Indiana 2025 2025 Regular Session

Indiana Senate Bill SB0506 Introduced / Bill

Filed 01/15/2025

                     
Introduced Version
SENATE BILL No. 506
_____
DIGEST OF INTRODUCED BILL
Citations Affected:  IC 25-26-13.
Synopsis:  Pharmacy employment regulations. Provides that a
pharmacy shall not require a pharmacist to work longer than 13 hours
per work day, and requires a pharmacy to allow at least eight hours
between consecutive shifts. Requires a pharmacy to provide certain
pharmacists with a break with certain conditions. Allows a Category I
pharmacy to allow certain individuals to pick up prescription refills
while a pharmacist is unavailable under certain circumstances.
Provides that if a pharmacist is on break or unavailable when a person
requests to speak to the pharmacist, the person must be informed of the
reason for the pharmacist being unavailable and given certain options.
Effective:  July 1, 2025.
Deery
January 16, 2025, read first time and referred to Committee on Health and Provider
Services.
2025	IN 506—LS 7149/DI 148 Introduced
First Regular Session of the 124th General Assembly (2025)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
  Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in  this  style  type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
  Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2024 Regular Session of the General Assembly.
SENATE BILL No. 506
A BILL FOR AN ACT to amend the Indiana Code concerning
professions and occupations.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 25-26-13-2, AS AMENDED BY P.L.143-2022,
2 SECTION 55, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
3 JULY 1, 2025]: Sec. 2. As used in this chapter:
4 "Administering" means the direct application of a drug to the body
5 of a person by injection, inhalation, ingestion, or any other means.
6 "Board" means the Indiana board of pharmacy.
7 "Controlled drugs" are those drugs on schedules I through V of the
8 federal Controlled Substances Act or on schedules I through V of
9 IC 35-48-2.
10 "Coronavirus disease" means the disease caused by the severe acute
11 respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
12 "Counseling" means effective communication between a pharmacist
13 and a patient concerning the contents, drug to drug interactions, route,
14 dosage, form, directions for use, precautions, and effective use of a
15 drug or device to improve the therapeutic outcome of the patient
16 through the effective use of the drug or device.
17 "Dispensing" means issuing one (1) or more doses of a drug in a
2025	IN 506—LS 7149/DI 148 2
1 suitable container with appropriate labeling for subsequent
2 administration to or use by a patient.
3 "Drug" means:
4 (1) articles or substances recognized in the official United States
5 Pharmacopoeia, official National Formulary, official
6 Homeopathic Pharmacopoeia of the United States, or any
7 supplement to any of them;
8 (2) articles or substances intended for use in the diagnosis, cure,
9 mitigation, treatment, or prevention of disease in man or animals;
10 (3) articles other than food intended to affect the structure or any
11 function of the body of man or animals; or
12 (4) articles intended for use as a component of any article
13 specified in subdivisions (1) through (3) and devices.
14 "Drug order" means a written order in a hospital or other health care
15 institution for an ultimate user for any drug or device, issued and
16 signed by a practitioner, or an order transmitted by other means of
17 communication from a practitioner, which is immediately reduced to
18 writing by the pharmacist, registered nurse, or other licensed health
19 care practitioner authorized by the hospital or institution. The order
20 shall contain the name and bed number of the patient; the name and
21 strength or size of the drug or device; unless specified by individual
22 institution policy or guideline, the amount to be dispensed either in
23 quantity or days; adequate directions for the proper use of the drug or
24 device when it is administered to the patient; and the name of the
25 prescriber.
26 "Drug regimen review" means the retrospective, concurrent, and
27 prospective review by a pharmacist of a patient's drug related history
28 that includes the following areas:
29 (1) Evaluation of prescriptions or drug orders and patient records
30 for drug allergies, rational therapy contradictions, appropriate
31 dose and route of administration, appropriate directions for use,
32 or duplicative therapies.
33 (2) Evaluation of prescriptions or drug orders and patient records
34 for drug-drug, drug-food, drug-disease, and drug-clinical
35 laboratory interactions.
36 (3) Evaluation of prescriptions or drug orders and patient records
37 for adverse drug reactions.
38 (4) Evaluation of prescriptions or drug orders and patient records
39 for proper utilization and optimal therapeutic outcomes.
40 "Drug utilization review" means a program designed to measure and
41 assess on a retrospective and prospective basis the proper use of drugs.
