It has information about taking care of all types of pets, including birds and snakes. It also has information about preparing livestock.

CVM Animal Health Specialists Deployed to Louisiana, Mississippi After Hurricanes

Animal health specialists from the Center for Veterinary Medicine (CVM) participated in the Federal government’s response to the damage from hurricanes Katrina and Rita. CVM veterinarians and a veterinary technician were deployed to take care of the thousands of displaced pets, in some cases treating them for exposure and injuries from the storm, and in other cases just keeping them housed and fed.

Shortly after Federal Emergency Management Agency officials realized the extent of the damage, the Public Health Service (PHS) began deploying its officers to Louisiana and Mississippi to help protect human and animal health.

Two CVM veterinarians were deployed to the disaster area as members of the PHS’s Commissioned Corps. A third CVM employee, a veterinary technician with experience in dealing with emergency situations, was able to go when the Food and Drug Administration (FDA) granted her special -permission.

PHS veterinarian CDR Charlotte Spires worked at the largest of the shelters, established at the Lamar Dixon Exposition facilities in Gonzales, LA. The 250-acre site was used for several disaster relief functions, including as a staging area for emergency services, as well as shelters for human and animal refugees.

The Lamar Dixon site served as a shelter for a total of nearly 6,400 animals during the emergency. As many as 400 volunteers worked there. The site was set up by the Humane Society of the United States.

Dr. Spires, who works in CVM Office of New Animal Drug Evaluation, worked for much of the time at the Lamar Dixon site as a triage veterinarian, assessing the health of incoming animals to determine which ones needed immediate treatment.

Working conditions were tough, she said. Fans provided the only cooling, but the heat index during the day reached 118°. At midnight, the temperature would drop only to about 90°. Workers were on their feet for far longer than normal eight-hour shifts.

Rescue workers would bring 200-300 dogs a night to the shelter, said Dr. Spires. In some cases, she said, displaced individuals would give rescue workers an address where a pet had been abandoned, so the rescuers could retrieve the animal. In another case, the rescuers would bring in animals not associated with any owner but found in the flooded area. Some of the animals were hard to handle because of the experience they had been through. Other animals were feral and not used to being handled, Dr. Spires said.

Shelter workers frequently suffered from animal bites and heat exhaustion—the two most common human health issues, Dr. Spires added.

The second largest shelter was set up at Louisiana State University AgCenter’s John M. Parker Coliseum, Baton Rouge, LA. It was established by the Louisiana State Veterinary Association.

The Parker Coliseum site processed nearly 2,000 animals. Most animals brought to the Parker Coliseum shelter were “owner identified,” meaning that they were placed at the facility until the owners could find someplace to live and then reclaim their pets.

The PHS deployed LCDR Elvira Hall-Robinson, a veterinarian with CVM’s Office of Research, to the Parker Coliseum. She conducted environmental and public health needs assessments at animal shelters in New Orleans parishes, collected animal and volunteer data from Parker Coliseum and Lamar-Dixon and made sure local authorities were aware of the situations at these local shelters.

While there, as part of her duties, Dr. Hall-Robinson and other members of the veterinary team contacted other animal rescue shelters that were not affiliated with the State Department of Agriculture to promote outreach to bring these facilities under the State’s Incident Command structure. These unaffiliated shelters were set up by many animal rescue support groups. Most did a good job following pet-owner reunification rules.

In addition to that, Dr. Hall-Robinson and other Commissioned Corps veterinarians helped the LA SPCA shelter veterinarian and provided veterinarian care to LA SPCA shelter animals, allowing the shelter veterinarian a chance to rest and start looking for a place to live.

Environmental assessment

Dr. Hall-Robinson’s deployment to the Parker Coliseum was actually her second deployment to the Katrina area. Although a veterinarian, she also has a strong background in food safety, and worked in that capacity in the U.S. Army. PHS made use of this background and sent her for her first post-Katrina deployment to serve as part of an environmental assessment team working in Mississippi.

Her work on the environmental assessment team was to check basic sanitation, including the safety of the food available to storm refugees.

Within a few days of the hurricane, the PHS environmental assessment teams were canvassing the areas affected by the hurricane to identify the areas in which storm refugees were sheltered, determine the number of people in the shelters, and check out basic sanitation. In addition, the teams were trying to -identify individuals who needed medical attention or had special needs.

Site Management

Another CVM employee who was not a PHS member, but was able to travel to Louisiana to help under a special arrangement with FDA, was Sharon Ricciardo, a Consumer Safety Officer in CVM’s Office of New Animal Drug -Evaluation.

