reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-33 - OUTPATIENT CLINIC PHARMACIES › Rule 480-33-.08 - Medications from Outside Sources Brought by Patients

Current through Rules and Regulations filed through June 27, 2024
The pharmacist-in-charge shall establish procedures relating to
				medications brought into the clinic. Such drugs shall not be administered
				unless they can be precisely identified. Administration shall be pursuant to an
				authorized practitioner's prescription drug order only. If such medications are
				not to be administered, the medication shall be returned to an adult member of
				the patient's immediate family or stored by the pharmacy and returned to the
				patient at the time of his/her departure from the clinic. Nothing in this
				section shall prohibit another method of accomplishing the intent of this
				section provided such method is approved by an agent of the Georgia State Board
				of Pharmacy. These medications shall not be maintained in any of the ancillary
				areas of the clinic.
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37, 26-4-100,
				 26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-33 - OUTPATIENT CLINIC PHARMACIES › Rule 480-33-.09 - Investigational Drugs

Current through Rules and Regulations filed through June 27, 2024
Investigational drugs shall be properly labeled.
				Investigational drugs shall be dispensed and administered by the pharmacist in
				accordance with an approved protocol that includes any requirements for a
				patient's appropriate informed consent. Nurses may administer such drugs only
				after they have been educated by the practitioner or the pharmacist. A central
				unit shall be maintained by the pharmacy wherein essential information
				regarding such drugs may be obtained. Investigational drugs in use shall be
				properly stored, distributed, and controlled maintaining the confidentiality of
				patient-medical staff information. The pharmacist-in-charge shall be
				responsible for policies and procedures concerning the use of investigational
				drugs.
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37, 26-4-100,
				 26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-33 - OUTPATIENT CLINIC PHARMACIES › Rule 480-33-.10 - Inspections

Current through Rules and Regulations filed through June 27, 2024
(1) Monthly. The
			 pharmacist-in-charge shall no less than once per month, personally or by
			 qualified designee, inspect all matters within his/her jurisdiction and
			 responsibility and make appropriate written records of such inspections. Such
			 inspections shall, at a minimum, verify that:
(a) Drugs are dispensed only by licensed
			 pharmacists;
(b) Pharmacy personnel
			 are properly directed and supervised;
(c) Drugs for external use are stored
			 separately and apart from drugs for oral internal use or injection;
(d) Drugs requiring special storage
			 conditions to insure their stability are properly stored;
(e) No outdated drugs are stocked in the
			 outpatient clinic pharmacy or the facility it serves;
(f) Distribution and administration of
			 controlled substances are properly and adequately documented and reported by
			 both pharmacy and medical personnel;
(g) Standard Ward Inventory. Verification of
			 standard ward inventory lists and accountability, including such updating if
			 applicable are maintained;
(h) All
			 necessary and required security and storage standards are met;
(i) Metric-apothecary weight and measure
			 conversion tables and charts and compatibility charts are available;
(j) All policies and procedures of the
			 director of pharmacy and of appropriate committees of the clinic relevant to
			 the pharmacy are being followed;
(k) All discontinued and out-dated
			 medications are returned to the pharmacy for proper disposition; and
(l) Disinfectants and other similar supplies
			 intended for external use are stored separately and apart from drugs for oral
			 internal use or for parenteral injection.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.01 - Carisoprodol

Current through Rules and Regulations filed through June 27, 2024
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.
O.C.G.A. Sec.
				 16-13-22.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.02 - Ketamine

Current through Rules and Regulations filed through June 27, 2024
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.
O.C.G.A. Secs. 26-4-37,
				 16-13-22,  50-13-4.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.03 - Sodium Oxybate

Current through Rules and Regulations filed through June 27, 2024
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.
O.C.G.A. Secs.
				 16-13-22,  26-4-27,  26-4-28.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.04 - Synthetic Cannabinoids

Current through Rules and Regulations filed through June 27, 2024
(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).
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.05 - Synthetic Cathinones

Current through Rules and Regulations filed through June 27, 2024
(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
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.06 - Hydrocodone Combination Products

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.07 - Hallucinogens

Current through Rules and Regulations filed through June 27, 2024
(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)
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.08 - Lidocaine

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.09 - Additional Compounds under Schedule IV

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.10 - Synthetic Opiates

Current through Rules and Regulations filed through June 27, 2024
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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.11 - Levocetirizine Dihydrochloride

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.12 - Synthetic Fentanyl

Current through Rules and Regulations filed through June 27, 2024
(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)
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.13 - Triamcinolone Acetonide Nasal Spray

