24 HB 1072/AP
House Bill 1072 (AS PASSED HOUSE AND SENATE)
By: Representatives Cooper of the 45
th
, Newton of the 127
th
, Parrish of the 158
th
, Jackson of
the 128
th
, Stephens of the 164
th
, and others
A BILL TO BE ENTITLED
AN ACT
To amend Titles 26, 31, and 48 of the Official Code of Georgia Annotated, relating to food,
1
drugs, and cosmetics, health, and revenue and taxation, respectively, so as to increase the2
public's access to prescription drugs by increasing the number of pharmacy technicians3
authorized to be supervised by a pharmacist in certain circumstances and by revising4
provisions relative to the drug repository program; to authorize the Georgia State Board of5
Pharmacy to increase the maximum ratio of pharmacists to pharmacy technicians in6
closed-door pharmacies; to provide definitions; to provide for additional pharmacy7
technicians for certain non-dispensing related duties in the drug repository program; to8
require reverse drug distributors to make and document diligent efforts to donate drugs rather9
than destroy them; to provide for an eligible recipient to substitute a drug under certain10
circumstances; to provide for legislative intent regarding certain settlement funds received11
by the state; to provide for referrals to the drug repository program; to exempt sales to or by12
certain eligible recipients in the drug repository program; to provide for related matters; to13
provide for legislative findings; to provide for an effective date and applicability; to repeal14
conflicting laws; and for other purposes.15
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16
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PART I
17
Closed-door pharmacies18
SECTION 1-1.19
Title 26 of the Official Code of Georgia Annotated, relating to food, drugs, and cosmetics,20
is amended in Code Section 26-4-82, relating to duties requiring professional judgment and21
responsibilities of a licensed pharmacist, by revising subsection (d) as follows:22
"(d) The board of pharmacy shall promulgate rules and regulations regarding the activities23
and utilization of pharmacy technicians in pharmacies, including the establishment of a24
registry as required in paragraph (7) of subsection (a) of Code Section 26-4-28; provided,25
however, that the pharmacist to pharmacy technician ratio shall not exceed one pharmacist26
providing direct supervision of four pharmacy technicians. The board may consider and27
approve an application to increase the ratio in a pharmacy located in a licensed hospital or
28
in a closed-door pharmacy. Such application must be made in writing and must be29
submitted to the board by the pharmacist in charge of a specific hospital pharmacy in this30
state or a specific closed-door pharmacy. At any time during which the pharmacist directly31
supervises four or more pharmacy technicians, two of such technicians must be certified. 32
At any time during which the pharmacist directly supervises three pharmacy technicians,33
one of such technicians must be certified. No certification is required for pharmacy34
technicians in pharmacies at any time during which the pharmacist directly supervises one35
or two pharmacy technicians. In order to be certified, pharmacy technicians must:36
(1) Have successfully passed a certification program approved by the board of pharmacy;37
(2) Have successfully passed an employer's training and assessment program which has38
been approved by the board of pharmacy; or39
(3) Have been certified by either the Pharmacy Technician Certification Board or any40
other nationally recognized certifying body approved by the board of pharmacy.41
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As used in this subsection, the term 'closed-door pharmacy' means a pharmacy that42
provides specialized services and is not open to the general public."43
PART II44
Drug repository program45
SECTION 2-1.46
The General Assembly finds:47
(1) Access to affordable medications is a public health issue that disproportionately48
impacts vulnerable patients, and a state's drug repository program can serve as a solution49
to thousands of families for life-saving and life-preserving medications; and50
(2) Participating recipient organizations can provide a valuable community benefit to51
families in need by making donated medications available and will be authorized to utilize52
additional pharmacy technicians to distribute donated medications under the drug53
repository program.54
SECTION 2-2.55
Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by revising56
Code Section 31-8-300, relating to definitions relative to the drug repository program, as57
follows:58
"31-8-300.59
As used in this article, the term:60
(1) 'Controlled substance' means a drug, substance, or immediate precursor in Schedules61
I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I through V of62
21 C.F.R. Part 1308 as of January 1, 2023.63
(2) 'Disposition' means destroy, dispose of, return, quarantine, or otherwise prevent from64
further distribution.65
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(3) 'Eligible drug' means an over-the-counter or prescription drug, including drugs66
labeled specifically for investigational use and approved by the United States Food and67
Drug Administration as such, which may be donated to the program pursuant to Code68
Section 31-8-301.69
(2)(4) 'Eligible patient' means an individual who is indigent, uninsured, underinsured, or70
enrolled in a public assistance health benefits program, in accordance with criteria71
established by the Department of Public Health pursuant to Code Section 31-8-304. 72
Other individuals may be considered eligible patients if the need for donated drugs for73
indigent, uninsured, underinsured, and public assistance health benefits program patients74
is less than the supply of donated drugs.75
(3)(5) 'Eligible recipient' means a pharmacy, hospital, federally qualified health center,76
