Full Text of SB0516 102nd General Assembly
SB0516sam001 102ND GENERAL ASSEMBLY | Sen. Karina Villa Filed: 4/7/2021
| | 10200SB0516sam001 | | LRB102 16149 CPF 23544 a |
|
| 1 | | AMENDMENT TO SENATE BILL 516
| 2 | | AMENDMENT NO. ______. Amend Senate Bill 516 by replacing | 3 | | everything after the enacting clause with the following:
| 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 |
| | | 10200SB0516sam001 | - 2 - | LRB102 16149 CPF 23544 a |
|
| 1 | | pharmacy school, prescriber or other health care professional, | 2 | | long-term care facility, or healthcare facility. "Donor" | 3 | | includes government agencies and entities that are federally | 4 | | authorized to possess medicine, including, but not limited to, | 5 | | drug manufacturers, repackagers, relabelers, outsourcing | 6 | | facilities, health care facilities operated by the U.S. | 7 | | Department of Veterans Affairs, and prisons. | 8 | | "Drug" means a prescription drug, over-the-counter drug, | 9 | | or supplies needed to administer a prescription or | 10 | | over-the-counter drug. | 11 | | "Eligible patient" means an individual: | 12 | | (1) with a prescription for the drug, if a | 13 | | prescription is required to dispense the drug, or who | 14 | | reports symptoms treated by the drug if the drug is | 15 | | over-the-counter; and | 16 | | (2) who is registered with the drug's manufacturer in | 17 | | accordance with federal Food and Drug Administration | 18 | | requirements, if the registration is required to dispense | 19 | | the drug. | 20 | | "Manufacturer" has the same meaning as defined in Section | 21 | | 15 of the Wholesale Drug Distribution Licensing Act. | 22 | | "Pharmacist" means an individual licensed to engage in the | 23 | | practice of pharmacy under the Pharmacy Practice Act or | 24 | | licensed to engage in the practice of pharmacy in another | 25 | | state. | 26 | | "Practitioner" means a person licensed in this State to |
| | | 10200SB0516sam001 | - 3 - | LRB102 16149 CPF 23544 a |
|
| 1 | | dispense or administer drugs or who is licensed in another | 2 | | state as a person authorized to dispense or administer drugs. | 3 | | "Prescription drug" means any prescribed drug that may be | 4 | | legally dispensed by a pharmacy. | 5 | | "Priority patient" means an eligible patient who is an | 6 | | Illinois resident and who is indigent, uninsured, | 7 | | underinsured, or enrolled in a public health benefits program. | 8 | | "Recipient" means any person or entity legally authorized | 9 | | to possess medicine with a license or permit in the state in | 10 | | which the person or entity is located, including, but not | 11 | | limited to, a wholesaler or distributor, reverse distributor, | 12 | | repackager, hospital, pharmacy, clinic, or prescriber office. | 13 | | "Returns processor" has the same meaning as defined in | 14 | | paragraph (18) of 21 U.S.C. 360eee. "Returns processor" | 15 | | includes, but is not limited to, a reverse distributor. | 16 | | "Unopened tamper-evident packaging" has the same meaning | 17 | | as defined in the United States Pharmacopeia (USP) General | 18 | | Chapter 659, Packaging and Storage Requirements, including, | 19 | | but not limited to, unopened unit-dose, multiple-dose, | 20 | | immediate, secondary, and tertiary packaging.
| 21 | | Section 10. Donating and receiving drugs. Notwithstanding | 22 | | any other law or rule, donors may donate drugs to recipients | 23 | | and recipients may receive donated drugs from donors. | 24 | | Recipients shall only dispense or administer drugs to eligible | 25 | | patients as described in Section 20, further donate drugs to |
| | | 10200SB0516sam001 | - 4 - | LRB102 16149 CPF 23544 a |
|
| 1 | | another recipient as described in Section 30, or dispose of | 2 | | drugs as described in Section 35. | 3 | | Section 15. Cost-free provision of drugs. Drugs donated | 4 | | for use under this Act are considered nonsaleable. When | 5 | | dispensing a drug to an eligible patient, the recipient must | 6 | | do so at no cost to the eligible patient, except that a | 7 | | reasonable handling fee may be charged. The handling fee may | 8 | | not exceed the direct or indirect cost to the recipient of | 9 | | providing the drug. Charging the fee does not constitute | 10 | | reselling. | 11 | | Section 20. Requirements for dispensing drugs; priority. | 12 | | (a) A recipient may only dispense or administer a | 13 | | prescription drug or provide an over-the-counter drug: | 14 | | (1) if the recipient is otherwise permitted by law to | 15 | | dispense or administer the drug; | 16 | | (2) that meets the requirements in Section 25; | 17 | | (3) that is repackaged into a new container or is in | 18 | | its original container with all previous patient | 19 | | information redacted or removed; | 20 | | (4) that is properly labeled in accordance with the | 21 | | rules and regulations of the Board of Pharmacy; | 22 | | (5) that has an expiration or beyond-use date brought | 23 | | forward from the donated prescription drug or | 24 | | over-the-counter drug that will not expire before the use |
| | | 10200SB0516sam001 | - 5 - | LRB102 16149 CPF 23544 a |
|
| 1 | | by the eligible patient based on the prescribing | 2 | | practitioner's directions for use or, for over-the-counter | 3 | | medicine, on the package's label; and | 4 | | (6) that is not adulterated or misbranded, as | 5 | | determined by a pharmacist or practitioner. | 6 | | (b) Recipients shall, to the greatest extent practicable, | 7 | | dispense drugs received under this Act to priority patients. | 8 | | Section 25. Requirements for accepting drugs. A drug | 9 | | received but not yet accepted into inventory shall be kept in a | 10 | | separate designated area. A drug may be accepted under this | 11 | | Act only if all of the following requirements are met: | 12 | | (1) The drug is in unopened tamper-evident packaging | 13 | | or has been repackaged according to Section 30. | 14 | | (2) The drug is not expired. | 15 | | (3) The drug is not a controlled substance. | 16 | | (4) The recipient maintains a written or electronic | 17 | | record of a donation made under this Act consisting of the | 18 | | name, strength, and quantity of each accepted drug and the | 19 | | name, address, and telephone number of the donor, unless a | 20 | | recipient is further donating to a recipient under common | 21 | | ownership or common control. Notwithstanding any other law | 22 | | or rule, no other record of a donation is required. | 23 | | (5) The donor has removed or redacted any patient name | 24 | | and prescription number on the drug or otherwise maintains | 25 | | patient confidentiality by executing a confidentiality |
| | | 10200SB0516sam001 | - 6 - | LRB102 16149 CPF 23544 a |
|
| 1 | | agreement with the recipient. | 2 | | (6) The drug has a method recognized by the United | 3 | | States Pharmacopeia to detect improper temperature | 4 | | variations if the drug requires temperature control other | 5 | | than room temperature storage.
| 6 | | Section 30. Donating and repackaging. Notwithstanding any | 7 | | other law or rule, a recipient may: | 8 | | (1) further donate drugs to another recipient; | 9 | | (2) repackage donated drugs as necessary for storage, | 10 | | dispensing, administration, or transfers in accordance | 11 | | with the following: | 12 | | (A) repackaged medicine shall be labeled with the | 13 | | drug's name, strength, and expiration date, and shall | 14 | | be kept in a separate designated area until inspected | 15 | | and initialed by a pharmacist, practitioner, or a | 16 | | pharmacy technician; and | 17 | | (B) if multiple packaged donated medicines with | 18 | | varied expiration dates are repackaged together, the | 19 | | shortest expiration date shall be used; and
| 20 | | (3) replenish a drug of the same drug name and | 21 | | strength previously dispensed or administered to an | 22 | | eligible patient in accordance with Section 340B of the | 23 | | federal Public Health Service Act. | 24 | | Section 35. Disposition of drugs. A donated drug that does |
| | | 10200SB0516sam001 | - 7 - | LRB102 16149 CPF 23544 a |
|
| 1 | | not meet the requirements of Section 25 must be disposed of by | 2 | | returning it to the donor, destroying it by an incinerator, | 3 | | medical waste hauler, or other lawful method, or transferring | 4 | | it to a returns processor. A record of disposal shall consist | 5 | | of the disposal method, the date of disposal, and the name and | 6 | | quantity of the drug disposed of. Notwithstanding any other | 7 | | law or rule, no other record of disposal shall be required. | 8 | | Section 40. Participation not required. Nothing in this | 9 | | Act requires that a pharmacy or pharmacist be a recipient of | 10 | | drugs under this Act. | 11 | | Section 45. Recordkeeping requirements. When performing | 12 | | any action associated with a program under this Act or | 13 | | otherwise processing a donated drug for tax, manufacturer, or | 14 | | other credit, a recipient shall be considered to be acting as a | 15 | | returns processor and shall comply with all recordkeeping | 16 | | requirements for nonsaleable returns under federal law. | 17 | | Section 50. Change of ownership. A donation or other | 18 | | transfer of possession or control of a drug under this Act | 19 | | shall not be construed as a change of ownership unless it is | 20 | | specified as such by the recipient. If a record of the | 21 | | donation's transaction information or history is required, the | 22 | | history shall begin with the donor of the drug, include all | 23 | | prior donations, and, if the drug was previously dispensed, |
| | | 10200SB0516sam001 | - 8 - | LRB102 16149 CPF 23544 a |
|
| 1 | | only include drug information required to be on the patient | 2 | | label in accordance with the Board of Pharmacy's rules and | 3 | | regulations.
