Full Text of SB1839 101st General Assembly
SB1839enr 101ST GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 2 | | Be it enacted by the People of the State of Illinois, | 3 | | represented in the General Assembly:
| 4 | | Section 3. The Pharmacy Practice Act is amended by changing | 5 | | Section 4 as follows:
| 6 | | (225 ILCS 85/4) (from Ch. 111, par. 4124)
| 7 | | (Section scheduled to be repealed on January 1, 2020)
| 8 | | Sec. 4. Exemptions. Nothing contained in any Section of | 9 | | this Act shall
apply
to, or in any manner interfere with:
| 10 | | (a) the lawful practice of any physician licensed to | 11 | | practice medicine in
all of its branches, dentist, | 12 | | podiatric physician,
veterinarian, or therapeutically or | 13 | | diagnostically certified optometrist within
the limits of
| 14 | | his or her license, or prevent him or her from
supplying to | 15 | | his
or her
bona fide patients
such drugs, medicines, or | 16 | | poisons as may seem to him appropriate;
| 17 | | (b) the sale of compressed gases;
| 18 | | (c) the sale of patent or proprietary medicines and | 19 | | household remedies
when sold in original and unbroken | 20 | | packages only, if such patent or
proprietary medicines and | 21 | | household remedies be properly and adequately
labeled as to | 22 | | content and usage and generally considered and accepted
as | 23 | | harmless and nonpoisonous when used according to the |
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| 1 | | directions
on the label, and also do not contain opium or | 2 | | coca leaves, or any
compound, salt or derivative thereof, | 3 | | or any drug which, according
to the latest editions of the | 4 | | following authoritative pharmaceutical
treatises and | 5 | | standards, namely, The United States | 6 | | Pharmacopoeia/National
Formulary (USP/NF), the United | 7 | | States Dispensatory, and the Accepted
Dental Remedies of | 8 | | the Council of Dental Therapeutics of the American
Dental | 9 | | Association or any or either of them, in use on the | 10 | | effective
date of this Act, or according to the existing | 11 | | provisions of the Federal
Food, Drug, and Cosmetic Act and | 12 | | Regulations of the Department of Health
and Human Services, | 13 | | Food and Drug Administration, promulgated thereunder
now | 14 | | in effect, is designated, described or considered as a | 15 | | narcotic,
hypnotic, habit forming, dangerous, or poisonous | 16 | | drug;
| 17 | | (d) the sale of poultry and livestock remedies in | 18 | | original and unbroken
packages only, labeled for poultry | 19 | | and livestock medication;
| 20 | | (e) the sale of poisonous substances or mixture of | 21 | | poisonous substances,
in unbroken packages, for | 22 | | nonmedicinal use in the arts or industries
or for | 23 | | insecticide purposes; provided, they are properly and | 24 | | adequately
labeled as to content and such nonmedicinal | 25 | | usage, in conformity
with the provisions of all applicable | 26 | | federal, state and local laws
and regulations promulgated |
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| 1 | | thereunder now in effect relating thereto
and governing the | 2 | | same, and those which are required under such applicable
| 3 | | laws and regulations to be labeled with the word "Poison", | 4 | | are also labeled
with the word "Poison" printed
thereon in | 5 | | prominent type and the name of a readily obtainable | 6 | | antidote
with directions for its administration;
| 7 | | (f) the delegation of limited prescriptive authority | 8 | | by a physician
licensed to
practice medicine in all its | 9 | | branches to a physician assistant
under Section 7.5 of the | 10 | | Physician Assistant Practice Act of 1987. This
delegated | 11 | | authority under Section 7.5 of the Physician Assistant | 12 | | Practice Act of 1987 may, but is not required to, include | 13 | | prescription of
controlled substances, as defined in | 14 | | Article II of the
Illinois Controlled Substances Act, in | 15 | | accordance with a written supervision agreement;
| 16 | | (g) the delegation of prescriptive authority by a | 17 | | physician
licensed to practice medicine in all its branches | 18 | | or a licensed podiatric physician to an advanced practice
| 19 | | registered nurse in accordance with a written | 20 | | collaborative
agreement under Sections 65-35 and 65-40 of | 21 | | the Nurse Practice Act; and
| 22 | | (h) the sale or distribution of dialysate or devices | 23 | | necessary to perform home peritoneal renal dialysis for | 24 | | patients with end-stage renal disease, provided that all of | 25 | | the following conditions are met: | 26 | | (1) the dialysate, comprised of dextrose or |
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| 1 | | icodextrin, or devices are approved or cleared by the | 2 | | federal Food and Drug Administration, as required by | 3 | | federal law; | 4 | | (2) the dialysate or devices are lawfully held by a | 5 | | manufacturer or the manufacturer's agent, which is | 6 | | properly registered with the Board as a manufacturer , | 7 | | third-party logistics provider, or wholesaler; | 8 | | (3) the dialysate or devices are held and delivered | 9 | | to the manufacturer or the manufacturer's agent in the | 10 | | original, sealed packaging from the manufacturing | 11 | | facility; | 12 | | (4) the dialysate or devices are delivered only | 13 | | upon receipt of a physician's prescription by a | 14 | | licensed pharmacy in which the prescription is | 15 | | processed in accordance with provisions set forth in | 16 | | this Act, and the transmittal of an order from the | 17 | | licensed pharmacy to the manufacturer or the | 18 | | manufacturer's agent; and | 19 | | (5) the manufacturer or the manufacturer's agent | 20 | | delivers the dialysate or devices directly to: (i) a | 21 | | patient with end-stage renal disease, or his or her | 22 | | designee, for the patient's self-administration of the | 23 | | dialysis therapy or (ii) a health care provider or | 24 | | institution for administration or delivery of the | 25 | | dialysis therapy to a patient with end-stage renal | 26 | | disease. |
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| 1 | | This paragraph (h) does not include any other drugs for | 2 | | peritoneal dialysis, except dialysate, as described in | 3 | | item (1) of this paragraph (h). All records of sales and | 4 | | distribution of dialysate to patients made pursuant to this | 5 | | paragraph (h) must be retained in accordance with Section | 6 | | 18 of this Act. | 7 | | (Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18; | 8 | | 100-863, eff. 8-14-18.)
