Bill Text: IL HB0119 | 2021-2022 | 102nd General Assembly | Chaptered


Bill Title: Creates the Illinois Drug Reuse Opportunity Program Act. Provides that, notwithstanding any other law or rule, donors may donate drugs to recipients and recipients may receive donated drugs from donors. Provides that recipients shall only dispense or administer drugs to eligible patients, further donate drugs to another recipient, or dispose of drugs in accordance with specified provisions. Provides that drugs donated for use under the Act are considered nonsaleable. Provides that, when dispensing a drugs to an eligible patient, the recipient must do so at no cost to the eligible patient, except that a reasonable handling fee may be charged. Provides that recipients may only dispense or administer a prescription drug or provide an over-the-counter drug if specified requirements are met. Provides that recipients shall, to the greatest extent practicable, dispense drugs received under the Act to priority patients. Provides that drugs may be accepted under the Act only if specified requirements are met. Contains requirements for the further donation of drugs by a recipient. Contains provisions regarding the disposition of specified drugs. Provides that nothing in the Act requires that a pharmacy or pharmacist be a recipient of drugs under the Act. Provides that the Act shall supersede any inconsistent law or rule for activities conducted under the Act. Contains other provisions. Amends the Pharmacy Practice Act, the Wholesale Drug Distribution Licensing Act, the Senior Pharmaceutical Assistance Act, the Illinois Food, Drug and Cosmetic Act, the Illinois Controlled Substances Act, and the Cannabis and Controlled Substances Tort Claims Act to provide that persons engaged in donating or accepting, or packaging, repackaging, or labeling, prescription drugs to the extent permitted or required under the Illinois Drug Reuse Opportunity Program Act are exempt from provisions of those other Acts that might prohibit or otherwise regulate such activity.

Spectrum: Slight Partisan Bill (Democrat 46-16)

Status: (Passed) 2021-08-16 - Public Act . . . . . . . . . 102-0389 [HB0119 Detail]

Download: Illinois-2021-HB0119-Chaptered.html



Public Act 102-0389
HB0119 EnrolledLRB102 04093 CPF 14109 b
AN ACT concerning health.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 1. Short title. This Act may be cited as the
Illinois Drug Reuse Opportunity Program Act.
Section 5. Definitions. In this Act:
"Controlled substance" means a drug, substance, or
immediate precursor in Schedules I through V of 21 CFR 1308.
"Dispense" has the same meaning as defined in Section 3 of
the Pharmacy Practice Act.
"Donor" means any person, including an individual member
of the public, or any entity legally authorized to possess
medicine, including, but not limited to, a wholesaler or
distributor, third party logistic provider, pharmacy,
dispenser, clinic, surgical or health center, detention and
rehabilitation center, jail, prison laboratory, medical or
pharmacy school, prescriber or other health care professional,
long-term care facility, or healthcare facility. "Donor"
includes government agencies and entities that are federally
authorized to possess medicine, including, but not limited to,
drug manufacturers, repackagers, relabelers, outsourcing
facilities, health care facilities operated by the U.S.
Department of Veterans Affairs, and prisons.
"Drug" means a prescription drug, over-the-counter drug,
or supplies needed to administer a prescription or
over-the-counter drug.
"Eligible patient" means an individual:
(1) with a prescription for the drug, if a
prescription is required to dispense the drug, or who
reports symptoms treated by the drug if the drug is
over-the-counter; and
(2) who is registered with the drug's manufacturer in
accordance with federal Food and Drug Administration
requirements, if the registration is required to dispense
the drug.
"Manufacturer" has the same meaning as defined in Section
15 of the Wholesale Drug Distribution Licensing Act.
"Pharmacist" means an individual licensed to engage in the
practice of pharmacy under the Pharmacy Practice Act or
licensed to engage in the practice of pharmacy in another
state.
"Practitioner" means a person licensed in this State to
dispense or administer drugs or who is licensed in another
state as a person authorized to dispense or administer drugs.
"Prescription drug" means any prescribed drug that may be
legally dispensed by a pharmacy. "Prescription drug" does not
include a drug for the treatment of cancer that can only be
dispensed to a patient registered with the drug manufacturer
in accordance with the federal Food and Drug Administration's
requirements.
"Priority patient" means an eligible patient who is an
Illinois resident and who is indigent, uninsured,
underinsured, or enrolled in a public health benefits program.
"Recipient" means any person or entity legally authorized
to possess medicine with a license or permit in the state in
which the person or entity is located, including, but not
limited to, a wholesaler or distributor, reverse distributor,
repackager, hospital, pharmacy, or clinic.
"Returns processor" has the same meaning as defined in
paragraph (18) of 21 U.S.C. 360eee. "Returns processor"
includes, but is not limited to, a reverse distributor.
"Unopened tamper-evident packaging" has the same meaning
as defined in the United States Pharmacopeia (USP) General
Chapter 659, Packaging and Storage Requirements, including,
but not limited to, unopened unit-dose, multiple-dose,
immediate, secondary, and tertiary packaging.
Section 10. Donating and receiving drugs. Notwithstanding
any other law or rule, donors may donate drugs to recipients
and recipients may receive donated drugs from donors.
Recipients shall only dispense or administer drugs to eligible
patients as described in Section 20, further donate drugs to
another recipient as described in Section 30, or dispose of
drugs as described in Section 35.
Section 15. Cost-free provision of drugs. Drugs donated
for use under this Act are considered nonsaleable. When
dispensing a drug to an eligible patient, the recipient must
do so at no cost to the eligible patient, except that a uniform
reasonable handling fee may be charged. The handling fee may
not exceed the direct or indirect cost to the recipient of
providing the drug. Charging the fee does not constitute
reselling.
Section 20. Requirements for dispensing drugs; priority.
(a) A recipient may only dispense or administer a
prescription drug or provide an over-the-counter drug:
(1) if the recipient is otherwise permitted by law to
dispense or administer the drug;
(2) that meets the requirements in Section 25;
(3) that is repackaged into a new container or is in
its original container with all previous patient
information redacted or removed;
(4) that is properly labeled in accordance with the
rules and regulations of the Board of Pharmacy;
(5) that has an expiration or beyond-use date brought
forward from the donated prescription drug or
over-the-counter drug that will not expire before the use
by the eligible patient based on the prescribing
practitioner's directions for use or, for over-the-counter
medicine, on the package's label; and
(6) that is not adulterated or misbranded, as
determined by a pharmacist or practitioner.
(b) Recipients shall, to the greatest extent practicable,
dispense drugs received under this Act to priority patients.
Section 25. Requirements for accepting drugs. A drug
received but not yet accepted into inventory shall be kept in a
separate designated area. A drug may be accepted under this
Act only if all of the following requirements are met:
(1) The drug is in unopened tamper-evident packaging
or has been repackaged according to Section 30.
(2) The drug is not expired.
(3) The drug is not a controlled substance.
(4) The recipient maintains a written or electronic
record of a donation made under this Act consisting of the
name, strength, and quantity of each accepted drug and the
name, address, and telephone number of the donor, unless a
recipient is further donating to a recipient under common
ownership or common control. Notwithstanding any other law
or rule, no other record of a donation is required.
(5) The donor has removed or redacted any patient name
and prescription number and any other patient identifying
information on the drug or otherwise maintains patient
confidentiality by executing a confidentiality agreement
with the recipient according to all State and federal
medical patient privacy laws, rules, or regulations.
