(720 ILCS 570/Art. III heading)
(720 ILCS 570/301) (from Ch. 56 1/2, par. 1301)
Sec. 301. The Department of Financial and Professional Regulation shall promulgate
rules and charge reasonable fees and fines relating to the registration and
control of the manufacture, distribution, and dispensing of controlled
substances within this State. The Department shall request a contact email address in its application for a new or renewed license to dispense controlled substances. All moneys received by the Department of Financial and
Professional Regulation under this Act shall be deposited into the respective
professional dedicated funds in like manner as the primary professional
licenses.
A pharmacy, manufacturer of controlled substances, or wholesale distributor of controlled substances that is regulated under this Act and owned and operated by the State is exempt from fees required under this Act. Pharmacists and pharmacy technicians working in facilities owned and operated by the State are not exempt from the payment of fees required by this Act and any rules adopted under this Act. Nothing in this Section shall be construed to prohibit the Department of Financial and Professional Regulation from imposing any fine or other penalty allowed under this Act.
(Source: P.A. 99-480, eff. 9-9-15.)
(720 ILCS 570/302) (from Ch. 56 1/2, par. 1302)
Sec. 302. (a) Every person who manufactures, distributes, or dispenses
any controlled substances; engages in chemical analysis, research, or
instructional activities which utilize controlled substances; purchases, stores, or administers euthanasia drugs, within this
State; provides canine odor detection services; proposes to engage in the
manufacture, distribution, or dispensing of any controlled substance; proposes to
engage in chemical analysis, research, or instructional activities
which utilize controlled substances; proposes to engage in purchasing, storing, or
administering euthanasia drugs; or proposes to provide canine odor detection services within this State, must obtain a
registration issued by the Department of Financial and Professional Regulation in
accordance with its rules. The rules shall
include, but not be limited to, setting the expiration date and renewal
period for each registration under this Act. The Department,
any facility or service licensed by the Department, and any veterinary hospital or clinic operated by a veterinarian or veterinarians licensed under the Veterinary Medicine and Surgery Practice Act of 2004 or maintained by a State-supported or publicly funded university or college shall be exempt
from the regulation requirements of this Section; however, such exemption shall not operate to bar the University of Illinois from requesting, nor the Department of Financial and Professional Regulation from issuing, a registration to the University of Illinois Veterinary Teaching Hospital under this Act. Neither a request for such registration nor the issuance of such registration to the University of Illinois shall operate to otherwise waive or modify the exemption provided in this subsection (a).
(b) Persons registered by the Department of Financial and Professional Regulation
under this Act to manufacture, distribute, or dispense controlled
substances, engage in chemical analysis, research, or instructional activities which utilize controlled substances, purchase, store, or administer euthanasia drugs, or provide canine odor detection services, may
possess, manufacture, distribute, engage in chemical analysis, research, or instructional activities which utilize controlled substances, dispense those
substances, or purchase, store, or administer euthanasia drugs, or provide canine odor detection services to the
extent authorized by their registration and in conformity
with the other provisions of this Article.
(c) The following persons need not register and may lawfully possess
controlled substances under this Act:
(d) A separate registration is required at each place of
business or professional practice where the applicant manufactures,
distributes, or dispenses controlled substances, or purchases, stores, or
administers euthanasia drugs.
Persons are required to obtain a separate registration for each
place of business or professional practice where controlled
substances are located or stored. A separate registration is
not required for every location at which a controlled substance
may be prescribed.
(e) The Department of Financial and Professional Regulation or the Illinois
State Police may inspect the controlled premises, as defined in Section
502 of this Act, of a registrant or applicant for registration in
accordance with this Act and the rules promulgated hereunder and with regard
to persons licensed by the Department, in accordance with subsection (bb)
of Section 30-5
of the Substance Use Disorder Act and
the rules and
regulations promulgated thereunder.
(Source: P.A. 99-163, eff. 1-1-16; 99-247, eff. 8-3-15; 99-642, eff. 7-28-16; 100-513, eff. 1-1-18; 100-759, eff. 1-1-19.)
(720 ILCS 570/303) (from Ch. 56 1/2, par. 1303)
Sec. 303. (a) The Department of Financial and Professional Regulation shall license an
applicant to manufacture, distribute or dispense controlled substances
included in Sections 202, 204, 206, 208, 210 and 212 of this Act or purchase,
store, or administer euthanasia drugs unless it
determines that the issuance of that license would be
inconsistent
with the public interest. In determining the public interest, the
Department of Financial and Professional Regulation shall consider the following:
(b) No license shall be granted to or renewed for any
person who
has within 5 years been convicted of a wilful violation of any law of the
United States or any law of any State relating to controlled substances, or
who is found to be deficient in any of the matters enumerated in
subsections (a)(1) through (a)(8).
(c) Licensure under subsection (a) does not entitle a
registrant to
manufacture, distribute or dispense controlled substances in Schedules I or
II other than those specified in the registration.
(d) Practitioners who are licensed to dispense any
controlled
substances in Schedules II through V are authorized to
conduct instructional activities with controlled substances
in Schedules II through V under the law of this State.
(e) If an applicant for registration is registered under the Federal law
to manufacture, distribute or dispense controlled substances, or purchase,
store, or administer euthanasia drugs, upon filing a
completed application for licensure in this State and
payment of all
fees due hereunder, he or she shall be licensed in this State to
the same extent
as his or her Federal registration, unless, within 30 days after completing his or her
application in this State, the Department of Financial and Professional Regulation
notifies the applicant that his or her application has not been granted. A
practitioner who is in compliance with the Federal law with respect to
registration to dispense controlled substances in Schedules II through V
need only send a current copy of that Federal registration to the
Department of Financial and Professional Regulation and he or she shall be deemed in
compliance with the registration provisions of this State.
(e-5) All of the fees and fines collected under
this Section 303 shall be deposited into the Illinois State Pharmacy
Disciplinary Fund.