| 9 | | Section 10. The Wholesale Drug Distribution Licensing Act | 10 | | is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80, | 11 | | and 155 and by adding Section 25.5 as follows:
| 12 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| 13 | | (Section scheduled to be repealed on January 1, 2023)
| 14 | | Sec. 15. Definitions. As used in this Act:
| 15 | | "Authentication" means the affirmative verification, | 16 | | before any wholesale distribution of a prescription drug | 17 | | occurs, that each transaction listed on the pedigree has | 18 | | occurred. | 19 | | "Authorized distributor of record" means a wholesale | 20 | | distributor with whom a manufacturer has established an ongoing | 21 | | relationship to distribute the manufacturer's prescription | 22 | | drug. An ongoing relationship is deemed to exist between a | 23 | | wholesale distributor and a manufacturer when the wholesale | 24 | | distributor, including any affiliated group of the wholesale |
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| 1 | | distributor, as defined in Section 1504 of the Internal Revenue | 2 | | Code, complies with the following: | 3 | | (1) The wholesale distributor has a written agreement | 4 | | currently in effect with the manufacturer evidencing the | 5 | | ongoing relationship; and | 6 | | (2) The wholesale distributor is listed on the | 7 | | manufacturer's current list of authorized distributors of | 8 | | record, which is updated by the manufacturer on no less | 9 | | than a monthly basis.
| 10 | | "Blood" means whole blood collected from a single donor and | 11 | | processed
either for transfusion or further manufacturing.
| 12 | | "Blood component" means that part of blood separated by | 13 | | physical or
mechanical means.
| 14 | | "Board" means the State Board of Pharmacy of the Department | 15 | | of
Professional Regulation.
| 16 | | "Chain pharmacy warehouse" means a physical location for | 17 | | prescription drugs that acts as a central warehouse and | 18 | | performs intracompany sales or transfers of the drugs to a | 19 | | group of chain or mail order pharmacies that have the same | 20 | | common ownership and control. Notwithstanding any other | 21 | | provision of this Act, a chain pharmacy warehouse shall be | 22 | | considered part of the normal distribution channel. | 23 | | "Co-licensed partner or product" means an instance where | 24 | | one or more parties have the right to engage in the | 25 | | manufacturing or marketing of a prescription drug, consistent | 26 | | with the FDA's implementation of the Prescription Drug |
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| 1 | | Marketing Act.
| 2 | | "Department" means the Department of Financial and
| 3 | | Professional Regulation.
| 4 | | "Drop shipment" means the sale of a prescription drug to a | 5 | | wholesale distributor by the manufacturer of the prescription | 6 | | drug or that manufacturer's co-licensed product partner, that | 7 | | manufacturer's third party logistics provider, or that | 8 | | manufacturer's exclusive distributor or by an authorized | 9 | | distributor of record that purchased the product directly from | 10 | | the manufacturer or one of these entities whereby the wholesale | 11 | | distributor or chain pharmacy warehouse takes title but not | 12 | | physical possession of such prescription drug and the wholesale | 13 | | distributor invoices the pharmacy, chain pharmacy warehouse, | 14 | | or other person authorized by law to dispense or administer | 15 | | such drug to a patient and the pharmacy, chain pharmacy | 16 | | warehouse, or other authorized person receives delivery of the | 17 | | prescription drug directly from the manufacturer, that | 18 | | manufacturer's third party logistics provider, or that | 19 | | manufacturer's exclusive distributor or from an authorized | 20 | | distributor of record that purchased the product directly from | 21 | | the manufacturer or one of these entities.
| 22 | | "Drug sample" means a unit of a prescription drug that is | 23 | | not intended to
be sold and is intended to promote the sale of | 24 | | the drug.
