Sunday, September 30, 2012
Friday, September 28, 2012
People, pets still troubled by drug shortages say doctors, veterinarians
Published: Thursday, September 27, 2012, 7:45 PM Updated: Thursday, September 27, 2012, 9:55 PM
Thursday, September 27, 2012
American Horse Daily: Consider the Source
American Horse Daily has an article today, September 27, 2012, entitled Consider the Source, When you're seeking horse health information, go to a reliable source. To read the entire article click here.
Wednesday, September 26, 2012
FDA Urged to Speed Approval of Drugs
LIFE & CULTURESeptember 25, 2012, 7:06 p.m. ET
By THOMAS M. BURTON
A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.
The President's Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.
The advisory report gave few details of what new laws or regulations might be required to limit a new drug's use to such populations. Historically, the FDA doesn't attempt to police how doctors use drugs, though companies' marketing is restricted to the conditions specified on the label.
To read the remainder of the article click here
Tuesday, September 25, 2012
Johnson City cancer center business manager pleads guilty to buying unapproved drugs
Updated September 19, 2012 8:41 PM
- Press Staff WriterRead more: http://www.johnsoncitypress.com/News/article.php?id=102462#ixzz27VZ118zG
Investigators say no proof unapproved drugs from McLeod were effective U.S. Attorney's office says with unapproved drugs "you don't know what you get"
By: | WJHL
Published: September 24, 2012
» 0 Comments | Post a Comment
JOHNSON CITY, Tenn. --
It's described as a scheme by top management at Mcleod Cancer and Blood Center to get foreign unapproved cancer drugs cheap, mingle them with FDA- approved ones and then hide the evidence from concerned nurses- ultimately giving the drugs to patients.
Tonight we have new information about the investigation.
McLeod’s former business manager Michael Dean Combs laid it all out last week. Combs pleaded guilty to receiving misbranded drugs in violation of the Food, Drug and Cosmetic Act.
It’s the result of a federal investigation centered around unapproved cancer drugs at clinics across the country.
We have team coverage tonight on the investigation, the future of the case and the potential impact on patients.
Combs is the first and only person to be charged locally so far.
Assistant U.S. Attorney Neil Smith wouldn't name any names, but did tell us "additional charges are anticipated."
To read the remainder of the article and see the video click here.
Coping With Critical Drug Shortages
Drug Shortages and Clinicians: No Time for ComplacencyComment on “Coping With Critical Drug Shortages"
Arch Intern Med. Published online September 24, 2012. doi:10.1001/2013
Published online September 2012
To read the article click here.
Monday, September 24, 2012
New York Times Article: At the Track, Racing Economics Collide With Veterinarians’ Oath
Horse-racing veterinarians are both doctor and
drugstore; the more drugs they prescribe, the more money they make. To read article click here http://www.nytimes.com/2012/09/22/us/at-the-track-racing-economics-collide-with-veterinarians-oath.html?smid=pl-share
Vermont Office Use Compounding
During the August 22, 2012, Vermont State Board of Pharmacy Meeting, the board discussed an email question regarding office use compounding. Although the specific question was not provided in the minutes, here is the answer given:
h. Istvan Nadas E-mail – Questions about Vermont office use compounding:
Question 1. See rule 8.19, the cap cannot exceed 5% of total annual sales. The alternative
would be for the veterinarian to write a script that can be filled at a pharmacy. Also, see the
FDA’s good manufacturing rules. Aprille will respond.
Question 2. They have to be licensed in Vermont as an out of state pharmacy and abide by
Vermont Statutes and rules. Aprille will respond.
Question 3. See answer to number one. Aprille will respond.
To see the entire board minutes click here.
Vermont State Board of Pharmacy Tables Whether to Grant Wells Pharmacy Network (previously Francks Labs) a Non-Residence Pharmacy Licence
The Vermont State Board of Pharmacy August 22, 2012, board meeting minutes reflect the following:
The following applications were tabled until next month until we get more info.
Wells Pharmacy Network, LLC – Ocala, FL. It is unclear what the business actually is. It appears the FDA shut down their compounding. The Board would like more information about this. DEA certificate was Francks Labs, not the applicant, Wells Pharmacy Network.The entire August 2012 board minutes can be found here.
The Makena Story
Michelle Oxman has written a blog entry entitled, What Does the Makena Story Tell Us About the Orphan Drug Act?, (September 24, 2012). The article deals with why prescription drugs are a large portion of health care spending. The article does a good job of explain the Orphan Drug Act (ODA) (P.L. 97-414) and of discussing the K-V v. FDA decision. To read this article click here.
