Indiana 2025 Regular Session

Indiana Senate Bill SB0506 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1
2	2	Introduced Version
3	3	SENATE BILL No. 506
4	4	_____
5	5	DIGEST OF INTRODUCED BILL
6	6	Citations Affected: IC 25-26-13.
7	7	Synopsis: Pharmacy employment regulations. Provides that a
8	8	pharmacy shall not require a pharmacist to work longer than 13 hours
9	9	per work day, and requires a pharmacy to allow at least eight hours
10	10	between consecutive shifts. Requires a pharmacy to provide certain
11	11	pharmacists with a break with certain conditions. Allows a Category I
12	12	pharmacy to allow certain individuals to pick up prescription refills
13	13	while a pharmacist is unavailable under certain circumstances.
14	14	Provides that if a pharmacist is on break or unavailable when a person
15	15	requests to speak to the pharmacist, the person must be informed of the
16	16	reason for the pharmacist being unavailable and given certain options.
17	17	Effective: July 1, 2025.
18	18	Deery
19	19	January 16, 2025, read first time and referred to Committee on Health and Provider
20	20	Services.
21	21	2025 IN 506—LS 7149/DI 148 Introduced
22	22	First Regular Session of the 124th General Assembly (2025)
23	23	PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
24	24	Constitution) is being amended, the text of the existing provision will appear in this style type,
25	25	additions will appear in this style type, and deletions will appear in this style type.
26	26	Additions: Whenever a new statutory provision is being enacted (or a new constitutional
27	27	provision adopted), the text of the new provision will appear in this style type. Also, the
28	28	word NEW will appear in that style type in the introductory clause of each SECTION that adds
29	29	a new provision to the Indiana Code or the Indiana Constitution.
30	30	Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
31	31	between statutes enacted by the 2024 Regular Session of the General Assembly.
32	32	SENATE BILL No. 506
33	33	A BILL FOR AN ACT to amend the Indiana Code concerning
34	34	professions and occupations.
35	35	Be it enacted by the General Assembly of the State of Indiana:
36	36	1 SECTION 1. IC 25-26-13-2, AS AMENDED BY P.L.143-2022,
37	37	2 SECTION 55, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
38	38	3 JULY 1, 2025]: Sec. 2. As used in this chapter:
39	39	4 "Administering" means the direct application of a drug to the body
40	40	5 of a person by injection, inhalation, ingestion, or any other means.
41	41	6 "Board" means the Indiana board of pharmacy.
42	42	7 "Controlled drugs" are those drugs on schedules I through V of the
43	43	8 federal Controlled Substances Act or on schedules I through V of
44	44	9 IC 35-48-2.
45	45	10 "Coronavirus disease" means the disease caused by the severe acute
46	46	11 respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
47	47	12 "Counseling" means effective communication between a pharmacist
48	48	13 and a patient concerning the contents, drug to drug interactions, route,
49	49	14 dosage, form, directions for use, precautions, and effective use of a
50	50	15 drug or device to improve the therapeutic outcome of the patient
51	51	16 through the effective use of the drug or device.
52	52	17 "Dispensing" means issuing one (1) or more doses of a drug in a
53	53	2025 IN 506—LS 7149/DI 148 2
54	54	1 suitable container with appropriate labeling for subsequent
55	55	2 administration to or use by a patient.
56	56	3 "Drug" means:
57	57	4 (1) articles or substances recognized in the official United States
58	58	5 Pharmacopoeia, official National Formulary, official
59	59	6 Homeopathic Pharmacopoeia of the United States, or any
60	60	7 supplement to any of them;
61	61	8 (2) articles or substances intended for use in the diagnosis, cure,
62	62	9 mitigation, treatment, or prevention of disease in man or animals;
63	63	10 (3) articles other than food intended to affect the structure or any
64	64	11 function of the body of man or animals; or
65	65	12 (4) articles intended for use as a component of any article
66	66	13 specified in subdivisions (1) through (3) and devices.