(f) The fee for registration as a manufacturer or wholesale distributor
of controlled substances shall be $50.00 per year, except that the fee for
registration as a manufacturer or wholesale distributor of controlled
substances that may be dispensed without a prescription under this Act
shall be $15.00 per year. The expiration date and renewal period for
each controlled substance license issued
under this Act shall be set by rule.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/303.05)
Sec. 303.05. Mid-level practitioner registration.
(a) The Department of Financial and Professional Regulation shall register licensed
physician assistants, licensed advanced practice registered nurses, and prescribing psychologists licensed under Section 4.2 of the Clinical Psychologist Licensing Act to prescribe and
dispense controlled substances under Section 303 and euthanasia
agencies to purchase, store, or administer animal euthanasia drugs under the
following circumstances:
(b) The mid-level practitioner shall only be licensed to prescribe those
schedules of controlled substances for which a licensed physician has delegated
prescriptive authority, except that an animal euthanasia agency does not have any
prescriptive authority.
A physician assistant and an advanced practice registered nurse are prohibited from prescribing medications and controlled substances not set forth in the required written delegation of authority or as authorized by their practice Act.
(c) Upon completion of all registration requirements, physician
assistants, advanced practice registered nurses, and animal euthanasia agencies may be issued a
mid-level practitioner
controlled substances license for Illinois.
(d) A collaborating physician may, but is not required to, delegate prescriptive authority to an advanced practice registered nurse as part of a written collaborative agreement, and the delegation of prescriptive authority shall conform to the requirements of Section 65-40 of the Nurse Practice Act.
(e) A collaborating physician may, but is not required to, delegate prescriptive authority to a physician assistant as part of a written collaborative agreement, and the delegation of prescriptive authority shall conform to the requirements of Section 7.5 of the Physician Assistant Practice Act of 1987.
(f) Nothing in this Section shall be construed to prohibit generic substitution.
(Source: P.A. 99-173, eff. 7-29-15; 100-453, eff. 8-25-17; 100-513, eff. 1-1-18; 100-863, eff. 8-14-18.)
(720 ILCS 570/303.1) (from Ch. 56 1/2, par. 1303.1)
Sec. 303.1.
Any person who delivers a check or other payment to the
Department of Financial and Professional Regulation that is returned to the Department
unpaid by the financial institution upon which it is drawn shall pay to the
Department,
in addition to the amount already owed to the Department, a fine of $50. If
the check or other payment was for a renewal or issuance fee and that person
practices without
paying the renewal fee or issuance fee and the fine due, an additional fine
of $100 shall be imposed. The fines imposed by this Section are in addition
to any other discipline provided under this Act for unlicensed
practice or practice on a nonrenewed license. The Department
of Financial and Professional Regulation shall notify the person that payment of fees
and fines shall be paid to the Department
by certified check or money order within 30 calendar days of the
notification. If, after the expiration of 30 days from the date of the
notification, the person has failed to submit the necessary remittance, the
Department of Financial and Professional Regulation shall automatically terminate the
license or certificate or deny
the application, without hearing. If, after termination or denial, the
person seeks a license or certificate, he or she shall apply to the
Department for restoration or issuance of the license or certificate and
pay all fees and fines due to the Department. The Department of Financial and Professional
Regulation may establish
a fee for the processing of an application for restoration of a license or
certificate to pay all expenses of processing this application. The Secretary
may waive the fines due under this Section in individual cases where the Secretary of the Department of Financial and Professional Regulation
finds that the fines would be unreasonable or unnecessarily
burdensome.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/304) (from Ch. 56 1/2, par. 1304)
Sec. 304. (a) A registration under Section 303 to manufacture,
distribute, or dispense a controlled substance or purchase, store, or
administer euthanasia drugs may be denied, refused renewal, suspended, or
revoked by the Department of Financial and Professional Regulation, and a fine of no more than $10,000 per violation may be imposed on the applicant or registrant, upon a finding
that the applicant or registrant:
(b) The Department of Financial and Professional Regulation may limit
revocation or suspension of a registration to the particular controlled
substance with respect to which grounds for revocation or suspension
exist.
(c) The Department of Financial and Professional Regulation shall promptly
notify the Administration, the Department and the Illinois State
Police or their successor agencies, of all orders denying,
suspending or revoking registration, all forfeitures of controlled
substances, and all final court dispositions, if any, of such denials,
suspensions, revocations or forfeitures.
(d) If Federal registration of any registrant is suspended, revoked,
refused renewal or refused issuance, then the Department of Financial and Professional
Regulation shall issue a notice and conduct a hearing in accordance
with Section 305 of this Act.
(Source: P.A. 97-334, eff. 1-1-12; 97-813, eff. 7-13-12.)
(720 ILCS 570/305) (from Ch. 56 1/2, par. 1305)
Sec. 305.
(a) Before denying, refusing renewal of, suspending, or revoking a
registration, or imposing a fine on an applicant or registrant, the Department of Financial and Professional Regulation shall serve upon
the applicant or registrant, by registered mail at the address in the
application or registration or by any other means authorized under the
Civil Practice Law or Rules of the Illinois Supreme Court for the service
of summons or subpoenas, a notice of hearing to determine why registration
should not be denied, refused renewal, suspended or revoked. The notice
shall contain a statement of the basis therefor and shall call upon the
applicant or registrant to appear before the Department of Financial and Professional
Regulation at a reasonable time and place. These proceedings shall be
conducted in accordance with Sections 2105-5, 2105-15, 2105-100, 2105-105,
2105-110,
2105-115, 2105-120, 2105-125, 2105-175, and 2105-325
of the Department of Professional Regulation Law (20 ILCS 2105/2105-5,
2105/2105-15, 2105/2105-100, 2105/2105-105, 2105/2105-110, 2105/2105-115,
2105/2105-120,
2105/2105-125, 2105/2105-175, and 2105/2105-325),
without
regard to any criminal prosecution or other proceeding. Except as
authorized in subsection (c), proceedings to refuse renewal or
suspend or
revoke registration shall not abate the existing registration, which shall
remain in effect until the Department of Financial and Professional Regulation has
held the hearing called for in the notice and found, with input from the
appropriate licensure or disciplinary board, that the registration
shall no longer remain in effect.
