CHRB Emergency Rule on Compounded Drugs Geared to Shield Veterinarians

In an attempt to help shield California's backstretch veterinary community from possible further punitive actions by the Veterinary Medical Board (VMB), the California Horse Racing Board (CHRB) has issued proposed emergency regulations designed to clear up discord between these two agencies about the correct use of compounded medications across California's backstretches.

The Food and Drug Administration (FDA) defines the compounding of drugs as “the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more FDA-approved drugs.”

The tranquilizer acepromazine is a prime example of this process, routinely compounded into liquid form to be prescribed and used on fractious dogs and horses. Other commonly used compounded medications across America's backstretches include dantrolene, used on horses that tie-up, and naquasone, for swelling.

Compounded drugs are not FDA-approved, but they are widely used in veterinary medicine provided the compounding process is done according to federal and state guidelines–a dynamic the CHRB has mirrored as a practical regulatory approach for many years, despite the existence of a state statute that essentially forbids drug compounding on CHRB licensed premises.

CHRB's Rule 1867 (b) states that “the possession and/or use on the premises of a facility under the jurisdiction of the Board of any drug, substance or medication that has not been approved by the United States Food and Drug Administration (FDA) for use in the United States.”

The California VMB interprets that rule categorically. Of the roughly 25 backstretch veterinarians currently working in Southern California, nearly all have accusations, are on probation or have record requests pending from the VMB in relation to potential Rule 1867 violations, according to the CHRB.

Last September, the CHRB issued an advisory to its relevant stakeholders stating that the agency's “longstanding interpretation” of rule 1867 “is that lawfully prescribed, compounded medications which are manufactured according to Federal and State guidelines do not violate this regulation.”

But CHRB equine medical director Jeff Blea said that the current Rule 1867 language “falls short of the intention of the rule.” It has been modified “to allow for quality standard care of racehorses by the use of compounded medications provided they are legally manufactured and prescribed in conjunction with a [veterinary client patient relationship].”

The proposed emergency rule making–one along a truncated timeline–appears geared to help shield veterinarians with pending cases by the VMB against them from a potential regulatory trap if they settle with the VMB and return to work under probation: should they then prescribe and administer compounded medications under the current Rule 1867 language, they could face stark professional consequences.

CHRB executive director Scott Chaney explained that the “sole purpose” of the proposed emergency rule making “is to clarify the language both for the vet' med' board but also for the practitioners.”

When asked if Rule 1867 (b)–adopted more than 20 years ago–should have been modified before to avoid the present professional threat that backstretch veterinarians currently face, Chaney pointed to how the CHRB has never cited a veterinarian for a Rule 1867 (b) violation, and that the board wasn't aware of the VMB filing accusations related to the same rule prior to 2020.

“Looking at it today, the easy answer is yes,” said Chaney. “But I think given it's our regulation and we were always purposeful and public about how we interpreted it, there was no reason.”

The proposed new rules modify Rule 1867 with provisions meaning that “possession or use of any compounded drug, substance, or medication, manufactured according to Federal and State laws and regulations, shall not be considered a prohibited veterinary practice” as long as no other human or animal drugs approved by the FDA to do the same job exist and are available, and that the drug is compounded by a California licensed veterinarian or California licensed pharmacy.

The proposed regulations do not differ substantially from any existing comparable federal regulations or statutes, according to the CHRB.

The CHRB has already noticed the proposed emergency regulations, giving interested parties a five-day public comment period. On Feb. 2, the board will submit them to the Office of Administrative Law (OAL). That office then has 10 days to accept or deny the proposed rules.

If the OAL indeed adopts the proposed emergency regulations in this truncated manner, the CHRB has 180 days to formally adopt the rules though its typical rule-making process. If the OAL denies the proposed rules, the CHRB can still adopt them through that normal rule-making process, but they won't go into effect until formally finalized.

The VMB, said Chaney, was involved in the drafting of the proposed regulations.

“We sent them the language we were thinking about, they made some suggestions. We incorporated a few of them but not all,” explained Chaney. “I know they discussed at their last meeting actually commenting, when they had the opportunity, on our regulation.”

The TDN emailed the VMB a series of questions, including whether the agency endorsed the proposed rules, and whether it would urge the OAL to accept or deny it. The VMB has not responded as of publication.

This action is the latest in a regulatory standoff between the CHRB and the VMB, ongoing since the VMB took the unprecedented step of suspending the license of equine medical director Blea at the end of 2021, only to reinstate his license the following September after finding him guilty of only fairly minor record-keeping offenses.

