FDA Information for Veterinarians

The FDA website contains an information just for Veterinarians. The FDA Vetrinarian page is found here. The following links are available on the FDA's website:

Information for Veterinarians

How can I tell if a drug is FDA-approved for animals?1

How can I tell if a drug is FDA-approved for people?2

How can I use an online database of drug labels to tell if a drug is FDA-approved?3

Should I report to FDA an adverse event for an unapproved animal drug?4

How can I tell if a flea and tick product is legitimate?5

“Dear Veterinarian” Letters6

Potassium Bromide: Is It Safe for Dogs?7

A Systematic Review of the Safety of Potassium Bromide in Dogs (JAVMA, Vol 240, No. 6, March 15, 2012)8

Concerns about marketed but unapproved animal drugs9

Bodybuilding.com and Jeremy DeLuca: Criminal Charges

Food and Drug Administration Office of Criminal Investigations

	U.S. Department of Justice Press Release

For Immediate Release May 22, 2012	United States Attorney District of Idaho Contact: Pamela Bearg Public Information Officer Wendy J. Olson U.S. Attorney Kevin T. Maloney Assistant U.S. Attorney (208) 334-1211

BOISE – U.S. Attorney Wendy J. Olson announced today that Bodybuilding.com, LLC, and Jeremy DeLuca, former president and vice president of Bodybuilding.com, LLC, pled guilty this morning in federal court in Boise to misdemeanor counts of introduction and delivery for introduction of misbranded drugs into interstate commerce. The charges are all violations of the Food, Drug and Cosmetic Act. As part of the plea, Bodybuilding.com, LLC agreed to pay a $7 million fine and DeLuca agreed to pay a $600,000 fine. The United States agreed to recommend that DeLuca receive probation and not be sentenced to any prison term. The plea agreements state that between March 2006 and September 2009, Bodybuilding.com, LLC, sold five products misbranded as dietary supplements, when they were actually drugs. The five products were: I Force Methadrol, Nutra Costal D-Stianozol, I Force Dymethazine, Rage RV5, and Genetic Edge Technologies (GET) SUS500. According to the plea agreements, the products were drugs because they contained synthetic anabolic steroids or synthetic chemical “clones” of anabolic steroids that were not dietary supplements and because they were labeled and promoted as products intended to affect the structure and function of the human body (building muscle mass). Jeremy DeLuca's plea agreement states that during the time period charged, he was president or vice president of Bodybuilding.com, LLC, and had authority over products offered for sale on the company's webstore. “Dietary supplements” must contain one or more “dietary ingredients.” A “dietary ingredient” is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of one or more of these dietary ingredients. Bodybuilding.com, LLC, is the largest internet retailer of supplements in the world. It does not manufacture dietary supplements, but only retails products made by others. The plea agreement further states that from 2007 to 2009, the FDA compliance officer at Bodybuilding.com, LLC informed company management, including Jeremy DeLuca, that some prohormone products carried on its website contained ingredients that did not qualify as dietary supplements. Olson stated that Bodybuilding.com, LLC and DeLuca were the fifth and sixth defendants to plead guilty in the District of Idaho's investigation into distribution of misbranded drugs through Bodybuilding.com's website. Product manufacturers Tribravus Enterprises, the makers of I Force Methadrol and I Force Dymethazine; R&D Holdings; and DDC, LLC, doing business as Advanced Muscle Science, pled guilty to corporate felonies for introduction and delivery for introduction of misbranded drugs into interstate commerce, with the intent to mislead and defraud. Bodybuilding.com, LLC, founder and CEO Ryan DeLuca pled guilty on April 9, 2012, to misdemeanor charges. “Today's guilty pleas signal that retailers, as well as manufacturers, of products sold as dietary supplements have a clear responsibility under the law to ensure that the products they are selling are indeed dietary supplements, and not synthetic steroids or steroid clones masquerading as dietary supplements,” said Olson. “Bodybuilding.com, LLC, Ryan DeLuca and Jeremy DeLuca have now all accepted responsibility for these violations of the Food, Drug and Cosmetic Act.” Olson said that today's pleas are the culmination of a detailed and thorough investigation that included the execution of search warrants in September 2009 at Bodybuilding.com, LLC's Boise warehouse and Meridian headquarters. “Since the execution of the search warrants, Bodybuilding.com, LLC has worked cooperatively with the FDA and the U.S. Attorney's Office to ensure that it no longer sells products that do not qualify as dietary supplements,” said Olson. “We were able to resolve this case through misdemeanor charges in part because of the actions Bodybuilding.com, LLC, its current management and its general counsel's office have taken over the last two and a half years to prioritize regulatory compliance. We are confident that Bodybuilding.com has put into place procedures to eliminate products with these ingredients from its product line.” Under federal sentencing law, corporations convicted of violating the Food, Drug and Cosmetic Act can be fined up to twice the gross gain from sales of the misbranded product. According to its plea agreement, Bodybuilding.com, LLC had gross gain of $3.5 million from misbranded prohormone products, including those specifically identified in the plea agreement. Thus, Bodybuilding.com, LLC, agreed to pay a $7 million fine. Jeremy DeLuca has agreed to pay a $100,000 fine for each of the six counts with which he is charged. “The FDA’s Office of Criminal Investigations is fully committed to investigating and supporting the prosecution of those who sell synthetic steroids or steroid clones but call them dietary supplements. We commend the U.S. Attorney’s Office for their diligence in prosecuting this case,” said Thomas Emerick, Special Agent in Charge, FDA’s Office of Criminal Investigations, Los Angeles Field Office. Sentencing is set for August 1, 2012, in Boise before Chief U.S. District Judge B. Lynn Winmill. The Food and Drug Administration, Office of Criminal Investigations investigated the case. Assistant United States Attorney Kevin Maloney and Special Assistant United States Attorney Jim Smith, Associate Chief Counsel of the Food and Drug Administration, prosecuted the case.

