FDA Really Wants Dallas' NuVision Pharmacy to Quit Making Drugs Contaminated by Endotoxins

If you more than glance at the website for NuVision Pharmacy, you might start having second thoughts about having the Dallas-based company compound your pharmaceuticals. Why, you might wonder by looking at the home page, did quality testing have to be expanded to check for endotoxins? Why is the "about us" section so keen to point out that the company "is not recalling all sterile injectables." And this "FDA response letter" certainly should give one pause:

There is no evidence to support the FDA's claim that our products lack sterility assurance. ...The FDA did not receive reports about fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product. This is information we voluntarily provided to the FDA. The FDA inspectors had no knowledge of this incident prior to our disclosure. ...Neither the FDA nor our pharmacy uncovered any evidence that the symptoms were caused by our product and were not due to an unknown alternative source.

See also: FDA Makes Dallas Supplement Maker Destroy $8 Million Worth of Bodybuilding Powder

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Medtronic: Letter and Questions Regarding compounding intrathecal baclofen; reports show a strong degree of variability in compounded samples

Dear Members of the Board, Lioresal® Intrathecal (baclofen ...

www.medtronicfeatures.com/wcm/groups/...sg/.../itb-lioresal-survey.pdf

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1 day ago - Although compounding intrathecal baclofen is a fairly common practice, the ... (attached) reported a strong degree of variability in compounded samples, with ...

FDA Once Again Warns Against Compounding Pharmacy

The U.S. Food and Drug Administration is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. 

The latest alert follows a warning from 2013, where the FDA cautioned the public that the sterility of products from the pharmacy could not be assured: http://www.cemag.us/news/2013/08/fda-cautions-against-healthcare-products

Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

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Unique Compounding Pharmacy Issues Recall, but Challenges FDA Decision July 22, 2014

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Articles on North Dakota Petition that would allow retailers such as Walmart and Walgreens to operate pharmacies

Pharmacy measure sponsors submit about 24000 signatures - Dickinson Press 
19 July 2014, 9:36 pm

Pharmacy measure sponsors submit about 24000 signatures Dickinson Press BISMARCK — Sponsors of a proposed change to North Dakota law that would allow national retailers such as Wal-Mart and Walgreens to operate pharmacies in the state turned in more than 10,000 extra signatures Friday to try to put the measure to voters.

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ND pharmacy measure sponsors submit 10000 extra signatures - In-Forum 
18 July 2014, 7:50 pm

ND pharmacy measure sponsors submit 10000 extra signatures In-Forum BISMARCK – Sponsors of a proposed change to North Dakota law that would allow national retailers such as Walmart and Walgreens to operate pharmacies in the state turned in more than 10,000 extra signatures Friday to try to put the measure to voters. Pharmacy petitions submittedBismarck Tribune all 8 news articles »

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Signed Petitions Handed in to Change ND Pharmacy Law - KVRR 
18 July 2014, 7:05 pm

Signed Petitions Handed in to Change ND Pharmacy Law KVRR The proposed measure would change a requirement in North Dakota law that says majority ownership in pharmacies in the state must be held by a registered pharmacist. That could open the door for big-box retailers such as Wal-Mart to operate pharmacies ...

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Pharmacy law petitions brought to Secretary Jaeger - Washington Times 
18 July 2014, 3:47 pm

Pharmacy law petitions brought to Secretary Jaeger Washington Times BISMARCK, N.D. (AP) - Supporters of changing North Dakota's pharmacy ownership law say they have the necessary signatures to get their measure on the ballot. The Secretary of State's Office says supporters brought more than 1,400 petitions to Secretary ...

Laminated Particleboard not a Great Idea for Sterile Compounding, FDA says in Warning Letter to a Texas Based Compounding Pharmacy!!

Posted 22 July 2014 By Alexander Gaffney, RAC Pharmaceutical compounders, take note: The US Food and Drug Administration (FDA) wants you to stop using laminated particleboard in your aseptic processing areas.That nugget of wisdom comes by way of a January 2014 Warning Letter to a Texas-based pharmaceutical compounding pharmacy, Home Intensive Care Pharmacy, released to the public on 22 July 2014.In its letter, FDA alleges that the company violated numerous federal regulations, including that it failed to receive "valid prescriptions for individually-identified patients" prior to compounding the drugs. FDA has cracked down on that practice in recent months, issuing 13 Warning Letters citing the deficiency since March 2013. In contrast, FDA issued just two letters citing the issue in the five years preceding that letter.But more concerning to FDA, it said, was the unsanitary conditions under which the drugs were allegedly compounded. "[Y]our sterile drug products are prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health," the agency wrote in its letter. - See more at: http://www.raps.org/regulatory-focus/news/2014/07/19801/FDA-Warning-for-Particleboard-Workbenches/#sthash.dV3wErRf.dpuf

