Sen. Jacqueline Y. Collins

Filed: 5/17/2007

 

 


 

 


 
09500SB0941sam001 LRB095 05749 KBJ 36498 a

1
AMENDMENT TO SENATE BILL 941

2     AMENDMENT NO. ______. Amend Senate Bill 941 by replacing
3 everything after the enacting clause with the following:
 
4     "Section 1. Short title. This Act may be cited as the
5 Cancer Drug Repository Program Act.
 
6     Section 5. Definitions. In this Act:
7     "Cancer drug" means a prescription drug that is used to
8 treat any of the following:
9         (1) Cancer or side effects of cancer.
10         (2) The side effects of any prescription drug that is
11     used to treat cancer or side effects of cancer.
12     "Department" means the Department of Public Health.
13     "Dispense" has the meaning given to that term in the
14 Pharmacy Practice Act of 1987.
15     "Pharmacist" means an individual licensed to engage in the
16 practice of pharmacy under the Pharmacy Practice Act of 1987.

 

 

09500SB0941sam001 - 2 - LRB095 05749 KBJ 36498 a

1     "Pharmacy" means a pharmacy registered in this State under
2 the Pharmacy Practice Act of 1987.
3     "Practitioner" means a person licensed in this State to
4 prescribe and administer drugs or licensed in another state and
5 recognized by this State as a person authorized to prescribe
6 and administer drugs.
7     "Prescription drug" means any prescribed drug that may be
8 legally dispensed by a pharmacy.
9     "Program" means the cancer drug repository program
10 established under this Act.
 
11     Section 10. Cancer drug repository program. The Department
12 shall establish and maintain a cancer drug repository program,
13 under which any person may donate a cancer drug or supplies
14 needed to administer a cancer drug for use by an individual who
15 meets eligibility criteria specified by the Department in
16 rules. Donations may be made on the premises of a pharmacy that
17 elects to participate in the program and meets requirements
18 specified by the Department in rules. The pharmacy may charge
19 an individual who receives a cancer drug or supplies needed to
20 administer a cancer drug under this Act a handling fee that may
21 not exceed the amount specified by the Department in rules. A
22 pharmacy that receives a donated cancer drug or supplies needed
23 to administer a cancer drug under this Act may distribute the
24 cancer drug or supplies to another eligible pharmacy for use
25 under the program.
 

 

 

09500SB0941sam001 - 3 - LRB095 05749 KBJ 36498 a

1     Section 15. Requirements for accepting and dispensing
2 cancer drugs and supplies. A cancer drug or supplies needed to
3 administer a cancer drug may be accepted and dispensed under
4 the program only if all of the following requirements are met:
5         (1) The cancer drug or supplies needed to administer a
6     cancer drug are in their original, unopened, sealed, and
7     tamper-evident unit-dose packaging or, if packaged in
8     single-unit doses, the single-unit-dose packaging is
9     unopened.
10         (2) The cancer drug bears an expiration date that is
11     later than 6 months after the date that the drug was
12     donated.
13         (3) The cancer drug or supplies needed to administer a
14     cancer drug are not adulterated or misbranded, as
15     determined by a pharmacist employed by, or under contract
16     with, the pharmacy where the drug or supplies are accepted
17     or dispensed. The pharmacist must inspect the drug or
18     supplies before the drug or supplies are dispensed.
19         (4) The cancer drug or supplies needed to administer a
20     cancer drug are prescribed by a practitioner for use by an
21     eligible individual.
 
22     Section 20. Resale of donated drugs or supplies prohibited.
23 No cancer drug or supplies needed to administer a cancer drug
24 that are donated for use under this Act may be resold.
 

 

 

09500SB0941sam001 - 4 - LRB095 05749 KBJ 36498 a

1     Section 25. Participation in program not required. Nothing
2 in this Act requires that a pharmacy or pharmacist participate
3 in the cancer drug repository program.
 
4     Section 30. Immunity.
5     (a) Unless the manufacturer's conduct is wilful and wanton,
6 a manufacturer of a drug or supply is not subject to criminal
7 or civil liability for injury, death, or loss to a person or
8 property for matters related to the donation, acceptance, or
9 dispensing of a cancer drug or supply manufactured by the
10 manufacturer that is donated by any person under this Act.
11     (b) Unless the person's conduct is wilful and wanton, a
12 person is immune from civil liability for injury to or the
13 death of the individual to whom the cancer drug or supply is
14 dispensed and may not be found guilty of unprofessional conduct
15 for his or her acts or omissions related to donating,
16 accepting, distributing, or dispensing a cancer drug or supply
17 under this Act.
 
18     Section 35. Rules. The Department shall adopt all of the
19 following as rules:
20         (1) Requirements for pharmacies to accept and dispense
21     donated cancer drugs or supplies needed to administer
22     cancer drugs under this Act, including all of the
23     following:

 

 

09500SB0941sam001 - 5 - LRB095 05749 KBJ 36498 a

1             (A) Eligibility criteria.
2             (B) Standards and procedures for accepting, safely
3         storing, and dispensing donated cancer drugs or
4         supplies needed to administer cancer drugs.
5             (C) Standards and procedures for inspecting
6         donated cancer drugs or supplies needed to administer
7         cancer drugs to determine whether the drugs or supplies
8         are in their original, unopened, sealed, and
9         tamper-evident unit-dose packaging or, if packaged in
10         single-unit doses, the single-unit-dose packaging is
11         unopened.
12             (D) Standards and procedures for inspecting
13         donated cancer drugs or supplies needed to administer
14         cancer drugs to determine that the drugs or supplies
15         needed to administer cancer drugs are not adulterated
16         or misbranded.
17         (2) Eligibility criteria for individuals to receive
18     donated cancer drugs or supplies needed to administer
19     cancer drugs dispensed under the cancer drug repository
20     program. The standards shall prioritize dispensation to
21     individuals who are uninsured or indigent but must permit
22     dispensation to others if an uninsured or indigent
23     individual is unavailable.
24         (3) A means, such as an identification card, by which
25     an individual who is eligible to receive a donated cancer
26     drug or supplies needed to administer a cancer drug may

