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Friday, August 29, 2014

Another Comment: More References to FDA-Approved Ingredients when they are not; they are made from untested formulas provided without warranty, with chemicals accompanied by COAs with Disclaimers regarding Test Results. How has this gone unquestioned for so long?

comment:
Anonymous said...
Here's another presentation that makes reference to FDA-approved ingredients, in the payer space. Accreditation can and has occurred in this area without considering the stark limitations from which these drug products arise: made according to untested formulas provided without warranty, with chemicals accompanied by certificates of analysis with disclaimers regarding test results. I'm not sure how this unsettling foundation has gone unquestioned by professionals and academics who have observed the rapid expansion of this industry in deafening silence.

 
http://c.ymcdn.com/sites/www.iacprx.org/resource/resmgr/CCH_2014/Session_6_Third_Party_Networ.pdf
 

Congressional Research Service Synthetic Drugs:: Overview and Issues for Congress August 15, 2014

CVM Updates FDA Issues Draft Guidance Recommending Global Standard Format for Veterinary Medical Products Electronic Records

CVM Updates FDA Issues Draft Guidance Recommending Global Standard Format for Veterinary Medical Products Electronic Records

A nonpharmacist should be capable of leading Ohio's Pharmacy Board: editorial

The General Assembly recently changed Ohio law so that the executive director of the State Board of Pharmacy no longer need be a licensed pharmacist.
Executive directors of some of Ohio's 20-plus occupational boards must be licensed members of the profession his or her board regulates. But that's not required of all executive directors. For example, Ohio doesn't require the State Medical Board's executive director to be a physician.
It's clear Gov. John Kasich's administration wanted Ohio law changed so a nonpharmacist could lead the Pharmacy Board's staff, something first proposed when the administration drafted the mid-biennium budget bill, House Bill 483.
For whatever reason, that didn't stay in HB 483. But the House inserted the proposal in another measure, Amended Substitute Senate Bill 230, and passed the amended bill 88-6. The Senate concurred, and Kasich signed the bill June 17.
The Ohio Pharmacists Association believes the state should have kept requiring the Pharmacy Board's executive director to be a pharmacist, given the complex rules the panel enforces. That's a fair point. But considering that the Medical Board staff is led by nondoctors, it's hard to see why similar management would imperil the Pharmacy Board.
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Houston and East Texas Area has a Number of Job Openings for Compounding Pharmacy Techs--Still Not Much Sign of Compounding Industry Growth Slowing Down

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Company
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Posted

Controlling the Cost of Compounded Medications: Health Plan/Employer Strategies


Thurs., Sept. 25, 2014
Click here for details

Must Read!!! Kentucky to Tackle Drug Compounder Concerns for Horses

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In a 12-month period that has seen drug compounders linked to horse deaths at a training center and integrity issues at the track, the Kentucky Horse Racing Commission is researching ways it could add regulatory oversight of drug compounders.
Reform-minded KHRC rules committee chairman Ned Bonnie on Aug. 27 called on fellow members of the committee to research the problems horse racing has encountered with drug compounders and come up with ideas to tackle the issue. The rules committee can make recommendations to the full commission.
"It's a serious matter in Kentucky and elsewhere," said Bonnie, who presented each of the committee members with research on compounders and other issues he hopes the committee will soon address.
Mary Scollay, Kentucky Equine Medical Director for the KHRC, said compounders operate under little federal oversight when compared to pharmaceutical companies that manufacture drugs. She said in recent months compounded medications have been linked to horse deaths and failed drug tests.
"There is risk. People should basically assume they are administering an unknown when they use a compounded substance," Scollay said. "They should be used with extreme caution. We have concerns with the health and safety of the horse and integrity of the sport. It is potentially a very dangerous situation."


Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/87063/kentucky-to-tackle-drug-compounder-concerns#ixzz3BnxcGF8H