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 largely of only fairly minor record-keeping offenses, according to various veterinary medical experts familiar with his cause.

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.”