nonprofit clinic, or other entity meeting the criteria established by the Department of77
Public Health pursuant to Code Section 31-8-304.78
(6) 'Expiration date' means the original expiration date provided by the manufacturer or79
repackager or the expiration date provided on the medication's packaging or prescription80
drug label.81
(4)(7) 'Health care facility' means a:82
(A) Nursing home licensed pursuant to Article 1 of Chapter 7 of this title;83
(B) Personal care home licensed pursuant to Code Section 31-7-12;84
(C) Assisted living community licensed pursuant to Code Section 31-7-12.2;85
(D) Hospice licensed pursuant to Article 9 of Chapter 7 of this title; and86
(E) Home health agency licensed pursuant to Article 7 of Chapter 7 of this title.87
(5)(8) 'Health care professional' means any of the following who provide medical, dental,88
or other health related diagnosis diagnoses, care, or treatment:89
(A) Physicians licensed to practice medicine under Chapter 34 of Title 43;90
(B) Registered nurses and licensed practical nurses licensed under Chapter 26 of91
Title 43;92
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(C) Physician assistants licensed under Chapter 34 of Title 43;
93
(D) Dentists and dental hygienists licensed under Chapter 11 of Title 43;94
(E) Optometrists licensed under Chapter 30 of Title 43; and95
(F) Pharmacists licensed under Chapter 4 of Title 26.96
(6)
(9) 'Hospital' means a facility licensed pursuant to Chapter 7 of this title.97
(7)(10) 'Program' means the drug repository program established pursuant to Code98
Section 31-8-301.99
(11) 'Short-dated' means within five months of a drug's expiration date."100
SECTION 2-3.101
Said title is further amended by revising Code Section 31-8-301, relating to the establishment102
of a drug repository program and criteria and requirements for unused over-the-counter and103
prescription drugs, as follows:104
"31-8-301.105
(a) The Department of Public Health shall establish a drug repository program to accept106
and dispense over-the-counter and prescription drugs donated for the purpose of being107
dispensed to eligible patients.108
(b) Drugs shall only be dispensed pursuant to the program if:109
(1) For prescription drugs, they do with an expiration date that does not expire before the110
completion of the medication by the eligible patient based on the prescribing health care111
professional's directions for use and, for over-the-counter drugs, they do with an112
expiration date that does not expire before use by the eligible patient based on the113
directions for use on the manufacturer's label; and114
(2) The drugs were donated in unopened tamper-evident packaging as defined by United115
States Pharmacopeia General Chapter 659, Packaging and Storage Requirements,116
including but not limited to unopened unit-dose and multiple-dose packaging.117
(c) The following drugs shall not be donated to the program:118
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(1) Controlled substances;
119
(2) Drugs subject to a federal Food and Drug Administration managed risk evaluation120
and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code121
if inventory transfer is prohibited by such strategy; or122
(3) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7."123
SECTION 2-4.124
Said title is further amended in Code Section 31-8-302, relating to procedures for donation125
and dispensing of unused over-the-counter and prescription drugs, by adding new subsections126
to read as follows:127
"(f) In addition to the maximum number of pharmacy technicians that are authorized to be
128
under the direct supervision of a pharmacist pursuant to subsection (d) of Code129
Section 26-4-82, a participating pharmacy may utilize up to two additional pharmacy130
technicians under the direct supervision of such pharmacist for duties related to the131
program; provided, however, that the two such additional pharmacy technicians shall not132
be authorized to assist the supervising pharmacist in connection with any activities related133
to completing a prescription drug order or preparation of a prescription drug for a patient,134
but shall only be authorized to perform non-dispensing related duties, such as, but not135
limited to, receiving and stocking inventory.136
(g) A reverse drug distributor permitted or licensed by the State Board of Pharmacy shall:137
(1) Make and document diligent efforts to donate eligible drugs within 30 days of taking138
possession to the program in accordance with Code Section 31-8-301 rather than destroy139
such drugs;140
(2) Not directly or indirectly by transferring to another entity or by other means, cause141
eligible drugs to be dispositioned, become short-dated, expire, or otherwise become142
ineligible for donation; and143
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(3) Make and document diligent efforts to ensure that any policy, contract, or other144
business arrangement between the reverse drug distributor and its clients or other parties145
does not prohibit the donation of eligible drugs received from any such client or other146
party to the program in accordance with Code Section 31-8-301; provides for the same147
rate of compensation for the client or other party for donation of eligible drugs and other148
disposition of such drugs; and does not require an eligible drug to be dispositioned,149
become short-dated, expire, or otherwise become ineligible for donation.150
(h) Any person or entity eligible to donate drugs under the program shall be allowed to151
donate eligible drugs in the same manner, at the same rate of compensation, and paid for152
by the same parties as applies to the disposition of drugs regardless of any policy, contract,153
or other business arrangement that would have otherwise directly or indirectly by154
transferring to another entity or by other means required an eligible drug to be155
dispositioned, become short-dated, expire, or otherwise become ineligible for donation.156
