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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 5. The Wholesale Drug Distribution Licensing Act | |||||||||||||||||||||||||||||||||||||||||
| 5 | is amended by changing Sections 15, 26, 31, 40, 50, 56, 60, 80, | |||||||||||||||||||||||||||||||||||||||||
| 6 | 155, 185, and 200 and by adding Section 25.7 as follows: | |||||||||||||||||||||||||||||||||||||||||
| 7 | (225 ILCS 120/15) (from Ch. 111, par. 8301-15) | |||||||||||||||||||||||||||||||||||||||||
| 8 | (Section scheduled to be repealed on January 1, 2028) | |||||||||||||||||||||||||||||||||||||||||
| 9 | Sec. 15. Definitions. As used in this Act: | |||||||||||||||||||||||||||||||||||||||||
| 10 | "Address of record" means the designated address recorded | |||||||||||||||||||||||||||||||||||||||||
| 11 | by the Department in the applicant's application file or | |||||||||||||||||||||||||||||||||||||||||
| 12 | licensee's license file maintained by the Department's | |||||||||||||||||||||||||||||||||||||||||
| 13 | licensure maintenance unit. | |||||||||||||||||||||||||||||||||||||||||
| 14 | "Authentication" means the affirmative verification, | |||||||||||||||||||||||||||||||||||||||||
| 15 | before any wholesale distribution of a prescription drug | |||||||||||||||||||||||||||||||||||||||||
| 16 | occurs, that each transaction listed on the pedigree has | |||||||||||||||||||||||||||||||||||||||||
| 17 | occurred. | |||||||||||||||||||||||||||||||||||||||||
| 18 | "Authorized distributor of record" means a wholesale | |||||||||||||||||||||||||||||||||||||||||
| 19 | distributor or virtual wholesale distributor with whom a | |||||||||||||||||||||||||||||||||||||||||
| 20 | manufacturer has established an ongoing relationship to | |||||||||||||||||||||||||||||||||||||||||
| 21 | distribute the manufacturer's prescription drug. An ongoing | |||||||||||||||||||||||||||||||||||||||||
| 22 | relationship is deemed to exist between a wholesale | |||||||||||||||||||||||||||||||||||||||||
| 23 | distributor or virtual wholesale distributor and a | |||||||||||||||||||||||||||||||||||||||||
| |||||||
| |||||||
| 1 | manufacturer when the wholesale distributor or virtual | ||||||
| 2 | wholesale distributor, including any affiliated group of the | ||||||
| 3 | wholesale distributor or virtual wholesale distributor, as | ||||||
| 4 | defined in Section 1504 of the Internal Revenue Code, complies | ||||||
| 5 | with the following: | ||||||
| 6 | (1) The wholesale distributor or virtual wholesale | ||||||
| 7 | distributor has a written agreement currently in effect | ||||||
| 8 | with the manufacturer evidencing the ongoing relationship; | ||||||
| 9 | and | ||||||
| 10 | (2) The wholesale distributor or virtual wholesale | ||||||
| 11 | distributor is listed on the manufacturer's current list | ||||||
| 12 | of authorized distributors of record, which is updated by | ||||||
| 13 | the manufacturer on no less than a monthly basis. | ||||||
| 14 | "Blood" means whole blood collected from a single donor | ||||||
| 15 | and processed either for transfusion or further manufacturing. | ||||||
| 16 | "Blood component" means that part of blood separated by | ||||||
| 17 | physical or mechanical means. | ||||||
| 18 | "Board" means the State Board of Pharmacy of the | ||||||
| 19 | Department of Financial and Professional Regulation. | ||||||
| 20 | "Chain pharmacy warehouse" means a physical location for | ||||||
| 21 | prescription drugs that acts as a central warehouse and | ||||||
| 22 | performs intracompany sales or transfers of the drugs to a | ||||||
| 23 | group of chain or mail order pharmacies that have the same | ||||||
| 24 | common ownership and control. Notwithstanding any other | ||||||
| 25 | provision of this Act, a chain pharmacy warehouse shall be | ||||||
| 26 | considered part of the normal distribution channel. | ||||||
| |||||||
| |||||||
| 1 | "Co-licensed partner or product" means an instance where | ||||||
| 2 | one or more parties have the right to engage in the | ||||||
| 3 | manufacturing or marketing of a prescription drug, consistent | ||||||
| 4 | with the FDA's implementation of the Prescription Drug | ||||||
| 5 | Marketing Act. | ||||||
| 6 | "Department" means the Department of Financial and | ||||||
| 7 | Professional Regulation. | ||||||
| 8 | "Drop shipment" means the sale of a prescription drug to a | ||||||
| 9 | wholesale distributor or virtual wholesale distributor by the | ||||||
| 10 | manufacturer of the prescription drug or that manufacturer's | ||||||
| 11 | co-licensed product partner, that manufacturer's third-party | ||||||
| 12 | logistics provider, or that manufacturer's exclusive | ||||||
| 13 | distributor or by an authorized distributor of record that | ||||||
| 14 | purchased the product directly from the manufacturer or one of | ||||||
| 15 | these entities whereby the wholesale distributor, virtual | ||||||
| 16 | wholesale distributor, or chain pharmacy warehouse takes title | ||||||
| 17 | but not physical possession of such prescription drug and the | ||||||
| 18 | wholesale distributor or virtual wholesale distributor | ||||||
| 19 | invoices the pharmacy, chain pharmacy warehouse, or other | ||||||
| 20 | person authorized by law to dispense or administer such drug | ||||||