(b) The Secretary of the Department of Financial and Professional Regulation may appoint an attorney duly
licensed to practice law in the State of Illinois to serve as the hearing
officer in any action to deny, refuse to renew, suspend, or revoke, or take any
other disciplinary action with regard to a registration. The hearing officer
shall have full authority to conduct the hearing. The hearing officer shall
report his or her findings and recommendations to the appropriate licensure or
disciplinary board within 30 days after receiving the record. The
Disciplinary Board shall have 60 days from receipt of the report to review the
report of the hearing officer and present its findings of fact, conclusions
of law, and recommendations to the Secretary of the Department of Financial and Professional Regulation.
(c) If the Department of Financial and Professional Regulation finds that
there is
an imminent danger to the public health or safety by the continued
manufacture, distribution or dispensing of controlled substances by the
registrant, the Department of Financial and Professional Regulation may, upon the
issuance of a written ruling stating the reasons for such finding and
without notice or hearing, suspend such registrant. The suspension shall
continue in effect for not more than 15 days during which time the
registrant shall be given a hearing on the issues involved in the
suspension. If after the hearing, and after
input from the appropriate licensure or disciplinary board,
the Department of Financial and Professional Regulation
finds that the public health
or safety requires the suspension to remain in effect it shall so remain
until the ruling is terminated by its own terms or subsequent ruling or is
dissolved by a circuit court upon determination that the
suspension was wholly without basis in fact and law.
(d) If, after a hearing as provided in subsection (a), the
Department of Financial and
Professional Regulation
finds that a registration should be refused
renewal, suspended or revoked, a written ruling to that effect shall be
entered. The Department of Financial and Professional Regulation's ruling shall remain
in effect until the ruling is terminated by its own terms or subsequent
ruling or is dissolved by a circuit court upon a determination that the
refusal to renew suspension or revocation was wholly without basis in fact and
law.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/306) (from Ch. 56 1/2, par. 1306)
Sec. 306. Every practitioner and person who is required under
this Act to be registered to manufacture, distribute or dispense controlled
substances or purchase, store, or administer euthanasia drugs under this
Act shall keep records and maintain inventories in
conformance with the recordkeeping and inventory requirements of the laws
of the United States and with any additional rules and forms issued by the
Department of Financial and Professional Regulation.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/307) (from Ch. 56 1/2, par. 1307)
Sec. 307.
Controlled substances in Schedules I and II shall be distributed by a
registrant to another registrant only pursuant to a written order.
Compliance with the laws of the United States respecting order forms shall
be deemed compliance with this Section.
(Source: P.A. 77-757.)
(720 ILCS 570/308) (from Ch. 56 1/2, par. 1308)
Sec. 308.
(Repealed).
(Source: P.A. 89-202, eff. 10-1-95. Repealed by P.A. 91-576, eff. 4-1-00.)
(720 ILCS 570/309) (from Ch. 56 1/2, par. 1309)
Sec. 309. On or after April 1, 2000, no person shall issue a
prescription for a Schedule II
controlled substance, which is a narcotic drug listed in Section 206 of
this Act; or which contains any quantity of amphetamine or
methamphetamine, their salts, optical isomers or salts of optical
isomers; phenmetrazine and its salts; gluthethimide; and pentazocine, other than on a written
prescription; provided
that in the case of an emergency, epidemic or a
sudden or unforeseen accident or calamity, the prescriber may issue a
lawful oral prescription where failure to
issue such a prescription might result in
loss of life or intense suffering, but such oral prescription shall
include a statement by the prescriber concerning the accident
or calamity, or circumstances constituting the emergency, the cause for
which an oral prescription was used. Within
7 days after issuing an
emergency prescription, the prescriber shall cause a written prescription for
the emergency quantity prescribed to be delivered to
the dispensing pharmacist. The prescription shall have written on its face
"Authorization for Emergency Dispensing", and the date of the emergency
prescription. The written prescription
may be delivered to the pharmacist in person, or by mail, but if delivered
by mail it must be postmarked within the 7-day period. Upon
receipt, the
dispensing pharmacist shall attach this prescription to the emergency oral
prescription earlier received and
reduced to writing. The dispensing pharmacist shall notify the Department of Financial and Professional Regulation
if the prescriber
fails to deliver the authorization for emergency dispensing on the
prescription to him or her. Failure of the dispensing pharmacist to do so
shall void the authority conferred by this paragraph to dispense without a
written prescription of a
prescriber. All prescriptions issued for Schedule II controlled substances
shall include both a written and numerical notation of quantity on the face
of the prescription. No prescription for a Schedule II controlled substance
may
be refilled. The Department shall provide, at no cost, audit reviews and necessary information to the Department of Financial and Professional Regulation in conjunction with ongoing investigations being conducted in whole or part by the Department of Financial and Professional Regulation.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/310) (from Ch. 56 1/2, par. 1310)
Sec. 310.
(Repealed).
(Source: P.A. 84-1308. Repealed by P.A. 91-576, eff. 4-1-00.)
(720 ILCS 570/311) (from Ch. 56 1/2, par. 1311)
Sec. 311.
(Repealed).
(Source: P.A. 89-202, eff. 10-1-95. Repealed by P.A. 91-576, eff. 4-1-00.)
(720 ILCS 570/311.5)
Sec. 311.5. Electronic prescriptions for controlled substances. Notwithstanding any other Section in this Act, a prescriber who is otherwise authorized to prescribe controlled substances in Illinois may issue an electronic prescription for Schedule II, III, IV, and V controlled substances if done in accordance with the federal rules for electronic prescriptions for controlled substances, as set forth in 21 C.F.R. Parts 1300, 1304, 1306, and 1311, as amended.
(Source: P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/311.6)
(This Section may contain text from a Public Act with a delayed effective date)
Sec. 311.6. Opioid prescriptions.
