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5-64-414. Controlled substance analog.

Arkansas Code — all titles (historical 2020) · legal_authorities

5-64-414. Controlled substance analog.

5-64-414. Controlled substance analog. (a)(1) “Controlled substance analog” means a substance: (A) The chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or Schedule II or that has a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance included in Schedule I or Schedule II; or (B) With respect to a particular individual, that the individual represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance included in Schedule I or Schedule II. (2) “Controlled substance analog” does not include: (A) A controlled substance; (B) A substance for which there is an approved new drug application; (C) A substance with respect to which an exemption is in effect for investigational use by a particular person under § 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355, to the extent conduct with respect to the substance is pursuant to the exemption; or (D) Any substance to the extent not intended for human consumption before an exemption takes effect with respect to the substance. (b) A controlled substance analog, to the extent intended for human consumption, is treated for the purposes of this chapter as a substance included in Schedule I. (c) Within ten (10) days after the initiation of prosecution with respect to a controlled substance analog by indictment or information, the prosecuting attorney shall notify the Secretary of the Department of Healt

Source: Arkansas Code — historical release 78 (November 6, 2020) · 5-64-414

Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. A text match is a research starting point; applicability is not established.

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Stable record: arkansas_code:legal_authorities:5-64-414
Source file: gov.ar.code.title.05.odt
Pages: Not recorded – Not recorded
Passage SHA-256: fccd24256d360c73c22588ed5ee0f368a2d48ba518f73b238070b3d1e3bd1570

Source location: content.xml paragraph 23430

Stored source content

5-64-414. Controlled substance analog. (a)(1) “Controlled substance analog” means a substance: (A) The chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or Schedule II or that has a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance included in Schedule I or Schedule II; or (B) With respect to a particular individual, that the individual represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system substantially similar to the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance included in Schedule I or Schedule II. (2) “Controlled substance analog” does not include: (A) A controlled substance; (B) A substance for which there is an approved new drug application; (C) A substance with respect to which an exemption is in effect for investigational use by a particular person under § 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355, to the extent conduct with respect to the substance is pursuant to the exemption; or (D) Any substance to the extent not intended for human consumption before an exemption takes effect with respect to the substance. (b) A controlled substance analog, to the extent intended for human consumption, is treated for the purposes of this chapter as a substance included in Schedule I. (c) Within ten (10) days after the initiation of prosecution with respect to a controlled substance analog by indictment or information, the prosecuting attorney shall notify the Secretary of the Department of Health of information relevant to emergency scheduling as provided for in § 5-64-201(a). (d) After final determination that the controlled substance analog should not be scheduled, no prosecution relating to that substance as a controlled substance analog may continue or take place.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. **(b) Filing application; contents** (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approv

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355

Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 355. This identifies an authority to review, not proof of applicability.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 355 — New drugs

Page 186 TITLE 21—FOOD AND DRUGS § 355 § 355. New drugs (a) Necessity of effective approval of application No person shall introduce or deliver for intro- duction into interstate commerce any new drug, unless an approval of an application filed pursu- ant to subsection (b) or (j) is effective with re- spect to such drug. (b) Filing application; contents (1)(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the ap- plication— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as compo- nents of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the arti- cles used as components thereof as the Sec- retary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent in- fringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug sub- stance (active ingredient) patent or a drug product (formulation or composition) pat- ent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an a

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 355

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 355. This identifies an authority to review, not proof of applicability.

Arkansas Code — all titles (historical 2020) · legal_authorities

5-64-201. Secretary's duties.

5-64-201. Secretary's duties. (a)(1)(A)(i) The Secretary of the Department of Health shall administer this chapter and may add a substance to or delete or reschedule any substance enumerated in a schedule under the procedures of the Arkansas Administrative Procedure Act, § 25-15-201 et seq. (ii) The secretary may promulgate without action or approval of the State Board of Health an emergency rule under the procedures of the Arkansas Administrative Procedure Act, § 25-15-201 et seq., that adds a substance to or deletes a substance from a schedule or reschedules a substance. (iii) If the secretary adds, deletes, or reschedules a substance through an emergency rule under the procedures of the Arkansas Administrative Procedure Act, § 25-15-201 et seq., the emergency rule may be effective for no longer than one hundred eighty (180) days. (B) However, the secretary shall not delete any substance from a schedule in effect on July 20, 1979, without prior approval by the Legislative Council. (2) In making a determination regarding a substance, the secretary shall consider the following: (A) The actual or relative potential for abuse; (B) The scientific evidence of its pharmacological effect, if known; (C) The state of current scientific knowledge regarding the substance; (D) The history and current pattern of abuse; (E) The scope, duration, and significance of abuse; (F) The risk to public health; (G) The potential of the substance to produce psychic or physiological dependence liability; and (H) Whether the substance is an immediate precursor of a substance already controlled under this subchapter. (b) After considering the factors enumerated in subsection (a) of this section, the secretary shall make findings with respect to the factors and issue a

Source: Arkansas Code — historical release 78 (November 6, 2020) · 5-64-201

Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 5-64-201. This identifies an authority to review, not proof of applicability.