| 4 | | Section 55. Retention of records. All records required | 5 | | under this Act shall be retained in physical or electronic | 6 | | format and on or off the recipient's premises for a period of 6 | 7 | | years. Donors or recipients may contract with one another or a | 8 | | third party to create or maintain records on each other's | 9 | | behalf. An identifier, such as a serial number or bar code, may | 10 | | be used in place of any or all information required by a record | 11 | | or label pursuant to this Act if it allows for such information | 12 | | to be readily retrievable. Upon request by a State or federal | 13 | | regulatory agency, the identifier used for requested records | 14 | | shall be replaced with the original information. An identifier | 15 | | shall not be used on patient labels when dispensing or | 16 | | administering a drug. | 17 | | Section 60. Authority. This Act supersedes any | 18 | | inconsistent law or rule for activities conducted under this | 19 | | Act. | 20 | | Section 65. Immunity. | 21 | | (a) Except as provided in subsection (b), no manufacturer, | 22 | | donor, or recipient shall be liable in any criminal or civil | 23 | | action, or be subject to professional discipline, for |
| | | 10200SB0516sam001 | - 9 - | LRB102 16149 CPF 23544 a |
|
| 1 | | activities solely and directly attributable to donating, | 2 | | receiving, or dispensing drugs under this Act. | 3 | | (b) The immunity provided in subsection (a) shall not | 4 | | apply: | 5 | | (1) if it is shown that the act or omission was an | 6 | | unreasonable, willful, wanton, or reckless act; | 7 | | (2) if it is shown that the person or entity knew or | 8 | | should have known that the donated drug was adulterated or | 9 | | misbranded; or | 10 | | (3) to acts or omissions outside the scope of a | 11 | | program under this Act. | 12 | | Section 90. The Pharmacy Practice Act is amended by | 13 | | changing Section 4 as follows:
| 14 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
| 15 | | (Section scheduled to be repealed on January 1, 2023)
| 16 | | Sec. 4. Exemptions. Nothing contained in any Section of | 17 | | this Act shall
apply
to, or in any manner interfere with:
| 18 | | (a) the lawful practice of any physician licensed to | 19 | | practice medicine in
all of its branches, dentist, | 20 | | podiatric physician,
veterinarian, or therapeutically or | 21 | | diagnostically certified optometrist within
the limits of
| 22 | | his or her license, or prevent him or her from
supplying to | 23 | | his
or her
bona fide patients
such drugs, medicines, or | 24 | | poisons as may seem to him appropriate;
|
| | | 10200SB0516sam001 | - 10 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (b) the sale of compressed gases;
| 2 | | (c) the sale of patent or proprietary medicines and | 3 | | household remedies
when sold in original and unbroken | 4 | | packages only, if such patent or
proprietary medicines and | 5 | | household remedies be properly and adequately
labeled as | 6 | | to content and usage and generally considered and accepted
| 7 | | as harmless and nonpoisonous when used according to the | 8 | | directions
on the label, and also do not contain opium or | 9 | | coca leaves, or any
compound, salt or derivative thereof, | 10 | | or any drug which, according
to the latest editions of the | 11 | | following authoritative pharmaceutical
treatises and | 12 | | standards, namely, The United States | 13 | | Pharmacopoeia/National
Formulary (USP/NF), the United | 14 | | States Dispensatory, and the Accepted
Dental Remedies of | 15 | | the Council of Dental Therapeutics of the American
Dental | 16 | | Association or any or either of them, in use on the | 17 | | effective
date of this Act, or according to the existing | 18 | | provisions of the Federal
Food, Drug, and Cosmetic Act and | 19 | | Regulations of the Department of Health
and Human | 20 | | Services, Food and Drug Administration, promulgated | 21 | | thereunder
now in effect, is designated, described or | 22 | | considered as a narcotic,
hypnotic, habit forming, | 23 | | dangerous, or poisonous drug;
| 24 | | (d) the sale of poultry and livestock remedies in | 25 | | original and unbroken
packages only, labeled for poultry | 26 | | and livestock medication;
|
| | | 10200SB0516sam001 | - 11 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (e) the sale of poisonous substances or mixture of | 2 | | poisonous substances,
in unbroken packages, for | 3 | | nonmedicinal use in the arts or industries
or for | 4 | | insecticide purposes; provided, they are properly and | 5 | | adequately
labeled as to content and such nonmedicinal | 6 | | usage, in conformity
with the provisions of all applicable | 7 | | federal, state and local laws
and regulations promulgated | 8 | | thereunder now in effect relating thereto
and governing | 9 | | the same, and those which are required under such | 10 | | applicable
laws and regulations to be labeled with the | 11 | | word "Poison", are also labeled
with the word "Poison" | 12 | | printed
thereon in prominent type and the name of a | 13 | | readily obtainable antidote
with directions for its | 14 | | administration;
| 15 | | (f) the delegation of limited prescriptive authority | 16 | | by a physician
licensed to
practice medicine in all its | 17 | | branches to a physician assistant
under Section 7.5 of the | 18 | | Physician Assistant Practice Act of 1987. This
delegated | 19 | | authority under Section 7.5 of the Physician Assistant | 20 | | Practice Act of 1987 may, but is not required to, include | 21 | | prescription of
controlled substances, as defined in | 22 | | Article II of the
Illinois Controlled Substances Act, in | 23 | | accordance with a written supervision agreement;
| 24 | | (g) the delegation of prescriptive authority by a | 25 | | physician
licensed to practice medicine in all its | 26 | | branches or a licensed podiatric physician to an advanced |
| | | 10200SB0516sam001 | - 12 - | LRB102 16149 CPF 23544 a |
|
| 1 | | practice
registered nurse in accordance with a written | 2 | | collaborative
agreement under Sections 65-35 and 65-40 of | 3 | | the Nurse Practice Act; and | 4 | | (g-5) the donation or acceptance, or the packaging,
| 5 | | repackaging, or labeling, of drugs to the
extent permitted | 6 | | under the Illinois Drug Reuse Opportunity Program Act; and
| 7 | | (h) the sale or distribution of dialysate or devices | 8 | | necessary to perform home peritoneal renal dialysis for | 9 | | patients with end-stage renal disease, provided that all | 10 | | of the following conditions are met: | 11 | | (1) the dialysate, comprised of dextrose or | 12 | | icodextrin, or devices are approved or cleared by the | 13 | | federal Food and Drug Administration, as required by | 14 | | federal law; | 15 | | (2) the dialysate or devices are lawfully held by | 16 | | a manufacturer or the manufacturer's agent, which is | 17 | | properly registered with the Board as a manufacturer, | 18 | | third-party logistics provider, or wholesaler; | 19 | | (3) the dialysate or devices are held and | 20 | | delivered to the manufacturer or the manufacturer's | 21 | | agent in the original, sealed packaging from the | 22 | | manufacturing facility; | 23 | | (4) the dialysate or devices are delivered only | 24 | | upon receipt of a physician's prescription by a | 25 | | licensed pharmacy in which the prescription is | 26 | | processed in accordance with provisions set forth in |
| | | 10200SB0516sam001 | - 13 - | LRB102 16149 CPF 23544 a |
|
| 1 | | this Act, and the transmittal of an order from the | 2 | | licensed pharmacy to the manufacturer or the | 3 | | manufacturer's agent; and | 4 | | (5) the manufacturer or the manufacturer's agent | 5 | | delivers the dialysate or devices directly to: (i) a | 6 | | patient with end-stage renal disease, or his or her | 7 | | designee, for the patient's self-administration of the | 8 | | dialysis therapy or (ii) a health care provider or | 9 | | institution for administration or delivery of the | 10 | | dialysis therapy to a patient with end-stage renal | 11 | | disease. | 12 | | This paragraph (h) does not include any other drugs | 13 | | for peritoneal dialysis, except dialysate, as described in | 14 | | item (1) of this paragraph (h). All records of sales and | 15 | | distribution of dialysate to patients made pursuant to | 16 | | this paragraph (h) must be retained in accordance with | 17 | | Section 18 of this Act. | 18 | | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | 19 | | 100-863, eff. 8-14-18; 101-420, eff. 8-16-19 .)
| 20 | | Section 95. The Wholesale Drug Distribution Licensing Act | 21 | | is amended by changing Section 15 as follows:
| 22 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| 23 | | (Section scheduled to be repealed on January 1, 2023)
| 24 | | Sec. 15. Definitions. As used in this Act:
|
| | | 10200SB0516sam001 | - 14 - | LRB102 16149 CPF 23544 a |
|
| 1 | | "Authentication" means the affirmative verification, | 2 | | before any wholesale distribution of a prescription drug | 3 | | occurs, that each transaction listed on the pedigree has | 4 | | occurred. | 5 | | "Authorized distributor of record" means a wholesale | 6 | | distributor with whom a manufacturer has established an | 7 | | ongoing relationship to distribute the manufacturer's | 8 | | prescription drug. An ongoing relationship is deemed to exist | 9 | | between a wholesale distributor and a manufacturer when the | 10 | | wholesale distributor, including any affiliated group of the | 11 | | wholesale distributor, as defined in Section 1504 of the | 12 | | Internal Revenue Code, complies with the following: | 13 | | (1) The wholesale distributor has a written agreement | 14 | | currently in effect with the manufacturer evidencing the | 15 | | ongoing relationship; and | 16 | | (2) The wholesale distributor is listed on the | 17 | | manufacturer's current list of authorized distributors of | 18 | | record, which is updated by the manufacturer on no less | 19 | | than a monthly basis.
| 20 | | "Blood" means whole blood collected from a single donor | 21 | | and processed
either for transfusion or further manufacturing.
| 22 | | "Blood component" means that part of blood separated by | 23 | | physical or
mechanical means.
| 24 | | "Board" means the State Board of Pharmacy of the | 25 | | Department of
Professional Regulation.
| 26 | | "Chain pharmacy warehouse" means a physical location for |
| | | 10200SB0516sam001 | - 15 - | LRB102 16149 CPF 23544 a |
|
| 1 | | prescription drugs that acts as a central warehouse and | 2 | | performs intracompany sales or transfers of the drugs to a | 3 | | group of chain or mail order pharmacies that have the same | 4 | | common ownership and control. Notwithstanding any other | 5 | | provision of this Act, a chain pharmacy warehouse shall be | 6 | | considered part of the normal distribution channel. | 7 | | "Co-licensed partner or product" means an instance where | 8 | | one or more parties have the right to engage in the | 9 | | manufacturing or marketing of a prescription drug, consistent | 10 | | with the FDA's implementation of the Prescription Drug | 11 | | Marketing Act.
| 12 | | "Department" means the Department of Financial and
| 13 | | Professional Regulation.
