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1 | AN ACT concerning regulation.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 1. The Regulatory Sunset Act is amended by changing | ||||||
5 | Section 4.23 and by adding Section 4.33 as follows:
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6 | (5 ILCS 80/4.23)
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7 | Sec. 4.23. Acts and Sections repealed on January 1,
2013. | ||||||
8 | The following Acts and Sections of Acts are
repealed on January | ||||||
9 | 1, 2013:
| ||||||
10 | The Dietetic and Nutrition Services Practice Act.
| ||||||
11 | The Elevator Safety and Regulation Act.
| ||||||
12 | The Fire Equipment Distributor and Employee Regulation Act | ||||||
13 | of 2011. | ||||||
14 | The Funeral Directors and Embalmers Licensing Code.
| ||||||
15 | The Naprapathic Practice Act.
| ||||||
16 | The Professional Counselor and Clinical Professional | ||||||
17 | Counselor
Licensing Act.
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18 | The Wholesale Drug Distribution Licensing Act.
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19 | Section 2.5 of the Illinois Plumbing License Law.
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20 | (Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
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21 | (5 ILCS 80/4.33 new) | ||||||
22 | Sec. 4.33. Act repealed on January 1,
2023. The following |
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1 | Act is
repealed on January 1, 2023: | ||||||
2 | The Wholesale Drug Distribution Licensing Act. | ||||||
3 | Section 5. The Wholesale Drug Distribution Licensing Act is | ||||||
4 | amended by changing Sections 15, 20, 25, 26, 50, 55, and 59 and | ||||||
5 | by adding Section 173 as follows:
| ||||||
6 | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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7 | (Section scheduled to be repealed on January 1, 2013)
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8 | Sec. 15. Definitions. As used in this Act:
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9 | "Authentication" means the affirmative verification, | ||||||
10 | before any wholesale distribution of a prescription drug | ||||||
11 | occurs, that each transaction listed on the pedigree has | ||||||
12 | occurred. | ||||||
13 | "Authorized distributor of record" means a wholesale | ||||||
14 | distributor with whom a manufacturer has established an ongoing | ||||||
15 | relationship to distribute the manufacturer's prescription | ||||||
16 | drug. An ongoing relationship is deemed to exist between a | ||||||
17 | wholesale distributor and a manufacturer when the wholesale | ||||||
18 | distributor, including any affiliated group of the wholesale | ||||||
19 | distributor, as defined in Section 1504 of the Internal Revenue | ||||||
20 | Code, complies with the following: | ||||||
21 | (1) The wholesale distributor has a written agreement | ||||||
22 | currently in effect with the manufacturer evidencing the | ||||||
23 | ongoing relationship; and | ||||||
24 | (2) The wholesale distributor is listed on the |
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1 | manufacturer's current list of authorized distributors of | ||||||
2 | record, which is updated by the manufacturer on no less | ||||||
3 | than a monthly basis.
| ||||||
4 | "Blood" means whole blood collected from a single donor and | ||||||
5 | processed
either for transfusion or further manufacturing.
| ||||||
6 | "Blood component" means that part of blood separated by | ||||||
7 | physical or
mechanical means.
| ||||||
8 | "Board" means the State Board of Pharmacy of the Department | ||||||
9 | of
Professional Regulation.
| ||||||
10 | "Chain pharmacy warehouse" means a physical location for | ||||||
11 | prescription drugs that acts as a central warehouse and | ||||||
12 | performs intracompany sales or transfers of the drugs to a | ||||||
13 | group of chain or mail order pharmacies that have the same | ||||||
14 | common ownership and control. Notwithstanding any other | ||||||
15 | provision of this Act, a chain pharmacy warehouse shall be | ||||||
16 | considered part of the normal distribution channel. | ||||||
17 | "Co-licensed partner or product" means an instance where | ||||||
18 | one or more parties have the right to engage in the | ||||||
19 | manufacturing or marketing of a prescription drug, consistent | ||||||
20 | with the FDA's implementation of the Prescription Drug | ||||||
21 | Marketing Act.
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22 | "Department" means the Department of Financial and
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23 | Professional Regulation.
| ||||||
24 | "Drop shipment" means the sale of a prescription drug to a | ||||||
25 | wholesale distributor by the manufacturer of the prescription | ||||||
26 | drug or that manufacturer's co-licensed product partner, that |
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| |||||||
1 | manufacturer's third party logistics provider, or that | ||||||
2 | manufacturer's exclusive distributor or by an authorized | ||||||
3 | distributor of record that purchased the product directly from | ||||||
4 | the manufacturer or one of these entities whereby the wholesale | ||||||
5 | distributor or chain pharmacy warehouse takes title but not | ||||||
6 | physical possession of such prescription drug and the wholesale | ||||||
7 | distributor invoices the pharmacy, chain pharmacy warehouse, | ||||||
8 | or other person authorized by law to dispense or administer | ||||||
9 | such drug to a patient and the pharmacy, chain pharmacy | ||||||
10 | warehouse, or other authorized person receives delivery of the | ||||||
11 | prescription drug directly from the manufacturer, that | ||||||
12 | manufacturer's third party logistics provider, or that | ||||||
13 | manufacturer's exclusive distributor or from an authorized | ||||||
14 | distributor of record that purchased the product directly from | ||||||
15 | the manufacturer or one of these entities.
