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093_HB0244eng
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1 AN ACT in relation to public aid.
2 Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
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7 (Section scheduled to be repealed on January 1, 2008)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
23 content and usage and generally considered and accepted as
24 harmless and nonpoisonous when used according to the
25 directions on the label, and also do not contain opium or
26 coca leaves, or any compound, salt or derivative thereof, or
27 any drug which, according to the latest editions of the
28 following authoritative pharmaceutical treatises and
29 standards, namely, The United States Pharmacopoeia/National
30 Formulary (USP/NF), the United States Dispensatory, and the
31 Accepted Dental Remedies of the Council of Dental
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1 Therapeutics of the American Dental Association or any or
2 either of them, in use on the effective date of this Act, or
3 according to the existing provisions of the Federal Food,
4 Drug, and Cosmetic Act and Regulations of the Department of
5 Health and Human Services, Food and Drug Administration,
6 promulgated thereunder now in effect, is designated,
7 described or considered as a narcotic, hypnotic, habit
8 forming, dangerous, or poisonous drug.;
9 (d) The sale of poultry and livestock remedies in
10 original and unbroken packages only, labeled for poultry and
11 livestock medication.;
12 (e) The sale of poisonous substances or mixture of
13 poisonous substances, in unbroken packages, for nonmedicinal
14 use in the arts or industries or for insecticide purposes;
15 provided, they are properly and adequately labeled as to
16 content and such nonmedicinal usage, in conformity with the
17 provisions of all applicable federal, state and local laws
18 and regulations promulgated thereunder now in effect relating
19 thereto and governing the same, and those which are required
20 under such applicable laws and regulations to be labeled with
21 the word "Poison", are also labeled with the word "Poison"
22 printed thereon in prominent type and the name of a readily
23 obtainable antidote with directions for its administration.;
24 (f) The delegation of limited prescriptive authority by
25 a physician licensed to practice medicine in all its branches
26 to a physician assistant under Section 7.5 of the Physician
27 Assistant Practice Act of 1987. This delegated authority may
28 but is not required to include prescription of Schedule III,
29 IV, or V controlled substances, as defined in Article II of
30 the Illinois Controlled Substances Act, in accordance with
31 written guidelines under Section 7.5 of the Physician
32 Assistant Practice Act of 1987.; and
33 (g) The delegation of limited prescriptive authority by
34 a physician licensed to practice medicine in all its branches
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1 to an advanced practice nurse in accordance with a written
2 collaborative agreement under Sections 15-15 and 15-20 of the
3 Nursing and Advanced Practice Nursing Act. This delegated
4 authority may but is not required to include the prescription
5 of Schedule III, IV, or V controlled substances as defined in
6 Article II of the Illinois Controlled Substances Act.
7 (h) The return and packaging, repackaging, and labeling
8 of prescription drugs to the extent permitted under Section
9 12-4.25d of the Illinois Public Aid Code.
10 (Source: P.A. 90-116, eff. 7-14-97; 90-253, eff. 7-29-97;
11 90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)
12 Section 10. The Wholesale Drug Distribution Licensing
13 Act is amended by changing Section 15 as follows:
14 (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
15 (Section scheduled to be repealed on January 1, 2013)
16 Sec. 15. Definitions. As used in this Act:
17 "Blood" means whole blood collected from a single donor
18 and processed either for transfusion or further
19 manufacturing.
20 "Blood component" means that part of blood separated by
21 physical or mechanical means.
22 "Board" means the State Board of Pharmacy of the
23 Department of Professional Regulation.
24 "Department" means the Department of Professional
25 Regulation.
26 "Director" means the Director of Professional Regulation.
27 "Drug sample" means a unit of a prescription drug that is
28 not intended to be sold and is intended to promote the sale
29 of the drug.
30 "Manufacturer" means anyone who is engaged in the
31 manufacturing, preparing, propagating, compounding,
32 processing, packaging, repackaging, or labeling of a
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1 prescription drug. "Manufacturer" does not include anyone who
2 is engaged in the packaging, repackaging, or labeling of a
3 prescription drug only to the extent permitted under Section
4 12-4.25d of the Illinois Public Aid Code.
5 "Person" means and includes a natural person,
6 partnership, association or corporation.
7 "Pharmacy distributor" means any pharmacy licensed in
8 this State or hospital pharmacy that is engaged in the
9 delivery or distribution of prescription drugs either to any
10 other pharmacy licensed in this State or to any other person
11 or entity including, but not limited to, a wholesale drug
12 distributor engaged in the delivery or distribution of
13 prescription drugs who is involved in the actual,
14 constructive, or attempted transfer of a drug in this State
15 to other than the ultimate consumer except as otherwise
16 provided for by law.
17 "Prescription drug" means any human drug required by
18 federal law or regulation to be dispensed only by a
19 prescription, including finished dosage forms and active
20 ingredients subject to subsection (b) of Section 503 of the
21 Federal Food, Drug and Cosmetic Act.
22 "Wholesale distribution" or "wholesale distributions"
23 means distribution of prescription drugs to persons other
24 than a consumer or patient, but does not include any of the
25 following:
26 (a) Intracompany sales, defined as any transaction
27 or transfer between any division, subsidiary, parent, or
28 affiliated or related company under the common ownership
29 and control of a corporate entity.
30 (b) The purchase or other acquisition by a hospital
31 or other health care entity that is a member of a group
32 purchasing organization of a drug for its own use from
33 the group purchasing organization or from other hospitals
34 or health care entities that are members of a group
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1 organization.