67	67	14 "Drug order" means a written order in a hospital or other health care
68	68	15 institution for an ultimate user for any drug or device, issued and
69	69	16 signed by a practitioner, or an order transmitted by other means of
70	70	17 communication from a practitioner, which is immediately reduced to
71	71	18 writing by the pharmacist, registered nurse, or other licensed health
72	72	19 care practitioner authorized by the hospital or institution. The order
73	73	20 shall contain the name and bed number of the patient; the name and
74	74	21 strength or size of the drug or device; unless specified by individual
75	75	22 institution policy or guideline, the amount to be dispensed either in
76	76	23 quantity or days; adequate directions for the proper use of the drug or
77	77	24 device when it is administered to the patient; and the name of the
78	78	25 prescriber.
79	79	26 "Drug regimen review" means the retrospective, concurrent, and
80	80	27 prospective review by a pharmacist of a patient's drug related history
81	81	28 that includes the following areas:
82	82	29 (1) Evaluation of prescriptions or drug orders and patient records
83	83	30 for drug allergies, rational therapy contradictions, appropriate
84	84	31 dose and route of administration, appropriate directions for use,
85	85	32 or duplicative therapies.
86	86	33 (2) Evaluation of prescriptions or drug orders and patient records
87	87	34 for drug-drug, drug-food, drug-disease, and drug-clinical
88	88	35 laboratory interactions.
89	89	36 (3) Evaluation of prescriptions or drug orders and patient records
90	90	37 for adverse drug reactions.
91	91	38 (4) Evaluation of prescriptions or drug orders and patient records
92	92	39 for proper utilization and optimal therapeutic outcomes.
93	93	40 "Drug utilization review" means a program designed to measure and
94	94	41 assess on a retrospective and prospective basis the proper use of drugs.
95	95	42 "Device" means an instrument, apparatus, implement, machine,
96	96	2025 IN 506—LS 7149/DI 148 3
97	97	1 contrivance, implant, in vitro reagent, or other similar or related article
98	98	2 including any component part or accessory, which is:
99	99	3 (1) recognized in the official United States Pharmacopoeia,
100	100	4 official National Formulary, or any supplement to them;
101	101	5 (2) intended for use in the diagnosis of disease or other conditions
102	102	6 or the cure, mitigation, treatment, or prevention of disease in man
103	103	7 or other animals; or
104	104	8 (3) intended to affect the structure or any function of the body of
105	105	9 man or other animals and which does not achieve any of its
106	106	10 principal intended purposes through chemical action within or on
107	107	11 the body of man or other animals and which is not dependent
108	108	12 upon being metabolized for the achievement of any of its
109	109	13 principal intended purposes.
110	110	14 "Electronic data intermediary" means an entity that provides the
111	111	15 infrastructure that connects a computer system or another electronic
112	112	16 device used by a prescribing practitioner with a computer system or
113	113	17 another electronic device used by a pharmacy to facilitate the secure
114	114	18 transmission of:
115	115	19 (1) an electronic prescription order;
116	116	20 (2) a refill authorization request;
117	117	21 (3) a communication; and
118	118	22 (4) other patient care information;
119	119	23 between a practitioner and a pharmacy.
120	120	24 "Electronic signature" means an electronic sound, symbol, or
121	121	25 process:
122	122	26 (1) attached to or logically associated with a record; and
123	123	27 (2) executed or adopted by a person;
124	124	28 with the intent to sign the record.
125	125	29 "Electronically transmitted" or "electronic transmission" means the
126	126	30 transmission of a prescription in electronic form. The term does not
127	127	31 include the transmission of a prescription by facsimile.
128	128	32 "Investigational or new drug" means any drug which is limited by
129	129	33 state or federal law to use under professional supervision of a
130	130	34 practitioner authorized by law to prescribe or administer such drug.
131	131	35 "Legend drug" has the meaning set forth in IC 16-18-2-199.
132	132	36 "License" and "permit" are interchangeable and mean a written
133	133	37 certificate from the Indiana board of pharmacy for the practice of
134	134	38 pharmacy or the operation of a pharmacy.
135	135	39 "Medication therapy management" means a distinct service or group
136	136	40 of services that optimize therapeutic outcomes for individuals that are
137	137	41 independent of, but may occur in conjunction with, the provision of a
138	138	42 medication or medical device. The term includes the following
139	139	2025 IN 506—LS 7149/DI 148 4
140	140	1 services:
141	141	2 (1) Performing or obtaining assessments of an individual's health
142	142	3 status.
143	143	4 (2) Formulating a medication treatment plan.
144	144	5 (3) Selecting, initiating, modifying, or administering medication
145	145	6 therapy.
