225 ILCS 120/ Wholesale Drug Distribution Licensing Act.

(225 ILCS 120/1) (from Ch. 111, par. 8301-1)

(Section scheduled to be repealed on January 1, 2028)

Sec. 1. Short title. This Act may be cited as the Wholesale Drug Distribution Licensing Act.

(Source: P.A. 87-594.)

(225 ILCS 120/3)

Sec. 3. (Repealed).

(Source: P.A. 95-689, eff. 10-29-07. Repealed by P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/5) (from Ch. 111, par. 8301-5)

(Section scheduled to be repealed on January 1, 2028)

Sec. 5. Scope. This Act applies to any person, partnership, corporation, or business firm engaging in the wholesale distribution of human prescription drugs within this State.

(Source: P.A. 87-594.)

(225 ILCS 120/10) (from Ch. 111, par. 8301-10)

(Section scheduled to be repealed on January 1, 2028)

Sec. 10. Purpose. The purpose of this Act is to implement the Federal Prescription Drug Marketing Act of 1987 (PDMA), U.S. Pub. L. 100-293, 102 Stat. 95, codified at U.S.C. Sec. 321 et seq.; and particularly PDMA requirements that no person or entity may engage in the wholesale distribution of human prescription drugs in any state unless the person or entity is licensed by that state in accordance with federally prescribed minimum standards, terms, and conditions as set forth in guidelines issued by United States Food and Drug Administration (FDA) regulations.

(Source: P.A. 87-594.)

(225 ILCS 120/15) (from Ch. 111, par. 8301-15)

(Section scheduled to be repealed on January 1, 2028)

Sec. 15. Definitions. As used in this Act:

"Address of record" means the designated address recorded by the Department in the applicant's application file or licensee's license file maintained by the Department's licensure maintenance unit.

"Authentication" means the affirmative verification, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree has occurred.

"Authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to exist between a wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with the following:

(1) The wholesale distributor has a written agreement currently in effect with the manufacturer evidencing the ongoing relationship; and

(2) The wholesale distributor is listed on the manufacturer's current list of authorized distributors of record, which is updated by the manufacturer on no less than a monthly basis.

"Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

"Blood component" means that part of blood separated by physical or mechanical means.

"Board" means the State Board of Pharmacy of the Department of Financial and Professional Regulation.

"Chain pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of the drugs to a group of chain or mail order pharmacies that have the same common ownership and control. Notwithstanding any other provision of this Act, a chain pharmacy warehouse shall be considered part of the normal distribution channel.

"Co-licensed partner or product" means an instance where one or more parties have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the FDA's implementation of the Prescription Drug Marketing Act.

"Department" means the Department of Financial and Professional Regulation.

"Drop shipment" means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug or that manufacturer's co-licensed product partner, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor or by an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities whereby the wholesale distributor or chain pharmacy warehouse takes title but not physical possession of such prescription drug and the wholesale distributor invoices the pharmacy, chain pharmacy warehouse, or other person authorized by law to dispense or administer such drug to a patient and the pharmacy, chain pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer, that manufacturer's third-party logistics provider, or that manufacturer's exclusive distributor or from an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities.

"Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

"Email address of record" means the designated email address recorded by the Department in the applicant's application file or the licensee's license file, as maintained by the Department's licensure maintenance unit.

"Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale, or a facility of a third-party logistics provider where prescription drugs are stored or handled.

"FDA" means the United States Food and Drug Administration.

"Manufacturer" means a person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" set forth in the FDA's regulations and guidances implementing the Prescription Drug Marketing Act. "Manufacturer" does not include anyone who is engaged in the packaging, repackaging, or labeling of drugs only to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.

"Manufacturer's exclusive distributor" means anyone who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug. A manufacturer's exclusive distributor must be licensed as a wholesale distributor under this Act and, in order to be considered part of the normal distribution channel, must also be an authorized distributor of record.

"Normal distribution channel" means a chain of custody for a prescription drug that goes, directly or by drop shipment, from (i) a manufacturer of the prescription drug, (ii) that manufacturer to that manufacturer's co-licensed partner, (iii) that manufacturer to that manufacturer's third-party logistics provider, or (iv) that manufacturer to that manufacturer's exclusive distributor to:

(1) a pharmacy or to other designated persons authorized by law to dispense or administer the drug to a patient;

(2) a wholesale distributor to a pharmacy or other designated persons authorized by law to dispense or administer the drug to a patient;

(3) a wholesale distributor to a chain pharmacy warehouse to that chain pharmacy warehouse's intracompany pharmacy to a patient or other designated persons authorized by law to dispense or administer the drug to a patient;

(4) a chain pharmacy warehouse to the chain pharmacy warehouse's intracompany pharmacy or other designated persons authorized by law to dispense or administer the drug to the patient;

(5) an authorized distributor of record to one other authorized distributor of record to an office-based health care practitioner authorized by law to dispense or administer the drug to the patient; or

(6) an authorized distributor to a pharmacy or other persons licensed to dispense or administer the drug.

"Pedigree" means a document or electronic file containing information that records each wholesale distribution of any given prescription drug from the point of origin to the final wholesale distribution point of any given prescription drug.

"Person" means and includes a natural person, partnership, association, corporation, or any other legal business entity.

"Pharmacy distributor" means any pharmacy licensed in this State or hospital pharmacy that is engaged in the delivery or distribution of prescription drugs either to any other pharmacy licensed in this State or to any other person or entity including, but not limited to, a wholesale drug distributor engaged in the delivery or distribution of prescription drugs who is involved in the actual, constructive, or attempted transfer of a drug in this State to other than the ultimate consumer except as otherwise provided for by law.

"Prescription drug" means any human drug, including any biological product (except for blood and blood components intended for transfusion or biological products that are also medical devices), required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to Section 503 of the Federal Food, Drug and Cosmetic Act.

"Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding that completed by the pharmacist responsible for dispensing the product to a patient.

"Secretary" means the Secretary of the Department of Financial and Professional Regulation.

"Suspicious order" includes, but is not limited to, an order of a controlled substance of unusual size, an order of a controlled substance deviating substantially from a normal pattern, and orders of controlled substances of unusual frequency as defined by 21 U.S.C. 802.

"Third-party logistics provider" means anyone who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition.

"Wholesale distribution" means the distribution of prescription drugs to persons other than a consumer or patient, but does not include any of the following:

(1) Intracompany sales of prescription drugs, meaning (i) any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity or (ii) any transaction or transfer between co-licensees of a co-licensed product.

(2) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.

(3) The distribution of prescription drug samples by manufacturers' representatives.

(4) Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with federal regulation.

(5) The sale of minimal quantities of prescription drugs by licensed pharmacies to licensed practitioners for office use or other licensed pharmacies.

(6) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

(7) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy or pharmacies from or with another pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets.

(8) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record when the manufacturer has stated in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the prescription drug and the supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel.

(9) The delivery of or the offer to deliver a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs when the common carrier does not store, warehouse, or take legal ownership of the prescription drug.

