Introduced Version
HOUSE BILL No. 1182
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 16-18-2-298.5; IC 16-19-4-11; IC 25-26;
IC 34-30-2.1-380.3.
Synopsis: Pharmacy matters. Removes the authority of the
commissioner's designated public health authority to issue a standing
order, prescription, or protocol to allow certain health practitioners to
administer or dispense an immunization or a pharmacist a smoking
cessation product. Requires the state health commissioner to issue a
standing order, prescription, or protocol (standing order) that allows a
pharmacist to treat or screen, test, administer, or dispense for certain
health conditions. Allows a pharmacist to order tests that are waived
under the federal Clinical Laboratory Improvement Amendments
(CLIA) or established under a standing order. Allows a pharmacy
intern or a pharmacy technician to perform a test that is: (1) delegated
by a supervising pharmacist; and (2) a waived test under CLIA. Allows
a pharmacy technician, who is certified to perform any activity
delegated by a supervising pharmacist or pharmacist owner if the
activities: (1) do not require the clinical judgment of a pharmacist; (2)
are not prohibited by a rule adopted by the Indiana board of pharmacy;
or (3) are not an activity required by law to be performed only by a
pharmacist. Provides that a health carrier may not deny reimbursement
for services and procedures that are performed by a pharmacist and that
are within the scope of the pharmacist's license if the same services and
procedures would be covered if performed by a physician, an advanced
practice registered nurse, or a physician assistant. Provides civil and
criminal immunity for a pharmacist related to filling a prescription for
a drug, medicine, or other prescribed substance. Establishes exceptions.
Effective: July 1, 2023.
Clere
January 10, 2023, read first time and referred to Committee on Public Health.
2023 IN 1182—LS 7429/DI 77 Introduced
First Regular Session of the 123rd General Assembly (2023)
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 2022 Regular Session of the General Assembly.
HOUSE BILL No. 1182
A BILL FOR AN ACT to amend the Indiana Code concerning
health.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 16-18-2-298.5, AS AMENDED BY P.L.96-2017,
2 SECTION 1, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
3 JULY 1, 2023]: Sec. 298.5. (a) "Public health authority", for purposes
4 of IC 16-22-8 and IC 16-41-9, means:
5 (1) the state health commissioner of the state department;
6 (2) a deputy or an assistant state health commissioner appointed
7 by the state health commissioner, or an agent expressly authorized
8 by the state health commissioner;
9 (3) the local health officer; or
10 (4) a health and hospital corporation established under
11 IC 16-22-8-6.
12 (b) "Public health authority", for purposes of IC 16-19 and
13 IC 16-42-27, means any of the following who is a licensed prescriber:
14 (1) A deputy or assistant state health commissioner appointed by
15 the state health commissioner to act as a public health authority.
16 (2) An agent employed by the state department that is expressly
17 authorized by the state health commissioner to act as a public
2023 IN 1182—LS 7429/DI 77 2
1 health authority.
2 SECTION 2. IC 16-19-4-11, AS AMENDED BY P.L.1-2022,
3 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
4 JULY 1, 2023]: Sec. 11. (a) The state health commissioner or the
5 commissioner's designated public health authority who is a licensed
6 prescriber may, as part of the individual's commissioner's official
7 capacity, issue a standing order, prescription, or protocol that allows a
8 pharmacist to administer or dispense any of the following:
9 (1) An immunization that is recommended by the federal Centers
10 for Disease Control and Prevention Advisory Committee on
11 Immunization Practices for individuals who are not less than
12 eleven (11) years of age.
13 (2) A smoking cessation product. However, the pharmacist must
14 inform the patient that the patient must have a follow-up
15 consultation with the patient's licensed prescriber.
16 (b) This subsection does not apply to a pharmacist. The state health
17 commissioner or the commissioner's designated public health authority
18 who is a licensed prescriber may, as part of the individual's
19 commissioner's official capacity, issue a standing order, prescription,
20 or protocol that allows an individual who is licensed, certified, or
21 registered by a board (as defined in IC 25-1-9-1), and if within the
22 individual's scope of practice, to administer or dispense an
23 immunization that is recommended by the federal Centers for Disease
24 Control and Prevention Advisory Committee on Immunization
25 Practices for individuals who are not less than eleven (11) years of age.
26 (c) A standing order described in subsection (a), (b), or (e) must
27 include the following:
28 (1) The purpose of the order.
29 (2) The eligible recipients.
30 (3) The geographic area covered by the standing order.
31 (4) The procedure for administering or dispensing the
32 immunization or product.
33 (5) A timeline for renewing or updating the standing order.
34 (d) The state health commissioner or designated public health
35 authority who issues a standing order, prescription, or protocol under
36 subsection (a), (b), or (e), or (f) is immune from civil liability related
37 to the issuing of the standing order, prescription, or protocol.
