Citing HPAI infections in dairies, drug residue risks and concerns about protocol drift, the FDA has reversed its stance on using aspirin, which was never approved for use in cattle. Protocol drift is a real thing . . . there are approved drugs with labeled indications, those should be our first line of treatment.” - Alison Vander Plaats, DVM Source: Hoard’s Dairyman, October … [Read more...]
FDA Safety Communication update: Evaluating plastic syringes made in China for potential device failures
In its August 16th update, the FDA recommendations have not changed. It recommends the following: Use syringes not manufactured in China, if possible. At this time, glass syringes, pre-filled syringes, or syringes used for topical purposes are not included. If you only have syringes manufactured in China, then continue to use them as needed until you are able to use … [Read more...]
FDA – defining VCPR, including telemedicine
The FDA recently published a Q&A page about federal requirements related to a veterinarian’s role in dispensing prescription animal drugs and establishing a veterinarian-client-patient relationship in the course of practice. The page only covers the veterinarian’s obligations under federal law. Consult state licensing boards to determine if there are additional requirements … [Read more...]
Understanding FIP in cats
JoAnna Pendergrass, DVM, shares information for cat owners about feline infectious peritonitis, a viral disease caused by a mutated form of the feline coronavirus. She clarified the feline coronavirus is not related to the Covid 19 coronavirus. Since this article was published, a treatment for FIP has been making news <Link>. Jeanette L. Maucher, DVM, shares Stokes … [Read more...]
FDA finalizes guidance to provide further clarity on VFD
To assist stakeholders involved with veterinary feed directives – veterinarians, VFD feed distributors (medicated feed mills, feed retailers) and clients (owners or other caretakers of the animals) the FDA has finalized Guidance for Industry (GFI) #120: Veterinary Feed Directive Regulation Questions and Answers. While the core recommendations in final GFI #120 remain the same … [Read more...]
USDA approves Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and swine
Pradalex (pradofloxacin injection) is a 3rd-generation fluoroquinolone ranked as a critically important antimicrobial. The labeling of the drug includes a statement that it should be used only after considering other, non-fluoroquinolone therapeutic options. Pradalex is approved in certain ages and classes of cattle for the treatment of bovine respiratory disease associated … [Read more...]
FDA approves first treatment for Giardia duodenalis in any animal species
Ayradia (metronidazole oral suspension) has been approved for the treatment of Giardia duodenalis infection in dogs. Ayradia is the first FDA-approved treatment for Giardia duodenalis for any animal species. <the> approval means there is an approved product for dogs that has known safety and effectiveness for this species and is manufactured to quality … [Read more...]
Chickens get worms. Deworming isn’t always easy.
Susan Brackney talked with poultry experts to understand why a one-size-fits-all solution doesn’t exist when it comes to deworming chickens. . . . the FDA considers all chickens to be food-producing animals, regardless of how the owner views it . . . which limits my options as a veterinarian. . . “ - Megan Lighty, DVM, PhD, DACPV Source: Hobby Farms, August 7, 2023. Link. To … [Read more...]
Does dog food expire?
Economies of scale from big bags of dog food diminish when it is not used up within four to six weeks. While dog foods don’t technically expire, foods past their “best by” or “use by” label dates are not as nutritious and are more likely to become moldy or otherwise compromised, writes Cindy Foley. The “use by” or “best by” dates are important enough to be considered as … [Read more...]
Why the FDA tightened rules around antimicrobial medications for animals
New regulations about the use of antimicrobial drugs for animals are now in place requiring animal owners to obtain prescriptions from veterinarians to get the drugs. William Flynn, DVM, MS, discussed the concerted effort across all sectors where antimicrobials are being used on NPR’s Weekend Edition. Source: NPR, June 10, 2023. Link. (4:02) INSIGHTS: A few animal owners … [Read more...]
The June deadline is here!
More than 100 products will no longer be labeled OTC after June 11. They will then require a prescription from a licensed veterinarian. The majority are labeled for use in food animals. Sixteen are labeled for food and companion animals, and two are specific to companion animals, according to the FDA. The FDA states that "veterinarians are generally not required to examine … [Read more...]
Atypical mad cow disease detected in South Carolina cow
An atypical case of bovine spongiform Encephalopathy was found in an older beef cow at a slaughter plant in South Carolina. It is the seventh case identified in the U.S. The animal never entered slaughter channels and at no time presented a risk to the food supply or human health in the United States. Atypical BSE generally occurs in older cattle and rarely and spontaneously … [Read more...]
Akorn drugs must be discarded due to bankruptcy
Akorn Operating Company LLC filed for Chapter 7 bankruptcy on February 23, 2023. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the quality activities of these marketed products. There are nine veterinary-specific drugs on Akorn's recall list while another 75 drugs … [Read more...]
EPA seeks to hand off pet pesticide regulation to FDA
Citing controversy, lack of action and resources to respond to untoward incidents with a popular flea coller, the EPA wants to relinquish its oversight of pet pesticide products. Under the current setup, the EPA is responsible for regulating pet pesticide products that are “not systemic,” or aren’t supposed to enter the bloodstream, while the FDA regulates “systemic” pet … [Read more...]
Pet food recalls
Anne Norris of the FDA’s Center for Veterinary Medicine monitors recalls sharing what happens “when a product violates federal laws and needs immediate legal action.” Recalls can happen in three ways: the company pulls the product on its own the product is pulled by formal FDA request the product is pulled by an FDA order under the agency’s mandatory recall … [Read more...]
