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093_HB0244ham001
LRB093 02637 DRJ 13496 a
1 AMENDMENT TO HOUSE BILL 244
2 AMENDMENT NO. . Amend House Bill 244 by replacing
3 everything after the enacting clause with the following:
4 "Section 5. The Pharmacy Practice Act of 1987 is amended
5 by changing Section 4 as follows:
6 (225 ILCS 85/4) (from Ch. 111, par. 4124)
7 (Section scheduled to be repealed on January 1, 2008)
8 Sec. 4. Exemptions. Nothing contained in any Section of
9 this Act shall apply to, or in any manner interfere with any
10 of the following:
11 (a) The lawful practice of any physician licensed to
12 practice medicine in all of its branches, dentist,
13 podiatrist, veterinarian, or therapeutically or
14 diagnostically certified optometrist within the limits of his
15 or her license, or prevent him or her from supplying to his
16 or her bona fide patients such drugs, medicines, or poisons
17 as may seem to him appropriate.;
18 (b) The sale of compressed gases.;
19 (c) The sale of patent or proprietary medicines and
20 household remedies when sold in original and unbroken
21 packages only, if such patent or proprietary medicines and
22 household remedies be properly and adequately labeled as to
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1 content and usage and generally considered and accepted as
2 harmless and nonpoisonous when used according to the
3 directions on the label, and also do not contain opium or
4 coca leaves, or any compound, salt or derivative thereof, or
5 any drug which, according to the latest editions of the
6 following authoritative pharmaceutical treatises and
7 standards, namely, The United States Pharmacopoeia/National
8 Formulary (USP/NF), the United States Dispensatory, and the
9 Accepted Dental Remedies of the Council of Dental
10 Therapeutics of the American Dental Association or any or
11 either of them, in use on the effective date of this Act, or
12 according to the existing provisions of the Federal Food,
13 Drug, and Cosmetic Act and Regulations of the Department of
14 Health and Human Services, Food and Drug Administration,
15 promulgated thereunder now in effect, is designated,
16 described or considered as a narcotic, hypnotic, habit
17 forming, dangerous, or poisonous drug.;
18 (d) The sale of poultry and livestock remedies in
19 original and unbroken packages only, labeled for poultry and
20 livestock medication.;
21 (e) The sale of poisonous substances or mixture of
22 poisonous substances, in unbroken packages, for nonmedicinal
23 use in the arts or industries or for insecticide purposes;
24 provided, they are properly and adequately labeled as to
25 content and such nonmedicinal usage, in conformity with the
26 provisions of all applicable federal, state and local laws
27 and regulations promulgated thereunder now in effect relating
28 thereto and governing the same, and those which are required
29 under such applicable laws and regulations to be labeled with
30 the word "Poison", are also labeled with the word "Poison"
31 printed thereon in prominent type and the name of a readily
32 obtainable antidote with directions for its administration.;
33 (f) The delegation of limited prescriptive authority by
34 a physician licensed to practice medicine in all its branches
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1 to a physician assistant under Section 7.5 of the Physician
2 Assistant Practice Act of 1987. This delegated authority may
3 but is not required to include prescription of Schedule III,
4 IV, or V controlled substances, as defined in Article II of
5 the Illinois Controlled Substances Act, in accordance with
6 written guidelines under Section 7.5 of the Physician
7 Assistant Practice Act of 1987.; and
8 (g) The delegation of limited prescriptive authority by
9 a physician licensed to practice medicine in all its branches
10 to an advanced practice nurse in accordance with a written
11 collaborative agreement under Sections 15-15 and 15-20 of the
12 Nursing and Advanced Practice Nursing Act. This delegated
13 authority may but is not required to include the prescription
14 of Schedule III, IV, or V controlled substances as defined in
15 Article II of the Illinois Controlled Substances Act.
16 (h) The return and packaging, repackaging, and labeling
17 of prescription drugs to the extent permitted under Section
18 12-4.25d of the Illinois Public Aid Code.
19 (Source: P.A. 90-116, eff. 7-14-97; 90-253, eff. 7-29-97;
20 90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)
21 Section 10. The Wholesale Drug Distribution Licensing
22 Act is amended by changing Section 15 as follows:
23 (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
24 (Section scheduled to be repealed on January 1, 2013)
25 Sec. 15. Definitions. As used in this Act:
26 "Blood" means whole blood collected from a single donor
27 and processed either for transfusion or further
28 manufacturing.
29 "Blood component" means that part of blood separated by
30 physical or mechanical means.
31 "Board" means the State Board of Pharmacy of the
32 Department of Professional Regulation.
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1 "Department" means the Department of Professional
2 Regulation.
3 "Director" means the Director of Professional Regulation.
4 "Drug sample" means a unit of a prescription drug that is
5 not intended to be sold and is intended to promote the sale
6 of the drug.
7 "Manufacturer" means anyone who is engaged in the
8 manufacturing, preparing, propagating, compounding,
9 processing, packaging, repackaging, or labeling of a
10 prescription drug. "Manufacturer" does not include anyone who
11 is engaged in the packaging, repackaging, or labeling of a
12 prescription drug only to the extent permitted under Section
13 12-4.25d of the Illinois Public Aid Code.
14 "Person" means and includes a natural person,
15 partnership, association or corporation.
16 "Pharmacy distributor" means any pharmacy licensed in
17 this State or hospital pharmacy that is engaged in the
18 delivery or distribution of prescription drugs either to any
19 other pharmacy licensed in this State or to any other person
20 or entity including, but not limited to, a wholesale drug
21 distributor engaged in the delivery or distribution of
22 prescription drugs who is involved in the actual,
23 constructive, or attempted transfer of a drug in this State
24 to other than the ultimate consumer except as otherwise
25 provided for by law.
