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
Friday, September 19, 2014
Here is a historical Reminder Involving a Compounded Cream Marketed as an Alernative to the Doctor's Prescription
a historical reminder involving a compounded cream marketed as an alternative to the doctor's prescription:
In the discharge of their functions, druggists, apothecaries, and other persons dealing in drugs, poisons and medicines, are required not only to be skillful, but also exceedingly cautious and prudent in view of the terrific consequences which may attend the least inattention on their part. The highest [***11] degree of care known among practical men must be used by them to prevent injury from the use of their compounds, and they are held to a special degree of responsibility corresponding with their superior knowledge, and are generally held liable for the slightest negligence.
Read entire case here
MESSAGE FROM THE ARIZONA NATUROPATHIC MEDICAL ASSOCIATION (AZNMA)--with spreadsheet of compounding substances
MESSAGE FROM THE ARIZONA NATUROPATHIC MEDICAL ASSOCIATION (AZNMA)
The AzNMA has been working this past year to bring you up to date information via emails, Facebook, and the January 2014 AzNMA Member Meeting with Mike Corrado of Civic Center Pharmacy — with regards to the Compounding Pharmacy Bill which passed by Congress in November 2013.
Compounding Pharmacy Bill
As a result of this bill passing, the FDA is requiring extensive information about compounded drugs – and the ingredients they’re made from – if those drugs are to continue to be allowed for use.
AANP has been addressing this issue through a member Work Group headed up by Dr. Mike Cronin, but now we need input from NDs who know particular medications very well. Those medications (59 of them) are noted in the attachment.
Our submittal has to be into FDA by September 30th.
Please review the Spreadsheet of Compounding Substances in the link below, and identify which compounded drug ingredients you’re knowledgeable about.
AANP has provided a template to make the job easier…please see the Sample Compounding Template link below.
Please forward this message to any and all colleagues you feel are able to assist.
If you can assist please send name and compounding substance that you are willing to work on to:
Question of the day September 19, 2014 Anyone know the answer to the last question in comments section asked by a reader about Diamondback and Michael Blaire? Minutes from North Carolina meeting can be found here: http://www.ncbop.org/about/Agendas%20and%20Minutes/Minutes05.14.pdf
Interesting Fact: Diamondback Drugs co-founder Michael Blaire sits on Board of Directors of Proposed Global On-Line Business Bank
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Here is Michael Blaire's bio from the Proposed Global On-Line Business Bank:
Michael Blaire
Owner, Diamondback Drugs
Before adopting Arizona as his home state in 1992, Michael Blaire founded and served as head pharmacist for three pharmacies in New York. From 1993 to 1999, he spearheaded operations and profitability initiatives for several Walgreens pharmacy locations throughout the Phoenix area. In 2001, Michael moved on to co-foundDiamondback Drugs, a veterinary compounding pharmacy that serves a number of well known zoos, aquariums and veterinarians nationwide.
Michael’s extensive experience in health care and small business eventually segued into a profound interest and involvement in politics. He is a founding member of the Arizona Chapter of the Republican Jewish Coalition and serves as a Republican Precinct Committeeman and State Committeeman for Legislative District 8. In 2010, Michael ran for the Arizona State House of Representatives and received endorsements from the Arizona Chamber of Commerce, the National Federation of Independent Businesses and the Arizona Republic.
Michael has been Chairman of the Arizona Pharmacy Alliance Political Action Committee, and Treasurer of COMP-PAC, political action committee for the International Academy of Compounding Pharmacists (IACP). He is a Leadership Council Member for the National Federation of Independent Businesses and serves on the Advisory Board for Pima Medical Institute. Michael is currently President of Temple Kol Ami in Scottsdale and Treasurer for IACP.
Originally from New York, Michael’s academic background spans a wide range of professional interests. He completed a Bachelor of Science in Microbiology and a Bachelor of Arts in Literature at the University of Rochester (Rochester, New York). He also holds a BS in Pharmacy from St. John’s University College of Pharmacy and Allied Health Professions and completed graduate studies in literature at Arizona State University.
Michael and his wife Dorothy, live in Scottsdale. They have four daughters.
Arizona State University, MA, English. Saint John’s University, BSPh, Pharmacy. University of Rochester, 1976 – 1980.
quoted from here
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Thursday, September 18, 2014
21st Century Cures: Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development--Written Testimony and link to watch hearing tomorrow
Friday, September 19, 2014 - 9:00am
2123 Rayburn
Background Documents and Information:
Witnesses:
Panel I
Dr. Janet Woodcock, Director
- Center for Drug Evaluation and Research
- U.S. Food and Drug Administration
- Witness Testimony (Truth in Testimony and CV)
Panel II
Dr. Kenneth J. Hillan
- Chief Executive Officer
- Achaogen, Inc.
- Witness Testimony (Truth in Testimony and CV)
Dr. Barbara E. Murray
- President
- Infectious Diseases Society of America
- Witness Testimony (Truth in Testimony and CV)
Mr. Kevin Outterson
- Professor of Law
- Boston University School of Law
- Witness Testimony (Truth in Testimony and CV)
Dr. Adrian Thomas
- Vice President, Global Market Access and Public Health
- Janssen Global Services, LLC
- Witness Testimony (Truth in Testimony and CV)
Mr. Allan Coukell
- Director, Medical Programs
- Pew Health Group
- The Pew Charitable Trusts
- Witness Testimony (Truth in Testimony and CV)
Dr. John H. Powers
- Assistant Clinical Professor of Medicine
- George Washington University School of Medicine
- Witness Testimony (Truth in Testimony and CV)
Congress:
US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences
http://raps.org/Regulatory-Focus/News/2014/09/02/20199/US-Canada-Continue-to-Push-for-Regulatory-Harmonization-in-the-Life-Sciences/
Evaluation of Compounded Bevacizumab Prepared for Intravitreal Injection
Nicolas A. Yannuzzi, MD1; Michael A. Klufas, MD1; Lucy Quach, BS2; Lauren M. Beatty, BA2; Stephen M. Kaminsky, PhD2; Ronald G. Crystal, MD2; Donald J. D’Amico, MD1; Szilárd Kiss, MD1
JAMA Ophthalmol. Published online September 18, 2014. doi:10.1001/jamaophthalmol.2014.3591
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