SB1454sam003 98TH GENERAL ASSEMBLY

Sen. William Delgado

Filed: 4/23/2013

09800SB1454sam003 LRB098 09389 RLC 44962 a

AMENDMENT TO SENATE BILL 1454

AMENDMENT NO. ______. Amend Senate Bill 1454, AS AMENDED, by replacing everything after the enacting clause with the following:

"Section 5. The Wholesale Drug Distribution Licensing Act is amended by changing Section 40 as follows:

(225 ILCS 120/40) (from Ch. 111, par. 8301-40)

(Section scheduled to be repealed on January 1, 2023)

Sec. 40. Rules and regulations. The Department shall make any rules and regulations, not inconsistent with law, as may be necessary to carry out the purposes and enforce the provisions of this Act. Rules and regulations that incorporate and set detailed standards for meeting each of the license prerequisites set forth in Section 25 of this Act shall be adopted no later than September 14, 1992. All rules and regulations promulgated under this Section shall conform to wholesale drug distributor licensing guidelines formally adopted by the FDA at 21 C.F.R. Part 205. In case of conflict between any rule or regulation adopted by the Department and any FDA wholesale drug distributor guideline, the FDA guideline shall control.

Notwithstanding any other provision of law, a distributor licensed and regulated by the Department of Financial and Professional Regulation, and registered and regulated by the United States Drug Enforcement Administration, shall be exempt from the storage, reporting, ordering, record keeping, and physical security control requirements for Schedule II controlled substances with regard to any material, compound, mixture, or preparation containing Hydrocodone. These Controlled Substances shall be subject to the same requirements as those imposed for Schedule III controlled substances.

(Source: P.A. 87-594.)

Section 10. The Illinois Controlled Substances Act is amended by changing Sections 102, 206, 208, 316, 319, and 320 and by adding Section 317.5 as follows:

(720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)

Sec. 102. Definitions. As used in this Act, unless the context otherwise requires:

(a) "Addict" means any person who habitually uses any drug, chemical, substance or dangerous drug other than alcohol so as to endanger the public morals, health, safety or welfare or who is so far addicted to the use of a dangerous drug or controlled substance other than alcohol as to have lost the power of self control with reference to his or her addiction.

(b) "Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion, or any other means, to the body of a patient, research subject, or animal (as defined by the Humane Euthanasia in Animal Shelters Act) by:

(1) a practitioner (or, in his or her presence, by his or her authorized agent),

(2) the patient or research subject pursuant to an order, or

(3) a euthanasia technician as defined by the Humane Euthanasia in Animal Shelters Act.

(c) "Agent" means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, dispenser, prescriber, or practitioner. It does not include a common or contract carrier, public warehouseman or employee of the carrier or warehouseman.

(c-1) "Anabolic Steroids" means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes:

(i) 3[beta],17-dihydroxy-5a-androstane,

(ii) 3[alpha],17[beta]-dihydroxy-5a-androstane,

(iii) 5[alpha]-androstan-3,17-dione,

(iv) 1-androstenediol (3[beta],

17[beta]-dihydroxy-5[alpha]-androst-1-ene),

(v) 1-androstenediol (3[alpha],

17[beta]-dihydroxy-5[alpha]-androst-1-ene),

(vi) 4-androstenediol

(3[beta],17[beta]-dihydroxy-androst-4-ene),

(vii) 5-androstenediol

(3[beta],17[beta]-dihydroxy-androst-5-ene),

(viii) 1-androstenedione

([5alpha]-androst-1-en-3,17-dione),

(ix) 4-androstenedione

(androst-4-en-3,17-dione),

(x) 5-androstenedione

(androst-5-en-3,17-dione),

(xi) bolasterone (7[alpha],17a-dimethyl-17[beta]-

hydroxyandrost-4-en-3-one),

(xii) boldenone (17[beta]-hydroxyandrost-

1,4,-diene-3-one),

(xiii) boldione (androsta-1,4-

diene-3,17-dione),

(xiv) calusterone (7[beta],17[alpha]-dimethyl-17

[beta]-hydroxyandrost-4-en-3-one),

(xv) clostebol (4-chloro-17[beta]-

hydroxyandrost-4-en-3-one),

(xvi) dehydrochloromethyltestosterone (4-chloro-

17[beta]-hydroxy-17[alpha]-methyl-

androst-1,4-dien-3-one),

(xvii) desoxymethyltestosterone (17[alpha]-methyl-5[alpha]

-androst-2-en-17[beta]-ol)(a.k.a., madol),

(xviii) [delta]1-dihydrotestosterone (a.k.a.

