With Louisiana’s first execution in four years set for just three weeks from today — and the state unable to obtain the necessary lethal-injection drug from the sole mass producer of the drug — observers say the state may have to resort to finding a specialty pharmacy willing to make a small batch.

The approach isn’t novel. A handful of states have conducted executions in the past year using lethal drugs bought from such operations, called compounding pharmacies. But acquiring the drug isn’t easy, and it isn’t without concern or controversy.

That’s because compounding pharmacies are not regulated by the U.S. Food and Drug Administration, and because a compounding pharmacy was recently linked to scores of deaths as a result of unsanitary conditions.

Further, the same ethical consideration that led the primary manufacturer to deny sales for the purpose of executions likely will limit the number of compounding pharmacies willing to make and sell a drug designed to kill, not heal.

“Ethically I wouldn’t do it. I just don’t believe in it.”—pharmacist Doug Boudreaux of Shreveport

The manufacturer’s reluctance led Missouri prison officials to buy the necessary drug from an out-of-state compounding pharmacy that wasn’t licensed to do business in the Missouri, prompting lawmakers to investigate the state’s execution method. And in Texas, a compounding pharmacy demanded that the drug be returned from prison officials when its identity was made public; the owner had been assured the transaction would be on the “down low,” he said.

Corrections officials nationwide “are just desperate to get any kind of drug,” said Fordham University law professor and death-penalty expert Deborah W. Denno. “They’re going to these pharmacies because that’s the only place where they can get lethal-injection drugs.”

Compounding pharmacies mix or alter drugs to fulfill generic prescriptions. Though they may make small, special formulas — say, a liquid version for someone who can’t tolerate a pill — some also make large batches for hospitals or other health-care facilities. Compounding pharmacies must be licensed by their state’s pharmacy board, according to the Death Penalty Information Center, so they’re not completely unregulated.

Death-penalty opponents say expired or inadequate drugs could result in a needlessly painful death or may not be effective at all, both of which would violate the U.S. Constitution’s ban on cruel and unusual punishment.

Convicted child-killer Christopher Sepulvado, from DeSoto Parish, is set to be put to death Feb. 5, a date that was moved up recently because a death warrant issued for March fell outside the timeline required by law. He was convicted in 1993 for beating his 6-year-old stepson with a screwdriver and then holding him down in scalding water.

Sepulvado has seen several execution dates come and go. Most recently, he won a stay of execution by successfully challenging the new method for execution.

The drug in question is pentobarbital, which is called for in the state Department of Public Safety and Corrections’ execution protocol. Because the drug is named in the official procedure, the state can’t use another method for execution.  It has a shelf life of three years.

The state recently disposed of an expired supply bought in May 2011, according to Sepulvado’s lawyers and a state Pharmacy Board official. State prison officials won’t say whether they have a new supply of pentobarbital, and it’s unclear how they plan to carry out the execution next month.

Federal Magistrate Stephen C. Riedlinger of Louisiana’s Middle District in Baton Rouge this week required the state to reveal by Jan. 24 whether it plans to make further changes to the execution protocol. In siding with Sepulvado’s attorneys, he said it’s critical that the state show whether it has safeguards in place “to ensure that their respective executions are performed without incident” and uniformly.

Deaths linked to compounding raises concerns

Compounding pharmacies came under scrutiny after a deadly meningitis outbreak in 2012 was linked to contaminated injections made by a Massachusetts outfit.

Death-penalty lawyers seized on the incident.

“There is a significant chance that it [the pentobarbital] could be contaminated, creating a grave likelihood that the lethal injection process could be extremely painful, or harm or handicap plaintiffs without actually killing them,” reads a lawsuit filed by three death-row inmates against the state of Texas, in response to information revealing that the state bought eight vials of compounded pentobarbital to use for execution.

However, several states have used compounded lethal-injection drugs, citing no restrictions when it comes to their state laws. And a federal judge in Ohio ruled in favor of using compounded drugs.

