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
Tuesday, September 25, 2012
Investigators say no proof unapproved drugs from McLeod were effective U.S. Attorney's office says with unapproved drugs "you don't know what you get"
By: NATE MORABITO | WJHL
Published: September 24, 2012
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JOHNSON CITY, Tenn. --
It's described as a scheme by top management at Mcleod Cancer and Blood Center to get foreign unapproved cancer drugs cheap, mingle them with FDA- approved ones and then hide the evidence from concerned nurses- ultimately giving the drugs to patients.
Tonight we have new information about the investigation.
McLeod’s former business manager Michael Dean Combs laid it all out last week. Combs pleaded guilty to receiving misbranded drugs in violation of the Food, Drug and Cosmetic Act.
It’s the result of a federal investigation centered around unapproved cancer drugs at clinics across the country.
We have team coverage tonight on the investigation, the future of the case and the potential impact on patients.
Combs is the first and only person to be charged locally so far.
Assistant U.S. Attorney Neil Smith wouldn't name any names, but did tell us "additional charges are anticipated."
To read the remainder of the article and see the video click here.
Coping With Critical Drug Shortages
Drug Shortages and Clinicians: No Time for ComplacencyComment on “Coping With Critical Drug Shortages"
Paula A. Rochon, MD, MPH; Jerry H. Gurwitz, MD
Arch Intern Med. Published online September 24, 2012. doi:10.1001/2013
Published online September 2012
To read the article click here.
Monday, September 24, 2012
New York Times Article: At the Track, Racing Economics Collide With Veterinarians’ Oath
Horse-racing veterinarians are both doctor and
drugstore; the more drugs they prescribe, the more money they make. To read article click here http://www.nytimes.com/2012/09/22/us/at-the-track-racing-economics-collide-with-veterinarians-oath.html?smid=pl-share
Vermont Office Use Compounding
During the August 22, 2012, Vermont State Board of Pharmacy Meeting, the board discussed an email question regarding office use compounding. Although the specific question was not provided in the minutes, here is the answer given:
h. Istvan Nadas E-mail – Questions about Vermont office use compounding:
Question 1. See rule 8.19, the cap cannot exceed 5% of total annual sales. The alternative
would be for the veterinarian to write a script that can be filled at a pharmacy. Also, see the
FDA’s good manufacturing rules. Aprille will respond.
Question 2. They have to be licensed in Vermont as an out of state pharmacy and abide by
Vermont Statutes and rules. Aprille will respond.
Question 3. See answer to number one. Aprille will respond.
To see the entire board minutes click here.
Vermont State Board of Pharmacy Tables Whether to Grant Wells Pharmacy Network (previously Francks Labs) a Non-Residence Pharmacy Licence
The Vermont State Board of Pharmacy August 22, 2012, board meeting minutes reflect the following:
The following applications were tabled until next month until we get more info.
Wells Pharmacy Network, LLC – Ocala, FL. It is unclear what the business actually is. It appears the FDA shut down their compounding. The Board would like more information about this. DEA certificate was Francks Labs, not the applicant, Wells Pharmacy Network.The entire August 2012 board minutes can be found here.
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