95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008
HB5980

 

Introduced , by Rep. Karen May

 

SYNOPSIS AS INTRODUCED:
 
See Index

    Creates the Prescription Drug Repository Program Act. Requires the Department of Public Health to establish a prescription drug repository program, under which any person may donate a prescription drug or supplies needed to administer a prescription drug for use by an individual who meets eligibility criteria specified by the Department. Sets forth requirements that prescription drugs or supplies must meet in order to be accepted and dispensed under the program. Provides that no drugs or supplies donated under the prescription drug repository program may be resold. Provides that nothing in the Act requires that a pharmacy or pharmacist participate in the prescription drug repository program. Provides for civil and criminal immunity for drug and supply manufacturers and individuals in relation to the donation, acceptance, or dispensing of prescription drugs or supplies under the prescription drug repository program. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Prescription Drug Repository Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB5980 LRB095 20046 DRJ 46495 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 1. Short title. This Act may be cited as the
5 Prescription Drug Repository Program Act.
 
6     Section 5. Definitions. In this Act:
7     "Department" means the Department of Public Health.
8     "Dispense" has the meaning given to that term in the
9 Pharmacy Practice Act.
10     "Pharmacist" means an individual licensed to engage in the
11 practice of pharmacy under the Pharmacy Practice Act.
12     "Pharmacy" means a pharmacy registered in this State under
13 the Pharmacy Practice Act.
14     "Practitioner" means a person licensed in this State to
15 prescribe and administer drugs or licensed in another state and
16 recognized by this State as a person authorized to prescribe
17 and administer drugs.
18     "Prescription drug" means any prescribed drug that may be
19 legally dispensed by a pharmacy. "Prescription drug" does not
20 include drugs for the treatment of cancer that can only be
21 dispensed to a patient registered with the drug manufacturer in
22 accordance with federal Food and Drug Administration
23 requirements.

 

 

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1     "Program" means the prescription drug repository program
2 established under this Act.
 
3     Section 10. Prescription drug repository program. The
4 Department shall establish and maintain a prescription drug
5 repository program, under which any person may donate a
6 prescription drug or supplies needed to administer a
7 prescription drug for use by an individual who meets
8 appropriate eligibility criteria. Donations may be made on the
9 premises of a pharmacy that elects to participate in the
10 program and meets appropriate requirements. The pharmacy may
11 charge an individual who receives a prescription drug or
12 supplies needed to administer a prescription drug under this
13 Act a handling fee that may not exceed an appropriate amount. A
14 pharmacy that receives a donated prescription drug or supplies
15 needed to administer a prescription drug under this Act may
16 distribute the prescription drug or supplies to another
17 eligible pharmacy for use under the program.
 
18     Section 15. Requirements for accepting and dispensing
19 prescription drugs and supplies. A prescription drug or
20 supplies needed to administer a prescription drug may be
21 accepted and dispensed under the program only if all of the
22 following requirements are met:
23         (1) The prescription drug or supplies needed to
24     administer a prescription drug are in their original,

 

 

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1     unopened, sealed, and tamper-evident unit-dose packaging
2     or, if packaged in single-unit doses, the single-unit-dose
3     packaging is unopened.
4         (2) The prescription drug bears an expiration date that
5     is later than 6 months after the date that the drug was
6     donated.
7         (3) The prescription drug or supplies needed to
8     administer a prescription drug are not adulterated or
9     misbranded, as determined by a pharmacist employed by, or
10     under contract with, the pharmacy where the drug or
11     supplies are accepted or dispensed. The pharmacist must
12     inspect the drug or supplies before the drug or supplies
13     are dispensed.
14         (4) The prescription drug or supplies needed to
15     administer a prescription drug are prescribed by a
16     practitioner for use by an eligible individual.
 
17     Section 20. Resale of donated drugs or supplies prohibited.
18 No prescription drug or supplies needed to administer a
19 prescription drug that are donated for use under this Act may
20 be resold.
 
21     Section 25. Participation in program not required. Nothing
22 in this Act requires that a pharmacy or pharmacist participate
23 in the prescription drug repository program.
 

 

 

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1     Section 30. Immunity.
2     (a) Unless the manufacturer's conduct is wilful and wanton,
3 a manufacturer of a drug or supply is not subject to criminal
4 or civil liability for injury, death, or loss to a person or
5 property for matters related to the donation, acceptance, or
6 dispensing of a prescription drug or supply manufactured by the
7 manufacturer that is donated by any person under this Act.
8     (b) Unless the person's conduct is wilful and wanton, a
9 person is immune from civil liability for injury to or the
10 death of the individual to whom the prescription drug or supply
11 is dispensed and may not be found guilty of unprofessional
12 conduct for his or her acts or omissions related to donating,
13 accepting, distributing, or dispensing a prescription drug or
14 supply under this Act.
 
15     Section 35. Rules. Notwithstanding any other rulemaking
16 authority that may exist, neither the Governor nor any agency
17 or agency head under the jurisdiction of the Governor has any
18 authority to make or promulgate rules to implement or enforce
19 the provisions of this Act. If, however, the Governor believes
20 that rules are necessary to implement or enforce the provisions
21 of this Act, the Governor may suggest rules to the General
22 Assembly by filing them with the Clerk of the House and
23 Secretary of the Senate and by requesting that the General
24 Assembly authorize such rulemaking by law, enact those
25 suggested rules into law, or take any other appropriate action

 

 

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1 in the General Assembly's discretion. Nothing contained in this
2 Act shall be interpreted to grant rulemaking authority under
3 any other Illinois statute where such authority is not
4 otherwise explicitly given. For the purposes of this Act,
5 "rules" is given the meaning contained in Section 1-70 of the
6 Illinois Administrative Procedure Act, and "agency" and
7 "agency head" are given the meanings contained in Sections 1-20
8 and 1-25 of the Illinois Administrative Procedure Act to the
9 extent that such definitions apply to agencies or agency heads
10 under the jurisdiction of the Governor.
 