26 "Prescription drug" means any human drug required by
27 federal law or regulation to be dispensed only by a
28 prescription, including finished dosage forms and active
29 ingredients subject to subsection (b) of Section 503 of the
30 Federal Food, Drug and Cosmetic Act.
31 "Wholesale distribution" or "wholesale distributions"
32 means distribution of prescription drugs to persons other
33 than a consumer or patient, but does not include any of the
34 following:
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1 (a) Intracompany sales, defined as any transaction
2 or transfer between any division, subsidiary, parent, or
3 affiliated or related company under the common ownership
4 and control of a corporate entity.
5 (b) The purchase or other acquisition by a hospital
6 or other health care entity that is a member of a group
7 purchasing organization of a drug for its own use from
8 the group purchasing organization or from other hospitals
9 or health care entities that are members of a group
10 organization.
11 (c) The sale, purchase, or trade of a drug or an
12 offer to sell, purchase, or trade a drug by a charitable
13 organization described in subsection (c)(3) of Section
14 501 of the U.S. Internal Revenue Code of 1954 to a
15 nonprofit affiliate of the organization to the extent
16 otherwise permitted by law.
17 (d) The sale, purchase, or trade of a drug or an
18 offer to sell, purchase, or trade a drug among hospitals
19 or other health care entities that are under common
20 control. For purposes of this Act, "common control"
21 means the power to direct or cause the direction of the
22 management and policies of a person or an organization,
23 whether by ownership of stock, voting rights, contract,
24 or otherwise.
25 (e) The sale, purchase, or trade of a drug or an
26 offer to sell, purchase, or trade a drug for emergency
27 medical reasons. For purposes of this Act, "emergency
28 medical reasons" include transfers of prescription drugs
29 by a retail pharmacy to another retail pharmacy to
30 alleviate a temporary shortage.
31 (f) The sale, purchase, or trade of a drug, an
32 offer to sell, purchase, or trade a drug, or the
33 dispensing of a drug pursuant to a prescription.
34 (g) The distribution of drug samples by
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1 manufacturers' representatives or distributors'
2 representatives.
3 (h) The sale, purchase, or trade of blood and blood
4 components intended for transfusion.
5 "Wholesale drug distributor" means any person or entity
6 engaged in wholesale distribution of prescription drugs,
7 including, but not limited to, manufacturers; repackers; own
8 label distributors; jobbers; private label distributors;
9 brokers; warehouses, including manufacturers' and
10 distributors' warehouses, chain drug warehouses, and
11 wholesale drug warehouses; independent wholesale drug
12 traders; and retail pharmacies that conduct wholesale
13 distributions, including, but not limited to, any pharmacy
14 distributor as defined in this Section. A wholesale drug
15 distributor shall not include any for hire carrier or person
16 or entity hired solely to transport prescription drugs.
17 (Source: P.A. 87-594.)
18 Section 15. The Illinois Public Aid Code is amended by
19 adding Section 12-4.25d as follows:
20 (305 ILCS 5/12-4.25d new)
21 Sec. 12-4.25d. Nursing homes; return of unused
22 prescription drugs.
23 (a) Pursuant to an agreement with the vendor pharmacy, a
24 provider of long-term care services under this Code may
25 return to the vendor pharmacy from which the drug product was
26 purchased, for repackaging and reimbursement to the
27 Department of Public Aid, a drug product that (i) was
28 dispensed to a resident of the provider's long-term care
29 facility and not used and (ii) meets all of the following
30 criteria:
31 (1) It is a prescription drug product that is not a
32 controlled substance.
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1 (2) It is sealed in an individually packaged unit.
2 (3) It is returned to the vendor pharmacy within
3 the recommended period of shelf life for the purpose of
4 redispensing the drug product.
5 (4) It is determined to be of acceptable integrity
6 by a licensed pharmacist.
7 (5) It consists of (i) oral or parenteral
8 medication in a single-dose sealed container approved by
9 the federal Food and Drug Administration, (ii) a topical
10 or inhalant drug product in a unit-of-use container
11 approved by the federal Food and Drug Administration, or
12 (iii) a parenteral medication in a multiple-dose sealed
13 container approved by the federal Food and Drug
14 Administration.
15 (6) No doses have been withdrawn from the container
16 in which the drug product is packaged.
17 An agreement between a provider of long-term care
18 services under this Code and a vendor pharmacy as described
19 in this subsection must comply with subsection (b).
20 (b) Notwithstanding the provisions of subsection (a):
21 (1) If a drug product is packaged in the
22 manufacturer's unit-dose package, the drug product may be
23 returned to the vendor pharmacy for redispensing and
24 reimbursement to the Department of Public Aid if the drug
25 may be redispensed for use before the expiration date, if
26 any, indicated on the package.
27 (2) If the drug product is repackaged in the
28 manufacturer's unit-dose or multiple-dose blister pack,
29 the drug product may be returned to the vendor pharmacy
30 for redispensing and reimbursement to the Department of
31 Public Aid if:
32 (A) the date on which the drug product was
33 repackaged and the drug product's lot number and
34 expiration date are indicated clearly on the package
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1 of the repackaged drug product;
2 (B) ninety days or fewer have elapsed from the
3 date the drug product was repackaged; and
4 (C) a repackaging log is maintained by the
5 pharmacy in the case of drug products repackaged in
6 advance of immediate needs.
7 (3) A drug product dispensed in a bulk dispensing
8 container may not be returned to the vendor pharmacy.
