Ohio's last dose of unexpired pentobarbital was used to put Harry Mitts to death Sept. 25 for fatally shooting two people, including a suburban Cleveland police officer.
The process of relying on compounding pharmacies for future pentobarbital supplies may require legislation to protect those pharmacies from lawsuits by capital punishment opponents.
Federal public defender Allen Bohnert said he was reviewing the new drug protocol's potential role in federal litigation challenging Ohio's execution procedures. The policy is in effect for the scheduled November execution of Ronald Phillips, sentenced to die for raping and killing his girlfriend's 3-year-old daughter in Akron in 1993.
"We're disappointed that Ohio has chosen to turn to these unregulated and questionable sources for their official execution drug," said Bohnert, who doesn't represent Phillips. A federal judge has indicated he would review the new policy.
The original manufacturer of pentobarbital, Denmark-based Lundbeck Inc., in 2011 put the drug off-limits for executions and required that prohibition remain when it sold the product to Lake Forest, Ill.-based Akorn Inc.
As a result, supplies had dried up in Ohio and around the country. Texas, the nation's busiest death-penalty state, disclosed in records released this week that it has turned to a compounding pharmacy to replenish its pentobarbital supply.
The U.S. Food and Drug Administration considers products from compounding pharmacies unapproved drugs and doesn't vouch for their safety or effectiveness. The businesses came under new scrutiny after last year's deadly meningitis outbreak was linked to contaminated injections made by a compounding pharmacy in Massachusetts.
Ohio's announcement Friday marks the third time the state has made a change related to the drug it uses in lethal injection.
In 2009, Ohio switched from a three-drug cocktail to a single dose of sodium thiopental. In 2011, it switched to pentobarbital when the manufacturer of sodium thiopental also restricted its distribution.
Bohnert said rules revised so often raise questions about the process.
"The fact that they need to change the protocol so frequently suggests that perhaps there should be a serious discussion about whether to have the death penalty in Ohio at all," he said.
Among other states struggling to find alternatives are Georgia, Missouri and Arkansas. A legal challenge has placed Missouri's proposal to use propofol on hold, and anesthesiologists are asking the state to reconsider out of fear it could lead to restrictions of the drug needed for hospital use.
Arkansas' governor has held off scheduling executions as the state's Department of Correction plans to rewrite its lethal injection procedure to include a different drug or drugs and as prisoners continue to challenge the state's new execution law in court.
In Georgia, after the state's supply of pentobarbital expired in March, it acquired the drug from a compounding pharmacy. A lawsuit is challenging the state's decision to shield the pharmacy and contends the drug could be unsafe.
Ohio already had a backup method that involved injecting midazolam and hydromorphone into muscles. That method has never been used.