HB2346 EngrossedLRB104 06540 BDA 16576 b HB2346 Engrossed LRB104 06540 BDA 16576 b
HB2346 Engrossed LRB104 06540 BDA 16576 b
1 AN ACT concerning health.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
4 Section 5. The Illinois Drug Reuse Opportunity Program Act
5 is amended by changing Sections 5, 45, and 55 and by adding
6 Section 70 as follows:
7 (410 ILCS 715/5)
8 Sec. 5. Definitions. In this Act:
9 "Controlled substance" means a drug, substance, or
10 immediate precursor in Schedules I through V of 21 CFR 1308.
11 "Department" means the Illinois Department of Public
12 Health.
13 "Dispense" has the same meaning as defined in Section 3 of
14 the Pharmacy Practice Act.
15 "Donor" means any person, including an individual member
16 of the public, or any entity legally authorized to possess
17 medicine, including, but not limited to, a wholesaler or
18 distributor, third party logistic provider, pharmacy,
19 dispenser, clinic, surgical or health center, detention and
20 rehabilitation center, jail, prison laboratory, medical or
21 pharmacy school, prescriber or other health care professional,
22 long-term care facility, or healthcare facility. "Donor"
23 includes government agencies and entities that are federally
HB2346 Engrossed LRB104 06540 BDA 16576 b
HB2346 Engrossed- 2 -LRB104 06540 BDA 16576 b HB2346 Engrossed - 2 - LRB104 06540 BDA 16576 b
HB2346 Engrossed - 2 - LRB104 06540 BDA 16576 b
1 authorized to possess medicine, including, but not limited to,
2 drug manufacturers, repackagers, relabelers, outsourcing
3 facilities, health care facilities operated by the U.S.
4 Department of Veterans Affairs, and prisons.
5 "Drug" means a prescription drug, over-the-counter drug,
6 or supplies needed to administer a prescription or
7 over-the-counter drug.
8 "Eligible patient" means an individual:
9 (1) with a prescription for the drug, if a
10 prescription is required to dispense the drug, or who
11 reports symptoms treated by the drug if the drug is
12 over-the-counter; and
13 (2) who is registered with the drug's manufacturer in
14 accordance with federal Food and Drug Administration
15 requirements, if the registration is required to dispense
16 the drug.
17 "Manufacturer" has the same meaning as defined in Section
18 15 of the Wholesale Drug Distribution Licensing Act.
19 "Pharmacist" means an individual licensed to engage in the
20 practice of pharmacy under the Pharmacy Practice Act or
21 licensed to engage in the practice of pharmacy in another
22 state.
23 "Practitioner" means a person licensed in this State to
24 dispense or administer drugs or who is licensed in another
25 state as a person authorized to dispense or administer drugs.
26 "Prescription drug" means any prescribed drug that may be
HB2346 Engrossed - 2 - LRB104 06540 BDA 16576 b
HB2346 Engrossed- 3 -LRB104 06540 BDA 16576 b HB2346 Engrossed - 3 - LRB104 06540 BDA 16576 b
HB2346 Engrossed - 3 - LRB104 06540 BDA 16576 b
1 legally dispensed by a pharmacy. "Prescription drug" does not
2 include a drug for the treatment of cancer that can only be
3 dispensed to a patient registered with the drug manufacturer
4 in accordance with the federal Food and Drug Administration's
5 requirements.
6 "Priority patient" means an eligible patient who is an
7 Illinois resident and who is indigent, uninsured,
8 underinsured, or enrolled in a public health benefits program.
9 "Recipient" means any person or entity legally authorized
10 to possess medicine with a license or permit in the state in
11 which the person or entity is located, including, but not
12 limited to, a wholesaler or distributor, reverse distributor,
13 repackager, hospital, pharmacy, or clinic.
14 "Returns processor" has the same meaning as defined in
15 paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
16 includes, but is not limited to, a reverse distributor.
17 "Unopened tamper-evident packaging" has the same meaning
18 as defined in the United States Pharmacopeia (USP) General
19 Chapter 659, Packaging and Storage Requirements, including,
20 but not limited to, unopened unit-dose, multiple-dose,
21 immediate, secondary, and tertiary packaging.
22 (Source: P.A. 102-389, eff. 1-1-22.)
23 (410 ILCS 715/45)
24 Sec. 45. Recordkeeping requirements. When performing any
25 action associated with a program under this Act or otherwise
HB2346 Engrossed - 3 - LRB104 06540 BDA 16576 b
HB2346 Engrossed- 4 -LRB104 06540 BDA 16576 b HB2346 Engrossed - 4 - LRB104 06540 BDA 16576 b
HB2346 Engrossed - 4 - LRB104 06540 BDA 16576 b
1 processing a donated drug for tax, manufacturer, or other
2 credit, a recipient shall be considered to be acting as a
3 returns processor and shall comply with all recordkeeping
4 requirements for nonsalable nonsaleable returns under federal
5 law. Records maintained under this Act may be accessed by the
6 Department upon request.
7 (Source: P.A. 102-389, eff. 1-1-22.)
8 (410 ILCS 715/55)
9 Sec. 55. Retention of records. All records required under
10 this Act shall be retained in physical or electronic format
11 and on or off the recipient's premises for a period of 6 years.
12 Donors or recipients may contract with one another or a third
13 party to create or maintain records on each other's behalf. An
14 identifier, such as a serial number or bar code, may be used in
15 place of any or all information required by a record or label
16 pursuant to this Act if it allows for such information to be
17 readily retrievable. Upon request by a State or federal
18 regulatory agency, the identifier used for requested records
19 shall be replaced with the original information. An identifier
20 shall not be used on patient labels when dispensing or
21 administering a drug. Records maintained under this Act may be
22 accessed by the Department upon request.
23 (Source: P.A. 102-389, eff. 1-1-22.)
24 (410 ILCS 715/70 new)
HB2346 Engrossed - 4 - LRB104 06540 BDA 16576 b
HB2346 Engrossed- 5 -LRB104 06540 BDA 16576 b HB2346 Engrossed - 5 - LRB104 06540 BDA 16576 b
HB2346 Engrossed - 5 - LRB104 06540 BDA 16576 b
1 Sec. 70. Program support provided by the Department.
2 (a) The Department shall:
3 (1) develop, maintain, and publish on its website
4 information regarding the names and locations of
5 pharmacies participating in the Illinois Drug Reuse
6 Opportunity Program;
7 (2) educate pharmacies in the State about the Illinois
8 Drug Reuse Opportunity Program and how to participate in
9 it voluntarily;
10 (3) develop and publish educational materials to allow
11 program participants and the Department to inform the
12 general public about the purposes and benefits of the
13 program; and
14 (4) collect information from participants and publish
15 the information in an annual report to the General
16 Assembly by December 31 of each calendar year, beginning
17 December 31, 2026.
18 (b) Pharmacy participants are required to notify the
19 Department of their participation in any program under this
20 Act and report any data required in a format established by the
21 Department.
HB2346 Engrossed - 5 - LRB104 06540 BDA 16576 b