(10) The sale or transfer from a retail pharmacy, mail order pharmacy, or chain pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer, the originating wholesale distributor, or a third party returns processor.

(11) The donation of drugs to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.

"Wholesale drug distributor" means anyone engaged in the wholesale distribution of prescription drugs into, out of, or within the State, including, without limitation, manufacturers; repackers; own label distributors; jobbers; private label distributors; brokers; warehouses, including manufacturers' and distributors' warehouses; manufacturer's exclusive distributors; and authorized distributors of record; drug wholesalers or distributors; independent wholesale drug traders; specialty wholesale distributors; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution. In order to be considered part of the normal distribution channel, a wholesale distributor must also be an authorized distributor of record.

(Source: P.A. 102-389, eff. 1-1-22; 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)

(225 ILCS 120/15.5)

(Section scheduled to be repealed on January 1, 2028)

Sec. 15.5. Address of record; email address of record. All applicants and licensees shall:

(1) provide a valid address and email address to the Department, which shall serve as the address of record and email address of record, respectively, at the time of application for licensure or renewal of a license; and

(2) inform the Department of any change of address of record or email address of record within 14 days after such change either through the Department's website or by contacting the Department's licensure maintenance unit.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/20) (from Ch. 111, par. 8301-20)

(Section scheduled to be repealed on January 1, 2028)

Sec. 20. Prohibited drug purchases or receipt. It shall be unlawful for any person or entity located in this State to knowingly receive any prescription drug from any source other than a person or entity required by the laws of this State to be licensed to ship into, out of, or within this State. A person or entity licensed under the laws of this State shall include, but is not limited to, a wholesale distributor, manufacturer, third-party logistics provider, pharmacy distributor, or pharmacy. Any person violating this Section shall, upon conviction, be adjudged guilty of a Class C misdemeanor. A second violation shall constitute a Class 4 felony.

(Source: P.A. 101-420, eff. 8-16-19.)

(225 ILCS 120/21)

(Section scheduled to be repealed on January 1, 2028)

Sec. 21. Reports to Department. Each licensee that is required to report suspicious orders under 21 U.S.C. 832 shall also submit such suspicions order reports to the Department.

(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)

(225 ILCS 120/24)

Sec. 24. (Repealed).

(Source: P.A. 95-689, eff. 10-29-07. Repealed by P.A. 98-692, eff. 7-1-14.)

(225 ILCS 120/25) (from Ch. 111, par. 8301-25)

(Section scheduled to be repealed on January 1, 2028)

Sec. 25. Wholesale drug distributor licensing requirements.

(a) Every resident wholesale distributor who engages in the wholesale distribution of prescription drugs must be licensed by the Department, and every non-resident wholesale distributor must be licensed in this State if it ships prescription drugs into this State, in accordance with this Act, before engaging in wholesale distributions of wholesale prescription drugs.

(b) The Department shall require without limitation all of the following information from each applicant for licensure under this Act:

(1) The name, full business address, and telephone number of the licensee.

(2) All trade or business names used by the licensee.

(3) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs.

(4) The type of ownership or operation, such as a partnership, corporation, or sole proprietorship.

(5) The name of the owner or operator of the wholesale distributor, including:

(A) if a natural person, the name of the natural person;

(B) if a partnership, the name of each partner and the name of the partnership;

(C) if a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation; and

(D) if a sole proprietorship, the full name of the sole proprietor and the name of the business entity.

(6) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.

(7) The name of the designated representative for the wholesale distributor, together with the personal information statement and fingerprints, as required under subsection (c) of this Section.

(8) Minimum liability insurance and other insurance as defined by rule.

(9) Any additional information required by the Department.

(c) Each wholesale distributor must designate an individual representative who shall serve as the contact person for the Department. This representative must provide the Department with all of the following information:

(1) Information concerning whether the person has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or State law regulating the possession, control, or distribution of prescription drugs or criminal violations, together with details concerning any such event.

(2) A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund which manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which such businesses were named as a party.

(3) A description of any misdemeanor or felony criminal offense of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the Department a copy of the final written order of disposition.

(4) The designated representative of an applicant for licensure as a wholesale drug distributor shall have his or her fingerprints submitted to the Illinois State Police in an electronic format that complies with the form and manner for requesting and furnishing criminal history record information as prescribed by the Illinois State Police. These fingerprints shall be checked against the Illinois State Police and Federal Bureau of Investigation criminal history record databases now and hereafter filed. The Illinois State Police shall charge applicants a fee for conducting the criminal history records check, which shall be deposited into the State Police Services Fund and shall not exceed the actual cost of the records check. The Illinois State Police shall furnish, pursuant to positive identification, records of Illinois convictions to the Department. The Department may require applicants to pay a separate fingerprinting fee, either to the Department or to a vendor. The Department, in its discretion, may allow an applicant who does not have reasonable access to a designated vendor to provide his or her fingerprints in an alternative manner. The Department may adopt any rules necessary to implement this Section.

The designated representative of a licensee shall receive and complete continuing training in applicable federal and State laws governing the wholesale distribution of prescription drugs.

(d) The Department may not issue a wholesale distributor license to an applicant, unless the Department first:

(1) ensures that a physical inspection of the facility satisfactory to the Department has occurred at the address provided by the applicant, as required under item (1) of subsection (b) of this Section; and

(2) determines that the designated representative meets each of the following qualifications:

(A) He or she is at least 21 years of age.

(B) He or she has been employed full-time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs.

(C) He or she is employed by the applicant full time in a managerial level position.

(D) He or she is actively involved in and aware of the actual daily operation of the wholesale distributor.

(E) He or she is physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including without limitation sick leave and vacation leave.

(F) He or she is serving in the capacity of a designated representative for only one applicant at a time, except where more than one licensed wholesale distributor is co-located in the same facility and such wholesale distributors are members of an affiliated group, as defined in Section 1504 of the Internal Revenue Code.

(e) If a wholesale distributor distributes prescription drugs from more than one facility, the wholesale distributor shall obtain a license for each facility.

(f) The information provided under this Section may not be disclosed to any person or entity other than the Department or another government entity in need of such information for licensing or monitoring purposes.

(Source: P.A. 102-538, eff. 8-20-21.)

(225 ILCS 120/25.5)

(Section scheduled to be repealed on January 1, 2028)

Sec. 25.5. Third-party logistics providers.

(a) Each resident third-party logistics provider must be licensed by the Department, and every non-resident third-party logistics provider must be licensed in this State, in accordance with this Act, prior to shipping a prescription drug into this State.

(b) The Department shall require, without limitation, all of the following information from each applicant for licensure under this Act:

(1) The name, full business address, and telephone number of the licensee.

(2) All trade or business names used by the licensee.

(3) Addresses, telephone numbers, and the names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs.

(4) The type of ownership or operation, such as a partnership, corporation, or sole proprietorship.

(5) The name of the owner or operator of the third-party logistics provider, including:

(A) if a natural person, the name of the natural person;

(B) if a partnership, the name of each partner and the name of the partnership;

(C) if a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation; and

(D) if a sole proprietorship, the full name of the sole proprietor and the name of the business entity.