146	146	7 (4) Monitoring and evaluating an individual's response to therapy,
147	147	8 including safety and effectiveness.
148	148	9 (5) Performing a comprehensive medication review to identify,
149	149	10 resolve, and prevent medication related problems, including
150	150	11 adverse drug events.
151	151	12 (6) Documenting the care delivered and communicating essential
152	152	13 information to the patient's other health care providers.
153	153	14 (7) Providing education and training designed to enhance patient
154	154	15 understanding and appropriate use of the individual's medications.
155	155	16 (8) Providing information and support services and resources
156	156	17 designed to enhance patient adherence with the individual's
157	157	18 therapeutic regimens, including medication synchronization.
158	158	19 (9) Coordinating and integrating medication therapy management
159	159	20 services within the broader health care services being provided to
160	160	21 an individual.
161	161	22 (10) Providing other patient care services allowable by law.
162	162	23 "Nonprescription drug" means a drug that may be sold without a
163	163	24 prescription and that is labeled for use by a patient in accordance with
164	164	25 state and federal laws.
165	165	26 "Person" means any individual, partnership, copartnership, firm,
166	166	27 company, corporation, association, joint stock company, trust, estate,
167	167	28 or municipality, or a legal representative or agent, unless this chapter
168	168	29 expressly provides otherwise.
169	169	30 "Practitioner" has the meaning set forth in IC 16-42-19-5.
170	170	31 "Pharmacist" means a person licensed under this chapter.
171	171	32 "Pharmacist intern" means a person who is:
172	172	33 (1) permitted by the board to engage in the practice of pharmacy
173	173	34 while under the personal supervision of a pharmacist and who is
174	174	35 satisfactorily progressing toward meeting the requirements for
175	175	36 licensure as a pharmacist;
176	176	37 (2) a graduate of an approved college of pharmacy or a graduate
177	177	38 who has established educational equivalency by obtaining a
178	178	39 Foreign Pharmacy Graduate Examination Committee Certificate
179	179	40 and who is permitted by the board to obtain practical experience
180	180	41 as a requirement for licensure as a pharmacist;
181	181	42 (3) a qualified applicant awaiting examination for licensure; or
182	182	2025 IN 506—LS 7149/DI 148 5
183	183	1 (4) an individual participating in a residency or fellowship
184	184	2 program.
185	185	3 "Pharmacy" means any facility, department, or other place where
186	186	4 prescriptions are filled or compounded and are sold, dispensed, offered,
187	187	5 or displayed for sale and which has as its principal purpose the
188	188	6 dispensing of drug and health supplies intended for the general health,
189	189	7 welfare, and safety of the public, without placing any other activity on
190	190	8 a more important level than the practice of pharmacy.
191	191	9 "Pharmacy personnel" means any of the following licensed or
192	192	10 registered under this chapter:
193	193	11 (1) Pharmacist.
194	194	12 (2) Pharmacy intern.
195	195	13 (3) Pharmacy technician.
196	196	14 (4) Technician in training.
197	197	15 "The practice of pharmacy" or "the practice of the profession of
198	198	16 pharmacy" means a patient oriented health care profession in which
199	199	17 pharmacists interact with and counsel patients and with other health
200	200	18 care professionals concerning drugs and devices used to enhance
201	201	19 patients' wellness, prevent illness, and optimize the outcome of a drug
202	202	20 or device, by accepting responsibility for performing or supervising a
203	203	21 pharmacist intern or an unlicensed person under section 18.5 of this
204	204	22 chapter to do the following acts, services, and operations:
205	205	23 (1) The offering of or performing of those acts, service operations,
206	206	24 or transactions incidental to the interpretation, evaluation, and
207	207	25 implementation of prescriptions or drug orders.
208	208	26 (2) The compounding, labeling, administering, dispensing, or
209	209	27 selling of drugs and devices, including radioactive substances,
210	210	28 whether dispensed under a practitioner's prescription or drug
211	211	29 order or sold or given directly to the ultimate consumer.
212	212	30 (3) The proper and safe storage and distribution of drugs and
213	213	31 devices.
214	214	32 (4) The maintenance of proper records of the receipt, storage,
215	215	33 sale, and dispensing of drugs and devices.
216	216	34 (5) Counseling, advising, and educating patients, patients'
217	217	35 caregivers, and health care providers and professionals, as
218	218	36 necessary, as to the contents, therapeutic values, uses, significant
219	219	37 problems, risks, and appropriate manner of use of drugs and
220	220	38 devices.