| ||||||
16 | "Drug sample" means a unit of a prescription drug that is | ||||||
17 | not intended to
be sold and is intended to promote the sale of | ||||||
18 | the drug.
| ||||||
19 | "Facility" means a facility of a wholesale distributor | ||||||
20 | where prescription drugs are stored, handled, repackaged, or | ||||||
21 | offered for sale. | ||||||
22 | "FDA" means the United States Food and Drug Administration.
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23 | "Manufacturer" means a person licensed or approved by the | ||||||
24 | FDA to engage in the manufacture of drugs or devices, | ||||||
25 | consistent with the definition of "manufacturer" set forth in | ||||||
26 | the FDA's regulations and guidances implementing the |
| |||||||
| |||||||
1 | Prescription Drug Marketing Act. | ||||||
2 | "Manufacturer's exclusive distributor" means anyone who | ||||||
3 | contracts with a manufacturer to provide or coordinate | ||||||
4 | warehousing, distribution, or other services on behalf of a | ||||||
5 | manufacturer and who takes title to that manufacturer's | ||||||
6 | prescription drug, but who does not have general responsibility | ||||||
7 | to direct the sale or disposition of the manufacturer's | ||||||
8 | prescription drug. A manufacturer's exclusive distributor must | ||||||
9 | be licensed as a wholesale distributor under this Act and, in | ||||||
10 | order to be considered part of the normal distribution channel, | ||||||
11 | must also be an authorized distributor of record.
| ||||||
12 | "Normal distribution channel" means a chain of custody for | ||||||
13 | a prescription drug that goes, directly or by drop shipment, | ||||||
14 | from (i) a manufacturer of the prescription drug, (ii) that | ||||||
15 | manufacturer to that manufacturer's co-licensed partner, (iii) | ||||||
16 | that manufacturer to that manufacturer's third party logistics | ||||||
17 | provider, or (iv) that manufacturer to that manufacturer's | ||||||
18 | exclusive distributor to: | ||||||
19 | (1) a pharmacy or to other designated persons | ||||||
20 | authorized by law to dispense or administer the drug to a | ||||||
21 | patient; | ||||||
22 | (2) a wholesale distributor to a pharmacy or other | ||||||
23 | designated persons authorized by law to dispense or | ||||||
24 | administer the drug to a patient; | ||||||
25 | (3) a wholesale distributor to a chain pharmacy | ||||||
26 | warehouse to that chain pharmacy warehouse's intracompany |
| |||||||
| |||||||
1 | pharmacy to a patient or other designated persons | ||||||
2 | authorized by law to dispense or administer the drug to a | ||||||
3 | patient; | ||||||
4 | (4) a chain pharmacy warehouse to the chain pharmacy | ||||||
5 | warehouse's intracompany pharmacy or other designated | ||||||
6 | persons authorized by law to dispense or administer the | ||||||
7 | drug to the patient; | ||||||
8 | (5) an authorized distributor of record to one other | ||||||
9 | authorized distributor of record to an office-based health | ||||||
10 | care practitioner authorized by law to dispense or | ||||||
11 | administer the drug to the patient; or | ||||||
12 | (6) an authorized distributor to a pharmacy or other | ||||||
13 | persons licensed to dispense or administer the drug. | ||||||
14 | "Pedigree" means a document or electronic file containing | ||||||
15 | information that records each wholesale distribution of any | ||||||
16 | given prescription drug from the point of origin to the final | ||||||
17 | wholesale distribution point of any given prescription drug.
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18 | "Person" means and includes a natural person, partnership, | ||||||
19 | association , or
corporation , or any other legal business | ||||||
20 | entity .
| ||||||
21 | "Pharmacy distributor" means any pharmacy licensed in this | ||||||
22 | State or
hospital pharmacy that is engaged in the delivery or | ||||||
23 | distribution of
prescription drugs either to any other pharmacy | ||||||
24 | licensed in this State or
to any other person or entity | ||||||
25 | including, but not limited to, a wholesale
drug distributor | ||||||
26 | engaged in the delivery or distribution of prescription
drugs |
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1 | who is involved in the actual, constructive, or attempted | ||||||
2 | transfer of
a drug in this State to other than the ultimate | ||||||
3 | consumer except as
otherwise provided for by law.