2 (c) The sale, purchase, or trade of a drug or an
3 offer to sell, purchase, or trade a drug by a charitable
4 organization described in subsection (c)(3) of Section
5 501 of the U.S. Internal Revenue Code of 1954 to a
6 nonprofit affiliate of the organization to the extent
7 otherwise permitted by law.
8 (d) The sale, purchase, or trade of a drug or an
9 offer to sell, purchase, or trade a drug among hospitals
10 or other health care entities that are under common
11 control. For purposes of this Act, "common control"
12 means the power to direct or cause the direction of the
13 management and policies of a person or an organization,
14 whether by ownership of stock, voting rights, contract,
15 or otherwise.
16 (e) The sale, purchase, or trade of a drug or an
17 offer to sell, purchase, or trade a drug for emergency
18 medical reasons. For purposes of this Act, "emergency
19 medical reasons" include transfers of prescription drugs
20 by a retail pharmacy to another retail pharmacy to
21 alleviate a temporary shortage.
22 (f) The sale, purchase, or trade of a drug, an
23 offer to sell, purchase, or trade a drug, or the
24 dispensing of a drug pursuant to a prescription.
25 (g) The distribution of drug samples by
26 manufacturers' representatives or distributors'
27 representatives.
28 (h) The sale, purchase, or trade of blood and blood
29 components intended for transfusion.
30 "Wholesale drug distributor" means any person or entity
31 engaged in wholesale distribution of prescription drugs,
32 including, but not limited to, manufacturers; repackers; own
33 label distributors; jobbers; private label distributors;
34 brokers; warehouses, including manufacturers' and
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1 distributors' warehouses, chain drug warehouses, and
2 wholesale drug warehouses; independent wholesale drug
3 traders; and retail pharmacies that conduct wholesale
4 distributions, including, but not limited to, any pharmacy
5 distributor as defined in this Section. A wholesale drug
6 distributor shall not include any for hire carrier or person
7 or entity hired solely to transport prescription drugs.
8 (Source: P.A. 87-594.)
9 Section 15. The Illinois Public Aid Code is amended by
10 adding Section 12-4.25d as follows:
11 (305 ILCS 5/12-4.25d new)
12 Sec. 12-4.25d. Nursing homes; return of unused
13 prescription drugs.
14 (a) Pursuant to an agreement with the vendor pharmacy, a
15 provider of long-term care services under this Code may
16 return to the vendor pharmacy from which the drug product was
17 purchased, for repackaging and reimbursement to the
18 Department of Public Aid, a drug product that (i) was
19 dispensed to a resident of the provider's long-term care
20 facility and not used and (ii) meets all of the following
21 criteria:
22 (1) It is a prescription drug product that is not a
23 controlled substance.
24 (2) It is sealed in an individually packaged unit.
25 (3) It is returned to the vendor pharmacy within
26 the recommended period of shelf life for the purpose of
27 redispensing the drug product.
28 (4) It is determined to be of acceptable integrity
29 by a licensed pharmacist.
30 (5) It consists of (i) oral or parenteral
31 medication in a single-dose sealed container approved by
32 the federal Food and Drug Administration, (ii) a topical
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1 or inhalant drug product in a unit-of-use container
2 approved by the federal Food and Drug Administration, or
3 (iii) a parenteral medication in a multiple-dose sealed
4 container approved by the federal Food and Drug
5 Administration.
6 (6) No doses have been withdrawn from the container
7 in which the drug product is packaged.
8 An agreement between a provider of long-term care
9 services under this Code and a vendor pharmacy as described
10 in this subsection must comply with subsection (b).
11 (b) Notwithstanding the provisions of subsection (a):
12 (1) If a drug product is packaged in the
13 manufacturer's unit-dose package, the drug product may be
14 returned to the vendor pharmacy for redispensing and
15 reimbursement to the Department of Public Aid if the drug
16 may be redispensed for use before the expiration date, if
17 any, indicated on the package.
18 (2) If the drug product is repackaged in the
19 manufacturer's unit-dose or multiple-dose blister pack,
20 the drug product may be returned to the vendor pharmacy
21 for redispensing and reimbursement to the Department of
22 Public Aid if:
23 (A) the date on which the drug product was
24 repackaged and the drug product's lot number and
25 expiration date are indicated clearly on the package
26 of the repackaged drug product;
27 (B) ninety days or fewer have elapsed from the
28 date the drug product was repackaged; and
29 (C) a repackaging log is maintained by the
30 pharmacy in the case of drug products repackaged in
31 advance of immediate needs.
32 (3) A drug product dispensed in a bulk dispensing
33 container may not be returned to the vendor pharmacy.
34 (c) A provider of long term-care services under this
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1 Code may establish procedures for the return of unused drug
2 products to the vendor pharmacies from which the drug
3 products were purchased.
4 (d) The Department of Public Aid:
5 (1) shall adopt rules for the reimbursement of
6 unused or redispensed drugs under this Section in the
7 case of providers of long-term care services and vendor
8 pharmacies that have entered into agreements described in
9 subsection (a);
10 (2) shall reimburse to the vendor pharmacy the
11 reasonable cost of services incurred in the
12 implementation of this Section, as determined by the
13 Director of Public Aid; and
14 (3) may establish procedures, if feasible, for
15 reimbursement to non-Medicaid payors for drug products
16 returned under this Section.
17 (e) The Department of Public Aid, in consultation with
18 the Department of Professional Regulation, shall adopt rules
19 to govern the repackaging and labeling of drug products
20 returned under this Section. The rules must provide for the
21 following:
22 (1) A formulary for the drug products to be
23 returned for repackaging.