(a) Notwithstanding any other provision of law, a prescription for a substance classified in Schedule II, III, IV, or V must be sent electronically, in accordance with Section 316. Prescriptions sent in accordance with this subsection (a) must be accepted by the dispenser in electronic format.
(b) Notwithstanding any other provision of this Section or any other provision of law, a prescriber shall not be required to issue prescriptions electronically if he or she certifies to the Department of Financial and Professional Regulation that he or she will not issue more than 25 prescriptions during a 12-month period. Prescriptions in both oral and written form for controlled substances shall be included in determining whether the prescriber will reach the limit of 25 prescriptions.
(c) The Department of Financial and Professional Regulation shall adopt rules for the administration of this Section. These rules shall provide for the implementation of any such exemption to the requirements under this Section that the Department of Financial and Professional Regulation may deem appropriate, including the exemption provided for in subsection (b).
(Source: P.A. 102-490, eff. 1-1-24 (See Section 55 of P.A. 102-1109 for effective date of P.A. 102-490).)
(720 ILCS 570/312) (from Ch. 56 1/2, par. 1312)
Sec. 312. Requirements for dispensing controlled substances.
(a) A practitioner, in good faith, may dispense a Schedule
II controlled substance, which is a narcotic drug listed in Section 206
of this Act; or which contains any quantity of amphetamine or
methamphetamine, their salts, optical isomers or salts of optical
isomers; phenmetrazine and its salts; or pentazocine; and Schedule III, IV, or V controlled substances
to any person upon
a written or electronic prescription of any prescriber, dated and signed
by the
person prescribing (or electronically validated in compliance with Section 311.5) on the day when issued and bearing the name and
address of the patient for whom, or the owner of the animal for which
the controlled substance is dispensed, and the full name, address and
registry number under the laws of the United States relating to
controlled substances of the prescriber, if he or she is
required by
those laws to be registered. If the prescription is for an animal it
shall state the species of animal for which it is ordered. The
practitioner filling the prescription shall, unless otherwise permitted, write the date of filling
and his or her own signature on the face of the written prescription or, alternatively, shall indicate such filling using a unique identifier as defined in paragraph (v) of Section 3 of the Pharmacy Practice Act.
The written prescription shall be
retained on file by the practitioner who filled it or pharmacy in which
the prescription was filled for a period of 2 years, so as to be readily
accessible for inspection or removal by any officer or employee engaged
in the enforcement of this Act. Whenever the practitioner's or
pharmacy's copy of any prescription is removed by an officer or
employee engaged in the enforcement of this Act, for the purpose of
investigation or as evidence, such officer or employee shall give to the
practitioner or pharmacy a receipt in lieu thereof. If the specific prescription is machine or computer generated and printed at the prescriber's office, the date does not need to be handwritten. A prescription
for a Schedule II controlled substance shall not be issued for more than a 30 day supply, except as provided in subsection (a-5), and shall be valid for up to 90 days
after the date of issuance. A written prescription for Schedule III, IV or
V controlled substances shall not be filled or refilled more than 6 months
after the date thereof or refilled more than 5 times unless renewed, in
writing, by the prescriber. A pharmacy shall maintain a policy regarding the type of identification necessary, if any, to receive a prescription in accordance with State and federal law. The pharmacy must post such information where prescriptions are filled.
(a-5) Physicians may issue multiple prescriptions (3 sequential 30-day supplies) for the same Schedule II controlled substance, authorizing up to a 90-day supply. Before authorizing a 90-day supply of a Schedule II controlled substance, the physician must meet the following conditions:
(a-10) Prescribers who issue a prescription for an opioid shall inform the patient that opioids are addictive and that opioid antagonists are available by prescription or from a pharmacy.
(b) In lieu of a written prescription required by this Section, a
pharmacist, in good faith, may dispense Schedule III, IV, or V
substances to any person either upon receiving a facsimile of a written,
signed prescription transmitted by the prescriber or the prescriber's agent
or upon a lawful oral prescription of a
prescriber which oral prescription shall be reduced
promptly to
writing by the pharmacist and such written memorandum thereof shall be
dated on the day when such oral prescription is received by the
pharmacist and shall bear the full name and address of the ultimate user
for whom, or of the owner of the animal for which the controlled
substance is dispensed, and the full name, address, and registry number
under the law of the United States relating to controlled substances of
the prescriber prescribing if he or she is required by those laws
to be so
registered, and the pharmacist filling such oral prescription shall
write the date of filling and his or her own signature on the face of such
written memorandum thereof. The facsimile copy of the prescription or
written memorandum of the oral
prescription shall be retained on file by the proprietor of the pharmacy
in which it is filled for a period of not less than two years, so as to
be readily accessible for inspection by any officer or employee engaged
in the enforcement of this Act in the same manner as a written
prescription. The facsimile copy of the prescription or oral prescription
and the written memorandum thereof
shall not be filled or refilled more than 6 months after the date
thereof or be refilled more than 5 times, unless renewed, in writing, by
the prescriber.
(c) Except for any non-prescription targeted methamphetamine precursor regulated by the Methamphetamine Precursor Control Act, a
controlled substance included in Schedule V shall not be
distributed or dispensed other than for a medical purpose and not for
the purpose of evading this Act, and then:
(d) Every practitioner shall keep a record or log of controlled substances
received by him or her and a record of all such controlled substances
administered, dispensed or professionally used by him or her otherwise than by
prescription. It shall, however, be sufficient compliance with this
paragraph if any practitioner utilizing controlled substances listed in
Schedules III, IV and V shall keep a record of all those substances
dispensed and distributed by him or her other than those controlled substances
which are administered by the direct application of a controlled
substance, whether by injection, inhalation, ingestion, or any other
means to the body of a patient or research subject. A practitioner who
dispenses, other than by administering, a controlled substance in
Schedule II, which is a narcotic drug listed in Section 206 of this Act,
or which contains any quantity of amphetamine or methamphetamine, their
salts, optical isomers or salts of optical isomers, pentazocine, or
methaqualone shall do so only upon
the issuance of a written prescription blank or electronic prescription issued by a
prescriber.
