Illinois General Assembly - Full Text of SB2535
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Full Text of SB2535  102nd General Assembly


Sen. Melinda Bush

Filed: 5/12/2021





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2    AMENDMENT NO. ______. Amend Senate Bill 2535 by replacing
3everything after the enacting clause with the following:
4    "Section 5. The Pharmacy Practice Act is amended by
5changing Section 19.1 as follows:
6    (225 ILCS 85/19.1)
7    (Section scheduled to be repealed on January 1, 2023)
8    Sec. 19.1. Dispensing opioid antagonists.
9    (a) Due to the recent rise in opioid-related deaths in
10Illinois and the existence of an opioid antagonist that can
11reverse the deadly effects of overdose, the General Assembly
12finds that in order to avoid further loss where possible, it is
13responsible to allow greater access of such an antagonist to
14those populations at risk of overdose.
15    (b) Notwithstanding any general or special law to the
16contrary, a licensed pharmacist shall may dispense an opioid



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1antagonist in accordance with written, standardized procedures
2or protocols developed by the Department with the Department
3of Public Health and the Department of Human Services and if
4the procedures or protocols are filed at the pharmacy before
5implementation and are available to the Department upon
7    (c) Before dispensing an opioid a pharmacist shall inform
8patients that opioids are addictive and offer to dispense an
9opioid antagonist pursuant to this Section, a pharmacist shall
10complete a training program approved by the Department of
11Human Services pursuant to Section 5-23 of the Substance Use
12Disorder Act. The training program shall include, but not be
13limited to, proper documentation and quality assurance.
14    (d) For the purpose of this Section, "opioid antagonist"
15means a drug that binds to opioid receptors and blocks or
16inhibits the effect of opioids acting on those receptors,
17including, but not limited to, naloxone hydrochloride or any
18other similarly acting and equally safe drug approved by the
19U.S. Food and Drug Administration for the treatment of drug
21(Source: P.A. 99-480, eff. 9-9-15; 99-642, eff. 7-28-16;
22100-759, eff. 1-1-193.)
23    Section 10. The Illinois Controlled Substances Act is
24amended by changing Sections 312 and 313 as follows:



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1    (720 ILCS 570/312)  (from Ch. 56 1/2, par. 1312)
2    Sec. 312. Requirements for dispensing controlled
4    (a) A practitioner, in good faith, may dispense a Schedule
5II controlled substance, which is a narcotic drug listed in
6Section 206 of this Act; or which contains any quantity of
7amphetamine or methamphetamine, their salts, optical isomers
8or salts of optical isomers; phenmetrazine and its salts; or
9pentazocine; and Schedule III, IV, or V controlled substances
10to any person upon a written or electronic prescription of any
11prescriber, dated and signed by the person prescribing (or
12electronically validated in compliance with Section 311.5) on
13the day when issued and bearing the name and address of the
14patient for whom, or the owner of the animal for which the
15controlled substance is dispensed, and the full name, address
16and registry number under the laws of the United States
17relating to controlled substances of the prescriber, if he or
18she is required by those laws to be registered. If the
19prescription is for an animal it shall state the species of
20animal for which it is ordered. The practitioner filling the
21prescription shall, unless otherwise permitted, write the date
22of filling and his or her own signature on the face of the
23written prescription or, alternatively, shall indicate such
24filling using a unique identifier as defined in paragraph (v)
25of Section 3 of the Pharmacy Practice Act. The written
26prescription shall be retained on file by the practitioner who



