(720 ILCS 570/220)

Sec. 220. Electronic health record systems. The Bureau of Pharmacy and Clinical Support Systems shall establish a form to allow EHR systems to certify the identity of a third party that will provide access to the Prescription Information Library for the EHR system using all or part of a computer program or system that is a federally certified Health IT Module for the EHR system. Before the Health IT Module is permitted to connect to the Prescription Information Library, it must enter into a business associate agreement with the EHR system that requires the Health IT Module to agree to adhere to all requirements imposed on the EHR system by the laws of this State, including data privacy and security obligations that the Bureau otherwise imposes on EHR systems.

(Source: P.A. 101-666, eff. 1-1-22.)

(720 ILCS 570/Art. III heading) ARTICLE III

(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:

(1) an agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if he or she is acting in the usual course of his or her employer's lawful business or employment;

(2) a common or contract carrier or warehouseman, or an agent or employee thereof, whose possession of any controlled substance is in the usual lawful course of such business or employment;

(3) an ultimate user or a person in possession of a controlled substance prescribed for the ultimate user under a lawful prescription of a practitioner, including an advanced practice registered nurse, practical nurse, or registered nurse licensed under the Nurse Practice Act, or a physician assistant licensed under the Physician Assistant Practice Act of 1987, who provides hospice services to a hospice patient or who provides home health services to a person, or a person in possession of any controlled substance pursuant to a lawful prescription of a practitioner or in lawful possession of a Schedule V substance. In this Section, "home health services" has the meaning ascribed to it in the Home Health, Home Services, and Home Nursing Agency Licensing Act; and "hospice patient" and "hospice services" have the meanings ascribed to them in the Hospice Program Licensing Act;

(4) officers and employees of this State or of the United States while acting in the lawful course of their official duties which requires possession of controlled substances;

(5) a registered pharmacist who is employed in, or the owner of, a pharmacy licensed under this Act and the Federal Controlled Substances Act, at the licensed location, or if he or she is acting in the usual course of his or her lawful profession, business, or employment;

(6) a holder of a temporary license issued under Section 17 of the Medical Practice Act of 1987 practicing within the scope of that license and in compliance with the rules adopted under this Act. In addition to possessing controlled substances, a temporary license holder may order, administer, and prescribe controlled substances when acting within the scope of his or her license and in compliance with the rules adopted 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:

(1) maintenance of effective controls against diversion of controlled substances into other than lawful medical, scientific, or industrial channels;

(2) compliance with applicable Federal, State and local law;

(3) any convictions of the applicant, or the designated agent of the applicant where applicable, under any law of the United States or of any State relating to any controlled substance;

(4) past experience in the manufacture or distribution of controlled substances, and the existence in the applicant's establishment of effective controls against diversion;

(5) furnishing by the applicant of false or fraudulent material in any application filed under this Act;

(6) suspension or revocation of the applicant's Federal registration to manufacture, distribute, or dispense controlled substances, or purchase, store, or administer euthanasia drugs, as authorized by Federal law;

(7) whether the applicant is suitably equipped with the facilities appropriate to carry on the operation described in his or her application;

(8) whether the applicant is of good moral character or, if the applicant is a partnership, association, corporation or other organization, whether the partners, directors, governing committee and managing officers are of good moral character;

(9) any other factors relevant to and consistent with the public health and safety; and

(10) evidence from court, medical disciplinary and pharmacy board records and those of State and Federal investigatory bodies that the applicant has not or does not prescribe controlled substances within the provisions of this Act.

(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:

(1) with respect to physician assistants,

(A) the physician assistant has been delegated written authority to prescribe any Schedule III through V controlled substances by a physician licensed to practice medicine in all its branches in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987; and the physician assistant has completed the appropriate application forms and has paid the required fees as set by rule; or

(B) the physician assistant has been delegated authority by a collaborating physician licensed to practice medicine in all its branches to prescribe or dispense Schedule II controlled substances through a written delegation of authority and under the following conditions:

(i) Specific Schedule II controlled substances by oral dosage or topical or transdermal application may be delegated, provided that the delegated Schedule II controlled substances are routinely prescribed by the collaborating physician. This delegation must identify the specific Schedule II controlled substances by either brand name or generic name. Schedule II controlled substances to be delivered by injection or other route of administration may not be delegated;

(ii) any delegation must be of controlled substances prescribed by the collaborating physician;

(iii) all prescriptions must be limited to no more than a 30-day supply, with any continuation authorized only after prior approval of the collaborating physician;

(iv) the physician assistant must discuss the condition of any patients for whom a controlled substance is prescribed monthly with the delegating physician;

(v) the physician assistant must have completed the appropriate application forms and paid the required fees as set by rule;

(vi) the physician assistant must provide evidence of satisfactory completion of 45 contact hours in pharmacology from any physician assistant program accredited by the Accreditation Review Commission on Education for the Physician Assistant (ARC-PA), or its predecessor agency, for any new license issued with Schedule II authority after the effective date of this amendatory Act of the 97th General Assembly; and

(vii) the physician assistant must annually complete at least 5 hours of continuing education in pharmacology;

(2) with respect to advanced practice registered nurses who do not meet the requirements of Section 65-43 of the Nurse Practice Act,

(A) the advanced practice registered nurse has been delegated authority to prescribe any Schedule III through V controlled substances by a collaborating physician licensed to practice medicine in all its branches or a collaborating podiatric physician in accordance with Section 65-40 of the Nurse Practice Act. The advanced practice registered nurse has completed the appropriate application forms and has paid the required fees as set by rule; or

(B) the advanced practice registered nurse has been delegated authority by a collaborating physician licensed to practice medicine in all its branches to prescribe or dispense Schedule II controlled substances through a written delegation of authority and under the following conditions:

(i) specific Schedule II controlled substances by oral dosage or topical or transdermal application may be delegated, provided that the delegated Schedule II controlled substances are routinely prescribed by the collaborating physician. This delegation must identify the specific Schedule II controlled substances by either brand name or generic name. Schedule II controlled substances to be delivered by injection or other route of administration may not be delegated;

(ii) any delegation must be of controlled substances prescribed by the collaborating physician;

(iii) all prescriptions must be limited to no more than a 30-day supply, with any continuation authorized only after prior approval of the collaborating physician;

(iv) the advanced practice registered nurse must discuss the condition of any patients for whom a controlled substance is prescribed monthly with the delegating physician or in the course of review as required by Section 65-40 of the Nurse Practice Act;

(v) the advanced practice registered nurse must have completed the appropriate application forms and paid the required fees as set by rule;

(vi) the advanced practice registered nurse must provide evidence of satisfactory completion of at least 45 graduate contact hours in pharmacology for any new license issued with Schedule II authority after the effective date of this amendatory Act of the 97th General Assembly; and

(vii) the advanced practice registered nurse must annually complete 5 hours of continuing education in pharmacology;

(2.5) with respect to advanced practice registered nurses certified as nurse practitioners, nurse midwives, or clinical nurse specialists who do not meet the requirements of Section 65-43 of the Nurse Practice Act practicing in a hospital affiliate,

(A) the advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist has been privileged to prescribe any Schedule II through V controlled substances by the hospital affiliate upon the recommendation of the appropriate physician committee of the hospital affiliate in accordance with Section 65-45 of the Nurse Practice Act, has completed the appropriate application forms, and has paid the required fees as set by rule; and

(B) an advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist has been privileged to prescribe any Schedule II controlled substances by the hospital affiliate upon the recommendation of the appropriate physician committee of the hospital affiliate, then the following conditions must be met:

(i) specific Schedule II controlled substances by oral dosage or topical or transdermal application may be designated, provided that the designated Schedule II controlled substances are routinely prescribed by advanced practice registered nurses in their area of certification; the privileging documents must identify the specific Schedule II controlled substances by either brand name or generic name; privileges to prescribe or dispense Schedule II controlled substances to be delivered by injection or other route of administration may not be granted;

(ii) any privileges must be controlled substances limited to the practice of the advanced practice registered nurse;

(iii) any prescription must be limited to no more than a 30-day supply;

(iv) the advanced practice registered nurse must discuss the condition of any patients for whom a controlled substance is prescribed monthly with the appropriate physician committee of the hospital affiliate or its physician designee; and

(v) the advanced practice registered nurse must meet the education requirements of this Section;

(3) with respect to animal euthanasia agencies, the euthanasia agency has obtained a license from the Department of Financial and Professional Regulation and obtained a registration number from the Department; or

(4) with respect to prescribing psychologists, the prescribing psychologist has been delegated authority to prescribe any nonnarcotic Schedule III through V controlled substances by a collaborating physician licensed to practice medicine in all its branches in accordance with Section 4.3 of the Clinical Psychologist Licensing Act, and the prescribing psychologist has completed the appropriate application forms and has paid the required fees as set by rule.

(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:

(1) has furnished any false or fraudulent material information in any application filed under this Act; or

(2) has been convicted of a felony under any law of the United States or any State relating to any controlled substance; or

(3) has had suspended or revoked his or her Federal registration to manufacture, distribute, or dispense controlled substances or purchase, store, or administer euthanasia drugs; or

(4) has been convicted of bribery, perjury, or other infamous crime under the laws of the United States or of any State; or

(5) has violated any provision of this Act or any rules promulgated hereunder, or any provision of the Methamphetamine Precursor Control Act or rules promulgated thereunder, whether or not he or she has been convicted of such violation; or

(6) has failed to provide effective controls against the diversion of controlled substances in other than legitimate medical, scientific or industrial channels.

(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 the quantity prescribed. All nonelectronic 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. 103-425, eff. 1-1-24.)

(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)

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) Beginning on the effective date of this amendatory Act of the 103rd General Assembly until December 31, 2028, 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 150 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 150 prescriptions. Beginning January 1, 2029, 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 50 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 50 prescriptions.

(b-5) Notwithstanding any other provision of this Section or any other provision of law, a prescriber shall not be required to issue prescriptions electronically under the following circumstances:

(1) prior to January 1, 2026, the prescriber demonstrates financial difficulties in buying or managing an electronic prescription option, whether it is an electronic health record or some other electronic prescribing product;

(2) on and after January 1, 2026, the prescriber provides proof of a waiver from the Centers for Medicare and Medicaid Services for the Electronic Prescribing for Controlled Substances Program due to demonstrated economic hardship for the previous compliance year;

(3) there is a temporary technological or electrical failure that prevents an electronic prescription from being issued;

(4) the prescription is for a drug that the practitioner reasonably determines would be impractical for the patient to obtain in a timely manner if prescribed by an electronic data transmission prescription and the delay would adversely impact the patient's medical condition;

(5) the prescription is for an individual who:

(A) resides in a nursing or assisted living facility;

(B) is receiving hospice or palliative care;

(C) is receiving care at an outpatient renal dialysis facility and the prescription is related to the care provided;

(D) is receiving care through the United States Department of Veterans Affairs; or

(E) is incarcerated in a state, detained, or confined in a correctional facility;

(6) the prescription prescribes a drug under a research protocol;

(7) the prescription is a non-patient specific prescription dispensed under a standing order, approved protocol for drug therapy, collaborative drug management, or comprehensive medication management, or in response to a public health emergency or other circumstance in which the practitioner may issue a non-patient specific prescription;

(8) the prescription is issued when the prescriber and dispenser are the same entity;

(9) the prescription is issued for a compound prescription containing 2 or more compounds; or

(10) the prescription is issued by a licensed veterinarian within 2 years after the effective date of this amendatory Act of the 103rd General Assembly.