The VMB has complaints currently open against a number of Southern California veterinarians citing them for various alleged offenses beyond Rule 1867 violations, including the alleged misuse of misbranded drugs and of record-keeping offenses.

“This is the only CHRB regulation that the vet' med' board was using in its accusations,” said Chaney, when asked if the CHRB was planning on issuing other similar proposed emergency regulations.

“There are other causes of action, this just eliminated one of them,” he added. “The others the CHRB can't address, like problems with the Veterinary Medicine Practice Act and prosecutorial philosophy.”

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Overlap Between Ferndale and Golden Gate Still in Limbo

A dispute that began in October over whether Ferndale (Humboldt County Fair) will once again have to run its second of two weeks of racing at the end of August against overlapping competition from the commercial licensee Golden Gate Fields (GGF) will now likely extend into March.

There are multiple reasons for the impasse. But the two main sticking points that emerged at Thursday's California Horse Racing Board (CHRB) were:

1) The two tracks, plus stakeholders from the California Authority of Racing Fairs (CARF), Thoroughbred Owners of California (TOC), and California Thoroughbred Trainers (CTT), couldn't present a unified compromise to the CHRB after being given three months to figure one out.

2) The CHRB itself failed to vote in a solution one way or the other, because two commissioners were absent from the regularly scheduled monthly meeting.

The lone motion that came up for the vote–to give Ferndale the entire two weeks un-overlapped in exchange for financial considerations to GGF that would be determined later–resulted in three yes votes and two nos.

But the results of the vote didn't count because the CHRB can't pass any measure unless at least four commissioners vote on the majority side.

“It looks like the horsemen are probably going to be getting an overdue vacation if we can't fix this,” said a frustrated CHRB vice chair Oscar Gonzales in the wake of seeing the motion he proposed fail.

Because the CHRB has already canceled its February meeting (and barring the unlikely event of an “emergency” meeting being called for in this case), the earliest the vote on the overlapped or un-overlapped week of dates could come up again is at the Mar. 16 meeting.

Back in October, the CHRB had voted in a 2023 race dates calendar for NorCal that largely mirrored the framework from the 2022 schedule.

The lone exception was that the board held off on a decision on the Ferndale vs. GGF one-week overlap. The two license applicants then requested more time to reach a compromise so commissioners wouldn't have to impose one, but their negotiations ended up not being fruitful.

On the pro-Ferndale side, testimony at CHRB meetings in recent months (and again on Jan. 19) has centered around preserving small-community racing; keeping alive the tradition of the fairs; Ferndale's stated necessity that a second week of un-overlapped racing is required for any racing there to be viable; Ferndale regularly out-drawing GGF in attendance, and the purported roles Ferndale plays in growing new fans and helping lower-level horse outfits survive.

In favor of giving GGF racing during the second week of Ferndale's meet, proponents have cited GGF's allegedly greater importance as the linchpin of NorCal racing, its ability to offer grass racing, and the additional purse money that would flow into the pockets of year-round, higher-level stables.

Commissioners have also taken note of recent upheaval and legal woes involving Ferndale. Back on Nov. 15, police arrested the fair association's bookkeeper on charges of embezzlement, and the fair association's general manager and three long-time directors have also recently stepped down.

A new GM could be in place by the end of the month, Jim Morgan, the legal counsel for the Humboldt County Fair, told the CHRB on Thursday.

“We're not against Golden Gate,” Morgan told commissioners while pleading his case for no overlap and two weeks of racing. But, Morgan added, “they do run in [10] of the 12 months out of the calendar year. So one week to Golden Gate doesn't mean as much as one week to Humboldt…

“We've been perceived as a minor-league venue and there is some truth to that,” Morgan said. “But we're also a gateway venue” that draws new fans, horse owners and horses into California's overall racing ecosystem.

Larry Swartzlander, CARF's executive director, said his organization has tried to broker a deal that gives Ferndale its solo two weeks in exchange for paying purse money to GGF.

“CARF's goal, if we get the second week un-overlapped, [is] obviously we want to raise purses at Humboldt,” Swartzlander said. “We want to make racing better. And we all understand that Humboldt is never going to have the same level of racing of Golden Gate or Pleasanton…

“CARF's position was to offer [$200,000 in purses] to Golden Gate,” Swartzlander said. “Golden Gate's counter is that they would prefer to have [bet] commissions. CARF's position is if we give up commissions [the deal] wouldn't work.”