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1filled it or pharmacy in which the prescription was filled for
2a period of 2 years, so as to be readily accessible for
3inspection or removal by any officer or employee engaged in
4the enforcement of this Act. Whenever the practitioner's or
5pharmacy's copy of any prescription is removed by an officer
6or employee engaged in the enforcement of this Act, for the
7purpose of investigation or as evidence, such officer or
8employee shall give to the practitioner or pharmacy a receipt
9in lieu thereof. If the specific prescription is machine or
10computer generated and printed at the prescriber's office, the
11date does not need to be handwritten. A prescription for a
12Schedule II controlled substance shall not be issued for more
13than a 30 day supply, except as provided in subsection (a-5),
14and shall be valid for up to 90 days after the date of
15issuance. A written prescription for Schedule III, IV or V
16controlled substances shall not be filled or refilled more
17than 6 months after the date thereof or refilled more than 5
18times unless renewed, in writing, by the prescriber. A
19pharmacy shall maintain a policy regarding the type of
20identification necessary, if any, to receive a prescription in
21accordance with State and federal law. The pharmacy must post
22such information where prescriptions are filled.
23    (a-5) Physicians may issue multiple prescriptions (3
24sequential 30-day supplies) for the same Schedule II
25controlled substance, authorizing up to a 90-day supply.
26Before authorizing a 90-day supply of a Schedule II controlled



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1substance, the physician must meet the following conditions:
2        (1) Each separate prescription must be issued for a
3    legitimate medical purpose by an individual physician
4    acting in the usual course of professional practice.
5        (2) The individual physician must provide written
6    instructions on each prescription (other than the first
7    prescription, if the prescribing physician intends for the
8    prescription to be filled immediately) indicating the
9    earliest date on which a pharmacy may fill that
10    prescription.
11        (3) The physician shall document in the medical record
12    of a patient the medical necessity for the amount and
13    duration of the 3 sequential 30-day prescriptions for
14    Schedule II narcotics.
15    (a-10) Prescribers who issue a prescription for an opioid
16shall inform the patient that opioids are addictive and that
17opioid antagonists are available by prescription or from a
19    (b) In lieu of a written prescription required by this
20Section, a pharmacist, in good faith, may dispense Schedule
21III, IV, or V substances to any person either upon receiving a
22facsimile of a written, signed prescription transmitted by the
23prescriber or the prescriber's agent or upon a lawful oral
24prescription of a prescriber which oral prescription shall be
25reduced promptly to writing by the pharmacist and such written
26memorandum thereof shall be dated on the day when such oral



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1prescription is received by the pharmacist and shall bear the
2full name and address of the ultimate user for whom, or of the
3owner of the animal for which the controlled substance is
4dispensed, and the full name, address, and registry number
5under the law of the United States relating to controlled
6substances of the prescriber prescribing if he or she is
7required by those laws to be so registered, and the pharmacist
8filling such oral prescription shall write the date of filling
9and his or her own signature on the face of such written
10memorandum thereof. The facsimile copy of the prescription or
11written memorandum of the oral prescription shall be retained
12on file by the proprietor of the pharmacy in which it is filled
13for a period of not less than two years, so as to be readily
14accessible for inspection by any officer or employee engaged
15in the enforcement of this Act in the same manner as a written
16prescription. The facsimile copy of the prescription or oral
17prescription and the written memorandum thereof shall not be
18filled or refilled more than 6 months after the date thereof or
19be refilled more than 5 times, unless renewed, in writing, by
20the prescriber.
21    (c) Except for any non-prescription targeted
22methamphetamine precursor regulated by the Methamphetamine
23Precursor Control Act, a controlled substance included in
24Schedule V shall not be distributed or dispensed other than
25for a medical purpose and not for the purpose of evading this
26Act, and then:



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1        (1) only personally by a person registered to dispense
2    a Schedule V controlled substance and then only to his or
3    her patients, or
4        (2) only personally by a pharmacist, and then only to
5    a person over 21 years of age who has identified himself or
6    herself to the pharmacist by means of 2 positive documents
7    of identification.
8        (3) the dispenser shall record the name and address of
9    the purchaser, the name and quantity of the product, the
10    date and time of the sale, and the dispenser's signature.
11        (4) no person shall purchase or be dispensed more than
12    120 milliliters or more than 120 grams of any Schedule V
13    substance which contains codeine, dihydrocodeine, or any
14    salts thereof, or ethylmorphine, or any salts thereof, in
15    any 96 hour period. The purchaser shall sign a form,
16    approved by the Department of Financial and Professional
17    Regulation, attesting that he or she has not purchased any
18    Schedule V controlled substances within the immediately
19    preceding 96 hours.
20        (5) (Blank).
21        (6) all records of purchases and sales shall be
22    maintained for not less than 2 years.
23        (7) no person shall obtain or attempt to obtain within
24    any consecutive 96 hour period any Schedule V substances
25    of more than 120 milliliters or more than 120 grams
26    containing codeine, dihydrocodeine or any of its salts, or