 

 

09500SB0941sam001 - 6 - LRB095 05749 KBJ 36498 a

1     indicate that eligibility.
2         (4) Necessary forms for administration of the cancer
3     drug repository program, including forms for use by persons
4     that donate, accept, distribute, or dispense cancer drugs
5     or supplies needed to administer cancer drugs under the
6     program.
7         (5) The maximum handling fee that a pharmacy may charge
8     for accepting, distributing, or dispensing donated cancer
9     drugs or supplies needed to administer cancer drugs.
10         (6) A list of cancer drugs and supplies needed to
11     administer cancer drugs, arranged by category or by
12     individual cancer drug or supply, that the cancer drug
13     repository program will accept for dispensing.
14         (7) A list of cancer drugs and supplies needed to
15     administer cancer drugs, arranged by category or by
16     individual cancer drug or supply, that the cancer drug
17     repository program will not accept for dispensing. The list
18     must include a statement that specifies the reason that the
19     drug or supplies are ineligible for donation.
20     The Department may also adopt any other rules deemed
21 necessary to implement this Act.
 
22     Section 90. The Pharmacy Practice Act of 1987 is amended by
23 changing Section 4 as follows:
 
24     (225 ILCS 85/4)  (from Ch. 111, par. 4124)

 

 

09500SB0941sam001 - 7 - LRB095 05749 KBJ 36498 a

1     (Section scheduled to be repealed on January 1, 2008)
2     Sec. 4. Exemptions. Nothing contained in any Section of
3 this Act shall apply to, or in any manner interfere with:
4     (a) the lawful practice of any physician licensed to
5 practice medicine in all of its branches, dentist, podiatrist,
6 veterinarian, or therapeutically or diagnostically certified
7 optometrist within the limits of his or her license, or prevent
8 him or her from supplying to his or her bona fide patients such
9 drugs, medicines, or poisons as may seem to him appropriate;
10     (b) the sale of compressed gases;
11     (c) the sale of patent or proprietary medicines and
12 household remedies when sold in original and unbroken packages
13 only, if such patent or proprietary medicines and household
14 remedies be properly and adequately labeled as to content and
15 usage and generally considered and accepted as harmless and
16 nonpoisonous when used according to the directions on the
17 label, and also do not contain opium or coca leaves, or any
18 compound, salt or derivative thereof, or any drug which,
19 according to the latest editions of the following authoritative
20 pharmaceutical treatises and standards, namely, The United
21 States Pharmacopoeia/National Formulary (USP/NF), the United
22 States Dispensatory, and the Accepted Dental Remedies of the
23 Council of Dental Therapeutics of the American Dental
24 Association or any or either of them, in use on the effective
25 date of this Act, or according to the existing provisions of
26 the Federal Food, Drug, and Cosmetic Act and Regulations of the

 

 

09500SB0941sam001 - 8 - LRB095 05749 KBJ 36498 a

1 Department of Health and Human Services, Food and Drug
2 Administration, promulgated thereunder now in effect, is
3 designated, described or considered as a narcotic, hypnotic,
4 habit forming, dangerous, or poisonous drug;
5     (d) the sale of poultry and livestock remedies in original
6 and unbroken packages only, labeled for poultry and livestock
7 medication;
8     (e) the sale of poisonous substances or mixture of
9 poisonous substances, in unbroken packages, for nonmedicinal
10 use in the arts or industries or for insecticide purposes;
11 provided, they are properly and adequately labeled as to
12 content and such nonmedicinal usage, in conformity with the
13 provisions of all applicable federal, state and local laws and
14 regulations promulgated thereunder now in effect relating
15 thereto and governing the same, and those which are required
16 under such applicable laws and regulations to be labeled with
17 the word "Poison", are also labeled with the word "Poison"
18 printed thereon in prominent type and the name of a readily
19 obtainable antidote with directions for its administration;
20     (f) the delegation of limited prescriptive authority by a
21 physician licensed to practice medicine in all its branches to
22 a physician assistant under Section 7.5 of the Physician
23 Assistant Practice Act of 1987. This delegated authority may
24 but is not required to include prescription of Schedule III,
25 IV, or V controlled substances, as defined in Article II of the
26 Illinois Controlled Substances Act, in accordance with written

 

 

09500SB0941sam001 - 9 - LRB095 05749 KBJ 36498 a

1 guidelines under Section 7.5 of the Physician Assistant
2 Practice Act of 1987; and
3     (g) the The delegation of limited prescriptive authority by
4 a physician licensed to practice medicine in all its branches
5 to an advanced practice nurse in accordance with a written
6 collaborative agreement under Sections 15-15 and 15-20 of the
7 Nursing and Advanced Practice Nursing Act. This delegated
8 authority may but is not required to include the prescription
9 of Schedule III, IV, or V controlled substances as defined in
10 Article II of the Illinois Controlled Substances Act; and .
11     (h) the donation or acceptance, or the packaging,
12 repackaging, or labeling, of prescription drugs to the extent
13 permitted or required under the Cancer Drug Repository Program
14 Act.
15 (Source: P.A. 90-116, eff. 7-14-97; 90-253, eff. 7-29-97;
16 90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)
 
