Full Text of SB2849 100th General Assembly
SB2849sam001 100TH GENERAL ASSEMBLY | Sen. Patricia Van Pelt Filed: 3/13/2018
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| 1 | | AMENDMENT TO SENATE BILL 2849
| 2 | | AMENDMENT NO. ______. Amend Senate Bill 2849 by replacing | 3 | | everything after the enacting clause with the following:
| 4 | | "Section 1. Short title. This Act may be cited as the | 5 | | Prescription Drug Repository 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 | | "Covered entity" means a long-term care facility licensed | 10 | | under the Nursing Home Care Act, an assisted living facility | 11 | | licensed under the Assisted Living and Shared Housing Act, a | 12 | | shared housing establishment licensed under the Assisted | 13 | | Living and Shared Housing Act, a pharmacy, a wholesaler, or a | 14 | | manufacturer, located inside or outside of the State. | 15 | | "Department" means the Department of Public Health. | 16 | | "Dispense" has the meaning given to that term in the |
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| 1 | | Pharmacy Practice Act. | 2 | | "Pharmacist" means an individual licensed to engage in the | 3 | | practice of pharmacy under the Pharmacy Practice Act. | 4 | | "Pharmacy" means a pharmacy registered in this State under | 5 | | the Pharmacy Practice Act. | 6 | | "Practitioner" means a person licensed in this State to | 7 | | prescribe and administer drugs or licensed in another state and | 8 | | recognized by this State as a person authorized to prescribe | 9 | | and administer drugs. | 10 | | "Prescription drug" means any prescribed drug that may be | 11 | | legally dispensed by a pharmacy. "Prescription drug" does not | 12 | | include drugs for the treatment of cancer that can only be | 13 | | dispensed to a patient registered with the drug manufacturer in | 14 | | accordance with federal Food and Drug Administration | 15 | | requirements. | 16 | | "Program" means the prescription drug repository program | 17 | | established under this Act. | 18 | | Section 10. Prescription drug repository program. The | 19 | | Department shall, by rule, establish and maintain a | 20 | | prescription drug repository program, under which a covered | 21 | | entity may donate a prescription drug or supplies needed to | 22 | | administer a prescription drug for use by an individual who | 23 | | meets appropriate eligibility criteria. The Department shall | 24 | | adopt the rules within one year after the effective date of | 25 | | this Act. Donations may be made on the premises of a pharmacy |
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| 1 | | that elects to participate in the program and meets appropriate | 2 | | requirements. The pharmacy may charge an individual who | 3 | | receives a prescription drug or supplies needed to administer a | 4 | | prescription drug under this Act a handling fee that may not | 5 | | exceed an appropriate amount. A pharmacy that receives a | 6 | | donated prescription drug or supplies needed to administer a | 7 | | prescription drug under this Act may distribute the | 8 | | prescription drug or supplies to another eligible pharmacy for | 9 | | use under the program. | 10 | | Section 15. Priority. Uninsured and underinsured | 11 | | individuals shall be given priority for drugs and supplies | 12 | | donated under this Act over other eligible persons. | 13 | | Section 20. Requirements for accepting and dispensing | 14 | | prescription drugs and supplies. A prescription drug or | 15 | | supplies needed to administer a prescription drug may be | 16 | | accepted and dispensed under the program only if all of the | 17 | | following requirements are met:
| 18 | | (1) The prescription drug or supplies needed to | 19 | | administer a prescription drug are in their original, | 20 | | unopened, sealed, and tamper-evident packaging or, if | 21 | | packaged in single-unit doses, the single-unit-dose | 22 | | packaging is unopened.