'1-testosterone') (17[beta]-hydroxy-

5[alpha]-androst-1-en-3-one),

(xix) 4-dihydrotestosterone (17[beta]-hydroxy-

androstan-3-one),

(xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-

5[alpha]-androstan-3-one),

(xxi) ethylestrenol (17[alpha]-ethyl-17[beta]-

hydroxyestr-4-ene),

(xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl-

1[beta],17[beta]-dihydroxyandrost-4-en-3-one),

(xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha],

17[beta]-dihydroxyandrost-1,4-dien-3-one),

(xxiv) furazabol (17[alpha]-methyl-17[beta]-

hydroxyandrostano[2,3-c]-furazan),

(xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one)

(xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy-

androst-4-en-3-one),

(xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]-

dihydroxy-estr-4-en-3-one),

(xxviii) mestanolone (17[alpha]-methyl-17[beta]-

hydroxy-5-androstan-3-one),

(xxix) mesterolone (1amethyl-17[beta]-hydroxy-

[5a]-androstan-3-one),

(xxx) methandienone (17[alpha]-methyl-17[beta]-

hydroxyandrost-1,4-dien-3-one),

(xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]-

dihydroxyandrost-5-ene),

(xxxii) methenolone (1-methyl-17[beta]-hydroxy-

5[alpha]-androst-1-en-3-one),

(xxxiii) 17[alpha]-methyl-3[beta], 17[beta]-

dihydroxy-5a-androstane),

(xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy

-5a-androstane),

(xxxv) 17[alpha]-methyl-3[beta],17[beta]-

dihydroxyandrost-4-ene),

(xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-

methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one),

(xxxvii) methyldienolone (17[alpha]-methyl-17[beta]-

hydroxyestra-4,9(10)-dien-3-one),

(xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]-

hydroxyestra-4,9-11-trien-3-one),

(xxxix) methyltestosterone (17[alpha]-methyl-17[beta]-

hydroxyandrost-4-en-3-one),

(xl) mibolerone (7[alpha],17a-dimethyl-17[beta]-

hydroxyestr-4-en-3-one),

(xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone

(17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]-

androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl-

1-testosterone'),

(xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one),

(xliii) 19-nor-4-androstenediol (3[beta], 17[beta]-

dihydroxyestr-4-ene),

(xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]-

dihydroxyestr-4-ene),

(xlv) 19-nor-5-androstenediol (3[beta], 17[beta]-

dihydroxyestr-5-ene),

(xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]-

dihydroxyestr-5-ene),

(xlvii) 19-nor-4,9(10)-androstadienedione

(estra-4,9(10)-diene-3,17-dione),

(xlviii) 19-nor-4-androstenedione (estr-4-

en-3,17-dione),

(xlix) 19-nor-5-androstenedione (estr-5-

en-3,17-dione),

(l) norbolethone (13[beta], 17a-diethyl-17[beta]-

hydroxygon-4-en-3-one),

(li) norclostebol (4-chloro-17[beta]-

hydroxyestr-4-en-3-one),

(lii) norethandrolone (17[alpha]-ethyl-17[beta]-

hydroxyestr-4-en-3-one),

(liii) normethandrolone (17[alpha]-methyl-17[beta]-

hydroxyestr-4-en-3-one),

(liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-

2-oxa-5[alpha]-androstan-3-one),

(lv) oxymesterone (17[alpha]-methyl-4,17[beta]-

dihydroxyandrost-4-en-3-one),

(lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-

17[beta]-hydroxy-(5[alpha]-androstan-3-one),

(lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-

(5[alpha]-androst-2-eno[3,2-c]-pyrazole),

(lviii) stenbolone (17[beta]-hydroxy-2-methyl-

(5[alpha]-androst-1-en-3-one),

(lix) testolactone (13-hydroxy-3-oxo-13,17-

secoandrosta-1,4-dien-17-oic

acid lactone),

(lx) testosterone (17[beta]-hydroxyandrost-

4-en-3-one),

(lxi) tetrahydrogestrinone (13[beta], 17[alpha]-

diethyl-17[beta]-hydroxygon-

4,9,11-trien-3-one),

(lxii) trenbolone (17[beta]-hydroxyestr-4,9,

11-trien-3-one).

Any person who is otherwise lawfully in possession of an anabolic steroid, or who otherwise lawfully manufactures, distributes, dispenses, delivers, or possesses with intent to deliver an anabolic steroid, which anabolic steroid is expressly intended for and lawfully allowed to be administered through implants to livestock or other nonhuman species, and which is approved by the Secretary of Health and Human Services for such administration, and which the person intends to administer or have administered through such implants, shall not be considered to be in unauthorized possession or to unlawfully manufacture, distribute, dispense, deliver, or possess with intent to deliver such anabolic steroid for purposes of this Act.

(d) "Administration" means the Drug Enforcement Administration, United States Department of Justice, or its successor agency.

(d-5) "Clinical Director, Prescription Monitoring Program" means a Department of Human Services administrative employee licensed to either prescribe or dispense controlled substances who shall run the clinical aspects of the Department of Human Services Prescription Monitoring Program and its Prescription Information Library.