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1    ethylmorphine or any of its salts. Any person obtaining
2    any such preparations or combination of preparations in
3    excess of this limitation shall be in unlawful possession
4    of such controlled substance.
5        (8) a person qualified to dispense controlled
6    substances under this Act and registered thereunder shall
7    at no time maintain or keep in stock a quantity of Schedule
8    V controlled substances in excess of 4.5 liters for each
9    substance; a pharmacy shall at no time maintain or keep in
10    stock a quantity of Schedule V controlled substances as
11    defined in excess of 4.5 liters for each substance, plus
12    the additional quantity of controlled substances necessary
13    to fill the largest number of prescription orders filled
14    by that pharmacy for such controlled substances in any one
15    week in the previous year. These limitations shall not
16    apply to Schedule V controlled substances which Federal
17    law prohibits from being dispensed without a prescription.
18        (9) no person shall distribute or dispense butyl
19    nitrite for inhalation or other introduction into the
20    human body for euphoric or physical effect.
21    (d) Every practitioner shall keep a record or log of
22controlled substances received by him or her and a record of
23all such controlled substances administered, dispensed or
24professionally used by him or her otherwise than by
25prescription. It shall, however, be sufficient compliance with
26this paragraph if any practitioner utilizing controlled



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1substances listed in Schedules III, IV and V shall keep a
2record of all those substances dispensed and distributed by
3him or her other than those controlled substances which are
4administered by the direct application of a controlled
5substance, whether by injection, inhalation, ingestion, or any
6other means to the body of a patient or research subject. A
7practitioner who dispenses, other than by administering, a
8controlled substance in Schedule II, which is a narcotic drug
9listed in Section 206 of this Act, or which contains any
10quantity of amphetamine or methamphetamine, their salts,
11optical isomers or salts of optical isomers, pentazocine, or
12methaqualone shall do so only upon the issuance of a written
13prescription blank or electronic prescription issued by a
15    (e) Whenever a manufacturer distributes a controlled
16substance in a package prepared by him or her, and whenever a
17wholesale distributor distributes a controlled substance in a
18package prepared by him or her or the manufacturer, he or she
19shall securely affix to each package in which that substance
20is contained a label showing in legible English the name and
21address of the manufacturer, the distributor and the quantity,
22kind and form of controlled substance contained therein. No
23person except a pharmacist and only for the purposes of
24filling a prescription under this Act, shall alter, deface or
25remove any label so affixed.
26    (f) Whenever a practitioner dispenses any controlled



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1substance except a non-prescription Schedule V product or a
2non-prescription targeted methamphetamine precursor regulated
3by the Methamphetamine Precursor Control Act, he or she shall
4affix to the container in which such substance is sold or
5dispensed, a label indicating the date of initial filling, the
6practitioner's name and address, the name of the patient, the
7name of the prescriber, the directions for use and cautionary
8statements, if any, contained in any prescription or required
9by law, the proprietary name or names or the established name
10of the controlled substance, and the dosage and quantity,
11except as otherwise authorized by regulation by the Department
12of Financial and Professional Regulation. No person shall
13alter, deface or remove any label so affixed as long as the
14specific medication remains in the container.
15    (g) A person to whom or for whose use any controlled
16substance has been prescribed or dispensed by a practitioner,
17or other persons authorized under this Act, and the owner of
18any animal for which such substance has been prescribed or
19dispensed by a veterinarian, may lawfully possess such
20substance only in the container in which it was delivered to
21him or her by the person dispensing such substance.
22    (h) The responsibility for the proper prescribing or
23dispensing of controlled substances that are under the
24prescriber's direct control is upon the prescriber. The
25responsibility for the proper filling of a prescription for
26controlled substance drugs rests with the pharmacist. An order



