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92_HB4003eng HB4003 Engrossed LRB9213211ACmg 1 AN ACT concerning the regulation of professions. 2 Be it enacted by the People of the State of Illinois, 3 represented in the General Assembly: 4 Section 5. The Regulatory Sunset Act is amended by 5 changing Section 4.13 and adding Section 4.23 as follows: 6 (5 ILCS 80/4.13) (from Ch. 127, par. 1904.13) 7 Sec. 4.13. Acts repealed on December 31, 2002. The 8 following Acts are repealed on December 31, 2002: 9 The Environmental Health Practitioner Licensing Act. 10 The Naprapathic Practice Act. 11The Wholesale Drug Distribution Licensing Act.12 The Dietetic and Nutrition Services Practice Act. 13 The Funeral Directors and Embalmers Licensing Code. 14 The Professional Counselor and Clinical Professional 15 Counselor Licensing Act. 16 (Source: P.A. 88-45; 89-61, eff. 6-30-95; revised 8-22-01.) 17 (5 ILCS 80/4.23 new) 18 Sec. 4.23. Act repealed on January 1, 2013. The 19 following Act is repealed on January 1, 2013: 20 The Wholesale Drug Distribution Licensing Act. 21 Section 10. The Wholesale Drug Distribution Licensing 22 Act is amended by changing Sections 25 and 35 as follows: 23 (225 ILCS 120/25) (from Ch. 111, par. 8301-25) 24 (Section scheduled to be repealed on December 31, 2002) 25 Sec. 25. Wholesale drug distributor licensing 26 requirements. All wholesale distributors and pharmacy 27 distributors, wherever located, who engage in wholesale 28 distribution into, out of, or within the State shall be HB4003 Engrossed -2- LRB9213211ACmg 1 subject to the following requirements: 2 (a) No person or distribution outlet shall act as a 3 wholesale drug distributor without first obtaining a license 4 to do so from the Department and paying any reasonable fee 5 required by the Department, the fee not to exceed $200 per6year. 7 (b) The Department may grant a temporary license when a 8 wholesale drug distributor first applies for a license to 9 operate within this State. A temporary license shall remain 10 valid until the Department finds that the applicant meets or 11 fails to meet the requirements for regular licensure. 12 Nevertheless, no temporary license shall be valid for more 13 than 90 days from the date of issuance. Any temporary 14 license issued under this subsection shall be renewable for a 15 similar period of time not to exceed 90 days under policies 16 and procedures prescribed by the Department. 17 (c) No license shall be issued or renewed for a 18 wholesale drug distributor to operate unless the wholesale 19 drug distributor shall operate in a manner prescribed by law 20 and according to the rules and regulations promulgated by the 21 Department. 22 (d) The Department may require a separate license for 23 each facility directly or indirectly owned or operated by the 24 same business entity within this State, or for a parent 25 entity with divisions, subsidiaries, and affiliate companies 26 within this State when operations are conducted at more than 27 one location and there exists joint ownership and control 28 among all the entities. 29 (e) As a condition for receiving and renewing any 30 wholesale drug distributor license issued under this Act, 31 each applicant shall satisfy the Department that it has and 32 will continuously maintain: 33 (1) acceptable storage and handling conditions plus 34 facilities standards; HB4003 Engrossed -3- LRB9213211ACmg 1 (2) minimum liability and other insurance as may be 2 required under any applicable federal or State law; 3 (3) a security system that includes after hours, 4 central alarm or comparable entry detection capability; 5 restricted premises access; adequate outside perimeter 6 lighting; comprehensive employment applicant screening; 7 and safeguards against employee theft; 8 (4) an electronic, manual, or any other reasonable 9 system of records, describing all wholesale distributor 10 activities governed by this Act for the 2 year period 11 following disposition of each product and reasonably 12 accessible during regular business hours as defined by 13 the Department's rules in any inspection authorized by 14 the Department; 15 (5) officers, directors, managers, and other 16 persons in charge of wholesale drug distribution, 17 storage, and handling who must at all times demonstrate 18 and maintain their capability of conducting business 19 according to sound financial practices as well as State 20 and federal law; 21 (6) complete, updated information, to be provided 22 the Department as a condition for obtaining and renewing 23 a license, about each wholesale distributor to be 24 licensed under this Act, including all pertinent licensee 25 ownership and other key personnel and facilities 26 information deemed necessary for enforcement of this Act. 27 Any changes in this information shall be submitted at the 28 time of license renewal or within 45 days from the date 29 of the change; 30 (7) written policies and procedures that assure 31 reasonable wholesale distributor preparation for, 32 protection against and handling of any facility security 33 or operation problems, including, but not limited to, 34 those caused by natural disaster or government emergency; HB4003 Engrossed -4- LRB9213211ACmg 1 inventory inaccuracies or product shipping and receiving; 2 outdated product or other unauthorized product control; 3 appropriate disposition of returned goods; and product 4 recalls; 5 (8) sufficient inspection procedures for all 6 incoming and outgoing product shipments; and 7 (9) operations in compliance with all federal legal 8 requirements applicable to wholesale drug distribution. 