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.14 - Sodium Chloride Injection for Catheter Flush

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-34 - CONTROLLED SUBSTANCES › Rule 480-34-.15

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A.
				§§
										16-13-22,  16-13-29,  26-4-5,  26-4-27,  26-4-28.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(1) Board. Board
			 means the Georgia State Board of Pharmacy.
(2) Drug Therapy Modification. Drug Therapy
			 Modification means the adjustment of dosages, dosage schedules, and/or
			 medications by a pharmacist under authority delegated and supervised by a
			 physician. Such medications need not be pharmaceutically or therapeutically
			 equivalent to the initial prescription issued to the patient by the prescribing
			 physician.
(3) Pharmacist.
			 Pharmacist means a person holding a current license to practice pharmacy in the
			 State of Georgia.
(4) Physician.
			 Physician means a person holding a current license to practice medicine in the
			 State of Georgia.
(5) Supervision
			 by a Physician. Supervision by a physician means the pharmacist has a means
			 available to communicate with the physician for consultation, assistance, and
			 direction in regards to drug therapy modification.
O.C.G.A. Secs.
				 16-13-41,  16-13-74,  26-4-6,  26-4-27,  26-4-28,  26-4-50,  26-4-81,  43-1-7, 43-34-26.2.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.02 - Pharmacist Certification

Current through Rules and Regulations filed through June 27, 2024
(1) A pharmacist may apply to the Board for a
			 certification which will allow the pharmacist to enter into a protocol or
			 agreement with a physician for drug therapy modification. Each application
			 shall be reviewed by the Board for completeness and authenticity before
			 certification can be issued. Such application shall include, but is not limited
			 to:
(a) Completion of an application form
			 approved by the Board to include at a minimum:
(i) Name, home address, telephone number, and
			 email address (if applicable);
(ii)
			 Georgia pharmacist license number, including any previous sanctions by the
			 Board or any other actions by a licensing or criminal authority; and
(iii) Current place of practice setting,
			 including name, address, and telephone number and place where the protocol and
			 patient records will be maintained.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.03 - Continuing Education

Current through Rules and Regulations filed through June 27, 2024
In order to renew a certification under this chapter, the
				continuing education must:
(1) Be from
			 a provider approved by the Board pursuant to Rule
			  480-3-.03  or a provider approved by
			 ACPE.
(2) Have been taken and
			 credit received for the continuing education during the 12 months preceding the
			 application for renewal.
(3) Have
			 been from a live program at least 1.0 contact hour (0.1 CEU) in
			 length.
(4) Have been on the topic
			 of the therapy area in which the Pharmacist seeks to make drug therapy
			 modifications.
O.C.G.A.
				§§
										26-4-27,  26-4-28,  26-4-50.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.04 - Requirements for a Protocol

Current through Rules and Regulations filed through June 27, 2024
(1) A physician may delegate authority to a
			 pharmacist certified under this chapter to modify drug therapy through a
			 protocol for a patient under the physician's direct medical care and
			 supervision. The protocol shall meet the applicable requirements for the
			 issuance of prescriptions provided in O.C.G.A. Section
			  16-13-41 or 
			  16-13-74, which ever is applicable.
(2) A
			 protocol shall be in writing and must contain the following:
(a) The printed name and signature of the
			 physician, along with the license number issued to the physician by the Georgia
			 Composite Board of Medical Examiners;
(b) The printed name and signature of the
			 pharmacist, along with the license number issued to the pharmacist by the
			 Board;
(c) The date the protocol
			 was established, and the date the protocol becomes effective;
(d) The length of time the protocol shall be
			 in effect;
(e) The identity of each
			 patient covered by the protocol, and a mechanism to inform the patient the
			 physician has authorized the pharmacist to modify the patient's drug therapy
			 pursuant to this protocol, including information as to how the patient may opt
			 out of the protocol;
(f) The
			 physician's diagnosis of condition or disease state for each patient identified
			 in the protocol, along with a listing of the initial drug therapy prescribed by
			 the physician for each patient;
(g)
			 A description of the parameters and responsibilities for drug therapy
			 modification;
(h) Description of
			 the monitoring required by the pharmacist and physician for each patient
			 identified in the protocol;
(i) The
			 procedures the pharmacist must follow when modifying drug therapy including,
			 but not limited to, the method and frequency of notification to the physician
			 of any drug therapy modification;
(j) For each patient's drug therapy
			 modification, the identification of types and categories of medications allowed
			 to be utilized, and the maximum/minimum dosage levels within each type and
			 category of medication; and
(k)
			 Identification of the documentation required by the pharmacist when drug
			 therapy has been modified, including, but not limited to, a record of any
			 problems or complications encountered, a list of recommendations, and a list of
			 all drug modifications.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.05 - Recordkeeping