| 25 | | "Facility" means a facility of a wholesale distributor | 26 | | where prescription drugs are stored, handled, repackaged, or |
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| 1 | | offered for sale , or a facility of a third-party logistics | 2 | | provider where prescription drugs are stored or handled . | 3 | | "FDA" means the United States Food and Drug Administration.
| 4 | | "Manufacturer" means a person licensed or approved by the | 5 | | FDA to engage in the manufacture of drugs or devices, | 6 | | consistent with the definition of "manufacturer" set forth in | 7 | | the FDA's regulations and guidances implementing the | 8 | | Prescription Drug Marketing Act. | 9 | | "Manufacturer's exclusive distributor" means anyone who | 10 | | contracts with a manufacturer to provide or coordinate | 11 | | warehousing, distribution, or other services on behalf of a | 12 | | manufacturer and who takes title to that manufacturer's | 13 | | prescription drug, but who does not have general responsibility | 14 | | to direct the sale or disposition of the manufacturer's | 15 | | prescription drug. A manufacturer's exclusive distributor must | 16 | | be licensed as a wholesale distributor under this Act and, in | 17 | | order to be considered part of the normal distribution channel, | 18 | | must also be an authorized distributor of record.
| 19 | | "Normal distribution channel" means a chain of custody for | 20 | | a prescription drug that goes, directly or by drop shipment, | 21 | | from (i) a manufacturer of the prescription drug, (ii) that | 22 | | manufacturer to that manufacturer's co-licensed partner, (iii) | 23 | | that manufacturer to that manufacturer's third party logistics | 24 | | provider, or (iv) that manufacturer to that manufacturer's | 25 | | exclusive distributor to: | 26 | | (1) a pharmacy or to other designated persons |
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| 1 | | authorized by law to dispense or administer the drug to a | 2 | | patient; | 3 | | (2) a wholesale distributor to a pharmacy or other | 4 | | designated persons authorized by law to dispense or | 5 | | administer the drug to a patient; | 6 | | (3) a wholesale distributor to a chain pharmacy | 7 | | warehouse to that chain pharmacy warehouse's intracompany | 8 | | pharmacy to a patient or other designated persons | 9 | | authorized by law to dispense or administer the drug to a | 10 | | patient; | 11 | | (4) a chain pharmacy warehouse to the chain pharmacy | 12 | | warehouse's intracompany pharmacy or other designated | 13 | | persons authorized by law to dispense or administer the | 14 | | drug to the patient; | 15 | | (5) an authorized distributor of record to one other | 16 | | authorized distributor of record to an office-based health | 17 | | care practitioner authorized by law to dispense or | 18 | | administer the drug to the patient; or | 19 | | (6) an authorized distributor to a pharmacy or other | 20 | | persons licensed to dispense or administer the drug. | 21 | | "Pedigree" means a document or electronic file containing | 22 | | information that records each wholesale distribution of any | 23 | | given prescription drug from the point of origin to the final | 24 | | wholesale distribution point of any given prescription drug.
| 25 | | "Person" means and includes a natural person, partnership, | 26 | | association,
corporation, or any other legal business entity.
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| 1 | | "Pharmacy distributor" means any pharmacy licensed in this | 2 | | State or
hospital pharmacy that is engaged in the delivery or | 3 | | distribution of
prescription drugs either to any other pharmacy | 4 | | licensed in this State or
to any other person or entity | 5 | | including, but not limited to, a wholesale
drug distributor | 6 | | engaged in the delivery or distribution of prescription
drugs | 7 | | who is involved in the actual, constructive, or attempted | 8 | | transfer of
a drug in this State to other than the ultimate | 9 | | consumer except as
otherwise provided for by law.
| 10 | | "Prescription drug" means any human drug, including any | 11 | | biological product (except for blood and blood components | 12 | | intended for transfusion or biological products that are also | 13 | | medical devices), required by federal law or
regulation to be | 14 | | dispensed only by a prescription, including finished
dosage | 15 | | forms and bulk drug substances
subject to Section
503 of the | 16 | | Federal Food, Drug and Cosmetic Act.
| 17 | | "Repackage" means repackaging or otherwise changing the | 18 | | container, wrapper, or labeling to further the distribution of | 19 | | a prescription drug, excluding that completed by the pharmacist | 20 | | responsible for dispensing the product to a patient. | 21 | | "Secretary" means the Secretary of Financial and | 22 | | Professional Regulation. | 23 | | " Third-party Third party logistics provider" means anyone | 24 | | who contracts with a prescription drug manufacturer to provide | 25 | | or coordinate warehousing, distribution, or other services on | 26 | | behalf of a manufacturer, but does not take title to the |
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| 1 | | prescription drug or have general responsibility to direct the | 2 | | prescription drug's sale or disposition. A third party | 3 | | logistics provider must be licensed as a wholesale distributor | 4 | | under this Act and, in order to be considered part of the | 5 | | normal distribution channel, must also be an authorized | 6 | | distributor of record. | 7 | | "Wholesale distribution"
means the distribution
of | 8 | | prescription drugs to persons other than a consumer or patient, | 9 | | but does
not include any of the following:
| 10 | | (1)
Intracompany sales of prescription drugs, meaning | 11 | | (i) any transaction or transfer
between any division, | 12 | | subsidiary, parent, or affiliated or related company
under | 13 | | the common ownership and control of a corporate entity or | 14 | | (ii) any transaction or transfer between co-licensees of a | 15 | | co-licensed product.
