Acting Administrator Robert W. Patterson, of the Drug Enforcement Administration (DEA) has issued a temporary scheduling order to schedule fentanyl-related substances, not currently listed in any schedule of the Controlled Substances Act (CSA) in schedule I.
This action is based on a finding by Patterson that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety, and is expected to reduce these substances’ flow into the country, and slow the alarming increase in overdose deaths linked to synthetic opioids.
“DEA is committed to using all of its tools to aggressively fight and address the opioid crisis and growing fentanyl problem plaguing the United States,” explains DEA Acting Administrator Robert W. Patterson.
“By proactively scheduling the whole class of illicit fentanyl substances simultaneously, federal agents and prosecutors can take swift and necessary action against those bringing this poison into our communities.”
A fentanyl analogue is a substance intended for human consumption that is substantially similar in its chemical makeup and effects to fentanyls already listed in Schedule I.
Fentanyl is often mixed with heroin and other substances (such as cocaine and methamphetamine) or used in counterfeit pharmaceutical prescription drugs.
Subsequently, users who buy these substances on the illicit market are often unaware of the specific substance they are actually consuming and the associated risk.
(Learn More. “It’s a cheap way for the dealers to make money. They don’t care if they’re killing people, they really don’t.” Courtesy of Elite Daily and YouTube. Posted on Jan 11, 2018)
As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl-related substances, and will be subject to criminal prosecution in the same manner as other controlled substances.
This will make it easier for federal prosecutors and agents to prosecute traffickers of all forms of fentanyl-related substances.
The Nature of the Problem and DEA’s Approach to Correct It
It is well known that deaths associated with the abuse of substances structurally related to fentanyl [2] in the United States are on the rise and have already reached alarming levels.
While a number of factors appear to be contributing to this public health crisis, chief among the causes is the sharp increase in recent years in the availability of illicitly produced, potent substances structurally related to fentanyl.
Fentanyl is approximately 100 times more potent than morphine, and the substances structurally related to fentanyl that DEA is temporarily controlling also tend to be potent substances.
Typically, these substances are manufactured outside the United States by clandestine manufacturers and then smuggled into the United States.
(Learn More. A drug called fentanyl is so powerful that if you simply touch it you can overdose quickly. The opiate was developed to treat extreme pain and is usually prescribed to advanced stage cancer patients, but it can be up to 100 times more powerful than morphine. An illegal version of the synthetic drug has been popping up all over the US and is posing a threat to law enforcement officers trying to get fentanyl off the streets. Courtesy of Inside Edition and YouTube. Posted on May 17, 2017)
Fentanyl is often mixed with heroin and other substances (such as cocaine and methamphetamine) or used in counterfeit pharmaceutical prescription drugs.
As a consequence, users who buy these substances on the illicit market are often unaware of the specific substance they are actually consuming and the associated risk.
According to the Centers for Disease Control and Prevention (CDC), drug overdose deaths involving synthetic opioids (excluding methadone), such as fentanyl and tramadol, increased from 5,544 in 2014 to 9,580 in 2015.
According to provisional data released in August 2017 by the CDC, National Center for Health Statistics, an estimated 55 Americans are dying every day from overdoses of synthetic opioids (excluding methadone).[3]
Drug overdose deaths involving synthetic opioids excluding methadone for the 12-month period ending in January of 2017 (20,145 deaths) more than doubled from the corresponding data for the period ending in January of 2016 (9,945 deaths).
DEA has responded to this crisis by issuing eight temporary scheduling orders to control seventeen substances structurally related to fentanyl since 2015.
However, this approach has not been completely effective in preventing the emergence of new substances structurally related to fentanyl.
This is because when DEA temporarily controls a given substance structurally related to fentanyl, illicit manufacturers located abroad begin producing new such substances through other structural modifications.
Those new nonscheduled substances then are smuggled into the United States, where they are distributed by traffickers in this country as a purportedly “noncontrolled” substance.[4]
In this way, traffickers are effectively circumventing the temporary control mechanism that Congress established under 21 U.S.C. 811(h) to combat newly emerging dangerous drugs.
(Learn More. One of the key sources of fentanyl in the United States is China. VICE News follows the path of the dangerous drug as it moves overseas onto U.S. soil and the effort to keep it from reaching the streets. Courtesy of VICE News, HBO and YouTube. Posted on Dec 21, 2017)
Post mortem toxicology and medical examiner reports collected by the DEA show mortality connected to substances structurally related to fentanyl.
Control of these substances is necessary to avoid an imminent hazard to the public safety.
Given the gravity of the ongoing fentanyl-related overdose crisis in the United States, protection of the public safety demands the utilization of 21 U.S.C. 811(h) in a manner that cannot be readily circumvented by drug traffickers.
Specifically, in issuing this temporary scheduling order, DEA exercises its authority to avoid an imminent hazard to the public safety by placing fentanyl-related substances, as defined later in this document, in schedule I.
These fentanyl-related substances—including those that have not yet been introduced by traffickers into the U.S. market—present a significant risk to the public health and safety and need to be controlled under section 811(h) to avoid an imminent hazard to the public safety.
It should also be noted that none of the substances that is being temporarily controlled has a currently accepted medical use in treatment in the United States; nor is any of the substances the subject of an exemption or approval under section 505 of the FD&C Act.
In accordance with section 811(h), if any exemption or approval is in effect under section 505 of the FD&C Act with respect to a substance that falls within the definition of a fentanyl-related substance set forth in this document, such substance is excluded from the temporary scheduling order.
To learn more, and view the Federal Register notice, go to https://www.federalregister.gov/documents/2018/02/06/2018-02319/schedules-of-controlled-substances-temporary-placement-of-fentanyl-related-substances-in-schedule-i
