Text of IL HB 4664 (2022)

102ND GENERAL ASSEMBLY State of Illinois 2021 and 2022 HB4664 Introduced , by Rep. Theresa Mah SYNOPSIS AS INTRODUCED: See Index Amends the Regulatory Sunset Act. Provides that the Wholesale Drug Distribution Licensing Act is repealed on January 1, 2028 (instead of January 1, 2023). Amends the Wholesale Drug Distribution Licensing Act. Defines "address of record", "email address of record", and "suspicious order". Changes the definition of "wholesale drug distributor". Provides that applicants and licensees must provide a valid address and email address to the Department of Financial and Professional Regulation and must inform the Department of any change of these within 14 days. Provides that each licensee required to report suspicious orders shall submit such report to the Department. Provides that an individual taxpayer identification number can be included on the application for an original license, the application can be made in writing or electronically, and the application shall be accompanied by the required, nonrefundable fee. Provides that any licensee who engages in the licensed practice while the license is expired shall be considered to be practicing without a license which is grounds for discipline. Removes provisions that provide that: the Department shall present to the State Board of Pharmacy of the Department for review all appropriation requests from the Illinois State Pharmacy Disciplinary Fund; the Department shall maintain a roster of the names and addresses of all registrants and all persons whose licenses have been suspended or revoked; and rules that set detailed standards for meeting each license prerequisite requirements shall be adopted no later than September 14, 1992. Provides that the written notice of disciplinary hearing may be served by email or physical mail to the respondent's email of record or address of record. Provides that the Department may subpoena and compel the relevant documents in connection with any hearing. Provides that if the Secretary of Financial and Professional Regulation disagrees with the recommendation of the Board or hearing officer, the Secretary may issue an order in contravention of the recommendation. Provides that the sanctions imposed upon the accused by the Department shall remain in full force and effect in order to protect the public pending final resolution of the proceedings. Repeals a provision concerning references to the Department or Director of Professional Regulation. Makes corresponding and other changes. Section 5 and Section 99 take effect upon becoming law. LRB102 24218 AMQ 33447 b A BILL FOR HB4664LRB102 24218 AMQ 33447 b 1 AN ACT concerning regulation. 2 Be it enacted by the People of the State of Illinois, 3represented in the General Assembly: 4 Section 5. The Regulatory Sunset Act is amended by 5changing Sections 4.33 and 4.38 as follows: 6 (5 ILCS 80/4.33) 7 Sec. 4.33. Acts repealed on January 1, 2023. The following 8Acts are repealed on January 1, 2023: 9 The Dietitian Nutritionist Practice Act. 10 The Elevator Safety and Regulation Act. 11 The Fire Equipment Distributor and Employee Regulation Act 12of 2011. 13 The Funeral Directors and Embalmers Licensing Code. 14 The Naprapathic Practice Act. 15 The Pharmacy Practice Act. 16 The Professional Counselor and Clinical Professional 17Counselor Licensing and Practice Act. 18 The Wholesale Drug Distribution Licensing Act. 19(Source: P.A. 101-621, eff. 12-20-19.) 20 (5 ILCS 80/4.38) 21 Sec. 4.38. Acts repealed on January 1, 2028. The following 22Acts are repealed on January 1, 2028: HB4664- 2 -LRB102 24218 AMQ 33447 b 1 The Acupuncture Practice Act. 2 The Clinical Social Work and Social Work Practice Act. 3 The Home Medical Equipment and Services Provider License 4Act. 5 The Illinois Petroleum Education and Marketing Act. 6 The Illinois Speech-Language Pathology and Audiology 7Practice Act. 8 The Interpreter for the Deaf Licensure Act of 2007. 9 The Nurse Practice Act. 10 The Nursing Home Administrators Licensing and Disciplinary 11Act. 12 The Physician Assistant Practice Act of 1987. 13 The Podiatric Medical Practice Act of 1987. 14 The Wholesale Drug Distribution Licensing Act. 15(Source: P.A. 100-220, eff. 8-18-17; 100-375, eff. 8-25-17; 16100-398, eff. 8-25-17; 100-414, eff. 8-25-17; 100-453, eff. 178-25-17; 100-513, eff. 9-20-17; 100-525, eff. 9-22-17; 18100-530, eff. 9-22-17; 100-560, eff. 12-8-17.) 19 Section 10. The Wholesale Drug Distribution Licensing Act 20is amended by changing Sections 15, 27, 30, 35, 40, 50, 57, 70, 2175, 80, 85, 100, 105, 110, 115, 120, 125, 135, 140, 155, 165, 22and 200 and by adding Sections 15.5, 21, and 31 as follows: 23 (225 ILCS 120/15) (from Ch. 111, par. 8301-15) 24 (Section scheduled to be repealed on January 1, 2023) HB4664- 3 -LRB102 24218 AMQ 33447 b 1 Sec. 15. Definitions. As used in this Act: 2 "Address of record" means the designated address recorded 3by the Department in the applicant's application file or 4licensee's license file maintained by the Department's 5licensure maintenance unit. 6 "Authentication" means the affirmative verification, 7before any wholesale distribution of a prescription drug 8occurs, that each transaction listed on the pedigree has 9occurred. 10 "Authorized distributor of record" means a wholesale 11distributor with whom a manufacturer has established an 12ongoing relationship to distribute the manufacturer's 13prescription drug. An ongoing relationship is deemed to exist 14between a wholesale distributor and a manufacturer when the 15wholesale distributor, including any affiliated group of the 16wholesale distributor, as defined in Section 1504 of the 17Internal Revenue Code, complies with the following: 18 (1) The wholesale distributor has a written agreement 19 currently in effect with the manufacturer evidencing the 20 ongoing relationship; and 21 (2) The wholesale distributor is listed on the 22 manufacturer's current list of authorized distributors of 23 record, which is updated by the manufacturer on no less 24 than a monthly basis. 25 "Blood" means whole blood collected from a single donor 26and processed either for transfusion or further manufacturing. HB4664- 4 -LRB102 24218 AMQ 33447 b 1 "Blood component" means that part of blood separated by 2physical or mechanical means. 3 "Board" means the State Board of Pharmacy of the 4Department of Professional Regulation. 5 "Chain pharmacy warehouse" means a physical location for 6prescription drugs that acts as a central warehouse and 7performs intracompany sales or transfers of the drugs to a 8group of chain or mail order pharmacies that have the same 9common ownership and control. Notwithstanding any other 10provision of this Act, a chain pharmacy warehouse shall be 11considered part of the normal distribution channel. 12 "Co-licensed partner or product" means an instance where 13one or more parties have the right to engage in the 14manufacturing or marketing of a prescription drug, consistent 15with the FDA's implementation of the Prescription Drug 16Marketing Act. 17 "Department" means the Department of Financial and 18Professional Regulation. 19 "Drop shipment" means the sale of a prescription drug to a 20wholesale distributor by the manufacturer of the prescription 21drug or that manufacturer's co-licensed product partner, that 22manufacturer's third-party third party logistics provider, or 23that manufacturer's exclusive distributor or by an authorized 24distributor of record that purchased the product directly from 25the manufacturer or one of these entities whereby the 26wholesale distributor or chain pharmacy warehouse takes title HB4664- 5 -LRB102 24218 AMQ 33447 b 1but not physical possession of such prescription drug and the 2wholesale distributor invoices the pharmacy, chain pharmacy 3warehouse, or other person authorized by law to dispense or 4administer such drug to a patient and the pharmacy, chain 5pharmacy warehouse, or other authorized person receives 6delivery of the prescription drug directly from the 7manufacturer, that manufacturer's third-party third party 8logistics provider, or that manufacturer's exclusive 9distributor or from an authorized distributor of record that 10purchased the product directly from the manufacturer or one of 11these entities. 12 "Drug sample" means a unit of a prescription drug that is 13not intended to be sold and is intended to promote the sale of 14the drug. 15 "Email address of record" means the designated email 16address recorded by the Department in the applicant's 17application file or the licensee's license file, as maintained 18by the Department's licensure maintenance unit. 19 "Facility" means a facility of a wholesale distributor 20where prescription drugs are stored, handled, repackaged, or 21offered for sale, or a facility of a third-party logistics 22provider where prescription drugs are stored or handled. 23 "FDA" means the United States Food and Drug 24Administration. 25 "Manufacturer" means a person licensed or approved by the 26FDA to engage in the manufacture of drugs or devices, HB4664- 6 -LRB102 24218 AMQ 33447 b 1consistent with the definition of "manufacturer" set forth in 2the FDA's regulations and guidances implementing the 3Prescription Drug Marketing Act. "Manufacturer" does not 4include anyone who is engaged in the packaging, repackaging, 5or labeling of drugs only to the extent permitted under the 6Illinois Drug Reuse Opportunity Program Act. 7 "Manufacturer's exclusive distributor" means anyone who 8contracts with a manufacturer to provide or coordinate 9warehousing, distribution, or other services on behalf of a 10manufacturer and who takes title to that manufacturer's 11prescription drug, but who does not have general 12responsibility to direct the sale or disposition of the 13manufacturer's prescription drug. A manufacturer's exclusive 14distributor must be licensed as a wholesale distributor under 15this Act and, in order to be considered part of the normal 16distribution channel, must also be an authorized distributor 17of record. 18 "Normal distribution channel" means a chain of custody for 19a prescription drug that goes, directly or by drop shipment, 20from (i) a manufacturer of the prescription drug, (ii) that 21manufacturer to that manufacturer's co-licensed partner, (iii) 22that manufacturer to that manufacturer's third-party third 23party logistics provider, or (iv) that manufacturer to that 24manufacturer's exclusive distributor to: 25 (1) a pharmacy or to other designated persons 26 authorized by law to dispense or administer the drug to a HB4664- 7 -LRB102 24218 AMQ 33447 b 1 patient; 2 (2) a wholesale distributor to a pharmacy or other 3 designated persons authorized by law to dispense or 4 administer the drug to a patient; 5 (3) a wholesale distributor to a chain pharmacy 6 warehouse to that chain pharmacy warehouse's intracompany 7 pharmacy to a patient or other designated persons 8 authorized by law to dispense or administer the drug to a 9 patient; 10 (4) a chain pharmacy warehouse to the chain pharmacy 11 warehouse's intracompany pharmacy or other designated 12 persons authorized by law to dispense or administer the 13 drug to the patient; 14 (5) an authorized distributor of record to one other 15 authorized distributor of record to an office-based health 16 care practitioner authorized by law to dispense or 17 administer the drug to the patient; or 18 (6) an authorized distributor to a pharmacy or other 19 persons licensed to dispense or administer the drug. 20 "Pedigree" means a document or electronic file containing 21information that records each wholesale distribution of any 22given prescription drug from the point of origin to the final 23wholesale distribution point of any given prescription drug. 24 "Person" means and includes a natural person, partnership, 25association, corporation, or any other legal business entity. 26 "Pharmacy distributor" means any pharmacy licensed in this HB4664- 8 -LRB102 24218 AMQ 33447 b 1State or hospital pharmacy that is engaged in the delivery or 2distribution of prescription drugs either to any other 3pharmacy licensed in this State or to any other person or 4entity including, but not limited to, a wholesale drug 5distributor engaged in the delivery or distribution of 6prescription drugs who is involved in the actual, 7constructive, or attempted transfer of a drug in this State to 8other than the ultimate consumer except as otherwise provided 9for by law. 10 "Prescription drug" means any human drug, including any 11biological product (except for blood and blood components 12intended for transfusion or biological products that are also 13medical devices), required by federal law or regulation to be 14dispensed only by a prescription, including finished dosage 15forms and bulk drug substances subject to Section 503 of the 16Federal Food, Drug and Cosmetic Act. 17 "Repackage" means repackaging or otherwise changing the 18container, wrapper, or labeling to further the distribution of 19a prescription drug, excluding that completed by the 20pharmacist responsible for dispensing the product to a 21patient. 