| 16 | | (2) The sale, purchase, distribution, trade, or | 17 | | transfer of a prescription drug or offer to sell, purchase, | 18 | | distribute, trade, or transfer a prescription drug for | 19 | | emergency medical reasons.
| 20 | | (3) The distribution of prescription drug samples by | 21 | | manufacturers' representatives. | 22 | | (4) Drug returns, when conducted by a hospital, health | 23 | | care entity, or charitable institution in accordance with | 24 | | federal regulation. | 25 | | (5) The sale of minimal quantities of prescription | 26 | | drugs by licensed pharmacies to licensed practitioners for |
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| 1 | | office use or other licensed pharmacies. | 2 | | (6) The sale, purchase, or trade of a drug, an offer to | 3 | | sell, purchase, or trade a drug, or the dispensing of a | 4 | | drug pursuant to a prescription. | 5 | | (7) The sale, transfer, merger, or consolidation of all | 6 | | or part of the business of a pharmacy or pharmacies from or | 7 | | with another pharmacy or pharmacies, whether accomplished | 8 | | as a purchase and sale of stock or business assets. | 9 | | (8) The sale, purchase, distribution, trade, or | 10 | | transfer of a prescription drug from one authorized | 11 | | distributor of record to one additional authorized | 12 | | distributor of record when the manufacturer has stated in | 13 | | writing to the receiving authorized distributor of record | 14 | | that the manufacturer is unable to supply the prescription | 15 | | drug and the supplying authorized distributor of record | 16 | | states in writing that the prescription drug being supplied | 17 | | had until that time been exclusively in the normal | 18 | | distribution channel. | 19 | | (9) The delivery of or the offer to deliver a | 20 | | prescription drug by a common carrier solely in the common | 21 | | carrier's usual course of business of transporting | 22 | | prescription drugs when the common carrier does not store, | 23 | | warehouse, or take legal ownership of the prescription | 24 | | drug. | 25 | | (10) The sale or transfer from a retail pharmacy, mail | 26 | | order pharmacy, or chain pharmacy warehouse of expired, |
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| 1 | | damaged, returned, or recalled prescription drugs to the | 2 | | original manufacturer, the originating wholesale | 3 | | distributor, or a third party returns processor.
| 4 | | "Wholesale drug distributor" means anyone
engaged in the
| 5 | | wholesale distribution of prescription drugs into, out of, or | 6 | | within the State, including without limitation
manufacturers; | 7 | | repackers; own label distributors; jobbers; private
label | 8 | | distributors; brokers; warehouses, including manufacturers' | 9 | | and
distributors' warehouses; manufacturer's exclusive | 10 | | distributors; and authorized distributors of record; drug | 11 | | wholesalers or distributors; independent wholesale drug | 12 | | traders; specialty wholesale distributors; third party | 13 | | logistics providers; and retail pharmacies that conduct | 14 | | wholesale distribution; and chain pharmacy warehouses that | 15 | | conduct wholesale distribution. In order to be considered part | 16 | | of the normal distribution channel, a wholesale distributor | 17 | | must also be an authorized distributor of record.
| 18 | | (Source: P.A. 97-804, eff. 1-1-13.)
| 19 | | (225 ILCS 120/20) (from Ch. 111, par. 8301-20)
| 20 | | (Section scheduled to be repealed on January 1, 2023)
| 21 | | Sec. 20. Prohibited drug purchases or receipt. It shall be | 22 | | unlawful
for any person or entity located in this State to | 23 | | knowingly receive any prescription
drug from any source other | 24 | | than a person or entity required by the laws of this State to | 25 | | be licensed to ship into, out of, or within this State. A |
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| 1 | | person or entity licensed under the laws of this State shall
| 2 | | include, but is not limited to, a wholesale distributor, | 3 | | manufacturer, third-party logistics provider,
pharmacy | 4 | | distributor, or pharmacy. Any person violating
this Section | 5 | | shall, upon conviction, be adjudged guilty of a Class C
| 6 | | misdemeanor. A second violation shall constitute a Class 4 | 7 | | felony.
| 8 | | (Source: P.A. 97-804, eff. 1-1-13.)