| 21 | to a patient and the pharmacy, chain pharmacy warehouse, or | ||||||
| 22 | other authorized person receives delivery of the prescription | ||||||
| 23 | drug directly from the manufacturer, that manufacturer's | ||||||
| 24 | third-party logistics provider, or that manufacturer's | ||||||
| 25 | exclusive distributor or from an authorized distributor of | ||||||
| 26 | record that purchased the product directly from the | ||||||
| |||||||
| |||||||
| 1 | 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 | "Email address of record" means the designated email | ||||||
| 6 | address recorded by the Department in the applicant's | ||||||
| 7 | application file or the licensee's license file, as maintained | ||||||
| 8 | by the Department's licensure maintenance unit. | ||||||
| 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 | ||||||
| |||||||
| |||||||
| 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 virtual wholesale | ||||||
| 13 | distributor third-party logistics provider, or (iv) that | ||||||
| 14 | manufacturer to that manufacturer's exclusive distributor or | ||||||
| 15 | third-party logistics provider to: | ||||||
| 16 | (1) a pharmacy or to other designated persons | ||||||
| 17 | authorized by law to dispense or administer the drug to a | ||||||
| 18 | patient; | ||||||
| 19 | (2) a wholesale distributor to a pharmacy or other | ||||||
| 20 | designated persons authorized by law to dispense or | ||||||
| 21 | administer the drug to a patient; | ||||||
| 22 | (3) a wholesale distributor to a chain pharmacy | ||||||
| 23 | warehouse to that chain pharmacy warehouse's intracompany | ||||||
| 24 | pharmacy to a patient or other designated persons | ||||||
| 25 | authorized by law to dispense or administer the drug to a | ||||||
| 26 | patient; | ||||||
| |||||||
| |||||||
| 1 | (4) a chain pharmacy warehouse to the chain pharmacy | ||||||
| 2 | warehouse's intracompany pharmacy or other designated | ||||||
| 3 | persons authorized by law to dispense or administer the | ||||||
| 4 | drug to the patient; | ||||||
| 5 | (5) an authorized distributor of record to one other | ||||||
| 6 | authorized distributor of record to an office-based health | ||||||
| 7 | care practitioner authorized by law to dispense or | ||||||
| 8 | administer the drug to the patient; or | ||||||
| 9 | (6) an authorized distributor to a pharmacy or other | ||||||
| 10 | persons licensed to dispense or administer the drug. | ||||||
| 11 | "Pedigree" means a document or electronic file containing | ||||||
| 12 | information that records each wholesale distribution of any | ||||||
| 13 | given prescription drug from the point of origin to the final | ||||||
| 14 | wholesale distribution point of any given prescription drug. | ||||||
| 15 | "Person" means and includes a natural person, partnership, | ||||||
| 16 | association, corporation, or any other legal business entity. | ||||||
| 17 | "Pharmacy distributor" means any pharmacy licensed in this | ||||||
| 18 | State or hospital pharmacy that is engaged in the delivery or | ||||||
| 19 | distribution of prescription drugs either to any other | ||||||
| 20 | pharmacy licensed in this State or to any other person or | ||||||
| 21 | entity including, but not limited to, a wholesale drug | ||||||
| 22 | distributor engaged in the delivery or distribution of | ||||||
| 23 | prescription drugs who is involved in the actual, | ||||||
| 24 | constructive, or attempted transfer of a drug in this State to | ||||||
| 25 | other than the ultimate consumer except as otherwise provided | ||||||
| 26 | for by law. | ||||||
| |||||||
| |||||||
| 1 | "Prescription drug" means any human drug, including any | ||||||
| 2 | biological product (except for blood and blood components | ||||||
| 3 | intended for transfusion or biological products that are also | ||||||
| 4 | medical devices), required by federal law or regulation to be | ||||||
| 5 | dispensed only by a prescription, including finished dosage | ||||||
| 6 | forms and bulk drug substances subject to Section 503 of the | ||||||
| 7 | Federal Food, Drug and Cosmetic Act. | ||||||
| 8 | "Repackage" means repackaging or otherwise changing the | ||||||
| 9 | container, wrapper, or labeling to further the distribution of | ||||||
| 10 | a prescription drug, excluding that completed by the | ||||||
| 11 | pharmacist responsible for dispensing the product to a | ||||||
| 12 | patient. | ||||||
| 13 | "Secretary" means the Secretary of the Department of | ||||||
| 14 | Financial and Professional Regulation. | ||||||
| 15 | "Suspicious order" includes, but is not limited to, an | ||||||
| 16 | order of a controlled substance of unusual size, an order of a | ||||||
| 17 | controlled substance deviating substantially from a normal | ||||||
| 18 | pattern, and orders of controlled substances of unusual | ||||||
| 19 | frequency as defined by 21 U.S.C. 802. | ||||||
| 20 | "Third-party logistics provider" means anyone who | ||||||
| 21 | contracts with a prescription drug manufacturer or virtual | ||||||
| 22 | wholesale distributor to provide or coordinate warehousing, | ||||||
| 23 | distribution, or other services on behalf of a manufacturer or | ||||||
| 24 | virtual wholesale distributor, but does not take title to the | ||||||
| 25 | prescription drug or have general responsibility to direct the | ||||||
