Bill Text: IL HB0119 | 2021-2022 | 102nd General Assembly | Engrossed
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Reinserts the provisions of the engrossed bill with the following changes. Provides that "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. Provides that 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 (rather than a reasonable handling fee) may be charged.
Spectrum: Slight Partisan Bill (Democrat 46-16)
Status: (Passed) 2021-08-16 - Public Act . . . . . . . . . 102-0389 [HB0119 Detail]
Download: Illinois-2021-HB0119-Engrossed.html
Bill Title: Reinserts the provisions of the engrossed bill with the following changes. Provides that "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. Provides that 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 (rather than a reasonable handling fee) may be charged.
Spectrum: Slight Partisan Bill (Democrat 46-16)
Status: (Passed) 2021-08-16 - Public Act . . . . . . . . . 102-0389 [HB0119 Detail]
Download: Illinois-2021-HB0119-Engrossed.html
| |||||||
| |||||||
| |||||||
1 | AN ACT concerning health.
| ||||||
2 | Be it enacted by the People of the State of Illinois,
| ||||||
3 | represented in the General Assembly:
| ||||||
4 | Section 1. Short title. This Act may be cited as the | ||||||
5 | Illinois Drug Reuse Opportunity Program Act.
| ||||||
6 | Section 5. Definitions. In this Act: | ||||||
7 | "Controlled substance" means a drug, substance, or | ||||||
8 | immediate precursor in Schedules I through V of 21 CFR 1308. | ||||||
9 | "Dispense" has the same meaning as defined in Section 3 of | ||||||
10 | the Pharmacy Practice Act. | ||||||
11 | "Donor" means any person, including an individual member | ||||||
12 | of the public, or any entity legally authorized to possess | ||||||
13 | medicine, including, but not limited to, a wholesaler or | ||||||
14 | distributor, third party logistic provider, pharmacy, | ||||||
15 | dispenser, clinic, surgical or health center, detention and | ||||||
16 | rehabilitation center, jail, prison laboratory, medical or | ||||||
17 | pharmacy school, prescriber or other health care professional, | ||||||
18 | long-term care facility, or healthcare facility. "Donor" | ||||||
19 | includes government agencies and entities that are federally | ||||||
20 | authorized to possess medicine, including, but not limited to, | ||||||
21 | drug manufacturers, repackagers, relabelers, outsourcing | ||||||
22 | facilities, health care facilities operated by the U.S. | ||||||
23 | Department of Veterans Affairs, and prisons. |
| |||||||
| |||||||
1 | "Drug" means a prescription drug, over-the-counter drug, | ||||||
2 | or supplies needed to administer a prescription or | ||||||
3 | over-the-counter drug. | ||||||
4 | "Eligible patient" means an individual: | ||||||
5 | (1) with a prescription for the drug, if a | ||||||
6 | prescription is required to dispense the drug, or who | ||||||
7 | reports symptoms treated by the drug if the drug is | ||||||
8 | over-the-counter; and | ||||||
9 | (2) who is registered with the drug's manufacturer in | ||||||
10 | accordance with federal Food and Drug Administration | ||||||
11 | requirements, if the registration is required to dispense | ||||||
12 | the drug. | ||||||
13 | "Manufacturer" has the same meaning as defined in Section | ||||||
14 | 15 of the Wholesale Drug Distribution Licensing Act. | ||||||
15 | "Pharmacist" means an individual licensed to engage in the | ||||||
16 | practice of pharmacy under the Pharmacy Practice Act or | ||||||
17 | licensed to engage in the practice of pharmacy in another | ||||||
18 | state. | ||||||
19 | "Practitioner" means a person licensed in this State to | ||||||
20 | dispense or administer drugs or who is licensed in another | ||||||
21 | state as a person authorized to dispense or administer drugs. | ||||||
22 | "Prescription drug" means any prescribed drug that may be | ||||||
23 | legally dispensed by a pharmacy. | ||||||
24 | "Priority patient" means an eligible patient who is an | ||||||
25 | Illinois resident and who is indigent, uninsured, | ||||||
26 | underinsured, or enrolled in a public health benefits program. |
| |||||||
| |||||||
1 | "Recipient" means any person or entity legally authorized | ||||||
2 | to possess medicine with a license or permit in the state in | ||||||
3 | which the person or entity is located, including, but not | ||||||
4 | limited to, a wholesaler or distributor, reverse distributor, | ||||||
5 | repackager, hospital, pharmacy, clinic, or prescriber office. | ||||||
6 | "Returns processor" has the same meaning as defined in | ||||||
7 | paragraph (18) of 21 U.S.C. 360eee. "Returns processor" | ||||||
8 | includes, but is not limited to, a reverse distributor. | ||||||
9 | "Unopened tamper-evident packaging" has the same meaning | ||||||
10 | as defined in the United States Pharmacopeia (USP) General | ||||||
11 | Chapter 659, Packaging and Storage Requirements, including, | ||||||
12 | but not limited to, unopened unit-dose, multiple-dose, | ||||||
13 | immediate, secondary, and tertiary packaging.
| ||||||
14 | Section 10. Donating and receiving drugs. Notwithstanding | ||||||
15 | any other law or rule, donors may donate drugs to recipients | ||||||
16 | and recipients may receive donated drugs from donors. | ||||||
17 | Recipients shall only dispense or administer drugs to eligible | ||||||
18 | patients as described in Section 20, further donate drugs to | ||||||
19 | another recipient as described in Section 30, or dispose of | ||||||
20 | drugs as described in Section 35.
| ||||||
21 | Section 15. Cost-free provision of drugs. Drugs donated | ||||||
22 | for use under this Act are considered nonsaleable. When | ||||||
23 | dispensing a drug to an eligible patient, the recipient must | ||||||
24 | do so at no cost to the eligible patient, except that a |
| |||||||
| |||||||
1 | reasonable handling fee may be charged. The handling fee may | ||||||
2 | not exceed the direct or indirect cost to the recipient of | ||||||
3 | providing the drug. Charging the fee does not constitute | ||||||
4 | reselling.
| ||||||
5 | Section 20. Requirements for dispensing drugs; priority. | ||||||
6 | (a) A recipient may only dispense or administer a | ||||||
7 | prescription drug or provide an over-the-counter drug: | ||||||
8 | (1) if the recipient is otherwise permitted by law to | ||||||
9 | dispense or administer the drug; | ||||||
10 | (2) that meets the requirements in Section 25; | ||||||
11 | (3) that is repackaged into a new container or is in | ||||||
12 | its original container with all previous patient | ||||||
13 | information redacted or removed; | ||||||
14 | (4) that is properly labeled in accordance with the | ||||||
15 | rules and regulations of the Board of Pharmacy; | ||||||
16 | (5) that has an expiration or beyond-use date brought | ||||||
17 | forward from the donated prescription drug or | ||||||
18 | over-the-counter drug that will not expire before the use | ||||||
19 | by the eligible patient based on the prescribing | ||||||
20 | practitioner's directions for use or, for over-the-counter | ||||||
21 | medicine, on the package's label; and | ||||||
22 | (6) that is not adulterated or misbranded, as | ||||||
23 | determined by a pharmacist or practitioner. | ||||||
24 | (b) Recipients shall, to the greatest extent practicable, | ||||||
25 | dispense drugs received under this Act to priority patients.
|
| |||||||
| |||||||
1 | Section 25. Requirements for accepting drugs. A drug | ||||||
2 | received but not yet accepted into inventory shall be kept in a | ||||||
3 | separate designated area. A drug may be accepted under this | ||||||
4 | Act only if all of the following requirements are met: | ||||||
5 | (1) The drug is in unopened tamper-evident packaging | ||||||
6 | or has been repackaged according to Section 30. | ||||||
7 | (2) The drug is not expired. | ||||||
8 | (3) The drug is not a controlled substance. | ||||||
9 | (4) The recipient maintains a written or electronic | ||||||
10 | record of a donation made under this Act consisting of the | ||||||
11 | name, strength, and quantity of each accepted drug and the | ||||||
12 | name, address, and telephone number of the donor, unless a | ||||||
13 | recipient is further donating to a recipient under common | ||||||
14 | ownership or common control. Notwithstanding any other law | ||||||
15 | or rule, no other record of a donation is required. | ||||||
16 | (5) The donor has removed or redacted any patient name | ||||||
17 | and prescription number on the drug or otherwise maintains | ||||||
18 | patient confidentiality by executing a confidentiality | ||||||
19 | agreement with the recipient. | ||||||
20 | (6) The drug has a method recognized by the United | ||||||
21 | States Pharmacopeia to detect improper temperature | ||||||
22 | variations if the drug requires temperature control other | ||||||
23 | than room temperature storage.
| ||||||
24 | Section 30. Donating and repackaging. Notwithstanding any |
| |||||||
| |||||||
1 | other law or rule, a recipient may: | ||||||
2 | (1) further donate drugs to another recipient; | ||||||
3 | (2) repackage donated drugs as necessary for storage, | ||||||
4 | dispensing, administration, or transfers in accordance | ||||||
5 | with the following: | ||||||
6 | (A) repackaged medicine shall be labeled with the | ||||||
7 | drug's name, strength, and expiration date, and shall | ||||||
8 | be kept in a separate designated area until inspected | ||||||
9 | and initialed by a pharmacist, practitioner, or a | ||||||
10 | pharmacy technician; and | ||||||
11 | (B) if multiple packaged donated medicines with | ||||||
12 | varied expiration dates are repackaged together, the | ||||||
13 | shortest expiration date shall be used; and
| ||||||
14 | (3) replenish a drug of the same drug name and | ||||||
15 | strength previously dispensed or administered to an | ||||||
16 | eligible patient in accordance with Section 340B of the | ||||||
17 | federal Public Health Service Act.
| ||||||
18 | Section 35. Disposition of drugs. A donated drug that does | ||||||
19 | not meet the requirements of Section 25 must be disposed of by | ||||||
20 | returning it to the donor, destroying it by an incinerator, | ||||||
21 | medical waste hauler, or other lawful method, or transferring | ||||||
22 | it to a returns processor. A record of disposal shall consist | ||||||
23 | of the disposal method, the date of disposal, and the name and | ||||||
24 | quantity of the drug disposed of. Notwithstanding any other | ||||||
25 | law or rule, no other record of disposal shall be required.
|
| |||||||
| |||||||
1 | Section 40. Participation not required. Nothing in this | ||||||
2 | Act requires that a pharmacy or pharmacist be a recipient of | ||||||
3 | drugs under this Act.