24 (2) The protection of the privacy of the individual
25 for whom the drug product was originally prescribed.
26 (3) The integrity, safe storage, and safe transfer
27 of the drug product, which may include, but need not be
28 limited to, limiting the drugs to those that were
29 originally dispensed by unit dose or an individually
30 sealed dose or that remain in intact packaging.
31 (4) The tracking of and accountability for the drug
32 products.
33 (5) Other matters necessary for implementing this
34 Section.
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1 Section 20. The Senior Pharmaceutical Assistance Act is
2 amended by changing Section 10 as follows:
3 (320 ILCS 50/10)
4 Sec. 10. Definitions. In this Act:
5 "Manufacturer" includes:
6 (1) An entity that is engaged in (a) the
7 production, preparation, propagation, compounding,
8 conversion, or processing of prescription drug products
9 (i) directly or indirectly by extraction from substances
10 of natural origin, (ii) independently by means of
11 chemical synthesis, or (iii) by combination of extraction
12 and chemical synthesis; or (b) the packaging,
13 repackaging, labeling or re-labeling, or distribution of
14 prescription drug products.
15 (2) The entity holding legal title to or possession
16 of the national drug code number for the covered
17 prescription drug.
18 The term does not include a wholesale distributor of
19 drugs, drugstore chain organization, or retail pharmacy
20 licensed by the State. The term also does not include an
21 entity that is engaged in the packaging, repackaging, or
22 labeling of a prescription drug only to the extent permitted
23 under Section 12-4.25d of the Illinois Public Aid Code.
24 "Prescription drug" means a drug that may be dispensed
25 only upon prescription by an authorized prescriber and that
26 is approved for safety and effectiveness as a prescription
27 drug under Section 505 or 507 of the Federal Food, Drug and
28 Cosmetic Act.
29 "Senior citizen" or "senior" means a person 65 years of
30 age or older.
31 (Source: P.A. 92-594, eff. 6-27-02.)
32 Section 25. The Illinois Food, Drug and Cosmetic Act is
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1 amended by changing Section 16 and adding Section 16.10 as
2 follows:
3 (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
4 Sec. 16. (a) The Director is hereby authorized to
5 promulgate regulations exempting from any labeling or
6 packaging requirement of this Act drugs and devices which are
7 (i), in accordance with the practice of the trade, to be
8 processed, labeled or repacked in substantial quantities at
9 establishments other than those where originally processed or
10 packaged on condition that such drugs and devices are not
11 adulterated or misbranded under the provisions of this Act
12 upon removal from such processing, labeling or repacking
13 establishment or (ii) packaged, repackaged, or labeled to the
14 extent permitted under Section 12-4.25d of the Illinois
15 Public Aid Code.
16 (b) Drugs and device labeling or packaging exemptions
17 adopted under the Federal Act and supplements thereto or
18 revisions thereof shall apply to drugs and devices in
19 Illinois except insofar as modified or rejected by
20 regulations promulgated by the Director.
21 (c) A drug intended for use by man which (A) is a
22 habit-forming drug to which Section 15 (d) applies; or (B)
23 because of its toxicity or other potentiality for harmful
24 effect or the method of its use or the collateral measures
25 necessary to its use is not safe for use except under the
26 supervision of a practitioner licensed by law to administer
27 such drug; or (C) is limited by an approved application under
28 Section 505 of the Federal Act or Section 17 of this Act to
29 use under the professional supervision of a practitioner
30 licensed by law to administer such drug, shall be dispensed
31 only in accordance with the provisions of the "Illinois
32 Controlled Substances Act". The act of dispensing a drug
33 contrary to the provisions of this paragraph shall be deemed
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1 to be an act which results in a drug being misbranded while
2 held for sale.
3 (d) Any drug dispensed by filling or refilling a written
4 or oral prescription of a practitioner licensed by law to
5 administer such drug shall be exempt from the requirements of
6 Section 15, except subsections (a), (k) and (l) and clauses
7 (2) and (3) of subsection (i), and the packaging requirements
8 of subsections (g), (h) and (q), if the drug bears a label
9 containing the proprietary name or names, or if there is
10 none, the established name or names of the drugs, the dosage
11 and quantity, unless the prescribing practitioner, in the
12 interest of the health of the patient, directs otherwise in
13 writing, the name and address of the dispenser, the serial
14 number and date of the prescription or of its filling, the
15 name of the prescriber and, if stated in the prescription,
16 the name of the patient, and the directions for use and the
17 cautionary statements, if any, contained in such
18 prescription. This exemption shall not apply to any drug
19 dispensed in the course of the conduct of business of
20 dispensing drugs pursuant to diagnosis by mail, or to a drug
21 dispensed in violation of subsection (a) of this Section.
22 (e) The Director may by regulation remove drugs subject
23 to Section 15 (d) and Section 17 from the requirements of
24 subsection (c) of this Section when such requirements are not
25 necessary for the protection of the public health.
26 (f) A drug which is subject to subsection (c) of this
27 Section shall be deemed to be misbranded if at any time
28 before dispensing its label fails to bear the statement
29 "Caution: Federal Law Prohibits Dispensing Without
30 Prescription" or "Caution: State Law Prohibits Dispensing
31 Without Prescription". A drug to which subsection (c) of this
32 Section does not apply shall be deemed to be misbranded if at
33 any time prior to dispensing its label bears the caution
34 statement quoted in the preceding sentence.