Medicine and supplies originally | 23 | | packaged by a pharmacy are acceptable for donation. | 24 | | (2) The prescription drug bears an expiration date that |
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| 1 | | is later than an amount of time determined by the | 2 | | Department after the date that the drug was donated.
| 3 | | (3) The prescription drug or supplies needed to | 4 | | administer a prescription drug are not adulterated or | 5 | | misbranded, as determined by a pharmacist employed by, or | 6 | | under contract with, the pharmacy where the drug or | 7 | | supplies are accepted or dispensed. The pharmacist must | 8 | | inspect the drug or supplies before the drug or supplies | 9 | | are dispensed.
| 10 | | (4) The prescription drug or supplies needed to | 11 | | administer a prescription drug are prescribed by a | 12 | | practitioner for use by an eligible individual.
| 13 | | (5) The prescription drug is not a controlled | 14 | | substance. | 15 | | (6) Drugs that can be dispensed only to a patient | 16 | | registered with the drug's manufacturer in accordance with | 17 | | federal Food and Drug Administration requirements may not | 18 | | be accepted or distributed under the provisions of the | 19 | | program. | 20 | | (7) A pharmacy shall maintain a written or electronic | 21 | | record of a donation under this Act consisting of the name, | 22 | | strength, and quantity of each accepted drug, and the name, | 23 | | address, and telephone number of the donor. No other record | 24 | | of a donation shall be required. | 25 | | Section 25. Resale of donated drugs or supplies prohibited. |
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| 1 | | No prescription drug or supplies needed to administer a | 2 | | prescription drug that are donated for use under this Act may | 3 | | be resold.
| 4 | | Section 30. Participation in program not required. Nothing | 5 | | in this Act requires that a pharmacy or pharmacist participate | 6 | | in the prescription drug repository program.
| 7 | | Section 90. The Pharmacy Practice Act is amended by | 8 | | changing Section 4 as follows:
| 9 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
| 10 | | (Section scheduled to be repealed on January 1, 2020)
| 11 | | Sec. 4. Exemptions. Nothing contained in any Section of | 12 | | this Act shall
apply
to, or in any manner interfere with:
| 13 | | (a) the lawful practice of any physician licensed to | 14 | | practice medicine in
all of its branches, dentist, | 15 | | podiatric physician,
veterinarian, or therapeutically or | 16 | | diagnostically certified optometrist within
the limits of
| 17 | | his or her license, or prevent him or her from
supplying to | 18 | | his
or her
bona fide patients
such drugs, medicines, or | 19 | | poisons as may seem to him appropriate;
| 20 | | (b) the sale of compressed gases;
| 21 | | (c) the sale of patent or proprietary medicines and | 22 | | household remedies
when sold in original and unbroken | 23 | | packages only, if such patent or
proprietary medicines and |
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| 1 | | household remedies be properly and adequately
labeled as to | 2 | | content and usage and generally considered and accepted
as | 3 | | harmless and nonpoisonous when used according to the | 4 | | directions
on the label, and also do not contain opium or | 5 | | coca leaves, or any
compound, salt or derivative thereof, | 6 | | or any drug which, according
to the latest editions of the | 7 | | following authoritative pharmaceutical
treatises and | 8 | | standards, namely, The United States | 9 | | Pharmacopoeia/National
Formulary (USP/NF), the United | 10 | | States Dispensatory, and the Accepted
Dental Remedies of | 11 | | the Council of Dental Therapeutics of the American
Dental | 12 | | Association or any or either of them, in use on the | 13 | | effective
date of this Act, or according to the existing | 14 | | provisions of the Federal
Food, Drug, and Cosmetic Act and | 15 | | Regulations of the Department of Health
and Human Services, | 16 | | Food and Drug Administration, promulgated thereunder
now | 17 | | in effect, is designated, described or considered as a | 18 | | narcotic,
hypnotic, habit forming, dangerous, or poisonous | 19 | | drug;
| 20 | | (d) the sale of poultry and livestock remedies in | 21 | | original and unbroken