| ||||||
4 | Section 45. Recordkeeping requirements. When performing | ||||||
5 | any action associated with a program under this Act or | ||||||
6 | otherwise processing a donated drug for tax, manufacturer, or | ||||||
7 | other credit, a recipient shall be considered to be acting as a | ||||||
8 | returns processor and shall comply with all recordkeeping | ||||||
9 | requirements for nonsaleable returns under federal law.
| ||||||
10 | Section 50. Change of ownership. A donation or other | ||||||
11 | transfer of possession or control of a drug under this Act | ||||||
12 | shall not be construed as a change of ownership unless it is | ||||||
13 | specified as such by the recipient. If a record of the | ||||||
14 | donation's transaction information or history is required, the | ||||||
15 | history shall begin with the donor of the drug, include all | ||||||
16 | prior donations, and, if the drug was previously dispensed, | ||||||
17 | only include drug information required to be on the patient | ||||||
18 | label in accordance with the Board of Pharmacy's rules and | ||||||
19 | regulations.
| ||||||
20 | Section 55. Retention of records. All records required | ||||||
21 | under this Act shall be retained in physical or electronic | ||||||
22 | format and on or off the recipient's premises for a period of 6 |
| |||||||
| |||||||
1 | years. Donors or recipients may contract with one another or a | ||||||
2 | third party to create or maintain records on each other's | ||||||
3 | behalf. An identifier, such as a serial number or bar code, may | ||||||
4 | be used in place of any or all information required by a record | ||||||
5 | or label pursuant to this Act if it allows for such information | ||||||
6 | to be readily retrievable. Upon request by a State or federal | ||||||
7 | regulatory agency, the identifier used for requested records | ||||||
8 | shall be replaced with the original information. An identifier | ||||||
9 | shall not be used on patient labels when dispensing or | ||||||
10 | administering a drug.
| ||||||
11 | Section 60. Authority. This Act supersedes any | ||||||
12 | inconsistent law or rule for activities conducted under this | ||||||
13 | Act.
| ||||||
14 | Section 65. Immunity. | ||||||
15 | (a) Except as provided in subsection (b), no manufacturer, | ||||||
16 | donor, or recipient shall be liable in any criminal or civil | ||||||
17 | action, or be subject to professional discipline, for | ||||||
18 | activities solely and directly attributable to donating, | ||||||
19 | receiving, or dispensing drugs under this Act. | ||||||
20 | (b) The immunity provided in subsection (a) shall not | ||||||
21 | apply: | ||||||
22 | (1) if it is shown that the act or omission was an | ||||||
23 | unreasonable, willful, wanton, or reckless act; | ||||||
24 | (2) if it is shown that the person or entity knew or |
| |||||||
| |||||||
1 | should have known that the donated drug was adulterated or | ||||||
2 | misbranded; or | ||||||
3 | (3) to acts or omissions outside the scope of a | ||||||
4 | program under this Act.
| ||||||
5 | Section 90. The Pharmacy Practice Act is amended by | ||||||
6 | changing Section 4 as follows:
| ||||||
7 | (225 ILCS 85/4) (from Ch. 111, par. 4124)
| ||||||
8 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
9 | Sec. 4. Exemptions. Nothing contained in any Section of | ||||||
10 | this Act shall
apply
to, or in any manner interfere with:
| ||||||
11 | (a) the lawful practice of any physician licensed to | ||||||
12 | practice medicine in
all of its branches, dentist, | ||||||
13 | podiatric physician,
veterinarian, or therapeutically or | ||||||
14 | diagnostically certified optometrist within
the limits of
| ||||||
15 | his or her license, or prevent him or her from
supplying to | ||||||
16 | his
or her
bona fide patients
such drugs, medicines, or | ||||||
17 | poisons as may seem to him appropriate;
| ||||||
18 | (b) the sale of compressed gases;
| ||||||
19 | (c) the sale of patent or proprietary medicines and | ||||||
20 | household remedies
when sold in original and unbroken | ||||||
21 | packages only, if such patent or
proprietary medicines and | ||||||
22 | household remedies be properly and adequately
labeled as | ||||||
23 | to content and usage and generally considered and accepted
| ||||||
24 | as harmless and nonpoisonous when used according to the |
| |||||||
| |||||||
1 | directions
on the label, and also do not contain opium or | ||||||
2 | coca leaves, or any
compound, salt or derivative thereof, | ||||||
3 | or any drug which, according
to the latest editions of the | ||||||
4 | following authoritative pharmaceutical
treatises and | ||||||
5 | standards, namely, The United States | ||||||
6 | Pharmacopoeia/National
Formulary (USP/NF), the United | ||||||
7 | States Dispensatory, and the Accepted
Dental Remedies of | ||||||
8 | the Council of Dental Therapeutics of the American
Dental | ||||||
9 | Association or any or either of them, in use on the | ||||||
10 | effective
date of this Act, or according to the existing | ||||||
11 | provisions of the Federal
Food, Drug, and Cosmetic Act and | ||||||
12 | Regulations of the Department of Health
and Human | ||||||
13 | Services, Food and Drug Administration, promulgated | ||||||
14 | thereunder
now in effect, is designated, described or | ||||||
15 | considered as a narcotic,
hypnotic, habit forming, | ||||||
16 | dangerous, or poisonous drug;
| ||||||
17 | (d) the sale of poultry and livestock remedies in | ||||||
18 | original and unbroken
packages only, labeled for poultry | ||||||
19 | and livestock medication;
| ||||||
20 | (e) the sale of poisonous substances or mixture of | ||||||
21 | poisonous substances,
in unbroken packages, for | ||||||
22 | nonmedicinal use in the arts or industries
or for | ||||||
23 | insecticide purposes; provided, they are properly and | ||||||
24 | adequately
labeled as to content and such nonmedicinal | ||||||
25 | usage, in conformity
with the provisions of all applicable | ||||||
26 | federal, state and local laws
and regulations promulgated |
| |||||||
| |||||||
1 | thereunder now in effect relating thereto
and governing | ||||||
2 | the same, and those which are required under such | ||||||
3 | applicable
laws and regulations to be labeled with the | ||||||
4 | word "Poison", are also labeled
with the word "Poison" | ||||||
5 | printed
thereon in prominent type and the name of a | ||||||
6 | readily obtainable antidote
with directions for its | ||||||
7 | administration;
| ||||||
8 | (f) the delegation of limited prescriptive authority | ||||||
9 | by a physician
licensed to
practice medicine in all its | ||||||
10 | branches to a physician assistant
under Section 7.5 of the | ||||||
11 | Physician Assistant Practice Act of 1987. This
delegated | ||||||
12 | authority under Section 7.5 of the Physician Assistant | ||||||
13 | Practice Act of 1987 may, but is not required to, include | ||||||
14 | prescription of
controlled substances, as defined in | ||||||
15 | Article II of the
Illinois Controlled Substances Act, in | ||||||
16 | accordance with a written supervision agreement;
| ||||||
17 | (g) the delegation of prescriptive authority by a | ||||||
18 | physician
licensed to practice medicine in all its | ||||||
19 | branches or a licensed podiatric physician to an advanced | ||||||
20 | practice
registered nurse in accordance with a written | ||||||
21 | collaborative
agreement under Sections 65-35 and 65-40 of | ||||||
22 | the Nurse Practice Act; and | ||||||
23 | (g-5) the donation or acceptance, or the packaging,
| ||||||
24 | repackaging, or labeling, of drugs to the
extent permitted | ||||||
25 | under the Illinois Drug Reuse Opportunity Program Act; and
| ||||||
26 | (h) the sale or distribution of dialysate or devices |
| |||||||
| |||||||
1 | necessary to perform home peritoneal renal dialysis for | ||||||
2 | patients with end-stage renal disease, provided that all | ||||||
3 | of the following conditions are met: | ||||||
4 | (1) the dialysate, comprised of dextrose or | ||||||
5 | icodextrin, or devices are approved or cleared by the | ||||||
6 | federal Food and Drug Administration, as required by | ||||||
7 | federal law; | ||||||
8 | (2) the dialysate or devices are lawfully held by | ||||||
9 | a manufacturer or the manufacturer's agent, which is | ||||||
10 | properly registered with the Board as a manufacturer, | ||||||
11 | third-party logistics provider, or wholesaler; | ||||||
12 | (3) the dialysate or devices are held and | ||||||
13 | delivered to the manufacturer or the manufacturer's | ||||||
14 | agent in the original, sealed packaging from the | ||||||
15 | manufacturing facility; | ||||||
16 | (4) the dialysate or devices are delivered only | ||||||
17 | upon receipt of a physician's prescription by a | ||||||
18 | licensed pharmacy in which the prescription is | ||||||
19 | processed in accordance with provisions set forth in | ||||||
20 | this Act, and the transmittal of an order from the | ||||||
21 | licensed pharmacy to the manufacturer or the | ||||||
22 | manufacturer's agent; and | ||||||
23 | (5) the manufacturer or the manufacturer's agent | ||||||
24 | delivers the dialysate or devices directly to: (i) a | ||||||
25 | patient with end-stage renal disease, or his or her | ||||||
26 | designee, for the patient's self-administration of the |
| |||||||
| |||||||
1 | dialysis therapy or (ii) a health care provider or | ||||||
2 | institution for administration or delivery of the | ||||||
3 | dialysis therapy to a patient with end-stage renal | ||||||
4 | disease. | ||||||
5 | This paragraph (h) does not include any other drugs | ||||||
6 | for peritoneal dialysis, except dialysate, as described in | ||||||
7 | item (1) of this paragraph (h). All records of sales and | ||||||
8 | distribution of dialysate to patients made pursuant to | ||||||
9 | this paragraph (h) must be retained in accordance with | ||||||
10 | Section 18 of this Act. | ||||||
11 | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | ||||||
12 | 100-863, eff. 8-14-18; 101-420, eff. 8-16-19 .)
| ||||||
13 | Section 95. The Wholesale Drug Distribution Licensing Act | ||||||
14 | is amended by changing Section 15 as follows:
| ||||||
15 | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| ||||||
16 | (Section scheduled to be repealed on January 1, 2023)
| ||||||
17 | Sec. 15. Definitions. As used in this Act:
| ||||||
18 | "Authentication" means the affirmative verification, | ||||||
19 | before any wholesale distribution of a prescription drug | ||||||
20 | occurs, that each transaction listed on the pedigree has | ||||||
21 | occurred. | ||||||
22 | "Authorized distributor of record" means a wholesale | ||||||
23 | distributor with whom a manufacturer has established an | ||||||
24 | ongoing relationship to distribute the manufacturer's |
| |||||||
| |||||||
1 | prescription drug. An ongoing relationship is deemed to exist | ||||||
2 | between a wholesale distributor and a manufacturer when the | ||||||
3 | wholesale distributor, including any affiliated group of the | ||||||
4 | wholesale distributor, as defined in Section 1504 of the | ||||||
5 | Internal Revenue Code, complies with the following: | ||||||
6 | (1) The wholesale distributor has a written agreement | ||||||
7 | currently in effect with the manufacturer evidencing the | ||||||
8 | ongoing relationship; and | ||||||
9 | (2) The wholesale distributor is listed on the | ||||||
10 | manufacturer's current list of authorized distributors of | ||||||
11 | record, which is updated by the manufacturer on no less | ||||||
12 | than a monthly basis.
