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The Senate Committee on Regulated Industries and Utilities offered the following
substitute to HB 196:
A BILL TO BE ENTITLED
AN ACT
To amend Chapter 2 of Title 2 of the Official Code of Georgia Annotated, relating to the1
Department of Agriculture, so as to provide for the study of the regulation of the production,2
distribution, and use of medical cannabis; to amend Article 9 of Chapter 12 of Title 16 of the3
Official Code of Georgia Annotated, relating to access to medical cannabis, so as to provide4
that the Georgia Access to Medical Cannabis Commission shall be subject to the5
Administrative Procedure Act, laws governing open meetings and open records, and state6
purchasing laws; to provide for information to be provided to the Medical Cannabis7
Commission Oversight Committee unless exempt from public disclosure under open records8
laws; to authorize the location of retail outlets for the dispensing of low THC oil and9
products to registered patients at Class 1 and Class 2 production facilities; to authorize the10
dispensing of low THC oil and products from any Class 1 or Class 2 production licensee by11
any dispensing licensee; to provide for additional Class 1 and Class 2 production licenses;12
to provide for criteria; to provide for appeals to the Georgia State-wide Business Court; to13
require each commissioner to file an annual financial disclosure statement; to amend Code14
Section 31-2A-18 of the Official Code of Georgia Annotated, relating to the Low THC Oil15
Patient Registry, so as to expand conditions for which low THC oil may be used for16
treatment; to provide for related matters; to provide for an effective date; to repeal conflicting17
laws; and for other purposes.18 23 LC 36 5597S
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BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:19
SECTION 1.20
Chapter 2 of Title 2 of the Official Code of Georgia Annotated, relating to the Department21
of Agriculture, is amended by adding a new Code section to read as follows:22
"2-2-14.23
Prior to September 1, 2023, the Commissioner shall undertake a thorough study of issues24
and problems relating to regulation of the production, distribution, and use of medical25
cannabis in the State of Georgia. No later than December 1, 2023, the Commissioner shall26
submit a report to the Governor, Lieutenant Governor, and Speaker of the House of27
Representatives detailing any organizational, budgetary, or legislative changes the28
Commissioner may recommend in regard to these issues."29
SECTION 2.30
Article 9 of Chapter 12 of Title 16 of the Official Code of Georgia Annotated, relating to31
access to medical cannabis, is amended by revising Code Section 16-12-202, relating to the32
creation of Georgia Access to Medical Cannabis Commission, terms, designation, meetings,33
vacancy, and compensation, by adding a new subsection to read as follows:34
"(f) The commission shall be subject to the provisions of Article 3 of Chapter 5, Chapter35
13, Chapter 14, and Article 4 of Chapter 18 of Title 50, except as otherwise provided in this36
article."37
SECTION 3.38
Said article is further amended by revising paragraphs (2) and (17) of Code39
Section 16-12-203, relating to powers, duties, and responsibilities of the Georgia Access to40
Medical Cannabis Commission, as follows:41 23 LC 36 5597S
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"(2) To execute a contract or contracts to purchase or obtain low THC oil, cannabis,42
cannabinoids, or any other derivative, compound, or substantially similar products from43
any available legal source and to provide logistics related thereto in accordance with this44
article. Such contract or contracts may be executed with one or more qualified45
corporations or with one or more governmental entities. Purchases made and contracts46
entered into pursuant to this paragraph shall not be subject to state purchasing laws47
contained in Article 3 of Chapter 5 of Title 50 or in other provisions of the Official Code48
of Georgia Annotated;"49
"(17) To levy fines for failure by a Class 1 production licensee, Class 2 production50
licensee, or dispensing licensee to operate in accordance with rules and regulations51
established by the commission within 14 days of written notice by the commission of52
specific violations. Such fines shall not exceed $25,000.00 for a first offense, $50,000.0053
for a failure to remedy the offense within 60 days after written notice of a first offense,54
and $75,000.00 for subsequent failures to remedy noncompliance within 90 days after55
written notice of a first offense. Following a third written notice of a recurring violation,56
the commission may also order a licensee to cease operations for a period of up to 3057
days to correct the violation. Any such fines or orders to cease operations shall be subject58
to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.';' provided,59
however, that any appeal from a final decision shall be made to the Georgia State-wide60
Business Court in accordance with Code Section 16-12-221.1."61
SECTION 4.62
Said article is further amended by revising Code Section 16-12-206, relating to annual,63
nontransferable dispensing license, adoption of rules, and fees, as follows:64
"16-12-206.65
(a)(1) Upon request by a licensed pharmacy in this state, the State Board of Pharmacy66
shall be authorized to develop an annual, nontransferable specialty dispensing license for67 23 LC 36 5597S