(6) The drug has a method recognized by the United
States Pharmacopeia to detect improper temperature
variations if the drug requires temperature control other
than room temperature storage.
Section 30. Donating and repackaging. Notwithstanding any
other law or rule, a recipient may:
(1) further donate drugs to another recipient;
(2) repackage donated drugs as necessary for storage,
dispensing, administration, or transfers in accordance
with the following:
(A) repackaged medicine shall be labeled with the
drug's name, strength, and expiration date, and shall
be kept in a separate designated area until inspected
and initialed by a pharmacist, practitioner, or a
pharmacy technician; and
(B) if multiple packaged donated medicines with
varied expiration dates are repackaged together, the
shortest expiration date shall be used; and
(3) replenish a drug of the same drug name and
strength previously dispensed or administered to an
eligible patient in accordance with Section 340B of the
federal Public Health Service Act.
Section 35. Disposition of drugs. A donated drug that does
not meet the requirements of Section 25 must be disposed of by
returning it to the donor, destroying it by an incinerator,
medical waste hauler, or other lawful method, or transferring
it to a returns processor. A record of disposal shall consist
of the disposal method, the date of disposal, and the name and
quantity of the drug disposed of. Notwithstanding any other
law or rule, no other record of disposal shall be required.
Section 40. Participation not required. Nothing in this
Act requires that a pharmacy or pharmacist be a recipient of
drugs under this Act.
Section 45. Recordkeeping requirements. When performing
any action associated with a program under this Act or
otherwise processing a donated drug for tax, manufacturer, or
other credit, a recipient shall be considered to be acting as a
returns processor and shall comply with all recordkeeping
requirements for nonsaleable returns under federal law.
Section 50. Change of ownership. A donation or other
transfer of possession or control of a drug under this Act
shall not be construed as a change of ownership unless it is
specified as such by the recipient. If a record of the
donation's transaction information or history is required, the
history shall begin with the donor of the drug, include all
prior donations, and, if the drug was previously dispensed,
only include drug information required to be on the patient
label in accordance with the Board of Pharmacy's rules and
regulations.
Section 55. Retention of records. All records required
under this Act shall be retained in physical or electronic
format and on or off the recipient's premises for a period of 6
years. Donors or recipients may contract with one another or a
third party to create or maintain records on each other's
behalf. An identifier, such as a serial number or bar code, may
be used in place of any or all information required by a record
or label pursuant to this Act if it allows for such information
to be readily retrievable. Upon request by a State or federal
regulatory agency, the identifier used for requested records
shall be replaced with the original information. An identifier
shall not be used on patient labels when dispensing or
administering a drug.
Section 60. Authority. This Act supersedes any
inconsistent law or rule for activities conducted under this
Act.
Section 65. Immunity.
(a) Except as provided in subsection (b), no manufacturer,
donor, or recipient shall be liable in any criminal or civil
action, or be subject to professional discipline, for
activities solely and directly attributable to donating,
receiving, or dispensing drugs under this Act.
(b) The immunity provided in subsection (a) shall not
apply:
(1) if it is shown that the act or omission was an
unreasonable, willful, wanton, or reckless act;
(2) if it is shown that the person or entity knew or
should have known that the donated drug was adulterated or
misbranded; or
(3) to acts or omissions outside the scope of a
program under this Act.
Section 90. The Pharmacy Practice Act is amended by
changing Section 4 as follows:
(225 ILCS 85/4) (from Ch. 111, par. 4124)
(Section scheduled to be repealed on January 1, 2023)
Sec. 4. Exemptions. Nothing contained in any Section of
this Act shall apply to, or in any manner interfere with:
(a) the lawful practice of any physician licensed to
practice medicine in all of its branches, dentist,
podiatric physician, veterinarian, or therapeutically or
diagnostically certified optometrist within the limits of
his or her license, or prevent him or her from supplying to
his or her bona fide patients such drugs, medicines, or
poisons as may seem to him appropriate;
(b) the sale of compressed gases;
(c) the sale of patent or proprietary medicines and
household remedies when sold in original and unbroken
packages only, if such patent or proprietary medicines and
household remedies be properly and adequately labeled as
to content and usage and generally considered and accepted
as harmless and nonpoisonous when used according to the
directions on the label, and also do not contain opium or
coca leaves, or any compound, salt or derivative thereof,
or any drug which, according to the latest editions of the
following authoritative pharmaceutical treatises and
standards, namely, The United States
Pharmacopoeia/National Formulary (USP/NF), the United
States Dispensatory, and the Accepted Dental Remedies of
the Council of Dental Therapeutics of the American Dental
Association or any or either of them, in use on the
effective date of this Act, or according to the existing
provisions of the Federal Food, Drug, and Cosmetic Act and
Regulations of the Department of Health and Human
Services, Food and Drug Administration, promulgated
thereunder now in effect, is designated, described or
considered as a narcotic, hypnotic, habit forming,
dangerous, or poisonous drug;
(d) the sale of poultry and livestock remedies in
original and unbroken packages only, labeled for poultry
and livestock medication;
(e) the sale of poisonous substances or mixture of
poisonous substances, in unbroken packages, for
nonmedicinal use in the arts or industries or for
insecticide purposes; provided, they are properly and
adequately labeled as to content and such nonmedicinal
usage, in conformity with the provisions of all applicable
federal, state and local laws and regulations promulgated
thereunder now in effect relating thereto and governing
the same, and those which are required under such
applicable laws and regulations to be labeled with the
word "Poison", are also labeled with the word "Poison"
printed thereon in prominent type and the name of a
readily obtainable antidote with directions for its
administration;
(f) the delegation of limited prescriptive authority
by a physician licensed to practice medicine in all its
branches to a physician assistant under Section 7.5 of the
Physician Assistant Practice Act of 1987. This delegated
authority under Section 7.5 of the Physician Assistant
Practice Act of 1987 may, but is not required to, include
prescription of controlled substances, as defined in
Article II of the Illinois Controlled Substances Act, in
accordance with a written supervision agreement;
(g) the delegation of prescriptive authority by a
physician licensed to practice medicine in all its
branches or a licensed podiatric physician to an advanced
practice registered nurse in accordance with a written
collaborative agreement under Sections 65-35 and 65-40 of
the Nurse Practice Act; and
(g-5) the donation or acceptance, or the packaging,
repackaging, or labeling, of drugs to the extent permitted
under the Illinois Drug Reuse Opportunity Program Act; and
(h) the sale or distribution of dialysate or devices
necessary to perform home peritoneal renal dialysis for
patients with end-stage renal disease, provided that all
of the following conditions are met:
(1) the dialysate, comprised of dextrose or
icodextrin, or devices are approved or cleared by the
federal Food and Drug Administration, as required by
federal law;
(2) the dialysate or devices are lawfully held by
a manufacturer or the manufacturer's agent, which is
properly registered with the Board as a manufacturer,
third-party logistics provider, or wholesaler;
(3) the dialysate or devices are held and
delivered to the manufacturer or the manufacturer's
agent in the original, sealed packaging from the
manufacturing facility;
(4) the dialysate or devices are delivered only
upon receipt of a physician's prescription by a
licensed pharmacy in which the prescription is
processed in accordance with provisions set forth in
this Act, and the transmittal of an order from the
licensed pharmacy to the manufacturer or the
manufacturer's agent; and
(5) the manufacturer or the manufacturer's agent
delivers the dialysate or devices directly to: (i) a
patient with end-stage renal disease, or his or her
designee, for the patient's self-administration of the
dialysis therapy or (ii) a health care provider or
institution for administration or delivery of the
dialysis therapy to a patient with end-stage renal
disease.
