LC 48 0911S
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The House Committee on Rules offers the following substitute to HB 196:
A BILL TO BE ENTITLED
AN ACT
To amend Article 9 of Chapter 12 of Title 16 of the Official Code of Georgia Annotated,1
relating to access to medical cannabis, so as to provide that the Georgia Access to Medical2
Cannabis Commission shall be subject to the Administrative Procedure Act, laws governing3
open meetings and open records, and state purchasing laws; to provide for information to be4
provided to the Medical Cannabis Commission Oversight Committee unless exempt from5
public disclosure under open records laws; to authorize the location of retail outlets for the6
dispensing of low THC oil and products to registered patients at Class 1 and Class 27
production facilities; to authorize the dispensing of low THC oil and products from any8
Class 1 or Class 2 production licensee by any dispensing licensee; to provide for additional9
Class 1 and Class 2 production licenses; to provide for criteria; to provide for appeals to the10
Georgia State-wide Business Court; to require each commissioner to file an annual financial11
disclosure statement; to amend Code Section 31-2A-18 of the Official Code of Georgia12
Annotated, relating to the Low THC Oil Patient Registry, so as to expand conditions for13
which low THC oil may be used for treatment; to provide for related matters; to provide for14
an effective date; to repeal conflicting laws; and for other purposes.15
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16 LC 48 0911S
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SECTION 1.17
Article 9 of Chapter 12 of Title 16 of the Official Code of Georgia Annotated, relating to18
access to medical cannabis, is amended by revising Code Section 16-12-202, relating to the19
creation of Georgia Access to Medical Cannabis Commission, terms, designation, meetings,20
vacancy, and compensation, by adding a new subsection to read as follows:21
"(f) The commission shall be subject to the provisions of Article 3 of Chapter 5, Chapter22
13, Chapter 14, and Article 4 of Chapter 18 of Title 50, except as otherwise provided in this23
article."24
SECTION 2.25
Said article is further amended by revising paragraphs (2) and (17) of Code26
Section 16-12-203, relating to powers, duties, and responsibilities of the Georgia Access to27
Medical Cannabis Commission, as follows:28
"(2) To execute a contract or contracts to purchase or obtain low THC oil, cannabis,29
cannabinoids, or any other derivative, compound, or substantially similar products from30
any available legal source and to provide logistics related thereto in accordance with this31
article. Such contract or contracts may be executed with one or more qualified32
corporations or with one or more governmental entities. Purchases made and contracts33
entered into pursuant to this paragraph shall not be subject to state purchasing laws34
contained in Article 3 of Chapter 5 of Title 50 or in other provisions of the Official Code35
of Georgia Annotated;"36
"(17) To levy fines for failure by a Class 1 production licensee, Class 2 production37
licensee, or dispensing licensee to operate in accordance with rules and regulations38
established by the commission within 14 days of written notice by the commission of39
specific violations. Such fines shall not exceed $25,000.00 for a first offense, $50,000.0040
for a failure to remedy the offense within 60 days after written notice of a first offense,41
and $75,000.00 for subsequent failures to remedy noncompliance within 90 days after42 LC 48 0911S
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written notice of a first offense. Following a third written notice of a recurring violation,43
the commission may also order a licensee to cease operations for a period of up to 3044
days to correct the violation. Any such fines or orders to cease operations shall be subject45
to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.';' provided,46
however, that any appeal from a final decision shall be made to the Georgia State-wide47
Business Court in accordance with Code Section 16-12-221.1."48
SECTION 3.49
Said article is further amended by revising Code Section 16-12-206, relating to annual,50
nontransferable dispensing license, adoption of rules, and fees, as follows:51
"16-12-206.52
(a)(1) Upon request by a licensed pharmacy in this state, the State Board of Pharmacy53
shall be authorized to develop an annual, nontransferable specialty dispensing license for54
an independent pharmacy with a registered office located within this state to dispense low55
THC oil and products to registered patients. The State Board of Pharmacy shall develop56
rules and regulations regarding dispensing pharmacies in this state in accordance with the57
requirements contained in subsection (b) of this Code section.58
(2) The commission shall be authorized to issue five dispensing licenses to each Class59
1 production licensee and each Class 2 production licensee for retail outlets to dispense60
low THC oil and products to registered patients. In addition, the commission shall be61
authorized to issue a dispensing license for a retail outlet to each Class 1 production62
licensee and each Class 2 production licensee for the purpose of establishing a retail63
outlet for the dispensing of low THC oil and products to registered patients at the location64
of the Class 1 production licensee's production facility or at the location of the Class 265
production licensee's production facility. The commission shall ensure that dispensing66
licenses shall be issued so that retail outlets are dispersed throughout the state. The67