| ||||||
13 | "Blood" means whole blood collected from a single donor | ||||||
14 | and processed
either for transfusion or further manufacturing.
| ||||||
15 | "Blood component" means that part of blood separated by | ||||||
16 | physical or
mechanical means.
| ||||||
17 | "Board" means the State Board of Pharmacy of the | ||||||
18 | Department of
Professional Regulation.
| ||||||
19 | "Chain pharmacy warehouse" means a physical location for | ||||||
20 | prescription drugs that acts as a central warehouse and | ||||||
21 | performs intracompany sales or transfers of the drugs to a | ||||||
22 | group of chain or mail order pharmacies that have the same | ||||||
23 | common ownership and control. Notwithstanding any other | ||||||
24 | provision of this Act, a chain pharmacy warehouse shall be | ||||||
25 | considered part of the normal distribution channel. | ||||||
26 | "Co-licensed partner or product" means an instance where |
| |||||||
| |||||||
1 | one or more parties have the right to engage in the | ||||||
2 | manufacturing or marketing of a prescription drug, consistent | ||||||
3 | with the FDA's implementation of the Prescription Drug | ||||||
4 | Marketing Act.
| ||||||
5 | "Department" means the Department of Financial and
| ||||||
6 | Professional Regulation.
| ||||||
7 | "Drop shipment" means the sale of a prescription drug to a | ||||||
8 | wholesale distributor by the manufacturer of the prescription | ||||||
9 | drug or that manufacturer's co-licensed product partner, that | ||||||
10 | manufacturer's third party logistics provider, or that | ||||||
11 | manufacturer's exclusive distributor or by an authorized | ||||||
12 | distributor of record that purchased the product directly from | ||||||
13 | the manufacturer or one of these entities whereby the | ||||||
14 | wholesale distributor or chain pharmacy warehouse takes title | ||||||
15 | but not physical possession of such prescription drug and the | ||||||
16 | wholesale distributor invoices the pharmacy, chain pharmacy | ||||||
17 | warehouse, or other person authorized by law to dispense or | ||||||
18 | administer such drug to a patient and the pharmacy, chain | ||||||
19 | pharmacy warehouse, or other authorized person receives | ||||||
20 | delivery of the prescription drug directly from the | ||||||
21 | manufacturer, that manufacturer's third party logistics | ||||||
22 | provider, or that manufacturer's exclusive distributor or from | ||||||
23 | an authorized distributor of record that purchased the product | ||||||
24 | directly from the manufacturer or one of these entities.
| ||||||
25 | "Drug sample" means a unit of a prescription drug that is | ||||||
26 | not intended to
be sold and is intended to promote the sale of |
| |||||||
| |||||||
1 | the drug.
| ||||||
2 | "Facility" means a facility of a wholesale distributor | ||||||
3 | where prescription drugs are stored, handled, repackaged, or | ||||||
4 | offered for sale, or a facility of a third-party logistics | ||||||
5 | provider where prescription drugs are stored or handled. | ||||||
6 | "FDA" means the United States Food and Drug | ||||||
7 | Administration.
| ||||||
8 | "Manufacturer" means a person licensed or approved by the | ||||||
9 | FDA to engage in the manufacture of drugs or devices, | ||||||
10 | consistent with the definition of "manufacturer" set forth in | ||||||
11 | the FDA's regulations and guidances implementing the | ||||||
12 | Prescription Drug Marketing Act. "Manufacturer" does not
| ||||||
13 | include anyone who is engaged in the packaging, repackaging, | ||||||
14 | or
labeling of drugs only to the extent permitted
under the | ||||||
15 | Illinois Drug Reuse Opportunity Program Act. | ||||||
16 | "Manufacturer's exclusive distributor" means anyone who | ||||||
17 | contracts with a manufacturer to provide or coordinate | ||||||
18 | warehousing, distribution, or other services on behalf of a | ||||||
19 | manufacturer and who takes title to that manufacturer's | ||||||
20 | prescription drug, but who does not have general | ||||||
21 | responsibility to direct the sale or disposition of the | ||||||
22 | manufacturer's prescription drug. A manufacturer's exclusive | ||||||
23 | distributor must be licensed as a wholesale distributor under | ||||||
24 | this Act and, in order to be considered part of the normal | ||||||
25 | distribution channel, must also be an authorized distributor | ||||||
26 | of record.
|
| |||||||
| |||||||
1 | "Normal distribution channel" means a chain of custody for | ||||||
2 | a prescription drug that goes, directly or by drop shipment, | ||||||
3 | from (i) a manufacturer of the prescription drug, (ii) that | ||||||
4 | manufacturer to that manufacturer's co-licensed partner, (iii) | ||||||
5 | that manufacturer to that manufacturer's third party logistics | ||||||
6 | provider, or (iv) that manufacturer to that manufacturer's | ||||||
7 | exclusive distributor to: | ||||||
8 | (1) a pharmacy or to other designated persons | ||||||
9 | authorized by law to dispense or administer the drug to a | ||||||
10 | patient; | ||||||
11 | (2) a wholesale distributor to a pharmacy or other | ||||||
12 | designated persons authorized by law to dispense or | ||||||
13 | administer the drug to a patient; | ||||||
14 | (3) a wholesale distributor to a chain pharmacy | ||||||
15 | warehouse to that chain pharmacy warehouse's intracompany | ||||||
16 | pharmacy to a patient or other designated persons | ||||||
17 | authorized by law to dispense or administer the drug to a | ||||||
18 | patient; | ||||||
19 | (4) a chain pharmacy warehouse to the chain pharmacy | ||||||
20 | warehouse's intracompany pharmacy or other designated | ||||||
21 | persons authorized by law to dispense or administer the | ||||||
22 | drug to the patient; | ||||||
23 | (5) an authorized distributor of record to one other | ||||||
24 | authorized distributor of record to an office-based health | ||||||
25 | care practitioner authorized by law to dispense or | ||||||
26 | administer the drug to the patient; or |
| |||||||
| |||||||
1 | (6) an authorized distributor to a pharmacy or other | ||||||
2 | persons licensed to dispense or administer the drug. | ||||||
3 | "Pedigree" means a document or electronic file containing | ||||||
4 | information that records each wholesale distribution of any | ||||||
5 | given prescription drug from the point of origin to the final | ||||||
6 | wholesale distribution point of any given prescription drug.
| ||||||
7 | "Person" means and includes a natural person, partnership, | ||||||
8 | association,
corporation, or any other legal business entity.
| ||||||
9 | "Pharmacy distributor" means any pharmacy licensed in this | ||||||
10 | State or
hospital pharmacy that is engaged in the delivery or | ||||||
11 | distribution of
prescription drugs either to any other | ||||||
12 | pharmacy licensed in this State or
to any other person or | ||||||
13 | entity including, but not limited to, a wholesale
drug | ||||||
14 | distributor engaged in the delivery or distribution of | ||||||
15 | prescription
drugs who is involved in the actual, | ||||||
16 | constructive, or attempted transfer of
a drug in this State to | ||||||
17 | other than the ultimate consumer except as
otherwise provided | ||||||
18 | for by law.
| ||||||
19 | "Prescription drug" means any human drug, including any | ||||||
20 | biological product (except for blood and blood components | ||||||
21 | intended for transfusion or biological products that are also | ||||||
22 | medical devices), required by federal law or
regulation to be | ||||||
23 | dispensed only by a prescription, including finished
dosage | ||||||
24 | forms and bulk drug substances
subject to Section
503 of the | ||||||
25 | Federal Food, Drug and Cosmetic Act.
| ||||||
26 | "Repackage" means repackaging or otherwise changing the |
| |||||||
| |||||||
1 | container, wrapper, or labeling to further the distribution of | ||||||
2 | a prescription drug, excluding that completed by the | ||||||
3 | pharmacist responsible for dispensing the product to a | ||||||
4 | patient. | ||||||
5 | "Secretary" means the Secretary of Financial and | ||||||
6 | Professional Regulation. | ||||||
7 | "Third-party logistics provider" means anyone who | ||||||
8 | contracts with a prescription drug manufacturer to provide or | ||||||
9 | coordinate warehousing, distribution, or other services on | ||||||
10 | behalf of a manufacturer, but does not take title to the | ||||||
11 | prescription drug or have general responsibility to direct the | ||||||
12 | prescription drug's sale or disposition. | ||||||
13 | "Wholesale distribution"
means the distribution
of | ||||||
14 | prescription drugs to persons other than a consumer or | ||||||
15 | patient, but does
not include any of the following:
| ||||||
16 | (1)
Intracompany sales of prescription drugs, meaning | ||||||
17 | (i) any transaction or transfer
between any division, | ||||||
18 | subsidiary, parent, or affiliated or related company
under | ||||||
19 | the common ownership and control of a corporate entity or | ||||||
20 | (ii) any transaction or transfer between co-licensees of a | ||||||
21 | co-licensed product.
| ||||||
22 | (2) The sale, purchase, distribution, trade, or | ||||||
23 | transfer of a prescription drug or offer to sell, | ||||||
24 | purchase, distribute, trade, or transfer a prescription | ||||||
25 | drug for emergency medical reasons.