| 26 | prescription drug's sale or disposition. | ||||||
| |||||||
| |||||||
| 1 | "Wholesale distribution" means the distribution of | ||||||
| 2 | prescription drugs to persons other than a consumer or | ||||||
| 3 | patient, but does not include any of the following: | ||||||
| 4 | (1) Intracompany sales of prescription drugs, meaning | ||||||
| 5 | (i) any transaction or transfer between any division, | ||||||
| 6 | subsidiary, parent, or affiliated or related company under | ||||||
| 7 | the common ownership and control of a corporate entity or | ||||||
| 8 | (ii) any transaction or transfer between co-licensees of a | ||||||
| 9 | co-licensed product. | ||||||
| 10 | (2) The sale, purchase, distribution, trade, or | ||||||
| 11 | transfer of a prescription drug or offer to sell, | ||||||
| 12 | purchase, distribute, trade, or transfer a prescription | ||||||
| 13 | drug for emergency medical reasons. | ||||||
| 14 | (3) The distribution of prescription drug samples by | ||||||
| 15 | manufacturers' representatives. | ||||||
| 16 | (4) Drug returns, when conducted by a hospital, health | ||||||
| 17 | care entity, or charitable institution in accordance with | ||||||
| 18 | federal regulation. | ||||||
| 19 | (5) The sale of minimal quantities of prescription | ||||||
| 20 | drugs by licensed pharmacies to licensed practitioners for | ||||||
| 21 | office use or other licensed pharmacies. | ||||||
| 22 | (6) The sale, purchase, or trade of a drug, an offer to | ||||||
| 23 | sell, purchase, or trade a drug, or the dispensing of a | ||||||
| 24 | drug pursuant to a prescription. | ||||||
| 25 | (7) The sale, transfer, merger, or consolidation of | ||||||
| 26 | all or part of the business of a pharmacy or pharmacies | ||||||
| |||||||
| |||||||
| 1 | from or with another pharmacy or pharmacies, whether | ||||||
| 2 | accomplished as a purchase and sale of stock or business | ||||||
| 3 | assets. | ||||||
| 4 | (8) The sale, purchase, distribution, trade, or | ||||||
| 5 | transfer of a prescription drug from one authorized | ||||||
| 6 | distributor of record to one additional authorized | ||||||
| 7 | distributor of record when the manufacturer has stated in | ||||||
| 8 | writing to the receiving authorized distributor of record | ||||||
| 9 | that the manufacturer is unable to supply the prescription | ||||||
| 10 | drug and the supplying authorized distributor of record | ||||||
| 11 | states in writing that the prescription drug being | ||||||
| 12 | supplied had until that time been exclusively in the | ||||||
| 13 | normal distribution channel. | ||||||
| 14 | (9) The delivery of or the offer to deliver a | ||||||
| 15 | prescription drug by a common carrier solely in the common | ||||||
| 16 | carrier's usual course of business of transporting | ||||||
| 17 | prescription drugs when the common carrier does not store, | ||||||
| 18 | warehouse, or take legal ownership of the prescription | ||||||
| 19 | drug. | ||||||
| 20 | (10) The sale or transfer from a retail pharmacy, mail | ||||||
| 21 | order pharmacy, or chain pharmacy warehouse of expired, | ||||||
| 22 | damaged, returned, or recalled prescription drugs to the | ||||||
| 23 | original manufacturer, the originating wholesale | ||||||
| 24 | distributor, or a third party returns processor. | ||||||
| 25 | (11) The donation of drugs to the extent permitted | ||||||
| 26 | under the Illinois Drug Reuse Opportunity Program Act. | ||||||
| |||||||
| |||||||
| 1 | "Wholesale drug distributor" means anyone engaged in the | ||||||
| 2 | wholesale distribution of prescription drugs into, out of, or | ||||||
| 3 | within the State, including, without limitation, | ||||||
| 4 | manufacturers; repackers; own label distributors; jobbers; | ||||||
| 5 | private label distributors; brokers; warehouses, including | ||||||
| 6 | manufacturers' and distributors' warehouses; manufacturer's | ||||||
| 7 | exclusive distributors; and authorized distributors of record; | ||||||
| 8 | drug wholesalers or distributors; independent wholesale drug | ||||||
| 9 | traders; specialty wholesale distributors; retail pharmacies | ||||||
| 10 | that conduct wholesale distribution; and chain pharmacy | ||||||
| 11 | warehouses that conduct wholesale distribution. In order to be | ||||||
| 12 | considered part of the normal distribution channel, a | ||||||
| 13 | wholesale distributor must also be an authorized distributor | ||||||
| 14 | of record. | ||||||
| 15 | "Virtual wholesale distributor" means any person engaged | ||||||
| 16 | in the wholesale distribution of prescription drugs into, out | ||||||
| 17 | of, or within the State who holds title to, but does not take | ||||||
| 18 | physical possession of, prescription drugs. | ||||||
| 19 | (Source: P.A. 102-389, eff. 1-1-22; 102-879, eff. 1-1-23; | ||||||
| 20 | 103-154, eff. 6-30-23.) | ||||||
| 21 | (225 ILCS 120/25.7 new) | ||||||
| 22 | Sec. 25.7. Virtual wholesale distributor licensing | ||||||
| 23 | requirements. | ||||||
| 24 | (a) Every virtual wholesale distributor that engages in | ||||||
| 25 | virtual drug distribution of prescription drugs shall be | ||||||
| |||||||
| |||||||
| 1 | licensed by the Department. A virtual wholesale distributor | ||||||
| 2 | shall only contract with entities licensed under this Act to | ||||||
