Friday, May 31, 2013

Question of the Day: May 31, 2013 Wouldn't It Be a Great Idea for the FDA to Create a Veterinary Compounding Advisory Subcommittee or Even Have Its Own Committee? Especially in light of Congress Calling for a Study of this Industry.

The Law of Compounding Medications And Drugs: Lowlite/Olympia Has Recently Been Sued--Dr. Mark W...

The Law of Compounding Medications And Drugs: Lowlite/Olympia Has Recently Been Sued--Dr. Mark W...: filed April 30, 2013, Case Number 3:2013cv03126. Here is docket summary.  Will post copy of complaint soon. Date Filed # Docket Text 04/3...

The Law of Compounding Medications And Drugs: COMPLAINT IN DR. MARK W. STURDY d/b/a )ROCHESTER ...

The Law of Compounding Medications And Drugs: COMPLAINT IN DR. MARK W. STURDY d/b/a )ROCHESTER ...: The Complaint   alleges that Lowlite/Olympia violated plaintiff's (a class action-too numerous to name) rights in sending or causing the...

The Law of Compounding Medications And Drugs: Who Will Be the Compounding Pharmacy Exhibitors At...

The Law of Compounding Medications And Drugs: Who Will Be the Compounding Pharmacy Exhibitors At...: 6/12/2013 - 6/16/2013 Sun & Fun Veterinary Conference 6/20/2013 - 6/23/2013 PACVET Conference 6/27/2013 - 6/30/2013 North Carolina VM...

Sunday, May 26, 2013

Drug Compounding for Veterinary Patients

Drugs have been compounded for veterinary practice for many years because it has been necessary in the course of routine practice. However, regulations and compliance policy guidelines (CPGs) should be recognized. A new CPG issued in July 2003 listed the current Food and Drug Administration (FDA) limitations on compounding for veterinary medicine. To summarize the guideline: drugs must not be compounded from bulk substances, and the compounding must not constitute manufacture of a new animal drug. Drug compounding on a case-by-case basis is allowed under the CPG. However, veterinarians and pharmacists must be aware of potential incompatibilities and practices that may interfere with the drug’s stability, purity, and/or potency.

American Association of Pharmaceutical Scientists Volume 07, Issue 02 2005

Saturday, May 25, 2013

Straight From the Horses Heart is Reporting--

Oklahoma Tornado Killed at Least 150 horses

Posted: May 24, 2013 by R.T. Fitch in Horse HealthHorse NewsHorse Rescue
Source: By Mary Rampellini of the Daily Racing Form
“We’ve counted, unfortunately, 150 horses or more that have been found [dead], were killed, or had to be put down,”
Lost HorsesIn a sobering count, more than 150 horses died as a result of the violent tornado that swept through Moore, Okla., on Monday. The number represents the entire community of farms that sit on the southern border of Oklahoma City, including Thoroughbreds and Quarter Horses who were based at Celestial Acres Training Center.
Several organizations coordinating horse-rescue efforts, as well as local veterinarians and horse owners themselves, determined the number, said Joe Lucas, executive vice president of the Thoroughbred Racing Association of Oklahoma.
“We’ve counted, unfortunately, 150 head or more that have been found [dead], were killed, or had to be put down,” Lucas said. “And that’s not just Celestial Acres. That’s the Moore area. That’s what we’ve gotten up to.”
Lucas said a hotline is being set up through the state Department of Agriculture for owners to inquire about lost horses. In addition, there are plans to post photos taken of both surviving and deceased horses for the purpose of identification. The Thoroughbred Racing Association of Oklahoma and the Oklahoma Quarter Horse Racing Association are helping with the process, Lucas said.
The team Lucas is working with has located 18 live horses in the Moore area, including five racehorses who were identified by their lip tattoos and sent to Remington Park in Oklahoma City on Wednesday.
“I think we’ve found everything that can be found that’s out there alive,” Lucas said.
Lucas said another 10 rescued horses were sent to facilities in Moore, and an additional three were shipped to Heritage Place, the auction house in Oklahoma City that has opened its doors to displaced horses.
“Horses that have fairly minor injuries that are treatable, they can spend the night for a few days until things get settled,” said Spence Kidney, general manager of Heritage Place. “Plus, if some are not sure where their horses are, it’s a central place to identify those horses. We’re just trying to chip in a little. It’s a terrible situation.”
Kidney said Wednesday the facilities received a miniature stallion, a paint horse, and a small gray mare who appears to be a Welsh pony.
The Oklahoma Thoroughbred Retirement Program is providing support to horses displaced by the storm, including helping owners with some of the medical costs for the treatment of injured animals. The organization, which is accepting donations through its website,, also is seeking feed and equipment donations.
“We’re raising money to take care of the horses themselves,” said Chris Kirk, a director of the Oklahoma Thoroughbred Retirement Program.
Kirk said one of the most heartwarming stories during this difficult time was the rescue of an unraced 3-year-old Thoroughbred filly named Sasha’s Image. She was found at Celestial Acres on Tuesday evening, more than 24 hours after the storm hit. Sasha’s Image was heard whinnying from beneath some barn doors.
“From what I was told, she was laying flat on her side,” Kirk said. “Her ears were laying flat over the top of her head. They got her up, and her ears were still flat. They said the next morning her ears were pricked up again. She was in a lot of distress, but she’s doing better.”
Tornado hits Durant’s farm in Texas
Tom Durant, the all-time leading owner at Lone Star Park near Dallas, experienced significant damage to his farm inGranbury, Texas, last Wednesday due to a tornado. Durant lost nine horses in the storm, five of them yearlings from the first crop of his multiple stakes winner Sing Baby Sing.
“We took a direct hit,” said Jack Bruner, private trainer for Durant.
Bruner said there was no loss of human life at the farm, but the barns were destroyed, as were four tractors, stores of hay, and “countless miles of fence.” Bruner said he has yet to locate the farm’s six-horse trailer. He said 15 of Durant’s horses remain in the care of Equine Sports Medicine Surgery, an equine clinic in Weatherford, Texas.
“I cannot express how much they’ve done,” he said. “We could not have done it without them.”
Bruner said the majority of Durant’s mares and foals are based at Lane’s End Texas, while his racing operation is at Lone Star. The farm on Thursday was being cleared. “We’re going to rebuild,” Bruner said.