| 14 | | "Drop shipment" means the sale of a prescription drug to a | 15 | | wholesale distributor by the manufacturer of the prescription | 16 | | drug or that manufacturer's co-licensed product partner, that | 17 | | manufacturer's third party logistics provider, or that | 18 | | manufacturer's exclusive distributor or by an authorized | 19 | | distributor of record that purchased the product directly from | 20 | | the manufacturer or one of these entities whereby the | 21 | | wholesale distributor or chain pharmacy warehouse takes title | 22 | | but not physical possession of such prescription drug and the | 23 | | wholesale distributor invoices the pharmacy, chain pharmacy | 24 | | warehouse, or other person authorized by law to dispense or | 25 | | administer such drug to a patient and the pharmacy, chain | 26 | | pharmacy warehouse, or other authorized person receives |
| | | 10200SB0516sam001 | - 16 - | LRB102 16149 CPF 23544 a |
|
| 1 | | delivery of the prescription drug directly from the | 2 | | manufacturer, that manufacturer's third party logistics | 3 | | provider, or that manufacturer's exclusive distributor or from | 4 | | an authorized distributor of record that purchased the product | 5 | | directly from the manufacturer or one of these entities.
| 6 | | "Drug sample" means a unit of a prescription drug that is | 7 | | not intended to
be sold and is intended to promote the sale of | 8 | | the drug.
| 9 | | "Facility" means a facility of a wholesale distributor | 10 | | where prescription drugs are stored, handled, repackaged, or | 11 | | offered for sale, or a facility of a third-party logistics | 12 | | provider where prescription drugs are stored or handled. | 13 | | "FDA" means the United States Food and Drug | 14 | | Administration.
| 15 | | "Manufacturer" means a person licensed or approved by the | 16 | | FDA to engage in the manufacture of drugs or devices, | 17 | | consistent with the definition of "manufacturer" set forth in | 18 | | the FDA's regulations and guidances implementing the | 19 | | Prescription Drug Marketing Act. "Manufacturer" does not
| 20 | | include anyone who is engaged in the packaging, repackaging, | 21 | | or
labeling of drugs only to the extent permitted
under the | 22 | | Illinois Drug Reuse Opportunity Program Act. | 23 | | "Manufacturer's exclusive distributor" means anyone who | 24 | | contracts with a manufacturer to provide or coordinate | 25 | | warehousing, distribution, or other services on behalf of a | 26 | | manufacturer and who takes title to that manufacturer's |
| | | 10200SB0516sam001 | - 17 - | LRB102 16149 CPF 23544 a |
|
| 1 | | prescription drug, but who does not have general | 2 | | responsibility to direct the sale or disposition of the | 3 | | manufacturer's prescription drug. A manufacturer's exclusive | 4 | | distributor must be licensed as a wholesale distributor under | 5 | | this Act and, in order to be considered part of the normal | 6 | | distribution channel, must also be an authorized distributor | 7 | | of record.
| 8 | | "Normal distribution channel" means a chain of custody for | 9 | | a prescription drug that goes, directly or by drop shipment, | 10 | | from (i) a manufacturer of the prescription drug, (ii) that | 11 | | manufacturer to that manufacturer's co-licensed partner, (iii) | 12 | | that manufacturer to that manufacturer's third party logistics | 13 | | provider, or (iv) that manufacturer to that manufacturer's | 14 | | exclusive distributor to: | 15 | | (1) a pharmacy or to other designated persons | 16 | | authorized by law to dispense or administer the drug to a | 17 | | patient; | 18 | | (2) a wholesale distributor to a pharmacy or other | 19 | | designated persons authorized by law to dispense or | 20 | | administer the drug to a patient; | 21 | | (3) a wholesale distributor to a chain pharmacy | 22 | | warehouse to that chain pharmacy warehouse's intracompany | 23 | | pharmacy to a patient or other designated persons | 24 | | authorized by law to dispense or administer the drug to a | 25 | | patient; | 26 | | (4) a chain pharmacy warehouse to the chain pharmacy |
| | | 10200SB0516sam001 | - 18 - | LRB102 16149 CPF 23544 a |
|
| 1 | | warehouse's intracompany pharmacy or other designated | 2 | | persons authorized by law to dispense or administer the | 3 | | drug to the patient; | 4 | | (5) an authorized distributor of record to one other | 5 | | authorized distributor of record to an office-based health | 6 | | care practitioner authorized by law to dispense or | 7 | | administer the drug to the patient; or | 8 | | (6) an authorized distributor to a pharmacy or other | 9 | | persons licensed to dispense or administer the drug. | 10 | | "Pedigree" means a document or electronic file containing | 11 | | information that records each wholesale distribution of any | 12 | | given prescription drug from the point of origin to the final | 13 | | wholesale distribution point of any given prescription drug.
| 14 | | "Person" means and includes a natural person, partnership, | 15 | | association,
corporation, or any other legal business entity.
| 16 | | "Pharmacy distributor" means any pharmacy licensed in this | 17 | | State or
hospital pharmacy that is engaged in the delivery or | 18 | | distribution of
prescription drugs either to any other | 19 | | pharmacy licensed in this State or
to any other person or | 20 | | entity including, but not limited to, a wholesale
drug | 21 | | distributor engaged in the delivery or distribution of | 22 | | prescription
drugs who is involved in the actual, | 23 | | constructive, or attempted transfer of
a drug in this State to | 24 | | other than the ultimate consumer except as
otherwise provided | 25 | | for by law.
| 26 | | "Prescription drug" means any human drug, including any |
| | | 10200SB0516sam001 | - 19 - | LRB102 16149 CPF 23544 a |
|
| 1 | | biological product (except for blood and blood components | 2 | | intended for transfusion or biological products that are also | 3 | | medical devices), required by federal law or
regulation to be | 4 | | dispensed only by a prescription, including finished
dosage | 5 | | forms and bulk drug substances
subject to Section
503 of the | 6 | | Federal Food, Drug and Cosmetic Act.
| 7 | | "Repackage" means repackaging or otherwise changing the | 8 | | container, wrapper, or labeling to further the distribution of | 9 | | a prescription drug, excluding that completed by the | 10 | | pharmacist responsible for dispensing the product to a | 11 | | patient. | 12 | | "Secretary" means the Secretary of Financial and | 13 | | Professional Regulation. | 14 | | "Third-party logistics provider" means anyone who | 15 | | contracts with a prescription drug manufacturer to provide or | 16 | | coordinate warehousing, distribution, or other services on | 17 | | behalf of a manufacturer, but does not take title to the | 18 | | prescription drug or have general responsibility to direct the | 19 | | prescription drug's sale or disposition. | 20 | | "Wholesale distribution"
means the distribution
of | 21 | | prescription drugs to persons other than a consumer or | 22 | | patient, but does
not include any of the following:
| 23 | | (1)
Intracompany sales of prescription drugs, meaning | 24 | | (i) any transaction or transfer
between any division, | 25 | | subsidiary, parent, or affiliated or related company
under | 26 | | the common ownership and control of a corporate entity or |
| | | 10200SB0516sam001 | - 20 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (ii) any transaction or transfer between co-licensees of a | 2 | | co-licensed product.
| 3 | | (2) The sale, purchase, distribution, trade, or | 4 | | transfer of a prescription drug or offer to sell, | 5 | | purchase, distribute, trade, or transfer a prescription | 6 | | drug for emergency medical reasons.
| 7 | | (3) The distribution of prescription drug samples by | 8 | | manufacturers' representatives. | 9 | | (4) Drug returns, when conducted by a hospital, health | 10 | | care entity, or charitable institution in accordance with | 11 | | federal regulation. | 12 | | (5) The sale of minimal quantities of prescription | 13 | | drugs by licensed pharmacies to licensed practitioners for | 14 | | office use or other licensed pharmacies. | 15 | | (6) The sale, purchase, or trade of a drug, an offer to | 16 | | sell, purchase, or trade a drug, or the dispensing of a | 17 | | drug pursuant to a prescription. | 18 | | (7) The sale, transfer, merger, or consolidation of | 19 | | all or part of the business of a pharmacy or pharmacies | 20 | | from or with another pharmacy or pharmacies, whether | 21 | | accomplished as a purchase and sale of stock or business | 22 | | assets. | 23 | | (8) The sale, purchase, distribution, trade, or | 24 | | transfer of a prescription drug from one authorized | 25 | | distributor of record to one additional authorized | 26 | | distributor of record when the manufacturer has stated in |
| | | 10200SB0516sam001 | - 21 - | LRB102 16149 CPF 23544 a |
|
| 1 | | writing to the receiving authorized distributor of record | 2 | | that the manufacturer is unable to supply the prescription | 3 | | drug and the supplying authorized distributor of record | 4 | | states in writing that the prescription drug being | 5 | | supplied had until that time been exclusively in the | 6 | | normal distribution channel. | 7 | | (9) The delivery of or the offer to deliver a | 8 | | prescription drug by a common carrier solely in the common | 9 | | carrier's usual course of business of transporting | 10 | | prescription drugs when the common carrier does not store, | 11 | | warehouse, or take legal ownership of the prescription | 12 | | drug. | 13 | | (10) The sale or transfer from a retail pharmacy, mail | 14 | | order pharmacy, or chain pharmacy warehouse of expired, | 15 | | damaged, returned, or recalled prescription drugs to the | 16 | | original manufacturer, the originating wholesale | 17 | | distributor, or a third party returns processor.
| 18 | | (11) The donation of drugs to the extent
permitted | 19 | | under the Illinois Drug Reuse Opportunity Program Act.
| 20 | | "Wholesale drug distributor" means anyone
engaged in the
| 21 | | wholesale distribution of prescription drugs into, out of, or | 22 | | within the State, including without limitation
manufacturers; | 23 | | repackers; own label distributors; jobbers; private
label | 24 | | distributors; brokers; warehouses, including manufacturers' | 25 | | and
distributors' warehouses; manufacturer's exclusive | 26 | | distributors; and authorized distributors of record; drug |
| | | 10200SB0516sam001 | - 22 - | LRB102 16149 CPF 23544 a |
|
| 1 | | wholesalers or distributors; independent wholesale drug | 2 | | traders; specialty wholesale distributors; and retail | 3 | | pharmacies that conduct wholesale distribution; and chain | 4 | | pharmacy warehouses that conduct wholesale distribution. In | 5 | | order to be considered part of the normal distribution | 6 | | channel, a wholesale distributor must also be an authorized | 7 | | distributor of record.