The best way to store dog food may surprise you
In recent dog food recall announcements, we noted comments about how dog food is stored. Storage information is not readily found on several brands’ websites. After a bit of digging here’s what we found. Key points: store dog food inside in original bags for best results, refresh monthly.” We reviewed packaging and labels from more than 12 brands for storage instructions, … [Read more...]
Evaluating the efficacy of intranasal flunixin in piglets
It is common practice to castrate piglets shortly after birth. The procedure is routinely done without any pain management treatments as there are no FDA approved drugs to control pain in pigs. Preliminary research from the College of Veterinary Medicine, North Carolina State University, showed the off-label use of intranasal flunixin meglumine mitigated pain post-castration … [Read more...]
Clarifying the recission of the FDA VCPR waiver
The Veterinary Virtual Care Association explains how the FDA’s rescission of the Covid-era waiver to agency regulations concerning the VCPR may affect practices and their clients. Source: VVCA, December 28, 2022. Link. This is not a new FDA policy, but simply a federal agency rescission of the COVID-era waiver pertaining to a regulation instituted decades ago. The … [Read more...]
FDA approves revised Micotil 300 labeling
To decrease the risk of accidental human injection and other potential routes of exposure, Micotil 300 is now packaged inside a tamper-proof shroud. Access to the product requires a quick-connect device, which is provided with a tube-fed safety syringe by Elanco or its distributors. Safe use and handling instructions are attached to the shroud so that the user can review … [Read more...]
Compounding webinar outlines FDA final guidance #256
Regulatory education FDA Veterinarian Amber McCoig examines the policies included in this guidance and what they mean for veterinarians and their teams in the webinar. She also discusses how the agency’s final guidance tries to balance the risks of compounding animal drugs from bulk substances when there is no FDA-approved drug available, and why the FDA can’t assure the … [Read more...]
FDA approves concurrent use of Pennchlor and Rumensin in rations
Producers can now get the benefits of therapeutic applications of chlortetracycline combined with the coccidiosis control and performance results of Rumensin for receiving/starter rations with the late July FDA approval of the combination. This combination approval of Rumensin and Pennchlor gives producers options for their receiving program to optimize productivity,” Sara K. … [Read more...]
Changes coming to compounded animal health medication
Complimentary Content Thank you, Nicole Clausen, Veterinary Care Logistics, for bringing this to our attention. FDA's Guidance for Industry (GFI 256) will affect how you order and prescribe compounded medications, according to Wedgewood Pharmacy. We noted these statements in its document: Veterinarians are responsible for understanding all applicable state regulations … [Read more...]
Get ready! All livestock antibiotics will be prescription-only in 2023.
The clock is ticking. Start now to educate producers ahead of this important transition to livestock antibiotics being available by prescription-only status. The new rule covers injectable tylosin, injectable and intramammary penicillin, injectable and oral tetracycline, sulfadimethoxine and sulfamethazine, and cephapirin and cephapirin benzathine intramammary tubes. Also, … [Read more...]
Over-the-counter access to antibiotics is going away
Medically important antibiotics in feed and water were removed from OTC channels when the Veterinary Feed Directive was implemented in 2017. The first phase of the VFD regulations did not address OTC antibiotics delivered via other methods like injectables, boluses and intramammary mastitis tubes. . . . the FDA has issued a new directive to bring all OTC drugs under veterinary … [Read more...]
Honeybees on the move
The USDA report on bee movement adds an additional dimension to beekeeping and survival as more animal health pros are engaged in bee health initiatives. Similar to food animals, bees experiences stress during transportation and more risks as they are deployed in monocultures. Honeybees fall into veterinarians' purview because of the VFD rule and changes in FDA policy on … [Read more...]
Pig ears recalled
Lennox Intl Inc. voluntarily recalled its Natural Pig ears because they may be contaminated with Salmonella, according to an FDA posting. The recalled products affected were shipped to nationwide distributors and/or retail stores from May 1 to July 3, 2019. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products . . … [Read more...]
FDA approves ProHeart® 12 (moxidectin) for prevention of heartworm disease in dogs
ProHeart 12 (moxidectin) extended-release injectable suspension for dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitis for 12 months had been approved by the FDA. ProHeart 12 is also approved for the treatment of existing larval and adult hookworm infections. Source: FDA, July 2, 2019. Link. The ProHeart® 12 formulation is … [Read more...]
FDA now posting adverse event report data
More than 30 years of adverse event reports related to animal drugs and devices used in animals is now available online as part of the FDA’s commitment to increase transparency. Previously, this detailed level of data was only available via a Freedom of Information Act request. It is now electronically accessible and available for automated searching. < link > The FDA … [Read more...]
FDA investigating potential link between certain diets and canine dilated cardiomyopathy
Updating a collaboration that began in July 2018, the FDA believes that the potential association between diet and DCM in dogs is a complex scientific issue that may involve multiple factors. The FDA’s Center for Veterinary Medicine (CVM) and the Veterinary Laboratory Investigation and Response Network (Vet-LIRN) will continue to investigate this potential association of … [Read more...]
FDA approves Pexion for canine noise aversion
Prescription help for dogs with noise aversion challenges is on the way. The FDA has announced approval of Pexion® (active ingredient: imepitoin) by Boehringer-Ingelheim to treat noise aversion in dogs. The drug was approved in 2013 in the EU for reducing the frequency of seizures associated with idiopathic epilepsy. Imepitoin is similar to Valium (diazepram) and other … [Read more...]