Ms. Ricciardo is a certified veterinary technician, licensed paramedic, and firefighter, and she has received specialized training in disaster response. Within days of the disaster, FDA had granted her administrative leave and CVM excused her from her regular duties, allowing her to travel to the Parker Coliseum site.

The initial challenges at the Parker site were organizing crates, collecting food for the animals, and receiving veterinary medical supplies. (Most supplies at the Lamar-Dixon and Parker sites were donated.) The Parker Coliseum site Incident Commander, a local veterinarian and lead member of the Louisiana Veterinary Medical Association, specifically requested assistance from Ms. Ricciardo to coordinate these logistics, due to Ms. Ricciardo’s expertise in disaster relief management.

Approximately 150 individuals worked at the Parker Coliseum shelter daily. Ms. Ricciardo’s job was to coordinate the staff, which included veterinarians, veterinary students, technicians, and general volunteers, some of whom had lost their houses in the storm, but still came to the shelter to work. Ms. -Ricciardo was also in charge of site safety and security, establishing shift rotations, talking to the press, and overseeing general site operations.

[Boxed text follows]

Public Health Service’s Commissioned Corps was originally organized in the late 1700s to take care of merchant marine sailors. It has a military type organization, and its members hold ranks similar to those of officers in the U.S. Navy.

The Corps is designed to be deployed quickly—possibly within hours—in crisis situations to provide human and animal medical emergency services. The Commissioned Corps includes physicians, nurses, dentists, veterinarians, and others with health -specialties.

CVM has several Commissioned Corps members, who, when not deployed, work alongside the Center’s civilian employees.

FDA Investigates Illegal Extralabel Use of Sulfonamides (Sulfa Drugs) in Dairy Cows

Some veterinarians have been illegally using sulfonamides (sulfa drugs) in lactating dairy cows, according to information reported to the Center for Veterinary Medicine (CVM).

For example, during a routine inspection of a Wisconsin dairy operation in August, a State inspector found containers of unapproved sulfa drugs in the milk barn—evidence of improper sulfa drug use. The regional milk specialist noticed a box of six tubes marked SXT, indicating a sulfa drug inside. The drug had been prescribed by a veterinarian, who later received a warning against prescribing any sulfa drug that was not specifically approved for use in lactating dairy cattle.

CVM’s concern is that the use of a small amount of a sulfonamide drug in a lactating dairy cow can result in the contamination of milk from several hundred cows when mixed in a bulk tank. The contamination levels could be high enough to present a risk to public health.

CVM issued a “CVM UPDATE” in August warning veterinarians that FDA’s rules prohibit the extralabel use of sulfa drugs in lactating cows. It also said, “CVM has received some information indicating that sulfonamides, some in combination with trimethoprim, are being prescribed for use in treating conditions in lactating dairy cattle for which they are not approved.” The article stated that unapproved use of sulfonamides is a frequent cause of violative residues in food-producing animals.

In some cases, FDA can permit extralabel, or off-label, use of FDA-approved animal and human drugs. The extralabel provisions are part of the 1994 Animal Medicinal Drug Use Clarification Act and its implementing regulation, Title 21, Code of Federal Regulations, Part 530 (21 CFR 530). However, FDA’s extralabel drug use rule specifically prohibits the use of some drugs in an extralabel fashion, including sulfa drugs in lactating dairy cows. (See box for other drugs prohibited from extralabel use.)

According to Dr. Mike Talley, CVM’s milk safety specialist, the only currently marketed drug approved for use in lactating dairy cows 20 months of age or older is sulfadimethoxine as an injectable or oral bolus. Use of the product also carries with it the responsibility to discard the cow’s milk for a certain period of time after treatment as prescribed on the -labeling.

CVM has also found that veterinarians are misusing the approved injectable product by intramammary infusion to treat mastitis. CVM is also concerned about veterinarians increasing the dose or treating conditions in lactating cattle not on the approved labeling. Administering a drug in an unapproved manner is another form of extralabel drug use and is prohibited in the case of sulfa drugs in lactating dairy cows.

The drug is also approved as a sustained release oral bolus, in beef cattle. However, CVM has received reports that veterinarians use the sustained release boluses to treat lactating dairy cattle.

