Full Text of SB2535 102nd General Assembly
SB2535sam002 102ND GENERAL ASSEMBLY | Sen. Melinda Bush Filed: 5/12/2021
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| 1 | | AMENDMENT TO SENATE BILL 2535
| 2 | | AMENDMENT NO. ______. Amend Senate Bill 2535 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 5. The Pharmacy Practice Act is amended by | 5 | | changing Section 19.1 as follows: | 6 | | (225 ILCS 85/19.1) | 7 | | (Section scheduled to be repealed on January 1, 2023) | 8 | | Sec. 19.1.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
| 10 | | Illinois and the existence of an opioid antagonist that can
| 11 | | reverse the deadly effects of overdose, the General Assembly
| 12 | | finds that in order to avoid further loss where possible, it is
| 13 | | responsible to allow greater access of such an antagonist to
| 14 | | those populations at risk of overdose. | 15 | | (b) Notwithstanding any general or special law to the
| 16 | | contrary, a licensed pharmacist shall may dispense an opioid |
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| 1 | | antagonist
in accordance with written, standardized procedures | 2 | | or
protocols developed by the Department with the Department | 3 | | of
Public Health and the Department of Human Services and if | 4 | | the
procedures or protocols are filed at the pharmacy before
| 5 | | implementation and are available to the Department upon
| 6 | | request. | 7 | | (c) Before dispensing an opioid a pharmacist shall inform | 8 | | patients that opioids are addictive and offer to dispense an | 9 | | opioid antagonist pursuant to this
Section, a pharmacist shall | 10 | | complete a training program
approved by the Department of | 11 | | Human Services pursuant to
Section 5-23 of the Substance Use | 12 | | Disorder Act. The training program shall include, but not be
| 13 | | limited to, proper documentation and quality assurance . | 14 | | (d) For the purpose of this Section, "opioid antagonist" | 15 | | means a drug that binds to opioid receptors and blocks or | 16 | | inhibits the effect of opioids acting on those receptors, | 17 | | including, but not limited to, naloxone hydrochloride or any | 18 | | other similarly acting and equally safe drug approved by the | 19 | | U.S. Food and Drug Administration for the treatment of drug | 20 | | overdose.
| 21 | | (Source: P.A. 99-480, eff. 9-9-15; 99-642, eff. 7-28-16; | 22 | | 100-759, eff. 1-1-193 .) | 23 | | Section 10. The Illinois Controlled Substances Act is | 24 | | amended 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 | 3 | | substances.
| 4 | | (a) A practitioner, in good faith, may dispense a Schedule
| 5 | | II controlled substance, which is a narcotic drug listed in | 6 | | Section 206
of this Act; or which contains any quantity of | 7 | | amphetamine or
methamphetamine, their salts, optical isomers | 8 | | or salts of optical
isomers; phenmetrazine and its salts; or | 9 | | pentazocine; and Schedule III, IV, or V controlled substances
| 10 | | to any person upon
a written or electronic prescription of any | 11 | | prescriber, dated and signed
by the
person prescribing (or | 12 | | electronically validated in compliance with Section 311.5) on | 13 | | the day when issued and bearing the name and
address of the | 14 | | patient for whom, or the owner of the animal for which
the | 15 | | controlled substance is dispensed, and the full name, address | 16 | | and
registry number under the laws of the United States | 17 | | relating to
controlled substances of the prescriber, if he or | 18 | | she is
required by
those laws to be registered. If the | 19 | | prescription is for an animal it
shall state the species of | 20 | | animal for which it is ordered. The
practitioner filling the | 21 | | prescription shall, unless otherwise permitted, write the date | 22 | | of filling
and his or her own signature on the face of the | 23 | | written prescription or, alternatively, shall indicate such | 24 | | filling using a unique identifier as defined in paragraph (v) | 25 | | of Section 3 of the Pharmacy Practice Act.