221	221	39 (6) Assessing, recording, and reporting events related to the use
222	222	40 of drugs or devices.
223	223	41 (7) Provision of the professional acts, professional decisions, and
224	224	42 professional services necessary to maintain all areas of a patient's
225	225	2025 IN 506—LS 7149/DI 148 6
226	226	1 pharmacy related care as specifically authorized to a pharmacist
227	227	2 under this article.
228	228	3 (8) Provision of medication therapy management.
229	229	4 "Prescription" means a written order or an order transmitted by other
230	230	5 means of communication from a practitioner to or for an ultimate user
231	231	6 for any drug or device containing:
232	232	7 (1) the name and address of the patient;
233	233	8 (2) the date of issue;
234	234	9 (3) the name and strength or size (if applicable) of the drug or
235	235	10 device;
236	236	11 (4) the amount to be dispensed (unless indicated by directions and
237	237	12 duration of therapy);
238	238	13 (5) adequate directions for the proper use of the drug or device by
239	239	14 the patient;
240	240	15 (6) the name of the practitioner; and
241	241	16 (7) if the prescription:
242	242	17 (A) is in written form, the signature of the practitioner; or
243	243	18 (B) is in electronic form, the electronic signature of the
244	244	19 practitioner.
245	245	20 "Record" means all papers, letters, memoranda, notes, prescriptions,
246	246	21 drug orders, invoices, statements, patient medication charts or files,
247	247	22 computerized records, or other written indicia, documents, or objects
248	248	23 which are used in any way in connection with the purchase, sale, or
249	249	24 handling of any drug or device.
250	250	25 "Sale" means every sale and includes:
251	251	26 (1) manufacturing, processing, transporting, handling, packaging,
252	252	27 or any other production, preparation, or repackaging;
253	253	28 (2) exposure, offer, or any other proffer;
254	254	29 (3) holding, storing, or any other possession;
255	255	30 (4) dispensing, giving, delivering, or any other supplying; and
256	256	31 (5) applying, administering, or any other using.
257	257	32 SECTION 2. IC 25-26-13-18, AS AMENDED BY P.L.202-2017,
258	258	33 SECTION 5, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
259	259	34 JULY 1, 2025]: Sec. 18. (a) To be eligible for issuance of a pharmacy
260	260	35 permit, an applicant must show to the satisfaction of the board that:
261	261	36 (1) Persons at the location will engage in the bona fide practice of
262	262	37 pharmacy. The application must show the number of hours each
263	263	38 week, if any, that the pharmacy will be open to the general public.
264	264	39 (2) The pharmacy will maintain a sufficient stock of emergency
265	265	40 and frequently prescribed drugs and devices as to adequately
266	266	41 serve and protect the public health.
267	267	42 (3) Except as provided in IC 25-26-13.5 and section sections 19
268	268	2025 IN 506—LS 7149/DI 148 7
269	269	1 and 19.5 of this chapter, a registered pharmacist will be in
270	270	2 personal attendance and on duty in the licensed premises at all
271	271	3 times when the practice of pharmacy is being conducted and that
272	272	4 the pharmacist will be responsible for the lawful conduct of the
273	273	5 pharmacy.
274	274	6 (4) The pharmacy will be located separate and apart from any area
275	275	7 containing merchandise not offered for sale under the pharmacy
276	276	8 permit. The pharmacy will:
277	277	9 (A) be stationary;
278	278	10 (B) be sufficiently secure, either through electronic or physical
279	279	11 means, or a combination of both, to protect the products
280	280	12 contained in the pharmacy and to detect and deter entry during
281	281	13 those times when the pharmacy is closed;
282	282	14 (C) be well lighted and ventilated with clean and sanitary
283	283	15 surroundings;
284	284	16 (D) be equipped with a sink with hot and cold running water
285	285	17 or some means for heating water, a proper sewage outlet, and
286	286	18 refrigeration;
287	287	19 (E) have a prescription filling area of sufficient size to permit
288	288	20 the practice of pharmacy as practiced at that particular
289	289	21 pharmacy; and
290	290	22 (F) have such additional fixtures, facilities, and equipment as
291	291	23 the board requires to enable it to operate properly as a
292	292	24 pharmacy in compliance with federal and state laws and
293	293	25 regulations governing pharmacies.