| 8 | | (Source: P.A. 101-420, eff. 8-16-19.)
| 9 | | Section 100. The Senior Pharmaceutical Assistance Act is | 10 | | amended by changing Section 10 as follows:
| 11 | | (320 ILCS 50/10)
| 12 | | Sec. 10. Definitions. In this Act:
| 13 | | "Manufacturer" includes:
| 14 | | (1) An entity that is engaged in (a) the production, | 15 | | preparation,
propagation, compounding, conversion, or | 16 | | processing of prescription drug
products (i) directly or | 17 | | indirectly by extraction from substances of natural
| 18 | | origin,
(ii) independently by means of chemical synthesis, | 19 | | or (iii) by combination of
extraction
and chemical | 20 | | synthesis; or (b) the packaging, repackaging, labeling or
| 21 | | re-labeling, or distribution of prescription drug | 22 | | products.
| 23 | | (2) The entity holding legal title to or possession of | 24 | | the national
drug code number for the covered prescription |
| | | 10200SB0516sam001 | - 23 - | LRB102 16149 CPF 23544 a |
|
| 1 | | drug.
| 2 | | The term does not include a wholesale distributor of | 3 | | drugs,
drugstore chain organization, or retail pharmacy | 4 | | licensed by the State. The term also does not include anyone | 5 | | who is engaged
in the packaging, repackaging, or labeling of
| 6 | | drugs only to the extent permitted under the Illinois Drug | 7 | | Reuse Opportunity Program Act.
| 8 | | "Prescription drug" means a drug that may be dispensed | 9 | | only upon
prescription by an authorized prescriber and that is | 10 | | approved for safety and
effectiveness as a prescription drug | 11 | | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic | 12 | | Act.
| 13 | | "Senior citizen" or "senior" means a person 65 years of | 14 | | age or
older.
| 15 | | (Source: P.A. 92-594, eff. 6-27-02.)
| 16 | | Section 105. The Illinois Food, Drug and Cosmetic Act is | 17 | | amended by changing Section 16 as follows:
| 18 | | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
| 19 | | Sec. 16.
(a) The Director is hereby authorized to | 20 | | promulgate
regulations exempting from any labeling or | 21 | | packaging requirement of this
Act drugs and devices which are | 22 | | (i) , in accordance with the practice of the
trade, to be | 23 | | processed, labeled or repacked in substantial quantities at
| 24 | | establishments other than those where originally processed or |
| | | 10200SB0516sam001 | - 24 - | LRB102 16149 CPF 23544 a |
|
| 1 | | packaged on
condition that such drugs and devices are not | 2 | | adulterated or misbranded
under the provisions of this Act | 3 | | upon removal from such processing,
labeling or repacking | 4 | | establishment or (ii) packaged, repackaged, or labeled to the
| 5 | | extent permitted under the Illinois Drug Reuse Opportunity | 6 | | Program Act .
| 7 | | (b) Drugs and device labeling or packaging exemptions | 8 | | adopted under the
Federal Act and supplements thereto or | 9 | | revisions thereof shall apply to
drugs and devices in Illinois | 10 | | except insofar as modified or rejected by
regulations | 11 | | promulgated by the Director.
| 12 | | (c) A drug intended for use by man which (A) is a | 13 | | habit-forming drug to
which Section 15 (d) applies; or (B) | 14 | | because of its toxicity or other
potentiality for harmful | 15 | | effect or the method of its use or the collateral
measures | 16 | | necessary to its use is not safe for use except under the
| 17 | | supervision of a practitioner licensed by law to administer | 18 | | such drug; or
(C) is limited by an approved application under | 19 | | Section 505 of the Federal
Act or Section 17 of this Act to use | 20 | | under the professional supervision of
a practitioner licensed | 21 | | by law to administer such drug, shall be dispensed
only in | 22 | | accordance with the provisions of the "Illinois Controlled
| 23 | | Substances Act". The act of dispensing a drug contrary to the | 24 | | provisions of
this paragraph shall be deemed to be an act which | 25 | | results in a drug being
misbranded while held for sale.
| 26 | | (d) Any drug dispensed by filling or refilling a written
|
| | | 10200SB0516sam001 | - 25 - | LRB102 16149 CPF 23544 a |
|
| 1 | | or oral prescription of a practitioner licensed by law to | 2 | | administer such
drug shall be exempt from the requirements of | 3 | | Section 15, except
subsections (a), (k) and (l) and clauses | 4 | | (2) and (3) of subsection (i), and
the packaging requirements | 5 | | of
subsections (g), (h) and (q), if the drug bears a label | 6 | | containing the
proprietary name or names, or if there is none, | 7 | | the established name or
names of the drugs, the dosage and | 8 | | quantity, unless the prescribing
practitioner, in the interest | 9 | | of the health of the patient, directs
otherwise in writing, | 10 | | the name and address of the dispenser, the serial
number and | 11 | | date of the prescription or of its filling, the name of the
| 12 | | prescriber and, if stated in the prescription, the name of the | 13 | | patient, and
the directions for use and the cautionary | 14 | | statements, if any, contained in
such prescription. This | 15 | | exemption shall not apply to any drug dispensed in
the course | 16 | | of the conduct of business of dispensing drugs pursuant to
| 17 | | diagnosis by mail, or to a drug dispensed in violation of | 18 | | subsection (a) of
this Section.
| 19 | | (e) The Director may by regulation remove drugs subject to
| 20 | | Section 15 (d) and Section 17 from the requirements of | 21 | | subsection (c) of
this Section when such requirements are not | 22 | | necessary for the protection of
the public health.
| 23 | | (f) A drug which is subject to subsection (c) of this | 24 | | Section
shall be deemed to be misbranded if at any time before | 25 | | dispensing its label
fails to bear the statement "Caution: | 26 | | Federal Law Prohibits Dispensing Without
Prescription" or |
| | | 10200SB0516sam001 | - 26 - | LRB102 16149 CPF 23544 a |
|
| 1 | | "Caution: State Law Prohibits Dispensing Without
| 2 | | Prescription". A drug to which subsection (c) of this Section | 3 | | does not apply
shall be deemed to be misbranded if at any time | 4 | | prior to dispensing its
label bears the caution statement | 5 | | quoted in the preceding sentence.
| 6 | | (g) Nothing in this Section shall be construed to relieve
| 7 | | any person from any requirement prescribed by or under | 8 | | authority of law
with respect to controlled substances now | 9 | | included or which may hereafter
be included within the | 10 | | classifications of controlled substances cannabis as
defined | 11 | | in applicable Federal laws relating to controlled substances | 12 | | or
cannabis or the Cannabis Control Act.
| 13 | | (Source: P.A. 84-1308.)
| 14 | | Section 110. The Illinois Controlled Substances Act is | 15 | | amended by changing Section 102 as follows: | 16 | | (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102) | 17 | | Sec. 102. Definitions. As used in this Act, unless the | 18 | | context
otherwise requires:
| 19 | | (a) "Addict" means any person who habitually uses any | 20 | | drug, chemical,
substance or dangerous drug other than alcohol | 21 | | so as to endanger the public
morals, health, safety or welfare | 22 | | or who is so far addicted to the use of a
dangerous drug or | 23 | | controlled substance other than alcohol as to have lost
the | 24 | | power of self control with reference to his or her addiction.
|
| | | 10200SB0516sam001 | - 27 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (b) "Administer" means the direct application of a | 2 | | controlled
substance, whether by injection, inhalation, | 3 | | ingestion, or any other
means, to the body of a patient, | 4 | | research subject, or animal (as
defined by the Humane | 5 | | Euthanasia in Animal Shelters Act) by:
| 6 | | (1) a practitioner (or, in his or her presence, by his | 7 | | or her authorized agent),
| 8 | | (2) the patient or research subject pursuant to an | 9 | | order, or
| 10 | | (3) a euthanasia technician as defined by the Humane | 11 | | Euthanasia in
Animal Shelters Act.
| 12 | | (c) "Agent" means an authorized person who acts on behalf | 13 | | of or at
the direction of a manufacturer, distributor, | 14 | | dispenser, prescriber, or practitioner. It does not
include a | 15 | | common or contract carrier, public warehouseman or employee of
| 16 | | the carrier or warehouseman.
