Sen. William Delgado

Filed: 5/15/2013

 

 


 

 


 
09800SB1454sam005LRB098 09389 RLC 45858 a

1
AMENDMENT TO SENATE BILL 1454

2    AMENDMENT NO. ______. Amend Senate Bill 1454, AS AMENDED,
3by replacing everything after the enacting clause with the
4following:
 
5    "Section 5. The Wholesale Drug Distribution Licensing Act
6is amended by changing Section 40 as follows:
 
7    (225 ILCS 120/40)  (from Ch. 111, par. 8301-40)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 40. Rules and regulations. The Department shall make
10any rules and regulations, not inconsistent with law, as may be
11necessary to carry out the purposes and enforce the provisions
12of this Act. Rules and regulations that incorporate and set
13detailed standards for meeting each of the license
14prerequisites set forth in Section 25 of this Act shall be
15adopted no later than September 14, 1992. All rules and
16regulations promulgated under this Section shall conform to

 

 

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1wholesale drug distributor licensing guidelines formally
2adopted by the FDA at 21 C.F.R. Part 205. In case of conflict
3between any rule or regulation adopted by the Department and
4any FDA wholesale drug distributor guideline, the FDA guideline
5shall control.
6    Notwithstanding any other provision of law, a distributor
7licensed and regulated by the Department of Financial and
8Professional Regulation, and registered and regulated by the
9United States Drug Enforcement Administration, shall be exempt
10from the storage, reporting, ordering, record keeping, and
11physical security control requirements for Schedule II
12controlled substances with regard to any material, compound,
13mixture, or preparation containing Hydrocodone. These
14Controlled Substances shall be subject to the same requirements
15as those imposed for Schedule III controlled substances.
16(Source: P.A. 87-594.)
 
17    Section 10. The Illinois Controlled Substances Act is
18amended by changing Sections 102, 316, 319, and 320 and by
19adding Sections 208.5 and 317.5 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
22context otherwise requires:
23    (a) "Addict" means any person who habitually uses any drug,
24chemical, substance or dangerous drug other than alcohol so as

 

 

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1to endanger the public morals, health, safety or welfare or who
2is so far addicted to the use of a dangerous drug or controlled
3substance other than alcohol as to have lost the power of self
4control with reference to his or her addiction.
5    (b) "Administer" means the direct application of a
6controlled substance, whether by injection, inhalation,
7ingestion, or any other means, to the body of a patient,
8research subject, or animal (as defined by the Humane
9Euthanasia in Animal Shelters Act) by:
10        (1) a practitioner (or, in his or her presence, by his
11    or her authorized agent),
12        (2) the patient or research subject pursuant to an
13    order, or
14        (3) a euthanasia technician as defined by the Humane
15    Euthanasia in Animal Shelters Act.
16    (c) "Agent" means an authorized person who acts on behalf
17of or at the direction of a manufacturer, distributor,
18dispenser, prescriber, or practitioner. It does not include a
19common or contract carrier, public warehouseman or employee of
20the carrier or warehouseman.
21    (c-1) "Anabolic Steroids" means any drug or hormonal
22substance, chemically and pharmacologically related to
23testosterone (other than estrogens, progestins,
24corticosteroids, and dehydroepiandrosterone), and includes:
25    (i) 3[beta],17-dihydroxy-5a-androstane, 
26    (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, 

 

 

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1    (iii) 5[alpha]-androstan-3,17-dione, 
2    (iv) 1-androstenediol (3[beta], 
3        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
4    (v) 1-androstenediol (3[alpha], 
5        17[beta]-dihydroxy-5[alpha]-androst-1-ene), 
6    (vi) 4-androstenediol  
7        (3[beta],17[beta]-dihydroxy-androst-4-ene), 
8    (vii) 5-androstenediol  
9        (3[beta],17[beta]-dihydroxy-androst-5-ene), 
10    (viii) 1-androstenedione  
11        ([5alpha]-androst-1-en-3,17-dione), 
12    (ix) 4-androstenedione  
13        (androst-4-en-3,17-dione), 
14    (x) 5-androstenedione  
15        (androst-5-en-3,17-dione), 
16    (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- 
17        hydroxyandrost-4-en-3-one), 
18    (xii) boldenone (17[beta]-hydroxyandrost- 
19        1,4,-diene-3-one), 
20    (xiii) boldione (androsta-1,4- 
21        diene-3,17-dione), 
22    (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 
23        [beta]-hydroxyandrost-4-en-3-one), 
24    (xv) clostebol (4-chloro-17[beta]- 
25        hydroxyandrost-4-en-3-one), 
26    (xvi) dehydrochloromethyltestosterone (4-chloro- 

 

 

