093_HB0699sam001
LRB093 05498 MKM 15928 a
1 AMENDMENT TO HOUSE BILL 699
2 AMENDMENT NO. . Amend House Bill 699 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7 (Section scheduled to be repealed on January 1, 2008)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 Section 16.10 as
11 follows:
12 (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
13 Sec. 16. (a) The Director is hereby authorized to
14 promulgate regulations exempting from any labeling or
15 packaging requirement of this Act drugs and devices which are
16 (i), in accordance with the practice of the trade, to be
17 processed, labeled or repacked in substantial quantities at
18 establishments other than those where originally processed or
19 packaged on condition that such drugs and devices are not
20 adulterated or misbranded under the provisions of this Act
21 upon removal from such processing, labeling or repacking
22 establishment or (ii) packaged, repackaged, or labeled to the
23 extent permitted under Section 12-4.25d of the Illinois
24 Public Aid Code.
25 (b) Drugs and device labeling or packaging exemptions
26 adopted under the Federal Act and supplements thereto or
27 revisions thereof shall apply to drugs and devices in
28 Illinois except insofar as modified or rejected by
29 regulations promulgated by the Director.
30 (c) A drug intended for use by man which (A) is a
31 habit-forming drug to which Section 15 (d) applies; or (B)
32 because of its toxicity or other potentiality for harmful
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1 effect or the method of its use or the collateral measures
2 necessary to its use is not safe for use except under the
3 supervision of a practitioner licensed by law to administer
4 such drug; or (C) is limited by an approved application under
5 Section 505 of the Federal Act or Section 17 of this Act to
6 use under the professional supervision of a practitioner
7 licensed by law to administer such drug, shall be dispensed
8 only in accordance with the provisions of the "Illinois
9 Controlled Substances Act". The act of dispensing a drug
10 contrary to the provisions of this paragraph shall be deemed
11 to be an act which results in a drug being misbranded while
12 held for sale.
13 (d) Any drug dispensed by filling or refilling a written
14 or oral prescription of a practitioner licensed by law to
15 administer such drug shall be exempt from the requirements of
16 Section 15, except subsections (a), (k) and (l) and clauses
17 (2) and (3) of subsection (i), and the packaging requirements
18 of subsections (g), (h) and (q), if the drug bears a label
19 containing the proprietary name or names, or if there is
20 none, the established name or names of the drugs, the dosage
21 and quantity, unless the prescribing practitioner, in the
22 interest of the health of the patient, directs otherwise in
23 writing, the name and address of the dispenser, the serial
24 number and date of the prescription or of its filling, the
25 name of the prescriber and, if stated in the prescription,
26 the name of the patient, and the directions for use and the
27 cautionary statements, if any, contained in such
28 prescription. This exemption shall not apply to any drug
29 dispensed in the course of the conduct of business of
30 dispensing drugs pursuant to diagnosis by mail, or to a drug
31 dispensed in violation of subsection (a) of this Section.
32 (e) The Director may by regulation remove drugs subject
33 to Section 15 (d) and Section 17 from the requirements of
34 subsection (c) of this Section when such requirements are not
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1 necessary for the protection of the public health.
2 (f) A drug which is subject to subsection (c) of this
3 Section shall be deemed to be misbranded if at any time
4 before dispensing its label fails to bear the statement
5 "Caution: Federal Law Prohibits Dispensing Without
6 Prescription" or "Caution: State Law Prohibits Dispensing
7 Without Prescription". A drug to which subsection (c) of this
8 Section does not apply shall be deemed to be misbranded if at
9 any time prior to dispensing its label bears the caution
10 statement quoted in the preceding sentence.
11 (g) Nothing in this Section shall be construed to
12 relieve any person from any requirement prescribed by or
13 under authority of law with respect to controlled substances
14 now included or which may hereafter be included within the
15 classifications of controlled substances cannabis as defined
16 in applicable Federal laws relating to controlled substances
17 or cannabis or the Cannabis Control Act.
18 (Source: P.A. 84-1308.)
19 (410 ILCS 620/16.10 new)
20 Sec. 16.10. Drug repository program.
21 (a) In this Section, "drug repository program" or
22 "program" means the drug repository program established by
23 the Department of Professional Regulation under subsection
24 (b).