(6) A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs.

(7) The name of the designated representative for the third-party logistics provider, together with the personal information statement and fingerprints, as required under subsection (c) of this Section.

(8) Minimum liability insurance and other insurance as defined by rule.

(9) Any additional information required by the Department.

(c) Each third-party logistics provider must designate an individual representative who shall serve as the contact person for the Department. This representative must provide the Department with all of the following information:

(1) Information concerning whether the person has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or State law regulating the possession, control, or distribution of prescription drugs or criminal violations, together with details concerning any such event.

(2) A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, that manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which such businesses were named as a party.

(3) A description of any misdemeanor or felony criminal offense of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the Department a copy of the final written order of disposition.

(4) The designated representative of an applicant for licensure as a third-party logistics provider shall have his or her fingerprints submitted to the Department of State Police in an electronic format that complies with the form and manner for requesting and furnishing criminal history record information as prescribed by the Department of State Police. These fingerprints shall be checked against the Department of State Police and Federal Bureau of Investigation criminal history record databases now and hereafter filed. The Department of State Police shall charge applicants a fee for conducting the criminal history records check, which shall be deposited into the State Police Services Fund and shall not exceed the actual cost of the records check. The Department of State Police shall furnish, pursuant to positive identification, records of Illinois convictions to the Department. The Department may require applicants to pay a separate fingerprinting fee, either to the Department or to a vendor. The Department, in its discretion, may allow an applicant who does not have reasonable access to a designated vendor to provide his or her fingerprints in an alternative manner. The Department may adopt any rules necessary to implement this paragraph (4).

(d) A third-party logistics provider shall not operate from a place of residence.

(e) A third-party logistics provider facility shall be located apart and separate from any retail pharmacy licensed by the Department.

(f) The Department may not issue a third-party logistics provider license to an applicant, unless the Department first:

(1) ensures that a physical inspection of the facility satisfactory to the Department has occurred at the address provided by the applicant, as required under item (1) of subsection (b) of this Section; such inspection is not required if the resident state of the third-party logistics provider facility does not license third-party logistics providers or if the resident state does not inspect third-party logistics providers. If the resident state does not inspect third-party logistics providers, a Verified Accredited Wholesale Distributors Accreditation or other inspection approved by the Department meets this requirement; and

(2) determines that the designated representative meets each of the following qualifications:

(A) He or she is at least 21 years of age.

(B) He or she is employed by the applicant full time in a managerial level position.

(C) He or she is actively involved in and aware of the actual daily operation of third-party logistics provider.

(g) A third-party logistics provider shall publicly display all licenses and have the most recent state and federal inspection reports readily available.

(Source: P.A. 101-420, eff. 8-16-19.)

(225 ILCS 120/26)

(Section scheduled to be repealed on January 1, 2028)

Sec. 26. Unlicensed practice; violation; civil penalty.

(a) Any person who practices, offers to practice, attempts to practice, or holds oneself out to practice as a wholesale drug distributor, pharmacy distributor, or third-party logistics provider without being licensed to ship into, out of, or within the State under this Act shall, in addition to any other penalty provided by law, pay a civil penalty to the Department in an amount not to exceed $10,000 for each offense as determined by the Department. The civil penalty shall be assessed by the Department after a hearing is held in accordance with the provisions set forth in this Act regarding the provision of a hearing for the discipline of a licensee.

(b) The Department has the authority and power to investigate any and all unlicensed activity.

(c) The civil penalty shall be paid within 60 days after the effective date of the order imposing the civil penalty. The order shall constitute a judgment and may be filed and execution had thereon in the same manner as any judgment from any court of record.

(Source: P.A. 101-420, eff. 8-16-19.)

(225 ILCS 120/27)

(Section scheduled to be repealed on January 1, 2028)

Sec. 27. Social security number, individual taxpayer identification number, or unique identifying number on license application. In addition to any other information required to be contained in the application, every application for an original license under this Act shall include the applicant's social security number, individual taxpayer identification number, or other unique identifying number deemed appropriate by the Department, which shall be retained in the agency's records pertaining to the license. As soon as practical, the Department shall assign a customer's identification number to each applicant for a license.

Every application for a renewal or restored license shall require the applicant's customer identification number.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/30) (from Ch. 111, par. 8301-30)

(Section scheduled to be repealed on January 1, 2028)

Sec. 30. License applications; renewal procedures. An application for an original license or renewal shall be made to the Department in writing or electronically on forms prescribed by the Department and shall be accompanied by the required fee, which shall not be refundable. Any such application shall require such information as in the judgment of the Department will enable the Board and Department to pass on the qualifications of the applicant for a license. If the application for renewal with the required fee is not received by the Department before the expiration date, the existing license shall lapse and become null and void. Failure to renew before the expiration date is cause for a late payment penalty, discipline, or both.

(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)

(225 ILCS 120/31)

(Section scheduled to be repealed on January 1, 2028)

Sec. 31. Expiration of license; renewal.

(a) The expiration date and renewal period for each license issued under this Act shall be set by rule.

(b) Any licensee who shall engage in the practice for which the license was issued while the license is expired or on inactive status shall be considered to be practicing without a license which shall be grounds for discipline under this Act.

(c) A wholesale drug distributor or third-party logistics provider whose license has been expired for one year or more may not have its license restored but must apply for a new license and meet all requirements for licensure. Any wholesale drug distributor or third-party logistics provider whose license has been expired for less than one year may apply for restoration of its license and shall have its license restored.

(d) Anyone operating on an expired license is engaged in unlawful practice and subject to discipline under this Act.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/35) (from Ch. 111, par. 8301-35)

(Section scheduled to be repealed on January 1, 2028)

Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.

(a) The Department shall provide by rule for a schedule of fees for the administration and enforcement of this Act, including, but not limited to, original licensure, renewal, and restoration. The fees shall be nonrefundable.

(b) All fees collected under this Act shall be deposited into the Illinois State Pharmacy Disciplinary Fund and shall be appropriated to the Department for the ordinary and contingent expenses of the Department in the administration of this Act. Moneys in the Fund may be transferred to the Professions Indirect Cost Fund as authorized by Section 2105-300 of the Department of Professional Regulation Law.

The moneys deposited into the Illinois State Pharmacy Disciplinary Fund shall be invested to earn interest which shall accrue to the Fund.

(c) Any person who delivers a check or other payment to the Department that is returned to the Department unpaid by the financial institution upon which it is drawn shall pay to the Department, in addition to the amount already owed to the Department, a fine of $50. The fines imposed by this Section are in addition to any other discipline provided under this Act for unlicensed practice or practice on a nonrenewed license. The Department shall notify the person that payment of fees and fines shall be paid to the Department by certified check or money order within 30 calendar days of the notification. If, after the expiration of 30 days from the date of the notification, the person has failed to submit the necessary remittance, the Department shall automatically terminate the license or certificate or deny the application, without hearing. If, after termination or denial, the person seeks a license or certificate, he or she shall apply to the Department for restoration or issuance of the license or certificate and pay all fees and fines due to the Department. The Department may establish a fee for the processing of an application for restoration of a license or certificate to pay all expenses of processing this application. The Secretary may waive the fines due under this Section in individual cases where the Secretary finds that the fines would be unreasonable or unnecessarily burdensome.

