Ill. Admin. Code tit. 68 § 1510.80

Current through Register Vol. 48, No. 43, October 25, 2024

Section 1510.80 - Application for Licensure

Each wholesale distributor, wherever located, who engages in wholesale distribution into, out of, or within Illinois shall be licensed by the Department in accordance with the Act and this Part before engaging in wholesale distribution of prescription drugs.

a) The applicant shall file with the Department an application that includes the following:

1) The name, full business address, and telephone number of the applicant;

2) All trade or business names used by the applicant;

3) Addresses, telephone numbers and names of contact persons at all facilities used by the applicant for the storage, handling and distribution of prescription drugs;

4) The type of ownership or operation (i.e., partnership, corporation or sole proprietorship). If a corporation, a copy of the Articles of Incorporation;

5) The names of the owner and/or operator of the entity, including:

A) The name of the person, if a person;

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

C) The name and title of each corporate officer and director, the corporate names, the name of the state where incorporated, and the name of the parent company, if any, if a corporation; or

D) The full name of the sole proprietor and the name of the business entity, if a sole proprietorship;

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 drug distributor, together with the personal information statement and fingerprints required by Section 25(b)(7) of the Act;

8) Minimum liability insurance set forth in Section 1510.15;

9) Each wholesale drug distributor must designate an individual representative to serve as the contact person for the Department. This representative must provide the Department with all the information required under the Act;

10) The fee set forth in Section 1510.65;

11) A resident state inspection report or report based on an inspection conducted by a third-party entity approved by the Department; and

12) Any additional information required by the Department.

b) The Department will consider the following factors in determining eligibility for licensure of persons who engage in the wholesale distribution of prescription drugs:

1) Any conviction of the applicant under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

2) Any felony conviction of the applicant under federal, state or local laws;

3) The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;

4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

5) Suspension or revocation by federal, state or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

6) Compliance with licensing requirements under previously granted licenses, if any;

7) Compliance with the requirements to maintain and/or make available to the state licensing authority or to federal, state or local law enforcement officials those records required to be maintained by wholesale drug distributors; and

8) Any other factors or qualifications the Department considers relevant to, and consistent with, public health and safety.

c) A separate license is required for each facility, directly or indirectly owned or operated by the same business, that distributes prescription drugs.

d) The Department reserves the right to deny a license to an applicant if it determines that the granting of that a license would not be in the public interest.

Ill. Admin. Code tit. 68, § 1510.80

Added at 44 Ill. Reg. 3363, effective 3/6/2020