24 LC 33 9607
House Bill 1072
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 Article 10 of Chapter 8 of Title 31 of the Official Code of Georgia Annotated,
1
relating to the drug repository program, so as to revise definitions; to provide for pharmacist2
to pharmacy technician ratios in the program; to require reverse drug distributors to make and3
document diligent efforts to donate drugs rather than destroy them; to provide for substitution4
of drugs in some instances; to provide for the intent of the General Assembly with respect5
to settlement funds received by the state relating to prescription drugs; to amend Code6
Section 48-8-3 of the Official Code of Georgia Annotated, relating to exemptions from sales7
and use taxes, so as to exempt sales to or by certain eligible recipients; to provide for related8
matters; to provide for legislative findings; to repeal conflicting laws; and for other purposes.9
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:10
SECTION 1.11
The General Assembly finds:12
(1) Access to affordable medications is a public health issue that disproportionately13
impacts vulnerable patients, and a state's drug repository program can serve as a solution14
to thousands of families for life-saving and life-preserving medications; and15
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(2) Participating recipient organizations can provide a valuable community benefit to
16
families in need by making donated medications available and will be authorized to utilize17
additional pharmacy technicians to distribute donated medications under the drug18
repository program.19
SECTION 2.20
Article 10 of Chapter 8 of Title 31 of the Official Code of Georgia Annotated, relating to the21
drug repository program, is amended by revising Code Section 31-8-300, relating to22
definitions, as follows:23
"31-8-300.24
As used in this article, the term:25
(1) 'Controlled substance' means a drug, substance, or immediate precursor in Schedules26
I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I through V of27
21 C.F.R. Part 1308 as of January 1, 2023
.28
(2) 'Disposition' means destroy, dispose of, return, quarantine, or otherwise prevent from29
further distribution.30
(3) 'Eligible drug' means an over-the-counter or prescription drug, including drugs31
labeled specifically for investigational use and approved by the United States Food and32
Drug Administration as such, which may be donated to the program pursuant to Code33
Section 31-8-301.34
(2)(4) 'Eligible patient' means an individual who is indigent, uninsured, underinsured, or35
enrolled in a public assistance health benefits program, in accordance with criteria36
established by the Department of Public Health pursuant to Code Section 31-8-304. 37
Other individuals may be considered eligible patients if the need for donated drugs for38
indigent, uninsured, underinsured, and public assistance health benefits program patients39
is less than the supply of donated drugs.40
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(3)(5) 'Eligible recipient' means a pharmacy, hospital, federally qualified health center,41
nonprofit clinic, or other entity meeting the criteria established by the Department of42
Public Health pursuant to Code Section 31-8-304.43
(6) 'Expiration date' means the original expiration date provided by the manufacturer or44
repackager or the expiration date provided on the medication's packaging or prescription45
drug label.46
(4)(7) 'Health care facility' means a:47
(A) Nursing home licensed pursuant to Article 1 of Chapter 7 of this title;48
(B) Personal care home licensed pursuant to Code Section 31-7-12;49
(C) Assisted living community licensed pursuant to Code Section 31-7-12.2;50
(D) Hospice licensed pursuant to Article 9 of Chapter 7 of this title; and51
(E) Home health agency licensed pursuant to Article 7 of Chapter 7 of this title.52
(5)(8) 'Health care professional' means any of the following who provide medical, dental,53
or other health related diagnosis diagnoses, care, or treatment:54
(A) Physicians licensed to practice medicine under Chapter 34 of Title 43;55
(B) Registered nurses and licensed practical nurses licensed under Chapter 26 of Title56
43;57
(C) Physician assistants licensed under Chapter 34 of Title 43;58
(D) Dentists and dental hygienists licensed under Chapter 11 of Title 43;59
(E) Optometrists licensed under Chapter 30 of Title 43; and60
(F) Pharmacists licensed under Chapter 4 of Title 26.61
(6)(9) 'Hospital' means a facility licensed pursuant to Chapter 7 of this title.62
(7)(10) 'Program' means the drug repository program established pursuant to Code63
Section 31-8-301.64
(11) 'Short-dated' means within five months of a drug's expiration date."65
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SECTION 3.
