Full Text of SB1454 98th General Assembly
SB1454eng 98TH GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning health.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 5. The Wholesale Drug Distribution Licensing Act is | 5 | | amended by changing Section 40 as follows:
| 6 | | (225 ILCS 120/40) (from Ch. 111, par. 8301-40)
| 7 | | (Section scheduled to be repealed on January 1, 2023)
| 8 | | Sec. 40. Rules and regulations. The Department shall
make | 9 | | any rules and regulations, not inconsistent with law, as may be
| 10 | | necessary to carry out the purposes and enforce the provisions | 11 | | of this Act.
Rules and regulations that incorporate and set | 12 | | detailed standards for
meeting each of the license | 13 | | prerequisites set forth in Section 25 of this
Act shall be | 14 | | adopted no later than September 14, 1992.
All rules and | 15 | | regulations promulgated under this Section shall
conform to | 16 | | wholesale drug distributor licensing guidelines formally | 17 | | adopted
by the FDA at 21 C.F.R. Part 205. In case of conflict | 18 | | between any rule
or regulation adopted by the Department and | 19 | | any FDA wholesale drug
distributor guideline, the FDA guideline | 20 | | shall control.
| 21 | | Notwithstanding any other provision of law, a distributor | 22 | | licensed and regulated by the Department of Financial and | 23 | | Professional Regulation, and registered and regulated by the |
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| 1 | | United States Drug Enforcement Administration, shall be exempt | 2 | | from the storage, reporting, ordering, record keeping, and | 3 | | physical security control requirements for Schedule II | 4 | | controlled substances with regard to any material, compound, | 5 | | mixture, or preparation containing Hydrocodone. These | 6 | | controlled substances shall be subject to the same requirements | 7 | | as those imposed for Schedule III controlled substances. | 8 | | (Source: P.A. 87-594 .)
| 9 | | Section 10. The Illinois Controlled Substances Act is | 10 | | amended by changing Sections 102, 316, 319, and 320 and by | 11 | | adding Sections 208.5 and 317.5 as follows: | 12 | | (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) | 13 | | Sec. 102. Definitions. As used in this Act, unless the | 14 | | context
otherwise requires:
| 15 | | (a) "Addict" means any person who habitually uses any drug, | 16 | | chemical,
substance or dangerous drug other than alcohol so as | 17 | | to endanger the public
morals, health, safety or welfare or who | 18 | | is so far addicted to the use of a
dangerous drug or controlled | 19 | | substance other than alcohol as to have lost
the power of self | 20 | | control with reference to his or her addiction.
| 21 | | (b) "Administer" means the direct application of a | 22 | | controlled
substance, whether by injection, inhalation, | 23 | | ingestion, or any other
means, to the body of a patient, | 24 | | research subject, or animal (as
defined by the Humane |
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| 1 | | Euthanasia in Animal Shelters Act) by:
| 2 | | (1) a practitioner (or, in his or her presence, by his | 3 | | or her authorized agent),
| 4 | | (2) the patient or research subject pursuant to an | 5 | | order, or
| 6 | | (3) a euthanasia technician as defined by the Humane | 7 | | Euthanasia in
Animal Shelters Act.
| 8 | | (c) "Agent" means an authorized person who acts on behalf | 9 | | of or at
the direction of a manufacturer, distributor, | 10 | | dispenser, prescriber, or practitioner. It does not
include a | 11 | | common or contract carrier, public warehouseman or employee of
| 12 | | the carrier or warehouseman.
| 13 | | (c-1) "Anabolic Steroids" means any drug or hormonal | 14 | | substance,
chemically and pharmacologically related to | 15 | | testosterone (other than
estrogens, progestins, | 16 | | corticosteroids, and dehydroepiandrosterone),
and includes:
| 17 | | (i) 3[beta],17-dihydroxy-5a-androstane, | 18 | | (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, | 19 | | (iii) 5[alpha]-androstan-3,17-dione, | 20 | | (iv) 1-androstenediol (3[beta], | 21 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 22 | | (v) 1-androstenediol (3[alpha], | 23 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 24 | | (vi) 4-androstenediol | 25 | | (3[beta],17[beta]-dihydroxy-androst-4-ene), | 26 | | (vii) 5-androstenediol |
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| 1 | | (3[beta],17[beta]-dihydroxy-androst-5-ene), | 2 | | (viii) 1-androstenedione | 3 | | ([5alpha]-androst-1-en-3,17-dione), | 4 | | (ix) 4-androstenedione | 5 | | (androst-4-en-3,17-dione), | 6 | | (x) 5-androstenedione | 7 | | (androst-5-en-3,17-dione), | 8 | | (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- | 9 | | hydroxyandrost-4-en-3-one), | 10 | | (xii) boldenone (17[beta]-hydroxyandrost- | 11 | | 1,4,-diene-3-one), | 12 | | (xiii) boldione (androsta-1,4- | 13 | | diene-3,17-dione), | 14 | | (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 | 15 | | [beta]-hydroxyandrost-4-en-3-one), | 16 | | (xv) clostebol (4-chloro-17[beta]- | 17 | | hydroxyandrost-4-en-3-one), | 18 | | (xvi) dehydrochloromethyltestosterone (4-chloro- | 19 | | 17[beta]-hydroxy-17[alpha]-methyl- | 20 | | androst-1,4-dien-3-one), | 21 | | (xvii) desoxymethyltestosterone | 22 | | (17[alpha]-methyl-5[alpha] | 23 | | -androst-2-en-17[beta]-ol)(a.k.a., madol), | 24 | | (xviii) [delta]1-dihydrotestosterone (a.k.a. | 25 | | '1-testosterone') (17[beta]-hydroxy- | 26 | | 5[alpha]-androst-1-en-3-one), |