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1 (g) Nothing in this Section shall be construed to
2 relieve any person from any requirement prescribed by or
3 under authority of law with respect to controlled substances
4 now included or which may hereafter be included within the
5 classifications of controlled substances cannabis as defined
6 in applicable Federal laws relating to controlled substances
7 or cannabis or the Cannabis Control Act.
8 (Source: P.A. 84-1308.)
9 (410 ILCS 620/16.10 new)
10 Sec. 16.10. Drug repository program.
11 (a) In this Section, "drug repository program" or
12 "program" means the drug repository program established by
13 the Department of Professional Regulation under subsection
14 (b).
15 (b) The Department of Professional Regulation, in
16 cooperation with the Department of Public Health, shall
17 establish a drug repository program to accept and dispense
18 prescription drugs donated for the purpose of being dispensed
19 to individuals who are residents of this State and meet
20 eligibility standards established in rules adopted by the
21 Department of Professional Regulation under subsection (e).
22 Only drugs in their original sealed and tamper-evident
23 unit-dose packaging may be accepted and dispensed. The
24 packaging must be unopened, except that drugs packaged in
25 single-unit doses may be accepted and dispensed when the
26 outside packaging is opened if the single-unit dose packaging
27 is undisturbed. Drugs donated by individuals bearing an
28 expiration date that is less than 6 months from the date the
29 drug is donated shall not be accepted or dispensed. A drug
30 shall not be accepted or dispensed if there is reason to
31 believe that it is adulterated as described in Section 14.
32 Subject to the limitation specified in this Section, unused
33 drugs dispensed for purposes of the medical assistance
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1 program under Article V of the Illinois Public Aid Code may
2 be accepted and dispensed under the drug repository program.
3 (c) Any person, including a drug manufacturer or any
4 health care facility, may donate prescription drugs to the
5 drug repository program. The drugs must be donated at a
6 pharmacy, hospital, or nonprofit clinic that elects to
7 participate in the program and meets criteria for
8 participation in the program established in rules adopted by
9 the Department of Professional Regulation under subsection
10 (e). Participation in the program by pharmacies, hospitals,
11 and nonprofit clinics is voluntary. Nothing in this Section
12 or any other provision of law requires a pharmacy, hospital,
13 or nonprofit clinic to participate in the program.
14 (d) A pharmacy, hospital, or nonprofit clinic eligible
15 to participate in the drug repository program shall dispense
16 drugs donated under this Section to individuals who are
17 residents of this State and meet the eligibility standards
18 established in rules adopted by the Department of
19 Professional Regulation under subsection (e) or to other
20 government entities and nonprofit private entities to be
21 dispensed to individuals who meet those eligibility
22 standards. A drug may be dispensed only pursuant to a
23 prescription issued by a licensed health professional
24 authorized to prescribe drugs, as provided by law. A
25 pharmacy, hospital, or nonprofit clinic that accepts donated
26 drugs must comply with all applicable federal laws and laws
27 of this State dealing with storage and distribution of
28 dangerous drugs and must inspect all drugs before dispensing
29 them to determine that they are not adulterated. The
30 pharmacy, hospital, or nonprofit clinic may charge
31 individuals receiving donated drugs a handling fee
32 established in accordance with rules adopted by the
33 Department of Professional Regulation under subsection (e).
34 Drugs donated to the drug repository program may not be
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1 resold.
2 (e) In consultation with the Department of Public
3 Health, the Department of Professional Regulation shall adopt
4 rules governing the drug repository program that establish
5 all of the following:
6 (1) Eligibility criteria for pharmacies, hospitals,
7 and nonprofit clinics to receive and dispense donated
8 drugs under the program.
9 (2) Standards and procedures for accepting, safely
10 storing, and dispensing donated drugs.
11 (3) Standards and procedures for inspecting donated
12 drugs to determine that the original unit-dose packaging
13 is sealed and tamper-evident and that the drugs are
14 unadulterated, safe, and suitable for dispensing.
15 (4) Eligibility standards for individuals to
16 receive donated drugs under the program, based on an
17 individual's economic need.
18 (5) A means, such as an identification card, by
19 which an individual who is eligible to receive donated
20 drugs may demonstrate eligibility to the pharmacy,
21 hospital, or nonprofit clinic dispensing the drugs.
22 (6) For drugs donated to the program by
23 individuals:
24 (A) A list of drugs, arranged either by
25 category or by individual drug, that the program
26 will accept from individuals.
27 (B) A list of drugs, arranged either by
28 category or by individual drug, that the program
29 will not accept from individuals. The list must
30 include a statement as to why each such drug is
31 ineligible for donation.
32 (C) A form that each donor must sign stating
33 that the donor is the owner of the drugs and intends
34 to voluntarily donate them to the program.
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1 (7) For drugs donated to the program by health care
2 facilities:
3 (A) A list of drugs, arranged either by
4 category or by individual drug, that the program
5 will accept from health care facilities.
6 (B) A list of drugs, arranged either by
7 category or by individual drug, that the program
8 will not accept from health care facilities. The
9 list must include a statement as to why each such
10 drug is ineligible for donation.
11 (8) Any other standards and procedures the
12 Department of Professional Regulation, in consultation
13 with the Department of Public Health, considers
14 appropriate.