17     Section 91. The Wholesale Drug Distribution Licensing Act
18 is amended by changing Section 15 as follows:
 
19     (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
20     (Section scheduled to be repealed on January 1, 2013)
21     Sec. 15. Definitions. As used in this Act:
22     "Blood" means whole blood collected from a single donor and
23 processed either for transfusion or further manufacturing.
24     "Blood component" means that part of blood separated by

 

 

09500SB0941sam001 - 10 - LRB095 05749 KBJ 36498 a

1 physical or mechanical means.
2     "Board" means the State Board of Pharmacy of the Department
3 of Professional Regulation.
4     "Department" means the Department of Professional
5 Regulation.
6     "Director" means the Director of Professional Regulation.
7     "Drug sample" means a unit of a prescription drug that is
8 not intended to be sold and is intended to promote the sale of
9 the drug.
10     "Manufacturer" means anyone who is engaged in the
11 manufacturing, preparing, propagating, compounding,
12 processing, packaging, repackaging, or labeling of a
13 prescription drug. "Manufacturer" does not include anyone who
14 is engaged in the packaging, repackaging, or labeling of
15 prescription drugs only to the extent required under the Cancer
16 Drug Repository Program Act.
17     "Person" means and includes a natural person, partnership,
18 association or corporation.
19     "Pharmacy distributor" means any pharmacy licensed in this
20 State or hospital pharmacy that is engaged in the delivery or
21 distribution of prescription drugs either to any other pharmacy
22 licensed in this State or to any other person or entity
23 including, but not limited to, a wholesale drug distributor
24 engaged in the delivery or distribution of prescription drugs
25 who is involved in the actual, constructive, or attempted
26 transfer of a drug in this State to other than the ultimate

 

 

09500SB0941sam001 - 11 - LRB095 05749 KBJ 36498 a

1 consumer except as otherwise provided for by law.
2     "Prescription drug" means any human drug required by
3 federal law or regulation to be dispensed only by a
4 prescription, including finished dosage forms and active
5 ingredients subject to subsection (b) of Section 503 of the
6 Federal Food, Drug and Cosmetic Act.
7     "Wholesale distribution" or "wholesale distributions"
8 means distribution of prescription drugs to persons other than
9 a consumer or patient, but does not include any of the
10 following:
11         (a) Intracompany sales, defined as any transaction or
12     transfer between any division, subsidiary, parent, or
13     affiliated or related company under the common ownership
14     and control of a corporate entity.
15         (b) The purchase or other acquisition by a hospital or
16     other health care entity that is a member of a group
17     purchasing organization of a drug for its own use from the
18     group purchasing organization or from other hospitals or
19     health care entities that are members of a group
20     organization.
21         (c) The sale, purchase, or trade of a drug or an offer
22     to sell, purchase, or trade a drug by a charitable
23     organization described in subsection (c)(3) of Section 501
24     of the U.S. Internal Revenue Code of 1954 to a nonprofit
25     affiliate of the organization to the extent otherwise
26     permitted by law.

 

 

09500SB0941sam001 - 12 - LRB095 05749 KBJ 36498 a

1         (d) The sale, purchase, or trade of a drug or an offer
2     to sell, purchase, or trade a drug among hospitals or other
3     health care entities that are under common control. For
4     purposes of this Act, "common control" means the power to
5     direct or cause the direction of the management and
6     policies of a person or an organization, whether by
7     ownership of stock, voting rights, contract, or otherwise.
8         (e) The sale, purchase, or trade of a drug or an offer
9     to sell, purchase, or trade a drug for emergency medical
10     reasons. For purposes of this Act, "emergency medical
11     reasons" include transfers of prescription drugs by a
12     retail pharmacy to another retail pharmacy to alleviate a
13     temporary shortage.
14         (f) The sale, purchase, or trade of a drug, an offer to
15     sell, purchase, or trade a drug, or the dispensing of a
16     drug pursuant to a prescription.
17         (g) The distribution of drug samples by manufacturers'
18     representatives or distributors' representatives.
19         (h) The sale, purchase, or trade of blood and blood
20     components intended for transfusion.
21         (i) The donation of prescription drugs to the extent
22     permitted under the Cancer Drug Repository Program Act.
23     "Wholesale drug distributor" means any person or entity
24 engaged in wholesale distribution of prescription drugs,
25 including, but not limited to, manufacturers; repackers; own
26 label distributors; jobbers; private label distributors;

 

 

09500SB0941sam001 - 13 - LRB095 05749 KBJ 36498 a

1 brokers; warehouses, including manufacturers' and
2 distributors' warehouses, chain drug warehouses, and wholesale
3 drug warehouses; independent wholesale drug traders; and
4 retail pharmacies that conduct wholesale distributions,
5 including, but not limited to, any pharmacy distributor as
6 defined in this Section. A wholesale drug distributor shall not
7 include any for hire carrier or person or entity hired solely
8 to transport prescription drugs.
9 (Source: P.A. 87-594.)
 
