The only time I've ever seen a ban this sweeping and unspecific, it was an act of the US Congress, the Synthetic Drug Abuse Prevention Act of 2012, passed in the summer of 2012 when they banned a large range of possible synthetic cannabinoids this same way - that is by naming all kinds of molecular substitutions and just saying they're all Schedule I now no matter if they have ever existed or not. The DEA or FDA, themselves, have never scheduled substances this way before. Frankly it's a little frightening since they could potentially do this kind of wholesale blanket ban to any class of chemicals such as cannabinoids, tryptamines, phenethylamines, amphetamines, cathinones or lysergamides.
Original Notice of Intent order from December 29th, 2017: https://www.federalregister.gov/documents/2017/12/29/2017-28114/schedules-of-controlled-substances-temporary-placement-of-fentanyl-related-substances-in-schedule-i
Order issued on February 6th, 2018: https://www.federalregister.gov/documents/2018/02/06/2018-02319/schedules-of-controlled-substances-temporary-placement-of-fentanyl-related-substances-in-schedule-i
SUMMARY: The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. 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.
DATES: This temporary scheduling order is effective February 6, 2018, until February 6, 2020. If this order is extended or made permanent, the DEA will publish a document in the Federal Register.
Background
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.
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 Start Printed Page 5189orders 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. 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. As explained below, 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.
What Is Controlled Under This Temporary Scheduling Order
On December 29, 2017, as required by 21 U.S.C. 811(h)(A), the DEA Administrator published a notice of intent to issue an order temporarily placing fentanyl-related substances in schedule I. 82 FR 61700. This temporary order places fentanyl-related substances in schedule I of the CSA for two years. DEA may extend the temporary scheduling for an additional year (a total of three years) if proceedings to permanently schedule the substances are pending. As defined in the notice of intent, as well as in this temporary order, fentanyl-related substances includes any substance not otherwise controlled in any schedule (i.e., not included under any other Administration Controlled Substance Code Number) that is structurally related to fentanyl by one or more of the following modifications:
(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
(B) substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C) substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D) replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
(E) replacement of the N-propionyl group by another acyl group. How DEA Will Identify Individual Fentanyl-Related Substances That Fall Within This Temporary Scheduling Order
As indicated, the temporary scheduling order includes all substances that fall within the above definition--even if such substances have not yet emerged on the illicit market in the United States. As a result, DEA cannot currently specify the chemical name of every potential substance that might fall under this new definition. However, because the definition of fentanyl-related substance describes a unique chemical structure, DEA has the authority to under 21 U.S.C. 811(h) to temporarily schedule this category of substance. In the future, if and when DEA identifies a specific new substance that falls under the definition, the agency will publish in the Federal Register, and on the agency website, the chemical name of such substance. Thus, the text of the definition of fentanyl-related substance includes language indicating that it "includes, but is not limited to, the following substances:" It bears emphasis, however, that even in the absence of a future publication by DEA specifically identifying such a substance, the substance is controlled by virtue of this temporary scheduling order if it falls within the definition of fentanyl-related substance.
To give you a notion of the possible analogs that are now banned by this action, here is a graphic of the molecules:
As you can see, they basically nailed it. Pretty much any fentanyl or carfentanil analog that could have been relatively easily made by simple ingredient substitution in a fentanyl synthesis is now Schedule I in the USA.
This is about the only thing I will stand with them on.