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1        17[beta]-hydroxy-17[alpha]-methyl- 
2        androst-1,4-dien-3-one), 
3    (xvii) desoxymethyltestosterone 
4    (17[alpha]-methyl-5[alpha] 
5        -androst-2-en-17[beta]-ol)(a.k.a., madol), 
6    (xviii) [delta]1-dihydrotestosterone (a.k.a.  
7        '1-testosterone') (17[beta]-hydroxy- 
8        5[alpha]-androst-1-en-3-one), 
9    (xix) 4-dihydrotestosterone (17[beta]-hydroxy- 
10        androstan-3-one), 
11    (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- 
12        5[alpha]-androstan-3-one), 
13    (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- 
14        hydroxyestr-4-ene), 
15    (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- 
16        1[beta],17[beta]-dihydroxyandrost-4-en-3-one), 
17    (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], 
18        17[beta]-dihydroxyandrost-1,4-dien-3-one), 
19    (xxiv) furazabol (17[alpha]-methyl-17[beta]- 
20        hydroxyandrostano[2,3-c]-furazan), 
21    (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one) 
22    (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- 
23        androst-4-en-3-one), 
24    (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- 
25        dihydroxy-estr-4-en-3-one), 
26    (xxviii) mestanolone (17[alpha]-methyl-17[beta]- 

 

 

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1        hydroxy-5-androstan-3-one), 
2    (xxix) mesterolone (1amethyl-17[beta]-hydroxy- 
3        [5a]-androstan-3-one), 
4    (xxx) methandienone (17[alpha]-methyl-17[beta]- 
5        hydroxyandrost-1,4-dien-3-one), 
6    (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- 
7        dihydroxyandrost-5-ene), 
8    (xxxii) methenolone (1-methyl-17[beta]-hydroxy- 
9        5[alpha]-androst-1-en-3-one), 
10    (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- 
11        dihydroxy-5a-androstane), 
12    (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy 
13        -5a-androstane), 
14    (xxxv) 17[alpha]-methyl-3[beta],17[beta]- 
15        dihydroxyandrost-4-ene), 
16    (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- 
17        methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), 
18    (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- 
19        hydroxyestra-4,9(10)-dien-3-one), 
20    (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- 
21        hydroxyestra-4,9-11-trien-3-one), 
22    (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- 
23        hydroxyandrost-4-en-3-one), 
24    (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- 
25        hydroxyestr-4-en-3-one), 
26    (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone  

 

 

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1        (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- 
2        androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- 
3        1-testosterone'), 
4    (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), 
5    (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- 
6        dihydroxyestr-4-ene), 
7    (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- 
8        dihydroxyestr-4-ene), 
9    (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- 
10        dihydroxyestr-5-ene), 
11    (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- 
12        dihydroxyestr-5-ene), 
13    (xlvii) 19-nor-4,9(10)-androstadienedione  
14        (estra-4,9(10)-diene-3,17-dione), 
15    (xlviii) 19-nor-4-androstenedione (estr-4- 
16        en-3,17-dione), 
17    (xlix) 19-nor-5-androstenedione (estr-5- 
18        en-3,17-dione), 
19    (l) norbolethone (13[beta], 17a-diethyl-17[beta]- 
20        hydroxygon-4-en-3-one), 
21    (li) norclostebol (4-chloro-17[beta]- 
22        hydroxyestr-4-en-3-one), 
23    (lii) norethandrolone (17[alpha]-ethyl-17[beta]- 
24        hydroxyestr-4-en-3-one), 
25    (liii) normethandrolone (17[alpha]-methyl-17[beta]- 
26        hydroxyestr-4-en-3-one), 

 

 

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1    (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- 
2        2-oxa-5[alpha]-androstan-3-one), 
3    (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- 
4        dihydroxyandrost-4-en-3-one), 
5    (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- 
6        17[beta]-hydroxy-(5[alpha]-androstan-3-one), 
7    (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- 
8        (5[alpha]-androst-2-eno[3,2-c]-pyrazole), 
9    (lviii) stenbolone (17[beta]-hydroxy-2-methyl- 
10        (5[alpha]-androst-1-en-3-one), 
11    (lix) testolactone (13-hydroxy-3-oxo-13,17- 
12        secoandrosta-1,4-dien-17-oic 
13        acid lactone), 
14    (lx) testosterone (17[beta]-hydroxyandrost- 
15        4-en-3-one), 
16    (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- 
17        diethyl-17[beta]-hydroxygon- 
18        4,9,11-trien-3-one), 
19    (lxii) trenbolone (17[beta]-hydroxyestr-4,9, 
20        11-trien-3-one). 
21    Any person who is otherwise lawfully in possession of an
22anabolic steroid, or who otherwise lawfully manufactures,
23distributes, dispenses, delivers, or possesses with intent to
24deliver an anabolic steroid, which anabolic steroid is
25expressly intended for and lawfully allowed to be administered
26through implants to livestock or other nonhuman species, and

 

 

