Horse Deaths and Doping Bring Increased Oversight for Pharmacies

Dispensers that customize medicines face new rules. But will they work?

By Alex Krales and Génesis Dávila SantiagO

In 2019, at least three horses around the country died or had to be euthanized after the pharmacy that prepared their medications added up to 21 times the dosage of an anti-parasite drug described on the package label.

The spate of deaths underscored how errors by compounding pharmacies have led to demise of multiple animals — including more than 30 horses in the past two decades, according to an analysis by the NYCity News Service. Such pharmacies have also been linked to performance-enhancing drugs given to race horses — including one that competed in the 2019 Kentucky Derby.

Compounding pharmacies — which differ from typical pharmacies in that they prepare medications on-site from raw ingredients, rather than using drugs produced by major pharmaceutical firms — have a market size valued at $2.07 billion in 2022, a figure predicted to reach $4.12 billion by 2031, according to InsightAce Analytic. 

But now, after years of industry resistance, the federal government is increasing oversight by ordering these pharmacies to report to the Food and Drug Administration within 15 days cases of any animals appearing to show ill effects from their medicines, among other new rules. 

PHOTO/FREEPIK

New Oversight a ‘Good Thing’ 

Natalie Young, a veterinary pharmacist who teaches at the University of North Carolina at Chapel Hill, said more stringent regulations will help the industry. 

“Others would probably disagree with me,” Young said, “but it’s a really good thing that the criteria is becoming more strict, because what it does is it eliminates bad compounders out of our industry.”

Young defended the ongoing need for compounding pharmacies. She described a case involving a young dog named Turk who survived only because a compounding pharmacy was able to make needed medication in a liquid.

She said compounded medications are also crucial for horses. 

“We have to make flavored paste to go around their gum line because a horse will kick you in the face. So it’s a safety issue” to provide customized, more palatable medication, she said.

‘Still Underreported’

Under the new regulations, all incidents of ill effects must be reported to the FDA, which will add them to a federal database once the agency is notified. While the FDA has run the database since the 1980s, reporting was voluntary before the new mandatory reporting law went into effect Nov. 1, 2023.

The FDA said the database is intended to help spot problems with drugs prepared by pharmacies. But even with the new rules, questions remain on how thoroughly pharmacies will report problems. 

From the time the new rules went into effect on Nov. 1, 2023, and mid-February 2024, no new cases involving compounding pharmacies appeared in the FDA’s database. 

The agency said it believes “AERs (adverse event reports) are still underreported.”

The new regulations also require compounding pharmacies to provide labels that clearly show the medications included in each mixture. as well as display the expiration date. The FDA additionally included guidance for compounding pharmacies to get information from veterinarians and document why the customized drugs are being prescribed, rather than using approved drugs already on the market.

The Professional Compounding Centers of America opposed part of the guidance — particularly the section on documenting the need for the prescription — saying chasing veterinarians for explanations would place a burden on their members.

“State regulations do not generally have requirements to document the rationale for using a compounded preparation as opposed to a manufactured drug because that is not and should not be their focus,” Lizzie Harbin, of the Professional Compounding Centers of America, wrote.

“The focus of the veterinarian should be on diagnosing and choosing the best treatment option for that animal or group of animals,” Harbin added.

A Nationwide Issue

The reach of some compounding pharmacies extends far beyond their local ZIP code, with some marketing their custom medications to customers across the nation.

While compounding pharmacies are largely regulated by states, the FDA exercises some oversight, including inspections and recalls, particularly for larger facilities that sell veterinary drugs across state lines.

In 2022, for instance, FDA inspectors found grimy, unsanitary and unclean areas where veterinary drugs were made at Wedgewood Village Pharmacy, Inc. in Swedesboro, N.J., a suburb of the greater Philadelphia area. That same year, the company recalled thousands of bottles, jars and vials of dozens of different medicines it made for animals. 

APS Pharmacy, a compounding medicine operation in Palm Harbor, Fla., was the subject of a 2022 FDA alert and had to recall some of its medication after investigators found evidence of non-sterile conditions at the operation that could sicken those taking the drugs. Investigators learned of at least two incidents of animals that had a bad reaction to eye medication prepared at the pharmacy, among other issues. 

The FDA has found other safety concerns among veterinary compounding pharmacies across the country in prior years, spurring drug recalls.

From 2006 to 2019, more than 30 horses died and a half dozen others were sickened after taking improperly manufactured drugs from compounding pharmacies. 

In 2006, two quarter horses used for racing died and another was badly sickened in Louisiana after being given a compounded drug containing clenbuterol, a powerful medication used to treat asthma in horses, that was 70 times as potent as the version approved by the FDA. 

The drug has also been abused by athletes and bodybuilders “to increase lean muscle mass and reduce body fat” — despite not being approved for use by people in the U.S., according to the Drug Enforcement Administration. 

In 2009, 21 polo ponies in Florida died from an overdose of the mineral selenium blended improperly by a compounding pharmacy into a vitamin and mineral supplement.

And in 2014, four horses in Kentucky and Florida died from a blend improperly mixed by a Kentucky compounding pharmacy that included the antiparasitic pyrimethamine and toltrazuril. Six other horses that took the same batch of medication became ill. 

Top Horses Allegedly Doped

Compounding pharmacies have also been linked with illegal doping of racehorses.

In 2018, a Louisiana veterinarian was sentenced to more than a year in prison and the Nebraska-based compounding pharmacy he worked with was fined $200,000 for conspiring to sell an unapproved opioid drug 40 times more powerful than morphine — a concoction designed to improve the performance of racehorses.

In July 2023, horse trainer Jason Servis was sentenced to four years in prison for his role in a long-running horse doping operation that included medicines made in unregulated compounding pharmacies. 

Among the horses allegedly doped: 2019 Dubai Golden Shaheen winner XY Jet, and Maximum Security, whose first-place 2019 Kentucky Derby was controversially disqualified after instant replay showed him veering into another horse’s path.

An explanation of Maximum Security’s #KyDerby disqualification. pic.twitter.com/vf8AN4qvD2

— Kentucky Derby (@KentuckyDerby) May 4, 2019

‘Fill in the Gaps’

While some compounding pharmacies have been linked with violations, deaths and doping, those in veterinary medicine still see a compelling need for the services.

“There’s no way we have all of the medications we need to suit every patient’s needs,” said veterinarian pharmacist Lauren Eichstadt Forsythe, author of the book, “Drug Compounding for Veterinary Professionals.” 

“The goal with compounding is to fill in the gaps where manufactured products can’t meet our needs,” Eichstadt Forsythe said.

ANIMAL DRUG CONCERNS