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| 1 | | (xix) 4-dihydrotestosterone (17[beta]-hydroxy- | 2 | | androstan-3-one), | 3 | | (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- | 4 | | 5[alpha]-androstan-3-one), | 5 | | (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- | 6 | | hydroxyestr-4-ene), | 7 | | (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- | 8 | | 1[beta],17[beta]-dihydroxyandrost-4-en-3-one), | 9 | | (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], | 10 | | 17[beta]-dihydroxyandrost-1,4-dien-3-one), | 11 | | (xxiv) furazabol (17[alpha]-methyl-17[beta]- | 12 | | hydroxyandrostano[2,3-c]-furazan), | 13 | | (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one) | 14 | | (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- | 15 | | androst-4-en-3-one), | 16 | | (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- | 17 | | dihydroxy-estr-4-en-3-one), | 18 | | (xxviii) mestanolone (17[alpha]-methyl-17[beta]- | 19 | | hydroxy-5-androstan-3-one), | 20 | | (xxix) mesterolone (1amethyl-17[beta]-hydroxy- | 21 | | [5a]-androstan-3-one), | 22 | | (xxx) methandienone (17[alpha]-methyl-17[beta]- | 23 | | hydroxyandrost-1,4-dien-3-one), | 24 | | (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- | 25 | | dihydroxyandrost-5-ene), | 26 | | (xxxii) methenolone (1-methyl-17[beta]-hydroxy- |
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| 1 | | 5[alpha]-androst-1-en-3-one), | 2 | | (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- | 3 | | dihydroxy-5a-androstane), | 4 | | (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy | 5 | | -5a-androstane), | 6 | | (xxxv) 17[alpha]-methyl-3[beta],17[beta]- | 7 | | dihydroxyandrost-4-ene), | 8 | | (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- | 9 | | methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), | 10 | | (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- | 11 | | hydroxyestra-4,9(10)-dien-3-one), | 12 | | (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- | 13 | | hydroxyestra-4,9-11-trien-3-one), | 14 | | (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- | 15 | | hydroxyandrost-4-en-3-one), | 16 | | (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- | 17 | | hydroxyestr-4-en-3-one), | 18 | | (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone | 19 | | (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- | 20 | | androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- | 21 | | 1-testosterone'), | 22 | | (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), | 23 | | (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- | 24 | | dihydroxyestr-4-ene), | 25 | | (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- | 26 | | dihydroxyestr-4-ene), |
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| 1 | | (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- | 2 | | dihydroxyestr-5-ene), | 3 | | (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- | 4 | | dihydroxyestr-5-ene), | 5 | | (xlvii) 19-nor-4,9(10)-androstadienedione | 6 | | (estra-4,9(10)-diene-3,17-dione), | 7 | | (xlviii) 19-nor-4-androstenedione (estr-4- | 8 | | en-3,17-dione), | 9 | | (xlix) 19-nor-5-androstenedione (estr-5- | 10 | | en-3,17-dione), | 11 | | (l) norbolethone (13[beta], 17a-diethyl-17[beta]- | 12 | | hydroxygon-4-en-3-one), | 13 | | (li) norclostebol (4-chloro-17[beta]- | 14 | | hydroxyestr-4-en-3-one), | 15 | | (lii) norethandrolone (17[alpha]-ethyl-17[beta]- | 16 | | hydroxyestr-4-en-3-one), | 17 | | (liii) normethandrolone (17[alpha]-methyl-17[beta]- | 18 | | hydroxyestr-4-en-3-one), | 19 | | (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- | 20 | | 2-oxa-5[alpha]-androstan-3-one), | 21 | | (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- | 22 | | dihydroxyandrost-4-en-3-one), | 23 | | (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- | 24 | | 17[beta]-hydroxy-(5[alpha]-androstan-3-one), | 25 | | (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- | 26 | | (5[alpha]-androst-2-eno[3,2-c]-pyrazole), |
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| 1 | | (lviii) stenbolone (17[beta]-hydroxy-2-methyl- | 2 | | (5[alpha]-androst-1-en-3-one), | 3 | | (lix) testolactone (13-hydroxy-3-oxo-13,17- | 4 | | secoandrosta-1,4-dien-17-oic | 5 | | acid lactone), | 6 | | (lx) testosterone (17[beta]-hydroxyandrost- | 7 | | 4-en-3-one), | 8 | | (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- | 9 | | diethyl-17[beta]-hydroxygon- | 10 | | 4,9,11-trien-3-one), | 11 | | (lxii) trenbolone (17[beta]-hydroxyestr-4,9, | 12 | | 11-trien-3-one).
| 13 | | Any person who is otherwise lawfully in possession of an | 14 | | anabolic
steroid, or who otherwise lawfully manufactures, | 15 | | distributes, dispenses,
delivers, or possesses with intent to | 16 | | deliver an anabolic steroid, which
anabolic steroid is | 17 | | expressly intended for and lawfully allowed to be
administered | 18 | | through implants to livestock or other nonhuman species, and
| 19 | | which is approved by the Secretary of Health and Human Services | 20 | | for such
administration, and which the person intends to | 21 | | administer or have
administered through such implants, shall | 22 | | not be considered to be in
unauthorized possession or to | 23 | | unlawfully manufacture, distribute, dispense,
deliver, or | 24 | | possess with intent to deliver such anabolic steroid for
| 25 | | purposes of this Act.