9 (c) A provider of long term-care services under this
10 Code may establish procedures for the return of unused drug
11 products to the vendor pharmacies from which the drug
12 products were purchased.
13 (d) The Department of Public Aid:
14 (1) shall adopt rules for the reimbursement of
15 unused or redispensed drugs under this Section in the
16 case of providers of long-term care services and vendor
17 pharmacies that have entered into agreements described in
18 subsection (a);
19 (2) shall reimburse to the vendor pharmacy the
20 reasonable cost of services incurred in the
21 implementation of this Section, as determined by the
22 Director of Public Aid; and
23 (3) may establish procedures, if feasible, for
24 reimbursement to non-Medicaid payors for drug products
25 returned under this Section.
26 (e) The Department of Public Aid, in consultation with
27 the Department of Professional Regulation, shall adopt rules
28 to govern the repackaging and labeling of drug products
29 returned under this Section. The rules must provide for the
30 following:
31 (1) A formulary for the drug products to be
32 returned for repackaging.
33 (2) The protection of the privacy of the individual
34 for whom the drug product was originally prescribed.
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1 (3) The integrity, safe storage, and safe transfer
2 of the drug product, which may include, but need not be
3 limited to, limiting the drugs to those that were
4 originally dispensed by unit dose or an individually
5 sealed dose or that remain in intact packaging.
6 (4) The tracking of and accountability for the drug
7 products.
8 (5) Other matters necessary for implementing this
9 Section.
10 Section 20. The Senior Pharmaceutical Assistance Act is
11 amended by changing Section 10 as follows:
12 (320 ILCS 50/10)
13 Sec. 10. Definitions. In this Act:
14 "Manufacturer" includes:
15 (1) An entity that is engaged in (a) the
16 production, preparation, propagation, compounding,
17 conversion, or processing of prescription drug products
18 (i) directly or indirectly by extraction from substances
19 of natural origin, (ii) independently by means of
20 chemical synthesis, or (iii) by combination of extraction
21 and chemical synthesis; or (b) the packaging,
22 repackaging, labeling or re-labeling, or distribution of
23 prescription drug products.
24 (2) The entity holding legal title to or possession
25 of the national drug code number for the covered
26 prescription drug.
27 The term does not include a wholesale distributor of
28 drugs, drugstore chain organization, or retail pharmacy
29 licensed by the State. The term also does not include an
30 entity that is engaged in the packaging, repackaging, or
31 labeling of a prescription drug only to the extent permitted
32 under Section 12-4.25d of the Illinois Public Aid Code.
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1 "Prescription drug" means a drug that may be dispensed
2 only upon prescription by an authorized prescriber and that
3 is approved for safety and effectiveness as a prescription
4 drug under Section 505 or 507 of the Federal Food, Drug and
5 Cosmetic Act.
6 "Senior citizen" or "senior" means a person 65 years of
7 age or older.
8 (Source: P.A. 92-594, eff. 6-27-02.)
9 Section 25. The Illinois Food, Drug and Cosmetic Act is
10 amended by changing Section 16 and adding 16.10 as follows:
11 (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
12 Sec. 16. (a) The Director is hereby authorized to
13 promulgate regulations exempting from any labeling or
14 packaging requirement of this Act drugs and devices which are
15 (i), in accordance with the practice of the trade, to be
16 processed, labeled or repacked in substantial quantities at
17 establishments other than those where originally processed or
18 packaged on condition that such drugs and devices are not
19 adulterated or misbranded under the provisions of this Act
20 upon removal from such processing, labeling or repacking
21 establishment or (ii) packaged, repackaged, or labeled to the
22 extent permitted under Section 12-4.25d of the Illinois
23 Public Aid Code.
24 (b) Drugs and device labeling or packaging exemptions
25 adopted under the Federal Act and supplements thereto or
26 revisions thereof shall apply to drugs and devices in
27 Illinois except insofar as modified or rejected by
28 regulations promulgated by the Director.
29 (c) A drug intended for use by man which (A) is a
30 habit-forming drug to which Section 15 (d) applies; or (B)
31 because of its toxicity or other potentiality for harmful
32 effect or the method of its use or the collateral measures
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1 necessary to its use is not safe for use except under the
2 supervision of a practitioner licensed by law to administer
3 such drug; or (C) is limited by an approved application under
4 Section 505 of the Federal Act or Section 17 of this Act to
5 use under the professional supervision of a practitioner
6 licensed by law to administer such drug, shall be dispensed
7 only in accordance with the provisions of the "Illinois
8 Controlled Substances Act". The act of dispensing a drug
9 contrary to the provisions of this paragraph shall be deemed
10 to be an act which results in a drug being misbranded while
11 held for sale.
12 (d) Any drug dispensed by filling or refilling a written
13 or oral prescription of a practitioner licensed by law to
14 administer such drug shall be exempt from the requirements of
15 Section 15, except subsections (a), (k) and (l) and clauses
16 (2) and (3) of subsection (i), and the packaging requirements
17 of subsections (g), (h) and (q), if the drug bears a label
18 containing the proprietary name or names, or if there is
19 none, the established name or names of the drugs, the dosage
20 and quantity, unless the prescribing practitioner, in the
21 interest of the health of the patient, directs otherwise in
22 writing, the name and address of the dispenser, the serial
23 number and date of the prescription or of its filling, the
24 name of the prescriber and, if stated in the prescription,
25 the name of the patient, and the directions for use and the
26 cautionary statements, if any, contained in such
27 prescription. This exemption shall not apply to any drug
28 dispensed in the course of the conduct of business of
29 dispensing drugs pursuant to diagnosis by mail, or to a drug
30 dispensed in violation of subsection (a) of this Section.