22 "Secretary" means the Secretary of the Department of 23Financial and Professional Regulation. 24 "Suspicious order" includes, but is not limited to, an 25order of a controlled substance of unusual size, an order of a 26controlled substance deviating substantially from a normal HB4664- 9 -LRB102 24218 AMQ 33447 b 1pattern, and orders of controlled substances of unusual 2frequency as defined by 21 USC 802. 3 "Third-party logistics provider" means anyone who 4contracts with a prescription drug manufacturer to provide or 5coordinate warehousing, distribution, or other services on 6behalf of a manufacturer, but does not take title to the 7prescription drug or have general responsibility to direct the 8prescription drug's sale or disposition. 9 "Wholesale distribution" means the distribution of 10prescription drugs to persons other than a consumer or 11patient, but does not include any of the following: 12 (1) Intracompany sales of prescription drugs, meaning 13 (i) any transaction or transfer between any division, 14 subsidiary, parent, or affiliated or related company under 15 the common ownership and control of a corporate entity or 16 (ii) any transaction or transfer between co-licensees of a 17 co-licensed product. 18 (2) The sale, purchase, distribution, trade, or 19 transfer of a prescription drug or offer to sell, 20 purchase, distribute, trade, or transfer a prescription 21 drug for emergency medical reasons. 22 (3) The distribution of prescription drug samples by 23 manufacturers' representatives. 24 (4) Drug returns, when conducted by a hospital, health 25 care entity, or charitable institution in accordance with 26 federal regulation. HB4664- 10 -LRB102 24218 AMQ 33447 b 1 (5) The sale of minimal quantities of prescription 2 drugs by licensed pharmacies to licensed practitioners for 3 office use or other licensed pharmacies. 4 (6) The sale, purchase, or trade of a drug, an offer to 5 sell, purchase, or trade a drug, or the dispensing of a 6 drug pursuant to a prescription. 7 (7) The sale, transfer, merger, or consolidation of 8 all or part of the business of a pharmacy or pharmacies 9 from or with another pharmacy or pharmacies, whether 10 accomplished as a purchase and sale of stock or business 11 assets. 12 (8) The sale, purchase, distribution, trade, or 13 transfer of a prescription drug from one authorized 14 distributor of record to one additional authorized 15 distributor of record when the manufacturer has stated in 16 writing to the receiving authorized distributor of record 17 that the manufacturer is unable to supply the prescription 18 drug and the supplying authorized distributor of record 19 states in writing that the prescription drug being 20 supplied had until that time been exclusively in the 21 normal distribution channel. 22 (9) The delivery of or the offer to deliver a 23 prescription drug by a common carrier solely in the common 24 carrier's usual course of business of transporting 25 prescription drugs when the common carrier does not store, 26 warehouse, or take legal ownership of the prescription HB4664- 11 -LRB102 24218 AMQ 33447 b 1 drug. 2 (10) The sale or transfer from a retail pharmacy, mail 3 order pharmacy, or chain pharmacy warehouse of expired, 4 damaged, returned, or recalled prescription drugs to the 5 original manufacturer, the originating wholesale 6 distributor, or a third party returns processor. 7 (11) The donation of drugs to the extent permitted 8 under the Illinois Drug Reuse Opportunity Program Act. 9 "Wholesale drug distributor" means anyone engaged in the 10wholesale distribution of prescription drugs into, out of, or 11within the State, including without limitation manufacturers; 12repackers; own label distributors; jobbers; private label 13distributors; brokers; virtual wholesalers or virtual 14distributors; warehouses, including manufacturers' and 15distributors' warehouses; manufacturer's exclusive 16distributors; and authorized distributors of record; drug 17wholesalers or distributors; independent wholesale drug 18traders; specialty wholesale distributors; and retail 19pharmacies that conduct wholesale distribution; and chain 20pharmacy warehouses that conduct wholesale distribution. In 21order to be considered part of the normal distribution 22channel, a wholesale distributor must also be an authorized 23distributor of record. 24(Source: P.A. 101-420, eff. 8-16-19; 102-389, eff. 1-1-22.) 25 (225 ILCS 120/15.5 new) HB4664- 12 -LRB102 24218 AMQ 33447 b 1 Sec. 15.5. Address of record; email address of record. All 2applicants and licensees shall: 3 (1) provide a valid address and email address to the 4 Department, which shall serve as the address of record and 5 email address of record, respectively, at the time of 6 application for licensure or renewal of a license; and 7 (2) inform the Department of any change of address of 8 record or email address of record within 14 days after 9 such change either through the Department's website or by 10 contacting the Department's licensure maintenance unit. 11 (225 ILCS 120/21 new) 12 Sec. 21. Reports to Department. Each licensee that is 13required to report suspicious orders under 21 USC 832 shall 14also submit such suspicions order reports to the Department. 15 (225 ILCS 120/27) 16 (Section scheduled to be repealed on January 1, 2023) 17 Sec. 27. Social security number, individual taxpayer 18identification number, or unique identifying number Security 19Number on license application. In addition to any other 20information required to be contained in the application, every 21application for an original license under this Act shall 22include the applicant's social security number, individual 23taxpayer identification number, or other unique identifying 24number deemed appropriate by the Department, Social Security HB4664- 13 -LRB102 24218 AMQ 33447 b 1Number, which shall be retained in the agency's records 2pertaining to the license. As soon as practical, the 3Department shall assign a customer's identification number to 4each applicant for a license. 5 Every application for a renewal or restored license shall 6require the applicant's customer identification number. 7(Source: P.A. 97-400, eff. 1-1-12.) 8 (225 ILCS 120/30) (from Ch. 111, par. 8301-30) 9 (Section scheduled to be repealed on January 1, 2023) 10 Sec. 30. License applications; renewal renewal application 11procedures. An application for an original license or renewal 12shall be made to the Department in writing or electronically 13on forms prescribed by the Department and shall be accompanied 14by the required fee, which shall not be refundable. Any such 15application shall require such information as in the judgment 16of the Department will enable the Board and Department to pass 17on the qualifications of the applicant for a license. 18Application for renewal of any license required by this Act 19shall be mailed or emailed to each licensee at least 60 days 20before the license expires. If the application for renewal 21with the required fee is not received by the Department before 22the expiration date, the existing license shall lapse and 23become null and void. Failure to renew before the expiration 24date is cause for a late payment penalty, discipline, or both. 25(Source: P.A. 101-420, eff. 8-16-19.) HB4664- 14 -LRB102 24218 AMQ 33447 b 1 (225 ILCS 120/31 new) 2 Sec. 31. Expiration of license; renewal. 3 (a) The expiration date and renewal period for each 4license issued under this Act shall be set by rule. 5 (b) Any licensee who shall engage in the practice for 6which the license was issued while the license is expired or on 7inactive status shall be considered to be practicing without a 8license which shall be grounds for discipline under this Act. 9 (c) A wholesale drug distributor or third-party logistics 10provider whose license has been expired for one year or more 11may not have its license restored but must apply for a new 12license and meet all requirements for licensure. Any wholesale 13drug distributor or third-party logistics provider whose 14license has been expired for less than one year may apply for 15restoration of its license and shall have its license 16restored. 17 (d) Anyone operating on an expired license is engaged in 18unlawful practice and subject to discipline under this Act. 19 (225 ILCS 120/35) (from Ch. 111, par. 8301-35) 20 (Section scheduled to be repealed on January 1, 2023) 21 Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund. 22 (a) The Department shall provide by rule for a schedule of 23fees for the administration and enforcement of this Act, 24including but not limited to original licensure, renewal, and HB4664- 15 -LRB102 24218 AMQ 33447 b 1restoration. The fees shall be nonrefundable. 2 (b) All fees collected under this Act shall be deposited 3into the Illinois State Pharmacy Disciplinary Fund and shall 4be appropriated to the Department for the ordinary and 5contingent expenses of the Department in the administration of 6this Act. Moneys in the Fund may be transferred to the 7Professions Indirect Cost Fund as authorized by Section 82105-300 of the Department of Financial and Professional 9Regulation Law (20 ILCS 2105/2105-300). 10 The moneys deposited into the Illinois State Pharmacy 11Disciplinary Fund shall be invested to earn interest which 12shall accrue to the Fund. 13 The Department shall present to the Board for its review 14and comment all appropriation requests from the Illinois State 15Pharmacy Disciplinary Fund. The Department shall give due 16consideration to any comments of the Board in making 17appropriation requests. 18 (c) Any person who delivers a check or other payment to the 19Department that is returned to the Department unpaid by the 20financial institution upon which it is drawn shall pay to the 21Department, in addition to the amount already owed to the 22Department, a fine of $50. The fines imposed by this Section 23are in addition to any other discipline provided under this 24Act for unlicensed practice or practice on a nonrenewed 25license. The Department shall notify the person that payment 26of fees and fines shall be paid to the Department by certified HB4664- 16 -LRB102 24218 AMQ 33447 b 1check or money order within 30 calendar days of the 2notification. If, after the expiration of 30 days from the 3date of the notification, the person has failed to submit the 4necessary remittance, the Department shall automatically 5terminate the license or certificate or deny the application, 6without hearing. If, after termination or denial, the person 7seeks a license or certificate, he or she shall apply to the 8Department for restoration or issuance of the license or 9certificate and pay all fees and fines due to the Department. 10The Department may establish a fee for the processing of an 11application for restoration of a license or certificate to pay 12all expenses of processing this application. The Secretary 13Director may waive the fines due under this Section in 14individual cases where the Secretary Director finds that the 15fines would be unreasonable or unnecessarily burdensome. 16 (d) (Blank). The Department shall maintain a roster of the 17names and addresses of all registrants and of all persons 18whose licenses have been suspended or revoked. This roster 19shall be available upon written request and payment of the 20required fee. 21 (e) A manufacturer of controlled substances, wholesale 22distributor of controlled substances, or third-party logistics 23provider that is licensed under this Act and owned and 24operated by the State is exempt from licensure, registration, 25renewal, and other fees required under this Act. Nothing in 26this subsection (e) shall be construed to prohibit the HB4664- 17 -LRB102 24218 AMQ 33447 b 1Department from imposing any fine or other penalty allowed 2under this Act. 3(Source: P.A. 101-420, eff. 8-16-19.) 4 (225 ILCS 120/40) (from Ch. 111, par. 8301-40) 5 (Section scheduled to be repealed on January 1, 2023) 6 Sec. 40. Rules and regulations. The Department shall make 7any rules and regulations, not inconsistent with law, as may 8be necessary to carry out the purposes and enforce the 9provisions of this Act. Rules and regulations that incorporate 10and set detailed standards for meeting each of the license 11prerequisites set forth in Section 25 of this Act shall be 12adopted no later than September 14, 1992. All rules and 13regulations promulgated under this Section shall conform to 14wholesale drug distributor licensing guidelines formally 15adopted by the FDA at 21 C.F.R. Part 205. In case of conflict 16between any rule or regulation adopted by the Department and 17any FDA wholesale drug distributor or third-party logistics 18provider guideline, the FDA guideline shall control. 