(d-10) "Compounding" means the preparation and mixing of components, excluding flavorings, (1) as the result of a prescriber's prescription drug order or initiative based on the prescriber-patient-pharmacist relationship in the course of professional practice or (2) for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. "Compounding" includes the preparation of drugs or devices in anticipation of receiving prescription drug orders based on routine, regularly observed dispensing patterns. Commercially available products may be compounded for dispensing to individual patients only if both of the following conditions are met: (i) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet the patient's needs and (ii) the prescribing practitioner has requested that the drug be compounded.

(e) "Control" means to add a drug or other substance, or immediate precursor, to a Schedule whether by transfer from another Schedule or otherwise.

(f) "Controlled Substance" means (i) a drug, substance, or immediate precursor in the Schedules of Article II of this Act or (ii) a drug or other substance, or immediate precursor, designated as a controlled substance by the Department through administrative rule. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in the Liquor Control Act and the Tobacco Products Tax Act.

(f-5) "Controlled substance analog" means a substance:

(1) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in Schedule I or II;

(2) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II; or

(3) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in Schedule I or II.

(g) "Counterfeit substance" means a controlled substance, which, or the container or labeling of which, without authorization bears the trademark, trade name, or other identifying mark, imprint, number or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person who in fact manufactured, distributed, or dispensed the substance.

(h) "Deliver" or "delivery" means the actual, constructive or attempted transfer of possession of a controlled substance, with or without consideration, whether or not there is an agency relationship.

(i) "Department" means the Illinois Department of Human Services (as successor to the Department of Alcoholism and Substance Abuse) or its successor agency.

(j) (Blank).

(k) "Department of Corrections" means the Department of Corrections of the State of Illinois or its successor agency.

(l) "Department of Financial and Professional Regulation" means the Department of Financial and Professional Regulation of the State of Illinois or its successor agency.

(m) "Depressant" means any drug that (i) causes an overall depression of central nervous system functions, (ii) causes impaired consciousness and awareness, and (iii) can be habit-forming or lead to a substance abuse problem, including but not limited to alcohol, cannabis and its active principles and their analogs, benzodiazepines and their analogs, barbiturates and their analogs, opioids (natural and synthetic) and their analogs, and chloral hydrate and similar sedative hypnotics.

(n) (Blank).

(o) "Director" means the Director of the Illinois State Police or his or her designated agents.

(p) "Dispense" means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a prescriber, including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for that delivery.

(q) "Dispenser" means a practitioner who dispenses.

(r) "Distribute" means to deliver, other than by administering or dispensing, a controlled substance.

(s) "Distributor" means a person who distributes.

(t) "Drug" means (1) substances recognized as drugs in the official United States Pharmacopoeia, Official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; (2) substances intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; (3) substances (other than food) intended to affect the structure of any function of the body of man or animals and (4) substances intended for use as a component of any article specified in clause (1), (2), or (3) of this subsection. It does not include devices or their components, parts, or accessories.

(t-3) "Electronic health record" or "EHR" means a systematic collection of electronic health information about individual patients. The EHR is a digital format that is capable of being shared across different health care settings.

(t-5) "Euthanasia agency" means an entity certified by the Department of Financial and Professional Regulation for the purpose of animal euthanasia that holds an animal control facility license or animal shelter license under the Animal Welfare Act. A euthanasia agency is authorized to purchase, store, possess, and utilize Schedule II nonnarcotic and Schedule III nonnarcotic drugs for the sole purpose of animal euthanasia.

(t-10) "Euthanasia drugs" means Schedule II or Schedule III substances (nonnarcotic controlled substances) that are used by a euthanasia agency for the purpose of animal euthanasia.

(u) "Good faith" means the prescribing or dispensing of a controlled substance by a practitioner in the regular course of professional treatment to or for any person who is under his or her treatment for a pathology or condition other than that individual's physical or psychological dependence upon or addiction to a controlled substance, except as provided herein: and application of the term to a pharmacist shall mean the dispensing of a controlled substance pursuant to the prescriber's order which in the professional judgment of the pharmacist is lawful. The pharmacist shall be guided by accepted professional standards including, but not limited to the following, in making the judgment:

(1) lack of consistency of prescriber-patient relationship,

(2) frequency of prescriptions for same drug by one prescriber for large numbers of patients,

(3) quantities beyond those normally prescribed,

(4) unusual dosages (recognizing that there may be clinical circumstances where more or less than the usual dose may be used legitimately),

(5) unusual geographic distances between patient, pharmacist and prescriber,

(6) consistent prescribing of habit-forming drugs.

(u-0.5) "Hallucinogen" means a drug that causes markedly altered sensory perception leading to hallucinations of any type.

(u-1) "Home infusion services" means services provided by a pharmacy in compounding solutions for direct administration to a patient in a private residence, long-term care facility, or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion.

(u-5) "Illinois State Police" means the State Police of the State of Illinois, or its successor agency.