This paragraph (h) does not include any other drugs
for peritoneal dialysis, except dialysate, as described in
item (1) of this paragraph (h). All records of sales and
distribution of dialysate to patients made pursuant to
this paragraph (h) must be retained in accordance with
Section 18 of this Act.
(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
100-863, eff. 8-14-18; 101-420, eff. 8-16-19.)
Section 95. The Wholesale Drug Distribution Licensing Act
is amended by changing Section 15 as follows:
(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
(Section scheduled to be repealed on January 1, 2023)
Sec. 15. Definitions. As used in this Act:
"Authentication" means the affirmative verification,
before any wholesale distribution of a prescription drug
occurs, that each transaction listed on the pedigree has
occurred.
"Authorized distributor of record" means a wholesale
distributor with whom a manufacturer has established an
ongoing relationship to distribute the manufacturer's
prescription drug. An ongoing relationship is deemed to exist
between a wholesale distributor and a manufacturer when the
wholesale distributor, including any affiliated group of the
wholesale distributor, as defined in Section 1504 of the
Internal Revenue Code, complies with the following:
(1) The wholesale distributor has a written agreement
currently in effect with the manufacturer evidencing the
ongoing relationship; and
(2) The wholesale distributor is listed on the
manufacturer's current list of authorized distributors of
record, which is updated by the manufacturer on no less
than a monthly basis.
"Blood" means whole blood collected from a single donor
and processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by
physical or mechanical means.
"Board" means the State Board of Pharmacy of the
Department of Professional Regulation.
"Chain pharmacy warehouse" means a physical location for
prescription drugs that acts as a central warehouse and
performs intracompany sales or transfers of the drugs to a
group of chain or mail order pharmacies that have the same
common ownership and control. Notwithstanding any other
provision of this Act, a chain pharmacy warehouse shall be
considered part of the normal distribution channel.
"Co-licensed partner or product" means an instance where
one or more parties have the right to engage in the
manufacturing or marketing of a prescription drug, consistent
with the FDA's implementation of the Prescription Drug
Marketing Act.
"Department" means the Department of Financial and
Professional Regulation.
"Drop shipment" means the sale of a prescription drug to a
wholesale distributor by the manufacturer of the prescription
drug or that manufacturer's co-licensed product partner, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or by an authorized
distributor of record that purchased the product directly from
the manufacturer or one of these entities whereby the
wholesale distributor or chain pharmacy warehouse takes title
but not physical possession of such prescription drug and the
wholesale distributor invoices the pharmacy, chain pharmacy
warehouse, or other person authorized by law to dispense or
administer such drug to a patient and the pharmacy, chain
pharmacy warehouse, or other authorized person receives
delivery of the prescription drug directly from the
manufacturer, that manufacturer's third party logistics
provider, or that manufacturer's exclusive distributor or from
an authorized distributor of record that purchased the product
directly from the manufacturer or one of these entities.
"Drug sample" means a unit of a prescription drug that is
not intended to be sold and is intended to promote the sale of
the drug.
"Facility" means a facility of a wholesale distributor
where prescription drugs are stored, handled, repackaged, or
offered for sale, or a facility of a third-party logistics
provider where prescription drugs are stored or handled.
"FDA" means the United States Food and Drug
Administration.
"Manufacturer" means a person licensed or approved by the
FDA to engage in the manufacture of drugs or devices,
consistent with the definition of "manufacturer" set forth in
the FDA's regulations and guidances implementing the
Prescription Drug Marketing Act. "Manufacturer" does not
include anyone who is engaged in the packaging, repackaging,
or labeling of drugs only to the extent permitted under the
Illinois Drug Reuse Opportunity Program Act.
"Manufacturer's exclusive distributor" means anyone who
contracts with a manufacturer to provide or coordinate
warehousing, distribution, or other services on behalf of a
manufacturer and who takes title to that manufacturer's
prescription drug, but who does not have general
responsibility to direct the sale or disposition of the
manufacturer's prescription drug. A manufacturer's exclusive
distributor must be licensed as a wholesale distributor under
this Act and, in order to be considered part of the normal
distribution channel, must also be an authorized distributor
of record.
"Normal distribution channel" means a chain of custody for
a prescription drug that goes, directly or by drop shipment,
from (i) a manufacturer of the prescription drug, (ii) that
manufacturer to that manufacturer's co-licensed partner, (iii)
that manufacturer to that manufacturer's third party logistics
provider, or (iv) that manufacturer to that manufacturer's
exclusive distributor to:
(1) a pharmacy or to other designated persons
authorized by law to dispense or administer the drug to a
patient;
(2) a wholesale distributor to a pharmacy or other
designated persons authorized by law to dispense or
administer the drug to a patient;
(3) a wholesale distributor to a chain pharmacy
warehouse to that chain pharmacy warehouse's intracompany
pharmacy to a patient or other designated persons
authorized by law to dispense or administer the drug to a
patient;
(4) a chain pharmacy warehouse to the chain pharmacy
warehouse's intracompany pharmacy or other designated
persons authorized by law to dispense or administer the
drug to the patient;
(5) an authorized distributor of record to one other
authorized distributor of record to an office-based health
care practitioner authorized by law to dispense or
administer the drug to the patient; or
(6) an authorized distributor to a pharmacy or other
persons licensed to dispense or administer the drug.
"Pedigree" means a document or electronic file containing
information that records each wholesale distribution of any
given prescription drug from the point of origin to the final
wholesale distribution point of any given prescription drug.
"Person" means and includes a natural person, partnership,
association, corporation, or any other legal business entity.
"Pharmacy distributor" means any pharmacy licensed in this
State or hospital pharmacy that is engaged in the delivery or
distribution of prescription drugs either to any other
pharmacy licensed in this State or to any other person or
entity including, but not limited to, a wholesale drug
distributor engaged in the delivery or distribution of
prescription drugs who is involved in the actual,
constructive, or attempted transfer of a drug in this State to
other than the ultimate consumer except as otherwise provided
for by law.
"Prescription drug" means any human drug, including any
biological product (except for blood and blood components
intended for transfusion or biological products that are also
medical devices), required by federal law or regulation to be
dispensed only by a prescription, including finished dosage
forms and bulk drug substances subject to Section 503 of the
Federal Food, Drug and Cosmetic Act.
"Repackage" means repackaging or otherwise changing the
container, wrapper, or labeling to further the distribution of
a prescription drug, excluding that completed by the
pharmacist responsible for dispensing the product to a
patient.
"Secretary" means the Secretary of Financial and
Professional Regulation.
"Third-party logistics provider" means anyone who
contracts with a prescription drug manufacturer to provide or
coordinate warehousing, distribution, or other services on
behalf of a manufacturer, but does not take title to the
prescription drug or have general responsibility to direct the
prescription drug's sale or disposition.