Role of the pharmacist in preventing distribution of counterfeit meds - American Pharmacists Association

American Pharmacists Association - Article March 24, 2012: - Role of the pharmacist in preventing distribution of counterfeit meds

"Summary: The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer.

Conclusion: The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring."

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Protocols To Minimize Risk of Errors When Compounding

Errors When Preparing Medications

Michael J. Gaunt, PharmD

Published Online: Sunday, October 24, 2010

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Pharmacies must implement and maintain protocols to minimize the risk of errors when compounding and mixing medications.

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Compounding. A pediatric infectious disease physician prescribed Videx (didanosine) 10 mg/mL suspension for a 6-year-old HIV patient. Instructions from the physician directed that the prescription be compounded using “200 mL of distilled water, 200 mL of Maalox cherry antacid, and adding Videx 4ng solution to equal 400 mL.” The pharmacist who initially filled the prescription contacted a pharmacist at the prescribing facility for directions on properly compounding the medication. These instructions were handwritten and attached to the original prescription and were also entered into the pharmacy computer system.

The patient continued to take the Videx suspension as prescribed for the next 4 years. The prescriptions were filled at the same community pharmacy and all, except for the one initially dispensed, were compounded by 1 of 2 pharmacists. One of the pharmacists compounded the prescription correctly, while his partner mixed 4 packages of Videx 4-g solution in each prescription he compounded, doubling the Videx concentration to 20 mg/mL rather than 10 mg/mL.

The error was discovered when the pharmacist found a note from his partner stating that the patient was owed 200 mL of Videx at no charge. The pharmacist was puzzled by this entry. He discovered that his partner had been improperly compounding the medication over the 4-year period that it was dispensed. The partner erroneously believed that each bottle of Videx made 200 mL and that, therefore, it took 2 bottles of Videx to make the 400 mL as directed in the prescription.

The partner attributed the error to ambiguous instructions written by the pharmacist who filled the original prescription. These instructions reportedly gave no milligram strength, just the final volume of the suspension. However, the partner acknowledged that he never reviewed the Videx package insert for instructions, nor did he seek clarification from his partner and/or the prescriber.