[Boxed text follows]

Drugs prohibited from extralabel use in all

food-producing animals:

• Chloramphenicol

• Clenbuterol

• Diethylstilbestrol

• Dimetridazole

• Furazolidone, nitrofurazone, other nitrofurans

• Fluoroquinolones

• Glycopeptides

• Ipronidazole

• Other nitroimidazoles

• Phenylbutazone in female dairy cattle 20 months of age or older

• Sulfonamide drugs in lactating dairy cattle (except approved label use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)

Ask CVM

A. If the same drug you are buying from Mexico is available in the United States, then CVM cannot grant you permission to import it. Our regulations do not recognize cost or different marketing status (over-the-counter versus prescription) as a reason to allow imports of drugs into the United States. However, if the drug you are importing has a necessary attribute not found with the drug available in the United States, such as different dosage forms (e.g., liquid versus tablet) or different strengths/concentrations, then CVM may grant your veterinarian permission to import a small amount of the drug for use with your pet. Requests for drug importation can be made only by veterinarians and are considered on a case-by-case basis by CVM’s Division of Compliance. Requests can be addressed to the Food and Drug Administration, Center for Veterinary Medicine, Division of Compliance, 7519 Standish Place, HFV-230, Rockville, MD 20855

Yes, and the procedures FDA uses to allow those drugs on the market will be changing. In the past, we made special exceptions to keep certain limited-use drugs available where needed, but now a new law will give us broader authority to make such drugs legally available.

The Minor Use & Minor Species Animal Health Act of 2004 (MUMS Act), among other purposes, was intended to improve FDA’s ability to encourage the development of products intended for use in aquarium fish.

The MUMS Act grew out of a concern of Congress and FDA about the lack of legally available drugs for use in minor species (including aquarium or ornamental fish, zoo animals, and many pets, such as guinea pigs or ferrets, as well as animals of agricultural importance such as sheep, goats, and catfish) or for minor use in major species. The primary reason for this lack of drug availability is the cost that potential drug sponsors face to put a drug through the FDA animal drug approval process. The potential market return typically is less than the cost of the approval. The market for aquarium fish products, in many cases, is simply too small to generate enough financial return to warrant the cost of approval.

FDA approval is currently the only basis for the legal marketing of animal drugs, and FDA has approved only one drug for use in aquarium fish. Therefore, all other aquarium drug products are actually being marketed without FDA approval. FDA could take legal action (if resources permitted) to remove all of these products from the market—leaving no means of treating aquarium fish.

Instead, the Agency has elected to use regulatory discretion to keep products intended for the treatment of aquarium fish available. For those products, FDA requires that they be produced under good manufacturing practices, registered, and listed with FDA. Also, FDA requires the manufacturer to follow drug labeling -requirements.

Meanwhile, FDA looked for a better system, which the MUMS Act will -offer.

The MUMS Act contains an entirely new basis for the legal marketing of animal drugs intended for use in minor species such as aquarium fish. This process will be considerably less expensive and time-consuming for sponsors than the approval process. This new category will be called the Legally-Marketed Unapproved New Animal Drug Index, or “The Index.”

FDA is in the process of writing regulations to implement the indexing provisions of the MUMS Act. The proposed regulations are due to be published by February 2006, and the final regulations are due by August 2007. The option to request indexing of drugs for minor species will be available after the publication of the final regulations.

The new process will be restricted to products that pose no food safety, environmental, or user safety concerns. Most products for aquarium fish should readily meet these requirements.

Under the new process, panels of qualified experts from outside the Agency will assess the available evidence relating to target animal safety and effectiveness of selected drug products. If the panel finds that the evidence supports a conclusion that the benefits of a product outweigh its risks under specified conditions of use, the drug manufacturer will request that the FDA include the product in an -index of drugs legally available for use in minor species.

If the FDA agrees with the conclusions of the expert panel, it will grant the manufacturer’s request and index the product.

Not all such products will be over the counter. The panel may conclude that a product should be available, but restricted to prescription status.

You can find out more about MUMS-related issues at CVM’s website http://www.fda.gov/cvm/minortoc.htm.

CVM Personnel Comings and Goings

New Hires

Office of Research

•   Heather Harbottle, Staff Fellow (Microbiologist)

Office of New Animal Drug Evaluation

•   Joseph Cormier, Staff Fellow -(Chemist)

•   Tong Zhou, Toxicologist

Office of Management

•   Kristin Cook   Program Support Assistant

•   Sonia Gallagher, Secretary

Departures

Office of Surveillance and Compliance

•   Sue Ann Williams, Consumer Safety Officer

Office of Management

    •   Dawn Calhoun, Program -Analyst

CVM Scientists Develop Nitrofuran Residue Detection Method for Shrimp

Center for Veterinary Medicine (CVM) scientists have developed a method for detecting residues of nitrofurans in shrimp and have created a video to show the process to other scientists so they can check imported foods to detect residues of the illegal drugs.