10     Section 92. 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 production,
16     preparation, propagation, compounding, conversion, or
17     processing of prescription drug products (i) directly or
18     indirectly by extraction from substances of natural
19     origin, (ii) independently by means of chemical synthesis,
20     or (iii) by combination of extraction and chemical
21     synthesis; or (b) the packaging, repackaging, labeling or
22     re-labeling, or distribution of prescription drug
23     products.
24         (2) The entity holding legal title to or possession of

 

 

09500SB0941sam001 - 14 - LRB095 05749 KBJ 36498 a

1     the national drug code number for the covered prescription
2     drug.
3     The term does not include a wholesale distributor of drugs,
4 drugstore chain organization, or retail pharmacy licensed by
5 the State. The term also does not include anyone who is engaged
6 in the packaging, repackaging, or labeling of prescription
7 drugs only to the extent required under the Cancer Drug
8 Repository Program Act.
9     "Prescription drug" means a drug that may be dispensed only
10 upon prescription by an authorized prescriber and that is
11 approved for safety and effectiveness as a prescription drug
12 under Section 505 or 507 of the Federal Food, Drug and Cosmetic
13 Act.
14     "Senior citizen" or "senior" means a person 65 years of age
15 or older.
16 (Source: P.A. 92-594, eff. 6-27-02.)
 
17     Section 93. The Illinois Food, Drug and Cosmetic Act is
18 amended by changing Section 16 as follows:
 
19     (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
20     Sec. 16. (a) The Director is hereby authorized to
21 promulgate regulations exempting from any labeling or
22 packaging requirement of this Act drugs and devices which are
23 (i) , in accordance with the practice of the trade, to be
24 processed, labeled or repacked in substantial quantities at

 

 

09500SB0941sam001 - 15 - LRB095 05749 KBJ 36498 a

1 establishments other than those where originally processed or
2 packaged on condition that such drugs and devices are not
3 adulterated or misbranded under the provisions of this Act upon
4 removal from such processing, labeling or repacking
5 establishment or (ii) packaged, repackaged, or labeled to the
6 extent required under the Cancer Drug Repository Program Act.
7     (b) Drugs and device labeling or packaging exemptions
8 adopted under the Federal Act and supplements thereto or
9 revisions thereof shall apply to drugs and devices in Illinois
10 except insofar as modified or rejected by regulations
11 promulgated by the Director.
12     (c) A drug intended for use by man which (A) is a
13 habit-forming drug to which Section 15 (d) applies; or (B)
14 because of its toxicity or other potentiality for harmful
15 effect or the method of its use or the collateral measures
16 necessary to its use is not safe for use except under the
17 supervision of a practitioner licensed by law to administer
18 such drug; or (C) is limited by an approved application under
19 Section 505 of the Federal Act or Section 17 of this Act to use
20 under the professional supervision of a practitioner licensed
21 by law to administer such drug, shall be dispensed only in
22 accordance with the provisions of the "Illinois Controlled
23 Substances Act". The act of dispensing a drug contrary to the
24 provisions of this paragraph shall be deemed to be an act which
25 results in a drug being misbranded while held for sale.
26     (d) Any drug dispensed by filling or refilling a written or

 

 

09500SB0941sam001 - 16 - LRB095 05749 KBJ 36498 a

1 oral prescription of a practitioner licensed by law to
2 administer such drug shall be exempt from the requirements of
3 Section 15, except subsections (a), (k) and (l) and clauses (2)
4 and (3) of subsection (i), and the packaging requirements of
5 subsections (g), (h) and (q), if the drug bears a label
6 containing the proprietary name or names, or if there is none,
7 the established name or names of the drugs, the dosage and
8 quantity, unless the prescribing practitioner, in the interest
9 of the health of the patient, directs otherwise in writing, the
10 name and address of the dispenser, the serial number and date
11 of the prescription or of its filling, the name of the
12 prescriber and, if stated in the prescription, the name of the
13 patient, and the directions for use and the cautionary
14 statements, if any, contained in such prescription. This
15 exemption shall not apply to any drug dispensed in the course
16 of the conduct of business of dispensing drugs pursuant to
17 diagnosis by mail, or to a drug dispensed in violation of
18 subsection (a) of this Section.
19     (e) The Director may by regulation remove drugs subject to
20 Section 15 (d) and Section 17 from the requirements of
21 subsection (c) of this Section when such requirements are not
22 necessary for the protection of the public health.
23     (f) A drug which is subject to subsection (c) of this
24 Section shall be deemed to be misbranded if at any time before
25 dispensing its label fails to bear the statement "Caution:
26 Federal Law Prohibits Dispensing Without Prescription" or

 

 

09500SB0941sam001 - 17 - LRB095 05749 KBJ 36498 a

1 "Caution: State Law Prohibits Dispensing Without
2 Prescription". A drug to which subsection (c) of this Section
3 does not apply shall be deemed to be misbranded if at any time
4 prior to dispensing its label bears the caution statement
5 quoted in the preceding sentence.
6     (g) Nothing in this Section shall be construed to relieve
7 any person from any requirement prescribed by or under
8 authority of law with respect to controlled substances now
9 included or which may hereafter be included within the
10 classifications of controlled substances cannabis as defined
11 in applicable Federal laws relating to controlled substances or
12 cannabis or the Cannabis Control Act.
13 (Source: P.A. 84-1308.)
 
14     Section 94. The Illinois Controlled Substances Act is
15 amended by changing Section 102 as follows:
 
16     (720 ILCS 570/102)  (from Ch. 56 1/2, par. 1102)
17     Sec. 102. Definitions. As used in this Act, unless the
18 context otherwise requires:
19     (a) "Addict" means any person who habitually uses any drug,
20 chemical, substance or dangerous drug other than alcohol so as
21 to endanger the public morals, health, safety or welfare or who
22 is so far addicted to the use of a dangerous drug or controlled
23 substance other than alcohol as to have lost the power of self
24 control with reference to his addiction.