The written | 26 | | prescription shall be
retained on file by the practitioner who |
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| 1 | | filled it or pharmacy in which
the prescription was filled for | 2 | | a period of 2 years, so as to be readily
accessible for | 3 | | inspection or removal by any officer or employee engaged
in | 4 | | the enforcement of this Act. Whenever the practitioner's or
| 5 | | pharmacy's copy of any prescription is removed by an officer | 6 | | or
employee engaged in the enforcement of this Act, for the | 7 | | purpose of
investigation or as evidence, such officer or | 8 | | employee shall give to the
practitioner or pharmacy a receipt | 9 | | in lieu thereof. If the specific prescription is machine or | 10 | | computer generated and printed at the prescriber's office, the | 11 | | date does not need to be handwritten. A prescription
for a | 12 | | Schedule II controlled substance shall not be issued for more | 13 | | than a 30 day supply, except as provided in subsection (a-5), | 14 | | and shall be valid for up to 90 days
after the date of | 15 | | issuance. A written prescription for Schedule III, IV or
V | 16 | | controlled substances shall not be filled or refilled more | 17 | | than 6 months
after the date thereof or refilled more than 5 | 18 | | times unless renewed, in
writing, by the prescriber. A | 19 | | pharmacy shall maintain a policy regarding the type of | 20 | | identification necessary, if any, to receive a prescription in | 21 | | accordance with State and federal law. The pharmacy must post | 22 | | such information where prescriptions are filled.
| 23 | | (a-5) Physicians may issue multiple prescriptions (3 | 24 | | sequential 30-day supplies) for the same Schedule II | 25 | | controlled substance, authorizing up to a 90-day supply. | 26 | | Before authorizing a 90-day supply of a Schedule II controlled |
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| 1 | | substance, 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 | 16 | | shall inform the patient that opioids are addictive and that | 17 | | opioid antagonists are available by prescription or from a | 18 | | pharmacy. | 19 | | (b) In lieu of a written prescription required by this | 20 | | Section, a
pharmacist, in good faith, may dispense Schedule | 21 | | III, IV, or V
substances to any person either upon receiving a | 22 | | facsimile of a written,
signed prescription transmitted by the | 23 | | prescriber or the prescriber's agent
or upon a lawful oral | 24 | | prescription of a
prescriber which oral prescription shall be | 25 | | reduced
promptly to
writing by the pharmacist and such written | 26 | | memorandum thereof shall be
dated on the day when such oral |
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| 1 | | prescription is received by the
pharmacist and shall bear the | 2 | | full name and address of the ultimate user
for whom, or of the | 3 | | owner of the animal for which the controlled
substance is | 4 | | dispensed, and the full name, address, and registry number
| 5 | | under the law of the United States relating to controlled | 6 | | substances of
the prescriber prescribing if he or she is | 7 | | required by those laws
to be so
registered, and the pharmacist | 8 | | filling such oral prescription shall
write the date of filling | 9 | | and his or her own signature on the face of such
written | 10 | | memorandum thereof. The facsimile copy of the prescription or
| 11 | | written memorandum of the oral
prescription shall be retained | 12 | | on file by the proprietor of the pharmacy
in which it is filled | 13 | | for a period of not less than two years, so as to
be readily | 14 | | accessible for inspection by any officer or employee engaged
| 15 | | in the enforcement of this Act in the same manner as a written
| 16 | | prescription. The facsimile copy of the prescription or oral | 17 | | prescription
and the written memorandum thereof
shall not be | 18 | | filled or refilled more than 6 months after the date
thereof or | 19 | | be refilled more than 5 times, unless renewed, in writing, by
| 20 | | the prescriber.