66
Said article is further amended by revising Code Section 31-8-301, relating to the67
establishment of a drug repository program and criteria and requirements for unused68
over-the-counter and prescription drugs, as follows:69
"31-8-301.70
(a) The Department of Public Health shall establish a drug repository program to accept71
and dispense over-the-counter and prescription drugs donated for the purpose of being72
dispensed to eligible patients.73
(b) Drugs shall only be dispensed pursuant to the program if:74
(1) For prescription drugs, they do
with an expiration date that does not expire before the75
completion of the medication by the eligible patient based on the prescribing health care76
professional's directions for use and, for over-the-counter drugs, they do with an77
expiration date that does not expire before use by the eligible patient based on the78
directions for use on the manufacturer's label; and79
(2) The drugs were donated in unopened tamper-evident packaging as defined by United80
States Pharmacopeia General Chapter 659, Packaging and Storage Requirements,81
including but not limited to unopened unit-dose and multiple-dose packaging.82
(c) The following drugs shall not be donated to the program:83
(1) Controlled substances;84
(2) Drugs subject to a federal Food and Drug Administration managed risk evaluation85
and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code86
if inventory transfer is prohibited by such strategy; or87
(3) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7."88
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SECTION 4.
89
Said article is further amended in Code Section 31-8-302, relating to procedures for donation90
and dispensing of unused over-the-counter and prescription drugs, by adding new subsections91
to read as follows:92
"(f) In addition to the maximum number of pharmacy technicians that are authorized to be
93
under the direct supervision of a pharmacist pursuant to subsection (d) of Code Section94
26-4-82, a participating pharmacy may utilize up to two additional pharmacy technicians95
under the direct supervision of such pharmacist for duties related to the program; provided,96
however, that the two such additional pharmacy technicians shall not be authorized to assist97
the supervising pharmacist in connection with any activities related to completing a98
prescription drug order or preparation of a prescription drug for a patient, but shall only be99
authorized to perform non-dispensing related duties, such as, but not limited to, receiving100
and stocking inventory.101
(g) A reverse drug distributor permitted or licensed by the State Board of Pharmacy shall:102
(1) Make and document diligent efforts to donate eligible drugs within 30 days of taking103
possession to the program in accordance with Code Section 31-8-301 rather than destroy104
such drugs;105
(2) Not directly or indirectly by transferring to another entity or by other means, cause106
eligible drugs to be dispositioned, become short-dated, expire, or otherwise become107
ineligible for donation; and108
(3) Make and document diligent efforts to ensure that any policy, contract, or other109
business arrangement between the reverse drug distributor and its clients or other parties110
does not prohibit the donation of eligible drugs received from any such client or other111
party to the program in accordance with Code Section 31-8-301; provides for the same112
rate of compensation for the client or other party for donation of eligible drugs and other113
disposition of such drugs; and does not require an eligible drug to be dispositioned,114
become short-dated, expire, or otherwise become ineligible for donation.115
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(h) Any person or entity eligible to donate drugs under the program shall be allowed to116
donate eligible drugs in the same manner, at the same rate of compensation, and paid for117
by the same parties as applies to the disposition of drugs regardless of any policy, contract,118
or other business arrangement that would have otherwise directly or indirectly by119
transferring to another entity or by other means required an eligible drug to be120
dispositioned, become short-dated, expire, or otherwise become ineligible for donation.121
(i) The donation, brokering, or other facilitation of a donation of a drug pursuant to this122
program shall not be considered wholesale distribution as defined in Code Section123
26-4-201 and shall not be subject to or require licensure as a wholesale distributor pursuant124
to Chapter 4 of Title 26.125
(j) Eligible recipients that provide pharmacy related services only for the purpose of126
dispensing donated or purchased drugs pursuant to the program shall not be subject to127
comprehensive formulary or minimum supply of drugs requirements contained in128
Chapter 4 of Title 26."129
SECTION 5.130
Said article is further amended by adding new Code sections to read as follows:131
