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
Wednesday, February 27, 2013
Tuesday, February 26, 2013
Pharmacy Practice Issues and Facility Qualifications in Sterile Product Compounding
2013 AAPS National Biotechnology Conference
Hot Topic
Pharmacy Practice Issues and Facility Qualifications in Sterile Product Compounding
10:30 am–noon
May 20, 2013
Sheraton San Diego Hotel and Marina, San Diego
May 20, 2013
Sheraton San Diego Hotel and Marina, San Diego
Overview
The fungal meningitis outbreak associated with tainted steroid injections from the New England Compounding Center has highlighted questions about the product needs of hospitals and clinics, as well as the qualifications of pharmacies that produce sterile products. This session will discuss sterile drug product distribution issues from the clinic or field perspective (e.g., a hospital pharmacy), including sterile product challenges facing a patient care organizations and why services from a group such as the New England Compounding Center may be needed. This session will also discuss technical issues of sterile product fabrication, with an emphasis on an approach to qualify pharmacies to produce sterile products.
Hotel/Travel
Sheraton San Diego Hotel and Marina
1380 Harbor Island Dr.
San Diego, CA 92101
1380 Harbor Island Dr.
San Diego, CA 92101
For more information click here
February 26, 2013 DOJ to Target Pharma and Device Current Good Management Practices (cGMPs) Violations
Over the last several years, we have written extensively about the ongoing government prosecution of pharmaceutical and medical device manufacturers involved in off-label promotion, misbranding, and other illegal marketing and promotional activities. Much of the focus and resources of the federal government, including the US Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Office of the Inspector General (OIG) for HHS have been devoted to investigating and prosecuting such large-scale cases, including the largest in history—a $3 billion fine against GlaxoSmithKline.
While the ongoing prosecution of these cases into the future likely will remain stable despite the U.S. Second Circuit’s decision in United States v. Caronia, DOJ recently announced in late January of this year, that compliance with current good manufacturing practices (cGMPs) will be one of the agency's “top areas of focus” in the coming year, “opening up new areas of uncertainty for those involved in compliance and regulatory activities for the pharmaceutical industry,” writes RAPS.
cGMP regulations are designed to assure that drugs meet safety, identity, and strength requirements and that they meet the quality and purity characteristics which they are represented to possess.
- See more at: http://www.policymed.com/2013/02/doj-to-target-pharma-and-device-current-good-management-practices-cgmps-violations.html#sthash.j9xBJxUa.dpuf
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