| 26 | | (d) "Administration" means the Drug Enforcement |
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| 1 | | Administration,
United States Department of Justice, or its | 2 | | successor agency.
| 3 | | (d-5) "Clinical Director, Prescription Monitoring Program" | 4 | | means a Department of Human Services administrative employee | 5 | | licensed to either prescribe or dispense controlled substances | 6 | | who shall run the clinical aspects of the Department of Human | 7 | | Services Prescription Monitoring Program and its Prescription | 8 | | Information Library. | 9 | | (d-10) "Compounding" means the preparation and mixing of | 10 | | components, excluding flavorings, (1) as the result of a | 11 | | prescriber's prescription drug order or initiative based on the | 12 | | prescriber-patient-pharmacist relationship in the course of | 13 | | professional practice or (2) for the purpose of, or incident | 14 | | to, research, teaching, or chemical analysis and not for sale | 15 | | or dispensing. "Compounding" includes the preparation of drugs | 16 | | or devices in anticipation of receiving prescription drug | 17 | | orders based on routine, regularly observed dispensing | 18 | | patterns. Commercially available products may be compounded | 19 | | for dispensing to individual patients only if both of the | 20 | | following conditions are met: (i) the commercial product is not | 21 | | reasonably available from normal distribution channels in a | 22 | | timely manner to meet the patient's needs and (ii) the | 23 | | prescribing practitioner has requested that the drug be | 24 | | compounded. | 25 | | (e) "Control" means to add a drug or other substance, or | 26 | | immediate
precursor, to a Schedule whether by
transfer from |
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| 1 | | another Schedule or otherwise.
| 2 | | (f) "Controlled Substance" means (i) a drug, substance, or | 3 | | immediate
precursor in the Schedules of Article II of this Act | 4 | | or (ii) a drug or other substance, or immediate precursor, | 5 | | designated as a controlled substance by the Department through | 6 | | administrative rule. The term does not include distilled | 7 | | spirits, wine, malt beverages, or tobacco, as those terms are
| 8 | | defined or used in the Liquor Control Act and the Tobacco | 9 | | Products Tax
Act.
| 10 | | (f-5) "Controlled substance analog" means a substance: | 11 | | (1) the chemical structure of which is substantially | 12 | | similar to the chemical structure of a controlled substance | 13 | | in Schedule I or II; | 14 | | (2) which has a stimulant, depressant, or | 15 | | hallucinogenic effect on the central nervous system that is | 16 | | substantially similar to or greater than the stimulant, | 17 | | depressant, or hallucinogenic effect on the central | 18 | | nervous system of a controlled substance in Schedule I or | 19 | | II; or | 20 | | (3) with respect to a particular person, which such | 21 | | person represents or intends to have a stimulant, | 22 | | depressant, or hallucinogenic effect on the central | 23 | | nervous system that is substantially similar to or greater | 24 | | than the stimulant, depressant, or hallucinogenic effect | 25 | | on the central nervous system of a controlled substance in | 26 | | Schedule I or II. |
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| 1 | | (g) "Counterfeit substance" means a controlled substance, | 2 | | which, or
the container or labeling of which, without | 3 | | authorization bears the
trademark, trade name, or other | 4 | | identifying mark, imprint, number or
device, or any likeness | 5 | | thereof, of a manufacturer, distributor, or
dispenser other | 6 | | than the person who in fact manufactured, distributed,
or | 7 | | dispensed the substance.
| 8 | | (h) "Deliver" or "delivery" means the actual, constructive | 9 | | or
attempted transfer of possession of a controlled substance, | 10 | | with or
without consideration, whether or not there is an | 11 | | agency relationship.
| 12 | | (i) "Department" means the Illinois Department of Human | 13 | | Services (as
successor to the Department of Alcoholism and | 14 | | Substance Abuse) or its successor agency.
| 15 | | (j) (Blank).
| 16 | | (k) "Department of Corrections" means the Department of | 17 | | Corrections
of the State of Illinois or its successor agency.
| 18 | | (l) "Department of Financial and Professional Regulation" | 19 | | means the Department
of Financial and Professional Regulation | 20 | | of the State of Illinois or its successor agency.
| 21 | | (m) "Depressant" means any drug that (i) causes an overall | 22 | | depression of central nervous system functions, (ii) causes | 23 | | impaired consciousness and awareness, and (iii) can be | 24 | | habit-forming or lead to a substance abuse problem, including | 25 | | but not limited to alcohol, cannabis and its active principles | 26 | | and their analogs, benzodiazepines and their analogs, |
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| 1 | | barbiturates and their analogs, opioids (natural and | 2 | | synthetic) and their analogs, and chloral hydrate and similar | 3 | | sedative hypnotics.
| 4 | | (n) (Blank).
| 5 | | (o) "Director" means the Director of the Illinois State | 6 | | Police or his or her designated agents.
| 7 | | (p) "Dispense" means to deliver a controlled substance to | 8 | | an
ultimate user or research subject by or pursuant to the | 9 | | lawful order of
a prescriber, including the prescribing, | 10 | | administering, packaging,
labeling, or compounding necessary | 11 | | to prepare the substance for that
delivery.
| 12 | | (q) "Dispenser" means a practitioner who dispenses.
| 13 | | (r) "Distribute" means to deliver, other than by | 14 | | administering or
dispensing, a controlled substance.
| 15 | | (s) "Distributor" means a person who distributes.
| 16 | | (t) "Drug" means (1) substances recognized as drugs in the | 17 | | official
United States Pharmacopoeia, Official Homeopathic | 18 | | Pharmacopoeia of the
United States, or official National | 19 | | Formulary, or any supplement to any
of them; (2) substances | 20 | | intended for use in diagnosis, cure, mitigation,
treatment, or | 21 | | prevention of disease in man or animals; (3) substances
(other | 22 | | than food) intended to affect the structure of any function of
| 23 | | the body of man or animals and (4) substances intended for use | 24 | | as a
component of any article specified in clause (1), (2), or | 25 | | (3) of this
subsection. It does not include devices or their | 26 | | components, parts, or
accessories.