19(Source: P.A. 101-420, eff. 8-16-19.) 20 (225 ILCS 120/50) (from Ch. 111, par. 8301-50) 21 (Section scheduled to be repealed on January 1, 2023) 22 Sec. 50. Inspection powers; access to records. 23 (a) Any pharmacy investigator authorized by the Department 24has the right of entry for inspection during normal business HB4664- 18 -LRB102 24218 AMQ 33447 b 1hours of premises purporting or appearing to be used by a 2wholesale drug distributor in this State, including the 3business premises of a person licensed pursuant to this Act. 4This right of entry shall permit the authorized pharmacy 5investigator unfettered access to the entire business 6premises. Any attempt to hinder an authorized pharmacy 7investigator from inspecting the business premises and 8documenting the inspection shall be a violation of this Act. 9The duly authorized investigators shall be required to show 10appropriate identification before being given access to a 11wholesale drug distributor's premises and delivery vehicles. 12 (b) With the exception of the most recent 12 months of 13records that must be kept on the premises where the drugs are 14stored, wholesale drug distributors may keep records regarding 15purchase and sales transactions electronically at a central 16location apart from the principal office of the wholesale drug 17distributor or the location at which the drugs were stored and 18from which they were shipped, provided that the records shall 19be made readily available for inspection within 2 working days 20of a request by the Department. The records may be kept in any 21form permissible under federal law applicable to prescription 22drugs record keeping. 23 (c) (Blank). 24(Source: P.A. 97-804, eff. 1-1-13.) 25 (225 ILCS 120/57) HB4664- 19 -LRB102 24218 AMQ 33447 b 1 (Section scheduled to be repealed on January 1, 2023) 2 Sec. 57. Pedigree. 3 (a) Each person who is engaged in the wholesale 4distribution of prescription drugs, including repackagers, but 5excluding the original manufacturer of the finished form of 6the prescription drug, that leave or have ever left the normal 7distribution channel shall, before each wholesale distribution 8of the drug, provide a pedigree to the person who receives the 9drug. A retail pharmacy, mail order pharmacy, or chain 10pharmacy warehouse must comply with the requirements of this 11Section only if the pharmacy or chain pharmacy warehouse 12engages in the wholesale distribution of prescription drugs. 13On or before July 1, 2009, the Department shall determine a 14targeted implementation date for electronic track and trace 15pedigree technology. This targeted implementation date shall 16not be sooner than July 1, 2010. Beginning on the date 17established by the Department, pedigrees may be implemented 18through an approved and readily available system that 19electronically tracks and traces the wholesale distribution of 20each prescription drug starting with the sale by the 21manufacturer through acquisition and sale by any wholesale 22distributor and until final sale to a pharmacy or other 23authorized person administering or dispensing the prescription 24drug. This electronic tracking system shall be deemed to be 25readily available only upon there being available a 26standardized system originating with the manufacturers and HB4664- 20 -LRB102 24218 AMQ 33447 b 1capable of being used on a wide scale across the entire 2pharmaceutical chain, including manufacturers, wholesale 3distributors, third-party logistics providers, and pharmacies. 4Consideration must also be given to the large-scale 5implementation of this technology across the supply chain and 6the technology must be proven to have no negative impact on the 7safety and efficacy of the pharmaceutical product. 8 (b) Each person who is engaged in the wholesale 9distribution of a prescription drug who is provided a pedigree 10for a prescription drug and attempts to further distribute 11that prescription drug, including repackagers, but excluding 12the original manufacturer of the finished form of the 13prescription drug, must affirmatively verify before any 14distribution of a prescription drug occurs that each 15transaction listed on the pedigree has occurred. 16 (c) The pedigree must include all necessary identifying 17information concerning each sale in the chain of distribution 18of the product from the manufacturer or the manufacturer's 19third-party third party logistics provider, co-licensed 20product partner, or exclusive distributor through acquisition 21and sale by any wholesale distributor or repackager, until 22final sale to a pharmacy or other person dispensing or 23administering the drug. This necessary chain of distribution 24information shall include, without limitation all of the 25following: 26 (1) The name, address, telephone number and, if HB4664- 21 -LRB102 24218 AMQ 33447 b 1 available, the e-mail address of each owner of the 2 prescription drug and each wholesale distributor of the 3 prescription drug. 4 (2) The name and address of each location from which 5 the product was shipped, if different from the owner's. 6 (3) Transaction dates. 7 (4) Certification that each recipient has 8 authenticated the pedigree. 9 (d) The pedigree must also include without limitation all 10of the following information concerning the prescription drug: 11 (1) The name and national drug code number of the 12 prescription drug. 13 (2) The dosage form and strength of the prescription 14 drug. 15 (3) The size of the container. 16 (4) The number of containers. 17 (5) The lot number of the prescription drug. 18 (6) The name of the manufacturer of the finished 19 dosage form. 20 (e) Each pedigree or electronic file shall be maintained 21by the purchaser and the wholesale distributor for at least 3 22years from the date of sale or transfer and made available for 23inspection or use within 5 business days upon a request of the 24Department. 25(Source: P.A. 101-420, eff. 8-16-19.) HB4664- 22 -LRB102 24218 AMQ 33447 b 1 (225 ILCS 120/70) (from Ch. 111, par. 8301-70) 2 (Section scheduled to be repealed on January 1, 2023) 3 Sec. 70. Immediate suspension of license or registration; 4hearing. The Secretary Director may, upon receipt of a 5written communication from the Secretary of Human Services or 6the Director of Public Health that continuation of practice of 7a person licensed or registered under this Act constitutes an 8immediate danger to the public, immediately suspend the 9license or registration of that person without a hearing. In 10instances in which the Secretary Director immediately suspends 11a license or registration under this Section, a hearing upon 12the person's license must be convened by the Board within 15 13days after the suspension and completed without appreciable 14delay. The hearing shall be held to determine whether to 15recommend to the Secretary Director that the person's license 16be revoked, suspended, placed on probationary status, or 17reinstated, or that the person be subject to other 18disciplinary action. In the hearing, the written communication 19and any other evidence submitted with the communication may be 20introduced as evidence against the person. The person or his 21or her counsel shall have the opportunity to discredit or 22impeach such evidence and submit rebuttal evidence. 23(Source: P.A. 89-507, eff. 7-1-97.) 24 (225 ILCS 120/75) (from Ch. 111, par. 8301-75) 25 (Section scheduled to be repealed on January 1, 2023) HB4664- 23 -LRB102 24218 AMQ 33447 b 1 Sec. 75. Automatic suspension. The determination by a 2circuit court that a licensee is subject to involuntary 3admission or judicial admission as provided in the Mental 4Health and Developmental Disabilities Code operates as an 5automatic suspension. The suspension shall end only upon (i) a 6finding by a court that the patient is no longer subject to 7involuntary admission or judicial admission and the issuance 8of an order so finding and discharging the patient and (ii) the 9recommendation of the Board to the Secretary Director that the 10licensee be allowed to resume his or her practice. 11(Source: P.A. 91-357, eff. 7-29-99.) 12 (225 ILCS 120/80) (from Ch. 111, par. 8301-80) 13 (Section scheduled to be repealed on January 1, 2023) 14 Sec. 80. Violations of Act. 15 (a) If any person violates the provisions of this Act, the 16Secretary Director may, in the name of the People of the State 17of Illinois through the Attorney General of the State of 18Illinois or the State's Attorney of any county in which the 19action is brought, petition for an order enjoining the 20violation or for an order enforcing compliance with this Act. 21Upon the filing of a verified petition in the court, the court 22may issue a temporary restraining order, without notice or 23bond, and may preliminarily and permanently enjoin the 24violation. If it is established that the person has violated 25or is violating the injunction, the Court may punish the HB4664- 24 -LRB102 24218 AMQ 33447 b 1offender for contempt of court. Proceedings under this Section 2shall be in addition to, and not in lieu of, all other remedies 3and penalties provided by this Act. 4 (b) Whoever knowingly conducts business as a wholesale 5drug distributor or third-party logistics provider in this 6State without being appropriately licensed under this Act 7shall be guilty of a Class A misdemeanor for a first violation 8and for each subsequent conviction shall be guilty of a Class 4 9felony. 10 (c) Whenever in the opinion of the Department any person 11not licensed in good standing under this Act violates any 12provision of this Act, the Department may issue a rule to show 13cause why an order to cease and desist should not be entered 14against him. The rule shall clearly set forth the grounds 15relied upon by the Department and shall provide a period of 7 16days from the date of the rule to file an answer to the 17satisfaction of the Department. Failure to answer to the 18satisfaction of the Department shall cause an order to cease 19and desist to be issued immediately. 20(Source: P.A. 101-420, eff. 8-16-19.) 21 (225 ILCS 120/85) (from Ch. 111, par. 8301-85) 22 (Section scheduled to be repealed on January 1, 2023) 23 Sec. 85. Investigations; notice of disciplinary hearing. 24The Department may investigate the actions of any applicant or 25of any person or persons holding or claiming to hold a license HB4664- 25 -LRB102 24218 AMQ 33447 b 1or registration. Before suspending, revoking, placing on 2probationary status, or taking any other disciplinary action 3as the Department may deem proper with regard to any license or 4certificate, at least 30 days before the date set for the 5hearing, the Department shall (i) notify the accused in 6writing of any charges made and the time and place for a 7hearing of the charges before the Board, (ii) direct him or her 8to file a written answer to the charges with the Board under 9oath within 20 days after the service of the notice, and (iii) 10inform the accused that if he or she fails to file an answer 11default will be taken against him or her and his or her license 12or certificate may be suspended, revoked, placed on 13probationary status, or have other disciplinary action, 14including limiting the scope, nature or extent of business, as 15provided for in this Act. The written notice may be served by 16personal delivery, email to the respondent's email address of 17record, or mail to the respondent's address of record or 18certified or registered mail to the respondent at the address 19of last notification to the Department. At the time and place 20fixed in the notice, the Board shall proceed to hear the 21charges and the parties or their counsel shall be accorded 22ample opportunity to present any statements, testimony, 23evidence and argument that may be pertinent to the charges or 24to their defense. The hearing may be continued from time to 25time. In case the accused person, after receiving notice, 26fails to file an answer, his or her license or certificate may HB4664- 26 -LRB102 24218 AMQ 33447 b 1in the discretion of the Secretary Director, having received 2first the recommendation of the Board, be suspended, revoked, 3placed on probationary status, or the Secretary Director may 4take whatever disciplinary action as he or she may deem proper 5as provided in this Act, including limiting the scope, nature, 6or extent of the person's practice, without a hearing, if the 7act or acts charged constitute sufficient grounds for such 8action under this Act. 9(Source: P.A. 87-594.) 