(d) (Blank).

(e) A manufacturer of controlled substances, wholesale distributor of controlled substances, or third-party logistics provider that is licensed under this Act and owned and operated by the State is exempt from licensure, registration, renewal, and other fees required under this Act. Nothing in this subsection (e) shall be construed to prohibit the Department from imposing any fine or other penalty allowed under this Act.

(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)

(225 ILCS 120/40) (from Ch. 111, par. 8301-40)

(Section scheduled to be repealed on January 1, 2028)

Sec. 40. Rules and regulations. The Department shall make any rules and regulations, not inconsistent with law, as may be necessary to carry out the purposes and enforce the provisions of this Act. All rules and regulations promulgated under this Section shall conform to wholesale drug distributor licensing guidelines formally adopted by the FDA at 21 C.F.R. Part 205. In case of conflict between any rule or regulation adopted by the Department and any FDA wholesale drug distributor or third-party logistics provider guideline, the FDA guideline shall control.

(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)

(225 ILCS 120/45)

Sec. 45. (Repealed).

(Source: P.A. 87-594. Repealed by P.A. 95-689, eff. 10-29-07.)

(225 ILCS 120/50) (from Ch. 111, par. 8301-50)

(Section scheduled to be repealed on January 1, 2028)

Sec. 50. Inspection powers; access to records.

(a) Any pharmacy investigator authorized by the Department has the right of entry for inspection of premises purporting or appearing to be used by a wholesale drug distributor in this State, including the business premises of a person licensed pursuant to this Act. This right of entry shall permit the authorized pharmacy investigator unfettered access to the entire business premises. Any attempt to hinder an authorized pharmacy investigator from inspecting the business premises and documenting the inspection shall be a violation of this Act. The duly authorized investigators shall be required to show appropriate identification before being given access to a wholesale drug distributor's premises and delivery vehicles.

(b) With the exception of the most recent 12 months of records that must be kept on the premises where the drugs are stored, wholesale drug distributors may keep records regarding purchase and sales transactions electronically at a central location apart from the principal office of the wholesale drug distributor or the location at which the drugs were stored and from which they were shipped, provided that the records shall be made readily available for inspection within 2 working days of a request by the Department. The records may be kept in any form permissible under federal law applicable to prescription drugs record keeping.

(c) (Blank).

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/55) (from Ch. 111, par. 8301-55)

(Section scheduled to be repealed on January 1, 2028)

Sec. 55. Discipline; grounds.

(a) The Department may refuse to issue, restore, or renew, or may revoke, suspend, place on probation, reprimand or take other disciplinary or non-disciplinary action as the Department may deem appropriate, including imposing fines not to exceed $10,000 for each violation, with regard to any applicant or licensee or any officer, director, manager, or shareholder who owns 5% or more interest in the business that holds the license for any one or a combination of the following reasons:

(1) Violation of this Act or of the rules adopted under this Act.

(2) Aiding or assisting another person in violating any provision of this Act or the rules adopted under this Act.

(3) Failing, within 60 days, to provide information in response to a written requirement made by the Department.

(4) Engaging in dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud, or harm the public. This includes violations of "good faith" as defined by the Illinois Controlled Substances Act and applies to all prescription drugs.

(5) Discipline by another U.S. jurisdiction or foreign nation, if at least one of the grounds for the discipline is the same or substantially equivalent to those set forth in this Act.

(6) Selling or engaging in the sale of drug samples provided at no cost by drug manufacturers.

(7) Conviction by plea of guilty or nolo contendere, finding of guilt, jury verdict, or entry of judgment or by sentencing of any crime, including, but not limited to, convictions, preceding sentences of supervision, conditional discharge, or first offender probation, under the laws of any jurisdiction of the United States that is (i) a felony or (ii) a misdemeanor, an essential element of which is dishonesty or that is directly related to the practice of this profession.

(8) Habitual or excessive use or addiction to alcohol, narcotics, stimulants, or any other chemical agent or drug by the designated representative, as provided for in item (7) of subsection (b) of Section 25 of this Act, any officer, or director that results in the inability to function with reasonable judgment, skill, or safety.

(9) Material misstatement in furnishing information to the Department.

(10) A finding by the Department that the licensee, after having his or her license placed on probationary status, has violated the terms of probation.

(11) Fraud or misrepresentation in applying for, or procuring, a license under this Act or in connection with applying for renewal of a license under this Act.

(12) Willfully making or filing false records or reports.

(13) A finding of a substantial discrepancy in a Department audit of a prescription drug, including a controlled substance as that term is defined in this Act or in the Illinois Controlled Substances Act.

(14) Falsifying a pedigree or selling, distributing, transferring, manufacturing, repackaging, handling, or holding a counterfeit prescription drug intended for human use.

(15) Interfering with a Department investigation.

(16) Failing to adequately secure controlled substances or other prescription drugs from diversion.

(17) Acquiring or distributing prescription drugs not obtained from a source licensed by the Department.

(18) Failing to properly store drugs.

(19) Failing to maintain the licensed premises with proper storage and security controls.

(b) The Department may refuse to issue or may suspend the license or registration of any person who fails to file a return, or to pay the tax, penalty or interest shown in a filed return, or to pay any final assessment of tax, penalty or interest, as required by any tax Act administered by the Illinois Department of Revenue, until the time the requirements of the tax Act are satisfied.

(c) The Department shall revoke the license or certificate of registration issued under this Act or any prior Act of this State of any person who has been convicted a second time of committing any felony under the Illinois Controlled Substances Act or the Methamphetamine Control and Community Protection Act or who has been convicted a second time of committing a Class 1 felony under Sections 8A-3 and 8A-6 of the Illinois Public Aid Code. A person whose license or certificate of registration issued under this Act or any prior Act of this State is revoked under this subsection (c) shall be prohibited from engaging in the practice of pharmacy in this State.

(Source: P.A. 97-804, eff. 1-1-13; 97-813, eff. 7-13-12; 98-463, eff. 8-16-13.)

(225 ILCS 120/56)

(Section scheduled to be repealed on January 1, 2028)

Sec. 56. Restrictions on transactions.

(a) A licensee shall receive prescription drug returns or exchanges from a pharmacy or other persons authorized to administer or dispense drugs or a chain pharmacy warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. Returns of expired, damaged, recalled, or otherwise non-saleable pharmaceutical products shall be distributed by the receiving wholesale distributor only to either the original manufacturer or a third party returns processor. Returns or exchanges of prescription drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, shall not be subject to the pedigree requirements of Section 57 of this Act, so long as they are exempt from the pedigree requirement of the FDA's currently applicable Prescription Drug Marketing Act guidance. Both licensees under this Act and pharmacies or other persons authorized to administer or dispense drugs shall be accountable for administering their returns process and ensuring that the aspects of this operation are secure and do not permit the entry of adulterated and counterfeit product.

