COMPOUNDING PHARMACIES AND LETHAL INJECTION

As drug short­ages and actions by phar­ma­ceu­ti­cal man­u­fac­tur­ers have made it more dif­fi­cult for pris­ons to obtain the drugs used in lethal injec­tions, some states have turned to com­pound­ing phar­ma­cies as sources of exe­cu­tion drugs. Compounding phar­ma­cies do not face the same approval process for their prod­ucts that large man­u­fac­tur­ers face, lead­ing to con­cerns about the safe­ty and effi­ca­cy of their products.

What are compounding pharmacies?

Compounding phar­ma­cies com­bine, mix, or alter drugs; tra­di­tion­al­ly com­pound­ing is used to meet the spe­cif­ic needs of an indi­vid­ual patient in response to a pre­scrip­tion. For exam­ple, a drug might be altered to remove an inac­tive ingre­di­ent for a patient with an aller­gy, or a med­ica­tion that typ­i­cal­ly comes in pill form might be put into liq­uid form for a child who can’t swal­low pills. However, some com­pound­ing phar­ma­cies are more like drug man­u­fac­tur­ers, pro­duc­ing large quan­ti­ties of drugs that are copies or near-copies of com­mer­cial­ly-avail­able drugs, rather than cus­tomiz­ing drugs for spe­cif­ic pre­scrip­tions. The Food and Drug Administration does not approve the products of com­pound­ing phar­ma­cies. Compounding phar­ma­cies must be licensed by their state’s phar­ma­cy board, but do not have to reg­is­ter with the FDA or inform the FDA what drugs they are making. 

On November 18, 2013, Congress passed the Drug Quality and Security Act. President Obama signed the bill into law on November 27^th. The act allows large-scale com­pound­ing phar­ma­cies to reg­is­ter as ​“out­sourc­ing facil­i­ties,” which will be sub­ject to FDA reg­u­la­tions. Compounders that do not reg­is­ter may still mix pre­scrip­tions for indi­vid­ual patients or pro­duce lim­it­ed quan­ti­ties ahead of pre­scrip­tions with­out fed­er­al over­sight. (New York Times, 11/​18/​13.)

Are com­pound­ing phar­ma­cies accred­it­ed? Are their products safe?

Compounding phar­ma­cies in the United States may be accred­it­ed by the Pharmacy Compounding Accreditation Board, but accred­i­ta­tion is not required. The Board requires that accred­it­ed phar­ma­cies use high-qual­i­ty chem­i­cals and equip­ment, give phar­ma­cists and tech­ni­cians reg­u­lar train­ing, test prod­ucts for qual­i­ty, and have an effec­tive recall mech­a­nism in place. Only about 180 phar­ma­cies in the United States have received accreditation.

The International Academy of Compounding Pharmacists is an inter­na­tion­al orga­ni­za­tion based in Texas, con­sist­ing of over 2700 phar­ma­cists and oth­er mem­bers of the phar­ma­cy com­mu­ni­ty who focus on com­pound­ing. The IACP’s mis­sion is ​“to pro­tect, pro­mote and advance the art and sci­ence of pharmacy compounding.” 

In 2012, a com­pound­ing phar­ma­cy in Massachusetts was found to be the source of an out­break of fun­gal menin­gi­tis that infect­ed over 700 peo­ple in 20 states, leav­ing 61 dead (New York Times, 10/​26/​12; Centers for Disease Control, 7/​1/​13). The New England Compounding Center was not accred­it­ed, and pro­duced large quan­ti­ties of drugs for hos­pi­tals across the coun­try, rather than the tra­di­tion­al com­pound­ing prac­tice of pro­duc­ing small quan­ti­ties in response to indi­vid­ual needs. An FDA inves­ti­ga­tion found mold and bac­te­ria in areas that should have been ster­ile and dis­cov­ered micro­bial growth in all 50 test­ed vials of methyl­pred­nisolone acetate, an injectable pain med­ica­tion that was linked to the menin­gi­tis out­break. The New England Compounding Center vol­un­tar­i­ly recalled all of its prod­ucts, ceased oper­a­tions, and hand­ed its license over to the Massachusetts Board of Registration in Pharmacy in October, 2012 (FDA, 11/​1/​12).