11     Section 90. The Pharmacy Practice Act is amended by
12 changing Section 4 as follows:
 
13     (225 ILCS 85/4)  (from Ch. 111, par. 4124)
14     (Section scheduled to be repealed on January 1, 2018)
15     Sec. 4. Exemptions. Nothing contained in any Section of
16 this Act shall apply to, or in any manner interfere with:
17     (a) the lawful practice of any physician licensed to
18 practice medicine in all of its branches, dentist, podiatrist,
19 veterinarian, or therapeutically or diagnostically certified
20 optometrist within the limits of his or her license, or prevent
21 him or her from supplying to his or her bona fide patients such
22 drugs, medicines, or poisons as may seem to him appropriate;
23     (b) the sale of compressed gases;
24     (c) the sale of patent or proprietary medicines and

 

 

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1 household remedies when sold in original and unbroken packages
2 only, if such patent or proprietary medicines and household
3 remedies be properly and adequately labeled as to content and
4 usage and generally considered and accepted as harmless and
5 nonpoisonous when used according to the directions on the
6 label, and also do not contain opium or coca leaves, or any
7 compound, salt or derivative thereof, or any drug which,
8 according to the latest editions of the following authoritative
9 pharmaceutical treatises and standards, namely, The United
10 States Pharmacopoeia/National Formulary (USP/NF), the United
11 States Dispensatory, and the Accepted Dental Remedies of the
12 Council of Dental Therapeutics of the American Dental
13 Association or any or either of them, in use on the effective
14 date of this Act, or according to the existing provisions of
15 the Federal Food, Drug, and Cosmetic Act and Regulations of the
16 Department of Health and Human Services, Food and Drug
17 Administration, promulgated thereunder now in effect, is
18 designated, described or considered as a narcotic, hypnotic,
19 habit forming, dangerous, or poisonous drug;
20     (d) the sale of poultry and livestock remedies in original
21 and unbroken packages only, labeled for poultry and livestock
22 medication;
23     (e) the sale of poisonous substances or mixture of
24 poisonous substances, in unbroken packages, for nonmedicinal
25 use in the arts or industries or for insecticide purposes;
26 provided, they are properly and adequately labeled as to

 

 

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1 content and such nonmedicinal usage, in conformity with the
2 provisions of all applicable federal, state and local laws and
3 regulations promulgated thereunder now in effect relating
4 thereto and governing the same, and those which are required
5 under such applicable laws and regulations to be labeled with
6 the word "Poison", are also labeled with the word "Poison"
7 printed thereon in prominent type and the name of a readily
8 obtainable antidote with directions for its administration;
9     (f) the delegation of limited prescriptive authority by a
10 physician licensed to practice medicine in all its branches to
11 a physician assistant under Section 7.5 of the Physician
12 Assistant Practice Act of 1987. This delegated authority under
13 Section 7.5 of the Physician Assistant Practice Act of 1987 may
14 but is not required to include prescription of controlled
15 substances, as defined in Article II of the Illinois Controlled
16 Substances Act, in accordance with written guidelines; and
17     (g) the The delegation of prescriptive authority by a
18 physician licensed to practice medicine in all its branches to
19 an advanced practice nurse in accordance with a written
20 collaborative agreement under Section 65-35 of the Nurse
21 Practice Act. This authority, which is delegated under Section
22 65-40 of the Nurse Practice Act, may but is not required to
23 include the prescription of Schedule III, IV, or V controlled
24 substances as defined in Article II of the Illinois Controlled
25 Substances Act; and .
26     (h) the donation or acceptance, or the packaging,

 

 

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1 repackaging, or labeling, of prescription drugs to the extent
2 permitted or required under the Prescription Drug Repository
3 Program Act.
4 (Source: P.A. 95-639, eff. 10-5-07.)
 
5     Section 91. The Wholesale Drug Distribution Licensing Act
6 is amended by changing Section 15 as follows:
 
7     (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
8     (Section scheduled to be repealed on January 1, 2013)
9     Sec. 15. Definitions. As used in this Act:
10     "Authentication" means the affirmative verification,
11 before any wholesale distribution of a prescription drug
12 occurs, that each transaction listed on the pedigree has
13 occurred.
14     "Authorized distributor of record" means a wholesale
15 distributor with whom a manufacturer has established an ongoing
16 relationship to distribute the manufacturer's prescription
17 drug. An ongoing relationship is deemed to exist between a
18 wholesale distributor and a manufacturer when the wholesale
19 distributor, including any affiliated group of the wholesale
20 distributor, as defined in Section 1504 of the Internal Revenue
21 Code, complies with the following:
22         (1) The wholesale distributor has a written agreement
23     currently in effect with the manufacturer evidencing the
24     ongoing relationship; and

 

 

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1         (2) The wholesale distributor is listed on the
2     manufacturer's current list of authorized distributors of
3     record, which is updated by the manufacturer on no less
4     than a monthly basis.
5     "Blood" means whole blood collected from a single donor and
6 processed either for transfusion or further manufacturing.
7     "Blood component" means that part of blood separated by
8 physical or mechanical means.
9     "Board" means the State Board of Pharmacy of the Department
10 of Professional Regulation.
11     "Chain pharmacy warehouse" means a physical location for
12 prescription drugs that acts as a central warehouse and
13 performs intracompany sales or transfers of the drugs to a
14 group of chain or mail order pharmacies that have the same
15 common ownership and control. Notwithstanding any other
16 provision of this Act, a chain pharmacy warehouse shall be
17 considered part of the normal distribution channel.
18     "Co-licensed partner or product" means an instance where
19 one or more parties have the right to engage in the
20 manufacturing or marketing of a prescription drug, consistent
21 with the FDA's implementation of the Prescription Drug
22 Marketing Act.
23     "Department" means the Department of Financial and
24 Professional Regulation.
25     "Drop shipment" means the sale of a prescription drug to a
26 wholesale distributor by the manufacturer of the prescription

 

 

