Georgia 2023-2024 Regular Session

Georgia House Bill HB1072 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1		-	24 HB 1072/AP
2		-	House Bill 1072 (AS PASSED HOUSE AND SENATE)
3		-	By: Representatives Cooper of the 45
4		-	th
5		-	, Newton of the 127
6		-	th
7		-	, Parrish of the 158
8		-	th
9		-	, Jackson of
10		-	the 128
11		-	th
12		-	, Stephens of the 164
13		-	th
14		-	, and others
	1	+	24 LC 52 0530S
	2	+	The Senate Committee on Health and Human Services offered the following
	3	+	substitute to HB 1072:
15	4		A BILL TO BE ENTITLED
16	5		AN ACT
17		-	To amend Titles 26, 31, and 48 of the Official Code of Georgia Annotated, relating to food,
18		-	1
	6	+	To amend Titles 26, 31, and 48 of the Official Code of Georgia Annotated, relating to food,1
19	7		drugs, and cosmetics, health, and revenue and taxation, respectively, so as to increase the2
20	8		public's access to prescription drugs by increasing the number of pharmacy technicians3
21	9		authorized to be supervised by a pharmacist in certain circumstances and by revising4
22	10		provisions relative to the drug repository program; to authorize the Georgia State Board of5
23	11		Pharmacy to increase the maximum ratio of pharmacists to pharmacy technicians in6
24	12		closed-door pharmacies; to provide definitions; to provide for additional pharmacy7
25	13		technicians for certain non-dispensing related duties in the drug repository program; to8
26	14		require reverse drug distributors to make and document diligent efforts to donate drugs rather9
27	15		than destroy them; to provide for an eligible recipient to substitute a drug under certain10
28	16		circumstances; to provide for legislative intent regarding certain settlement funds received11
29	17		by the state; to provide for referrals to the drug repository program; to exempt sales to or by12
30	18		certain eligible recipients in the drug repository program; to provide for related matters; to13
31	19		provide for legislative findings; to provide for an effective date and applicability; to repeal14
32	20		conflicting laws; and for other purposes.15
33	21		BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16
34		-	H. B. 1072
35		-	- 1 - 24 HB 1072/AP
36		-	PART I
37		-	17
	22	+	- 1 - 24 LC 52 0530S
	23	+	PART I17
38	24		Closed-door pharmacies18
39	25		SECTION 1-1.19
40	26		Title 26 of the Official Code of Georgia Annotated, relating to food, drugs, and cosmetics,20
41	27		is amended in Code Section 26-4-82, relating to duties requiring professional judgment and21
42	28		responsibilities of a licensed pharmacist, by revising subsection (d) as follows:22
43	29		"(d) The board of pharmacy shall promulgate rules and regulations regarding the activities23
44	30		and utilization of pharmacy technicians in pharmacies, including the establishment of a24
45	31		registry as required in paragraph (7) of subsection (a) of Code Section 26-4-28; provided,25
46	32		however, that the pharmacist to pharmacy technician ratio shall not exceed one pharmacist26
47	33		providing direct supervision of four pharmacy technicians. The board may consider and27
48		-	approve an application to increase the ratio in a pharmacy located in a licensed hospital or
49		-	28
	34	+	approve an application to increase the ratio in a pharmacy located in a licensed hospital or28
50	35		in a closed-door pharmacy. Such application must be made in writing and must be29
51	36		submitted to the board by the pharmacist in charge of a specific hospital pharmacy in this30
52	37		state or a specific closed-door pharmacy. At any time during which the pharmacist directly31
53	38		supervises four or more pharmacy technicians, two of such technicians must be certified. 32
54	39		At any time during which the pharmacist directly supervises three pharmacy technicians,33
55	40		one of such technicians must be certified. No certification is required for pharmacy34
56	41		technicians in pharmacies at any time during which the pharmacist directly supervises one35
57	42		or two pharmacy technicians. In order to be certified, pharmacy technicians must:36
58	43		(1) Have successfully passed a certification program approved by the board of pharmacy;37
59	44		(2) Have successfully passed an employer's training and assessment program which has38
