Information for
compounders

Compounding drugs for executions risks breaking state and federal regulations.

1. Lethal injection protocols often involve Schedule II controlled substances (e.g., Pentobarbital, Fentanyl, Hydromorphone) subject to strict federal regulations.
2. Pharmacists who compound and dispense these drugs without a valid medical prescription may violate state and federal law, including the Food, Drug, and Cosmetic Act (FDCA) and the Controlled Substances Act (CSA).
3. Active ingredients for many execution drugs are not available domestically. Compounders may be unknowingly procuring ingredients on the black-market.
4. Supplying drugs for lethal injection executions increases a pharmacy’s risk of:
   • high profile state investigations;
   • financial losses;
   • regulatory action;
   • media scrutiny; and
   • legal action (including product liability actions and tort claims).

The pharmacies that secretly supply execution drugs are often eventually identified publicly.

Executions, particularly those that are botched—a frequent occurrence because these drugs were never meant to be used for executions—receive intense media and political attention.

A pharmacy’s association with the harm caused to both prisoners and the broader patient population can seriously damage its credibility, a fact that has been noted in recent Congressional letters to the FDA and DEA. For example:

• A pharmacy that secretly supplied the Texas Department of Criminal Justice with execution drugs over many years was later prohibited by the DEA from dealing in controlled substances following a series of violations, including causing the death of a patient by Fentanyl.
• A pharmacy that secretly supplied the Missouri Department of Corrections with execution drugs was revealed to have had 1,892 violations of pharmacy regulations. The FDA warned that the pharmacy’s conduct “could lead to contamination of drugs, potentially putting patients at risk.”
• Another pharmacy compounding Pentobarbital, an emerging drug of abuse, for use in executions was cited by state and federal officials for scores of safety violations, in one case sending a child to the hospital after compounding the wrong drug.

Insurers are increasingly alert to the legal and reputational exposures associated with execution-related compounding.

• Professional and general liability insurance may exclude coverage for claims related to executions.
• Some insurers are now including questions for applicants that require disclosure of potential involvement in execution drug compounding—and may deny coverage if such activity exists.
• The International Academy of Compounding Pharmacists (now APC) has warned members about these risks, questioned the legality of providing drugs for executions, and raised concerns about lack of insurance protection.