(i) The donation, brokering, or other facilitation of a donation of a drug pursuant to this157
program shall not be considered wholesale distribution as defined in Code Section158
26-4-201 and shall not be subject to or require licensure as a wholesale distributor pursuant159
to Chapter 4 of Title 26.160
(j) Eligible recipients that provide pharmacy related services only for the purpose of161
dispensing donated or purchased drugs pursuant to the program shall not be subject to162
comprehensive formulary or minimum supply of drugs requirements contained in163
Chapter 4 of Title 26."164
SECTION 2-5.165
Said article is further amended by adding new Code sections to read as follows:166
"31-8-305.167
(a) Notwithstanding Article 5 of Chapter 4 of Title 26, an eligible recipient may substitute:168
(1) A prescribed drug with a therapeutically equivalent drug; or169
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(2) A biological product with an interchangeable biological product.170
(b) Substitutions made pursuant to subsection (a) of this Code section may include, but are171
not limited to:172
(1) Splitting a combination drug into two or more drugs;173
(2) Combining two or more drugs into a combination drug; and174
(3) Substituting a different form of a prescribed drug, including, but not limited to, an175
oral tablet or capsule.176
(c) If an eligible recipient dispenses or administers a substitute drug pursuant to this Code177
section, such substitution shall be communicated to the patient and the prescribing health178
care professional, unless the program's substitution policy is readily available on the179
eligible recipient's website.180
(d) Whenever a substitution is made, the eligible recipient shall record on the original181
prescription or the patient's prescription drug label that there has been a substitution and182
the identity of the dispensed drug product or interchangeable biological product.183
31-8-306.184
(a) It is the intent of the General Assembly that a portion of the proceeds of settlements185
received by the state relating to prescription drugs that are not controlled substances be186
appropriated for purposes of the program and distributed to eligible recipients in proportion187
to each such recipient's participation rate in the program.188
(b) It is further the intent of the General Assembly that if funds are appropriated for189
purposes of this article, the department shall be required to distribute such appropriations190
to eligible recipients in proportion to each such recipient's level of participation in the191
program.192
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31-8-307.193
(a) Hospitals and pharmacies licensed in this state and state programs that provide health194
care coverage or health care services to patients, recipients, or other individuals in this195
state, including, but not limited to, Medicaid, PeachCare for Kids Program, alcohol and196
drug awareness programs, and the Department of Corrections shall provide such patients,197
recipients, or other individuals with referral information to the program for eligible drugs198
available through the program for:199
(1) Drugs not currently covered under a state program;200
(2) Patients who do not meet the eligibility coverage for a state program or become201
unenrolled or leave a state program;202
(3) Drugs that are covered under a state program but are otherwise inaccessible to a203
patient due to, but not limited to a gap in coverage or out-of-pocket costs that are too high204
for a specific patient, recipient, or other individual; a prior authorization requirement; step205
therapy requirements; or high co-payments; or206
(4) A patient, recipient, or other individual for a drug that is covered under a state207
program but that the claim for coverage is denied with respect to the specific patient,208
recipient, or other individual.209
(b) Recipients of the federal Title X Family Planning Program shall make and document210
diligent efforts to subcontract with interested eligible recipients participating in the211
program to offer family planning services to rural and low-income populations.212
(c) If an eligible recipient offers value-added services and referrals, in addition to just213
providing medicine, such eligible recipient may also be eligible for discounted medication214
pricing to help widen such eligible recipient's formularies of medication and increase215
financial sustainability of its participation in the program."216
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SECTION 2-6.
217
Title 48 of the Official Code of Georgia Annotated, relating to revenue and taxation, is218
amended in Code Section 48-8-3, relating to exemptions from sales and use taxes, by219
deleting "or" at the end of paragraph (103), by replacing the period with "; or" at the end of220
paragraph (104), and by adding a new paragraph to read as follows:221
"(105) Sales to or by an eligible recipient, as defined in Code Section 31-8-300, which
222
provides pharmacy related services only for the purpose of dispensing donated or223
purchased drugs pursuant to the drug repository program established under Article 10 of224
Chapter 8 of Title 31, if such organization qualifies as a tax-exempt organization under225
Section 501(c)(3) of the Internal Revenue Code or is an organization that is treated for226
federal income tax purposes as a disregarded entity of a tax-exempt organization under227
Section 501(c)(3) of the Internal Revenue Code."228
PART III229
Effective date and repealer230
SECTION 3-1.231
This Act shall become effective upon its approval by the Governor or upon its becoming law232
without such approval; provided, however, that Section 2-6 of this Act shall be applicable233
to taxable years beginning on or after January 1, 2025.234
SECTION 3-2.235
All laws and parts of laws in conflict with this Act are repealed.236
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