Saturday, September 22, 2012
Man convicted for role in international counterfeit drug distribution scheme
Man convicted for role in international counterfeit drug distribution scheme
Man convicted for role in international counterfeit drug distribution scheme
LOS ANGELES — A Puerto Rican man faces up to 10 years in prison after being found guilty by a jury this week on federal charges stemming from his role as a key operative for a drug ring that distributed large quantities of Chinese-made counterfeit pharmaceuticals throughout the United States and worldwide.
Francis Ortiz Gonzalez, 36, was convicted following a six-day trial on one count of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals. His sentencing is set for Nov. 8 before U.S. District Judge George Wu. Ortiz-Gonzalez. His wife, Ideliz Aleman-Valentin, and two other defendants were named in a 30-count indictment handed down by a grand jury in Los Angeles in June 2009. The jury that convicted Ortiz acquitted Aleman-Valentin.
In 2009, special agents with U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) executed a federal search warrant at Ortiz-Gonzalez's residence in Trujillo Alto, Puerto Rico, a suburb of San Juan. Inside the home, investigators found more than 100,000 pills made to resemble a variety of popular prescription medications, including Viagra, Cialis, Valium, Xanax and Lipitor. The ensuing investigation revealed that Ortiz-Gonzalez had packaged and shipped more than 160,000 counterfeit tablets during a six-month period in 2009 while working for the organization. Many of those shipments were mailed to Southern California, which is why the case was brought to Los Angeles.
The burgeoning popularity of e-commerce has led to an explosion in the number of websites offering prescription drugs online," said Claude Arnold, special agent in charge for HSI Los Angeles. "But consumers who are considering purchasing pharmaceutical products over the Internet should heed that old expression 'buyer beware.' Part of what you're paying for when you buy established brands, regardless of the product, is quality control. Imposter drugs like these pose a serious threat to users who mistakenly assume these substances are safe."
The indictment allege that Ortiz-Gonzalez acted as U.S.-based distributor for a criminal enterprise, allegedly headed by Bo Jiang, 34, a Chinese national whose last known residence is New Zealand. In January 2011, Jiang was taken into custody on a provisional arrest warrant by authorities in New Zealand, but fled shortly after being released on bond. He remains a fugitive.
According to the indictment, Jiang advertised the counterfeit medications over the Internet. As part of the scheme, he allegedly recruited individuals from around the world to act as distributors for the products. The U.S.-based distributors, including Ortiz-Gonzalez, were responsible for receiving the parcels of counterfeit pharmaceuticals from China, then repacking and shipping them to fill individual customer's orders throughout the United States.
The probe, which commenced in 2008, involved HIS Los Angeles, the Food and Drug Administration, Office of Criminal Investigations and the U.S. Postal Inspection Service.
The Department of Homeland Security and the Department of Justice are working together to combat intellectual property crimes. In fiscal year 2011, HSI and U.S. Customs and Border Protection made nearly 25,000 seizures involving counterfeited and pirated products, a 24 percent increase compared to fiscal year 2010.
As the largest investigative arm of the Department of Homeland Security, HSI plays a leading role in targeting criminal organizations responsible for producing, smuggling and distributing counterfeit products. HSI focuses not only on keeping counterfeit products off our streets, but also on dismantling the criminal organizations behind such illicit activity.
You may also visit us on Facebook, Twitter and YouTube, or access this news release on your mobile device.
August 9, 2012
Los Angeles, CA
Man convicted for role in international counterfeit drug distribution scheme
Search continues for organization's ringleader
Francis Ortiz Gonzalez, 36, was convicted following a six-day trial on one count of conspiracy and seven counts of trafficking in counterfeit pharmaceuticals. His sentencing is set for Nov. 8 before U.S. District Judge George Wu. Ortiz-Gonzalez. His wife, Ideliz Aleman-Valentin, and two other defendants were named in a 30-count indictment handed down by a grand jury in Los Angeles in June 2009. The jury that convicted Ortiz acquitted Aleman-Valentin.
In 2009, special agents with U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) executed a federal search warrant at Ortiz-Gonzalez's residence in Trujillo Alto, Puerto Rico, a suburb of San Juan. Inside the home, investigators found more than 100,000 pills made to resemble a variety of popular prescription medications, including Viagra, Cialis, Valium, Xanax and Lipitor. The ensuing investigation revealed that Ortiz-Gonzalez had packaged and shipped more than 160,000 counterfeit tablets during a six-month period in 2009 while working for the organization. Many of those shipments were mailed to Southern California, which is why the case was brought to Los Angeles.
The burgeoning popularity of e-commerce has led to an explosion in the number of websites offering prescription drugs online," said Claude Arnold, special agent in charge for HSI Los Angeles. "But consumers who are considering purchasing pharmaceutical products over the Internet should heed that old expression 'buyer beware.' Part of what you're paying for when you buy established brands, regardless of the product, is quality control. Imposter drugs like these pose a serious threat to users who mistakenly assume these substances are safe."