"Wholesale distribution" means the distribution of
prescription drugs to persons other than a consumer or
patient, but does not include any of the following:
(1) Intracompany sales of prescription drugs, meaning
(i) any transaction or transfer between any division,
subsidiary, parent, or affiliated or related company under
the common ownership and control of a corporate entity or
(ii) any transaction or transfer between co-licensees of a
co-licensed product.
(2) The sale, purchase, distribution, trade, or
transfer of a prescription drug or offer to sell,
purchase, distribute, trade, or transfer a prescription
drug for emergency medical reasons.
(3) The distribution of prescription drug samples by
manufacturers' representatives.
(4) Drug returns, when conducted by a hospital, health
care entity, or charitable institution in accordance with
federal regulation.
(5) The sale of minimal quantities of prescription
drugs by licensed pharmacies to licensed practitioners for
office use or other licensed pharmacies.
(6) The sale, purchase, or trade of a drug, an offer to
sell, purchase, or trade a drug, or the dispensing of a
drug pursuant to a prescription.
(7) The sale, transfer, merger, or consolidation of
all or part of the business of a pharmacy or pharmacies
from or with another pharmacy or pharmacies, whether
accomplished as a purchase and sale of stock or business
assets.
(8) The sale, purchase, distribution, trade, or
transfer of a prescription drug from one authorized
distributor of record to one additional authorized
distributor of record when the manufacturer has stated in
writing to the receiving authorized distributor of record
that the manufacturer is unable to supply the prescription
drug and the supplying authorized distributor of record
states in writing that the prescription drug being
supplied had until that time been exclusively in the
normal distribution channel.
(9) The delivery of or the offer to deliver a
prescription drug by a common carrier solely in the common
carrier's usual course of business of transporting
prescription drugs when the common carrier does not store,
warehouse, or take legal ownership of the prescription
drug.
(10) The sale or transfer from a retail pharmacy, mail
order pharmacy, or chain pharmacy warehouse of expired,
damaged, returned, or recalled prescription drugs to the
original manufacturer, the originating wholesale
distributor, or a third party returns processor.
(11) The donation of drugs to the extent permitted
under the Illinois Drug Reuse Opportunity Program Act.
"Wholesale drug distributor" means anyone engaged in the
wholesale distribution of prescription drugs into, out of, or
within the State, including without limitation manufacturers;
repackers; own label distributors; jobbers; private label
distributors; brokers; warehouses, including manufacturers'
and distributors' warehouses; manufacturer's exclusive
distributors; and authorized distributors of record; drug
wholesalers or distributors; independent wholesale drug
traders; specialty wholesale distributors; and retail
pharmacies that conduct wholesale distribution; and chain
pharmacy warehouses that conduct wholesale distribution. In
order to be considered part of the normal distribution
channel, a wholesale distributor must also be an authorized
distributor of record.
(Source: P.A. 101-420, eff. 8-16-19.)
Section 100. The Senior Pharmaceutical Assistance Act is
amended by changing Section 10 as follows:
(320 ILCS 50/10)
Sec. 10. Definitions. In this Act:
"Manufacturer" includes:
(1) An entity that is engaged in (a) the production,
preparation, propagation, compounding, conversion, or
processing of prescription drug products (i) directly or
indirectly by extraction from substances of natural
origin, (ii) independently by means of chemical synthesis,
or (iii) by combination of extraction and chemical
synthesis; or (b) the packaging, repackaging, labeling or
re-labeling, or distribution of prescription drug
products.
(2) The entity holding legal title to or possession of
the national drug code number for the covered prescription
drug.
The term does not include a wholesale distributor of
drugs, drugstore chain organization, or retail pharmacy
licensed by the State. The term also does not include anyone
who is engaged in the packaging, repackaging, or labeling of
drugs only to the extent permitted under the Illinois Drug
Reuse Opportunity Program Act.
"Prescription drug" means a drug that may be dispensed
only upon prescription by an authorized prescriber and that is
approved for safety and effectiveness as a prescription drug
under Section 505 or 507 of the Federal Food, Drug and Cosmetic
Act.
"Senior citizen" or "senior" means a person 65 years of
age or older.
(Source: P.A. 92-594, eff. 6-27-02.)
Section 105. The Illinois Food, Drug and Cosmetic Act is
amended by changing Section 16 as follows:
(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
Sec. 16. (a) The Director is hereby authorized to
promulgate regulations exempting from any labeling or
packaging requirement of this Act drugs and devices which are
(i) , in accordance with the practice of the trade, to be
processed, labeled or repacked in substantial quantities at
establishments other than those where originally processed or
packaged on condition that such drugs and devices are not
adulterated or misbranded under the provisions of this Act
upon removal from such processing, labeling or repacking
establishment or (ii) packaged, repackaged, or labeled to the
extent permitted under the Illinois Drug Reuse Opportunity
Program Act.
(b) Drugs and device labeling or packaging exemptions
adopted under the Federal Act and supplements thereto or
revisions thereof shall apply to drugs and devices in Illinois
except insofar as modified or rejected by regulations
promulgated by the Director.
(c) A drug intended for use by man which (A) is a
habit-forming drug to which Section 15 (d) applies; or (B)
because of its toxicity or other potentiality for harmful
effect or the method of its use or the collateral measures
necessary to its use is not safe for use except under the
supervision of a practitioner licensed by law to administer
such drug; or (C) is limited by an approved application under
Section 505 of the Federal Act or Section 17 of this Act to use
under the professional supervision of a practitioner licensed
by law to administer such drug, shall be dispensed only in
accordance with the provisions of the "Illinois Controlled
Substances Act". The act of dispensing a drug contrary to the
provisions of this paragraph shall be deemed to be an act which
results in a drug being misbranded while held for sale.
(d) Any drug dispensed by filling or refilling a written
or oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of
Section 15, except subsections (a), (k) and (l) and clauses
(2) and (3) of subsection (i), and the packaging requirements
of subsections (g), (h) and (q), if the drug bears a label
containing the proprietary name or names, or if there is none,
the established name or names of the drugs, the dosage and
quantity, unless the prescribing practitioner, in the interest
of the health of the patient, directs otherwise in writing,
the name and address of the dispenser, the serial number and
date of the prescription or of its filling, the name of the
prescriber and, if stated in the prescription, the name of the
patient, and the directions for use and the cautionary
statements, if any, contained in such prescription. This
exemption shall not apply to any drug dispensed in the course
of the conduct of business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of
subsection (a) of this Section.
(e) The Director may by regulation remove drugs subject to
Section 15 (d) and Section 17 from the requirements of
subsection (c) of this Section when such requirements are not
necessary for the protection of the public health.
(f) A drug which is subject to subsection (c) of this
Section shall be deemed to be misbranded if at any time before
dispensing its label fails to bear the statement "Caution:
Federal Law Prohibits Dispensing Without Prescription" or
"Caution: State Law Prohibits Dispensing Without
Prescription". A drug to which subsection (c) of this Section
does not apply shall be deemed to be misbranded if at any time
prior to dispensing its label bears the caution statement
quoted in the preceding sentence.
(g) Nothing in this Section shall be construed to relieve
any person from any requirement prescribed by or under
authority of law with respect to controlled substances now
included or which may hereafter be included within the
classifications of controlled substances cannabis as defined
in applicable Federal laws relating to controlled substances
or cannabis or the Cannabis Control Act.
(Source: P.A. 84-1308.)