294	294	26 (b) Prior to opening a pharmacy after receipt of a pharmacy permit,
295	295	27 the permit holder shall submit the premises to a qualifying inspection
296	296	28 by a representative of the board and shall present a physical inventory
297	297	29 of the drugs and all other items in the inventory on the premises.
298	298	30 (c) At all times, the wholesale value of the drug inventory on the
299	299	31 licensed items must be at least ten percent (10%) of the wholesale
300	300	32 value of the items in the licensed area.
301	301	33 SECTION 3. IC 25-26-13-19.5 IS ADDED TO THE INDIANA
302	302	34 CODE AS A NEW SECTION TO READ AS FOLLOWS
303	303	35 [EFFECTIVE JULY 1, 2025]: Sec. 19.5. (a) This section applies to a
304	304	36 pharmacy that:
305	305	37 (1) holds a Category I permit (as defined in section 17 this
306	306	38 chapter);
307	307	39 (2) is staffed by a single pharmacist who is unexpectedly
308	308	40 unable to perform the individual's professional duties and
309	309	41 responsibilities due to the pharmacist's own medical
310	310	42 emergency; and
311	311	2025 IN 506—LS 7149/DI 148 8
312	312	1 (3) is unable to promptly identify a qualified pharmacist to
313	313	2 relieve an ill pharmacist described in subdivision (2) because
314	314	3 of the exigency of the emergency.
315	315	4 (b) A pharmacy described in subsection (a) may allow
316	316	5 prescription refills to be picked up by a patient or the patient's
317	317	6 agent for not more than two (2) hours after the pharmacist
318	318	7 becomes unavailable if the prescription refill:
319	319	8 (1) has been previously prepared and checked by a
320	320	9 pharmacist; and
321	321	10 (2) does not require the consultation of a pharmacist.
322	322	11 (c) A person who requests to speak to a pharmacist while the
323	323	12 pharmacist is unavailable must be told that:
324	324	13 (1) the pharmacist is unavailable due to a medical emergency;
325	325	14 and
326	326	15 (2) the person may provide a telephone number at which the
327	327	16 next available pharmacist may contact the person.
328	328	17 SECTION 4. IC 25-26-13-35 IS ADDED TO THE INDIANA
329	329	18 CODE AS A NEW SECTION TO READ AS FOLLOWS
330	330	19 [EFFECTIVE JULY 1, 2025]: Sec. 35. (a) A pharmacy:
331	331	20 (1) shall not require pharmacy personnel to work longer than
332	332	21 thirteen (13) continuous hours unless a pharmacy personnel
333	333	22 member volunteers to work longer than thirteen (13)
334	334	23 continuous hours; and
335	335	24 (2) shall allow at least eight (8) hours of time off between
336	336	25 consecutive shifts.
337	337	26 This subsection does not apply to pharmacy personnel who are
338	338	27 on-call but not actively performing a work related activity.
339	339	28 (b) A pharmacy shall allow any pharmacy personnel working
340	340	29 longer than six (6) continuous hours per work day a thirty (30)
341	341	30 minute, uninterrupted break if the following are satisfied:
342	342	31 (1) Unless the pharmacy is closed to the public, if a
343	343	32 pharmacist takes a break, the pharmacist shall:
344	344	33 (A) remain on the licensed premises of the pharmacy if no
345	345	34 other pharmacist is available during the break; and
346	346	35 (B) be available in case of an emergency.
347	347	36 (2) If operations are consistent with the law, medication can
348	348	37 continue to be prepared and dispensed during the
349	349	38 pharmacist's break.
350	350	39 (3) In the case of a pharmacy holding a Category I permit, a
351	351	40 person who requests to speak to the pharmacist must be told
352	352	41 that:
353	353	42 (A) the pharmacist is on break; and
354	354	2025 IN 506—LS 7149/DI 148 9
355	355	1 (B) the person may either:
356	356	2 (i) wait for the pharmacist to return from break; or
357	357	3 (ii) provide a telephone number at which the pharmacist
358	358	4 may contact the person after returning from break.
359	359	5 After returning from break, the pharmacist shall attempt to
360	360	6 contact any person who requested counseling during the
361	361	7 break.
362	362	2025 IN 506—LS 7149/DI 148