25 (b) The Department of Professional Regulation, in
26 cooperation with the Department of Public Health, shall
27 establish a drug repository program to accept and dispense
28 prescription drugs donated for the purpose of being dispensed
29 to individuals who are residents of this State and meet
30 eligibility standards established in rules adopted by the
31 Department of Professional Regulation under subsection (e).
32 Only drugs in their original sealed and tamper-evident
33 unit-dose packaging may be accepted and dispensed. The
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1 packaging must be unopened, except that drugs packaged in
2 single-unit doses may be accepted and dispensed when the
3 outside packaging is opened if the single-unit dose packaging
4 is undisturbed. Drugs donated by individuals bearing an
5 expiration date that is less than 6 months from the date the
6 drug is donated shall not be accepted or dispensed. A drug
7 shall not be accepted or dispensed if there is reason to
8 believe that it is adulterated as described in Section 14.
9 Subject to the limitation specified in this Section, unused
10 drugs dispensed for purposes of the medical assistance
11 program under Article V of the Illinois Public Aid Code may
12 be accepted and dispensed under the drug repository program.
13 (c) Any person, including a drug manufacturer or any
14 health care facility, may donate prescription drugs to the
15 drug repository program. The drugs must be donated at a
16 pharmacy, hospital, or nonprofit clinic that elects to
17 participate in the program and meets criteria for
18 participation in the program established in rules adopted by
19 the Department of Professional Regulation under subsection
20 (e). Participation in the program by pharmacies, hospitals,
21 and nonprofit clinics is voluntary. Nothing in this Section
22 or any other provision of law requires a pharmacy, hospital,
23 or nonprofit clinic to participate in the program.
24 (d) A pharmacy, hospital, or nonprofit clinic eligible
25 to participate in the drug repository program shall dispense
26 drugs donated under this Section to individuals who are
27 residents of this State and meet the eligibility standards
28 established in rules adopted by the Department of
29 Professional Regulation under subsection (e) or to other
30 government entities and nonprofit private entities to be
31 dispensed to individuals who meet those eligibility
32 standards. A drug may be dispensed only pursuant to a
33 prescription issued by a licensed health professional
34 authorized to prescribe drugs, as provided by law. A
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1 pharmacy, hospital, or nonprofit clinic that accepts donated
2 drugs must comply with all applicable federal laws and laws
3 of this State dealing with storage and distribution of
4 dangerous drugs and must inspect all drugs before dispensing
5 them to determine that they are not adulterated. The
6 pharmacy, hospital, or nonprofit clinic may charge
7 individuals receiving donated drugs a handling fee
8 established in accordance with rules adopted by the
9 Department of Professional Regulation under subsection (e).
10 Drugs donated to the drug repository program may not be
11 resold.
12 (e) In consultation with the Department of Public
13 Health, the Department of Professional Regulation shall adopt
14 rules governing the drug repository program that establish
15 all of the following:
16 (1) Eligibility criteria for pharmacies, hospitals,
17 and nonprofit clinics to receive and dispense donated
18 drugs under the program.
19 (2) Standards and procedures for accepting, safely
20 storing, and dispensing donated drugs.
21 (3) Standards and procedures for inspecting donated
22 drugs to determine that the original unit-dose packaging
23 is sealed and tamper-evident and that the drugs are
24 unadulterated, safe, and suitable for dispensing.
25 (4) Eligibility standards for individuals to
26 receive donated drugs under the program, based on an
27 individual's economic need.
28 (5) A means, such as an identification card, by
29 which an individual who is eligible to receive donated
30 drugs may demonstrate eligibility to the pharmacy,
31 hospital, or nonprofit clinic dispensing the drugs.
32 (6) For drugs donated to the program by
33 individuals:
34 (A) A list of drugs, arranged either by
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1 category or by individual drug, that the program
2 will accept from individuals.
3 (B) A list of drugs, arranged either by
4 category or by individual drug, that the program
5 will not accept from individuals. The list must
6 include a statement as to why each such drug is
7 ineligible for donation.
8 (C) A form that each donor must sign stating
9 that the donor is the owner of the drugs and intends
10 to voluntarily donate them to the program.
11 (7) For drugs donated to the program by health care
12 facilities:
13 (A) A list of drugs, arranged either by
14 category or by individual drug, that the program
15 will accept from health care facilities.
16 (B) A list of drugs, arranged either by
17 category or by individual drug, that the program
18 will not accept from health care facilities. The
19 list must include a statement as to why each such
20 drug is ineligible for donation.