| ||||||
26 | (3) The distribution of prescription drug samples by |
| |||||||
| |||||||
1 | manufacturers' representatives. | ||||||
2 | (4) Drug returns, when conducted by a hospital, health | ||||||
3 | care entity, or charitable institution in accordance with | ||||||
4 | federal regulation. | ||||||
5 | (5) The sale of minimal quantities of prescription | ||||||
6 | drugs by licensed pharmacies to licensed practitioners for | ||||||
7 | office use or other licensed pharmacies. | ||||||
8 | (6) The sale, purchase, or trade of a drug, an offer to | ||||||
9 | sell, purchase, or trade a drug, or the dispensing of a | ||||||
10 | drug pursuant to a prescription. | ||||||
11 | (7) The sale, transfer, merger, or consolidation of | ||||||
12 | all or part of the business of a pharmacy or pharmacies | ||||||
13 | from or with another pharmacy or pharmacies, whether | ||||||
14 | accomplished as a purchase and sale of stock or business | ||||||
15 | assets. | ||||||
16 | (8) The sale, purchase, distribution, trade, or | ||||||
17 | transfer of a prescription drug from one authorized | ||||||
18 | distributor of record to one additional authorized | ||||||
19 | distributor of record when the manufacturer has stated in | ||||||
20 | writing to the receiving authorized distributor of record | ||||||
21 | that the manufacturer is unable to supply the prescription | ||||||
22 | drug and the supplying authorized distributor of record | ||||||
23 | states in writing that the prescription drug being | ||||||
24 | supplied had until that time been exclusively in the | ||||||
25 | normal distribution channel. | ||||||
26 | (9) The delivery of or the offer to deliver a |
| |||||||
| |||||||
1 | prescription drug by a common carrier solely in the common | ||||||
2 | carrier's usual course of business of transporting | ||||||
3 | prescription drugs when the common carrier does not store, | ||||||
4 | warehouse, or take legal ownership of the prescription | ||||||
5 | drug. | ||||||
6 | (10) The sale or transfer from a retail pharmacy, mail | ||||||
7 | order pharmacy, or chain pharmacy warehouse of expired, | ||||||
8 | damaged, returned, or recalled prescription drugs to the | ||||||
9 | original manufacturer, the originating wholesale | ||||||
10 | distributor, or a third party returns processor.
| ||||||
11 | (11) The donation of drugs to the extent
permitted | ||||||
12 | under the Illinois Drug Reuse Opportunity Program Act.
| ||||||
13 | "Wholesale drug distributor" means anyone
engaged in the
| ||||||
14 | wholesale distribution of prescription drugs into, out of, or | ||||||
15 | within the State, including without limitation
manufacturers; | ||||||
16 | repackers; own label distributors; jobbers; private
label | ||||||
17 | distributors; brokers; warehouses, including manufacturers' | ||||||
18 | and
distributors' warehouses; manufacturer's exclusive | ||||||
19 | distributors; and authorized distributors of record; drug | ||||||
20 | wholesalers or distributors; independent wholesale drug | ||||||
21 | traders; specialty wholesale distributors; and retail | ||||||
22 | pharmacies that conduct wholesale distribution; and chain | ||||||
23 | pharmacy warehouses that conduct wholesale distribution. In | ||||||
24 | order to be considered part of the normal distribution | ||||||
25 | channel, a wholesale distributor must also be an authorized | ||||||
26 | distributor of record.
|
| |||||||
| |||||||
1 | (Source: P.A. 101-420, eff. 8-16-19.)
| ||||||
2 | Section 100. The Senior Pharmaceutical Assistance Act is | ||||||
3 | amended by changing Section 10 as follows:
| ||||||
4 | (320 ILCS 50/10)
| ||||||
5 | Sec. 10. Definitions. In this Act:
| ||||||
6 | "Manufacturer" includes:
| ||||||
7 | (1) An entity that is engaged in (a) the production, | ||||||
8 | preparation,
propagation, compounding, conversion, or | ||||||
9 | processing of prescription drug
products (i) directly or | ||||||
10 | indirectly by extraction from substances of natural
| ||||||
11 | origin,
(ii) independently by means of chemical synthesis, | ||||||
12 | or (iii) by combination of
extraction
and chemical | ||||||
13 | synthesis; or (b) the packaging, repackaging, labeling or
| ||||||
14 | re-labeling, or distribution of prescription drug | ||||||
15 | products.
| ||||||
16 | (2) The entity holding legal title to or possession of | ||||||
17 | the national
drug code number for the covered prescription | ||||||
18 | drug.
| ||||||
19 | The term does not include a wholesale distributor of | ||||||
20 | drugs,
drugstore chain organization, or retail pharmacy | ||||||
21 | licensed by the State. The term also does not include anyone | ||||||
22 | who is engaged
in the packaging, repackaging, or labeling of
| ||||||
23 | drugs only to the extent permitted under the Illinois Drug | ||||||
24 | Reuse Opportunity Program Act.
|
| |||||||
| |||||||
1 | "Prescription drug" means a drug that may be dispensed | ||||||
2 | only upon
prescription by an authorized prescriber and that is | ||||||
3 | approved for safety and
effectiveness as a prescription drug | ||||||
4 | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic | ||||||
5 | Act.
| ||||||
6 | "Senior citizen" or "senior" means a person 65 years of | ||||||
7 | age or
older.
| ||||||
8 | (Source: P.A. 92-594, eff. 6-27-02.)
| ||||||
9 | Section 105. The Illinois Food, Drug and Cosmetic Act is | ||||||
10 | amended by changing Section 16 as follows:
| ||||||
11 | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
| ||||||
12 | Sec. 16.
(a) The Director is hereby authorized to | ||||||
13 | promulgate
regulations exempting from any labeling or | ||||||
14 | packaging requirement of this
Act drugs and devices which are | ||||||
15 | (i) , in accordance with the practice of the
trade, to be | ||||||
16 | processed, labeled or repacked in substantial quantities at
| ||||||
17 | establishments other than those where originally processed or | ||||||
18 | packaged on
condition that such drugs and devices are not | ||||||
19 | adulterated or misbranded
under the provisions of this Act | ||||||
20 | upon removal from such processing,
labeling or repacking | ||||||
21 | establishment or (ii) packaged, repackaged, or labeled to the
| ||||||
22 | extent permitted under the Illinois Drug Reuse Opportunity | ||||||
23 | Program Act .
| ||||||
24 | (b) Drugs and device labeling or packaging exemptions |
| |||||||
| |||||||
1 | adopted under the
Federal Act and supplements thereto or | ||||||
2 | revisions thereof shall apply to
drugs and devices in Illinois | ||||||
3 | except insofar as modified or rejected by
regulations | ||||||
4 | promulgated by the Director.
| ||||||
5 | (c) A drug intended for use by man which (A) is a | ||||||
6 | habit-forming drug to
which Section 15 (d) applies; or (B) | ||||||
7 | because of its toxicity or other
potentiality for harmful | ||||||
8 | effect or the method of its use or the collateral
measures | ||||||
9 | necessary to its use is not safe for use except under the
| ||||||
10 | supervision of a practitioner licensed by law to administer | ||||||
11 | such drug; or
(C) is limited by an approved application under | ||||||
12 | Section 505 of the Federal
Act or Section 17 of this Act to use | ||||||
13 | under the professional supervision of
a practitioner licensed | ||||||
14 | by law to administer such drug, shall be dispensed
only in | ||||||
15 | accordance with the provisions of the "Illinois Controlled
| ||||||
16 | Substances Act". The act of dispensing a drug contrary to the | ||||||
17 | provisions of
this paragraph shall be deemed to be an act which | ||||||
18 | results in a drug being
misbranded while held for sale.
| ||||||
19 | (d) Any drug dispensed by filling or refilling a written
| ||||||
20 | or oral prescription of a practitioner licensed by law to | ||||||
21 | administer such
drug shall be exempt from the requirements of | ||||||
22 | Section 15, except
subsections (a), (k) and (l) and clauses | ||||||
23 | (2) and (3) of subsection (i), and
the packaging requirements | ||||||
24 | of
subsections (g), (h) and (q), if the drug bears a label | ||||||
25 | containing the
proprietary name or names, or if there is none, | ||||||
26 | the established name or
names of the drugs, the dosage and |
| |||||||
| |||||||
1 | quantity, unless the prescribing
practitioner, in the interest | ||||||
2 | of the health of the patient, directs
otherwise in writing, | ||||||
3 | the name and address of the dispenser, the serial
number and | ||||||
4 | date of the prescription or of its filling, the name of the
| ||||||
5 | prescriber and, if stated in the prescription, the name of the | ||||||
6 | patient, and
the directions for use and the cautionary | ||||||
7 | statements, if any, contained in
such prescription. This | ||||||
8 | exemption shall not apply to any drug dispensed in
the course | ||||||
9 | of the conduct of business of dispensing drugs pursuant to
| ||||||
10 | diagnosis by mail, or to a drug dispensed in violation of | ||||||
11 | subsection (a) of
this Section.
| ||||||
12 | (e) The Director may by regulation remove drugs subject to
| ||||||
13 | Section 15 (d) and Section 17 from the requirements of | ||||||
14 | subsection (c) of
this Section when such requirements are not | ||||||
15 | necessary for the protection of
the public health.
| ||||||
16 | (f) A drug which is subject to subsection (c) of this | ||||||
17 | Section
shall be deemed to be misbranded if at any time before | ||||||
18 | dispensing its label
fails to bear the statement "Caution: | ||||||
19 | Federal Law Prohibits Dispensing Without
Prescription" or | ||||||
20 | "Caution: State Law Prohibits Dispensing Without
| ||||||
21 | Prescription". A drug to which subsection (c) of this Section | ||||||
22 | does not apply
shall be deemed to be misbranded if at any time | ||||||
23 | prior to dispensing its
label bears the caution statement | ||||||
24 | quoted in the preceding sentence.
| ||||||
25 | (g) Nothing in this Section shall be construed to relieve
| ||||||
26 | any person from any requirement prescribed by or under |
| |||||||
| |||||||
1 | authority of law
with respect to controlled substances now | ||||||
2 | included or which may hereafter
be included within the | ||||||
3 | classifications of controlled substances cannabis as
defined | ||||||
4 | in applicable Federal laws relating to controlled substances | ||||||
5 | or
cannabis or the Cannabis Control Act.
| ||||||
6 | (Source: P.A. 84-1308.)
| ||||||
7 | Section 110. The Illinois Controlled Substances Act is | ||||||
8 | amended by changing Section 102 as follows:
| ||||||
9 | (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) | ||||||
10 | Sec. 102. Definitions. As used in this Act, unless the | ||||||
11 | context
otherwise requires:
| ||||||
12 | (a) "Addict" means any person who habitually uses any | ||||||
13 | drug, chemical,
substance or dangerous drug other than alcohol | ||||||
14 | so as to endanger the public
morals, health, safety or welfare | ||||||
15 | or who is so far addicted to the use of a
dangerous drug or | ||||||
16 | controlled substance other than alcohol as to have lost
the | ||||||
17 | power of self control with reference to his or her addiction.
| ||||||
18 | (b) "Administer" means the direct application of a | ||||||
19 | controlled
substance, whether by injection, inhalation, | ||||||
20 | ingestion, or any other
means, to the body of a patient, | ||||||
21 | research subject, or animal (as
defined by the Humane | ||||||
22 | Euthanasia in Animal Shelters Act) by:
| ||||||
23 | (1) a practitioner (or, in his or her presence, by his | ||||||
24 | or her authorized agent),
|
| |||||||
| |||||||
1 | (2) the patient or research subject pursuant to an | ||||||
2 | order, or
| ||||||
3 | (3) a euthanasia technician as defined by the Humane | ||||||
4 | Euthanasia in
Animal Shelters Act.