| ||||||
4 | "Prescription drug" means any human drug, including any | ||||||
5 | biological product (except for blood and blood components | ||||||
6 | intended for transfusion or biological products that are also | ||||||
7 | medical devices), required by federal law or
regulation to be | ||||||
8 | dispensed only by a prescription, including finished
dosage | ||||||
9 | forms and bulk drug substances
subject to Section
503 of the | ||||||
10 | Federal Food, Drug and Cosmetic Act.
| ||||||
11 | "Repackage" means repackaging or otherwise changing the | ||||||
12 | container, wrapper, or labeling to further the distribution of | ||||||
13 | a prescription drug, excluding that completed by the pharmacist | ||||||
14 | responsible for dispensing the product to a patient. | ||||||
15 | "Secretary" means the Secretary of Financial and | ||||||
16 | Professional Regulation. | ||||||
17 | "Third party logistics provider" means anyone who | ||||||
18 | contracts with a prescription drug manufacturer to provide or | ||||||
19 | coordinate warehousing, distribution, or other services on | ||||||
20 | behalf of a manufacturer, but does not take title to the | ||||||
21 | prescription drug or have general responsibility to direct the | ||||||
22 | prescription drug's sale or disposition. A third party | ||||||
23 | logistics provider must be licensed as a wholesale distributor | ||||||
24 | under this Act and, in order to be considered part of the | ||||||
25 | normal distribution channel, must also be an authorized | ||||||
26 | distributor of record. |
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1 | "Wholesale distribution"
means the distribution
of | ||||||
2 | prescription drugs to persons other than a consumer or patient, | ||||||
3 | but does
not include any of the following:
| ||||||
4 | (1)
Intracompany sales of prescription drugs, meaning | ||||||
5 | (i) any transaction or transfer
between any division, | ||||||
6 | subsidiary, parent, or affiliated or related company
under | ||||||
7 | the common ownership and control of a corporate entity or | ||||||
8 | (ii) any transaction or transfer between co-licensees of a | ||||||
9 | co-licensed product.
| ||||||
10 | (2) The sale, purchase, distribution, trade, or | ||||||
11 | transfer of a prescription drug or offer to sell, purchase, | ||||||
12 | distribute, trade, or transfer a prescription drug for | ||||||
13 | emergency medical reasons.
| ||||||
14 | (3) The distribution of prescription drug samples by | ||||||
15 | manufacturers' representatives. | ||||||
16 | (4) Drug returns, when conducted by a hospital, health | ||||||
17 | care entity, or charitable institution in accordance with | ||||||
18 | federal regulation. | ||||||
19 | (5) The sale of minimal quantities of prescription | ||||||
20 | drugs by licensed retail pharmacies to licensed | ||||||
21 | practitioners for office use or other licensed pharmacies . | ||||||
22 | (6) The sale, purchase, or trade of a drug, an offer to | ||||||
23 | sell, purchase, or trade a drug, or the dispensing of a | ||||||
24 | drug pursuant to a prescription. | ||||||
25 | (7) The sale, transfer, merger, or consolidation of all | ||||||
26 | or part of the business of a pharmacy or pharmacies from or |
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1 | with another pharmacy or pharmacies, whether accomplished | ||||||
2 | as a purchase and sale of stock or business assets. | ||||||
3 | (8) The sale, purchase, distribution, trade, or | ||||||
4 | transfer of a prescription drug from one authorized | ||||||
5 | distributor of record to one additional authorized | ||||||
6 | distributor of record when the manufacturer has stated in | ||||||
7 | writing to the receiving authorized distributor of record | ||||||
8 | that the manufacturer is unable to supply the prescription | ||||||
9 | drug and the supplying authorized distributor of record | ||||||
10 | states in writing that the prescription drug being supplied | ||||||
11 | had until that time been exclusively in the normal | ||||||
12 | distribution channel. | ||||||
13 | (9) The delivery of or the offer to deliver a | ||||||
14 | prescription drug by a common carrier solely in the common | ||||||
15 | carrier's usual course of business of transporting | ||||||
16 | prescription drugs when the common carrier does not store, | ||||||
17 | warehouse, or take legal ownership of the prescription | ||||||
18 | drug. | ||||||
19 | (10) The sale or transfer from a retail pharmacy, mail | ||||||
20 | order pharmacy, or chain pharmacy warehouse of expired, | ||||||
21 | damaged, returned, or recalled prescription drugs to the | ||||||
22 | original manufacturer, the originating wholesale | ||||||
23 | distributor, or a third party returns processor.