(e) Whenever a manufacturer distributes a controlled substance in a
package prepared by him or her, and whenever a wholesale distributor
distributes a controlled substance in a package prepared by him or her or the
manufacturer, he or she shall securely affix to each package in which that
substance is contained a label showing in legible English the name and
address of the manufacturer, the distributor and the quantity, kind and
form of controlled substance contained therein. No person except a
pharmacist and only for the purposes of filling a prescription under
this Act, shall alter, deface or remove any label so affixed.
(f) Whenever a practitioner dispenses any controlled substance except a non-prescription Schedule V product or a non-prescription targeted methamphetamine precursor regulated by the Methamphetamine Precursor Control Act, he or she
shall affix to the container in which such substance is sold or
dispensed, a label indicating the date of initial filling, the practitioner's
name and address, the name
of the patient, the name of the prescriber,
the directions
for use and cautionary statements, if any, contained in any prescription
or required by law, the proprietary name or names or the established name
of the controlled substance, and the dosage and quantity, except as otherwise
authorized by regulation by the Department of Financial and Professional Regulation. No
person shall alter, deface or remove any label so affixed as long as the specific medication remains in the container.
(g) A person to whom or for whose use any controlled substance has
been prescribed or dispensed by a practitioner, or other persons
authorized under this Act, and the owner of any animal for which such
substance has been prescribed or dispensed by a veterinarian, may
lawfully possess such substance only in the container in which it was
delivered to him or her by the person dispensing such substance.
(h) The responsibility for the proper prescribing or dispensing of
controlled substances that are under the prescriber's direct control is upon the prescriber. The responsibility for
the proper filling of a prescription for controlled substance drugs
rests with the pharmacist. An order purporting to be a prescription
issued to any individual, which is not in the regular course of
professional treatment nor part of an authorized methadone maintenance
program, nor in legitimate and authorized research instituted by any
accredited hospital, educational institution, charitable foundation, or
federal, state or local governmental agency, and which is intended to
provide that individual with controlled substances sufficient to
maintain that individual's or any other individual's physical or
psychological addiction, habitual or customary use, dependence, or
diversion of that controlled substance is not a prescription within the
meaning and intent of this Act; and the person issuing it, shall be
subject to the penalties provided for violations of the law relating to
controlled substances.
(i) A prescriber shall not pre-print or cause to be
pre-printed a
prescription for any controlled substance; nor shall any practitioner
issue, fill or cause to be issued or filled, a pre-printed prescription
for any controlled substance.
(i-5) A prescriber may use a machine or electronic device to individually generate a printed prescription, but the prescriber is still required to affix his or her manual signature.
(j) No person shall manufacture, dispense, deliver, possess with
intent to deliver, prescribe, or administer or cause to be administered
under his or her direction any anabolic steroid, for any use in humans other than
the treatment of disease in accordance with the order of a physician licensed
to practice medicine in all its branches for a
valid medical purpose in the course of professional practice. The use of
anabolic steroids for the purpose of hormonal manipulation that is intended
to increase muscle mass, strength or weight without a medical necessity to
do so, or for the intended purpose of improving physical appearance or
performance in any form of exercise, sport, or game, is not a valid medical
purpose or in the course of professional practice.
(k) Controlled substances may be mailed if all of the following conditions are met:
(l) Notwithstanding any other provision of this Act to the contrary, emergency medical services personnel may administer Schedule II, III, IV, or V controlled substances to a person in the scope of their employment without a written, electronic, or oral prescription of a prescriber.
(Source: P.A. 102-1040, eff. 1-1-23.)
(720 ILCS 570/313) (from Ch. 56 1/2, par. 1313)
Sec. 313. (a) Controlled substances which are lawfully administered in
hospitals or institutions licensed under the Hospital Licensing Act shall
be exempt from the requirements of Sections 312, 315.6, and 316, except
that the
prescription for the controlled substance shall be in writing on the
patient's record, signed by the prescriber, and dated, and shall state the
name and quantity of controlled substances ordered and the quantity
actually administered. The records of such prescriptions shall be
maintained for two years and shall be available for inspection by officers
and employees of the Illinois State Police and the Department of Financial and
Professional Regulation.
The exemption under this subsection (a) does not apply to a prescription (including an outpatient prescription from an emergency department or outpatient clinic) for more than a 72-hour supply of a discharge medication to be consumed outside of the hospital or institution.
(b) Controlled substances that can lawfully be administered or dispensed
directly to a patient in a long-term care facility licensed by the Department
of Public Health as a skilled nursing facility, intermediate care facility, or
long-term care facility for residents under 22 years of age, are exempt from
the requirements of Section 312 except that a prescription
for a
Schedule II controlled substance must be either a prescription signed
by the prescriber or a prescription transmitted by the prescriber or
prescriber's agent to the dispensing pharmacy by facsimile. The
facsimile serves as the original prescription and must be maintained for 2
years from the date of issue in the same manner as a written prescription
signed by the prescriber.
(c) A prescription that is generated for a Schedule II controlled substance
to be compounded for direct administration to a patient in a private
residence, long-term care facility, or hospice program
may be transmitted by
facsimile by the prescriber or the prescriber's agent to the pharmacy providing
the home infusion services. The facsimile serves as the original
prescription for purposes of this paragraph (c) and it shall be maintained in
the same manner as the original prescription.
(c-1) A prescription generated for a Schedule II controlled substance for a
patient residing in a hospice certified by Medicare under Title XVIII of the
Social Security Act or
licensed by the State may be transmitted by the practitioner or the
practitioner's
agent to the dispensing pharmacy by facsimile or electronically as provided in Section 311.5. The practitioner or
practitioner's
agent must note on the prescription that the patient is a hospice patient. The
facsimile or electronic record serves as the original prescription for purposes of this
paragraph (c-1) and it shall be maintained in the same manner as the original
prescription.