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1which is approved by the Secretary of Health and Human Services
2for such administration, and which the person intends to
3administer or have administered through such implants, shall
4not be considered to be in unauthorized possession or to
5unlawfully manufacture, distribute, dispense, deliver, or
6possess with intent to deliver such anabolic steroid for
7purposes of this Act.
8    (d) "Administration" means the Drug Enforcement
9Administration, United States Department of Justice, or its
10successor agency.
11    (d-5) "Clinical Director, Prescription Monitoring Program"
12means a Department of Human Services administrative employee
13licensed to either prescribe or dispense controlled substances
14who shall run the clinical aspects of the Department of Human
15Services Prescription Monitoring Program and its Prescription
16Information Library.
17    (d-10) "Compounding" means the preparation and mixing of
18components, excluding flavorings, (1) as the result of a
19prescriber's prescription drug order or initiative based on the
20prescriber-patient-pharmacist relationship in the course of
21professional practice or (2) for the purpose of, or incident
22to, research, teaching, or chemical analysis and not for sale
23or dispensing. "Compounding" includes the preparation of drugs
24or devices in anticipation of receiving prescription drug
25orders based on routine, regularly observed dispensing
26patterns. Commercially available products may be compounded

 

 

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1for dispensing to individual patients only if both of the
2following conditions are met: (i) the commercial product is not
3reasonably available from normal distribution channels in a
4timely manner to meet the patient's needs and (ii) the
5prescribing practitioner has requested that the drug be
6compounded.
7    (e) "Control" means to add a drug or other substance, or
8immediate precursor, to a Schedule whether by transfer from
9another Schedule or otherwise.
10    (f) "Controlled Substance" means (i) a drug, substance, or
11immediate precursor in the Schedules of Article II of this Act
12or (ii) a drug or other substance, or immediate precursor,
13designated as a controlled substance by the Department through
14administrative rule. The term does not include distilled
15spirits, wine, malt beverages, or tobacco, as those terms are
16defined or used in the Liquor Control Act and the Tobacco
17Products Tax Act.
18    (f-5) "Controlled substance analog" means a substance:
19        (1) the chemical structure of which is substantially
20    similar to the chemical structure of a controlled substance
21    in Schedule I or II;
22        (2) which has a stimulant, depressant, or
23    hallucinogenic effect on the central nervous system that is
24    substantially similar to or greater than the stimulant,
25    depressant, or hallucinogenic effect on the central
26    nervous system of a controlled substance in Schedule I or

 

 

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1    II; or
2        (3) with respect to a particular person, which such
3    person represents or intends to have a stimulant,
4    depressant, or hallucinogenic effect on the central
5    nervous system that is substantially similar to or greater
6    than the stimulant, depressant, or hallucinogenic effect
7    on the central nervous system of a controlled substance in
8    Schedule I or II.
9    (g) "Counterfeit substance" means a controlled substance,
10which, or the container or labeling of which, without
11authorization bears the trademark, trade name, or other
12identifying mark, imprint, number or device, or any likeness
13thereof, of a manufacturer, distributor, or dispenser other
14than the person who in fact manufactured, distributed, or
15dispensed the substance.
16    (h) "Deliver" or "delivery" means the actual, constructive
17or attempted transfer of possession of a controlled substance,
18with or without consideration, whether or not there is an
19agency relationship.
20    (i) "Department" means the Illinois Department of Human
21Services (as successor to the Department of Alcoholism and
22Substance Abuse) or its successor agency.
23    (j) (Blank).
24    (k) "Department of Corrections" means the Department of
25Corrections of the State of Illinois or its successor agency.
26    (l) "Department of Financial and Professional Regulation"

 

 

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1means the Department of Financial and Professional Regulation
2of the State of Illinois or its successor agency.
3    (m) "Depressant" means any drug that (i) causes an overall
4depression of central nervous system functions, (ii) causes
5impaired consciousness and awareness, and (iii) can be
6habit-forming or lead to a substance abuse problem, including
7but not limited to alcohol, cannabis and its active principles
8and their analogs, benzodiazepines and their analogs,
9barbiturates and their analogs, opioids (natural and
10synthetic) and their analogs, and chloral hydrate and similar
11sedative hypnotics.
12    (n) (Blank).
13    (o) "Director" means the Director of the Illinois State
14Police or his or her designated agents.
15    (p) "Dispense" means to deliver a controlled substance to
16an ultimate user or research subject by or pursuant to the
17lawful order of a prescriber, including the prescribing,
18administering, packaging, labeling, or compounding necessary
19to prepare the substance for that delivery.
20    (q) "Dispenser" means a practitioner who dispenses.
21    (r) "Distribute" means to deliver, other than by
22administering or dispensing, a controlled substance.
23    (s) "Distributor" means a person who distributes.
24    (t) "Drug" means (1) substances recognized as drugs in the
25official United States Pharmacopoeia, Official Homeopathic
26Pharmacopoeia of the United States, or official National

