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Chapter 480-34 CONTROLLED SUBSTANCES

Rule 480-34-.01 Carisoprodol

This rule was adopted to protect the health, safety, and welfare of the public. This rule places Carisoprodol (known as Soma) under Schedule IV, of the Georgia Controlled Substances Act, Code Section 16-13-28(a)(2-25). The Board finds that:

(a) Carisoprodol has a high potential for abuse;
(b) It appears to have an addictive effect on the human body;
(c) It is regarded as a threat to public health and safety by other states, as well as the U.S. Drug Enforcement Administration;
(d) It has a history of increasing abuse;
(e) The abuse and need to obtain the drug results in multiple uses and combinations, and multiple violations of the law;
(f) It has the same risk the public health of the citizens of the state of Georgia as any substance already contained in the Controlled Substances Act;
(g) It has shown great potential for physiological dependence;
(h) It is not a precursor of a substance already scheduled in Georgia;
(i) It is about to be placed under Schedule IV of the federal Controlled Substances Act.

Rule 480-34-.02 Ketamine

This rule was adopted to protect the health, safety, and welfare of the public. This rule places Ketamine under Schedule III of the Georgia Controlled Substances Act, Code Section 16-13-27(8). The Board finds:

(a) that Ketamine has an extremely high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of Ketamine demonstrate that the public would be at risk if it is not regulated as a controlled substance;
(c) that the pattern of abuse of Ketamine and the scope and significance of that abuse support regulation;
(d) that there exists an imminent peril to the public health and welfare with regard to the abuse of Ketamine;
(e) that Ketamine has the same risk to the public health of citizens of the State of Georgia as any substance already contained in the Controlled Substances Act;
(f) that Ketamine has no known precursor already scheduled under the Act; and
(g) that the DEA has filed the intent to add Ketamine to the Federal Controlled Substances Act under Schedule III.

Rule 480-34-.03 Sodium Oxybate

This Chapter was adopted to protect the health, safety, and welfare of the public. This Chapter places Sodium Oxybate (known as Xyrem) that is contained in a drug product for which an application has been approved under Section 505 of the Federal Food, Drug and Cosmetic Act under Schedule III, of the Georgia Controlled Substances Act, Code Section 16-13-28(a)(2-25). The Board finds that:

(a) Sodium Oxybate has a high potential for abuse;
(b) It appears to have an addictive effect on the human body;
(c) It is regarded as a threat to public health and safety by other states, as well as the U.S. Drug Enforcement Administration;
(d) It has a history of increasing abuse;
(e) The abuse and need to obtain the drug results in multiple uses and combinations, and multiple violations of the law;
(f) It has the same risk to the public health of the citizens of the state of Georgia as any substance already contained in the Controlled Substances Act;
(g) It has shown great potential for physiological dependence;
(h) It is not a precursor of a substance already scheduled in Georgia;
(i) It is about to be placed under Schedule III of the federal Controlled Substances Act.

Rule 480-34-.04 Synthetic Cannabinoids

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including any material, compound, mixture, or preparation which contains these substances or their derivatives, salts, isomers, or salts of isomers, halogen analogues, and/or homologues, collectively known as Synthetic Cannabinoids, under Schedule I, of the Georgia Controlled Substances Act, Code Section 16-13-25(12)as follows:
(M) (1-Pentylindol-3-yl)-(2,2,3,3-tetramethylcyclopropyl) methanone (UR-144)
(N) [1-(5-fluoropentyl)indole-3yl]-(2,2,3,3-tetramethylcyclopropyl) methanone (XLR11)
(O) [1,1'-biphenyl]-3-yl-carbamic acid, cyclohexyl ester (URB602)
(P) [1-(2-morpholin-4-ylethyl)-1H-indol-3-yl]-(2,2,3,3-tetramethylcyclopropyl) methanone (A-796,260)
(Q) [3-(3-carbamoylphenyl)phenyl] N-cyclohexylcarbamate (URB597).
(R) 6-methyl-2-[(4-methylphenyl)amino]-1-benzoxazin-4-one (URB754)
(S) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide (AKB48)
(T) 1-pentyl-3-(1-adamantylamido)indole (2NE1)
(U) 1-(5-fluoropentyl)-N-tricyclo[3.31.13,7]dec-1-yl-1H-indole-3-carboxamide (STS-135)
(V) 1-naphthalenyl[4-(pentylox)-1-naphthalenyl]-methanone (CB-13)
(W) (1-(5-chloropentyl)indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (5-Chloro-UR-144)
(X) (1-(5-bromopentyl)indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (5-Bromo-UR- 144)
(Y) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indole-3-carboxamide (ADBICA)
(Z) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indole-3-carboxamide (5-Fluoro-ADBICA)
(aa) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indole-3-carboxamide (5fluoro-ABICA)
(bb) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (FUB-144)
(cc) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indole-3-carboxamide (5-fluoro-ABICA);
(dd) 1-naphthalenyl(1-pentyl-1H-indazol-3-yl)-methanone (THJ 018);
(ee) 1-(cyclohexylmethyl)-8-quinolinyl ester-1H-indole-3-carboxylic acid (BB-22);
(ff) Naphthalene-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (NM2201).
(2) This rule is based on the following findings of the Board:
(a) that Synthetic Cannabinoids have an extremely high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(c) that the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(d) that there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(e) that these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule I under the Controlled Substances Act;
(f) that these compounds have no known precursor already scheduled under the Act; and
(g) that the DEA encourages all states to add these compounds to their respective Controlled Substances Acts while DEA follows its procedures to add such compounds to the Federal Controlled Substances Act under Schedule I.