 

 

09500SB0941sam001 - 18 - LRB095 05749 KBJ 36498 a

1     (b) "Administer" means the direct application of a
2 controlled substance, whether by injection, inhalation,
3 ingestion, or any other means, to the body of a patient,
4 research subject, or animal (as defined by the Humane
5 Euthanasia in Animal Shelters Act) by:
6         (1) a practitioner (or, in his presence, by his
7     authorized agent),
8         (2) the patient or research subject at the lawful
9     direction of the practitioner, or
10         (3) a euthanasia technician as defined by the Humane
11     Euthanasia in Animal Shelters Act.
12     (c) "Agent" means an authorized person who acts on behalf
13 of or at the direction of a manufacturer, distributor, or
14 dispenser. It does not include a common or contract carrier,
15 public warehouseman or employee of the carrier or warehouseman.
16     (c-1) "Anabolic Steroids" means any drug or hormonal
17 substance, chemically and pharmacologically related to
18 testosterone (other than estrogens, progestins, and
19 corticosteroids) that promotes muscle growth, and includes:
20             (i) boldenone,
21             (ii) chlorotestosterone,
22             (iii) chostebol,
23             (iv) dehydrochlormethyltestosterone,
24             (v) dihydrotestosterone,
25             (vi) drostanolone,
26             (vii) ethylestrenol,

 

 

09500SB0941sam001 - 19 - LRB095 05749 KBJ 36498 a

1             (viii) fluoxymesterone,
2             (ix) formebulone,
3             (x) mesterolone,
4             (xi) methandienone,
5             (xii) methandranone,
6             (xiii) methandriol,
7             (xiv) methandrostenolone,
8             (xv) methenolone,
9             (xvi) methyltestosterone,
10             (xvii) mibolerone,
11             (xviii) nandrolone,
12             (xix) norethandrolone,
13             (xx) oxandrolone,
14             (xxi) oxymesterone,
15             (xxii) oxymetholone,
16             (xxiii) stanolone,
17             (xxiv) stanozolol,
18             (xxv) testolactone,
19             (xxvi) testosterone,
20             (xxvii) trenbolone, and
21             (xxviii) any salt, ester, or isomer of a drug or
22         substance described or listed in this paragraph, if
23         that salt, ester, or isomer promotes muscle growth.
24     Any person who is otherwise lawfully in possession of an
25 anabolic steroid, or who otherwise lawfully manufactures,
26 distributes, dispenses, delivers, or possesses with intent to

 

 

09500SB0941sam001 - 20 - LRB095 05749 KBJ 36498 a

1 deliver an anabolic steroid, which anabolic steroid is
2 expressly intended for and lawfully allowed to be administered
3 through implants to livestock or other nonhuman species, and
4 which is approved by the Secretary of Health and Human Services
5 for such administration, and which the person intends to
6 administer or have administered through such implants, shall
7 not be considered to be in unauthorized possession or to
8 unlawfully manufacture, distribute, dispense, deliver, or
9 possess with intent to deliver such anabolic steroid for
10 purposes of this Act.
11     (d) "Administration" means the Drug Enforcement
12 Administration, United States Department of Justice, or its
13 successor agency.
14     (e) "Control" means to add a drug or other substance, or
15 immediate precursor, to a Schedule under Article II of this Act
16 whether by transfer from another Schedule or otherwise.
17     (f) "Controlled Substance" means a drug, substance, or
18 immediate precursor in the Schedules of Article II of this Act.
19     (g) "Counterfeit substance" means a controlled substance,
20 which, or the container or labeling of which, without
21 authorization bears the trademark, trade name, or other
22 identifying mark, imprint, number or device, or any likeness
23 thereof, of a manufacturer, distributor, or dispenser other
24 than the person who in fact manufactured, distributed, or
25 dispensed the substance.
26     (h) "Deliver" or "delivery" means the actual, constructive

 

 

09500SB0941sam001 - 21 - LRB095 05749 KBJ 36498 a

1 or attempted transfer of possession of a controlled substance,
2 with or without consideration, whether or not there is an
3 agency relationship. The term does not include the donation of
4 prescription drugs to the extent permitted under the Cancer
5 Drug Repository Program Act.
6     (i) "Department" means the Illinois Department of Human
7 Services (as successor to the Department of Alcoholism and
8 Substance Abuse) or its successor agency.
9     (j) "Department of State Police" means the Department of
10 State Police of the State of Illinois or its successor agency.
11     (k) "Department of Corrections" means the Department of
12 Corrections of the State of Illinois or its successor agency.
13     (l) "Department of Professional Regulation" means the
14 Department of Professional Regulation of the State of Illinois
15 or its successor agency.
16     (m) "Depressant" or "stimulant substance" means:
17         (1) a drug which contains any quantity of (i)
18     barbituric acid or any of the salts of barbituric acid
19     which has been designated as habit forming under section
20     502 (d) of the Federal Food, Drug, and Cosmetic Act (21
21     U.S.C. 352 (d)); or
22         (2) a drug which contains any quantity of (i)
23     amphetamine or methamphetamine and any of their optical
24     isomers; (ii) any salt of amphetamine or methamphetamine or
25     any salt of an optical isomer of amphetamine; or (iii) any
26     substance which the Department, after investigation, has

 

 

