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FDA Issues Warning Letter To Rapid Equine Solutions After Finding Dirty Compounding Rooms, Potency Issues

The Food and Drug Administration has issued a warning letter to Pennsylvania-based Rapid Equine Solutions following its inspection of the facility last summer, asking the pharmacy to provide more information about what its employees are doing to prevent serious problems at the facility.

The letter, dated June 12 of this year, describes observations made by federal inspectors between July 22 and Aug. 9, 2019 that include “insanitary conditions,” “potency issues,” and misbranding. Inspectors described “an unknown white film on the floor in the sterile production room and debris in the corners of the room” as well as several bugs lingering around the sterile and non-sterile preparation areas, while fly tape hung from the ceiling above the laboratory sink.

Further, the letter notes that a batch of toltrazuril/pyrimethamine paste compounded for the treatment of horses with Equine Protozoal Myeloencephalitis (EPM) was found to have incorrect amounts of both ingredients in it per its labeling. There was only 3 percent of the declared amount of toltrazuril in the paste, but 2,122 percent the amount of pyrimethamine declared on the label. The investigation followed the deaths of three horses in Maine and Ohio who were given the paste.

The drug combination, which has proven a popular choice for treating EPM, is the same one that was formulated incorrectly in 2014 by a Kentucky compounder which released batches with too much pyrimethamine in them. At least four horses died and several more fell ill in that case.

Rapid Equine provided the FDA with responses outlining its plans for eliminating the problems identified by investigators, but the agency writes in its warning letter this month those responses don't include enough specific information about what the facility is doing to improve their processes.

In 2019, Maine regulators suspended Rapid Equine's license after they say they discovered the mail-order facility was acting as a wholesaler for compounded drugs and was selling large amounts of compounds to a harness veterinarian who sold them without a prescription. Compounded drugs are not FDA-approved and are not intended to be produced and sold or stored in bulk; rather, they should be formulated to order for a specific patient to treat a diagnosed condition as prescribed by a veterinarian.

According to the online license verification system for the Pennsylvania State Board of Pharmacy, regulators there have taken no disciplinary action against Rapid Equine's license, which was renewed in August 2019 — on the same day FDA inspectors concluded their observation of the pharmacy's unsanitary conditions.

Read the June 2020 FDA warning letter here.

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Canadian HOF Rider Don Seymour Dies

Canadian Hall of Fame jockey Don Seymour, who stamped himself one of the nation’s leading riders after riding two Triple Crown winners, died June 26 at his home in Barrie, Ontario. Surrounded by his family, including his mother Mary, at the time of his death, he reportedly had been suffering from chronic obstructive pulmonary disease since earlier this year. He was 59.

Born and raised in Hamilton, Ontario, Seymour was a leading rider in Alberta in the 1980s before relocating to ride at Woodbine Racetrack in Etobicoke, Ontario. Best remembered for sweeping consecutive Triple Crowns in 1988-89 with Kinghaven Farm runners With Approval and Izvestia–both horses would go on to be named Horses of the Year–he also accompanied Canadian champion Play The King, who finished second behind U.S. Sprint Champion Gulch in the 1988 GI Breeders’ Cup Sprint en route to Canadian Horse of the Year honors.

Voted the Sovereign Award-winning rider in 1985, 1987, 1989 and 1990, he was honored with the Avelino Gomez Memorial Award in 1995 and was inducted into the Canadian Horse Racing Hall of Fame in 1999. After an early retirement from the saddle in 1994 with 2,141 career wins, including 171 stakes wins, Seymour served as a placing judge and official clocker before leaving the track for good in 2002.

A private family service will be held followed by a public celebration of Seymour’s life at a later date. In his memory, donations may be made to the Heart and Stroke Foundation.

The post Canadian HOF Rider Don Seymour Dies appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.

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Breeders’ Cup Extends Racing Age Nomination Discount Deadline To Aug. 15

Due to changes in racetrack schedules and auction sales dates as a result of COVID-19 restrictions, the Breeders' Cup announced Monday that it is extending the discount deadline for horses of racing age to Saturday, Aug. 15.

All horses must be Breeders' Cup-nominated in order to compete in the Breeders' Cup World Championships, which is scheduled to be held at Keeneland Race Course Lexington, Ky., Nov. 6-7.

The original horses of racing age nomination discount deadline was July 15.