Second Question of the Day July 22, 2014 Is this Press Release from the Texas Alliance of Independet Pharmacists entitled Texans Enjoying More Options With Custom Tailored Medications Prepared by Pharmacists a sign that compounding pharmacies in Texas are startig to lose business in light of all the illegal activities of compounding pharmacies coming to light or is it a sign of how much profit is made in Texas on compounded medications in light of "Texans benefiting?"

press release

July 22, 2014, 11:04 a.m. EDT

Texans Enjoying More Options with Custom Tailored Medications Prepared by Pharmacists

AUSTIN, Texas, Jul 22, 2014 (BUSINESS WIRE) -- As changes in the nation’s healthcare system continue to pressure medical providers to be less generous with time and resources, Texas independent pharmacists are offering patients more through the practice of compounding.
According to the Alliance of Independent Pharmacists of Texas (Alliance) www.aiptexas.org , Texans are enjoying greater options in the medicines and dosages than ever before as more pharmacists create solutions to meet a patient’s individual unique need. The process of compounding includes making medication easier to swallow for a child or elderly patient, providing medications and dosages adapted for a patient’s specific need, providing medications not commercially manufactured and providing medications in short supply.
Sherry Floyd was one such patient. For years, the Westlake, Texas, resident suffered from debilitating migraines that were often caused by muscle tension in her shoulders. Common prescription medications for migraines didn’t help much, but recently she has been using a customized pain cream compounded by her local compounding pharmacy that has given her the best relief in years. “The pain cream has given me definite relief from the shoulder pain that often triggers my migraines,” said Floyd.
“While many patients benefit from mass-produced medications, others greatly benefit from compounding,” said Nathan Pope, Pharm.D, FACA, Clinical Assistant Professor at The University of Texas at Austin College of Pharmacy. “One patient’s needs may be different from another’s and compounding lets pharmacists and doctors work together to formulate a dosage and medication mix that is tailored to a specific patient. Compounding pharmacists also supply surgery centers and doctors’ offices with medications that are not available through drug manufacturers.”
The compounding medication was an essential role of pharmacists dating back to the origins of the profession: for hundreds of years, an individual pharmacist mixed each medicine for their patients. In the early 1950s, with the advent of mass-produced medications by drug manufacturers, compounding became less common. More recently, as patients, doctors and pharmacists look for ways to address specific individual needs, compounding has regained popularity.
Compounders, as well as all pharmacists, are highly trained healthcare professionals. Students graduate as a Doctor of Pharmacy (Pharm.D) by completing coursework that typically includes two years of pre-pharmacy work and four years of pharmacy school. They learn the chemistry of the human body and how it reacts with different medications and the final year includes a series of rotations on-site in different pharmacy settings. Additionally, pharmacists must receive 30 hours of continuing education every two years to keep their Texas pharmacy license current.
Many compounders are also independent pharmacists who provide vital healthcare services to Texans in their communities. Community members often first visit independent pharmacists for suggestions and medical advice on symptoms. For patients who have limited or no healthcare coverage, independent pharmacists may be the only healthcare professional they see regularly.
Patients that believe they might benefit from compounded medication should talk to their pharmacist or doctor to discuss options available to them. For more information on compounding, visit www.aiptexas.org .
NOTE TO MEDIA: Compounding pharmacists are located in many communities throughout Texas and we are happy to assist you in identifying a local pharmacist to provide their perspective and insight into the benefits of compounding for patients.
SOURCE: Alliance of Independent Pharmacists of Texas
for Alliance of Independent Pharmacists of Texas
Bill Noble , 512-474-2005
bnoble@noblestrategic.com
or
Laura Sorrell , 512-474-2005
lsorrell@noblestrategic.com

2014 C P Health Products Inc. 7/15/14

2014 C P Health Products Inc. 7/15/14

2014 Noni Connection dba Puna Noni 7/14/14

2014 Noni Connection dba Puna Noni 7/14/14

Must Read! High Importance Re: Compounded Drugs! 2014 Oakdell Pharmacy, Inc 5/27/14

2014 Oakdell Pharmacy, Inc 5/27/14