 

 

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1Formulary, or any supplement to any of them; (2) substances
2intended for use in diagnosis, cure, mitigation, treatment, or
3prevention of disease in man or animals; (3) substances (other
4than food) intended to affect the structure of any function of
5the body of man or animals and (4) substances intended for use
6as a component of any article specified in clause (1), (2), or
7(3) of this subsection. It does not include devices or their
8components, parts, or accessories.
9    (t-3) "Electronic health record" or "EHR" means a
10systematic collection of electronic health information about
11individual patients. The EHR is a digital format that is
12capable of being shared across different health care settings.
13    (t-5) "Euthanasia agency" means an entity certified by the
14Department of Financial and Professional Regulation for the
15purpose of animal euthanasia that holds an animal control
16facility license or animal shelter license under the Animal
17Welfare Act. A euthanasia agency is authorized to purchase,
18store, possess, and utilize Schedule II nonnarcotic and
19Schedule III nonnarcotic drugs for the sole purpose of animal
20euthanasia.
21    (t-10) "Euthanasia drugs" means Schedule II or Schedule III
22substances (nonnarcotic controlled substances) that are used
23by a euthanasia agency for the purpose of animal euthanasia.
24    (u) "Good faith" means the prescribing or dispensing of a
25controlled substance by a practitioner in the regular course of
26professional treatment to or for any person who is under his or

 

 

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1her treatment for a pathology or condition other than that
2individual's physical or psychological dependence upon or
3addiction to a controlled substance, except as provided herein:
4and application of the term to a pharmacist shall mean the
5dispensing of a controlled substance pursuant to the
6prescriber's order which in the professional judgment of the
7pharmacist is lawful. The pharmacist shall be guided by
8accepted professional standards including, but not limited to
9the following, in making the judgment:
10        (1) lack of consistency of prescriber-patient
11    relationship,
12        (2) frequency of prescriptions for same drug by one
13    prescriber for large numbers of patients,
14        (3) quantities beyond those normally prescribed,
15        (4) unusual dosages (recognizing that there may be
16    clinical circumstances where more or less than the usual
17    dose may be used legitimately),
18        (5) unusual geographic distances between patient,
19    pharmacist and prescriber,
20        (6) consistent prescribing of habit-forming drugs.
21    (u-0.5) "Hallucinogen" means a drug that causes markedly
22altered sensory perception leading to hallucinations of any
23type.
24    (u-1) "Home infusion services" means services provided by a
25pharmacy in compounding solutions for direct administration to
26a patient in a private residence, long-term care facility, or

 

 

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1hospice setting by means of parenteral, intravenous,
2intramuscular, subcutaneous, or intraspinal infusion.
3    (u-5) "Illinois State Police" means the State Police of the
4State of Illinois, or its successor agency.
5    (v) "Immediate precursor" means a substance:
6        (1) which the Department has found to be and by rule
7    designated as being a principal compound used, or produced
8    primarily for use, in the manufacture of a controlled
9    substance;
10        (2) which is an immediate chemical intermediary used or
11    likely to be used in the manufacture of such controlled
12    substance; and
13        (3) the control of which is necessary to prevent,
14    curtail or limit the manufacture of such controlled
15    substance.
16    (w) "Instructional activities" means the acts of teaching,
17educating or instructing by practitioners using controlled
18substances within educational facilities approved by the State
19Board of Education or its successor agency.
20    (x) "Local authorities" means a duly organized State,
21County or Municipal peace unit or police force.
22    (y) "Look-alike substance" means a substance, other than a
23controlled substance which (1) by overall dosage unit
24appearance, including shape, color, size, markings or lack
25thereof, taste, consistency, or any other identifying physical
26characteristic of the substance, would lead a reasonable person

 

 

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1to believe that the substance is a controlled substance, or (2)
2is expressly or impliedly represented to be a controlled
3substance or is distributed under circumstances which would
4lead a reasonable person to believe that the substance is a
5controlled substance. For the purpose of determining whether
6the representations made or the circumstances of the
7distribution would lead a reasonable person to believe the
8substance to be a controlled substance under this clause (2) of
9subsection (y), the court or other authority may consider the
10following factors in addition to any other factor that may be
11relevant:
12        (a) statements made by the owner or person in control
13    of the substance concerning its nature, use or effect;
14        (b) statements made to the buyer or recipient that the
15    substance may be resold for profit;
16        (c) whether the substance is packaged in a manner
17    normally used for the illegal distribution of controlled
18    substances;
19        (d) whether the distribution or attempted distribution
20    included an exchange of or demand for money or other
21    property as consideration, and whether the amount of the
22    consideration was substantially greater than the
23    reasonable retail market value of the substance.
24    Clause (1) of this subsection (y) shall not apply to a
25noncontrolled substance in its finished dosage form that was
26initially introduced into commerce prior to the initial