(v) "Immediate precursor" means a substance:

(1) which the Department has found to be and by rule designated as being a principal compound used, or produced primarily for use, in the manufacture of a controlled substance;

(2) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and

(3) the control of which is necessary to prevent, curtail or limit the manufacture of such controlled substance.

(w) "Instructional activities" means the acts of teaching, educating or instructing by practitioners using controlled substances within educational facilities approved by the State Board of Education or its successor agency.

(x) "Local authorities" means a duly organized State, County or Municipal peace unit or police force.

(y) "Look-alike substance" means a substance, other than a controlled substance which (1) by overall dosage unit appearance, including shape, color, size, markings or lack thereof, taste, consistency, or any other identifying physical characteristic of the substance, would lead a reasonable person to believe that the substance is a controlled substance, or (2) is expressly or impliedly represented to be a controlled substance or is distributed under circumstances which would lead a reasonable person to believe that the substance is a controlled substance. For the purpose of determining whether the representations made or the circumstances of the distribution would lead a reasonable person to believe the substance to be a controlled substance under this clause (2) of subsection (y), the court or other authority may consider the following factors in addition to any other factor that may be relevant:

(a) statements made by the owner or person in control of the substance concerning its nature, use or effect;

(b) statements made to the buyer or recipient that the substance may be resold for profit;

(c) whether the substance is packaged in a manner normally used for the illegal distribution of controlled substances;

(d) whether the distribution or attempted distribution included an exchange of or demand for money or other property as consideration, and whether the amount of the consideration was substantially greater than the reasonable retail market value of the substance.

Clause (1) of this subsection (y) shall not apply to a noncontrolled substance in its finished dosage form that was initially introduced into commerce prior to the initial introduction into commerce of a controlled substance in its finished dosage form which it may substantially resemble.

Nothing in this subsection (y) prohibits the dispensing or distributing of noncontrolled substances by persons authorized to dispense and distribute controlled substances under this Act, provided that such action would be deemed to be carried out in good faith under subsection (u) if the substances involved were controlled substances.

Nothing in this subsection (y) or in this Act prohibits the manufacture, preparation, propagation, compounding, processing, packaging, advertising or distribution of a drug or drugs by any person registered pursuant to Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).

(y-1) "Mail-order pharmacy" means a pharmacy that is located in a state of the United States that delivers, dispenses or distributes, through the United States Postal Service or other common carrier, to Illinois residents, any substance which requires a prescription.

(z) "Manufacture" means the production, preparation, propagation, compounding, conversion or processing of a controlled substance other than methamphetamine, either directly or indirectly, by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling of its container, except that this term does not include:

(1) by an ultimate user, the preparation or compounding of a controlled substance for his or her own use; or

(2) by a practitioner, or his or her authorized agent under his or her supervision, the preparation, compounding, packaging, or labeling of a controlled substance:

(a) as an incident to his or her administering or dispensing of a controlled substance in the course of his or her professional practice; or

(b) as an incident to lawful research, teaching or chemical analysis and not for sale.

(z-1) (Blank).

(z-5) "Medication shopping" means the conduct prohibited under subsection (a) of Section 314.5 of this Act.

(z-10) "Mid-level practitioner" means (i) a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987, (ii) an advanced practice nurse who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatrist, in accordance with Section 65-40 of the Nurse Practice Act, or (iii) an animal euthanasia agency.

(aa) "Narcotic drug" means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(1) opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation; however the term "narcotic drug" does not include the isoquinoline alkaloids of opium;

(2) (blank);

(3) opium poppy and poppy straw;

(4) coca leaves, except coca leaves and extracts of coca leaves from which substantially all of the cocaine and ecgonine, and their isomers, derivatives and salts, have been removed;

(5) cocaine, its salts, optical and geometric isomers, and salts of isomers;

(6) ecgonine, its derivatives, their salts, isomers, and salts of isomers;

(7) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (1) through (6).

(bb) "Nurse" means a registered nurse licensed under the Nurse Practice Act.

(cc) (Blank).

(dd) "Opiate" means any substance having an addiction forming or addiction sustaining liability similar to morphine or being capable of conversion into a drug having addiction forming or addiction sustaining liability.

(ee) "Opium poppy" means the plant of the species Papaver somniferum L., except its seeds.

(ee-5) "Oral dosage" means a tablet, capsule, elixir, or solution or other liquid form of medication intended for administration by mouth, but the term does not include a form of medication intended for buccal, sublingual, or transmucosal administration.

(ff) "Parole and Pardon Board" means the Parole and Pardon Board of the State of Illinois or its successor agency.

(gg) "Person" means any individual, corporation, mail-order pharmacy, government or governmental subdivision or agency, business trust, estate, trust, partnership or association, or any other entity.