| ||||||
24 | "Wholesale drug distributor" means anyone
engaged in the
| ||||||
25 | wholesale distribution of prescription drugs into, out of, or | ||||||
26 | within the State , including without limitation
manufacturers; |
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| |||||||
1 | repackers; own label distributors; jobbers; private
label | ||||||
2 | distributors; brokers; warehouses, including manufacturers' | ||||||
3 | and
distributors' warehouses; manufacturer's exclusive | ||||||
4 | distributors; and authorized distributors of record; drug | ||||||
5 | wholesalers or distributors; independent wholesale drug | ||||||
6 | traders; specialty wholesale distributors; third party | ||||||
7 | logistics providers; and retail pharmacies that conduct | ||||||
8 | wholesale distribution; and chain pharmacy warehouses that | ||||||
9 | conduct wholesale distribution. In order to be considered part | ||||||
10 | of the normal distribution channel, a wholesale distributor | ||||||
11 | must also be an authorized distributor of record.
| ||||||
12 | (Source: P.A. 95-689, eff. 10-29-07.)
| ||||||
13 | (225 ILCS 120/20) (from Ch. 111, par. 8301-20)
| ||||||
14 | (Section scheduled to be repealed on January 1, 2013)
| ||||||
15 | Sec. 20. Prohibited drug purchases or receipt. It shall be | ||||||
16 | unlawful
for any person or entity located in this State to | ||||||
17 | knowingly purchase or receive any prescription
drug from any | ||||||
18 | source other than a person or entity required by the laws of | ||||||
19 | this State to be licensed to ship into, out of, or within this | ||||||
20 | State licensed under the
laws of this State or the state of | ||||||
21 | domicile except where otherwise
provided . A person or entity | ||||||
22 | licensed under the laws of this State shall
include, but is not | ||||||
23 | limited to, a wholesale distributor, manufacturer,
pharmacy | ||||||
24 | distributor, or pharmacy. Any person violating
this Section | ||||||
25 | shall, upon conviction, be adjudged guilty of a Class C
|
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| |||||||
1 | misdemeanor. A second violation shall constitute a Class 4 | ||||||
2 | felony.
| ||||||
3 | (Source: P.A. 87-594.)
| ||||||
4 | (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
| ||||||
5 | (Section scheduled to be repealed on January 1, 2013)
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6 | Sec. 25. Wholesale drug distributor licensing | ||||||
7 | requirements.
| ||||||
8 | (a) Every resident wholesale distributor who engages in the | ||||||
9 | wholesale distribution of prescription drugs must be licensed | ||||||
10 | by the Department, and every non-resident wholesale | ||||||
11 | distributor must be licensed in this State if it ships | ||||||
12 | prescription drugs into this State, in accordance with this | ||||||
13 | Act, before engaging in wholesale distributions of wholesale | ||||||
14 | prescription drugs.
| ||||||
15 | (b) The Department shall require without limitation all of | ||||||
16 | the following information from each applicant for licensure | ||||||
17 | under this Act: | ||||||
18 | (1) The name, full business address, and telephone | ||||||
19 | number of the licensee. | ||||||
20 | (2) All trade or business names used by the licensee. | ||||||
21 | (3) Addresses, telephone numbers, and the names of | ||||||
22 | contact persons for all facilities used by the licensee for | ||||||
23 | the storage, handling, and distribution of prescription | ||||||
24 | drugs. | ||||||
25 | (4) The type of ownership or operation, such as a |
| |||||||
| |||||||
1 | partnership, corporation, or sole proprietorship. | ||||||
2 | (5) The name of the owner or operator of the wholesale | ||||||
3 | distributor, including: | ||||||
4 | (A) if a natural person, the name of the natural | ||||||
5 | person; | ||||||
6 | (B) if a partnership, the name of each partner and | ||||||
7 | the name of the partnership; | ||||||
8 | (C) if a corporation, the name and title of each | ||||||
9 | corporate officer and director, the corporate names, | ||||||
10 | and the name of the state of incorporation; and | ||||||
11 | (D) if a sole proprietorship, the full name of the | ||||||
12 | sole proprietor and the name of the business entity. | ||||||
13 | (6) A list of all licenses and permits issued to the | ||||||
14 | applicant by any other state that authorizes the applicant | ||||||
15 | to purchase or possess prescription drugs. | ||||||
16 | (7) The name of the designated representative for the | ||||||
17 | wholesale distributor, together with the personal | ||||||
18 | information statement and fingerprints, as required under
| ||||||
19 | subsection (c) of this Section. | ||||||
20 | (8) Minimum liability insurance and other insurance as | ||||||
21 | defined by rule. | ||||||
22 | (9) Any additional information required by the | ||||||
23 | Department.
