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As a veterinarian, Dr. Gary Brummel relies on xylazine as a tranquilizer in the treatment of large animals, including cattle and horses. 

He says the drug is the only one of its kind that is strong enough to ensure the animal’s safety, as well as the health and well being of veterinarians who provide treatment. Xylazine, he added, is also used to treat large zoo animals.

Brummel, a practitioner at Lebanon’s 5th Avenue Animal Hospital, and his colleagues around Pennsylvania are concerned that a new rule proposed by Gov. Josh Shapiro to combat the opioid epidemic will prevent veterinarians across the state from having access to the powerful sedative.

“It’s a very scary proposition because there is no other practical alternative,” said Brummel. 

In mid-April, Shapiro announced at a press conference in Philadelphia’s Kensington neighborhood, the epicenter of the city’s opioid crisis, that he was directing the state Department of Health to schedule xylazine as a Schedule III controlled substance.

Xylazine, which is also known as “Tranq,” is being used illegally as an addictive adulterant to illegal heroin and fentanyl, and the lethal combo has contributed to the rise in overdose deaths around the country – including hundreds in Philadelphia, according to published reports.

State health officials have reported that xylazine use by humans may cause skin ulcers, decaying tissue and lead to bacterial infections. When used in combination with an opioid to increase the high the user feels, xylazine may worsen respiratory depression in the event of a drug overdose. Because xylazine is not an opioid, naloxone is not known to be effective at reversing overdoses caused by its use.   

Jim Donmoyer, director of the Lebanon County Commission on Drugs and Alcohol, said that none of the 14 overdose drug deaths in the county between Jan. 1 and May 5 of his year have shown the presence of xylazine in the system of the deceased. But that’s just for now.

“I can’t tell you how many people are using it or whether it is currently being used because I don’t know,” said Donmoyer. “But what I can tell you, based on past experience, is that what happens in Philadelphia will trickle across the state.”

Shapiro, who is a former state Attorney General, is making moves to schedule xylazine so that law enforcement officials can prosecute cases against anyone caught illegally possessing the drug, which is being shipped to the U.S. from China, according to Dr. William Croushore Jr., secretary/treasurer of the Pennsylvania Veterinary Medical Association.   

“There is no substantive evidence that xylazine is being diverted from veterinary sources,” said Croushore. “The xylazine that they are using to cut fentanyl is being imported from China illegally. Without penalties, the state police in Pennsylvania and the DEA, federally, can’t do anything about this xylazine coming in because they don’t have the authority to prosecute anyone for possession since it is not a controlled substance.”

Although Shapiro announced veterinarians would still have access to xylazine, making it a controlled substance could be problematic for practitioners. Brummel said any veterinarian that wants to use a scheduled drug must have a Drug Enforcement Agency license to possess it.

“If he (Shaprio) schedules it, then veterinarians would have to obtain a DEA license, which is not a cheap proposition by itself,” said Brummel. “So that’s going to increase our costs and we would also have to do a different level of record keeping, which is going to increase our paperwork. This will increase our cost to producers.”

That point, however, is somewhat moot. Brummel added Pennsylvania practitioners might not even be able to purchase xylazine if it becomes a scheduled drug in the commonwealth.

“They (the manufacturers) also have to go through the process to even sell it as a product and they may say, ‘Hey, we’re not going to make enough money, so we’re not going to even bother,’” said Brummel. “So, our fear is that we won’t even have access to it, period. They don’t want to go through the process with the DEA.”

Brummel noted that the DEA licensing process is time-consuming and arduous. 

“Where the problem lies is that the people who are making it are not scheduled to manufacture, so they have to go through all of the DEA processes to get qualified to make scheduled product, which you can imagine is a huge process, very expensive and it takes a long period of time,” said Brummel. “I believe I read somewhere that it is a two-year process to even be able to do it (obtain a DEA license).”

Croushore, who practices in Somerset County, told LebTown that Shapiro had only two options in addressing the illegal use of xylazine: issue an order, which is the route he is taking through the Pennsylvania Department of Health, or sign a legislative bill into law. Croushore is the PVMA point person who is working with several other like-minded organizations to present their concerns to the Shapiro administration.

“I don’t want to say we’ve lobbied, but we’ve had conversations with the Shapiro administration about the unintended consequences if this rule goes through,” said Croushore. “I can say I am guardedly optimistic that eventually – soon, hopefully – that there will be legislation, but, as of now, it hasn’t been introduced.” 

Croushore said the American Veterinary Medical Association and PVMA support a federal bill currently being pursued, because the federal bill would allow veterinarians to maintain access and have the ability to legitimately use the critical animal sedative under its current prescription status. 

“The PVMA’s position is that we would like to see something similar to what is happening at the federal level with the Combating Illicit Xylazine Act (H.R. 1839/S. 993). They (the state) do not have the ability to do that by executive order, that would have to be done by legislation.”