31 (e) The Director may by regulation remove drugs subject
32 to Section 15 (d) and Section 17 from the requirements of
33 subsection (c) of this Section when such requirements are not
34 necessary for the protection of the public health.
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1 (f) A drug which is subject to subsection (c) of this
2 Section shall be deemed to be misbranded if at any time
3 before dispensing its label fails to bear the statement
4 "Caution: Federal Law Prohibits Dispensing Without
5 Prescription" or "Caution: State Law Prohibits Dispensing
6 Without Prescription". A drug to which subsection (c) of this
7 Section does not apply shall be deemed to be misbranded if at
8 any time prior to dispensing its label bears the caution
9 statement quoted in the preceding sentence.
10 (g) Nothing in this Section shall be construed to
11 relieve any person from any requirement prescribed by or
12 under authority of law with respect to controlled substances
13 now included or which may hereafter be included within the
14 classifications of controlled substances cannabis as defined
15 in applicable Federal laws relating to controlled substances
16 or cannabis or the Cannabis Control Act.
17 (Source: P.A. 84-1308.)
18 (410 ILCS 620/16.10 new)
19 Sec. 16.10. Drug repository program.
20 (a) In this Section, "drug repository program" or
21 "program" means the drug repository program established by
22 the Department of Professional Regulation under subsection
23 (b).
24 (b) The Department of Professional Regulation, in
25 cooperation with the Department of Public Health, shall
26 establish a drug repository program to accept and dispense
27 prescription drugs donated for the purpose of being dispensed
28 to individuals who are residents of this State and meet
29 eligibility standards established in rules adopted by the
30 Department of Professional Regulation under subsection (e).
31 Only drugs in their original sealed and tamper-evident
32 unit-dose packaging may be accepted and dispensed. The
33 packaging must be unopened, except that drugs packaged in
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1 single-unit doses may be accepted and dispensed when the
2 outside packaging is opened if the single-unit dose packaging
3 is undisturbed. Drugs donated by individuals bearing an
4 expiration date that is less than 6 months from the date the
5 drug is donated shall not be accepted or dispensed. A drug
6 shall not be accepted or dispensed if there is reason to
7 believe that it is adulterated as described in Section 14.
8 Subject to the limitation specified in this Section, unused
9 drugs dispensed for purposes of the medical assistance
10 program under Article V of the Illinois Public Aid Code may
11 be accepted and dispensed under the drug repository program.
12 (c) Any person, including a drug manufacturer or any
13 health care facility, may donate prescription drugs to the
14 drug repository program. The drugs must be donated at a
15 pharmacy, hospital, or nonprofit clinic that elects to
16 participate in the program and meets criteria for
17 participation in the program established in rules adopted by
18 the Department of Professional Regulation under subsection
19 (e). Participation in the program by pharmacies, hospitals,
20 and nonprofit clinics is voluntary. Nothing in this Section
21 or any other provision of law requires a pharmacy, hospital,
22 or nonprofit clinic to participate in the program.
23 (d) A pharmacy, hospital, or nonprofit clinic eligible
24 to participate in the drug repository program shall dispense
25 drugs donated under this Section to individuals who are
26 residents of this State and meet the eligibility standards
27 established in rules adopted by the Department of
28 Professional Regulation under subsection (e) or to other
29 government entities and nonprofit private entities to be
30 dispensed to individuals who meet those eligibility
31 standards. A drug may be dispensed only pursuant to a
32 prescription issued by a licensed health professional
33 authorized to prescribe drugs, as provided by law. A
34 pharmacy, hospital, or nonprofit clinic that accepts donated
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1 drugs must comply with all applicable federal laws and laws
2 of this State dealing with storage and distribution of
3 dangerous drugs and must inspect all drugs before dispensing
4 them to determine that they are not adulterated. The
5 pharmacy, hospital, or nonprofit clinic may charge
6 individuals receiving donated drugs a handling fee
7 established in accordance with rules adopted by the
8 Department of Professional Regulation under subsection (e).
9 Drugs donated to the drug repository program may not be
10 resold.
11 (e) In consultation with the Department of Public
12 Health, the Department of Professional Regulation shall adopt
13 rules governing the drug repository program that establish
14 all of the following:
15 (1) Eligibility criteria for pharmacies, hospitals,
16 and nonprofit clinics to receive and dispense donated
17 drugs under the program.
18 (2) Standards and procedures for accepting, safely
19 storing, and dispensing donated drugs.
20 (3) Standards and procedures for inspecting donated
21 drugs to determine that the original unit-dose packaging
22 is sealed and tamper-evident and that the drugs are
23 unadulterated, safe, and suitable for dispensing.
24 (4) Eligibility standards for individuals to
25 receive donated drugs under the program, based on an
26 individual's economic need.
27 (5) A means, such as an identification card, by
28 which an individual who is eligible to receive donated
29 drugs may demonstrate eligibility to the pharmacy,
30 hospital, or nonprofit clinic dispensing the drugs.
31 (6) For drugs donated to the program by
32 individuals:
33 (A) A list of drugs, arranged either by
34 category or by individual drug, that the program
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1 will accept from individuals.
2 (B) A list of drugs, arranged either by
3 category or by individual drug, that the program
4 will not accept from individuals. The list must
5 include a statement as to why each such drug is
6 ineligible for donation.
7 (C) A form that each donor must sign stating
8 that the donor is the owner of the drugs and intends
9 to voluntarily donate them to the program.