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| 1 | | (t-3) "Electronic health record" or "EHR" means a | 2 | | systematic collection of electronic health information about | 3 | | individual patients. The EHR is a digital format that is | 4 | | capable of being shared across different health care settings. | 5 | | (t-5) "Euthanasia agency" means
an entity certified by the | 6 | | Department of Financial and Professional Regulation for the
| 7 | | purpose of animal euthanasia that holds an animal control | 8 | | facility license or
animal
shelter license under the Animal | 9 | | Welfare Act. A euthanasia agency is
authorized to purchase, | 10 | | store, possess, and utilize Schedule II nonnarcotic and
| 11 | | Schedule III nonnarcotic drugs for the sole purpose of animal | 12 | | euthanasia.
| 13 | | (t-10) "Euthanasia drugs" means Schedule II or Schedule III | 14 | | substances
(nonnarcotic controlled substances) that are used | 15 | | by a euthanasia agency for
the purpose of animal euthanasia.
| 16 | | (u) "Good faith" means the prescribing or dispensing of a | 17 | | controlled
substance by a practitioner in the regular course of | 18 | | professional
treatment to or for any person who is under his or | 19 | | her treatment for a
pathology or condition other than that | 20 | | individual's physical or
psychological dependence upon or | 21 | | addiction to a controlled substance,
except as provided herein: | 22 | | and application of the term to a pharmacist
shall mean the | 23 | | dispensing of a controlled substance pursuant to the
| 24 | | prescriber's order which in the professional judgment of the | 25 | | pharmacist
is lawful. The pharmacist shall be guided by | 26 | | accepted professional
standards including, but not limited to |
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| 1 | | the following, in making the
judgment:
| 2 | | (1) lack of consistency of prescriber-patient | 3 | | relationship,
| 4 | | (2) frequency of prescriptions for same drug by one | 5 | | prescriber for
large numbers of patients,
| 6 | | (3) quantities beyond those normally prescribed,
| 7 | | (4) unusual dosages (recognizing that there may be | 8 | | clinical circumstances where more or less than the usual | 9 | | dose may be used legitimately),
| 10 | | (5) unusual geographic distances between patient, | 11 | | pharmacist and
prescriber,
| 12 | | (6) consistent prescribing of habit-forming drugs.
| 13 | | (u-0.5) "Hallucinogen" means a drug that causes markedly | 14 | | altered sensory perception leading to hallucinations of any | 15 | | type. | 16 | | (u-1) "Home infusion services" means services provided by a | 17 | | pharmacy in
compounding solutions for direct administration to | 18 | | a patient in a private
residence, long-term care facility, or | 19 | | hospice setting by means of parenteral,
intravenous, | 20 | | intramuscular, subcutaneous, or intraspinal infusion.
| 21 | | (u-5) "Illinois State Police" means the State
Police of the | 22 | | State of Illinois, or its successor agency. | 23 | | (v) "Immediate precursor" means a substance:
| 24 | | (1) which the Department has found to be and by rule | 25 | | designated as
being a principal compound used, or produced | 26 | | primarily for use, in the
manufacture of a controlled |
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| 1 | | substance;
| 2 | | (2) which is an immediate chemical intermediary used or | 3 | | likely to
be used in the manufacture of such controlled | 4 | | substance; and
| 5 | | (3) the control of which is necessary to prevent, | 6 | | curtail or limit
the manufacture of such controlled | 7 | | substance.
| 8 | | (w) "Instructional activities" means the acts of teaching, | 9 | | educating
or instructing by practitioners using controlled | 10 | | substances within
educational facilities approved by the State | 11 | | Board of Education or
its successor agency.
| 12 | | (x) "Local authorities" means a duly organized State, | 13 | | County or
Municipal peace unit or police force.
| 14 | | (y) "Look-alike substance" means a substance, other than a | 15 | | controlled
substance which (1) by overall dosage unit | 16 | | appearance, including shape,
color, size, markings or lack | 17 | | thereof, taste, consistency, or any other
identifying physical | 18 | | characteristic of the substance, would lead a reasonable
person | 19 | | to believe that the substance is a controlled substance, or (2) | 20 | | is
expressly or impliedly represented to be a controlled | 21 | | substance or is
distributed under circumstances which would | 22 | | lead a reasonable person to
believe that the substance is a | 23 | | controlled substance. For the purpose of
determining whether | 24 | | the representations made or the circumstances of the
| 25 | | distribution would lead a reasonable person to believe the | 26 | | substance to be
a controlled substance under this clause (2) of |
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| 1 | | subsection (y), the court or
other authority may consider the | 2 | | following factors in addition to any other
factor that may be | 3 | | relevant:
| 4 | | (a) statements made by the owner or person in control | 5 | | of the substance
concerning its nature, use or effect;
| 6 | | (b) statements made to the buyer or recipient that the | 7 | | substance may
be resold for profit;
| 8 | | (c) whether the substance is packaged in a manner | 9 | | normally used for the
illegal distribution of controlled | 10 | | substances;
| 11 | | (d) whether the distribution or attempted distribution | 12 | | included an
exchange of or demand for money or other | 13 | | property as consideration, and
whether the amount of the | 14 | | consideration was substantially greater than the
| 15 | | reasonable retail market value of the substance.
| 16 | | Clause (1) of this subsection (y) shall not apply to a | 17 | | noncontrolled
substance in its finished dosage form that was | 18 | | initially introduced into
commerce prior to the initial | 19 | | introduction into commerce of a controlled
substance in its | 20 | | finished dosage form which it may substantially resemble.
| 21 | | Nothing in this subsection (y) prohibits the dispensing or | 22 | | distributing
of noncontrolled substances by persons authorized | 23 | | to dispense and
distribute controlled substances under this | 24 | | Act, provided that such action
would be deemed to be carried | 25 | | out in good faith under subsection (u) if the
substances | 26 | | involved were controlled substances.