09500SB0941sam001 - 22 - LRB095 05749 KBJ 36498 a

1     found to be, and by rule designated as, habit forming
2     because of its depressant or stimulant effect on the
3     central nervous system; or
4         (3) lysergic acid diethylamide; or
5         (4) any drug which contains any quantity of a substance
6     which the Department, after investigation, has found to
7     have, and by rule designated as having, a potential for
8     abuse because of its depressant or stimulant effect on the
9     central nervous system or its hallucinogenic effect.
10     (n) (Blank).
11     (o) "Director" means the Director of the Department of
12 State Police or the Department of Professional Regulation or
13 his designated agents.
14     (p) "Dispense" means to deliver a controlled substance to
15 an ultimate user or research subject by or pursuant to the
16 lawful order of a prescriber, including the prescribing,
17 administering, packaging, labeling, or compounding necessary
18 to prepare the substance for that delivery.
19     (q) "Dispenser" means a practitioner who dispenses.
20     (r) "Distribute" means to deliver, other than by
21 administering or dispensing, a controlled substance.
22     (s) "Distributor" means a person who distributes.
23     (t) "Drug" means (1) substances recognized as drugs in the
24 official United States Pharmacopoeia, Official Homeopathic
25 Pharmacopoeia of the United States, or official National
26 Formulary, or any supplement to any of them; (2) substances

 

 

09500SB0941sam001 - 23 - LRB095 05749 KBJ 36498 a

1 intended for use in diagnosis, cure, mitigation, treatment, or
2 prevention of disease in man or animals; (3) substances (other
3 than food) intended to affect the structure of any function of
4 the body of man or animals and (4) substances intended for use
5 as a component of any article specified in clause (1), (2), or
6 (3) of this subsection. It does not include devices or their
7 components, parts, or accessories.
8     (t-5) "Euthanasia agency" means an entity certified by the
9 Department of Professional Regulation for the purpose of animal
10 euthanasia that holds an animal control facility license or
11 animal shelter license under the Animal Welfare Act. A
12 euthanasia agency is authorized to purchase, store, possess,
13 and utilize Schedule II nonnarcotic and Schedule III
14 nonnarcotic drugs for the sole purpose of animal euthanasia.
15     (t-10) "Euthanasia drugs" means Schedule II or Schedule III
16 substances (nonnarcotic controlled substances) that are used
17 by a euthanasia agency for the purpose of animal euthanasia.
18     (u) "Good faith" means the prescribing or dispensing of a
19 controlled substance by a practitioner in the regular course of
20 professional treatment to or for any person who is under his
21 treatment for a pathology or condition other than that
22 individual's physical or psychological dependence upon or
23 addiction to a controlled substance, except as provided herein:
24 and application of the term to a pharmacist shall mean the
25 dispensing of a controlled substance pursuant to the
26 prescriber's order which in the professional judgment of the

 

 

09500SB0941sam001 - 24 - LRB095 05749 KBJ 36498 a

1 pharmacist is lawful. The pharmacist shall be guided by
2 accepted professional standards including, but not limited to
3 the following, in making the judgment:
4         (1) lack of consistency of doctor-patient
5     relationship,
6         (2) frequency of prescriptions for same drug by one
7     prescriber for large numbers of patients,
8         (3) quantities beyond those normally prescribed,
9         (4) unusual dosages,
10         (5) unusual geographic distances between patient,
11     pharmacist and prescriber,
12         (6) consistent prescribing of habit-forming drugs.
13     (u-1) "Home infusion services" means services provided by a
14 pharmacy in compounding solutions for direct administration to
15 a patient in a private residence, long-term care facility, or
16 hospice setting by means of parenteral, intravenous,
17 intramuscular, subcutaneous, or intraspinal infusion.
18     (v) "Immediate precursor" means a substance:
19         (1) which the Department has found to be and by rule
20     designated as being a principal compound used, or produced
21     primarily for use, in the manufacture of a controlled
22     substance;
23         (2) which is an immediate chemical intermediary used or
24     likely to be used in the manufacture of such controlled
25     substance; and
26         (3) the control of which is necessary to prevent,

 

 

09500SB0941sam001 - 25 - LRB095 05749 KBJ 36498 a

1     curtail or limit the manufacture of such controlled
2     substance.
3     (w) "Instructional activities" means the acts of teaching,
4 educating or instructing by practitioners using controlled
5 substances within educational facilities approved by the State
6 Board of Education or its successor agency.
7     (x) "Local authorities" means a duly organized State,
8 County or Municipal peace unit or police force.
9     (y) "Look-alike substance" means a substance, other than a
10 controlled substance which (1) by overall dosage unit
11 appearance, including shape, color, size, markings or lack
12 thereof, taste, consistency, or any other identifying physical
13 characteristic of the substance, would lead a reasonable person
14 to believe that the substance is a controlled substance, or (2)
15 is expressly or impliedly represented to be a controlled
16 substance or is distributed under circumstances which would
17 lead a reasonable person to believe that the substance is a
18 controlled substance. For the purpose of determining whether
19 the representations made or the circumstances of the
20 distribution would lead a reasonable person to believe the
21 substance to be a controlled substance under this clause (2) of
22 subsection (y), the court or other authority may consider the
23 following factors in addition to any other factor that may be
24 relevant:
25         (a) statements made by the owner or person in control
26     of the substance concerning its nature, use or effect;

 

 

09500SB0941sam001 - 26 - LRB095 05749 KBJ 36498 a

1         (b) statements made to the buyer or recipient that the
2     substance may be resold for profit;
3         (c) whether the substance is packaged in a manner
4     normally used for the illegal distribution of controlled
5     substances;
6         (d) whether the distribution or attempted distribution
7     included an exchange of or demand for money or other
8     property as consideration, and whether the amount of the
9     consideration was substantially greater than the
10     reasonable retail market value of the substance.
11     Clause (1) of this subsection (y) shall not apply to a
12 noncontrolled substance in its finished dosage form that was
13 initially introduced into commerce prior to the initial
14 introduction into commerce of a controlled substance in its
15 finished dosage form which it may substantially resemble.
16     Nothing in this subsection (y) prohibits the dispensing or
17 distributing of noncontrolled substances by persons authorized
18 to dispense and distribute controlled substances under this
19 Act, provided that such action would be deemed to be carried
20 out in good faith under subsection (u) if the substances
21 involved were controlled substances.
22     Nothing in this subsection (y) or in this Act prohibits the
23 manufacture, preparation, propagation, compounding,
24 processing, packaging, advertising or distribution of a drug or
25 drugs by any person registered pursuant to Section 510 of the
26 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).