Section 110. The Illinois Controlled Substances Act is
amended by changing Section 102 as follows:
(720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
Sec. 102. Definitions. As used in this Act, unless the
context otherwise requires:
(a) "Addict" means any person who habitually uses any
drug, chemical, substance or dangerous drug other than alcohol
so as to endanger the public morals, health, safety or welfare
or who is so far addicted to the use of a dangerous drug or
controlled substance other than alcohol as to have lost the
power of self control with reference to his or her addiction.
(b) "Administer" means the direct application of a
controlled substance, whether by injection, inhalation,
ingestion, or any other means, to the body of a patient,
research subject, or animal (as defined by the Humane
Euthanasia in Animal Shelters Act) by:
(1) a practitioner (or, in his or her presence, by his
or her authorized agent),
(2) the patient or research subject pursuant to an
order, or
(3) a euthanasia technician as defined by the Humane
Euthanasia in Animal Shelters Act.
(c) "Agent" means an authorized person who acts on behalf
of or at the direction of a manufacturer, distributor,
dispenser, prescriber, or practitioner. It does not include a
common or contract carrier, public warehouseman or employee of
the carrier or warehouseman.
(c-1) "Anabolic Steroids" means any drug or hormonal
substance, chemically and pharmacologically related to
testosterone (other than estrogens, progestins,
corticosteroids, and dehydroepiandrosterone), and includes:
(i) 3[beta],17-dihydroxy-5a-androstane,
(ii) 3[alpha],17[beta]-dihydroxy-5a-androstane,
(iii) 5[alpha]-androstan-3,17-dione,
(iv) 1-androstenediol (3[beta],
17[beta]-dihydroxy-5[alpha]-androst-1-ene),
(v) 1-androstenediol (3[alpha],
17[beta]-dihydroxy-5[alpha]-androst-1-ene),
(vi) 4-androstenediol
(3[beta],17[beta]-dihydroxy-androst-4-ene),
(vii) 5-androstenediol
(3[beta],17[beta]-dihydroxy-androst-5-ene),
(viii) 1-androstenedione
([5alpha]-androst-1-en-3,17-dione),
(ix) 4-androstenedione
(androst-4-en-3,17-dione),
(x) 5-androstenedione
(androst-5-en-3,17-dione),
(xi) bolasterone (7[alpha],17a-dimethyl-17[beta]-
hydroxyandrost-4-en-3-one),
(xii) boldenone (17[beta]-hydroxyandrost-
1,4,-diene-3-one),
(xiii) boldione (androsta-1,4-
diene-3,17-dione),
(xiv) calusterone (7[beta],17[alpha]-dimethyl-17
[beta]-hydroxyandrost-4-en-3-one),
(xv) clostebol (4-chloro-17[beta]-
hydroxyandrost-4-en-3-one),
(xvi) dehydrochloromethyltestosterone (4-chloro-
17[beta]-hydroxy-17[alpha]-methyl-
androst-1,4-dien-3-one),
(xvii) desoxymethyltestosterone
(17[alpha]-methyl-5[alpha]
-androst-2-en-17[beta]-ol)(a.k.a., madol),
(xviii) [delta]1-dihydrotestosterone (a.k.a.
'1-testosterone') (17[beta]-hydroxy-
5[alpha]-androst-1-en-3-one),
(xix) 4-dihydrotestosterone (17[beta]-hydroxy-
androstan-3-one),
(xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl-
5[alpha]-androstan-3-one),
(xxi) ethylestrenol (17[alpha]-ethyl-17[beta]-
hydroxyestr-4-ene),
(xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl-
1[beta],17[beta]-dihydroxyandrost-4-en-3-one),
(xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha],
17[beta]-dihydroxyandrost-1,4-dien-3-one),
(xxiv) furazabol (17[alpha]-methyl-17[beta]-
hydroxyandrostano[2,3-c]-furazan),
(xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one,
(xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy-
androst-4-en-3-one),
(xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]-
dihydroxy-estr-4-en-3-one),
(xxviii) mestanolone (17[alpha]-methyl-17[beta]-
hydroxy-5-androstan-3-one),
(xxix) mesterolone (1amethyl-17[beta]-hydroxy-
[5a]-androstan-3-one),
(xxx) methandienone (17[alpha]-methyl-17[beta]-
hydroxyandrost-1,4-dien-3-one),
(xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]-
dihydroxyandrost-5-ene),
(xxxii) methenolone (1-methyl-17[beta]-hydroxy-
5[alpha]-androst-1-en-3-one),
(xxxiii) 17[alpha]-methyl-3[beta], 17[beta]-
dihydroxy-5a-androstane,
(xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy
-5a-androstane,
(xxxv) 17[alpha]-methyl-3[beta],17[beta]-
dihydroxyandrost-4-ene),
(xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]-
methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one),
(xxxvii) methyldienolone (17[alpha]-methyl-17[beta]-
hydroxyestra-4,9(10)-dien-3-one),
(xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]-
hydroxyestra-4,9-11-trien-3-one),
(xxxix) methyltestosterone (17[alpha]-methyl-17[beta]-
hydroxyandrost-4-en-3-one),
(xl) mibolerone (7[alpha],17a-dimethyl-17[beta]-
hydroxyestr-4-en-3-one),
(xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone
(17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]-
androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl-
1-testosterone'),
(xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one),
(xliii) 19-nor-4-androstenediol (3[beta], 17[beta]-
dihydroxyestr-4-ene),
(xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]-
dihydroxyestr-4-ene),
(xlv) 19-nor-5-androstenediol (3[beta], 17[beta]-
dihydroxyestr-5-ene),
(xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]-
dihydroxyestr-5-ene),
(xlvii) 19-nor-4,9(10)-androstadienedione
(estra-4,9(10)-diene-3,17-dione),
(xlviii) 19-nor-4-androstenedione (estr-4-
en-3,17-dione),
(xlix) 19-nor-5-androstenedione (estr-5-
en-3,17-dione),
(l) norbolethone (13[beta], 17a-diethyl-17[beta]-
hydroxygon-4-en-3-one),
(li) norclostebol (4-chloro-17[beta]-
hydroxyestr-4-en-3-one),
(lii) norethandrolone (17[alpha]-ethyl-17[beta]-
hydroxyestr-4-en-3-one),
(liii) normethandrolone (17[alpha]-methyl-17[beta]-
hydroxyestr-4-en-3-one),
(liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy-
2-oxa-5[alpha]-androstan-3-one),
(lv) oxymesterone (17[alpha]-methyl-4,17[beta]-
dihydroxyandrost-4-en-3-one),
(lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene-
17[beta]-hydroxy-(5[alpha]-androstan-3-one),
(lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy-
(5[alpha]-androst-2-eno[3,2-c]-pyrazole),
(lviii) stenbolone (17[beta]-hydroxy-2-methyl-
(5[alpha]-androst-1-en-3-one),
(lix) testolactone (13-hydroxy-3-oxo-13,17-
secoandrosta-1,4-dien-17-oic
acid lactone),
(lx) testosterone (17[beta]-hydroxyandrost-
4-en-3-one),
(lxi) tetrahydrogestrinone (13[beta], 17[alpha]-
diethyl-17[beta]-hydroxygon-
4,9,11-trien-3-one),
(lxii) trenbolone (17[beta]-hydroxyestr-4,9,
11-trien-3-one).