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1 drug or that manufacturer's co-licensed product partner, that
2 manufacturer's third party logistics provider, or that
3 manufacturer's exclusive distributor or by an authorized
4 distributor of record that purchased the product directly from
5 the manufacturer or one of these entities whereby the wholesale
6 distributor or chain pharmacy warehouse takes title but not
7 physical possession of such prescription drug and the wholesale
8 distributor invoices the pharmacy, chain pharmacy warehouse,
9 or other person authorized by law to dispense or administer
10 such drug to a patient and the pharmacy, chain pharmacy
11 warehouse, or other authorized person receives delivery of the
12 prescription drug directly from the manufacturer, that
13 manufacturer's third party logistics provider, or that
14 manufacturer's exclusive distributor or from an authorized
15 distributor of record that purchased the product directly from
16 the manufacturer or one of these entities.
17     "Drug sample" means a unit of a prescription drug that is
18 not intended to be sold and is intended to promote the sale of
19 the drug.
20     "Facility" means a facility of a wholesale distributor
21 where prescription drugs are stored, handled, repackaged, or
22 offered for sale.
23     "FDA" means the United States Food and Drug Administration.
24     "Manufacturer" means a person licensed or approved by the
25 FDA to engage in the manufacture of drugs or devices,
26 consistent with the definition of "manufacturer" set forth in

 

 

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1 the FDA's regulations and guidances implementing the
2 Prescription Drug Marketing Act. "Manufacturer" does not
3 include anyone who is engaged in the packaging, repackaging, or
4 labeling of prescription drugs only to the extent required
5 under the Prescription Drug Repository Program Act.
6     "Manufacturer's exclusive distributor" means anyone who
7 contracts with a manufacturer to provide or coordinate
8 warehousing, distribution, or other services on behalf of a
9 manufacturer and who takes title to that manufacturer's
10 prescription drug, but who does not have general responsibility
11 to direct the sale or disposition of the manufacturer's
12 prescription drug. A manufacturer's exclusive distributor must
13 be licensed as a wholesale distributor under this Act and, in
14 order to be considered part of the normal distribution channel,
15 must also be an authorized distributor of record.
16     "Normal distribution channel" means a chain of custody for
17 a prescription drug that goes, directly or by drop shipment,
18 from (i) a manufacturer of the prescription drug, (ii) that
19 manufacturer to that manufacturer's co-licensed partner, (iii)
20 that manufacturer to that manufacturer's third party logistics
21 provider, or (iv) that manufacturer to that manufacturer's
22 exclusive distributor to:
23         (1) a pharmacy or to other designated persons
24     authorized by law to dispense or administer the drug to a
25     patient;
26         (2) a wholesale distributor to a pharmacy or other

 

 

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1     designated persons authorized by law to dispense or
2     administer the drug to a patient;
3         (3) a wholesale distributor to a chain pharmacy
4     warehouse to that chain pharmacy warehouse's intracompany
5     pharmacy to a patient or other designated persons
6     authorized by law to dispense or administer the drug to a
7     patient;
8         (4) a chain pharmacy warehouse to the chain pharmacy
9     warehouse's intracompany pharmacy or other designated
10     persons authorized by law to dispense or administer the
11     drug to the patient;
12         (5) an authorized distributor of record to one other
13     authorized distributor of record to an office-based health
14     care practitioner authorized by law to dispense or
15     administer the drug to the patient; or
16         (6) an authorized distributor to a pharmacy or other
17     persons licensed to dispense or administer the drug.
18     "Pedigree" means a document or electronic file containing
19 information that records each wholesale distribution of any
20 given prescription drug from the point of origin to the final
21 wholesale distribution point of any given prescription drug.
22     "Person" means and includes a natural person, partnership,
23 association or corporation.
24     "Pharmacy distributor" means any pharmacy licensed in this
25 State or hospital pharmacy that is engaged in the delivery or
26 distribution of prescription drugs either to any other pharmacy

 

 

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1 licensed in this State or to any other person or entity
2 including, but not limited to, a wholesale drug distributor
3 engaged in the delivery or distribution of prescription drugs
4 who is involved in the actual, constructive, or attempted
5 transfer of a drug in this State to other than the ultimate
6 consumer except as otherwise provided for by law.
7     "Prescription drug" means any human drug, including any
8 biological product (except for blood and blood components
9 intended for transfusion or biological products that are also
10 medical devices), required by federal law or regulation to be
11 dispensed only by a prescription, including finished dosage
12 forms and bulk drug substances subject to Section 503 of the
13 Federal Food, Drug and Cosmetic Act.
14     "Repackage" means repackaging or otherwise changing the
15 container, wrapper, or labeling to further the distribution of
16 a prescription drug, excluding that completed by the pharmacist
17 responsible for dispensing the product to a patient.
18     "Secretary" means the Secretary of Financial and
19 Professional Regulation.
20     "Third party logistics provider" means anyone who
21 contracts with a prescription drug manufacturer to provide or
22 coordinate warehousing, distribution, or other services on
23 behalf of a manufacturer, but does not take title to the
24 prescription drug or have general responsibility to direct the
25 prescription drug's sale or disposition. A third party
26 logistics provider must be licensed as a wholesale distributor

 

 

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1 under this Act and, in order to be considered part of the
2 normal distribution channel, must also be an authorized
3 distributor of record.
4     "Wholesale distribution" means the distribution of
5 prescription drugs to persons other than a consumer or patient,
6 but does not include any of the following:
7         (1) Intracompany sales of prescription drugs, meaning
8     (i) any transaction or transfer between any division,
9     subsidiary, parent, or affiliated or related company under
10     the common ownership and control of a corporate entity or
11     (ii) any transaction or transfer between co-licensees of a
12     co-licensed product.
13         (2) The sale, purchase, distribution, trade, or
14     transfer of a prescription drug or offer to sell, purchase,
15     distribute, trade, or transfer a prescription drug for
16     emergency medical reasons.
17         (3) The distribution of prescription drug samples by
18     manufacturers' representatives.
19         (4) Drug returns, when conducted by a hospital, health
20     care entity, or charitable institution in accordance with
21     federal regulation.
22         (5) The sale of minimal quantities of prescription
23     drugs by retail pharmacies to licensed practitioners for
24     office use.
25         (6) The sale, purchase, or trade of a drug, an offer to
26     sell, purchase, or trade a drug, or the dispensing of a