10 (225 ILCS 120/100) (from Ch. 111, par. 8301-100) 11 (Section scheduled to be repealed on January 1, 2023) 12 Sec. 100. Subpoena power; administration of oaths. The 13Department shall have power to subpoena and bring before it 14any person in this State and to take testimony, either orally 15or by deposition or both, with the same fees and mileage and in 16the same manner as prescribed by law in judicial proceedings 17in civil cases in circuit courts of this State. The Department 18may subpoena and compel the production of documents, papers, 19files, books, and records in connection with any hearing or 20investigation. 21 The Secretary, hearing officer, and Director and any 22member of the Board shall each have power to administer oaths 23to witnesses at any hearing which the Department is authorized 24to conduct under this Act, and any other oaths required or 25authorized to be administered by the Department under this HB4664- 27 -LRB102 24218 AMQ 33447 b 1Act. 2(Source: P.A. 87-594.) 3 (225 ILCS 120/105) (from Ch. 111, par. 8301-105) 4 (Section scheduled to be repealed on January 1, 2023) 5 Sec. 105. Report of findings and recommendation. At the 6conclusion of the hearing, the Board shall present to the 7Secretary Director a written report of its findings of fact, 8conclusions of law, and recommendations. The report shall 9contain a finding whether or not the accused person violated 10this Act or failed to comply with the conditions required in 11this Act. The Board shall specify the nature of the violation 12or failure to comply and shall make its recommendations to the 13Secretary Director. 14 The report of findings of fact, conclusion of law, and 15recommendations of the Board shall be the basis for the 16Department's order for refusal or for the granting of a 17license or registration. The finding is not admissible in 18evidence against the person in a criminal prosecution brought 19for the violation of this Act, but the hearing and finding are 20not a bar to a criminal prosecution brought for the violation 21of this Act. 22(Source: P.A. 87-594.) 23 (225 ILCS 120/110) (from Ch. 111, par. 8301-110) 24 (Section scheduled to be repealed on January 1, 2023) HB4664- 28 -LRB102 24218 AMQ 33447 b 1 Sec. 110. Hearing officers; appointment. Notwithstanding 2any other provision of this Act, the Secretary Director shall 3have the authority to appoint any attorney duly licensed to 4practice law in the State of Illinois to serve as the hearing 5officer in any action before the Board for refusal to issue or 6renew a license, or the discipline of a licensee. The Director 7shall notify the Board of any such appointment. The hearing 8officer shall have full authority to conduct the hearing. 9There shall be present at least one member of the Board at any 10such hearing. The hearing officer shall report his findings of 11fact, conclusions of law, and recommendations to the Board and 12the Secretary Director. The Board shall have 60 days from 13receipt of the report to review the report of the hearing 14officer and present its findings of fact, conclusions of law, 15and recommendations to the Secretary Director. If the Board 16fails to present its report within the 60 day period, the 17Secretary Director may issue an order based on report of the 18hearing officer and the record of the proceedings or issue an 19order remanding the matter back to the hearing officer for 20additional proceedings in accordance with the order. If the 21Secretary disagrees with the recommendation of the Board or 22the hearing officer, the Secretary may issue an order in 23contravention of the recommendation. However, if the Board 24does present its report within the specified 60 days, the 25Director's order shall be based upon the report of the Board. 26(Source: P.A. 87-594.) HB4664- 29 -LRB102 24218 AMQ 33447 b 1 (225 ILCS 120/115) (from Ch. 111, par. 8301-115) 2 (Section scheduled to be repealed on January 1, 2023) 3 Sec. 115. Motion for rehearing. In any case involving the 4refusal to issue, renew, or discipline of a license or 5registration, a copy of the Board's report shall be served 6upon the respondent by the Department, either personally or as 7provided in this Act for the service of the notice of hearing. 8Within 20 days after service, the respondent may present to 9the Department a motion in writing for a rehearing, which 10shall specify the particular grounds for rehearing. If no 11motion for rehearing is filed, then upon the expiration of the 12time specified for filing a motion, or if a motion for 13rehearing is denied, then upon denial the Secretary Director 14may enter an order in accordance with recommendations of the 15Board. If the respondent orders from the reporting service and 16pays for a transcript of the record within the time for filing 17a motion for rehearing, the 20-day 20 day period within which a 18motion may be filed shall commence upon the delivery of the 19transcript to the respondent. 20(Source: P.A. 87-594.) 21 (225 ILCS 120/120) (from Ch. 111, par. 8301-120) 22 (Section scheduled to be repealed on January 1, 2023) 23 Sec. 120. Rehearing by order of Secretary Director. 24Whenever the Secretary Director is satisfied that substantial HB4664- 30 -LRB102 24218 AMQ 33447 b 1justice has not been done in the revocation, suspension, or 2refusal to issue or renew a license or registration, the 3Secretary Director may order a rehearing by the same hearing 4office or Board. 5(Source: P.A. 87-594.) 6 (225 ILCS 120/125) (from Ch. 111, par. 8301-125) 7 (Section scheduled to be repealed on January 1, 2023) 8 Sec. 125. Duties of the Board Board recommendations to 9Director; disagreement. The Board shall exercise the rights, 10powers, and duties which have been vested in the Board under 11this Act, and any other duties conferred upon the Board by law. 12None of the disciplinary functions, powers, and duties 13enumerated in this Act shall be exercised by the Department 14except upon the action and report in writing of the Board, 15except as otherwise provided in this Act. 16 In all instances under this Act in which the Board has 17rendered a recommendation to the Director with respect to a 18particular license or certificate, the Director shall, in the 19event that he or she disagrees with or takes action contrary to 20the recommendation of the Board, file with the Board and 21Secretary of State his or her specific written reasons for 22disagreement with the Board. These reasons shall be filed 23within 30 days after the Director taking the contrary 24position. 25 The action and report in writing of a majority of the Board HB4664- 31 -LRB102 24218 AMQ 33447 b 1is sufficient authority upon which the Director may act. 2(Source: P.A. 87-594.) 3 (225 ILCS 120/135) (from Ch. 111, par. 8301-135) 4 (Section scheduled to be repealed on January 1, 2023) 5 Sec. 135. Disciplinary consent orders. Notwithstanding the 6provisions of this Act concerning the conduct of hearings and 7recommendations for disciplinary actions, the Secretary 8Director shall have the authority to negotiate agreements with 9licensees and registrants resulting in disciplinary consent 10orders. Consent orders may provide for any of the forms of 11discipline otherwise provided in this Act. Consent orders 12shall provide that they were not entered into a result of any 13coercion by the Department. The Director shall forward copies 14of all final consent orders to the Board within 30 days after 15their entry. 16(Source: P.A. 87-594.) 17 (225 ILCS 120/140) (from Ch. 111, par. 8301-140) 18 (Section scheduled to be repealed on January 1, 2023) 19 Sec. 140. Orders; prima facie proof. An order or a 20certified copy thereof, over the seal of the Department and 21purporting to be signed by the Secretary Director, shall be 22prima facie proof that: 23 (a) the signature is the genuine signature of the 24 Secretary Director; HB4664- 32 -LRB102 24218 AMQ 33447 b 1 (b) the Secretary Director is duly appointed and 2 qualified; and 3 (c) the Board and its members are qualified to act. 4(Source: P.A. 91-357, eff. 7-29-99.) 5 (225 ILCS 120/155) (from Ch. 111, par. 8301-155) 6 (Section scheduled to be repealed on January 1, 2023) 7 Sec. 155. Temporary suspension of license; hearing. The 8Secretary Director may temporarily suspend licensure as a 9wholesale drug distributor or third-party logistics provider, 10without a hearing, simultaneously with the institution of 11proceedings for a hearing provided for in Section 85 of this 12Act, if the Secretary Director finds that evidence in his or 13her possession indicates that a continuation in business would 14constitute an imminent danger to the public. In the event that 15the Secretary Director temporarily suspends a license or 16certificate without a hearing, a hearing by the Department 17must be held within 10 days after the suspension has occurred 18and be concluded without appreciable delay. 19(Source: P.A. 101-420, eff. 8-16-19.) 20 (225 ILCS 120/165) (from Ch. 111, par. 8301-165) 21 (Section scheduled to be repealed on January 1, 2023) 22 Sec. 165. Certification of record; receipt for costs. The 23Department shall not be required to certify any record to the 24court, to file an answer in court, or to otherwise appear in HB4664- 33 -LRB102 24218 AMQ 33447 b 1any court in a judicial review proceeding unless and until the 2Department has received from the plaintiff payment of the 3costs of furnishing and certifying the record, which costs 4shall be determined by the Department. Failure on the part of 5the plaintiff to file a receipt in court shall be grounds for 6dismissal of the action. During the pendency and hearing of 7any and all judicial proceedings incident to the disciplinary 8action, the sanctions imposed upon the accused by the 9Department because of acts or omissions related to the 10delivery of direct patient care as specified in the 11Department's final administrative decision, shall, as a matter 12of public policy, remain in full force and effect in order to 13protect the public pending final resolution of any of the 14proceedings. 15The Department shall not be required to certify any record to 16the court or file any answer in court or otherwise appear in 17any court in a judicial review proceeding, unless there is 18filed in the court, with the complaint, a receipt from the 19Department acknowledging payment of the costs of furnishing 20and certifying the record, which costs shall be computed at 21the rate of 25 cents per page of such record. Failure on the 22part of the plaintiff to file a receipt in court shall be 23grounds for dismissal of the action. 24(Source: P.A. 87-594.) 25 (225 ILCS 120/200) HB4664- 34 -LRB102 24218 AMQ 33447 b 1 (Section scheduled to be repealed on January 1, 2023) 2 Sec. 200. Drugs in shortage. 3 (a) For the purpose of this Section, "drug in shortage" 4means a drug, as defined in Section 356c of the Federal Food, 5Drug, and Cosmetic Act, listed on the drug shortage list 6maintained by the U.S. Food and Drug Administration in 7accordance with Section 356e of the Federal Food, Drug, and 8Cosmetic Act. 9 (b) Any person engaged in the wholesale distribution of a 10drug in shortage in this State must be licensed by the 11Department. 12 (c) It is unlawful for any person, other than a 13manufacturer, a manufacturer's exclusive distributor, a 14third-party third party logistics provider, or an authorized 15distributor of record, to purchase or receive a drug in 16shortage from any person not licensed by the Department. This 17subsection (c) does not apply to the return of drugs or the 18purchase or receipt of drugs pursuant to any of the 19distributions that are specifically excluded from the 20definition of "wholesale distribution" in Section 15 of the 21Wholesale Drug Distribution Licensing Act. 22 (d) A person found to have violated a provision of this 23Section shall be subject to administrative fines, orders for 24restitution, and orders for disgorgement. 25 (e) The Department shall create a centralized, searchable 26database of those entities licensed to engage in wholesale HB4664- 35 -LRB102 24218 AMQ 33447 b 1distribution, including manufacturers, wholesale 2distributors, and pharmacy distributors, to enable purchasers 3of a drug in shortage to easily verify the licensing status of 4an entity offering such drugs. 5 (f) The Department shall establish a system for reporting 6the reasonable suspicion that a violation of this Act has been 7committed by a distributor of a drug in shortage. Reports made 8through this system shall be referred to the Office of the 9Attorney General and the appropriate State's Attorney's office 10for further investigation and prosecution. 11 (g) The Department shall adopt rules to carry out the 12provisions of this Section. 13 (h) Nothing in this Section prohibits one hospital 14pharmacy from purchasing or receiving a drug in shortage from 15another hospital pharmacy in the event of a medical emergency. 16(Source: P.A. 98-355, eff. 8-16-13.) 17 (225 ILCS 120/3 rep.) 18 Section 15. The Wholesale Drug Distribution Licensing Act 19is amended by repealing Section 3. 20 Section 99. Effective date. This Section and Section 5 21take effect upon becoming law. HB4664- 36 -LRB102 24218 AMQ 33447 b 1 INDEX 2 Statutes amended in order of appearance 3 5 ILCS 80/4.33 4 5 ILCS 80/4.38 5 225 ILCS 120/15from Ch. 111, par. 8301-15 6 225 ILCS 120/15.5 new 7 225 ILCS 120/21 new 8 225 ILCS 120/27 9 225 ILCS 120/30from Ch. 111, par. 8301-30 10 225 ILCS 120/31 new 11 225 ILCS 120/35from Ch. 111, par. 8301-35 12 225 ILCS 120/40from Ch. 111, par. 8301-40 13 225 ILCS 120/50from Ch. 111, par. 8301-50 14 225 ILCS 120/57 15 225 ILCS 120/70from Ch. 111, par. 8301-70 16 225 ILCS 120/75from Ch. 111, par. 8301-75 17 225 ILCS 120/80from Ch. 111, par. 8301-80 18 225 ILCS 120/85from Ch. 111, par. 8301-85 19 225 ILCS 120/100from Ch. 111, par. 8301-100 20 225 ILCS 120/105from Ch. 111, par. 8301-105 21 225 ILCS 120/110from Ch. 111, par. 8301-110 22 225 ILCS 120/115from Ch. 111, par. 8301-115 23 225 ILCS 120/120from Ch. 111, par. 8301-120 24 225 ILCS 120/125from Ch. 111, par. 8301-125 25 225 ILCS 120/135from Ch. 111, par. 8301-135 HB4664- 37 -LRB102 24218 AMQ 33447 b

