25 LC 56 0290
Senate Bill 195
By: Senators Hufstetler of the 52nd, Kirkpatrick of the 32nd, Watson of the 1st, Parent of the
44th and Orrock of the 36th
A BILL TO BE ENTITLED
AN ACT
To amend Article 6 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated,
1
relating to pharmacies, so as to provide that pharmacists are authorized to dispense 2
preexposure prophylaxis and postexposure prophylaxis under certain conditions; to amend3
Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to4
medical practice, so as to provide for the approval or development of a training program for5
pharmacists by the Georgia State Board of Pharmacy; to require pharmacists to complete6
such training program before dispensing preexposure prophylaxis or postexposure7
prophylaxis; to provide for patient requirements; to provide for limitations and conditions;8
to provide for sanctions; to provide for definitions; to provide for related matters; to repeal9
conflicting laws; and for other purposes.10
BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:11
SECTION 1.12
Article 6 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating to13
pharmacies, is amended by adding a new Code section to read as follows:14
"26-4-120.
15
(a) As used in this Code section, the term:16
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(1) 'CLIA-waived' means a test system which is listed on the federal Food and Drug17
Administration's Clinical Laboratory Improvement Assessment program data base with18
a complexity rating of 'waived.'19
(2) 'Dispense' means to issue one or more doses of a drug in a suitable container with20
appropriate labeling for subsequent administration to, or use by, a patient.21
(3) 'HIV' shall have the same meaning as set forth in paragraph (10) of Code Section22
31-22-9.1.23
(4) 'HIV test' shall have the same meaning as set forth in paragraph (12) of Code Section24
31-22-9.1.25
(5) 'Licensed practitioner' means a physician licensed to practice medicine in this state26
or an advanced practice registered nurse or physician assistant acting pursuant to27
delegated authority by a physician in accordance with Code Section 43-34-23 or 43-34-2528
or subsection (e.1) of Code Section 43-34-103.29
(6) 'Postexposure prophylaxis' means any HIV prevention drug or drug combination30
determined by the Georgia State Board of Pharmacy to meet the clinical eligibility31
recommendations provided in the federal Centers for Disease Control and Prevention32
guidelines for postexposure prophylaxis for the prevention of HIV infection and other33
infections.34
(7) 'Preexposure prophylaxis' means any HIV prevention drug or drug combination35
determined by the Georgia State Board of Pharmacy to meet the same clinical eligibility36
recommendations provided in the federal Centers for Disease Control and Prevention37
guidelines for preexposure prophylaxis for the prevention of HIV infection and other38
infections.39
(b) Notwithstanding any other law to the contrary, a pharmacist is authorized to dispense40
and administer preexposure prophylaxis and postexposure prophylaxis without a41
prescription from a licensed practitioner in accordance with this Code section.42
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(c) Before dispensing or administering preexposure prophylaxis or postexposure43
prophylaxis to a patient, a pharmacist shall complete a training program, accredited by the44
Accreditation Council for Pharmacy Education or a similar health authority or professional45
body and approved by the Georgia State Board of Pharmacy, on the use of preexposure46
prophylaxis and postexposure prophylaxis. Such training program shall be approved no47
later than January 1, 2026. The training program shall include, but is not limited to:48
(1) Pharmacology education of preexposure prophylaxis and postexposure prophylaxis;49
(2) Preexposure prophylaxis and postexposure prophylaxis and contraindicated50
medications;51
(3) Financial assistance programs for preexposure prophylaxis and postexposure52
prophylaxis; and53
(4) Relevant federal guidelines, including those issued by the federal Centers for Disease54
Control and Prevention, regarding preexposure prophylaxis and postexposure55
prophylaxis.56
(d) A pharmacist shall be authorized to dispense at least a 30 day supply and up to a 6057
day supply or administer a long-acting injectable of preexposure prophylaxis if:58
(1) The patient is HIV negative, as documented by a test result obtained by the patient59
within the previous seven days from an HIV antigen/antibody test or antibody-only test60
or from a rapid point-of-care fingerstick blood test approved by the federal Food and61
Drug Administration; provided, however, that, if the patient does not provide such a test62
result, the pharmacist may order and administer a CLIA-waived HIV test. The results of63
any such test shall either be sent directly to the pharmacist or verified by the pharmacist64
prior to prescribing, dispensing, or administering the drugs;65
(2) The patient does not report taking any contraindicated medications;66
(3) The pharmacist documents, to the extent possible, the services provided by the67
pharmacist in the patient's record in the pharmacy's record system;68
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(4) The pharmacist dispenses or administers preexposure prophylaxis to a single patient69
pursuant to Centers for Disease Control and Prevention clinical practice guidelines for70
preexposure prophylaxis for the prevention of HIV infection or as directed otherwise by71
a licensed practitioner;72
(5) The pharmacist notifies the patient's primary care provider of any actions taken or73