(c) The Department of Financial and Professional Regulation may adopt rules for the administration of this Section to the requirements under this Section that the Department of Financial and Professional Regulation may deem appropriate.

(d) Any prescriber who makes a good faith effort to prescribe electronically, but for reasons not within the prescriber's control is unable to prescribe electronically, may be exempt from any disciplinary action.

(e) Any pharmacist who dispenses in good faith based upon a valid prescription that is not prescribed electronically may be exempt from any disciplinary action. A pharmacist is not required to ensure or responsible for ensuring the prescriber's compliance under subsection (b), nor may any other entity or organization require a pharmacist to ensure the prescriber's compliance with that subsection. A pharmacist may not refuse to fill a valid prescription solely because it is not prescribed electronically.

(f) It shall be a violation of this Section for any prescriber or dispenser to adopt a policy contrary to this Section.

(g) A compliance action with respect to this Section initiated by the Department of Financial and Professional Regulation prior to December 31, 2030 is limited to a non-disciplinary warning letter or citation, unless the prescriber or dispenser fails to abide by the initial non-disciplinary warning letter or citation, has acted in bad faith, or a pattern of practice in violation of this Section occurs.

(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); 103-425, eff. 1-1-24; 103-563, eff. 11-17-23; 103-732, eff. 8-2-24.)

(720 ILCS 570/312) (from Ch. 56 1/2, par. 1312)

(Text of Section before amendment by P.A. 103-881)

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:

(1) Each separate prescription must be issued for a legitimate medical purpose by an individual physician acting in the usual course of professional practice.

(2) The individual physician must provide written instructions on each prescription (other than the first prescription, if the prescribing physician intends for the prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill that prescription.

(3) The physician shall document in the medical record of a patient the medical necessity for the amount and duration of the 3 sequential 30-day prescriptions for Schedule II narcotics.

(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:

(1) only personally by a person registered to dispense a Schedule V controlled substance and then only to his or her patients, or

(2) only personally by a pharmacist, and then only to a person over 21 years of age who has identified himself or herself to the pharmacist by means of 2 positive documents of identification.

The dispenser shall record the name and address of the purchaser, the name and quantity of the product, the date and time of the sale, and the dispenser's signature.

No person shall purchase or be dispensed more than 120 milliliters or more than 120 grams of any Schedule V substance which contains codeine, dihydrocodeine, or any salts thereof, or ethylmorphine, or any salts thereof, in any 96-hour period. The purchaser shall sign a form, approved by the Department of Financial and Professional Regulation, attesting that he or she has not purchased any Schedule V controlled substances within the immediately preceding 96 hours.

All records of purchases and sales shall be maintained for not less than 2 years.

No person shall obtain or attempt to obtain within any consecutive 96-hour period any Schedule V substances of more than 120 milliliters or more than 120 grams containing codeine, dihydrocodeine or any of its salts, or ethylmorphine or any of its salts. Any person obtaining any such preparations or combination of preparations in excess of this limitation shall be in unlawful possession of such controlled substance.

A person qualified to dispense controlled substances under this Act and registered thereunder shall at no time maintain or keep in stock a quantity of Schedule V controlled substances in excess of 4.5 liters for each substance; a pharmacy shall at no time maintain or keep in stock a quantity of Schedule V controlled substances as defined in excess of 4.5 liters for each substance, plus the additional quantity of controlled substances necessary to fill the largest number of prescription orders filled by that pharmacy for such controlled substances in any one week in the previous year. These limitations shall not apply to Schedule V controlled substances which Federal law prohibits from being dispensed without a prescription.

No person shall distribute or dispense butyl nitrite for inhalation or other introduction into the human body for euphoric or physical effect.

(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:

(1) The controlled substances are not outwardly dangerous and are not likely, of their own force, to cause injury to a person's life or health.

(2) The inner container of a parcel containing controlled substances must be marked and sealed as required under this Act and its rules, and be placed in a plain outer container or securely wrapped in plain paper.

(3) If the controlled substances consist of prescription medicines, the inner container must be labeled to show the name and address of the pharmacy or practitioner dispensing the prescription.

(4) The outside wrapper or container must be free of markings that would indicate the nature of the contents.

(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; 103-154, eff. 6-30-23.)

(Text of Section after amendment by P.A. 103-881)

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:

(1) Each separate prescription must be issued for a legitimate medical purpose by an individual physician acting in the usual course of professional practice.

(2) The individual physician must provide written instructions on each prescription (other than the first prescription, if the prescribing physician intends for the prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill that prescription.

(3) The physician shall document in the medical record of a patient the medical necessity for the amount and duration of the 3 sequential 30-day prescriptions for Schedule II narcotics.

(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:

(1) only personally by a person registered to dispense a Schedule V controlled substance and then only to his or her patients, or

(2) only personally by a pharmacist, and then only to a person over 21 years of age who has identified himself or herself to the pharmacist by means of 2 positive documents of identification.

The dispenser shall record the name and address of the purchaser, the name and quantity of the product, the date and time of the sale, and the dispenser's signature.

No person shall purchase or be dispensed more than 120 milliliters or more than 120 grams of any Schedule V substance which contains codeine, dihydrocodeine, or any salts thereof, or ethylmorphine, or any salts thereof, in any 96-hour period. The purchaser shall sign a form, approved by the Department of Financial and Professional Regulation, attesting that he or she has not purchased any Schedule V controlled substances within the immediately preceding 96 hours.

All records of purchases and sales shall be maintained for not less than 2 years.