 

 

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1     drug pursuant to a prescription.
2         (7) The sale, transfer, merger, or consolidation of all
3     or part of the business of a pharmacy or pharmacies from or
4     with another pharmacy or pharmacies, whether accomplished
5     as a purchase and sale of stock or business assets.
6         (8) The sale, purchase, distribution, trade, or
7     transfer of a prescription drug from one authorized
8     distributor of record to one additional authorized
9     distributor of record when the manufacturer has stated in
10     writing to the receiving authorized distributor of record
11     that the manufacturer is unable to supply the prescription
12     drug and the supplying authorized distributor of record
13     states in writing that the prescription drug being supplied
14     had until that time been exclusively in the normal
15     distribution channel.
16         (9) The delivery of or the offer to deliver a
17     prescription drug by a common carrier solely in the common
18     carrier's usual course of business of transporting
19     prescription drugs when the common carrier does not store,
20     warehouse, or take legal ownership of the prescription
21     drug.
22         (10) The sale or transfer from a retail pharmacy, mail
23     order pharmacy, or chain pharmacy warehouse of expired,
24     damaged, returned, or recalled prescription drugs to the
25     original manufacturer, the originating wholesale
26     distributor, or a third party returns processor.

 

 

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1         (11) The donation of prescription drugs to the extent
2     permitted under the Prescription Drug Repository Program
3     Act.
4     "Wholesale drug distributor" means anyone engaged in the
5 wholesale distribution of prescription drugs, including
6 without limitation manufacturers; repackers; own label
7 distributors; jobbers; private label distributors; brokers;
8 warehouses, including manufacturers' and distributors'
9 warehouses; manufacturer's exclusive distributors; and
10 authorized distributors of record; drug wholesalers or
11 distributors; independent wholesale drug traders; specialty
12 wholesale distributors; third party logistics providers; and
13 retail pharmacies that conduct wholesale distribution; and
14 chain pharmacy warehouses that conduct wholesale distribution.
15 In order to be considered part of the normal distribution
16 channel, a wholesale distributor must also be an authorized
17 distributor of record.
18 (Source: P.A. 95-689, eff. 10-29-07.)
 
19     Section 92. The Senior Pharmaceutical Assistance Act is
20 amended by changing Section 10 as follows:
 
21     (320 ILCS 50/10)
22     Sec. 10. Definitions. In this Act:
23     "Manufacturer" includes:
24         (1) An entity that is engaged in (a) the production,

 

 

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1     preparation, propagation, compounding, conversion, or
2     processing of prescription drug products (i) directly or
3     indirectly by extraction from substances of natural
4     origin, (ii) independently by means of chemical synthesis,
5     or (iii) by combination of extraction and chemical
6     synthesis; or (b) the packaging, repackaging, labeling or
7     re-labeling, or distribution of prescription drug
8     products.
9         (2) The entity holding legal title to or possession of
10     the national drug code number for the covered prescription
11     drug.
12     The term does not include a wholesale distributor of drugs,
13 drugstore chain organization, or retail pharmacy licensed by
14 the State. The term also does not include anyone who is engaged
15 in the packaging, repackaging, or labeling of prescription
16 drugs only to the extent required under the Prescription Drug
17 Repository Program Act.
18     "Prescription drug" means a drug that may be dispensed only
19 upon prescription by an authorized prescriber and that is
20 approved for safety and effectiveness as a prescription drug
21 under Section 505 or 507 of the Federal Food, Drug and Cosmetic
22 Act.
23     "Senior citizen" or "senior" means a person 65 years of age
24 or older.
25 (Source: P.A. 92-594, eff. 6-27-02.)
 

 

 

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1     Section 93. The Illinois Food, Drug and Cosmetic Act is
2 amended by changing Section 16 as follows:
 
3     (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
4     Sec. 16. (a) The Director is hereby authorized to
5 promulgate regulations exempting from any labeling or
6 packaging requirement of this Act drugs and devices which are
7 (i) , in accordance with the practice of the trade, to be
8 processed, labeled or repacked in substantial quantities at
9 establishments other than those where originally processed or
10 packaged on condition that such drugs and devices are not
11 adulterated or misbranded under the provisions of this Act upon
12 removal from such processing, labeling or repacking
13 establishment or (ii) packaged, repackaged, or labeled to the
14 extent required under the Prescription Drug Repository Program
15 Act.
16     (b) Drugs and device labeling or packaging exemptions
17 adopted under the Federal Act and supplements thereto or
18 revisions thereof shall apply to drugs and devices in Illinois
19 except insofar as modified or rejected by regulations
20 promulgated by the Director.
21     (c) A drug intended for use by man which (A) is a
22 habit-forming drug to which Section 15 (d) applies; or (B)
23 because of its toxicity or other potentiality for harmful
24 effect or the method of its use or the collateral measures
25 necessary to its use is not safe for use except under the

 

 

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1 supervision of a practitioner licensed by law to administer
2 such drug; or (C) is limited by an approved application under
3 Section 505 of the Federal Act or Section 17 of this Act to use
4 under the professional supervision of a practitioner licensed
5 by law to administer such drug, shall be dispensed only in
6 accordance with the provisions of the "Illinois Controlled
7 Substances Act". The act of dispensing a drug contrary to the
8 provisions of this paragraph shall be deemed to be an act which
9 results in a drug being misbranded while held for sale.
10     (d) Any drug dispensed by filling or refilling a written or
11 oral prescription of a practitioner licensed by law to
12 administer such drug shall be exempt from the requirements of
13 Section 15, except subsections (a), (k) and (l) and clauses (2)
14 and (3) of subsection (i), and the packaging requirements of
15 subsections (g), (h) and (q), if the drug bears a label
16 containing the proprietary name or names, or if there is none,
17 the established name or names of the drugs, the dosage and
18 quantity, unless the prescribing practitioner, in the interest
19 of the health of the patient, directs otherwise in writing, the
20 name and address of the dispenser, the serial number and date
21 of the prescription or of its filling, the name of the
22 prescriber and, if stated in the prescription, the name of the
23 patient, and the directions for use and the cautionary
24 statements, if any, contained in such prescription. This
25 exemption shall not apply to any drug dispensed in the course
26 of the conduct of business of dispensing drugs pursuant to

