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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJanuary 2017

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WHEREAS, the Secretary of the Delaware Department of State ("Secretary") has been charged by the Delaware legislature with placing substances in Schedule I if the Secretary finds that the substances: (1) have high potential for abuse; and (2) have no accepted medical use in treatment in the United States or lack accepted safety for use in treatment under medical supervision. 16 Del.C. §4713; and
WHEREAS, available data and information for 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700) indicate that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States and lacks accepted safety for use under medical supervision; and
WHEREAS, U-47700 is not currently listed in any schedule under Delaware law; and
WHEREAS, U-47700, also known as "Pink," is a synthetic opioid recently encountered by law enforcement and public health officials and is being abused for its opioid properties. It is available over the Internet and is marketed as a "research chemical." The DEA is aware of the identification of U-47700 from toxicology reports and other evidence in a number of states, including New Jersey and Pennsylvania and has received data documenting at least 46 confirmed fatalities associated with the substance. The safety risks to users are significant and the public health risks include large numbers of drug treatment admissions, emergency room visits and fatal overdoses; and
WHEREAS, on November 14, 2016, the Federal Drug Enforcement Agency published in the Federal Register a Final Order, 81 FR 79389 (Nov. 14, 2016), temporarily placing U-47700 in Schedule I for a two-year period, with a possible extension of one additional year, finding that this synthetic opioid has a high potential for abuse, no currently accepted medical use in treatment in the United States and lacks accepted safety for use under medical supervision; and
WHEREAS, the Delaware Controlled Substance Advisory Committee has recommended the enactment of an emergency regulation placing U-47700 in Schedule I; and
WHEREAS, the Secretary finds that adoption of a regulation placing U-47700 temporarily in Schedule I under Delaware law must occur on an emergency basis in order to properly protect the public until such time as the legislature may reconvene to adopt a statutory amendment to 16 Del.C. §4714; and
WHEREAS, the Secretary will accept, consider and respond to petitions by any interested person for the reconsideration or revision of this regulation by addressing the same to the attention of the Office of Controlled Substances, Cannon Building, 861 Silver Lake Blvd., Dover, DE 19904; and
WHEREAS, a copy of this Final Order will be submitted to the Registrar for publication in the next issue of the Delaware Register of Regulations;
NOW, THEREFORE, IT IS ORDERED this 15th day of December, 2016:
10.3 Pursuant to 16 Del.C. §4713 the Secretary of State finds that the synthetic opioid, 3, 4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, has high potential for abuse; has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision, and therefore:
10.3.1 The Secretary of State, as authorized by 16 Del.C. §4713, does hereby add by rule 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, in Schedule I of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
2. In accordance with the provisions of 29 Del.C. §10119(3), this Order shall be effective for 120 days from the date of execution.
SO ORDERED this 15th day of December, 2016.
16 Del.C. §4713 establishes that "[t]he Secretary [of State] shall place a substance in Schedule I if the Secretary finds that the substance: (1) Has high potential for abuse; and (2) Has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision." Further, emergency regulations may be promulgated pursuant to the Administrative Procedures Act, so long as an agency determines there exists "an imminent peril to the public health, safety or welfare." 29 Del.C. §10119. Such a regulation will only be effective for a maximum of 120 days, but may be renewed once for an additional period of sixty days. 29 Del.C. §10119(3). The Uniform Controlled Substance Act Regulations also directly address the adoption of emergency regulations. Specifically, the regulations state at Section 9.3:
If the Secretary of State, upon the recommendation of the Committee, finds that an imminent peril to the public health, safety or welfare requires adoption of a regulation upon fewer than twenty (20) days notice and states in writing his/her reasons for that finding, the Secretary of State may proceed without prior notice or hearing or upon any abbreviated notice and hearing he/she finds practicable, to adopt an emergency regulation. Such rules will be effective for a period not longer than 120 days, but the adoption of an identical rule under the procedures discussed above is not precluded.
10.3 Pursuant to 16 Del.C. §4713 the Secretary of State finds that the synthetic opioid, 3, 4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, has high potential for abuse; has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision, and therefore:
10.3.1 The Secretary of State, as authorized by 16 Del.C. §4713, does hereby add by rule 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, in Schedule I of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
IT IS SO RECOMMENDED this 9th day of December 2016.
1.5 The conduct of all hearings and issuance of orders shall be in accordance with the procedures established pursuant to this section, Chapter 101 of Title 29, section 8735 of Title 29, and sections 4731 through 4736 of Title 16.
1.6 The Drug Control Administrator for the Division of Professional Regulation is responsible for the performance of the regular administrative functions of the Committee and other duties as the Committee may direct.