(d) Controlled substances which are lawfully administered
and/or dispensed
in drug abuse treatment programs licensed by the Department shall be exempt
from the requirements of Sections 312 and 316, except that the
prescription
for such controlled substances shall be issued and authenticated
on official prescription logs prepared and maintained in accordance with 77 Ill. Adm. Code 2060: Alcoholism and Substance Abuse Treatment and Intervention Licenses, and in compliance with other applicable State and federal laws. The Department-licensed drug treatment program shall report applicable prescriptions via electronic record keeping software approved by the Department. This software must be compatible with the specifications of the Department. Drug abuse treatment programs shall report to the Department methadone prescriptions or medications dispensed through the use of Department-approved File Transfer Protocols (FTPs). Methadone prescription records must be maintained in accordance with the applicable requirements as set forth by the Department in accordance with 77 Ill. Adm. Code 2060: Alcoholism and Substance Abuse Treatment and Intervention Licenses, and in compliance with other applicable State and federal laws.
(e) Nothing in this Act shall be construed to limit the authority of a hospital pursuant to Section 65-45 of the Nurse Practice Act to grant hospital clinical privileges to an individual advanced practice registered nurse to select, order or administer medications, including controlled substances to provide services within a hospital. Nothing in this Act shall be construed to limit the authority of an ambulatory surgical treatment center pursuant to Section 65-45 of the Nurse Practice Act to grant ambulatory surgical treatment center clinical privileges to an individual advanced practice registered nurse to select, order or administer medications, including controlled substances to provide services within an ambulatory surgical treatment center.
(Source: P.A. 102-608, eff. 8-27-21.)
(720 ILCS 570/314)
Sec. 314. (Repealed).
(Source: P.A. 77-757. Repealed by P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/314.5)
Sec. 314.5. Medication shopping; pharmacy shopping.
(a) It shall be unlawful for any person knowingly or intentionally to fraudulently obtain or fraudulently seek to obtain any controlled substance or prescription for a controlled substance from a prescriber or dispenser while being supplied with any controlled substance or prescription for a controlled substance by another prescriber or dispenser, without disclosing the fact of the existing controlled substance or prescription for a controlled substance to the prescriber or dispenser from whom the subsequent controlled substance or prescription for a controlled substance is sought.
(b) It shall be unlawful for a person knowingly or intentionally to fraudulently obtain or fraudulently seek to obtain any controlled substance from a pharmacy while being supplied with any controlled substance by another pharmacy, without disclosing the fact of the existing controlled substance to the pharmacy from which the subsequent controlled substance is sought.
(c) A person may be in violation of Section 3.23 of the Illinois Food, Drug and Cosmetic Act or Section 406 of this Act when medication shopping or pharmacy shopping, or both.
(c-5) Effective January 1, 2018, each prescriber possessing an Illinois controlled substances license shall register with the Prescription Monitoring Program. Notwithstanding any provision of this Act to the contrary, beginning on and after the effective date of this amendatory Act of the 101st General Assembly, a licensed veterinarian shall be exempt from registration and prohibited from accessing patient information in the Prescription Monitoring Program. Licensed veterinarians that are existing registrants shall be removed from the Prescription Monitoring Program. Each prescriber or his or her designee shall also document an attempt to access patient information in the Prescription Monitoring Program to assess patient access to controlled substances when providing an initial prescription for Schedule II narcotics such as opioids, except for prescriptions for oncology treatment or palliative care, or a 7-day or less supply provided by a hospital emergency department when treating an acute, traumatic medical condition. This attempt to access shall be documented in the patient's medical record. The hospital shall facilitate the designation of a prescriber's designee for the purpose of accessing the Prescription Monitoring Program for services provided at the hospital.
(d) When a person has been identified as having 5 or more prescribers or 5 or more pharmacies, or both, that do not utilize a common electronic file as specified in Section 20 of the Pharmacy Practice Act for controlled substances within the course of a 6-month period, the Prescription Monitoring Program may issue an unsolicited report to the prescribers, dispensers, and their designees informing them of the potential medication shopping. If an unsolicited report is issued to a prescriber or prescribers, then the
report must also be sent to the applicable dispensing pharmacy.
(e) Nothing in this Section shall be construed to create a requirement that any prescriber, dispenser, or pharmacist request any patient medication disclosure, report any patient activity, or prescribe or refuse to prescribe or dispense any medications.
(f) This Section shall not be construed to apply to inpatients or residents at hospitals or other institutions or to institutional pharmacies.
(g) Any patient feedback, including grades, ratings, or written or verbal statements, in opposition to a clinical decision that the prescription of a controlled substance is not medically necessary shall not be the basis of any adverse action, evaluation, or any other type of negative credentialing, contracting, licensure, or employment action taken against a prescriber or dispenser.
(Source: P.A. 101-414, eff. 8-16-19; 102-527, eff. 8-20-21.)
(720 ILCS 570/315)
Sec. 315. (Repealed).
(Source: P.A. 77-757. Repealed by P.A. 97-334, eff. 1-1-12.)
(720 ILCS 570/315.5)
Sec. 315.5. Opioid education for prescribers. Every prescriber who is licensed to prescribe controlled
substances shall, during the pre-renewal period, complete 3 hours of continuing education on safe opioid
prescribing practices offered or accredited by a professional association, State government agency, or federal government
agency. Notwithstanding any individual licensing Act or administrative rule, a
prescriber may count these 3 hours toward the total continuing education hours required for renewal of a
professional license. Continuing education on safe opioid prescribing practices applied to meet any other State
licensure requirement or professional accreditation or certification requirement may be used toward the
requirement under this Section.
The Department of Financial and Professional Regulation may adopt rules for the administration of this Section.
(Source: P.A. 100-1106, eff. 1-1-19.)
(720 ILCS 570/315.6)
Sec. 315.6. Risks of dependence on opioids.
(a) Definitions. As used in this Section:
(b) The Department shall develop and make available on its website information on the risks of developing a physical or psychological dependence on opioids and any alternative treatments, including the Opioid Alternative Pilot Program.