To ensure patient safety, physicians and pharmacists must proactively assess the accuracy and safety of compounded medications. Before dispensing, clear, accurate, step-by-step recipes should be on file. Institute a process to ensure that all compounding recipes undergo a documented approval process prior to use, as well as an updated review every year. Establish an independent double-check process for all calculations completed each time a compound is made. A compounding logbook should be maintained documenting each compound made, the recipe followed, and all ingredients, including quantities, used. This logbook should be reviewed weekly and with each refill dispensed as a quality control check.

Mixing. An 8-month-old girl was prescribed amoxicillin/clavulanate potassium suspension to treat an ear infection. The prescription was taken to the family’s local community pharmacy, where a stock medication bottle labeled with instructions to give the child a half teaspoonful twice daily by mouth was dispensed. When the family arrived home, they measured a half teaspoonful of the powder and administered it to the girl. The pharmacy had failed to mix the powder prior to dispensing the medication. The girl was rushed to the emergency department, where she was treated for the antibiotic overdose.

To reduce the risk of this type of error, consider placing new prescriptions for oral liquid medications, especially those that need to be reconstituted, in a separate area away from other prescriptions waiting to be picked up. Mark the area as “not to be dispensed without speaking to the pharmacist.” Include specific product descriptions on the prescription label (eg, orange-flavored, white, opaque liquid). Review the label, route of administration, and directions for use with the patient; open the bottle with the patient and/or caregiver. Ensure that oral syringes (without caps) or other appropriate measuring devices are provided or are available for purchase. Provide education to patients regarding proper use and cleaning of the measuring device. Have the patient demonstrate how to measure and administer the dose to validate learning.

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Dr. Gaunt is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition. 

This article can be found here.

Pharmacists Included as "Health Care Providers" Under Pennsylvania Health Care Records Law

This article appears in the Pennsylvania Pharmacists Association news:

Diana Yap, APhA - April 10, 2012 - Pennsylvania appeals court opinion declares pharmacists are ‘health care providers’ under the law, citing state Pharmacy Practice Act and state board of pharmacy regulations. Calling pharmacists “health care providers” for the purposes of the Pennsylvania Medical Records Act (MRA), the Superior Court of Pennsylvania on March 23 issued an opinion important to pharmacy in the case of Landay v Rite Aid. The ruling reversed a lower court decision holding that the state’s MRA didn’t apply to pharmacies because a pharmacy customer was not a “patient.” “We find the fact that the court concluded that a pharmacist is a health care provider and that the recipient of prescription medication is a patient very interesting and promising, especially in light of the fact that certain government entities and others sometimes like to argue that pharmacists are not providers,” Patricia A. Epple, CAE, CEO of the Pennsylvania Pharmacists Association, told pharmacist.com. Read more: http://www.pharmacist.com/AM/Template.cfm?Section=Pharmacy_News&Template=/CM/ContentDisplay.cfm&ContentID=28264 

Georgia law regarding office use

Georgia law regarding office use of compounded drugs is as follows: It is illegal for any person or entity to purchase compounded medications within the state or out of state for office use or dispensing unless the company you are purchasing from has all necessary federal and state manufacturing licenses and all applicable state wholesale licenses. All compounded medications must be patient specific. This can be found at http://SOS.Georgia.gov/plb/pharmacy

Import Alert 61-07

Import Alert 61-07

The Role and Education of the Veterinary Pharmacist

A interesting article entitled, The Role and Education of the Veterinary Pharmacist, Am. J. Pharm. Educ. 2009 February 19; 73(1): 16, notes that the practice of veterinary pharmacy is an emerging field in the United States.  That entire article can be read by clicking here.

More retailers offering pet prescriptions--But Are Retailers A Safe Place From Which To Buy Your Pet Medications

The recent article below points out that a number of retailers are now offering pharmacy services for sick pets. However, it may not be a good idea to buy your pet prescriptions from retailers. As the article points out: "The problem pet owners face is that pharmacists at these stores aren't trained about the medication and how it can affect the animals," Lund said. "The pharmacist or some website isn't going to help you when you're having a reaction at 10 p.m."