 

 

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1 diagnosis by mail, or to a drug dispensed in violation of
2 subsection (a) of this Section.
3     (e) The Director may by regulation remove drugs subject to
4 Section 15 (d) and Section 17 from the requirements of
5 subsection (c) of this Section when such requirements are not
6 necessary for the protection of the public health.
7     (f) A drug which is subject to subsection (c) of this
8 Section shall be deemed to be misbranded if at any time before
9 dispensing its label fails to bear the statement "Caution:
10 Federal Law Prohibits Dispensing Without Prescription" or
11 "Caution: State Law Prohibits Dispensing Without
12 Prescription". A drug to which subsection (c) of this Section
13 does not apply shall be deemed to be misbranded if at any time
14 prior to dispensing its label bears the caution statement
15 quoted in the preceding sentence.
16     (g) Nothing in this Section shall be construed to relieve
17 any person from any requirement prescribed by or under
18 authority of law with respect to controlled substances now
19 included or which may hereafter be included within the
20 classifications of controlled substances cannabis as defined
21 in applicable Federal laws relating to controlled substances or
22 cannabis or the Cannabis Control Act.
23 (Source: P.A. 84-1308.)
 
24     Section 94. The Illinois Controlled Substances Act is
25 amended by changing Section 102 as follows:
 

 

 

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1     (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
2     Sec. 102. Definitions. As used in this Act, unless the
3 context otherwise requires:
4     (a) "Addict" means any person who habitually uses any drug,
5 chemical, substance or dangerous drug other than alcohol so as
6 to endanger the public morals, health, safety or welfare or who
7 is so far addicted to the use of a dangerous drug or controlled
8 substance other than alcohol as to have lost the power of self
9 control with reference to his addiction.
10     (b) "Administer" means the direct application of a
11 controlled substance, whether by injection, inhalation,
12 ingestion, or any other means, to the body of a patient,
13 research subject, or animal (as defined by the Humane
14 Euthanasia in Animal Shelters Act) by:
15         (1) a practitioner (or, in his presence, by his
16     authorized agent),
17         (2) the patient or research subject at the lawful
18     direction of the practitioner, or
19         (3) a euthanasia technician as defined by the Humane
20     Euthanasia in Animal Shelters Act.
21     (c) "Agent" means an authorized person who acts on behalf
22 of or at the direction of a manufacturer, distributor, or
23 dispenser. It does not include a common or contract carrier,
24 public warehouseman or employee of the carrier or warehouseman.
25     (c-1) "Anabolic Steroids" means any drug or hormonal

 

 

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1 substance, chemically and pharmacologically related to
2 testosterone (other than estrogens, progestins, and
3 corticosteroids) that promotes muscle growth, and includes:
4             (i) boldenone,
5             (ii) chlorotestosterone,
6             (iii) chostebol,
7             (iv) dehydrochlormethyltestosterone,
8             (v) dihydrotestosterone,
9             (vi) drostanolone,
10             (vii) ethylestrenol,
11             (viii) fluoxymesterone,
12             (ix) formebulone,
13             (x) mesterolone,
14             (xi) methandienone,
15             (xii) methandranone,
16             (xiii) methandriol,
17             (xiv) methandrostenolone,
18             (xv) methenolone,
19             (xvi) methyltestosterone,
20             (xvii) mibolerone,
21             (xviii) nandrolone,
22             (xix) norethandrolone,
23             (xx) oxandrolone,
24             (xxi) oxymesterone,
25             (xxii) oxymetholone,
26             (xxiii) stanolone,

 

 

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1             (xxiv) stanozolol,
2             (xxv) testolactone,
3             (xxvi) testosterone,
4             (xxvii) trenbolone, and
5             (xxviii) any salt, ester, or isomer of a drug or
6         substance described or listed in this paragraph, if
7         that salt, ester, or isomer promotes muscle growth.
8     Any person who is otherwise lawfully in possession of an
9 anabolic steroid, or who otherwise lawfully manufactures,
10 distributes, dispenses, delivers, or possesses with intent to
11 deliver an anabolic steroid, which anabolic steroid is
12 expressly intended for and lawfully allowed to be administered
13 through implants to livestock or other nonhuman species, and
14 which is approved by the Secretary of Health and Human Services
15 for such administration, and which the person intends to
16 administer or have administered through such implants, shall
17 not be considered to be in unauthorized possession or to
18 unlawfully manufacture, distribute, dispense, deliver, or
19 possess with intent to deliver such anabolic steroid for
20 purposes of this Act.
21     (d) "Administration" means the Drug Enforcement
22 Administration, United States Department of Justice, or its
23 successor agency.
24     (e) "Control" means to add a drug or other substance, or
25 immediate precursor, to a Schedule under Article II of this Act
26 whether by transfer from another Schedule or otherwise.

 

 

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1     (f) "Controlled Substance" means a drug, substance, or
2 immediate precursor in the Schedules of Article II of this Act.
3     (g) "Counterfeit substance" means a controlled substance,
4 which, or the container or labeling of which, without
5 authorization bears the trademark, trade name, or other
6 identifying mark, imprint, number or device, or any likeness
7 thereof, of a manufacturer, distributor, or dispenser other
8 than the person who in fact manufactured, distributed, or
9 dispensed the substance.
10     (h) "Deliver" or "delivery" means the actual, constructive
11 or attempted transfer of possession of a controlled substance,
12 with or without consideration, whether or not there is an
13 agency relationship. The term does not include the donation of
14 prescription drugs to the extent permitted under the
15 Prescription Drug Repository Program Act.
16     (i) "Department" means the Illinois Department of Human
17 Services (as successor to the Department of Alcoholism and
18 Substance Abuse) or its successor agency.
19     (j) "Department of State Police" means the Department of
20 State Police of the State of Illinois or its successor agency.
21     (k) "Department of Corrections" means the Department of
22 Corrections of the State of Illinois or its successor agency.
23     (l) "Department of Professional Regulation" means the
24 Department of Professional Regulation of the State of Illinois
25 or its successor agency.
26     (m) "Depressant" or "stimulant substance" means:

 

 

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1         (1) a drug which contains any quantity of (i)
2     barbituric acid or any of the salts of barbituric acid
3     which has been designated as habit forming under section
4     502 (d) of the Federal Food, Drug, and Cosmetic Act (21
5     U.S.C. 352 (d)); or
6         (2) a drug which contains any quantity of (i)
7     amphetamine or methamphetamine and any of their optical
8     isomers; (ii) any salt of amphetamine or methamphetamine or
9     any salt of an optical isomer of amphetamine; or (iii) any
10     substance which the Department, after investigation, has
11     found to be, and by rule designated as, habit forming
12     because of its depressant or stimulant effect on the
13     central nervous system; or
14         (3) lysergic acid diethylamide; or
15         (4) any drug which contains any quantity of a substance
16     which the Department, after investigation, has found to
17     have, and by rule designated as having, a potential for
18     abuse because of its depressant or stimulant effect on the
19     central nervous system or its hallucinogenic effect.
20     (n) (Blank).
21     (o) "Director" means the Director of the Department of
22 State Police or the Department of Professional Regulation or
23 his designated agents.
24     (p) "Dispense" means to deliver a controlled substance to
25 an ultimate user or research subject by or pursuant to the
26 lawful order of a prescriber, including the prescribing,

 

 

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1 administering, packaging, labeling, or compounding necessary
2 to prepare the substance for that delivery.
3     (q) "Dispenser" means a practitioner who dispenses.
4     (r) "Distribute" means to deliver, other than by
5 administering or dispensing, a controlled substance.
6     (s) "Distributor" means a person who distributes.
7     (t) "Drug" means (1) substances recognized as drugs in the
8 official United States Pharmacopoeia, Official Homeopathic
9 Pharmacopoeia of the United States, or official National
10 Formulary, or any supplement to any of them; (2) substances
11 intended for use in diagnosis, cure, mitigation, treatment, or
12 prevention of disease in man or animals; (3) substances (other
13 than food) intended to affect the structure of any function of
14 the body of man or animals and (4) substances intended for use
15 as a component of any article specified in clause (1), (2), or
16 (3) of this subsection. It does not include devices or their
17 components, parts, or accessories.
18     (t-5) "Euthanasia agency" means an entity certified by the
19 Department of Professional Regulation for the purpose of animal
20 euthanasia that holds an animal control facility license or
21 animal shelter license under the Animal Welfare Act. A
22 euthanasia agency is authorized to purchase, store, possess,
23 and utilize Schedule II nonnarcotic and Schedule III
24 nonnarcotic drugs for the sole purpose of animal euthanasia.
25     (t-10) "Euthanasia drugs" means Schedule II or Schedule III
26 substances (nonnarcotic controlled substances) that are used

 

 

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1 by a euthanasia agency for the purpose of animal euthanasia.
2     (u) "Good faith" means the prescribing or dispensing of a
3 controlled substance by a practitioner in the regular course of
4 professional treatment to or for any person who is under his
5 treatment for a pathology or condition other than that
6 individual's physical or psychological dependence upon or
7 addiction to a controlled substance, except as provided herein:
8 and application of the term to a pharmacist shall mean the
9 dispensing of a controlled substance pursuant to the
10 prescriber's order which in the professional judgment of the
11 pharmacist is lawful. The pharmacist shall be guided by
12 accepted professional standards including, but not limited to
13 the following, in making the judgment:
14         (1) lack of consistency of doctor-patient
15     relationship,
16         (2) frequency of prescriptions for same drug by one
17     prescriber for large numbers of patients,
18         (3) quantities beyond those normally prescribed,
19         (4) unusual dosages,
20         (5) unusual geographic distances between patient,
21     pharmacist and prescriber,
22         (6) consistent prescribing of habit-forming drugs.
23     (u-1) "Home infusion services" means services provided by a
24 pharmacy in compounding solutions for direct administration to
25 a patient in a private residence, long-term care facility, or
26 hospice setting by means of parenteral, intravenous,

 

 

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1 intramuscular, subcutaneous, or intraspinal infusion.
2     (v) "Immediate precursor" means a substance:
3         (1) which the Department has found to be and by rule
4     designated as being a principal compound used, or produced
5     primarily for use, in the manufacture of a controlled
6     substance;
7         (2) which is an immediate chemical intermediary used or
8     likely to be used in the manufacture of such controlled
9     substance; and
10         (3) the control of which is necessary to prevent,
11     curtail or limit the manufacture of such controlled
12     substance.
13     (w) "Instructional activities" means the acts of teaching,
14 educating or instructing by practitioners using controlled
15 substances within educational facilities approved by the State
16 Board of Education or its successor agency.
17     (x) "Local authorities" means a duly organized State,
18 County or Municipal peace unit or police force.
19     (y) "Look-alike substance" means a substance, other than a
20 controlled substance which (1) by overall dosage unit
21 appearance, including shape, color, size, markings or lack
22 thereof, taste, consistency, or any other identifying physical
23 characteristic of the substance, would lead a reasonable person
24 to believe that the substance is a controlled substance, or (2)
25 is expressly or impliedly represented to be a controlled
26 substance or is distributed under circumstances which would

 

 

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1 lead a reasonable person to believe that the substance is a
2 controlled substance. For the purpose of determining whether
3 the representations made or the circumstances of the
4 distribution would lead a reasonable person to believe the
5 substance to be a controlled substance under this clause (2) of
6 subsection (y), the court or other authority may consider the
7 following factors in addition to any other factor that may be
8 relevant:
9         (a) statements made by the owner or person in control
10     of the substance concerning its nature, use or effect;
11         (b) statements made to the buyer or recipient that the
12     substance may be resold for profit;
13         (c) whether the substance is packaged in a manner
14     normally used for the illegal distribution of controlled
15     substances;
16         (d) whether the distribution or attempted distribution
17     included an exchange of or demand for money or other
18     property as consideration, and whether the amount of the
19     consideration was substantially greater than the
20     reasonable retail market value of the substance.
21     Clause (1) of this subsection (y) shall not apply to a
22 noncontrolled substance in its finished dosage form that was
23 initially introduced into commerce prior to the initial
24 introduction into commerce of a controlled substance in its
25 finished dosage form which it may substantially resemble.
26     Nothing in this subsection (y) prohibits the dispensing or