(c) The Department shall develop and make available upon request to all prescribers, pharmacists, and patients in the State a pamphlet which explains the risks of developing a physical or psychological dependence on opioids. This pamphlet may contain any information which the Secretary of the Department deems necessary and may be revised by the Department whenever new information becomes available. The pamphlet shall be downloadable from the Department's website.
(d) A pharmacist shall, prior to dispensing an opioid that is a Schedule II controlled substance, furnish the pamphlet or information therein developed by the Department and discuss the risks of developing a physical or psychological dependence on opioids.
(Source: P.A. 102-608, eff. 8-27-21.)
(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 that includes the following components and requirements:
(a-5) Notwithstanding subsection (a), a licensed veterinarian is exempt from the reporting requirements of this Section. If a person who is presenting an animal for treatment is suspected of fraudulently obtaining any controlled substance or prescription for a controlled substance, the licensed veterinarian shall report that information to the local law enforcement agency.
(b) The Department, by rule, may include in the Prescription 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) The Department of Human Services shall appoint a full-time Clinical Director of the Prescription Monitoring Program.
(e) (Blank).
(f) Within one year of January 1, 2018 (the effective date of Public Act 100-564), the Department shall adopt rules requiring all Electronic Health Records Systems to interface with the Prescription Monitoring Program application program on or before January 1, 2021 to ensure that all providers have access to specific patient records during the treatment of their patients. These rules shall also address the electronic integration of pharmacy records with the Prescription Monitoring Program to allow for faster transmission of the information required under this Section. The Department shall establish actions to be taken if a prescriber's Electronic Health Records System does not effectively interface with the Prescription Monitoring Program within the required timeline.
(g) The Department, in consultation with the Prescription Monitoring Program Advisory Committee, shall adopt rules allowing licensed prescribers or pharmacists who have registered to access the Prescription Monitoring Program to authorize a licensed or non-licensed designee employed in that licensed prescriber's office or a licensed designee in a licensed pharmacist's pharmacy who has received training in the federal Health Insurance Portability and Accountability Act and 42 CFR 2 to consult the Prescription Monitoring Program on their behalf. The rules shall include reasonable parameters concerning a practitioner's authority to authorize a designee, and the eligibility of a person to be selected as a designee. In this subsection (g), "pharmacist" shall include a clinical pharmacist employed by and designated by a Medicaid Managed Care Organization providing services under Article V of the Illinois Public Aid Code under a contract with the Department of Healthcare and Family Services for the sole purpose of clinical review of services provided to persons covered by the entity under the contract to determine compliance with subsections (a) and (b) of Section 314.5 of this Act. A managed care entity pharmacist shall notify prescribers of review activities.
(Source: P.A. 101-81, eff. 7-12-19; 101-414, eff. 8-16-19; 102-527, eff. 8-20-21; 102-813, eff. 5-13-22.)
(720 ILCS 570/317)
Sec. 317. Central repository for collection of information.
(a) The Department must designate a central repository for
the collection of information transmitted under Section 316 and former Section 321.
(b) The central repository must do the following:
All prescribers shall designate one or more medical specialties or fields of medical care and treatment for which the prescriber prescribes controlled substances when registering with the Prescription Monitoring Program.
No fee shall be charged for access by a prescriber or dispenser.
(Source: P.A. 99-480, eff. 9-9-15.)
(720 ILCS 570/318)
Sec. 318. Confidentiality of information.
(a) Information received by the central repository under Section 316 and former Section 321
is confidential.
(a-1) To ensure the federal Health Insurance Portability and Accountability Act and confidentiality of substance use disorder patient records rules that mandate the privacy of an individual's prescription data reported to the Prescription Monitoring Program received from a retail dispenser under this Act, and in order to execute the duties and responsibilities under Section 316 of this Act and rules for disclosure under this Section, the Clinical Director of the Prescription Monitoring Program or his or her designee shall maintain direct access to all Prescription Monitoring Program data. Any request for Prescription Monitoring Program data from any other department or agency must be approved in writing by the Clinical Director of the Prescription Monitoring Program or his or her designee unless otherwise permitted by law. Prescription Monitoring Program data shall only be disclosed as permitted by law.
(a-2) As an active step to address the current opioid crisis in this State and to prevent and reduce addiction resulting from a sports injury or an accident, the Prescription Monitoring Program and the Department of Public Health shall coordinate a continuous review of the Prescription Monitoring Program and the Department of Public Health data to determine if a patient may be at risk of opioid addiction. Each patient discharged from any medical facility with an International Classification of Disease, 10th edition code related to a sport or accident injury shall be subject to the data review. If the discharged patient is dispensed a controlled substance, the Prescription Monitoring Program shall alert the patient's prescriber as to the addiction risk and urge each to follow the Centers for Disease Control and Prevention guidelines or his or her respective profession's treatment guidelines related to the patient's injury. This subsection (a-2), other than this sentence, is inoperative on or after January 1, 2024.
(b) The Department must carry out a program to protect the
confidentiality of the information described in subsection (a). The Department
may
disclose the information to another person only under
subsection (c), (d), or (f) and may charge a fee not to exceed the actual cost
of
furnishing the
information.
(c) The Department may disclose confidential information described
in subsection (a) to any person who is engaged in receiving, processing, or
storing the information.
(d) The Department may release confidential information described
in subsection (a) to the following persons:
(e) Before the Department releases confidential information under
subsection (d), the applicant must demonstrate in writing to the Department that:
(f) The Department may receive and release prescription record information under Section 316 and former Section 321 to:
(f-5) In accordance with a confidentiality agreement entered into with the Department, a medical director, or a public health administrator and their delegated analysts, of a county or municipal health department or the Department of Public Health shall have access to data from the system for any of the following purposes:
At a minimum, the confidentiality agreement entered into with the Department shall:
(g) The information described in subsection (f) may not be released until it
has been reviewed by an employee of the Department who is licensed as a
prescriber or a dispenser
and until that employee has certified
that further investigation is warranted. However, failure to comply with this
subsection (g) does not invalidate the use of any evidence that is otherwise
admissible in a proceeding described in subsection (h).
