In 2011, the sole U.S.-based manufacturer of sodium thiopental, a key component in lethal injection protocols across the country, ceased producing the drug. Since then, many of the nation’s death penalty states have sought alternative drugs and suppliers. During the past several months, an increasing number of states have turned to compounding pharmacies that can create various drugs using raw materials, bypassing the need for a commercial manufacturer. In response, challenges to the constitutionality of using these largely unregulated and often untested compounded drugs have been filed in many states by a coalition of capital defenders, volunteer law firms, and the UC Berkeley Death Penalty Clinic's Lethal Injection Project.
Compounding pharmacies combine, mix, or alter drugs to provide copies or near-copies of commercially available drugs for individual clients. Unlike commercially manufactured drugs, compounded drugs do not require the approval of the U.S. Food and Drug Administration (FDA) and often fail to conform to its requirements. In a recent investigation, the Missouri Board of Pharmacy found that one of every five drugs made by compounding pharmacies in that state failed to meet federal guidelines and standards. Compounded drugs that do not meet federal quality standards pose substantial health risks. In 2012, a compounding pharmacy in Massachusetts was responsible for an outbreak of fungal meningitis that infected more than 700 people in 20 states, leaving 64 dead. This event sparked a national debate over regulatory practices governing compounding pharmacies. In response to the outbreak and subsequent events involving compounded drugs, the FDA conducted a priority inspection program. Federal regulators discovered numerous unsafe practices at 31 compounding pharmacies located in 18 states. As a result, Congress passed the Drug Quality and Security Act, enhancing the FDA’s role in overseeing the safety and quality of drug compounding activities. In practice, however, state agencies continue to be responsible for the day-to-day oversight of compounding pharmacies.
With the increased scrutiny of compounding pharmacies, several states are now attempting to withhold all information regarding the origin, manufacturer, and chemical composition of their lethal injection drugs. Death-sentenced prisoners in several states have raised constitutional challenges to the use of compounded and untested drugs in executions. Recently, however, the en banc U.S. Court of Appeals for the Eighth Circuit ruled in In Re Lombardi that states may continue with their practice of concealing the identity of their execution drug suppliers. The court also held for the first time that a prisoner must propose an alternative method for his own execution in order to state a claim for relief under the Eighth Amendment.
Prisoners have also raised legal challenges to the states’ methods of purchasing the drugs. At a legislative hearing on February 10, 2014, George Lombardi of Missouri’s Department of Corrections admitted that his state obtained pentobarbital in Oklahoma via secret cash payments to protect the anonymity of the pharmacy. An investigation by a local news agency revealed that the drugs were obtained from a Tulsa-based compounding pharmacy called The Apothecary Shoppe. That investigation further uncovered that The Apothecary Shoppe did not have the proper licenses from the state. Although The Apothecary Shoppe has yet to confirm or deny these allegations, a federal judge has temporarily barred the pharmacy from supplying any execution drugs to the Missouri Department of Corrections until the next scheduled hearing.
Legislators and courts are now calling upon states to conduct full reviews of their lethal injection protocols. Litigation regarding the safety of lethal injection protocols is ongoing in Florida, Louisiana, and Ohio; meanwhile, other states are considering options that would bypass the lethal injection controversy altogether. Lawmakers in Virginia, Wyoming, and Missouri have proposed bills this year that would permit executions by electrocution, firing squad, and gas chamber, respectively, when lethal injection is unavailable. While the Virginia bill was recently tabled in the state senate, legislation in the other states is still pending.