packages only, labeled for poultry | 22 | | and livestock medication;
| 23 | | (e) the sale of poisonous substances or mixture of | 24 | | poisonous substances,
in unbroken packages, for | 25 | | nonmedicinal use in the arts or industries
or for | 26 | | insecticide purposes; provided, they are properly and |
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| 1 | | adequately
labeled as to content and such nonmedicinal | 2 | | usage, in conformity
with the provisions of all applicable | 3 | | federal, state and local laws
and regulations promulgated | 4 | | thereunder now in effect relating thereto
and governing the | 5 | | same, and those which are required under such applicable
| 6 | | laws and regulations to be labeled with the word "Poison", | 7 | | are also labeled
with the word "Poison" printed
thereon in | 8 | | prominent type and the name of a readily obtainable | 9 | | antidote
with directions for its administration;
| 10 | | (f) the delegation of limited prescriptive authority | 11 | | by a physician
licensed to
practice medicine in all its | 12 | | branches to a physician assistant
under Section 7.5 of the | 13 | | Physician Assistant Practice Act of 1987. This
delegated | 14 | | authority under Section 7.5 of the Physician Assistant | 15 | | Practice Act of 1987 may, but is not required to, include | 16 | | prescription of
controlled substances, as defined in | 17 | | Article II of the
Illinois Controlled Substances Act, in | 18 | | accordance with a written supervision agreement;
| 19 | | (g) the delegation of prescriptive authority by a | 20 | | physician
licensed to practice medicine in all its branches | 21 | | or a licensed podiatric physician to an advanced practice
| 22 | | registered nurse in accordance with a written | 23 | | collaborative
agreement under Sections 65-35 and 65-40 of | 24 | | the Nurse Practice Act; and | 25 | | (g-5) the donation or acceptance, or the packaging, | 26 | | repackaging, or labeling, of prescription drugs to the |
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| 1 | | extent permitted or required under the Prescription Drug | 2 | | Repository Program Act; and
| 3 | | (h) the sale or distribution of dialysate or devices | 4 | | necessary to perform home peritoneal renal dialysis for | 5 | | patients with end-stage renal disease, provided that all of | 6 | | the following conditions are met: | 7 | | (1) the dialysate, comprised of dextrose or | 8 | | icodextrin, or devices are approved or cleared by the | 9 | | federal Food and Drug Administration, as required by | 10 | | federal law; | 11 | | (2) the dialysate or devices are lawfully held by a | 12 | | manufacturer or the manufacturer's agent, which is | 13 | | properly registered with the Board as a manufacturer or | 14 | | wholesaler; | 15 | | (3) the dialysate or devices are held and delivered | 16 | | to the manufacturer or the manufacturer's agent in the | 17 | | original, sealed packaging from the manufacturing | 18 | | facility; | 19 | | (4) the dialysate or devices are delivered only | 20 | | upon receipt of a physician's prescription by a | 21 | | licensed pharmacy in which the prescription is | 22 | | processed in accordance with provisions set forth in | 23 | | this Act, and the transmittal of an order from the | 24 | | licensed pharmacy to the manufacturer or the | 25 | | manufacturer's agent; and | 26 | | (5) the manufacturer or the manufacturer's agent |
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| 1 | | delivers the dialysate or devices directly to: (i) a | 2 | | patient with end-stage renal disease, or his or her | 3 | | designee, for the patient's self-administration of the | 4 | | dialysis therapy or (ii) a health care provider or | 5 | | institution for administration or delivery of the | 6 | | dialysis therapy to a patient with end-stage renal | 7 | | disease. | 8 | | This paragraph (h) does not include any other drugs for | 9 | | peritoneal dialysis, except dialysate, as described in | 10 | | item (1) of this paragraph (h). All records of sales and | 11 | | distribution of dialysate to patients made pursuant to this | 12 | | paragraph (h) must be retained in accordance with Section | 13 | | 18 of this Act. | 14 | | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | 15 | | revised 9-29-17.)