Rule 480-34-.05 Synthetic Cathinones

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places an additional newly identified compound, including any material, compound, mixture, or preparation which contains these substances or their derivatives, salts, isomers, or salts of isomers, halogen analogues, or homologues, collectively known as a Synthetic Cathinone, under Schedule I, of the Georgia Controlled Substances Act, Code Section 16-13-25(12)as follows:
(aa) N-acetyl-3,4-methylenedioxymethcathinone
(2) This rule is based on the following findings of the Board:
(a) that Synthetic Cathinones have an extremely high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(c) that the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(d) that there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(e) that these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule I under the Controlled Substances Act;
(f) that these compounds have no known precursor already scheduled under the Act; and
(g) that the DEA encourages all states to add these compounds to their respective Controlled Substances Acts while DEA follows its procedures to add such compounds to the Federal Controlled Substances Act under Schedule I.

Rule 480-34-.06 Hydrocodone Combination Products

(1) Effective October 6, 2014, Official Code of Georgia Annotated (O.C.G.A.) §§ 16-13-27(4)(C), 16-13-27(4)(D) are hereby removed from Schedule III of the Georgia Controlled Substances Act, O.C.G.A. 16-13-25, et. seq. The following language shall be deleted from O.C.G.A. §§ 16-13-27(4): "(C) Not more than 300 milligrams of dihydrocodeinone (hydrocodone), or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium; (D) Not more than 300 milligrams of dihydrocodeinone (hydrocodone), or any of its salts, per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts."
(2) Effective October 6, 2014, all Hydrocodone Combination Products (HCPs) in the State of Georgia are Schedule II controlled substances.
(a) Each registrant possessing HCPs must make an actual count inventory of all HCPs as of October 6, 2014 and maintain it with the registrant's biennial DEA inventory.
(b) All HCPs products must be treated as any other Schedule II controlled substance. There can be no oral prescriptions except in the case of an emergency, and all hard-copy HCP prescriptions must be issued on security paper.
(c) For any HCP prescription written and filled before October 6, 2014 with authorized refills, the prescription can be refilled only for the authorized number of refills prior to April 8, 2015.
(3) This rule is based on the following findings of the Board:
(a) that as Schedule III controlled substances, HCPs have an extremely high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of HCPs demonstrate that the public is at extreme risk if HCPs are not regulated as Schedule II controlled substances;
(c) that the history and pattern of abuse of HCPs as a Schedule III controlled substance and the scope and significance of that abuse support stricter regulation;
(d) that as a Schedule III controlled substance, there exists an imminent peril to the public health and welfare with regard to the abuse of HCPs;
(e) that HCPs have the same risk to the public health of citizens of the State of Georgia as other Schedule II controlled substances already contained in the Georgia Controlled Substances Act;
(f) that as of October 6, 2014, the U.S. Drug Enforcement Administration has removed all reference to HCPs from Schedule III of 21 CFR 1308.13, which places all HCPs under Schedule II of 21 CFR 1308.12.