(b) A manufacturer or wholesale distributor licensed under this Act may furnish prescription drugs only to a person licensed by the appropriate state licensing authorities. Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must affirmatively verify that the person is legally authorized to receive the prescription drugs by contacting the appropriate state licensing authorities.

(c) Prescription drugs furnished by a manufacturer or wholesale distributor licensed under this Act may be delivered only to the premises listed on the license, provided that the manufacturer or wholesale distributor may furnish prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if:

(1) the identity and authorization of the recipient is properly established; and

(2) this method of receipt is employed only to meet the immediate needs of a particular patient of the authorized person.

(d) Prescription drugs may be furnished to a hospital pharmacy receiving area, provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor by the next business day after the delivery to the pharmacy receiving area.

(e) A manufacturer or wholesale distributor licensed under this Act may not accept payment for, or allow the use of, a person or entity's credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial officer listed on the license of a person or entity legally authorized to receive the prescription drugs. Any account established for the purchase of prescription drugs must bear the name of the licensee. This subsection (e) shall not be construed to prohibit a pharmacy or chain pharmacy warehouse from receiving prescription drugs if payment for the prescription drugs is processed through the pharmacy's or chain pharmacy warehouse's contractual drug manufacturer or wholesale distributor.

(Source: P.A. 95-689, eff. 10-29-07.)

(225 ILCS 120/57)

(Section scheduled to be repealed on January 1, 2028)

Sec. 57. Pedigree.

(a) Each person who is engaged in the wholesale distribution of prescription drugs, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, that leave or have ever left the normal distribution channel shall, before each wholesale distribution of the drug, provide a pedigree to the person who receives the drug. A retail pharmacy, mail order pharmacy, or chain pharmacy warehouse must comply with the requirements of this Section only if the pharmacy or chain pharmacy warehouse engages in the wholesale distribution of prescription drugs. On or before July 1, 2009, the Department shall determine a targeted implementation date for electronic track and trace pedigree technology. This targeted implementation date shall not be sooner than July 1, 2010. Beginning on the date established by the Department, pedigrees may be implemented through an approved and readily available system that electronically tracks and traces the wholesale distribution of each prescription drug starting with the sale by the manufacturer through acquisition and sale by any wholesale distributor and until final sale to a pharmacy or other authorized person administering or dispensing the prescription drug. This electronic tracking system shall be deemed to be readily available only upon there being available a standardized system originating with the manufacturers and capable of being used on a wide scale across the entire pharmaceutical chain, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. Consideration must also be given to the large-scale implementation of this technology across the supply chain and the technology must be proven to have no negative impact on the safety and efficacy of the pharmaceutical product.

(b) Each person who is engaged in the wholesale distribution of a prescription drug who is provided a pedigree for a prescription drug and attempts to further distribute that prescription drug, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, must affirmatively verify before any distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred.

(c) The pedigree must include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer or the manufacturer's third-party logistics provider, co-licensed product partner, or exclusive distributor through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. This necessary chain of distribution information shall include, without limitation all of the following:

(1) The name, address, telephone number and, if available, the e-mail address of each owner of the prescription drug and each wholesale distributor of the prescription drug.

(2) The name and address of each location from which the product was shipped, if different from the owner's.

(3) Transaction dates.

(4) Certification that each recipient has authenticated the pedigree.

(d) The pedigree must also include without limitation all of the following information concerning the prescription drug:

(1) The name and national drug code number of the prescription drug.

(2) The dosage form and strength of the prescription drug.

(3) The size of the container.

(4) The number of containers.

(5) The lot number of the prescription drug.

(6) The name of the manufacturer of the finished dosage form.

(e) Each pedigree or electronic file shall be maintained by the purchaser and the wholesale distributor for at least 3 years from the date of sale or transfer and made available for inspection or use within 5 business days upon a request of the Department.

(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)

(225 ILCS 120/58)

(Section scheduled to be repealed on January 1, 2028)

Sec. 58. Prohibited acts. It is unlawful for a person to perform or cause the performance of or aid and abet any of the following acts:

(1) Failure to obtain a license in accordance with this Act or operating without a valid license when a license is required by this Act.

(2) If the requirements of subsection (a) of Section 56 of this Act are applicable and are not met, the purchasing or otherwise receiving of a prescription drug from a pharmacy.

(3) If licensure is required pursuant to subsection (b) of Section 56 of this Act, the sale, distribution, or transfer of a prescription drug to a person that is not authorized under the law of the jurisdiction in which the person receives the prescription drug to receive the prescription drug.

(4) Failure to deliver prescription drugs to specified premises, as required by subsection (c) of Section 56 of this Act.

(5) Accepting payment or credit for the sale of prescription drugs in violation of subsection (e) of Section 56 of this Act.

(6) Failure to maintain or provide pedigrees as required by this Act.

(7) Failure to obtain, pass, or authenticate a pedigree as required by this Act.

(8) Providing the Department or any federal official with false or fraudulent records or making false or fraudulent statements regarding any matter within the provisions of this Act.

(9) Obtaining or attempting to obtain a prescription drug by fraud, deceit, or misrepresentation or engaging in misrepresentation or fraud in the distribution of a prescription drug.

(10) The manufacture, repacking, sale, transfer, delivery, holding, or offering for sale of any prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or that has otherwise been rendered unfit for distribution, except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved under federal law by the FDA.

(11) The adulteration, misbranding, or counterfeiting of any prescription drug, except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved under federal law by the FDA.

(12) The receipt of any prescription drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit and the delivery or proffered delivery of such drug for pay or otherwise.

(13) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of a prescription drug or the commission of any other act with respect to a prescription drug that results in the prescription drug being misbranded. The acts prohibited in this Section do not include the obtaining or the attempt to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity performed by a prescription drug manufacturer or the agent of a prescription drug manufacturer.

(Source: P.A. 95-689, eff. 10-29-07.)

(225 ILCS 120/59)

(Section scheduled to be repealed on January 1, 2028)

Sec. 59. Injunctive action; cease and desist order.

(a) If any person violates the provisions of this Act, the Secretary, in the name of the People of the State of Illinois, through the Attorney General or the State's Attorney of the county where the violation is alleged to have occurred, may petition for an order enjoining the violation or for an order enforcing compliance with this Act. Upon the filing of a verified petition, the court with appropriate jurisdiction may issue a temporary restraining order, without notice or bond, and may preliminarily and permanently enjoin the violation. If it is established that the person has violated or is violating the injunction, then the court may punish the offender for contempt of court. Proceedings under this Section are in addition to, and not in lieu of, all other remedies and penalties provided by this Act.

