TITLE 68: PROFESSIONS AND OCCUPATIONS
CHAPTER VII: DEPARTMENT OF PROFESSIONAL REGULATION
SUBCHAPTER b: PROFESSIONS AND OCCUPATIONS
PART 1510 WHOLESALE DRUG DISTRIBUTION LICENSING ACT
SECTION 1510.100 APPLICATION FOR LICENSURE


 

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.

 

(Source:  Added at 44 Ill. Reg. 3363, effective March 6, 2020)