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,
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provision adopted), the text of the new provision will appear in this style type. Also, the
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a new provision to the Indiana Code or the Indiana Constitution.
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between statutes enacted by the 2022 Regular Session of the General Assembly.
HOUSE ENROLLED ACT No. 1017
AN ACT to amend the Indiana Code concerning health.
Be it enacted by the General Assembly of the State of Indiana:
SECTION 1. IC 25-1-8-1, AS AMENDED BY P.L.3-2014,
SECTION 24, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2023]: Sec. 1. Except as provided in section 2.5 of this
chapter, as used in this chapter, "board" means any of the entities
described in IC 25-0.5-9.
SECTION 2. IC 25-1-8-2.5 IS ADDED TO THE INDIANA CODE
AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
1, 2023]: Sec. 2.5. (a) As used in this section, "board" means any of
the entities described in IC 25-0.5-1.
(b) In addition to the fees assessed under section 2 of this
chapter, at the time of license, registration, or certification
renewal, each person who is issued a license, registration, or
certificate by a board must pay the fee determined under
subsection (d).
(c) The fees collected under this section must be deposited in the
prescription drug donation repository program account of the state
general fund established by IC 25-26-13-30.
(d) The amount of the fee under this section must be an amount
per license needed to administer the prescription drug donation
repository program, as determined by the Indiana professional
licensing agency after review by the budget committee. In addition,
the amount of the fee determined under this subsection may not be
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subsequently increased unless the increase is reviewed by the
budget committee.
SECTION 3. IC 25-26-13-30, AS AMENDED BY P.L.1-2006,
SECTION 464, IS AMENDED TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2023]: Sec. 30. (a) Within the state general
fund there are established the following accounts:
(1) The impaired pharmacists account is established within the
state general fund to provide money for the rehabilitation of
impaired pharmacists under this article.
(2) The prescription drug donation repository program
account to provide money to administer the prescription drug
donation repository program under this article.
The account accounts shall be administered by the Indiana
professional licensing agency.
(b) Expenses of administering the account accounts shall be paid
from money in the each account. The impaired pharmacists account
consists of money collected under section 4.5(b) of this chapter. The
prescription drug donation repository program account consists of
money collected under IC 25-1-8-2.5.
(c) The treasurer of state shall invest the money in the account
accounts not currently needed to meet the obligations of the each
account in the same manner as other public money may be invested.
Money remaining in the account accounts at the end of a state fiscal
year does not revert to the state general fund.
(d) There is appropriated to the board from the each account an
amount sufficient to carry out the purpose purposes described in
subsection (a).
SECTION 4. IC 25-26-14-11, AS AMENDED BY P.L.143-2022,
SECTION 72, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2023]: Sec. 11. As used in this chapter, "wholesale
distribution" means to distribute legend drugs to persons other than a
consumer or patient. The term does not include:
(1) a sale or transfer between a division, a subsidiary, a parent, an
affiliated, or a related company under the common ownership and
control of a corporate entity;
(2) the purchase or acquisition by a hospital or other health care
entity that is a member of a group purchasing organization of a
drug for the hospital's or health care entity's own use from the
group purchasing organization or from other hospitals or health
care entities that are members of the organization;
(3) the sale or transfer of a drug by a charitable organization
described in Section 501(c)(3) of the Internal Revenue Code, to:
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(A) a nonprofit affiliate of the organization; or
(B) a nonprofit entity described in Section 501(c)(3) of the
Internal Revenue Code that is not affiliated with the
organization;
to the extent otherwise permitted by law;
(4) the sale of a drug among hospitals or other health care entities
that are under common control;
(5) the sale of a drug for emergency medical reasons, including
transfers of legend drugs by a retail pharmacy to another retail
pharmacy to alleviate a temporary shortage, if the gross dollar
value of the transfers does not exceed five percent (5%) of the
total legend drug sales revenue of either the transferor or
transferee pharmacy during any twelve (12) consecutive month
period;
(6) the sale of a drug or the dispensing of a drug pursuant to a
prescription;
(7) the distribution of drug samples by manufacturers'
representatives or distributors' representatives;
(8) the sale of blood and blood components intended for
transfusion;
(9) the sale of a drug by a retail pharmacy to a practitioner (as
defined in IC 25-26-13-2) for office use, if the gross dollar value
of the transfers does not exceed five percent (5%) of the retail
pharmacy's total legend drug sales during any twelve (12)
consecutive months;
(10) the sale of a drug by a retail pharmacy that is ending its
business and liquidating its inventory to another retail pharmacy;
(11) drug returns by a hospital, health care entity, or charitable
institution conducted under 21 CFR 203.23;
(12) the sale of minimal quantities of drugs by retail pharmacies
to licensed practitioners for office use;
(13) the distribution of prescription drugs by the original
manufacturer of the finished form of the prescription drug or the
distribution of the co-licensed products by a partner of the
original manufacturer of the finished form of the prescription
drug;
(14) drug returns that meet criteria established by rules adopted
by the board; or
(15) the sale of a drug for research or clinical trial purposes,
provided the seller is authorized by the federal Food and Drug
Administration to sell the drug for research or clinical trial
purposes; or
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(16) the donation, acceptance, distribution, or dispensing of a
legend drug as part of the prescription drug donation
repository program under IC 25-26-26.