10 (7) For drugs donated to the program by health care
11 facilities:
12 (A) A list of drugs, arranged either by
13 category or by individual drug, that the program
14 will accept from health care facilities.
15 (B) A list of drugs, arranged either by
16 category or by individual drug, that the program
17 will not accept from health care facilities. The
18 list must include a statement as to why each such
19 drug is ineligible for donation.
20 (8) Any other standards and procedures the
21 Department of Professional Regulation, in consultation
22 with the Department of Public Health, considers
23 appropriate.
24 Section 30. The Illinois Controlled Substances Act is
25 amended by changing Section 102 as follows:
26 (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
27 Sec. 102. Definitions. As used in this Act, unless the
28 context otherwise requires:
29 (a) "Addict" means any person who habitually uses any
30 drug, chemical, substance or dangerous drug other than
31 alcohol so as to endanger the public morals, health, safety
32 or welfare or who is so far addicted to the use of a
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1 dangerous drug or controlled substance other than alcohol as
2 to have lost the power of self control with reference to his
3 addiction.
4 (b) "Administer" means the direct application of a
5 controlled substance, whether by injection, inhalation,
6 ingestion, or any other means, to the body of a patient or
7 research subject by:
8 (1) a practitioner (or, in his presence, by his
9 authorized agent), or
10 (2) the patient or research subject at the lawful
11 direction of the practitioner.
12 (c) "Agent" means an authorized person who acts on
13 behalf of or at the direction of a manufacturer, distributor,
14 or dispenser. It does not include a common or contract
15 carrier, public warehouseman or employee of the carrier or
16 warehouseman.
17 (c-1) "Anabolic Steroids" means any drug or hormonal
18 substance, chemically and pharmacologically related to
19 testosterone (other than estrogens, progestins, and
20 corticosteroids) that promotes muscle growth, and includes:
21 (i) boldenone,
22 (ii) chlorotestosterone,
23 (iii) chostebol,
24 (iv) dehydrochlormethyltestosterone,
25 (v) dihydrotestosterone,
26 (vi) drostanolone,
27 (vii) ethylestrenol,
28 (viii) fluoxymesterone,
29 (ix) formebulone,
30 (x) mesterolone,
31 (xi) methandienone,
32 (xii) methandranone,
33 (xiii) methandriol,
34 (xiv) methandrostenolone,
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1 (xv) methenolone,
2 (xvi) methyltestosterone,
3 (xvii) mibolerone,
4 (xviii) nandrolone,
5 (xix) norethandrolone,
6 (xx) oxandrolone,
7 (xxi) oxymesterone,
8 (xxii) oxymetholone,
9 (xxiii) stanolone,
10 (xxiv) stanozolol,
11 (xxv) testolactone,
12 (xxvi) testosterone,
13 (xxvii) trenbolone, and
14 (xxviii) any salt, ester, or isomer of a drug
15 or substance described or listed in this paragraph,
16 if that salt, ester, or isomer promotes muscle
17 growth.
18 Any person who is otherwise lawfully in possession of an
19 anabolic steroid, or who otherwise lawfully manufactures,
20 distributes, dispenses, delivers, or possesses with intent to
21 deliver an anabolic steroid, which anabolic steroid is
22 expressly intended for and lawfully allowed to be
23 administered through implants to livestock or other nonhuman
24 species, and which is approved by the Secretary of Health and
25 Human Services for such administration, and which the person
26 intends to administer or have administered through such
27 implants, shall not be considered to be in unauthorized
28 possession or to unlawfully manufacture, distribute,
29 dispense, deliver, or possess with intent to deliver such
30 anabolic steroid for purposes of this Act.
31 (d) "Administration" means the Drug Enforcement
32 Administration, United States Department of Justice, or its
33 successor agency.
34 (e) "Control" means to add a drug or other substance, or
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1 immediate precursor, to a Schedule under Article II of this
2 Act whether by transfer from another Schedule or otherwise.
3 (f) "Controlled Substance" means a drug, substance, or
4 immediate precursor in the Schedules of Article II of this
5 Act.
6 (g) "Counterfeit substance" means a controlled
7 substance, which, or the container or labeling of which,
8 without authorization bears the trademark, trade name, or
9 other identifying mark, imprint, number or device, or any
10 likeness thereof, of a manufacturer, distributor, or
11 dispenser other than the person who in fact manufactured,
12 distributed, or dispensed the substance.
13 (h) "Deliver" or "delivery" means the actual,
14 constructive or attempted transfer of possession of a
15 controlled substance, with or without consideration, whether
16 or not there is an agency relationship.
17 (i) "Department" means the Illinois Department of Human
18 Services (as successor to the Department of Alcoholism and
19 Substance Abuse) or its successor agency.
20 (j) "Department of State Police" means the Department of
21 State Police of the State of Illinois or its successor
22 agency.
23 (k) "Department of Corrections" means the Department of
24 Corrections of the State of Illinois or its successor agency.
25 (l) "Department of Professional Regulation" means the
26 Department of Professional Regulation of the State of
27 Illinois or its successor agency.
28 (m) "Depressant" or "stimulant substance" means:
29 (1) a drug which contains any quantity of (i)
30 barbituric acid or any of the salts of barbituric acid
31 which has been designated as habit forming under section
32 502 (d) of the Federal Food, Drug, and Cosmetic Act (21
33 U.S.C. 352 (d)); or
34 (2) a drug which contains any quantity of (i)
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1 amphetamine or methamphetamine and any of their optical
2 isomers; (ii) any salt of amphetamine or methamphetamine
3 or any salt of an optical isomer of amphetamine; or (iii)
4 any substance which the Department, after investigation,
5 has found to be, and by rule designated as, habit forming
6 because of its depressant or stimulant effect on the
7 central nervous system; or
8 (3) lysergic acid diethylamide; or
9 (4) any drug which contains any quantity of a
10 substance which the Department, after investigation, has
11 found to have, and by rule designated as having, a
12 potential for abuse because of its depressant or
13 stimulant effect on the central nervous system or its
14 hallucinogenic effect.