The author of this blog believes there is a great need for trained, specialized pharmacist in veterinary medicine. We need more colleges and universities that offer a specialized degree in veterinary pharmacy. To ensure a pet's safety and wellbeing, pet owners should check out the pharmacy and pharmacist they are doing business with. A good place for a pet owner to start their research is with the state board of pharmacy to see if the pharmacy or pharmacist has ever been disciplined or fined.  Another area to examine is whether the pharmacy and pharmacist are knowledge of veterinary medications.

More retailers offering pet prescriptions

BY JUSTINE GRIFFIN - SUN SENTINEL

FORT LAUDERDALE, Fla. -- Retailers are making it easier and cheaper for pet owners to get the medication they need to care for their sick cats and dogs.

Winn-Dixie is the latest chain to extend its pharmacy services to reach sick pets. The Jacksonville, Fla.-based grocery chain began offering pet prescriptions recently when it partnered with Center Pet Pharmacies, a Washington, D.C.-based company that specializes in pet medication. Target launched its pet refills program at stores with pharmacies in 2010, and Wal-Mart began in March of this year.

"We already had a nice size business of pet owners at our pharmacies who used our services to get discounted prices on antibiotics and other cross-over drugs," said Mike LeBlanc, director of pharmacy business development for Winn-Dixie. "It just seemed natural to provide drugs for pets at the same time."

Most often pet owners get their prescription medications from their veterinarian's office or online through sites like 1-800-PetMeds.com. But veterinarians like Kristy Lund at Lund Animal Hospital in Boca Raton, Fla., are seeing more patients opt to have refills sent to places like Wal-Mart or Target, where cheaper generic alternatives are offered.

"In today's economy, more people have to bargain-shop, and this provides a service for those who may be struggling with care costs," Lund said.

In 2012, American pet owners are expected to spend nearly $53 billion on their animals, according to the American Pet Products Association. Pet owners will spend more than $13 billion on medical care costs alone, which is an expected 1.3 percent increase from the total spent in 2011.

"The problem pet owners face is that pharmacists at these stores aren't trained about the medication and how it can affect the animals," Lund said. "The pharmacist or some website isn't going to help you when you're having a reaction at 10 p.m."

Most veterinarian practices have pharmacies inside their offices. Veterinarians are required to attend seminars every two years to keep their drug administering licenses active. Retailers, like Winn-Dixie, partner with pet compounding pharmacies which specialize in developing drugs in smaller dosages for animals, which does not require their employees to have special training to administer animal prescriptions.

Pet supplies chains like Petsmart and Petco do not sell prescription medications. Walgreens and CVS Pharmacy do not sell pet medicines either.

Although Publix doesn't offer pet-specific medications, "cross-over" drugs, which are treatments like antibiotics or anti-inflammatory capsules used by both pets and humans, can be picked up from its pharmacies.

Most cross-over prescriptions can be filled in the same day, LeBlanc said. Specialized pet medications take 24 to 48 hours to fill. Pet prescriptions filled by Winn-Dixie pharmacies also will include personalized instructions similar to when human prescriptions are filled and delivered. About 75 percent of all Winn-Dixie locations have pharmacies.

"These services make our shopper's lives easier," LeBlanc said. "They're already purchasing pet food inside the store, and now they have the opportunity to take care of another pet need here too."

Pet medicines can come in bacon or other flavors, and or be switched from a capsule to a gel depending on a pet owner's needs, said Kenny Kramm, owner of Center Pet Pharmacies.

Read more here: http://www.newsobserver.com/2012/06/28/2165994/more-retailers-offering-pet-prescriptions.html#storylink=cpy

Read more here: http://www.newsobserver.com/2012/06/28/2165994/more-retailers-offering-pet-prescriptions.html#storylink=cpy

Government Regulation of Compounding

There is much disagreement about whether states, the federal govenment, or both should regulate compounding.  Here are a two general articles on government regulation:

1.  Meron, Daniel (2007) "Balancing Government Regulation Against Access to
Drugs," Address to Seton Hall University School of Law, February 16, 2007.  Read here

2.  Lewyn, Michael (2010) "Character Counts: The “Character of the Government Action" in Regulatory Takings Actions," Seton Hall Law Review: Vol. 40: Iss. 2, Article 4. Read here