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093_HB0409
LRB093 04118 DRJ 04158 b
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7 (Section scheduled to be repealed on January 1, 2008)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 required 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 required 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) Every provider of long-term care services under this
15 Code shall return to the vendor pharmacy from which the drug
16 product was purchased, for repackaging and reimbursement to
17 the Department of Public Aid, every drug product that (i) was
18 dispensed to a resident of the provider's long-term care
19 facility and not used and (ii) meets all of the following
20 criteria:
21 (1) It is a prescription drug product that is not a
22 controlled substance.
23 (2) It is sealed in an individually packaged unit.
24 (3) It is returned to the vendor pharmacy within
25 the recommended period of shelf life for the purpose of
26 redispensing the drug product.
27 (4) It is determined to be of acceptable integrity
28 by a licensed pharmacist.
29 (5) It consists of (i) oral or parenteral
30 medication in a single-dose sealed container approved by
31 the federal Food and Drug Administration, (ii) a topical
32 or inhalant drug product in a unit-of-use container
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1 approved by the federal Food and Drug Administration, or
2 (iii) a parenteral medication in a multiple-dose sealed
3 container approved by the federal Food and Drug
4 Administration.
5 (6) No doses have been withdrawn from the container
6 in which the drug product is packaged.
7 If a provider of long-term care services under this Code
8 returns a drug product under this Section to the vendor
9 pharmacy from which the drug product was purchased, the
10 pharmacy must accept the returned product.
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 shall
14 be 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 shall 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) Every provider of long term-care services under this
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1 Code shall establish procedures for the return of unused
2 drug products to the vendor pharmacies from which the drug
3 products were purchased.
4 (d) The Department of Public Aid:
5 (1) shall reimburse to the vendor pharmacy the
6 reasonable cost of services incurred in the
7 implementation of this Section, as determined by the
8 Director of Public Aid; and
9 (2) may establish procedures, if feasible, for
10 reimbursement to non-Medicaid payors for drug products
11 returned under this Section.
12 (e) The Department of Public Aid, in consultation with
13 the Department of Professional Regulation, shall adopt rules
14 to govern the repackaging and labeling of drug products
15 returned under this Section. The rules must provide for the
16 following:
17 (1) A formulary for the drug products to be
18 returned for repackaging.
19 (2) The protection of the privacy of the individual
20 for whom the drug product was originally prescribed.
21 (3) The integrity, safe storage, and safe transfer
22 of the drug product, which may include, but need not be
23 limited to, limiting the drugs to those that were
24 originally dispensed by unit dose or an individually
25 sealed dose or that remain in intact packaging.
26 (4) The tracking of and accountability for the drug
27 products.
28 (5) Other matters necessary for implementing this
29 Section.
30 (f) A provider of long-term care services that fails to
31 comply with this Section is subject to a civil penalty of
32 $30,000 for each incident of noncompliance. The Department
33 may impose a civil penalty under this Section only after it
34 provides all of the following to the provider:
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1 (1) Written notice of the alleged violation and the
2 resulting penalty.
3 (2) Written notice of the provider's right to
4 request an administrative hearing on the question of the
5 alleged violation.
6 (3) An opportunity to present evidence, orally or
7 in writing or both, on the question of the alleged
8 violation before an impartial hearing examiner appointed
9 by the Director of Public Aid.
10 (4) A written decision from the Director of Public
11 Aid, based on the evidence introduced at the hearing and
12 the hearing examiner's recommendations, finding that the
13 provider violated this Section and imposing the civil
14 penalty.
15 A provider must request an administrative hearing under
16 this subsection within 15 days after receiving the notice of
17 violation from the Department. If a provider requests a
18 hearing within that time, the Department shall stay the
19 imposition of a penalty pending the outcome of the hearing.
20 The Department of Public Aid may impose a penalty on a
21 provider under this Section regardless of whether a change in
22 ownership of the provider has taken place since the time of
23 the violation, provided that (i) the Department sent notice
24 of the alleged violation and the resulting penalty to the
25 provider before the effective date of the change in ownership
26 and (ii) a record of the notice is readily available in a
27 central registry maintained by the Department.
28 (g) The Attorney General may bring an action in the
29 circuit court to enforce the collection of a monetary penalty
30 imposed under this Section. Alternatively, for the purpose of
31 collecting a penalty imposed under this Section, the
32 Department may use all or part of the amount of the penalty
33 to offset payments owed by the Department to the provider
34 under this Code.