 

 

09500SB0941sam001 - 27 - LRB095 05749 KBJ 36498 a

1     (y-1) "Mail-order pharmacy" means a pharmacy that is
2 located in a state of the United States, other than Illinois,
3 that delivers, dispenses or distributes, through the United
4 States Postal Service or other common carrier, to Illinois
5 residents, any substance which requires a prescription.
6     (z) "Manufacture" means the production, preparation,
7 propagation, compounding, conversion or processing of a
8 controlled substance other than methamphetamine, either
9 directly or indirectly, by extraction from substances of
10 natural origin, or independently by means of chemical
11 synthesis, or by a combination of extraction and chemical
12 synthesis, and includes any packaging or repackaging of the
13 substance or labeling of its container, except that this term
14 does not include:
15         (1) by an ultimate user, the preparation or compounding
16     of a controlled substance for his own use; or
17         (2) by a practitioner, or his authorized agent under
18     his supervision, the preparation, compounding, packaging,
19     or labeling of a controlled substance:
20             (a) as an incident to his administering or
21         dispensing of a controlled substance in the course of
22         his professional practice; or
23             (b) as an incident to lawful research, teaching or
24         chemical analysis and not for sale; or .
25         (3) the packaging, repackaging, or labeling of
26     prescription drugs only to the extent required under the

 

 

09500SB0941sam001 - 28 - LRB095 05749 KBJ 36498 a

1     Cancer Drug Repository Program Act.
2     (z-1) (Blank).
3     (aa) "Narcotic drug" means any of the following, whether
4 produced directly or indirectly by extraction from substances
5 of natural origin, or independently by means of chemical
6 synthesis, or by a combination of extraction and chemical
7 synthesis:
8         (1) opium and opiate, and any salt, compound,
9     derivative, or preparation of opium or opiate;
10         (2) any salt, compound, isomer, derivative, or
11     preparation thereof which is chemically equivalent or
12     identical with any of the substances referred to in clause
13     (1), but not including the isoquinoline alkaloids of opium;
14         (3) opium poppy and poppy straw;
15         (4) coca leaves and any salts, compound, isomer, salt
16     of an isomer, derivative, or preparation of coca leaves
17     including cocaine or ecgonine, and any salt, compound,
18     isomer, derivative, or preparation thereof which is
19     chemically equivalent or identical with any of these
20     substances, but not including decocainized coca leaves or
21     extractions of coca leaves which do not contain cocaine or
22     ecgonine (for the purpose of this paragraph, the term
23     "isomer" includes optical, positional and geometric
24     isomers).
25     (bb) "Nurse" means a registered nurse licensed under the
26 Nursing and Advanced Practice Nursing Act.

 

 

09500SB0941sam001 - 29 - LRB095 05749 KBJ 36498 a

1     (cc) (Blank).
2     (dd) "Opiate" means any substance having an addiction
3 forming or addiction sustaining liability similar to morphine
4 or being capable of conversion into a drug having addiction
5 forming or addiction sustaining liability.
6     (ee) "Opium poppy" means the plant of the species Papaver
7 somniferum L., except its seeds.
8     (ff) "Parole and Pardon Board" means the Parole and Pardon
9 Board of the State of Illinois or its successor agency.
10     (gg) "Person" means any individual, corporation,
11 mail-order pharmacy, government or governmental subdivision or
12 agency, business trust, estate, trust, partnership or
13 association, or any other entity.
14     (hh) "Pharmacist" means any person who holds a certificate
15 of registration as a registered pharmacist, a local registered
16 pharmacist or a registered assistant pharmacist under the
17 Pharmacy Practice Act of 1987.
18     (ii) "Pharmacy" means any store, ship or other place in
19 which pharmacy is authorized to be practiced under the Pharmacy
20 Practice Act of 1987.
21     (jj) "Poppy straw" means all parts, except the seeds, of
22 the opium poppy, after mowing.
23     (kk) "Practitioner" means a physician licensed to practice
24 medicine in all its branches, dentist, podiatrist,
25 veterinarian, scientific investigator, pharmacist, physician
26 assistant, advanced practice nurse, licensed practical nurse,

 

 

09500SB0941sam001 - 30 - LRB095 05749 KBJ 36498 a

1 registered nurse, hospital, laboratory, or pharmacy, or other
2 person licensed, registered, or otherwise lawfully permitted
3 by the United States or this State to distribute, dispense,
4 conduct research with respect to, administer or use in teaching
5 or chemical analysis, a controlled substance in the course of
6 professional practice or research.
7     (ll) "Pre-printed prescription" means a written
8 prescription upon which the designated drug has been indicated
9 prior to the time of issuance.
10     (mm) "Prescriber" means a physician licensed to practice
11 medicine in all its branches, dentist, podiatrist or
12 veterinarian who issues a prescription, a physician assistant
13 who issues a prescription for a Schedule III, IV, or V
14 controlled substance in accordance with Section 303.05 and the
15 written guidelines required under Section 7.5 of the Physician
16 Assistant Practice Act of 1987, or an advanced practice nurse
17 with prescriptive authority in accordance with Section 303.05
18 and a written collaborative agreement under Sections 15-15 and
19 15-20 of the Nursing and Advanced Practice Nursing Act.
20     (nn) "Prescription" means a lawful written, facsimile, or
21 verbal order of a physician licensed to practice medicine in
22 all its branches, dentist, podiatrist or veterinarian for any
23 controlled substance, of a physician assistant for a Schedule
24 III, IV, or V controlled substance in accordance with Section
25 303.05 and the written guidelines required under Section 7.5 of
26 the Physician Assistant Practice Act of 1987, or of an advanced

