Delaware Administrative Code
Title 24 - Regulated Professions and Occupations
Department of State
Division of Professional Regulation
Uniform Controlled Substances Act Regulations
Section 10.0 - Procedures for Adoption of Regulations

Universal Citation: 24 DE Admin Code 10.0

Current through Register Vol. 28, No. 3, September 1, 2024

10.1 Notice. Prior to the adoption, amendment or repeal of any of these controlled substances regulations, the Secretary of State/Committee will give at least twenty (20) days notice of the intended action.

10.1.1 The notice will include a statement of either the terms of substance of the intended action or a description of the subjects and issues involved, or the time when, and the place where to present their views thereon.

10.1.2 The notice will be mailed to persons who have made timely request of the Office of Controlled Substances for advance notice of such rule-making proceedings and shall be published in two newspapers of general circulation in this State.

10.2 Hearing. The Secretary of State shall designate the Committee to preside over hearings. The Committee will afford all interested persons a reasonable opportunity to submit data, views or arguments, orally or in writing.

10.3 Emergency Regulations. 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 then twenty (20) days notice and states in writing the reasons for that finding, the Secretary of State may proceed without prior notice or hearing or upon any abbreviated notice and hearing the Secretary 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.

10.3.1 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:
10.3.1.1 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.

10.3.2 Pursuant to 16 Del.C. § 4717, the Secretary of State has the authority to place a substance in Schedule III where the Secretary finds that the substance has a potential for abuse less than the substances listed in Schedules I and II; has currently accepted medical use in treatment in the United States; and abuse of the substance may lead to moderate or low physical dependence or high psychological dependence, and therefore:
10.3.2.1 The Secretary of State, as authorized by 16 Del.C. § 4717, does hereby add by regulation illicit xylazine and its isomers, esters, ethers, salts and salts of isomers, esters and ethers, in Schedule III of the Uniform Controlled Substances Act, 16 Del.C. Ch. 47.
10.3.2.1.1 Testing strips to determine the presence of xylazine or xylazine-related substances are exempt from subsection 10.3.2.1.

10.3.2.2 For the purpose of this subsection:
10.3.2.2.1 "Illicit" use of xylazine means any use in the human species or any use that is not licit use.

10.3.2.2.2 "Licit" use of xylazine means:
10.3.2.2.2.1 Any administration to nonhuman species a drug containing xylazine that has been approved by the Secretary of Health and Human Services under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b); or that is permissible under section 512(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(4)).

10.3.2.2.2.2 The manufacturing, importation, or use of xylazine as an active pharmaceutical ingredient for manufacturing an animal drug approved under section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) or issued an investigation use exemption under subsection (j) of such section 512.

10.3.2.2.2.3 The manufacturing, importation, or use of a xylazine bulk chemical for pharmaceutical compounding by licensed pharmacists or veterinarians.

10.3.2.2.2.4 Another use approved or permissible under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

10.4 Finding and Availability. The Secretary of State will maintain on file any adoption, amendment or repeal of these regulations. In addition, copies of these regulations will be available for public inspection at the Office of Controlled Substances.

Disclaimer: These regulations may not be the most recent version. Delaware may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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