Any person who is otherwise lawfully in possession of an
anabolic steroid, or who otherwise lawfully manufactures,
distributes, dispenses, delivers, or possesses with intent to
deliver an anabolic steroid, which anabolic steroid is
expressly intended for and lawfully allowed to be administered
through implants to livestock or other nonhuman species, and
which is approved by the Secretary of Health and Human
Services for such administration, and which the person intends
to administer or have administered through such implants,
shall not be considered to be in unauthorized possession or to
unlawfully manufacture, distribute, dispense, deliver, or
possess with intent to deliver such anabolic steroid for
purposes of this Act.
(d) "Administration" means the Drug Enforcement
Administration, United States Department of Justice, or its
successor agency.
(d-5) "Clinical Director, Prescription Monitoring Program"
means a Department of Human Services administrative employee
licensed to either prescribe or dispense controlled substances
who shall run the clinical aspects of the Department of Human
Services Prescription Monitoring Program and its Prescription
Information Library.
(d-10) "Compounding" means the preparation and mixing of
components, excluding flavorings, (1) as the result of a
prescriber's prescription drug order or initiative based on
the prescriber-patient-pharmacist relationship in the course
of professional practice or (2) for the purpose of, or
incident to, research, teaching, or chemical analysis and not
for sale or dispensing. "Compounding" includes the preparation
of drugs or devices in anticipation of receiving prescription
drug orders based on routine, regularly observed dispensing
patterns. Commercially available products may be compounded
for dispensing to individual patients only if both of the
following conditions are met: (i) the commercial product is
not reasonably available from normal distribution channels in
a timely manner to meet the patient's needs and (ii) the
prescribing practitioner has requested that the drug be
compounded.
(e) "Control" means to add a drug or other substance, or
immediate precursor, to a Schedule whether by transfer from
another Schedule or otherwise.
(f) "Controlled Substance" means (i) a drug, substance,
immediate precursor, or synthetic drug in the Schedules of
Article II of this Act or (ii) a drug or other substance, or
immediate precursor, designated as a controlled substance by
the Department through administrative rule. The term does not
include distilled spirits, wine, malt beverages, or tobacco,
as those terms are defined or used in the Liquor Control Act of
1934 and the Tobacco Products Tax Act of 1995.
(f-5) "Controlled substance analog" means a substance:
(1) the chemical structure of which is substantially
similar to the chemical structure of a controlled
substance in Schedule I or II;
(2) which has a stimulant, depressant, or
hallucinogenic effect on the central nervous system that
is substantially similar to or greater than the stimulant,
depressant, or hallucinogenic effect on the central
nervous system of a controlled substance in Schedule I or
II; or
(3) with respect to a particular person, which such
person represents or intends to have a stimulant,
depressant, or hallucinogenic effect on the central
nervous system that is substantially similar to or greater
than the stimulant, depressant, or hallucinogenic effect
on the central nervous system of a controlled substance in
Schedule I or II.
(g) "Counterfeit substance" means a controlled substance,
which, or the container or labeling of which, without
authorization bears the trademark, trade name, or other
identifying mark, imprint, number or device, or any likeness
thereof, of a manufacturer, distributor, or dispenser other
than the person who in fact manufactured, distributed, or
dispensed the substance.
(h) "Deliver" or "delivery" means the actual, constructive
or attempted transfer of possession of a controlled substance,
with or without consideration, whether or not there is an
agency relationship. "Deliver" or "delivery" does not include
the donation of drugs to the extent permitted under the
Illinois Drug Reuse Opportunity Program Act.
(i) "Department" means the Illinois Department of Human
Services (as successor to the Department of Alcoholism and
Substance Abuse) or its successor agency.
(j) (Blank).
(k) "Department of Corrections" means the Department of
Corrections of the State of Illinois or its successor agency.
(l) "Department of Financial and Professional Regulation"
means the Department of Financial and Professional Regulation
of the State of Illinois or its successor agency.
(m) "Depressant" means any drug that (i) causes an overall
depression of central nervous system functions, (ii) causes
impaired consciousness and awareness, and (iii) can be
habit-forming or lead to a substance abuse problem, including
but not limited to alcohol, cannabis and its active principles
and their analogs, benzodiazepines and their analogs,
barbiturates and their analogs, opioids (natural and
synthetic) and their analogs, and chloral hydrate and similar
sedative hypnotics.
(n) (Blank).
(o) "Director" means the Director of the Illinois State
Police or his or her designated agents.
(p) "Dispense" means to deliver a controlled substance to
an ultimate user or research subject by or pursuant to the
lawful order of a prescriber, including the prescribing,
administering, packaging, labeling, or compounding necessary
to prepare the substance for that delivery.
(q) "Dispenser" means a practitioner who dispenses.
(r) "Distribute" means to deliver, other than by
administering or dispensing, a controlled substance.
(s) "Distributor" means a person who distributes.
(t) "Drug" means (1) substances recognized as drugs in the
official United States Pharmacopoeia, Official Homeopathic
Pharmacopoeia of the United States, or official National
Formulary, or any supplement to any of them; (2) substances
intended for use in diagnosis, cure, mitigation, treatment, or
prevention of disease in man or animals; (3) substances (other
than food) intended to affect the structure of any function of
the body of man or animals and (4) substances intended for use
as a component of any article specified in clause (1), (2), or
(3) of this subsection. It does not include devices or their
components, parts, or accessories.
(t-3) "Electronic health record" or "EHR" means an
electronic record of health-related information on an
individual that is created, gathered, managed, and consulted
by authorized health care clinicians and staff.
(t-4) "Emergency medical services personnel" has the
meaning ascribed to it in the Emergency Medical Services (EMS)
Systems Act.
(t-5) "Euthanasia agency" means an entity certified by the
Department of Financial and Professional Regulation for the
purpose of animal euthanasia that holds an animal control
facility license or animal shelter license under the Animal
Welfare Act. A euthanasia agency is authorized to purchase,
store, possess, and utilize Schedule II nonnarcotic and
Schedule III nonnarcotic drugs for the sole purpose of animal
euthanasia.
(t-10) "Euthanasia drugs" means Schedule II or Schedule
III substances (nonnarcotic controlled substances) that are
used by a euthanasia agency for the purpose of animal
euthanasia.
(u) "Good faith" means the prescribing or dispensing of a
controlled substance by a practitioner in the regular course
of professional treatment to or for any person who is under his
or her treatment for a pathology or condition other than that
individual's physical or psychological dependence upon or
addiction to a controlled substance, except as provided
herein: and application of the term to a pharmacist shall mean
the dispensing of a controlled substance pursuant to the
prescriber's order which in the professional judgment of the
pharmacist is lawful. The pharmacist shall be guided by
accepted professional standards including, but not limited to
the following, in making the judgment:
(1) lack of consistency of prescriber-patient
relationship,
(2) frequency of prescriptions for same drug by one
prescriber for large numbers of patients,
(3) quantities beyond those normally prescribed,
(4) unusual dosages (recognizing that there may be
clinical circumstances where more or less than the usual
dose may be used legitimately),
(5) unusual geographic distances between patient,
pharmacist and prescriber,
(6) consistent prescribing of habit-forming drugs.
(u-0.5) "Hallucinogen" means a drug that causes markedly
altered sensory perception leading to hallucinations of any
type.