| 9 | | (225 ILCS 120/25.5 new) | 10 | | Sec. 25.5. Third-party logistics providers. | 11 | | (a) Each resident third-party logistics provider must be | 12 | | licensed by the Department, and every non-resident third-party | 13 | | logistics provider must be licensed in this State, in | 14 | | accordance with this Act, prior to shipping a prescription drug | 15 | | into this State. | 16 | | (b) The Department shall require, without limitation, all | 17 | | of the following information from each applicant for licensure | 18 | | under this Act: | 19 | | (1) The name, full business address, and telephone | 20 | | number of the licensee. | 21 | | (2) All trade or business names used by the licensee. | 22 | | (3) Addresses, telephone numbers, and the names of | 23 | | contact persons for all facilities used by the licensee for | 24 | | the storage, handling, and distribution of prescription | 25 | | drugs. |
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| 1 | | (4) The type of ownership or operation, such as a | 2 | | partnership, corporation, or sole proprietorship. | 3 | | (5) The name of the owner or operator of the | 4 | | third-party logistics provider, including: | 5 | | (A) if a natural person, the name of the natural | 6 | | person; | 7 | | (B) if a partnership, the name of each partner and | 8 | | the name of the partnership; | 9 | | (C) if a corporation, the name and title of each | 10 | | corporate officer and director, the corporate names, | 11 | | and the name of the state of incorporation; and | 12 | | (D) if a sole proprietorship, the full name of the | 13 | | sole proprietor and the name of the business entity. | 14 | | (6) A list of all licenses and permits issued to the | 15 | | applicant by any other state that authorizes the applicant | 16 | | to purchase or possess prescription drugs. | 17 | | (7) The name of the designated representative for the | 18 | | third-party logistics provider, together with the personal | 19 | | information statement and fingerprints, as required under | 20 | | subsection (c) of this Section. | 21 | | (8) Minimum liability insurance and other insurance as | 22 | | defined by rule. | 23 | | (9) Any additional information required by the | 24 | | Department. | 25 | | (c) Each third-party logistics provider must designate an | 26 | | individual representative who shall serve as the contact person |
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| 1 | | for the Department. This representative must provide the | 2 | | Department with all of the following information: | 3 | | (1) Information concerning whether the person has been | 4 | | enjoined, either temporarily or permanently, by a court of | 5 | | competent jurisdiction from violating any federal or State | 6 | | law regulating the possession, control, or distribution of | 7 | | prescription drugs or criminal violations, together with | 8 | | details concerning any such event. | 9 | | (2) A description of any involvement by the person with | 10 | | any business, including any investments, other than the | 11 | | ownership of stock in a publicly traded company or mutual | 12 | | fund, that manufactured, administered, prescribed, | 13 | | distributed, or stored pharmaceutical products and any | 14 | | lawsuits in which such businesses were named as a party. | 15 | | (3) A description of any misdemeanor or felony criminal | 16 | | offense of which the person, as an adult, was found guilty, | 17 | | regardless of whether adjudication of guilt was withheld or | 18 | | whether the person pled guilty or nolo contendere. If the | 19 | | person indicates that a criminal conviction is under appeal | 20 | | and submits a copy of the notice of appeal of that criminal | 21 | | offense, the applicant must, within 15 days after the | 22 | | disposition of the appeal, submit to the Department a copy | 23 | | of the final written order of disposition. | 24 | | (4) The designated representative of an applicant for | 25 | | licensure as a third-party logistics provider shall have | 26 | | his or her fingerprints submitted to the Department of |
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| 1 | | State Police in an electronic format that complies with the | 2 | | form and manner for requesting and furnishing criminal | 3 | | history record information as prescribed by the Department | 4 | | of State Police. These fingerprints shall be checked | 5 | | against the Department of State Police and Federal Bureau | 6 | | of Investigation criminal history record databases now and | 7 | | hereafter filed. The Department of State Police shall | 8 | | charge applicants a fee for conducting the criminal history | 9 | | records check, which shall be deposited into the State | 10 | | Police Services Fund and shall not exceed the actual cost | 11 | | of the records check. The Department of State Police shall | 12 | | furnish, pursuant to positive identification, records of | 13 | | Illinois convictions to the Department. The Department may | 14 | | require applicants to pay a separate fingerprinting fee, | 15 | | either to the Department or to a vendor. The Department, in | 16 | | its discretion, may allow an applicant who does not have | 17 | | reasonable access to a designated vendor to provide his or | 18 | | her fingerprints in an alternative manner. The Department | 19 | | may adopt any rules necessary to implement this paragraph | 20 | | (4). | 21 | | (d) A third-party logistics provider shall not operate from | 22 | | a place of residence. | 23 | | (e) A third-party logistics provider facility shall be | 24 | | located apart and separate from any retail pharmacy licensed by | 25 | | the Department. | 26 | | (f) The Department may not issue a third-party logistics |
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| 1 | | provider license to an applicant, unless the Department first: | 2 | | (1) ensures that a physical inspection of the facility | 3 | | satisfactory to the Department has occurred at the address | 4 | | provided by the applicant, as required under item (1) of | 5 | | subsection (b) of this Section; such inspection is not | 6 | | required if the resident state of the third-party logistics | 7 | | provider facility does not license third-party logistics | 8 | | providers or if the resident state does not inspect | 9 | | third-party logistics providers. If the resident state | 10 | | does not inspect third-party logistics providers, a | 11 | | Verified Accredited Wholesale Distributors Accreditation | 12 | | or other inspection approved by the Department meets this | 13 | | requirement; and | 14 | | (2) determines that the designated representative | 15 | | meets each of the following qualifications: | 16 | | (A) He or she is at least 21 years of age. | 17 | | (B) He or she is employed by the applicant full | 18 | | time in a managerial level position. | 19 | | (C) He or she is actively involved in and aware of | 20 | | the actual daily operation of third-party logistics | 21 | | provider. | 22 | | (g) A third-party logistics provider shall publicly | 23 | | display all licenses and have the most recent state and federal | 24 | | inspection reports readily available.