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1 (h) All penalties collected under this Section shall be
2 deposited into the General Revenue Fund and credited to the
3 Medicaid account.
4 (i) A licensed physician, pharmacist, or other health
5 care professional is not subject to liability for compliance
6 with this Section when acting within the scope of practice of
7 his or her license and in good faith compliance with the
8 rules adopted by the Department of Public Aid under 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 required
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 as follows:
11 (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
12 Sec. 16. (a) The Director is hereby authorized to
13 promulgate regulations exempting from any labeling or
14 packaging requirement of this Act drugs and devices which are
15 (i), in accordance with the practice of the trade, to be
16 processed, labeled or repacked in substantial quantities at
17 establishments other than those where originally processed or
18 packaged on condition that such drugs and devices are not
19 adulterated or misbranded under the provisions of this Act
20 upon removal from such processing, labeling or repacking
21 establishment or (ii) packaged, repackaged, or labeled to the
22 extent required under Section 12-4.25d of the Illinois Public
23 Aid Code.
24 (b) Drugs and device labeling or packaging exemptions
25 adopted under the Federal Act and supplements thereto or
26 revisions thereof shall apply to drugs and devices in
27 Illinois except insofar as modified or rejected by
28 regulations promulgated by the Director.
29 (c) A drug intended for use by man which (A) is a
30 habit-forming drug to which Section 15 (d) applies; or (B)
31 because of its toxicity or other potentiality for harmful
32 effect or the method of its use or the collateral measures
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1 necessary to its use is not safe for use except under the
2 supervision of a practitioner licensed by law to administer
3 such drug; or (C) is limited by an approved application under
4 Section 505 of the Federal Act or Section 17 of this Act to
5 use under the professional supervision of a practitioner
6 licensed by law to administer such drug, shall be dispensed
7 only in accordance with the provisions of the "Illinois
8 Controlled Substances Act". The act of dispensing a drug
9 contrary to the provisions of this paragraph shall be deemed
10 to be an act which results in a drug being misbranded while
11 held for sale.
12 (d) Any drug dispensed by filling or refilling a written
13 or oral prescription of a practitioner licensed by law to
14 administer such drug shall be exempt from the requirements of
15 Section 15, except subsections (a), (k) and (l) and clauses
16 (2) and (3) of subsection (i), and the packaging requirements
17 of subsections (g), (h) and (q), if the drug bears a label
18 containing the proprietary name or names, or if there is
19 none, the established name or names of the drugs, the dosage
20 and quantity, unless the prescribing practitioner, in the
21 interest of the health of the patient, directs otherwise in
22 writing, the name and address of the dispenser, the serial
23 number and date of the prescription or of its filling, the
24 name of the prescriber and, if stated in the prescription,
25 the name of the patient, and the directions for use and the
26 cautionary statements, if any, contained in such
27 prescription. This exemption shall not apply to any drug
28 dispensed in the course of the conduct of business of
29 dispensing drugs pursuant to diagnosis by mail, or to a drug
30 dispensed in violation of subsection (a) of this Section.
31 (e) The Director may by regulation remove drugs subject
32 to Section 15 (d) and Section 17 from the requirements of
33 subsection (c) of this Section when such requirements are not
34 necessary for the protection of the public health.
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1 (f) A drug which is subject to subsection (c) of this
2 Section shall be deemed to be misbranded if at any time
3 before dispensing its label fails to bear the statement
4 "Caution: Federal Law Prohibits Dispensing Without
5 Prescription" or "Caution: State Law Prohibits Dispensing
6 Without Prescription". A drug to which subsection (c) of this
7 Section does not apply shall be deemed to be misbranded if at
8 any time prior to dispensing its label bears the caution
9 statement quoted in the preceding sentence.
10 (g) Nothing in this Section shall be construed to
11 relieve any person from any requirement prescribed by or
12 under authority of law with respect to controlled substances
13 now included or which may hereafter be included within the
14 classifications of controlled substances cannabis as defined
15 in applicable Federal laws relating to controlled substances
16 or cannabis or the Cannabis Control Act.
17 (Source: P.A. 84-1308.)