| 17 | | (c-1) "Anabolic Steroids" means any drug or hormonal | 18 | | substance,
chemically and pharmacologically related to | 19 | | testosterone (other than
estrogens, progestins, | 20 | | corticosteroids, and dehydroepiandrosterone),
and includes:
| 21 | | (i) 3[beta],17-dihydroxy-5a-androstane, | 22 | | (ii) 3[alpha],17[beta]-dihydroxy-5a-androstane, | 23 | | (iii) 5[alpha]-androstan-3,17-dione, | 24 | | (iv) 1-androstenediol (3[beta], | 25 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 26 | | (v) 1-androstenediol (3[alpha], |
| | | 10200SB0516sam001 | - 28 - | LRB102 16149 CPF 23544 a |
|
| 1 | | 17[beta]-dihydroxy-5[alpha]-androst-1-ene), | 2 | | (vi) 4-androstenediol | 3 | | (3[beta],17[beta]-dihydroxy-androst-4-ene), | 4 | | (vii) 5-androstenediol | 5 | | (3[beta],17[beta]-dihydroxy-androst-5-ene), | 6 | | (viii) 1-androstenedione | 7 | | ([5alpha]-androst-1-en-3,17-dione), | 8 | | (ix) 4-androstenedione | 9 | | (androst-4-en-3,17-dione), | 10 | | (x) 5-androstenedione | 11 | | (androst-5-en-3,17-dione), | 12 | | (xi) bolasterone (7[alpha],17a-dimethyl-17[beta]- | 13 | | hydroxyandrost-4-en-3-one), | 14 | | (xii) boldenone (17[beta]-hydroxyandrost- | 15 | | 1,4,-diene-3-one), | 16 | | (xiii) boldione (androsta-1,4- | 17 | | diene-3,17-dione), | 18 | | (xiv) calusterone (7[beta],17[alpha]-dimethyl-17 | 19 | | [beta]-hydroxyandrost-4-en-3-one), | 20 | | (xv) clostebol (4-chloro-17[beta]- | 21 | | hydroxyandrost-4-en-3-one), | 22 | | (xvi) dehydrochloromethyltestosterone (4-chloro- | 23 | | 17[beta]-hydroxy-17[alpha]-methyl- | 24 | | androst-1,4-dien-3-one), | 25 | | (xvii) desoxymethyltestosterone | 26 | | (17[alpha]-methyl-5[alpha] |
| | | 10200SB0516sam001 | - 29 - | LRB102 16149 CPF 23544 a |
|
| 1 | | -androst-2-en-17[beta]-ol)(a.k.a., madol), | 2 | | (xviii) [delta]1-dihydrotestosterone (a.k.a. | 3 | | '1-testosterone') (17[beta]-hydroxy- | 4 | | 5[alpha]-androst-1-en-3-one), | 5 | | (xix) 4-dihydrotestosterone (17[beta]-hydroxy- | 6 | | androstan-3-one), | 7 | | (xx) drostanolone (17[beta]-hydroxy-2[alpha]-methyl- | 8 | | 5[alpha]-androstan-3-one), | 9 | | (xxi) ethylestrenol (17[alpha]-ethyl-17[beta]- | 10 | | hydroxyestr-4-ene), | 11 | | (xxii) fluoxymesterone (9-fluoro-17[alpha]-methyl- | 12 | | 1[beta],17[beta]-dihydroxyandrost-4-en-3-one), | 13 | | (xxiii) formebolone (2-formyl-17[alpha]-methyl-11[alpha], | 14 | | 17[beta]-dihydroxyandrost-1,4-dien-3-one), | 15 | | (xxiv) furazabol (17[alpha]-methyl-17[beta]- | 16 | | hydroxyandrostano[2,3-c]-furazan), | 17 | | (xxv) 13[beta]-ethyl-17[beta]-hydroxygon-4-en-3-one, | 18 | | (xxvi) 4-hydroxytestosterone (4,17[beta]-dihydroxy- | 19 | | androst-4-en-3-one), | 20 | | (xxvii) 4-hydroxy-19-nortestosterone (4,17[beta]- | 21 | | dihydroxy-estr-4-en-3-one), | 22 | | (xxviii) mestanolone (17[alpha]-methyl-17[beta]- | 23 | | hydroxy-5-androstan-3-one), | 24 | | (xxix) mesterolone (1amethyl-17[beta]-hydroxy- | 25 | | [5a]-androstan-3-one), | 26 | | (xxx) methandienone (17[alpha]-methyl-17[beta]- |
| | | 10200SB0516sam001 | - 30 - | LRB102 16149 CPF 23544 a |
|
| 1 | | hydroxyandrost-1,4-dien-3-one), | 2 | | (xxxi) methandriol (17[alpha]-methyl-3[beta],17[beta]- | 3 | | dihydroxyandrost-5-ene), | 4 | | (xxxii) methenolone (1-methyl-17[beta]-hydroxy- | 5 | | 5[alpha]-androst-1-en-3-one), | 6 | | (xxxiii) 17[alpha]-methyl-3[beta], 17[beta]- | 7 | | dihydroxy-5a-androstane, | 8 | | (xxxiv) 17[alpha]-methyl-3[alpha],17[beta]-dihydroxy | 9 | | -5a-androstane, | 10 | | (xxxv) 17[alpha]-methyl-3[beta],17[beta]- | 11 | | dihydroxyandrost-4-ene), | 12 | | (xxxvi) 17[alpha]-methyl-4-hydroxynandrolone (17[alpha]- | 13 | | methyl-4-hydroxy-17[beta]-hydroxyestr-4-en-3-one), | 14 | | (xxxvii) methyldienolone (17[alpha]-methyl-17[beta]- | 15 | | hydroxyestra-4,9(10)-dien-3-one), | 16 | | (xxxviii) methyltrienolone (17[alpha]-methyl-17[beta]- | 17 | | hydroxyestra-4,9-11-trien-3-one), | 18 | | (xxxix) methyltestosterone (17[alpha]-methyl-17[beta]- | 19 | | hydroxyandrost-4-en-3-one), | 20 | | (xl) mibolerone (7[alpha],17a-dimethyl-17[beta]- | 21 | | hydroxyestr-4-en-3-one), | 22 | | (xli) 17[alpha]-methyl-[delta]1-dihydrotestosterone | 23 | | (17b[beta]-hydroxy-17[alpha]-methyl-5[alpha]- | 24 | | androst-1-en-3-one)(a.k.a. '17-[alpha]-methyl- | 25 | | 1-testosterone'), | 26 | | (xlii) nandrolone (17[beta]-hydroxyestr-4-en-3-one), |
| | | 10200SB0516sam001 | - 31 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (xliii) 19-nor-4-androstenediol (3[beta], 17[beta]- | 2 | | dihydroxyestr-4-ene), | 3 | | (xliv) 19-nor-4-androstenediol (3[alpha], 17[beta]- | 4 | | dihydroxyestr-4-ene), | 5 | | (xlv) 19-nor-5-androstenediol (3[beta], 17[beta]- | 6 | | dihydroxyestr-5-ene), | 7 | | (xlvi) 19-nor-5-androstenediol (3[alpha], 17[beta]- | 8 | | dihydroxyestr-5-ene), | 9 | | (xlvii) 19-nor-4,9(10)-androstadienedione | 10 | | (estra-4,9(10)-diene-3,17-dione), | 11 | | (xlviii) 19-nor-4-androstenedione (estr-4- | 12 | | en-3,17-dione), | 13 | | (xlix) 19-nor-5-androstenedione (estr-5- | 14 | | en-3,17-dione), | 15 | | (l) norbolethone (13[beta], 17a-diethyl-17[beta]- | 16 | | hydroxygon-4-en-3-one), | 17 | | (li) norclostebol (4-chloro-17[beta]- | 18 | | hydroxyestr-4-en-3-one), | 19 | | (lii) norethandrolone (17[alpha]-ethyl-17[beta]- | 20 | | hydroxyestr-4-en-3-one), | 21 | | (liii) normethandrolone (17[alpha]-methyl-17[beta]- | 22 | | hydroxyestr-4-en-3-one), | 23 | | (liv) oxandrolone (17[alpha]-methyl-17[beta]-hydroxy- | 24 | | 2-oxa-5[alpha]-androstan-3-one), | 25 | | (lv) oxymesterone (17[alpha]-methyl-4,17[beta]- | 26 | | dihydroxyandrost-4-en-3-one), |
| | | 10200SB0516sam001 | - 32 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (lvi) oxymetholone (17[alpha]-methyl-2-hydroxymethylene- | 2 | | 17[beta]-hydroxy-(5[alpha]-androstan-3-one), | 3 | | (lvii) stanozolol (17[alpha]-methyl-17[beta]-hydroxy- | 4 | | (5[alpha]-androst-2-eno[3,2-c]-pyrazole), | 5 | | (lviii) stenbolone (17[beta]-hydroxy-2-methyl- | 6 | | (5[alpha]-androst-1-en-3-one), | 7 | | (lix) testolactone (13-hydroxy-3-oxo-13,17- | 8 | | secoandrosta-1,4-dien-17-oic | 9 | | acid lactone), | 10 | | (lx) testosterone (17[beta]-hydroxyandrost- | 11 | | 4-en-3-one), | 12 | | (lxi) tetrahydrogestrinone (13[beta], 17[alpha]- | 13 | | diethyl-17[beta]-hydroxygon- | 14 | | 4,9,11-trien-3-one), | 15 | | (lxii) trenbolone (17[beta]-hydroxyestr-4,9, | 16 | | 11-trien-3-one).
| 17 | | Any person who is otherwise lawfully in possession of an | 18 | | anabolic
steroid, or who otherwise lawfully manufactures, | 19 | | distributes, dispenses,
delivers, or possesses with intent to | 20 | | deliver an anabolic steroid, which
anabolic steroid is | 21 | | expressly intended for and lawfully allowed to be
administered | 22 | | through implants to livestock or other nonhuman species, and
| 23 | | which is approved by the Secretary of Health and Human | 24 | | Services for such
administration, and which the person intends | 25 | | to administer or have
administered through such implants, | 26 | | shall not be considered to be in
unauthorized possession or to |
| | | 10200SB0516sam001 | - 33 - | LRB102 16149 CPF 23544 a |
|
| 1 | | unlawfully manufacture, distribute, dispense,
deliver, or | 2 | | possess with intent to deliver such anabolic steroid for
| 3 | | purposes of this Act.
| 4 | | (d) "Administration" means the Drug Enforcement | 5 | | Administration,
United States Department of Justice, or its | 6 | | successor agency.
| 7 | | (d-5) "Clinical Director, Prescription Monitoring Program" | 8 | | means a Department of Human Services administrative employee | 9 | | licensed to either prescribe or dispense controlled substances | 10 | | who shall run the clinical aspects of the Department of Human | 11 | | Services Prescription Monitoring Program and its Prescription | 12 | | Information Library. | 13 | | (d-10) "Compounding" means the preparation and mixing of | 14 | | components, excluding flavorings, (1) as the result of a | 15 | | prescriber's prescription drug order or initiative based on | 16 | | the prescriber-patient-pharmacist relationship in the course | 17 | | of professional practice or (2) for the purpose of, or | 18 | | incident to, research, teaching, or chemical analysis and not | 19 | | for sale or dispensing. "Compounding" includes the preparation | 20 | | of drugs or devices in anticipation of receiving prescription | 21 | | drug orders based on routine, regularly observed dispensing | 22 | | patterns. Commercially available products may be compounded | 23 | | for dispensing to individual patients only if both of the | 24 | | following conditions are met: (i) the commercial product is | 25 | | not reasonably available from normal distribution channels in | 26 | | a timely manner to meet the patient's needs and (ii) the |
| | | 10200SB0516sam001 | - 34 - | LRB102 16149 CPF 23544 a |
|
| 1 | | prescribing practitioner has requested that the drug be | 2 | | compounded. | 3 | | (e) "Control" means to add a drug or other substance, or | 4 | | immediate
precursor, to a Schedule whether by
transfer from | 5 | | another Schedule or otherwise.