HB4664 EngrossedLRB102 24218 AMQ 33447 b 1 AN ACT concerning regulation. 2 Be it enacted by the People of the State of Illinois, 3represented in the General Assembly: 4 Section 5. The Regulatory Sunset Act is amended by 5changing Sections 4.33 and 4.38 as follows: 6 (5 ILCS 80/4.33) 7 Sec. 4.33. Acts repealed on January 1, 2023. The following 8Acts are repealed on January 1, 2023: 9 The Dietitian Nutritionist Practice Act. 10 The Elevator Safety and Regulation Act. 11 The Fire Equipment Distributor and Employee Regulation Act 12of 2011. 13 The Funeral Directors and Embalmers Licensing Code. 14 The Naprapathic Practice Act. 15 The Pharmacy Practice Act. 16 The Professional Counselor and Clinical Professional 17Counselor Licensing and Practice Act. 18 The Wholesale Drug Distribution Licensing Act. 19(Source: P.A. 101-621, eff. 12-20-19.) 20 (5 ILCS 80/4.38) 21 Sec. 4.38. Acts repealed on January 1, 2028. The following 22Acts are repealed on January 1, 2028: HB4664 Engrossed- 2 -LRB102 24218 AMQ 33447 b 1 The Acupuncture Practice Act. 2 The Clinical Social Work and Social Work Practice Act. 3 The Home Medical Equipment and Services Provider License 4Act. 5 The Illinois Petroleum Education and Marketing Act. 6 The Illinois Speech-Language Pathology and Audiology 7Practice Act. 8 The Interpreter for the Deaf Licensure Act of 2007. 9 The Nurse Practice Act. 10 The Nursing Home Administrators Licensing and Disciplinary 11Act. 12 The Physician Assistant Practice Act of 1987. 13 The Podiatric Medical Practice Act of 1987. 14 The Wholesale Drug Distribution Licensing Act. 15(Source: P.A. 100-220, eff. 8-18-17; 100-375, eff. 8-25-17; 16100-398, eff. 8-25-17; 100-414, eff. 8-25-17; 100-453, eff. 178-25-17; 100-513, eff. 9-20-17; 100-525, eff. 9-22-17; 18100-530, eff. 9-22-17; 100-560, eff. 12-8-17.) 19 Section 10. The Wholesale Drug Distribution Licensing Act 20is amended by changing Sections 15, 27, 30, 35, 40, 50, 57, 70, 2175, 80, 85, 100, 105, 110, 115, 120, 125, 135, 140, 155, 165, 22and 200 and by adding Sections 15.5, 21, and 31 as follows: 23 (225 ILCS 120/15) (from Ch. 111, par. 8301-15) 24 (Section scheduled to be repealed on January 1, 2023) HB4664 Engrossed- 3 -LRB102 24218 AMQ 33447 b 1 Sec. 15. Definitions. As used in this Act: 2 "Address of record" means the designated address recorded 3by the Department in the applicant's application file or 4licensee's license file maintained by the Department's 5licensure maintenance unit. 6 "Authentication" means the affirmative verification, 7before any wholesale distribution of a prescription drug 8occurs, that each transaction listed on the pedigree has 9occurred. 10 "Authorized distributor of record" means a wholesale 11distributor with whom a manufacturer has established an 12ongoing relationship to distribute the manufacturer's 13prescription drug. An ongoing relationship is deemed to exist 14between a wholesale distributor and a manufacturer when the 15wholesale distributor, including any affiliated group of the 16wholesale distributor, as defined in Section 1504 of the 17Internal Revenue Code, complies with the following: 18 (1) The wholesale distributor has a written agreement 19 currently in effect with the manufacturer evidencing the 20 ongoing relationship; and 21 (2) The wholesale distributor is listed on the 22 manufacturer's current list of authorized distributors of 23 record, which is updated by the manufacturer on no less 24 than a monthly basis. 25 "Blood" means whole blood collected from a single donor 26and processed either for transfusion or further manufacturing. HB4664 Engrossed- 4 -LRB102 24218 AMQ 33447 b 1 "Blood component" means that part of blood separated by 2physical or mechanical means. 3 "Board" means the State Board of Pharmacy of the 4Department of Professional Regulation. 5 "Chain pharmacy warehouse" means a physical location for 6prescription drugs that acts as a central warehouse and 7performs intracompany sales or transfers of the drugs to a 8group of chain or mail order pharmacies that have the same 9common ownership and control. Notwithstanding any other 10provision of this Act, a chain pharmacy warehouse shall be 11considered part of the normal distribution channel. 12 "Co-licensed partner or product" means an instance where 13one or more parties have the right to engage in the 14manufacturing or marketing of a prescription drug, consistent 15with the FDA's implementation of the Prescription Drug 16Marketing Act. 17 "Department" means the Department of Financial and 18Professional Regulation. 19 "Drop shipment" means the sale of a prescription drug to a 20wholesale distributor by the manufacturer of the prescription 21drug or that manufacturer's co-licensed product partner, that 22manufacturer's third-party third party logistics provider, or 23that manufacturer's exclusive distributor or by an authorized 24distributor of record that purchased the product directly from 25the manufacturer or one of these entities whereby the 26wholesale distributor or chain pharmacy warehouse takes title HB4664 Engrossed- 5 -LRB102 24218 AMQ 33447 b 1but not physical possession of such prescription drug and the 2wholesale distributor invoices the pharmacy, chain pharmacy 3warehouse, or other person authorized by law to dispense or 4administer such drug to a patient and the pharmacy, chain 5pharmacy warehouse, or other authorized person receives 6delivery of the prescription drug directly from the 7manufacturer, that manufacturer's third-party third party 8logistics provider, or that manufacturer's exclusive 9distributor or from an authorized distributor of record that 10purchased the product directly from the manufacturer or one of 11these entities. 12 "Drug sample" means a unit of a prescription drug that is 13not intended to be sold and is intended to promote the sale of 14the drug. 15 "Email address of record" means the designated email 16address recorded by the Department in the applicant's 17application file or the licensee's license file, as maintained 18by the Department's licensure maintenance unit. 19 "Facility" means a facility of a wholesale distributor 20where prescription drugs are stored, handled, repackaged, or 21offered for sale, or a facility of a third-party logistics 22provider where prescription drugs are stored or handled. 23 "FDA" means the United States Food and Drug 24Administration. 25 "Manufacturer" means a person licensed or approved by the 26FDA to engage in the manufacture of drugs or devices, HB4664 Engrossed- 6 -LRB102 24218 AMQ 33447 b 1consistent with the definition of "manufacturer" set forth in 2the FDA's regulations and guidances implementing the 3Prescription Drug Marketing Act. "Manufacturer" does not 4include anyone who is engaged in the packaging, repackaging, 5or labeling of drugs only to the extent permitted under the 6Illinois Drug Reuse Opportunity Program Act. 7 "Manufacturer's exclusive distributor" means anyone who 8contracts with a manufacturer to provide or coordinate 9warehousing, distribution, or other services on behalf of a 10manufacturer and who takes title to that manufacturer's 11prescription drug, but who does not have general 12responsibility to direct the sale or disposition of the 13manufacturer's prescription drug. A manufacturer's exclusive 14distributor must be licensed as a wholesale distributor under 15this Act and, in order to be considered part of the normal 16distribution channel, must also be an authorized distributor 17of record. 18 "Normal distribution channel" means a chain of custody for 19a prescription drug that goes, directly or by drop shipment, 20from (i) a manufacturer of the prescription drug, (ii) that 21manufacturer to that manufacturer's co-licensed partner, (iii) 22that manufacturer to that manufacturer's third-party third 23party logistics provider, or (iv) that manufacturer to that 24manufacturer's exclusive distributor to: 25 (1) a pharmacy or to other designated persons 26 authorized by law to dispense or administer the drug to a HB4664 Engrossed- 7 -LRB102 24218 AMQ 33447 b 1 patient; 2 (2) a wholesale distributor to a pharmacy or other 3 designated persons authorized by law to dispense or 4 administer the drug to a patient; 5 (3) a wholesale distributor to a chain pharmacy 6 warehouse to that chain pharmacy warehouse's intracompany 7 pharmacy to a patient or other designated persons 8 authorized by law to dispense or administer the drug to a 9 patient; 10 (4) a chain pharmacy warehouse to the chain pharmacy 11 warehouse's intracompany pharmacy or other designated 12 persons authorized by law to dispense or administer the 13 drug to the patient; 14 (5) an authorized distributor of record to one other 15 authorized distributor of record to an office-based health 16 care practitioner authorized by law to dispense or 17 administer the drug to the patient; or 18 (6) an authorized distributor to a pharmacy or other 19 persons licensed to dispense or administer the drug. 20 "Pedigree" means a document or electronic file containing 21information that records each wholesale distribution of any 22given prescription drug from the point of origin to the final 23wholesale distribution point of any given prescription drug. 24 "Person" means and includes a natural person, partnership, 25association, corporation, or any other legal business entity. 26 "Pharmacy distributor" means any pharmacy licensed in this HB4664 Engrossed- 8 -LRB102 24218 AMQ 33447 b 1State or hospital pharmacy that is engaged in the delivery or 2distribution of prescription drugs either to any other 3pharmacy licensed in this State or to any other person or 4entity including, but not limited to, a wholesale drug 5distributor engaged in the delivery or distribution of 6prescription drugs who is involved in the actual, 7constructive, or attempted transfer of a drug in this State to 8other than the ultimate consumer except as otherwise provided 9for by law. 10 "Prescription drug" means any human drug, including any 11biological product (except for blood and blood components 12intended for transfusion or biological products that are also 13medical devices), required by federal law or regulation to be 14dispensed only by a prescription, including finished dosage 15forms and bulk drug substances subject to Section 503 of the 16Federal Food, Drug and Cosmetic Act. 17 "Repackage" means repackaging or otherwise changing the 18container, wrapper, or labeling to further the distribution of 19a prescription drug, excluding that completed by the 20pharmacist responsible for dispensing the product to a 21patient. 22 "Secretary" means the Secretary of the Department of 23Financial and Professional Regulation. 24 "Suspicious order" includes, but is not limited to, an 25order of a controlled substance of unusual size, an order of a 26controlled substance deviating substantially from a normal HB4664 Engrossed- 9 -LRB102 24218 AMQ 33447 b 1pattern, and orders of controlled substances of unusual 2frequency as defined by 21 USC 802. 3 "Third-party logistics provider" means anyone who 4contracts with a prescription drug manufacturer to provide or 5coordinate warehousing, distribution, or other services on 6behalf of a manufacturer, but does not take title to the 7prescription drug or have general responsibility to direct the 8prescription drug's sale or disposition. 9 "Wholesale distribution" means the distribution of 10prescription drugs to persons other than a consumer or 11patient, but does not include any of the following: 12 (1) Intracompany sales of prescription drugs, meaning 13 (i) any transaction or transfer between any division, 14 subsidiary, parent, or affiliated or related company under 15 the common ownership and control of a corporate entity or 16 (ii) any transaction or transfer between co-licensees of a 17 co-licensed product. 