commission shall develop rules and regulations regarding retail dispensing licensees in68 LC 48 0911S
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this state in accordance with the requirements contained in subsection (b) of this Code69
section. The commission shall be authorized to issue one additional dispensing license70
to each Class 1 and Class 2 production licensee when the Low THC Oil Patient Registry71
established and maintained pursuant to Code Section 31-2A-18 reaches 25,000 patients72
and for every increase of 10,000 patients thereafter.73
(b) The State Board of Pharmacy and the commission shall separately adopt rules relating74
to the dispensing of low THC oil and products, with the State Board of Pharmacy75
promulgating rules and regulations for pharmacies that dispense low THC oil and products76
and the commission promulgating rules and regulations for other retail outlets that dispense77
low THC oil and products. Such rules shall include but not be limited to:78
(1) Standards, procedures, and protocols for the effective use of low THC oil and79
products as authorized by state law and related rules and regulations;80
(2) Standards, procedures, and protocols for the dispensing of low THC oil and products81
by a pharmacy with a dispensing license and by retail dispensing licensees and for the82
utilization of a tracking system;83
(3) Procedures and protocols to provide that no low THC oil or products may be sold to84
or transferred to a location outside of this state;85
(4) The establishment of standards, procedures, and protocols for determining the86
amount of usable low THC oil and products that is necessary to constitute an adequate87
supply for registered patients in this state to ensure uninterrupted availability for a period88
of one month, including amounts for topical treatments;89
(5) The establishment of standards, procedures, and protocols to ensure that all low THC90
oil and products dispensed are consistently pharmaceutical grade;91
(6) The establishment of standards and procedures for the revocation, suspension, and92
nonrenewal of dispensing licenses;93
(7) The establishment of other licensing, renewal, and operational standards which are94
deemed necessary by the State Board of Pharmacy and the commission;95 LC 48 0911S
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(8) The establishment of standards and procedures for testing low THC oil and products96
for levels of tetrahydrocannabinol or other testing parameters deemed appropriate by the97
State Board of Pharmacy and the commission;98
(9) The establishment of health, safety, and security requirements for pharmacies and99
retail dispensing licensees dispensing low THC oil and products; and100
(10) Requirements for the issuance of dispensing licenses to pharmacies and Class 1 and101
Class 2 production licensees.102
(c) The commission shall be authorized, by rules and regulations, to establish fees for103
dispensing licenses to Class 1 and Class 2 production licensees commensurate with the104
location of the retail outlet and demand for low THC oil and products at such location.105
(d) Each dispensing location shall be authorized to sell low THC oil and products from any106
Class 1 or Class 2 production licensee in this state."107
SECTION 4.108
Said article is further amended by revising Code Section 16-12-207, relating to establishment109
of Medical Cannabis Commission Oversight Committee, membership, inspections, provision110
of information, plan for accredited lab testing, and patient and physician input, as follows:111
"16-12-207.112
(a) The General Assembly shall establish a Medical Cannabis Commission Oversight113
Committee with two members appointed by the Lieutenant Governor and two members114
appointed by the Speaker of the House of Representatives. Any member of the Medical115
Cannabis Commission Oversight Committee shall be permitted to inspect any production116
facility upon request and after reasonable notice is provided to the production facility.117
(b) The commission shall promptly provide any document or information requested by the118
oversight committee that is in its possession, provided that the commission shall not be119
required to share documents containing data identifying individual patients or physicians,120
information marked as trade secrets by applicants or licensees, information that in the view121 LC 48 0911S
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of the commission would interfere with an ongoing licensing applicant selection process,122
or information that in the judgment of the commission would create law enforcement or123
security risks to the citizens of Georgia any information that would be exempt from public124
disclosure pursuant to Code Section 50-18-72 or pursuant to state or federal privacy laws.125
(c) No later than August 1, 2021, the oversight committee shall recommend to the126
commission a process and plan for providing accredited lab testing of products produced127
by licensees and for labeling such products. The commission shall consider the128
recommendations of the oversight committee in adopting policies, procedures, and129
regulations regarding such testing and labeling Reserved.130
(d) The oversight committee may regularly seek input from patients and physicians as to131
the availability and quality of products produced pursuant to this chapter, and recommend132
to the commission changes to policies, procedures, and regulations to improve availability133
and quality. The commission shall consider such recommendations in adopting policies,134
procedures, and regulations."135
SECTION 5.136
Said article is further amended by revising subsection (a) of Code Section 16-12-211, relating137