| 6 | | (f) "Controlled Substance" means (i) a drug, substance, | 7 | | immediate
precursor, or synthetic drug in the Schedules of | 8 | | Article II of this Act or (ii) a drug or other substance, or | 9 | | immediate precursor, designated as a controlled substance by | 10 | | the Department through administrative rule. The term does not | 11 | | include distilled spirits, wine, malt beverages, or tobacco, | 12 | | as those terms are
defined or used in the Liquor Control Act of | 13 | | 1934 and the Tobacco Products Tax
Act of 1995.
| 14 | | (f-5) "Controlled substance analog" means a substance: | 15 | | (1) the chemical structure of which is substantially | 16 | | similar to the chemical structure of a controlled | 17 | | substance in Schedule I or II; | 18 | | (2) which has a stimulant, depressant, or | 19 | | hallucinogenic effect on the central nervous system that | 20 | | is substantially similar to or greater than the stimulant, | 21 | | depressant, or hallucinogenic effect on the central | 22 | | nervous system of a controlled substance in Schedule I or | 23 | | II; or | 24 | | (3) with respect to a particular person, which such | 25 | | person represents or intends to have a stimulant, | 26 | | depressant, or hallucinogenic effect on the central |
| | | 10200SB0516sam001 | - 35 - | LRB102 16149 CPF 23544 a |
|
| 1 | | nervous system that is substantially similar to or greater | 2 | | than the stimulant, depressant, or hallucinogenic effect | 3 | | on the central nervous system of a controlled substance in | 4 | | Schedule I or II. | 5 | | (g) "Counterfeit substance" means a controlled substance, | 6 | | which, or
the container or labeling of which, without | 7 | | authorization bears the
trademark, trade name, or other | 8 | | identifying mark, imprint, number or
device, or any likeness | 9 | | thereof, of a manufacturer, distributor, or
dispenser other | 10 | | than the person who in fact manufactured, distributed,
or | 11 | | dispensed the substance.
| 12 | | (h) "Deliver" or "delivery" means the actual, constructive | 13 | | or
attempted transfer of possession of a controlled substance, | 14 | | with or
without consideration, whether or not there is an | 15 | | agency relationship.
"Deliver" or "delivery" does not include
| 16 | | the donation of drugs to the extent permitted
under the | 17 | | Illinois Drug Reuse Opportunity Program Act.
| 18 | | (i) "Department" means the Illinois Department of Human | 19 | | Services (as
successor to the Department of Alcoholism and | 20 | | Substance Abuse) or its successor agency.
| 21 | | (j) (Blank).
| 22 | | (k) "Department of Corrections" means the Department of | 23 | | Corrections
of the State of Illinois or its successor agency.
| 24 | | (l) "Department of Financial and Professional Regulation" | 25 | | means the Department
of Financial and Professional Regulation | 26 | | of the State of Illinois or its successor agency.
|
| | | 10200SB0516sam001 | - 36 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (m) "Depressant" means any drug that (i) causes an overall | 2 | | depression of central nervous system functions, (ii) causes | 3 | | impaired consciousness and awareness, and (iii) can be | 4 | | habit-forming or lead to a substance abuse problem, including | 5 | | but not limited to alcohol, cannabis and its active principles | 6 | | and their analogs, benzodiazepines and their analogs, | 7 | | barbiturates and their analogs, opioids (natural and | 8 | | synthetic) and their analogs, and chloral hydrate and similar | 9 | | sedative hypnotics.
| 10 | | (n) (Blank).
| 11 | | (o) "Director" means the Director of the Illinois State | 12 | | Police or his or her designated agents.
| 13 | | (p) "Dispense" means to deliver a controlled substance to | 14 | | an
ultimate user or research subject by or pursuant to the | 15 | | lawful order of
a prescriber, including the prescribing, | 16 | | administering, packaging,
labeling, or compounding necessary | 17 | | to prepare the substance for that
delivery.
| 18 | | (q) "Dispenser" means a practitioner who dispenses.
| 19 | | (r) "Distribute" means to deliver, other than by | 20 | | administering or
dispensing, a controlled substance.
| 21 | | (s) "Distributor" means a person who distributes.
| 22 | | (t) "Drug" means (1) substances recognized as drugs in the | 23 | | official
United States Pharmacopoeia, Official Homeopathic | 24 | | Pharmacopoeia of the
United States, or official National | 25 | | Formulary, or any supplement to any
of them; (2) substances | 26 | | intended for use in diagnosis, cure, mitigation,
treatment, or |
| | | 10200SB0516sam001 | - 37 - | LRB102 16149 CPF 23544 a |
|
| 1 | | prevention of disease in man or animals; (3) substances
(other | 2 | | than food) intended to affect the structure of any function of
| 3 | | the body of man or animals and (4) substances intended for use | 4 | | as a
component of any article specified in clause (1), (2), or | 5 | | (3) of this
subsection. It does not include devices or their | 6 | | components, parts, or
accessories.
| 7 | | (t-3) "Electronic health record" or "EHR" means an | 8 | | electronic record of health-related information on an | 9 | | individual that is created, gathered, managed, and consulted | 10 | | by authorized health care clinicians and staff. | 11 | | (t-4) "Emergency medical services personnel" has the | 12 | | meaning ascribed to it in the Emergency Medical Services (EMS) | 13 | | Systems Act. | 14 | | (t-5) "Euthanasia agency" means
an entity certified by the | 15 | | Department of Financial and Professional Regulation for the
| 16 | | purpose of animal euthanasia that holds an animal control | 17 | | facility license or
animal
shelter license under the Animal | 18 | | Welfare Act. A euthanasia agency is
authorized to purchase, | 19 | | store, possess, and utilize Schedule II nonnarcotic and
| 20 | | Schedule III nonnarcotic drugs for the sole purpose of animal | 21 | | euthanasia.
| 22 | | (t-10) "Euthanasia drugs" means Schedule II or Schedule | 23 | | III substances
(nonnarcotic controlled substances) that are | 24 | | used by a euthanasia agency for
the purpose of animal | 25 | | euthanasia.
| 26 | | (u) "Good faith" means the prescribing or dispensing of a |
| | | 10200SB0516sam001 | - 38 - | LRB102 16149 CPF 23544 a |
|
| 1 | | controlled
substance by a practitioner in the regular course | 2 | | of professional
treatment to or for any person who is under his | 3 | | or her treatment for a
pathology or condition other than that | 4 | | individual's physical or
psychological dependence upon or | 5 | | addiction to a controlled substance,
except as provided | 6 | | herein: and application of the term to a pharmacist
shall mean | 7 | | the dispensing of a controlled substance pursuant to the
| 8 | | prescriber's order which in the professional judgment of the | 9 | | pharmacist
is lawful. The pharmacist shall be guided by | 10 | | accepted professional
standards including, but not limited to | 11 | | the following, in making the
judgment:
| 12 | | (1) lack of consistency of prescriber-patient | 13 | | relationship,
| 14 | | (2) frequency of prescriptions for same drug by one | 15 | | prescriber for
large numbers of patients,
| 16 | | (3) quantities beyond those normally prescribed,
| 17 | | (4) unusual dosages (recognizing that there may be | 18 | | clinical circumstances where more or less than the usual | 19 | | dose may be used legitimately),
| 20 | | (5) unusual geographic distances between patient, | 21 | | pharmacist and
prescriber,
| 22 | | (6) consistent prescribing of habit-forming drugs.
| 23 | | (u-0.5) "Hallucinogen" means a drug that causes markedly | 24 | | altered sensory perception leading to hallucinations of any | 25 | | type. | 26 | | (u-1) "Home infusion services" means services provided by |
| | | 10200SB0516sam001 | - 39 - | LRB102 16149 CPF 23544 a |
|
| 1 | | a pharmacy in
compounding solutions for direct administration | 2 | | to a patient in a private
residence, long-term care facility, | 3 | | or hospice setting by means of parenteral,
intravenous, | 4 | | intramuscular, subcutaneous, or intraspinal infusion.
| 5 | | (u-5) "Illinois State Police" means the State
Police of | 6 | | the State of Illinois, or its successor agency. | 7 | | (v) "Immediate precursor" means a substance:
| 8 | | (1) which the Department has found to be and by rule | 9 | | designated as
being a principal compound used, or produced | 10 | | primarily for use, in the
manufacture of a controlled | 11 | | substance;
| 12 | | (2) which is an immediate chemical intermediary used | 13 | | or likely to
be used in the manufacture of such controlled | 14 | | substance; and
| 15 | | (3) the control of which is necessary to prevent, | 16 | | curtail or limit
the manufacture of such controlled | 17 | | substance.
| 18 | | (w) "Instructional activities" means the acts of teaching, | 19 | | educating
or instructing by practitioners using controlled | 20 | | substances within
educational facilities approved by the State | 21 | | Board of Education or
its successor agency.
| 22 | | (x) "Local authorities" means a duly organized State, | 23 | | County or
Municipal peace unit or police force.
| 24 | | (y) "Look-alike substance" means a substance, other than a | 25 | | controlled
substance which (1) by overall dosage unit | 26 | | appearance, including shape,
color, size, markings or lack |
| | | 10200SB0516sam001 | - 40 - | LRB102 16149 CPF 23544 a |
|
| 1 | | thereof, taste, consistency, or any other
identifying physical | 2 | | characteristic of the substance, would lead a reasonable
| 3 | | person to believe that the substance is a controlled | 4 | | substance, or (2) is
expressly or impliedly represented to be | 5 | | a controlled substance or is
distributed under circumstances | 6 | | which would lead a reasonable person to
believe that the | 7 | | substance is a controlled substance. For the purpose of
| 8 | | determining whether the representations made or the | 9 | | circumstances of the
distribution would lead a reasonable | 10 | | person to believe the substance to be
a controlled substance | 11 | | under this clause (2) of subsection (y), the court or
other | 12 | | authority may consider the following factors in addition to | 13 | | any other
factor that may be relevant:
| 14 | | (a) statements made by the owner or person in control | 15 | | of the substance
concerning its nature, use or effect;
| 16 | | (b) statements made to the buyer or recipient that the | 17 | | substance may
be resold for profit;
| 18 | | (c) whether the substance is packaged in a manner | 19 | | normally used for the
illegal distribution of controlled | 20 | | substances;
| 21 | | (d) whether the distribution or attempted distribution | 22 | | included an
exchange of or demand for money or other | 23 | | property as consideration, and
whether the amount of the | 24 | | consideration was substantially greater than the
| 25 | | reasonable retail market value of the substance.