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an independent pharmacy with a registered office located within this state to dispense low68
THC oil and products to registered patients. The State Board of Pharmacy shall develop69
rules and regulations regarding dispensing pharmacies in this state in accordance with the70
requirements contained in subsection (b) of this Code section.71
(2) The commission shall be authorized to issue five dispensing licenses to each Class72
1 production licensee and each Class 2 production licensee for retail outlets to dispense73
low THC oil and products to registered patients. In addition, the commission shall be74
authorized to issue a dispensing license for a retail outlet to each Class 1 production75
licensee and each Class 2 production licensee for the purpose of establishing a retail76
outlet for the dispensing of low THC oil and products to registered patients at the location77
of the Class 1 production licensee's production facility or at the location of the Class 278
production licensee's production facility. The commission shall ensure that dispensing79
licenses shall be issued so that retail outlets are dispersed throughout the state. The80
commission shall develop rules and regulations regarding retail dispensing licensees in81
this state in accordance with the requirements contained in subsection (b) of this Code82
section. The commission shall be authorized to issue one additional dispensing license83
to each Class 1 and Class 2 production licensee when the Low THC Oil Patient Registry84
established and maintained pursuant to Code Section 31-2A-18 reaches 25,000 75,00085
patients and for every increase of 10,000 50,000 patients thereafter.86
(b) The State Board of Pharmacy and the commission shall separately adopt rules relating87
to the dispensing of low THC oil and products, with the State Board of Pharmacy88
promulgating rules and regulations for pharmacies that dispense low THC oil and products89
and the commission promulgating rules and regulations for other retail outlets that dispense90
low THC oil and products. Such rules shall include but not be limited to:91
(1) Standards, procedures, and protocols for the effective use of low THC oil and92
products as authorized by state law and related rules and regulations;93 23 LC 36 5597S
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(2) Standards, procedures, and protocols for the dispensing of low THC oil and products94
by a pharmacy with a dispensing license and by retail dispensing licensees and for the95
utilization of a tracking system;96
(3) Procedures and protocols to provide that no low THC oil or products may be sold to97
or transferred to a location outside of this state;98
(4) The establishment of standards, procedures, and protocols for determining the99
amount of usable low THC oil and products that is necessary to constitute an adequate100
supply for registered patients in this state to ensure uninterrupted availability for a period101
of one month, including amounts for topical treatments;102
(5) The establishment of standards, procedures, and protocols to ensure that all low THC103
oil and products dispensed are consistently pharmaceutical grade;104
(6) The establishment of standards and procedures for the revocation, suspension, and105
nonrenewal of dispensing licenses;106
(7) The establishment of other licensing, renewal, and operational standards which are107
deemed necessary by the State Board of Pharmacy and the commission;108
(8) The establishment of standards and procedures for testing low THC oil and products109
for levels of tetrahydrocannabinol or other testing parameters deemed appropriate by the110
State Board of Pharmacy and the commission;111
(9) The establishment of health, safety, and security requirements for pharmacies and112
retail dispensing licensees dispensing low THC oil and products; and113
(10) Requirements for the issuance of dispensing licenses to pharmacies and Class 1 and114
Class 2 production licensees.115
(c) The commission shall be authorized, by rules and regulations, to establish fees for116
dispensing licenses to Class 1 and Class 2 production licensees commensurate with the117
location of the retail outlet and demand for low THC oil and products at such location.118
(d) Each dispensing location shall be authorized to sell low THC oil and products from any119
Class 1 or Class 2 production licensee in this state."120 23 LC 36 5597S
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SECTION 5.121
Said article is further amended by revising Code Section 16-12-207, relating to establishment122
of Medical Cannabis Commission Oversight Committee, membership, inspections, provision123
of information, plan for accredited lab testing, and patient and physician input, as follows:124
"16-12-207.125
(a) The General Assembly shall establish a Medical Cannabis Commission Oversight126
Committee with two members appointed by the Lieutenant Governor and two members127
appointed by the Speaker of the House of Representatives. Any member of the Medical128
Cannabis Commission Oversight Committee shall be permitted to inspect any production129
facility upon request and after reasonable notice is provided to the production facility.130
(b) The commission shall promptly provide any document or information requested by the131
oversight committee that is in its possession, provided that the commission shall not be132
required to share documents containing data identifying individual patients or physicians,133