| 21 | | (c) Except for any non-prescription targeted | 22 | | methamphetamine precursor regulated by the Methamphetamine | 23 | | Precursor Control Act, a
controlled substance included in | 24 | | Schedule V shall not be
distributed or dispensed other than | 25 | | for a medical purpose and not for
the purpose of evading this | 26 | | Act, 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 | 22 | | controlled substances
received by him or her and a record of | 23 | | all such controlled substances
administered, dispensed or | 24 | | professionally used by him or her otherwise than by
| 25 | | prescription. It shall, however, be sufficient compliance with | 26 | | this
paragraph if any practitioner utilizing controlled |
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| 1 | | substances listed in
Schedules III, IV and V shall keep a | 2 | | record of all those substances
dispensed and distributed by | 3 | | him or her other than those controlled substances
which are | 4 | | administered by the direct application of a controlled
| 5 | | substance, whether by injection, inhalation, ingestion, or any | 6 | | other
means to the body of a patient or research subject. A | 7 | | practitioner who
dispenses, other than by administering, a | 8 | | controlled substance in
Schedule II, which is a narcotic drug | 9 | | listed in Section 206 of this Act,
or which contains any | 10 | | quantity of amphetamine or methamphetamine, their
salts, | 11 | | optical isomers or salts of optical isomers, pentazocine, or
| 12 | | methaqualone shall do so only upon
the issuance of a written | 13 | | prescription blank or electronic prescription issued by a
| 14 | | prescriber.
| 15 | | (e) Whenever a manufacturer distributes a controlled | 16 | | substance in a
package prepared by him or her, and whenever a | 17 | | wholesale distributor
distributes a controlled substance in a | 18 | | package prepared by him or her or the
manufacturer, he or she | 19 | | shall securely affix to each package in which that
substance | 20 | | is contained a label showing in legible English the name and
| 21 | | address of the manufacturer, the distributor and the quantity, | 22 | | kind and
form of controlled substance contained therein. No | 23 | | person except a
pharmacist and only for the purposes of | 24 | | filling a prescription under
this Act, shall alter, deface or | 25 | | remove any label so affixed.
| 26 | | (f) Whenever a practitioner dispenses any controlled |
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| 1 | | substance except a non-prescription Schedule V product or a | 2 | | non-prescription targeted methamphetamine precursor regulated | 3 | | by the Methamphetamine Precursor Control Act, he or she
shall | 4 | | affix to the container in which such substance is sold or
| 5 | | dispensed, a label indicating the date of initial filling, the | 6 | | practitioner's
name and address, the name
of the patient, the | 7 | | name of the prescriber,
the directions
for use and cautionary | 8 | | statements, if any, contained in any prescription
or required | 9 | | by law, the proprietary name or names or the established name
| 10 | | of the controlled substance, and the dosage and quantity, | 11 | | except as otherwise
authorized by regulation by the Department | 12 | | of Financial and Professional Regulation. No
person shall | 13 | | alter, deface or remove any label so affixed as long as the | 14 | | specific medication remains in the container.
| 15 | | (g) A person to whom or for whose use any controlled | 16 | | substance has
been prescribed or dispensed by a practitioner, | 17 | | or other persons
authorized under this Act, and the owner of | 18 | | any animal for which such
substance has been prescribed or | 19 | | dispensed by a veterinarian, may
lawfully possess such | 20 | | substance only in the container in which it was
delivered to | 21 | | him or her by the person dispensing such substance.
| 22 | | (h) The responsibility for the proper prescribing or | 23 | | dispensing of
controlled substances that are under the | 24 | | prescriber's direct control is upon the prescriber. The | 25 | | responsibility for
the proper filling of a prescription for | 26 | | controlled substance drugs
rests with the pharmacist. An order |
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| 1 | | purporting to be a prescription
issued to any individual, | 2 | | which is not in the regular course of
professional treatment | 3 | | nor part of an authorized methadone maintenance
program, nor | 4 | | in legitimate and authorized research instituted by any
| 5 | | accredited hospital, educational institution, charitable | 6 | | foundation, or
federal, state or local governmental agency, | 7 | | and which is intended to
provide that individual with | 8 | | controlled substances sufficient to
maintain that individual's | 9 | | or any other individual's physical or
psychological addiction, | 10 | | habitual or customary use, dependence, or
diversion of that | 11 | | controlled substance is not a prescription within the
meaning | 12 | | and intent of this Act; and the person issuing it, shall be
| 13 | | subject to the penalties provided for violations of the law | 14 | | relating to
controlled substances.
