Wednesday, January 9, 2019

A Closer Look At New Pharmaceutical Hazardous Waste Regs

Law360-Jan 4, 2019
[4] Pharmaceutical means any drug or dietary supplement for use by humans or ... compounded drugs; investigational new drugs; pharmaceuticals remaining in ..

NCOIL Approves Model Laws on Repackaged Drugs, PBM Licensure

WorkCompCentral-Jan 7, 2019
The National Council of Insurance Legislators wrapped up 2018 by approving a model law related to physician dispensing and compounded drugs in workers' ...

Looking to 2019 and beyond - accessing the US pharma/biotech ...

JD Supra (press release)-Jan 8, 2019
FDA's increased focus on Chinese drug manufacturers has led to numerous .... into a 2012 fungal meningitis outbreak resulted from drugs compounded in .

FDA 2018 Year in Review: Good Manufacturing Practice

The National Law Review-Jan 8, 2019
In December, FDA issued the Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the ...

CDER's Work to Ensure Drug Safety is An Ongoing Top Priority

FDA.gov-Jan 8, 2019
Today, I'd like to discuss the work we do to make sure the drugs we approve ... many steps to strengthen safety measures for compounded drugs, especially in ...
CDER Outlines Drug Safety Priorities
Regulatory Focus-Jan 8, 2019

FDA 2018 Year in Review: Drug Quality Security Act Implementation

The National Law Review-Jan 8, 2019
Compounded drug products that are essentially copies of commercially ... Under 503B, a compounded drug must not be essentially a copy of one or more ..

Tuesday, January 1, 2019

Dearborn pharmacist accused of Medicare fraud costing $1.2 million

WDIV ClickOnDetroit-3 hours ago
A Dearborn pharmacist accused of prescribing medication to dead people and billing Medicare and Medicaid is now facing serious consequences. Haytham ...
19 hours ago - That litigation challenges the FDA's authorization of the bulk compounding of drugs, including vasopressin, that have not satisfied the legal requirements under .