to Class 1 production licenses, application fees, revocation, and limitation of ownership, as138
follows:139
"(a) The commission may issue up to two initial Class 1 production licenses. The140
commission shall issue four additional Class 1 production licenses pursuant to subsection141
(a) of Code Section 16-12-221, provided that the total number of Class 1 and Class 2142
production licenses shall not exceed 15 production licenses. A Class 1 production licensee143
shall be authorized to:144
(1) Grow cannabis only in indoor facilities for use in producing low THC oil, limited to145
100,000 square feet of cultivation space; and146
(2) Manufacture low THC oil and products."147 LC 48 0911S
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SECTION 6.148
Said article is further amended by revising subsection (a) of Code Section 16-12-212, relating149
to Class 2 production licenses, application fees, revocation, and limitation of ownership, as150
follows:151
"(a) The commission may issue up to four initial Class 2 production licenses. The152
commission shall issue seven additional Class 2 production licenses pursuant to subsection153
(a) of Code Section 16-12-221, provided that the total number of Class 1 and Class 2154
production licenses shall not exceed 15 production licenses. A Class 2 production licensee155
shall be authorized to:156
(1) Grow cannabis only in indoor facilities for use in producing low THC oil, limited157
to 50,000 square feet of cultivation space; and158
(2) Manufacture low THC oil and products."159
SECTION 7.160
Said article is further amended by revising Code Section 16-12-220, relating to confidential161
nature of data, exclusion, and patient privacy, as follows:162
"16-12-220.163
(a) All working papers, recorded information, documents, and copies produced by,164
obtained by, or disclosed to the commission pursuant to the activities conducted pursuant165
to this part, other than information published in an official commission report regarding the166
activities conducted pursuant to this article, shall be confidential data and shall not be167
subject to Article 4 of Chapter 18 of Title 50; provided, however, that any contract,168
memorandum of understanding, or cooperative endeavor agreement entered into by the169
commission pursuant to this article shall be subject to Article 4 of Chapter 18 of Title 50,170
relating to open records.171 LC 48 0911S
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(b) In no event shall the commission disclose any information that would reveal the172
identity or health information of any registered patient or violate the federal Health173
Insurance Portability and Accountability Act of 1996, Public Law 104-191."174
SECTION 8.175
Said article is further amended by revising subsection (a) of Code Section 16-12-221, relating176
to contracts awarded through bids or proposals, minimum contract terms and renewals,177
subcontracting, and giving or receiving things of value limited, as follows:178
"(a)(1) The commission shall grant initial licenses under this part pursuant to contracts179
awarded through competitive sealed bids or competitive sealed proposals as provided for180
in Article 3 of Chapter 5 of Title 50. After issuance of two initial Class 1 production181
licenses pursuant to Code Section 16-12-211 and four initial Class 2 production licenses182
pursuant to Code Section 16-12-212, and in the commission shall issue one additional183
Class 2 production license for every increase of 5,000 patients in the Low THC Oil184
Patient Registry established and maintained pursuant to Code Section 31-2A-18 and one185
additional Class 1 production license for every increase of 10,000 patients in the Low186
THC Oil Patient Registry, subject to the overall limit of total number of Class 1 and Class187
2 production licenses contained in Code Sections 16-12-211 and 16-12-212. The initial188
increase in the number of patients in the Low THC Oil Patient Registry shall be based on189
the number of patients in the registry as of January 1, 2023.190
(2) In the event that the commission revokes a Class 1 or Class 2 production license, a191
Class 1 or Class 2 production license is surrendered for any reason, or the commission192
issues an additional Class 1 production license pursuant to Code Section 16-12-214, the193
commission shall be authorized to issue any replacement Class 1 or Class 2 production194
licenses in accordance with rules and regulations established by the commission for such195
purpose. Such rules and regulations shall not otherwise conflict with this article, and to196 LC 48 0911S
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the extent practicable, such rules and regulations shall incorporate provisions and197
processes similar to Article 3 of Chapter 5 of Title 50."198
SECTION 9.199
Said article is further amended by adding a new Code section to read as follows:200
"16-12-221.1.201
(a) The Georgia State-wide Business Court shall exercise exclusive jurisdiction over any202
appeal by a party aggrieved by a final decision of the commission pursuant to this article.203
The Georgia State-wide Business Court shall conduct expedited hearings on any such204
appeals, and review by the court shall be confined to the record.205
(b) The court shall not substitute its judgment for that of the commission as to the weight206
of the evidence on questions of fact committed to the discretion of the commission. The207
court may affirm any decision of the commission in whole or in part. The court shall208
reverse or remand any case for further proceedings if material rights of the appellant have209
been prejudiced because the commission's findings, inferences, conclusions, or decisions210
are:211
(1) In violation of constitutional or statutory provisions or applicable procurement rules;212