Even though U.S. District Court Judge Gregory Frost called the use of compounded drugs an “experiment” in the lethal injection process, he ruled that it did not violate the U.S. Constitution.

“The law teaches that Ohio is free to innovate and to evolve its procedures for administering capital punishment,” Frost said, according to a report by the Associated Press.

Denno, of Fordham, said federal officials have not offered guidance.

“There’s been no federal oversight,” she said. “That’s why the states have been able to do this.”

Right now, Denno said that because of the nature of compounded drugs — the fact that they are intended for a person-by-person basis, rather than for mass consumption — it’s almost impossible to tell whether any single batch of compounded pentobarbital would be as potent or well-made as the manufactured version.

Compounded lethal drugs have short history

The first known use of compounded pentobarbital for lethal injection resulted in what may have been a difficult execution in 2012, according to a report by the Associated Press.

South Dakota officials obtained a single dose of pentobarbital from a compounding pharmacy for the execution of Eric Robert.

Pentobarbital, which also is used to euthanized animals, is a barbiturate that in large doses should first knock someone out, then stop a person’s breathing.

During the execution, Robert’s eyes remained open. He seemed to clear his throat and gasp for air, according to the report by AP.

Since then, Pennsylvania announced that it had received compounded pentobarbital in 2012. In 2013, five more states — Colorado, Georgia, Texas, Ohio and Missouri — either obtained or attempted to obtain a compounded version of the drug.

In Texas, officials cited their state law when refusing to return compounded pentobarbital after the pharmacist had a change of heart.

Texas announced Oct. 2 that it had purchased pentobarbital from a compounding pharmacy in The Woodlands, near Houston. Two days later, owner Jasper Lovoi demanded the drugs be returned because he said he had been promised secrecy by the state, according to AP.

“It was my belief that this information would be kept on the ‘down low’ and that it was unlikely that it would be discovered that my pharmacy provided these drugs,” Lovoi said in the letter, according to AP.

Ethical and legal considerations

Mixing up a drug for execution is morally tricky for pharmacists.

At least one licensed compounding pharmacist said he’d never make a drug he knew would be used for lethal injection.

“Ethically I wouldn’t do it,” said Doug Boudreaux of Shreveport and a former member of the Louisiana Board of Pharmacy. “I just don’t believe in it.”

The executive director of the Death Penalty Information Center said such work is a clear conflict for pharmacists.

“The death penalty is outside of the medical industry, outside of health,” Richard Dieter said.

Malcolm Broussard, the executive director of the Louisiana Board of Pharmacy, said that he’s not aware of any compounding pharmacy in the state that has agreed to sell pentobarbital to the Louisiana State Penitentiary Pharmacy for lethal injection use — but that doesn’t mean it would be illegal.

“A pharmacy is authorized to procure drugs from any source authorized to distribute or dispense drugs in this state,” Broussard said.

However, he said it would be illegal for the state to buy pentobarbital from an out-of-state pharmacy that’s not licensed in Louisiana.

The state’s most most recent survey, conducted in December 2012, showed that of the 1,397 licensed pharmacies within the state, 768 said they compound medications, Broussard said. Only 268 include the compounding of sterile preparations, which can be used in injections.

Only six compounding pharmacies in the state received voluntary accreditation by the Pharmacy Compounding Accreditation Board, according to its website. The organization trains pharmacists and technicians and requires that pharmacies use high-quality chemicals and equipment.

Broussard is encouraging the Pharmacy Board to consider more closely regulating compounding pharmacies, based on the deaths linked to the Massachusetts lab.

Though Dieter’s organization is opposed to the death penalty, he said he doesn’t distrust specialty drug makers as a whole. But he’s frustrated that officials are using death row as a laboratory.

“It depends on the compounding pharmacy we’re talking about,” he said. “It could be that these drugs are fine, that these sources are well prepared, but that’s not always the case.

“Clearly there’s an experimentation, or trial-and-error, going on.”