| 16 | | Section 95. The Wholesale Drug Distribution Licensing Act | 17 | | is amended by changing Section 15 as follows:
| 18 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| 19 | | (Section scheduled to be repealed on January 1, 2023)
| 20 | | Sec. 15. Definitions. As used in this Act:
| 21 | | "Authentication" means the affirmative verification, | 22 | | before any wholesale distribution of a prescription drug | 23 | | occurs, that each transaction listed on the pedigree has | 24 | | occurred. |
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| 1 | | "Authorized distributor of record" means a wholesale | 2 | | distributor with whom a manufacturer has established an ongoing | 3 | | relationship to distribute the manufacturer's prescription | 4 | | drug. An ongoing relationship is deemed to exist between a | 5 | | wholesale distributor and a manufacturer when the wholesale | 6 | | distributor, including any affiliated group of the wholesale | 7 | | distributor, as defined in Section 1504 of the Internal Revenue | 8 | | Code, complies with the following: | 9 | | (1) The wholesale distributor has a written agreement | 10 | | currently in effect with the manufacturer evidencing the | 11 | | ongoing relationship; and | 12 | | (2) The wholesale distributor is listed on the | 13 | | manufacturer's current list of authorized distributors of | 14 | | record, which is updated by the manufacturer on no less | 15 | | than a monthly basis.
| 16 | | "Blood" means whole blood collected from a single donor and | 17 | | processed
either for transfusion or further manufacturing.
| 18 | | "Blood component" means that part of blood separated by | 19 | | physical or
mechanical means.
| 20 | | "Board" means the State Board of Pharmacy of the Department | 21 | | of
Professional Regulation.
| 22 | | "Chain pharmacy warehouse" means a physical location for | 23 | | prescription drugs that acts as a central warehouse and | 24 | | performs intracompany sales or transfers of the drugs to a | 25 | | group of chain or mail order pharmacies that have the same | 26 | | common ownership and control. Notwithstanding any other |
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| 1 | | provision of this Act, a chain pharmacy warehouse shall be | 2 | | considered part of the normal distribution channel. | 3 | | "Co-licensed partner or product" means an instance where | 4 | | one or more parties have the right to engage in the | 5 | | manufacturing or marketing of a prescription drug, consistent | 6 | | with the FDA's implementation of the Prescription Drug | 7 | | Marketing Act.
| 8 | | "Department" means the Department of Financial and
| 9 | | Professional Regulation.
| 10 | | "Drop shipment" means the sale of a prescription drug to a | 11 | | wholesale distributor by the manufacturer of the prescription | 12 | | drug or that manufacturer's co-licensed product partner, that | 13 | | manufacturer's third party logistics provider, or that | 14 | | manufacturer's exclusive distributor or by an authorized | 15 | | distributor of record that purchased the product directly from | 16 | | the manufacturer or one of these entities whereby the wholesale | 17 | | distributor or chain pharmacy warehouse takes title but not | 18 | | physical possession of such prescription drug and the wholesale | 19 | | distributor invoices the pharmacy, chain pharmacy warehouse, | 20 | | or other person authorized by law to dispense or administer | 21 | | such drug to a patient and the pharmacy, chain pharmacy | 22 | | warehouse, or other authorized person receives delivery of the | 23 | | prescription drug directly from the manufacturer, that | 24 | | manufacturer's third party logistics provider, or that | 25 | | manufacturer's exclusive distributor or from an authorized | 26 | | distributor of record that purchased the product directly from |
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| 1 | | the manufacturer or one of these entities.
| 2 | | "Drug sample" means a unit of a prescription drug that is | 3 | | not intended to
be sold and is intended to promote the sale of | 4 | | the drug.
| 5 | | "Facility" means a facility of a wholesale distributor | 6 | | where prescription drugs are stored, handled, repackaged, or | 7 | | offered for sale. | 8 | | "FDA" means the United States Food and Drug Administration.
| 9 | | "Manufacturer" means a person licensed or approved by the | 10 | | FDA to engage in the manufacture of drugs or devices, | 11 | | consistent with the definition of "manufacturer" set forth in | 12 | | the FDA's regulations and guidances implementing the | 13 | | Prescription Drug Marketing Act. "Manufacturer" does not | 14 | | include anyone who is engaged in the packaging, repackaging, or | 15 | | labeling of prescription drugs only to the extent required | 16 | | under the Prescription Drug Repository Program Act. | 17 | | "Manufacturer's exclusive distributor" means anyone who | 18 | | contracts with a manufacturer to provide or coordinate | 19 | | warehousing, distribution, or other services on behalf of a | 20 | | manufacturer and who takes title to that manufacturer's | 21 | | prescription drug, but who does not have general responsibility | 22 | | to direct the sale or disposition of the manufacturer's | 23 | | prescription drug. A manufacturer's exclusive distributor must | 24 | | be licensed as a wholesale distributor under this Act and, in | 25 | | order to be considered part of the normal distribution channel, | 26 | | must also be an authorized distributor of record.