15 (n) (Blank).
16 (o) "Director" means the Director of the Department of
17 State Police or the Department of Professional Regulation or
18 his designated agents.
19 (p) "Dispense" means to deliver a controlled substance
20 to an ultimate user or research subject by or pursuant to the
21 lawful order of a prescriber, including the prescribing,
22 administering, packaging, labeling, or compounding necessary
23 to prepare the substance for that delivery.
24 (q) "Dispenser" means a practitioner who dispenses.
25 (r) "Distribute" means to deliver, other than by
26 administering or dispensing, a controlled substance.
27 (s) "Distributor" means a person who distributes.
28 (t) "Drug" means (1) substances recognized as drugs in
29 the official United States Pharmacopoeia, Official
30 Homeopathic Pharmacopoeia of the United States, or official
31 National Formulary, or any supplement to any of them; (2)
32 substances intended for use in diagnosis, cure, mitigation,
33 treatment, or prevention of disease in man or animals; (3)
34 substances (other than food) intended to affect the structure
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1 of any function of the body of man or animals and (4)
2 substances intended for use as a component of any article
3 specified in clause (1), (2), or (3) of this subsection. It
4 does not include devices or their components, parts, or
5 accessories.
6 (t-5) "Euthanasia agency" means an entity certified by
7 the Department of Professional Regulation for the purpose of
8 animal euthanasia that holds an animal control facility
9 license or animal shelter license under the Animal Welfare
10 Act. A euthanasia agency is authorized to purchase, store,
11 possess, and utilize Schedule II nonnarcotic and Schedule III
12 nonnarcotic drugs for the sole purpose of animal euthanasia.
13 (u) "Good faith" means the prescribing or dispensing of
14 a controlled substance by a practitioner in the regular
15 course of professional treatment to or for any person who is
16 under his treatment for a pathology or condition other than
17 that individual's physical or psychological dependence upon
18 or addiction to a controlled substance, except as provided
19 herein: and application of the term to a pharmacist shall
20 mean the dispensing of a controlled substance pursuant to the
21 prescriber's order which in the professional judgment of the
22 pharmacist is lawful. The pharmacist shall be guided by
23 accepted professional standards including, but not limited to
24 the following, in making the judgment:
25 (1) lack of consistency of doctor-patient
26 relationship,
27 (2) frequency of prescriptions for same drug by one
28 prescriber for large numbers of patients,
29 (3) quantities beyond those normally prescribed,
30 (4) unusual dosages,
31 (5) unusual geographic distances between patient,
32 pharmacist and prescriber,
33 (6) consistent prescribing of habit-forming drugs.
34 (u-1) "Home infusion services" means services provided
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1 by a pharmacy in compounding solutions for direct
2 administration to a patient in a private residence, long-term
3 care facility, or hospice setting by means of parenteral,
4 intravenous, intramuscular, subcutaneous, or intraspinal
5 infusion.
6 (v) "Immediate precursor" means a substance:
7 (1) which the Department has found to be and by
8 rule designated as being a principal compound used, or
9 produced primarily for use, in the manufacture of a
10 controlled substance;
11 (2) which is an immediate chemical intermediary
12 used or likely to be used in the manufacture of such
13 controlled substance; and
14 (3) the control of which is necessary to prevent,
15 curtail or limit the manufacture of such controlled
16 substance.
17 (w) "Instructional activities" means the acts of
18 teaching, educating or instructing by practitioners using
19 controlled substances within educational facilities approved
20 by the State Board of Education or its successor agency.
21 (x) "Local authorities" means a duly organized State,
22 County or Municipal peace unit or police force.
23 (y) "Look-alike substance" means a substance, other than
24 a controlled substance which (1) by overall dosage unit
25 appearance, including shape, color, size, markings or lack
26 thereof, taste, consistency, or any other identifying
27 physical characteristic of the substance, would lead a
28 reasonable person to believe that the substance is a
29 controlled substance, or (2) is expressly or impliedly
30 represented to be a controlled substance or is distributed
31 under circumstances which would lead a reasonable person to
32 believe that the substance is a controlled substance. For the
33 purpose of determining whether the representations made or
34 the circumstances of the distribution would lead a reasonable
-22- LRB093 02637 DRJ 13496 a
1 person to believe the substance to be a controlled substance
2 under this clause (2) of subsection (y), the court or other
3 authority may consider the following factors in addition to
4 any other factor that may be relevant:
5 (a) statements made by the owner or person in
6 control of the substance concerning its nature, use or
7 effect;
8 (b) statements made to the buyer or recipient that
9 the substance may be resold for profit;
10 (c) whether the substance is packaged in a manner
11 normally used for the illegal distribution of controlled
12 substances;
13 (d) whether the distribution or attempted
14 distribution included an exchange of or demand for money
15 or other property as consideration, and whether the
16 amount of the consideration was substantially greater
17 than the reasonable retail market value of the substance.
18 Clause (1) of this subsection (y) shall not apply to a
19 noncontrolled substance in its finished dosage form that was
20 initially introduced into commerce prior to the initial
21 introduction into commerce of a controlled substance in its
22 finished dosage form which it may substantially resemble.