quoted from here

Wednesday, May 22, 2013

Product Safety Information GONAbreed - Veterinarians

Product Safety Information GONAbreed - Veterinarians

More Information on Farm Bill from AVMA

Farm Bills Clear Senate and House Agriculture Committees, Await Floor Time

By: Gina Luke, assistant director, Governmental Relations Division
The Committees on Agriculture in both chambers of Congress marked up draft versions of the Farm Bill the week of May 13 and included several provisions of importance to veterinary medicine. The Farm Bill, which is set to expire Sept. 30, will cost almost $100 billion annually over five years and would set national policy for farm subsidies, rural programs and food aid.
The Farm Bill will extend some programs, modify others and establish new programs for five years. The Senate Agriculture, Nutrition and Forestry Committee approved its bill—S. 954, Agriculture Reform, Food, and Jobs Act of 2013—by a vote of 15-5, and the House Agriculture Committee passed its bill—H.R. 1949, Federal Agriculture Reform and Risk Management Act of 2013—by a vote of 36-10.
AVMA saw several of its top priorities included in the legislation, which are outlined in the attached chart. Both versions of the Farm Bill include:
The Senate’s version of the Farm Bill also includes a provision to establish a Foundation for Food and Agriculture Research. The House version adds a priority area of research that will be eligible for competitive grant fundingwithin the USDA’s Agriculture and Food Research Institute. The research will focus on the safe and effective applications of animal drugs for minor species and the minor uses of these drugs within major species.
The next step in the legislative process is for the each chamber of Congress to consider the bills put forward by their respective bodies. This process may begin as soon as May 20 in the Senate, and possibly the week of June 10 in the House.
Once each chamber passes its bill, a conference committee will convene to iron out the differences between the two bills. Each conference committee will have an onerous task, since the House version cuts $4 billion a year from food aid and farm spending, including $2.5 billion a year from the food stamp program, whereas, the Senate version cuts $2.4 billion from these areas. The committee’s ability to resolve their differences will be essential to passing the final legislation, which lawmakers have attempted to push through Congress for three years in a row.
See the committees’ websites for more information on S. 954 and H.R. 1949, including en bloc amendment details.

Tuesday, May 21, 2013

Hearing on and Link to Text of Farm Bill S. 954

Senate Floor Schedule
Wednesday, May 22, 2013
9:30 a.m.: Convene and begin a period of morning business.

Thereafter, resume consideration of S.954, the Farm bill.

Tuesday, May 14, 2013

Upcoming GADA Meetings and Workshops


The Law of Compounding Medications And Drugs: Sun & Fun Veterinary Conference 6/12/2013 - 6/16/...