18 Section 30. The Illinois Controlled Substances Act is
19 amended by changing Section 102 as follows:
20 (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
21 Sec. 102. Definitions. As used in this Act, unless the
22 context otherwise requires:
23 (a) "Addict" means any person who habitually uses any
24 drug, chemical, substance or dangerous drug other than
25 alcohol so as to endanger the public morals, health, safety
26 or welfare or who is so far addicted to the use of a
27 dangerous drug or controlled substance other than alcohol as
28 to have lost the power of self control with reference to his
29 addiction.
30 (b) "Administer" means the direct application of a
31 controlled substance, whether by injection, inhalation,
32 ingestion, or any other means, to the body of a patient or
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1 research subject by:
2 (1) a practitioner (or, in his presence, by his
3 authorized agent), or
4 (2) the patient or research subject at the lawful
5 direction of the practitioner.
6 (c) "Agent" means an authorized person who acts on
7 behalf of or at the direction of a manufacturer, distributor,
8 or dispenser. It does not include a common or contract
9 carrier, public warehouseman or employee of the carrier or
10 warehouseman.
11 (c-1) "Anabolic Steroids" means any drug or hormonal
12 substance, chemically and pharmacologically related to
13 testosterone (other than estrogens, progestins, and
14 corticosteroids) that promotes muscle growth, and includes:
15 (i) boldenone,
16 (ii) chlorotestosterone,
17 (iii) chostebol,
18 (iv) dehydrochlormethyltestosterone,
19 (v) dihydrotestosterone,
20 (vi) drostanolone,
21 (vii) ethylestrenol,
22 (viii) fluoxymesterone,
23 (ix) formebulone,
24 (x) mesterolone,
25 (xi) methandienone,
26 (xii) methandranone,
27 (xiii) methandriol,
28 (xiv) methandrostenolone,
29 (xv) methenolone,
30 (xvi) methyltestosterone,
31 (xvii) mibolerone,
32 (xviii) nandrolone,
33 (xix) norethandrolone,
34 (xx) oxandrolone,
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1 (xxi) oxymesterone,
2 (xxii) oxymetholone,
3 (xxiii) stanolone,
4 (xxiv) stanozolol,
5 (xxv) testolactone,
6 (xxvi) testosterone,
7 (xxvii) trenbolone, and
8 (xxviii) any salt, ester, or isomer of a drug
9 or substance described or listed in this paragraph,
10 if that salt, ester, or isomer promotes muscle
11 growth.
12 Any person who is otherwise lawfully in possession of an
13 anabolic steroid, or who otherwise lawfully manufactures,
14 distributes, dispenses, delivers, or possesses with intent to
15 deliver an anabolic steroid, which anabolic steroid is
16 expressly intended for and lawfully allowed to be
17 administered through implants to livestock or other nonhuman
18 species, and which is approved by the Secretary of Health and
19 Human Services for such administration, and which the person
20 intends to administer or have administered through such
21 implants, shall not be considered to be in unauthorized
22 possession or to unlawfully manufacture, distribute,
23 dispense, deliver, or possess with intent to deliver such
24 anabolic steroid for purposes of this Act.
25 (d) "Administration" means the Drug Enforcement
26 Administration, United States Department of Justice, or its
27 successor agency.
28 (e) "Control" means to add a drug or other substance, or
29 immediate precursor, to a Schedule under Article II of this
30 Act whether by transfer from another Schedule or otherwise.
31 (f) "Controlled Substance" means a drug, substance, or
32 immediate precursor in the Schedules of Article II of this
33 Act.
34 (g) "Counterfeit substance" means a controlled
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1 substance, which, or the container or labeling of which,
2 without authorization bears the trademark, trade name, or
3 other identifying mark, imprint, number or device, or any
4 likeness thereof, of a manufacturer, distributor, or
5 dispenser other than the person who in fact manufactured,
6 distributed, or dispensed the substance.
7 (h) "Deliver" or "delivery" means the actual,
8 constructive or attempted transfer of possession of a
9 controlled substance, with or without consideration, whether
10 or not there is an agency relationship.
11 (i) "Department" means the Illinois Department of Human
12 Services (as successor to the Department of Alcoholism and
13 Substance Abuse) or its successor agency.
14 (j) "Department of State Police" means the Department of
15 State Police of the State of Illinois or its successor
16 agency.