21 (8) Any other standards and procedures the
22 Department of Professional Regulation, in consultation
23 with the Department of Public Health, considers
24 appropriate.
25 Section 30. The Illinois Controlled Substances Act is
26 amended by changing Section 102 as follows:
27 (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
28 Sec. 102. Definitions. As used in this Act, unless the
29 context otherwise requires:
30 (a) "Addict" means any person who habitually uses any
31 drug, chemical, substance or dangerous drug other than
32 alcohol so as to endanger the public morals, health, safety
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1 or welfare or who is so far addicted to the use of a
2 dangerous drug or controlled substance other than alcohol as
3 to have lost the power of self control with reference to his
4 addiction.
5 (b) "Administer" means the direct application of a
6 controlled substance, whether by injection, inhalation,
7 ingestion, or any other means, to the body of a patient or
8 research subject by:
9 (1) a practitioner (or, in his presence, by his
10 authorized agent), or
11 (2) the patient or research subject at the lawful
12 direction of the practitioner.
13 (c) "Agent" means an authorized person who acts on
14 behalf of or at the direction of a manufacturer, distributor,
15 or dispenser. It does not include a common or contract
16 carrier, public warehouseman or employee of the carrier or
17 warehouseman.
18 (c-1) "Anabolic Steroids" means any drug or hormonal
19 substance, chemically and pharmacologically related to
20 testosterone (other than estrogens, progestins, and
21 corticosteroids) that promotes muscle growth, and includes:
22 (i) boldenone,
23 (ii) chlorotestosterone,
24 (iii) chostebol,
25 (iv) dehydrochlormethyltestosterone,
26 (v) dihydrotestosterone,
27 (vi) drostanolone,
28 (vii) ethylestrenol,
29 (viii) fluoxymesterone,
30 (ix) formebulone,
31 (x) mesterolone,
32 (xi) methandienone,
33 (xii) methandranone,
34 (xiii) methandriol,
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1 (xiv) methandrostenolone,
2 (xv) methenolone,
3 (xvi) methyltestosterone,
4 (xvii) mibolerone,
5 (xviii) nandrolone,
6 (xix) norethandrolone,
7 (xx) oxandrolone,
8 (xxi) oxymesterone,
9 (xxii) oxymetholone,
10 (xxiii) stanolone,
11 (xxiv) stanozolol,
12 (xxv) testolactone,
13 (xxvi) testosterone,
14 (xxvii) trenbolone, and
15 (xxviii) any salt, ester, or isomer of a drug
16 or substance described or listed in this paragraph,
17 if that salt, ester, or isomer promotes muscle
18 growth.
19 Any person who is otherwise lawfully in possession of an
20 anabolic steroid, or who otherwise lawfully manufactures,
21 distributes, dispenses, delivers, or possesses with intent to
22 deliver an anabolic steroid, which anabolic steroid is
23 expressly intended for and lawfully allowed to be
24 administered through implants to livestock or other nonhuman
25 species, and which is approved by the Secretary of Health and
26 Human Services for such administration, and which the person
27 intends to administer or have administered through such
28 implants, shall not be considered to be in unauthorized
29 possession or to unlawfully manufacture, distribute,
30 dispense, deliver, or possess with intent to deliver such
31 anabolic steroid for purposes of this Act.
32 (d) "Administration" means the Drug Enforcement
33 Administration, United States Department of Justice, or its
34 successor agency.
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1 (e) "Control" means to add a drug or other substance, or
2 immediate precursor, to a Schedule under Article II of this
3 Act whether by transfer from another Schedule or otherwise.
4 (f) "Controlled Substance" means a drug, substance, or
5 immediate precursor in the Schedules of Article II of this
6 Act.
7 (g) "Counterfeit substance" means a controlled
8 substance, which, or the container or labeling of which,
9 without authorization bears the trademark, trade name, or
10 other identifying mark, imprint, number or device, or any
11 likeness thereof, of a manufacturer, distributor, or
12 dispenser other than the person who in fact manufactured,
13 distributed, or dispensed the substance.
14 (h) "Deliver" or "delivery" means the actual,
15 constructive or attempted transfer of possession of a
16 controlled substance, with or without consideration, whether
17 or not there is an agency relationship.