tests conducted under this subsection, or, if the patient does not have a primary care74
provider or refuses to consent to the notification of such provider, the pharmacist shall75
provide the patient with a list of physicians, clinics, or other healthcare service providers76
to contact regarding ongoing care for preexposure prophylaxis; and77
(6) The pharmacist is otherwise in compliance with the requirements of Code Section78
43-34-26.2.79
(e) A pharmacist shall be authorized to dispense or administer a 28 day supply of80
postexposure prophylaxis if:81
(1) The pharmacist, upon screening the patient, determines the patient meets the clinical82
criteria set forth in the Centers for Disease Control and Prevention guidelines for83
postexposure prophylaxis; and84
(2) The pharmacist notifies the patient's primary care provider of the postexposure85
prophylaxis treatment, or, if the patient does not have a primary care provider or refuses86
to consent to the notification of such provider, the pharmacist shall provide the patient87
with a list of physicians, clinics, or other healthcare service providers to contact regarding88
follow-up care for postexposure prophylaxis."89
SECTION 2.90
Article 2 of Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to91
medical practice, is amended by adding a new Code section to read as follows:92
"43-34-26.2.93
(a) As used in this Code section, the term:94
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(1) 'Administer' means the provision of a unit dose of a long-acting injectable for PEP95
or PrEP by a pharmacist or nurse pursuant to a PEP or PrEP order contained in a PEP or96
PrEP protocol agreement with a physician.97
(2) 'Adverse event' means an event that is a negative consequence of the administration98
of a long-acting injectable for PEP or PrEP by a pharmacist that results in an unintended99
reaction, injury, or illness, which may or may not have been preventable.100
(3) 'PEP' means any HIV prevention drug or drug combination determined by the101
Georgia State Board of Pharmacy to meet the clinical eligibility recommendations102
provided in the federal Centers for Disease Control and Prevention guidelines for103
postexposure prophylaxis for the prevention of HIV infection and other infections.104
(4) 'PrEP' means any HIV prevention drug or drug combination determined by the105
Georgia State Board of Pharmacy to meet the same clinical eligibility recommendations106
provided in the federal Centers for Disease Control and Prevention guidelines for107
preexposure prophylaxis for the prevention of HIV infection and other infections.108
(5) 'PEP or PrEP order' means a prescription drug order, contained in a PEP or PrEP109
protocol agreement, for a long-acting injectable for PEP or PrEP issued by a physician110
for a group of patients who meet certain criteria and to be administered by a pharmacist.111
(6) 'PEP or PrEP protocol agreement' means a written document mutually agreed upon112
and signed by a physician and a pharmacist, by which document the physician prescribes113
a long-acting injectable for PEP or PrEP, if determined appropriate by the physician, by114
means of a PEP or PrEP order for administration by a pharmacist.115
(7) 'Pharmacist' means an individual licensed under Chapter 4 of Title 26 to engage in116
the practice of pharmacy in the State of Georgia.117
(8) 'Pharmacy intern' means a pharmacy intern as defined in paragraph (19) of Code118
Section 26-4-5.119
(9) 'Physician' means an individual licensed to practice medicine and surgery pursuant120
to this article and whose principal place of practice is located in this state.121
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(b) A physician engaged in the active practice of medicine may prescribe a long-acting122
injectable for PEP or PrEP for a group of patients via a PEP or PrEP order contained in a123
PEP or PrEP protocol agreement to be administered by a pharmacist, provided that the124
physician resides in Georgia and the pharmacist holds current certification in Basic Cardiac125
Life Support.126
(c) A PEP or PrEP protocol agreement between a physician and a pharmacist pursuant to127
this Code section shall, without limitation:128
(1) Contain the current names, addresses, telephone numbers, and professional license129
numbers of the physician and the pharmacist;130
(2) Contain a provision for immediate consultation between the pharmacist and the131
physician. If the physician is not available, the physician for purposes of consultation132
may designate another physician who concurs with the terms of the PEP or PrEP protocol133
agreement;134
(3) Require the pharmacist to take an appropriate case history and determine whether the135
patient has had a physical examination within the past year and shall not administer a136
long-acting injectable for PEP or PrEP to a patient with any condition for which such137
long-acting injectable for PEP or PrEP is contraindicated;138
(4) Require the pharmacist to provide the recipient with the appropriate and current PEP139
or PrEP information;140
(5) Require the pharmacist to provide written information to the recipient to be141
developed by the Department of Public Health on the importance of having and142
periodically seeing a primary care physician;143
(6) Require the pharmacist or his or her employer to retain documentation of each dose144
of PEP or PrEP administered. Such documentation shall include, but not be limited to:145
(A) The administering pharmacist's name, address, telephone number, and professional146
license number;147