17 (k) "Department of Corrections" means the Department of
18 Corrections of the State of Illinois or its successor agency.
19 (l) "Department of Professional Regulation" means the
20 Department of Professional Regulation of the State of
21 Illinois or its successor agency.
22 (m) "Depressant" or "stimulant substance" means:
23 (1) a drug which contains any quantity of (i)
24 barbituric acid or any of the salts of barbituric acid
25 which has been designated as habit forming under section
26 502 (d) of the Federal Food, Drug, and Cosmetic Act (21
27 U.S.C. 352 (d)); or
28 (2) a drug which contains any quantity of (i)
29 amphetamine or methamphetamine and any of their optical
30 isomers; (ii) any salt of amphetamine or methamphetamine
31 or any salt of an optical isomer of amphetamine; or (iii)
32 any substance which the Department, after investigation,
33 has found to be, and by rule designated as, habit forming
34 because of its depressant or stimulant effect on the
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1 central nervous system; or
2 (3) lysergic acid diethylamide; or
3 (4) any drug which contains any quantity of a
4 substance which the Department, after investigation, has
5 found to have, and by rule designated as having, a
6 potential for abuse because of its depressant or
7 stimulant effect on the central nervous system or its
8 hallucinogenic effect.
9 (n) (Blank).
10 (o) "Director" means the Director of the Department of
11 State Police or the Department of Professional Regulation or
12 his designated agents.
13 (p) "Dispense" means to deliver a controlled substance
14 to an ultimate user or research subject by or pursuant to the
15 lawful order of a prescriber, including the prescribing,
16 administering, packaging, labeling, or compounding necessary
17 to prepare the substance for that delivery.
18 (q) "Dispenser" means a practitioner who dispenses.
19 (r) "Distribute" means to deliver, other than by
20 administering or dispensing, a controlled substance.
21 (s) "Distributor" means a person who distributes.
22 (t) "Drug" means (1) substances recognized as drugs in
23 the official United States Pharmacopoeia, Official
24 Homeopathic Pharmacopoeia of the United States, or official
25 National Formulary, or any supplement to any of them; (2)
26 substances intended for use in diagnosis, cure, mitigation,
27 treatment, or prevention of disease in man or animals; (3)
28 substances (other than food) intended to affect the structure
29 of any function of the body of man or animals and (4)
30 substances intended for use as a component of any article
31 specified in clause (1), (2), or (3) of this subsection. It
32 does not include devices or their components, parts, or
33 accessories.
34 (t-5) "Euthanasia agency" means an entity certified by
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1 the Department of Professional Regulation for the purpose of
2 animal euthanasia that holds an animal control facility
3 license or animal shelter license under the Animal Welfare
4 Act. A euthanasia agency is authorized to purchase, store,
5 possess, and utilize Schedule II nonnarcotic and Schedule III
6 nonnarcotic drugs for the sole purpose of animal euthanasia.
7 (u) "Good faith" means the prescribing or dispensing of
8 a controlled substance by a practitioner in the regular
9 course of professional treatment to or for any person who is
10 under his treatment for a pathology or condition other than
11 that individual's physical or psychological dependence upon
12 or addiction to a controlled substance, except as provided
13 herein: and application of the term to a pharmacist shall
14 mean the dispensing of a controlled substance pursuant to the
15 prescriber's order which in the professional judgment of the
16 pharmacist is lawful. The pharmacist shall be guided by
17 accepted professional standards including, but not limited to
18 the following, in making the judgment:
19 (1) lack of consistency of doctor-patient
20 relationship,
21 (2) frequency of prescriptions for same drug by one
22 prescriber for large numbers of patients,
23 (3) quantities beyond those normally prescribed,
24 (4) unusual dosages,
25 (5) unusual geographic distances between patient,
26 pharmacist and prescriber,
27 (6) consistent prescribing of habit-forming drugs.
28 (u-1) "Home infusion services" means services provided
29 by a pharmacy in compounding solutions for direct
30 administration to a patient in a private residence, long-term
31 care facility, or hospice setting by means of parenteral,
32 intravenous, intramuscular, subcutaneous, or intraspinal
33 infusion.