 

 

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1introduction into commerce of a controlled substance in its
2finished dosage form which it may substantially resemble.
3    Nothing in this subsection (y) prohibits the dispensing or
4distributing of noncontrolled substances by persons authorized
5to dispense and distribute controlled substances under this
6Act, provided that such action would be deemed to be carried
7out in good faith under subsection (u) if the substances
8involved were controlled substances.
9    Nothing in this subsection (y) or in this Act prohibits the
10manufacture, preparation, propagation, compounding,
11processing, packaging, advertising or distribution of a drug or
12drugs by any person registered pursuant to Section 510 of the
13Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
14    (y-1) "Mail-order pharmacy" means a pharmacy that is
15located in a state of the United States that delivers,
16dispenses or distributes, through the United States Postal
17Service or other common carrier, to Illinois residents, any
18substance which requires a prescription.
19    (z) "Manufacture" means the production, preparation,
20propagation, compounding, conversion or processing of a
21controlled substance other than methamphetamine, either
22directly or indirectly, by extraction from substances of
23natural origin, or independently by means of chemical
24synthesis, or by a combination of extraction and chemical
25synthesis, and includes any packaging or repackaging of the
26substance or labeling of its container, except that this term

 

 

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1does not include:
2        (1) by an ultimate user, the preparation or compounding
3    of a controlled substance for his or her own use; or
4        (2) by a practitioner, or his or her authorized agent
5    under his or her supervision, the preparation,
6    compounding, packaging, or labeling of a controlled
7    substance:
8            (a) as an incident to his or her administering or
9        dispensing of a controlled substance in the course of
10        his or her professional practice; or
11            (b) as an incident to lawful research, teaching or
12        chemical analysis and not for sale.
13    (z-1) (Blank).
14    (z-5) "Medication shopping" means the conduct prohibited
15under subsection (a) of Section 314.5 of this Act.
16    (z-10) "Mid-level practitioner" means (i) a physician
17assistant who has been delegated authority to prescribe through
18a written delegation of authority by a physician licensed to
19practice medicine in all of its branches, in accordance with
20Section 7.5 of the Physician Assistant Practice Act of 1987,
21(ii) an advanced practice nurse who has been delegated
22authority to prescribe through a written delegation of
23authority by a physician licensed to practice medicine in all
24of its branches or by a podiatrist, in accordance with Section
2565-40 of the Nurse Practice Act, or (iii) an animal euthanasia
26agency.

 

 

09800SB1454sam005- 19 -LRB098 09389 RLC 45858 a

1    (aa) "Narcotic drug" means any of the following, whether
2produced directly or indirectly by extraction from substances
3of vegetable origin, or independently by means of chemical
4synthesis, or by a combination of extraction and chemical
5synthesis:
6        (1) opium, opiates, derivatives of opium and opiates,
7    including their isomers, esters, ethers, salts, and salts
8    of isomers, esters, and ethers, whenever the existence of
9    such isomers, esters, ethers, and salts is possible within
10    the specific chemical designation; however the term
11    "narcotic drug" does not include the isoquinoline
12    alkaloids of opium;
13        (2) (blank);
14        (3) opium poppy and poppy straw;
15        (4) coca leaves, except coca leaves and extracts of
16    coca leaves from which substantially all of the cocaine and
17    ecgonine, and their isomers, derivatives and salts, have
18    been removed;
19        (5) cocaine, its salts, optical and geometric isomers,
20    and salts of isomers;
21        (6) ecgonine, its derivatives, their salts, isomers,
22    and salts of isomers;
23        (7) any compound, mixture, or preparation which
24    contains any quantity of any of the substances referred to
25    in subparagraphs (1) through (6).
26    (bb) "Nurse" means a registered nurse licensed under the

 

 

09800SB1454sam005- 20 -LRB098 09389 RLC 45858 a

1Nurse Practice Act.
2    (cc) (Blank).
3    (dd) "Opiate" means any substance having an addiction
4forming or addiction sustaining liability similar to morphine
5or being capable of conversion into a drug having addiction
6forming or addiction sustaining liability.
7    (ee) "Opium poppy" means the plant of the species Papaver
8somniferum L., except its seeds.
9    (ee-5) "Oral dosage" means a tablet, capsule, elixir, or
10solution or other liquid form of medication intended for
11administration by mouth, but the term does not include a form
12of medication intended for buccal, sublingual, or transmucosal
13administration.
14    (ff) "Parole and Pardon Board" means the Parole and Pardon
15Board of the State of Illinois or its successor agency.
16    (gg) "Person" means any individual, corporation,
17mail-order pharmacy, government or governmental subdivision or
18agency, business trust, estate, trust, partnership or
19association, or any other entity.
20    (hh) "Pharmacist" means any person who holds a license or
21certificate of registration as a registered pharmacist, a local
22registered pharmacist or a registered assistant pharmacist
23under the Pharmacy Practice Act.
24    (ii) "Pharmacy" means any store, ship or other place in
25which pharmacy is authorized to be practiced under the Pharmacy
26Practice Act.