18 (i) "Department" means the Illinois Department of Human
19 Services (as successor to the Department of Alcoholism and
20 Substance Abuse) or its successor agency.
21 (j) "Department of State Police" means the Department of
22 State Police of the State of Illinois or its successor
23 agency.
24 (k) "Department of Corrections" means the Department of
25 Corrections of the State of Illinois or its successor agency.
26 (l) "Department of Professional Regulation" means the
27 Department of Professional Regulation of the State of
28 Illinois or its successor agency.
29 (m) "Depressant" or "stimulant substance" means:
30 (1) a drug which contains any quantity of (i)
31 barbituric acid or any of the salts of barbituric acid
32 which has been designated as habit forming under section
33 502 (d) of the Federal Food, Drug, and Cosmetic Act (21
34 U.S.C. 352 (d)); or
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1 (2) a drug which contains any quantity of (i)
2 amphetamine or methamphetamine and any of their optical
3 isomers; (ii) any salt of amphetamine or methamphetamine
4 or any salt of an optical isomer of amphetamine; or (iii)
5 any substance which the Department, after investigation,
6 has found to be, and by rule designated as, habit forming
7 because of its depressant or stimulant effect on the
8 central nervous system; or
9 (3) lysergic acid diethylamide; or
10 (4) any drug which contains any quantity of a
11 substance which the Department, after investigation, has
12 found to have, and by rule designated as having, a
13 potential for abuse because of its depressant or
14 stimulant effect on the central nervous system or its
15 hallucinogenic effect.
16 (n) (Blank).
17 (o) "Director" means the Director of the Department of
18 State Police or the Department of Professional Regulation or
19 his designated agents.
20 (p) "Dispense" means to deliver a controlled substance
21 to an ultimate user or research subject by or pursuant to the
22 lawful order of a prescriber, including the prescribing,
23 administering, packaging, labeling, or compounding necessary
24 to prepare the substance for that delivery.
25 (q) "Dispenser" means a practitioner who dispenses.
26 (r) "Distribute" means to deliver, other than by
27 administering or dispensing, a controlled substance.
28 (s) "Distributor" means a person who distributes.
29 (t) "Drug" means (1) substances recognized as drugs in
30 the official United States Pharmacopoeia, Official
31 Homeopathic Pharmacopoeia of the United States, or official
32 National Formulary, or any supplement to any of them; (2)
33 substances intended for use in diagnosis, cure, mitigation,
34 treatment, or prevention of disease in man or animals; (3)
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1 substances (other than food) intended to affect the structure
2 of any function of the body of man or animals and (4)
3 substances intended for use as a component of any article
4 specified in clause (1), (2), or (3) of this subsection. It
5 does not include devices or their components, parts, or
6 accessories.
7 (t-5) "Euthanasia agency" means an entity certified by
8 the Department of Professional Regulation for the purpose of
9 animal euthanasia that holds an animal control facility
10 license or animal shelter license under the Animal Welfare
11 Act. A euthanasia agency is authorized to purchase, store,
12 possess, and utilize Schedule II nonnarcotic and Schedule III
13 nonnarcotic drugs for the sole purpose of animal euthanasia.
14 (u) "Good faith" means the prescribing or dispensing of
15 a controlled substance by a practitioner in the regular
16 course of professional treatment to or for any person who is
17 under his treatment for a pathology or condition other than
18 that individual's physical or psychological dependence upon
19 or addiction to a controlled substance, except as provided
20 herein: and application of the term to a pharmacist shall
21 mean the dispensing of a controlled substance pursuant to the
22 prescriber's order which in the professional judgment of the
23 pharmacist is lawful. The pharmacist shall be guided by
24 accepted professional standards including, but not limited to
25 the following, in making the judgment:
26 (1) lack of consistency of doctor-patient
27 relationship,
28 (2) frequency of prescriptions for same drug by one
29 prescriber for large numbers of patients,
30 (3) quantities beyond those normally prescribed,
31 (4) unusual dosages,
32 (5) unusual geographic distances between patient,
33 pharmacist and prescriber,
34 (6) consistent prescribing of habit-forming drugs.
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1 (u-1) "Home infusion services" means services provided
2 by a pharmacy in compounding solutions for direct
3 administration to a patient in a private residence, long-term
4 care facility, or hospice setting by means of parenteral,
5 intravenous, intramuscular, subcutaneous, or intraspinal
6 infusion.