David Duggan, the general manager and vice president for GGF, told the CHRB that, “I don't see any light at the end of the tunnel for us coming to a suitable arrangement.”

When CHRB chairman Gregory Ferraro, DVM, asked what losing that one week of racing would cost GGF, Duggan replied, “Off the top of my head, mister chairman, it would certainly be north of $250,000 [in commissions].”

Bill Nader, the TOC's president and chief executive officer, said the value of GGF's turf course “shouldn't be understated” during the summer months.

“I think it's important for the viability of Golden Gate, and also for the purse structure, that we go with the overlap of the two weeks, so we support the Golden Gate Fields position,” Nader said.

“We respect Ferndale as a complementary player in the overall landscape of racing in northern California. But in the lead role, maintaining the overlap and giving Golden Gate [that week is] important for the California horse population, for the ability to be able to run on the turf, and also for people who are supporting racing as fans,” Nader said.

“A half-mile track is something that's interesting for a short period of time,” Nader continued. “But it's not the brand that we want to present for California racing, particularly at that time of year.”

Alan Balch, the CTT's executive director, said he agreed with the TOC's position, adding that “more than anywhere else in the state, [NorCal] trainers are also owners. And we look at [being able to race at GGF] as maximizing racing opportunities.”

Commissioner Wendy Mitchell framed the question in terms of serving a constituency.

“Ferndale is a remote, northern California location [in which] there's a community concerned,” Mitchell said. “This is a fair [that] we need to be supporting, because otherwise we're leaving part of our population out in the wilderness…. And I think we need to give them the dates in order for them to [help grow the overall racing product statewide].”

Chairman Ferraro offered a counterpoint.

“The thing, Wendy, is that our constituency is really the horsemen of California. And we're talking about taking hundreds of thousands of dollars out of their purse money to benefit  a local fair,” Ferraro said. “That balance has got to be there. Our primary responsibility is to ensure the health and viability of racing in California, so that would concern me.”

Mitchell respectfully voiced disagreement: “I don't think it's just the horsemen that are our constituency. I think we have multiple stakeholders and constituencies here.”

The board batted around the idea of giving the two sides more time to work out a compromise. But Morgan stated that the fair's board would prefer an answer right away.

Morgan explained that Ferndale has to bring aboard a new GM, and that it would be tough to hire a competent person without being able to tell them what the budget and racing-related revenues for 2023 are going to look like. He also added that horsemen in the Pacific Northwest are now already starting to plan where they'll be racing in the summer, and delays and further uncertainty will only harm Ferndale's efforts to recruit them.

Gonzales made a motion to give the two weeks un-overlapped to Ferndale, with the understanding that Ferndale will have to “bridge the gap” financially with GGF before the March CHRB meeting.

But that motion only set off another verbal spiral over exactly what such a money compromise might be valued at. There was also talk that the current clashing offers of purse money versus bet commissions amounted to an “apples to oranges” type of comparison that benefitted nobody.

When the motion came to a vote, commissioners Gonzales, Mitchell and Brenda Washington Davis voted in favor of giving Ferndale its own two weeks without competition.

Commissioners Ferraro and Thomas Hudnut voted no.

Commissioners Dennis Alfieri and Damascus Castellanos were not present.

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Trainer Mullins Suspended, Fined for Clenbuterol Positive in Del Mar Winner

Trainer Jeff Mullins has been suspended 30 days and fined $1,500 as the result of a “settlement agreement and mutual release” with the California Horse Racing Board (CHRB) to adjudicate a clenbuterol positive triggered by one of his winning trainees at Del Mar last summer.

The conditions of the agreement call for Mullins to serve 15 days of the suspension, with the remaining 15 days conditionally stayed.

The stewards' ruling, dated Jan. 7, stated that Mullins is “placed on probation for ONE YEAR from the date of this ruling and may not have any violation of CHRB Rules and Regulations…regarding Class I, II or III drug substances. The term of suspension shall be from Jan. 9, 2023, through Jan. 23, 2023. If JEFF MULLINS violates a condition of the probation, FIFTEEN DAYS of stayed suspension shall be imposed following a notice and hearing.”

The positive for clenbuterol (a bronchodilator), which under CHRB rules is a Class 3, Penalty Category B violation, occurred in the gelding Inch (Violence), who won a $50,000/NW3L starter-allowance grass sprint Aug. 25.