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1purporting to be a prescription issued to any individual,
2which is not in the regular course of professional treatment
3nor part of an authorized methadone maintenance program, nor
4in legitimate and authorized research instituted by any
5accredited hospital, educational institution, charitable
6foundation, or federal, state or local governmental agency,
7and which is intended to provide that individual with
8controlled substances sufficient to maintain that individual's
9or any other individual's physical or psychological addiction,
10habitual or customary use, dependence, or diversion of that
11controlled substance is not a prescription within the meaning
12and intent of this Act; and the person issuing it, shall be
13subject to the penalties provided for violations of the law
14relating to controlled substances.
15    (i) A prescriber shall not pre-print or cause to be
16pre-printed a prescription for any controlled substance; nor
17shall any practitioner issue, fill or cause to be issued or
18filled, a pre-printed prescription for any controlled
20    (i-5) A prescriber may use a machine or electronic device
21to individually generate a printed prescription, but the
22prescriber is still required to affix his or her manual
24    (j) No person shall manufacture, dispense, deliver,
25possess with intent to deliver, prescribe, or administer or
26cause to be administered under his or her direction any



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1anabolic steroid, for any use in humans other than the
2treatment of disease in accordance with the order of a
3physician licensed to practice medicine in all its branches
4for a valid medical purpose in the course of professional
5practice. The use of anabolic steroids for the purpose of
6hormonal manipulation that is intended to increase muscle
7mass, strength or weight without a medical necessity to do so,
8or for the intended purpose of improving physical appearance
9or performance in any form of exercise, sport, or game, is not
10a valid medical purpose or in the course of professional
12    (k) Controlled substances may be mailed if all of the
13following conditions are met:
14        (1) The controlled substances are not outwardly
15    dangerous and are not likely, of their own force, to cause
16    injury to a person's life or health.
17        (2) The inner container of a parcel containing
18    controlled substances must be marked and sealed as
19    required under this Act and its rules, and be placed in a
20    plain outer container or securely wrapped in plain paper.
21        (3) If the controlled substances consist of
22    prescription medicines, the inner container must be
23    labeled to show the name and address of the pharmacy or
24    practitioner dispensing the prescription.
25        (4) The outside wrapper or container must be free of
26    markings that would indicate the nature of the contents.



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1    (l) Notwithstanding any other provision of this Act to the
2contrary, emergency medical services personnel may administer
3Schedule II, III, IV, or V controlled substances to a person in
4the scope of their employment without a written, electronic,
5or oral prescription of a prescriber.
6(Source: P.A. 99-78, eff. 7-20-15; 99-480, eff. 9-9-15;
7100-280, eff. 1-1-18.)
8    (720 ILCS 570/313)  (from Ch. 56 1/2, par. 1313)
9    Sec. 313. (a) Controlled substances which are lawfully
10administered in hospitals or institutions licensed under the
11Hospital Licensing Act shall be exempt from the requirements
12of Sections 312 and 316, except that the prescription for the
13controlled substance shall be in writing on the patient's
14record, signed by the prescriber, and dated, and shall state
15the name and quantity of controlled substances ordered and the
16quantity actually administered. The records of such
17prescriptions shall be maintained for two years and shall be
18available for inspection by officers and employees of the
19Illinois State Police and the Department of Financial and
20Professional Regulation.
21    The exemption under this subsection (a) does not apply to
22a prescription (including an outpatient prescription from an
23emergency department or outpatient clinic) for more than a
2472-hour supply of a discharge medication to be consumed
25outside of the hospital or institution.