1.7 A majority of members shall constitute a quorum, and no action shall be taken without the affirmative vote of at least 5 members. For proceedings involving the denial, suspension or revocation of a controlled substance registration at least 1 member of the quorum must be from the same profession as the practitioner whose registration is the subject of the proceeding. Any member who fails to attend 3 consecutive meetings, or who fails to attend at least half of all regular business meetings during any calendar year, shall automatically upon such occurrence be deemed to have resigned from office and a replacement shall be appointed by the Secretary of State.
Act” means the Controlled Substance Act, 16 Del.C. Ch. 47.
Administer” or “administration” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or any other means. The administration of a drug directly to a patient by a practitioner is administration not an act of dispensing.
Controlled substance” means any substance or drug defined, enumerated or included in this chapter and Title 21, Code of Federal Regulations.
Direct supervision” means the supervising practitioner, pharmacist or licensee will be present and immediately available within the dispensing area.
Dispense” or “dispensing” means the interpretation, evaluation, and implementation of a prescription drug or, including the preparation and delivery of a drug to a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
Dispenser” means a person authorized by this State to dispense or distribute to the ultimate user any controlled substance.
Practitioner” means physician, dentist, veterinarian, podiatrist, nurse practitioner, physician assistant or other individual, licensed, registered, or otherwise permitted, by the United States or the State of Delaware to prescribe, dispense or store a controlled substance in the course of professional practice but does not include a pharmacist, a pharmacy, or an institutional practitioner.
Pharmacist” means any pharmacist licensed by the State of Delaware to dispense controlled substances and shall include any other person (e.g. pharmacist intern) authorized by the State of Delaware to prescribe, dispense or store controlled substances under the supervision of a pharmacist licensed by this State.
Prescription” means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (e.g. an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.)
Register” and “registered” refer to registration required by 16 Del.C. §4732.
3.3.2 Proceedings for denying, suspending or revoking a registration shall be held before the Committee. The Committee will forward their recommendation in writing to the Secretary of State for his/her review and decision. Persons complained against may appear personally or by counsel, and may produce any competent evidence in their behalf in answer to the alleged violation.
3.3.3 Whenever a registration is denied, suspended, or revoked by the Secretary of State, the Secretary of State or his/her designee will reduce in writing his/her findings and rulings, and the reasons therefor, and forward them to the persons applying for registration or complained against within 15 days of receiving the written recommendation of the Committee. This provision shall in no way stay any such denial, suspension, or revocation. The Secretary of State’s decision is final and conclusive. A person aggrieved may file an appeal as provided in 16 Del.C. §4786.
4.9 Pursuant to authority granted by 16 Del.C. §4732 the Secretary of State finds that waiver of the registration requirements contained in that section as to non-resident practitioners is consistent with the public health and safety subject to the conditions contained in this regulation.
5.1 All dispensed prescriptions including samples shall be labeled in compliance with 24 Del.C. §2522.
6.1.3 Other records required by 21 CFR 1300 to the end of 1316. The information for prescribed controlled substances may be kept either in a log or on patient records provided such records or logs are made available for inspection. The information for dispensed controlled substances must be maintained in a separate log. Entries must include the date dispensed, name and address of the patient, name and strength of medication, and amount dispensed.
6.3.1 Pharmacies. Whenever the pharmacist in charge of a pharmacy in the State of Delaware leaves his position, a complete inventory of all medication covered by 16 Del.C., Ch. 47 be taken by the present and prospective pharmacist-in-charge. A copy of such inventory will be sent to the Office of Controlled Substances and another copy retained on the premises.
8.3 Administrative inspections of controlled premises may be conducted in accordance with the provisions under 16 Del.C. §4782.
10.2 Pursuant to 16 Del.C. §4718(f) and 16 Del.C. §4720(c) the Secretary of State finds that the compounds, mixtures or preparations listed in 21 CFR 1301.21, 21 CFR 1308.24 contain one or more active medical ingredients not having a stimulant or depressant effect on the central nervous system and that the admixtures included therein are in combinations, quantities, proportions, or concentrations that vitiate the potential for abuse of the substances which have a stimulant or depressant effect on the central nervous system, and therefore:
10.2.1 The Secretary of State, as authorized by 16 Del.C. §4718(f) and 16 Del.C. §4720(c), does hereby except by rule the substances listed in 21 CFR 130.21, CFR 1308.24 and 21 CFR 1308.32 from Schedules III and IV of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
10.3 Pursuant to 16 Del.C. §4713 the Secretary of State finds that the synthetic opioid, 3, 4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, has high potential for abuse; has no accepted medical use in treatment in the United States or lacks accepted safety for use in treatment under medical supervision, and therefore:
10.3.1 The Secretary of State, as authorized by 16 Del.C. §4713, does hereby add by rule 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (also known as U-47700) and it isomers, esters, ethers, salts and salts of isomers, esters and ethers, in Schedule I of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
Last Updated: December 31 1969 19:00:00.
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