Is it True: Pharma Trying to put Vet Compounding Pharmacies Out of Business?

ig Pharma Trying to put Vet Compounding Pharmacies Out of Business

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Proven ingredients mixed to create effective medicines to become illegal if big pharma gets it's way. These money hungry sluts want to control everything related to the drug market. No doubt medication for people will be next!

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You have used compounded medications for your pet, and those medications are under attack by the big drug companies.

The big drug companies are trying to intrude on your relationship with your veterinarian and your pets. Last month, a provision they proposed was temporarily removed from a Senate bill (S.959) that would have greatly limited your vet’s ability to prescribe compounded medication for dogs, cats and horses.

This provision allowed the FDA to severely restrict compounded medications for dogs, cats and horses. Treatment options for elephants, giraffes, hamsters and other “minor species” were not limited. Yes, you are reading this correctly. The proposal actually targets family pets and horses. Why? Because that’s where the money is.

The proposal is the work of the Animal Health Institute (AHI), a group created and funded by the big drug companies. They want your money. You and your vet want the best possible care for your pets.

We know that many pet owners rely on compounded medication to treat serious and chronic conditions in your pets. They can be literally lifesavers. But now, we hear those corporate interests who would put profits before pets are hoping to insert this provision back in as early as late June when S.959 is debated on the Senate floor. As one AHI lobbyist was quoted in the trade press: “We hope our absence from the bill is temporary.” What’s more, the same drug company lobbyist criticized the “permissiveness” of the original language restricting treatment options for your pets. Have they no shame? 

We can’t let that happen. The consequences are too severe. Please take action today to tell Congress to leave medical decisions about dogs, cats and horses to you and your veterinarian.

http://www.mymedsmatter.com/?vvsrc=/Camp...95/Respond


Animal Health Institute - Big Pharma lobby group. Located 1000 feet from the White House.

This post is quoted from here

http://www.ahi.org/about/member-directory/

http://maps.google.com/maps?client=safar...IgBEPwSMAA

Update: Texas Board of Pharmacy Is Seeking Pharmacits to Assist in Disciplinary Proceedings??? Are there Going to Be So Many Their Lawyers Can't Handle Them? Are Maybe so Complex and Relating to Compounding That It Makes More Sense for Pharmacists to Handle Them?

1. TX Pharmacy Board ‏@txpharmacyboard 15h

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for... http://fb.me/U8JMmgiQ 
   
   Here is what the FB link says:
   
   

   TSBP is seeking pharmacists to assist in disciplinary proceedings, including case preparation and presentation for non-therapeutic dispensing and negligent practice cases. To learn more about this opportunity to advance professional care and concern for the practice of pharmacy, contact Caroline Hotchkiss at 512/305-8046.

KUDOS--This Article MAKES AN EXCELLENT POINT THAT HAS BEEN MADE SEVERAL TIMES ON THIS BLOG: Make pharmacy regulations meaningful May 28, 2013 10:12 PM