Rule 480-34-.07 Hallucinogens

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places additional newly identified compounds, including any material, compound, mixture, or preparation which contains any quantity of the following substances, their salts, isomers (whether optical, position, or geometrics), and salts of isomers under Schedule I of the Georgia Controlled Substances Act, Section 16-13-25(3)as follows:
(BBBB) Methoxyphencyclidine (MeO-PCP)
(CCCC) 4-hydroxy-N-methyl-N-isopropyltryptamine (4-OH-MiPT)
(DDDD) N,[ALPHA]-dimethyl-5-benzofuranethanamine (5-MAPB)
(EEEE) 1-pentyl-N-(phenylmethyl)-1H-indole-3-carboxamide (SDB-006)
(FFFF) methyl (S)-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (MDMB-CHMICA)
(2) This rule is based on the following findings of the Board:
(a) that hallucinogens have an extremely high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(c) that the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(d) that there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(e) that these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule I under the Controlled Substances Act; and
(f) that these compounds have no known precursor already scheduled under the Act.

Rule 480-34-.08 Lidocaine

(1) This rule was adopted to protect the health, safety, and welfare of the public. Lidocaine topical, 40 mg/gm. or less (4.0%) is deleted from Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(520).
(2) This rule is based on the following findings of the Board:
(a) that lidocaine topical, 40 mg/gm. or less (4.0%) does not have a high potential for abuse;
(b) that the Board has considered the scientific evidence of its pharmacological effects, the state of current scientific knowledge regarding the drug, the history and current pattern of abuse, the scope, duration, and significance of abuse, the potential of the drug to produce psychic or physiological dependence liability; and
(c) that the drug is no longer included as a prescription drug under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Section 301, et. seq., as amended.

Rule 480-34-.09 Additional Compounds under Schedule IV

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places additional newly identified compounds, including any material, compound, mixture, or preparation which contains any quantity of the following substances, their salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specified chemical designation, including as having a stimulant or depressant effect on the central nervous system or a hallucinogenic effect, under Schedule IV of the Georgia Controlled Substances Act, Section 16-13-28 as follows:

(14.3) Flubromazepam

(30.07) Pyrazolam

(2) This rule is based on the following findings of the Board:
(a) that benzodiazepines have a high potential for abuse;
(b) that scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(c) that the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(d) that there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(e) that these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule IV under the Controlled Substances Act; and
(f) that these compounds have no known precursor already scheduled under the Act.

Rule 480-34-.10 Synthetic Opiates

This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including their isomers, esters, ethers, salts and salts of isomers, esters, and ethers, whenever the existence of these isomers, esters, ethers, or salts is possible within the specific chemical designation under Schedule I of the Georgia Controlled Substances Act, Section 16-13-25(1)as follows:

(RR) trans-3,4-dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide (U-47700)

(b) This rule is based on the following findings of the Board:
(1) that Synthetic Opiates have an extremely high potential for abuse;
(2) that scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(3) that the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(4) that there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(5) that these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule I under the Controlled Substances Act; and
(6) that these compounds have no known precursor already scheduled under the Act.

Rule 480-34-.11 Levocetirizine Dihydrochloride

(1) This rule was adopted to protect the health, safety, and welfare of the public. Levocetirizine dihydrochloride in 5 mg tablets or an oral solution of 2.5 mg per 5 mL (.05 mg per mL), as identified in Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(516.75), is hereby removed from the list of dangerous drugs of the Georgia Dangerous Drugs Act.
(2) This rule is based on the following findings of the Board:
(a) that levocetirizine dihydrochloride does not have a high potential for abuse;
(b) that the Board has considered the scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug; the history and current pattern of abuse; the scope, duration, and significance of abuse; the potential of the drug to produce psychic or physiological dependence liability; and
(c) that the drug, when in 5 mg tablets or an oral solution of 2.5 mg per 5 mL (.05 mg per mL), has been approved for non-prescription status by the Federal Food and Drug Administration.