The indictment allege that Ortiz-Gonzalez acted as U.S.-based distributor for a criminal enterprise, allegedly headed by Bo Jiang, 34, a Chinese national whose last known residence is New Zealand. In January 2011, Jiang was taken into custody on a provisional arrest warrant by authorities in New Zealand, but fled shortly after being released on bond. He remains a fugitive.
According to the indictment, Jiang advertised the counterfeit medications over the Internet. As part of the scheme, he allegedly recruited individuals from around the world to act as distributors for the products. The U.S.-based distributors, including Ortiz-Gonzalez, were responsible for receiving the parcels of counterfeit pharmaceuticals from China, then repacking and shipping them to fill individual customer's orders throughout the United States.
The probe, which commenced in 2008, involved HIS Los Angeles, the Food and Drug Administration, Office of Criminal Investigations and the U.S. Postal Inspection Service.
The Department of Homeland Security and the Department of Justice are working together to combat intellectual property crimes. In fiscal year 2011, HSI and U.S. Customs and Border Protection made nearly 25,000 seizures involving counterfeited and pirated products, a 24 percent increase compared to fiscal year 2010.
As the largest investigative arm of the Department of Homeland Security, HSI plays a leading role in targeting criminal organizations responsible for producing, smuggling and distributing counterfeit products. HSI focuses not only on keeping counterfeit products off our streets, but also on dismantling the criminal organizations behind such illicit activity.
You may also visit us on Facebook, Twitter and YouTube, or access this news release on your mobile device.
U.S. Immigration and Customs Enforcement (ICE) is the largest investigative arm of the Department of Homeland Security.
ICE is a 21st century law enforcement agency with broad responsibilities for a number of key homeland security priorities. For more information, visit www.ICE.gov. To report suspicious activity, call 1-866-347-2423 or complete our tip form.
ICE is a 21st century law enforcement agency with broad responsibilities for a number of key homeland security priorities. For more information, visit www.ICE.gov. To report suspicious activity, call 1-866-347-2423 or complete our tip form.
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Friday, September 21, 2012
K-V v. Cook (Georgia)
On September 10 2012, K-V filed a Motion for Leave to File a Surreply in Opposition to Defendants' Motion to Dismiss with Brief in Support. To view that motion click here. On September 18, 2012 Georgia filed a Response to Motion for Leave to File a Surreply in Opposition to Defendant's Motion to Dismiss. to view that response click here.
Franck's Answer and Counterclaim in Insurance Litigation
On September 20, 2012, Franck's Lab, Inc., filed an Answer and Affirmative defenses to Complaint and also filed a Counterclaim against the Cincinnati Insurance Company. To view the answer click here.
.
.
K-V v. Keck (SC)
On September 12, 2012, K-V Pharmaceutical Company, Ther-Rx Corporation filed a Supplemental Submission, which was a statement with regard to South Carolina's DHHS's Provider Manual. To view this supplemental filing, click here.
Settlement Conference Set in K-V v. Hamos (Illinois)
| 09/19/2012 | 25 | MINUTE entry before Honorable Susan E. Cox: Case called for status hearing. Status hearing stricken. Settlement discussion held in chambers. Settlement conference set for 10/12/12 at 9:00 a.m. Parties are to review and to comply with this Court's Standing Order Setting Settlement Conference which is available through the Court's web page. Plaintiffs' counsel to submit a written itemization of damages and settlement demand to defendants' counsel with a brief explanation of why such a settlement is appropriate on or before 9/28/12. A courtesy copy of this submission must be sent to the Court at the same time. Defendants' counsel to submit a written offer to plaintiffs' counsel and the Court with a brief explanation of why such a settlement is appropriate on or before 10/05/12. The settlement conference date may only be changed by the granting of a motion. Mailed notice (vkd, ) (Entered: 09/19/2012) |
Gary D. Osborn and Apothecure Inc. Sentencing Continued to 10/3/2012
| 09/14/2012 | 54 | ELECTRONIC ORDER as to Gary D Osborn, Apothecure Inc: Sentencing CONTINUED to 10/3/2012 02:00 PM in US Courthouse, Courtroom 1570, 1100 Commerce St., Dallas, TX 75242-1310 before Judge Barbara M.G. Lynn. (Ordered by Judge Barbara M.G. Lynn on 9/14/2012) (chmb) (Entered: 09/14/2012) |
Thursday, September 20, 2012
Drugs and Medications Corner—Compounding Pharmacy: Essential Need, But Be Cautious
Article located here:
Drugs and Medications Corner—Compounding Pharmacy: Essential Need, But Be Cautious
RELEASE: May 28, 2009
AUTHOR/ADMINISTRATOR: By Joseph J. Bertone, DVM,
MS, Diplomate ACVIM; Pr
This special section, Drugs and Medications Corner, will feature a series of
articles from the USEF’s Drugs and Medications Program and the veterinary
community to communicate the latest news to better educate the equine
community.Let me start by saying that I’m a strong supporter of legitimate, medically valid compounding pharmacy practice. If used prudently, the practice of compounding plays an important role in veterinary medicine and in your horse’s health. Many horses and other animals are well served by compounded drugs. In the situation where there is not an FDA-approved drug for a particular medical condition, appropriate and judicious compounding may be an important adjunct to veterinary medicine. In a case where legitimate compounding is necessary, one must always weigh the risk versus the benefit of using a compounded (therefore not FDA-approved) medication. This involves finding high quality, ethical compounders. I would argue that the only way to improve the likelihood of having a good compounder, realistically, would be to ensure they are ethical, concerned about the quality of the product and the well-being of the patient, and not pirates of approved drugs.