| 3 | take physical possession of prescription drugs if the | ||||||
| 4 | prescription drugs are being shipped into the State. | ||||||
| 5 | (b) Each applicant for licensure as a virtual wholesale | ||||||
| 6 | distributor under this Act shall submit the following | ||||||
| 7 | information to the Department: | ||||||
| 8 | (1) the name, full business address, and telephone | ||||||
| 9 | number of the applicant; | ||||||
| 10 | (2) all trade or business names used by the applicant; | ||||||
| 11 | (3) addresses, email addresses, telephone numbers, and | ||||||
| 12 | the names of contact persons for all facilities used by | ||||||
| 13 | the applicant for the storage, handling, and distribution | ||||||
| 14 | of prescription drugs; | ||||||
| 15 | (4) the applicant's type of ownership or operation, | ||||||
| 16 | such as a partnership, corporation, or sole | ||||||
| 17 | proprietorship; | ||||||
| 18 | (5) the name of each person with an ownership or | ||||||
| 19 | operation interest in the applicant, including the | ||||||
| 20 | following: | ||||||
| 21 | (A) if the applicant is a natural person, the name | ||||||
| 22 | of the person; | ||||||
| 23 | (B) if the applicant is a partnership, the name of | ||||||
| 24 | each partner and the name of the partnership; | ||||||
| 25 | (C) if the applicant is a corporation, the name | ||||||
| 26 | and title of each person who owns 5% or more of its | ||||||
| |||||||
| |||||||
| 1 | stock and each corporate officer and director and the | ||||||
| 2 | name of the state of incorporation; | ||||||
| 3 | (D) if the applicant is a sole proprietorship, the | ||||||
| 4 | full name of the sole proprietor and the name of the | ||||||
| 5 | business entity and the state of organization; | ||||||
| 6 | (E) if the applicant is a limited liability | ||||||
| 7 | company, the name and title of each member or manager | ||||||
| 8 | and the name of the business entity and the state of | ||||||
| 9 | organization; | ||||||
| 10 | (F) if the applicant is a limited liability | ||||||
| 11 | partnership, the name and title of each partner and | ||||||
| 12 | the name of the partnership and the state of | ||||||
| 13 | organization; and | ||||||
| 14 | (G) if the applicant is a limited partnership, the | ||||||
| 15 | name and title of each partner and the name of the | ||||||
| 16 | partnership and the state of organization; | ||||||
| 17 | (6) a list of all licenses and permits issued to the | ||||||
| 18 | applicant by any other state that authorizes the applicant | ||||||
| 19 | to purchase or facilitate the distribution of prescription | ||||||
| 20 | drugs; | ||||||
| 21 | (7) minimum liability insurance and other insurance as | ||||||
| 22 | defined by rule; | ||||||
| 23 | (8) the name and license number of the third-party | ||||||
| 24 | logistics provider who provides warehouse and shipping | ||||||
| 25 | services to the applicant; and | ||||||
| 26 | (9) any additional information required by the | ||||||
| |||||||
| |||||||
| 1 | Department. | ||||||
| 2 | (c) A virtual wholesale distributor shall ensure that any | ||||||
| 3 | licensed entity providing distribution services to the virtual | ||||||
| 4 | wholesale distributor complies with the following: | ||||||
| 5 | (1) the licensed entity is in compliance with all | ||||||
| 6 | rules related to storage and distribution of prescription | ||||||
| 7 | drugs; | ||||||
| 8 | (2) the licensed entity has designated a | ||||||
| 9 | representative who is at least 21 years of age and who has | ||||||
| 10 | adequate education, experience, and training to be | ||||||
| 11 | employed by the licensed entity full time in a managerial | ||||||
| 12 | level position and to be actively involved in and aware of | ||||||
| 13 | the actual daily operation of the virtual wholesale | ||||||
| 14 | distributor; | ||||||
| 15 | (3) the licensed entity contracts with carriers that | ||||||
| 16 | provide adequate security to guard against in-transit | ||||||
| 17 | losses; and | ||||||
| 18 | (4) the licensed entity is compliant with Title II of | ||||||
| 19 | the federal Drug Quality and Security Act. | ||||||
| 20 | (d) A virtual wholesale distributor shall not operate out | ||||||
| 21 | of a location that is a residence or personal dwelling. | ||||||
| 22 | (225 ILCS 120/26) | ||||||
| 23 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 24 | Sec. 26. Unlicensed practice; violation; civil penalty. | ||||||
| 25 | (a) Any person who practices, offers to practice, attempts | ||||||
| |||||||
| |||||||
| 1 | to practice, or holds oneself out to practice as a wholesale | ||||||
| 2 | drug distributor, pharmacy distributor, virtual wholesale | ||||||
| 3 | distributor, or third-party logistics provider without being | ||||||
| 4 | licensed to ship into, out of, or within the State under this | ||||||
| 5 | Act shall, in addition to any other penalty provided by law, | ||||||
| 6 | pay a civil penalty to the Department in an amount not to | ||||||
| 7 | exceed $10,000 for each offense as determined by the | ||||||
| 8 | Department. The civil penalty shall be assessed by the | ||||||
| 9 | Department after a hearing is held in accordance with the | ||||||
| 10 | provisions set forth in this Act regarding the provision of a | ||||||