No person shall obtain or attempt to obtain within any consecutive 96-hour period any Schedule V substances of more than 120 milliliters or more than 120 grams containing codeine, dihydrocodeine or any of its salts, or ethylmorphine or any of its salts. Any person obtaining any such preparations or combination of preparations in excess of this limitation shall be in unlawful possession of such controlled substance.

A person qualified to dispense controlled substances under this Act and registered thereunder shall at no time maintain or keep in stock a quantity of Schedule V controlled substances in excess of 4.5 liters for each substance; a pharmacy shall at no time maintain or keep in stock a quantity of Schedule V controlled substances as defined in excess of 4.5 liters for each substance, plus the additional quantity of controlled substances necessary to fill the largest number of prescription orders filled by that pharmacy for such controlled substances in any one week in the previous year. These limitations shall not apply to Schedule V controlled substances which Federal law prohibits from being dispensed without a prescription.

No person shall distribute or dispense butyl nitrite for inhalation or other introduction into the human body for euphoric or physical effect.

(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, 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:

(1) The controlled substances are not outwardly dangerous and are not likely, of their own force, to cause injury to a person's life or health.

(2) The inner container of a parcel containing controlled substances must be marked and sealed as required under this Act and its rules, and be placed in a plain outer container or securely wrapped in plain paper.

(3) If the controlled substances consist of prescription medicines, the inner container must be labeled to show the name and address of the pharmacy or practitioner dispensing the prescription.

(4) The outside wrapper or container must be free of markings that would indicate the nature of the contents.

(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; 103-154, eff. 6-30-23; 103-881, eff. 1-1-25.)

(720 ILCS 570/313) (from Ch. 56 1/2, par. 1313)

(Text of Section before amendment by P.A. 103-881)

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.)

(Text of Section after amendment by P.A. 103-881)

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 substance use disorder 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. Substance use disorder 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; 103-881, eff. 1-1-25.)

(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)

(Text of Section before amendment by P.A. 103-531)

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.)

(Text of Section after amendment by P.A. 103-531)

Sec. 315.5. Opioid education for prescribers. In accordance with the requirement for prescribers of controlled substances to undergo training under Section 1263 of the Consolidated Appropriations Act, 2023 (Public Law 117-328), every prescriber who is licensed to prescribe controlled substances shall, during the pre-renewal period, complete one hour 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 this hour 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. 103-531, eff. 1-1-25.)

(720 ILCS 570/315.6)

Sec. 315.6. Risks of dependence on opioids.

(a) Definitions. As used in this Section:

(1) "Opioid" means a narcotic drug or substance that is a Schedule II controlled substance under paragraph (1), (2), (3), or (5) of subsection (b) or under subsection (c) of Section 206 of this Act.

(2) "Department" means the Department of Human Services.

(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:

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

(A) The recipient's name and address.

(B) The recipient's date of birth and gender.

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

(D) (Blank).

(E) The quantity of the controlled substance dispensed and days supply.

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

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

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

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

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

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

(2) The information required to be transmitted under this Section must be transmitted not later than the end of the business day on which a controlled substance is dispensed, or at such other time as may be required by the Department by administrative rule.

(3) A dispenser must transmit electronically, as provided by Department rule, the information required to be transmitted under this Section.

(3.5) The requirements of paragraphs (1), (2), and (3) of this subsection also apply to opioid treatment programs that are licensed or certified by the Department of Human Services' Division of Substance Use Prevention and Recovery and are authorized by the federal Drug Enforcement Administration to prescribe Schedule II, III, IV, or V controlled substances for the treatment of opioid use disorders. Opioid treatment programs shall attempt to obtain written patient consent, shall document attempts to obtain the written consent, and shall not transmit information without patient consent. Documentation obtained under this paragraph shall not be utilized for law enforcement purposes, as proscribed under 42 CFR 2, as amended by 42 U.S.C. 290dd-2. Treatment of a patient shall not be conditioned upon his or her written consent.

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

(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) It is the responsibility of any new, ceased, or unconnected healthcare facility and its selected Electronic Health Records System or Pharmacy Management System to make contact with and ensure integration with the Prescription Monitoring Program. As soon as practicable after the effective date of this amendatory Act of the 103rd General Assembly, the Department shall adopt rules requiring Electronic Health Records Systems and Pharmacy Management Systems to interface, by January 1, 2024, with the Prescription Monitoring Program to ensure that providers have access to specific patient records during the treatment of their patients. The Department shall identify actions to be taken if a prescriber's Electronic Health Records System and Pharmacy Management Systems does not effectively interface with the Prescription Monitoring Program once the Prescription Monitoring Program is aware of the non-integrated connection.

(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. 102-527, eff. 8-20-21; 102-813, eff. 5-13-22; 103-477, eff. 8-4-23.)

(720 ILCS 570/316.1)

Sec. 316.1. Access to the integration of pharmacy records with the Prescription Monitoring Program.

(a) Subject to the requirements and limitations set out in this Section and in administrative rule, the Department shall not require, either expressly or effectively, Electronic Health Records Systems, pharmacies, or other providers to utilize a particular entity or system for access to the integration of pharmacy records with the Prescription Monitoring Program.