There are essentially two major forms of good pharmacy compounding practices in veterinary medicine. The first, which occurs fairly rarely, is the use of an FDA approved drug to make a new formulation. An example would be use of Zantac™ tablets with additional flavoring to make a palatable ready-to-use paste. Use of an approved drug to produce a new formulation will invariably lead to a more expensive product than the approved drug itself. The other far more common form of legitimate pharmacy compounding, which is the subject of this article, is the use of bulk chemical powders, purchased from chemical suppliers, to make unapproved drugs. These chemical suppliers are invariably not the same suppliers for the chemicals that are found in the FDA approved drugs. The quality of the powders used in compounding pharmacy can be highly variable. Only the best, most concerned and ethical pharmacists will ensure that the quality of the bulk powder that they use is of the highest quality and appropriate (and from a legitimate source). In fact, invariably these are the pharmacies with the higher prices. They choose to not sacrifice quality for greater profit. A third type of compounding is called “Piracy” which is the use of a chemical powder to make a drug knock-off of an approved FDA product. There is a great deal of profit in piracy, because the pharmacist uses inexpensive bulk powders to compound products which can be sold to veterinarians at a significant discount as compared to the cost of the approved product. In my opinion, a compounding pharmacist who elects to sacrifice this extreme profit, and refuses to compound pirate drugs, is an ethical individual who wants to help patients, clients and veterinarians. I recently contacted one of these ethical pharmacists. He said in the last 4 weeks alone, he has tabulated and refused the piracy requests of over 20 different veterinarians.
All FDA approved and registered drugs undergo strict manufacturing controls to assure that the bottle, tablet, paste, or powder contains what the label says it contains and ONLY what the label says it contains. The FDA approved chemicals used are very expensive and almost invariably are not available to compounding pharmacies for animals. Although many pharmacy compounders do their best, neither the ingredients nor the processes used to mix the drugs they sell meet the FDA standard for an approved drug. The FDA standard is considered the ‘gold standard’ both for reducing the most risk and providing the most benefit. Most importantly, the FDA standard assures you that what is supposed to be in the drug is, in fact, in the drug. In addition, an FDA approved drug is also assured to be safe and efficacious. This FDA approved drug manufacturing process is government regulated and highly enforced. These processes are true for FDA approved generic drugs as well as for patent or brand name drugs. Compounded medications have often been misleadingly called generic drugs. They clearly are not. Ethical compounders will gladly tell you this. If you or your veterinarian requests a compounded form of an FDA-approved drug, the ethical compounder should always refuse to compound the product, and instead should steer you to an approved product.
How should compounded drugs complement veterinary medicine? Well, it costs a lot of money and time (development, testing, approval process, etc) to produce an FDA approved drug. Many of the markets for veterinary drugs and the necessary return on investments are too small for the large pharmaceutical companies to decide to pursue their development. Compounded drugs should fill the need if a disease seriously affects a patient’s quality of life and there is no approved drug available to treat it. A good example of such a situation is the compounding of pergolide to treat Pituitary Pars Intermedia Dysfunction (PPID also known as Equine Cushing’s syndrome). Compounded drugs may also complement veterinary medicine when an essential FDA-approved drug goes on backorder or the manufacturer withdraws the product. Lower cost is not a legitimate reason to compound a drug. Even in a case where there is a legitimate reason to compound a medication (pergolide for PPID, potassium bromide to treat seizures, dipyrone withdrawn from the market), a compounded drug that is a bargain is likely not made from an appropriate bulk source.
Veterinarians and horse owners alike must completely understand how to use compounded drugs in a thoughtful manner. They must never become overly comfortable with the use of these drugs.