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| 1 | | Nothing in this subsection (y) or in this Act prohibits the | 2 | | manufacture,
preparation, propagation, compounding, | 3 | | processing, packaging, advertising
or distribution of a drug or | 4 | | drugs by any person registered pursuant to
Section 510 of the | 5 | | Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
| 6 | | (y-1) "Mail-order pharmacy" means a pharmacy that is | 7 | | located in a state
of the United States that delivers, | 8 | | dispenses or
distributes, through the United States Postal | 9 | | Service or other common
carrier, to Illinois residents, any | 10 | | substance which requires a prescription.
| 11 | | (z) "Manufacture" means the production, preparation, | 12 | | propagation,
compounding, conversion or processing of a | 13 | | controlled substance other than methamphetamine, either
| 14 | | directly or indirectly, by extraction from substances of | 15 | | natural origin,
or independently by means of chemical | 16 | | synthesis, or by a combination of
extraction and chemical | 17 | | synthesis, and includes any packaging or
repackaging of the | 18 | | substance or labeling of its container, except that
this term | 19 | | does not include:
| 20 | | (1) by an ultimate user, the preparation or compounding | 21 | | of a
controlled substance for his or her own use; or
| 22 | | (2) by a practitioner, or his or her authorized agent | 23 | | under his or her
supervision, the preparation, | 24 | | compounding, packaging, or labeling of a
controlled | 25 | | substance:
| 26 | | (a) as an incident to his or her administering or |
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| 1 | | dispensing of a
controlled substance in the course of | 2 | | his or her professional practice; or
| 3 | | (b) as an incident to lawful research, teaching or | 4 | | chemical
analysis and not for sale.
| 5 | | (z-1) (Blank).
| 6 | | (z-5) "Medication shopping" means the conduct prohibited | 7 | | under subsection (a) of Section 314.5 of this Act. | 8 | | (z-10) "Mid-level practitioner" means (i) a physician | 9 | | assistant who has been delegated authority to prescribe through | 10 | | a written delegation of authority by a physician licensed to | 11 | | practice medicine in all of its branches, in accordance with | 12 | | Section 7.5 of the Physician Assistant Practice Act of 1987, | 13 | | (ii) an advanced practice nurse who has been delegated | 14 | | authority to prescribe through a written delegation of | 15 | | authority by a physician licensed to practice medicine in all | 16 | | of its branches or by a podiatrist, in accordance with Section | 17 | | 65-40 of the Nurse Practice Act, or (iii) an animal euthanasia | 18 | | agency. | 19 | | (aa) "Narcotic drug" means any of the following, whether | 20 | | produced
directly or indirectly by extraction from substances | 21 | | of vegetable origin,
or independently by means of chemical | 22 | | synthesis, or by a combination of
extraction and chemical | 23 | | synthesis:
| 24 | | (1) opium, opiates, derivatives of opium and opiates, | 25 | | including their isomers, esters, ethers, salts, and salts | 26 | | of isomers, esters, and ethers, whenever the existence of |
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| 1 | | such isomers, esters, ethers, and salts is possible within | 2 | | the specific chemical designation; however the term | 3 | | "narcotic drug" does not include the isoquinoline | 4 | | alkaloids of opium;
| 5 | | (2) (blank);
| 6 | | (3) opium poppy and poppy straw;
| 7 | | (4) coca leaves, except coca leaves and extracts of | 8 | | coca leaves from which substantially all of the cocaine and | 9 | | ecgonine, and their isomers, derivatives and salts, have | 10 | | been removed;
| 11 | | (5) cocaine, its salts, optical and geometric isomers, | 12 | | and salts of isomers; | 13 | | (6) ecgonine, its derivatives, their salts, isomers, | 14 | | and salts of isomers; | 15 | | (7) any compound, mixture, or preparation which | 16 | | contains any quantity of any of the substances referred to | 17 | | in subparagraphs (1) through (6). | 18 | | (bb) "Nurse" means a registered nurse licensed under the
| 19 | | Nurse Practice Act.
| 20 | | (cc) (Blank).
| 21 | | (dd) "Opiate" means any substance having an addiction | 22 | | forming or
addiction sustaining liability similar to morphine | 23 | | or being capable of
conversion into a drug having addiction | 24 | | forming or addiction sustaining
liability.
| 25 | | (ee) "Opium poppy" means the plant of the species Papaver
| 26 | | somniferum L., except its seeds.