42 "Device" means an instrument, apparatus, implement, machine,
2025	IN 506—LS 7149/DI 148 3
1 contrivance, implant, in vitro reagent, or other similar or related article
2 including any component part or accessory, which is:
3 (1) recognized in the official United States Pharmacopoeia,
4 official National Formulary, or any supplement to them;
5 (2) intended for use in the diagnosis of disease or other conditions
6 or the cure, mitigation, treatment, or prevention of disease in man
7 or other animals; or
8 (3) intended to affect the structure or any function of the body of
9 man or other animals and which does not achieve any of its
10 principal intended purposes through chemical action within or on
11 the body of man or other animals and which is not dependent
12 upon being metabolized for the achievement of any of its
13 principal intended purposes.
14 "Electronic data intermediary" means an entity that provides the
15 infrastructure that connects a computer system or another electronic
16 device used by a prescribing practitioner with a computer system or
17 another electronic device used by a pharmacy to facilitate the secure
18 transmission of:
19 (1) an electronic prescription order;
20 (2) a refill authorization request;
21 (3) a communication; and
22 (4) other patient care information;
23 between a practitioner and a pharmacy.
24 "Electronic signature" means an electronic sound, symbol, or
25 process:
26 (1) attached to or logically associated with a record; and
27 (2) executed or adopted by a person;
28 with the intent to sign the record.
29 "Electronically transmitted" or "electronic transmission" means the
30 transmission of a prescription in electronic form. The term does not
31 include the transmission of a prescription by facsimile.
32 "Investigational or new drug" means any drug which is limited by
33 state or federal law to use under professional supervision of a
34 practitioner authorized by law to prescribe or administer such drug.
35 "Legend drug" has the meaning set forth in IC 16-18-2-199.
36 "License" and "permit" are interchangeable and mean a written
37 certificate from the Indiana board of pharmacy for the practice of
38 pharmacy or the operation of a pharmacy.
39 "Medication therapy management" means a distinct service or group
40 of services that optimize therapeutic outcomes for individuals that are
41 independent of, but may occur in conjunction with, the provision of a
42 medication or medical device. The term includes the following
2025	IN 506—LS 7149/DI 148 4
1 services:
2 (1) Performing or obtaining assessments of an individual's health
3 status.
4 (2) Formulating a medication treatment plan.
5 (3) Selecting, initiating, modifying, or administering medication
6 therapy.
7 (4) Monitoring and evaluating an individual's response to therapy,
8 including safety and effectiveness.
9 (5) Performing a comprehensive medication review to identify,
10 resolve, and prevent medication related problems, including
11 adverse drug events.
12 (6) Documenting the care delivered and communicating essential
13 information to the patient's other health care providers.
14 (7) Providing education and training designed to enhance patient
15 understanding and appropriate use of the individual's medications.
16 (8) Providing information and support services and resources
17 designed to enhance patient adherence with the individual's
18 therapeutic regimens, including medication synchronization.
19 (9) Coordinating and integrating medication therapy management
20 services within the broader health care services being provided to
21 an individual.
22 (10) Providing other patient care services allowable by law.
23 "Nonprescription drug" means a drug that may be sold without a
24 prescription and that is labeled for use by a patient in accordance with
25 state and federal laws.
26 "Person" means any individual, partnership, copartnership, firm,
27 company, corporation, association, joint stock company, trust, estate,
28 or municipality, or a legal representative or agent, unless this chapter
29 expressly provides otherwise.
30 "Practitioner" has the meaning set forth in IC 16-42-19-5.
31 "Pharmacist" means a person licensed under this chapter.
32 "Pharmacist intern" means a person who is:
33 (1) permitted by the board to engage in the practice of pharmacy
34 while under the personal supervision of a pharmacist and who is
35 satisfactorily progressing toward meeting the requirements for
36 licensure as a pharmacist;
37 (2) a graduate of an approved college of pharmacy or a graduate
38 who has established educational equivalency by obtaining a
39 Foreign Pharmacy Graduate Examination Committee Certificate
40 and who is permitted by the board to obtain practical experience
41 as a requirement for licensure as a pharmacist;
42 (3) a qualified applicant awaiting examination for licensure; or
2025	IN 506—LS 7149/DI 148 5
1 (4) an individual participating in a residency or fellowship
2 program.