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| 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 |
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| 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 pharmacy | 12 | | licensed in this State or
to any other person or entity | 13 | | including, but not limited to, a wholesale
drug distributor | 14 | | engaged in the delivery or distribution of prescription
drugs | 15 | | who is involved in the actual, constructive, or attempted | 16 | | transfer of
a drug in this State to other than the ultimate | 17 | | consumer except as
otherwise provided for by law.
| 18 | | "Prescription drug" means any human drug, including any | 19 | | biological product (except for blood and blood components | 20 | | intended for transfusion or biological products that are also | 21 | | medical devices), required by federal law or
regulation to be | 22 | | dispensed only by a prescription, including finished
dosage | 23 | | forms and bulk drug substances
subject to Section
503 of the | 24 | | Federal Food, Drug and Cosmetic Act.
| 25 | | "Repackage" means repackaging or otherwise changing the | 26 | | container, wrapper, or labeling to further the distribution of |
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| 1 | | a prescription drug, excluding that completed by the pharmacist | 2 | | responsible for dispensing the product to a patient. | 3 | | "Secretary" means the Secretary of Financial and | 4 | | Professional Regulation. | 5 | | "Third party logistics provider" means anyone who | 6 | | contracts with a prescription drug manufacturer to provide or | 7 | | coordinate warehousing, distribution, or other services on | 8 | | behalf of a manufacturer, but does not take title to the | 9 | | prescription drug or have general responsibility to direct the | 10 | | prescription drug's sale or disposition. A third party | 11 | | logistics provider must be licensed as a wholesale distributor | 12 | | under this Act and, in order to be considered part of the | 13 | | normal distribution channel, must also be an authorized | 14 | | distributor of record. | 15 | | "Wholesale distribution"
means the distribution
of | 16 | | prescription drugs to persons other than a consumer or patient, | 17 | | but does
not include any of the following:
| 18 | | (1)
Intracompany sales of prescription drugs, meaning | 19 | | (i) any transaction or transfer
between any division, | 20 | | subsidiary, parent, or affiliated or related company
under | 21 | | the common ownership and control of a corporate entity or | 22 | | (ii) any transaction or transfer between co-licensees of a | 23 | | co-licensed product.
| 24 | | (2) The sale, purchase, distribution, trade, or | 25 | | transfer of a prescription drug or offer to sell, purchase, | 26 | | distribute, trade, or transfer a prescription drug for |
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| 1 | | emergency medical reasons.
| 2 | | (3) The distribution of prescription drug samples by | 3 | | manufacturers' representatives. | 4 | | (4) Drug returns, when conducted by a hospital, health | 5 | | care entity, or charitable institution in accordance with | 6 | | federal regulation. | 7 | | (5) The sale of minimal quantities of prescription | 8 | | drugs by licensed pharmacies to licensed practitioners for | 9 | | office use or other licensed pharmacies. | 10 | | (6) The sale, purchase, or trade of a drug, an offer to | 11 | | sell, purchase, or trade a drug, or the dispensing of a | 12 | | drug pursuant to a prescription. | 13 | | (7) The sale, transfer, merger, or consolidation of all | 14 | | or part of the business of a pharmacy or pharmacies from or | 15 | | with another pharmacy or pharmacies, whether accomplished | 16 | | as a purchase and sale of stock or business assets. | 17 | | (8) The sale, purchase, distribution, trade, or | 18 | | transfer of a prescription drug from one authorized | 19 | | distributor of record to one additional authorized | 20 | | distributor of record when the manufacturer has stated in | 21 | | writing to the receiving authorized distributor of record | 22 | | that the manufacturer is unable to supply the prescription | 23 | | drug and the supplying authorized distributor of record | 24 | | states in writing that the prescription drug being supplied | 25 | | had until that time been exclusively in the normal | 26 | | distribution channel. |
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| 1 | | (9) The delivery of or the offer to deliver a | 2 | | prescription drug by a common carrier solely in the common | 3 | | carrier's usual course of business of transporting | 4 | | prescription drugs when the common carrier does not store, | 5 | | warehouse, or take legal ownership of the prescription | 6 | | drug. | 7 | | (10) The sale or transfer from a retail pharmacy, mail | 8 | | order pharmacy, or chain pharmacy warehouse of expired, | 9 | | damaged, returned, or recalled prescription drugs to the | 10 | | original manufacturer, the originating wholesale | 11 | | distributor, or a third party returns processor.