(hh) "Pharmacist" means any person who holds a license or certificate of registration as a registered pharmacist, a local registered pharmacist or a registered assistant pharmacist under the Pharmacy Practice Act.

(ii) "Pharmacy" means any store, ship or other place in which pharmacy is authorized to be practiced under the Pharmacy Practice Act.

(ii-5) "Pharmacy shopping" means the conduct prohibited under subsection (b) of Section 314.5 of this Act.

(ii-10) "Physician" (except when the context otherwise requires) means a person licensed to practice medicine in all of its branches.

(jj) "Poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.

(kk) "Practitioner" means a physician licensed to practice medicine in all its branches, dentist, optometrist, podiatrist, veterinarian, scientific investigator, pharmacist, physician assistant, advanced practice nurse, licensed practical nurse, registered nurse, hospital, laboratory, or pharmacy, or other person licensed, registered, or otherwise lawfully permitted by the United States or this State to distribute, dispense, conduct research with respect to, administer or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

(ll) "Pre-printed prescription" means a written prescription upon which the designated drug has been indicated prior to the time of issuance; the term does not mean a written prescription that is individually generated by machine or computer in the prescriber's office.

(mm) "Prescriber" means a physician licensed to practice medicine in all its branches, dentist, optometrist, podiatrist or veterinarian who issues a prescription, a physician assistant who issues a prescription for a controlled substance in accordance with Section 303.05, a written delegation, and a written supervision agreement required under Section 7.5 of the Physician Assistant Practice Act of 1987, or an advanced practice nurse with prescriptive authority delegated under Section 65-40 of the Nurse Practice Act and in accordance with Section 303.05, a written delegation, and a written collaborative agreement under Section 65-35 of the Nurse Practice Act.

(nn) "Prescription" means a written, facsimile, or oral order, or an electronic order that complies with applicable federal requirements, of a physician licensed to practice medicine in all its branches, dentist, podiatrist or veterinarian for any controlled substance, of an optometrist for a Schedule III, IV, or V controlled substance in accordance with Section 15.1 of the Illinois Optometric Practice Act of 1987, of a physician assistant for a controlled substance in accordance with Section 303.05, a written delegation, and a written supervision agreement required under Section 7.5 of the Physician Assistant Practice Act of 1987, or of an advanced practice nurse with prescriptive authority delegated under Section 65-40 of the Nurse Practice Act who issues a prescription for a controlled substance in accordance with Section 303.05, a written delegation, and a written collaborative agreement under Section 65-35 of the Nurse Practice Act when required by law.

(nn-5) "Prescription Information Library" (PIL) means an electronic library that contains reported controlled substance data.

(nn-10) "Prescription Monitoring Program" (PMP) means the entity that collects, tracks, and stores reported data on controlled substances and select drugs pursuant to Section 316.

(nn-11) "Prescription Monitoring Program Advisory Committee" (PMPAC) means a committee of voting members consisting of licensed healthcare providers representing all professions who are licensed to prescribe or dispense controlled substances. The Chairperson of the PMPAC may appoint non-licensed persons who are associated with professional organizations representing licensed healthcare providers. Non-licensed members shall serve as non-voting members. A majority of the PMPAC shall be licensed health care providers who are licensed to prescribe controlled substances. The Committee shall serve in a consultant context regarding longitudinal evaluations of compliance with evidence based clinical practice and the prescribing of controlled substances. The Committee shall make recommendations regarding scheduling of controlled substances and recommendations concerning continuing education designed at improving the health and safety of the citizens of Illinois regarding pharmacotherapies of controlled substances.

(oo) "Production" or "produce" means manufacture, planting, cultivating, growing, or harvesting of a controlled substance other than methamphetamine.

(pp) "Registrant" means every person who is required to register under Section 302 of this Act.

(qq) "Registry number" means the number assigned to each person authorized to handle controlled substances under the laws of the United States and of this State.

(qq-5) "Secretary" means, as the context requires, either the Secretary of the Department or the Secretary of the Department of Financial and Professional Regulation, and the Secretary's designated agents.

(rr) "State" includes the State of Illinois and any state, district, commonwealth, territory, insular possession thereof, and any area subject to the legal authority of the United States of America.

(rr-5) "Stimulant" means any drug that (i) causes an overall excitation of central nervous system functions, (ii) causes impaired consciousness and awareness, and (iii) can be habit-forming or lead to a substance abuse problem, including but not limited to amphetamines and their analogs, methylphenidate and its analogs, cocaine, and phencyclidine and its analogs.

(ss) "Ultimate user" means a person who lawfully possesses a controlled substance for his or her own use or for the use of a member of his or her household or for administering to an animal owned by him or her or by a member of his or her household.

(Source: P.A. 96-189, eff. 8-10-09; 96-268, eff. 8-11-09; 97-334, eff. 1-1-12.)

(720 ILCS 570/206) (from Ch. 56 1/2, par. 1206)

Sec. 206. (a) The controlled substances listed in this Section are included in Schedule II.

