Statutes > Illinois Statutes > CHAPTER 225 PROFESSIONS AND OCCUPATIONS > 225 ILCS 120/ Wholesale Drug Distribution Licensing Act.

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    (Section scheduled to be repealed on January 1, 2013)
    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)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 3. References to Department or Director of Professional Regulation. References in this Act (i) to the Department of Professional Regulation are deemed, in appropriate contexts, to be references to the Department of Financial and Professional Regulation and (ii) to the Director of Professional Regulation are deemed, in appropriate contexts, to be references to the Secretary of Financial and Professional Regulation.
(Source: P.A. 95‑689, eff. 10‑29‑07.)

    (225 ILCS 120/5) (from Ch. 111, par. 8301‑5)
    (Section scheduled to be repealed on January 1, 2013)
    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    (Section scheduled to be repealed on January 1, 2013)
    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    (Section scheduled to be repealed on January 1, 2013)
    Sec. 15. Definitions. As used in this Act:
    "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 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.
    "Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale.
    "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'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 or corporation.
    "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 Financial and Professional Regulation.
    "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. A third party logistics provider 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.
    "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 retail pharmacies to licensed practitioners for office use.
        (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.
    "Wholesale drug distributor" means anyone engaged in the wholesale distribution of prescription drugs, 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; third party logistics providers; and 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. 95‑689, eff. 10‑29‑07.)

    (225 ILCS 120/20) (from Ch. 111, par. 8301‑20)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 20. Prohibited drug purchases or receipt. It shall be unlawful for any person or entity to knowingly purchase or receive any prescription drug from any source other than a person or entity licensed under the laws of this State or the state of domicile except where otherwise provided. A person or entity licensed under the laws of this State shall include, but is not limited to, a wholesale distributor, manufacturer, 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. 87‑594.)

    (225 ILCS 120/24)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 24. Bond required. The Department shall require every wholesale distributor applying for licensure under this Act to submit a bond not to exceed $100,000 or another equivalent means of security acceptable to the Department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to a fund established by the Department. Chain pharmacy warehouses and warehouses that are operated by agencies of this State that are not engaged in wholesale distribution are exempt from the bond requirement of this Section. The purpose of the bond is to secure payment of any fines or penalties imposed by the Department and any fees and costs incurred by the Department regarding that license, which are authorized under State law and which the licensee fails to pay 30 days after the fines, penalties, or costs become final. The Department may make a claim against the bond or security until one year after the licensee's license ceases to be valid. A single bond may suffice to cover all facilities operated by an applicant or its affiliates licensed in this State.
    The Department shall establish a fund, separate from its other accounts, in which to deposit the wholesale distributor bonds required under this Section.
(Source: P.A. 95‑689, eff. 10‑29‑07.)

    (225 ILCS 120/25)(from Ch. 111, par. 8301‑25)
    (Section scheduled to be repealed on January 1, 2013)
    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 person, the name of the 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 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 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. 94‑942, eff. 1‑1‑07; 95‑689, eff. 10‑29‑07.)

    (225 ILCS 120/26)
    (Section scheduled to be repealed on January 1, 2013)
    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 or pharmacy distributor without being licensed 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 $5,000 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. 89‑474, eff. 6‑18‑96.)

    (225 ILCS 120/27)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 27. Social Security Number on license application. In addition to any other information required to be contained in the application, every application for an original, renewal, or restored license under this Act shall include the applicant's Social Security Number.
(Source: P.A. 90‑144, eff. 7‑23‑97.)

    (225 ILCS 120/30) (from Ch. 111, par. 8301‑30)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 30. License renewal application procedures. Application blanks for renewal of any license required by this Act shall be mailed to each licensee at least 60 days before the license expires. 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. 87‑594.)

    (225 ILCS 120/35)(from Ch. 111, par. 8301‑35)
    (Section scheduled to be repealed on January 1, 2013)
    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 (20 ILCS 2105/2105‑300).
    The moneys deposited into the Illinois State Pharmacy Disciplinary Fund shall be invested to earn interest which shall accrue to the Fund.
    The Department shall present to the Board for its review and comment all appropriation requests from the Illinois State Pharmacy Disciplinary Fund. The Department shall give due consideration to any comments of the Board in making appropriation requests.
    (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 Director may waive the fines due under this Section in individual cases where the Director finds that the fines would be unreasonable or unnecessarily burdensome.
    (d) The Department shall maintain a roster of the names and addresses of all registrants and of all persons whose licenses have been suspended or revoked. This roster shall be available upon written request and payment of the required fee.<