Unfortunately, it takes a spectacular tragedy like the deaths of 21 polo horses to bring many of these issues to the forefront. These types of incidents harm not only the animals involved, but also ethical compounding pharmacies and all of veterinary medicine, not to mention other present and future patients. These newsworthy deaths likely only account for a tiny fraction of the horses, other animals and clients injured by poor compounding practices. Less newsworthy cases included horses who were administered compounded medications intra-articularly (injected into their joints), and others whose tendons were injected with inappropriate materials, leading to euthanasia or crippling retirement. Another group of horses died from enteritis in association with compounded drugs. These cases likely pale in numbers to all the cases, in horses as well as other species, where inadequate care is provided when veterinarians order and compounders produce pirated poor quality knock-offs of Gastrogard™ (omeprazole), ivermectin, Regu-Mate™ (altrenogest), Ketofen® (ketoprofen), Banamine™ (flunixin meglumine), dexamethasone (steroid), Equipoise® (boldenone), ketamine (anesthetic), etc, etc, etc. The real shame is that in most of the other cases, the owner thinks that s/he is providing appropriate treatment for their animal, never realizing that the drug being given may be inadequately dosed, inactivated or unavailable in the form being used. There have been numerous instances of cats that should receive a drug orally, intramuscularly, etc, but instead have the drug compounded into a hand cream based topical medication (for easier administration). Unfortunatley, in this form, the drug simply sits on the skin and is never, or minimally, absorbed. This sham is big business.
Yet another issue is compounded drugs that are purported to be “the same as” an approved drug, but which are not what they say they are. For example, Naquasone® is an FDA approved product that has been withdrawn from the US market. It is now only available in Canada. Veterinarians requested that compounders produce this product. The original product had dexamethasone in combination with trichloromethiazide, a diuretic. The USEF recently found that diuretics other than trichloromethiazide were being used in some of the compounded products. Diuretics are considered Forbidden Substances under the USEF Equine Drugs and Medications Rule. Diuretics can be used for legitimate therapeutic treatment if a Medication Report Form is appropriately filed and the horse is withdrawn from competition for at least 24 hours following the last administration. However, not all diuretics are cleared in 24 hours. So substituting one diuretic for another may be dangerous to the animal’s health, as well as to your show season. When you file the Medication Report Form, you must declare the specific drug(s) that were administered. If you didn’t know what drug was given, how do you appropriately file for it? Who bears the consequence of the mistake? Whose mistake was this? Did the manufacturer of the powder mistakenly, or purposefully, switch the product label? Did the compounder make the error? Did the veterinarian ask for the wrong thing? Some compounders even put copy-cat names on their version of the product that mimic the brand name Naquasone®. The losers are the clients and the patients.
Adverse drug events are one of the biggest concerns with any drug, and are the major reason for the stringent testing protocols required to get FDA approval for a drug. There are two general types of adverse drug events. These are: 1. lack of efficacy, (the drug doesn’t work) which most often occurs because the drug is not absorbed, or it is the wrong drug, or it does not reach high enough levels to affect a cure, and 2. toxicity, (the drug causes damage to the patient). An example of the first adverse event would be a compounded “form” of Gastrogard™ (omeprazole). In Gastrogard™, the product is formulated in a patented manner to allow the drug (omeprazole) to be absorbed in the equine gut. The compounded form of omeprazole does not achieve the same absorption. Other drugs (such as pergolide) might be mixed into a suspension (to be given orally) with products that inactivate the drug. The route of administration is of concern in regards to toxicity as well as efficacy. In general, the greatest risk of toxicity occurs with the intra-articular route of administration, followed by intravenous administration, then intramuscular, and lastly oral administration.
So what are the questions to ask to ensure you are using a compounded drug in the most safe and efficacious manner? The questions that the veterinarian has to ask are:
— Is it worth the risk? Does the condition have to be treated? Is there no FDA approved drug to treat it?
— Has the active ingredient of the drug been shown to be important to treat the medical condition?
— Is the drug sufficiently absorbed and active from the route you intend to administer the product?
The questions that the pharmacist has to ask:
— Is the chemical the right one and pure?
— Is the amount needed present in the formulation? No more, no less.
— Is the final product safe for the intended route of administration?
— Can the pharmacist make a safe drug from that route?
Clearly this is a team effort of the veterinarian and the pharmacist. For all practical purposes you have to have an ethical high quality compounding pharmacist. The compounder should be the type that sacrifices profit (does not pirate) and purchases the highest quality products that they can. The pharmacist must be the type that willingly sends veterinarians to use the FDA approved drug if it is available so as to support the quality of animal care.
Wednesday, September 19, 2012
FDA’s Role in Animal Health
Yes! No! Maybe So! – What FDA Does and Does Not Regulate
by Ashley Steel, Center for Veterinary Medicine, FDA
Each week, FDA’s Center for Veterinary Medicine (CVM) receives a variety of
phone calls and e-mails from consumers asking questions like, “Who regulates
flea and tick products?” and “How do I treat my cat’s urinary tract infection?”
While CVM’s Communications Staff is happy to direct consumers to the appropriate
resources, it may be helpful to know that FDA is not the only organization
responsible for protecting animal health. FDA regulates the drugs, devices, and
feed given to or used on over one hundred million companion and food-producing
animals in the U.S. Several other government and non-government organizations
also play a role in animal health.