15 Section 30. The Illinois Controlled Substances Act is
16 amended by changing Section 102 as follows:
17 (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
18 Sec. 102. Definitions. As used in this Act, unless the
19 context otherwise requires:
20 (a) "Addict" means any person who habitually uses any
21 drug, chemical, substance or dangerous drug other than
22 alcohol so as to endanger the public morals, health, safety
23 or welfare or who is so far addicted to the use of a
24 dangerous drug or controlled substance other than alcohol as
25 to have lost the power of self control with reference to his
26 addiction.
27 (b) "Administer" means the direct application of a
28 controlled substance, whether by injection, inhalation,
29 ingestion, or any other means, to the body of a patient or
30 research subject by:
31 (1) a practitioner (or, in his presence, by his
32 authorized agent), or
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1 (2) the patient or research subject at the lawful
2 direction of the practitioner.
3 (c) "Agent" means an authorized person who acts on
4 behalf of or at the direction of a manufacturer, distributor,
5 or dispenser. It does not include a common or contract
6 carrier, public warehouseman or employee of the carrier or
7 warehouseman.
8 (c-1) "Anabolic Steroids" means any drug or hormonal
9 substance, chemically and pharmacologically related to
10 testosterone (other than estrogens, progestins, and
11 corticosteroids) that promotes muscle growth, and includes:
12 (i) boldenone,
13 (ii) chlorotestosterone,
14 (iii) chostebol,
15 (iv) dehydrochlormethyltestosterone,
16 (v) dihydrotestosterone,
17 (vi) drostanolone,
18 (vii) ethylestrenol,
19 (viii) fluoxymesterone,
20 (ix) formebulone,
21 (x) mesterolone,
22 (xi) methandienone,
23 (xii) methandranone,
24 (xiii) methandriol,
25 (xiv) methandrostenolone,
26 (xv) methenolone,
27 (xvi) methyltestosterone,
28 (xvii) mibolerone,
29 (xviii) nandrolone,
30 (xix) norethandrolone,
31 (xx) oxandrolone,
32 (xxi) oxymesterone,
33 (xxii) oxymetholone,
34 (xxiii) stanolone,
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1 (xxiv) stanozolol,
2 (xxv) testolactone,
3 (xxvi) testosterone,
4 (xxvii) trenbolone, and
5 (xxviii) any salt, ester, or isomer of a drug
6 or substance described or listed in this paragraph,
7 if that salt, ester, or isomer promotes muscle
8 growth.
9 Any person who is otherwise lawfully in possession of an
10 anabolic steroid, or who otherwise lawfully manufactures,
11 distributes, dispenses, delivers, or possesses with intent to
12 deliver an anabolic steroid, which anabolic steroid is
13 expressly intended for and lawfully allowed to be
14 administered through implants to livestock or other nonhuman
15 species, and which is approved by the Secretary of Health and
16 Human Services for such administration, and which the person
17 intends to administer or have administered through such
18 implants, shall not be considered to be in unauthorized
19 possession or to unlawfully manufacture, distribute,
20 dispense, deliver, or possess with intent to deliver such
21 anabolic steroid for purposes of this Act.
22 (d) "Administration" means the Drug Enforcement
23 Administration, United States Department of Justice, or its
24 successor agency.
25 (e) "Control" means to add a drug or other substance, or
26 immediate precursor, to a Schedule under Article II of this
27 Act whether by transfer from another Schedule or otherwise.
28 (f) "Controlled Substance" means a drug, substance, or
29 immediate precursor in the Schedules of Article II of this
30 Act.
31 (g) "Counterfeit substance" means a controlled
32 substance, which, or the container or labeling of which,
33 without authorization bears the trademark, trade name, or
34 other identifying mark, imprint, number or device, or any
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1 likeness thereof, of a manufacturer, distributor, or
2 dispenser other than the person who in fact manufactured,
3 distributed, or dispensed the substance.
4 (h) "Deliver" or "delivery" means the actual,
5 constructive or attempted transfer of possession of a
6 controlled substance, with or without consideration, whether
7 or not there is an agency relationship.
8 (i) "Department" means the Illinois Department of Human
9 Services (as successor to the Department of Alcoholism and
10 Substance Abuse) or its successor agency.
11 (j) "Department of State Police" means the Department of
12 State Police of the State of Illinois or its successor
13 agency.
14 (k) "Department of Corrections" means the Department of
15 Corrections of the State of Illinois or its successor agency.
16 (l) "Department of Professional Regulation" means the
17 Department of Professional Regulation of the State of
18 Illinois or its successor agency.
19 (m) "Depressant" or "stimulant substance" means:
20 (1) a drug which contains any quantity of (i)
21 barbituric acid or any of the salts of barbituric acid
22 which has been designated as habit forming under section
23 502 (d) of the Federal Food, Drug, and Cosmetic Act (21
24 U.S.C. 352 (d)); or
25 (2) a drug which contains any quantity of (i)
26 amphetamine or methamphetamine and any of their optical
27 isomers; (ii) any salt of amphetamine or methamphetamine
28 or any salt of an optical isomer of amphetamine; or (iii)
29 any substance which the Department, after investigation,
30 has found to be, and by rule designated as, habit forming
31 because of its depressant or stimulant effect on the
32 central nervous system; or
33 (3) lysergic acid diethylamide; or
34 (4) any drug which contains any quantity of a
HB0244 Engrossed -19- LRB093 02637 DRJ 02647 b
1 substance which the Department, after investigation, has
2 found to have, and by rule designated as having, a
3 potential for abuse because of its depressant or
4 stimulant effect on the central nervous system or its
5 hallucinogenic effect.
6 (n) (Blank).