The Law of Compounding Medications And Drugs: Sun & Fun Veterinary Conference 6/12/2013 - 6/16/...: MORE INFORMATION CAN BE FOUND HERE

Question of the Day: 5/14/2013 Why Don't Veterinarians Sit on State Boards of Pharmacy?

I have posed this question before in a different manner, and kudos to all those states boards of pharmacy who have been adding consumers, doctors, etc to their state boards of pharmacy. I am not aware of any veterinarians who sit on these boards. Readers correct me if I am wrong and you know a veterinarian who sits on a state board of pharmacy.  But with one of the greatest stakes in compounding medications and drugs, I would think these folks would want and need a voice on the state boards of pharmacy.

Ed Silverman-Pharmalot Blog--Novartis Scrambles To Woo Vets Angry Over Production Problems

Novartis Scrambles To Woo Vets Angry Over Production Problems

Now that Novartis has shrunk operations at its troubled Lincoln, Nebraska, plant, the drugmaker is scrambling to win back a key set of customers – veterinarians. And to do so, Novartis is cutting the price of its Sentinel tablets for flea and heartworm prevention for dogs – one of just three products that are now being made at the facility – nearly in half from 2011 levels.
The idea, of course, is to convince vets to restock its medicine after a 16-month hiatus. Production, you recall, was halted early last year after the FDA found numerous serious and embarrassing manufacturing gaffes at the plant, including repeated failures to investigate customer complaints of foreign tablets found in packaged medicines and filing required field reports with the agency (see a recent FDA report here).
During the ensuing months, Novartis shuffled management of its over-the-counter unit (look here) and proclaimed a new emphasis on quality production (read this). The plant recently resumed activities, although 300 jobs were eliminated and only two other medicines are now being made there – the Excedrin pain reliever and the Theraflu cough-and-cold treatment (read here).  
The difficulties caused a 19 percent drop in sales of its consumer health division last year, which includes both OTC and animal health medicines and accounted for 16 percent of companywide sales. And last August, the drugmaker begged vets to stick with its meds once production resumed (back story). This explains the bid to woo veterinarians who, unlike physicians who treat humans, dispense and also sell medications. Besides the price cut, Novartis (NVS) is offering an added discount for purchases this month.
continue reading here

Saturday, May 11, 2013

Animal Antibiotic Use Continues Upwards, FDA Keeps Blinders

With legislation in 2008, Congress for the first time asked the Food and Drug Administration (FDA) to collect and report to the public the overall sales of antibiotics used in food animals. February 6 marked the release of a third year's worth of data.
Penicillins and tetracyclines sold for animal use increased for the second year in a row. From 11.5 million pounds in 2009, sales rose to 14.4 million pounds in 2011. The two classes of antibiotics remain the most commonly used antibiotics in livestock and poultry, despite their obvious import for treating infections in people as well. In 2011, animal sales accounted for 38 percent of total penicillin sales and 98 percent of total tetracycline sales, including in humans.
Use of antibiotics in animals overall also continues to rise, to 29.9 million pounds in 2011. That compares with at least 7.3 million pounds (according to FDA data, comparing to 7.7 million according to Pew) sold for use in humans. The fact that 3.9 times more antibiotics are used in animals than humans, as this new infographic illustrates from the PEW Charitable Trusts, may shock most Americans.
For 34 years, the FDA considered the routine use of penicillins and tetracyclines in animal feed, for purposes like growth promotion, a public health threat. The agency had moved in 1977 to withdraw its approval for these animal feed products on the grounds that such use had not been shown to be safe for people. That official stance remained on the books until 2011.
IATP produced a recent bibliography listing 147 studies comprising a compelling body of evidence that this routine use antibiotics at nontherapeutic levels in animal feed helps drive an epidemic of expensive, hard-to-treat superbug infections in people, including those coming from a meat supply replete with bacteria resistant to multiple antibiotics.
In December 2011, FDA backtracked from its 1977 proposal claiming the move to protect public health by ending addition of penicillins and tetracyclines to animal feed was now outdated.Instead, said FDA, it was changing focus, by asking pharmaceutical companies to voluntarily to reduce the sales of their antibiotic products sold for use in animal feed.
So, if the success of FDA's approach strikes you as unlikely, you're not alone. Along with my partners in Keep Antibiotics Working, I have been quite skeptical of this voluntary approach, but apparently there's been skepticism within the FDA as well.
Last March, a Federal judge ordered the FDA to reverse its decision and withdraw the animal products after all. In effect, the judge said that the stand first taken by the FDA in 1977 had been right. The FDA has appealed the judge's decision.
"In the face of the antibiotic resistance crisis, we cannot afford to be standing still. We need strong action to combat the overuse of antibiotics in animal agriculture," said Steven Roach, Public Health Program Director at Food Animal Concerns Trust (FACT) and a member of Keep Antibiotics Working.
Nothing less will suffice for the public's health. The World Economic Forum recently reported that overuse and misuse of antibiotics has created the real and immediate threat that once easily treatable infections will rage, and be unresponsive to treatment with any existing antibiotics.
As a parent of young children who get bacterial bronchitis, ear infections and skin infections, that keeps me awake at night.

