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, October 3, 2012
Tennessee Board of Pharmacy Board Meeting involved a complaint about a compounding pharmacy
The July 26-27, 2012 Tennessee Board of Pharmacy Board Meeting involved a complaint about a compounding pharmacy that was making commercially available products. The complaint was dismissed. Here is the entry from the meeting minutes:
Anonymous complaint alleged that compounding pharmacy compounded commercially available products (Untraflex and/or Neuro-Gel Plus) and shipped them to physicians’ offices in a contiguous state.
Investigation revealed that pharmacy is not compounding commercially available products and that the products are being billed as prescribed.
Prior discipline: none
Recommendation: Dismiss
Apothecure, Inc. and Gary Osborn Get No Jail Time: $100,000 Fine Imposed
The judge has sentenced Gary Osborn on Counts 1-2 to 1 year of probation and imposed a $100,000 fine. The judge has sentenced Apothecure Inc., Counts 1-2 to 5 years of probation and imposed a $100,000 fine.
Meningitis Cases Are Linked to Steroid Injections in Spine
By DENISE GRADY
Published: October 2, 2012
Dr. April Pettit, an infectious diseases specialist at Vanderbilt University, was worried about her patient. He had been ill withmeningitis for two weeks, he was not getting better, and she could not figure out why. Antibiotics, the usual treatment, were not helping. Bacteria, the usual suspects, could not be found. Click here to read the rest of the article.
Pharmacy Automation Market to Grow at 8% CAGR to 2017: New Market Research Report at ReportsnReports.com
PRWeb – Sun, Sep 30, 2012
“Pharmacy Automation: Technologies and Global Markets” research report provides a comprehensive analysis of the pharmacy automation market’s current operations and equipment, current trends, and detailed patent analysis.
Dallas, Texas (PRWEB) September 30, 2012
This report says global inpatient and outpatient pharmacy automation market was valued at $2.4 billion in 2011 and should reach $2.6 billion in 2012. Total market value is expected to reach nearly $3.9 in 2017 after increasing at a five-year compound annual growth rate (CAGR) of 8%. The inpatient segment of the pharmacy automation market is expected to have a value of nearly $2 billion in 2012 and more than $2.8 billion in 2017, a CAGR of 7.3%. The outpatient segment should total $636 million in 2012 and $1 billion in 2017, a CAGR of 10.1%.
Although pharmacy automation dates back to the 1970s with the introduction of pill-counting machines, the pharmacy automation market continues to advance and deliver impressive technology and improve efficiency. The increasing demand for accuracy, safety, industry standards and competency in the pharmacy environment by regulatory authorities, manufacturers, healthcare professionals and consumers has forced the growth of this market. To read the rest of the report, click here.
Tuesday, October 2, 2012
FDA shoots warning across bow of CanadaDrugs.com Reports tie Internet drug company to FDA's probe of counterfeit Avastin Read more: FDA shoots warning across bow of CanadaDrugs.com - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/fda-shoots-warning-across-bow-canadadrugscom/2012-10-02#ixzz28CzxTTp8 Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing
October 2, 2012 | By Eric
Palmer
Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions
The FDA has sent a
warning letter to one of the most prolific Internet drug providers from Canada,
which reports have tied to an investigation of counterfeits of the cancer
drug Avastin that were
sold to physician practices in the U.S. this year.
The agency this week posted a warning letter sent to
a lawyer in Manitoba claiming that hundreds of websites it identified, including
CanadaDrugs.com, were offering for sale drugs made at unapproved facilities. It
said the sites were even offering domperidone, which it said is no longer
approved for sale in the U.S. because of dangers to breastfeeding
women.
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.
An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.
A similar warning letter regarding "Arkadiy Kisin/White Forest Solutions" was also sent to a series of email addresses and lists dozens of Internet pharmacy sites offering contraceptives and "unapproved drugs" including Accutane, which it says has not been approved for sale in the U.S. since 2010.
An investigation this year by The Wall Street Journal tied the owner of CanadaDrugs.com, Kris Thorkelson, to a probe by federal authorities into companies that the FDA said supplied counterfeit Avastin to U.S. doctors. It said subpoenas sent to physicians asking for information about where they obtained the drugs named Thorkelson. The warning letter says, the "FDA is taking this action against your firm because of the inherent risk in buying unapproved and misbranded new drugs." It gives the companies 10 days to respond.
The FDA in February and April discovered the
counterfeit cancer drugs. Some of the recovered boxes were labeled Altuzan,
which is the brand name for Avastin in Turkey. Tests, however, determined that
there was no active ingredient in the counterfeits. So far, there have been no
reports of problems related to the drugs, according to the FDA and Genentech,
the Roche ($RHHBY) unit that
makes the cancer treatment.
Read the remainder of the article here
The warning letter to CanadaDrugs.com
The letter to Arkadiy Kisin/White Forest Solutions
Dr. Margaret Hamburg, FDA Commissioner, delivering the keynote address at the 2012 Interchange. Image courtesy of C-SPAN. Leading Health Care, Law Enforcement and Government Officials Join with Industry and Patient Advocates to Assess State of Counterfeit Medicines
.S. FDA Commissioner Hamburg Urges Physicians, Patients to Only Purchase Medicines from Reliable Sources to Better Protect Against Fake Drugs
Washington, D.C. (September 28, 2012) – The Partnership for Safe Medicines (PSM) today convened leading domestic and international stakeholders in the fight against counterfeit and substandard medicines, making a renewed commitment to work together and implement new solutions to protect patients worldwide. U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg, in a keynote to the conference, highlighted new efforts her agency is undertaking to reduce the threat and pledged the FDA’s ongoing support to ensure a safe U.S. drug supply.
"The American people have every right to expect that the medicines they rely on are exactly what the package and label say they are – and that the medicines have been carefully evaluated by FDA for safety, efficacy, and quality," said FDA Commissioner Margaret A. Hamburg, M.D. "Our success in addressing this global challenge will depend on collaborating with public health and regulatory partners here in the United States and around the world."
PSM Executive Director Scott LaGanga.
Image courtesy of C-SPAN.
Image courtesy of C-SPAN.
“This year’s Interchange was our boldest, most ambitious effort to date,” said PSM President Dr. Marvin D. Shepherd. “By bringing together stakeholders from as far away as India and Great Britain to share information and ideas on how to win the war on counterfeit medicines, we are sending a message to counterfeiters worldwide: the noose is tightening, and you can’t hide forever. As regulators and law enforcement agencies in the U.S. and abroad come to grips with the great public health risk of fake drugs, our efforts and successes will only intensify in the future.” To read more click here
Subscribe to:
Posts (Atom)