SECTION 5. IC 25-26-26 IS ADDED TO THE INDIANA CODE
AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2023]:
Chapter 26. Prescription Drug Donation Repository Program
Sec. 1. (a) Nothing in this chapter restricts the use of samples by
a physician or other person legally authorized to prescribe drugs
under state and federal law during the course of the physician's or
other person's duties at an eligible entity.
(b) Nothing in this chapter authorizes the resale of prescription
drugs by any person.
(c) Nothing in this chapter requires a:
(1) central repository;
(2) local repository; or
(3) person who donates, transfers, or receives a prescription
drug under this chapter;
to have a license as a wholesale drug distributor.
Sec. 2. As used in this chapter, "board" means the Indiana
board of pharmacy (IC 25-26-13-3).
Sec. 3. As used in this chapter, "eligible entity" means any of the
following:
(1) A physician's office.
(2) A hospital licensed under IC 16-21.
(3) A health clinic, including the following:
(A) A federally qualified health center as defined in 42
U.S.C. 1396d(l)(2)(B).
(B) A rural health clinic described in section 42 U.S.C.
1396d(l)(1).
(4) A nonprofit health clinic that provides medical care to
patients who are indigent, uninsured, underinsured, or unable
to pay for the services.
(5) A charitable organization that is exempt from taxation
under Section 501(c)(3) of the Internal Revenue Code that has
as its primary purpose the sponsorship or support of
programs designed to improve the quality, awareness, and
availability of medical services to individuals.
(6) A health facility licensed under IC 16-28.
(7) A pharmacy that has a permit issued under IC 25-26-13.
Sec. 4. As used in this chapter, "eligible recipient" means an
individual who:
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(1) is a resident of the state of Indiana;
(2) has an income that is below two hundred percent (200%)
of the federal poverty level, as defined by the most recently
revised poverty income guidelines published by the federal
Department of Health and Human Services; and
(3) is either:
(A) uninsured and has no third party prescription drug
reimbursement coverage; or
(B) underinsured and has no active third party
prescription drug reimbursement coverage for the drug
prescribed.
Sec. 5. As used in this chapter, "pharmacy" has the meaning set
forth in IC 25-26-13-2.
Sec. 6. As used in this chapter, "practitioner" means any of the
following:
(1) A physician licensed under IC 25-22.5.
(2) A dentist licensed to practice dentistry under IC 25-14.
(3) A podiatrist licensed to practice podiatric medicine under
IC 25-29.
(4) A pharmacist licensed under IC 25-26-13.
(5) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-24-3.
(6) An advanced practice registered nurse who meets the
requirements of IC 25-23-1-19.5.
(7) A physician assistant licensed under IC 25-27.5 who is
delegated prescriptive authority under IC 25-27.5-5-6.
Sec. 7. (a) As used in this chapter, "prescription drug" means a
drug, as defined in IC 25-26-13-2, that requires a prescription
before being dispensed or administered to a patient.
(b) The term does not include:
(1) an abortion inducing drug (as defined in IC 16-18-2-1.6);
or
(2) controlled substances (as defined in IC 35-48-1-9).
Sec. 8. As used in this chapter, "program" refers to the
prescription drug donation repository program established by
section 10 of this chapter.
Sec. 9. As used in this chapter, "supplies" means the supplies
necessary to administer the donated prescription drugs.
Sec. 10. (a) The prescription drug donation repository program
is established. The program allows a person to donate prescription
drugs and supplies to a central repository or local repository for
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use by an individual who is an eligible recipient.
(b) The board (IC 25-26-13-3) shall administer and maintain the
program.
(c) The board may establish a central repository that accepts
donated prescription drugs and supplies, conducts a safety
inspection of the prescription drugs, and ships donated
prescription drugs and supplies to a local repository.
(d) The board may contract with a third party to implement and
administer the program.