(b) Whenever, in the opinion of the Department, a person violates any provision of this Act, the Department may issue a rule to show cause why an order to cease and desist shall not be entered against that person. The rule shall clearly set forth the grounds relied upon by the Department and shall allow a person at least 7 days after the date of the rule to file an answer satisfactory to the Department. Failure to answer to the satisfaction of the Department shall cause an order to cease and desist to be issued.

(Source: P.A. 97-804, eff. 1-1-13.)

(225 ILCS 120/60) (from Ch. 111, par. 8301-60)

(Section scheduled to be repealed on January 1, 2028)

Sec. 60. Wholesaler licensing; complaints. The Department may refuse to issue a license to establish a new licensed wholesale drug distributorship, if an owner of the wholesale drug distributorship applying for a license was an owner of a wholesale drug distributorship that had its license revoked, unless the owner presents sufficient evidence indicating rehabilitation. Once a complaint has been filed by the Department against a wholesale drug distributorship the Department may refuse to issue a license to establish a new licensed wholesale drug distributorship, until such time as the Department issues a decision on the complaint if an owner of the new wholesale drug distributorship was also an owner of a wholesale drug distributorship against which the complaint was filed. Neither an application for change of ownership nor for a change of location for any such wholesale drug distributorship shall be acted on by the Department until such time as the Department issues a decision on the complaint. In the event that the wholesale drug distributorship against which the complaint has been filed ceases to be licensed by the Department, for any reason, before the Department's decision on the complaint and an owner or that wholesale drug distributorship applies for a license to establish a new wholesale drug distributorship, the Department shall conduct a hearing on the complaint earlier filed, regardless of whether that wholesale drug distributorship is presently licensed by the Department. If the conduct for which the complaint was originally filed would have been sufficient to result in a revocation of a license to operate a licensed wholesale drug distributorship, then the conduct shall constitute sufficient grounds for denial of an application for a license.

(Source: P.A. 87-594.)

(225 ILCS 120/65) (from Ch. 111, par. 8301-65)

(Section scheduled to be repealed on January 1, 2028)

Sec. 65. Pending disciplinary proceeding. The Department shall render no final administrative decision relative to any application for a license or certificate of registration under this Act if the applicant for the license or certificate of registration is the subject of a pending disciplinary proceeding under this Act or another Act administered by the Department. For purposes of this Section "applicant" means an individual or sole proprietor, or an individual who is an officer, director, or owner of a 5% or more beneficial interest in the applicant.

(Source: P.A. 87-594.)

(225 ILCS 120/70) (from Ch. 111, par. 8301-70)

(Section scheduled to be repealed on January 1, 2028)

Sec. 70. Immediate suspension of license or registration; hearing. The Secretary may, upon receipt of a written communication from the Secretary of Human Services or the Director of Public Health that continuation of practice of a person licensed or registered under this Act constitutes an immediate danger to the public, immediately suspend the license or registration of that person without a hearing. In instances in which the Secretary immediately suspends a license or registration under this Section, a hearing upon the person's license must be convened by the Board within 15 days after the suspension and completed without appreciable delay. The hearing shall be held to determine whether to recommend to the Secretary that the person's license be revoked, suspended, placed on probationary status, or reinstated, or that the person be subject to other disciplinary action. In the hearing, the written communication and any other evidence submitted with the communication may be introduced as evidence against the person. The person or his or her counsel shall have the opportunity to discredit or impeach such evidence and submit rebuttal evidence.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/75) (from Ch. 111, par. 8301-75)

(Section scheduled to be repealed on January 1, 2028)

Sec. 75. Automatic suspension. The determination by a circuit court that a licensee is subject to involuntary admission or judicial admission as provided in the Mental Health and Developmental Disabilities Code operates as an automatic suspension. The suspension shall end only upon (i) a finding by a court that the patient is no longer subject to involuntary admission or judicial admission and the issuance of an order so finding and discharging the patient and (ii) the recommendation of the Board to the Secretary that the licensee be allowed to resume his or her practice.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/80) (from Ch. 111, par. 8301-80)

(Section scheduled to be repealed on January 1, 2028)

Sec. 80. Violations of Act.

(a) If any person violates the provisions of this Act, the Secretary may, in the name of the People of the State of Illinois through the Attorney General of the State of Illinois or the State's Attorney of any county in which the action is brought, petition for an order enjoining the violation or for an order enforcing compliance with this Act. Upon the filing of a verified petition in the court, the court may issue a temporary restraining order, without notice or bond, and may preliminarily and permanently enjoin the violation. If it is established that the person has violated or is violating the injunction, the Court may punish the offender for contempt of court. Proceedings under this Section shall be in addition to, and not in lieu of, all other remedies and penalties provided by this Act.

(b) Whoever knowingly conducts business as a wholesale drug distributor or third-party logistics provider in this State without being appropriately licensed under this Act shall be guilty of a Class A misdemeanor for a first violation and for each subsequent conviction shall be guilty of a Class 4 felony.

(c) Whenever in the opinion of the Department any person not licensed in good standing under this Act violates any provision of this Act, the Department may issue a rule to show cause why an order to cease and desist should not be entered against him. The rule shall clearly set forth the grounds relied upon by the Department and shall provide a period of 7 days from the date of the rule to file an answer to the satisfaction of the Department. Failure to answer to the satisfaction of the Department shall cause an order to cease and desist to be issued immediately.

(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)

(225 ILCS 120/85) (from Ch. 111, par. 8301-85)

(Section scheduled to be repealed on January 1, 2028)

Sec. 85. Investigations; notice of disciplinary hearing. The Department may investigate the actions of any applicant or of any person or persons holding or claiming to hold a license or registration. Before suspending, revoking, placing on probationary status, or taking any other disciplinary action as the Department may deem proper with regard to any license or certificate, at least 30 days before the date set for the hearing, the Department shall (i) notify the accused in writing of any charges made and the time and place for a hearing of the charges before the Board, (ii) direct him or her to file a written answer to the charges with the Board under oath within 20 days after the service of the notice, and (iii) inform the accused that if he or she fails to file an answer default will be taken against him or her and his or her license or certificate may be suspended, revoked, placed on probationary status, or have other disciplinary action, including limiting the scope, nature or extent of business, as provided for in this Act. The written notice may be served by personal delivery, email to the respondent's email address of record, or mail to the respondent's address of record. At the time and place fixed in the notice, the Board shall proceed to hear the charges and the parties or their counsel shall be accorded ample opportunity to present any statements, testimony, evidence and argument that may be pertinent to the charges or to their defense. The hearing may be continued from time to time. In case the accused person, after receiving notice, fails to file an answer, his or her license or certificate may in the discretion of the Secretary, having received first the recommendation of the Board, be suspended, revoked, placed on probationary status, or the Secretary may take whatever disciplinary action as he or she may deem proper as provided in this Act, including limiting the scope, nature, or extent of the person's practice, without a hearing, if the act or acts charged constitute sufficient grounds for such action under this Act.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/90) (from Ch. 111, par. 8301-90)

(Section scheduled to be repealed on January 1, 2028)

Sec. 90. Record of proceedings. The Department, at its expense, shall preserve a record of all proceedings at the formal hearing of any case involving the refusal to issue or renew a license or discipline of a licensee. The notice of hearing, complaint, and all other documents in the nature of pleadings and written motions filed in the proceedings, the transcript of testimony, the report of the Board or hearing officer, and orders of the Department shall be the record of the proceeding.

