Missouri Execution Drug Supplier Being Sold After Committing Nearly 2,000 Violations of Pharmacy Regulations

The assets of The Apothecary Shoppe, a Tulsa, Oklahoma com­pound­ing phar­ma­cy that pro­vid­ed lethal injec­tion drugs to Missouri, have been auc­tioned off after the com­pa­ny default­ed on its loans, and is being sold after admit­ting to near­ly two thou­sand vio­la­tions of phar­ma­cy reg­u­la­tions, accord­ing to a report by BuzzFeed News. Inspectors from the fed­er­al Food and Drug Administration and the Oklahoma Board of Pharmacy found that the drug com­pounder had com­mit­ted ​“sig­nif­i­cant” vio­la­tions of phar­ma­cy reg­u­la­tions, includ­ing engag­ing in ques­tion­able poten­cy, dis­in­fect­ing, and ster­il­iza­tion prac­tices. State inves­ti­ga­tors wit­nessed improp­er refrig­er­a­tion, stor­age, and ster­il­iza­tion prac­tices at the phar­ma­cy and caught the com­pa­ny pro­duc­ing drugs with­out legit­i­mate med­ical need, improp­er­ly expand­ing drug expi­ra­tion dates, and oper­at­ing dur­ing peri­ods in which its lab was not certified.

In 2013 and 2014, the phar­ma­cy pre­pared exe­cu­tion drugs for at least three Missouri exe­cu­tions, receiv­ing cash pay­ments from the Department of Corrections. In chal­lenges to Missouri’s lethal injec­tion prac­tices, death-row pris­on­ers – ham­pered by state exe­cu­tion secre­cy pro­vi­sions – argued in court that ​“Compounding-phar­ma­cy prod­ucts do not meet the require­ments for iden­ti­ty, puri­ty, poten­cy, effi­ca­cy, and safe­ty that phar­ma­ceu­ti­cals pro­duced under FDA reg­u­la­tion must meet.” 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. Missouri respond­ed in its court fil­ings that the con­demned pris­on­ers’ con­cerns were spec­u­la­tive and that the inmates did ​“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.” The prob­lems found at The Apothecary Shoppe con­firmed the pris­on­ers’ concerns. 

The com­pa­ny admit­ted to com­mit­ting 1,892 vio­la­tions of phar­ma­cy reg­u­la­tions. State reg­u­la­tors had demand­ed that the phar­ma­cy recall its prod­ucts and cease com­pound­ing new drugs until it com­plied with reg­u­la­tions. The phar­ma­cy was fined $50,000, and the licens­es of The Apothecary Shoppe and its head phar­ma­cist were placed on five years’ probation.