| 26 | | Clause (1) of this subsection (y) shall not apply to a |
| | | 10200SB0516sam001 | - 41 - | LRB102 16149 CPF 23544 a |
|
| 1 | | noncontrolled
substance in its finished dosage form that was | 2 | | initially introduced into
commerce prior to the initial | 3 | | introduction into commerce of a controlled
substance in its | 4 | | finished dosage form which it may substantially resemble.
| 5 | | Nothing in this subsection (y) prohibits the dispensing or | 6 | | distributing
of noncontrolled substances by persons authorized | 7 | | to dispense and
distribute controlled substances under this | 8 | | Act, provided that such action
would be deemed to be carried | 9 | | out in good faith under subsection (u) if the
substances | 10 | | involved were controlled substances.
| 11 | | Nothing in this subsection (y) or in this Act prohibits | 12 | | the manufacture,
preparation, propagation, compounding, | 13 | | processing, packaging, advertising
or distribution of a drug | 14 | | or drugs by any person registered pursuant to
Section 510 of | 15 | | the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
| 16 | | (y-1) "Mail-order pharmacy" means a pharmacy that is | 17 | | located in a state
of the United States that delivers, | 18 | | dispenses or
distributes, through the United States Postal | 19 | | Service or other common
carrier, to Illinois residents, any | 20 | | substance which requires a prescription.
| 21 | | (z) "Manufacture" means the production, preparation, | 22 | | propagation,
compounding, conversion or processing of a | 23 | | controlled substance other than methamphetamine, either
| 24 | | directly or indirectly, by extraction from substances of | 25 | | natural origin,
or independently by means of chemical | 26 | | synthesis, or by a combination of
extraction and chemical |
| | | 10200SB0516sam001 | - 42 - | LRB102 16149 CPF 23544 a |
|
| 1 | | synthesis, and includes any packaging or
repackaging of the | 2 | | substance or labeling of its container, except that
this term | 3 | | does not include:
| 4 | | (1) by an ultimate user, the preparation or | 5 | | compounding of a
controlled substance for his or her own | 6 | | use; or
| 7 | | (2) by a practitioner, or his or her authorized agent | 8 | | under his or her
supervision, the preparation, | 9 | | compounding, packaging, or labeling of a
controlled | 10 | | substance:
| 11 | | (a) as an incident to his or her administering or | 12 | | dispensing of a
controlled substance in the course of | 13 | | his or her professional practice; or
| 14 | | (b) as an incident to lawful research, teaching or | 15 | | chemical
analysis and not for sale ; or .
| 16 | | (3) the packaging, repackaging, or labeling of
drugs | 17 | | only to the extent permitted under the
Illinois Drug Reuse | 18 | | Opportunity Program Act.
| 19 | | (z-1) (Blank).
| 20 | | (z-5) "Medication shopping" means the conduct prohibited | 21 | | under subsection (a) of Section 314.5 of this Act. | 22 | | (z-10) "Mid-level practitioner" means (i) a physician | 23 | | assistant who has been delegated authority to prescribe | 24 | | through a written delegation of authority by a physician | 25 | | licensed to practice medicine in all of its branches, in | 26 | | accordance with Section 7.5 of the Physician Assistant |
| | | 10200SB0516sam001 | - 43 - | LRB102 16149 CPF 23544 a |
|
| 1 | | Practice Act of 1987, (ii) an advanced practice registered | 2 | | nurse who has been delegated authority to prescribe through a | 3 | | written delegation of authority by a physician licensed to | 4 | | practice medicine in all of its branches or by a podiatric | 5 | | physician, in accordance with Section 65-40 of the Nurse | 6 | | Practice Act, (iii) an advanced practice registered nurse | 7 | | certified as a nurse practitioner, nurse midwife, or clinical | 8 | | nurse specialist who has been granted authority to prescribe | 9 | | by a hospital affiliate in accordance with Section 65-45 of | 10 | | the Nurse Practice Act, (iv) an animal euthanasia agency, or | 11 | | (v) a prescribing psychologist. | 12 | | (aa) "Narcotic drug" means any of the following, whether | 13 | | produced
directly or indirectly by extraction from substances | 14 | | of vegetable origin,
or independently by means of chemical | 15 | | synthesis, or by a combination of
extraction and chemical | 16 | | synthesis:
| 17 | | (1) opium, opiates, derivatives of opium and opiates, | 18 | | including their isomers, esters, ethers, salts, and salts | 19 | | of isomers, esters, and ethers, whenever the existence of | 20 | | such isomers, esters, ethers, and salts is possible within | 21 | | the specific chemical designation; however the term | 22 | | "narcotic drug" does not include the isoquinoline | 23 | | alkaloids of opium;
| 24 | | (2) (blank);
| 25 | | (3) opium poppy and poppy straw;
| 26 | | (4) coca leaves, except coca leaves and extracts of |
| | | 10200SB0516sam001 | - 44 - | LRB102 16149 CPF 23544 a |
|
| 1 | | coca leaves from which substantially all of the cocaine | 2 | | and ecgonine, and their isomers, derivatives and salts, | 3 | | have been removed;
| 4 | | (5) cocaine, its salts, optical and geometric isomers, | 5 | | and salts of isomers; | 6 | | (6) ecgonine, its derivatives, their salts, isomers, | 7 | | and salts of isomers; | 8 | | (7) any compound, mixture, or preparation which | 9 | | contains any quantity of any of the substances referred to | 10 | | in subparagraphs (1) through (6). | 11 | | (bb) "Nurse" means a registered nurse licensed under the
| 12 | | Nurse Practice Act.
| 13 | | (cc) (Blank).
| 14 | | (dd) "Opiate" means any substance having an addiction | 15 | | forming or
addiction sustaining liability similar to morphine | 16 | | or being capable of
conversion into a drug having addiction | 17 | | forming or addiction sustaining
liability.
| 18 | | (ee) "Opium poppy" means the plant of the species Papaver
| 19 | | somniferum L., except its seeds.
| 20 | | (ee-5) "Oral dosage" means a tablet, capsule, elixir, or | 21 | | solution or other liquid form of medication intended for | 22 | | administration by mouth, but the term does not include a form | 23 | | of medication intended for buccal, sublingual, or transmucosal | 24 | | administration. | 25 | | (ff) "Parole and Pardon Board" means the Parole and Pardon | 26 | | Board of
the State of Illinois or its successor agency.
|
| | | 10200SB0516sam001 | - 45 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (gg) "Person" means any individual, corporation, | 2 | | mail-order pharmacy,
government or governmental subdivision or | 3 | | agency, business trust, estate,
trust, partnership or | 4 | | association, or any other entity.
| 5 | | (hh) "Pharmacist" means any person who holds a license or | 6 | | certificate of
registration as a registered pharmacist, a | 7 | | local registered pharmacist
or a registered assistant | 8 | | pharmacist under the Pharmacy Practice Act.
| 9 | | (ii) "Pharmacy" means any store, ship or other place in | 10 | | which
pharmacy is authorized to be practiced under the | 11 | | Pharmacy Practice Act.
| 12 | | (ii-5) "Pharmacy shopping" means the conduct prohibited | 13 | | under subsection (b) of Section 314.5 of this Act. | 14 | | (ii-10) "Physician" (except when the context otherwise | 15 | | requires) means a person licensed to practice medicine in all | 16 | | of its branches. | 17 | | (jj) "Poppy straw" means all parts, except the seeds, of | 18 | | the opium
poppy, after mowing.
| 19 | | (kk) "Practitioner" means a physician licensed to practice | 20 | | medicine in all
its branches, dentist, optometrist, podiatric | 21 | | physician,
veterinarian, scientific investigator, pharmacist, | 22 | | physician assistant,
advanced practice registered nurse,
| 23 | | licensed practical
nurse, registered nurse, emergency medical | 24 | | services personnel, hospital, laboratory, or pharmacy, or | 25 | | other
person licensed, registered, or otherwise lawfully | 26 | | permitted by the
United States or this State to distribute, |
| | | 10200SB0516sam001 | - 46 - | LRB102 16149 CPF 23544 a |
|
| 1 | | dispense, conduct research
with respect to, administer or use | 2 | | in teaching or chemical analysis, a
controlled substance in | 3 | | the course of professional practice or research.
| 4 | | (ll) "Pre-printed prescription" means a written | 5 | | prescription upon which
the designated drug has been indicated | 6 | | prior to the time of issuance; the term does not mean a written | 7 | | prescription that is individually generated by machine or | 8 | | computer in the prescriber's office.
| 9 | | (mm) "Prescriber" means a physician licensed to practice | 10 | | medicine in all
its branches, dentist, optometrist, | 11 | | prescribing psychologist licensed under Section 4.2 of the | 12 | | Clinical Psychologist Licensing Act with prescriptive | 13 | | authority delegated under Section 4.3 of the Clinical | 14 | | Psychologist Licensing Act, podiatric physician, or
| 15 | | veterinarian who issues a prescription, a physician assistant | 16 | | who
issues a
prescription for a controlled substance
in | 17 | | accordance
with Section 303.05, a written delegation, and a | 18 | | written collaborative agreement required under Section 7.5
of | 19 | | the
Physician Assistant Practice Act of 1987, an advanced | 20 | | practice registered
nurse with prescriptive authority | 21 | | delegated under Section 65-40 of the Nurse Practice Act and in | 22 | | accordance with Section 303.05, a written delegation,
and a | 23 | | written
collaborative agreement under Section 65-35 of the | 24 | | Nurse Practice Act, an advanced practice registered nurse | 25 | | certified as a nurse practitioner, nurse midwife, or clinical | 26 | | nurse specialist who has been granted authority to prescribe |
| | | 10200SB0516sam001 | - 47 - | LRB102 16149 CPF 23544 a |
|
| 1 | | by a hospital affiliate in accordance with Section 65-45 of | 2 | | the Nurse Practice Act and in accordance with Section 303.05, | 3 | | or an advanced practice registered nurse certified as a nurse | 4 | | practitioner, nurse midwife, or clinical nurse specialist who | 5 | | has full practice authority pursuant to Section 65-43 of the | 6 | | Nurse Practice Act.