(Source: P.A. 87-594.)

(225 ILCS 120/95) (from Ch. 111, par. 8301-95)

(Section scheduled to be repealed on January 1, 2028)

Sec. 95. Order requiring attendance of witnesses and production of evidence. Any circuit court may, upon application of the Department or its designee or of the applicant or licensee against whom proceedings of this Act are pending, enter an order requiring the attendance of witnesses and their testimony and the production of documents, papers, files, books and records in connection with any hearing or investigation. The court may compel obedience to its order by proceedings for contempt.

(Source: P.A. 87-594.)

(225 ILCS 120/100) (from Ch. 111, par. 8301-100)

(Section scheduled to be repealed on January 1, 2028)

Sec. 100. Subpoena power; administration of oaths. The Department shall have power to subpoena and bring before it any person in this State and to take testimony, either orally or by deposition or both, with the same fees and mileage and in the same manner as prescribed by law in judicial proceedings in civil cases in circuit courts of this State. The Department may subpoena and compel the production of documents, papers, files, books, and records in connection with any hearing or investigation.

The Secretary, hearing officer, and any member of the Board shall each have power to administer oaths to witnesses at any hearing which the Department is authorized to conduct under this Act, and any other oaths required or authorized to be administered by the Department under this Act.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/105) (from Ch. 111, par. 8301-105)

(Section scheduled to be repealed on January 1, 2028)

Sec. 105. Report of findings and recommendation. At the conclusion of the hearing, the Board shall present to the Secretary a written report of its findings of fact, conclusions of law, and recommendations. The report shall contain a finding whether or not the accused person violated this Act or failed to comply with the conditions required in this Act. The Board shall specify the nature of the violation or failure to comply and shall make its recommendations to the Secretary.

The report of findings of fact, conclusion of law, and recommendations of the Board shall be the basis for the Department's order for refusal or for the granting of a license or registration. The finding is not admissible in evidence against the person in a criminal prosecution brought for the violation of this Act, but the hearing and finding are not a bar to a criminal prosecution brought for the violation of this Act.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/110) (from Ch. 111, par. 8301-110)

(Section scheduled to be repealed on January 1, 2028)

Sec. 110. Hearing officers; appointment. Notwithstanding any other provision of this Act, the Secretary shall have the authority to appoint any attorney duly licensed to practice law in the State of Illinois to serve as the hearing officer in any action before the Board for refusal to issue or renew a license, or the discipline of a licensee. The hearing officer shall report his findings of fact, conclusions of law, and recommendations to the Board and the Secretary. The Board shall have 60 days from receipt of the report to review the report of the hearing officer and present its findings of fact, conclusions of law, and recommendations to the Secretary. If the Board fails to present its report within the 60-day period, the Secretary may issue an order based on the report of the hearing officer and the record of the proceedings or issue an order remanding the matter back to the hearing officer for additional proceedings in accordance with the order. If the Secretary disagrees with the recommendation of the Board or the hearing officer, the Secretary may issue an order in contravention of the recommendation.

(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)

(225 ILCS 120/115) (from Ch. 111, par. 8301-115)

(Section scheduled to be repealed on January 1, 2028)

Sec. 115. Motion for rehearing. In any case involving the refusal to issue, renew, or discipline of a license or registration, a copy of the Board's report shall be served upon the respondent by the Department, either personally or as provided in this Act for the service of the notice of hearing. Within 20 days after service, the respondent may present to the Department a motion in writing for a rehearing, which shall specify the particular grounds for rehearing. If no motion for rehearing is filed, then upon the expiration of the time specified for filing a motion, or if a motion for rehearing is denied, then upon denial the Secretary may enter an order in accordance with recommendations of the Board. If the respondent orders from the reporting service and pays for a transcript of the record within the time for filing a motion for rehearing, the 20-day period within which a motion may be filed shall commence upon the delivery of the transcript to the respondent.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/120) (from Ch. 111, par. 8301-120)

(Section scheduled to be repealed on January 1, 2028)

Sec. 120. Rehearing by order of Secretary. Whenever the Secretary is satisfied that substantial justice has not been done in the revocation, suspension, or refusal to issue or renew a license or registration, the Secretary may order a rehearing by the same hearing office or Board.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/125) (from Ch. 111, par. 8301-125)

(Section scheduled to be repealed on January 1, 2028)

Sec. 125. Duties of the Board. The Board shall exercise the rights, powers, and duties which have been vested in the Board under this Act, and any other duties conferred upon the Board by law.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/130) (from Ch. 111, par. 8301-130)

(Section scheduled to be repealed on January 1, 2028)

Sec. 130. State liability for disciplinary action without reasonable basis. In the event that the Department's order of revocation, suspension, placing the licensee on probationary status, or other order or formal disciplinary action is without any reasonable basis, then the State of Illinois shall be liable to the injured party for those special damages suffered as a direct result of such order.

(Source: P.A. 87-594.)

(225 ILCS 120/135) (from Ch. 111, par. 8301-135)

(Section scheduled to be repealed on January 1, 2028)

Sec. 135. Disciplinary consent orders. Notwithstanding the provisions of this Act concerning the conduct of hearings and recommendations for disciplinary actions, the Secretary shall have the authority to negotiate agreements with licensees resulting in disciplinary consent orders. Consent orders may provide for any of the forms of discipline otherwise provided in this Act. Consent orders shall provide that they were not entered into a result of any coercion by the Department.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/140) (from Ch. 111, par. 8301-140)

(Section scheduled to be repealed on January 1, 2028)

Sec. 140. Orders; prima facie proof. An order or a certified copy thereof, over the seal of the Department and purporting to be signed by the Secretary, shall be prima facie proof that:

(a) the signature is the genuine signature of the Secretary;

(b) the Secretary is duly appointed and qualified; and

(c) the Board and its members are qualified to act.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/145) (from Ch. 111, par. 8301-145)

(Section scheduled to be repealed on January 1, 2028)

Sec. 145. Restoration of certificate. At any time after suspension or revocation of any certificate, the Department may restore it to the accused person upon the written recommendation of the Board.

(Source: P.A. 87-594.)

(225 ILCS 120/150) (from Ch. 111, par. 8301-150)

(Section scheduled to be repealed on January 1, 2028)

Sec. 150. Surrender of license or registration. Upon the revocation or suspension of any license or registration, the holder shall immediately surrender the license or registration to the Department and if the licensee fails to do so, the Department shall have the right to seize the license or certificate.

(Source: P.A. 87-594.)