7 (v) "Immediate precursor" means a substance:
8 (1) which the Department has found to be and by
9 rule designated as being a principal compound used, or
10 produced primarily for use, in the manufacture of a
11 controlled substance;
12 (2) which is an immediate chemical intermediary
13 used or likely to be used in the manufacture of such
14 controlled substance; and
15 (3) the control of which is necessary to prevent,
16 curtail or limit the manufacture of such controlled
17 substance.
18 (w) "Instructional activities" means the acts of
19 teaching, educating or instructing by practitioners using
20 controlled substances within educational facilities approved
21 by the State Board of Education or its successor agency.
22 (x) "Local authorities" means a duly organized State,
23 County or Municipal peace unit or police force.
24 (y) "Look-alike substance" means a substance, other than
25 a controlled substance which (1) by overall dosage unit
26 appearance, including shape, color, size, markings or lack
27 thereof, taste, consistency, or any other identifying
28 physical characteristic of the substance, would lead a
29 reasonable person to believe that the substance is a
30 controlled substance, or (2) is expressly or impliedly
31 represented to be a controlled substance or is distributed
32 under circumstances which would lead a reasonable person to
33 believe that the substance is a controlled substance. For the
34 purpose of determining whether the representations made or
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1 the circumstances of the distribution would lead a reasonable
2 person to believe the substance to be a controlled substance
3 under this clause (2) of subsection (y), the court or other
4 authority may consider the following factors in addition to
5 any other factor that may be relevant:
6 (a) statements made by the owner or person in
7 control of the substance concerning its nature, use or
8 effect;
9 (b) statements made to the buyer or recipient that
10 the substance may be resold for profit;
11 (c) whether the substance is packaged in a manner
12 normally used for the illegal distribution of controlled
13 substances;
14 (d) whether the distribution or attempted
15 distribution included an exchange of or demand for money
16 or other property as consideration, and whether the
17 amount of the consideration was substantially greater
18 than the reasonable retail market value of the substance.
19 Clause (1) of this subsection (y) shall not apply to a
20 noncontrolled substance in its finished dosage form that was
21 initially introduced into commerce prior to the initial
22 introduction into commerce of a controlled substance in its
23 finished dosage form which it may substantially resemble.
24 Nothing in this subsection (y) prohibits the dispensing
25 or distributing of noncontrolled substances by persons
26 authorized to dispense and distribute controlled substances
27 under this Act, provided that such action would be deemed to
28 be carried out in good faith under subsection (u) if the
29 substances involved were controlled substances.
30 Nothing in this subsection (y) or in this Act prohibits
31 the manufacture, preparation, propagation, compounding,
32 processing, packaging, advertising or distribution of a drug
33 or drugs by any person registered pursuant to Section 510 of
34 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
-23- LRB093 05498 MKM 15928 a
1 (y-1) "Mail-order pharmacy" means a pharmacy that is
2 located in a state of the United States, other than Illinois,
3 that delivers, dispenses or distributes, through the United
4 States Postal Service or other common carrier, to Illinois
5 residents, any substance which requires a prescription.
6 (z) "Manufacture" means the production, preparation,
7 propagation, compounding, conversion or processing of a
8 controlled substance, either directly or indirectly, by
9 extraction from substances of natural origin, or
10 independently by means of chemical synthesis, or by a
11 combination of extraction and chemical synthesis, and
12 includes any packaging or repackaging of the substance or
13 labeling of its container, except that this term does not
14 include:
15 (1) by an ultimate user, the preparation or
16 compounding of a controlled substance for his own use; or
17 (2) by a practitioner, or his authorized agent
18 under his supervision, the preparation, compounding,
19 packaging, or labeling of a controlled substance:
20 (a) as an incident to his administering or
21 dispensing of a controlled substance in the course
22 of his professional practice; or
23 (b) as an incident to lawful research,
24 teaching or chemical analysis and not for sale; or.
25 (3) 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 (z-1) "Methamphetamine manufacturing chemical" means any
29 of the following chemicals or substances containing any of
30 the following chemicals: benzyl methyl ketone, ephedrine,
31 methyl benzyl ketone, phenylacetone, phenyl-2-propanone, or
32 pseudoephedrine or any of the salts, optical isomers, or
33 salts of optical isomers of the above-listed chemicals.