| ||||||
5 | (c) "Agent" means an authorized person who acts on behalf | ||||||
6 | of or at
the direction of a manufacturer, distributor, | ||||||
7 | dispenser, prescriber, or practitioner. It does not
include a | ||||||
8 | common or contract carrier, public warehouseman or employee of
| ||||||
9 | the carrier or warehouseman.
| ||||||
10 | (c-1) "Anabolic Steroids" means any drug or hormonal | ||||||
11 | substance,
chemically and pharmacologically related to | ||||||
12 | testosterone (other than
estrogens, progestins, | ||||||
13 | corticosteroids, and dehydroepiandrosterone),
and includes:
| ||||||
14 | (i) 3[beta],17-dihydroxy-5a-androstane, | ||||||
15 | (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, | ||||||
16 | (iii) 5[alpha]-androstan-3,17-dione, | ||||||
17 | (iv) 1-androstenediol (3[beta], | ||||||
18 | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | ||||||
19 | (v) 1-androstenediol (3[alpha], | ||||||
20 | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | ||||||
21 | (vi) 4-androstenediol | ||||||
22 | (3[beta],17[beta]-dihydroxy-androst-4-ene), | ||||||
23 | (vii) 5-androstenediol | ||||||
24 | (3[beta],17[beta]-dihydroxy-androst-5-ene), | ||||||
25 | (viii) 1-androstenedione | ||||||
26 | ([5alpha]-androst-1-en-3,17-dione), |
| |||||||
| |||||||
1 | (ix) 4-androstenedione | ||||||
2 | (androst-4-en-3,17-dione), | ||||||
3 | (x) 5-androstenedione | ||||||
4 | (androst-5-en-3,17-dione), | ||||||
5 | (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- | ||||||
6 | hydroxyandrost-4-en-3-one), | ||||||
7 | (xii) boldenone (17[beta]-hydroxyandrost- | ||||||
8 | 1,4,-diene-3-one), | ||||||
9 | (xiii) boldione (androsta-1,4- | ||||||
10 | diene-3,17-dione), | ||||||
11 | (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 | ||||||
12 | [beta]-hydroxyandrost-4-en-3-one), | ||||||
13 | (xv) clostebol (4-chloro-17[beta]- | ||||||
14 | hydroxyandrost-4-en-3-one), | ||||||
15 | (xvi) dehydrochloromethyltestosterone (4-chloro- | ||||||
16 | 17[beta]-hydroxy-17[alpha]-methyl- | ||||||
17 | androst-1,4-dien-3-one), | ||||||
18 | (xvii) desoxymethyltestosterone | ||||||
19 | (17[alpha]-methyl-5[alpha] | ||||||
20 | -androst-2-en-17[beta]-ol)(a.k.a., madol), | ||||||
21 | (xviii) [delta]1-dihydrotestosterone (a.k.a. | ||||||
22 | '1-testosterone') (17[beta]-hydroxy- | ||||||
23 | 5[alpha]-androst-1-en-3-one), | ||||||
24 | (xix) 4-dihydrotestosterone (17[beta]-hydroxy- | ||||||
25 | androstan-3-one), | ||||||
26 | (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- |
| |||||||
| |||||||
1 | 5[alpha]-androstan-3-one), | ||||||
2 | (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- | ||||||
3 | hydroxyestr-4-ene), | ||||||
4 | (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- | ||||||
5 | 1[beta],17[beta]-dihydroxyandrost-4-en-3-one), | ||||||
6 | (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], | ||||||
7 | 17[beta]-dihydroxyandrost-1,4-dien-3-one), | ||||||
8 | (xxiv) furazabol (17[alpha]-methyl-17[beta]- | ||||||
9 | hydroxyandrostano[2,3-c]-furazan), | ||||||
10 | (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, | ||||||
11 | (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- | ||||||
12 | androst-4-en-3-one), | ||||||
13 | (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- | ||||||
14 | dihydroxy-estr-4-en-3-one), | ||||||
15 | (xxviii) mestanolone (17[alpha]-methyl-17[beta]- | ||||||
16 | hydroxy-5-androstan-3-one), | ||||||
17 | (xxix) mesterolone (1amethyl-17[beta]-hydroxy- | ||||||
18 | [5a]-androstan-3-one), | ||||||
19 | (xxx) methandienone (17[alpha]-methyl-17[beta]- | ||||||
20 | hydroxyandrost-1,4-dien-3-one), | ||||||
21 | (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- | ||||||
22 | dihydroxyandrost-5-ene), | ||||||
23 | (xxxii) methenolone (1-methyl-17[beta]-hydroxy- | ||||||
24 | 5[alpha]-androst-1-en-3-one), | ||||||
25 | (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- | ||||||
26 | dihydroxy-5a-androstane, |
| |||||||
| |||||||
1 | (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy | ||||||
2 | -5a-androstane, | ||||||
3 | (xxxv) 17[alpha]-methyl-3[beta],17[beta]- | ||||||
4 | dihydroxyandrost-4-ene), | ||||||
5 | (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- | ||||||
6 | methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), | ||||||
7 | (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- | ||||||
8 | hydroxyestra-4,9(10)-dien-3-one), | ||||||
9 | (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- | ||||||
10 | hydroxyestra-4,9-11-trien-3-one), | ||||||
11 | (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- | ||||||
12 | hydroxyandrost-4-en-3-one), | ||||||
13 | (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- | ||||||
14 | hydroxyestr-4-en-3-one), | ||||||
15 | (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone | ||||||
16 | (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- | ||||||
17 | androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- | ||||||
18 | 1-testosterone'), | ||||||
19 | (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), | ||||||
20 | (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- | ||||||
21 | dihydroxyestr-4-ene), | ||||||
22 | (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- | ||||||
23 | dihydroxyestr-4-ene), | ||||||
24 | (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- | ||||||
25 | dihydroxyestr-5-ene), | ||||||
26 | (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- |
| |||||||
| |||||||
1 | dihydroxyestr-5-ene), | ||||||
2 | (xlvii) 19-nor-4,9(10)-androstadienedione | ||||||
3 | (estra-4,9(10)-diene-3,17-dione), | ||||||
4 | (xlviii) 19-nor-4-androstenedione (estr-4- | ||||||
5 | en-3,17-dione), | ||||||
6 | (xlix) 19-nor-5-androstenedione (estr-5- | ||||||
7 | en-3,17-dione), | ||||||
8 | (l) norbolethone (13[beta], 17a-diethyl-17[beta]- | ||||||
9 | hydroxygon-4-en-3-one), | ||||||
10 | (li) norclostebol (4-chloro-17[beta]- | ||||||
11 | hydroxyestr-4-en-3-one), | ||||||
12 | (lii) norethandrolone (17[alpha]-ethyl-17[beta]- | ||||||
13 | hydroxyestr-4-en-3-one), | ||||||
14 | (liii) normethandrolone (17[alpha]-methyl-17[beta]- | ||||||
15 | hydroxyestr-4-en-3-one), | ||||||
16 | (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- | ||||||
17 | 2-oxa-5[alpha]-androstan-3-one), | ||||||
18 | (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- | ||||||
19 | dihydroxyandrost-4-en-3-one), | ||||||
20 | (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- | ||||||
21 | 17[beta]-hydroxy-(5[alpha]-androstan-3-one), | ||||||
22 | (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- | ||||||
23 | (5[alpha]-androst-2-eno[3,2-c]-pyrazole), | ||||||
24 | (lviii) stenbolone (17[beta]-hydroxy-2-methyl- | ||||||
25 | (5[alpha]-androst-1-en-3-one), | ||||||
26 | (lix) testolactone (13-hydroxy-3-oxo-13,17- |
| |||||||
| |||||||
1 | secoandrosta-1,4-dien-17-oic | ||||||
2 | acid lactone), | ||||||
3 | (lx) testosterone (17[beta]-hydroxyandrost- | ||||||
4 | 4-en-3-one), | ||||||
5 | (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- | ||||||
6 | diethyl-17[beta]-hydroxygon- | ||||||
7 | 4,9,11-trien-3-one), | ||||||
8 | (lxii) trenbolone (17[beta]-hydroxyestr-4,9, | ||||||
9 | 11-trien-3-one).
| ||||||
10 | Any person who is otherwise lawfully in possession of an | ||||||
11 | anabolic
steroid, or who otherwise lawfully manufactures, | ||||||
12 | distributes, dispenses,
delivers, or possesses with intent to | ||||||
13 | deliver an anabolic steroid, which
anabolic steroid is | ||||||
14 | expressly intended for and lawfully allowed to be
administered | ||||||
15 | through implants to livestock or other nonhuman species, and
| ||||||
16 | which is approved by the Secretary of Health and Human | ||||||
17 | Services for such
administration, and which the person intends | ||||||
18 | to administer or have
administered through such implants, | ||||||
19 | shall not be considered to be in
unauthorized possession or to | ||||||
20 | unlawfully manufacture, distribute, dispense,
deliver, or | ||||||
21 | possess with intent to deliver such anabolic steroid for
| ||||||
22 | purposes of this Act.
| ||||||
23 | (d) "Administration" means the Drug Enforcement | ||||||
24 | Administration,
United States Department of Justice, or its | ||||||
25 | successor agency.
| ||||||
26 | (d-5) "Clinical Director, Prescription Monitoring Program" |
| |||||||
| |||||||
1 | means a Department of Human Services administrative employee | ||||||
2 | licensed to either prescribe or dispense controlled substances | ||||||
3 | who shall run the clinical aspects of the Department of Human | ||||||
4 | Services Prescription Monitoring Program and its Prescription | ||||||
5 | Information Library. | ||||||
6 | (d-10) "Compounding" means the preparation and mixing of | ||||||
7 | components, excluding flavorings, (1) as the result of a | ||||||
8 | prescriber's prescription drug order or initiative based on | ||||||
9 | the prescriber-patient-pharmacist relationship in the course | ||||||
10 | of professional practice or (2) for the purpose of, or | ||||||
11 | incident to, research, teaching, or chemical analysis and not | ||||||
12 | for sale or dispensing. "Compounding" includes the preparation | ||||||
13 | of drugs or devices in anticipation of receiving prescription | ||||||
14 | drug orders based on routine, regularly observed dispensing | ||||||
15 | patterns. Commercially available products may be compounded | ||||||
16 | for dispensing to individual patients only if both of the | ||||||
17 | following conditions are met: (i) the commercial product is | ||||||
18 | not reasonably available from normal distribution channels in | ||||||
19 | a timely manner to meet the patient's needs and (ii) the | ||||||
20 | prescribing practitioner has requested that the drug be | ||||||
21 | compounded. | ||||||
22 | (e) "Control" means to add a drug or other substance, or | ||||||
23 | immediate
precursor, to a Schedule whether by
transfer from | ||||||
24 | another Schedule or otherwise.