Daily Racing Form's Steve Andersen reported that during the suspension, Mullins's son, Jeff Jr., will be the official trainer.

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CHRB Spat Erupts Over Ferndale’s Future

In the wake of a recent embezzlement arrest and a spate of resignations by Humboldt County Fair Association executives, California Horse Racing Board (CHRB) commissioner Thomas Hudnut on Thursday questioned whether or not the Northern California half-miler better known as Ferndale would be able to operate its traditional late-August race meet in 2023.

Jim Morgan, the legal counsel for the Humboldt County Fair, immediately provided assurances that Ferndale's racing would not be affected by the in-process criminal audit and management shakeup.

And another CHRB member, vice chair Oscar Gonzales, quickly leapt to Ferndale's defense, accusing Hudnut of delivering a “low blow” simply for making his query about the fair's level of financial and management fitness.

That testy exchange evolved out of a seemingly routine agenda item during the Dec. 15 monthly meeting.

Back in October, the CHRB voted in a 2023 race dates calendar for NorCal that largely mirrored the framework from the 2022 schedule.

The lone exception was that the board held off on a decision on whether Ferndale would once again have to run its second of two weeks of racing against overlapping competition from the commercial licensee Golden Gate Fields.

The CHRB was prepared to decide that issue on Thursday. But the license applicants jointly requested another month to try to reach a compromise so commissioners wouldn't have to impose one. A chief issue relates to stabling.

But since that last CHRB meeting, Ferndale police on Nov. 15 arrested the fair association's bookkeeper, Nina Tafarella, on charges of having embezzled from the fair and another nonprofit.

Then on Dec. 5, Rich Silacci, the fair association's general manager, abruptly resigned from his position. He claimed that his stepping down was unrelated to the embezzlement arrest, and that he had already made his decision beforehand based on being burned out from the job.

According to a Dec. 6 story in the California-based news outlet North Coast Journal, “the fair's books are currently being audited for evidence of embezzlement. Three long-time directors with the fair association have also stepped down in the last few weeks, leaving four open board positions.”

The Journal wrote that according to Silacci's final report to the board, auditors are still reviewing several years' worth of transactions, but the association's bank statements show a healthy balance of 'just over a million dollars,' which is close to or ahead of where the balance stood the prior year.

“Given the disarray at the Humboldt County Fair that we've read about in the press of late, is Humboldt County going to be able to mount a fair next summer?” Hudnut asked.

“Is it going to have sufficient personnel?” Hudnut continued. “And maybe should Humboldt take the year off from horse racing?”

Morgan replied, “The answer is, we'll handle the disarray. I'm not sure of the extent of the issue once it shakes out. Humboldt is committed to have a fair this year, next year, and every year.

“Members did resign, yes,” Morgan explained. “And the general manager, that position is going to be up for renewal with a new individual. But the fair is functional and they're ready to move forward.”

Hudnut said he trusts that next month Morgan will be able to back up those assurances with a more detailed plan for Ferndale's race meet, especially considering the board still has to vote on how to handle the potential dates overlap with Golden Gate.

“Until otherwise, I will be skeptical of Humboldt's ability to carry on effective racing next summer,” Hudnut said.

Gonzales then spoke up.

“I don't think it's all that fair to ask whether Humboldt is prepared to race,” Gonzales said. “Of course they're prepared to race. There's been some growing [pains].

“The TOC just had some turmoil in their organization not that long ago,” Gonzales continued, obliquely referencing the resignations earlier this year of both the Thoroughbred Owners of California president and a board member. “I don't see anybody asking whether the TOC is fit to represent.

“All organizations have some ups and downs. This is horse racing. And I don't appreciate those low blows there,” Gonzales said, directing his remarks to Hudnut.

“I resent that,” Hudnut retorted. “I don't think they're low blows when you ask legitimate questions about what's been in the press.”

Gonzales replied, “They're fit to race, and they just need some time to sort some things out. That's all.”

Chairman Gregory Ferraro, DVM, then stepped in to stem the spat.

“I don't think it's unreasonable to ask them to address the issues next month, to tell us what the status is,” Ferraro said, declaring that the discussion is to be placed on the January agenda.

In conclusion, Morgan underscored that “Humboldt's clearly addressing the issues and resolving them. And I'm optimistic that we will solve it, and be a participant with live racing for many years to come.”

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