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| 1 | | (ee-5) "Oral dosage" means a tablet, capsule, elixir, or | 2 | | solution or other liquid form of medication intended for | 3 | | administration by mouth, but the term does not include a form | 4 | | of medication intended for buccal, sublingual, or transmucosal | 5 | | administration. | 6 | | (ff) "Parole and Pardon Board" means the Parole and Pardon | 7 | | Board of
the State of Illinois or its successor agency.
| 8 | | (gg) "Person" means any individual, corporation, | 9 | | mail-order pharmacy,
government or governmental subdivision or | 10 | | agency, business trust, estate,
trust, partnership or | 11 | | association, or any other entity.
| 12 | | (hh) "Pharmacist" means any person who holds a license or | 13 | | certificate of
registration as a registered pharmacist, a local | 14 | | registered pharmacist
or a registered assistant pharmacist | 15 | | under the Pharmacy Practice Act.
| 16 | | (ii) "Pharmacy" means any store, ship or other place in | 17 | | which
pharmacy is authorized to be practiced under the Pharmacy | 18 | | Practice Act.
| 19 | | (ii-5) "Pharmacy shopping" means the conduct prohibited | 20 | | under subsection (b) of Section 314.5 of this Act. | 21 | | (ii-10) "Physician" (except when the context otherwise | 22 | | requires) means a person licensed to practice medicine in all | 23 | | of its branches. | 24 | | (jj) "Poppy straw" means all parts, except the seeds, of | 25 | | the opium
poppy, after mowing.
| 26 | | (kk) "Practitioner" means a physician licensed to practice |
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| 1 | | medicine in all
its branches, dentist, optometrist, | 2 | | podiatrist,
veterinarian, scientific investigator, pharmacist, | 3 | | physician assistant,
advanced practice nurse,
licensed | 4 | | practical
nurse, registered nurse, hospital, laboratory, or | 5 | | pharmacy, or other
person licensed, registered, or otherwise | 6 | | lawfully permitted by the
United States or this State to | 7 | | distribute, dispense, conduct research
with respect to, | 8 | | administer or use in teaching or chemical analysis, a
| 9 | | controlled substance in the course of professional practice or | 10 | | research.
| 11 | | (ll) "Pre-printed prescription" means a written | 12 | | prescription upon which
the designated drug has been indicated | 13 | | prior to the time of issuance; the term does not mean a written | 14 | | prescription that is individually generated by machine or | 15 | | computer in the prescriber's office.
| 16 | | (mm) "Prescriber" means a physician licensed to practice | 17 | | medicine in all
its branches, dentist, optometrist, podiatrist | 18 | | or
veterinarian who issues a prescription, a physician | 19 | | assistant who
issues a
prescription for a controlled substance
| 20 | | in accordance
with Section 303.05, a written delegation, and a | 21 | | written supervision agreement required under Section 7.5
of the
| 22 | | Physician Assistant Practice Act of 1987, or an advanced | 23 | | practice
nurse with prescriptive authority delegated under | 24 | | Section 65-40 of the Nurse Practice Act and in accordance with | 25 | | Section 303.05, a written delegation,
and a written
| 26 | | collaborative agreement under Section 65-35 of the Nurse |
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| 1 | | Practice Act.
| 2 | | (nn) "Prescription" means a written, facsimile, or oral | 3 | | order, or an electronic order that complies with applicable | 4 | | federal requirements,
of
a physician licensed to practice | 5 | | medicine in all its branches,
dentist, podiatrist or | 6 | | veterinarian for any controlled
substance, of an optometrist | 7 | | for a Schedule III, IV, or V controlled substance in accordance | 8 | | with Section 15.1 of the Illinois Optometric Practice Act of | 9 | | 1987, of a physician assistant for a
controlled substance
in | 10 | | accordance with Section 303.05, a written delegation, and a | 11 | | written supervision agreement required under
Section 7.5 of the
| 12 | | Physician Assistant Practice Act of 1987, or of an advanced | 13 | | practice
nurse with prescriptive authority delegated under | 14 | | Section 65-40 of the Nurse Practice Act who issues a | 15 | | prescription for a
controlled substance in accordance
with
| 16 | | Section 303.05, a written delegation, and a written | 17 | | collaborative agreement under Section 65-35 of the Nurse | 18 | | Practice Act when required by law.
| 19 | | (nn-5) "Prescription Information Library" (PIL) means an | 20 | | electronic library that contains reported controlled substance | 21 | | data. | 22 | | (nn-10) "Prescription Monitoring Program" (PMP) means the | 23 | | entity that collects, tracks, and stores reported data on | 24 | | controlled substances and select drugs pursuant to Section 316. | 25 | | (nn-11) "Prescription Monitoring Program Advisory | 26 | | Committee" (PMPAC) means a committee of voting members |
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| 1 | | consisting of licensed healthcare providers representing all | 2 | | professions who are licensed to prescribe or dispense | 3 | | controlled substances. The Chairperson of the PMPAC may appoint | 4 | | non-licensed persons who are associated with professional | 5 | | organizations representing licensed healthcare providers. | 6 | | Non-licensed members shall serve as non-voting members. A | 7 | | majority of the PMPAC shall be licensed health care providers | 8 | | who are licensed to prescribe controlled substances. The | 9 | | Committee shall serve in a consultant context regarding | 10 | | longitudinal evaluations of compliance with evidence based | 11 | | clinical practice and the prescribing of controlled | 12 | | substances. The Committee shall make recommendations regarding | 13 | | scheduling of controlled substances and recommendations | 14 | | concerning continuing education designed at improving the | 15 | | health and safety of the citizens of Illinois regarding | 16 | | pharmacotherapies of controlled substances. | 17 | | (oo) "Production" or "produce" means manufacture, | 18 | | planting,
cultivating, growing, or harvesting of a controlled | 19 | | substance other than methamphetamine.
| 20 | | (pp) "Registrant" means every person who is required to | 21 | | register
under Section 302 of this Act.
| 22 | | (qq) "Registry number" means the number assigned to each | 23 | | person
authorized to handle controlled substances under the | 24 | | laws of the United
States and of this State.