Yes!
Animal Drugs – The Federal Food, Drug, and Cosmetic Act
gives FDA the legal authority to approve and regulate drugs for animals. Before
a drug company can market an animal drug, the company must get the drug approved
by FDA. To get FDA approval, the drug company must prove that:
- the drug is safe and effective for a specific use in a specific animal species. If the drug is for use in food-producing animals, the drug company must also prove that food products made from treated animals are safe for people to eat;
- the manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity. The drug company must show that the drug can be consistently produced from batch to batch; and
- the labeling is appropriate and truthful. The drug company must make sure that the labeling contains all necessary information to use the drug safely and effectively, including the risks associated with the drug.
FDA’s role does not stop after an animal drug is approved. As long as the
animal drug is marketed in the U.S., FDA continues to monitor:
- the drug’s safety and effectiveness;
- the drug’s manufacturing process to make sure quality and consistency are maintained from batch to batch; and
- how the drug is marketed to make sure the advertisements are truthful and not misleading.
Besides the standard approval process, two additional pathways to the
marketplace are available for some animal drugs for minor species or minor uses
in a major species. These two pathways are conditional approval and
indexing.
| For the complete definition of the term “drug,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(g) [21 U.S.C. 321]3.
For more information about the animal drug approval
process, please visit:
From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process4
For an online database of FDA-approved animal drugs,
please see Animal Drugs @ FDA6
For more information about minor species, minor uses, conditional approval,
and indexing, please visit: |
Animal Devices – The key difference between an animal device
and an animal drug is how the product works. If it relies on a chemical action
occurring in or on the animal’s body to work, the product is a drug, not a
device. If it needs to be metabolized by the animal’s body to work, the product
is a drug, not a device.
Antibiotics, anesthetics, and insulin are examples of drugs. Needles,
syringes, surgical instruments, X-ray equipment, certain diagnostic test kits,
and dental appliances are examples of devices.
Unlike animal drugs, animal devices do not have to be approved by FDA before
they can be marketed. Manufacturers and distributers of animal devices are
responsible for making sure they are safe, effective, and properly labeled. FDA
has the authority to take regulatory action if an animal device is adulterated
or misbranded.
| For the complete definition of the term “device,”
please see the Federal Food, Drug, and Cosmetic Act at Section 201(h) [21 U.S.C. 321]10.
For more information about animal devices, please
visit: How
FDA Regulates Veterinary Devices11
|
Animal Feed – The Federal Food, Drug, and Cosmetic Act
requires food for both people and animals to be:
- safe;
- produced under sanitary conditions; and
- truthfully labeled.
Animal feed includes pet food and pet treats, as well as feed for
food-producing animals, such as cattle, pigs, chickens, and farmed-raised fish.
Unlike animal drugs, animal feed does not have to be approved by FDA before it
can be marketed. However, FDA makes sure the ingredients in the feed are safe
and have an appropriate function, and many ingredients must be approved by FDA
before they can be used in animal feed. FDA also evaluates the human food safety
aspect of animal feed for food-producing animals. That is, FDA makes sure it’s
safe for people to eat food products made from animals that ate the feed.
| For more information about animal feed, please visit: Animal Food & Feeds12 |
Turtles Under 4 Inches – Under federal law, FDA banned the
sale of turtles less than 4 inches long in 1975 because of human health
concerns. Small turtles may seem like fun additions to the home, but they carry
dangerous bacteria called Salmonella.
| For more information about turtle safety, please visit: Pet Turtles - A Common Source of Salmonella13 |
No!
Vaccines for Animal Diseases – FDA does not regulate
vaccines for animal diseases. Veterinary biologics, including vaccines for
animal diseases, are regulated by the U.S. Department of Agriculture.
| For more information about vaccines for animal disease, please visit: Veterinary Biologics (USDA)14 |
Maybe So!
Pharmacies – Pharmacists are licensed by their state board
of pharmacy and must follow the rules and regulations of that state board. FDA
is responsible for approving and regulating the drugs sold in pharmacies. Some
pharmacies also compound drugs. FDA has rules and policies about compounding
drugs that apply to those pharmacies.
|
For more information about boards of pharmacy and
for contact information for each state board of pharmacy, please visit the
website of the National Association
of Boards of Pharmacy (NABP)15
For more information about the compounding of animal
drugs, please visit: Compounding of
Animal Drugs16
Please refer questions about a specific drug for your animal or drug pricing
to your veterinarian or pharmacist. |
Practice of Veterinary Medicine – Veterinarians are licensed
by their state veterinary licensing board and must meet the requirements of the
licensing board to practice in that state. FDA regulates the devices and drugs
that veterinarians use, and the conditions under which veterinarians may
prescribe drugs for extra-label uses.
| What does “extra-label” mean?When an approved drug is used in a manner other than what is stated on the label, it is an extra-label use. This is commonly called an “off-label” use because the drug is used in a way that is “off the label.” |
| For more information about veterinary licensing
boards and for contact information for each state veterinary licensing board,
please visit the website of the American Association of Veterinary State Boards (AAVSB)17 .