7 (o) "Director" means the Director of the Department of
8 State Police or the Department of Professional Regulation or
9 his designated agents.
10 (p) "Dispense" means to deliver a controlled substance
11 to an ultimate user or research subject by or pursuant to the
12 lawful order of a prescriber, including the prescribing,
13 administering, packaging, labeling, or compounding necessary
14 to prepare the substance for that delivery.
15 (q) "Dispenser" means a practitioner who dispenses.
16 (r) "Distribute" means to deliver, other than by
17 administering or dispensing, a controlled substance.
18 (s) "Distributor" means a person who distributes.
19 (t) "Drug" means (1) substances recognized as drugs in
20 the official United States Pharmacopoeia, Official
21 Homeopathic Pharmacopoeia of the United States, or official
22 National Formulary, or any supplement to any of them; (2)
23 substances intended for use in diagnosis, cure, mitigation,
24 treatment, or prevention of disease in man or animals; (3)
25 substances (other than food) intended to affect the structure
26 of any function of the body of man or animals and (4)
27 substances intended for use as a component of any article
28 specified in clause (1), (2), or (3) of this subsection. It
29 does not include devices or their components, parts, or
30 accessories.
31 (t-5) "Euthanasia agency" means an entity certified by
32 the Department of Professional Regulation for the purpose of
33 animal euthanasia that holds an animal control facility
34 license or animal shelter license under the Animal Welfare
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1 Act. A euthanasia agency is authorized to purchase, store,
2 possess, and utilize Schedule II nonnarcotic and Schedule III
3 nonnarcotic drugs for the sole purpose of animal euthanasia.
4 (u) "Good faith" means the prescribing or dispensing of
5 a controlled substance by a practitioner in the regular
6 course of professional treatment to or for any person who is
7 under his treatment for a pathology or condition other than
8 that individual's physical or psychological dependence upon
9 or addiction to a controlled substance, except as provided
10 herein: and application of the term to a pharmacist shall
11 mean the dispensing of a controlled substance pursuant to the
12 prescriber's order which in the professional judgment of the
13 pharmacist is lawful. The pharmacist shall be guided by
14 accepted professional standards including, but not limited to
15 the following, in making the judgment:
16 (1) lack of consistency of doctor-patient
17 relationship,
18 (2) frequency of prescriptions for same drug by one
19 prescriber for large numbers of patients,
20 (3) quantities beyond those normally prescribed,
21 (4) unusual dosages,
22 (5) unusual geographic distances between patient,
23 pharmacist and prescriber,
24 (6) consistent prescribing of habit-forming drugs.
25 (u-1) "Home infusion services" means services provided
26 by a pharmacy in compounding solutions for direct
27 administration to a patient in a private residence, long-term
28 care facility, or hospice setting by means of parenteral,
29 intravenous, intramuscular, subcutaneous, or intraspinal
30 infusion.
31 (v) "Immediate precursor" means a substance:
32 (1) which the Department has found to be and by
33 rule designated as being a principal compound used, or
34 produced primarily for use, in the manufacture of a
HB0244 Engrossed -21- LRB093 02637 DRJ 02647 b
1 controlled substance;
2 (2) which is an immediate chemical intermediary
3 used or likely to be used in the manufacture of such
4 controlled substance; and
5 (3) the control of which is necessary to prevent,
6 curtail or limit the manufacture of such controlled
7 substance.
8 (w) "Instructional activities" means the acts of
9 teaching, educating or instructing by practitioners using
10 controlled substances within educational facilities approved
11 by the State Board of Education or its successor agency.
12 (x) "Local authorities" means a duly organized State,
13 County or Municipal peace unit or police force.
14 (y) "Look-alike substance" means a substance, other than
15 a controlled substance which (1) by overall dosage unit
16 appearance, including shape, color, size, markings or lack
17 thereof, taste, consistency, or any other identifying
18 physical characteristic of the substance, would lead a
19 reasonable person to believe that the substance is a
20 controlled substance, or (2) is expressly or impliedly
21 represented to be a controlled substance or is distributed
22 under circumstances which would lead a reasonable person to
23 believe that the substance is a controlled substance. For the
24 purpose of determining whether the representations made or
25 the circumstances of the distribution would lead a reasonable
26 person to believe the substance to be a controlled substance
27 under this clause (2) of subsection (y), the court or other
28 authority may consider the following factors in addition to
29 any other factor that may be relevant:
30 (a) statements made by the owner or person in
31 control of the substance concerning its nature, use or
32 effect;
33 (b) statements made to the buyer or recipient that
34 the substance may be resold for profit;
HB0244 Engrossed -22- LRB093 02637 DRJ 02647 b
1 (c) whether the substance is packaged in a manner
2 normally used for the illegal distribution of controlled
3 substances;
4 (d) whether the distribution or attempted
5 distribution included an exchange of or demand for money
6 or other property as consideration, and whether the
7 amount of the consideration was substantially greater
8 than the reasonable retail market value of the substance.
9 Clause (1) of this subsection (y) shall not apply to a
10 noncontrolled substance in its finished dosage form that was
11 initially introduced into commerce prior to the initial
12 introduction into commerce of a controlled substance in its
13 finished dosage form which it may substantially resemble.
14 Nothing in this subsection (y) prohibits the dispensing
15 or distributing of noncontrolled substances by persons
16 authorized to dispense and distribute controlled substances
17 under this Act, provided that such action would be deemed to
18 be carried out in good faith under subsection (u) if the
19 substances involved were controlled substances.