| 25 | | (qq-5) "Secretary" means, as the context requires, either | 26 | | the Secretary of the Department or the Secretary of the |
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| 1 | | Department of Financial and Professional Regulation, and the | 2 | | Secretary's designated agents. | 3 | | (rr) "State" includes the State of Illinois and any state, | 4 | | district,
commonwealth, territory, insular possession thereof, | 5 | | and any area
subject to the legal authority of the United | 6 | | States of America.
| 7 | | (rr-5) "Stimulant" means any drug that (i) causes an | 8 | | overall excitation of central nervous system functions, (ii) | 9 | | causes impaired consciousness and awareness, and (iii) can be | 10 | | habit-forming or lead to a substance abuse problem, including | 11 | | but not limited to amphetamines and their analogs, | 12 | | methylphenidate and its analogs, cocaine, and phencyclidine | 13 | | and its analogs. | 14 | | (ss) "Ultimate user" means a person who lawfully possesses | 15 | | a
controlled substance for his or her own use or for the use of | 16 | | a member of his or her
household or for administering to an | 17 | | animal owned by him or her or by a member
of his or her | 18 | | household.
| 19 | | (Source: P.A. 96-189, eff. 8-10-09; 96-268, eff. 8-11-09; | 20 | | 97-334, eff. 1-1-12 .)
| 21 | | (720 ILCS 570/208.5 new) | 22 | | Sec. 208.5. Dihydrocodeinone (Hydrocodone). | 23 | | (a) Dihydrocodeinone (Hydrocodone) with one or more | 24 | | active, non-narcotic ingredients in regional therapeutic | 25 | | amounts is a Schedule III controlled substance, subject to the |
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| 1 | | requirements for prescribing of Schedule III controlled | 2 | | substances with the exception that any prescription must be | 3 | | limited to no more than a 30-day supply with any continuation | 4 | | requiring a new prescription. Prescribers may issue multiple | 5 | | prescriptions (3 sequential 30-day supplies) for | 6 | | Dihydrocodeinone (Hydrocodone), authorizing up to a 90-day | 7 | | supply. Before authorizing a 90-day supply of Dihydrocodeinone | 8 | | (Hydrocodone), the prescriber must meet the following | 9 | | conditions: | 10 | | (1) each separate prescription must be issued for a | 11 | | legitimate medical purpose by an individual prescriber | 12 | | acting in the usual course of professional practice; and | 13 | | (2) the individual prescriber must provide written | 14 | | instructions on each prescription (other than the first | 15 | | prescription, if the prescribing physician intends for the | 16 | | prescription to be filled immediately) indicating the | 17 | | earliest date on which a pharmacy may fill that | 18 | | prescription. | 19 | | (b) Nothing in this Section shall be construed to affect | 20 | | hospitals, long-term care facilities, hospices, and other | 21 | | institutions addressed in Section 313.
| 22 | | (720 ILCS 570/316)
| 23 | | Sec. 316. Prescription monitoring program. | 24 | | (a) The Department must provide for a
prescription | 25 | | monitoring program for Schedule II, III, IV, and V controlled |
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| 1 | | substances , the purpose of which is to develop a clinical tool | 2 | | to assist healthcare providers in preventing accidental | 3 | | overdoses or duplications of controlled substances to the | 4 | | patients they are treating. The program shall include that | 5 | | includes the following components and requirements:
| 6 | | (1) The
dispenser must transmit to the
central | 7 | | repository, in a form and manner specified by the | 8 | | Department, the following information:
| 9 | | (A) The recipient's name.
| 10 | | (B) The recipient's address.
| 11 | | (C) The national drug code number of the controlled
| 12 | | substance
dispensed.
| 13 | | (D) The date the controlled substance is | 14 | | dispensed.
| 15 | | (E) The quantity of the controlled substance | 16 | | dispensed.
| 17 | | (F) The dispenser's United States Drug Enforcement | 18 | | Administration
registration number.
| 19 | | (G) The prescriber's United States Drug | 20 | | Enforcement Administration
registration number.
| 21 | | (H) The dates the controlled substance | 22 | | prescription is filled. | 23 | | (I) The payment type used to purchase the | 24 | | controlled substance (i.e. Medicaid, cash, third party | 25 | | insurance). | 26 | | (J) The patient location code (i.e. home, nursing |
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| 1 | | home, outpatient, etc.) for the controlled substances | 2 | | other than those filled at a retail pharmacy. | 3 | | (K) Any additional information that may be | 4 | | required by the department by administrative rule, | 5 | | including but not limited to information required for | 6 | | compliance with the criteria for electronic reporting | 7 | | of the American Society for Automation and Pharmacy or | 8 | | its successor.
| 9 | | (2) The information required to be transmitted under | 10 | | this Section must be
transmitted not more than 7 days after | 11 | | the date on which a
controlled substance is dispensed, or | 12 | | at such other time as may be required by the Department by | 13 | | administrative rule.
| 14 | | (3) A dispenser must transmit the information required | 15 | | under this Section
by:
| 16 | | (A) an electronic device compatible with the | 17 | | receiving device of the
central repository;
| 18 | | (B) a computer diskette;
| 19 | | (C) a magnetic tape; or
| 20 | | (D) a pharmacy universal claim form or Pharmacy | 21 | | Inventory Control form;
| 22 | | (4) The Department may impose a civil fine of up to | 23 | | $100 per day for willful failure to report controlled | 24 | | substance dispensing to the Prescription Monitoring | 25 | | Program. The fine shall be calculated on no more than the | 26 | | number of days from the time the report was required to be |
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| 1 | | made until the time the problem was resolved, and shall be | 2 | | payable to the Prescription Monitoring Program.