Sec. 11. (a) An eligible entity may apply to the board or a third
party that has contracted with the board under section 10(d) of this
chapter to participate as a local repository in the program. The
board or a third party shall approve or deny the eligible entity's
application to participate as a local repository.
(b) Donations of prescription drugs and supplies under the
program may be made on the premises of the central repository or
a local repository.
(c) A local repository must meet the following requirements:
(1) Comply with all laws applicable to the storage and
distribution of prescription drugs.
(2) Provide to the board the name, street address, and
telephone number of the eligible entity approved by the board
or third party to participate as a local repository, and any
state license or registration number issued to the eligible
entity, including the name of the issuing agency or board.
(3) The name and telephone number of the responsible
practitioner who is employed by or under contract with the
eligible entity.
(4) A statement, signed and dated by the responsible
practitioner, indicating that the eligible entity meets the
eligibility requirements under this chapter.
Sec. 12. (a) A local repository may withdraw from participation
in the program at any time by providing written notice to the
board.
(b) The board or a third party contracting with the board under
section 10(d) of this chapter may rescind a local repository's
participation in the program under this chapter for cause.
Sec. 13. Any individual who is at least eighteen (18) years of age
may donate legally obtained prescription drugs or supplies to the
central repository or a local repository. A practitioner who is
employed by or under contract with the central repository or local
repository shall determine whether the prescription drugs or
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supplies meet the requirements of this chapter.
Sec. 14. (a) Except for prescription drugs donated directly from
a drug manufacturer, a prescription drug that requires storage
temperatures other than normal room temperature as specified by
the drug manufacturer or the United States Pharmacopoeia, or its
supplements, may not be donated or accepted as part of the
program.
(b) The central repository or a local repository may accept or
dispense a prescription drug and supplies if the following
requirements are met:
(1) The drug is in its original sealed and tamper evident
packaging. However, a prescription drug in a single unit dose
or blister pack with the outside packaging opened may be
accepted if the single unit dose packaging is undisturbed.
(2) The drug has been stored according to manufacturer or
United States Pharmacopoeia, or its supplements, storage
requirements, unless a United States Pharmacopoeia
recognized method to detect improper temperature variations
has been used.
(3) The packaging contains the expiration date of the drug
and the drug has not expired.
(4) The drug or its packaging does not have any physical signs
of tampering, misbranding, deterioration, compromised
integrity, or adulteration.
(5) If a prescription drug is subject to risk evaluation and
mitigation under 21 U.S.C. 355-1(f)(3), all of the required
guidelines for the prescription drug are followed.
(6) The supplies are in its original sealed packaging and are
not expired.
(c) The donated prescription drugs and supplies must be
inventoried at the central repository or a local repository. If the
drug:
(1) has been continually under the control of a practitioner or
drug manufacturer, the inventory must include the name of
the drug, strength of the drug, quantity of the drug, and date
of donation; or
(2) has not been continually under the control of a
practitioner or drug manufacturer, the repository shall collect
a donation form that is signed by the person making the
donation or the person's authorized representative.
(d) The central repository or a local repository shall maintain
records of the prescription drugs and supplies that are donated,
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accepted, distributed, and dispensed under the program. The
records must be maintained for two (2) years from the date the
prescription drugs or supplies are donated, accepted, distributed,
and dispensed under the program.
(e) The central repository or a local repository may repackage
donated prescription drugs as necessary for storage, dispensing,
administration, or transfers if the repackaged prescription drug is:
(1) labeled with the drug name, strength, and expiration date;
and
(2) kept in a separate designated area until inspected and
initialed by a practitioner with knowledge or experience with
the prescription drug.
If multiple packaged donated prescription drugs with varied
expiration dates are repackaged together, the shortest expiration
date shall be used. A drug manufacturer's original expiration date
may be used in place of a beyond use date.
(f) Donated prescription drugs that do not meet the
requirements of this section must be disposed of by:
(1) returning it to the drug donor;
(2) destroying it by an incinerator, medical waste hauler, or
other lawful method; or
(3) transferring it to a reverse distributor.
(g) A record of disposed prescription drugs under subsection (f)
must contain the following information:
(1) The disposal method that was used.
(2) The date of disposal.
(3) The name, strength, and quantity of each drug disposed.
Any other information concerning the disposal of the prescription
drugs is not required.
Sec. 15. The central repository or a local repository may charge
an individual who receives a prescription drug or supplies a
handling fee that may not exceed the lesser of twenty-five dollars
($25) or the repository's cost of providing the drug or supplies
including the following:
(1) The current and anticipated costs of educating eligible
donors.
(2) Providing technical support to participating donors.
(3) Shipping and handling, labor, storage, licensing, utilities,
advertising, technology, supplies, and equipment.