3 "Pharmacy" means any facility, department, or other place where
4 prescriptions are filled or compounded and are sold, dispensed, offered,
5 or displayed for sale and which has as its principal purpose the
6 dispensing of drug and health supplies intended for the general health,
7 welfare, and safety of the public, without placing any other activity on
8 a more important level than the practice of pharmacy.
9 "Pharmacy personnel" means any of the following licensed or
10 registered under this chapter:
11 (1) Pharmacist.
12 (2) Pharmacy intern.
13 (3) Pharmacy technician.
14 (4) Technician in training.
15 "The practice of pharmacy" or "the practice of the profession of
16 pharmacy" means a patient oriented health care profession in which
17 pharmacists interact with and counsel patients and with other health
18 care professionals concerning drugs and devices used to enhance
19 patients' wellness, prevent illness, and optimize the outcome of a drug
20 or device, by accepting responsibility for performing or supervising a
21 pharmacist intern or an unlicensed person under section 18.5 of this
22 chapter to do the following acts, services, and operations:
23 (1) The offering of or performing of those acts, service operations,
24 or transactions incidental to the interpretation, evaluation, and
25 implementation of prescriptions or drug orders.
26 (2) The compounding, labeling, administering, dispensing, or
27 selling of drugs and devices, including radioactive substances,
28 whether dispensed under a practitioner's prescription or drug
29 order or sold or given directly to the ultimate consumer.
30 (3) The proper and safe storage and distribution of drugs and
31 devices.
32 (4) The maintenance of proper records of the receipt, storage,
33 sale, and dispensing of drugs and devices.
34 (5) Counseling, advising, and educating patients, patients'
35 caregivers, and health care providers and professionals, as
36 necessary, as to the contents, therapeutic values, uses, significant
37 problems, risks, and appropriate manner of use of drugs and
38 devices.
39 (6) Assessing, recording, and reporting events related to the use
40 of drugs or devices.
41 (7) Provision of the professional acts, professional decisions, and
42 professional services necessary to maintain all areas of a patient's
2025	IN 506—LS 7149/DI 148 6
1 pharmacy related care as specifically authorized to a pharmacist
2 under this article.
3 (8) Provision of medication therapy management.
4 "Prescription" means a written order or an order transmitted by other
5 means of communication from a practitioner to or for an ultimate user
6 for any drug or device containing:
7 (1) the name and address of the patient;
8 (2) the date of issue;
9 (3) the name and strength or size (if applicable) of the drug or
10 device;
11 (4) the amount to be dispensed (unless indicated by directions and
12 duration of therapy);
13 (5) adequate directions for the proper use of the drug or device by
14 the patient;
15 (6) the name of the practitioner; and
16 (7) if the prescription:
17 (A) is in written form, the signature of the practitioner; or
18 (B) is in electronic form, the electronic signature of the
19 practitioner.
20 "Record" means all papers, letters, memoranda, notes, prescriptions,
21 drug orders, invoices, statements, patient medication charts or files,
22 computerized records, or other written indicia, documents, or objects
23 which are used in any way in connection with the purchase, sale, or
24 handling of any drug or device.
25 "Sale" means every sale and includes:
26 (1) manufacturing, processing, transporting, handling, packaging,
27 or any other production, preparation, or repackaging;
28 (2) exposure, offer, or any other proffer;
29 (3) holding, storing, or any other possession;
30 (4) dispensing, giving, delivering, or any other supplying; and
31 (5) applying, administering, or any other using.
32 SECTION 2. IC 25-26-13-18, AS AMENDED BY P.L.202-2017,
33 SECTION 5, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
34 JULY 1, 2025]: Sec. 18. (a) To be eligible for issuance of a pharmacy
35 permit, an applicant must show to the satisfaction of the board that:
36 (1) Persons at the location will engage in the bona fide practice of
37 pharmacy. The application must show the number of hours each
38 week, if any, that the pharmacy will be open to the general public.
39 (2) The pharmacy will maintain a sufficient stock of emergency
40 and frequently prescribed drugs and devices as to adequately
41 serve and protect the public health.
42 (3) Except as provided in IC 25-26-13.5 and section sections 19
2025	IN 506—LS 7149/DI 148 7
1 and 19.5 of this chapter, a registered pharmacist will be in
2 personal attendance and on duty in the licensed premises at all
3 times when the practice of pharmacy is being conducted and that
4 the pharmacist will be responsible for the lawful conduct of the
5 pharmacy.