Nitrofurans are broad spectrum antibiotics that have been used in a variety of species, including chicken, turkey, pigs, cattle, shrimp, and fish. However, the Food and Drug Administration withdrew approval for use of nitrofurans (furazolidone and nitrofurazones) as antiprotozoals in poultry and swine in 1991, because the drugs are considered to be mutagenic and carcinogenic. In 2002, FDA also withdrew approval for remaining topical uses in food-producing animals. FDA has no approved uses of nitrofurans in food-producing -animals.

However, nitrofurans are used in other countries. The European Union detected nitrofurans in imported shrimp in 2002, so regulators in the United States developed a method to detect that use.

Nitrofurans are quickly metabolized in animals, so residue detection methods must be able to spot the drug’s metabolites. Researchers in CVM’s Office of Research, Dr. Pak-Sin Chu and Dr. Mayda Lopez, developed a method for detecting the metabolites in shrimp. It is a modified method based on methods used for land animals. It detects bound residues of nitrofuran drugs, and has a sensitivity of 1 part per billion. The method uses liquid chromatography-tandem mass spectrometry, and was described in an article in an issue of the Journal of Agricultural and Food Chemistry.

CVM has shared the methodology with the Food and Drug Administration’s regulatory enforcement arm—the Office of Regulatory Affairs. A modified version of the methodology can be used in field laboratories, for enforcement actions.

Dr. Chu and Dr. Lopez have developed a written Standard Operating Procedure describing the method. They also created a video that fully describes the steps in the process. The audience for the video is primarily analytical chemists and regulatory -scientists.

The 33-minute video includes seven sections: introduction, sample pre-washing, hydrolysis and derivatization, sample cleanup, liquid chromatography-tandem mass spectrometry, quantitation, and confirmation. It shows Dr. Lopez performing the steps of the method.

“Lab techniques that are hard to accurately capture with words can be effectively illustrated with the power of visual presentation,” Dr. Chu said. The video is a cost-effective option for making such presentations to several labs, he added.

Regulatory Activities

The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:

• Phillip V. Banks, co-owner, Phillip and Vincent Banks Dairy Farm, Normandy, TN

• Mike D Griffith, partner, G & G Dairy, Twin Falls, ID

• Charles F. Luchsinger and Susan B. Luchsinger, co-owners, Silver Spring Farm, Syracuse, NY

• Kevin R. Martin, owner, Martin-Vue Farms, Goshen, IN

• Marlen L. Martin, owner, Marlen Martin Farm, Goshen, IN

• Melvin Medeiros, owner, Maria Medeiros Dairy, Laton, CA

• Donald N. Pope, owner, Donald Pope Veal Farm, Whitewater, WI

• Samuel O. Smith, owner, Smith Dairy, Cornersville, TN

• George E. Vander Dussen, owner, Providence Dairy, Texico, NM

The above violations involved gentamicin in dairy cows, penicillin in dairy cows, dihydrostreptomycin in a dairy cow, neomycin in a veal calf, and sulfadimethoxine in dairy cows.

A Warning Letter was issued to Eugene R. Anderson, DVM, owner, Morris Veterinary Center, PSC, Morris, MN, because an investigation revealed that the practices of the veterinary center caused animal drugs to be unsafe under Section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 360b, and adulterated within the meaning of Section 501(a)(5) of the Act, because drugs were prescribed for use in a manner that did not conform with their approved uses or with regulations for Extralabel Drug Use in Animals, 21 CFR Part 530. The above violations involved sulfadimethoxine and oxytetracycline in lactating dairy cattle.

A Warning Letter was issued to Gary D. Daniels, DVM; Dale A. Timm, DVM; Myron A. Cyphers, DVM; Henry Peeters, DVM, Chosen Valley Veterinary Clinic, Chatfield, MN. An investigation confirmed that the new animal drugs sulfadimethoxine and gentamicin sulfate were caused to be unsafe under -Section 512(a) of the Act, 21 U.S.C. 360b, and adulterated within the meaning of Section 501(a)(5) of the Act because the drugs were used in a manner that did not conform with their approved uses or with the regulations for Extralabel Drug Use in Animals, 21 CFR Part 530. In addition, the investigation found that the clinic was compounding and distributing the unapproved new animal drug GM 100. The GM 100 drug product is a new animal drug as defined under Section 201(v) of the Act. The composition is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The drug is adulterated under Section 501(a)(5) of the Act because it is unsafe within the meaning of Section 512 of the Act. Section 512 in part deems a new animal drug to be unsafe unless an approved new animal drug application (NADA) is in effect for the specific product in question. The Chosen Valley Veterinary Clinic holds no FDA approval of an application for its GM 100 drug product.

