(225 ILCS 120/25)
(from Ch. 111, par. 8301-25)
(Section scheduled to be repealed on January 1, 2023)
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
(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
(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
(9) Any additional information required by the
(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. 97-804, eff. 1-1-13.)