Follow David Wallinga, M.D. on Twitter:
source found here

Thursday, May 9, 2013

State pharmacy boards back more FDA oversight

State pharmacy boards back more FDA oversight

Alexander: Senate-Passed Bill Will Lead to “Faster Approvals of Animal Medicines and Lower Costs for Farmers” Urges House to pass bill that will reduce FDA approval time for animal drug

Thursday, May 09, 2013Liz Wolgemuth 202-228-4729
Washington, D.C., May 9 – U.S. Senator Lamar Alexander (R-Tenn.), the Ranking Member of the Senate Health, Education, Labor and Pensions Committee, today praised the Senate’s passage of the reauthorization Animal Drug User Fee Act and Animal Generic Drug User Fee Act.

Alexander said: “These programs have reduced the average waiting time for the FDA to approve generic animal drugs by 450 days and eliminated a backlog of applications, meaning farmers get faster access to cheaper and better medicines, and people are healthier. I urge the House to pass these important reauthorizations.”

In Tennessee, more than 17,500 beef cattle farmers have been Beef Quality Assurance Certified, meaning that they have the proper training and knowledge to handle and administer animal drug products. “Tennessee farmers want to do all they can do to produce a safe and wholesome product not only to feed others, but also their own families,” Alexander added.

The Senate Health, Education, Labor and Pensions Committee passed the legislation out of committee on March 20. At a committee markup of the legislation on February 27, Alexander praised the results of the animal drug user fee programs and said he would work to get the Animal Drug User Fee Act and Animal Generic Drug User Fee Act reauthorized before August.

The House Energy and Commerce Committee passed companion legislation reauthorizing both programs on Wednesday.

Thursday, May 2, 2013


Can the government silence and shut down licensed professionals for giving advice online?
That’s the question the Institute for Justice is asking with regard to Dr. Ron Hines, a highly regarded Texas-licensed veterinarian who’s reportedly never had any complaints against him.
Per the Institute for Justice, being a disabled and retired senior citizen, the internet allowed Hines to remain productive in his golden years. Yet he’s been fined and shut down for giving advice on the internet, often for free, to people around the planet who have no other access toveterinary care for their animals.
The organization describes Hines and his activities:
Dr. Ron Hines—a retired and physically disabled Texas-licensed veterinarian—has used the Internet since 2002 to help pet owners from across the country and around the world, often for free and sometimes for a $58 flat fee.  Ron helps people who have conflicting diagnoses from their local vets, who live in remote parts of the world without access to trustworthy veterinarians, and who cannot afford traditional veterinary care. No one has ever complained about Ron’s advice.
Then Ron discovered that he had been on a decade-long crime spree.  In Texas, it is a crime for a veterinarian to give advice over the Internet without having first physically examined the animal.  On March 25, 2013, the Texas State Board of Veterinary Medical Examiners shut Ron down, suspended his license, fined him, and made him retake portions of the veterinary licensing exam.  Texas did this without even an allegation that Ron harmed any animal.
Now Ron is fighting back.  Together with the Institute for Justice, Ron has filed a free-speech lawsuit in federal court to defend his First Amendment right to communicate with people about their pets using the Internet.  But this case is bigger than Ron Hines.  It is about protecting Internet freedom and free speech for Americans everywhere.
While IJ says this lawsuit involves free speech and internet freedom, it also, the organization says, centers on one of the most important unresolved issues in First Amendment law: When does occupational licensing trump the First Amendment?
The outcome will have widespread implications for medicine, law, psychology, investment advice and many other occupations that often involve nothing but speech in the form of advice. The facts make it an ideal lawsuit for eventual consideration by the U.S. Supreme Court.
quoted from source found here