For more information about extra-label drug use in animals, please visit: Please refer specific questions about your animal’s health to your veterinarian. |
Flea and Tick Products – FDA regulates some flea and tick
products for animals while the Environmental Protection Agency (EPA) regulates
others. If a product is regulated by EPA, it will have an EPA Registration
Number (sometimes written as “EPA Reg. No.”) on the label. If a product is
regulated by FDA, it will typically have the statement “Approved by FDA”
followed by a six-digit New Animal Drug Application (NADA) or Abbreviated New
Animal Drug Application (ANADA) number on the label.
|
For more information about flea and tick products, please visit: |
Milk, Eggs, Meat, Poultry, and Catfish – The responsibility
of food safety is shared by FDA and the U.S. Department of Agriculture (USDA).
FDA regulates milk and milk products, such as cheese, cream, and ice cream. FDA
also regulates “shell eggs” which, as the name implies, are eggs still inside
their shells. USDA regulates “egg products” which are eggs that have been
removed from their shells for processing. In general, USDA regulates meat,
poultry, and catfish.
|
For more information about food and food safety, please visit: |
Not on the Regulatory
RadarSome products on the market for animals don’t fall under the
regulatory authority of any government or non-government organization,
including:
|
For questions or concerns about FDA-regulated animal products, contact CVM’s
Communications Staff at:
Phone: 240-276-9300
Fax: 240-276-9115
E-mail: AskCVM@fda.hhs.gov
Address: 7519 Standish Place
Rockville, MD 20855
Fax: 240-276-9115
E-mail: AskCVM@fda.hhs.gov
Address: 7519 Standish Place
Rockville, MD 20855
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FDA OUDLC Updated website
Office of Unapproved Drugs and Labeling Compliance (OUDLC)
OUDLC’s Mission
To promote and protect public health through science driven,
comprehensive, strategies and actions that communicate potential risks about
drug products and minimize exposure to unsafe, ineffective, or poor quality
unapproved or misbranded drugs.
OUDLC’s Vision
Using scientific, risk based strategies, and comprehensive compliance, we are global leaders in the effort to eliminate exposure to unapproved or misbranded drugs.Immediate Office
Office Director: Kathleen Anderson, Pharm.D. (acting)
Associate Director for Policy and Communication: Gail Bormel, J.D., R.Ph.
(acting)Associate Director for Program Management and Organizational Strategy: Akilah Green, RN, MS, RAC (acting)
Associate Director for Risk Science, Intelligence, and Prioritization: Meghan Murphy, Ph.D. (acting)
Senior Medical Advisor: Charles Lee, MD
Director, Division of Prescription Drugs: Judy McMeekin, Pharm.D. (acting)
Director, Division of Non-Prescription Drugs and Health Fraud: Elizabeth Miller, Pharm.D. (acting)
Divisions
Mailing Address
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Unapproved Drugs and Labeling Compliance
10903 New Hampshire Ave.
Silver Spring, MD 20993
Ph: (301) 796-3110
Fax: (301) 847-8745
Email: OUDLCMail@fda.hhs.gov
Center for Drug Evaluation and Research
Office of Compliance
Office of Unapproved Drugs and Labeling Compliance
10903 New Hampshire Ave.
Silver Spring, MD 20993
Ph: (301) 796-3110
Fax: (301) 847-8745
Email: OUDLCMail@fda.hhs.gov
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Hologic, Inc Has Filed For Relief from the Automatic Stay in K-V Bankruptcy
HOLOGIC, INC.’S has filed a MOTION FOR RELIEF FROM THE AUTOMATIC STAY. A hearing on that motion has been set for September 21, 2012, at 10:00 a.m. Eastern Time. To view the motion, click here.
MAINE VETERINARY PRACTICE ACT Regarding Prescriptions
Title 32: PROFESSIONS AND OCCUPATIONS Chapter 71-A: MAINE VETERINARY PRACTICE ACT OF 1975
HEADING: PL 1997, C. 246, §1 (RPR) §4876. Prescriptions of other veterinarians. A licensed veterinarian may sell and dispense the written
prescription of another licensed veterinarian with respect to any prescription
or administration of a drug, medicine or nutritional substance on, for or to any
animal in accordance with this chapter. [2011, c. 30, §1
(NEW).] SECTION HISTORY 2011, c. 30, §1 (NEW).
New Article: Do we need authorized orphan drugs when compounded medications are available?