18 (2) The sale, purchase, distribution, trade, or 19 transfer of a prescription drug or offer to sell, 20 purchase, distribute, trade, or transfer a prescription 21 drug for emergency medical reasons. 22 (3) The distribution of prescription drug samples by 23 manufacturers' representatives. 24 (4) Drug returns, when conducted by a hospital, health 25 care entity, or charitable institution in accordance with 26 federal regulation. HB4664 Engrossed- 10 -LRB102 24218 AMQ 33447 b 1 (5) The sale of minimal quantities of prescription 2 drugs by licensed pharmacies to licensed practitioners for 3 office use or other licensed pharmacies. 4 (6) The sale, purchase, or trade of a drug, an offer to 5 sell, purchase, or trade a drug, or the dispensing of a 6 drug pursuant to a prescription. 7 (7) The sale, transfer, merger, or consolidation of 8 all or part of the business of a pharmacy or pharmacies 9 from or with another pharmacy or pharmacies, whether 10 accomplished as a purchase and sale of stock or business 11 assets. 12 (8) The sale, purchase, distribution, trade, or 13 transfer of a prescription drug from one authorized 14 distributor of record to one additional authorized 15 distributor of record when the manufacturer has stated in 16 writing to the receiving authorized distributor of record 17 that the manufacturer is unable to supply the prescription 18 drug and the supplying authorized distributor of record 19 states in writing that the prescription drug being 20 supplied had until that time been exclusively in the 21 normal distribution channel. 22 (9) The delivery of or the offer to deliver a 23 prescription drug by a common carrier solely in the common 24 carrier's usual course of business of transporting 25 prescription drugs when the common carrier does not store, 26 warehouse, or take legal ownership of the prescription HB4664 Engrossed- 11 -LRB102 24218 AMQ 33447 b 1 drug. 2 (10) The sale or transfer from a retail pharmacy, mail 3 order pharmacy, or chain pharmacy warehouse of expired, 4 damaged, returned, or recalled prescription drugs to the 5 original manufacturer, the originating wholesale 6 distributor, or a third party returns processor. 7 (11) The donation of drugs to the extent permitted 8 under the Illinois Drug Reuse Opportunity Program Act. 9 "Wholesale drug distributor" means anyone engaged in the 10wholesale distribution of prescription drugs into, out of, or 11within the State, including without limitation manufacturers; 12repackers; own label distributors; jobbers; private label 13distributors; brokers; warehouses, including manufacturers' 14and distributors' warehouses; manufacturer's exclusive 15distributors; and authorized distributors of record; drug 16wholesalers or distributors; independent wholesale drug 17traders; specialty wholesale distributors; and retail 18pharmacies that conduct wholesale distribution; and chain 19pharmacy warehouses that conduct wholesale distribution. In 20order to be considered part of the normal distribution 21channel, a wholesale distributor must also be an authorized 22distributor of record. 23(Source: P.A. 101-420, eff. 8-16-19; 102-389, eff. 1-1-22.) 24 (225 ILCS 120/15.5 new) 25 Sec. 15.5. Address of record; email address of record. All HB4664 Engrossed- 12 -LRB102 24218 AMQ 33447 b 1applicants and licensees shall: 2 (1) provide a valid address and email address to the 3 Department, which shall serve as the address of record and 4 email address of record, respectively, at the time of 5 application for licensure or renewal of a license; and 6 (2) inform the Department of any change of address of 7 record or email address of record within 14 days after 8 such change either through the Department's website or by 9 contacting the Department's licensure maintenance unit. 10 (225 ILCS 120/21 new) 11 Sec. 21. Reports to Department. Each licensee that is 12required to report suspicious orders under 21 USC 832 shall 13also submit such suspicions order reports to the Department. 14 (225 ILCS 120/27) 15 (Section scheduled to be repealed on January 1, 2023) 16 Sec. 27. Social security number, individual taxpayer 17identification number, or unique identifying number Security 18Number on license application. In addition to any other 19information required to be contained in the application, every 20application for an original license under this Act shall 21include the applicant's social security number, individual 22taxpayer identification number, or other unique identifying 23number deemed appropriate by the Department, Social Security 24Number, which shall be retained in the agency's records HB4664 Engrossed- 13 -LRB102 24218 AMQ 33447 b 1pertaining to the license. As soon as practical, the 2Department shall assign a customer's identification number to 3each applicant for a license. 4 Every application for a renewal or restored license shall 5require the applicant's customer identification number. 6(Source: P.A. 97-400, eff. 1-1-12.) 7 (225 ILCS 120/30) (from Ch. 111, par. 8301-30) 8 (Section scheduled to be repealed on January 1, 2023) 9 Sec. 30. License applications; renewal renewal application 10procedures. An application for an original license or renewal 11shall be made to the Department in writing or electronically 12on forms prescribed by the Department and shall be accompanied 13by the required fee, which shall not be refundable. Any such 14application shall require such information as in the judgment 15of the Department will enable the Board and Department to pass 16on the qualifications of the applicant for a license. 17Application for renewal of any license required by this Act 18shall be mailed or emailed to each licensee at least 60 days 19before the license expires. If the application for renewal 20with the required fee is not received by the Department before 21the expiration date, the existing license shall lapse and 22become null and void. Failure to renew before the expiration 23date is cause for a late payment penalty, discipline, or both. 24(Source: P.A. 101-420, eff. 8-16-19.) HB4664 Engrossed- 14 -LRB102 24218 AMQ 33447 b 1 (225 ILCS 120/31 new) 2 Sec. 31. Expiration of license; renewal. 3 (a) The expiration date and renewal period for each 4license issued under this Act shall be set by rule. 5 (b) Any licensee who shall engage in the practice for 6which the license was issued while the license is expired or on 7inactive status shall be considered to be practicing without a 8license which shall be grounds for discipline under this Act. 9 (c) A wholesale drug distributor or third-party logistics 10provider whose license has been expired for one year or more 11may not have its license restored but must apply for a new 12license and meet all requirements for licensure. Any wholesale 13drug distributor or third-party logistics provider whose 14license has been expired for less than one year may apply for 15restoration of its license and shall have its license 16restored. 17 (d) Anyone operating on an expired license is engaged in 18unlawful practice and subject to discipline under this Act. 19 (225 ILCS 120/35) (from Ch. 111, par. 8301-35) 20 (Section scheduled to be repealed on January 1, 2023) 21 Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund. 22 (a) The Department shall provide by rule for a schedule of 23fees for the administration and enforcement of this Act, 24including but not limited to original licensure, renewal, and 25restoration. The fees shall be nonrefundable. HB4664 Engrossed- 15 -LRB102 24218 AMQ 33447 b 1 (b) All fees collected under this Act shall be deposited 2into the Illinois State Pharmacy Disciplinary Fund and shall 3be appropriated to the Department for the ordinary and 4contingent expenses of the Department in the administration of 5this Act. Moneys in the Fund may be transferred to the 6Professions Indirect Cost Fund as authorized by Section 72105-300 of the Department of Financial and Professional 8Regulation Law (20 ILCS 2105/2105-300). 9 The moneys deposited into the Illinois State Pharmacy 10Disciplinary Fund shall be invested to earn interest which 11shall accrue to the Fund. 12 The Department shall present to the Board for its review 13and comment all appropriation requests from the Illinois State 14Pharmacy Disciplinary Fund. The Department shall give due 15consideration to any comments of the Board in making 16appropriation requests. 17 (c) Any person who delivers a check or other payment to the 18Department that is returned to the Department unpaid by the 19financial institution upon which it is drawn shall pay to the 20Department, in addition to the amount already owed to the 21Department, a fine of $50. The fines imposed by this Section 22are in addition to any other discipline provided under this 23Act for unlicensed practice or practice on a nonrenewed 24license. The Department shall notify the person that payment 25of fees and fines shall be paid to the Department by certified 26check or money order within 30 calendar days of the HB4664 Engrossed- 16 -LRB102 24218 AMQ 33447 b 1notification. If, after the expiration of 30 days from the 2date of the notification, the person has failed to submit the 3necessary remittance, the Department shall automatically 4terminate the license or certificate or deny the application, 5without hearing. If, after termination or denial, the person 6seeks a license or certificate, he or she shall apply to the 7Department for restoration or issuance of the license or 8certificate and pay all fees and fines due to the Department. 9The Department may establish a fee for the processing of an 10application for restoration of a license or certificate to pay 11all expenses of processing this application. The Secretary 12Director may waive the fines due under this Section in 13individual cases where the Secretary Director finds that the 14fines would be unreasonable or unnecessarily burdensome. 15 (d) (Blank). The Department shall maintain a roster of the 16names and addresses of all registrants and of all persons 17whose licenses have been suspended or revoked. This roster 18shall be available upon written request and payment of the 19required fee. 20 (e) A manufacturer of controlled substances, wholesale 21distributor of controlled substances, or third-party logistics 22provider that is licensed under this Act and owned and 23operated by the State is exempt from licensure, registration, 24renewal, and other fees required under this Act. Nothing in 25this subsection (e) shall be construed to prohibit the 26Department from imposing any fine or other penalty allowed HB4664 Engrossed- 17 -LRB102 24218 AMQ 33447 b 1under this Act. 2(Source: P.A. 101-420, eff. 8-16-19.) 3 (225 ILCS 120/40) (from Ch. 111, par. 8301-40) 4 (Section scheduled to be repealed on January 1, 2023) 5 Sec. 40. Rules and regulations. The Department shall make 6any rules and regulations, not inconsistent with law, as may 7be necessary to carry out the purposes and enforce the 8provisions of this Act. Rules and regulations that incorporate 9and set detailed standards for meeting each of the license 10prerequisites set forth in Section 25 of this Act shall be 11adopted no later than September 14, 1992. All rules and 12regulations promulgated under this Section shall conform to 13wholesale drug distributor licensing guidelines formally 14adopted by the FDA at 21 C.F.R. Part 205. In case of conflict 15between any rule or regulation adopted by the Department and 16any FDA wholesale drug distributor or third-party logistics 17provider guideline, the FDA guideline shall control. 18(Source: P.A. 101-420, eff. 8-16-19.) 19 (225 ILCS 120/50) (from Ch. 111, par. 8301-50) 20 (Section scheduled to be repealed on January 1, 2023) 21 Sec. 50. Inspection powers; access to records. 22 (a) Any pharmacy investigator authorized by the Department 23has the right of entry for inspection during normal business 24hours of premises purporting or appearing to be used by a HB4664 Engrossed- 18 -LRB102 24218 AMQ 33447 b 1wholesale drug distributor in this State, including the 2business premises of a person licensed pursuant to this Act. 3This right of entry shall permit the authorized pharmacy 4investigator unfettered access to the entire business 5premises. Any attempt to hinder an authorized pharmacy 6investigator from inspecting the business premises and 7documenting the inspection shall be a violation of this Act. 8The duly authorized investigators shall be required to show 9appropriate identification before being given access to a 10wholesale drug distributor's premises and delivery vehicles. 