| ||||||
24 | (c) Each wholesale distributor must designate an | ||||||
25 | individual representative who shall serve as the contact person | ||||||
26 | for the Department. This representative must provide the
|
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| |||||||
1 | Department with all of the following information:
| ||||||
2 | (1) Information concerning whether the person has been | ||||||
3 | enjoined, either temporarily or permanently, by a court of | ||||||
4 | competent jurisdiction from violating any federal or State | ||||||
5 | law regulating the possession, control, or distribution of | ||||||
6 | prescription drugs or criminal violations, together with | ||||||
7 | details concerning any such event. | ||||||
8 | (2) A description of any involvement by the person with | ||||||
9 | any business, including any investments, other than the | ||||||
10 | ownership of stock in a publicly traded company or mutual | ||||||
11 | fund which manufactured, administered, prescribed, | ||||||
12 | distributed, or stored pharmaceutical products and any | ||||||
13 | lawsuits in which such businesses were named as a party. | ||||||
14 | (3) A description of any misdemeanor or felony criminal | ||||||
15 | offense of which the person, as an adult, was found guilty, | ||||||
16 | regardless of whether adjudication of guilt was withheld or | ||||||
17 | whether the person pled guilty or nolo contendere. If the | ||||||
18 | person indicates that a criminal conviction is under appeal | ||||||
19 | and submits a copy of the notice of appeal of that criminal | ||||||
20 | offense, the applicant must, within 15 days after the | ||||||
21 | disposition of the appeal, submit to the Department a copy | ||||||
22 | of the final written order of disposition. | ||||||
23 | (4) The designated representative of an applicant for | ||||||
24 | licensure as a wholesale drug distributor shall have his or | ||||||
25 | her fingerprints submitted to the Department of State | ||||||
26 | Police in an electronic format that complies with the form |
| |||||||
| |||||||
1 | and manner for requesting and furnishing criminal history | ||||||
2 | record information as prescribed by the Department of State | ||||||
3 | Police. These fingerprints shall be checked against the | ||||||
4 | Department of State Police and Federal Bureau of | ||||||
5 | Investigation criminal history record databases now and | ||||||
6 | hereafter filed. The Department of State Police shall | ||||||
7 | charge applicants a fee for conducting the criminal history | ||||||
8 | records check, which shall be deposited into the State | ||||||
9 | Police Services Fund and shall not exceed the actual cost | ||||||
10 | of the records check. The Department of State Police shall | ||||||
11 | furnish, pursuant to positive identification, records of | ||||||
12 | Illinois convictions to the Department. The Department may | ||||||
13 | require applicants to pay a separate fingerprinting fee, | ||||||
14 | either to the Department or to a vendor. The Department, in | ||||||
15 | its discretion, may allow an applicant who does not have | ||||||
16 | reasonable access to a designated vendor to provide his or | ||||||
17 | her fingerprints in an alternative manner. The Department | ||||||
18 | may adopt any rules necessary to implement this Section. | ||||||
19 | The designated representative of a licensee shall | ||||||
20 | receive and complete continuing training in applicable | ||||||
21 | federal and State laws governing the wholesale | ||||||
22 | distribution of prescription drugs.
| ||||||
23 | (d) The Department may not issue a wholesale distributor | ||||||
24 | license to an applicant, unless the Department first: | ||||||
25 | (1) ensures that a physical inspection of the facility | ||||||
26 | satisfactory to the Department has occurred at the address |
| |||||||
| |||||||
1 | provided by the applicant, as required under item (1) of | ||||||
2 | subsection (b) of this Section; and | ||||||
3 | (2) determines that the designated representative | ||||||
4 | meets each of the following qualifications: | ||||||
5 | (A) He or she is at least 21 years of age. | ||||||
6 | (B) He or she has been employed full-time for at | ||||||
7 | least 3 years in a pharmacy or with a wholesale | ||||||
8 | distributor in a capacity related to the dispensing and | ||||||
9 | distribution of, and recordkeeping relating to, | ||||||
10 | prescription drugs. | ||||||
11 | (C) He or she is employed by the applicant full | ||||||
12 | time in a managerial level position. | ||||||
13 | (D) He or she is actively involved in and aware of | ||||||
14 | the actual daily operation of the wholesale | ||||||
15 | distributor. | ||||||
16 | (E) He or she is physically present at the facility | ||||||
17 | of the applicant during regular business hours, except | ||||||
18 | when the absence of the designated representative is | ||||||
19 | authorized, including without limitation sick leave | ||||||
20 | and vacation leave. | ||||||
21 | (F) He or she is serving in the capacity of a | ||||||
22 | designated representative for only one applicant at a | ||||||
23 | time, except where more than one licensed wholesale | ||||||
24 | distributor is co-located in the same facility and such | ||||||
25 | wholesale distributors are members of an affiliated | ||||||
26 | group, as defined in Section 1504 of the Internal |
| |||||||
| |||||||
1 | Revenue Code.
| ||||||
2 | (e) If a wholesale distributor distributes prescription | ||||||
3 | drugs from more than one facility, the wholesale distributor | ||||||
4 | shall obtain a license for each facility.
| ||||||
5 | (f) The information provided under this Section may not be | ||||||
6 | disclosed to any person or entity other than the Department or | ||||||
7 | another government entity in need of such information for | ||||||
8 | licensing or monitoring purposes.