| 25 | | (225 ILCS 120/26)
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| 1 | | (Section scheduled to be repealed on January 1, 2023)
| 2 | | Sec. 26. Unlicensed practice; violation; civil penalty.
| 3 | | (a) Any person who practices, offers to practice, attempts | 4 | | to practice, or
holds oneself out to practice as a wholesale | 5 | | drug distributor , or pharmacy
distributor , or third-party | 6 | | logistics provider without being licensed to ship into, out of, | 7 | | or within the State under this Act shall, in
addition to any | 8 | | other penalty provided by law, pay a civil penalty to the
| 9 | | Department in an amount not to exceed $10,000 for each offense | 10 | | as determined by
the Department. The civil penalty shall be | 11 | | assessed by the Department after a
hearing is held in | 12 | | accordance with the provisions set forth in this Act
regarding | 13 | | the provision of a hearing for the discipline of a licensee.
| 14 | | (b) The Department has the authority and power to | 15 | | investigate any and all
unlicensed activity.
| 16 | | (c) The civil penalty shall be paid within 60 days after | 17 | | the effective date
of the order imposing the civil penalty. The | 18 | | order shall constitute a judgment
and may be filed and | 19 | | execution had thereon in the same manner as any judgment
from | 20 | | any court of record.
| 21 | | (Source: P.A. 97-804, eff. 1-1-13.)
| 22 | | (225 ILCS 120/30) (from Ch. 111, par. 8301-30)
| 23 | | (Section scheduled to be repealed on January 1, 2023)
| 24 | | Sec. 30. License renewal application procedures. | 25 | | Application blanks
for renewal of any license required by this |
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| 1 | | Act shall be mailed or emailed to each
licensee at least 60 | 2 | | days before the license expires. If the application
for renewal | 3 | | with the required fee is not received by the Department before
| 4 | | the expiration date, the existing license shall lapse and | 5 | | become null and
void. Failure to renew before the expiration | 6 | | date is cause for a late
payment penalty, discipline, or both.
| 7 | | (Source: P.A. 87-594 .)
| 8 | | (225 ILCS 120/35) (from Ch. 111, par. 8301-35)
| 9 | | (Section scheduled to be repealed on January 1, 2023)
| 10 | | Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
| 11 | | (a) The Department shall provide by rule for a schedule of | 12 | | fees for the
administration and
enforcement of this Act, | 13 | | including but not limited to original licensure,
renewal, and
| 14 | | restoration. The fees shall be nonrefundable.
| 15 | | (b) All fees collected under this Act shall be deposited | 16 | | into the Illinois
State
Pharmacy
Disciplinary Fund and shall be | 17 | | appropriated to the Department for the ordinary
and
contingent | 18 | | expenses of the Department in the administration of this Act. | 19 | | Moneys in the Fund may be transferred to the Professions
| 20 | | Indirect Cost Fund as authorized by Section 2105-300 of the
| 21 | | Department of Professional Regulation Law (20 ILCS | 22 | | 2105/2105-300).
| 23 | | The moneys deposited into the Illinois State Pharmacy | 24 | | Disciplinary Fund shall
be invested to earn interest which | 25 | | shall accrue to the Fund.
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| 1 | | The Department shall present to the Board for its review | 2 | | and comment all
appropriation requests from the Illinois State | 3 | | Pharmacy Disciplinary Fund. The
Department shall give due | 4 | | consideration to any comments of the Board in making
| 5 | | appropriation requests.