 

 

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1 distributing of noncontrolled substances by persons authorized
2 to dispense and distribute controlled substances under this
3 Act, provided that such action would be deemed to be carried
4 out in good faith under subsection (u) if the substances
5 involved were controlled substances.
6     Nothing in this subsection (y) or in this Act prohibits the
7 manufacture, preparation, propagation, compounding,
8 processing, packaging, advertising or distribution of a drug or
9 drugs by any person registered pursuant to Section 510 of the
10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
11     (y-1) "Mail-order pharmacy" means a pharmacy that is
12 located in a state of the United States, other than Illinois,
13 that delivers, dispenses or distributes, through the United
14 States Postal Service or other common carrier, to Illinois
15 residents, any substance which requires a prescription.
16     (z) "Manufacture" means the production, preparation,
17 propagation, compounding, conversion or processing of a
18 controlled substance other than methamphetamine, either
19 directly or indirectly, by extraction from substances of
20 natural origin, or independently by means of chemical
21 synthesis, or by a combination of extraction and chemical
22 synthesis, and includes any packaging or repackaging of the
23 substance or labeling of its container, except that this term
24 does not include:
25         (1) by an ultimate user, the preparation or compounding
26     of a controlled substance for his own use; or

 

 

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1         (2) by a practitioner, or his authorized agent under
2     his supervision, the preparation, compounding, packaging,
3     or labeling of a controlled substance:
4             (a) as an incident to his administering or
5         dispensing of a controlled substance in the course of
6         his professional practice; or
7             (b) as an incident to lawful research, teaching or
8         chemical analysis and not for sale; or .
9         (3) the packaging, repackaging, or labeling of
10     prescription drugs only to the extent required under the
11     Prescription Drug Repository Program Act.
12     (z-1) (Blank).
13     (aa) "Narcotic drug" means any of the following, whether
14 produced directly or indirectly by extraction from substances
15 of natural origin, or independently by means of chemical
16 synthesis, or by a combination of extraction and chemical
17 synthesis:
18         (1) opium and opiate, and any salt, compound,
19     derivative, or preparation of opium or opiate;
20         (2) any salt, compound, isomer, derivative, or
21     preparation thereof which is chemically equivalent or
22     identical with any of the substances referred to in clause
23     (1), but not including the isoquinoline alkaloids of opium;
24         (3) opium poppy and poppy straw;
25         (4) coca leaves and any salts, compound, isomer, salt
26     of an isomer, derivative, or preparation of coca leaves

 

 

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1     including cocaine or ecgonine, and any salt, compound,
2     isomer, derivative, or preparation thereof which is
3     chemically equivalent or identical with any of these
4     substances, but not including decocainized coca leaves or
5     extractions of coca leaves which do not contain cocaine or
6     ecgonine (for the purpose of this paragraph, the term
7     "isomer" includes optical, positional and geometric
8     isomers).
9     (bb) "Nurse" means a registered nurse licensed under the
10 Nurse Practice Act.
11     (cc) (Blank).
12     (dd) "Opiate" means any substance having an addiction
13 forming or addiction sustaining liability similar to morphine
14 or being capable of conversion into a drug having addiction
15 forming or addiction sustaining liability.
16     (ee) "Opium poppy" means the plant of the species Papaver
17 somniferum L., except its seeds.
18     (ff) "Parole and Pardon Board" means the Parole and Pardon
19 Board of the State of Illinois or its successor agency.
20     (gg) "Person" means any individual, corporation,
21 mail-order pharmacy, government or governmental subdivision or
22 agency, business trust, estate, trust, partnership or
23 association, or any other entity.
24     (hh) "Pharmacist" means any person who holds a license or
25 certificate of registration as a registered pharmacist, a local
26 registered pharmacist or a registered assistant pharmacist

 

 

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1 under the Pharmacy Practice Act.
2     (ii) "Pharmacy" means any store, ship or other place in
3 which pharmacy is authorized to be practiced under the Pharmacy
4 Practice Act.
5     (jj) "Poppy straw" means all parts, except the seeds, of
6 the opium poppy, after mowing.
7     (kk) "Practitioner" means a physician licensed to practice
8 medicine in all its branches, dentist, optometrist,
9 podiatrist, veterinarian, scientific investigator, pharmacist,
10 physician assistant, advanced practice nurse, licensed
11 practical nurse, registered nurse, hospital, laboratory, or
12 pharmacy, or other person licensed, registered, or otherwise
13 lawfully permitted by the United States or this State to
14 distribute, dispense, conduct research with respect to,
15 administer or use in teaching or chemical analysis, a
16 controlled substance in the course of professional practice or
17 research.
18     (ll) "Pre-printed prescription" means a written
19 prescription upon which the designated drug has been indicated
20 prior to the time of issuance.
21     (mm) "Prescriber" means a physician licensed to practice
22 medicine in all its branches, dentist, optometrist, podiatrist
23 or veterinarian who issues a prescription, a physician
24 assistant who issues a prescription for a Schedule III, IV, or
25 V controlled substance in accordance with Section 303.05 and
26 the written guidelines required under Section 7.5 of the

 

 

