CBI's Pharmaceutical Compliance Congress started off both mornings of their two day conference with a matter sure to get industry members' attention: enforcement. A variety of government attorneys offered a glimpse into their approach to healthcare fraud, and shared insights into what they consider to be best practices regarding compliance. Carmen Ortiz, U.S. Attorney for the District of Massachusetts, began by highlighting the high priority areas of 2014. The "enforcement panel" of five government attorneys followed, splitting their time between healthcare fraud on the one hand, and the importance of robust compliance programs on the other. On Wednesday, Assistant Attorney General, Stuart Delery, spoke regarding civil enforcement and non-monetary penalties the Department of Justice (DOJ) has utilized See more here
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, January 30, 2014
MUST READ Interview with Jane Axelrad, CDER's associate director for policy---FDA News FDA to Partner with States on Compounding Oversight
Jane Axelrad, CDER’s associate director for policy, spoke with Drug Daily Bulletin to discuss the FDA’s strategy for regulating compounding pharmacies following the recent passage of the Drug Quality and Security Act.
FDAnews: What is the greatest challenge the FDA faces as it sets out to regulate the compounding industry with its new authorities?
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