| 6 | | (c) Any person who delivers a check or other payment to the | 7 | | Department that
is returned to the Department unpaid by the | 8 | | financial institution upon
which it is drawn shall pay to the | 9 | | Department, in addition to the amount
already owed to the | 10 | | Department, a fine of $50. The fines imposed by this Section | 11 | | are in addition
to any other discipline provided under this Act | 12 | | for unlicensed
practice or practice on a nonrenewed license. | 13 | | The Department shall notify
the person that payment of fees and | 14 | | fines shall be paid to the Department
by certified check or | 15 | | money order within 30 calendar days of the
notification. If, | 16 | | after the expiration of 30 days from the date of the
| 17 | | notification, the person has failed to submit the necessary | 18 | | remittance, the
Department shall automatically terminate the | 19 | | license or certificate or deny
the application, without | 20 | | hearing. If, after termination or denial, the
person seeks a | 21 | | license or certificate, he or she shall apply to the
Department | 22 | | for restoration or issuance of the license or certificate and
| 23 | | pay all fees and fines due to the Department. The Department | 24 | | may establish
a fee for the processing of an application for | 25 | | restoration of a license or
certificate to pay all expenses of | 26 | | processing this application. The Director
may waive the fines |
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| 1 | | due under this Section in individual cases where the
Director | 2 | | finds that the fines would be unreasonable or unnecessarily
| 3 | | burdensome.
| 4 | | (d) The Department shall maintain a roster of the names and | 5 | | addresses of
all registrants and of all persons whose licenses | 6 | | have been suspended or
revoked. This roster shall be available | 7 | | upon written request and payment of
the required fee.
| 8 | | (e) A manufacturer of controlled substances , or wholesale | 9 | | distributor of controlled substances , or third-party logistics | 10 | | provider that is licensed under this Act and owned and operated | 11 | | by the State is exempt from licensure, registration, renewal, | 12 | | and other fees required under this Act. Nothing in this | 13 | | subsection (e) shall be construed to prohibit the Department
| 14 | | from imposing any fine or other penalty allowed under this Act.
| 15 | | (Source: P.A. 95-689, eff. 10-29-07 .)
| 16 | | (225 ILCS 120/40) (from Ch. 111, par. 8301-40)
| 17 | | (Section scheduled to be repealed on January 1, 2023)
| 18 | | Sec. 40. Rules and regulations. The Department shall
make | 19 | | any rules and regulations, not inconsistent with law, as may be
| 20 | | necessary to carry out the purposes and enforce the provisions | 21 | | of this Act.
Rules and regulations that incorporate and set | 22 | | detailed standards for
meeting each of the license | 23 | | prerequisites set forth in Section 25 of this
Act shall be | 24 | | adopted no later than September 14, 1992.
All rules and | 25 | | regulations promulgated under this Section shall
conform to |
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| 1 | | wholesale drug distributor licensing guidelines formally | 2 | | adopted
by the FDA at 21 C.F.R. Part 205. In case of conflict | 3 | | between any rule
or regulation adopted by the Department and | 4 | | any FDA wholesale drug
distributor or third-party logistics | 5 | | provider guideline, the FDA guideline shall control.
| 6 | | (Source: P.A. 87-594 .)
| 7 | | (225 ILCS 120/57)
| 8 | | (Section scheduled to be repealed on January 1, 2023) | 9 | | Sec. 57. Pedigree. | 10 | | (a) Each person who is engaged in the wholesale | 11 | | distribution of prescription drugs, including repackagers, but | 12 | | excluding the original manufacturer of the finished form of the | 13 | | prescription drug, that leave or have ever left the normal | 14 | | distribution channel shall, before each wholesale distribution | 15 | | of the drug, provide a pedigree to the person who receives the
| 16 | | drug. A retail pharmacy, mail order pharmacy, or chain pharmacy | 17 | | warehouse must comply with the requirements of this Section | 18 | | only if the pharmacy or chain pharmacy warehouse engages in the | 19 | | wholesale distribution of prescription drugs. On or before July | 20 | | 1, 2009, the Department shall determine a targeted | 21 | | implementation date for electronic track and trace pedigree | 22 | | technology. This targeted implementation date shall not be | 23 | | sooner than July 1, 2010. Beginning on the date established by | 24 | | the Department, pedigrees may be implemented through an | 25 | | approved and readily available system that electronically |
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| 1 | | tracks and traces the wholesale distribution of each | 2 | | prescription drug starting with the sale by the manufacturer | 3 | | through acquisition and sale by any wholesale distributor and | 4 | | until final sale to a pharmacy or other authorized person | 5 | | administering or dispensing the prescription drug. This | 6 | | electronic tracking system shall be deemed to be readily | 7 | | available only upon there being available a standardized system | 8 | | originating with the manufacturers and capable of being used on | 9 | | a wide scale across the entire pharmaceutical chain, including | 10 | | manufacturers, wholesale distributors, third-party logistics | 11 | | providers, and pharmacies. Consideration must also be given to | 12 | | the large-scale implementation of this technology across the | 13 | | supply chain and the technology must be proven to have no | 14 | | negative impact on the safety and efficacy of the | 15 | | pharmaceutical product. | 16 | | (b) Each person who is engaged in the wholesale | 17 | | distribution of a prescription drug who is provided a pedigree | 18 | | for a prescription drug and attempts to further distribute that | 19 | | prescription drug, including repackagers, but excluding the | 20 | | original manufacturer of the finished form of the prescription | 21 | | drug, must affirmatively verify before any distribution of a | 22 | | prescription drug occurs that each transaction listed on the | 23 | | pedigree has occurred. | 24 | | (c) The pedigree must include all necessary identifying | 25 | | information concerning each sale in the chain of distribution | 26 | | of the product from the manufacturer or the manufacturer's |