60	45		been approved by the board of pharmacy; or39
61	46		(3) Have been certified by either the Pharmacy Technician Certification Board or any40
62	47		other nationally recognized certifying body approved by the board of pharmacy.41
63		-	H. B. 1072
64		-	- 2 - 24 HB 1072/AP
	48	+	- 2 - 24 LC 52 0530S
65	49		As used in this subsection, the term 'closed-door pharmacy' means a pharmacy that42
66	50		provides specialized services and is not open to the general public."43
67	51		PART II44
68	52		Drug repository program45
69	53		SECTION 2-1.46
70	54		The General Assembly finds:47
71	55		(1) Access to affordable medications is a public health issue that disproportionately48
72	56		impacts vulnerable patients, and a state's drug repository program can serve as a solution49
73	57		to thousands of families for life-saving and life-preserving medications; and50
74	58		(2) Participating recipient organizations can provide a valuable community benefit to51
75	59		families in need by making donated medications available and will be authorized to utilize52
76	60		additional pharmacy technicians to distribute donated medications under the drug53
77	61		repository program.54
78	62		SECTION 2-2.55
79	63		Title 31 of the Official Code of Georgia Annotated, relating to health, is amended by revising56
80	64		Code Section 31-8-300, relating to definitions relative to the drug repository program, as57
81	65		follows:58
82	66		"31-8-300.59
83	67		As used in this article, the term:60
84	68		(1) 'Controlled substance' means a drug, substance, or immediate precursor in Schedules61
85	69		I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I through V of62
86	70		21 C.F.R. Part 1308 as of January 1, 2023.63
87	71		(2) 'Disposition' means destroy, dispose of, return, quarantine, or otherwise prevent from64
88	72		further distribution.65
89		-	H. B. 1072
90		-	- 3 - 24 HB 1072/AP
	73	+	- 3 - 24 LC 52 0530S
91	74		(3) 'Eligible drug' means an over-the-counter or prescription drug, including drugs66
92	75		labeled specifically for investigational use and approved by the United States Food and67
93	76		Drug Administration as such, which may be donated to the program pursuant to Code68
94	77		Section 31-8-301.69
95	78		(2)(4) 'Eligible patient' means an individual who is indigent, uninsured, underinsured, or70
96	79		enrolled in a public assistance health benefits program, in accordance with criteria71
97	80		established by the Department of Public Health pursuant to Code Section 31-8-304. 72
98	81		Other individuals may be considered eligible patients if the need for donated drugs for73
99	82		indigent, uninsured, underinsured, and public assistance health benefits program patients74
100	83		is less than the supply of donated drugs.75
101	84		(3)(5) 'Eligible recipient' means a pharmacy, hospital, federally qualified health center,76
102	85		nonprofit clinic, or other entity meeting the criteria established by the Department of77
103	86		Public Health pursuant to Code Section 31-8-304.78
104	87		(6) 'Expiration date' means the original expiration date provided by the manufacturer or79
105	88		repackager or the expiration date provided on the medication's packaging or prescription80
106	89		drug label.81
107	90		(4)(7) 'Health care facility' means a:82
108	91		(A) Nursing home licensed pursuant to Article 1 of Chapter 7 of this title;83
109	92		(B) Personal care home licensed pursuant to Code Section 31-7-12;84
110	93		(C) Assisted living community licensed pursuant to Code Section 31-7-12.2;85
111	94		(D) Hospice licensed pursuant to Article 9 of Chapter 7 of this title; and86
112	95		(E) Home health agency licensed pursuant to Article 7 of Chapter 7 of this title.87
113	96		(5)(8) 'Health care professional' means any of the following who provide medical, dental,88
114	97		or other health related diagnosis diagnoses, care, or treatment:89
115	98		(A) Physicians licensed to practice medicine under Chapter 34 of Title 43;90
116	99		(B) Registered nurses and licensed practical nurses licensed under Chapter 26 of91
117	100		Title 43;92
118		-	H. B. 1072
119		-	- 4 - 24 HB 1072/AP
120		-	(C) Physician assistants licensed under Chapter 34 of Title 43;