| 11 | hearing for the discipline of a licensee. | ||||||
| 12 | (b) The Department has the authority and power to | ||||||
| 13 | investigate any and all unlicensed activity. | ||||||
| 14 | (c) The civil penalty shall be paid within 60 days after | ||||||
| 15 | the effective date of the order imposing the civil penalty. | ||||||
| 16 | The order shall constitute a judgment and may be filed and | ||||||
| 17 | execution had thereon in the same manner as any judgment from | ||||||
| 18 | any court of record. | ||||||
| 19 | (Source: P.A. 101-420, eff. 8-16-19.) | ||||||
| 20 | (225 ILCS 120/31) | ||||||
| 21 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 22 | Sec. 31. Expiration of license; renewal. | ||||||
| 23 | (a) The expiration date and renewal period for each | ||||||
| 24 | license issued under this Act shall be set by rule. | ||||||
| 25 | (b) Any licensee who shall engage in the practice for | ||||||
| |||||||
| |||||||
| 1 | which the license was issued while the license is expired or on | ||||||
| 2 | inactive status shall be considered to be practicing without a | ||||||
| 3 | license which shall be grounds for discipline under this Act. | ||||||
| 4 | (c) A wholesale drug distributor, virtual wholesale | ||||||
| 5 | distributor, or third-party logistics provider whose license | ||||||
| 6 | has been expired for one year or more may not have its license | ||||||
| 7 | restored but must apply for a new license and meet all | ||||||
| 8 | requirements for licensure. Any wholesale drug distributor, | ||||||
| 9 | virtual wholesale distributor, or third-party logistics | ||||||
| 10 | provider whose license has been expired for less than one year | ||||||
| 11 | may apply for restoration of its license and shall have its | ||||||
| 12 | license restored. | ||||||
| 13 | (d) Anyone operating on an expired license is engaged in | ||||||
| 14 | unlawful practice and subject to discipline under this Act. | ||||||
| 15 | (Source: P.A. 102-879, eff. 1-1-23.) | ||||||
| 16 | (225 ILCS 120/40) (from Ch. 111, par. 8301-40) | ||||||
| 17 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 18 | Sec. 40. Rules and regulations. The Department shall make | ||||||
| 19 | any rules and regulations, not inconsistent with law, as may | ||||||
| 20 | be necessary to carry out the purposes and enforce the | ||||||
| 21 | provisions of this Act. All rules and regulations promulgated | ||||||
| 22 | under this Section shall conform to wholesale drug distributor | ||||||
| 23 | licensing guidelines formally adopted by the FDA at 21 C.F.R. | ||||||
| 24 | Part 205. In case of conflict between any rule or regulation | ||||||
| 25 | adopted by the Department and any FDA wholesale drug | ||||||
| |||||||
| |||||||
| 1 | distributor, virtual wholesale distributor, or third-party | ||||||
| 2 | logistics provider guideline, the FDA guideline shall control. | ||||||
| 3 | (Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.) | ||||||
| 4 | (225 ILCS 120/50) (from Ch. 111, par. 8301-50) | ||||||
| 5 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 6 | Sec. 50. Inspection powers; access to records. | ||||||
| 7 | (a) Any pharmacy investigator authorized by the Department | ||||||
| 8 | has the right of entry for inspection of premises purporting | ||||||
| 9 | or appearing to be used by a wholesale drug distributor, | ||||||
| 10 | virtual wholesale distributor, or third-party logistics | ||||||
| 11 | provider in this State, including the business premises of a | ||||||
| 12 | person licensed pursuant to this Act. This right of entry | ||||||
| 13 | shall permit the authorized pharmacy investigator unfettered | ||||||
| 14 | access to the entire business premises. Any attempt to hinder | ||||||
| 15 | an authorized pharmacy investigator from inspecting the | ||||||
| 16 | business premises and documenting the inspection shall be a | ||||||
| 17 | violation of this Act. The duly authorized investigators shall | ||||||
| 18 | be required to show appropriate identification before being | ||||||
| 19 | given access to the a wholesale drug distributor's premises | ||||||
| 20 | and delivery vehicles. | ||||||
| 21 | (b) With the exception of the most recent 12 months of | ||||||
| 22 | records that must be kept on the premises where the drugs are | ||||||
| 23 | stored, wholesale drug distributors, virtual wholesale | ||||||
| 24 | distributors, and third-party logistics providers may keep | ||||||
| 25 | records regarding purchase and sales transactions | ||||||
| |||||||
| |||||||
| 1 | electronically at a central location apart from the principal | ||||||
| 2 | office of the wholesale drug distributor or the location at | ||||||
| 3 | which the drugs were stored and from which they were shipped, | ||||||
| 4 | provided that the records shall be made readily available for | ||||||
| 5 | inspection within 2 working days of a request by the | ||||||
| 6 | Department. The records may be kept in any form permissible | ||||||
| 7 | under federal law applicable to prescription drugs record | ||||||
| 8 | keeping. | ||||||
| 9 | (c) (Blank). | ||||||
| 10 | (Source: P.A. 102-879, eff. 1-1-23.) | ||||||
| 11 | (225 ILCS 120/56) | ||||||
| 12 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 13 | Sec. 56. Restrictions on transactions. | ||||||
