Tuesday, March 27, 2018


03/01/2018Pharmacy Resources IncorporatedLos Angeles District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
03/08/2018Medaus, Inc.Dallas District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued 
03/13/2018Biotek, Inc.Denver District OfficeUnapproved New Drugs/MisbrandedNot Issued *
03/15/2018Keshava Organics Pvt. Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued 

FDA takes key step in advancing oversight of drug compounding and implementing new laws ...
FDA Commissioner Scott Gottlieb, MD, announced Friday a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, the provisions limit the bulk drug substances that outsourcing facilities can use in ...

Monday, March 26, 2018

OC Man Pleads Guilty in Health-Care Compounding Pharmacy Fraud


OC Man Pleads Guilty in Health-Care Fraud

Cape May County Herald-5 hours ago
From January 2015 through April 2016, Hunter and McAllister recruited individuals to obtain very expensive and unnecessary compounded medications from an out-of-state pharmacy, identified in the informations as the “Compounding Pharmacy.” The conspirators knew that certain compound medications – including pain, .

Compounding facilities face new FDA regs

Compounding facilities face new FDA regs

ModernMedicine-5 hours ago
Due to problems with compounded medications—including the 2012 fungal meningitis outbreak that led to 64 deaths—FDA is releasing a draft guidance that will determine which bulk drug substances outsourcing facilities can use to compound drugs. “…Compounding from bulk drug substances generally presents greater ...