23 Nothing in this subsection (y) prohibits the dispensing
24 or distributing of noncontrolled substances by persons
25 authorized to dispense and distribute controlled substances
26 under this Act, provided that such action would be deemed to
27 be carried out in good faith under subsection (u) if the
28 substances involved were controlled substances.
29 Nothing in this subsection (y) or in this Act prohibits
30 the manufacture, preparation, propagation, compounding,
31 processing, packaging, advertising or distribution of a drug
32 or drugs by any person registered pursuant to Section 510 of
33 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
34 (y-1) "Mail-order pharmacy" means a pharmacy that is
-23- LRB093 02637 DRJ 13496 a
1 located in a state of the United States, other than Illinois,
2 that delivers, dispenses or distributes, through the United
3 States Postal Service or other common carrier, to Illinois
4 residents, any substance which requires a prescription.
5 (z) "Manufacture" means the production, preparation,
6 propagation, compounding, conversion or processing of a
7 controlled substance, either directly or indirectly, by
8 extraction from substances of natural origin, or
9 independently by means of chemical synthesis, or by a
10 combination of extraction and chemical synthesis, and
11 includes any packaging or repackaging of the substance or
12 labeling of its container, except that this term does not
13 include:
14 (1) by an ultimate user, the preparation or
15 compounding of a controlled substance for his own use; or
16 (2) by a practitioner, or his authorized agent
17 under his supervision, the preparation, compounding,
18 packaging, or labeling of a controlled substance:
19 (a) as an incident to his administering or
20 dispensing of a controlled substance in the course
21 of his professional practice; or
22 (b) as an incident to lawful research,
23 teaching or chemical analysis and not for sale; or.
24 (3) the packaging, repackaging, or labeling of a
25 prescription drug to the extent permitted under Section
26 12-4.25d of the Illinois Public Aid Code.
27 (z-1) "Methamphetamine manufacturing chemical" means any
28 of the following chemicals or substances containing any of
29 the following chemicals: benzyl methyl ketone, ephedrine,
30 methyl benzyl ketone, phenylacetone, phenyl-2-propanone, or
31 pseudoephedrine or any of the salts, optical isomers, or
32 salts of optical isomers of the above-listed chemicals.
33 (aa) "Narcotic drug" means any of the following, whether
34 produced directly or indirectly by extraction from substances
-24- LRB093 02637 DRJ 13496 a
1 of natural origin, or independently by means of chemical
2 synthesis, or by a combination of extraction and chemical
3 synthesis:
4 (1) opium and opiate, and any salt, compound,
5 derivative, or preparation of opium or opiate;
6 (2) any salt, compound, isomer, derivative, or
7 preparation thereof which is chemically equivalent or
8 identical with any of the substances referred to in
9 clause (1), but not including the isoquinoline alkaloids
10 of opium;
11 (3) opium poppy and poppy straw;
12 (4) coca leaves and any salts, compound, isomer,
13 salt of an isomer, derivative, or preparation of coca
14 leaves including cocaine or ecgonine, and any salt,
15 compound, isomer, derivative, or preparation thereof
16 which is chemically equivalent or identical with any of
17 these substances, but not including decocainized coca
18 leaves or extractions of coca leaves which do not contain
19 cocaine or ecgonine (for the purpose of this paragraph,
20 the term "isomer" includes optical, positional and
21 geometric isomers).
22 (bb) "Nurse" means a registered nurse licensed under the
23 Nursing and Advanced Practice Nursing Act.
24 (cc) (Blank).
25 (dd) "Opiate" means any substance having an addiction
26 forming or addiction sustaining liability similar to morphine
27 or being capable of conversion into a drug having addiction
28 forming or addiction sustaining liability.
29 (ee) "Opium poppy" means the plant of the species
30 Papaver somniferum L., except its seeds.
31 (ff) "Parole and Pardon Board" means the Parole and
32 Pardon Board of the State of Illinois or its successor
33 agency.
34 (gg) "Person" means any individual, corporation,
-25- LRB093 02637 DRJ 13496 a
1 mail-order pharmacy, government or governmental subdivision
2 or agency, business trust, estate, trust, partnership or
3 association, or any other entity.
4 (hh) "Pharmacist" means any person who holds a
5 certificate of registration as a registered pharmacist, a
6 local registered pharmacist or a registered assistant
7 pharmacist under the Pharmacy Practice Act of 1987.
8 (ii) "Pharmacy" means any store, ship or other place in
9 which pharmacy is authorized to be practiced under the
10 Pharmacy Practice Act of 1987.
11 (jj) "Poppy straw" means all parts, except the seeds, of
12 the opium poppy, after mowing.
13 (kk) "Practitioner" means a physician licensed to
14 practice medicine in all its branches, dentist, podiatrist,
15 veterinarian, scientific investigator, pharmacist, physician
16 assistant, advanced practice nurse, licensed practical nurse,
17 registered nurse, hospital, laboratory, or pharmacy, or other
18 person licensed, registered, or otherwise lawfully permitted
19 by the United States or this State to distribute, dispense,
20 conduct research with respect to, administer or use in
21 teaching or chemical analysis, a controlled substance in the
22 course of professional practice or research.
23 (ll) "Pre-printed prescription" means a written
24 prescription upon which the designated drug has been
25 indicated prior to the time of issuance.