6 (4) The pharmacy will be located separate and apart from any area
7 containing merchandise not offered for sale under the pharmacy
8 permit. The pharmacy will:
9 (A) be stationary;
10 (B) be sufficiently secure, either through electronic or physical
11 means, or a combination of both, to protect the products
12 contained in the pharmacy and to detect and deter entry during
13 those times when the pharmacy is closed;
14 (C) be well lighted and ventilated with clean and sanitary
15 surroundings;
16 (D) be equipped with a sink with hot and cold running water
17 or some means for heating water, a proper sewage outlet, and
18 refrigeration;
19 (E) have a prescription filling area of sufficient size to permit
20 the practice of pharmacy as practiced at that particular
21 pharmacy; and
22 (F) have such additional fixtures, facilities, and equipment as
23 the board requires to enable it to operate properly as a
24 pharmacy in compliance with federal and state laws and
25 regulations governing pharmacies.
26 (b) Prior to opening a pharmacy after receipt of a pharmacy permit,
27 the permit holder shall submit the premises to a qualifying inspection
28 by a representative of the board and shall present a physical inventory
29 of the drugs and all other items in the inventory on the premises.
30 (c) At all times, the wholesale value of the drug inventory on the
31 licensed items must be at least ten percent (10%) of the wholesale
32 value of the items in the licensed area.
33 SECTION 3. IC 25-26-13-19.5 IS ADDED TO THE INDIANA
34 CODE AS A NEW SECTION TO READ AS FOLLOWS
35 [EFFECTIVE JULY 1, 2025]: Sec. 19.5. (a) This section applies to a
36 pharmacy that:
37 (1) holds a Category I permit (as defined in section 17 this
38 chapter);
39 (2) is staffed by a single pharmacist who is unexpectedly
40 unable to perform the individual's professional duties and
41 responsibilities due to the pharmacist's own medical
42 emergency; and
2025	IN 506—LS 7149/DI 148 8
1 (3) is unable to promptly identify a qualified pharmacist to
2 relieve an ill pharmacist described in subdivision (2) because
3 of the exigency of the emergency.
4 (b) A pharmacy described in subsection (a) may allow
5 prescription refills to be picked up by a patient or the patient's
6 agent for not more than two (2) hours after the pharmacist
7 becomes unavailable if the prescription refill:
8 (1) has been previously prepared and checked by a
9 pharmacist; and
10 (2) does not require the consultation of a pharmacist.
11 (c) A person who requests to speak to a pharmacist while the
12 pharmacist is unavailable must be told that:
13 (1) the pharmacist is unavailable due to a medical emergency;
14 and
15 (2) the person may provide a telephone number at which the
16 next available pharmacist may contact the person.
17 SECTION 4. IC 25-26-13-35 IS ADDED TO THE INDIANA
18 CODE AS A NEW SECTION TO READ AS FOLLOWS
19 [EFFECTIVE JULY 1, 2025]: Sec. 35. (a) A pharmacy:
20 (1) shall not require pharmacy personnel to work longer than
21 thirteen (13) continuous hours unless a pharmacy personnel
22 member volunteers to work longer than thirteen (13)
23 continuous hours; and
24 (2) shall allow at least eight (8) hours of time off between
25 consecutive shifts.
26 This subsection does not apply to pharmacy personnel who are
27 on-call but not actively performing a work related activity.
28 (b) A pharmacy shall allow any pharmacy personnel working
29 longer than six (6) continuous hours per work day a thirty (30)
30 minute, uninterrupted break if the following are satisfied:
31 (1) Unless the pharmacy is closed to the public, if a
32 pharmacist takes a break, the pharmacist shall:
33 (A) remain on the licensed premises of the pharmacy if no
34 other pharmacist is available during the break; and
35 (B) be available in case of an emergency.
36 (2) If operations are consistent with the law, medication can
37 continue to be prepared and dispensed during the
38 pharmacist's break.
39 (3) In the case of a pharmacy holding a Category I permit, a
40 person who requests to speak to the pharmacist must be told
41 that:
42 (A) the pharmacist is on break; and
2025	IN 506—LS 7149/DI 148 9
1 (B) the person may either:
2 (i) wait for the pharmacist to return from break; or
3 (ii) provide a telephone number at which the pharmacist
4 may contact the person after returning from break.
5 After returning from break, the pharmacist shall attempt to
6 contact any person who requested counseling during the
7 break.
2025	IN 506—LS 7149/DI 148