 

 

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1    (ii-5) "Pharmacy shopping" means the conduct prohibited
2under subsection (b) of Section 314.5 of this Act.
3    (ii-10) "Physician" (except when the context otherwise
4requires) means a person licensed to practice medicine in all
5of its branches.
6    (jj) "Poppy straw" means all parts, except the seeds, of
7the opium poppy, after mowing.
8    (kk) "Practitioner" means a physician licensed to practice
9medicine in all its branches, dentist, optometrist,
10podiatrist, veterinarian, scientific investigator, pharmacist,
11physician assistant, advanced practice nurse, licensed
12practical nurse, registered nurse, hospital, laboratory, or
13pharmacy, or other person licensed, registered, or otherwise
14lawfully permitted by the United States or this State to
15distribute, dispense, conduct research with respect to,
16administer or use in teaching or chemical analysis, a
17controlled substance in the course of professional practice or
18research.
19    (ll) "Pre-printed prescription" means a written
20prescription upon which the designated drug has been indicated
21prior to the time of issuance; the term does not mean a written
22prescription that is individually generated by machine or
23computer in the prescriber's office.
24    (mm) "Prescriber" means a physician licensed to practice
25medicine in all its branches, dentist, optometrist, podiatrist
26or veterinarian who issues a prescription, a physician

 

 

09800SB1454sam005- 22 -LRB098 09389 RLC 45858 a

1assistant who issues a prescription for a controlled substance
2in accordance with Section 303.05, a written delegation, and a
3written supervision agreement required under Section 7.5 of the
4Physician Assistant Practice Act of 1987, or an advanced
5practice nurse with prescriptive authority delegated under
6Section 65-40 of the Nurse Practice Act and in accordance with
7Section 303.05, a written delegation, and a written
8collaborative agreement under Section 65-35 of the Nurse
9Practice Act.
10    (nn) "Prescription" means a written, facsimile, or oral
11order, or an electronic order that complies with applicable
12federal requirements, of a physician licensed to practice
13medicine in all its branches, dentist, podiatrist or
14veterinarian for any controlled substance, of an optometrist
15for a Schedule III, IV, or V controlled substance in accordance
16with Section 15.1 of the Illinois Optometric Practice Act of
171987, of a physician assistant for a controlled substance in
18accordance with Section 303.05, a written delegation, and a
19written supervision agreement required under Section 7.5 of the
20Physician Assistant Practice Act of 1987, or of an advanced
21practice nurse with prescriptive authority delegated under
22Section 65-40 of the Nurse Practice Act who issues a
23prescription for a controlled substance in accordance with
24Section 303.05, a written delegation, and a written
25collaborative agreement under Section 65-35 of the Nurse
26Practice Act when required by law.

 

 

09800SB1454sam005- 23 -LRB098 09389 RLC 45858 a

1    (nn-5) "Prescription Information Library" (PIL) means an
2electronic library that contains reported controlled substance
3data.
4    (nn-10) "Prescription Monitoring Program" (PMP) means the
5entity that collects, tracks, and stores reported data on
6controlled substances and select drugs pursuant to Section 316.
7    (nn-11) "Prescription Monitoring Program Advisory
8Committee" (PMPAC) means a committee of voting members
9consisting of licensed healthcare providers representing all
10professions who are licensed to prescribe or dispense
11controlled substances. The Chairperson of the PMPAC may appoint
12non-licensed persons who are associated with professional
13organizations representing licensed healthcare providers.
14Non-licensed members shall serve as non-voting members. A
15majority of the PMPAC shall be licensed health care providers
16who are licensed to prescribe controlled substances. The
17Committee shall serve in a consultant context regarding
18longitudinal evaluations of compliance with evidence based
19clinical practice and the prescribing of controlled
20substances. The Committee shall make recommendations regarding
21scheduling of controlled substances and recommendations
22concerning continuing education designed at improving the
23health and safety of the citizens of Illinois regarding
24pharmacotherapies of controlled substances.
25    (oo) "Production" or "produce" means manufacture,
26planting, cultivating, growing, or harvesting of a controlled

 

 

