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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, August 29, 2013
New York denies Mercaldo Apothecary pharmacy’s application to be Medicaid provider after investigation found pharmacy stocked expired drugs and unsanitary and unsafe condition
The state Office of the Medicaid Inspector General has denied the application of a Manhasset pharmacy for its enrollment application to be a Medicaid provider after an investigation found the pharmacy stocked expired drugs and operated under unsanitary and unsafe conditions.
In a press release Tuesday, Medicaid Inspector General James Cox said Mercaldo Apothecary, which operates as Maclennan Pharmacy at 588 Plandome Road, had been rejected as a Medicaid provider.
According to the release, state investigators found 38 expired drugs among the pharmacy’s inventory, including one that had expired in 2006, according to the release. State regulations prohibit pharmacies from carrying expired drugs without segregating the drugs from other medications.
In addition, investigators found a dirty pharmacy refrigerator that did not have an inside thermometer and also stored food, which is prohibited, according to the release.
The pharmacy’s counter, the Medicaid inspector general said, was found to be dusty and cluttered, and investigators found the store appeared so disheveled that wheelchair access to its aisles was thought to be impossible. Federal regulations prohibit the enrollment of an applicant whose location limits access to those with disabilities into any program that receives federal reimbursement.
The pharmacy’s sink had no running hot water and its drain was clogged, according to the release. State regulations require that hot and cold water be available in a pharmacy’s compounding and dispensing area, according to the release.
“The fact that this provider violated so many of Medicaid’s pharmacy standards has a direct bearing on their ability to provide quality medical services or supplies to Medicaid patients,” Cox said in a statement. “And they will be prohibited from doing so as long as they continue to disregard basic standards meant to protect Medicaid consumers from such practices.”
According to the release, the pharmacy was referred to the state Education Department’s Office of Professional Discipline for continued investigation.
Anthony Mercaldo, a licensed pharmacist and the company’s vice president, said he was unaware of the conditions found by the state’s investigators and declined further comment, saying Maclennan “just received a nice article in the Manhasset Press about our decades and decades of service, and we don’t really want this out there.”
Mercaldo told Newsday the company initially applied for the Medicaid program as a “favor to a few customers,” but pulled its Medicaid provider application after Medicaid officials began trying to obtain “more and more information.”
Mercaldo told Newsday the program was not worth the company’s small number of Medicaid customers.
“They kept coming back for more information and we kept providing them more and more information,” Mercaldo told Newsday of Medicaid officials. “At some point, we decided to stop the application.
quoted from here
While it is claimed that large-scale compounding pharmacies only make up 10% of the compounding market, they may supply much more (NY Times). The pharmacies inspected by the FDA are thought to be some of the largest outsourcers in the country. -
Prescription for Meningitis? Unsafe Pharmaceutical Practice Linked to Nationwide Death and Illness
Posted August 28, 2013 |
By: Tatum Brontë and Mark Zamora, Esq.
Last fall, the outbreak of fungal meningitis, which spanned across at least 20 states and took as many as 63 lives, was not an isolated event nor entirely unexpected. The outbreak joins the ranks of many other adverse events caused by the shady practices of drug manufacturing—practices the Food and Drug Administration has failed to gain authority over for nearly 15 years.
At the center? Lives lost and some injured for life. Traditional compounding is still a vital part of the drug industry today. What started as a way for local pharmacists to prepare tailor-made medicine made perfect sense; a liquid product for a mom to give her infant or a dose without an allergen (such as dye). Given their nature, compounding pharmacies fall under the state law and larger protective stipulations, including a 2002 protective ruling from the Supreme Court and the Food and Drug Administration Modernization Act of 1997 (FDAMA). For example, FDAMA exempts, under certain criteria, compounding pharmacies from registration and the obligation to permit access to records during an inspection.
In other words, compounding pharmacies are exempt from FDA oversight.
Where this gets ugly: Free from federal binds and offering drugs for cheaper prices (compare brand name Makena at $1,500 a dose to $25 offered by pharmacies), the demand for compounding pharmacy supply is growing. Now, with shipment across state lines and unregulated mass production, these “pharmacies” are comfortably in the grey area between state and federal jurisdiction. The risk? Lack of appropriate air filtration and insufficient microbial testing, among other risks of contamination—grounds for fungal meningitis and tainted medicine.