“Although most Breeders' Cup nominated horses join the program as weanlings, there are a few each year that didn't get the Breeders' Cup advantage as a foal,” said Dora Delgado, Breeders' Cup Executive Vice President and Chief Racing Officer. “We created the horses of racing age nomination program to make sure all runners have a chance to compete in our racing programs including the Breeders' Cup World Championships. Now that racing has resumed in most locations, we believe our one-month extension will allow horsemen to better evaluate their racing stock and nominate to the Breeders' Cup program, providing eligibility for their entire racing career.”

The nomination discounts are as follows:

2-year-olds by a nominated Breeders' Cup stallion can join the program for US$12,000. This one-time nomination fee makes the racehorse Breeders' Cup-eligible for its entire racing career.
Runners which are 3-year-olds and older that were foaled in the Northern Hemisphere and sired by a nominated stallion will receive a 50% discount off normal racehorse nomination fees. Three-year-olds and older which were born in the Southern Hemisphere can be nominated for 25% of their regular nomination fee.
All nominated racehorses are eligible for the Breeders' Cup World Championships, which will have purses and awards totaling more than $35 million this year, and for any other Breeders' Cup racing program for their entire racing careers.

Following the Aug. 15 deadline, the price for all non-nominated runners reverts back to the standard racehorse nomination fee of US$100,000 or more until Oct. 26, when all runners must be pre-entered for the Breeders' Cup World Championships races.

Owners may nominate their horses of racing age online at https://members.breederscup.com/Nomination/RacehorseNominationTerms1 or by calling the Breeders' Cup Racing department at 859-514-9422.

Owners of horses of racing age by non-nominated stallions also can take advantage of discounted prices before Aug. 15. Two-year-olds by non-nominated stallions can join the program for US$18,000; Northern Hemisphere 3-year-olds and older for US$100,000 and Southern Hemisphere 3-year-olds and older for US$50,000.

Below is the complete list of nomination prices and deadlines:

Horses of Racing Age sired by Nominated Stallion and Nominated before Aug. 15.

Two-Year-Olds: $12,000 (US)
Three-Year-Olds & Up (Northern Hemisphere-bred): $50,000 (US)
Three-Year-Olds & Up (Southern Hemisphere-bred): $25,000 (US)

Horses of Racing Age sired by Nominated Stallion and Nominated after Aug. 15.

Two-Year-Olds: $100,000 (US)
Three-Year-Olds & Up (Northern Hemisphere-bred): $100,000 (US)
Three-Year-Olds & Up (Southern Hemisphere-bred): $100,000 (US)

Sired by NON-Nominated Stallion and Nominated before Aug. 15.

Two-Year-Olds: $18,000 (US)
Three-Year-Olds & Up (Northern Hemisphere-bred): $100,000 (US)
Three-Year-Olds & Up (Southern Hemisphere-bred): $50,000 (US)

Sired by NON-Nominated Stallion and Nominated after Aug. 15.

Two-Year-Olds: $200,000 (US)
Three-Year-Olds & Up (Northern Hemisphere-bred): $200,000 (US)
Three-Year-Olds & Up (Southern Hemisphere-bred): $200,000 (US)

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‘A Great Mind’: $3.65 Million Purchase Cezanne Will Try Two-Turn Allowance Before Derby Prep

A $3.65 million 2-year-old at last spring's Fasig-Tipton Gulfstream sale, Cezanne lived up to early expectations when breaking his maiden on debut earlier this month at Santa Anita Park. For his second start, the 3-year-old son of Curlin will step up to two turns in a one-mile allowance race at Los Alamitos this Thursday.

Trained by Bob Baffert for owners Mrs. John Magnier, Michael Tabor, Derrick Smith, and St. Elias Stable, Cezanne is out of the Bernardini mare Achieving. His third dam is the Deputy Minister mare Better Than Honour, the dam of Belmont Stakes winners Jazil and Rags to Riches.

In his debut, the colt sat just off the pace before making his bid between rivals on the turn, then pulling away down the lane to win by 2 1/4 lengths, completing 6 1/2 furlongs on the fast main track in 1:16.13. Since that start, Cezanne has breezed twice at Santa Anita, going five furlongs in 1:01.80 on June 22 and a half-mile in :48 flat on June 28.

“He's still a little heavy,” Baffert told the Daily Racing Form. “More racing will help him. He's shown us he's a top horse. He's got a great mind and doesn't get excited. He's been behaving himself.”

Should his two-turn debut prove successful, Cezanne could be considered for a Kentucky Derby prep race, said Baffert.

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