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, August 1, 2014
Medical labs to get new FDA oversight
By MELISSA HEALY Los Angeles Times
Last modified: 2014-08-01T03:34:10Z
Published: Thursday, Jul. 31, 2014 - 1:00 am
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Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpyThe Food & Drug Administration on Thursday announced it would step up its regulation of a class of lab tests that have been key in ushering in an era of personalized medicine - a step the agency has long considered against strong opposition by small labs. The FDA's proposal would tighten the agency's oversight of laboratory-developed tests, which are designed, manufactured and used within a single lab. Most of the tests that would now come under more stringent review are used by physicians and hospitals to help diagnose and treat patients, and they have been widely used to detect certain types of gene-based cancers and guide their treatment.
As medical practice has grown increasingly dependent on genomic analysis, many small or specialized labs have gotten into the business of devising diagnostic tests, tailoring them to the needs of specialized practices, and providing laboratory services to hospitals and physicians.
Read more here: http://www.sacbee.com/2014/07/31/6597538/medical-labs-to-get-new-fda-oversight.html#storylink=cpy
Scrutiny flares as next Missouri execution looms
Time appears to be running out for convicted Missouri killer Michael Worthington, who is scheduled on Wednesday to become the country’s first person executed since last month’s prolonged and problematic lethal injection of an Arizona inmate.
For nearly 120 minutes on July 23, Joseph R. Wood III snorted and gasped “like a fish out of water” before dying.
His execution, the country’s third this year described as “botched,” has prompted renewed calls for a halt to all lethal injections.
On Monday, the American Civil Liberties Union suggested a nationwide suspension of the death penalty. It and other death penalty opponents say that what happened during the botched executions violates Eighth Amendment protection against cruel and unusual punishment. continue to read here
Read more here: http://www.kansascity.com/news/local/crime/article863263.html#storylink=cpy
For nearly 120 minutes on July 23, Joseph R. Wood III snorted and gasped “like a fish out of water” before dying.
His execution, the country’s third this year described as “botched,” has prompted renewed calls for a halt to all lethal injections.
On Monday, the American Civil Liberties Union suggested a nationwide suspension of the death penalty. It and other death penalty opponents say that what happened during the botched executions violates Eighth Amendment protection against cruel and unusual punishment. continue to read here
Read more here: http://www.kansascity.com/news/local/crime/article863263.html#storylink=cpy
Judge Approves New England Compounding Settlements
Daily Bankruptcy Review ,
Jacqueline Palank,
August 01, 2014,
(c) 2014 Dow Jones & Company, Inc.
Victims of a deadly meningitis outbreak will share as much as $100 million under settlements that won court approval Thursday in the bankruptcy case of the Massachusetts pharmacy tied to the outbreak. ...
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Do You Make These Five Mistakes with Your Pharmacy Benefit? The burchfield group
These are tough times. No corporation can afford to conduct business as
usual; and most CFOs in America are desperately looking for ways to
reduce costs. Yet there is one area that is often overlooked. Your
pharmacy benefit cost.
We all know health care costs are continuing their steady rise, and
pharmacy benefit cost makes up 10% to 20% of your total health care
costs. Pharmacy costs are expected to rise between 6% and 7% in 2009.
Unfortunately these costs are often hidden and neglected.
A quick way to calculate your potential pharmacy benefit savings is as
follows. Take your number of employees in thousands and multiply it by
$100,000. For example, a company with 11,000 employees has the
potential for savings of $1.1million. Ask yourself if this is a significant
enough opportunity that you want to do something about it.
For corporations with retiree medical benefits, the ruling under FASB 106
requires accrual for these benefits. The Board believes that failure to
recognize an obligation prior to its payment impairs the usefulness and
integrity of the employer's financial statements. Failure to manage these
costs has a compounding effect.
Here are five pharmacy benefit mistakes your organization may be
making that could cost the company millions.
1. Allowing Human Resources to negotiate with Pharmacy
Benefit Manager (PBM) companies without the clout of
pharmacy benefit specialists.
HR has its hands full with other priorities, is often understaffed and can
lack the scale required to get the best deal when negotiating with PBMs.
PBMs often come to your HR/Benefits team with offers to extend the
contract for incremental savings. While many HR departments have
some staff and expertise, chances are they only see PBM contracts once
every two or three years. Are they up-to-date on the latest pharmacy
pricing, trends and definitions of terms? Why take this risk when millions
could be at stake
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Must READ! Lot of Valuable Information! FDA Reveals Expectations of Conditions at Outsourcing Facilities
Cheryl A. Thompson
BETHESDA, MD 01 Aug 2014-A document from FDA offers clues as to the extent that sterile drug products from outsourcing facilities will be made under conditions different from those described in the United States Pharmacopeia (USP) standards for pharmaceutical compounding.
Fifty-one sites as of July 25, according to the agency, had registered as compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
The sites have been able to register without paying a fee.
But come October 1, the first official registration period opens and fee collection starts.
In preparation, FDA on July 1 issued a draft of "Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act" (PDF) and invited comments from the public.
According to pharmacy consultant E. Clyde Buchanan, pharmacists can expect sterile drug products from FDA-registered outsourcing facilities "to be made under conditions more stringent" than those specified in USP chapter 797.
That is because FDA drafted current good manufacturing practice (CGMP) requirements that impose "a higher level of quality control and quality assurance activities," he explained.
Buchanan runs an eponymous consulting firm and is a coauthor of Compounding Sterile Preparations, Third Edition, published by ASHP.
continue to read here
BETHESDA, MD 01 Aug 2014-A document from FDA offers clues as to the extent that sterile drug products from outsourcing facilities will be made under conditions different from those described in the United States Pharmacopeia (USP) standards for pharmaceutical compounding.
Fifty-one sites as of July 25, according to the agency, had registered as compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
The sites have been able to register without paying a fee.
But come October 1, the first official registration period opens and fee collection starts.
In preparation, FDA on July 1 issued a draft of "Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act" (PDF) and invited comments from the public.
According to pharmacy consultant E. Clyde Buchanan, pharmacists can expect sterile drug products from FDA-registered outsourcing facilities "to be made under conditions more stringent" than those specified in USP chapter 797.
That is because FDA drafted current good manufacturing practice (CGMP) requirements that impose "a higher level of quality control and quality assurance activities," he explained.
Buchanan runs an eponymous consulting firm and is a coauthor of Compounding Sterile Preparations, Third Edition, published by ASHP.
continue to read here
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