(1) Any entity or system for integration (transmitting the data maintained by the Prescription Monitoring Program) into an Electronic Health Records System, Certified Health IT Module, Pharmacy Dispensing System, or Pharmacy Management System must meet applicable requirements outlined in administrative rule, including, but not limited to, the following:

(A) enter into a data sharing agreement with the Department of Human Services, Prescription Monitoring Program;

(B) all security requirements noted within this Section, administrative rule, and all other applicable State and federal security and privacy requirements;

(C) the Prescription Monitoring Program shall have administrative control over the approval of each site and individual integration point and the Prescription Monitoring Program shall have the ability to disable individual integration points, at no additional cost to the State;

(D) interstate data sharing shall be completed with written authorization from the Prescription Monitoring Program;

(E) data available from the Prescription Monitoring Program shall not be stored, cached, or sold and the State may inspect and review an entity or system for integration to assure and confirm the same, subject to a reasonable non-disclosure agreement, as permitted by State law, to protect the entity's or system's trade secrets or other proprietary information;

(F) analysis of data shall only be allowed with express written permission from the Prescription Monitoring Program; and

(G) access to audit data, shall be available in hourly to real-time increments at no cost to the State.

(2) Electronic Health Record Systems, Certified Health IT Modules, Pharmacy Management Systems, and Pharmacy Dispensing Systems integrated with the Prescription Monitoring Program must meet applicable requirements outlined in rule, including, but not limited to, the following:

(A) provide their customers (healthcare entity, pharmacy, provider, prescriber, dispenser, etc.) the choice of approved integration vendor, meeting the requirements of this Section and administrative rule, or direct connect to the Illinois Prescription Monitoring Program;

(B) provide their customers with access to the data provided by the customer's chosen integration vendor as allowed under State and federal statute; and

(C) follow all State and federal security and privacy standards.

(3) Customers required to integrate under State or federal law must meet the requirements outlined in administrative rule, including, but not limited to, the following:

(A) the customer retains the choice of which integration vendor or direct connect is utilized to connect to the Illinois Prescription Monitoring Program; and

(B) customers seeking to contract with a new integration vendor, shall enter into a memorandum of understanding with the Prescription Monitoring Program.

(b) The Illinois Prescription Monitoring Program may exercise the power, by rule, to require Memoranda of Understanding with all customers. The general contents of the memorandum of understanding shall be set out in rule and shall include, but not be limited to:

(1) the acknowledgment and choice of the customer of the method of integration with the Prescription Monitoring Program and

(2) the data use and other requirements on the customer in accessing and using the Prescription Monitoring Program.

A fee cannot be levied as part of a memorandum of understanding required by the Department under this Section.

(c) Non-compliance by the Integration Vendor, Electronic Health Record System, Certified Health IT Module, Pharmacy Management System or Pharmacy Dispensing System, customer, or any parties required to comply with this Section may result in the party being prohibited from serving as entity or system for integration with the Prescription Monitoring Program, termination of contracts, agreements, or other business relationships. The Department shall institute appropriate cure notices, as necessary to remedy non-compliance.

(Source: P.A. 103-477, eff. 7-1-24.)

(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:

(1) Create a database for information required to be transmitted under Section 316 in the form required under rules adopted by the Department, including search capability for the following:

(A) A recipient's name and address.

(B) A recipient's date of birth and gender.

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

(D) (Blank).

(E) The quantities and days supply of a controlled substance dispensed.

(F) A dispenser's Administration registration number.

(G) A prescriber's Administration registration number.

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

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

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

(2) Provide the Department with a database maintained by the central repository. The Department of Financial and Professional Regulation must provide the Department with electronic access to the license information of a prescriber or dispenser.

(3) Secure the information collected by the central repository and the database maintained by the central repository against access by unauthorized persons.

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. 103-477, eff. 8-4-23.)

(720 ILCS 570/318)

(Text of Section before amendment by P.A. 103-881)

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:

(1) A governing body that licenses practitioners and is engaged in an investigation, an adjudication, or a prosecution of a violation under any State or federal law that involves a controlled substance.

(2) An investigator for the Consumer Protection Division of the office of the Attorney General, a prosecuting attorney, the Attorney General, a deputy Attorney General, or an investigator from the office of the Attorney General, who is engaged in any of the following activities involving controlled substances:

(A) an investigation;

(B) an adjudication; or

(C) a prosecution of a violation under any State or federal law that involves a controlled substance.

(3) A law enforcement officer who is:

(A) authorized by the Illinois State Police or the office of a county sheriff or State's Attorney or municipal police department of Illinois to receive information of the type requested for the purpose of investigations involving controlled substances; or

(B) approved by the Department to receive information of the type requested for the purpose of investigations involving controlled substances; and

(C) engaged in the investigation or prosecution of a violation under any State or federal law that involves a controlled substance.

(4) Select representatives of the Department of Children and Family Services through the indirect online request process. Access shall be established by an intergovernmental agreement between the Department of Children and Family Services and the Department of Human Services.

(e) Before the Department releases confidential information under subsection (d), the applicant must demonstrate in writing to the Department that:

(1) the applicant has reason to believe that a violation under any State or federal law that involves a controlled substance has occurred; and

(2) the requested information is reasonably related to the investigation, adjudication, or prosecution of the violation described in subdivision (1).

(f) The Department may receive and release prescription record information under Section 316 and former Section 321 to:

(1) a governing body that licenses practitioners;

(2) an investigator for the Consumer Protection Division of the office of the Attorney General, a prosecuting attorney, the Attorney General, a deputy Attorney General, or an investigator from the office of the Attorney General;

(3) any Illinois law enforcement officer who is:

(A) authorized to receive the type of information released; and

(B) approved by the Department to receive the type of information released; or

(4) prescription monitoring entities in other states per the provisions outlined in subsection (g) and (h) below;

confidential prescription record information collected under Sections 316 and 321 (now repealed) that identifies vendors or practitioners, or both, who are prescribing or dispensing large quantities of Schedule II, III, IV, or V controlled substances outside the scope of their practice, pharmacy, or business, as determined by the Advisory Committee created by Section 320.

(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:

(1) developing education programs or public health interventions relating to prescribing trends and controlled substance use; or

(2) conducting analyses and publish reports on prescribing trends in their respective jurisdictions.