11 (b) With the exception of the most recent 12 months of 12records that must be kept on the premises where the drugs are 13stored, wholesale drug distributors may keep records regarding 14purchase and sales transactions electronically at a central 15location apart from the principal office of the wholesale drug 16distributor or the location at which the drugs were stored and 17from which they were shipped, provided that the records shall 18be made readily available for inspection within 2 working days 19of a request by the Department. The records may be kept in any 20form permissible under federal law applicable to prescription 21drugs record keeping. 22 (c) (Blank). 23(Source: P.A. 97-804, eff. 1-1-13.) 24 (225 ILCS 120/57) 25 (Section scheduled to be repealed on January 1, 2023) HB4664 Engrossed- 19 -LRB102 24218 AMQ 33447 b 1 Sec. 57. Pedigree. 2 (a) Each person who is engaged in the wholesale 3distribution of prescription drugs, including repackagers, but 4excluding the original manufacturer of the finished form of 5the prescription drug, that leave or have ever left the normal 6distribution channel shall, before each wholesale distribution 7of the drug, provide a pedigree to the person who receives the 8drug. A retail pharmacy, mail order pharmacy, or chain 9pharmacy warehouse must comply with the requirements of this 10Section only if the pharmacy or chain pharmacy warehouse 11engages in the wholesale distribution of prescription drugs. 12On or before July 1, 2009, the Department shall determine a 13targeted implementation date for electronic track and trace 14pedigree technology. This targeted implementation date shall 15not be sooner than July 1, 2010. Beginning on the date 16established by the Department, pedigrees may be implemented 17through an approved and readily available system that 18electronically tracks and traces the wholesale distribution of 19each prescription drug starting with the sale by the 20manufacturer through acquisition and sale by any wholesale 21distributor and until final sale to a pharmacy or other 22authorized person administering or dispensing the prescription 23drug. This electronic tracking system shall be deemed to be 24readily available only upon there being available a 25standardized system originating with the manufacturers and 26capable of being used on a wide scale across the entire HB4664 Engrossed- 20 -LRB102 24218 AMQ 33447 b 1pharmaceutical chain, including manufacturers, wholesale 2distributors, third-party logistics providers, and pharmacies. 3Consideration must also be given to the large-scale 4implementation of this technology across the supply chain and 5the technology must be proven to have no negative impact on the 6safety and efficacy of the pharmaceutical product. 7 (b) Each person who is engaged in the wholesale 8distribution of a prescription drug who is provided a pedigree 9for a prescription drug and attempts to further distribute 10that prescription drug, including repackagers, but excluding 11the original manufacturer of the finished form of the 12prescription drug, must affirmatively verify before any 13distribution of a prescription drug occurs that each 14transaction listed on the pedigree has occurred. 15 (c) The pedigree must include all necessary identifying 16information concerning each sale in the chain of distribution 17of the product from the manufacturer or the manufacturer's 18third-party third party logistics provider, co-licensed 19product partner, or exclusive distributor through acquisition 20and sale by any wholesale distributor or repackager, until 21final sale to a pharmacy or other person dispensing or 22administering the drug. This necessary chain of distribution 23information shall include, without limitation all of the 24following: 25 (1) The name, address, telephone number and, if 26 available, the e-mail address of each owner of the HB4664 Engrossed- 21 -LRB102 24218 AMQ 33447 b 1 prescription drug and each wholesale distributor of the 2 prescription drug. 3 (2) The name and address of each location from which 4 the product was shipped, if different from the owner's. 5 (3) Transaction dates. 6 (4) Certification that each recipient has 7 authenticated the pedigree. 8 (d) The pedigree must also include without limitation all 9of the following information concerning the prescription drug: 10 (1) The name and national drug code number of the 11 prescription drug. 12 (2) The dosage form and strength of the prescription 13 drug. 14 (3) The size of the container. 15 (4) The number of containers. 16 (5) The lot number of the prescription drug. 17 (6) The name of the manufacturer of the finished 18 dosage form. 19 (e) Each pedigree or electronic file shall be maintained 20by the purchaser and the wholesale distributor for at least 3 21years from the date of sale or transfer and made available for 22inspection or use within 5 business days upon a request of the 23Department. 24(Source: P.A. 101-420, eff. 8-16-19.) 25 (225 ILCS 120/70) (from Ch. 111, par. 8301-70) HB4664 Engrossed- 22 -LRB102 24218 AMQ 33447 b 1 (Section scheduled to be repealed on January 1, 2023) 2 Sec. 70. Immediate suspension of license or registration; 3hearing. The Secretary Director may, upon receipt of a 4written communication from the Secretary of Human Services or 5the Director of Public Health that continuation of practice of 6a person licensed or registered under this Act constitutes an 7immediate danger to the public, immediately suspend the 8license or registration of that person without a hearing. In 9instances in which the Secretary Director immediately suspends 10a license or registration under this Section, a hearing upon 11the person's license must be convened by the Board within 15 12days after the suspension and completed without appreciable 13delay. The hearing shall be held to determine whether to 14recommend to the Secretary Director that the person's license 15be revoked, suspended, placed on probationary status, or 16reinstated, or that the person be subject to other 17disciplinary action. In the hearing, the written communication 18and any other evidence submitted with the communication may be 19introduced as evidence against the person. The person or his 20or her counsel shall have the opportunity to discredit or 21impeach such evidence and submit rebuttal evidence. 22(Source: P.A. 89-507, eff. 7-1-97.) 23 (225 ILCS 120/75) (from Ch. 111, par. 8301-75) 24 (Section scheduled to be repealed on January 1, 2023) 25 Sec. 75. Automatic suspension. The determination by a HB4664 Engrossed- 23 -LRB102 24218 AMQ 33447 b 1circuit court that a licensee is subject to involuntary 2admission or judicial admission as provided in the Mental 3Health and Developmental Disabilities Code operates as an 4automatic suspension. The suspension shall end only upon (i) a 5finding by a court that the patient is no longer subject to 6involuntary admission or judicial admission and the issuance 7of an order so finding and discharging the patient and (ii) the 8recommendation of the Board to the Secretary Director that the 9licensee be allowed to resume his or her practice. 10(Source: P.A. 91-357, eff. 7-29-99.) 11 (225 ILCS 120/80) (from Ch. 111, par. 8301-80) 12 (Section scheduled to be repealed on January 1, 2023) 13 Sec. 80. Violations of Act. 14 (a) If any person violates the provisions of this Act, the 15Secretary Director may, in the name of the People of the State 16of Illinois through the Attorney General of the State of 17Illinois or the State's Attorney of any county in which the 18action is brought, petition for an order enjoining the 19violation or for an order enforcing compliance with this Act. 20Upon the filing of a verified petition in the court, the court 21may issue a temporary restraining order, without notice or 22bond, and may preliminarily and permanently enjoin the 23violation. If it is established that the person has violated 24or is violating the injunction, the Court may punish the 25offender for contempt of court. Proceedings under this Section HB4664 Engrossed- 24 -LRB102 24218 AMQ 33447 b 1shall be in addition to, and not in lieu of, all other remedies 2and penalties provided by this Act. 3 (b) Whoever knowingly conducts business as a wholesale 4drug distributor or third-party logistics provider in this 5State without being appropriately licensed under this Act 6shall be guilty of a Class A misdemeanor for a first violation 7and for each subsequent conviction shall be guilty of a Class 4 8felony. 9 (c) Whenever in the opinion of the Department any person 10not licensed in good standing under this Act violates any 11provision of this Act, the Department may issue a rule to show 12cause why an order to cease and desist should not be entered 13against him. The rule shall clearly set forth the grounds 14relied upon by the Department and shall provide a period of 7 15days from the date of the rule to file an answer to the 16satisfaction of the Department. Failure to answer to the 17satisfaction of the Department shall cause an order to cease 18and desist to be issued immediately. 19(Source: P.A. 101-420, eff. 8-16-19.) 20 (225 ILCS 120/85) (from Ch. 111, par. 8301-85) 21 (Section scheduled to be repealed on January 1, 2023) 22 Sec. 85. Investigations; notice of disciplinary hearing. 23The Department may investigate the actions of any applicant or 24of any person or persons holding or claiming to hold a license 25or registration. Before suspending, revoking, placing on HB4664 Engrossed- 25 -LRB102 24218 AMQ 33447 b 1probationary status, or taking any other disciplinary action 2as the Department may deem proper with regard to any license or 3certificate, at least 30 days before the date set for the 4hearing, the Department shall (i) notify the accused in 5writing of any charges made and the time and place for a 6hearing of the charges before the Board, (ii) direct him or her 7to file a written answer to the charges with the Board under 8oath within 20 days after the service of the notice, and (iii) 9inform the accused that if he or she fails to file an answer 10default will be taken against him or her and his or her license 11or certificate may be suspended, revoked, placed on 12probationary status, or have other disciplinary action, 13including limiting the scope, nature or extent of business, as 14provided for in this Act. The written notice may be served by 15personal delivery, email to the respondent's email address of 16record, or mail to the respondent's address of record or 17certified or registered mail to the respondent at the address 18of last notification to the Department. At the time and place 19fixed in the notice, the Board shall proceed to hear the 20charges and the parties or their counsel shall be accorded 21ample opportunity to present any statements, testimony, 22evidence and argument that may be pertinent to the charges or 23to their defense. The hearing may be continued from time to 24time. In case the accused person, after receiving notice, 25fails to file an answer, his or her license or certificate may 26in the discretion of the Secretary Director, having received HB4664 Engrossed- 26 -LRB102 24218 AMQ 33447 b 1first the recommendation of the Board, be suspended, revoked, 2placed on probationary status, or the Secretary Director may 3take whatever disciplinary action as he or she may deem proper 4as provided in this Act, including limiting the scope, nature, 5or extent of the person's practice, without a hearing, if the 6act or acts charged constitute sufficient grounds for such 7action under this Act. 8(Source: P.A. 87-594.) 9 (225 ILCS 120/100) (from Ch. 111, par. 8301-100) 10 (Section scheduled to be repealed on January 1, 2023) 11 Sec. 100. Subpoena power; administration of oaths. The 12Department shall have power to subpoena and bring before it 13any person in this State and to take testimony, either orally 14or by deposition or both, with the same fees and mileage and in 15the same manner as prescribed by law in judicial proceedings 16in civil cases in circuit courts of this State. The Department 17may subpoena and compel the production of documents, papers, 18files, books, and records in connection with any hearing or 19investigation. 20 The Secretary, hearing officer, and Director and any 21member of the Board shall each have power to administer oaths 22to witnesses at any hearing which the Department is authorized 23to conduct under this Act, and any other oaths required or 24authorized to be administered by the Department under this 25Act. HB4664 Engrossed- 27 -LRB102 24218 AMQ 33447 b 1(Source: P.A. 87-594.) 2 (225 ILCS 120/105) (from Ch. 111, par. 8301-105) 3 (Section scheduled to be repealed on January 1, 2023) 4 Sec. 105. Report of findings and recommendation. At the 5conclusion of the hearing, the Board shall present to the 6Secretary Director a written report of its findings of fact, 7conclusions of law, and recommendations. The report shall 8contain a finding whether or not the accused person violated 9this Act or failed to comply with the conditions required in 10this Act. The Board shall specify the nature of the violation 11or failure to comply and shall make its recommendations to the 12Secretary Director. 