09800SB1454sam005- 24 -LRB098 09389 RLC 45858 a

1substance other than methamphetamine.
2    (pp) "Registrant" means every person who is required to
3register under Section 302 of this Act.
4    (qq) "Registry number" means the number assigned to each
5person authorized to handle controlled substances under the
6laws of the United States and of this State.
7    (qq-5) "Secretary" means, as the context requires, either
8the Secretary of the Department or the Secretary of the
9Department of Financial and Professional Regulation, and the
10Secretary's designated agents.
11    (rr) "State" includes the State of Illinois and any state,
12district, commonwealth, territory, insular possession thereof,
13and any area subject to the legal authority of the United
14States of America.
15    (rr-5) "Stimulant" means any drug that (i) causes an
16overall excitation of central nervous system functions, (ii)
17causes impaired consciousness and awareness, and (iii) can be
18habit-forming or lead to a substance abuse problem, including
19but not limited to amphetamines and their analogs,
20methylphenidate and its analogs, cocaine, and phencyclidine
21and its analogs.
22    (ss) "Ultimate user" means a person who lawfully possesses
23a controlled substance for his or her own use or for the use of
24a member of his or her household or for administering to an
25animal owned by him or her or by a member of his or her
26household.

 

 

09800SB1454sam005- 25 -LRB098 09389 RLC 45858 a

1(Source: P.A. 96-189, eff. 8-10-09; 96-268, eff. 8-11-09;
297-334, eff. 1-1-12.)
 
3    (720 ILCS 570/208.5 new)
4    Sec. 208.5. Dihydrocodeinone (Hydrocodone).
5    (a) Dihydrocodeinone (Hydrocodone) with one or more
6active, non-narcotic ingredients in regional therapeutic
7amounts is a Schedule III controlled substance, subject to the
8requirements for prescribing of Schedule III controlled
9substances with the exception that any prescription must be
10limited to no more than a 30-day supply with any continuation
11requiring a new prescription. Prescribers may issue multiple
12prescriptions (3 sequential 30-day supplies) for
13Dihydrocodeinone (Hydrocodone), authorizing up to a 90-day
14supply. Before authorizing a 90-day supply of Dihydrocodeinone
15(Hydrocodone), the prescriber must meet the following
16conditions:
17        (1) each separate prescription must be issued for a
18    legitimate medical purpose by an individual prescriber
19    acting in the usual course of professional practice; and
20        (2) the individual prescriber must provide written
21    instructions on each prescription (other than the first
22    prescription, if the prescribing physician intends for the
23    prescription to be filled immediately) indicating the
24    earliest date on which a pharmacy may fill that
25    prescription.

 

 

09800SB1454sam005- 26 -LRB098 09389 RLC 45858 a

1    (b) Nothing in this Section shall be construed to affect
2hospitals, long-term care facilities, hospices, and other
3institutions addressed in Section 313.
 
4    (720 ILCS 570/316)
5    Sec. 316. Prescription monitoring program.
6    (a) The Department must provide for a prescription
7monitoring program for Schedule II, III, IV, and V controlled
8substances, the purpose of which is to develop a clinical tool
9to assist healthcare providers in preventing accidental
10overdoses or duplications of controlled substances to the
11patients they are treating. The Program shall include that
12includes the following components and requirements:
13        (1) The dispenser must transmit to the central
14    repository, in a form and manner specified by the
15    Department, the following information:
16            (A) The recipient's name.
17            (B) The recipient's address.
18            (C) The national drug code number of the controlled
19        substance dispensed.
20            (D) The date the controlled substance is
21        dispensed.
22            (E) The quantity of the controlled substance
23        dispensed.
24            (F) The dispenser's United States Drug Enforcement
25        Administration registration number.

 

 

09800SB1454sam005- 27 -LRB098 09389 RLC 45858 a

1            (G) The prescriber's United States Drug
2        Enforcement Administration registration number.
3            (H) The dates the controlled substance
4        prescription is filled.
5            (I) The payment type used to purchase the
6        controlled substance (i.e. Medicaid, cash, third party
7        insurance).
8            (J) The patient location code (i.e. home, nursing
9        home, outpatient, etc.) for the controlled substances
10        other than those filled at a retail pharmacy.
11            (K) Any additional information that may be
12        required by the department by administrative rule,
13        including but not limited to information required for
14        compliance with the criteria for electronic reporting
15        of the American Society for Automation and Pharmacy or
16        its successor.
17        (2) The information required to be transmitted under
18    this Section must be transmitted not more than 7 days after
19    the date on which a controlled substance is dispensed, or
20    at such other time as may be required by the Department by
21    administrative rule.
22        (3) A dispenser must transmit the information required
23    under this Section by:
24            (A) an electronic device compatible with the
25        receiving device of the central repository;
26            (B) a computer diskette;

 

 