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(B) The name, dose, manufacturer, and lot number of the long-acting injectable for148
PEP or PrEP;149
(C) The recipient's name, address, date of birth, and telephone number;150
(D) The date of administration and injection site;151
(E) A signed and dated consent form by which the recipient consents to the152
administration of the long-acting injectable for PEP or PrEP and authorizes the153
pharmacy or nurse to notify the recipient's primary care provider of the long-acting154
injectable for PEP or PrEP administered to the recipient; and155
(F) Any adverse events or complications that occur;156
(7) Require the pharmacist to make documented reasonable efforts to obtain the name157
of the recipient's primary care provider and to notify such primary care provider of the158
long-acting injectable for PEP or PrEP administered by the pharmacist within 72 hours159
of administration;160
(8) Require the pharmacist to administer the long-acting injectable for PEP or PrEP to161
a patient in a private room, area with a privacy screen, or other interior area in which the162
patient's privacy can be maintained. In no event shall a pharmacist administer a163
long-acting injectable for PEP or PrEP to a patient in a manner that is designed so that164
the patient can be served while remaining in his or her personal vehicle;165
(9) Require, as a condition of administration of the long-acting injectable for PEP or166
PrEP, the recipient to remain under the observation of a pharmacist for a period of not167
less than 15 minutes immediately subsequent to the administration of the long-acting168
injectable for PEP or PrEP;169
(10) Contain procedures to follow up on the occurrence of an adverse event or170
complication;171
(11) Require the pharmacist to maintain individual liability insurance coverage or be172
individually covered by his or her employer's liability insurance coverage in an amount173
not less than $250,000.00 to cover claims arising from administration of long-acting174
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injectables for PEP or PrEP by the pharmacist pursuant to a PEP or PrEP protocol175
agreement and to provide proof of such coverage to the physician for submission to the176
board with the PEP or PrEP protocol agreement. The pharmacist shall also retain a copy177
of the proof of insurance coverage, including the name of the insurer and policy number,178
on site at his or her primary location for inspection by the Georgia Drugs and Narcotics179
Agency, upon request;180
(12) Require the pharmacist to post proof of the PEP or PrEP protocol agreement in a181
conspicuous location within the pharmacy or other setting in which the long-acting182
injectables for PEP or PrEP is being administered;183
(13) Require the pharmacist to submit a signed and notarized affidavit to the physician184
attesting to the following:185
(A) Compliance with paragraph (11) of this subsection regarding maintenance of186
liability insurance;187
(B) Verification that the pharmacist holds current certification in Basic Cardiac Life188
Support as required by subsection (b) of this Code section;189
(C) The pharmacist has a copy of the PEP or PrEP protocol agreement and agrees to190
comply with its requirements; and191
(D) Identification of the pharmacist's location or locations in which he or she will be192
administering long-acting injectables for PEP or PrEP pursuant to the PEP or PrEP193
protocol agreement.194
The pharmacist shall keep a copy of the affidavit on site at his or her primary location for195
inspection by the Georgia Drugs and Narcotics Agency upon request. The Georgia Drugs196
and Narcotics Agency shall have the authority to impose sanctions in accordance with197
subsection (n) of this Code section on any pharmacist subject to the requirements of this198
paragraph who does not submit the information required by this paragraph and to notify199
the delegating physician and the applicable licensing board for such person of violations200
of this paragraph; and201
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(14) Be renewed and, if necessary, revised or updated biennially by the physician and202
the pharmacist. A PEP or PrEP protocol agreement that is not renewed biennially shall203
expire.204
(d)(1) A pharmacist who is a party to a PEP or PrEP protocol agreement pursuant to this205
Code section shall not delegate the administration of a long-acting injectable for PEP or206
PrEP to any individual other than:207
(A) A pharmacy intern; or208
(B) A qualified pharmacy technician in accordance with paragraph (2) of this209
subsection,210
under the direct supervision of the pharmacist whether or not any such other individual211
is under the supervision, direct or otherwise, of the pharmacist.212
(2) A pharmacist who is a party to a PEP or PrEP protocol agreement pursuant to this213
Code section may authorize one or more qualified pharmacy technicians to administer214
long-acting injectable for PEP or PrEP pursuant to Code Section 26-4-52 so long as:215
(A) The physician with whom the PEP or PrEP protocol agreement is entered into has216
approved such authorization; and217
(B) Such authorization is included in the PEP or PrEP protocol agreement between the218
physician and pharmacist.219
(e) A pharmacist administering long-acting injectables for PEP or PrEP pursuant to a PEP220
or PrEP protocol agreement authorized by this Code section shall maintain policies and221
procedures for the handling and disposal of used or contaminated equipment and supplies.222
(f) Nothing in this Code section shall be construed to authorize a physician to prescribe223
