and antipyretic effects [2]. 2013 May;5(5):330. Willow tree bark contains salicin from which aspirin (acetylsalicylic acid) can be derived. For over 3500 years, willow bark has been used as a traditional medicine to treat fevers and pain [1].

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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. According to the authors, these were linked to 55 fatal cases of fungal meningitis.

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NABP’s Verified Pharmacy Program Celebrates 10th Anniversary

National Association of Boards of Pharmacy

Since its inception in 2013, VPP has become the most widely recognized multistate uniform pharmacy inspection program accepted by state boards of pharmacy. It also serves as a prerequisite for pharmacies wanting to pursue an NABP Compounding Pharmacy Accreditation. To date, VPP has completed over 2,400 on-site inspections.

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

FDA Law Blog: Biosimilars

As a reminder, in Title I of the 2013 Drug Quality and Security Act (DQSA) (the Compounding Quality Act), Congress created the “outsourcing facility” FDA registration category, and set forth statutory parameters for their operation in new section 503B of the FDCA. 353b(a)(8). 353b(a)(8). Draft Guidance III.B.2(e) Draft Guidance III.B.2(d)

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UNC team discovers interactions vital for hepatitis A virus replication

Pharmaceutical Technology

The team also found that the oral compound, RG7834, developed by Hoffmann-La Roche, hindered replication at a crucial step, preventing the virus from infecting liver cells. In addition, the research indicates that the compound was safe at the dosage level used in this research and the acute timeframe of the study.