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Public Act 102-0389 | ||||
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AN ACT concerning health.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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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.
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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
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(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.
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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:
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(225 ILCS 85/4) (from Ch. 111, par. 4124)
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(Section scheduled to be repealed on January 1, 2023)
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Sec. 4. Exemptions. Nothing contained in any Section of | ||
this Act shall
apply
to, or in any manner interfere with:
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(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
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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;
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(b) the sale of compressed gases;
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(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
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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;
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(d) the sale of poultry and livestock remedies in | ||
original and unbroken
packages only, labeled for poultry | ||
and livestock medication;
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(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;
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(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;
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(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,
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repackaging, or labeling, of drugs to the
extent permitted | ||
under the Illinois Drug Reuse Opportunity Program Act; and
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(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 .)
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Section 95. The Wholesale Drug Distribution Licensing Act | ||
is amended by changing Section 15 as follows:
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(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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(Section scheduled to be repealed on January 1, 2023)
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Sec. 15. Definitions. As used in this Act:
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"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.
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"Blood" means whole blood collected from a single donor | ||
and processed
either for transfusion or further manufacturing.
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"Blood component" means that part of blood separated by | ||
physical or
mechanical means.
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"Board" means the State Board of Pharmacy of the | ||
Department of
Professional Regulation.
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"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.
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"Department" means the Department of Financial and
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Professional Regulation.
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"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.
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"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.
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"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.
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"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
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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.
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"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.
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"Person" means and includes a natural person, partnership, | ||
association,
corporation, or any other legal business entity.
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"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.
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"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.
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"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.)
|