(225 ILCS 120/155) (from Ch. 111, par. 8301-155)

(Section scheduled to be repealed on January 1, 2028)

Sec. 155. Temporary suspension of license; hearing. The Secretary may temporarily suspend licensure as a wholesale drug distributor or third-party logistics provider, without a hearing, simultaneously with the institution of proceedings for a hearing provided for in Section 85 of this Act, if the Secretary finds that evidence in his or her possession indicates that a continuation in business would constitute an imminent danger to the public. In the event that the Secretary temporarily suspends a license or certificate without a hearing, a hearing by the Department must be held within 10 days after the suspension has occurred and be concluded without appreciable delay.

(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)

(225 ILCS 120/160) (from Ch. 111, par. 8301-160)

(Section scheduled to be repealed on January 1, 2028)

Sec. 160. Administrative Review Law; venue. All final administrative decisions of the Department are subject to judicial review under the Administrative Review Law and its rules. The term "administrative decision" is defined as in Section 3-101 of the Code of Civil Procedure.

Proceedings for judicial review shall be commenced in the circuit court of the county in which the party applying for review resides; but if the party is not a resident of this State, the venue shall be in Sangamon County.

(Source: P.A. 87-594.)

(225 ILCS 120/165) (from Ch. 111, par. 8301-165)

(Section scheduled to be repealed on January 1, 2028)

Sec. 165. Certification of record. The Department shall not be required to certify any record to the court, to file an answer in court, or to otherwise appear in any court in a judicial review proceeding unless and until the Department has received from the plaintiff payment of the costs of furnishing and certifying the record, which costs shall be determined by the Department. Failure on the part of the plaintiff to file a receipt in court shall be grounds for dismissal of the action. During the pendency and hearing of any and all judicial proceedings incident to the disciplinary action, the sanctions imposed upon the accused by the Department because of acts or omissions related to the delivery of direct patient care as specified in the Department's final administrative decision, shall, as a matter of public policy, remain in full force and effect in order to protect the public pending final resolution of any of the proceedings.

(Source: P.A. 102-879, eff. 1-1-23.)

(225 ILCS 120/170) (from Ch. 111, par. 8301-170)

(Section scheduled to be repealed on January 1, 2028)

Sec. 170. Penalties. Any person who is found to have violated any provision of this Act is guilty of a Class A misdemeanor. On conviction of a second or subsequent offense, the violator shall be guilty of a Class 4 felony. All criminal fines, monies, or property collected or received by the Department under this Section or any other State or federal statute, including, but not limited to, property forfeited to the Department under Section 505 of the Illinois Controlled Substances Act or Section 85 of the Methamphetamine Control and Community Protection Act, shall be deposited into the Professional Regulation Evidence Fund.

(Source: P.A. 94-556, eff. 9-11-05.)

(225 ILCS 120/173)

(Section scheduled to be repealed on January 1, 2028)

Sec. 173. Confidentiality. All information collected by the Department in the course of an examination or investigation of a licensee or applicant, including, but not limited to, any complaint against a licensee filed with the Department and information collected to investigate any such complaint, shall be maintained for the confidential use of the Department and shall not be disclosed. The Department may not disclose the information to anyone other than law enforcement officials, other regulatory agencies that have an appropriate regulatory interest as determined by the Secretary, or a party presenting a lawful subpoena to the Department. Information and documents disclosed to a federal, State, county, or local law enforcement agency shall not be disclosed by the agency for any purpose to any other agency or person. A formal complaint filed against a licensee by the Department or any order issued by the Department against a licensee or applicant shall be a public record, except as otherwise prohibited by law.

(Source: P.A. 97-804, eff. 1-1-13.)

(225 ILCS 120/175) (from Ch. 111, par. 8301-175)

(Section scheduled to be repealed on January 1, 2028)

Sec. 175. Administrative procedure. The Illinois Administrative Procedure Act is hereby expressly adopted and incorporated as if the provisions of that Act were included in this Act, except that the provision of paragraph (d) of Section 10-65 of the Illinois Administrative Procedure Act, which provides that at hearings the licensee has the right to show compliance with all lawful requirements for retention, continuation, or renewal of the license, is specifically excluded. For the purpose of this Act, the notice required under Section 10-25 of the Administrative Procedure Act is deemed sufficient when mailed to the last known address of a party.

(Source: P.A. 87-594; 88-670, eff. 12-2-94.)

(225 ILCS 120/180) (from Ch. 111, par. 8301-180)

(Section scheduled to be repealed on January 1, 2028)

Sec. 180. Conflict of laws. In the event of a conflict between any provision of this Act and the Mental Health and Developmental Disabilities Confidentiality Act, the provisions of this Act shall govern.

(Source: P.A. 87-594.)

(225 ILCS 120/185) (from Ch. 111, par. 8301-185)

(Section scheduled to be repealed on January 1, 2028)

Sec. 185. Home rule preemption. The regulation and licensing of wholesale drug distributors are exclusive powers and functions of the State. A home rule unit may not regulate or license wholesale drug distributors. This Section is a denial and limitation of home rule powers and functions under subsection (h) of Section 6 of Article VII of the Illinois Constitution.

(Source: P.A. 87-594.)

(225 ILCS 120/195) (from Ch. 111, par. 8301-195)

(Section scheduled to be repealed on January 1, 2028)

Sec. 195. Effective date. This Act shall take effect upon becoming law.

(Source: P.A. 87-594.)

(225 ILCS 120/200)

(Section scheduled to be repealed on January 1, 2028)

Sec. 200. Drugs in shortage.

(a) For the purpose of this Section, "drug in shortage" means a drug, as defined in Section 356c of the Federal Food, Drug, and Cosmetic Act, listed on the drug shortage list maintained by the U.S. Food and Drug Administration in accordance with Section 356e of the Federal Food, Drug, and Cosmetic Act.

(b) Any person engaged in the wholesale distribution of a drug in shortage in this State must be licensed by the Department.

(c) It is unlawful for any person, other than a manufacturer, a manufacturer's exclusive distributor, a third-party logistics provider, or an authorized distributor of record, to purchase or receive a drug in shortage from any person not licensed by the Department. This subsection (c) does not apply to the return of drugs or the purchase or receipt of drugs pursuant to any of the distributions that are specifically excluded from the definition of "wholesale distribution" in Section 15 of the Wholesale Drug Distribution Licensing Act.

(d) A person found to have violated a provision of this Section shall be subject to administrative fines, orders for restitution, and orders for disgorgement.

(e) The Department shall create a centralized, searchable database of those entities licensed to engage in wholesale distribution, including manufacturers, wholesale distributors, and pharmacy distributors, to enable purchasers of a drug in shortage to easily verify the licensing status of an entity offering such drugs.

(f) The Department shall establish a system for reporting the reasonable suspicion that a violation of this Act has been committed by a distributor of a drug in shortage. Reports made through this system shall be referred to the Office of the Attorney General and the appropriate State's Attorney's office for further investigation and prosecution.

(g) The Department shall adopt rules to carry out the provisions of this Section.

(h) Nothing in this Section prohibits one hospital pharmacy from purchasing or receiving a drug in shortage from another hospital pharmacy in the event of a medical emergency.

(Source: P.A. 102-879, eff. 1-1-23.)