| 7 | | (nn) "Prescription" means a written, facsimile, or oral | 8 | | order, or an electronic order that complies with applicable | 9 | | federal requirements,
of
a physician licensed to practice | 10 | | medicine in all its branches,
dentist, podiatric physician or | 11 | | veterinarian for any controlled
substance, of an optometrist | 12 | | in accordance with Section 15.1 of the Illinois Optometric | 13 | | Practice Act of 1987, of a prescribing psychologist licensed | 14 | | under Section 4.2 of the Clinical Psychologist Licensing Act | 15 | | with prescriptive authority delegated under Section 4.3 of the | 16 | | Clinical Psychologist Licensing Act, of a physician assistant | 17 | | for a
controlled substance
in accordance with Section 303.05, | 18 | | a written delegation, and a written collaborative agreement | 19 | | required under
Section 7.5 of the
Physician Assistant Practice | 20 | | Act of 1987, of an advanced practice registered
nurse with | 21 | | prescriptive authority delegated under Section 65-40 of the | 22 | | Nurse Practice Act who issues a prescription for a
controlled | 23 | | substance in accordance
with
Section 303.05, a written | 24 | | delegation, and a written collaborative agreement under | 25 | | Section 65-35 of the Nurse Practice Act, of an advanced | 26 | | practice registered nurse certified as a nurse practitioner, |
| | | 10200SB0516sam001 | - 48 - | LRB102 16149 CPF 23544 a |
|
| 1 | | nurse midwife, or clinical nurse specialist who has been | 2 | | granted authority to prescribe by a hospital affiliate in | 3 | | accordance with Section 65-45 of the Nurse Practice Act and in | 4 | | accordance with Section 303.05 when required by law, or of an | 5 | | advanced practice registered nurse certified as a nurse | 6 | | practitioner, nurse midwife, or clinical nurse specialist who | 7 | | has full practice authority pursuant to Section 65-43 of the | 8 | | Nurse Practice Act.
| 9 | | (nn-5) "Prescription Information Library" (PIL) means an | 10 | | electronic library that contains reported controlled substance | 11 | | data. | 12 | | (nn-10) "Prescription Monitoring Program" (PMP) means the | 13 | | entity that collects, tracks, and stores reported data on | 14 | | controlled substances and select drugs pursuant to Section | 15 | | 316. | 16 | | (oo) "Production" or "produce" means manufacture, | 17 | | planting,
cultivating, growing, or harvesting of a controlled | 18 | | substance other than methamphetamine.
| 19 | | (pp) "Registrant" means every person who is required to | 20 | | register
under Section 302 of this Act.
| 21 | | (qq) "Registry number" means the number assigned to each | 22 | | person
authorized to handle controlled substances under the | 23 | | laws of the United
States and of this State.
| 24 | | (qq-5) "Secretary" means, as the context requires, either | 25 | | the Secretary of the Department or the Secretary of the | 26 | | Department of Financial and Professional Regulation, and the |
| | | 10200SB0516sam001 | - 49 - | LRB102 16149 CPF 23544 a |
|
| 1 | | Secretary's designated agents. | 2 | | (rr) "State" includes the State of Illinois and any state, | 3 | | district,
commonwealth, territory, insular possession thereof, | 4 | | and any area
subject to the legal authority of the United | 5 | | States of America.
| 6 | | (rr-5) "Stimulant" means any drug that (i) causes an | 7 | | overall excitation of central nervous system functions, (ii) | 8 | | causes impaired consciousness and awareness, and (iii) can be | 9 | | habit-forming or lead to a substance abuse problem, including | 10 | | but not limited to amphetamines and their analogs, | 11 | | methylphenidate and its analogs, cocaine, and phencyclidine | 12 | | and its analogs. | 13 | | (rr-10) "Synthetic drug" includes, but is not limited to, | 14 | | any synthetic cannabinoids or piperazines or any synthetic | 15 | | cathinones as provided for in Schedule I. | 16 | | (ss) "Ultimate user" means a person who lawfully possesses | 17 | | a
controlled substance for his or her own use or for the use of | 18 | | a member of his or her
household or for administering to an | 19 | | animal owned by him or her or by a member
of his or her | 20 | | household.
| 21 | | (Source: P.A. 99-78, eff. 7-20-15; 99-173, eff. 7-29-15; | 22 | | 99-371, eff. 1-1-16; 99-480, eff. 9-9-15; 99-642, eff. | 23 | | 7-28-16; 100-280, eff. 1-1-18; 100-453, eff. 8-25-17; 100-513, | 24 | | eff. 1-1-18; 100-789, eff. 1-1-19; 100-863, eff. 8-14-18 .)
| 25 | | Section 115. The Cannabis and Controlled Substances Tort |
| | | 10200SB0516sam001 | - 50 - | LRB102 16149 CPF 23544 a |
|
| 1 | | Claims Act is amended by changing Section 3 as follows:
| 2 | | (740 ILCS 20/3) (from Ch. 70, par. 903)
| 3 | | Sec. 3. Definitions. As used in this Act, unless the | 4 | | context otherwise
requires:
| 5 | | "Cannabis" includes marihuana, hashish, and other | 6 | | substances that
are identified as including any parts of the | 7 | | plant Cannabis Sativa, whether
growing or not, the seeds of | 8 | | that plant, the resin extracted from any part of
that plant, | 9 | | and any compound, manufacture, salt, derivative, mixture, or
| 10 | | preparation of that plant, its seeds, or resin, including
| 11 | | tetrahydrocannabinol (THC) and all other cannabinol | 12 | | derivatives, including
its naturally occurring or | 13 | | synthetically produced ingredients, whether
produced directly | 14 | | or indirectly by extraction, independently by means of
| 15 | | chemical synthesis, or by a combination of extraction and | 16 | | chemical
synthesis. "Cannabis" does not include the mature | 17 | | stalks of that plant, fiber
produced from those stalks, oil or | 18 | | cake made from the seeds of that plant,
any other compound, | 19 | | manufacture, salt, derivative, mixture, or preparation
of | 20 | | mature stalks (except the extracted resin), fiber, oil
or | 21 | | cake, or the sterilized seeds of that plant that are incapable | 22 | | of
germination.
| 23 | | "Controlled substance" means a drug, substance, or | 24 | | immediate precursor in
the Schedules of Article II of the | 25 | | Illinois Controlled Substances Act.
|
| | | 10200SB0516sam001 | - 51 - | LRB102 16149 CPF 23544 a |
|
| 1 | | "Counterfeit substance" means a controlled substance or | 2 | | the container or
labeling of a controlled substance that, | 3 | | without authorization, bears the
trademark, trade name, or | 4 | | other identifying mark, imprint, number, device,
or any | 5 | | likeness thereof of a manufacturer, distributor, or dispenser | 6 | | other
than the person who in fact manufactured, distributed, | 7 | | or dispensed the
substance.
| 8 | | "Deliver" or "delivery" means the actual, constructive, or | 9 | | attempted
transfer of possession of a controlled substance or | 10 | | cannabis, with or
without consideration, whether or not there | 11 | | is an agency relationship. "Deliver" or "delivery" does not
| 12 | | include the donation of drugs to the extent
permitted under | 13 | | the Illinois Drug Reuse Opportunity Program Act.
| 14 | | "Manufacture" means the production, preparation, | 15 | | propagation,
compounding, conversion, or processing of a | 16 | | controlled substance, either
directly or indirectly, by | 17 | | extraction from substances of natural origin,
independently by | 18 | | means of chemical synthesis, or by a combination of
extraction | 19 | | and chemical synthesis, and includes any packaging or
| 20 | | repackaging of the substance or labeling of its container, | 21 | | except that the
term does not include:
| 22 | | (1) by an ultimate user, the preparation or | 23 | | compounding of a
controlled substance for his own use;
| 24 | | (2) by a practitioner or his authorized agent under | 25 | | his supervision,
the preparation, compounding, packaging, | 26 | | or labeling of a controlled substance:
|
| | | 10200SB0516sam001 | - 52 - | LRB102 16149 CPF 23544 a |
|
| 1 | | (A) as an incident to his administering or | 2 | | dispensing of a controlled
substance in the course of | 3 | | his professional practice; or
| 4 | | (B) as an incident to lawful research, teaching or | 5 | | chemical analysis
and not for sale; or
| 6 | | (3) the preparation, compounding, packaging, or | 7 | | labeling of cannabis
as an incident to lawful research, | 8 | | teaching, or chemical analysis and not
for sale ; or . | 9 | | (4) the packaging, repackaging, or labeling of
drugs | 10 | | only to the extent permitted under the
Illinois Drug Reuse | 11 | | Opportunity Program Act.
| 12 | | "Owner" means a person who has possession of or any | 13 | | interest
whatsoever in the property involved.
| 14 | | "Person" means an individual, a corporation, a government,
| 15 | | a governmental subdivision or agency, a business trust, an | 16 | | estate, a trust,
a partnership or association, or any other | 17 | | entity.
| 18 | | "Production" means planting, cultivating, tending, or | 19 | | harvesting.
| 20 | | "Property" means real property, including things growing | 21 | | on,
affixed to, and found in land, and tangible or intangible | 22 | | personal
property, including rights, services, privileges, | 23 | | interests, claims,
and securities.
| 24 | | (Source: P.A. 96-328, eff. 8-11-09.)".
|
|