The federal bill does provide penalties for illicit use while allowing the federal Food and Drug Administration to oversee its use as a prescription animal drug. The bill states that anyone found importing, manufacturing, or possessing xylazine for distribution and use in humans would be subjected to harsher penalties under the Controlled Substance Act. 

Croushore said Pennsylvania officials could easily craft and pass legislation that’s similar to a law that was created in one other state since the length of that particular bill was only two pages. 

“We are hoping that they do introduce legislation,” said Croushore. “There is precedent for this in other states. Tennessee has gone that route. They made a state law that’s similar to the one (bill) before Congress right now and in Louisiana, there’s a bill that’s similar to the federal bill.” 

Croushore also noted that a rule could easily be rescinded by the Shapiro administration even if adopted, given its temporary status. 

“They could rescind it as easily as they enacted it. It will expire after a year unless they make it permanent, and the threshold for making it permanent is a little higher,” said Croushore. “They could still rescind it. That’s why the legislation – the legislative route is so important – because if we don’t get legislation they will have to enact a permanent rule because they have no choice in prosecuting illicit xylazine. There has to be a disincentive for its use (in humans).”

What the status of scheduling xylazine is or if there is a bill that’s being drafted is unclear to LebTown as of publication. A search of the Pennsylvania General Assembly’s legislative database did not return any bills currently under consideration that mention the drug.

The state Department of Health had published in the April 22 edition of the Pennsylvania Bulletin its intent to issue a final notice to temporarily schedule xylazine as a Class III to “avoid an imminent hazard to public safety.”

The state attorney general then has, by law, 30 days from receipt of the proposed notice to provide any written comments to the health department. If the AG’s office received the notice, the 30-day comment period would have expired on Monday, May 22. 

Croushore said he was told by Shapiro administration officials that the proposed rule has not been sent to the AG’s office for review and potential comment. 

“What I can tell you is that the rule that they originally proposed was supposed to have gone to the AG on May 3. That has not yet happened, and it may still happen,” said Croushore.

The Attorney General’s office did respond to a LebTown inquiry on whether they had been transmitted the proposed notice until after this article was originally published. However, a spokesperson for Attorney General Michelle Henry later said that the AG’s office had in fact been transmitted an initial notice from Shapiro on April 12 and that the AG’s office provided a response the next day, indicating support of the measure.

Further confusing the issue, the spokesperson also noted that the AG’s office had received an amended notice on Friday, May 19, and again indicated their support. What changes that amendment contains was not immediately clear – the Attorney General’s office declined to share a copy, and referred LebTown to the Department of Health, which did not immediately respond to LebTown inquires.

Getting clear information from the state on the current status of the proposed temporary scheduling, or whether the administration or legislators may push for permanent legislation, has proven difficult.

LebTown was told last Friday by a Shapiro administration press official that interviews would be arranged with spokespersons from the departments of Health and Agriculture, but the Department of Agriculture had already refused comment Thursday and referred LebTown to the governor’s press office instead. 

The lack of updates has left some wondering whether the administration may have decided to change course and not implement the order. A spokesperson for Shapiro would not speak on the record about the status of the proposed order, despite having originally said they would, and did not respond to LebTown attempts at followup earlier this week.

LebTown had previously heard that the administration may be amending the rule to exempt legal prescription xylazine from being classified as a controlled substance, but has yet been able to confirm this.

The governor’s office did not immediately respond to LebTown inquiries as whether this was accurate and, if so, when the change would be announced. It was not immediately clear if, in that scenario, the administration would need to publish the revised proposed notice again and restart the 30 day comment period.

Brummel told LebTown that if the administration is planning to let the rule die and introduce a bill instead, he would hope that the administration would make a public announcement concerning its intentions. 

“I think personally it says more about the governor to say, ‘Ok, you know what? After doing further due diligence, that wasn’t the right move, we’ve backed off and we’re going to go this route instead because it makes more sense to have it available while still having the outcome we want as far as enforcement goes,’” said Brummel.

Croushore said he was pleasantly surprised with how easily it has been to work with the administration on this issue, and his comments suggest that the administration may be already exploring ways to respond to the public health and policing needs, while also minimizing impact to veterinarians who rely on xylazine for veterinary anesthesia.

“The issue hasn’t gone away, but they’ve been very attentive to us so that they can have penalties for possession while keeping it (xylazine) in the hands of veterinarians,” said Croushore. “They’ve been very responsive to us, much more so than I originally thought they might be.” 

While the Shapiro administration’s plan remain unclear, as is any timeline for the proposed rescheduling to become official, one thing is known: the ball is squarely in their court.

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James Mentzer

James Mentzer is a freelance writer whose published works include the books Pennsylvania Manufacturing: Alive and Well; Bucks County: A Snapshot in Time; United States Merchant Marine Academy: In Service to the Nation 1943-2018; A Century of Excellence: Spring Brook Country Club 1921-2021; and Lancaster...