09800SB1454sam005- 28 -LRB098 09389 RLC 45858 a

1            (C) a magnetic tape; or
2            (D) a pharmacy universal claim form or Pharmacy
3        Inventory Control form;
4        (4) The Department may impose a civil fine of up to
5    $100 per day for willful failure to report controlled
6    substance dispensing to the Prescription Monitoring
7    Program. The fine shall be calculated on no more than the
8    number of days from the time the report was required to be
9    made until the time the problem was resolved, and shall be
10    payable to the Prescription Monitoring Program.
11    (b) The Department, by rule, may include in the monitoring
12program certain other select drugs that are not included in
13Schedule II, III, IV, or V. The prescription monitoring program
14does not apply to controlled substance prescriptions as
15exempted under Section 313.
16    (c) The collection of data on select drugs and scheduled
17substances by the Prescription Monitoring Program may be used
18as a tool for addressing oversight requirements of long-term
19care institutions as set forth by Public Act 96-1372. Long-term
20care pharmacies shall transmit patient medication profiles to
21the Prescription Monitoring Program monthly or more frequently
22as established by administrative rule.
23    (d) By January 1, 2018, all Electronic Health Records
24Systems should interface with the Prescription Monitoring
25Program application program interface to insure that all
26providers have access to specific patient records as they are

 

 

09800SB1454sam005- 29 -LRB098 09389 RLC 45858 a

1treating the patient. No prescriber shall be fined or otherwise
2penalized if the electronic health records system he or she is
3using does not effectively interface with the Prescription
4Monitoring Program.
5(Source: P.A. 97-334, eff. 1-1-12.)
 
6    (720 ILCS 570/317.5 new)
7    Sec. 317.5. Access to the Prescription Monitoring Program
8Database.
9    (a) All licensed prescribers of controlled substances may
10register for individual access to the Prescription Monitoring
11Program, where the data is to be used in treating their
12patients.
13    (b) Those licensed prescribers who have registered to
14access the Prescription Monitoring Program, may authorize a
15designee to consult the Prescription Monitoring Program on
16their behalf. The practitioner assumes all liability from that
17authorization. The Prescription Monitoring Program Advisory
18Committee shall draft rules with reasonable parameters
19concerning a practitioner's authority to authorize a designee.
20    (c) Any Electronic Medical Records System may apply for
21access to the Prescription Monitoring Program on behalf of
22their enrolled practitioners.
23    (d) A Pharmacist-in-charge (PIC) or his or her designee
24(which may be permitted by administrative rules) may register
25for individual access to the Prescription Monitoring Program.

 

 

09800SB1454sam005- 30 -LRB098 09389 RLC 45858 a

1    (e) Any Pharmacy Electronic Record System may apply for
2access to the Prescription Monitoring Program on behalf of
3their enrolled pharmacies to streamline access to patient
4specific data to address provision of pharmaceutical care.
5    (f) Prescribers, pharmacists, or persons acting on their
6behalf, in good faith, are immune from any recourse (civil or
7criminal liability, or professional discipline) arising from
8any false, incomplete or inaccurate information submitted to or
9reported to the Prescription Monitoring Program registry.
 
10    (720 ILCS 570/319)
11    Sec. 319. Rules. The Department must adopt rules under the
12Illinois Administrative Procedure Act to implement Sections
13316 through 321, including the following:
14        (1) Information collection and retrieval procedures
15    for the central repository, including the controlled
16    substances to be included in the program required under
17    Section 316 and Section 321 (now repealed).
18        (2) Design for the creation of the database required
19    under Section 317.
20        (3) Requirements for the development and installation
21    of on-line electronic access by the Department to
22    information collected by the central repository.
23        (4) The process for choosing members for the advisory
24    committee, the clinical consulting long term care advisory
25    committee, and the clinical outcomes research group under

 

 

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1    the direction of the Prescription Monitoring Program
2    Clinical Director.
3(Source: P.A. 97-334, eff. 1-1-12.)
 
4    (720 ILCS 570/320)
5    Sec. 320. Advisory committee.
6    (a) The Secretary of the Department of Human Services must
7appoint an advisory committee to assist the Department in
8implementing the controlled substance prescription monitoring
9program created by Section 316 and former Section 321 of this
10Act. The Advisory Committee consists of prescribers and
11dispensers.
12    (b) The Secretary of the Department of Human Services or
13his or her designee must determine the number of members to
14serve on the advisory committee. The Chair of the Prescription
15Monitoring Program Advisory Committee and the other clinical
16consulting committees shall be the Prescription Monitoring
17Program Clinical Director Secretary must choose one of the
18members of the advisory committee to serve as chair of the
19committee.
20    (c) The advisory committee may appoint its other officers
21as it deems appropriate.
22    (d) The members of the advisory committee shall receive no
23compensation for their services as members of the advisory
24committee but may be reimbursed for their actual expenses
25incurred in serving on the advisory committee.

 

 

09800SB1454sam005- 32 -LRB098 09389 RLC 45858 a

1    (e) The advisory committee shall:
2        (1) provide a uniform approach to reviewing this Act in
3    order to determine whether changes should be recommended to
4    the General Assembly.
5        (2) review current drug schedules in order to manage
6    changes to the administrative rules pertaining to the
7    utilization of this Act.
8(Source: P.A. 97-334, eff. 1-1-12.)".