After admitting to more than a thousand pharmaceutical violations, a pharmacy that sold execution drugs to Missouri auctioned off its assets last week after it defaulted on its loans. The sale is expected to be finalized in the coming weeks.
The Apothecary Shoppe, based in Tulsa, Oklahoma, mixed execution drugs for at least three executions held in Missouri in 2013 and 2014. A year after its identity became public, the pharmacy faced investigations by state and federal regulators that revealed “significant” violations of pharmacy regulations, BuzzFeed News has learned.
The pharmacy issued a recall on some of the drugs it made, and was forced to shut down its mixing practice for a time. Its license is currently on probation.
In March 2015, a year after its role in selling lethal drugs had been revealed, the Food and Drug Administration inspected the pharmacy. Two investigators found questionable potency, disinfecting and sterilization practices. In response to a Freedom of Information Act request, an FDA official told BuzzFeed News in late February that the investigation is ongoing.
A month after the FDA inspection, however, investigators with the Oklahoma Board of Pharmacy arrived at the facility as part of a routine inspection. Over the next few months, the three investigators would find hundreds of violations of pharmacy guidelines at the facility.
While inspectors were there, they observed pharmacy techs wearing no masks or goggles while compounding drugs. Pharmacists were storing drugs in a blue Igloo cooler so they wouldn’t have to walk to the proper refrigeration unit in another room; regulators seized the blue cooler and the drugs it was storing. The pharmacy was extending the expiration date on its drugs without proper testing or documentation, and used questionable sterilization practices.
Compounding pharmacies, unlike drug manufacturers, mix drugs based on specific prescriptions. They are lightly regulated by the FDA, and the products they make have a significantly higher failure rate than manufactured drugs.
State regulators caught the Apothecary Shoppe making a testosterone injection without a legitimate medical need — and said the drug should have instead been made by manufacturers. The head pharmacist, David Kent Johnson, told the board regulators that he would stop making that drug immediately.
The investigators also discovered unexplained irregularities in a lab certification. In a complaint, the board noted that in the first certification report they received indicated the pharmacy was operating without its lab being certified for a time.
“Another copy of the report was given to [investigators] on June 9, 2015; this report appeared to have been altered,” the board wrote in a complaint against the pharmacy.
Investigators “were not able to ascertain if the documents were changed by the inspection company or by the pharmacy,” said Cindy Fain, Chief Compliance Officer for the board. “That’s why the statement is so vague in the Complaint.”
The regulators gave Johnson a letter on May 28, 2015, noting all of the violations, and asking the pharmacy to recall its drugs and stop making new drugs until it complied with regulations. They also asked for more documentation about the pharmacy’s practices.
Johnson responded with a letter the next day that regulators wrote was “inadequate, and the required documentation was not produced.” They returned to the pharmacy weeks later and found the pharmacy “in significant violation of [pharmacy] guidelines.”
The board of pharmacy subpoenaed the Apothecary Shoppe’s records and again asked for a recall and for it to stop its compounding. This time, the pharmacy acquiesced.
In total, the pharmacy admitted guilt to an astounding 1,892 violations of state pharmacy guidelines. Johnson agreed to guilt on 1,887 violations, and neither admitted nor denied violating the other five requirements.
The pharmacy declined to comment on the violations.
The licenses of the Apothecary Shoppe and Johnson were both placed on probation for five years. They also had to pay $50,000 in fines altogether, and Johnson will undergo additional training. The Oklahoma Board of Pharmacy said the fine has been paid and the pharmacy can continue to compound drugs while the licenses are on probation.
The pharmacy’s receiver, put in place by a court, said the potential buyers were all aware of the pharmacy’s regulation problems.
“The issues have all been cleared,” David Rhoades said. “It did not have anything to do with the financial troubles. It was disclosed to all potential purchasers.”
Many of these violations were similar to concerns raised years ago by death row inmates in Missouri, who questioned the qualifications of the drug maker that the state had tried to keep secret.
“Compounding-pharmacy products do not meet the requirements for identity, purity, potency, efficacy, and safety that pharmaceuticals produced under FDA regulation must meet,” the inmates argued in court. Among the possibilities they listed, were that the drug may not be sterile, may be less potent than it needs to be, or may be contaminated.
The state responded that their concerns were speculation.
“What the [inmates] allege, is that if the pharmacist makes a serious mistake in compounding the pentobarbital, or uses the wrong ingredients, and if the laboratory, which tests the chemical for purity, potency, and sterility, fails to catch the error through accident or incompetence, then something could go wrong with an execution,” the state wrote, arguing the lawsuit should be dismissed.
“[This] allegation does not make a plausible claim that Missouri’s execution procedure is sure or very likely to cause serious illness or needless suffering and give rise to sufficiently imminent dangers.”
Attorney General Chris Koster’s office did not respond to a request for comment about the Apothecary Shoppe’s inspections.
In November 2015, months after the Board of Pharmacy and the FDA investigated the facility, the pharmacy defaulted on its loans. The bank took the Apothecary Shoppe to court, placing a court-approved receiver in charge to run the business. Last week, an Oklahoma company called Marcain Properties bid the highest on the Apothecary Shoppe’s assets. The company is affiliated with other pharmacy businesses in the area.
According to the Apothecary Shoppe’s receiver, the plan is currently to keep on the pharmacy’s employees. The new owners may change the name, he said.
That a pharmacy with such questionable policies could be selected by the state to provide drugs for lethal injections happened, in part, because of the shroud of secrecy put in place just before the state decided to use the Apothecary Shoppe for its execution drugs.
In October 2013, Gov. Jay Nixon announced the Department of Corrections would be expanding secrecy around executions. For the first time in the state, the execution drug supplier would be confidential. Behind the scenes, a select few individuals in the Department of Corrections selected the Apothecary Shoppe which, at the time, was not licensed to sell in the state.
Although Missouri attempted to keep the pharmacy’s identity hidden, going so far as to pay the pharmacy more than $30,000 in cash, an un-redacted document from 2013 pointed to the Apothecary Shoppe. An email also indicates that the pharmacy offered to supply execution drugs to Louisiana.
The Apothecary Shoppe stopped selling execution drugs in February 2014, after death row inmates sued the pharmacy. In turn, the state found a new execution drug supplier and has withheld all information about the pharmacy. Earlier this year, a state judge ruled that the expanded secrecy violates state law.
Gov. Jay Nixon’s office, as well as the Missouri Department of Corrections, which he oversees, did not respond to requests for comment.
Recently, other states have begun to employ the expanded execution secrecy like Missouri has. States that carry a lot of executions out like Texas, Oklahoma and Florida all attempt to keep their drug suppliers hidden.
Georgia also has a secret compounding pharmacy mix its lethal injection drugs. Last year, the state had to call off an execution after the syringe had particles floating in it.
Arkansas executions are currently on hold after a state judge found the state’s secrecy law violated the state constitution. The issue is now before the Arkansas Supreme Court.
Virginia could be the next state to expand its secrecy. Last week, Gov. Terry McAuliffe called for more secrecy for its potential execution drug suppliers. His office did not respond when asked about the situation in Missouri.
Virginia Attorney General Mark Herring said in a legal opinion this week that McAuliffe’s proposal would be legal. When approached with the problems Missouri has faced, his office said it is a policy decision for lawmakers and the governor to decide.
The “Attorney General's recent opinion just laid out his best evaluation of what the law allows and requires in this area, and it will be for the General Assembly to set the state's policy within those limits,” a spokesperson said.
After Gov. McAuliffe called for the measure, the Virginia legislature approved on Wednesday a bill that would grant anonymity to its executioners. McAuliffe is expected to sign it.