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1    (a-5) In a hospital or institutions licensed under the
2Hospital Licensing Act, all prescribers of an opioid shall
3inform the patient that opioids are addictive and that opioid
4antagonists are available by prescription or from a pharmacy.
5Upon discharge any patient who has overdosed on controlled
6substances shall be provided with an opioid antagonist. If the
7patient is not able to pay for the opioid antagonist, then the
8State of Illinois shall reimburse the hospital for the opioid
9antagonist from federal grant funds to address substance use
10disorder or other State funds for the same purpose.
11    (b) Controlled substances that can lawfully be
12administered or dispensed directly to a patient in a long-term
13care facility licensed by the Department of Public Health as a
14skilled nursing facility, intermediate care facility, or
15long-term care facility for residents under 22 years of age,
16are exempt from the requirements of Section 312 except that a
17prescription for a Schedule II controlled substance must be
18either a prescription signed by the prescriber or a
19prescription transmitted by the prescriber or prescriber's
20agent to the dispensing pharmacy by facsimile. The facsimile
21serves as the original prescription and must be maintained for
222 years from the date of issue in the same manner as a written
23prescription signed by the prescriber.
24    (c) A prescription that is generated for a Schedule II
25controlled substance to be compounded for direct
26administration to a patient in a private residence, long-term



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1care facility, or hospice program may be transmitted by
2facsimile by the prescriber or the prescriber's agent to the
3pharmacy providing the home infusion services. The facsimile
4serves as the original prescription for purposes of this
5paragraph (c) and it shall be maintained in the same manner as
6the original prescription.
7    (c-1) A prescription generated for a Schedule II
8controlled substance for a patient residing in a hospice
9certified by Medicare under Title XVIII of the Social Security
10Act or licensed by the State may be transmitted by the
11practitioner or the practitioner's agent to the dispensing
12pharmacy by facsimile or electronically as provided in Section
13311.5. The practitioner or practitioner's agent must note on
14the prescription that the patient is a hospice patient. The
15facsimile or electronic record serves as the original
16prescription for purposes of this paragraph (c-1) and it shall
17be maintained in the same manner as the original prescription.
18    (d) Controlled substances which are lawfully administered
19and/or dispensed in drug abuse treatment programs licensed by
20the Department shall be exempt from the requirements of
21Sections 312 and 316, except that the prescription for such
22controlled substances shall be issued and authenticated on
23official prescription logs prepared and maintained in
24accordance with 77 Ill. Adm. Code 2060: Alcoholism and
25Substance Abuse Treatment and Intervention Licenses, and in
26compliance with other applicable State and federal laws. The



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1Department-licensed drug treatment program shall report
2applicable prescriptions via electronic record keeping
3software approved by the Department. This software must be
4compatible with the specifications of the Department. Drug
5abuse treatment programs shall report to the Department
6methadone prescriptions or medications dispensed through the
7use of Department-approved File Transfer Protocols (FTPs).
8Methadone prescription records must be maintained in
9accordance with the applicable requirements as set forth by
10the Department in accordance with 77 Ill. Adm. Code 2060:
11Alcoholism and Substance Abuse Treatment and Intervention
12Licenses, and in compliance with other applicable State and
13federal laws.
14    (e) Nothing in this Act shall be construed to limit the
15authority of a hospital pursuant to Section 65-45 of the Nurse
16Practice Act to grant hospital clinical privileges to an
17individual advanced practice registered nurse to select, order
18or administer medications, including controlled substances to
19provide services within a hospital. Nothing in this Act shall
20be construed to limit the authority of an ambulatory surgical
21treatment center pursuant to Section 65-45 of the Nurse
22Practice Act to grant ambulatory surgical treatment center
23clinical privileges to an individual advanced practice
24registered nurse to select, order or administer medications,
25including controlled substances to provide services within an
26ambulatory surgical treatment center.



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1(Source: P.A. 100-513, eff. 1-1-18.)
2    Section 99. Effective date. This Act takes effect January
31, 2022.".