"31-8-305.132
(a) Notwithstanding Article 5 of Chapter 4 of Title 26, an eligible recipient may substitute:133
(1) A prescribed drug with a therapeutically equivalent drug; or134
(2) A biological product with an interchangeable biological product.135
(b) Substitutions made pursuant to subsection (a) of this Code section may include, but are136
not limited to:137
(1) Splitting a combination drug into two or more drugs;138
(2) Combining two or more drugs into a combination drug; and139
(3) Substituting a different form of a prescribed drug, including, but not limited to, an140
oral tablet or capsule.141
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(c) If an eligible recipient dispenses or administers a substitute drug pursuant to this Code142
section, such substitution shall be communicated to the patient and the prescribing health143
care professional, unless the program's substitution policy is readily available on the144
eligible recipient's website.145
(d) Whenever a substitution is made, the eligible recipient shall record on the original146
prescription or the patient's prescription drug label that there has been a substitution and147
the identity of the dispensed drug product or interchangeable biological product.148
31-8-306.149
(a) It is the intent of the General Assembly that a portion of the proceeds of settlements150
received by the state relating to prescription drugs that are not controlled substances be151
appropriated for purposes of the program and distributed to eligible recipients in proportion152
to each such recipient's participation rate in the program.153
(b) It is further the intent of the General Assembly that if funds are appropriated for154
purposes of this article, the department shall be required to distribute such appropriations155
to eligible recipients in proportion to each such recipient's level of participation in the156
program.157
31-8-307.158
(a) Hospitals and pharmacies licensed in this state and state programs that provide health159
care coverage or health care services to patients, recipients, or other individuals in this160
state, including, but not limited to, Medicaid, PeachCare for Kids Program, alcohol and161
drug awareness programs, and the Department of Corrections shall provide such patients,162
recipients, or other individuals with referral information to the program for eligible drugs163
available through the program for:164
(1) Drugs not currently covered under a state program;165
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(2) Patients who do not meet the eligibility coverage for a state program or become166
unenrolled or leave a state program;167
(3) Drugs that are covered under a state program but are otherwise inaccessible to a168
patient due to, but not limited to a gap in coverage or out-of-pocket costs that are too high169
for a specific patient, recipient, or other individual; a prior authorization requirement; step170
therapy requirements; or high co-payments; or171
(4) A patient, recipient, or other individual for a drug that is covered under a state172
program but that the claim for coverage is denied with respect to the specific patient,173
recipient, or other individual.174
(b) Recipients of the federal Title X Family Planning Program shall make and document175
diligent efforts to subcontract with interested eligible recipients participating in the176
program to offer family planning services to rural and low-income populations.177
(c) If an eligible recipient offers value-added services and referrals, in addition to just178
providing medicine, such eligible recipient may also be eligible for discounted medication179
pricing to help widen such eligible recipient's formularies of medication and increase180
financial sustainability of its participation in the program."181
SECTION 6.182
Code Section 48-8-3 of the Official Code of Georgia Annotated, relating to exemptions from183
sales and use taxes, is amended by striking "or" at the end of paragraph (103), by striking the184
period and substituting in lieu thereof "; or" at the end of paragraph (104), and by adding a185
new paragraph to read as follows:186
"(105) Sales to or by an eligible recipient, as defined in Code Section 31-8-300, which187
provides pharmacy related services only for the purpose of dispensing donated or188
purchased drugs pursuant to the drug repository program established under Article 10 of189
Chapter 8 of Title 31, if such organization qualifies as a tax-exempt organization under190
Section 501(c)(3) of the Internal Revenue Code or is an organization that is treated for191
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federal income tax purposes as a disregarded entity of a tax-exempt organization under192
Section 501(c)(3) of the Internal Revenue Code."193
SECTION 7.194
All laws and parts of laws in conflict with this Act are repealed.195
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