38 (e) Notwithstanding subsection (a) and subsection (b), the state
39 health commissioner or the commissioner's designated public health
40 authority may issue a standing order, prescription, or protocol to
41 administer or dispense an immunization that is recommended by the
42 federal Centers for Disease Control and Prevention Advisory
2023 IN 1182—LS 7429/DI 77 3
1 Committee on Immunization Practices for individuals who are at least
2 five (5) years of age. Nothing in this subsection authorizes the state
3 health commissioner or the commissioner's designated public health
4 authority to:
5 (1) require an individual to receive an immunization for
6 COVID-19; or
7 (2) waive or otherwise allow a minor to receive an immunization
8 without the consent of the parent or guardian as required under
9 IC 16-36-1.
10 This subsection expires at the conclusion of the federal public health
11 emergency concerning COVID-19 that was renewed on October 15,
12 2021, or any subsequent renewal of the declared federal public health
13 emergency concerning COVID-19.
14 (f) The state health commissioner shall, as part of the
15 commissioner's official capacity, issue a standing order,
16 prescription, or protocol that allows a pharmacist to treat or
17 screen, test, administer, or dispense for any of the following:
18 (1) Respiratory illness, including;
19 (A) influenza;
20 (B) severe acute respiratory syndrome coronavirus
21 (SARS-CoV-2 ); and
22 (C) respiratory syncytial virus (RSV).
23 (2) Group A streptococcus pharyngitis (strep throat).
24 (3) Lice.
25 (4) Certain minor skin conditions.
26 (5) Emerging or existing public health threats identified by
27 the state health commissioner.
28 SECTION 3. IC 25-26-12-31.3 IS ADDED TO THE INDIANA
29 CODE AS A NEW SECTION TO READ AS FOLLOWS
30 [EFFECTIVE JULY 1, 2023]: Sec. 31.3. A pharmacist may treat
31 health conditions and order tests to guide the pharmacist's clinical
32 decision making under a standing order, prescription, or protocol
33 issued by the state health commissioner. However, the test must be:
34 (1) a waived test under the federal Clinical Laboratory
35 Improvement Amendments (CLIA), including a test system
36 cleared by the Food and Drug Administration for home use or
37 a test approved for waiver under the CLIA; or
38 (2) established under the standing order, prescription, or
39 protocol issued by the state health commissioner.
40 SECTION 4. IC 25-26-13-31.5, AS AMENDED BY P.L.207-2021,
41 SECTION 37, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
42 JULY 1, 2023]: Sec. 31.5. (a) Subject to rules adopted under
2023 IN 1182—LS 7429/DI 77 4
1 subsection (c), a pharmacist intern or a pharmacist student may
2 administer an immunization to an individual under a drug order or
3 prescription.
4 (b) Subject to rules adopted under subsection (c), a pharmacist
5 intern or a pharmacist student may administer an immunization to an
6 individual or a group of individuals under a drug order, under a
7 prescription, or according to a protocol approved by a physician.
8 (c) The board shall adopt rules under IC 4-22-2 to establish
9 requirements applying to a pharmacist intern or a pharmacist student
10 who administers an immunization to an individual or group of
11 individuals. The rules adopted under this section:
12 (1) must provide for the direct supervision of the pharmacist
13 intern or pharmacist student by a pharmacist, a physician, a
14 physician assistant, an advanced practice registered nurse, or a
15 registered nurse; and
16 (2) may not be less stringent than the requirements applying to a
17 pharmacist who administers an immunization to an individual as
18 provided under section 31.2 of this chapter.
19 (d) A pharmacy intern may perform a test that is:
20 (1) delegated by a supervising pharmacist; and
21 (2) a waived test under the federal Clinical Laboratory
22 Improvement Amendments (CLIA), including a test system
23 cleared by the Food and Drug Administration for home use or
24 a test approved for waiver under the CLIA.
25 SECTION 5. IC 25-26-13-31.7, AS AMENDED BY P.L.143-2022,
26 SECTION 63, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
27 JULY 1, 2023]: Sec. 31.7. (a) Subject to rules adopted under
28 subsection (c), a pharmacy technician may administer any
29 immunization to an individual under a drug order or prescription, as
30 delegated by the pharmacist.
31 (b) Subject to rules adopted under subsection (c), a pharmacy
32 technician may administer an immunization to an individual or a group
33 of individuals under a drug order, under a prescription, or according to
34 a protocol approved by a physician, as delegated by the pharmacist.
35 (c) The board shall adopt rules under IC 4-22-2 to establish
36 requirements applying to a pharmacy technician who administers an
37 immunization to an individual or group of individuals. The rules
38 adopted under this section must provide for the direct supervision of
39 the pharmacy technician by a pharmacist, a physician, a physician
40 assistant, or an advanced practice registered nurse. Before July 1, 2021,
41 the board shall adopt emergency rules under IC 4-22-2-37.1 to establish
42 the requirements described in this subsection. Notwithstanding
2023 IN 1182—LS 7429/DI 77 5
1 IC 4-22-2-37.1(g), an emergency rule adopted by the board under this
2 subsection and in the manner provided by IC 4-22-2-37.1 expires on
3 the date on which a rule that supersedes the emergency rule is adopted
4 by the board under IC 4-22-2-24 through IC 4-22-2-36.