(u-1) "Home infusion services" means services provided by
a pharmacy in compounding solutions for direct administration
to a patient in a private residence, long-term care facility,
or hospice setting by means of parenteral, intravenous,
intramuscular, subcutaneous, or intraspinal infusion.
(u-5) "Illinois State Police" means the State Police of
the State of Illinois, or its successor agency.
(v) "Immediate precursor" means a substance:
(1) which the Department has found to be and by rule
designated as being a principal compound used, or produced
primarily for use, in the manufacture of a controlled
substance;
(2) which is an immediate chemical intermediary used
or likely to be used in the manufacture of such controlled
substance; and
(3) the control of which is necessary to prevent,
curtail or limit the manufacture of such controlled
substance.
(w) "Instructional activities" means the acts of teaching,
educating or instructing by practitioners using controlled
substances within educational facilities approved by the State
Board of Education or its successor agency.
(x) "Local authorities" means a duly organized State,
County or Municipal peace unit or police force.
(y) "Look-alike substance" means a substance, other than a
controlled substance which (1) by overall dosage unit
appearance, including shape, color, size, markings or lack
thereof, taste, consistency, or any other identifying physical
characteristic of the substance, would lead a reasonable
person to believe that the substance is a controlled
substance, or (2) is expressly or impliedly represented to be
a controlled substance or is distributed under circumstances
which would lead a reasonable person to believe that the
substance is a controlled substance. For the purpose of
determining whether the representations made or the
circumstances of the distribution would lead a reasonable
person to believe the substance to be a controlled substance
under this clause (2) of subsection (y), the court or other
authority may consider the following factors in addition to
any other factor that may be relevant:
(a) statements made by the owner or person in control
of the substance concerning its nature, use or effect;
(b) statements made to the buyer or recipient that the
substance may be resold for profit;
(c) whether the substance is packaged in a manner
normally used for the illegal distribution of controlled
substances;
(d) whether the distribution or attempted distribution
included an exchange of or demand for money or other
property as consideration, and whether the amount of the
consideration was substantially greater than the
reasonable retail market value of the substance.
Clause (1) of this subsection (y) shall not apply to a
noncontrolled substance in its finished dosage form that was
initially introduced into commerce prior to the initial
introduction into commerce of a controlled substance in its
finished dosage form which it may substantially resemble.
Nothing in this subsection (y) prohibits the dispensing or
distributing of noncontrolled substances by persons authorized
to dispense and distribute controlled substances under this
Act, provided that such action would be deemed to be carried
out in good faith under subsection (u) if the substances
involved were controlled substances.
Nothing in this subsection (y) or in this Act prohibits
the manufacture, preparation, propagation, compounding,
processing, packaging, advertising or distribution of a drug
or drugs by any person registered pursuant to Section 510 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
(y-1) "Mail-order pharmacy" means a pharmacy that is
located in a state of the United States that delivers,
dispenses or distributes, through the United States Postal
Service or other common carrier, to Illinois residents, any
substance which requires a prescription.
(z) "Manufacture" means the production, preparation,
propagation, compounding, conversion or processing of a
controlled substance other than methamphetamine, either
directly or indirectly, by extraction from substances of
natural origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis, and includes any packaging or repackaging of the
substance or labeling of its container, except that this term
does not include:
(1) by an ultimate user, the preparation or
compounding of a controlled substance for his or her own
use; or
(2) by a practitioner, or his or her authorized agent
under his or her supervision, the preparation,
compounding, packaging, or labeling of a controlled
substance:
(a) as an incident to his or her administering or
dispensing of a controlled substance in the course of
his or her professional practice; or
(b) as an incident to lawful research, teaching or
chemical analysis and not for sale; or .
(3) the packaging, repackaging, or labeling of drugs
only to the extent permitted under the Illinois Drug Reuse
Opportunity Program Act.
(z-1) (Blank).
(z-5) "Medication shopping" means the conduct prohibited
under subsection (a) of Section 314.5 of this Act.
(z-10) "Mid-level practitioner" means (i) 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, (ii) 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, (iii) 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, (iv) an animal euthanasia agency, or
(v) a prescribing psychologist.
(aa) "Narcotic drug" means any of the following, whether
produced directly or indirectly by extraction from substances
of vegetable origin, or independently by means of chemical
synthesis, or by a combination of extraction and chemical
synthesis:
(1) opium, opiates, derivatives of opium and opiates,
including their isomers, esters, ethers, salts, and salts
of isomers, esters, and ethers, whenever the existence of
such isomers, esters, ethers, and salts is possible within
the specific chemical designation; however the term
"narcotic drug" does not include the isoquinoline
alkaloids of opium;
(2) (blank);
(3) opium poppy and poppy straw;
(4) coca leaves, except coca leaves and extracts of
coca leaves from which substantially all of the cocaine
and ecgonine, and their isomers, derivatives and salts,
have been removed;
(5) cocaine, its salts, optical and geometric isomers,
and salts of isomers;
(6) ecgonine, its derivatives, their salts, isomers,
and salts of isomers;
(7) any compound, mixture, or preparation which
contains any quantity of any of the substances referred to
in subparagraphs (1) through (6).
(bb) "Nurse" means a registered nurse licensed under the
Nurse Practice Act.
(cc) (Blank).
(dd) "Opiate" means any substance having an addiction
forming or addiction sustaining liability similar to morphine
or being capable of conversion into a drug having addiction
forming or addiction sustaining liability.
(ee) "Opium poppy" means the plant of the species Papaver
somniferum L., except its seeds.
(ee-5) "Oral dosage" means a tablet, capsule, elixir, or
solution or other liquid form of medication intended for
administration by mouth, but the term does not include a form
of medication intended for buccal, sublingual, or transmucosal
administration.
(ff) "Parole and Pardon Board" means the Parole and Pardon
Board of the State of Illinois or its successor agency.
(gg) "Person" means any individual, corporation,
mail-order pharmacy, government or governmental subdivision or
agency, business trust, estate, trust, partnership or
association, or any other entity.
(hh) "Pharmacist" means any person who holds a license or
certificate of registration as a registered pharmacist, a
local registered pharmacist or a registered assistant
pharmacist under the Pharmacy Practice Act.
(ii) "Pharmacy" means any store, ship or other place in
which pharmacy is authorized to be practiced under the
Pharmacy Practice Act.
(ii-5) "Pharmacy shopping" means the conduct prohibited
under subsection (b) of Section 314.5 of this Act.
(ii-10) "Physician" (except when the context otherwise
requires) means a person licensed to practice medicine in all
of its branches.
(jj) "Poppy straw" means all parts, except the seeds, of
the opium poppy, after mowing.
(kk) "Practitioner" means a physician licensed to practice
medicine in all its branches, dentist, optometrist, podiatric
physician, veterinarian, scientific investigator, pharmacist,
physician assistant, advanced practice registered nurse,
licensed practical nurse, registered nurse, emergency medical
services personnel, hospital, laboratory, or pharmacy, or
other person licensed, registered, or otherwise lawfully
permitted by the United States or this State to distribute,
dispense, conduct research with respect to, administer or use
in teaching or chemical analysis, a controlled substance in
the course of professional practice or research.
(ll) "Pre-printed prescription" means a written
prescription upon which the designated drug has been indicated
prior to the time of issuance; the term does not mean a written
prescription that is individually generated by machine or
computer in the prescriber's office.
