Section 1 Short title
This Act may be cited as the “End Gas Station Heroin Act”.
End Gas Station Heroin Act
A BILL
To amend the Controlled Substances Act to schedule MGM–15 and MGM–16 as Schedule I Controlled substances, and to amend the controlled Substances Act to schedule synthetic 7-hydroxymitragynine, and Mitragynine Pseudoindoxyl, as a Schedule I above a specific threshold under the Controlled Substances Act, and to expand enforcement actions against drug manufacturers and distributors of emerging synthetic opioids, commonly known as gas station heroin.
Sec. 2 Scheduling of 7-hydroxymitragynine and mitragynine pseudoindoxyl
Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) is amended, in subsection (b), by adding at the end the following:
“(23)
“(A) 7-hydroxymitragynine (7–OH) and mitragynine pseudoindoxyl, including their salts, isomers, salts of isomers, esters, ethers, and synthetic analogs, whenever the existence of such forms is possible.
“(B) This paragraph shall not apply to 7-hydroxymitragynine or mitragynine pseudoindoxyl naturally occurring in Mitragyna speciosa Korth (kratom) or in a finished kratom product, provided that—
“(i) in the case of a solid, powdered, or encapsulated product, the concentration of 7-hydroxymitragynine and mitragynine pseudoindoxyl, individually or in combination, does not exceed 1 milligram per gram of product;
“(ii) in the case of a liquid product, the concentration of 7-hydroxymitragynine and mitragynine pseudoindoxyl, individually or in combination, does not exceed 1 milligram per milliliter of product; and
“(iii) the combined amount of 7-hydroxymitragynine and mitragynine pseudoindoxyl, including their salts, isomers, salts of isomers, esters, ethers, and synthetic analogs, does not exceed 1 part per 100 parts mitragynine by mass.
“(C) For purposes of this paragraph, any 7-hydroxymitragynine or mitragynine pseudoindoxyl that is synthesized, chemically converted, concentrated, enriched, isolated, or otherwise produced through manufacturing processes shall not qualify for the exemption described in subparagraph (B).”
Sec. 3 Enforcement against emerging synthetic opioids in commercial distribution
Treatment as a Schedule I controlled substance— Notwithstanding any other provision of law, a covered emerging synthetic opioid shall, solely for purposes of prohibiting and enforcing against its knowing or intentional manufacture, importation, exportation, distribution, dispensing, or possession with intent to manufacture, import, export, distribute, or dispense, be treated as a controlled substance in Schedule I of section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)).
Civil and criminal enforcement— No person shall be subject under this section to criminal or civil enforcement based solely on the purchase, receipt, simple possession, or personal use of a covered emerging synthetic opioid.
Covered emerging synthetic opioid— For purposes of this section, the term covered emerging synthetic opioid means a substance that—
is being manufactured, offered, advertised, sold, distributed, or otherwise introduced into commercial distribution, or is intended by the person engaging in the prohibited conduct to be introduced into commercial distribution;
is an opioid receptor agonist, or partial agonist and, based on scientifically reliable evidence, demonstrates greater functional potency than morphine at the human mu-opioid receptor in a validated assay identified by regulation, or demonstrates greater analgesic or respiratory-depressant potency than morphine based on other scientifically reliable evidence;
is produced through chemical synthesis or semisynthesis;
is not the subject of an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
is intended for human consumption;
is not otherwise listed in any schedule under section 202 of the Controlled Substances Act (21 U.S.C. 812); and
is not excluded under subsection (g).
Covered conduct— This section shall apply only to the knowing or intentional manufacture, distribution, or possession with intent to manufacture or distribute a covered emerging synthetic opioid.
No simple possession enforcement— No person may be investigated, arrested, charged, prosecuted, or subjected to civil penalties under this section solely for simple possession or personal consumption of a covered emerging synthetic opioid. Nothing in this subsection shall prohibit enforcement based on possession with intent to manufacture, distribute, dispense, import, or export.
Relationship to the controlled substance analogue enforcement act— If a substance qualifies both as—
a controlled substance analogue under section 102(32) of the Controlled Substances Act (21 U.S.C. 802(32)); and
a covered emerging synthetic opioid under this section,
Exclusions— The term covered emerging synthetic opioid does not include—
a substance approved as a drug for medical treatment under the Controlled Substances Act (21 U.S.C. 801 et seq.);
a substance not intended for human consumption;
a naturally occurring constituent of a plant, fungus, or other botanical material, or a constituent derived through brewing or extraction process of a natural plant, fungus, or other botanical material, unless the constituent has been intentionally, isolated, enriched, concentrated, chemically converted, or added to a product for human consumption;
a substance possessed or transferred solely for legitimate scientific, medical, forensic, analytical, or law-enforcement purposes; or
a substance otherwise exempted by the Attorney General through regulation.
Limitation to commercial conduct— Enforcement under this section may be based only on the quantity or portion of a substance that is—
introduced or intended to be introduced into commercial distribution; and
connected to conduct described in subsection (a).
Definitions— For the purposes of this section—
the term commercial distribution means the advertisement, offering for sale, sale, shipment, transfer for value, or distribution of a substance or product in or affecting interstate, intrastate, or foreign commerce;
whether a substance is “intended for human consumption” shall be determined from all relevant facts and circumstances, potentially including labeling, advertising, dosage form, method of sale, representations by the seller, customary use, and evidence concerning the intended market;
the term scientifically reliable evidence includes validated in vitro, animal, human, pharmacokinetic, pharmacodynamic, receptor-binding, functional-activity, or other scientifically accepted evidence identified by the Attorney General, in consultation with the Secretary of Health and Human Services; and
the term semisynthesis means the chemical modification or conversion of a naturally occurring substance into a chemically distinct substance.