34 (v) "Immediate precursor" means a substance:
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1 (1) which the Department has found to be and by
2 rule designated as being a principal compound used, or
3 produced primarily for use, in the manufacture of a
4 controlled substance;
5 (2) which is an immediate chemical intermediary
6 used or likely to be used in the manufacture of such
7 controlled substance; and
8 (3) the control of which is necessary to prevent,
9 curtail or limit the manufacture of such controlled
10 substance.
11 (w) "Instructional activities" means the acts of
12 teaching, educating or instructing by practitioners using
13 controlled substances within educational facilities approved
14 by the State Board of Education or its successor agency.
15 (x) "Local authorities" means a duly organized State,
16 County or Municipal peace unit or police force.
17 (y) "Look-alike substance" means a substance, other than
18 a controlled substance which (1) by overall dosage unit
19 appearance, including shape, color, size, markings or lack
20 thereof, taste, consistency, or any other identifying
21 physical characteristic of the substance, would lead a
22 reasonable person to believe that the substance is a
23 controlled substance, or (2) is expressly or impliedly
24 represented to be a controlled substance or is distributed
25 under circumstances which would lead a reasonable person to
26 believe that the substance is a controlled substance. For the
27 purpose of determining whether the representations made or
28 the circumstances of the distribution would lead a reasonable
29 person to believe the substance to be a controlled substance
30 under this clause (2) of subsection (y), the court or other
31 authority may consider the following factors in addition to
32 any other factor that may be relevant:
33 (a) statements made by the owner or person in
34 control of the substance concerning its nature, use or
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1 effect;
2 (b) statements made to the buyer or recipient that
3 the substance may be resold for profit;
4 (c) whether the substance is packaged in a manner
5 normally used for the illegal distribution of controlled
6 substances;
7 (d) whether the distribution or attempted
8 distribution included an exchange of or demand for money
9 or other property as consideration, and whether the
10 amount of the consideration was substantially greater
11 than the reasonable retail market value of the substance.
12 Clause (1) of this subsection (y) shall not apply to a
13 noncontrolled substance in its finished dosage form that was
14 initially introduced into commerce prior to the initial
15 introduction into commerce of a controlled substance in its
16 finished dosage form which it may substantially resemble.
17 Nothing in this subsection (y) prohibits the dispensing
18 or distributing of noncontrolled substances by persons
19 authorized to dispense and distribute controlled substances
20 under this Act, provided that such action would be deemed to
21 be carried out in good faith under subsection (u) if the
22 substances involved were controlled substances.
23 Nothing in this subsection (y) or in this Act prohibits
24 the manufacture, preparation, propagation, compounding,
25 processing, packaging, advertising or distribution of a drug
26 or drugs by any person registered pursuant to Section 510 of
27 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
28 (y-1) "Mail-order pharmacy" means a pharmacy that is
29 located in a state of the United States, other than Illinois,
30 that delivers, dispenses or distributes, through the United
31 States Postal Service or other common carrier, to Illinois
32 residents, any substance which requires a prescription.
33 (z) "Manufacture" means the production, preparation,
34 propagation, compounding, conversion or processing of a
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1 controlled substance, either directly or indirectly, by
2 extraction from substances of natural origin, or
3 independently by means of chemical synthesis, or by a
4 combination of extraction and chemical synthesis, and
5 includes any packaging or repackaging of the substance or
6 labeling of its container, except that this term does not
7 include:
8 (1) by an ultimate user, the preparation or
9 compounding of a controlled substance for his own use; or
10 (2) by a practitioner, or his authorized agent
11 under his supervision, the preparation, compounding,
12 packaging, or labeling of a controlled substance:
13 (a) as an incident to his administering or
14 dispensing of a controlled substance in the course
15 of his professional practice; or
16 (b) as an incident to lawful research,
17 teaching or chemical analysis and not for sale or;.
18 (3) the packaging, repackaging, or labeling of a
19 prescription drug to the extent required under Section
20 12-4.25d of the Illinois Public Aid Code.
21 (z-1) "Methamphetamine manufacturing chemical" means any
22 of the following chemicals or substances containing any of
23 the following chemicals: benzyl methyl ketone, ephedrine,
24 methyl benzyl ketone, phenylacetone, phenyl-2-propanone, or
25 pseudoephedrine or any of the salts, optical isomers, or
26 salts of optical isomers of the above-listed chemicals.