26 (mm) "Prescriber" means a physician licensed to practice
27 medicine in all its branches, dentist, podiatrist or
28 veterinarian who issues a prescription, a physician assistant
29 who issues a prescription for a Schedule III, IV, or V
30 controlled substance in accordance with Section 303.05 and
31 the written guidelines required under Section 7.5 of the
32 Physician Assistant Practice Act of 1987, or an advanced
33 practice nurse with prescriptive authority in accordance with
34 Section 303.05 and a written collaborative agreement under
-26- LRB093 02637 DRJ 13496 a
1 Sections 15-15 and 15-20 of the Nursing and Advanced Practice
2 Nursing Act.
3 (nn) "Prescription" means a lawful written, facsimile,
4 or verbal order of a physician licensed to practice medicine
5 in all its branches, dentist, podiatrist or veterinarian for
6 any controlled substance, of a physician assistant for a
7 Schedule III, IV, or V controlled substance in accordance
8 with Section 303.05 and the written guidelines required under
9 Section 7.5 of the Physician Assistant Practice Act of 1987,
10 or of an advanced practice nurse who issues a prescription
11 for a Schedule III, IV, or V controlled substance in
12 accordance with Section 303.05 and a written collaborative
13 agreement under Sections 15-15 and 15-20 of the Nursing and
14 Advanced Practice Nursing Act.
15 (oo) "Production" or "produce" means manufacture,
16 planting, cultivating, growing, or harvesting of a controlled
17 substance.
18 (pp) "Registrant" means every person who is required to
19 register under Section 302 of this Act.
20 (qq) "Registry number" means the number assigned to each
21 person authorized to handle controlled substances under the
22 laws of the United States and of this State.
23 (rr) "State" includes the State of Illinois and any
24 state, district, commonwealth, territory, insular possession
25 thereof, and any area subject to the legal authority of the
26 United States of America.
27 (ss) "Ultimate user" means a person who lawfully
28 possesses a controlled substance for his own use or for the
29 use of a member of his household or for administering to an
30 animal owned by him or by a member of his household.
31 (Source: P.A. 91-403, eff. 1-1-00; 91-714, eff. 6-2-00;
32 92-449, eff. 1-1-02.)
33 Section 35. The Cannabis and Controlled Substances
-27- LRB093 02637 DRJ 13496 a
1 Tort Claims Act is amended by changing Section 3 as follows:
2 (740 ILCS 20/3) (from Ch. 70, par. 903)
3 Sec. 3. Definitions. As used in this Act, unless the
4 context otherwise requires:
5 "Cannabis" includes marihuana, hashish, and other
6 substances that are identified as including any parts of the
7 plant Cannabis Sativa, whether growing or not, the seeds of
8 that plant, the resin extracted from any part of that plant,
9 and any compound, manufacture, salt, derivative, mixture, or
10 preparation of that plant, its seeds, or resin, including
11 tetrahydrocannabinol (THC) and all other cannabinol
12 derivatives, including its naturally occurring or
13 synthetically produced ingredients, whether produced directly
14 or indirectly by extraction, independently by means of
15 chemical synthesis, or by a combination of extraction and
16 chemical synthesis. "Cannabis" does not include the mature
17 stalks of that plant, fiber produced from those stalks, oil
18 or cake made from the seeds of that plant, any other
19 compound, manufacture, salt, derivative, mixture, or
20 preparation of mature stalks (except the extracted resin),
21 fiber, oil or cake, or the sterilized seeds of that plant
22 that are incapable of germination.
23 "Controlled substance" means a drug, substance, or
24 immediate precursor in the Schedules of Article II of the
25 Illinois Controlled Substances Act.
26 "Counterfeit substance" means a controlled substance or
27 the container or labeling of a controlled substance that,
28 without authorization, bears the trademark, trade name, or
29 other identifying mark, imprint, number, device, or any
30 likeness thereof of a manufacturer, distributor, or dispenser
31 other than the person who in fact manufactured, distributed,
32 or dispensed the substance.
33 "Deliver" or "delivery" means the actual, constructive,
-28- LRB093 02637 DRJ 13496 a
1 or attempted transfer of possession of a controlled substance
2 or cannabis, with or without consideration, whether or not
3 there is an agency relationship.
4 "Manufacture" means the production, preparation,
5 propagation, compounding, conversion, or processing of a
6 controlled substance, either directly or indirectly, by
7 extraction from substances of natural origin, independently
8 by means of chemical synthesis, or by a combination of
9 extraction and chemical synthesis, and includes any packaging
10 or repackaging of the substance or labeling of its container,
11 except that the term does not include:
12 (1) by an ultimate user, the preparation or
13 compounding of a controlled substance for his own use;
14 (2) by a practitioner or his authorized agent under
15 his supervision, the preparation, compounding, packaging,
16 or labeling of a controlled substance;
17 (A) as an incident to his administering or
18 dispensing of a controlled substance in the course
19 of his professional practice; or
20 (B) as an incident to lawful research,
21 teaching or chemical analysis and not for sale; or
22 (3) the preparation, compounding, packaging, or
23 labeling of cannabis as an incident to lawful research,
24 teaching, or chemical analysis and not for sale; or.
25 (4) the packaging, repackaging, or labeling of a
26 prescription drug to the extent permitted under Section
27 12-4.25d of the Illinois Public Aid Code.
28 "Owner" means a person who has possession of or any
29 interest whatsoever in the property involved.
30 "Person" means an individual, a corporation, a
31 government, a governmental subdivision or agency, a business
32 trust, an estate, a trust, a partnership or association, or
33 any other entity.
34 "Production" means planting, cultivating, tending, or
-29- LRB093 02637 DRJ 13496 a
1 harvesting.
2 "Property" means real property, including things growing
3 on, affixed to, and found in land, and tangible or intangible
4 personal property, including rights, services, privileges,
5 interests, claims, and securities.
6 (Source: P.A. 87-544.)".
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