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...

Click to continue reading this essay... »

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications

• FDA finds more impurities in recalled high blood pressure drug valsartan

• Chinese API maker Jiangsu Yew Pharma suspended for refusing Hungarian inspectors

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 ...

Cigna deal gets antitrust nod, positive sign for CVS/Aetna
Reuters-16 hours ago

Cigna Says Express Scripts Acquisition Passes Antitrust Review
Insurance Journal-14 hours ago

Overnight Health Care: Opioid legislation passes overwhelmingly ...
The Hill-14 hours ago

Justice Department clears Cigna-Express Scripts deal to proceed
Health Data Management-17 hours ago

Merger of Cigna and Express Scripts Gets Approval From Justice Dept.
In-Depth-New York Times-15 hours ago

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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

cleveland.com-15 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 ...

Senate advances bill to end pharmacy 'gag clauses'
Washington Examiner-15 hours ago

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04/12/2018

1000525461

ADMA Biologics Inc.

483

FL

Manufacturer

09/17/2018

08/31/2018

3012746140

Pentec Health, Inc.

FMD-145 Letter

PA

Outsourcing Facility

09/17/2018

08/15/2018

3007426960

Westlab Pharmacy, Inc. dba Westlab Pharmacy

483

FL

Producer of Sterile Drug Products

09/17/2018

08/17/2018

3014461693

HomeChoice Partners, Inc.

483

GA

Producer of Sterile Drug Products

09/17/2018

09/07/2018

Best Nutrition Products, Inc.

San Francisco District Office

CGMP/Dietary Supplement/Adulterated/Misbranded

Not Issued *

09/06/2018

Adaptive Energy LLC

Center for Food Safety and Applied Nutrition

New Drug/Misbranded

Not Issued *

09/05/2018

Jabones Y Productos Especializados SA de CV

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

09/04/2018

Lernapharm (Loris) Inc.

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

09/04/2018

Mitra Distributing Inc.

Center for Drug Evaluation and Research

Finished Pharmaceuticals/Unapproved New Drug/Misbranded

Not Issued *

08/29/2018

Pharmaceutical Laboratories and Consultants, Inc.

Detroit District Office

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

08/29/2018

Fagron, Inc

Detroit District Office

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Not Issued *

08/28/2018

Celletech, Ltd

Minneapolis District Office

New Drugs/Dietary Supplements/Food Labeling/Misbranded

Not Issued *

08/20/2018

Tri-Coast Pharmacy

Dallas District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

07/25/2018

Boothwyn Pharmacy LLC

New Jersey District Office

Compounding Pharmacy/Adulterated Drug Products

Not Issued *

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 ...

Cigna-Express scripts deal gets anti-trust approval
Nasdaq-6 hours ago

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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 ...

Local Store Continues to Sell CBD Oil, Despite Pharmacy Board Ruling

WKSU News-4 hours ago

While some stores are pulling CBD or Cannabidiol products from their shelves following a state pharmacy board directive, one local store continues to sell it.

Trump urges Senate to pass legislation prohibiting pharmacy 'gag ...

CNBC-7 hours ago

President Donald Trump supports Congress enacting legislation that would prohibit "gag clauses." "Gag clauses" prevent pharmacists from telling patients that ...

Senate passes bill to stop pharmacy 'gag clauses' that boost drug prices
cleveland.com-3 hours ago

Senate votes to ban pharmacy 'gag clauses'
Washington Times-2 hours ago

Senate advances bill to end pharmacy 'gag clauses'
Washington Examiner-3 hours ago

Trump Supports Legislation Banning Pharmacy Price 'Gag Clauses'
The Epoch Times-3 hours ago

Former Employees Detail An Alleged Pharma Scheme At Dallas ...

D Healthcare Daily-3 hours ago

... allowing the company to select drugs that would return the highest possible ... were granting $20,000-plus reimbursements for compounded pain creams, ...