(b) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis:

(1) Opium and opiates, and any salt, compound, derivative or preparation of opium or opiate, excluding apomorphine, dextrorphan, levopropoxyphene, nalbuphine, nalmefene, naloxone, and naltrexone, and their respective salts, but including the following:

(i) Raw Opium;

(ii) Opium extracts;

(iii) Opium fluid extracts;

(iv) Powdered opium;

(v) Granulated opium;

(vi) Tincture of opium;

(vii) Codeine;

(viii) Ethylmorphine;

(ix) Etorphine Hydrochloride;

(x) Hydrocodone;

(xi) Hydromorphone;

(xii) Metopon;

(xiii) Morphine;

(xiv) Oxycodone;

(xv) Oxymorphone;

(xv.5) Tapentadol;

(xvi) Thebaine;

(xvii) Thebaine-derived butorphanol.

(xviii) Dextromethorphan, except drug products that may be dispensed pursuant to a prescription order of a practitioner and are sold in compliance with the safety and labeling standards as set forth by the United States Food and Drug Administration, or drug products containing dextromethorphan that are sold in solid, tablet, liquid, capsule, powder, thin film, or gel form and which are formulated, packaged, and sold in dosages and concentrations for use as an over-the-counter drug product. For the purposes of this Section, "over-the-counter drug product" means a drug that is available to consumers without a prescription and sold in compliance with the safety and labeling standards as set forth by the United States Food and Drug Administration.

(2) Any salt, compound, isomer, derivative or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subparagraph (1), but not including the isoquinoline alkaloids of opium;

(3) Opium poppy and poppy straw;

(4) Coca leaves and any salt, compound, isomer, salt of an isomer, derivative, or preparation of coca leaves including cocaine or ecgonine, and any salt, compound, isomer, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, but not including decocainized coca leaves or extractions of coca leaves which do not contain cocaine or ecgonine (for the purpose of this paragraph, the term "isomer" includes optical, positional and geometric isomers);

(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrine alkaloids of the opium poppy).

(c) Unless specifically excepted or unless listed in another schedule any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, whenever the existence of these isomers, esters, ethers and salts is possible within the specific chemical designation, dextrorphan excepted:

(1) Alfentanil;

(1.1) Carfentanil;

(2) Alphaprodine;

(3) Anileridine;

(4) Bezitramide;

(5) Bulk Dextropropoxyphene (non-dosage forms);

(6) Dihydrocodeine;

(6.5) Dihydrocodeinone (Hydrocodone), with one or more active, non-narcotic ingredients in regional therapeutic amounts;

(7) Diphenoxylate;

(8) Fentanyl;

(9) Sufentanil;

(9.5) Remifentanil;

(10) Isomethadone;

(11) Levomethorphan;

(12) Levorphanol (Levorphan);

(13) Metazocine;

(14) Methadone;

(15) Methadone-Intermediate,

4-cyano-2-dimethylamino-4,4-diphenyl-1-butane;

(16) Moramide-Intermediate,

2-methyl-3-morpholino-1,1-diphenylpropane-carboxylic

acid;

(17) Pethidine (meperidine);

(18) Pethidine-Intermediate-A,

4-cyano-1-methyl-4-phenylpiperidine;

(19) Pethidine-Intermediate-B,

ethyl-4-phenylpiperidine-4-carboxylate;

(20) Pethidine-Intermediate-C,

1-methyl-4-phenylpiperidine-4-carboxylic acid;

(21) Phenazocine;

(22) Piminodine;

(23) Racemethorphan;

(24) Racemorphan;

(25) Levo-alphacetylmethadol (some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM).

(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers;

(2) Methamphetamine, its salts, isomers, and salts of its isomers;

(3) Phenmetrazine and its salts;

(4) Methylphenidate;

(5) Lisdexamfetamine.

(e) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Amobarbital;

(2) Secobarbital;

(3) Pentobarbital;

(4) Pentazocine;

(5) Phencyclidine;

(6) Gluthethimide;

(7) (Blank).

(f) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:

(1) Immediate precursor to amphetamine and methamphetamine:

(i) Phenylacetone

Some trade or other names: phenyl-2-propanone;

P2P; benzyl methyl ketone; methyl benzyl ketone.

(2) Immediate precursors to phencyclidine:

(i) 1-phenylcyclohexylamine;

(ii) 1-piperidinocyclohexanecarbonitrile (PCC).

(3) Nabilone.

(Source: P.A. 97-334, eff. 1-1-12.)

(720 ILCS 570/208) (from Ch. 56 1/2, par. 1208)

Sec. 208. (a) The controlled substances listed in this Section are included in Schedule III.

(b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation;

(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under Title 21, Code of Federal Regulations, Section 308.32, and any other drug of the quantitative composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances;

(2) Benzphetamine;

(3) Chlorphentermine;

(4) Clortermine;

(5) Phendimetrazine.

