Fraud cases underscore new challenges for compounding ... - Atlanta

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14 hours ago - Fraud is a leading concern of federal investigators and the compounding pharmacies they oversee. Compounded drugs are covered by Medicare's Part D program, and they accounted for a 56 percent increase in costs over the last year, according to a June report on Medicare spending.

U.S. feds building accounting fraud case against Valeant, with former CEO, CFO at the center: Report

FDA savages Chinese API maker in warning letter

Tuesday, November 1, 2016

The FDA has savaged a Chinese API maker in a warning letter for a long list of violations, including hiding questionable products, lying to inspectors about products made at the Beijing plant and systemic data manipulation.

September 30, 2016

Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy

Chicago District Office

Compounding Pharmacy/Adulteration/Misbranding

Not Issued *

October 19, 2016

Beijing Taiyang Pharmaceutical Industry Co Ltd

Center for Drug Evaluation and Research

CGMP/Finished Pharmaceuticals/Adulterated

Not Issued *

October 19, 2016

Walgreens Infusion Services

Dallas District Office

Drug Product/Adulterated

Not Issued *

October 19, 2016

Walgreens Infusion Services

Dallas District Office

Drug Product/Adulterated

Not Issued *

October 07, 2016

Buck Mountain Herbs Botanicals, Inc.

Kansas City District Office

Unapproved New Animal Drug/Adulterated

Not Issued *

FDA Veterinary News November 1, 2016

News from CVM Search Approved Animal Drugs on the Redesigned Animal Drugs @ FDA FDA Seeks Public Input on Next Steps to Help Ensure Judicious Use of Antimicrobials in Animal Agriculture   FDA Issues Direct Final Rule Revising Categorization of Animal Drugs Used in Medicated Feeds   FDA Approves Nocita, a New Animal Drug for Local Post-operative Pain in Dogs   FDA Issues Final Rule on Food Ingredients that May Be "Generally Recognized as Safe"

FDA Releases Revised Guidance about Animal Drug User Fees, Fee Waivers and Reductions

The U.S. Food and Drug Administration (FDA) has issued a draft revision of Guidance for Industry (GFI) #170: Animal Drug User Fees and Fee Waivers and Reductions. This guidance describes the fees the agency is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, the information the FDA recommends sponsors submit in support of a request for a fee waiver or reduction, how to submit such a request, and the FDA’s process for reviewing these requests. This draft revision of the guidance clarifies the criteria for Barrier to Innovation waivers, clarifies the procedures for Small Business waivers, and makes additional clarifying changes.

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