COMMENTARY When government agencies turn to unregulated drug sources: Implications for the drug supply chain and public health are grave Prashant Yadav * , Rebecca Lynn Weintraub, Andy Stergachis article info Article history: Received 2 January 2018 Accepted 27 June 2018 Available online 1 August 2018 abstract Objective: To highlight how sourcing practices for lethal injections drugs are undermining state and federal regulatory structures established to preserve the security and integrity of the medicines supply chain in the United States. Summary: Unable to find sources for execution products approved by the U.S. Food and Drug Administration (FDA), some states have started sourcing the required drugs or active in- gredients from unapproved foreign manufacturers or have contracted with small com- pounding pharmacists to compound them. Many states have passed legislation barring the disclosure of information regarding the origin and chain of custody for prisons' stocks of compounded lethal injection drugs. This creates a regulatory vacuum and prevents the responsible authorities (e.g., FDA, Drug Enforcement Agency, state boards of pharmacy) from performing their crucial roles to ensure quality and supply chain transparency for medicines in circulation. Conclusion: By purchasing medicines from noneFDA-approved suppliers and enacting lethal injection sourcing secrecy laws, states are undermining the robust enforcement of chain of custody and pharmaceutical supply chain transparency. The secrecy surrounding the execu- tion drug procurement risks creating illicit supply channels. Once an illicit supply channel is established with a supplier, it creates risks that other drug products move through it, particularly in a context where the FDA, Drug Enforcement Agency, and state boards of pharmacy are prevented from performing their usual regulatory duties. Lawmakers have the obligation and authority to step in and close this regulatory gap to promote public health and safety. © 2018 American Pharmacists Association ® . Published by Elsevier Inc. All rights reserved. Ensuring the safety and efficacy of medicines is imper- ative for patients, physicians, and public health. Apart from therapeutic failure and risks of illnesses or death, poor- quality or harmful medicines can erode public confidence in the health system. 1 Usually, pharmacists, physicians, and other health professionals in the United States have little reason to worry about issues of medicine safety and quality because of the system of safeguards run by the U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and state professional regulatory boards and agencies. However, recent efforts by departments of corrections in some states to secure drugs for use in lethal injections are undermining the integrity of the supply chain and putting patients at risk. A regulatory vacuum for execution drugs Over the last few years, the FDA-approved pharmaceutical manufacturers of the drugs used in lethal injections in the United States have turned away from supplying these drugs to prisons, 2 ending “the open market for execution drugs.” 3 Moreover, the European Commission has imposed strict con- trols on the export of drugs used to carry out lethal injections. Unable to purchase manufactured products for executions, state officials have contracted with small compounding phar- macists to prepare formulations of the required drugs or in some instances have turned to unapproved foreign suppliers. * Correspondence: Prashant Yadav, PhD, Visiting Scholar, Global Health and Social Medicine Harvard Medical School, 641 Huntington Avenue, Boston, MA 02115. E-mail address: Prashant_Yadav@hms.harvard.edu (P. Yadav). Contents lists available at ScienceDirect Journal of the American Pharmacists Association journal homepage: www.japha.org https://doi.org/10.1016/j.japh.2018.06.019 1544-3191/© 2018 American Pharmacists Association ® . Published by Elsevier Inc. All rights reserved. Journal of the American Pharmacists Association 58 (2018) 477e480 SCIENCE AND PRACTICE