OUR VIEW

How much clearer does it have to be? The laws that are meant to ensure compounded medications are safe are not getting the job done.
Last year’s outbreak of fungal meningitis caused by contaminated medicine killed 55 patients, including 15 people in Tennessee. Hundreds more were sickened.
And yet, another compounding pharmacy, this one in West Tennessee, has been identified as the likely source of a new spate of infections in North Carolina and Illinois.
Facilities in 13 states overall received supplies of the medicine.
Main Street Family Pharmacy LLC in Newbern has now recalled all its sterile products. Tennessee health officials on Tuesday released the names of seven Tennessee facilities that received the drug.
Main Street shipped the medications about two weeks after state inspectors found violations at the pharmacy in November. Inspectors concluded that “the processes they were following at the time did not indicate there was any problem,” says Terry Grinder, interim director of the Tennessee Pharmacy Board.
How can that be, since the inspection helped lead to Main Street’s top pharmacist being fined and placed on two years’ probation; 109 medications on the pharmacy’s shelves were found to be outdated, and 11 prescriptions were not written on tamper-resistant paper as required under state law?
Main Street also was cited in 2011 for having expired medications used for drug compounding; sterilization equipment out of compliance; and shipping compounded drugs directly to physicians’ offices without patient-specific prescriptions, a direct violation of state law.
The state did not shut down the pharmacy then, either.
So maybe these dangerous problems continue because compounding pharmacies know that the consequences for breaking the rules are minor, if they are imposed at all.
And let’s not pretend that health officials and pharmacies do not understand the risk to patients’ safety if their medications are not compounded under strictly controlled conditions and made for specific patients. The deadly outbreak caused by the New England Compounding Center unfolded before Main Street was inspected in November.
Then, early in 2013, the Tennessee General Assembly acted irresponsibly by approving a loophole in the specific-patient prescription requirement. It was suggested that the risk of shortages outweighs the risk of contamination.
That is an important discussion to have, but why are the only options ample supply or lax safeguards? Shouldn’t compounding pharmacies ensure that they are adequately staffed and supplied without resorting to shortcuts?
Pharmacists are not physicians, but they are their partners in care. Shouldn’t they also adhere to the key tenet, “First, do no harm”?
quoted from here

NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing May 29, 2013 6:15 pm

May 29, 2013 6:15 pm Topics: Compounding

NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony (PDF) presented at a United States House subcommittee hearing on May 23, 2013. The hearing, “Examining Drug Compounding” was held to provide US Committee on Energy and Commerce Health Subcommittee members an opportunity to hear testimony from Food and Drug Administration (FDA) and health care experts regarding the importance of drug compounding to patients and the current regulation of compounding on the federal and state levels. In its testimony, NABP noted that the clarifications in the proposed Pharmaceutical Compounding Quality and Accountability Act (S 959) regarding the distinction between compounding and manufacturing “provide a safe and equitable environment for both compounding and manufacturing to occur in the best interest of the patient.” The Association stressed that the distinction between compounding and manufacturing is “critical to maintain the present authority of the states and address one of the contributing factors to the NECC [New England Compounding Center] crisis, specifically, the ambiguous authority between the states and FDA.”  The proposed legislation also specifies that a “compounding manufacturer” cannot be licensed as a pharmacy, and NABP notes that this provision is “essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.”
continue reading here

News Release: FLORIDA DEPARTMENT OF HEALTH PROVIDES UPDATE ON MULTISTATE EPIDEMIOLOGICAL INVESTIGATION ASSOCIATED WITH STEROID INJECTIONS

Link to press release can be found here 

Thank you to Kenneth Woliner, MD, ABFM, www.holisticfamilymed.com, for providing the link to the press release.

13 new illnesses linked to TN drug compounder May 29, 2013 5:45 PM

Written by

Walter F. Roche Jr.

The Tennessean

The number of adverse events suspected of coming from steroid medications from a Tennessee drug compounder has nearly tripled with 13 new cases reported by the Florida Health Department.

In a statement released Wednesday, Florida officials said adverse reactions were limited to skin abscesses and did not involve any life-threatening conditions. The disclosure boosts the total number of cases in the growing cluster to 20, including five in Illinois and two in North Carolina.
According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.
No adverse reactions have been reported in Tennessee, where seven clinics got the drugs. Among them was Axis Medical Clinic in Robertson County.
Dr. Paul Yim, who has been operating the clinic in White House for 15 years, said in a telephone interview Wednesday that he is contacting an estimated 200 patients who were injected with the steroids.
“We’ve not had any complaints or reports of infection,” Yim said. “None at all.”
The drug is the same one blamed for a nationwide fungal meningitis outbreak that has taken the lives of 15 Tennessee patients and 55 nationwide. Those tainted spinal steroids were shipped around the country by the now-bankrupt New England Compounding Center in Massachusetts.
Yim said Axis Medical is contacting any patients who got shots with methylprednisolone acetate over the past six months. He said he has been working with the state health department to collect information on the patients, including their age, the date of the shots and the date of the last visit.
He said Main Street Family Pharmacy was suggested to him by a medical supply firm and he has been buying drugs from the firm for about two years without any problems. He described Main Street sales staff as “pleasant and professional.”