| 14 | (a) A licensee shall receive prescription drug returns or | ||||||
| 15 | exchanges from a pharmacy or other persons authorized to | ||||||
| 16 | administer or dispense drugs or a chain pharmacy warehouse | ||||||
| 17 | pursuant to the terms and conditions of the agreement between | ||||||
| 18 | the wholesale distributor, virtual wholesale distributor, or | ||||||
| 19 | third-party logistics provider and the pharmacy or chain | ||||||
| 20 | pharmacy warehouse. Returns of expired, damaged, recalled, or | ||||||
| 21 | otherwise non-saleable pharmaceutical products shall be | ||||||
| 22 | distributed by the receiving wholesale distributor or | ||||||
| 23 | third-party logistics provider only to either the original | ||||||
| 24 | manufacturer or a third party returns processor. Returns or | ||||||
| 25 | exchanges of prescription drugs, saleable or otherwise, | ||||||
| |||||||
| |||||||
| 1 | including any redistribution by a receiving wholesaler, shall | ||||||
| 2 | not be subject to the pedigree requirements of Section 57 of | ||||||
| 3 | this Act, so long as they are exempt from the pedigree | ||||||
| 4 | requirement of the FDA's currently applicable Prescription | ||||||
| 5 | Drug Marketing Act guidance. Both licensees under this Act and | ||||||
| 6 | pharmacies or other persons authorized to administer or | ||||||
| 7 | dispense drugs shall be accountable for administering their | ||||||
| 8 | returns process and ensuring that the aspects of this | ||||||
| 9 | operation are secure and do not permit the entry of | ||||||
| 10 | adulterated and counterfeit product. | ||||||
| 11 | (b) A manufacturer, or wholesale distributor, virtual | ||||||
| 12 | wholesale distributor, or third-party logistics provider | ||||||
| 13 | licensed under this Act may furnish prescription drugs only to | ||||||
| 14 | a person licensed by the appropriate state licensing | ||||||
| 15 | authorities. Before furnishing prescription drugs to a person | ||||||
| 16 | not known to the manufacturer or licensee wholesale | ||||||
| 17 | distributor, the manufacturer or licensee wholesale | ||||||
| 18 | distributor must affirmatively verify that the person is | ||||||
| 19 | legally authorized to receive the prescription drugs by | ||||||
| 20 | contacting the appropriate state licensing authorities. | ||||||
| 21 | (c) Prescription drugs furnished by a manufacturer, or | ||||||
| 22 | wholesale distributor, virtual wholesale distributor, or | ||||||
| 23 | third-party logistics provider licensed under this Act may be | ||||||
| 24 | delivered only to the premises listed on the license, provided | ||||||
| 25 | that the manufacturer or licensee wholesale distributor may | ||||||
| 26 | furnish prescription drugs to an authorized person or agent of | ||||||
| |||||||
| |||||||
| 1 | that person at the premises of the manufacturer or licensee | ||||||
| 2 | wholesale distributor if: | ||||||
| 3 | (1) the identity and authorization of the recipient is | ||||||
| 4 | properly established; and | ||||||
| 5 | (2) this method of receipt is employed only to meet | ||||||
| 6 | the immediate needs of a particular patient of the | ||||||
| 7 | authorized person. | ||||||
| 8 | (d) Prescription drugs may be furnished to a hospital | ||||||
| 9 | pharmacy receiving area, provided that a pharmacist or | ||||||
| 10 | authorized receiving personnel signs, at the time of delivery, | ||||||
| 11 | a receipt showing the type and quantity of the prescription | ||||||
| 12 | drug received. Any discrepancy between the receipt and the | ||||||
| 13 | type and quantity of the prescription drug actually received | ||||||
| 14 | shall be reported to the delivering manufacturer, or wholesale | ||||||
| 15 | distributor, or third-party logistics provider by the next | ||||||
| 16 | business day after the delivery to the pharmacy receiving | ||||||
| 17 | area. | ||||||
| 18 | (e) A manufacturer, or wholesale distributor, or virtual | ||||||
| 19 | wholesale distributor licensed under this Act may not accept | ||||||
| 20 | payment for, or allow the use of, a person or entity's credit | ||||||
| 21 | to establish an account for the purchase of prescription drugs | ||||||
| 22 | from any person other than the owner of record, the chief | ||||||
| 23 | executive officer, or the chief financial officer listed on | ||||||
| 24 | the license of a person or entity legally authorized to | ||||||
| 25 | receive the prescription drugs. Any account established for | ||||||
| 26 | the purchase of prescription drugs must bear the name of the | ||||||
| |||||||
| |||||||
| 1 | licensee. This subsection (e) shall not be construed to | ||||||
| 2 | prohibit a pharmacy or chain pharmacy warehouse from receiving | ||||||
| 3 | prescription drugs if payment for the prescription drugs is | ||||||
| 4 | processed through the pharmacy's or chain pharmacy warehouse's | ||||||
| 5 | contractual drug manufacturer or wholesale distributor. | ||||||
| 6 | (Source: P.A. 95-689, eff. 10-29-07.) | ||||||
| 7 | (225 ILCS 120/60) (from Ch. 111, par. 8301-60) | ||||||
| 8 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 9 | Sec. 60. Wholesaler licensing; complaints. The Department | ||||||
| 10 | may refuse to issue a license to establish a new licensed | ||||||
| 11 | wholesale drug distributor, virtual wholesale distributor, or | ||||||