34 (aa) "Narcotic drug" means any of the following, whether
-24- LRB093 05498 MKM 15928 a
1 produced directly or indirectly by extraction from substances
2 of natural origin, or independently by means of chemical
3 synthesis, or by a combination of extraction and chemical
4 synthesis:
5 (1) opium and opiate, and any salt, compound,
6 derivative, or preparation of opium or opiate;
7 (2) any salt, compound, isomer, derivative, or
8 preparation thereof which is chemically equivalent or
9 identical with any of the substances referred to in
10 clause (1), but not including the isoquinoline alkaloids
11 of opium;
12 (3) opium poppy and poppy straw;
13 (4) coca leaves and any salts, compound, isomer,
14 salt of an isomer, derivative, or preparation of coca
15 leaves including cocaine or ecgonine, and any salt,
16 compound, isomer, derivative, or preparation thereof
17 which is chemically equivalent or identical with any of
18 these substances, but not including decocainized coca
19 leaves or extractions of coca leaves which do not contain
20 cocaine or ecgonine (for the purpose of this paragraph,
21 the term "isomer" includes optical, positional and
22 geometric isomers).
23 (bb) "Nurse" means a registered nurse licensed under the
24 Nursing and Advanced Practice Nursing Act.
25 (cc) (Blank).
26 (dd) "Opiate" means any substance having an addiction
27 forming or addiction sustaining liability similar to morphine
28 or being capable of conversion into a drug having addiction
29 forming or addiction sustaining liability.
30 (ee) "Opium poppy" means the plant of the species
31 Papaver somniferum L., except its seeds.
32 (ff) "Parole and Pardon Board" means the Parole and
33 Pardon Board of the State of Illinois or its successor
34 agency.
-25- LRB093 05498 MKM 15928 a
1 (gg) "Person" means any individual, corporation,
2 mail-order pharmacy, government or governmental subdivision
3 or agency, business trust, estate, trust, partnership or
4 association, or any other entity.
5 (hh) "Pharmacist" means any person who holds a
6 certificate of registration as a registered pharmacist, a
7 local registered pharmacist or a registered assistant
8 pharmacist under the Pharmacy Practice Act of 1987.
9 (ii) "Pharmacy" means any store, ship or other place in
10 which pharmacy is authorized to be practiced under the
11 Pharmacy Practice Act of 1987.
12 (jj) "Poppy straw" means all parts, except the seeds, of
13 the opium poppy, after mowing.
14 (kk) "Practitioner" means a physician licensed to
15 practice medicine in all its branches, dentist, podiatrist,
16 veterinarian, scientific investigator, pharmacist, physician
17 assistant, advanced practice nurse, licensed practical nurse,
18 registered nurse, hospital, laboratory, or pharmacy, or other
19 person licensed, registered, or otherwise lawfully permitted
20 by the United States or this State to distribute, dispense,
21 conduct research with respect to, administer or use in
22 teaching or chemical analysis, a controlled substance in the
23 course of professional practice or research.
24 (ll) "Pre-printed prescription" means a written
25 prescription upon which the designated drug has been
26 indicated prior to the time of issuance.
27 (mm) "Prescriber" means a physician licensed to practice
28 medicine in all its branches, dentist, podiatrist or
29 veterinarian who issues a prescription, a physician assistant
30 who issues a prescription for a Schedule III, IV, or V
31 controlled substance in accordance with Section 303.05 and
32 the written guidelines required under Section 7.5 of the
33 Physician Assistant Practice Act of 1987, or an advanced
34 practice nurse with prescriptive authority in accordance with
-26- LRB093 05498 MKM 15928 a
1 Section 303.05 and a written collaborative agreement under
2 Sections 15-15 and 15-20 of the Nursing and Advanced Practice
3 Nursing Act.
4 (nn) "Prescription" means a lawful written, facsimile,
5 or verbal order of a physician licensed to practice medicine
6 in all its branches, dentist, podiatrist or veterinarian for
7 any controlled substance, of a physician assistant for a
8 Schedule III, IV, or V controlled substance in accordance
9 with Section 303.05 and the written guidelines required under
10 Section 7.5 of the Physician Assistant Practice Act of 1987,
11 or of an advanced practice nurse who issues a prescription
12 for a Schedule III, IV, or V controlled substance in
13 accordance with Section 303.05 and a written collaborative
14 agreement under Sections 15-15 and 15-20 of the Nursing and
15 Advanced Practice Nursing Act.
16 (oo) "Production" or "produce" means manufacture,
17 planting, cultivating, growing, or harvesting of a controlled
18 substance.