(c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a potential for abuse associated with a depressant effect on the central nervous system:

(1) Any compound, mixture, or preparation containing amobarbital, secobarbital, pentobarbital or any salt thereof and one or more other active medicinal ingredients which are not listed in any schedule;

(2) Any suppository dosage form containing amobarbital, secobarbital, pentobarbital or any salt of any of these drugs and approved by the Federal Food and Drug Administration for marketing only as a suppository;

(3) Any substance which contains any quantity of a derivative of barbituric acid, or any salt thereof:

(3.1) Aprobarbital;

(3.2) Butabarbital (secbutabarbital);

(3.3) Butalbital;

(3.4) Butobarbital (butethal);

(4) Chlorhexadol;

(5) Methyprylon;

(6) Sulfondiethylmethane;

(7) Sulfonethylmethane;

(8) Sulfonmethane;

(9) Lysergic acid;

(10) Lysergic acid amide;

(10.1) Tiletamine or zolazepam or both, or any salt of either of them.

Some trade or other names for a tiletamine-zolazepam

combination product: Telazol.

Some trade or other names for Tiletamine:

2-(ethylamino)-2-(2-thienyl)-cyclohexanone.

Some trade or other names for zolazepam:

4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-

[3,4-e], [1,4]-diazepin-7(1H)-one, and flupyrazapon.

(11) Any material, compound, mixture or preparation containing not more than 12.5 milligrams of pentazocine or any of its salts, per 325 milligrams of aspirin;

(12) Any material, compound, mixture or preparation containing not more than 12.5 milligrams of pentazocine or any of its salts, per 325 milligrams of acetaminophen;

(13) Any material, compound, mixture or preparation containing not more than 50 milligrams of pentazocine or any of its salts plus naloxone HCl USP 0.5 milligrams, per dosage unit;

(14) Ketamine;

(15) Thiopental.

(d) Nalorphine.

(d.5) Buprenorphine.

(e) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, as set forth below:

(1) not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium;

(2) not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active non-narcotic ingredients in recognized therapeutic amounts;

(3) (blank) not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium;

(4) (blank) not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts;

(5) not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts;

(6) not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts;

(7) not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts;

(8) not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, non-narcotic ingredients in recognized therapeutic amounts.

(f) Anabolic steroids, except the following anabolic steroids that are exempt:

(1) Androgyn L.A.;

(2) Andro-Estro 90-4;

(3) depANDROGYN;

(4) DEPO-T.E.;

(5) depTESTROGEN;

(6) Duomone;

(7) DURATESTRIN;

(8) DUO-SPAN II;

(9) Estratest;

(10) Estratest H.S.;

(11) PAN ESTRA TEST;

(12) Premarin with Methyltestosterone;

(13) TEST-ESTRO Cypionates;

(14) Testosterone Cyp 50 Estradiol Cyp 2;

(15) Testosterone Cypionate-Estradiol Cypionate injection; and

(16) Testosterone Enanthate-Estradiol Valerate injection.

(g) Hallucinogenic substances.

(1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product. Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro- 6,6,9-trimethyl-3-pentyl-6H-dibenzo (b,d) pyran-1-ol) or (-)-delta-9-(trans)-tetrahydrocannabinol.

(2) (Reserved).

(h) The Department may except by rule any compound, mixture, or preparation containing any stimulant or depressant substance listed in subsection (b) from the application of all or any part of this Act if the compound, mixture, or preparation contains one or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system, and if the admixtures are included therein in combinations, quantity, proportion, or concentration that vitiate the potential for abuse of the substances which have a stimulant or depressant effect on the central nervous system.

(Source: P.A. 96-328, eff. 8-11-09; 96-1000, eff. 7-2-10; 97-334, eff. 1-1-12.)

(720 ILCS 570/316)

Sec. 316. Prescription monitoring program.

(a) The Department must provide for a prescription monitoring program for Schedule II, III, IV, and V controlled substances, the purpose of which is to develop a clinical tool to assist healthcare providers in preventing accidental overdoses or duplications of controlled substances to the patients they are treating. The Program shall include that includes the following components and requirements:

(1) The dispenser must transmit to the central repository, in a form and manner specified by the Department, the following information:

(A) The recipient's name.

(B) The recipient's address.

(C) The national drug code number of the controlled substance dispensed.

(D) The date the controlled substance is dispensed.

(E) The quantity of the controlled substance dispensed.

(F) The dispenser's United States Drug Enforcement Administration registration number.

(G) The prescriber's United States Drug Enforcement Administration registration number.

(H) The dates the controlled substance prescription is filled.

(I) The payment type used to purchase the controlled substance (i.e. Medicaid, cash, third party insurance).

(J) The patient location code (i.e. home, nursing home, outpatient, etc.) for the controlled substances other than those filled at a retail pharmacy.