Current through Rules and Regulations filed through June 27, 2024
(1) Each pharmacist
			 certified for drug therapy modification, who enters into a drug therapy
			 modification protocol with a physician, shall establish and maintain a separate
			 record system which shall include, but not limited to, the following:
(a) A patient medical record for each patient
			 named in the protocol;
(b)
			 Documentation of any action taken regarding drug therapy, including counseling
			 of the patient in regard to the new medication;
(c) Documentation of any prescription drug
			 order initiated by the pharmacist on behalf of the physician pursuant to the
			 protocol;
(d) Documentation of any
			 test results supporting drug therapy modification;
(e) Documentation of any notification to the
			 physician regarding drug therapy modification;
(f) Documentation of any problems or adverse
			 effects encountered due to the initial drug order or any drug therapy
			 modification; and
(g) Other
			 pertinent patient information;
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.06 - Financial Remuneration for Professional Services

Current through Rules and Regulations filed through June 27, 2024
Nothing in this rule shall be construed to prohibit the
				pharmacist from being remunerated for the professional services
				rendered.
O.C.G.A. Secs.
				 16-13-41,  16-13-74,  26-4-6,  26-4-27,  26-4-28,  26-4-50,  26-4-81,  43-1-7, 43-34-26.2.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.07 - Authority to Initiate Modification of Drug Therapy

Current through Rules and Regulations filed through June 27, 2024
Nothing in this chapter shall be construed to limit or restrict
				the authority of a pharmacist to substitute a drug as provided in O.C.G.A.
				Section
				 26-4-81.
O.C.G.A. Secs.
				 16-13-41,  16-13-74,  26-4-6,  26-4-27,  26-4-28,  26-4-50,  26-4-81,  43-1-7, 43-34-26.2.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-35 - PHARMACIST MODIFICATION OF DRUG THERAPY › Rule 480-35-.08 - Exception

Current through Rules and Regulations filed through June 27, 2024
Nothing in this chapter shall be construed to limit hospital
				pharmacists from participating in medication therapy management by protocol or
				other legal authority established or approved by a member of the hospital
				medical staff for the care and treatment of hospital
				patients.
O.C.G.A. Secs.
				 16-13-41,  16-13-74,  26-4-6,  26-4-27,  26-4-28,  26-4-50,  26-4-81,  43-1-7, 43-34-26.2.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
As used in this chapter, the following terms:
(1) "Board" shall mean the Georgia Board of
			 Pharmacy.
(2) "Remote prescription
			 drug order processing" shall mean the processing of prescription or patient
			 information from a location other than the location from which the prescription
			 medication is received and dispensed. It shall not include the dispensing of a
			 drug, but may include:
(a) Receiving the
			 prescription order from the primary dispensing pharmacy;
(b) Interpreting, analyzing, or clarifying
			 prescriptions;
(c) Entering
			 prescription or patient data into a data processing system;
(d) Transferring prescription
			 information;
(e) Performing a drug
			 regimen review;
(f) Performing a
			 drug allergy review;
(g) Performing
			 therapeutic interventions; or
(h)
			 Any combination of these order processing functions.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.02 - Licensing

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Secondary remote entry pharmacists who perform remote prescription drug order
			 processing shall be licensed by the Board.
(2) When a secondary remote entry pharmacist
			 performs remote prescription drug processing from any pharmacy, the pharmacy
			 must be licensed in this State.
(3)
			 Secondary remote entry pharmacists who perform remote prescription drug order
			 processing shall either be employed by or contracted with the primary
			 dispensing pharmacy or be employed by an organization that has a written
			 contract describing the scope of services to be provided and the
			 responsibilities and accountabilities of each pharmacy and the contractor. Such
			 contract shall be available for review by the Board or its
			 representative.
O.C.G.A.
				§§
										26-4-4,  26-4-5,  26-4-27,  26-4-28,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.03 - Personnel and Supervision

