The Horse:Your Guide To Equine Health Care provides monthly equine health care information to horse owners, breeders, veterinarians, barn/farm managers, trainer/riding instructors, and others involved in the hands-on care of the horse.
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36 TheHorse.com THE HORSE September 2016 but mainly assists industry with compli- ance with the laws." Responsible Manufacturing Practices Ultimately, the responsibility of feed safety falls back onto the manufacturers and distributors. With regard to natural contaminants, feed manufacturers do implement several research-based strate- gies to reduce and prevent their occur- rence, including: ■ Rapid drying to reduce water content and preserve the grain; ■ Shorter storage times of grains and feed products; ■ Using antimicrobial additives, such as propionic acid, to help prevent mold growth; ■ Adding probiotics, such as Lactobacil- lus species, which not only benefit the animal but also control harmful microorganism growth; and ■ Using heat treatment, such as pelleting or extrusion, to reduce pathogens and toxin levels in feed. Although not intentional, medicinal contamination does happen with the production of both medicated and non- medicated feeds at the same feed mill. The table below lists the most recent in- cidences of drug contamination in horse feeds in the United States. Currently, the FDA requires facilities producing medicated feed (e.g., livestock feed containing antibiotics or growth enhancement products) to follow current good manufacturing practice require- ments (CGMPs) to help keep feed safe. "In general, these CGMPs for production of medicated feed do not apply to nonmedicated animal food like horses'," says Anne Norris, health com- munications specialist in the FDA's Office of Foods and Veterinary Medicine. The Preventive Controls for Animal Food (PCAF) rule fills this gap in federal regu- lation to address additional aspects of producing safe animal feed by providing general CGMPs and preventive controls regulations. What does this mean for mills making horse feed? Beginning in September 2016, mills that manufacture, process, pack, or hold animal food (both medicated and nonmedicated) in the United States will be subject to the PCAF rule and will be required to implement the new CGMP requirements, says Norris. Also, feed mills will be required to determine whether there are hazards, such as ionophore con- tamination, requiring preventive controls for their animal food and, if so, to identify and implement those controls. What changes might you see at your lo- cal feed mill? "In general, mills have been NUTRITION LEGEND ® Multi Dose (hyaluronate sodium) For Intravenous Use in Horses Only Not for Intra-Articular Use and LEGEND ® (hyaluronate sodium) Injectable Solution 4 mL For Intravenous Use In Horses Only 2 mL For Intravenous or Intra-Articular Use In Horses Only BRIEF SUMMARY Prior to use please consult the product insert, a summary of which follows: CAUTION Federal Law restricts this drug to use by or on the order of a licensed veterinarian. INDICATIONS LEGEND ® Injectable Solution and LEGEND ® Multi Dose Injectable Solution are indicated in the treatment of equine joint dysfunction associated with equine osteoarthritis. CONTRAINDICATIONS There are no known contraindications for the use of LEGEND ® Injectable Solution and LEGEND ® Multi Dose Injectable Solution in horses. RESIDUE WARNINGS Do not use in horses intended for human consumption. HUMAN WARNINGS Not for use in humans. Keep out of reach of children. ANIMAL SAFETY WARNING For LEGEND Injectable Solution 4 mL and LEGEND Multi Dose Injectable Solution – Not for Intra-articular use. The Intra-articular safety of hyaluronate sodium with benzyl alcohol has not been evaluated. PRECAUTIONS Complete lameness evaluation should be conducted by a veterinarian. Sterile procedure during the injection process must be followed. Intra-articular injections should not be made through skin that is inflamed, infected or has had a topical product applied. The safety of LEGEND Injectable Solution and LEGEND Multi Dose has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares. ADVERSE REACTIONS No side effects were observed in LEGEND Injectable Solution clinical field trials. Side effects reported post-approval: Following intravenous use: Occasional depression, lethargy, and fever. Following intra- articular (LEGEND Injectable Solution – 2 mL only) use: joint or injection site swelling and joint pain. For medical emergencies or to report adverse reactions, call 1-800-422-9874. ANIMAL SAFETY SUMMARY Animal safety studies utilizing LEGEND Multi Dose Injectable Solution were not performed. LEGEND Multi Dose Injectable Solution was approved based on the conclusion that the safety of LEGEND Multi Dose Injectable Solution will not differ from that demonstrated for the original formulation of LEGEND Injectable Solution. LEGEND Injectable Solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dose of 40 mg. Treatments were given weekly for nine consecutive weeks. No adverse clinical or clinical pathologic signs were observed. Injection site swelling of the joint capsule was similar to that seen in the saline treated control horses. No gross or histological lesions were observed in areas of the treated joint. For customer care or to obtain product information, including a Material Safety Data Sheet, call 1-888-637-4251 Option 2. ®LEGEND is a registered trademark, and ™ the Horse Logo is a trademark, of Merial. ©2016 Merial, Inc., Duluth, GA. All rights reserved. Recent Drug CONTAMINATIONS of Horse Feed DATE STATES AFFECTED DRUG NAME February 2014 California Zilpaterol October 2014 North Carolina, South Carolina, Tennessee, Virginia Monensin October 2014 Florida Monensin January 2015 Alabama, Georgia, South Carolina Monensin September 2015 Arizona, California Monensin FDA Recalls, Market Withdrawals, & Safety Alerts (www.fda.gov/Safety/Recalls) Beginning September 2016, feed mills that manufacture, process, pack, or hold animal feed in the United States will be required to implement the new current good manufacturing practice requirements.