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Wednesday, August 28, 2013
August 28, 2013, 8:06 a.m. ET.Imprimis Pharmaceuticals, Inc. Acquires Intellectual Property for Ophthalmic Compound Development Opportunity
Acquisition is in line with IP Acquisition Strategy and Business Model Imprimis Acquires Intellectual Property from Novel Drug Solutions and Eye Care Northwest
SAN DIEGO, Aug. 28, 2013 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), which is focused on the commercialization of drug formulations through a growing proprietary network of compounding pharmacy relationships and by utilizing the FDA 505(b)(2) development pathway, has announced it has acquired intellectual property, including a provisional patent application, related to an ophthalmic compound for intraoperative ocular injection of anti-inflammatory and anti-bacterial agents. Imprimis believes this formulation has the potential to significantly impact the fast-growing $5 billion global cataract surgery drug market. The acquisition allows Imprimis to pursue the commercial development of certain proprietary innovations and also provides Imprimis with a preemptive right on additional Novel Drug Solutions and Eye Care Northwest intellectual property and drug development opportunities.
Imprimis CEO, Mark L. Baum, said, "This is an important acquisition of a novel drug formulation with an important clinical track record. It is gratifying to see our Asset Review Methodology (ARM(TM)) at work. We believe that going forward our growing group of drug discovery and development relationships will bring additional clinically relevant formulations to our company, and these assets will drive additional value for our shareholders. We are in the process of conducting a feasibility assessment related to the development of this asset, together with a team which consists of leaders from the ophthalmic development and regulatory community. Imprimis will continue to develop partnerships with inventors and secure assets which will support our strategic objectives."
The target compound, referred to as IPI-140, is based on a novel combination of moxifloxacin and triamcinolone. IPI-140 was co-invented by Novel Drug Solutions of Randolph, New Jersey and Dr. Jeffrey T. Liegner of Sparta, New Jersey. IPI-140 has been successfully administered by Dr. Liegner in more than 1,500 patients in his surgical practice.
Dr. Liegner stated, "The current treatment regimen for the prevention of post-cataract surgery complication is primarily a pre-operative and post-operative self-administered eye drop regimen, which requires from the patient strict compliance and careful adherence to a prescribed dosing schedule. Individuals with physical limitations, impaired manual dexterity, or those who lack of a supportive care giver, are particularly vulnerable to non-compliance and the subsequent complications of untreated post-surgical issues. This uniquely designed drug, utilizing a fourth generation quinolone therapy combined with potent inflammatory suppression, when placed as a depot inside the vitreous concurrent with cataract surgery, or any intraocular procedure, addresses the primary ocular complications of ophthalmic surgery: infection risk and post-operative inflammation."
Imprimis believes that IPI140 may have broad application in ophthalmic surgery, including the $5 billion global cataract surgery drug market. According to Ocular Surgery News, the cataract surgery market continues to grow tremendously not only because of the expanding aging population, but because the age at which patients demand cataract surgery has lowered, portending a global market size of $7-$9 billion in the next 5-7 years.
Imprimis expects to continue to leverage its exclusive relationships with Novel Drug Solutions, Eye Care Northwest, and others to acquire assets with a proven clinical track record.
Seven Oncologists Charged with Importing Unapproved Drugs
August 13, 2013: Seven Oncologists Charged with Importing Unapproved Drugs - U.S. Department of Justice Press Release
Seven Ohio oncologists were charged with importing cancer medications that had not been approved by the Food and Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.
The doctors were charged with causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act. Their names, ages and the city where they practiced medicine are:
Ranjan Bhandari, 56, Liverpool.
Timmappa Bidari, 68, Parma.
David Fishman, 62, Euclid.
Su-Chiao Kuo, 60, Brunswick.
Marwan Massouh, 54, Westlake.
Poornanand Palaparty, 62, Cleveland.
Hassan Tahsildar, 55, Euclid
"These doctors used drugs that had not been approved by the FDA," Dettelbach said. "Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected."
"FDA's regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers," said Antoinette V. Henry, Special Agent in Charge, FDA's Office of Criminal Investigations. "We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products."
The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges.
Read more: Seven Oncologists Charged with Importing Unapproved Drugs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/press-releases/seven-oncologists-charged-importing-unapproved-drugs#ixzz2dGoFL7Rp
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