Current through Rules and Regulations filed through June 27, 2024
(1)
			 The primary dispensing pharmacy shall have a licensed pharmacist on site during
			 business hours and his/her duties shall include the verification of the
			 validity of all prescriptions. Such pharmacist shall be responsible for
			 obtaining and recording all information needed. This shall include but not be
			 limited to the following patient information: biographical information,
			 medication history, drug allergies, and other information as required. Pharmacy
			 technicians and pharmacy interns/externs may assist a pharmacist located at the
			 primary dispensing pharmacy with remote prescription drug order processing.
			 Such pharmacies shall comply with Georgia laws and rules set forth pertaining
			 to ratios and the supervision of pharmacy technicians and pharmacy
			 interns/externs.
(2) If the
			 secondary remote entry pharmacist is engaging in the remote services listed in
			 rule  480-36-.01  from
			 a Georgia Board of Pharmacy licensed pharmacy, then pharmacy technicians and
			 pharmacy interns/externs may assist the secondary remote entry pharmacist with
			 remote prescription drug order processing.
(3) The secondary remote entry pharmacist
			 shall be responsible for assuring the accuracy of prescriptions for which
			 he/she performed or supervised remote prescription drug order processing. This
			 responsibility shall exclude the compounding, preparation, dispensing, and
			 counseling for prescriptions for which he/she has performed remote prescription
			 drug order processing. The pharmacist shall verify the data entered into the
			 computer system is consistent with the prescription. The pharmacist shall
			 conduct a drug regimen review for each prescription. Any activity requiring the
			 exercise of professional judgment shall be performed by the secondary remote
			 entry pharmacist and shall not be delegated to pharmacy technicians. The
			 secondary remote entry pharmacist shall be responsible for verification of all
			 activities performed by pharmacy technicians, or pharmacy
			 interns/externs.
O.C.G.A.
				§§
										26-4-4,  26-4-5,  26-4-27,  26-4-28,  26-4-60,  26-4-80,  26-4-82,  26-4-83,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.04 - Policy and Procedures

Current through Rules and Regulations filed through June 27, 2024
The primary dispensing pharmacy shall have a written policy and
				procedure that relates to the remote processing of prescriptions and such
				policy shall be available for inspection by the Board or its representative.
				The policy shall at a minimum include the following:
(a) The responsibilities of the primary
			 dispensing pharmacy and secondary remote entry pharmacist;
(b) A list of the name, address, telephone
			 numbers, and permit/registration/license numbers of all pharmacies and
			 pharmacists involved in remote processing;
(c) Procedures for protecting the
			 confidentiality and integrity of patient information;
(d) Procedures for ensuring that pharmacists
			 performing prospective drug reviews have access to appropriate drug information
			 resources;
(e) Procedures for
			 maintaining required records;
(f)
			 Procedures for complying with all applicable laws and regulations to include
			 counseling.
O.C.G.A.
				§§
										26-4-4,  26-4-5,  26-4-27,  26-4-28,  26-4-60,  26-4-80,  26-4-82,  26-4-83,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.05 - Record Keeping

Current through Rules and Regulations filed through June 27, 2024
(1)
			 The primary dispensing pharmacy and the secondary remote entry pharmacist shall
			 share a common electronic file or have technology which allows sufficient
			 information necessary to process a non-dispensing function.
(2) In addition to any other required
			 records, the primary dispensing pharmacy shall maintain retrievable records
			 which show, for each prescription remotely processed, each individual
			 processing function and identity of the pharmacist or pharmacy technician who
			 performs a processing function and the pharmacist who checked the processing
			 function.
(3) Prescriptions
			 processed by a secondary pharmacist must be separately identifiable and
			 retrievable upon request by a GDNA agent during inspection.
(4) These records maintained by the primary
			 dispensing pharmacy shall be readily retrievable for at least two years through
			 the primary dispensing pharmacy, and shall be available for inspection by the
			 Board or its representative.
(5)
			 The record keeping required by this rule is in addition to the record keeping
			 required under Rule Chapter 480-10 and any other Board rules and state and
			 federal laws.
O.C.G.A.
				§§
										16-13-34, 16-3-39,  26-4-4,  26-4-5,  26-4-27,  26-4-28,  26-4-60,  26-4-80,  26-4-82,  26-4-83,  26-4-85,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.06 - Patient Counseling

Current through Rules and Regulations filed through June 27, 2024
(1) It
			 shall be the responsibility of the pharmacist on duty at the primary dispensing
			 pharmacy to perform patient counseling of all prescriptions, as required,
			 including those assisted by remote processing.
(2) The secondary remote entry pharmacist
			 shall not perform patient counseling on behalf of the primary dispensing
			 pharmacy.
O.C.G.A.
				§§
										26-4-4,  26-4-5,  26-4-27,  26-4-28,  26-4-85.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-36 - RETAIL PHARMACY REQUIREMENTS FOR REMOTE PRESCRIPTION DRUG ORDER PROCESSING › Rule 480-36-.07 - Notification to Patients