| ||||||
9 | (Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
| ||||||
10 | (225 ILCS 120/26)
| ||||||
11 | (Section scheduled to be repealed on January 1, 2013)
| ||||||
12 | Sec. 26. Unlicensed practice; violation; civil penalty.
| ||||||
13 | (a) Any person who practices, offers to practice, attempts | ||||||
14 | to practice, or
holds oneself out to practice as a wholesale | ||||||
15 | drug distributor or pharmacy
distributor without being | ||||||
16 | licensed to ship into, out of, or within the State under this | ||||||
17 | Act shall, in
addition to any other penalty provided by law, | ||||||
18 | pay a civil penalty to the
Department in an amount not to | ||||||
19 | exceed $10,000 $5,000 for each offense as determined by
the | ||||||
20 | Department. The civil penalty shall be assessed by the | ||||||
21 | Department after a
hearing is held in accordance with the | ||||||
22 | provisions set forth in this Act
regarding the provision of a | ||||||
23 | hearing for the discipline of a licensee.
| ||||||
24 | (b) The Department has the authority and power to | ||||||
25 | investigate any and all
unlicensed activity.
|
| |||||||
| |||||||
1 | (c) The civil penalty shall be paid within 60 days after | ||||||
2 | the effective date
of the order imposing the civil penalty. The | ||||||
3 | order shall constitute a judgment
and may be filed and | ||||||
4 | execution had thereon in the same manner as any judgment
from | ||||||
5 | any court of record.
| ||||||
6 | (Source: P.A. 89-474, eff. 6-18-96.)
| ||||||
7 | (225 ILCS 120/50) (from Ch. 111, par. 8301-50)
| ||||||
8 | (Section scheduled to be repealed on January 1, 2013)
| ||||||
9 | Sec. 50. Inspection powers; access to records.
| ||||||
10 | (a) Any pharmacy investigator authorized by the Department
| ||||||
11 | has the right of entry for inspection during normal business | ||||||
12 | hours
of premises purporting or appearing to be used by a | ||||||
13 | wholesale
drug distributor in this State , including the | ||||||
14 | business premises of a person licensed pursuant to this Act. | ||||||
15 | This right of entry shall permit the authorized pharmacy | ||||||
16 | investigator unfettered access to the entire business | ||||||
17 | premises. Any attempt to hinder an authorized pharmacy | ||||||
18 | investigator from inspecting the business premises and | ||||||
19 | documenting the inspection shall be a violation of this Act . | ||||||
20 | The duly authorized investigators shall be
required to show | ||||||
21 | appropriate identification before being given access to a
| ||||||
22 | wholesale drug distributor's premises and delivery vehicles. | ||||||
23 | Any wholesale
drug distributor providing adequate | ||||||
24 | documentation of the most recent
satisfactory inspection less | ||||||
25 | than 3 years old of the distributor's
wholesale drug |
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1 | distribution activities and facilities by either the U.S.
FDA, | ||||||
2 | a State agency, or any person or entity lawfully designated by | ||||||
3 | a State
agency to perform an inspection determined to be | ||||||
4 | comparable by the
Department shall be exempt from further | ||||||
5 | inspection for a period of time to
be determined by the | ||||||
6 | Department. The exemption shall not bar the
Department from | ||||||
7 | initiating an investigation of a public or governmental
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8 | complaint received by the Department regarding a wholesale drug
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9 | distributor. Wholesale drug distributors shall be given an | ||||||
10 | opportunity to
correct minor violations determined by these | ||||||
11 | investigations.
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12 | (b) With the exception of the most recent 12 months of | ||||||
13 | records that must be kept on the premises where the drugs are | ||||||
14 | stored, wholesale Wholesale drug distributors may keep records | ||||||
15 | regarding purchase and
sales transactions electronically at a | ||||||
16 | central location apart from the principal office of
the | ||||||
17 | wholesale drug distributor or the location at which the drugs | ||||||
18 | were
stored and from which they were shipped, provided that the | ||||||
19 | records shall
be made readily available for inspection within 2 | ||||||
20 | working days of a request by the
Department. The records may be | ||||||
21 | kept in any form permissible under federal
law applicable to | ||||||
22 | prescription drugs record keeping.
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23 | (c) (Blank).
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24 | (Source: P.A. 94-942, eff. 1-1-07.)
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25 | (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
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1 | (Section scheduled to be repealed on January 1, 2013)
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2 | Sec. 55. Discipline; grounds.
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3 | (a) The Department may refuse to issue, restore, or renew, | ||||||
4 | or may revoke,
suspend, place on probation, reprimand or take | ||||||
5 | other disciplinary or non-disciplinary action as
the | ||||||
6 | Department may deem appropriate, including imposing fines not | ||||||
7 | to exceed $10,000 for each violation, with regard to any | ||||||
8 | applicant or licensee or any officer, director, manager, or | ||||||
9 | shareholder who owns 5% or more interest in the business that | ||||||
10 | holds the license proper for any one or a combination of the | ||||||
11 | following reasons:
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12 | (1) Violation of this Act or of the its rules adopted | ||||||
13 | under this Act .