Congress held hear­ings in response to the out­break to deter­mine what reg­u­la­to­ry action might pre­vent future out­breaks. The CEO of IACP tes­ti­fied at the hear­ings and voiced sup­port for increased over­sight of com­pound­ing phar­ma­cies that man­u­fac­ture new drugs, rather than alter­ing drugs for the use of indi­vid­ual patients. In May, 2013, a Senate com­mit­tee approved a bill that would give the FDA greater author­i­ty over com­pound­ing phar­ma­cies (New York Times, 5/​22/​13).

UPDATE: The CDC said that 63 peo­ple have died from the fun­gal menin­gi­tis out­break linked to com­pound­ing phar­ma­cies, includ­ing 24 peo­ple in 2013. The FDA has report­ed 14 mul­ti­state or nation­al vol­un­tary recalls of com­pound­ing phar­ma­cy prod­ucts in 2013. (Wall Street Journal, 9/​9/​13)

States’ use of lethal injec­tion drugs from compounding pharmacies

(For a list of states that have used com­pound­ed drugs in exe­cu­tions or announced inten­tions to do so, vis­it our State-by-State Lethal Injection page.)

As lethal injec­tion drugs have become less acces­si­ble due to a com­bi­na­tion of short­ages and mea­sures imple­ment­ed by phar­ma­ceu­ti­cal com­pa­nies intend­ed to stop the drugs’ use in exe­cu­tions, some Departments of Corrections have begun to use com­pound­ing phar­ma­cies as a source of those drugs. South Dakota obtained pen­to­bar­bi­tal, an anes­thet­ic used in exe­cu­tions, from a com­pound­ing phar­ma­cy for the October 15, 2012 exe­cu­tion of Eric Robert. The same source was like­ly used in the October 30, 2012 exe­cu­tion of Donald Moeller, but the Department of Corrections did not release infor­ma­tion on the drug (Reprieve, 6/​18/​13).

In 2012, in response to a court order to reveal the source of its lethal injec­tion drugs, Pennsylvania announced that the drugs were obtained from com­pound­ing phar­ma­cies (Patriot-News, 11/​6/​12). Pennsylvania’s exe­cu­tion pro­to­col is the sub­ject of a fed­er­al class action law­suit. No exe­cu­tions have been car­ried out in the state since 1999. In March 2013, in antic­i­pa­tion of an exe­cu­tion that was lat­er stayed on unre­lat­ed grounds, the Director of Colorado​’s Department of Corrections wrote a letter to 97 com­pound­ing phar­ma­cies in the state, ask­ing them to pro­vide sodi­um thiopen­tal for the exe­cu­tion (The Denver Post, 3/​12/​13).

After Georgia​’s sup­ply of pen­to­bar­bi­tal expired in March 2013, the state announced that it planned to obtain a new sup­ply from a com­pound­ing phar­ma­cy for the sched­uled exe­cu­tion of Warren Hill (Associated Press, 7/​11/​13). Hill’s exe­cu­tion was car­ried out in 2015. 

In 2018, inves­tiga­tive reporter Chris McDaniel dis­cov­ered that Texas secret­ly obtained exe­cu­tion drugs from the Greenpark Compounding Pharmacy, a phar­ma­cy that the Texas State Board of Pharmacy has cit­ed for 48 vio­la­tions in the past eight years, includ­ing ​“keep­ing out-of-date drugs in stock, using improp­er pro­ce­dures to pre­pare IV solu­tions, and inad­e­quate clean­ing of hands and gloves.” Greenpark’s license was put on pro­ba­tion in November 2016 after it botched a pre­scrip­tion for three chil­dren, send­ing one of them to the hos­pi­tal for emer­gency care. (BuzzFeed News 11/​28/​18)