| ||||||
25 | (f) "Controlled Substance" means (i) a drug, substance, | ||||||
26 | immediate
precursor, or synthetic drug in the Schedules of |
| |||||||
| |||||||
1 | Article II of this Act or (ii) a drug or other substance, or | ||||||
2 | immediate precursor, designated as a controlled substance by | ||||||
3 | the Department through administrative rule. The term does not | ||||||
4 | include distilled spirits, wine, malt beverages, or tobacco, | ||||||
5 | as those terms are
defined or used in the Liquor Control Act of | ||||||
6 | 1934 and the Tobacco Products Tax
Act of 1995.
| ||||||
7 | (f-5) "Controlled substance analog" means a substance: | ||||||
8 | (1) the chemical structure of which is substantially | ||||||
9 | similar to the chemical structure of a controlled | ||||||
10 | substance in Schedule I or II; | ||||||
11 | (2) which has a stimulant, depressant, or | ||||||
12 | hallucinogenic effect on the central nervous system that | ||||||
13 | is substantially similar to or greater than the stimulant, | ||||||
14 | depressant, or hallucinogenic effect on the central | ||||||
15 | nervous system of a controlled substance in Schedule I or | ||||||
16 | II; or | ||||||
17 | (3) with respect to a particular person, which such | ||||||
18 | person represents or intends to have a stimulant, | ||||||
19 | depressant, or hallucinogenic effect on the central | ||||||
20 | nervous system that is substantially similar to or greater | ||||||
21 | than the stimulant, depressant, or hallucinogenic effect | ||||||
22 | on the central nervous system of a controlled substance in | ||||||
23 | Schedule I or II. | ||||||
24 | (g) "Counterfeit substance" means a controlled substance, | ||||||
25 | which, or
the container or labeling of which, without | ||||||
26 | authorization bears the
trademark, trade name, or other |
| |||||||
| |||||||
1 | identifying mark, imprint, number or
device, or any likeness | ||||||
2 | thereof, of a manufacturer, distributor, or
dispenser other | ||||||
3 | than the person who in fact manufactured, distributed,
or | ||||||
4 | dispensed the substance.
| ||||||
5 | (h) "Deliver" or "delivery" means the actual, constructive | ||||||
6 | or
attempted transfer of possession of a controlled substance, | ||||||
7 | with or
without consideration, whether or not there is an | ||||||
8 | agency relationship.
"Deliver" or "delivery" does not include
| ||||||
9 | the donation of drugs to the extent permitted
under the | ||||||
10 | Illinois Drug Reuse Opportunity Program Act.
| ||||||
11 | (i) "Department" means the Illinois Department of Human | ||||||
12 | Services (as
successor to the Department of Alcoholism and | ||||||
13 | Substance Abuse) or its successor agency.
| ||||||
14 | (j) (Blank).
| ||||||
15 | (k) "Department of Corrections" means the Department of | ||||||
16 | Corrections
of the State of Illinois or its successor agency.
| ||||||
17 | (l) "Department of Financial and Professional Regulation" | ||||||
18 | means the Department
of Financial and Professional Regulation | ||||||
19 | of the State of Illinois or its successor agency.
| ||||||
20 | (m) "Depressant" means any drug that (i) causes an overall | ||||||
21 | depression of central nervous system functions, (ii) causes | ||||||
22 | impaired consciousness and awareness, and (iii) can be | ||||||
23 | habit-forming or lead to a substance abuse problem, including | ||||||
24 | but not limited to alcohol, cannabis and its active principles | ||||||
25 | and their analogs, benzodiazepines and their analogs, | ||||||
26 | barbiturates and their analogs, opioids (natural and |
| |||||||
| |||||||
1 | synthetic) and their analogs, and chloral hydrate and similar | ||||||
2 | sedative hypnotics.
| ||||||
3 | (n) (Blank).
| ||||||
4 | (o) "Director" means the Director of the Illinois State | ||||||
5 | Police or his or her designated agents.
| ||||||
6 | (p) "Dispense" means to deliver a controlled substance to | ||||||
7 | an
ultimate user or research subject by or pursuant to the | ||||||
8 | lawful order of
a prescriber, including the prescribing, | ||||||
9 | administering, packaging,
labeling, or compounding necessary | ||||||
10 | to prepare the substance for that
delivery.
| ||||||
11 | (q) "Dispenser" means a practitioner who dispenses.
| ||||||
12 | (r) "Distribute" means to deliver, other than by | ||||||
13 | administering or
dispensing, a controlled substance.
| ||||||
14 | (s) "Distributor" means a person who distributes.
| ||||||
15 | (t) "Drug" means (1) substances recognized as drugs in the | ||||||
16 | official
United States Pharmacopoeia, Official Homeopathic | ||||||
17 | Pharmacopoeia of the
United States, or official National | ||||||
18 | Formulary, or any supplement to any
of them; (2) substances | ||||||
19 | intended for use in diagnosis, cure, mitigation,
treatment, or | ||||||
20 | prevention of disease in man or animals; (3) substances
(other | ||||||
21 | than food) intended to affect the structure of any function of
| ||||||
22 | the body of man or animals and (4) substances intended for use | ||||||
23 | as a
component of any article specified in clause (1), (2), or | ||||||
24 | (3) of this
subsection. It does not include devices or their | ||||||
25 | components, parts, or
accessories.
| ||||||
26 | (t-3) "Electronic health record" or "EHR" means an |
| |||||||
| |||||||
1 | electronic record of health-related information on an | ||||||
2 | individual that is created, gathered, managed, and consulted | ||||||
3 | by authorized health care clinicians and staff. | ||||||
4 | (t-4) "Emergency medical services personnel" has the | ||||||
5 | meaning ascribed to it in the Emergency Medical Services (EMS) | ||||||
6 | Systems Act. | ||||||
7 | (t-5) "Euthanasia agency" means
an entity certified by the | ||||||
8 | Department of Financial and Professional Regulation for the
| ||||||
9 | purpose of animal euthanasia that holds an animal control | ||||||
10 | facility license or
animal
shelter license under the Animal | ||||||
11 | Welfare Act. A euthanasia agency is
authorized to purchase, | ||||||
12 | store, possess, and utilize Schedule II nonnarcotic and
| ||||||
13 | Schedule III nonnarcotic drugs for the sole purpose of animal | ||||||
14 | euthanasia.
| ||||||
15 | (t-10) "Euthanasia drugs" means Schedule II or Schedule | ||||||
16 | III substances
(nonnarcotic controlled substances) that are | ||||||
17 | used by a euthanasia agency for
the purpose of animal | ||||||
18 | euthanasia.
| ||||||
19 | (u) "Good faith" means the prescribing or dispensing of a | ||||||
20 | controlled
substance by a practitioner in the regular course | ||||||
21 | of professional
treatment to or for any person who is under his | ||||||
22 | or her treatment for a
pathology or condition other than that | ||||||
23 | individual's physical or
psychological dependence upon or | ||||||
24 | addiction to a controlled substance,
except as provided | ||||||
25 | herein: and application of the term to a pharmacist
shall mean | ||||||
26 | the dispensing of a controlled substance pursuant to the
|
| |||||||
| |||||||
1 | prescriber's order which in the professional judgment of the | ||||||
2 | pharmacist
is lawful. The pharmacist shall be guided by | ||||||
3 | accepted professional
standards including, but not limited to | ||||||
4 | the following, in making the
judgment:
| ||||||
5 | (1) lack of consistency of prescriber-patient | ||||||
6 | relationship,
| ||||||
7 | (2) frequency of prescriptions for same drug by one | ||||||
8 | prescriber for
large numbers of patients,
| ||||||
9 | (3) quantities beyond those normally prescribed,
| ||||||
10 | (4) unusual dosages (recognizing that there may be | ||||||
11 | clinical circumstances where more or less than the usual | ||||||
12 | dose may be used legitimately),
| ||||||
13 | (5) unusual geographic distances between patient, | ||||||
14 | pharmacist and
prescriber,
| ||||||
15 | (6) consistent prescribing of habit-forming drugs.
| ||||||
16 | (u-0.5) "Hallucinogen" means a drug that causes markedly | ||||||
17 | altered sensory perception leading to hallucinations of any | ||||||
18 | type. | ||||||
19 | (u-1) "Home infusion services" means services provided by | ||||||
20 | a pharmacy in
compounding solutions for direct administration | ||||||
21 | to a patient in a private
residence, long-term care facility, | ||||||
22 | or hospice setting by means of parenteral,
intravenous, | ||||||
23 | intramuscular, subcutaneous, or intraspinal infusion.
| ||||||
24 | (u-5) "Illinois State Police" means the State
Police of | ||||||
25 | the State of Illinois, or its successor agency. | ||||||
26 | (v) "Immediate precursor" means a substance:
|
| |||||||
| |||||||
1 | (1) which the Department has found to be and by rule | ||||||
2 | designated as
being a principal compound used, or produced | ||||||
3 | primarily for use, in the
manufacture of a controlled | ||||||
4 | substance;
| ||||||
5 | (2) which is an immediate chemical intermediary used | ||||||
6 | or likely to
be used in the manufacture of such controlled | ||||||
7 | substance; and
| ||||||
8 | (3) the control of which is necessary to prevent, | ||||||
9 | curtail or limit
the manufacture of such controlled | ||||||
10 | substance.
| ||||||
11 | (w) "Instructional activities" means the acts of teaching, | ||||||
12 | educating
or instructing by practitioners using controlled | ||||||
13 | substances within
educational facilities approved by the State | ||||||
14 | Board of Education or
its successor agency.
| ||||||
15 | (x) "Local authorities" means a duly organized State, | ||||||
16 | County or
Municipal peace unit or police force.