M. Dooms, Hilde Pince and Steven Simoens have written a Commentary for the Journal of Clinical Pharmacy and Therapeutics. The commentary is entitled, Do we need authorized orphan drugs when compounded medications are available? It appears in the September 14, 2012 edition and can be viewed here
Tuesday, September 18, 2012
DEA Crackdown May Be Coming Down on Prescription and Compounded Controlled Substances
Pharmacies Ill-Prepared For Potential DEA Crackdown
Law360, New York (September 18, 2012, 8:38 PM ET) -- Many pharmacies' day-to-day operations appear to violate the U.S. Drug Enforcement Administration's policies on controlled substances, and the pharmacies are risking their DEA registrations if the agency cracks down — a not-implausible scenario as the DEA battles widespread prescription drug abuse.
At issue is whether retail and compounding pharmacies can give controlled substances to doctors, rather than directly to patients. A prime example, pointed to by the industry and supportive lawmakers, is intrathecal pain medications that must be injected directly into a patient's spinal fluid....
At issue is whether retail and compounding pharmacies can give controlled substances to doctors, rather than directly to patients. A prime example, pointed to by the industry and supportive lawmakers, is intrathecal pain medications that must be injected directly into a patient's spinal fluid....
To view the full article, requires a subscription here.
Louisiana Board of Veterinary Medicine Rules and Regulations Relating to Prescriptions
Louisiana's Principles of Veterinary Medical Ethics of the American Veterinary Medical Association (AVMA)
III. THE VETERINARIAN - CLIENT – PATIENT
RELATIONSHIP
A. The
veterinarian - client - patient relationship (VCPR) is the basis for
interaction among veterinarians, their clients, and their patients. A VCPR exists when all of the following
conditions have been met:
(1) The
veterinarian has assumed responsibility for making clinical judgments regarding
the health of the animal(s) and the need for medical treatment, and the client
has agreed to follow the veterinarian’s instructions.
(2) The
veterinarian has sufficient knowledge of the animal(s) to initiate at least a
general or preliminary diagnosis of the medical condition of the
animal(s). This means that the
veterinarian has recently seen and is personally acquainted with the keeping
and care of the animal(s) by virtue of an examination of the animal(s), or by
medically appropriate and timely visits to the premises where the animal(s) are
kept.
Kansas Veterinary Rules Regarding Prescriptions
KANSAS ADMINISTRATIVE REGULATIONS
PUBLISHED APRIL 1997
Kansas Board Veterinary Examiners
Amendment/Addendum to the Kansas Administration Regulations
Article 7.--STANDARDS OF VETERINARY PRACTICE
70-7-1 The practice of veterinary medicine. Each veterinarian shall meet the following minimum standards in the practice of veterinary medicine.
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(j) Controlled drugs. The veterinarian shall ensure that a separate written ledger is maintained when a controlled
drug is administered or dispensed.
(k) Locked area. If controlled drugs are used, the veterinarian shall ensure that a locked area for the storage
of controlled substances is provided.
(l) Dispensation of medications for companion animals.
(1) All prescription drugs to be dispensed for use by a companion animal may be dispensed only on the order of a licensed veterinarian who has an existing veterinary client-patient relationship as defined by the Kansas veterinary practice act. The veterinarian shall ensure that labels will be affixed to any unlabeled container containing any medication dispensed and to each factory-labeled container that contains prescription drugs or controlled substances dispensed for companion animals. The label shall be affixed to the immediate container and shall include the following information:
(A) The name and address of the veterinarian and, if the drug is a controlled substance, the veterinarian’s telephone number;
(B) the date of delivery or dispensing;
(C) the name of the patient, the client’s name, and, if the drug is a controlled substance, the client’s address;
(D) the species of the animal;
(E) the name, active ingredient, strength, and quantity of the drug dispensed;(F) directions for use specified by the practitioner including dosage, frequency, route of administration, and duration of therapy; and
(G) any cautionary statements required by law, including statements indicating that the drug is not for human consumption, is poisonous, or has withdrawal periods associated with the drug. If the size of the immediate container is insufficient to be labeled, the container shall be enclosed within another container large enough to be labeled.
(2) The term ‘‘companion animal’’ shall have the meaning specified in K.S.A. 47-816 and amendments thereto.
(m) Dispensation of medications for food or commercial animals. All prescription drugs to be dispensed for
food used by a food animal or used by a commercial animal may be dispensed only on a written order of a licensed veterinarian with an existing veterinary-client-patient relationship as defined by the Kansas veterinary practice act. That veterinarian shall maintain the original written order on file in the veterinarian’s office. A copy of the written order shall be on file with the distributor, and a second copy shall be maintained on the premises of the patient-client. The written order shall include the following information:
(1) The name and address of the veterinarian and, if the drug is a controlled substance, the veterinarian’s telephone number;
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