Friday, September 21, 2018

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
ASHINGTON — The Food and Drug Administration doesn't have enough funding or staff to properly regulate pharmaceutical compounders, a top ...
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

Thursday, September 20, 2018

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 ...

St. Louis pharmacist admits tax, conspiracy charges 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 ...

Wednesday, September 19, 2018

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 ...
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 

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...

Tuesday, September 18, 2018

Coke eyeing cannabis-infused drink market

MD Linx-19 hours ago
Reuters Health News | September 17, 2018. Coca Cola Co said on Monday it was closely watching the growing marijuana-infused drinks market, responding to .

Is it time for community pharmacy to let go of dispensing?

The Pharmaceutical Journal-4 hours ago
It was the most polarising debate of the conference. A panel of pharmacists at the 2018 International Pharmaceutical Federation (FIP) Congress in Glasgow was .

Hundreds of prescriptions with sensitive information found scattered in ...

KFOX El Paso-9 hours ago
A spokesperson for Providence later said the prescriptions had been filled and they were under the pharmacy's jurisdiction. However, the spokeswoman was 

Texas county, union funds seek opioid limits from pharmacy benefit ...

Reuters-15 hours ago
Lawyers for a Texas county and two union employee benefit funds have asked a federal judge to force the three largest U.S. pharmacy benefit managers to edit ..

More Changes to the Pharmacy Industry Coming as DOJ Approves ...

BioSpace (press release) (blog)-46 minutes ago
In March, U.S. insurer CIGNA Corporation announced it was acquiring pharmacybenefits manager Express Scripts for approximately $52 billion. On Monday ...

Raymond pharmacist pleads guilty in compound pharmacy case

Hattiesburg American-2 hours ago
Another Mississippi pharmacist has pleaded guilty for his role in a multi-state compound pharmacy scheme with roots in Hattiesburg that bilked TRICARE and 

Senate passes bill to stop pharmacy 'gag clauses' that boost drug prices hours ago
The Senate passed a bill to block "gag clauses" that keep pharmacists from telling customers if their drugs would cost less if they pay out-of-pocket instead of ...
09/07/2018Best Nutrition Products, Inc.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
09/06/2018Adaptive Energy LLCCenter for Food Safety and Applied NutritionNew Drug/MisbrandedNot Issued *
09/05/2018Jabones Y Productos Especializados SA de CVCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
09/04/2018Lernapharm (Loris) Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
09/04/2018Mitra Distributing Inc.Center for Drug Evaluation and ResearchFinished Pharmaceuticals/Unapproved New Drug/MisbrandedNot Issued *
08/29/2018Pharmaceutical Laboratories and Consultants, Inc.Detroit District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
08/29/2018Fagron, IncDetroit District OfficeCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *
08/28/2018Celletech, LtdMinneapolis District OfficeNew Drugs/Dietary Supplements/Food Labeling/MisbrandedNot Issued *
08/20/2018Tri-Coast PharmacyDallas District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
07/25/2018Boothwyn Pharmacy LLCNew Jersey District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *

Monday, September 17, 2018

Big Pharma was supposed to self-police fentanyl prescriptions. It failed ...

KSLA-7 hours ago
In May 2014, the regulators became aware that Awerbuch had been arraigned on federal charges of health care fraud and distribution of controlled substances.

PHILADELPHIA, Sept. 17, 2018 /PRNewswire/ -- Berger Montague is pleased to announce that the Texas A&M University Research Foundation has agreed to pay $750,000 to resolve grant fraud claims under the False Claims Act ("FCA").

$750000 Settlement Reached in Grant Fraud Lawsuit Against Texas ...

PR Newswire (press release)-3 hours ago
Relators alleged fraud in connection with grant requirements or regulations, ... in matters involving healthcare fraud, defense contracting fraud, IRS fraud,

Former Margate mortgage consultant pleads guilty in NJ drug ...

Press of Atlantic City-Sep 13, 2018
The conspirators learned that certain compound medication prescriptions — including pain, scar, and anti-fungal creams, as well as vitamin combinations .

Ex-Margate mortgage consultant pleads guilty in compounding scheme

Press of Atlantic City-Sep 14, 2018
The conspirators learned that certain compound medication prescriptions — including pain, scar and anti-fungal creams, and vitamin combinations — were ...

Pharmacists have critical role in protecting antibiotics by encouraging ...

The Pharmaceutical Journal-15 hours ago
Delegates at the International Pharmaceutical Federation's 2018 Congress heard how pharmacists have a critical role in antimicrobial stewardship and helping 

Merger of Cigna and Express Scripts Gets Approval From Justice Dept.

Merger of Cigna and Express Scripts Gets Approval From Justice Dept.

New York Times-3 hours ago
The $52 billion deal, announced last March, is one of two proposed transactions involving pharmacy companies before the Justice Department. Last December ...

Another pharmacist pleads guilty in $400M-plus health fraud; The 45-year-old Moran co-owned Medworx, a Ridgeland pharmacy

Another pharmacist pleads guilty in $400M-plus health fraud

Washington Times-4 hours ago
(AP) - Another Mississippi pharmacist is pleading guilty to helping run a fraud that ... The 45-year-old Moran co-owned Medworx, a Ridgeland pharmacy. He also .

Opioid MDL Stakes Rise For Pharmacy Benefit Cos.

Law360-2 hours ago
Law360 (September 17, 2018, 7:22 PM EDT) -- The nation's biggest pharmacy benefit management companies should be forced to clamp down on painkiller ...