121		-	93
	101	+	- 4 - 24 LC 52 0530S
	102	+	(C) Physician assistants licensed under Chapter 34 of Title 43;93
122	103		(D) Dentists and dental hygienists licensed under Chapter 11 of Title 43;94
123	104		(E) Optometrists licensed under Chapter 30 of Title 43; and95
124	105		(F) Pharmacists licensed under Chapter 4 of Title 26.96
125		-	(6)
126		-	(9) 'Hospital' means a facility licensed pursuant to Chapter 7 of this title.97
	106	+	(6)(9) 'Hospital' means a facility licensed pursuant to Chapter 7 of this title.97
127	107		(7)(10) 'Program' means the drug repository program established pursuant to Code98
128	108		Section 31-8-301.99
129	109		(11) 'Short-dated' means within five months of a drug's expiration date."100
130	110		SECTION 2-3.101
131	111		Said title is further amended by revising Code Section 31-8-301, relating to the establishment102
132	112		of a drug repository program and criteria and requirements for unused over-the-counter and103
133	113		prescription drugs, as follows:104
134	114		"31-8-301.105
135	115		(a) The Department of Public Health shall establish a drug repository program to accept106
136	116		and dispense over-the-counter and prescription drugs donated for the purpose of being107
137	117		dispensed to eligible patients.108
138	118		(b) Drugs shall only be dispensed pursuant to the program if:109
139	119		(1) For prescription drugs, they do with an expiration date that does not expire before the110
140	120		completion of the medication by the eligible patient based on the prescribing health care111
141	121		professional's directions for use and, for over-the-counter drugs, they do with an112
142	122		expiration date that does not expire before use by the eligible patient based on the113
143	123		directions for use on the manufacturer's label; and114
144	124		(2) The drugs were donated in unopened tamper-evident packaging as defined by United115
145	125		States Pharmacopeia General Chapter 659, Packaging and Storage Requirements,116
146	126		including but not limited to unopened unit-dose and multiple-dose packaging.117
147	127		(c) The following drugs shall not be donated to the program:118
148		-	H. B. 1072
149		-	- 5 - 24 HB 1072/AP
150		-	(1) Controlled substances;
151		-	119
	128	+	- 5 - 24 LC 52 0530S
	129	+	(1) Controlled substances;119
152	130		(2) Drugs subject to a federal Food and Drug Administration managed risk evaluation120
153	131		and mitigation strategy pursuant to Section 355-1 of Title 21 of the United States Code121
154	132		if inventory transfer is prohibited by such strategy; or122
155	133		(3) Drugs that there is reason to believe are adulterated pursuant to Code Section 26-3-7."123
156	134		SECTION 2-4.124
157	135		Said title is further amended in Code Section 31-8-302, relating to procedures for donation125
158	136		and dispensing of unused over-the-counter and prescription drugs, by adding new subsections126
159	137		to read as follows:127
160		-	"(f) In addition to the maximum number of pharmacy technicians that are authorized to be
161		-	128
	138	+	"(f) In addition to the maximum number of pharmacy technicians that are authorized to be128
162	139		under the direct supervision of a pharmacist pursuant to subsection (d) of Code129
163	140		Section 26-4-82, a participating pharmacy may utilize up to two additional pharmacy130
164	141		technicians under the direct supervision of such pharmacist for duties related to the131
165	142		program; provided, however, that the two such additional pharmacy technicians shall not132
166	143		be authorized to assist the supervising pharmacist in connection with any activities related133
167	144		to completing a prescription drug order or preparation of a prescription drug for a patient,134
168	145		but shall only be authorized to perform non-dispensing related duties, such as, but not135
169	146		limited to, receiving and stocking inventory.136
170	147		(g) A reverse drug distributor permitted or licensed by the State Board of Pharmacy shall:137
171	148		(1) Make and document diligent efforts to donate eligible drugs within 30 days of taking138
172	149		possession to the program in accordance with Code Section 31-8-301 rather than destroy139