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1 Physician Assistant Practice Act of 1987, or an advanced
2 practice nurse with prescriptive authority delegated under
3 Section 65-40 of the Nurse Practice Act and in accordance with
4 Section 303.05 and a written collaborative agreement under
5 Section 65-35 of the Nurse Practice Act.
6     (nn) "Prescription" means a lawful written, facsimile, or
7 verbal order of a physician licensed to practice medicine in
8 all its branches, dentist, podiatrist or veterinarian for any
9 controlled substance, of an optometrist for a Schedule III, IV,
10 or V controlled substance in accordance with Section 15.1 of
11 the Illinois Optometric Practice Act of 1987, of a physician
12 assistant for a Schedule III, IV, or V controlled substance in
13 accordance with Section 303.05 and the written guidelines
14 required under Section 7.5 of the Physician Assistant Practice
15 Act of 1987, or of an advanced practice nurse with prescriptive
16 authority delegated under Section 65-40 of the Nurse Practice
17 Act who issues a prescription for a Schedule III, IV, or V
18 controlled substance in accordance with Section 303.05 and a
19 written collaborative agreement under Section 65-35 of the
20 Nurse Practice Act.
21     (oo) "Production" or "produce" means manufacture,
22 planting, cultivating, growing, or harvesting of a controlled
23 substance other than methamphetamine.
24     (pp) "Registrant" means every person who is required to
25 register under Section 302 of this Act.
26     (qq) "Registry number" means the number assigned to each

 

 

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1 person authorized to handle controlled substances under the
2 laws of the United States and of this State.
3     (rr) "State" includes the State of Illinois and any state,
4 district, commonwealth, territory, insular possession thereof,
5 and any area subject to the legal authority of the United
6 States of America.
7     (ss) "Ultimate user" means a person who lawfully possesses
8 a controlled substance for his own use or for the use of a
9 member of his household or for administering to an animal owned
10 by him or by a member of his household.
11 (Source: P.A. 94-556, eff. 9-11-05; 95-242, eff. 1-1-08;
12 95-639, eff. 10-5-07; 95-689, eff. 10-29-07; revised
13 11-19-07.)
 
14     Section 95. The Cannabis and Controlled Substances Tort
15 Claims Act is amended by changing Section 3 as follows:
 
16     (740 ILCS 20/3)  (from Ch. 70, par. 903)
17     Sec. 3. Definitions. As used in this Act, unless the
18 context otherwise requires:
19     "Cannabis" includes marihuana, hashish, and other
20 substances that are identified as including any parts of the
21 plant Cannabis Sativa, whether growing or not, the seeds of
22 that plant, the resin extracted from any part of that plant,
23 and any compound, manufacture, salt, derivative, mixture, or
24 preparation of that plant, its seeds, or resin, including

 

 

HB5980 - 36 - LRB095 20046 DRJ 46495 b

1 tetrahydrocannabinol (THC) and all other cannabinol
2 derivatives, including its naturally occurring or
3 synthetically produced ingredients, whether produced directly
4 or indirectly by extraction, independently by means of chemical
5 synthesis, or by a combination of extraction and chemical
6 synthesis. "Cannabis" does not include the mature stalks of
7 that plant, fiber produced from those stalks, oil or cake made
8 from the seeds of that plant, any other compound, manufacture,
9 salt, derivative, mixture, or preparation of mature stalks
10 (except the extracted resin), fiber, oil or cake, or the
11 sterilized seeds of that plant that are incapable of
12 germination.
13     "Controlled substance" means a drug, substance, or
14 immediate precursor in the Schedules of Article II of the
15 Illinois Controlled Substances Act.
16     "Counterfeit substance" means a controlled substance or
17 the container or labeling of a controlled substance that,
18 without authorization, bears the trademark, trade name, or
19 other identifying mark, imprint, number, device, or any
20 likeness thereof of a manufacturer, distributor, or dispenser
21 other than the person who in fact manufactured, distributed, or
22 dispensed the substance.
23     "Deliver" or "delivery" means the actual, constructive, or
24 attempted transfer of possession of a controlled substance or
25 cannabis, with or without consideration, whether or not there
26 is an agency relationship. The term does not include the

 

 

HB5980 - 37 - LRB095 20046 DRJ 46495 b

1 donation of prescription drugs to the extent permitted under
2 the Prescription Drug Repository Program Act.
3     "Manufacture" means the production, preparation,
4 propagation, compounding, conversion, or processing of a
5 controlled substance, either directly or indirectly, by
6 extraction from substances of natural origin, independently by
7 means of chemical synthesis, or by a combination of extraction
8 and chemical synthesis, and includes any packaging or
9 repackaging of the substance or labeling of its container,
10 except that the term does not include:
11         (1) by an ultimate user, the preparation or compounding
12     of a controlled substance for his own use;
13         (2) by a practitioner or his authorized agent under his
14     supervision, the preparation, compounding, packaging, or
15     labeling of a controlled substance: ;
16             (A) as an incident to his administering or
17         dispensing of a controlled substance in the course of
18         his professional practice; or
19             (B) as an incident to lawful research, teaching or
20         chemical analysis and not for sale; or
21         (3) the preparation, compounding, packaging, or
22     labeling of cannabis as an incident to lawful research,
23     teaching, or chemical analysis and not for sale; or .
24         (4) the packaging, repackaging, or labeling of
25     prescription drugs only to the extent required under the
26     Prescription Drug Repository Program Act.

 

 

HB5980 - 38 - LRB095 20046 DRJ 46495 b

1     "Owner" means a person who has possession of or any
2 interest whatsoever in the property involved.
3     "Person" means an individual, a corporation, a government,
4 a governmental subdivision or agency, a business trust, an
5 estate, a trust, a partnership or association, or any other
6 entity.
7     "Production" means planting, cultivating, tending, or
8 harvesting.
9     "Property" means real property, including things growing
10 on, affixed to, and found in land, and tangible or intangible
11 personal property, including rights, services, privileges,
12 interests, claims, and securities.
13 (Source: P.A. 87-544.)

 

 

HB5980 - 39 - LRB095 20046 DRJ 46495 b

1 INDEX
2 Statutes amended in order of appearance
3     New Act
4     225 ILCS 85/4 from Ch. 111, par. 4124
5     225 ILCS 120/15 from Ch. 111, par. 8301-15
6     320 ILCS 50/10
7     410 ILCS 620/16 from Ch. 56 1/2, par. 516
8     720 ILCS 570/102 from Ch. 56 1/2, par. 1102
9     740 ILCS 20/3 from Ch. 70, par. 903