continue reading here

American Academy of Ophthalmology Issues Statement on Provisions to Pharmaceutical Compounding Quality and Accountability Act

WASHINGTON, May 29, 2013 /PRNewswire-USNewswire/ -- As legislation to toughen oversight of compounding pharmaceuticals goes to the Senate floor for further debate, ophthalmologists are warning Congress of the unintended consequences of proposed provisions to the bill that require a named prescription for many uses of compounded drugs. While it is largely supportive of the higher safety standards bill S. 959 (the Pharmaceutical Compounding Quality and Accountability Act) would impose on compounding pharmacies and manufacturers, the American Academy of Ophthalmology is seeking exemptions from Sections 503A(d)(4) for biological products and 503A(d)(3) for marketed drugs to allow for continued office use of safe, sterile compounded ophthalmic drugs without a specific patient designation. The Academy points out that there is no evidence to suggest that labeling a drug with a patient's name increases the safety of the repackaging process.

(Logo: http://photos.prnewswire.com/prnh/20130405/MM89329LOGO)

"Safe, sterile compounded medications have long been essential tools available to ophthalmologists for urgent treatment of eye diseases and conditions, benefitting millions of patients," said David W. Parke II , M.D., CEO of the American Academy of Ophthalmology. "The American Academy of Ophthalmology shares the concerns of Congress regarding the need to ensure that these products are compounded in the most sterile and safest manner possible in order to protect public health. As part of that process, however, the Academy urges the continued availability of these sight-saving medications without requiring patient-specific prescriptions, as time is often a critical element in preventing irreversible blindness. The Academy believes that compounding can be done in a safe and efficacious manner and support Congress in ensuring the safe availability of these medications for eye physicians and surgeons and the patients they serve."

continue to read here

New Compounding Pharmacy Scandal in TN May 29th, 2013 // 1:01 pm @ jmpickett

Last month, Tennessee passed a law that eased the restrictions on the state’s compounding pharmacies. Now FDA is looking into seven cases of patients suffering adverse events after they were injected with possibly contaminated drugs that were compounded by a TN pharmacy.
That is why Main Street Family Pharmacy is doing a recall of all of its sterile drug products. Most of them are injectable drugs. It appears that the drugs that are related to the adverse events have methylprednisolone acetate, which is the drug that led to the killer outbreak of fungal meningitis last year.
That outbreak has 740 cases and led to 55 deaths so far. It is the most grave public health crisis in the US in 40 years, and was traced to the New England Compounding Center. That scandal has led FDA to scrutinize drug compounders more closely.
For example, in 2013, FDA started an aggressive effort to do inspections of dozens of drug compounders in many states. There have been some product recalls, too. FDA wants Congress to give them more oversight authority, as well.

• May 30 – Audit Your Lab Like an FDAer
• June 12 – Avoid Warning Letter Disasters with a Strong cGMP Quality Agreement

However, Tennessee last month passed a law to cut down on drug shortages by letting compounders make more drugs and also avoid reliance on compounders out of state. This law also would allow compounders in TN to make/dispense drugs without a specific prescription for a patient. Some experts think this is dangerous.
Records show that Main Street Family Pharmacy shipped product to AL, AR, CA, FL, KY, IL, LA, MS, NM, NC, SC, TN, and TX. So far, patients in NC and IL have infections.
It is not clear how many patients got injected with the tainted drugs, but the TN Department of Health says that the firm had a license as a manufacturer, wholesaler and distributor in 2010.
quoted here

Press Announcements FDA announces import of injectable nutrition drugs

Press Announcements FDA announces import of injectable nutrition drugs

Meet the career con man who made a fortune selling illegal pharmaceuticals online—and pulled off a federal sting that forced Google to pay $500 million.

read the story here