(h) An investigator or a law enforcement officer receiving confidential
information under subsection (c), (d), or (f) may disclose the information to a
law enforcement officer or an attorney for the office of the Attorney General
for use as evidence in the following:
(i) The Department may compile statistical reports from the
information described in subsection (a). The reports must not include
information that identifies, by name, license or address, any practitioner, dispenser, ultimate user, or other person
administering a controlled substance.
(j) Based upon federal, initial and maintenance funding, a prescriber and dispenser inquiry system shall be developed to assist the health care community in its goal of effective clinical practice and to prevent patients from diverting or abusing medications.
(k) The Department shall establish, by rule, the process by which to evaluate possible erroneous association of prescriptions to any licensed prescriber or end user of the Illinois Prescription Information Library (PIL).
(l) The Prescription Monitoring Program Advisory Committee is authorized to evaluate the need for and method of establishing a patient specific identifier.
(m) Patients who identify prescriptions attributed to them that were not obtained by them shall be given access to their personal prescription history pursuant to the validation process as set forth by administrative rule.
(n) The Prescription Monitoring Program is authorized to develop operational push reports to entities with compatible electronic medical records. The process shall be covered within administrative rule established by the Department.
(o) Hospital emergency departments and freestanding healthcare facilities providing healthcare to walk-in patients may obtain, for the purpose of improving patient care, a unique identifier for each shift to utilize the PIL system.
(p) The Prescription Monitoring Program shall automatically create a log-in to the inquiry system when a prescriber or dispenser obtains or renews his or her controlled substance license. The Department of Financial and Professional Regulation must provide the Prescription Monitoring Program with electronic access to the license information of a prescriber or dispenser to facilitate the creation of this profile. The Prescription Monitoring Program shall send the prescriber or dispenser information regarding the inquiry system, including instructions on how to log into the system, instructions on how to use the system to promote effective clinical practice, and opportunities for continuing education for the prescribing of controlled substances. The Prescription Monitoring Program shall also send to all enrolled prescribers, dispensers, and designees information regarding the unsolicited reports produced pursuant to Section 314.5 of this Act.
(q) A prescriber or dispenser may authorize a designee to consult the inquiry system established by the Department under this subsection on his or her behalf, provided that all the following conditions are met:
The Prescription Monitoring Program shall send to registered designees information regarding the inquiry system, including instructions on how to log onto the system.
(r) The Prescription Monitoring Program shall maintain an Internet website in conjunction with its prescriber and dispenser inquiry system. This website shall include, at a minimum, the following information:
The content of the Internet website shall be periodically reviewed by the Prescription Monitoring Program Advisory Committee as set forth in Section 320 and updated in accordance with the recommendation of the advisory committee.
(s) The Prescription Monitoring Program shall regularly send electronic updates to the registered users of the Program. The Prescription Monitoring Program Advisory Committee shall review any communications sent to registered users and also make recommendations for communications as set forth in Section 320. These updates shall include the following information:
(t) Notwithstanding any other provision of this Act, neither the Prescription Monitoring Program nor any other person shall disclose any information in violation of the restrictions and requirements of paragraph (3.5) of subsection (a) of Section 316 as implemented under Public Act 102-527.
(Source: P.A. 102-751, eff. 1-1-23.)
(720 ILCS 570/319)
Sec. 319. Rules. The Department shall adopt rules under the Illinois
Administrative
Procedure Act to
implement Sections 316 through 321, including the following:
(Source: P.A. 99-480, eff. 9-9-15.)
(720 ILCS 570/320)
Sec. 320. Advisory committee.
(a) There is created a Prescription Monitoring Program Advisory Committee to
assist the Department of Human Services in implementing the Prescription Monitoring Program created by this Article and to advise the Department on the professional performance of prescribers and dispensers and other matters germane to the advisory committee's field of competence.
(b) The Prescription Monitoring Program Advisory Committee shall consist of 15 members appointed by the Clinical Director of the Prescription Monitoring Program composed of prescribers and dispensers licensed to practice medicine in his or her respective profession as follows: one family or primary care physician; one pain specialist physician; 4 other physicians, one of whom may be an ophthalmologist; 2 advanced practice registered nurses; one physician assistant; one optometrist; one dentist; one clinical representative from a statewide organization representing hospitals; and 3 pharmacists. The Advisory Committee members serving on August 26, 2018 (the effective date of Public Act 100-1093) shall continue to serve until January 1, 2019. Prescriber and dispenser nominations for membership on the Committee shall be submitted by their respective professional associations. If there are more nominees than membership positions for a prescriber or dispenser category, as provided in this subsection (b), the Clinical Director of the Prescription Monitoring Program shall appoint a member or members for each profession as provided in this subsection (b), from the nominations to
serve on the advisory committee. At the first meeting of the Committee in 2019 members shall draw lots for initial terms and 6 members shall serve 3 years, 5 members shall serve 2 years, and 5 members shall serve one year. Thereafter, members shall serve 3-year terms. Members may serve more than one term but no more than 3 terms. The Clinical Director of the Prescription Monitoring Program may appoint a representative of an organization representing a profession required to be appointed. The Clinical Director of the Prescription Monitoring Program shall serve as the Secretary of the committee.
(c) The advisory committee may appoint a chairperson and 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, unless appropriated by the General Assembly, but may be reimbursed for
their actual expenses incurred in serving on the advisory committee.
(e) The advisory committee shall:
(f) The Advisory Committee shall select from its members 10 members of the Peer Review Committee composed of:
The purpose of the Peer Review Committee is to establish a formal peer review of professional performance of prescribers and dispensers. The deliberations, information, and communications of the Peer Review Committee are privileged and confidential and shall not be disclosed in any manner except in accordance with current law.
(720 ILCS 570/321)
Sec. 321. (Repealed).
(Source: P.A. 95-442, eff. 1-1-08. Repealed by P.A. 97-334, eff. 1-1-12.)
Structure Illinois Compiled Statutes