Sec. 16. (a) The central repository or a local repository:
(1) that receives prescription drugs or supplies may transfer
the prescription drugs or supplies to:
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(A) the central repository or a local repository for use in
the program; or
(B) a central repository or local repository located in
another state; and
(2) may receive prescription drugs or supplies from a central
repository or local repository located in another state.
(b) The Indiana department of health may receive prescription
drugs or supplies directly from a prescription drug donation
repository contractor and may distribute the prescription drugs
and supplies through practitioners licensed to dispense
prescription drugs and supplies to an eligible recipient.
(c) The Indiana department of health may receive and distribute
the prescription drugs or supplies under this section during or in
preparation for a state of disaster emergency proclaimed by the
governor or during or in preparation for a public health
emergency.
Sec. 17. The prescription drugs or supplies that are prescribed
by a practitioner for use by an eligible recipient must be dispensed
by:
(1) a pharmacist; or
(2) the prescribing practitioner or the practitioner's
authorized agent.
Sec. 18. An individual may receive prescription drugs or
supplies under the program if the following conditions are met:
(1) The prescription drugs or supplies are prescribed for the
individual by a practitioner.
(2) The individual attests that the individual is an eligible
recipient.
(3) The individual acknowledges that the drugs may have been
donated and consents to a waiver releasing the central or local
repository from any liability for injury, death, or loss to a
person or property related to the donation, acceptance,
distribution, or dispensing of the donated prescription drug,
unless the person's acts or omissions were not performed
reasonably and in good faith.
Sec. 19. (a) A prescription drug or supplies donated under this
chapter may not be resold.
(b) A prescription drug dispensed through the program is not
eligible for reimbursement under a medical assistance program.
Sec. 20. (a) If a person who donates prescription drugs under
this chapter to the central repository or a local repository receives
a notice that a prescription drug has been recalled, the person shall
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inform the central repository or local repository of the recall.
(b) If the central repository or local repository receives a recall
notification under this chapter, the central repository or local
repository shall perform a uniform destruction of all of the recalled
prescription drugs in the central repository or local repository.
However, a prescription drug may be retained if the drug has an
affixed lot number to exclude it from the recall.
Sec. 21. (a) An entity that participates in a drug donation or
repository program in another state may participate in the
program.
(b) If the entity under subsection (a) is a pharmacy that is
licensed in another state, the pharmacy may dispense donated
prescription drugs and supplies to residents of Indiana.
(c) The central repository or a local repository may donate or
transfer prescription drugs and supplies to an out-of-state entity
that participates in a drug donation or repository program in
another state if the drug donation program or repository program
in that state allows for the donation or transfer of prescription
drugs and supplies to the central repository or a local repository
located in Indiana.
(d) Notwithstanding any other law, an out-of-state entity that
participates in the program is required to comply with the laws
and rules of Indiana, unless the law or rule is in conflict with a law
or rule in the state where the entity is located.
Sec. 22. (a) As used in this section, "person" refers to the
following:
(1) The board, including the employees, agents, or volunteers
of the board.
(2) An individual who has donated a prescription drug in
accordance with this chapter.
(3) A central repository or a local repository.
(4) An eligible entity participating in the prescription drug
donation repository program under this chapter.
(5) A practitioner participating in the prescription drug
donation repository program under this chapter.
(b) Except as provided in subsection (d), a drug manufacturer
acting in good faith is immune from civil or criminal liability for an
injury, death, or loss relating to the donation, acceptance, or
dispensing of a prescription drug manufactured by the drug
manufacturer that is donated under this chapter, including liability
for failure to transfer or communicate product or consumer
information or the expiration date of the donated prescription
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drug.
(c) Except as provided in subsection (d), a person acting in good
faith is immune from civil or criminal liability for an act or
omission concerning the donation, acceptance, inspection, or
dispensing of a prescription drug in the prescription drug donation
repository program under this chapter.
(d) The immunity provided in subsection (b) or subsection (c)
does not apply to gross negligence or willful or wanton misconduct.
(e) A person who is immune under this section is not subject to
professional discipline by the board regulating the person's
profession for an act or omission subject to the immunity.
Sec. 23. Nothing in this chapter requires a central repository or
local repository to accept any donated drug.
Sec. 24. The board may adopt rules under IC 4-22-2 to
administer the program.
SECTION 6. IC 34-30-2.1-383.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2023]: Sec. 383.5. IC 25-26-26-22
(Concerning the prescription drug donation repository program).
HEA 1017 — Concur Speaker of the House of Representatives
President of the Senate
President Pro Tempore
Governor of the State of Indiana
Date: Time:
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