27 (aa) "Narcotic drug" means any of the following, whether
28 produced directly or indirectly by extraction from substances
29 of natural origin, or independently by means of chemical
30 synthesis, or by a combination of extraction and chemical
31 synthesis:
32 (1) opium and opiate, and any salt, compound,
33 derivative, or preparation of opium or opiate;
34 (2) any salt, compound, isomer, derivative, or
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1 preparation thereof which is chemically equivalent or
2 identical with any of the substances referred to in
3 clause (1), but not including the isoquinoline alkaloids
4 of opium;
5 (3) opium poppy and poppy straw;
6 (4) coca leaves and any salts, compound, isomer,
7 salt of an isomer, derivative, or preparation of coca
8 leaves including cocaine or ecgonine, and any salt,
9 compound, isomer, derivative, or preparation thereof
10 which is chemically equivalent or identical with any of
11 these substances, but not including decocainized coca
12 leaves or extractions of coca leaves which do not contain
13 cocaine or ecgonine (for the purpose of this paragraph,
14 the term "isomer" includes optical, positional and
15 geometric isomers).
16 (bb) "Nurse" means a registered nurse licensed under the
17 Nursing and Advanced Practice Nursing Act.
18 (cc) (Blank).
19 (dd) "Opiate" means any substance having an addiction
20 forming or addiction sustaining liability similar to morphine
21 or being capable of conversion into a drug having addiction
22 forming or addiction sustaining liability.
23 (ee) "Opium poppy" means the plant of the species
24 Papaver somniferum L., except its seeds.
25 (ff) "Parole and Pardon Board" means the Parole and
26 Pardon Board of the State of Illinois or its successor
27 agency.
28 (gg) "Person" means any individual, corporation,
29 mail-order pharmacy, government or governmental subdivision
30 or agency, business trust, estate, trust, partnership or
31 association, or any other entity.
32 (hh) "Pharmacist" means any person who holds a
33 certificate of registration as a registered pharmacist, a
34 local registered pharmacist or a registered assistant
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1 pharmacist under the Pharmacy Practice Act of 1987.
2 (ii) "Pharmacy" means any store, ship or other place in
3 which pharmacy is authorized to be practiced under the
4 Pharmacy Practice Act of 1987.
5 (jj) "Poppy straw" means all parts, except the seeds, of
6 the opium poppy, after mowing.
7 (kk) "Practitioner" means a physician licensed to
8 practice medicine in all its branches, dentist, podiatrist,
9 veterinarian, scientific investigator, pharmacist, physician
10 assistant, advanced practice nurse, licensed practical nurse,
11 registered nurse, hospital, laboratory, or pharmacy, or other
12 person licensed, registered, or otherwise lawfully permitted
13 by the United States or this State to distribute, dispense,
14 conduct research with respect to, administer or use in
15 teaching or chemical analysis, a controlled substance in the
16 course of professional practice or research.
17 (ll) "Pre-printed prescription" means a written
18 prescription upon which the designated drug has been
19 indicated prior to the time of issuance.
20 (mm) "Prescriber" means a physician licensed to practice
21 medicine in all its branches, dentist, podiatrist or
22 veterinarian who issues a prescription, a physician assistant
23 who issues a prescription for a Schedule III, IV, or V
24 controlled substance in accordance with Section 303.05 and
25 the written guidelines required under Section 7.5 of the
26 Physician Assistant Practice Act of 1987, or an advanced
27 practice nurse with prescriptive authority in accordance with
28 Section 303.05 and a written collaborative agreement under
29 Sections 15-15 and 15-20 of the Nursing and Advanced Practice
30 Nursing Act.
31 (nn) "Prescription" means a lawful written, facsimile,
32 or verbal order of a physician licensed to practice medicine
33 in all its branches, dentist, podiatrist or veterinarian for
34 any controlled substance, of a physician assistant for a
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1 Schedule III, IV, or V controlled substance in accordance
2 with Section 303.05 and the written guidelines required under
3 Section 7.5 of the Physician Assistant Practice Act of 1987,
4 or of an advanced practice nurse who issues a prescription
5 for a Schedule III, IV, or V controlled substance in
6 accordance with Section 303.05 and a written collaborative
7 agreement under Sections 15-15 and 15-20 of the Nursing and
8 Advanced Practice Nursing Act.
9 (oo) "Production" or "produce" means manufacture,
10 planting, cultivating, growing, or harvesting of a controlled
11 substance.