9 (f) The Department shall consider, at a minimum, the 10 following factors in reviewing the qualifications of persons 11 who engage in wholesale distribution of prescription drugs in 12 this State: 13 (1) any conviction of the applicant under any 14 federal, State, or local laws relating to drug samples, 15 wholesale or retail drug distribution, or distribution of 16 controlled substances; 17 (2) any felony convictions of the applicant under 18 federal, State, or local laws; 19 (3) the applicant's past experience in the 20 manufacture or distribution of prescription drugs, 21 including controlled substances; 22 (4) the furnishing by the applicant of false or 23 fraudulent material in any application made in connection 24 with drug manufacturing or distribution; 25 (5) suspension or revocation by federal, State, or 26 local government of any license currently or previously 27 held by the applicant for the manufacture or distribution 28 of any drug, including controlled substances; 29 (6) compliance with licensing requirements under 30 previously granted licenses, if any; 31 (7) compliance with requirements to maintain and 32 make available to the Department or to federal, State, or 33 local law enforcement officials those records required by 34 this Act; and HB4003 Engrossed -5- LRB9213211ACmg 1 (8) any other factors or qualifications the 2 Department considers relevant to and consistent with the 3 public health and safety, including whether the granting 4 of the license would not be in the public interest. 5 (9) All requirements set forth in this subsection 6 shall conform to wholesale drug distributor licensing 7 guidelines formally adopted by the U.S. Food and Drug 8 Administration (FDA). In case of conflict between any 9 wholesale drug distributor licensing requirement imposed 10 by the Department and any FDA wholesale drug distributor 11 licensing guideline, the FDA guideline shall control. 12 (g) An agent or employee of any licensed wholesale drug 13 distributor need not seek licensure under this Section and 14 may lawfully possess pharmaceutical drugs when the agent or 15 employee is acting in the usual course of business or 16 employment. 17 (h) The issuance of a license under this Act shall not 18 change or affect tax liability imposed by the State on any 19 wholesale drug distributor. 20 (i) A license issued under this Act shall not be sold, 21 transferred, or assigned in any manner. 22 (Source: P.A. 87-594.) 23 (225 ILCS 120/35) (from Ch. 111, par. 8301-35) 24 (Section scheduled to be repealed on December 31, 2002) 25 Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund. 26 (a) The Department shall provide by rule for a schedule 27 of fees for the administration and enforcement of this Act, 28 including but not limited to original licensure, renewal, and 29 restoration. The fees shall be nonrefundable.The following30fees shall be imposed by the Department and are not31refundable.32(1) The fee for application for a certificate of33registration as a wholesale drug distributor is $200.HB4003 Engrossed -6- LRB9213211ACmg 1(2) The fee for the renewal of a certificate of2registration as a wholesale drug distributor is $200 per3year.4(3) The fee for the change of person responsible5for drugs is $50.6(4) The fee for the issuance of a duplicate license7to replace a license that has been lost or destroyed is8$25.9(5) The fee for certification of a registrant's10record for any purpose is $25.11(6) The fee for a roster of licensed wholesale drug12distributors shall be the actual cost of producing the13roster.14(7) The fee for wholesale drug distributor15licensing, disciplinary, or investigative records16obtained under subpoena is $1 per page.17 (b) All fees collected under this Act shall be deposited 18 into the Illinois State Pharmacy Disciplinary Fund and shall 19 be appropriated to the Department for the ordinary and 20 contingent expenses of the Department in the administration 21 of this Act.All moneys received by the Department under this22Act shall be deposited into the Illinois State Pharmacy23Disciplinary Fund in the State Treasury and shall be used24only for the following purposes: (i) by the State Board of25Pharmacy in the exercise of its powers and performance of its26duties, as such use is made by the Department upon the27recommendations of the State Board of Pharmacy, (ii) for28costs directly related to license renewal of persons licensed29under this Act, and (iii) for direct and allocable indirect30costs related to the public purposes of the Department of31Professional Regulation.Moneys in the Fund may be 32 transferred to the Professions Indirect Cost Fund as 33 authorized by Section 2105-300 of the Department of 34 Professional Regulation Law (20 ILCS 2105/2105-300). HB4003 Engrossed -7- LRB9213211ACmg 1 The moneys deposited into the Illinois State Pharmacy 2 Disciplinary Fund shall be invested to earn interest which 3 shall accrue to the Fund. 4 The Department shall present to the Board for its review 5 and comment all appropriation requests from the Illinois 6 State Pharmacy Disciplinary Fund. The Department shall give 7 due consideration to any comments of the Board in making 8 appropriation requests. 9 (c) Any person who delivers a check or other payment to 10 the Department that is returned to the Department unpaid by 11 the financial institution upon which it is drawn shall pay to 12 the Department, in addition to the amount already owed to the 13 Department, a fine of $50. The fines imposed by this 14 Section are in addition to any other discipline provided 15 under this Act for unlicensed practice or practice on a 16 nonrenewed license. The Department shall notify the person 17 that payment of fees and fines shall be paid to the 18 Department by certified check or money order within 30 19 calendar days of the notification. If, after the expiration 20 of 30 days from the date of the notification, the person has 21 failed to submit the necessary remittance, the Department 22 shall automatically terminate the license or certificate or 23 deny the application, without hearing. If, after termination 24 or denial, the person seeks a license or certificate, he or 25 she shall apply to the Department for restoration or issuance 26 of the license or certificate and pay all fees and fines due 27 to the Department. The Department may establish a fee for 28 the processing of an application for restoration of a license 29 or certificate to pay all expenses of processing this 30 application. The Director may waive the fines due under this 31 Section in individual cases where the Director finds that the 32 fines would be unreasonable or unnecessarily burdensome. 33 (d) The Department shall maintain a roster of the names 34 and addresses of all registrants and of all persons whose HB4003 Engrossed -8- LRB9213211ACmg 1 licenses have been suspended or revoked. This roster shall 2 be available upon written request and payment of the required 3 fee. 4 (Source: P.A. 91-239, eff. 1-1-00; 92-146, eff. 1-1-02.) 5 Section 99. Effective date. This Act takes effect upon 6 becoming law.