| 12 | | (11) The donation of prescription drugs to the extent | 13 | | permitted under the Prescription Drug Repository Program | 14 | | Act.
| 15 | | "Wholesale drug distributor" means anyone
engaged in the
| 16 | | wholesale distribution of prescription drugs into, out of, or | 17 | | within the State, including without limitation
manufacturers; | 18 | | repackers; own label distributors; jobbers; private
label | 19 | | distributors; brokers; warehouses, including manufacturers' | 20 | | and
distributors' warehouses; manufacturer's exclusive | 21 | | distributors; and authorized distributors of record; drug | 22 | | wholesalers or distributors; independent wholesale drug | 23 | | traders; specialty wholesale distributors; third party | 24 | | logistics providers; and retail pharmacies that conduct | 25 | | wholesale distribution; and chain pharmacy warehouses that | 26 | | conduct wholesale distribution. In order to be considered part |
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| 1 | | of the normal distribution channel, a wholesale distributor | 2 | | must also be an authorized distributor of record.
| 3 | | (Source: P.A. 97-804, eff. 1-1-13.)
| 4 | | Section 100. The Senior Pharmaceutical Assistance Act is | 5 | | amended by changing Section 10 as follows:
| 6 | | (320 ILCS 50/10)
| 7 | | Sec. 10. Definitions. In this Act:
| 8 | | "Manufacturer" includes:
| 9 | | (1) An entity that is engaged in (a) the production, | 10 | | preparation,
propagation, compounding, conversion, or | 11 | | processing of prescription drug
products (i) directly or | 12 | | indirectly by extraction from substances of natural
| 13 | | origin,
(ii) independently by means of chemical synthesis, | 14 | | or (iii) by combination of
extraction
and chemical | 15 | | synthesis; or (b) the packaging, repackaging, labeling or
| 16 | | re-labeling, or distribution of prescription drug | 17 | | products.
| 18 | | (2) The entity holding legal title to or possession of | 19 | | the national
drug code number for the covered prescription | 20 | | drug.
| 21 | | The term does not include a wholesale distributor of drugs,
| 22 | | drugstore chain organization, or retail pharmacy licensed by | 23 | | the State. The term also does not include anyone who is engaged | 24 | | in the packaging, repackaging, or labeling of prescription |
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| 1 | | drugs only to the extent required under the Prescription Drug | 2 | | Repository Program Act.
| 3 | | "Prescription drug" means a drug that may be dispensed only | 4 | | upon
prescription by an authorized prescriber and that is | 5 | | approved for safety and
effectiveness as a prescription drug | 6 | | under Section 505 or 507 of the Federal
Food, Drug and Cosmetic | 7 | | Act.
| 8 | | "Senior citizen" or "senior" means a person 65 years of age | 9 | | or
older.
| 10 | | (Source: P.A. 92-594, eff. 6-27-02.)
| 11 | | Section 105. The Illinois Food, Drug and Cosmetic Act is | 12 | | amended by changing Section 16 as follows:
| 13 | | (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
| 14 | | Sec. 16. (a) The Director is hereby authorized to | 15 | | promulgate
regulations exempting from any labeling or | 16 | | packaging requirement of this
Act drugs and devices which are | 17 | | (i) , in accordance with the practice of the
trade, to be | 18 | | processed, labeled or repacked in substantial quantities at
| 19 | | establishments other than those where originally processed or | 20 | | packaged on
condition that such drugs and devices are not | 21 | | adulterated or misbranded
under the provisions of this Act upon | 22 | | removal from such processing,
labeling or repacking | 23 | | establishment or (ii) packaged, repackaged, or labeled to the | 24 | | extent required under the Prescription Drug Repository Program |
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| 1 | | Act .