 

 

09500SB0941sam001 - 31 - LRB095 05749 KBJ 36498 a

1 practice nurse who issues a prescription for a Schedule III,
2 IV, or V controlled substance in accordance with Section 303.05
3 and a written collaborative agreement under Sections 15-15 and
4 15-20 of the Nursing and Advanced Practice Nursing Act.
5     (oo) "Production" or "produce" means manufacture,
6 planting, cultivating, growing, or harvesting of a controlled
7 substance other than methamphetamine.
8     (pp) "Registrant" means every person who is required to
9 register under Section 302 of this Act.
10     (qq) "Registry number" means the number assigned to each
11 person authorized to handle controlled substances under the
12 laws of the United States and of this State.
13     (rr) "State" includes the State of Illinois and any state,
14 district, commonwealth, territory, insular possession thereof,
15 and any area subject to the legal authority of the United
16 States of America.
17     (ss) "Ultimate user" means a person who lawfully possesses
18 a controlled substance for his own use or for the use of a
19 member of his household or for administering to an animal owned
20 by him or by a member of his household.
21 (Source: P.A. 93-596, eff. 8-26-03; 93-626, eff. 12-23-03;
22 94-556, eff. 9-11-05.)
 
23     Section 95. The Cannabis and Controlled Substances Tort
24 Claims Act is amended by changing Section 3 as follows:
 

 

 

09500SB0941sam001 - 32 - LRB095 05749 KBJ 36498 a

1     (740 ILCS 20/3)  (from Ch. 70, par. 903)
2     Sec. 3. Definitions. As used in this Act, unless the
3 context otherwise requires:
4     "Cannabis" includes marihuana, hashish, and other
5 substances that are identified as including any parts of the
6 plant Cannabis Sativa, whether growing or not, the seeds of
7 that plant, the resin extracted from any part of that plant,
8 and any compound, manufacture, salt, derivative, mixture, or
9 preparation of that plant, its seeds, or resin, including
10 tetrahydrocannabinol (THC) and all other cannabinol
11 derivatives, including its naturally occurring or
12 synthetically produced ingredients, whether produced directly
13 or indirectly by extraction, independently by means of chemical
14 synthesis, or by a combination of extraction and chemical
15 synthesis. "Cannabis" does not include the mature stalks of
16 that plant, fiber produced from those stalks, oil or cake made
17 from the seeds of that plant, any other compound, manufacture,
18 salt, derivative, mixture, or preparation of mature stalks
19 (except the extracted resin), fiber, oil or cake, or the
20 sterilized seeds of that plant that are incapable of
21 germination.
22     "Controlled substance" means a drug, substance, or
23 immediate precursor in the Schedules of Article II of the
24 Illinois Controlled Substances Act.
25     "Counterfeit substance" means a controlled substance or
26 the container or labeling of a controlled substance that,

 

 

09500SB0941sam001 - 33 - LRB095 05749 KBJ 36498 a

1 without authorization, bears the trademark, trade name, or
2 other identifying mark, imprint, number, device, or any
3 likeness thereof of a manufacturer, distributor, or dispenser
4 other than the person who in fact manufactured, distributed, or
5 dispensed the substance.
6     "Deliver" or "delivery" means the actual, constructive, or
7 attempted transfer of possession of a controlled substance or
8 cannabis, with or without consideration, whether or not there
9 is an agency relationship. The term does not include the
10 donation of prescription drugs to the extent permitted under
11 the Cancer Drug Repository Program Act.
12     "Manufacture" means the production, preparation,
13 propagation, compounding, conversion, or processing of a
14 controlled substance, either directly or indirectly, by
15 extraction from substances of natural origin, independently by
16 means of chemical synthesis, or by a combination of extraction
17 and chemical synthesis, and includes any packaging or
18 repackaging of the substance or labeling of its container,
19 except that the term does not include:
20         (1) by an ultimate user, the preparation or compounding
21     of a controlled substance for his own use;
22         (2) by a practitioner or his authorized agent under his
23     supervision, the preparation, compounding, packaging, or
24     labeling of a controlled substance: ;
25             (A) as an incident to his administering or
26         dispensing of a controlled substance in the course of

 

 

09500SB0941sam001 - 34 - LRB095 05749 KBJ 36498 a

1         his professional practice; or
2             (B) as an incident to lawful research, teaching or
3         chemical analysis and not for sale; or
4         (3) the preparation, compounding, packaging, or
5     labeling of cannabis as an incident to lawful research,
6     teaching, or chemical analysis and not for sale; or .
7         (4) the packaging, repackaging, or labeling of
8     prescription drugs only to the extent required under the
9     Cancer Drug Repository Program Act.
10     "Owner" means a person who has possession of or any
11 interest whatsoever in the property involved.
12     "Person" means an individual, a corporation, a government,
13 a governmental subdivision or agency, a business trust, an
14 estate, a trust, a partnership or association, or any other
15 entity.
16     "Production" means planting, cultivating, tending, or
17 harvesting.
18     "Property" means real property, including things growing
19 on, affixed to, and found in land, and tangible or intangible
20 personal property, including rights, services, privileges,
21 interests, claims, and securities.
22 (Source: P.A. 87-544.)".