information marked as trade secrets by applicants or licensees, information that in the view134
of the commission would interfere with an ongoing licensing applicant selection process,135
or information that in the judgment of the commission would create law enforcement or136
security risks to the citizens of Georgia any information that would be exempt from public137
disclosure pursuant to Code Section 50-18-72 or pursuant to state or federal privacy laws.138
(c) No later than August 1, 2021, the oversight committee shall recommend to the139
commission a process and plan for providing accredited lab testing of products produced140
by licensees and for labeling such products. The commission shall consider the141
recommendations of the oversight committee in adopting policies, procedures, and142
regulations regarding such testing and labeling Reserved.143
(d) The oversight committee may regularly seek input from patients and physicians as to144
the availability and quality of products produced pursuant to this chapter, and recommend145
to the commission changes to policies, procedures, and regulations to improve availability146 23 LC 36 5597S
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and quality. The commission shall consider such recommendations in adopting policies,147
procedures, and regulations."148
SECTION 6.149
Said article is further amended by revising Code Section 16-12-220, relating to confidential150
nature of data, exclusion, and patient privacy, as follows:151
"16-12-220.152
(a) All working papers, recorded information, documents, and copies produced by,153
obtained by, or disclosed to the commission pursuant to the activities conducted pursuant154
to this part, other than information published in an official commission report regarding the155
activities conducted pursuant to this article, shall be confidential data and shall not be156
subject to Article 4 of Chapter 18 of Title 50; provided, however, that any contract,157
memorandum of understanding, or cooperative endeavor agreement entered into by the158
commission pursuant to this article shall be subject to Article 4 of Chapter 18 of Title 50,159
relating to open records.160
(b) In no event shall the commission disclose any information that would reveal the161
identity or health information of any registered patient or violate the federal Health162
Insurance Portability and Accountability Act of 1996, Public Law 104-191."163
SECTION 7.164
Said article is further amended by revising subsection (a) of Code Section 16-12-221, relating165
to contracts awarded through bids or proposals, minimum contract terms and renewals,166
subcontracting, and giving or receiving things of value limited, as follows:167
"(a)(1) The commission shall grant initial licenses under this part pursuant to contracts168
awarded through competitive sealed bids or competitive sealed proposals as provided for169
in Article 3 of Chapter 5 of Title 50. After issuance of two initial Class 1 production170
licenses pursuant to Code Section 16-12-211 and four initial Class 2 production licenses171 23 LC 36 5597S
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pursuant to Code Section 16-12-212, and in the Department of Agriculture shall issue one172
additional class 2 production license for every increase of 50,000 patients provided that173
the Low THC Oil Patient Registry exceeds 250,000 patients, the current production174
licenses are inadequate to address the registry patient demand, and the grant of such175
licenses is ratified by the legislature. Thereafter, the initial increase in the number of176
production licenses in the Low THC Oil Patient Registry shall be based on the findings177
of the Commissioner of the Department of Agriculture as provided in Code Section178
2-2-14.179
(2) In the event that the commission revokes a Class 1 or Class 2 production license, a180
Class 1 or Class 2 production license is surrendered for any reason, or the commission181
issues an additional Class 1 production license pursuant to Code Section 16-12-214, the182
commission shall be authorized to issue any replacement Class 1 or Class 2 production183
licenses in accordance with rules and regulations established by the commission for such184
purpose. Such rules and regulations shall not otherwise conflict with this article, and to185
the extent practicable, such rules and regulations shall incorporate provisions and186
processes similar to Article 3 of Chapter 5 of Title 50."187
SECTION 8.188
Said article is further amended by adding a new Code section to read as follows:189
"16-12-221.1.190
(a) The Georgia State-wide Business Court shall exercise exclusive jurisdiction over any191
appeal by a party aggrieved by a final decision of the commission pursuant to this article.192
The Georgia State-wide Business Court shall conduct expedited hearings on any such193
appeals, and review by the court shall be confined to the record.194
(b) The court shall not substitute its judgment for that of the commission as to the weight195
of the evidence on questions of fact committed to the discretion of the commission. The196
court may affirm any decision of the commission in whole or in part. The court shall197 23 LC 36 5597S
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reverse or remand any case for further proceedings if material rights of the appellant have198
been prejudiced because the commission's findings, inferences, conclusions, or decisions199
are:200