Rule 480-34-.12 Synthetic Fentanyl

(a) This rule was adopted to protect the health, safety, and welfare of the public. This rule places newly identified compounds, including any derivatives, their salts, isomers, or salts of isomers, unless specifically utilized as part of the manufacturing process by a commercial industry of a substance or material not intended for human ingestion or consumption, as a prescription administered under medical supervision, or for research at a recognized institution, whenever the existence of these salts, isomers, or salts of isomers is possible within the specific chemical designation or unless specifically excepted or listed in this or another schedule, structurally derived from fentanyl, and whether or not further modified in any of the following ways under Schedule I of the Georgia Controlled Substances Act, Section 16-13-25(13)as follows:
(H) Tetrahydrofuran fentanyl (N-phenyl-N-[1-(2-phenylethyl)piperidin-4-yl]oxolane-2-carboxamide)
(b) This rule is based on the following findings of the Board:
(1) That synthetic fentanyls have an extremely high potential for abuse;
(2) That scientific evidence and scientific knowledge of the pharmacological effects of these compounds demonstrate that the public is at extreme risk if they are not regulated as controlled substances;
(3) That the pattern of abuse of these compounds and the scope and significance of that abuse support regulation;
(4) That there exists an imminent peril to the public health and welfare with regard to the abuse of these compounds;
(5) That these compounds have the same risk to the public health of citizens of the State of Georgia as other substances already contained in Schedule I under the Controlled Substances Act; and
(6) That these compounds have no known precursor already scheduled under the Act.

Rule 480-34-.13 Triamcinolone Acetonide Nasal Spray

(1) This rule was adopted to protect the health, safety, and welfare of the public. Triamcinolone acetonide nasal spray 55mcg per spray or less, is hereby deleted from the dangerous drug list as referenced in the Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(976).
(2) This rule is based on the following findings of the Board:
(a) that triamcinolone acetonide nasal spray 55mcg per spray or less does not have a high potential for abuse;
(b) that the Board has considered the scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug; the history and current pattern of abuse; the scope, duration, and significance of abuse; the potential of the drug to produce psychic or physiological dependence liability; and
(c) that the drug, when in nasal spray form of 55mcg per spray or less has been approved for non-prescription status by the Federal Food and Drug Administration.

Rule 480-34-.14 Sodium Chloride Injection for Catheter Flush

(1) This rule was adopted to protect the health, safety, and welfare of the public. Sodium chloride injection in quantities of 10cc or less, when used as a catheter flush solution to act by physically occupying space within a catheter and exerting pressure on the patient's circulating blood, is hereby deleted from the dangerous drug list as referenced in Official Code of Georgia Annotated (O.C.G.A.) § 16-13-71(b)(867).
(2) This rule is based on the following findings of the Board:
(a) that sodium chloride injection in quantities of 10cc or less does not have a high potential for abuse;
(b) that the Board has considered the scientific evidence of its pharmacological effects, the state of current scientific knowledge regarding the drug, the history and current pattern of abuse, the scope, duration, and significance of abuse, the potential of the drug to produce psychic or physiological dependence liability; and
(c) that the Federal Food and Drug Administration concluded that sodium chloride injection (saline injection or flush), when used as a catheter flush solution and acting in this manner, this solution meets the definition of a device in that it affects the structure or function of the body, and does not achieve its primary intended purposes through chemical or metabolic action.

Rule 480-34-.15 Additional Compounds under Schedule V

(1) This rule was adopted to protect the health, safety, and welfare of the public. This rule places an additional compound as specifically identified here under Schedule V of the Georgia Controlled Substances Act, Section 16-13-29 as follows:
(1.5) Epidiolex: A drug product in finished dosage formulation in its original container that has been approved by and labelled in compliance with the U.S. Food and Drug Administration (FDA) that contains cannabidiol (CBD) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols.
(2) This rule is based on the following findings of the Board:
(a) that the FDA approved the drug Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex is an oral solution that contains CBD extracted from the cannabis plant.
(b) that the U.S. Drug Enforcement Administration (DEA) did seek a medical and scientific evaluation or scheduling recommendation from the U.S. Department of Health and Human Services (HHS) with respect to the Epidiolex formulation. In responding to that request, HHS advised DEA that it found the Epidiolex formulation to have a very low potential for abuse and therefore, recommended that if DEA concluded that control of the drug was required under the Single Convention, Epidiolex should be placed in Schedule V of the Federal Controlled Substance Act (CSA).
(c) that the Board has considered, based on available information, the potential for abuse; scientific evidence of its pharmacological effects; the state of current scientific knowledge regarding the drug; the history and current pattern of abuse; the scope, duration, and significance of abuse; and the potential of the drug to produce psychic or physiological dependence liability.