At a minimum, the confidentiality agreement entered into with the Department shall:

(i) prohibit analysis and reports produced under subparagraph (2) from including information that identifies, by name, license, or address, any practitioner, dispenser, ultimate user, or other person administering a controlled substance; and

(ii) specify the appropriate technical and physical safeguards that the county or municipal health department must implement to ensure the privacy and security of data obtained from the system. The data from the system shall not be admissible as evidence, nor discoverable in any action of any kind in any court or before any tribunal, board, agency, or person. The disclosure of any such information or data, whether proper or improper, shall not waive or have any effect upon its confidentiality, non-discoverability, or non-admissibility.

(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:

(1) A proceeding under any State or federal law that involves a controlled substance.

(2) A criminal proceeding or a proceeding in juvenile court that involves a controlled substance.

(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.

(1) An inquirer shall have read-only access to a stand-alone database which shall contain records for the previous 12 months.

(2) Dispensers may, upon positive and secure identification, make an inquiry on a patient or customer solely for a medical purpose as delineated within the federal HIPAA law.

(3) The Department shall provide a one-to-one secure link and encrypted software necessary to establish the link between an inquirer and the Department. Technical assistance shall also be provided.

(4) Written inquiries are acceptable but must include the fee and the requester's Drug Enforcement Administration license number and submitted upon the requester's business stationery.

(5) As directed by the Prescription Monitoring Program Advisory Committee and the Clinical Director for the Prescription Monitoring Program, aggregate data that does not indicate any prescriber, practitioner, dispenser, or patient may be used for clinical studies.

(6) Tracking analysis shall be established and used per administrative rule.

(7) Nothing in this Act or Illinois law shall be construed to require a prescriber or dispenser to make use of this inquiry system.

(8) If there is an adverse outcome because of a prescriber or dispenser making an inquiry, which is initiated in good faith, the prescriber or dispenser shall be held harmless from any civil liability.

(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:

(1) the designee so authorized is employed by the same hospital or health care system; is employed by the same professional practice; or is under contract with such practice, hospital, or health care system;

(2) the prescriber or dispenser takes reasonable steps to ensure that such designee is sufficiently competent in the use of the inquiry system;

(3) the prescriber or dispenser remains responsible for ensuring that access to the inquiry system by the designee is limited to authorized purposes and occurs in a manner that protects the confidentiality of the information obtained from the inquiry system, and remains responsible for any breach of confidentiality; and

(4) the ultimate decision as to whether or not to prescribe or dispense a controlled substance remains with the prescriber or dispenser.

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:

(1) current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other controlled substances as determined by the Advisory Committee;

(2) accredited continuing education programs related to prescribing of controlled substances;

(3) programs or information developed by health care professionals that may be used to assess patients or help ensure compliance with prescriptions;

(4) updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing;

(5) relevant medical studies related to prescribing;

(6) other information regarding the prescription of controlled substances; and

(7) information regarding prescription drug disposal events, including take-back programs or other disposal options or events.

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:

(1) opportunities for accredited continuing education programs related to prescribing of controlled substances;

(2) current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other drugs as determined by the Advisory Committee;

(3) programs or information developed by health care professionals that may be used to assess patients or help ensure compliance with prescriptions;

(4) updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing;

(5) relevant medical studies related to prescribing;

(6) other information regarding prescribing of controlled substances;

(7) information regarding prescription drug disposal events, including take-back programs or other disposal options or events; and

(8) reminders that the Prescription Monitoring Program is a useful clinical tool.

(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.)

(Text of Section after amendment by P.A. 103-881)

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 substance use disorders 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 use disorder. 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 risk of developing a substance use disorder 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:

(1) A governing body that licenses practitioners and is engaged in an investigation, an adjudication, or a prosecution of a violation under any State or federal law that involves a controlled substance.

(2) An investigator for the Consumer Protection Division of the office of the Attorney General, a prosecuting attorney, the Attorney General, a deputy Attorney General, or an investigator from the office of the Attorney General, who is engaged in any of the following activities involving controlled substances:

(A) an investigation;

(B) an adjudication; or

(C) a prosecution of a violation under any State or federal law that involves a controlled substance.

(3) A law enforcement officer who is:

(A) authorized by the Illinois State Police or the office of a county sheriff or State's Attorney or municipal police department of Illinois to receive information of the type requested for the purpose of investigations involving controlled substances; or

(B) approved by the Department to receive information of the type requested for the purpose of investigations involving controlled substances; and

(C) engaged in the investigation or prosecution of a violation under any State or federal law that involves a controlled substance.

(4) Select representatives of the Department of Children and Family Services through the indirect online request process. Access shall be established by an intergovernmental agreement between the Department of Children and Family Services and the Department of Human Services.

(e) Before the Department releases confidential information under subsection (d), the applicant must demonstrate in writing to the Department that:

(1) the applicant has reason to believe that a violation under any State or federal law that involves a controlled substance has occurred; and

(2) the requested information is reasonably related to the investigation, adjudication, or prosecution of the violation described in subdivision (1).

(f) The Department may receive and release prescription record information under Section 316 and former Section 321 to:

(1) a governing body that licenses practitioners;

(2) an investigator for the Consumer Protection Division of the office of the Attorney General, a prosecuting attorney, the Attorney General, a deputy Attorney General, or an investigator from the office of the Attorney General;

(3) any Illinois law enforcement officer who is:

(A) authorized to receive the type of information released; and

(B) approved by the Department to receive the type of information released; or

(4) prescription monitoring entities in other states per the provisions outlined in subsection (g) and (h) below;

confidential prescription record information collected under Sections 316 and 321 (now repealed) that identifies vendors or practitioners, or both, who are prescribing or dispensing large quantities of Schedule II, III, IV, or V controlled substances outside the scope of their practice, pharmacy, or business, as determined by the Advisory Committee created by Section 320.