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14 | (2) Aiding or assisting another person in violating any | ||||||
15 | provision of
this Act or the its rules adopted under this | ||||||
16 | Act .
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17 | (3) Failing, within 60 days, to provide information in | ||||||
18 | response respond to a written requirement made by
the | ||||||
19 | Department for information .
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20 | (4) Engaging in dishonorable, unethical, or | ||||||
21 | unprofessional conduct of a
character likely to deceive, | ||||||
22 | defraud, or harm the public. This includes
violations of | ||||||
23 | "good faith" as defined by the Illinois Controlled | ||||||
24 | Substances
Act and applies to all prescription drugs.
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25 | (5) Discipline by another U.S. jurisdiction or foreign | ||||||
26 | nation, if at
least one of the grounds for the discipline |
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1 | is the same or substantially
equivalent to those set forth | ||||||
2 | in this Act.
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3 | (6) Selling or engaging in the sale of drug samples | ||||||
4 | provided at no cost
by drug manufacturers.
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5 | (7) Conviction by of or entry of a plea of guilty or | ||||||
6 | nolo contendere , finding of guilt, jury verdict, or entry | ||||||
7 | of judgment or by sentencing of any crime, including, but | ||||||
8 | not limited to, convictions, preceding sentences of | ||||||
9 | supervision, conditional discharge, or first offender | ||||||
10 | probation, under the laws of any jurisdiction of the United | ||||||
11 | States (i) by the applicant or licensee, or any officer, | ||||||
12 | director,
manager or shareholder who owns more than 5% of | ||||||
13 | stock, to any crime under the laws of the United States or | ||||||
14 | any state or territory of the United States that is a | ||||||
15 | felony or (ii) a misdemeanor, of which an essential element | ||||||
16 | of which is dishonesty , or any crime that is directly | ||||||
17 | related to the practice of this profession.
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18 | (8) Habitual or excessive use or addiction to alcohol, | ||||||
19 | narcotics,
stimulants, or any other chemical agent or drug | ||||||
20 | by the designated representative, as provided for in item | ||||||
21 | (7) of subsection (b) of Section 25 of this Act, any | ||||||
22 | officer, or director that results in the
inability to | ||||||
23 | function with reasonable judgment, skill, or safety.
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24 | (b) The Department may refuse to issue, restore, or renew, | ||||||
25 | or may
revoke, suspend, place on probation, reprimand or take | ||||||
26 | other disciplinary
action as the Department may deem property |
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1 | including fines not to exceed
$10,000 per offense
for any of | ||||||
2 | the following reasons:
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3 | (9) (1) Material misstatement in furnishing | ||||||
4 | information to the Department.
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5 | (2) Making any misrepresentation for the purpose of | ||||||
6 | obtaining a license.
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7 | (10) (3) A finding by the Department that the licensee, | ||||||
8 | after having his
or her license placed on probationary | ||||||
9 | status, has violated the terms of
probation.
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10 | (11) Fraud or misrepresentation in applying for, or | ||||||
11 | procuring, a license under this Act or in connection with | ||||||
12 | applying for renewal of a license under this Act. (4) A | ||||||
13 | finding that licensure or registration has been applied for | ||||||
14 | or
obtained by fraudulent means.
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15 | (12) (5) Willfully making or filing false records or | ||||||
16 | reports.
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17 | (13) (6) A finding of a substantial discrepancy in a | ||||||
18 | Department audit
of a prescription drug, including a | ||||||
19 | controlled substance as that term is
defined in this Act or | ||||||
20 | in the Illinois Controlled Substances Act.
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21 | (14) Falsifying a pedigree or selling, distributing, | ||||||
22 | transferring, manufacturing, repackaging, handling, or | ||||||
23 | holding a counterfeit prescription drug intended for human | ||||||
24 | use. | ||||||
25 | (15) Interfering with a Department investigation. | ||||||
26 | (16) Failing to adequately secure controlled |
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1 | substances or other prescription drugs from diversion. | ||||||
2 | (17) Acquiring or distributing prescription drugs not | ||||||
3 | obtained from a source licensed by the Department. | ||||||
4 | (18) Failing to properly store drugs. | ||||||
5 | (19) Failing to maintain the licensed premises with | ||||||
6 | proper storage and security controls. | ||||||
7 | (b) (c) The Department may refuse to issue or may suspend | ||||||
8 | the license or
registration of any person who fails to file a | ||||||
9 | return, or to pay the tax,
penalty or interest shown in a filed | ||||||
10 | return, or to pay any final assessment
of tax, penalty or | ||||||
11 | interest, as required by any tax Act administered by the
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12 | Illinois Department of Revenue, until the time the requirements | ||||||
13 | of
the tax Act are satisfied.
