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August 19, 2015

"FDA warns Ohio not to illegally import execution drugs"

The title of this post is the headline of this notable new article in my own Columbus Dispatch. The piece provides both the latest news and effective background on the difficulties Ohio has been facing of late in the operation of its death machinery:

A U.S. Food and Drug Administration official wrote June 26 to Gary Mohr, director of the Ohio Department of Rehabilitation Correction, saying the agency learned the state “intends to obtain bulk and finished dosage forms of sodium thiopental.  Since sodium thiopental is not available in the United States, we assume the product would be obtained from an overseas source.”

“Please note that there is no FDA approved application for sodium thiopental,” wrote Domenic Veneziano, the federal agency’s director of import operations, “and it is illegal to import an unapproved new drug into the United States.”

Prisons spokeswoman JoEllen Smith confirmed receipt of the letter, but she would not say if the state followed through with an overseas purchase of the drug used in executions.  “DRC continues to seek all legal means to obtain the drugs necessary to carry out court ordered executions. This process has included multiple options,” Smith said.  The agency does not yet have drugs for the next execution, she said....

The latest development comes less than five months before Ohio’s scheduled execution of Ronald Phillips of Summit County on Jan. 21, 2016.  Another 20 executions have been set through May 2019.

Ohio’s last execution was Jan. 16, 2014, when Dennis McGuire struggled and gasped for several minutes before succumbing to a combination of midazolam, a sedative, and hydromorphone, a morphine derivative.  The drugs had never been used in combination for an execution anywhere in the U.S.  Prison officials subsequently abandoned using those drugs, and turned to the General Assembly for help.   The legislature passed a law permitting the agency to buy drugs under a secret contract with a “compounding pharmacy,” typically smaller businesses which mix ingredients to user specifications.

Sodium thiopental is no longer available for purchase in the U.S. The last domestic manufacturer stopped production in 2011, largely because states were using it for executions.  Ohio’s revised execution policy calls for using large doses of sedatives, either sodium thiopental or pentobarbital.  

August 19, 2015 at 01:43 PM | Permalink


I would tell FDA: GFY.

Posted by: federalist | Aug 19, 2015 2:11:40 PM

Please, note the word, "and," and not "or," used in the definition of a drug. A substance intended to be used as poison is not under the jurisdiction of the FDA.

From CFR Title 21

§ 321. Definitions; generally

(g)(1) The term ‘‘drug’’ means (A) articles rec-
ognized in the official United States Pharma-
copoeia, official Homoeopathic Pharmacopoeia
of the United States, or official National For-
mulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles
(other than food) intended to affect the struc-
ture or any function of the body of man or other
animals; and (D) articles intended for use as a
component of any article specified in clause (A),
(B), or (C).

Posted by: Supremacy Claus | Aug 20, 2015 12:18:40 AM

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