| 15 | | (i) A prescriber shall not pre-print or cause to be
| 16 | | pre-printed a
prescription for any controlled substance; nor | 17 | | shall any practitioner
issue, fill or cause to be issued or | 18 | | filled, a pre-printed prescription
for any controlled | 19 | | substance.
| 20 | | (i-5) A prescriber may use a machine or electronic device | 21 | | to individually generate a printed prescription, but the | 22 | | prescriber is still required to affix his or her manual | 23 | | signature. | 24 | | (j) No person shall manufacture, dispense, deliver, | 25 | | possess with
intent to deliver, prescribe, or administer or | 26 | | cause to be administered
under his or her direction any |
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| 1 | | anabolic steroid, for any use in humans other than
the | 2 | | treatment of disease in accordance with the order of a | 3 | | physician licensed
to practice medicine in all its branches | 4 | | for a
valid medical purpose in the course of professional | 5 | | practice. The use of
anabolic steroids for the purpose of | 6 | | hormonal manipulation that is intended
to increase muscle | 7 | | mass, strength or weight without a medical necessity to
do so, | 8 | | or for the intended purpose of improving physical appearance | 9 | | or
performance in any form of exercise, sport, or game, is not | 10 | | a valid medical
purpose or in the course of professional | 11 | | practice.
| 12 | | (k) Controlled substances may be mailed if all of the | 13 | | following 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 | 2 | | contrary, emergency medical services personnel may administer | 3 | | Schedule II, III, IV, or V controlled substances to a person in | 4 | | the scope of their employment without a written, electronic, | 5 | | or oral prescription of a prescriber. | 6 | | (Source: P.A. 99-78, eff. 7-20-15; 99-480, eff. 9-9-15; | 7 | | 100-280, 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 | 10 | | administered in
hospitals or institutions licensed under the | 11 | | Hospital Licensing Act shall
be exempt from the requirements | 12 | | of Sections 312 and 316, except
that the
prescription for the | 13 | | controlled substance shall be in writing on the
patient's | 14 | | record, signed by the prescriber, and dated, and shall state | 15 | | the
name and quantity of controlled substances ordered and the | 16 | | quantity
actually administered. The records of such | 17 | | prescriptions shall be
maintained for two years and shall be | 18 | | available for inspection by officers
and employees of the | 19 | | Illinois State Police and the Department of Financial and
| 20 | | Professional Regulation. | 21 | | The exemption under this subsection (a) does not apply to | 22 | | a prescription (including an outpatient prescription from an | 23 | | emergency department or outpatient clinic) for more than a | 24 | | 72-hour supply of a discharge medication to be consumed | 25 | | outside of the hospital or institution.
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| 1 | | (a-5) In a hospital or institutions licensed under the | 2 | | Hospital Licensing Act, all prescribers of an opioid shall | 3 | | inform the patient that opioids are addictive and that opioid | 4 | | antagonists are available by prescription or from a pharmacy. | 5 | | Upon discharge any patient who has overdosed on controlled | 6 | | substances shall be provided with an opioid antagonist. If the | 7 | | patient is not able to pay for the opioid antagonist, then the | 8 | | State of Illinois shall reimburse the hospital for the opioid | 9 | | antagonist from federal grant funds to address substance use | 10 | | disorder or other State funds for the same purpose. | 11 | | (b) Controlled substances that can lawfully be | 12 | | administered or dispensed
directly to a patient in a long-term | 13 | | care facility licensed by the Department
of Public Health as a | 14 | | skilled nursing facility, intermediate care facility, or
| 15 | | long-term care facility for residents under 22 years of age, | 16 | | are exempt from
the requirements of Section 312 except that a | 17 | | prescription
for a
Schedule II controlled substance must be | 18 | | either a prescription signed
by the prescriber or a | 19 | | prescription transmitted by the prescriber or
prescriber's | 20 | | agent to the dispensing pharmacy by facsimile. The
facsimile | 21 | | serves as the original prescription and must be maintained for | 22 | | 2
years from the date of issue in the same manner as a written | 23 | | prescription
signed by the prescriber.