12 (pp) "Registrant" means every person who is required to
13 register under Section 302 of this Act.
14 (qq) "Registry number" means the number assigned to each
15 person authorized to handle controlled substances under the
16 laws of the United States and of this State.
17 (rr) "State" includes the State of Illinois and any
18 state, district, commonwealth, territory, insular possession
19 thereof, and any area subject to the legal authority of the
20 United States of America.
21 (ss) "Ultimate user" means a person who lawfully
22 possesses a controlled substance for his own use or for the
23 use of a member of his household or for administering to an
24 animal owned by him or by a member of his household.
25 (Source: P.A. 91-403, eff. 1-1-00; 91-714, eff. 6-2-00;
26 92-449, eff. 1-1-02.)
27 Section 35. The Cannabis and Controlled Substances
28 Tort Claims Act is amended by changing Section 3 as follows:
29 (740 ILCS 20/3) (from Ch. 70, par. 903)
30 Sec. 3. Definitions. As used in this Act, unless the
31 context otherwise requires:
32 "Cannabis" includes marihuana, hashish, and other
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1 substances that are identified as including any parts of the
2 plant Cannabis Sativa, whether growing or not, the seeds of
3 that plant, the resin extracted from any part of that plant,
4 and any compound, manufacture, salt, derivative, mixture, or
5 preparation of that plant, its seeds, or resin, including
6 tetrahydrocannabinol (THC) and all other cannabinol
7 derivatives, including its naturally occurring or
8 synthetically produced ingredients, whether produced directly
9 or indirectly by extraction, independently by means of
10 chemical synthesis, or by a combination of extraction and
11 chemical synthesis. "Cannabis" does not include the mature
12 stalks of that plant, fiber produced from those stalks, oil
13 or cake made from the seeds of that plant, any other
14 compound, manufacture, salt, derivative, mixture, or
15 preparation of mature stalks (except the extracted resin),
16 fiber, oil or cake, or the sterilized seeds of that plant
17 that are incapable of germination.
18 "Controlled substance" means a drug, substance, or
19 immediate precursor in the Schedules of Article II of the
20 Illinois Controlled Substances Act.
21 "Counterfeit substance" means a controlled substance or
22 the container or labeling of a controlled substance that,
23 without authorization, bears the trademark, trade name, or
24 other identifying mark, imprint, number, device, or any
25 likeness thereof of a manufacturer, distributor, or dispenser
26 other than the person who in fact manufactured, distributed,
27 or dispensed the substance.
28 "Deliver" or "delivery" means the actual, constructive,
29 or attempted transfer of possession of a controlled substance
30 or cannabis, with or without consideration, whether or not
31 there is an agency relationship.
32 "Manufacture" means the production, preparation,
33 propagation, compounding, conversion, or processing of a
34 controlled substance, either directly or indirectly, by
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1 extraction from substances of natural origin, independently
2 by means of chemical synthesis, or by a combination of
3 extraction and chemical synthesis, and includes any packaging
4 or repackaging of the substance or labeling of its container,
5 except that the term does not include:
6 (1) by an ultimate user, the preparation or
7 compounding of a controlled substance for his own use;
8 (2) by a practitioner or his authorized agent under
9 his supervision, the preparation, compounding, packaging,
10 or labeling of a controlled substance;
11 (A) as an incident to his administering or
12 dispensing of a controlled substance in the course
13 of his professional practice; or
14 (B) as an incident to lawful research,
15 teaching or chemical analysis and not for sale; or
16 (3) the preparation, compounding, packaging, or
17 labeling of cannabis as an incident to lawful research,
18 teaching, or chemical analysis and not for sale; or.
19 (4) the packaging, repackaging, or labeling of a
20 prescription drug to the extent required under Section
21 12-4.25d of the Illinois Public Aid Code.
22 "Owner" means a person who has possession of or any
23 interest whatsoever in the property involved.
24 "Person" means an individual, a corporation, a
25 government, a governmental subdivision or agency, a business
26 trust, an estate, a trust, a partnership or association, or
27 any other entity.
28 "Production" means planting, cultivating, tending, or
29 harvesting.
30 "Property" means real property, including things growing
31 on, affixed to, and found in land, and tangible or intangible
32 personal property, including rights, services, privileges,
33 interests, claims, and securities.
34 (Source: P.A. 87-544.)
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