(mm) "Prescriber" means a physician licensed to practice
medicine in all its branches, dentist, optometrist,
prescribing psychologist licensed under Section 4.2 of the
Clinical Psychologist Licensing Act with prescriptive
authority delegated under Section 4.3 of the Clinical
Psychologist Licensing Act, podiatric physician, or
veterinarian who issues a prescription, a physician assistant
who issues a prescription for a controlled substance in
accordance with Section 303.05, a written delegation, and a
written collaborative agreement required under Section 7.5 of
the Physician Assistant Practice Act of 1987, an advanced
practice registered nurse with prescriptive authority
delegated under Section 65-40 of the Nurse Practice Act and in
accordance with Section 303.05, a written delegation, and a
written collaborative agreement under Section 65-35 of the
Nurse Practice Act, 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 and in accordance with Section 303.05,
or an advanced practice registered nurse certified as a nurse
practitioner, nurse midwife, or clinical nurse specialist who
has full practice authority pursuant to Section 65-43 of the
Nurse Practice Act.
(nn) "Prescription" means a written, facsimile, or oral
order, or an electronic order that complies with applicable
federal requirements, of a physician licensed to practice
medicine in all its branches, dentist, podiatric physician or
veterinarian for any controlled substance, of an optometrist
in accordance with Section 15.1 of the Illinois Optometric
Practice Act of 1987, of a prescribing psychologist licensed
under Section 4.2 of the Clinical Psychologist Licensing Act
with prescriptive authority delegated under Section 4.3 of the
Clinical Psychologist Licensing Act, of a physician assistant
for a controlled substance in accordance with Section 303.05,
a written delegation, and a written collaborative agreement
required under Section 7.5 of the Physician Assistant Practice
Act of 1987, of an advanced practice registered nurse with
prescriptive authority delegated under Section 65-40 of the
Nurse Practice Act who issues a prescription for a controlled
substance in accordance with Section 303.05, a written
delegation, and a written collaborative agreement under
Section 65-35 of the Nurse Practice Act, of 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 and in
accordance with Section 303.05 when required by law, or of an
advanced practice registered nurse certified as a nurse
practitioner, nurse midwife, or clinical nurse specialist who
has full practice authority pursuant to Section 65-43 of the
Nurse Practice Act.
(nn-5) "Prescription Information Library" (PIL) means an
electronic library that contains reported controlled substance
data.
(nn-10) "Prescription Monitoring Program" (PMP) means the
entity that collects, tracks, and stores reported data on
controlled substances and select drugs pursuant to Section
316.
(oo) "Production" or "produce" means manufacture,
planting, cultivating, growing, or harvesting of a controlled
substance other than methamphetamine.
(pp) "Registrant" means every person who is required to
register under Section 302 of this Act.
(qq) "Registry number" means the number assigned to each
person authorized to handle controlled substances under the
laws of the United States and of this State.
(qq-5) "Secretary" means, as the context requires, either
the Secretary of the Department or the Secretary of the
Department of Financial and Professional Regulation, and the
Secretary's designated agents.
(rr) "State" includes the State of Illinois and any state,
district, commonwealth, territory, insular possession thereof,
and any area subject to the legal authority of the United
States of America.
(rr-5) "Stimulant" means any drug that (i) causes an
overall excitation of central nervous system functions, (ii)
causes impaired consciousness and awareness, and (iii) can be
habit-forming or lead to a substance abuse problem, including
but not limited to amphetamines and their analogs,
methylphenidate and its analogs, cocaine, and phencyclidine
and its analogs.
(rr-10) "Synthetic drug" includes, but is not limited to,
any synthetic cannabinoids or piperazines or any synthetic
cathinones as provided for in Schedule I.
(ss) "Ultimate user" means a person who lawfully possesses
a controlled substance for his or her own use or for the use of
a member of his or her household or for administering to an
animal owned by him or her or by a member of his or her
household.
(Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15;
99-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff.
7-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513,
eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18.)
Section 115. The Cannabis and Controlled Substances Tort
Claims Act is amended by changing Section 3 as follows:
(740 ILCS 20/3) (from Ch. 70, par. 903)
Sec. 3. Definitions. As used in this Act, unless the
context otherwise requires:
"Cannabis" includes marihuana, hashish, and other
substances that are identified as including any parts of the
plant Cannabis Sativa, whether growing or not, the seeds of
that plant, the resin extracted from any part of that plant,
and any compound, manufacture, salt, derivative, mixture, or
preparation of that plant, its seeds, or resin, including
tetrahydrocannabinol (THC) and all other cannabinol
derivatives, including its naturally occurring or
synthetically produced ingredients, whether produced directly
or indirectly by extraction, independently by means of
chemical synthesis, or by a combination of extraction and
chemical synthesis. "Cannabis" does not include the mature
stalks of that plant, fiber produced from those stalks, oil or
cake made from the seeds of that plant, any other compound,
manufacture, salt, derivative, mixture, or preparation of
mature stalks (except the extracted resin), fiber, oil or
cake, or the sterilized seeds of that plant that are incapable
of germination.
"Controlled substance" means a drug, substance, or
immediate precursor in the Schedules of Article II of the
Illinois Controlled Substances Act.
"Counterfeit substance" means a controlled substance or
the container or labeling of a controlled substance that,
without authorization, bears the trademark, trade name, or
other identifying mark, imprint, number, device, or any
likeness thereof of a manufacturer, distributor, or dispenser
other than the person who in fact manufactured, distributed,
or dispensed the substance.
"Deliver" or "delivery" means the actual, constructive, or
attempted transfer of possession of a controlled substance or
cannabis, with or without consideration, whether or not there
is an agency relationship. "Deliver" or "delivery" does not
include the donation of drugs to the extent permitted under
the Illinois Drug Reuse Opportunity Program Act.
"Manufacture" means the production, preparation,
propagation, compounding, conversion, or processing of a
controlled substance, either directly or indirectly, by
extraction from substances of natural origin, independently by
means of chemical synthesis, or by a combination of extraction
and chemical synthesis, and includes any packaging or
repackaging of the substance or labeling of its container,
except that the term does not include:
(1) by an ultimate user, the preparation or
compounding of a controlled substance for his own use;
(2) by a practitioner or his authorized agent under
his supervision, the preparation, compounding, packaging,
or labeling of a controlled substance:
(A) as an incident to his administering or
dispensing of a controlled substance in the course of
his professional practice; or
(B) as an incident to lawful research, teaching or
chemical analysis and not for sale; or
(3) the preparation, compounding, packaging, or
labeling of cannabis as an incident to lawful research,
teaching, or chemical analysis and not for sale; or .
(4) the packaging, repackaging, or labeling of drugs
only to the extent permitted under the Illinois Drug Reuse
Opportunity Program Act.
"Owner" means a person who has possession of or any
interest whatsoever in the property involved.
"Person" means an individual, a corporation, a government,
a governmental subdivision or agency, a business trust, an
estate, a trust, a partnership or association, or any other
entity.
"Production" means planting, cultivating, tending, or
harvesting.
"Property" means real property, including things growing
on, affixed to, and found in land, and tangible or intangible
personal property, including rights, services, privileges,
interests, claims, and securities.
(Source: P.A. 96-328, eff. 8-11-09.)
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