Ill. Admin. Code tit. 68 § 1510.100

Current through Register Vol. 48, No. 52, December 27, 2024

Section 1510.100 - Application for Licensure

Each resident and nonresident third-party logistics provider must be licensed by the Department, in accordance with the Act, prior to shipping a prescription drug into Illinois.

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 for all facilities used by the applicant 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 applicant, 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 applicant, 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 1510.20;

9) Each applicant 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 as a third-party logistics provider:

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 license would not be in the public interest.

Ill. Admin. Code tit. 68, § 1510.100

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