173	150		such drugs;140
174	151		(2) Not directly or indirectly by transferring to another entity or by other means, cause141
175	152		eligible drugs to be dispositioned, become short-dated, expire, or otherwise become142
176	153		ineligible for donation; and143
177		-	H. B. 1072
178		-	- 6 - 24 HB 1072/AP
	154	+	- 6 - 24 LC 52 0530S
179	155		(3) Make and document diligent efforts to ensure that any policy, contract, or other144
180	156		business arrangement between the reverse drug distributor and its clients or other parties145
181	157		does not prohibit the donation of eligible drugs received from any such client or other146
182	158		party to the program in accordance with Code Section 31-8-301; provides for the same147
183	159		rate of compensation for the client or other party for donation of eligible drugs and other148
184	160		disposition of such drugs; and does not require an eligible drug to be dispositioned,149
185	161		become short-dated, expire, or otherwise become ineligible for donation.150
186	162		(h) Any person or entity eligible to donate drugs under the program shall be allowed to151
187	163		donate eligible drugs in the same manner, at the same rate of compensation, and paid for152
188	164		by the same parties as applies to the disposition of drugs regardless of any policy, contract,153
189	165		or other business arrangement that would have otherwise directly or indirectly by154
190	166		transferring to another entity or by other means required an eligible drug to be155
191	167		dispositioned, become short-dated, expire, or otherwise become ineligible for donation.156
192	168		(i) The donation, brokering, or other facilitation of a donation of a drug pursuant to this157
193	169		program shall not be considered wholesale distribution as defined in Code Section158
194	170		26-4-201 and shall not be subject to or require licensure as a wholesale distributor pursuant159
195	171		to Chapter 4 of Title 26.160
196	172		(j) Eligible recipients that provide pharmacy related services only for the purpose of161
197	173		dispensing donated or purchased drugs pursuant to the program shall not be subject to162
198	174		comprehensive formulary or minimum supply of drugs requirements contained in163
199	175		Chapter 4 of Title 26."164
200	176		SECTION 2-5.165
201	177		Said article is further amended by adding new Code sections to read as follows:166
202	178		"31-8-305.167
203	179		(a) Notwithstanding Article 5 of Chapter 4 of Title 26, an eligible recipient may substitute:168
204	180		(1) A prescribed drug with a therapeutically equivalent drug; or169
205		-	H. B. 1072
206		-	- 7 - 24 HB 1072/AP
	181	+	- 7 - 24 LC 52 0530S
207	182		(2) A biological product with an interchangeable biological product.170
208	183		(b) Substitutions made pursuant to subsection (a) of this Code section may include, but are171
209	184		not limited to:172
210	185		(1) Splitting a combination drug into two or more drugs;173
211	186		(2) Combining two or more drugs into a combination drug; and174
212	187		(3) Substituting a different form of a prescribed drug, including, but not limited to, an175
213	188		oral tablet or capsule.176
214	189		(c) If an eligible recipient dispenses or administers a substitute drug pursuant to this Code177
215	190		section, such substitution shall be communicated to the patient and the prescribing health178
216	191		care professional, unless the program's substitution policy is readily available on the179
217	192		eligible recipient's website.180
218	193		(d) Whenever a substitution is made, the eligible recipient shall record on the original181
219	194		prescription or the patient's prescription drug label that there has been a substitution and182
220	195		the identity of the dispensed drug product or interchangeable biological product.183
221	196		31-8-306.184
222	197		(a) It is the intent of the General Assembly that a portion of the proceeds of settlements185
223	198		received by the state relating to prescription drugs that are not controlled substances be186
224	199		appropriated for purposes of the program and distributed to eligible recipients in proportion187
225	200		to each such recipient's participation rate in the program.188
