MedPage Today: Vaccine Battles Rage

https://www.medpagetoday.com/infectiousdisease/vaccines/78335?xid=nl_mpt_morningbreak2019-03-04&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MorningBreak_030419&utm_term=NL_Daily_Morn_Break_Active

FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine

The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure. Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from...

Dr. Reddy's solid dose plant pinched by FDA for missteps

Wednesday, February 27, 2019

The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories, and the Form 483s keep falling out.

FDA In Brief: FDA finalizes guidance on evaluating the clinical need for outsourcing facilities to compound drugs with bulk drug substances; provides final decision on two substances

Today, the U.S. Food and Drug Administration issued a final guidance for industry, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This guidance addresses the FDA’s policies for developing a list of bulk drug substances that can be used in compounding under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the 503B bulks list, including the agency’s interpretation of “bulk drug substance for which there is a clinical need,” which is the statutory standard for compounding from bulk drug substances. The guidance also highlights criteria the agency generally intends to use to ...

NECC Execs Say Conspiracy Convictions 'Legally Impossible' - Law360

https://www.law360.com/.../necc-execs-say-conspiracy-convictions-legally-impossible

3 days ago - Two former executives at the New England Compounding Center asked a ... who ship drugs in bulk, rendering the argument that NECC illegally masqueraded as a ... law regarding the FDA'sauthority to regulate compounding pharmacies was ..

West Monroe doctor charged with fraud in health care scheme

MyArkLaMiss (press release) (blog)-21 hours ago

Sixty-year-old Thomley, owner of Thomley's Christmas Tree Farm, and his wife Hope Thomley, 52, initially were charged with pharmacist Glenn "Doyle" Beach 

Bills aim to add to druggist role

Arkansas Online-2 hours ago

Bills allowing pharmacists to dispense birth-control pills and stop-smoking products and to administer vaccines to children age 7 or older -- all without a doctor's .

Pharmacists responsible for 2012 Meningitis outbreak facing new ...

WSYM-TV-20 hours ago

Pharmacists responsible for 2012 Meningitis outbreak facing new charges ... Cadden was a pharmacist and the found of the pharmacy at the center of the 2012 ...

Amazon continues its push into the pharmacy business, and has ...

CNBC-Feb 27, 2019

Amazon has tapped 14-year company veteran Nader Kabbani to run its new pharmacy business, including the team that came in through last year's acquisition ...

Amazon reportedly taps former Kindle and Flex exec to lead pharmacy ...
GeekWire-Feb 27, 2019

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What hospital executives should ask their pharmacy: 3 questions with ...

Becker's Hospital Review-20 minutes ago

Hospital pharmacies' role continues to evolve. Today, they play a critical role in delivering safe, effective care for patients. They are also uniquely positioned to