(1) In violation of constitutional or statutory provisions or applicable procurement rules;201
(2) Made upon unlawful procedures;202
(3) Affected by other error of law;203
(4) Not reasonably supported by substantial evidence in view of the reliable and204
probative evidence in the record as a whole; or205
(5) Arbitrary or capricious or characterized by abuse of discretion or clearly unwarranted206
exercise of discretion."207
SECTION 9.208
Said article is further amended by revising subsection (c) of Code Section 16-12-222, relating209
to transfer of ownership, appeals, meaning of license, and transfer fees, as follows:210
"(c) A licensee who has been denied transfer approval by the commission may file an211
appeal in the Superior Court of Fulton County in accordance with Chapter 13 of Title 50,212
the 'Georgia Administrative Procedure Act.' with the Georgia State-wide Business Court213
in accordance with Code Section 16-12-221.1."214
SECTION 10.215
Said article is further amended by revising subsection (b) of Code Section 16-12-223,216
relating to revocation of license and appeal, as follows:217
"(b) A licensee whose license has been revoked by the commission may file an appeal in218
the Superior Court of Fulton County in accordance with Chapter 13 of Title 50, the219
'Georgia Administrative Procedure Act.' with the Georgia State-wide Business Court in220
accordance with Code Section 16-12-221.1."221 23 LC 36 5597S
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SECTION 11.222
Said article is further amended by revising Code Section 16-12-224, relating to limitation on223
ownership by member or former member of commission, limitation on physician's224
involvement, and identification when contributing to political campaigns, as follows:225
"16-12-224.226
(a) No current member of the commission, or former member of the commission for a227
period of five years from the date such individual ceased to be a member, shall own,228
operate, have a financial interest in, or be employed by a low THC oil or product229
manufacturer or distributor, including any licensee under this part.230
(b) No physician who, presently or during the period of such business relationship,231
certifies individuals to the commission pursuant to Code Section 31-2A-18 for the use of232
low THC oil and products to treat certain conditions shall own, operate, have a financial233
interest in, or be employed by a low THC oil or product manufacturer or distributor,234
including any licensee under this part. This subsection shall not prohibit a physician from235
furnishing a registered patient or his or her caregiver, upon request, with the names of low236
THC oil and product manufacturers or distributors. Any physician violating this Code237
section shall be guilty of a misdemeanor.238
(c) Each member of the commission shall file an annual financial disclosure statement for239
the preceding calendar year with the Office of Inspector General no later than July 1 of240
each year. Such financial disclosure shall include ownership interests in businesses,241
income, and source or sources of income for the previous calendar year. For any242
commissioner serving as of May 1, 2023, such disclosure for the 2022 calendar year shall243
be filed with the Office of Inspector General no later than May 31, 2023.244
(c)(d) A licensee that makes a campaign contribution pursuant to Article 2 of Chapter 5245
of Title 21 shall identify itself as a licensee under this part to the recipient of such246
campaign contribution."247 23 LC 36 5597S
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SECTION 12.248
Code Section 31-2A-18 of the Official Code of Georgia Annotated, relating to the Low THC249
Oil Patient Registry, is amended by revising paragraph (3) of subsection (a) as follows:250
"(3) 'Condition' means:251
(A) Cancer, when such disease is diagnosed as end stage or the treatment produces252
related wasting illness or recalcitrant nausea and vomiting;253
(B) Amyotrophic lateral sclerosis, when such disease is diagnosed as severe or end254
stage;255
(C) Seizure disorders related to a diagnosis of epilepsy or trauma related head injuries;256
(D) Multiple sclerosis, when such disease is diagnosed as severe or end stage;257
(E) Crohn's disease;258
(F) Mitochondrial disease;259
(G) Parkinson's disease, when such disease is diagnosed as severe or end stage;260
(H) Sickle cell disease, when such disease is diagnosed as severe or end stage;261
(I) Tourette's syndrome, when such syndrome is diagnosed as severe;262
(J) Autism spectrum disorder, when such disorder is diagnosed for a patient who is at263
least 18 years of age, or severe autism, when diagnosed for a patient who is less than264
18 years of age;265
(K) Epidermolysis bullosa;266
(L) Alzheimer's disease, when such disease is diagnosed as severe or end stage;267
(M) Acquired immune deficiency syndrome, when such syndrome is diagnosed as268
severe or end stage;269
(N) Peripheral neuropathy, when such symptoms are diagnosed as severe or end stage;270
(O) Post-traumatic stress disorder resulting from direct exposure to or the witnessing271
of a trauma for a patient who is at least 18 years of age; or272
(P) Intractable pain;273
(Q) Ulcerative colitis; or274 23 LC 36 5597S
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(R) Myasthenia Gravis."275
SECTION 13.276
This Act shall become effective upon its approval by the Governor or upon its becoming law277
without such approval.278
SECTION 14.279
All laws and parts of laws in conflict with this Act are repealed.280