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Prior to utilizing remote prescription drug order processing, the primary
			 dispensing pharmacy shall:
(a) Notify patients
			 their prescription drug order may be processed in part by an offsite pharmacist
			 or pharmacy. Such notification may be provided through use of a sign in the
			 pharmacy which states: "Remote Order Processing Utilized Here." Such sign must
			 be clear and legible with letters at least three (3) inches in size, and the
			 sign shall be free from obstruction and visible to patients at the time the
			 prescription is presented to the pharmacy.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-37 - REMOTE AUTOMATED MEDICATION SYSTEMS › Rule 480-37-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of this Chapter, the following words shall
				mean:
(a) "Board" means the Georgia
			 Board of Pharmacy
(b) "GDNA" means
			 the Georgia Drugs and Narcotics Agency.
(c) "Remote automated medication system" or
			 "RAMS" means an automated mechanical system in which medication is stored and
			 retrieved for a specific patient pursuant to a practitioner's prescription
			 medication order.
O.C.G.A. Secs.
				 26-4-5,  26-4-28.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-37 - REMOTE AUTOMATED MEDICATION SYSTEMS › Rule 480-37-.02 - Licensure

Current through Rules and Regulations filed through June 27, 2024
(a) In order to
			 install or operate a RAMS, a Georgia licensed pharmacy must make application
			 for licensure to the Board on a form approved by the Board, and pay a fee. No
			 person other than an approved licensed pharmacy may install or operate a RAMS.
			 Each location having a RAMS must have a separate license from the Board. If
			 more than one licensed pharmacy operates a RAMS at the same skilled nursing
			 facility or hospice, each licensed pharmacy must maintain a registration at the
			 skilled nursing facility or hospice. A Georgia licensed pharmacy that has paid
			 a fee for one RAMS location will be required to pay fees for the additional
			 locations.
(b) Licenses are renewed
			 for two years and expire on June 30th of each odd-numbered year. Renewals are
			 contingent upon the renewal of the pharmacy facility license. If the
			 application for renewal is not made and the fee paid before September 1st of
			 the odd-numbered year, the license shall lapse, and an application for
			 reinstatement shall be required. Reinstatement is at the sole discretion of the
			 Board.
(c) A Georgia licensed
			 pharmacy may only use the RAMS at a skilled nursing facility or hospice
			 licensed as such pursuant to O.C.G.A. T. 31, Ch. 7, that does not have an
			 on-site licensed pharmacy.
(d) The
			 Pharmacist-in-Charge (PIC) for a licensed pharmacy shall be considered the PIC
			 for each separate license to operate a RAMS at a skilled nursing facility or
			 hospice.
(e) The RAMS must collect,
			 control, and maintain all transaction information.
O.C.G.A. §§
									26-4-5,  26-4-28,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-37 - REMOTE AUTOMATED MEDICATION SYSTEMS › Rule 480-37-.03 - Minimum Requirements

Current through Rules and Regulations filed through June 27, 2024
Minimum Requirements. A pharmacy may use a RAMS provided
				that:
(a) The pharmacy has a policy
			 and procedure manual at the skilled nursing facility or hospice that includes:
1. The type or name of each RAMS including a
			 serial number or other identifying nomenclature.
2. A method to ensure security of a RAMS to
			 prevent unauthorized access. Such method may include the use of electronic
			 passwords, biometric identification (optic scanning or fingerprint) or other
			 coded identification.
3. A process
			 of filling and stocking a RAMS with drugs; an electronic or hard copy record of
			 medication filled into the system including the product identification, lot
			 number, and expiration date.
4.
			 Documentation of inventory procedures including removal of any
			 discontinued/outdated medications.
5. Compliance with a Continuous Quality
			 Improvement Program.
6. A method to
			 ensure that patient confidentiality is maintained.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-37 - REMOTE AUTOMATED MEDICATION SYSTEMS › Rule 480-37-.04 - Dispensing Drugs

Current through Rules and Regulations filed through June 27, 2024
Drugs shall only be dispensed by the RAMS pursuant to
				prescription drug orders of practitioners authorized under the laws of this
				state to prescribe drugs.
O.C.G.A. Secs.
				 16-13-41,  16-13-74,  26-4-5,  26-4-28.