(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:

(1) developing education programs or public health interventions relating to prescribing trends and controlled substance use; or

(2) conducting analyses and publish reports on prescribing trends in their respective jurisdictions.

At a minimum, the confidentiality agreement entered into with the Department shall:

(i) prohibit analysis and reports produced under subparagraph (2) from including information that identifies, by name, license, or address, any practitioner, dispenser, ultimate user, or other person administering a controlled substance; and

(ii) specify the appropriate technical and physical safeguards that the county or municipal health department must implement to ensure the privacy and security of data obtained from the system. The data from the system shall not be admissible as evidence, nor discoverable in any action of any kind in any court or before any tribunal, board, agency, or person. The disclosure of any such information or data, whether proper or improper, shall not waive or have any effect upon its confidentiality, non-discoverability, or non-admissibility.

(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:

(1) A proceeding under any State or federal law that involves a controlled substance.

(2) A criminal proceeding or a proceeding in juvenile court that involves a controlled substance.

(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.

(1) An inquirer shall have read-only access to a stand-alone database which shall contain records for the previous 12 months.

(2) Dispensers may, upon positive and secure identification, make an inquiry on a patient or customer solely for a medical purpose as delineated within the federal HIPAA law.

(3) The Department shall provide a one-to-one secure link and encrypted software necessary to establish the link between an inquirer and the Department. Technical assistance shall also be provided.

(4) Written inquiries are acceptable but must include the fee and the requester's Drug Enforcement Administration license number and submitted upon the requester's business stationery.

(5) As directed by the Prescription Monitoring Program Advisory Committee and the Clinical Director for the Prescription Monitoring Program, aggregate data that does not indicate any prescriber, practitioner, dispenser, or patient may be used for clinical studies.

(6) Tracking analysis shall be established and used per administrative rule.

(7) Nothing in this Act or Illinois law shall be construed to require a prescriber or dispenser to make use of this inquiry system.

(8) If there is an adverse outcome because of a prescriber or dispenser making an inquiry, which is initiated in good faith, the prescriber or dispenser shall be held harmless from any civil liability.

(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:

(1) the designee so authorized is employed by the same hospital or health care system; is employed by the same professional practice; or is under contract with such practice, hospital, or health care system;

(2) the prescriber or dispenser takes reasonable steps to ensure that such designee is sufficiently competent in the use of the inquiry system;

(3) the prescriber or dispenser remains responsible for ensuring that access to the inquiry system by the designee is limited to authorized purposes and occurs in a manner that protects the confidentiality of the information obtained from the inquiry system, and remains responsible for any breach of confidentiality; and

(4) the ultimate decision as to whether or not to prescribe or dispense a controlled substance remains with the prescriber or dispenser.

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:

(1) current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other controlled substances as determined by the Advisory Committee;

(2) accredited continuing education programs related to prescribing of controlled substances;

(3) programs or information developed by health care professionals that may be used to assess patients or help ensure compliance with prescriptions;

(4) updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing;

(5) relevant medical studies related to prescribing;

(6) other information regarding the prescription of controlled substances; and

(7) information regarding prescription drug disposal events, including take-back programs or other disposal options or events.

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:

(1) opportunities for accredited continuing education programs related to prescribing of controlled substances;

(2) current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other drugs as determined by the Advisory Committee;

(3) programs or information developed by health care professionals that may be used to assess patients or help ensure compliance with prescriptions;

(4) updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing;

(5) relevant medical studies related to prescribing;

(6) other information regarding prescribing of controlled substances;

(7) information regarding prescription drug disposal events, including take-back programs or other disposal options or events; and

(8) reminders that the Prescription Monitoring Program is a useful clinical tool.

(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; 103-881, eff. 1-1-25.)

(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:

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

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

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

(Source: P.A. 99-480, eff. 9-9-15.)

(720 ILCS 570/320)

(Text of Section before amendment by P.A. 103-881)

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:

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

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

(3) review the following: current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other controlled substances; accredited continuing education programs related to prescribing and dispensing; programs or information developed by health care professional organizations that may be used to assess patients or help ensure compliance with prescriptions; updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing and dispensing; relevant medical studies; and other publications which involve the prescription of controlled substances;

(4) make recommendations for inclusion of these materials or other studies which may be effective resources for prescribers and dispensers on the Internet website of the inquiry system established under Section 318;

(5) semi-annually review the content of the Internet website of the inquiry system established pursuant to Section 318 to ensure this Internet website has the most current available information;

(6) semi-annually review opportunities for federal grants and other forms of funding to support projects which will increase the number of pilot programs which integrate the inquiry system with electronic health records; and

(7) semi-annually review communication to be sent to all registered users of the inquiry system established pursuant to Section 318, including recommendations for relevant accredited continuing education and information regarding prescribing and dispensing.

(f) The Advisory Committee shall select from its members 10 members of the Peer Review Committee composed of:

(1) 3 physicians;

(2) 3 pharmacists;

(3) one dentist;

(4) one advanced practice registered nurse;

(4.5) (blank);

(5) one physician assistant; and

(6) one optometrist.

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.

(1) The Peer Review Committee shall periodically review the data contained within the prescription monitoring program to identify those prescribers or dispensers who may be prescribing or dispensing outside the currently accepted standard and practice of their profession. The Peer Review Committee member, whose profession is the same as the prescriber or dispenser being reviewed, shall prepare a preliminary report and recommendation for any non-action or action. The Prescription Monitoring Program Clinical Director and staff shall provide the necessary assistance and data as required.

