On December 29th, the Drug Enforcement Administration (“DEA”) published notice of its intent to temporarily control fentanyl-related substances that are not currently regulated under the Controlled Substances Act (“CSA”). Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 82 Fed. Reg. 61700 (Dec. 29, 2017). DEA has temporarily scheduled other substances fentanyl-related substances over the past four years, including cyclopropyl fentanyl on January 4, 2018. Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I, 83 Fed. Reg. 469 (Jan. 4, 2018). However, as DEA notes these prior scheduling actions have not proven effective because when it temporarily schedules a fentanyl-related substance, illicit manufacturers abroad structurally modify the substances and smuggle them into the U.S. and distribute them as non-controlled substances. Also, the alternative of attempting to prosecute these individuals under the controlled substances analogue statute is difficult. Temporary Placement of Fentanyl-Related Substances, 61701 n.3. This does not affect the scheduling of already approved fentanyl pharmaceutical products that are FDA-approved and currently regulated/scheduled by DEA.
DEA is now attempting to temporarily schedule fentanyl-related products by defining the class of products in such a manner so as to be broad enough to effectively capture any fentanyl-products being illicitly manufactured. Previously, the agency has had to schedule each substance based on its chemical make-up to ensure it met the legal definition of a controlled substance. In almost all cases, the CSA controls a drug or substance by its specific formulation. In this case, DEA is attempting to control a substance based on a definition of its potential formulation.
DEA’s notice states that deaths associated with the abuse of substances structurally related to fentanyl in the U.S. have reached an alarming level. DEA asserts that “chief among the causes is the sharp increase in recent years is the availability of illicitly produced, potent substances structurally related to fentanyl.” Fentanyl is about a hundred times more potent than morphine and the substances subject to temporary control are typically manufactured outside the U.S. by clandestine manufacturers and smuggled into the country and are often mixed with heroin, cocaine and methamphetamine or used in counterfeit pharmaceutical prescription drugs.
None of the affected fentanyl-related substances have an accepted medical use in the U.S. nor are they the subject of an exemption or approval under section 505 of the Food, Drug and Cosmetic Act. Fentanyl-related substances subject to exemption or approval will be excluded from the temporary scheduling order.
DEA’s attempt to create a definition for such substances includes the temporary scheduling of any non-controlled substance not assigned a DEA Controlled Substance Code Number that is structurally related to fentanyl by any one or more of the following specific modifications:
- Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
- Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
- Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
- Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
- Replacement of the N-propionyl group by another acyl group.
As noted above, this is a different approach to scheduling and we will see if these definitions can withstand the expected challenges from defense attorneys related to whether this type of scheduling is consistent with the CSA.
DEA will publish the scheduling order in the Federal Register on or after January 29, 2018 and it will be effective immediately. Temporary scheduling will last for two years, but DEA can extend it for an additional year if proceedings to permanently schedule the substances are pending.