| ||||||
17 | (y) "Look-alike substance" means a substance, other than a | ||||||
18 | controlled
substance which (1) by overall dosage unit | ||||||
19 | appearance, including shape,
color, size, markings or lack | ||||||
20 | thereof, taste, consistency, or any other
identifying physical | ||||||
21 | characteristic of the substance, would lead a reasonable
| ||||||
22 | person to believe that the substance is a controlled | ||||||
23 | substance, or (2) is
expressly or impliedly represented to be | ||||||
24 | a controlled substance or is
distributed under circumstances | ||||||
25 | which would lead a reasonable person to
believe that the | ||||||
26 | substance is a controlled substance. For the purpose of
|
| |||||||
| |||||||
1 | determining whether the representations made or the | ||||||
2 | circumstances of the
distribution would lead a reasonable | ||||||
3 | person to believe the substance to be
a controlled substance | ||||||
4 | under this clause (2) of subsection (y), the court or
other | ||||||
5 | authority may consider the following factors in addition to | ||||||
6 | any other
factor that may be relevant:
| ||||||
7 | (a) statements made by the owner or person in control | ||||||
8 | of the substance
concerning its nature, use or effect;
| ||||||
9 | (b) statements made to the buyer or recipient that the | ||||||
10 | substance may
be resold for profit;
| ||||||
11 | (c) whether the substance is packaged in a manner | ||||||
12 | normally used for the
illegal distribution of controlled | ||||||
13 | substances;
| ||||||
14 | (d) whether the distribution or attempted distribution | ||||||
15 | included an
exchange of or demand for money or other | ||||||
16 | property as consideration, and
whether the amount of the | ||||||
17 | consideration was substantially greater than the
| ||||||
18 | reasonable retail market value of the substance.
| ||||||
19 | Clause (1) of this subsection (y) shall not apply to a | ||||||
20 | noncontrolled
substance in its finished dosage form that was | ||||||
21 | initially introduced into
commerce prior to the initial | ||||||
22 | introduction into commerce of a controlled
substance in its | ||||||
23 | finished dosage form which it may substantially resemble.
| ||||||
24 | Nothing in this subsection (y) prohibits the dispensing or | ||||||
25 | distributing
of noncontrolled substances by persons authorized | ||||||
26 | to dispense and
distribute controlled substances under this |
| |||||||
| |||||||
1 | Act, provided that such action
would be deemed to be carried | ||||||
2 | out in good faith under subsection (u) if the
substances | ||||||
3 | involved were controlled substances.
| ||||||
4 | Nothing in this subsection (y) or in this Act prohibits | ||||||
5 | the manufacture,
preparation, propagation, compounding, | ||||||
6 | processing, packaging, advertising
or distribution of a drug | ||||||
7 | or drugs by any person registered pursuant to
Section 510 of | ||||||
8 | the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
| ||||||
9 | (y-1) "Mail-order pharmacy" means a pharmacy that is | ||||||
10 | located in a state
of the United States that delivers, | ||||||
11 | dispenses or
distributes, through the United States Postal | ||||||
12 | Service or other common
carrier, to Illinois residents, any | ||||||
13 | substance which requires a prescription.
| ||||||
14 | (z) "Manufacture" means the production, preparation, | ||||||
15 | propagation,
compounding, conversion or processing of a | ||||||
16 | controlled substance other than methamphetamine, either
| ||||||
17 | directly or indirectly, by extraction from substances of | ||||||
18 | natural origin,
or independently by means of chemical | ||||||
19 | synthesis, or by a combination of
extraction and chemical | ||||||
20 | synthesis, and includes any packaging or
repackaging of the | ||||||
21 | substance or labeling of its container, except that
this term | ||||||
22 | does not include:
| ||||||
23 | (1) by an ultimate user, the preparation or | ||||||
24 | compounding of a
controlled substance for his or her own | ||||||
25 | use; or
| ||||||
26 | (2) by a practitioner, or his or her authorized agent |
| |||||||
| |||||||
1 | under his or her
supervision, the preparation, | ||||||
2 | compounding, packaging, or labeling of a
controlled | ||||||
3 | substance:
| ||||||
4 | (a) as an incident to his or her administering or | ||||||
5 | dispensing of a
controlled substance in the course of | ||||||
6 | his or her professional practice; or
| ||||||
7 | (b) as an incident to lawful research, teaching or | ||||||
8 | chemical
analysis and not for sale ; or .
| ||||||
9 | (3) the packaging, repackaging, or labeling of
drugs | ||||||
10 | only to the extent permitted under the
Illinois Drug Reuse | ||||||
11 | Opportunity Program Act.
| ||||||
12 | (z-1) (Blank).
| ||||||
13 | (z-5) "Medication shopping" means the conduct prohibited | ||||||
14 | under subsection (a) of Section 314.5 of this Act. | ||||||
15 | (z-10) "Mid-level practitioner" means (i) a physician | ||||||
16 | assistant who has been delegated authority to prescribe | ||||||
17 | through a written delegation of authority by a physician | ||||||
18 | licensed to practice medicine in all of its branches, in | ||||||
19 | accordance with Section 7.5 of the Physician Assistant | ||||||
20 | Practice Act of 1987, (ii) an advanced practice registered | ||||||
21 | nurse who has been delegated authority to prescribe through a | ||||||
22 | written delegation of authority by a physician licensed to | ||||||
23 | practice medicine in all of its branches or by a podiatric | ||||||
24 | physician, in accordance with Section 65-40 of the Nurse | ||||||
25 | Practice Act, (iii) an advanced practice registered nurse | ||||||
26 | certified as a nurse practitioner, nurse midwife, or clinical |
| |||||||
| |||||||
1 | nurse specialist who has been granted authority to prescribe | ||||||
2 | by a hospital affiliate in accordance with Section 65-45 of | ||||||
3 | the Nurse Practice Act, (iv) an animal euthanasia agency, or | ||||||
4 | (v) a prescribing psychologist. | ||||||
5 | (aa) "Narcotic drug" means any of the following, whether | ||||||
6 | produced
directly or indirectly by extraction from substances | ||||||
7 | of vegetable origin,
or independently by means of chemical | ||||||
8 | synthesis, or by a combination of
extraction and chemical | ||||||
9 | synthesis:
| ||||||
10 | (1) opium, opiates, derivatives of opium and opiates, | ||||||
11 | including their isomers, esters, ethers, salts, and salts | ||||||
12 | of isomers, esters, and ethers, whenever the existence of | ||||||
13 | such isomers, esters, ethers, and salts is possible within | ||||||
14 | the specific chemical designation; however the term | ||||||
15 | "narcotic drug" does not include the isoquinoline | ||||||
16 | alkaloids of opium;
| ||||||
17 | (2) (blank);
| ||||||
18 | (3) opium poppy and poppy straw;
| ||||||
19 | (4) coca leaves, except coca leaves and extracts of | ||||||
20 | coca leaves from which substantially all of the cocaine | ||||||
21 | and ecgonine, and their isomers, derivatives and salts, | ||||||
22 | have been removed;
| ||||||
23 | (5) cocaine, its salts, optical and geometric isomers, | ||||||
24 | and salts of isomers; | ||||||
25 | (6) ecgonine, its derivatives, their salts, isomers, | ||||||
26 | and salts of isomers; |
| |||||||
| |||||||
1 | (7) any compound, mixture, or preparation which | ||||||
2 | contains any quantity of any of the substances referred to | ||||||
3 | in subparagraphs (1) through (6). | ||||||
4 | (bb) "Nurse" means a registered nurse licensed under the
| ||||||
5 | Nurse Practice Act.
| ||||||
6 | (cc) (Blank).
| ||||||
7 | (dd) "Opiate" means any substance having an addiction | ||||||
8 | forming or
addiction sustaining liability similar to morphine | ||||||
9 | or being capable of
conversion into a drug having addiction | ||||||
10 | forming or addiction sustaining
liability.
| ||||||
11 | (ee) "Opium poppy" means the plant of the species Papaver
| ||||||
12 | somniferum L., except its seeds.
| ||||||
13 | (ee-5) "Oral dosage" means a tablet, capsule, elixir, or | ||||||
14 | solution or other liquid form of medication intended for | ||||||
15 | administration by mouth, but the term does not include a form | ||||||
16 | of medication intended for buccal, sublingual, or transmucosal | ||||||
17 | administration. | ||||||
18 | (ff) "Parole and Pardon Board" means the Parole and Pardon | ||||||
19 | Board of
the State of Illinois or its successor agency.
| ||||||
20 | (gg) "Person" means any individual, corporation, | ||||||
21 | mail-order pharmacy,
government or governmental subdivision or | ||||||
22 | agency, business trust, estate,
trust, partnership or | ||||||
23 | association, or any other entity.
| ||||||
24 | (hh) "Pharmacist" means any person who holds a license or | ||||||
25 | certificate of
registration as a registered pharmacist, a | ||||||
26 | local registered pharmacist
or a registered assistant |
| |||||||
| |||||||
1 | pharmacist under the Pharmacy Practice Act.
| ||||||
2 | (ii) "Pharmacy" means any store, ship or other place in | ||||||
3 | which
pharmacy is authorized to be practiced under the | ||||||
4 | Pharmacy Practice Act.
| ||||||
5 | (ii-5) "Pharmacy shopping" means the conduct prohibited | ||||||
6 | under subsection (b) of Section 314.5 of this Act. | ||||||
7 | (ii-10) "Physician" (except when the context otherwise | ||||||
8 | requires) means a person licensed to practice medicine in all | ||||||
9 | of its branches. | ||||||
10 | (jj) "Poppy straw" means all parts, except the seeds, of | ||||||
11 | the opium
poppy, after mowing.
| ||||||
12 | (kk) "Practitioner" means a physician licensed to practice | ||||||
13 | medicine in all
its branches, dentist, optometrist, podiatric | ||||||
14 | physician,
veterinarian, scientific investigator, pharmacist, | ||||||
15 | physician assistant,
advanced practice registered nurse,
| ||||||
16 | licensed practical
nurse, registered nurse, emergency medical | ||||||
17 | services personnel, hospital, laboratory, or pharmacy, or | ||||||
18 | other
person licensed, registered, or otherwise lawfully | ||||||
19 | permitted by the
United States or this State to distribute, | ||||||
20 | dispense, conduct research
with respect to, administer or use | ||||||
21 | in teaching or chemical analysis, a
controlled substance in | ||||||
22 | the course of professional practice or research.
| ||||||
23 | (ll) "Pre-printed prescription" means a written | ||||||
24 | prescription upon which
the designated drug has been indicated | ||||||
25 | prior to the time of issuance; the term does not mean a written | ||||||
26 | prescription that is individually generated by machine or |
| |||||||
| |||||||
1 | computer in the prescriber's office.