13 The report of findings of fact, conclusion of law, and 14recommendations of the Board shall be the basis for the 15Department's order for refusal or for the granting of a 16license or registration. The finding is not admissible in 17evidence against the person in a criminal prosecution brought 18for the violation of this Act, but the hearing and finding are 19not a bar to a criminal prosecution brought for the violation 20of this Act. 21(Source: P.A. 87-594.) 22 (225 ILCS 120/110) (from Ch. 111, par. 8301-110) 23 (Section scheduled to be repealed on January 1, 2023) 24 Sec. 110. Hearing officers; appointment. Notwithstanding HB4664 Engrossed- 28 -LRB102 24218 AMQ 33447 b 1any other provision of this Act, the Secretary Director shall 2have the authority to appoint any attorney duly licensed to 3practice law in the State of Illinois to serve as the hearing 4officer in any action before the Board for refusal to issue or 5renew a license, or the discipline of a licensee. The Director 6shall notify the Board of any such appointment. The hearing 7officer shall have full authority to conduct the hearing. 8There shall be present at least one member of the Board at any 9such hearing. The hearing officer shall report his findings of 10fact, conclusions of law, and recommendations to the Board and 11the Secretary Director. The Board shall have 60 days from 12receipt of the report to review the report of the hearing 13officer and present its findings of fact, conclusions of law, 14and recommendations to the Secretary Director. If the Board 15fails to present its report within the 60 day period, the 16Secretary Director may issue an order based on report of the 17hearing officer and the record of the proceedings or issue an 18order remanding the matter back to the hearing officer for 19additional proceedings in accordance with the order. If the 20Secretary disagrees with the recommendation of the Board or 21the hearing officer, the Secretary may issue an order in 22contravention of the recommendation. However, if the Board 23does present its report within the specified 60 days, the 24Director's order shall be based upon the report of the Board. 25(Source: P.A. 87-594.) HB4664 Engrossed- 29 -LRB102 24218 AMQ 33447 b 1 (225 ILCS 120/115) (from Ch. 111, par. 8301-115) 2 (Section scheduled to be repealed on January 1, 2023) 3 Sec. 115. Motion for rehearing. In any case involving the 4refusal to issue, renew, or discipline of a license or 5registration, a copy of the Board's report shall be served 6upon the respondent by the Department, either personally or as 7provided in this Act for the service of the notice of hearing. 8Within 20 days after service, the respondent may present to 9the Department a motion in writing for a rehearing, which 10shall specify the particular grounds for rehearing. If no 11motion for rehearing is filed, then upon the expiration of the 12time specified for filing a motion, or if a motion for 13rehearing is denied, then upon denial the Secretary Director 14may enter an order in accordance with recommendations of the 15Board. If the respondent orders from the reporting service and 16pays for a transcript of the record within the time for filing 17a motion for rehearing, the 20-day 20 day period within which a 18motion may be filed shall commence upon the delivery of the 19transcript to the respondent. 20(Source: P.A. 87-594.) 21 (225 ILCS 120/120) (from Ch. 111, par. 8301-120) 22 (Section scheduled to be repealed on January 1, 2023) 23 Sec. 120. Rehearing by order of Secretary Director. 24Whenever the Secretary Director is satisfied that substantial 25justice has not been done in the revocation, suspension, or HB4664 Engrossed- 30 -LRB102 24218 AMQ 33447 b 1refusal to issue or renew a license or registration, the 2Secretary Director may order a rehearing by the same hearing 3office or Board. 4(Source: P.A. 87-594.) 5 (225 ILCS 120/125) (from Ch. 111, par. 8301-125) 6 (Section scheduled to be repealed on January 1, 2023) 7 Sec. 125. Duties of the Board Board recommendations to 8Director; disagreement. The Board shall exercise the rights, 9powers, and duties which have been vested in the Board under 10this Act, and any other duties conferred upon the Board by law. 11None of the disciplinary functions, powers, and duties 12enumerated in this Act shall be exercised by the Department 13except upon the action and report in writing of the Board, 14except as otherwise provided in this Act. 15 In all instances under this Act in which the Board has 16rendered a recommendation to the Director with respect to a 17particular license or certificate, the Director shall, in the 18event that he or she disagrees with or takes action contrary to 19the recommendation of the Board, file with the Board and 20Secretary of State his or her specific written reasons for 21disagreement with the Board. These reasons shall be filed 22within 30 days after the Director taking the contrary 23position. 24 The action and report in writing of a majority of the Board 25is sufficient authority upon which the Director may act. HB4664 Engrossed- 31 -LRB102 24218 AMQ 33447 b 1(Source: P.A. 87-594.) 2 (225 ILCS 120/135) (from Ch. 111, par. 8301-135) 3 (Section scheduled to be repealed on January 1, 2023) 4 Sec. 135. Disciplinary consent orders. Notwithstanding the 5provisions of this Act concerning the conduct of hearings and 6recommendations for disciplinary actions, the Secretary 7Director shall have the authority to negotiate agreements with 8licensees and registrants resulting in disciplinary consent 9orders. Consent orders may provide for any of the forms of 10discipline otherwise provided in this Act. Consent orders 11shall provide that they were not entered into a result of any 12coercion by the Department. The Director shall forward copies 13of all final consent orders to the Board within 30 days after 14their entry. 15(Source: P.A. 87-594.) 16 (225 ILCS 120/140) (from Ch. 111, par. 8301-140) 17 (Section scheduled to be repealed on January 1, 2023) 18 Sec. 140. Orders; prima facie proof. An order or a 19certified copy thereof, over the seal of the Department and 20purporting to be signed by the Secretary Director, shall be 21prima facie proof that: 22 (a) the signature is the genuine signature of the 23 Secretary Director; 24 (b) the Secretary Director is duly appointed and HB4664 Engrossed- 32 -LRB102 24218 AMQ 33447 b 1 qualified; and 2 (c) the Board and its members are qualified to act. 3(Source: P.A. 91-357, eff. 7-29-99.) 4 (225 ILCS 120/155) (from Ch. 111, par. 8301-155) 5 (Section scheduled to be repealed on January 1, 2023) 6 Sec. 155. Temporary suspension of license; hearing. The 7Secretary Director may temporarily suspend licensure as a 8wholesale drug distributor or third-party logistics provider, 9without a hearing, simultaneously with the institution of 10proceedings for a hearing provided for in Section 85 of this 11Act, if the Secretary Director finds that evidence in his or 12her possession indicates that a continuation in business would 13constitute an imminent danger to the public. In the event that 14the Secretary Director temporarily suspends a license or 15certificate without a hearing, a hearing by the Department 16must be held within 10 days after the suspension has occurred 17and be concluded without appreciable delay. 18(Source: P.A. 101-420, eff. 8-16-19.) 19 (225 ILCS 120/165) (from Ch. 111, par. 8301-165) 20 (Section scheduled to be repealed on January 1, 2023) 21 Sec. 165. Certification of record; receipt for costs. The 22Department shall not be required to certify any record to the 23court, to file an answer in court, or to otherwise appear in 24any court in a judicial review proceeding unless and until the HB4664 Engrossed- 33 -LRB102 24218 AMQ 33447 b 1Department has received from the plaintiff payment of the 2costs of furnishing and certifying the record, which costs 3shall be determined by the Department. Failure on the part of 4the plaintiff to file a receipt in court shall be grounds for 5dismissal of the action. During the pendency and hearing of 6any and all judicial proceedings incident to the disciplinary 7action, the sanctions imposed upon the accused by the 8Department because of acts or omissions related to the 9delivery of direct patient care as specified in the 10Department's final administrative decision, shall, as a matter 11of public policy, remain in full force and effect in order to 12protect the public pending final resolution of any of the 13proceedings. 14The Department shall not be required to certify any record to 15the court or file any answer in court or otherwise appear in 16any court in a judicial review proceeding, unless there is 17filed in the court, with the complaint, a receipt from the 18Department acknowledging payment of the costs of furnishing 19and certifying the record, which costs shall be computed at 20the rate of 25 cents per page of such record. Failure on the 21part of the plaintiff to file a receipt in court shall be 22grounds for dismissal of the action. 23(Source: P.A. 87-594.) 24 (225 ILCS 120/200) 25 (Section scheduled to be repealed on January 1, 2023) HB4664 Engrossed- 34 -LRB102 24218 AMQ 33447 b 1 Sec. 200. Drugs in shortage. 2 (a) For the purpose of this Section, "drug in shortage" 3means a drug, as defined in Section 356c of the Federal Food, 4Drug, and Cosmetic Act, listed on the drug shortage list 5maintained by the U.S. Food and Drug Administration in 6accordance with Section 356e of the Federal Food, Drug, and 7Cosmetic Act. 8 (b) Any person engaged in the wholesale distribution of a 9drug in shortage in this State must be licensed by the 10Department. 11 (c) It is unlawful for any person, other than a 12manufacturer, a manufacturer's exclusive distributor, a 13third-party third party logistics provider, or an authorized 14distributor of record, to purchase or receive a drug in 15shortage from any person not licensed by the Department. This 16subsection (c) does not apply to the return of drugs or the 17purchase or receipt of drugs pursuant to any of the 18distributions that are specifically excluded from the 19definition of "wholesale distribution" in Section 15 of the 20Wholesale Drug Distribution Licensing Act. 21 (d) A person found to have violated a provision of this 22Section shall be subject to administrative fines, orders for 23restitution, and orders for disgorgement. 24 (e) The Department shall create a centralized, searchable 25database of those entities licensed to engage in wholesale 26distribution, including manufacturers, wholesale HB4664 Engrossed- 35 -LRB102 24218 AMQ 33447 b 1distributors, and pharmacy distributors, to enable purchasers 2of a drug in shortage to easily verify the licensing status of 3an entity offering such drugs. 4 (f) The Department shall establish a system for reporting 5the reasonable suspicion that a violation of this Act has been 6committed by a distributor of a drug in shortage. Reports made 7through this system shall be referred to the Office of the 8Attorney General and the appropriate State's Attorney's office 9for further investigation and prosecution. 10 (g) The Department shall adopt rules to carry out the 11provisions of this Section. 12 (h) Nothing in this Section prohibits one hospital 13pharmacy from purchasing or receiving a drug in shortage from 14another hospital pharmacy in the event of a medical emergency. 15(Source: P.A. 98-355, eff. 8-16-13.) 16 (225 ILCS 120/3 rep.) 17 Section 15. The Wholesale Drug Distribution Licensing Act 18is amended by repealing Section 3. 19 Section 99. Effective date. This Section and Section 5 20take effect upon becoming law. HB4664 Engrossed- 36 -LRB102 24218 AMQ 33447 b 1 INDEX 2 Statutes amended in order of appearance 3 5 ILCS 80/4.33 4 5 ILCS 80/4.38 5 225 ILCS 120/15from Ch. 111, par. 8301-15 6 225 ILCS 120/15.5 new 7 225 ILCS 120/21 new 8 225 ILCS 120/27 9 225 ILCS 120/30from Ch. 111, par. 8301-30 10 225 ILCS 120/31 new 11 225 ILCS 120/35from Ch. 111, par. 8301-35 12 225 ILCS 120/40from Ch. 111, par. 8301-40 13 225 ILCS 120/50from Ch. 111, par. 8301-50 14 225 ILCS 120/57 15 225 ILCS 120/70from Ch. 111, par. 8301-70 16 225 ILCS 120/75from Ch. 111, par. 8301-75 17 225 ILCS 120/80from Ch. 111, par. 8301-80 18 225 ILCS 120/85from Ch. 111, par. 8301-85 19 225 ILCS 120/100from Ch. 111, par. 8301-100 20 225 ILCS 120/105from Ch. 111, par. 8301-105 21 225 ILCS 120/110from Ch. 111, par. 8301-110 22 225 ILCS 120/115from Ch. 111, par. 8301-115 23 225 ILCS 120/120from Ch. 111, par. 8301-120 24 225 ILCS 120/125from Ch. 111, par. 8301-125 25 225 ILCS 120/135from Ch. 111, par. 8301-135 HB4664 Engrossed- 37 -LRB102 24218 AMQ 33447 b