A Warning Letter was issued to Wendy J. Raak, president, Xtreme Design, Inc., Rosemount, MN, because an inspection revealed that this veterinary product distributing facility is marketing and distributing Xtreme Shampoo and Xtreme Spray. Section 201(g) of the Act defines a drug as an article intended in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals or intended to affect the structure or function of the body of man or other animals. The representations made for the Xtreme products indicate that they are intended for use, among other things, in the cure, prevention, and treatment of disease in horses and/or to affect the structure or function of their bodies. These include statements such as, “Helps on all skin fungus, ringworm, rainrot, girth itch, thrush, proud flesh, greasy heel, cankers and scratches.” These products are therefore drugs under the Act. Because they are not the subject of approved new animal applications (NADAs), they are unsafe under Section 512(a) of the Act, and thus adulterated under Section 501(a)(5) of the Act.

Approvals for July through September 2005

DRAXXIN (tulathromycin) Injectable Solution (NADA 141-244), filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of tulathromycin solution in cattle, by subcutaneous injection, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella mulitocida, and Histophilus somni (Haemophilus somnus); for the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni; and in swine, by intramuscular injection, for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, P. multocida, Bordetella bronchiseptica, and H. parasuis. The regulations are also amended to add the acceptable daily intake for total residues of tulathromycin and tolerances for residues of tulathromycin in edible tissues of cattle and swine. Notice of approval was published July 12, 2005.

DECTOMAX (doramectin) Pour-On Solution for Cattle (NADA 141-095), filed by Pfizer, Inc. The supplemental application provides for a period of protection from reinfestation with two species of external parasites following topical administration of doramectin solution on cattle. Specifically, the period of persistent effectiveness is 42 days for Linognathus vituli and 77 days for Bovicola (Damalinia) bovis. Notice of approval was published July 26, 2005.

TERRAMYCIN-343 (oxytetracycline HCl) Soluble Powder (NADA 8-622), filed by Pfizer, Inc. The supplemental NADA provides for use of the product for skeletal marking of finfish fry and fingerlings by immersion. The approval of this supplemental NADA relied on publicly available safety and effectiveness data contained in Public Master File (PMF) 5667, which were compiled under National Research Support Project-7 (NRSP-7), a national agricultural research program for obtaining clearances for use of new drugs in minor animal species and for special uses. The supplemental NADA also provides for the addition of statements to product labeling warning against the use of this product in drinking water of lactating dairy cattle. In addition, FDA has found that the regulations contain incorrect statements warning against the use of oxytetracycline soluble powder in calves intended for veal. Accordingly, the regulations in 21 CFR 520.1660d are amended to reflect appropriate warning statements for this product. This action is being taken to improve the accuracy of the regulations. Notice of approval was published July 18, 2005.

Phenylbutazone 20% Injection (phenylbutazone) (ANADA 200-371), filed by Sparhawk Laboratories, Inc. The ANADA provides for veterinary prescription use of Phenylbutazone 20% Injection for relief of inflammatory conditions associated with the musculoskeletal system in horses. Sparhawk Laboratories, Inc.’s product is approved as a generic copy of Schering-Plough Animal Health Corp.’s, BUTAZOLIDIN Injectable 20%, approved under NADA 11-575. Notice of approval was published August 17, 2005.

Tiamulin Liquid Concentrate (12.3% tiamulin hydrogen fumarate) (ANADA 200-360), filed by Phoenix Scientific, Inc. The ANADA provides for use of tiamulin concentrate solution to prepare medicated drinking water for the treatment of swine dysentery and swine pneumonia. Phoenix Scientific, Inc.’s Tiamulin Liquid Concentrate is approved as a generic copy of Boehringer Ingelheim Vetmedica, Inc.’s DENAGARD (tiamulin) Liquid Concentrate approved under NADA 140-916. Notice of approval was published July 26, 2005.

Speclinx-50 (spectinomycin dihydrochloride pentahydrate and lincomycin hydrochloride monohydrate) Water Soluble Powder (ANADA 200-380), filed by Cross Vetpharm Group Ltd. This ANADA provides for use of SPECLINX-50 Water Soluble Powder to create a solution administered through the drinking water of chickens. This solution acts as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin. Cross Vetpharm Group Ltd.’s SPECLINX-50 Water Soluble Powder is approved as a generic copy of Pharmacia & Upjohn Co.’s L-S 50 Water Soluble Powder, approved under NADA 046-109. Notice of approval was published July 15, 2005.

Flunixin Meglumine (flunixin meglumine ) Injection (ANADA 200-124), filed by Phoenix Scientific, Inc. The supplemental ANADA provides for veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. Notice of approval was published August 22, 2005.

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