TITLE 77: PUBLIC HEALTH
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AUTHORITY: Implementing and authorized by Sections 316, 317, 318, 319 and 320 of the Illinois Controlled Substances Act [720 ILCS 570].
SOURCE: Adopted at 39 Ill. Reg. 6444, effective April 22, 2015; amended at 47 Ill. Reg. 10948, effective July 7, 2023.
Section 2081.10 Authority
This Part is promulgated pursuant to the Illinois Controlled Substances Act that empowers the Department of Human Services to codify the efforts of this State to conform with the regulatory systems of the federal government and other states to establish national coordination of efforts to control the abuse of Schedule II, III, IV and V retail dispensed drugs. It relates to the collection of prescription information listed in Schedule II, III, IV and V within Sections 206, 208, 210 and 212 of the Act, or in the federal Schedule II, III, IV and V and "Amendment of Schedules" list of drugs at 21 USC 812(b)(2), (b)(3), (b)(4), (b)(5) and (c).
Section 2081.20 Definitions and Incorporation by Reference
No incorporations by reference in this Part include any later amendments or editions. The definitions that apply to this Part are those found in the Act and those in this Section.
"Act" means the Illinois Controlled Substances Act [720 ILCS 570].
"Birth Date" means the medication recipient's birth date.
"Central Repository" means a place designated by the Department where Schedule II, III, IV and V drug data is stored or housed.
"Clinical Director" means a DHS administrative employee licensed to either prescribe or dispense controlled substances who shall run the clinical aspects of the DHS Prescription Monitoring Program and its Prescription Information Library [720 ILCS 570/102(d-5)].
"Controlled Substance" means a drug, substance, or immediate precursor in the Schedules of Article II of the Illinois Controlled Substances Act, or a drug or other substance, or immediate precursor, designated as a controlled substance by the DHS [720 ILCS 570/102(f)].
"DEA Number" means the United States Drug Enforcement Agency prescriber or dispenser registration number.
"Department" or "DHS" means the Illinois Department of Human Services, or its successor agency.
"Dispenser" means any practitioner or pharmacy that dispenses a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a prescriber [720 ILCS 570/102(p) and (q)].
"DPH" means the Illinois Department of Public Health.
"Electronic Device" means using a computer system to transmit prescriptions from a prescriber directly to a dispenser.
"Exempt Prescribers in Hospitals and Institutions" means prescribers in hospitals or institutions licensed under the Hospital Licensing Act [210 ILCS 85] who authorize the administration or dispensing of Schedule II drugs within the hospital or institution, for consumption within the hospital or institution (e.g., controlled substance prescriptions when a prescriber does not maintain his or her own DEA and State controlled substance license, but prescribes based upon the institution's (hospital's) controlled substance licenses).
"Facsimile Equipment" means any device capable of sending or receiving facsimiles of documents through connection with a telecommunications network.
"HFS" means the Illinois Department of Healthcare and Family Services.
"Illinois Controlled Substances License Number" means the State license number issued by the Illinois Department of Financial and Professional Regulation (DFPR) permitting prescribers to possess, prescribe or dispense, and permitting dispensers to possess and dispense, controlled substances in Illinois pursuant to the Controlled Substances Act (see 77 Ill. Adm. Code 3100).
"Licensed Healthcare Provider" means any individual who meets the professional licensing requirements and follows the standards set forth by DFPR and are authorized to prescribe or dispense controlled substances within Illinois.
"Long Term Care" or "LTC" means:
any facility defined by Section 1-113 of the Nursing Home Care Act; and
any skilled nursing facility or a nursing facility that meets the requirements of section 1819(a), (b), (c) and (d) or section 1919(a), (b), (c) and (d) of the Social Security Act (42 U.S.C. 1395i-3(a), (b), (c) and (d) and 1396r(a), (b), (c) and (d)).
"Long Term Care Pharmacy" or "LTC Pharmacy" means those pharmacies that, either as a primary or secondary focus, provide prescription services to those inpatient institutions licensed as LTC facilities by DPH.
"Mid-level Practitioner" means:
a physician assistant who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches, in accordance with Section 7.5 of the Physician Assistant Practice Act of 1987 [225 ILCS 95];
an advanced practice registered nurse who has been delegated authority to prescribe through a written delegation of authority by a physician licensed to practice medicine in all of its branches or by a podiatric physician, in accordance with Section 65-40 of the Nurse Practice Act [225 ILCS 65];
an advanced practice registered nurse certified as a nurse practitioner, nurse midwife, or clinical nurse specialist who has been granted authority to prescribe by a hospital affiliate in accordance with Section 65-45 of the Nurse Practice Act;
an animal euthanasia agency; or
a prescribing psychologist. [720 ILCS 570/102(z-10)]
"National Drug Code Identification Number" or "NDC Identification Number" means the number used to provide uniform product identification for all substances recognized as drugs in the United States Pharmacopoeia National Formulary, USP31-NF26 (US Pharmacopoeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852 (2013)).
"Patient ID" means the identification of the individual receiving the medication or the responsible individual obtaining the medication on behalf of the recipient or the owner of the animal. The standards for establishing patient ID for the purpose of proper filling of a prescription are established by 77 Ill. Adm. Code 2080.70(d).
"Patient Location Code" means the portion of a LTC pharmacy's system of electronic files that identifies with which LTC facility, and what classification of care, the individual patient is associated.
"Prescribed" means ordered by a prescriber verbally, electronically or in writing.
"Prescriber" means the healthcare professional that is authorized to prescribe medications as set forth in the various professional practices of the State of Illinois.
"Prescription Information Library" or "PIL" means an electronic library containing 12 months of controlled substance, retail, prescription information that is accessible only by prescribers and dispensers for patient treatment usage [720 ILCS 570/102(nn-5)].
"Prescription Monitoring Program" or "PMP" means the entity that collects, tracks, and stores reported data on controlled substances and select drugs [720 ILCS 570/102(nn-10)].
"Prescription Monitoring Program Advisory Committee" or "PMPAC" means a committee consisting of licensed healthcare providers representing all professions that are licensed to prescribe or dispense controlled substances. The committee serves in a consultant context regarding longitudinal evaluations of compliance with evidence based clinical practice and controlled substances. The committee makes recommendations regarding scheduling of controlled substances and recommendations concerning continuing education designed at improving the health and safety of the citizens of Illinois regarding pharmacotherapies of controlled substances (e.g., the choice of medications, the frequency of refills, concomitant pharmacotherapies of other medications, all of which affect clinical response and possible dependency on those therapies).
"Quantities of a Controlled Substance Dispensed" means the total of a National Drug Code product dispensed whether it is in a solid unit such as a tablet or capsule, in a liquid unit such as milliliters, or in another unit as specified within the product identification.
"Recipient's Name" means the given or common name of a person who is the intended user of a dispensed medication. It may also mean the species or common name or common given name of an animal that is the intended user of a dispensed medication. If an animal's name is entered, the owner's name is required also.
"Schedule Drug" means any substances listed in the federal Controlled Substances Act (21 U.S.C. 812) or the Illinois Controlled Substances Act [720 ILCS 570] or by the Department pursuant to its authority under Section 202 of the Illinois Controlled Substances Act. Schedule, I, II, III, IV and V substances are listed in section 812 of the federal Controlled Substances Act (21 U.S.C. 812(b)(2), (b)(3), (b)(4), (b)(5) and (c)) and Sections 204, 206, 208, 210 and 212 of the Illinois Controlled Substances Act.
"Sex" means the medication recipient's biological status of being male or female at birth.
(Source: Amended at 47 Ill. Reg. 10948, effective July 7, 2023)