| 12 | third-party logistics provider distributorship, if an owner of | ||||||
| 13 | the entity wholesale drug distributorship applying for a | ||||||
| 14 | license was an owner of a wholesale drug distributor, virtual | ||||||
| 15 | wholesale distributor, or third-party logistics provider | ||||||
| 16 | distributorship that had its license revoked, unless the owner | ||||||
| 17 | presents sufficient evidence indicating rehabilitation. Once a | ||||||
| 18 | complaint has been filed by the Department against a wholesale | ||||||
| 19 | drug distributor, virtual wholesale distributor, or | ||||||
| 20 | third-party logistics provider distributorship the Department | ||||||
| 21 | may refuse to issue a license to establish a new licensed | ||||||
| 22 | wholesale drug distributor, virtual wholesale distributor, or | ||||||
| 23 | third-party logistics provider distributorship, until such | ||||||
| 24 | time as the Department issues a decision on the complaint if an | ||||||
| 25 | owner of the new wholesale drug distributor, virtual wholesale | ||||||
| |||||||
| |||||||
| 1 | distributor, or third-party logistics provider distributorship | ||||||
| 2 | was also an owner of a wholesale drug distributor, virtual | ||||||
| 3 | wholesale distributor, or third-party logistics provider | ||||||
| 4 | distributorship against which the complaint was filed. Neither | ||||||
| 5 | an application for change of ownership nor for a change of | ||||||
| 6 | location for any such entity wholesale drug distributorship | ||||||
| 7 | shall be acted on by the Department until such time as the | ||||||
| 8 | Department issues a decision on the complaint. In the event | ||||||
| 9 | that the wholesale drug distributor, virtual wholesale | ||||||
| 10 | distributor, or third-party logistics provider distributorship | ||||||
| 11 | against which the complaint has been filed ceases to be | ||||||
| 12 | licensed by the Department, for any reason, before the | ||||||
| 13 | Department's decision on the complaint and an owner or that | ||||||
| 14 | wholesale drug distributor, virtual wholesale distributor, or | ||||||
| 15 | third-party logistics provider distributorship applies for a | ||||||
| 16 | license to establish a new wholesale drug distributor, virtual | ||||||
| 17 | wholesale distributor, or third-party logistics provider | ||||||
| 18 | distributorship, the Department shall conduct a hearing on the | ||||||
| 19 | complaint earlier filed, regardless of whether that wholesale | ||||||
| 20 | drug distributor, virtual wholesale distributor, or | ||||||
| 21 | third-party logistics provider distributorship is presently | ||||||
| 22 | licensed by the Department. If the conduct for which the | ||||||
| 23 | complaint was originally filed would have been sufficient to | ||||||
| 24 | result in a revocation of a license to operate a licensed | ||||||
| 25 | wholesale drug distributor, virtual wholesale distributor, or | ||||||
| 26 | third-party logistics provider distributorship, then the | ||||||
| |||||||
| |||||||
| 1 | conduct shall constitute sufficient grounds for denial of an | ||||||
| 2 | application for a license. | ||||||
| 3 | (Source: P.A. 87-594.) | ||||||
| 4 | (225 ILCS 120/80) (from Ch. 111, par. 8301-80) | ||||||
| 5 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 6 | Sec. 80. Violations of Act. | ||||||
| 7 | (a) If any person violates the provisions of this Act, the | ||||||
| 8 | Secretary may, in the name of the People of the State of | ||||||
| 9 | Illinois through the Attorney General of the State of Illinois | ||||||
| 10 | or the State's Attorney of any county in which the action is | ||||||
| 11 | brought, petition for an order enjoining the violation or for | ||||||
| 12 | an order enforcing compliance with this Act. Upon the filing | ||||||
| 13 | of a verified petition in the court, the court may issue a | ||||||
| 14 | temporary restraining order, without notice or bond, and may | ||||||
| 15 | preliminarily and permanently enjoin the violation. If it is | ||||||
| 16 | established that the person has violated or is violating the | ||||||
| 17 | injunction, the Court may punish the offender for contempt of | ||||||
| 18 | court. Proceedings under this Section shall be in addition to, | ||||||
| 19 | and not in lieu of, all other remedies and penalties provided | ||||||
| 20 | by this Act. | ||||||
| 21 | (b) Whoever knowingly conducts business as a wholesale | ||||||
| 22 | drug distributor, virtual wholesale distributor, or | ||||||
| 23 | third-party logistics provider in this State without being | ||||||
| 24 | appropriately licensed under this Act shall be guilty of a | ||||||
| 25 | Class A misdemeanor for a first violation and for each | ||||||
| |||||||
| |||||||
| 1 | subsequent conviction shall be guilty of a Class 4 felony. | ||||||
| 2 | (c) Whenever in the opinion of the Department any person | ||||||
| 3 | not licensed in good standing under this Act violates any | ||||||
| 4 | provision of this Act, the Department may issue a rule to show | ||||||
| 5 | cause why an order to cease and desist should not be entered | ||||||
| 6 | against him. The rule shall clearly set forth the grounds | ||||||
| 7 | relied upon by the Department and shall provide a period of 7 | ||||||