(K) Any additional information that may be required by the department by administrative rule, including but not limited to information required for compliance with the criteria for electronic reporting of the American Society for Automation and Pharmacy or its successor.

(2) The information required to be transmitted under this Section must be transmitted not more than 7 days after the date on which a controlled substance is dispensed, or at such other time as may be required by the Department by administrative rule.

(3) A dispenser must transmit the information required under this Section by:

(A) an electronic device compatible with the receiving device of the central repository;

(B) a computer diskette;

(C) a magnetic tape; or

(D) a pharmacy universal claim form or Pharmacy Inventory Control form;

(4) The Department may impose a civil fine of up to $100 per day for willful failure to report controlled substance dispensing to the Prescription Monitoring Program. The fine shall be calculated on no more than the number of days from the time the report was required to be made until the time the problem was resolved, and shall be payable to the Prescription Monitoring Program.

(b) The Department, by rule, may include in the monitoring program certain other select drugs that are not included in Schedule II, III, IV, or V. The prescription monitoring program does not apply to controlled substance prescriptions as exempted under Section 313.

(c) The collection of data on select drugs and scheduled substances by the Prescription Monitoring Program may be used as a tool for addressing oversight requirements of long-term care institutions as set forth by Public Act 96-1372. Long-term care pharmacies shall transmit patient medication profiles to the Prescription Monitoring Program monthly or more frequently as established by administrative rule.

(d) By January 1, 2015, all Electronic Health Records Systems should interface with the Prescription Monitoring Program application program interface to insure that all providers have access to specific patient records as they are treating the patient. No prescriber shall be fined or otherwise penalized if the electronic health records system he or she is using does not effectively interface with the Prescription Monitoring Program.

(Source: P.A. 97-334, eff. 1-1-12.)

(720 ILCS 570/317.5 new)

Sec. 317.5. Access to the Prescription Monitoring Program Database.

(a) All licensed prescribers of controlled substances may register for individual access to the Prescription Monitoring Program, where the data is to be used in treating their patients.

(b) Those licensed prescribers who have registered to access the Prescription Monitoring Program, may authorize a designee to consult the Prescription Monitoring Program on their behalf. The practitioner assumes all liability from that authorization. The Prescription Monitoring Program Advisory Committee shall draft rules with reasonable parameters concerning a practitioner's authority to authorize a designee.

(c) Any Electronic Medical Records System may apply for access to the Prescription Monitoring Program on behalf of their enrolled practitioners.

(d) A Pharmacist-in-charge (PIC) or his or her designee (which may be permitted by administrative rules) may register for individual access to the Prescription Monitoring Program.

(e) Any Pharmacy Electronic Record System may apply for access to the Prescription Monitoring Program on behalf of their enrolled pharmacies to streamline access to patient specific data to address provision of pharmaceutical care.

(f) Prescribers, pharmacists, or persons acting on their behalf, in good faith, are immune from any recourse (civil or criminal liability, or professional discipline) arising from any false, incomplete or inaccurate information submitted to or reported to the Prescription Monitoring Program registry.

(720 ILCS 570/319)

Sec. 319. Rules. The Department must adopt rules under the Illinois Administrative Procedure Act to implement Sections 316 through 321, including the following:

(1) Information collection and retrieval procedures for the central repository, including the controlled substances to be included in the program required under Section 316 and Section 321 (now repealed).

(2) Design for the creation of the database required under Section 317.

(3) Requirements for the development and installation of on-line electronic access by the Department to information collected by the central repository.

(4) The process for choosing members for the advisory committee, the clinical consulting long term care advisory committee, and the clinical outcomes research group under the direction of the Prescription Monitoring Program Clinical Director.

(Source: P.A. 97-334, eff. 1-1-12.)

(720 ILCS 570/320)

Sec. 320. Advisory committee.

(a) The Secretary of the Department of Human Services must appoint an advisory committee to assist the Department in implementing the controlled substance prescription monitoring program created by Section 316 and former Section 321 of this Act. The Advisory Committee consists of prescribers and dispensers.

(b) The Secretary of the Department of Human Services or his or her designee must determine the number of members to serve on the advisory committee. The Chair of the Prescription Monitoring Program Advisory Committee and the other clinical consulting committees shall be the Prescription Monitoring Program Clinical Director Secretary must choose one of the members of the advisory committee to serve as chair of the committee.

(c) The advisory committee may appoint its other officers as it deems appropriate.

(d) The members of the advisory committee shall receive no compensation for their services as members of the advisory committee but may be reimbursed for their actual expenses incurred in serving on the advisory committee.

(e) The advisory committee shall:

(1) provide a uniform approach to reviewing this Act in order to determine whether changes should be recommended to the General Assembly.

(2) review current drug schedules in order to manage changes to the administrative rules pertaining to the utilization of this Act.

(Source: P.A. 97-334, eff. 1-1-12.)".