| 3 | | (b) The Department, by rule, may include in the monitoring | 4 | | program certain other select drugs that are not included in | 5 | | Schedule II, III, IV, or V. The prescription monitoring program | 6 | | does not apply to
controlled substance prescriptions as | 7 | | exempted under Section
313.
| 8 | | (c) The collection of data on select drugs and scheduled | 9 | | substances by the Prescription Monitoring Program may be used | 10 | | as a tool for addressing oversight requirements of long-term | 11 | | care institutions as set forth by Public Act 96-1372. Long-term | 12 | | care pharmacies shall transmit patient medication profiles to | 13 | | the Prescription Monitoring Program monthly or more frequently | 14 | | as established by administrative rule. | 15 | | (d) By January 1, 2018, all Electronic Health Records | 16 | | Systems should interface with the Prescription Monitoring | 17 | | Program application program interface to insure that all | 18 | | providers have access to specific patient records as they are | 19 | | treating the patient. No prescriber shall be fined or otherwise | 20 | | penalized if the electronic health records system he or she is | 21 | | using does not effectively interface with the Prescription | 22 | | Monitoring Program. | 23 | | (Source: P.A. 97-334, eff. 1-1-12.)
| 24 | | (720 ILCS 570/317.5 new) | 25 | | Sec. 317.5. Access to the Prescription Monitoring Program |
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| 1 | | Database. | 2 | | (a) All licensed prescribers of controlled substances may | 3 | | register for individual access to the Prescription Monitoring | 4 | | Program, where the data is to be used in treating their | 5 | | patients. | 6 | | (b) Those licensed prescribers who have registered to | 7 | | access the Prescription Monitoring Program may authorize a | 8 | | designee to consult the Prescription Monitoring Program on | 9 | | their behalf. The practitioner assumes all liability from that | 10 | | authorization. The Prescription Monitoring Program Advisory | 11 | | Committee shall draft rules with reasonable parameters | 12 | | concerning a practitioner's authority to authorize a designee. | 13 | | (c) Any Electronic Medical Records System may apply for | 14 | | access to the Prescription Monitoring Program on behalf of | 15 | | their enrolled practitioners. | 16 | | (d) A pharmacist-in-charge (PIC) or his or her designee | 17 | | (which may be permitted by administrative rules) may register | 18 | | for individual access to the Prescription Monitoring Program. | 19 | | (e) Any Pharmacy Electronic Record System may apply for | 20 | | access to the Prescription Monitoring Program on behalf of | 21 | | their enrolled pharmacies to streamline access to patient | 22 | | specific data to address provision of pharmaceutical care. | 23 | | (f) Prescribers, pharmacists, or persons acting on their | 24 | | behalf, in good faith, are immune from any recourse (civil or | 25 | | criminal liability, or professional discipline) arising from | 26 | | any false, incomplete or inaccurate information submitted to or |
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| 1 | | reported to the Prescription Monitoring Program registry.
| 2 | | (720 ILCS 570/319)
| 3 | | Sec. 319. Rules. The Department must adopt rules under the | 4 | | Illinois
Administrative
Procedure Act to
implement Sections | 5 | | 316 through 321, including the following:
| 6 | | (1) Information collection and retrieval procedures | 7 | | for the central
repository, including the
controlled | 8 | | substances to be included in
the program
required under | 9 | | Section 316 and Section 321 (now repealed).
| 10 | | (2) Design for the creation of the database required | 11 | | under Section
317.
| 12 | | (3) Requirements for the development and installation | 13 | | of on-line
electronic access by the Department to | 14 | | information collected by the
central repository. | 15 | | (4) The process for choosing members for the advisory | 16 | | committee, the clinical consulting long term care advisory | 17 | | committee, and the clinical outcomes research group under | 18 | | the direction of the Prescription Monitoring Program | 19 | | Clinical Director.
| 20 | | (Source: P.A. 97-334, eff. 1-1-12.)
| 21 | | (720 ILCS 570/320)
| 22 | | Sec. 320. Advisory committee.
| 23 | | (a) The Secretary of the Department of Human Services must | 24 | | appoint an advisory committee to
assist the Department in |
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| 1 | | implementing the controlled substance
prescription
monitoring | 2 | | program created by Section 316 and former Section 321 of this | 3 | | Act.
The Advisory Committee consists of prescribers and | 4 | | dispensers.
| 5 | | (b) The Secretary of the Department of Human Services or | 6 | | his or her designee must determine the number of members to
| 7 | | serve on the advisory committee. The Chair of the Prescription | 8 | | Monitoring Program Advisory Committee and the other clinical | 9 | | consulting committees shall be the Prescription Monitoring | 10 | | Program Clinical Director Secretary must choose one of the | 11 | | members
of the advisory committee to serve as chair of the | 12 | | committee .
| 13 | | (c) The advisory committee may appoint its other officers | 14 | | as it deems
appropriate.
| 15 | | (d) The members of the advisory committee shall receive no | 16 | | compensation for
their services as members of the advisory | 17 | | committee but may be reimbursed for
their actual expenses | 18 | | incurred in serving on the advisory committee.
| 19 | | (e) The advisory committee shall: | 20 | | (1) provide a uniform approach to reviewing this Act in | 21 | | order to determine whether changes should be recommended to | 22 | | the General Assembly. | 23 | | (2) review current drug schedules in order to manage | 24 | | changes to the administrative rules pertaining to the | 25 | | utilization of this Act. | 26 | | (Source: P.A. 97-334, eff. 1-1-12.)
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