(2) Made upon unlawful procedures;213
(3) Affected by other error of law;214
(4) Not reasonably supported by substantial evidence in view of the reliable and215
probative evidence in the record as a whole; or216
(5) Arbitrary or capricious or characterized by abuse of discretion or clearly unwarranted217
exercise of discretion.218
(c) The court shall require a litigation bond or other form of surety payable to the state219
from any protesting party in an amount determined by the court, which shall be forfeited220
if the court affirms, in whole, the decision of the commission."221 LC 48 0911S
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SECTION 10.222
Said article is further amended by revising subsection (c) of Code Section 16-12-222, relating223
to transfer of ownership, appeals, meaning of license, and transfer fees, as follows:224
"(c) A licensee who has been denied transfer approval by the commission may file an225
appeal with the Georgia State-wide Business Court in accordance with Code Section226
16-12-221.1. in the Superior Court of Fulton County in accordance with Chapter 13 of227
Title 50, the 'Georgia Administrative Procedure Act.'"228
SECTION 11.229
Said article is further amended by revising subsection (b) of Code Section 16-12-223,230
relating to revocation of license and appeal, as follows:231
"(b) A licensee whose license has been revoked by the commission may file an appeal with232
the Georgia State-wide Business Court in accordance with Code Section 16-12-221.1. in233
the Superior Court of Fulton County in accordance with Chapter 13 of Title 50, the234
'Georgia Administrative Procedure Act.'"235
SECTION 12.236
Said article is further amended by revising Code Section 16-12-224, relating to limitation on237
ownership by member or former member of commission, limitation on physician's238
involvement, and identification when contributing to political campaigns, as follows:239
"16-12-224.240
(a) No current member of the commission, or former member of the commission for a241
period of five years from the date such individual ceased to be a member, shall own,242
operate, have a financial interest in, or be employed by a low THC oil or product243
manufacturer or distributor, including any licensee under this part.244
(b) No physician who, presently or during the period of such business relationship,245
certifies individuals to the commission pursuant to Code Section 31-2A-18 for the use of246 LC 48 0911S
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low THC oil and products to treat certain conditions shall own, operate, have a financial247
interest in, or be employed by a low THC oil or product manufacturer or distributor,248
including any licensee under this part. This subsection shall not prohibit a physician from249
furnishing a registered patient or his or her caregiver, upon request, with the names of low250
THC oil and product manufacturers or distributors. Any physician violating this Code251
section shall be guilty of a misdemeanor.252
(c) Each member of the commission shall file an annual financial disclosure statement for253
the preceding calendar year with the Office of Inspector General no later than July 1 of254
each year. Such financial disclosure shall include ownership interests in businesses,255
income, and source or sources of income for the previous calendar year. For any256
commissioner serving as of May 1, 2023, such disclosure for the 2022 calendar year shall257
be filed with the Office of Inspector General no later than May 31, 2023.258
(c)(d) A licensee that makes a campaign contribution pursuant to Article 2 of Chapter 5259
of Title 21 shall identify itself as a licensee under this part to the recipient of such260
campaign contribution."261
SECTION 13.262
Code Section 31-2A-18 of the Official Code of Georgia Annotated, relating to the Low THC263
Oil Patient Registry, is amended by revising paragraph (3) of subsection (a) as follows:264
"(3) 'Condition' means:265
(A) Cancer, when such disease is diagnosed as end stage or the treatment produces266
related wasting illness or recalcitrant nausea and vomiting;267
(B) Amyotrophic lateral sclerosis, when such disease is diagnosed as severe or end268
stage;269
(C) Seizure disorders related to a diagnosis of epilepsy or trauma related head injuries;270
(D) Multiple sclerosis, when such disease is diagnosed as severe or end stage;271
(E) Crohn's disease;272 LC 48 0911S
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(F) Mitochondrial disease;273
(G) Parkinson's disease, when such disease is diagnosed as severe or end stage;274
(H) Sickle cell disease, when such disease is diagnosed as severe or end stage;275
(I) Tourette's syndrome, when such syndrome is diagnosed as severe;276
(J) Autism spectrum disorder, when such disorder is diagnosed for a patient who is at277
least 18 years of age, or severe autism, when diagnosed for a patient who is less than278
18 years of age;279
(K) Epidermolysis bullosa;280
(L) Alzheimer's disease, when such disease is diagnosed as severe or end stage;281
(M) Acquired immune deficiency syndrome, when such syndrome is diagnosed as282
severe or end stage;283
(N) Peripheral neuropathy, when such symptoms are diagnosed as severe or end stage;284
(O) Post-traumatic stress disorder resulting from direct exposure to or the witnessing285
of a trauma for a patient who is at least 18 years of age; or286
(P) Intractable pain;287
(Q) Ulcerative colitis; or288
(R) Myasthenia Gravis."289
SECTION 14.290
This Act shall become effective upon its approval by the Governor or upon its becoming law291
without such approval.292
SECTION 15.293
All laws and parts of laws in conflict with this Act are repealed.294