Wednesday, November 26, 2014
FDA 2014 Records Relating to Downing Labs, LLC (formerly NuVision Pharmacy)
Downing Labs, LLC (formerly NuVision Pharmacy, Inc.), Dallas, TX, 483 Response Dated 8/20/2014 (PDF - 4.2MB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc.), Dallas, TX, 483 Response Dated 8/6/2014 (PDF - 4MB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc), Dallas, TX, FDA Requested Recall Letter Issued 9/9/2014 (PDF - 941KB)Downing Labs, LLC (formerly NuVision Pharmacy, Inc), Dallas, TX, 483 Issued 7/16/2014 (PDF - 2.1MB)
Another Important Comment from a Reader Regarding the article Compounding Pharmacies Even nurses may not realize the important role compounded medications play in their everyday lives. By Elizabeth Rosto Sitko
"In fact, any time a nurse mixes two medicines to give to a patient on the floor, that's a compound [maybe, maybe not].
Even the act of splitting tablets [definitely not] or reconstituting antibiotic liquid for a child is considered compounding" [if an approved dosage form, definitely not].
And if "This article seeks to clear up some of the confusion," it should make these clarifications. But if the article is for the sole purpose of marketing the industry, game on!
Another Very Informative Comment from a Reader to a Question of the Day. This should make compounding pharmacists stop and think.
Question of the Day November 25, 2014 Since the business model for compounding pharmacies is based on profit and growing your business, how many independent pharmacies or small pharmacies will still be around in five years? Since the compounding industry is pushing back against any type of federal regulation and continue to claim, despite evidence to the contrary, that NECC was a one time deal, won't they eventually be the demise of all the smaller, locally owned compounding pharmacies who will not be able to stay in business and compete as more and more larger corporations and larger compounding pharmacies buy up smaller pharmacies or force them out of business? From a business model viewpoint is there anyway these smaller compounding pharmacies can stay in business without breaking the law? Aren't compounders their own worst enemy by training more and more pharmacists, not through universities and colleges to compound, but through trade groups designed to make money and by encouraging and allowing more and more growth of compounding pharmacies and pharmacists? Won't good, law abiding compounding pharmacists and pharmacies be forced out of business under this profit driven model? And the FDA or federal government won't be to blame. The compounding industry will be to blame.
Make sure you check out the RX Trace blog and all of Dirk Rodgers commentary on the DSCSA: FDA Publishes Draft Guidance for DSCSA Data exchange
FDA Publishes Draft Guidance For DSCSA Data Exchange
As expected, the FDA has published the draft guidance on standards for paper and electronic data exchange that was mandated by the U.S. Drug Supply Chain Security Act (DSCSA). And the guidance is early–by one day–fulfilling the intent of the FDA as expressed in the DSCSA Data Exchange workshop held last spring (see “The 2014 FDA DSCSA Workshop“).
The new guidance document can be found on the FDA website at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf
I will provide my full analysis in upcoming FDANews coverage of the DSCSA. Watch theFDANews website for that!
quoted from RX Trace
The new guidance document can be found on the FDA website at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf
I will provide my full analysis in upcoming FDANews coverage of the DSCSA. Watch theFDANews website for that!
quoted from RX Trace
Performance enhancer may spur horse bleeding HORSE BIZ Gregory A. Hall, ghall@courier-journal.com 4:23 p.m. EST November 12, 2014
As horse racing officials work to address the use of the performance-enhancing drug cobalt, a Kentucky regulatory veterinarian said Wednesday that new research is demonstrating that cobalt use may have a potentially deadly side effect.
Dr. Mary Scollay, the equine medical director for the Kentucky Horse Racing Commission, told a Kentucky legislative subcommittee that early testing is showing that the use of cobalt -- a blood doping agent increases stamina by spurring the creation of red blood cells -- may contribute to exercise-induced respiratory hemorrhaging (EIPH), a respiratory bleeding condition that limits horses' running ability and is deadly in the worst cases.
Regulators nationally have been debating possible rules to address cobalt use, but have yet to reach an agreement.
more
Dr. Mary Scollay, the equine medical director for the Kentucky Horse Racing Commission, told a Kentucky legislative subcommittee that early testing is showing that the use of cobalt -- a blood doping agent increases stamina by spurring the creation of red blood cells -- may contribute to exercise-induced respiratory hemorrhaging (EIPH), a respiratory bleeding condition that limits horses' running ability and is deadly in the worst cases.
Regulators nationally have been debating possible rules to address cobalt use, but have yet to reach an agreement.
more
Grand Prairie, Texas LONE STAR PARK TAKES MEASURES TO ASSURE INTEGRITY OF THE SPORT FOR SEASON’S RICHEST RACE
GRAND PRAIRIE, Texas (Saturday, November 15, 2014) – In the days leading up to Lone Star Park’s richest race of the season, the Grade 1 $860,519 Texas Classic Futurity, officials of the Texas Racing Commission teamed with seven out-of-state investigators and veterinarians to provide a “super security” environment around the qualifying horses and horsemen for the track’s biggest race of the year.
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