5 (d) The board must approve all programs that provide training to
6 pharmacy technicians to administer immunizations as permitted by this
7 section.
8 (e) A pharmacy technician may perform a test that is:
9 (1) delegated by a supervising pharmacist; and
10 (2) a waived test under the federal Clinical Laboratory
11 Improvement Amendments (CLIA), including a test system
12 cleared by the federal Food and Drug Administration for
13 home use or a test approved for waiver under the CLIA.
14 SECTION 6. IC 25-26-13-34 IS ADDED TO THE INDIANA
15 CODE AS A NEW SECTION TO READ AS FOLLOWS
16 [EFFECTIVE JULY 1, 2023]: Sec. 34. A health carrier (as defined
17 in IC 27-1-46-3) may not deny reimbursement for services and
18 procedures that are performed by a pharmacist and that are
19 within the scope of the pharmacist's license if the same services and
20 procedures would be covered if performed by a physician, an
21 advanced practice registered nurse, or a physician assistant.
22 SECTION 7. IC 25-26-13-35 IS ADDED TO THE INDIANA
23 CODE AS A NEW SECTION TO READ AS FOLLOWS
24 [EFFECTIVE JULY 1, 2023]: Sec. 35. (a) Nothing in this section
25 grants civil immunity to a pharmacist or pharmacy whose actions
26 or omissions, as proven by clear and convincing evidence,
27 constitute gross negligence or willful or wanton misconduct,
28 including fraud and intentional acts.
29 (b) For purposes of this section, the absence of a diagnosis or a
30 diagnosis code on the prescription by the prescriber indicating that
31 the drug, medicine, or other substance is intended for a purpose
32 other than to cause an abortion does not constitute actual
33 knowledge.
34 (c) Unless a pharmacist or pharmacy has actual knowledge that
35 a prescription is intended for the purpose of causing an abortion,
36 a pharmacist or pharmacy is not subject to a criminal action
37 related to filling a prescription for a drug, medicine, or other
38 prescribed substance.
39 (d) Unless a pharmacist or pharmacy has actual knowledge that
40 a prescription is intended for the purpose of causing an abortion,
41 a pharmacist or pharmacy is immune from civil liability for
42 damages arising from filling a prescription for a drug, medicine, or
2023 IN 1182—LS 7429/DI 77 6
1 other prescribed substance.
2 SECTION 8. IC 25-26-19-8, AS AMENDED BY P.L.58-2014,
3 SECTION 15, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
4 JULY 1, 2023]: Sec. 8. A licensed pharmacy technician may not
5 perform the following activities:
6 (1) Providing advice or consultation with the prescribing
7 practitioner or other licensed health care provider regarding the
8 patient or the interpretation and application of information
9 contained in the prescription or drug order, medical record, or
10 patient profile.
11 (2) Providing advice or consultation with the patient regarding the
12 interpretation of the prescription or the application of information
13 contained in the patient profile or medical record.
14 (3) Dispensing prescription drug information to the patient.
15 (4) Final check on all aspects of the completed prescription and
16 assumption of the responsibility for the filled prescription,
17 including the appropriateness of the drug for the patient and the
18 accuracy of the:
19 (A) drug dispensed;
20 (B) strength of the drug dispensed; and
21 (C) labeling of the prescription.
22 (5) Receiving a new prescription drug order over the telephone or
23 electronically unless the original information is recorded so a
24 pharmacist may review the prescription drug order as transmitted.
25 (6) Any activity required by law to be performed only by a
26 pharmacist.
27 (7) Any activity that requires the clinical judgment of a
28 pharmacist and is prohibited by a rule adopted by the board.
29 (b) Notwithstanding subsection (a), a licensed pharmacy
30 technician, who holds an active certification from the Pharmacy
31 Technician Certification Board or other nationally recognized
32 certification approved by the board, may perform any activity
33 delegated by a supervising pharmacist or pharmacist owner,
34 including those activities described in subsection (a)(4) and (a)(5),
35 if the activities:
36 (1) do not require the clinical judgment of a pharmacist;
37 (2) are not prohibited by a rule adopted by the board; or
38 (3) are not an activity required by law to be performed only
39 by a pharmacist.
40 (c) A technician who performs the activities permitted under
41 subsection (b) must be properly trained and competent to perform
42 the delegated task. The pharmacy must keep a record of the
2023 IN 1182—LS 7429/DI 77 7
1 technician's training and documentation to support the
2 technician's competency.
3 SECTION 9. IC 34-30-2.1-380.3 IS ADDED TO THE INDIANA
4 CODE AS A NEW SECTION TO READ AS FOLLOWS
5 [EFFECTIVE JULY 1, 2023]: Sec. 380.3. IC 25-26-13-35
6 (Concerning filling a prescription).
2023 IN 1182—LS 7429/DI 77