(2) The Peer Review Committee may identify prescribers or dispensers who may be prescribing outside the currently accepted medical standards in the course of their professional practice and send the identified prescriber or dispenser a request for information regarding their prescribing or dispensing practices. This request for information shall be sent via certified mail, return receipt requested. A prescriber or dispenser shall have 30 days to respond to the request for information.

(3) The Peer Review Committee shall refer a prescriber or a dispenser to the Department of Financial and Professional Regulation in the following situations:

(i) if a prescriber or dispenser does not respond to three successive requests for information;

(ii) in the opinion of a majority of members of the Peer Review Committee, the prescriber or dispenser does not have a satisfactory explanation for the practices identified by the Peer Review Committee in its request for information; or

(iii) following communications with the Peer Review Committee, the prescriber or dispenser does not sufficiently rectify the practices identified in the request for information in the opinion of a majority of the members of the Peer Review Committee.

(4) The Department of Financial and Professional Regulation may initiate an investigation and discipline in accordance with current laws and rules for any prescriber or dispenser referred by the Peer Review Committee.

(5) The Peer Review Committee shall prepare an annual report starting on July 1, 2017. This report shall contain the following information: the number of times the Peer Review Committee was convened; the number of prescribers or dispensers who were reviewed by the Peer Review Committee; the number of requests for information sent out by the Peer Review Committee; and the number of prescribers or dispensers referred to the Department of Financial and Professional Regulation. The annual report shall be delivered electronically to the Department and to the General Assembly. The report to the General Assembly shall be filed with the Clerk of the House of Representatives and the Secretary of the Senate in electronic form only, in the manner that the Clerk and the Secretary shall direct. The report prepared by the Peer Review Committee shall not identify any prescriber, dispenser, or patient.

(Source: P.A. 100-513, eff. 1-1-18; 100-861, eff. 8-14-18; 100-1093, eff. 8-26-18;101-81, eff. 7-12-19; 101-414, eff. 8-16-19.)

(Text of Section after amendment by P.A. 103-881)

Sec. 320. Advisory committee.

(a) There is created a Prescription Monitoring Program Advisory Committee to assist the Department of Human Services and Department of Public Health 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:

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

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

(3) review the following: current clinical guidelines developed by health care professional organizations on the prescribing of opioids or other controlled substances; accredited continuing education programs related to prescribing and dispensing; programs or information developed by health care professional organizations that may be used to assess patients or help ensure compliance with prescriptions; updates from the Food and Drug Administration, the Centers for Disease Control and Prevention, and other public and private organizations which are relevant to prescribing and dispensing; relevant medical studies; and other publications which involve the prescription of controlled substances;

(4) make recommendations for inclusion of these materials or other studies which may be effective resources for prescribers and dispensers on the Internet website of the inquiry system established under Section 318;

(5) semi-annually review the content of the Internet website of the inquiry system established pursuant to Section 318 to ensure this Internet website has the most current available information;

(6) semi-annually review opportunities for federal grants and other forms of funding to support projects which will increase the number of pilot programs which integrate the inquiry system with electronic health records; and

(7) semi-annually review communication to be sent to all registered users of the inquiry system established pursuant to Section 318, including recommendations for relevant accredited continuing education and information regarding prescribing and dispensing.

(f) The Advisory Committee shall select from its members 10 members of the Peer Review Committee composed of:

(1) 3 physicians;

(2) 3 pharmacists;

(3) one dentist;

(4) one advanced practice registered nurse;

(4.5) (blank);

(5) one physician assistant; and

(6) one optometrist.

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.

(1) The Peer Review Committee shall periodically review the data contained within the prescription monitoring program to identify those prescribers or dispensers who may be prescribing or dispensing outside the currently accepted standard and practice of their profession. The Peer Review Committee member, whose profession is the same as the prescriber or dispenser being reviewed, shall prepare a preliminary report and recommendation for any non-action or action. The Prescription Monitoring Program Clinical Director and staff shall provide the necessary assistance and data as required.

(2) The Peer Review Committee may identify prescribers or dispensers who may be prescribing outside the currently accepted medical standards in the course of their professional practice and send the identified prescriber or dispenser a request for information regarding their prescribing or dispensing practices. This request for information shall be sent via certified mail, return receipt requested. A prescriber or dispenser shall have 30 days to respond to the request for information.

(3) The Peer Review Committee shall refer a prescriber or a dispenser to the Department of Financial and Professional Regulation in the following situations:

(i) if a prescriber or dispenser does not respond to three successive requests for information;

(ii) in the opinion of a majority of members of the Peer Review Committee, the prescriber or dispenser does not have a satisfactory explanation for the practices identified by the Peer Review Committee in its request for information; or

(iii) following communications with the Peer Review Committee, the prescriber or dispenser does not sufficiently rectify the practices identified in the request for information in the opinion of a majority of the members of the Peer Review Committee.

(4) The Department of Financial and Professional Regulation may initiate an investigation and discipline in accordance with current laws and rules for any prescriber or dispenser referred by the Peer Review Committee.

(5) The Peer Review Committee shall prepare an annual report starting on July 1, 2017. This report shall contain the following information: the number of times the Peer Review Committee was convened; the number of prescribers or dispensers who were reviewed by the Peer Review Committee; the number of requests for information sent out by the Peer Review Committee; and the number of prescribers or dispensers referred to the Department of Financial and Professional Regulation. The annual report shall be delivered electronically to the Department and to the General Assembly. The report to the General Assembly shall be filed with the Clerk of the House of Representatives and the Secretary of the Senate in electronic form only, in the manner that the Clerk and the Secretary shall direct. The report prepared by the Peer Review Committee shall not identify any prescriber, dispenser, or patient.

(Source: P.A. 103-881, eff. 1-1-25.)