Markey, Hatch push for opioid warning

Boston Herald-17 hours ago

“Because of the confusing names and ingredients, many families may not know that they have just left the pharmacy with a bottle full of danger,” Markey said .

FDA to Veterinarians: Use Approved Mirtazapine Product

FDA to Veterinarians: Use Approved Mirtazapine Product American Veterinarian Compounded formulations, on the other hand, have not been reviewed by ... “As with many compoundedtransdermal drugs, the rate and degree of ...

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy

VP of Sales for North Alabama Compounding Pharmacy Charged in Insurance Conspiracy

Insurance News Net

"Global Compounding stole from insurance programs, including Medicare and TRICARE, by using a marketing scheme that increased the sales of ...

Athenex Gets FDA Compounding Policy Wrong, Amicus Says

Athenex Gets FDA Compounding Policy Wrong, Amicus Says Law360 Chiming in through an amicus brief Thursday, PharMEDium Services LLC said the FDA only allows for drugs to be compounded in bulk under section ..

Very High Importance! 'Stuff floating' in compounded drugs prompts FDA to appeal for more funding STAT

'Stuff floating' in compounded drugs prompts FDA to appeal for more funding STAT ASHINGTON — The Food and Drug Administration doesn't have enough funding or staff to properly regulate pharmaceutical compounders, a top ...

• English court backs NHS in fight with Bayer, Novartis over off-label Avastin use

• FDA berates Chinese drugmaker tied to global valsartan recall

Pharma push for Medicare donut hole change tangles opioid negotiations

A push by Big Pharma to claw back Medicare Part D donut hole money as part of the opioids package has hit against sharp Democratic opposition.  READ MORE

FDA Animal Drug Safety Communication: FDA Reminds Veterinarians of the Differences Between Approved and Compounded Formulas of Transdermal Mirtazapine for the Management of Weight Loss in Cats

In a Dear Veterinarian Letter issued today, the U.S. Food and Drug Administration reminded veterinarians of the differences between Mirataz (mirtazapine transdermal ointment), an animal drug that the FDA approved in May 2018 with demonstrated safety and effectiveness to manage undesired weight loss in cats, compared to the use of compounded formulations of transdermal mirtazapine, which some veterinarians started prescribing before there was an FDA-approved product available. FDA approval of this drug means that veterinarians have an approved mirtazapine product with known safety, efficacy, and quality to provide to their patients rather than relying on the only previously available products that are compounded from bulk drug substances that are unapproved animal drugs. Unlike FDA-approved Mirataz, compounded formulations of transdermal mirtazapine have not been reviewed by the FDA for safety or effectiveness and may vary in quality and potency. With many compounded transdermal drugs, the rate and degree of absorption are unknown and may vary to deliver too little or too much of the active ingredient, making treatment outcomes unpredictable. Manufactured for Kindred Biosciences Inc., Mirataz is a prescription animal drug that is intended to be applied topically on the inner surface of the cat’s ear once daily for 14 days. Mirataz must be prescribed by a licensed veterinarian because a trained professional is needed to correctly diagnose the cause of weight loss in cats and determine whether the drug is an appropriate treatment. Press Release

Essential! High Importance! Must Read!! Blindsided:At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs Their tragedies expose a shadowy US industry that sells drugs with little government oversight. by Stephanie M. Lee

https://www.buzzfeednews.com/article/stephaniemlee/guardian-pharmacy-compounding-lawsuits-cataracts

Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products

The U.S. Food and Drug Administration is alerting pet owners and veterinarians to be aware of the potential for neurologic adverse events in dogs and cats when treated with drugs that are in the isoxazoline class. Since these products have obtained their respective FDA approvals, data received by the agency as part of its routine post-marketing activities indicates that some animals receiving Bravecto, Nexgard or Simparica have experienced adverse events such as muscle tremors, ataxia, and seizures. Another product in this class, Credelio, recently received FDA approval. These products are approved for the treatment and prevention of flea infestations, and the treatment and control of tick infestations. The FDA is working with manufacturers of isoxazoline products to include new label information to highlight neurologic events because these events were seen consistently across the isoxazoline class of products. See more…

Is CBD illegal? Pharmacy board says yes, but dozens of stores sell it

WLWT Cincinnati-17 hours ago

The spokeswoman for the state's Board of Pharmacy told Dykes that the agency is not taking enforcement action at this point against stores selling CBD products ...

Local stores sell CBD despite state order
Athens NEWS-14 hours ago

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St. Louis pharmacist admits tax, conspiracy charges

STLtoday.com-18 hours ago

ST. LOUIS • A St. Louis pharmacist pleaded guilty Tuesday to federal charges in two separate cases and admitted a role in a kickback conspiracy and also ...

PharMEDium says compounder misinterpreting law to compete with Endo

PharMEDium says compounder misinterpreting law to compete with ...

Reuters-8 hours ago

PharMEDium, one of the largest U.S. compounding pharmacy companies, says a smaller firm making a compounded drug that competes with Endo International ...

Keeping pharmacy in pharmacy

Australian Journal of Pharmacy (blog)-1 hour ago

In it's latest communique, the Victorian Pharmacy Authority said it, and other state and territory pharmacy registering authorities have “intervened to stop a retail ...

Very High Importance!! Doctor disciplined by California medical board for menopause therapy: The therapy Dr Hall was prescribing is known as bio-identical hormones which are extolled as a ‘safer’ alternative to traditional hormone replacement therapy.

Doctor disciplined by California medical board for menopause therapy

Infosurhoy-22 hours ago

Bioidentical hormones are synthesized in a lab and either made by major drug companies or in a compounding pharmacy, which makes personalized .

Doctor Denies Charges in Cream Scheme

WorkCompCentral-17 hours ago

A Waxahachie anesthesiologist is rejecting federal charges that he received kickbacks as part of a two-state compounding medication scheme that defrauded ...

Anesthesiologist faces up to 10 years in prison for alleged healthcare ...
Becker's ASC Review-19 hours ago

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ASA Congratulates Elizabeth Rebello on Appointment to FDA ...

asahq.org/.../asa-congratulates-elizabeth-rebello-on-appointment-to-fda-pharmacy-co...

12 hours ago - Elizabeth Rebello, Rph, M.D., FASA, was recently appointed to serve on the PharmacyCompounding Advisory Committee of the Food and Drug Administration 

DOJ Lays Out Arguments Opposing APA Challenges to Vacate Rules

Posted: 18 Sep 2018 06:53 PM PDT

By Anne K. Walsh —

From Serialization to Full Traceability: 2018 Outlook On Compliance

In just two months, pharmaceuticals entering the US pharma supply chain through drug manufacturers will be serialized according to the Drug Supply Chain Security Act(DSCSA).  It’s already been a long journey, but this is only the beginning.  Companies can’t even take a break.  In just one year the wholesale distributor saleable returns requirement will force manufacturers to either capture aggregation data or connect to a Verification Router Service (VRS)—or both!  The year after that, dispenser requirements will lead to even more verification requests coming through.  And...

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