| 8 | days from the date of the rule to file an answer to the | ||||||
| 9 | satisfaction of the Department. Failure to answer to the | ||||||
| 10 | satisfaction of the Department shall cause an order to cease | ||||||
| 11 | and desist to be issued immediately. | ||||||
| 12 | (Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.) | ||||||
| 13 | (225 ILCS 120/155) (from Ch. 111, par. 8301-155) | ||||||
| 14 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 15 | Sec. 155. Temporary suspension of license; hearing. The | ||||||
| 16 | Secretary may temporarily suspend licensure as a wholesale | ||||||
| 17 | drug distributor, virtual wholesale distributor, or | ||||||
| 18 | third-party logistics provider, without a hearing, | ||||||
| 19 | simultaneously with the institution of proceedings for a | ||||||
| 20 | hearing provided for in Section 85 of this Act, if the | ||||||
| 21 | Secretary finds that evidence in his or her possession | ||||||
| 22 | indicates that a continuation in business would constitute an | ||||||
| 23 | imminent danger to the public. In the event that the Secretary | ||||||
| 24 | temporarily suspends a license or certificate without a | ||||||
| 25 | hearing, a hearing by the Department must be held within 10 | ||||||
| |||||||
| |||||||
| 1 | days after the suspension has occurred and be concluded | ||||||
| 2 | without appreciable delay. | ||||||
| 3 | (Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.) | ||||||
| 4 | (225 ILCS 120/185) (from Ch. 111, par. 8301-185) | ||||||
| 5 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 6 | Sec. 185. Home rule preemption. The regulation and | ||||||
| 7 | licensing of wholesale drug distributors, virtual wholesale | ||||||
| 8 | distributors, and third-party logistics providers are | ||||||
| 9 | exclusive powers and functions of the State. A home rule unit | ||||||
| 10 | may not regulate or license wholesale drug distributors, | ||||||
| 11 | virtual wholesale distributors, and third-party logistics | ||||||
| 12 | providers. This Section is a denial and limitation of home | ||||||
| 13 | rule powers and functions under subsection (h) of Section 6 of | ||||||
| 14 | Article VII of the Illinois Constitution. | ||||||
| 15 | (Source: P.A. 87-594.) | ||||||
| 16 | (225 ILCS 120/200) | ||||||
| 17 | (Section scheduled to be repealed on January 1, 2028) | ||||||
| 18 | Sec. 200. Drugs in shortage. | ||||||
| 19 | (a) For the purpose of this Section, "drug in shortage" | ||||||
| 20 | means a drug, as defined in Section 356c of the Federal Food, | ||||||
| 21 | Drug, and Cosmetic Act, listed on the drug shortage list | ||||||
| 22 | maintained by the U.S. Food and Drug Administration in | ||||||
| 23 | accordance with Section 356e of the Federal Food, Drug, and | ||||||
| 24 | Cosmetic Act. | ||||||
| |||||||
| |||||||
| 1 | (b) Any person engaged in the wholesale distribution of a | ||||||
| 2 | drug in shortage in this State must be licensed by the | ||||||
| 3 | Department. | ||||||
| 4 | (c) It is unlawful for any person, other than a | ||||||
| 5 | manufacturer, a manufacturer's exclusive distributor, a | ||||||
| 6 | virtual wholesale distributor, a third-party logistics | ||||||
| 7 | provider, or an authorized distributor of record, to purchase | ||||||
| 8 | or receive a drug in shortage from any person not licensed by | ||||||
| 9 | the Department. This subsection (c) does not apply to the | ||||||
| 10 | return of drugs or the purchase or receipt of drugs pursuant to | ||||||
| 11 | any of the distributions that are specifically excluded from | ||||||
| 12 | the definition of "wholesale distribution" in Section 15 of | ||||||
| 13 | the Wholesale Drug Distribution Licensing Act. | ||||||
| 14 | (d) A person found to have violated a provision of this | ||||||
| 15 | Section shall be subject to administrative fines, orders for | ||||||
| 16 | restitution, and orders for disgorgement. | ||||||
| 17 | (e) The Department shall create a centralized, searchable | ||||||
| 18 | database of those entities licensed to engage in wholesale | ||||||
| 19 | distribution, including manufacturers, wholesale | ||||||
| 20 | distributors, virtual wholesale distributors, and pharmacy | ||||||
| 21 | distributors, to enable purchasers of a drug in shortage to | ||||||
| 22 | easily verify the licensing status of an entity offering such | ||||||
| 23 | drugs. | ||||||
| 24 | (f) The Department shall establish a system for reporting | ||||||
| 25 | the reasonable suspicion that a violation of this Act has been | ||||||
| 26 | committed by a distributor of a drug in shortage. Reports made | ||||||
| |||||||
| |||||||
| 1 | through this system shall be referred to the Office of the | ||||||
| 2 | Attorney General and the appropriate State's Attorney's office | ||||||
| 3 | for further investigation and prosecution. | ||||||
| 4 | (g) The Department shall adopt rules to carry out the | ||||||
| 5 | provisions of this Section. | ||||||
| 6 | (h) Nothing in this Section prohibits one hospital | ||||||
| 7 | pharmacy from purchasing or receiving a drug in shortage from | ||||||
| 8 | another hospital pharmacy in the event of a medical emergency. | ||||||
| 9 | (Source: P.A. 102-879, eff. 1-1-23.) | ||||||
| 10 | Section 99. Effective date. This Act takes effect upon | ||||||
| 11 | becoming law. | ||||||