20 Nothing in this subsection (y) or in this Act prohibits
21 the manufacture, preparation, propagation, compounding,
22 processing, packaging, advertising or distribution of a drug
23 or drugs by any person registered pursuant to Section 510 of
24 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
25 (y-1) "Mail-order pharmacy" means a pharmacy that is
26 located in a state of the United States, other than Illinois,
27 that delivers, dispenses or distributes, through the United
28 States Postal Service or other common carrier, to Illinois
29 residents, any substance which requires a prescription.
30 (z) "Manufacture" means the production, preparation,
31 propagation, compounding, conversion or processing of a
32 controlled substance, either directly or indirectly, by
33 extraction from substances of natural origin, or
34 independently by means of chemical synthesis, or by a
HB0244 Engrossed -23- LRB093 02637 DRJ 02647 b
1 combination of extraction and chemical synthesis, and
2 includes any packaging or repackaging of the substance or
3 labeling of its container, except that this term does not
4 include:
5 (1) by an ultimate user, the preparation or
6 compounding of a controlled substance for his own use; or
7 (2) by a practitioner, or his authorized agent
8 under his supervision, the preparation, compounding,
9 packaging, or labeling of a controlled substance:
10 (a) as an incident to his administering or
11 dispensing of a controlled substance in the course
12 of his professional practice; or
13 (b) as an incident to lawful research,
14 teaching or chemical analysis and not for sale; or.
15 (3) the packaging, repackaging, or labeling of a
16 prescription drug to the extent permitted under Section
17 12-4.25d of the Illinois Public Aid Code.
18 (z-1) "Methamphetamine manufacturing chemical" means any
19 of the following chemicals or substances containing any of
20 the following chemicals: benzyl methyl ketone, ephedrine,
21 methyl benzyl ketone, phenylacetone, phenyl-2-propanone, or
22 pseudoephedrine or any of the salts, optical isomers, or
23 salts of optical isomers of the above-listed chemicals.
24 (aa) "Narcotic drug" means any of the following, whether
25 produced directly or indirectly by extraction from substances
26 of natural origin, or independently by means of chemical
27 synthesis, or by a combination of extraction and chemical
28 synthesis:
29 (1) opium and opiate, and any salt, compound,
30 derivative, or preparation of opium or opiate;
31 (2) any salt, compound, isomer, derivative, or
32 preparation thereof which is chemically equivalent or
33 identical with any of the substances referred to in
34 clause (1), but not including the isoquinoline alkaloids
HB0244 Engrossed -24- LRB093 02637 DRJ 02647 b
1 of opium;
2 (3) opium poppy and poppy straw;
3 (4) coca leaves and any salts, compound, isomer,
4 salt of an isomer, derivative, or preparation of coca
5 leaves including cocaine or ecgonine, and any salt,
6 compound, isomer, derivative, or preparation thereof
7 which is chemically equivalent or identical with any of
8 these substances, but not including decocainized coca
9 leaves or extractions of coca leaves which do not contain
10 cocaine or ecgonine (for the purpose of this paragraph,
11 the term "isomer" includes optical, positional and
12 geometric isomers).
13 (bb) "Nurse" means a registered nurse licensed under the
14 Nursing and Advanced Practice Nursing Act.
15 (cc) (Blank).
16 (dd) "Opiate" means any substance having an addiction
17 forming or addiction sustaining liability similar to morphine
18 or being capable of conversion into a drug having addiction
19 forming or addiction sustaining liability.
20 (ee) "Opium poppy" means the plant of the species
21 Papaver somniferum L., except its seeds.
22 (ff) "Parole and Pardon Board" means the Parole and
23 Pardon Board of the State of Illinois or its successor
24 agency.
25 (gg) "Person" means any individual, corporation,
26 mail-order pharmacy, government or governmental subdivision
27 or agency, business trust, estate, trust, partnership or
28 association, or any other entity.
29 (hh) "Pharmacist" means any person who holds a
30 certificate of registration as a registered pharmacist, a
31 local registered pharmacist or a registered assistant
32 pharmacist under the Pharmacy Practice Act of 1987.
33 (ii) "Pharmacy" means any store, ship or other place in
34 which pharmacy is authorized to be practiced under the
HB0244 Engrossed -25- LRB093 02637 DRJ 02647 b
1 Pharmacy Practice Act of 1987.
2 (jj) "Poppy straw" means all parts, except the seeds, of
3 the opium poppy, after mowing.
4 (kk) "Practitioner" means a physician licensed to
5 practice medicine in all its branches, dentist, podiatrist,
6 veterinarian, scientific investigator, pharmacist, physician
7 assistant, advanced practice nurse, licensed practical nurse,
8 registered nurse, hospital, laboratory, or pharmacy, or other
9 person licensed, registered, or otherwise lawfully permitted
10 by the United States or this State to distribute, dispense,
11 conduct research with respect to, administer or use in
12 teaching or chemical analysis, a controlled substance in the
13 course of professional practice or research.
14 (ll) "Pre-printed prescription" means a written
15 prescription upon which the designated drug has been
16 indicated prior to the time of issuance.
