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Illinois General Assembly· HB 2346Governor Approved

IDPH-ILLINOIS DROP ACT-DUTIES, the official text

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HB2346 Enrolled                     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 Enrolled        -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 Enrolled    -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 Enrolled        -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 Enrolled       -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 recipients shall notify the Department of

19 their participation in the dispensing of drugs under this Act

20 and shall report any data required in a reasonable format

21 established by the Department.
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