19 (pp) "Registrant" means every person who is required to
20 register under Section 302 of this Act.
21 (qq) "Registry number" means the number assigned to each
22 person authorized to handle controlled substances under the
23 laws of the United States and of this State.
24 (rr) "State" includes the State of Illinois and any
25 state, district, commonwealth, territory, insular possession
26 thereof, and any area subject to the legal authority of the
27 United States of America.
28 (ss) "Ultimate user" means a person who lawfully
29 possesses a controlled substance for his own use or for the
30 use of a member of his household or for administering to an
31 animal owned by him or by a member of his household.
32 (Source: P.A. 91-403, eff. 1-1-00; 91-714, eff. 6-2-00;
33 92-449, eff. 1-1-02.)
-27- LRB093 05498 MKM 15928 a
1 Section 35. The Cannabis and Controlled Substances
2 Tort Claims Act is amended by changing Section 3 as follows:
3 (740 ILCS 20/3) (from Ch. 70, par. 903)
4 Sec. 3. Definitions. As used in this Act, unless the
5 context otherwise requires:
6 "Cannabis" includes marihuana, hashish, and other
7 substances that are identified as including any parts of the
8 plant Cannabis Sativa, whether growing or not, the seeds of
9 that plant, the resin extracted from any part of that plant,
10 and any compound, manufacture, salt, derivative, mixture, or
11 preparation of that plant, its seeds, or resin, including
12 tetrahydrocannabinol (THC) and all other cannabinol
13 derivatives, including its naturally occurring or
14 synthetically produced ingredients, whether produced directly
15 or indirectly by extraction, independently by means of
16 chemical synthesis, or by a combination of extraction and
17 chemical synthesis. "Cannabis" does not include the mature
18 stalks of that plant, fiber produced from those stalks, oil
19 or cake made from the seeds of that plant, any other
20 compound, manufacture, salt, derivative, mixture, or
21 preparation of mature stalks (except the extracted resin),
22 fiber, oil or cake, or the sterilized seeds of that plant
23 that are incapable of germination.
24 "Controlled substance" means a drug, substance, or
25 immediate precursor in the Schedules of Article II of the
26 Illinois Controlled Substances Act.
27 "Counterfeit substance" means a controlled substance or
28 the container or labeling of a controlled substance that,
29 without authorization, bears the trademark, trade name, or
30 other identifying mark, imprint, number, device, or any
31 likeness thereof of a manufacturer, distributor, or dispenser
32 other than the person who in fact manufactured, distributed,
33 or dispensed the substance.
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1 "Deliver" or "delivery" means the actual, constructive,
2 or attempted transfer of possession of a controlled substance
3 or cannabis, with or without consideration, whether or not
4 there is an agency relationship.
5 "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, independently
9 by means of chemical synthesis, or by a combination of
10 extraction and chemical synthesis, and includes any packaging
11 or repackaging of the substance or labeling of its container,
12 except that the term does not include:
13 (1) by an ultimate user, the preparation or
14 compounding of a controlled substance for his own use;
15 (2) by a practitioner or his authorized agent under
16 his supervision, the preparation, compounding, packaging,
17 or labeling of a controlled substance;
18 (A) as an incident to his administering or
19 dispensing of a controlled substance in the course
20 of his professional practice; or
21 (B) as an incident to lawful research,
22 teaching or chemical analysis and not for sale; or
23 (3) the preparation, compounding, packaging, or
24 labeling of cannabis as an incident to lawful research,
25 teaching, or chemical analysis and not for sale; or.
26 (4) the packaging, repackaging, or labeling of a
27 prescription drug to the extent permitted under Section
28 12-4.25d of the Illinois Public Aid Code.
29 "Owner" means a person who has possession of or any
30 interest whatsoever in the property involved.
31 "Person" means an individual, a corporation, a
32 government, a governmental subdivision or agency, a business
33 trust, an estate, a trust, a partnership or association, or
34 any other entity.
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1 "Production" means planting, cultivating, tending, or
2 harvesting.
3 "Property" means real property, including things growing
4 on, affixed to, and found in land, and tangible or intangible
5 personal property, including rights, services, privileges,
6 interests, claims, and securities.
7 (Source: P.A. 87-544.)".