17 (mm) "Prescriber" means a physician licensed to practice
18 medicine in all its branches, dentist, podiatrist or
19 veterinarian who issues a prescription, a physician assistant
20 who issues a prescription for a Schedule III, IV, or V
21 controlled substance in accordance with Section 303.05 and
22 the written guidelines required under Section 7.5 of the
23 Physician Assistant Practice Act of 1987, or an advanced
24 practice nurse with prescriptive authority in accordance with
25 Section 303.05 and a written collaborative agreement under
26 Sections 15-15 and 15-20 of the Nursing and Advanced Practice
27 Nursing Act.
28 (nn) "Prescription" means a lawful written, facsimile,
29 or verbal order of a physician licensed to practice medicine
30 in all its branches, dentist, podiatrist or veterinarian for
31 any controlled substance, of a physician assistant for a
32 Schedule III, IV, or V controlled substance in accordance
33 with Section 303.05 and the written guidelines required under
34 Section 7.5 of the Physician Assistant Practice Act of 1987,
HB0244 Engrossed -26- LRB093 02637 DRJ 02647 b
1 or of an advanced practice nurse who issues a prescription
2 for a Schedule III, IV, or V controlled substance in
3 accordance with Section 303.05 and a written collaborative
4 agreement under Sections 15-15 and 15-20 of the Nursing and
5 Advanced Practice Nursing Act.
6 (oo) "Production" or "produce" means manufacture,
7 planting, cultivating, growing, or harvesting of a controlled
8 substance.
9 (pp) "Registrant" means every person who is required to
10 register under Section 302 of this Act.
11 (qq) "Registry number" means the number assigned to each
12 person authorized to handle controlled substances under the
13 laws of the United States and of this State.
14 (rr) "State" includes the State of Illinois and any
15 state, district, commonwealth, territory, insular possession
16 thereof, and any area subject to the legal authority of the
17 United States of America.
18 (ss) "Ultimate user" means a person who lawfully
19 possesses a controlled substance for his own use or for the
20 use of a member of his household or for administering to an
21 animal owned by him or by a member of his household.
22 (Source: P.A. 91-403, eff. 1-1-00; 91-714, eff. 6-2-00;
23 92-449, eff. 1-1-02.)
24 Section 35. The Cannabis and Controlled Substances
25 Tort Claims Act is amended by changing Section 3 as follows:
26 (740 ILCS 20/3) (from Ch. 70, par. 903)
27 Sec. 3. Definitions. As used in this Act, unless the
28 context otherwise requires:
29 "Cannabis" includes marihuana, hashish, and other
30 substances that are identified as including any parts of the
31 plant Cannabis Sativa, whether growing or not, the seeds of
32 that plant, the resin extracted from any part of that plant,
HB0244 Engrossed -27- LRB093 02637 DRJ 02647 b
1 and any compound, manufacture, salt, derivative, mixture, or
2 preparation of that plant, its seeds, or resin, including
3 tetrahydrocannabinol (THC) and all other cannabinol
4 derivatives, including its naturally occurring or
5 synthetically produced ingredients, whether produced directly
6 or indirectly by extraction, independently by means of
7 chemical synthesis, or by a combination of extraction and
8 chemical synthesis. "Cannabis" does not include the mature
9 stalks of that plant, fiber produced from those stalks, oil
10 or cake made from the seeds of that plant, any other
11 compound, manufacture, salt, derivative, mixture, or
12 preparation of mature stalks (except the extracted resin),
13 fiber, oil or cake, or the sterilized seeds of that plant
14 that are incapable of germination.
15 "Controlled substance" means a drug, substance, or
16 immediate precursor in the Schedules of Article II of the
17 Illinois Controlled Substances Act.
18 "Counterfeit substance" means a controlled substance or
19 the container or labeling of a controlled substance that,
20 without authorization, bears the trademark, trade name, or
21 other identifying mark, imprint, number, device, or any
22 likeness thereof of a manufacturer, distributor, or dispenser
23 other than the person who in fact manufactured, distributed,
24 or dispensed the substance.
25 "Deliver" or "delivery" means the actual, constructive,
26 or attempted transfer of possession of a controlled substance
27 or cannabis, with or without consideration, whether or not
28 there is an agency relationship.
29 "Manufacture" means the production, preparation,
30 propagation, compounding, conversion, or processing of a
31 controlled substance, either directly or indirectly, by
32 extraction from substances of natural origin, independently
33 by means of chemical synthesis, or by a combination of
34 extraction and chemical synthesis, and includes any packaging
HB0244 Engrossed -28- LRB093 02637 DRJ 02647 b
1 or repackaging of the substance or labeling of its container,
2 except that the term does not include:
3 (1) by an ultimate user, the preparation or
4 compounding of a controlled substance for his own use;
5 (2) by a practitioner or his authorized agent under
6 his supervision, the preparation, compounding, packaging,
7 or labeling of a controlled substance;
8 (A) as an incident to his administering or
9 dispensing of a controlled substance in the course
10 of his professional practice; or
11 (B) as an incident to lawful research,
12 teaching or chemical analysis and not for sale; or
13 (3) the preparation, compounding, packaging, or
14 labeling of cannabis as an incident to lawful research,
15 teaching, or chemical analysis and not for sale; or.
16 (4) the packaging, repackaging, or labeling of a
17 prescription drug to the extent permitted under Section
18 12-4.25d of the Illinois Public Aid Code.
19 "Owner" means a person who has possession of or any
20 interest whatsoever in the property involved.
21 "Person" means an individual, a corporation, a
22 government, a governmental subdivision or agency, a business
23 trust, an estate, a trust, a partnership or association, or
24 any other entity.
25 "Production" means planting, cultivating, tending, or
26 harvesting.
27 "Property" means real property, including things growing
28 on, affixed to, and found in land, and tangible or intangible
29 personal property, including rights, services, privileges,
30 interests, claims, and securities.
31 (Source: P.A. 87-544.)
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