any other drugs pursuant to a PEP or PrEP protocol agreement or a PEP or PrEP order224
other than those long-acting injectables for PEP or PrEP specifically authorized in such225
PEP or PrEP protocol agreement or PEP or PrEP order.226
(g) A delegating physician may not enter into a PEP or PrEP protocol agreement with227
more than ten pharmacists at any one time; provided, however, a delegating physician may228
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enter into a PEP or PrEP protocol agreement with more than ten pharmacists at any one229
time so long as the pharmacists are employees or agents of the same corporate entity.230
(h) It shall be unlawful for a physician who is employed by a pharmacist to enter into a231
PEP or PrEP protocol agreement or otherwise delegate medical acts to such pharmacist. 232
It shall be unlawful for a physician who is employed by a pharmacy to enter into a PEP or233
PrEP protocol agreement or otherwise delegate medical acts to a pharmacist who is also234
employed by such pharmacy.235
(i) The board shall have the authority to promulgate rules and regulations governing a236
physician who is a party to a PEP or PrEP protocol agreement in order to carry out the237
intent and purposes of this Code section. Further, the board shall:238
(1) Require that the PEP or PrEP protocol agreement, along with the affidavit by the239
pharmacist submitted pursuant to paragraph (13) of subsection (c) of this Code section240
and the proof of insurance required pursuant to paragraph (11) of subsection (c) of this241
Code section, be filed by the physician with the board and be made available by the board242
for public inspection; and243
(2) Promulgate by rule an approved standard protocol template that may be utilized as244
a PEP or PrEP protocol agreement and make such template available on the board's245
website.246
(j) Nothing in this Code section shall be construed to require a physician to enter into a 247
PEP or PrEP protocol agreement. A public or private managed care system, health plan,248
hospital, insurance company, or similar entity shall not require a physician, pharmacist, or249
nurse to enter into a PEP or PrEP protocol agreement as a condition for participation in or250
reimbursement from such entity.251
(k) No physician who complies with the provisions of this Code section shall be subject252
to criminal or civil liability or discipline for unprofessional conduct for:253
(1) Entering into a PEP or PrEP protocol agreement with a pharmacist;254
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(2) Issuing a PEP or PrEP order contained in a PEP or PrEP protocol agreement with a255
pharmacist; or256
(3) The acts or omissions of a pharmacist pursuant to a PEP or PrEP protocol agreement257
including the administration of a long-acting injectable for PEP or PrEP.258
Nothing in this subsection shall be interpreted as altering liability of an employer for acts259
of his or her employees.260
(l) This Code section shall not apply to any activities conducted by a hospital, physician's261
office, nursing home, or other health care facility designated by the Department of Public262
Health or conducted within any other facility or entity owned, operated, or leased by a263
hospital.264
(m) This Code section shall not be interpreted as limiting the authority of any authorized265
person to dispense or administer long-acting injectables for PEP or PrEP.266
(n)(1) A pharmacist who knowingly does not comply with paragraph (11) of267
subsection (c) of this Code section may be assessed a fine of up to $2,500.00 by the268
board.269
(2) A pharmacist who knowingly administers a long-acting injectable for PEP or PrEP270
without a PEP or PrEP protocol agreement as required by this Code section may be271
assessed a fine of up to $2,500.00 and may be prohibited from administering long-acting272
injectables for PEP or PrEP pursuant to this Code section for up to one year as273
determined by the board.274
(3) A pharmacist who knowingly does not comply with paragraph (5) of subsection (c)275
of this Code section may be subject to the following sanctions by the board:276
(A) Upon the first violation, the issuance of a warning;277
(B) Upon the second violation, a fine of up to $500.00; and278
(C) Upon a third or subsequent violation, prohibition from administering long-acting279
injectables for PEP or PrEP pursuant to this Code section for up to one year.280
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(4) A pharmacist who knowingly does not comply with paragraph (12) of subsection (c)281
of this Code section may be subject to the following sanctions by the board:282
(A) Upon the first or second violation, the issuance of a warning; and283
(B) Upon a third or subsequent violation, prohibition from administering long-acting284
injectables for PEP or PrEP pursuant to this Code section for up to six months.285
(5) A pharmacist who knowingly does not comply with paragraph (13) of subsection (c)286
of this Code section may be subject to the following sanctions by the Georgia Drugs and287
Narcotics Agency:288
(A) Upon the first violation, the issuance of a warning;289
(B) Upon the second violation, a fine of up to $5,000.00; and290
(C) Upon a third or subsequent violation, prohibition from administering long-acting291
injectables for PEP or PrEP pursuant to this Code section.292
(6) The sanctions contained in this subsection shall be supplemental to any other293
sanctions or penalties to which a pharmacist may otherwise be subject."294
SECTION 3.295
All laws and parts of laws in conflict with this Act are repealed.296
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