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| 1 | | third party logistics provider, co-licensed product partner, | 2 | | or exclusive distributor through acquisition and sale by any | 3 | | wholesale distributor or repackager, until final sale to a | 4 | | pharmacy or other person dispensing or administering the drug. | 5 | | This necessary chain of distribution information shall | 6 | | include, without limitation all of the following: | 7 | | (1) The name, address, telephone number and, if | 8 | | available, the e-mail address of each owner of the | 9 | | prescription drug and each wholesale distributor of the | 10 | | prescription drug. | 11 | | (2) The name and address of each location from which | 12 | | the product was shipped, if different from the owner's. | 13 | | (3) Transaction dates. | 14 | | (4) Certification that each recipient has | 15 | | authenticated the pedigree. | 16 | | (d) The pedigree must also include without limitation all | 17 | | of the following information concerning the prescription drug: | 18 | | (1) The name and national drug code number of the | 19 | | prescription drug. | 20 | | (2) The dosage form and strength of the prescription | 21 | | drug. | 22 | | (3) The size of the container. | 23 | | (4) The number of containers. | 24 | | (5) The lot number of the prescription drug. | 25 | | (6) The name of the manufacturer of the finished dosage | 26 | | form. |
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| 1 | | (e) Each pedigree or electronic file shall be maintained by | 2 | | the purchaser and the wholesale distributor for at least 3 | 3 | | years from the date of sale or transfer and made available for | 4 | | inspection or use within 5 business days upon a request of the | 5 | | Department.
| 6 | | (Source: P.A. 95-689, eff. 10-29-07 .)
| 7 | | (225 ILCS 120/80) (from Ch. 111, par. 8301-80)
| 8 | | (Section scheduled to be repealed on January 1, 2023)
| 9 | | Sec. 80. Violations of Act.
| 10 | | (a) If any person violates the provisions of this Act, the
| 11 | | Director may, in the name of the People of the State of | 12 | | Illinois through
the Attorney General of the State of Illinois | 13 | | or the State's Attorney of
any county in which the action is | 14 | | brought, petition for an order enjoining
the violation or for | 15 | | an order enforcing compliance with this Act. Upon
the filing of | 16 | | a verified petition in the court, the court may issue a
| 17 | | temporary restraining order, without notice or bond, and may | 18 | | preliminarily
and permanently enjoin the violation. If it is | 19 | | established that the
person has violated or is violating the | 20 | | injunction, the Court may punish
the offender for contempt of | 21 | | court. Proceedings under this Section shall
be in addition to, | 22 | | and not in lieu of, all other remedies and penalties
provided | 23 | | by this Act.
| 24 | | (b) Whoever knowingly conducts business as a wholesale drug | 25 | | distributor or third-party logistics provider
in this State |
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| 1 | | without being appropriately licensed under this Act shall be
| 2 | | guilty of a Class A misdemeanor for a first violation and for | 3 | | each
subsequent conviction shall be guilty of a Class 4 felony.
| 4 | | (c) Whenever in the opinion of the Department any person | 5 | | not licensed in
good standing under this Act violates any | 6 | | provision of this Act, the
Department may issue a rule to show | 7 | | cause why an order to cease and desist
should not be entered | 8 | | against him. The rule shall clearly set forth the
grounds | 9 | | relied upon by the Department and shall provide a period of 7 | 10 | | days
from the date of the rule to file an answer to the | 11 | | satisfaction of the
Department. Failure to answer to the | 12 | | satisfaction of the Department shall
cause an order to cease | 13 | | and desist to be issued immediately.
| 14 | | (Source: P.A. 87-594 .)
| 15 | | (225 ILCS 120/155) (from Ch. 111, par. 8301-155)
| 16 | | (Section scheduled to be repealed on January 1, 2023)
| 17 | | Sec. 155. Temporary suspension of license; hearing. The | 18 | | Director
may temporarily suspend licensure as a wholesale drug | 19 | | distributor or third-party logistics provider ,
without a | 20 | | hearing, simultaneously with the institution of proceedings | 21 | | for a
hearing provided for in Section 85 of this Act, if the | 22 | | Director finds that
evidence in his or her possession indicates | 23 | | that a continuation in business
would constitute an imminent | 24 | | danger to the public. In the event that the
Director | 25 | | temporarily suspends a license or certificate without a
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| 1 | | hearing, a hearing by the Department must be held within 10 | 2 | | days after
the suspension has occurred and be concluded without | 3 | | appreciable delay.
| 4 | | (Source: P.A. 87-594 .)
| 5 | | Section 99. Effective date. This Act takes effect upon | 6 | | becoming law.
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