| 24 | | (c) A prescription that is generated for a Schedule II | 25 | | controlled substance
to be compounded for direct | 26 | | administration to a patient in a private
residence, long-term |
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| 1 | | care facility, or hospice program
may be transmitted by
| 2 | | facsimile by the prescriber or the prescriber's agent to the | 3 | | pharmacy providing
the home infusion services. The facsimile | 4 | | serves as the original
prescription for purposes of this | 5 | | paragraph (c) and it shall be maintained in
the same manner as | 6 | | the original prescription.
| 7 | | (c-1) A prescription generated for a Schedule II | 8 | | controlled substance for a
patient residing in a hospice | 9 | | certified by Medicare under Title XVIII of the
Social Security | 10 | | Act or
licensed by the State may be transmitted by the | 11 | | practitioner or the
practitioner's
agent to the dispensing | 12 | | pharmacy by facsimile or electronically as provided in Section | 13 | | 311.5. The practitioner or
practitioner's
agent must note on | 14 | | the prescription that the patient is a hospice patient. The
| 15 | | facsimile or electronic record serves as the original | 16 | | prescription for purposes of this
paragraph (c-1) and it shall | 17 | | be maintained in the same manner as the original
prescription.
| 18 | | (d) Controlled substances which are lawfully administered
| 19 | | and/or dispensed
in drug abuse treatment programs licensed by | 20 | | the Department shall be exempt
from the requirements of | 21 | | Sections 312 and 316, except that the
prescription
for such | 22 | | controlled substances shall be issued and authenticated
on | 23 | | official prescription logs prepared and maintained in | 24 | | accordance with 77 Ill. Adm. Code 2060: Alcoholism and | 25 | | Substance Abuse Treatment and Intervention Licenses, and in | 26 | | compliance with other applicable State and federal laws. The |
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| 1 | | Department-licensed drug treatment program shall report | 2 | | applicable prescriptions via electronic record keeping | 3 | | software approved by the Department. This software must be | 4 | | compatible with the specifications of the Department. Drug | 5 | | abuse treatment programs shall report to the Department | 6 | | methadone prescriptions or medications dispensed through the | 7 | | use of Department-approved File Transfer Protocols (FTPs). | 8 | | Methadone prescription records must be maintained in | 9 | | accordance with the applicable requirements as set forth by | 10 | | the Department in accordance with 77 Ill. Adm. Code 2060: | 11 | | Alcoholism and Substance Abuse Treatment and Intervention | 12 | | Licenses, and in compliance with other applicable State and | 13 | | federal laws. | 14 | | (e) Nothing in this Act shall be construed to limit the | 15 | | authority of a hospital pursuant to Section 65-45 of the Nurse | 16 | | Practice Act to grant hospital clinical privileges to an | 17 | | individual advanced practice registered nurse to select, order | 18 | | or administer medications, including controlled substances to | 19 | | provide services within a hospital. Nothing in this Act shall | 20 | | be construed to limit the authority of an ambulatory surgical | 21 | | treatment center pursuant to Section 65-45 of the Nurse | 22 | | Practice Act to grant ambulatory surgical treatment center | 23 | | clinical privileges to an individual advanced practice | 24 | | registered nurse to select, order or administer medications, | 25 | | including controlled substances to provide services within an | 26 | | ambulatory 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 | 3 | | 1, 2022.".
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