| ||||||
2 | (mm) "Prescriber" means a physician licensed to practice | ||||||
3 | medicine in all
its branches, dentist, optometrist, | ||||||
4 | prescribing psychologist licensed under Section 4.2 of the | ||||||
5 | Clinical Psychologist Licensing Act with prescriptive | ||||||
6 | authority delegated under Section 4.3 of the Clinical | ||||||
7 | Psychologist Licensing Act, podiatric physician, or
| ||||||
8 | veterinarian who issues a prescription, a physician assistant | ||||||
9 | who
issues a
prescription for a controlled substance
in | ||||||
10 | accordance
with Section 303.05, a written delegation, and a | ||||||
11 | written collaborative agreement required under Section 7.5
of | ||||||
12 | the
Physician Assistant Practice Act of 1987, an advanced | ||||||
13 | practice registered
nurse with prescriptive authority | ||||||
14 | delegated under Section 65-40 of the Nurse Practice Act and in | ||||||
15 | accordance with Section 303.05, a written delegation,
and a | ||||||
16 | written
collaborative agreement under Section 65-35 of the | ||||||
17 | Nurse Practice Act, an advanced practice registered nurse | ||||||
18 | certified as a nurse practitioner, nurse midwife, or clinical | ||||||
19 | nurse specialist who has been granted authority to prescribe | ||||||
20 | by a hospital affiliate in accordance with Section 65-45 of | ||||||
21 | the Nurse Practice Act and in accordance with Section 303.05, | ||||||
22 | or an advanced practice registered nurse certified as a nurse | ||||||
23 | practitioner, nurse midwife, or clinical nurse specialist who | ||||||
24 | has full practice authority pursuant to Section 65-43 of the | ||||||
25 | Nurse Practice Act.
| ||||||
26 | (nn) "Prescription" means a written, facsimile, or oral |
| |||||||
| |||||||
1 | order, or an electronic order that complies with applicable | ||||||
2 | federal requirements,
of
a physician licensed to practice | ||||||
3 | medicine in all its branches,
dentist, podiatric physician or | ||||||
4 | veterinarian for any controlled
substance, of an optometrist | ||||||
5 | in accordance with Section 15.1 of the Illinois Optometric | ||||||
6 | Practice Act of 1987, of a prescribing psychologist licensed | ||||||
7 | under Section 4.2 of the Clinical Psychologist Licensing Act | ||||||
8 | with prescriptive authority delegated under Section 4.3 of the | ||||||
9 | Clinical Psychologist Licensing Act, of a physician assistant | ||||||
10 | for a
controlled substance
in accordance with Section 303.05, | ||||||
11 | a written delegation, and a written collaborative agreement | ||||||
12 | required under
Section 7.5 of the
Physician Assistant Practice | ||||||
13 | Act of 1987, of an advanced practice registered
nurse with | ||||||
14 | prescriptive authority delegated under Section 65-40 of the | ||||||
15 | Nurse Practice Act who issues a prescription for a
controlled | ||||||
16 | substance in accordance
with
Section 303.05, a written | ||||||
17 | delegation, and a written collaborative agreement under | ||||||
18 | Section 65-35 of the Nurse Practice Act, of an advanced | ||||||
19 | practice registered nurse certified as a nurse practitioner, | ||||||
20 | nurse midwife, or clinical nurse specialist who has been | ||||||
21 | granted authority to prescribe by a hospital affiliate in | ||||||
22 | accordance with Section 65-45 of the Nurse Practice Act and in | ||||||
23 | accordance with Section 303.05 when required by law, or of an | ||||||
24 | advanced practice registered nurse certified as a nurse | ||||||
25 | practitioner, nurse midwife, or clinical nurse specialist who | ||||||
26 | has full practice authority pursuant to Section 65-43 of the |
| |||||||
| |||||||
1 | Nurse Practice Act.
| ||||||
2 | (nn-5) "Prescription Information Library" (PIL) means an | ||||||
3 | electronic library that contains reported controlled substance | ||||||
4 | data. | ||||||
5 | (nn-10) "Prescription Monitoring Program" (PMP) means the | ||||||
6 | entity that collects, tracks, and stores reported data on | ||||||
7 | controlled substances and select drugs pursuant to Section | ||||||
8 | 316. | ||||||
9 | (oo) "Production" or "produce" means manufacture, | ||||||
10 | planting,
cultivating, growing, or harvesting of a controlled | ||||||
11 | substance other than methamphetamine.
| ||||||
12 | (pp) "Registrant" means every person who is required to | ||||||
13 | register
under Section 302 of this Act.
| ||||||
14 | (qq) "Registry number" means the number assigned to each | ||||||
15 | person
authorized to handle controlled substances under the | ||||||
16 | laws of the United
States and of this State.
| ||||||
17 | (qq-5) "Secretary" means, as the context requires, either | ||||||
18 | the Secretary of the Department or the Secretary of the | ||||||
19 | Department of Financial and Professional Regulation, and the | ||||||
20 | Secretary's designated agents. | ||||||
21 | (rr) "State" includes the State of Illinois and any state, | ||||||
22 | district,
commonwealth, territory, insular possession thereof, | ||||||
23 | and any area
subject to the legal authority of the United | ||||||
24 | States of America.
| ||||||
25 | (rr-5) "Stimulant" means any drug that (i) causes an | ||||||
26 | overall excitation of central nervous system functions, (ii) |
| |||||||
| |||||||
1 | causes impaired consciousness and awareness, and (iii) can be | ||||||
2 | habit-forming or lead to a substance abuse problem, including | ||||||
3 | but not limited to amphetamines and their analogs, | ||||||
4 | methylphenidate and its analogs, cocaine, and phencyclidine | ||||||
5 | and its analogs. | ||||||
6 | (rr-10) "Synthetic drug" includes, but is not limited to, | ||||||
7 | any synthetic cannabinoids or piperazines or any synthetic | ||||||
8 | cathinones as provided for in Schedule I. | ||||||
9 | (ss) "Ultimate user" means a person who lawfully possesses | ||||||
10 | a
controlled substance for his or her own use or for the use of | ||||||
11 | a member of his or her
household or for administering to an | ||||||
12 | animal owned by him or her or by a member
of his or her | ||||||
13 | household.
| ||||||
14 | (Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15; | ||||||
15 | 99-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff. | ||||||
16 | 7-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513, | ||||||
17 | eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18 .)
| ||||||
18 | Section 115. The Cannabis and Controlled Substances Tort | ||||||
19 | Claims Act is amended by changing Section 3 as follows:
| ||||||
20 | (740 ILCS 20/3) (from Ch. 70, par. 903)
| ||||||
21 | Sec. 3. Definitions. As used in this Act, unless the | ||||||
22 | context otherwise
requires:
| ||||||
23 | "Cannabis" includes marihuana, hashish, and other | ||||||
24 | substances that
are identified as including any parts of the |
| |||||||
| |||||||
1 | plant Cannabis Sativa, whether
growing or not, the seeds of | ||||||
2 | that plant, the resin extracted from any part of
that plant, | ||||||
3 | and any compound, manufacture, salt, derivative, mixture, or
| ||||||
4 | preparation of that plant, its seeds, or resin, including
| ||||||
5 | tetrahydrocannabinol (THC) and all other cannabinol | ||||||
6 | derivatives, including
its naturally occurring or | ||||||
7 | synthetically produced ingredients, whether
produced directly | ||||||
8 | or indirectly by extraction, independently by means of
| ||||||
9 | chemical synthesis, or by a combination of extraction and | ||||||
10 | chemical
synthesis. "Cannabis" does not include the mature | ||||||
11 | stalks of that plant, fiber
produced from those stalks, oil or | ||||||
12 | cake made from the seeds of that plant,
any other compound, | ||||||
13 | manufacture, salt, derivative, mixture, or preparation
of | ||||||
14 | mature stalks (except the extracted resin), fiber, oil
or | ||||||
15 | cake, or the sterilized seeds of that plant that are incapable | ||||||
16 | of
germination.
| ||||||
17 | "Controlled substance" means a drug, substance, or | ||||||
18 | immediate precursor in
the Schedules of Article II of the | ||||||
19 | Illinois Controlled Substances Act.
| ||||||
20 | "Counterfeit substance" means a controlled substance or | ||||||
21 | the container or
labeling of a controlled substance that, | ||||||
22 | without authorization, bears the
trademark, trade name, or | ||||||
23 | other identifying mark, imprint, number, device,
or any | ||||||
24 | likeness thereof of a manufacturer, distributor, or dispenser | ||||||
25 | other
than the person who in fact manufactured, distributed, | ||||||
26 | or dispensed the
substance.
|
| |||||||
| |||||||
1 | "Deliver" or "delivery" means the actual, constructive, or | ||||||
2 | attempted
transfer of possession of a controlled substance or | ||||||
3 | cannabis, with or
without consideration, whether or not there | ||||||
4 | is an agency relationship. "Deliver" or "delivery" does not
| ||||||
5 | include the donation of drugs to the extent
permitted under | ||||||
6 | the Illinois Drug Reuse Opportunity Program Act.
| ||||||
7 | "Manufacture" means the production, preparation, | ||||||
8 | propagation,
compounding, conversion, or processing of a | ||||||
9 | controlled substance, either
directly or indirectly, by | ||||||
10 | extraction from substances of natural origin,
independently by | ||||||
11 | means of chemical synthesis, or by a combination of
extraction | ||||||
12 | and chemical synthesis, and includes any packaging or
| ||||||
13 | repackaging of the substance or labeling of its container, | ||||||
14 | except that the
term does not include:
| ||||||
15 | (1) by an ultimate user, the preparation or | ||||||
16 | compounding of a
controlled substance for his own use;
| ||||||
17 | (2) by a practitioner or his authorized agent under | ||||||
18 | his supervision,
the preparation, compounding, packaging, | ||||||
19 | or labeling of a controlled substance:
| ||||||
20 | (A) as an incident to his administering or | ||||||
21 | dispensing of a controlled
substance in the course of | ||||||
22 | his professional practice; or
| ||||||
23 | (B) as an incident to lawful research, teaching or | ||||||
24 | chemical analysis
and not for sale; or
| ||||||
25 | (3) the preparation, compounding, packaging, or | ||||||
26 | labeling of cannabis
as an incident to lawful research, |
| |||||||
| |||||||
1 | teaching, or chemical analysis and not
for sale ; or . | ||||||
2 | (4) the packaging, repackaging, or labeling of
drugs | ||||||
3 | only to the extent permitted under the
Illinois Drug Reuse | ||||||
4 | Opportunity Program Act.
| ||||||
5 | "Owner" means a person who has possession of or any | ||||||
6 | interest
whatsoever in the property involved.
| ||||||
7 | "Person" means an individual, a corporation, a government,
| ||||||
8 | a governmental subdivision or agency, a business trust, an | ||||||
9 | estate, a trust,
a partnership or association, or any other | ||||||
10 | entity.
| ||||||
11 | "Production" means planting, cultivating, tending, or | ||||||
12 | harvesting.
| ||||||
13 | "Property" means real property, including things growing | ||||||
14 | on,
affixed to, and found in land, and tangible or intangible | ||||||
15 | personal
property, including rights, services, privileges, | ||||||
16 | interests, claims,
and securities.
| ||||||
17 | (Source: P.A. 96-328, eff. 8-11-09.)
|