226	201		(b) It is further the intent of the General Assembly that if funds are appropriated for189
227	202		purposes of this article, the department shall be required to distribute such appropriations190
228	203		to eligible recipients in proportion to each such recipient's level of participation in the191
229	204		program.192
230		-	H. B. 1072
231		-	- 8 - 24 HB 1072/AP
	205	+	- 8 - 24 LC 52 0530S
232	206		31-8-307.193
233	207		(a) Hospitals and pharmacies licensed in this state and state programs that provide health194
234	208		care coverage or health care services to patients, recipients, or other individuals in this195
235	209		state, including, but not limited to, Medicaid, PeachCare for Kids Program, alcohol and196
236	210		drug awareness programs, and the Department of Corrections shall provide such patients,197
237	211		recipients, or other individuals with referral information to the program for eligible drugs198
238	212		available through the program for:199
239	213		(1) Drugs not currently covered under a state program;200
240	214		(2) Patients who do not meet the eligibility coverage for a state program or become201
241	215		unenrolled or leave a state program;202
242	216		(3) Drugs that are covered under a state program but are otherwise inaccessible to a203
243	217		patient due to, but not limited to a gap in coverage or out-of-pocket costs that are too high204
244	218		for a specific patient, recipient, or other individual; a prior authorization requirement; step205
245	219		therapy requirements; or high co-payments; or206
246	220		(4) A patient, recipient, or other individual for a drug that is covered under a state207
247	221		program but that the claim for coverage is denied with respect to the specific patient,208
248	222		recipient, or other individual.209
249	223		(b) Recipients of the federal Title X Family Planning Program shall make and document210
250	224		diligent efforts to subcontract with interested eligible recipients participating in the211
251	225		program to offer family planning services to rural and low-income populations.212
252	226		(c) If an eligible recipient offers value-added services and referrals, in addition to just213
253	227		providing medicine, such eligible recipient may also be eligible for discounted medication214
254	228		pricing to help widen such eligible recipient's formularies of medication and increase215
255	229		financial sustainability of its participation in the program."216
256		-	H. B. 1072
257		-	- 9 - 24 HB 1072/AP
258		-	SECTION 2-6.
259		-	217
	230	+	- 9 - 24 LC 52 0530S
	231	+	SECTION 2-6.217
260	232		Title 48 of the Official Code of Georgia Annotated, relating to revenue and taxation, is218
261	233		amended in Code Section 48-8-3, relating to exemptions from sales and use taxes, by219
262	234		deleting "or" at the end of paragraph (103), by replacing the period with "; or" at the end of220
263	235		paragraph (104), and by adding a new paragraph to read as follows:221
264		-	"(105) Sales to or by an eligible recipient, as defined in Code Section 31-8-300, which
265		-	222
	236	+	"(105) Sales to or by an eligible recipient, as defined in Code Section 31-8-300, which222
266	237		provides pharmacy related services only for the purpose of dispensing donated or223
267	238		purchased drugs pursuant to the drug repository program established under Article 10 of224
268	239		Chapter 8 of Title 31, if such organization qualifies as a tax-exempt organization under225
269	240		Section 501(c)(3) of the Internal Revenue Code or is an organization that is treated for226
270	241		federal income tax purposes as a disregarded entity of a tax-exempt organization under227
271	242		Section 501(c)(3) of the Internal Revenue Code."228
272	243		PART III229
273	244		Effective date and repealer230
274	245		SECTION 3-1.231
275	246		This Act shall become effective upon its approval by the Governor or upon its becoming law232
276	247		without such approval; provided, however, that Section 2-6 of this Act shall be applicable233
277	248		to taxable years beginning on or after January 1, 2025.234
278	249		SECTION 3-2.235
279	250		All laws and parts of laws in conflict with this Act are repealed.236
280		-	H. B. 1072
281	251		- 10 -