| 2 | | (b) Drugs and device labeling or packaging exemptions | 3 | | adopted under the
Federal Act and supplements thereto or | 4 | | revisions thereof shall apply to
drugs and devices in Illinois | 5 | | except insofar as modified or rejected by
regulations | 6 | | promulgated by the Director.
| 7 | | (c) A drug intended for use by man which (A) is a | 8 | | habit-forming drug to
which Section 15 (d) applies; or (B) | 9 | | because of its toxicity or other
potentiality for harmful | 10 | | effect or the method of its use or the collateral
measures | 11 | | necessary to its use is not safe for use except under the
| 12 | | supervision of a practitioner licensed by law to administer | 13 | | such drug; or
(C) is limited by an approved application under | 14 | | Section 505 of the Federal
Act or Section 17 of this Act to use | 15 | | under the professional supervision of
a practitioner licensed | 16 | | by law to administer such drug, shall be dispensed
only in | 17 | | accordance with the provisions of the "Illinois Controlled
| 18 | | Substances Act". The act of dispensing a drug contrary to the | 19 | | provisions of
this paragraph shall be deemed to be an act which | 20 | | results in a drug being
misbranded while held for sale.
| 21 | | (d) Any drug dispensed by filling or refilling a written
or | 22 | | oral prescription of a practitioner licensed by law to | 23 | | administer such
drug shall be exempt from the requirements of | 24 | | Section 15, except
subsections (a), (k) and (l) and clauses (2) | 25 | | and (3) of subsection (i), and
the packaging requirements of
| 26 | | subsections (g), (h) and (q), if the drug bears a label |
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| 1 | | containing the
proprietary name or names, or if there is none, | 2 | | the established name or
names of the drugs, the dosage and | 3 | | quantity, unless the prescribing
practitioner, in the interest | 4 | | of the health of the patient, directs
otherwise in writing, the | 5 | | name and address of the dispenser, the serial
number and date | 6 | | of the prescription or of its filling, the name of the
| 7 | | prescriber and, if stated in the prescription, the name of the | 8 | | patient, and
the directions for use and the cautionary | 9 | | statements, if any, contained in
such prescription. This | 10 | | exemption shall not apply to any drug dispensed in
the course | 11 | | of the conduct of business of dispensing drugs pursuant to
| 12 | | diagnosis by mail, or to a drug dispensed in violation of | 13 | | subsection (a) of
this Section.
| 14 | | (e) The Director may by regulation remove drugs subject to
| 15 | | Section 15 (d) and Section 17 from the requirements of | 16 | | subsection (c) of
this Section when such requirements are not | 17 | | necessary for the protection of
the public health.
| 18 | | (f) A drug which is subject to subsection (c) of this | 19 | | Section
shall be deemed to be misbranded if at any time before | 20 | | dispensing its label
fails to bear the statement "Caution: | 21 | | Federal Law Prohibits Dispensing Without
Prescription" or | 22 | | "Caution: State Law Prohibits Dispensing Without
| 23 | | Prescription". A drug to which subsection (c) of this Section | 24 | | does not apply
shall be deemed to be misbranded if at any time | 25 | | prior to dispensing its
label bears the caution statement | 26 | | quoted in the preceding sentence.
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| | | 10000SB2849sam001 | - 22 - | LRB100 19083 MJP 36763 a |
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| 1 | | (g) Nothing in this Section shall be construed to relieve
| 2 | | any person from any requirement prescribed by or under | 3 | | authority of law
with respect to controlled substances now | 4 | | included or which may hereafter
be included within the | 5 | | classifications of controlled substances cannabis as
defined | 6 | | in applicable Federal laws relating to controlled substances or
| 7 | | cannabis or the Cannabis Control Act.
| 8 | | (Source: P.A. 84-1308.)".
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