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14 | (c) (d) The Department shall revoke the license or | ||||||
15 | certificate of
registration issued under this Act or any prior | ||||||
16 | Act of
this State of any person who has been convicted a second | ||||||
17 | time of committing
any felony under the Illinois Controlled | ||||||
18 | Substances Act or the Methamphetamine Control and Community | ||||||
19 | Protection Act
or who
has been convicted a second time of | ||||||
20 | committing a Class 1 felony under
Sections 8A-3 and 8A-6 of the | ||||||
21 | Illinois Public Aid Code. A
person whose license or certificate | ||||||
22 | of registration issued under
this Act or any prior Act of this | ||||||
23 | State is revoked under this
subsection (b) (c) shall be | ||||||
24 | prohibited from engaging in the practice of
pharmacy in this | ||||||
25 | State.
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26 | (Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07; |
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1 | revised 11-18-11.)
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2 | (225 ILCS 120/59)
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3 | (Section scheduled to be repealed on January 1, 2013) | ||||||
4 | Sec. 59. Injunctive action; cease and desist order. | ||||||
5 | Enforcement; order to cease distribution of a drug. | ||||||
6 | (a) If any person violates the provisions of this Act, the | ||||||
7 | Secretary, in the name of the People of the State of Illinois, | ||||||
8 | through the Attorney General or the State's Attorney of the | ||||||
9 | county where the violation is alleged to have occurred, may | ||||||
10 | petition for an order enjoining the violation or for an order | ||||||
11 | enforcing compliance with this Act. Upon the filing of a | ||||||
12 | verified petition, the court with appropriate jurisdiction may | ||||||
13 | issue a temporary restraining order, without notice or bond, | ||||||
14 | and may preliminarily and permanently enjoin the violation. If | ||||||
15 | it is established that the person has violated or is violating | ||||||
16 | the injunction, then the court may punish the offender for | ||||||
17 | contempt of court. Proceedings under this Section are in | ||||||
18 | addition to, and not in lieu of, all other remedies and | ||||||
19 | penalties provided by this Act. The Department shall issue an | ||||||
20 | order requiring the appropriate person, including the | ||||||
21 | distributors or retailers of a drug, to immediately cease | ||||||
22 | distribution of the drug within this State, if the Department | ||||||
23 | finds that there is a reasonable probability that: | ||||||
24 | (1) a wholesale distributor has (i) violated a | ||||||
25 | provision in this Act or (ii) falsified a pedigree or sold, |
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1 | distributed, transferred, manufactured, repackaged, | ||||||
2 | handled, or held a counterfeit prescription drug intended | ||||||
3 | for human use; | ||||||
4 | (2) the prescription drug at issue, as a result of a | ||||||
5 | violation in paragraph (1) of this subsection (a), could | ||||||
6 | cause serious, adverse health consequences or death; and | ||||||
7 | (3) other procedures would result in unreasonable | ||||||
8 | delay. | ||||||
9 | (b) Whenever, in the opinion of the Department, a person | ||||||
10 | violates any provision of this Act, the Department may issue a | ||||||
11 | rule to show cause why an order to cease and desist shall not | ||||||
12 | be entered against that person. The rule shall clearly set | ||||||
13 | forth the grounds relied upon by the Department and shall allow | ||||||
14 | a person at least 7 days after the date of the rule to file an | ||||||
15 | answer satisfactory to the Department. Failure to answer to the | ||||||
16 | satisfaction of the Department shall cause an order to cease | ||||||
17 | and desist to be issued. An order issued under this Section | ||||||
18 | shall provide the person subject to the order with an | ||||||
19 | opportunity for an informal hearing, to be held not later than | ||||||
20 | 10 days after the date of the issuance of the order, on the | ||||||
21 | actions required by the order. If, after providing an | ||||||
22 | opportunity for a hearing, the Department determines that | ||||||
23 | inadequate grounds exist to support the actions required by the | ||||||
24 | order, the Department shall vacate the order.
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25 | (Source: P.A. 95-689, eff. 10-29-07.) |
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1 | (225 ILCS 120/173 new) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2 | Sec. 173. Confidentiality. All information collected by | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
3 | the Department in the course of an examination or investigation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
4 | of a licensee or applicant, including, but not limited to, any | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
5 | complaint against a licensee filed with the Department and | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
6 | information collected to investigate any such complaint, shall | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
7 | be maintained for the confidential use of the Department and | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
8 | shall not be disclosed. The Department may not disclose the | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
9 | information to anyone other than law enforcement officials, | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
10 | other regulatory agencies that have an appropriate regulatory | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
11 | interest as determined by the Secretary, or a party presenting | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
12 | a lawful subpoena to the Department. Information and documents | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
13 | disclosed to a federal, State, county, or local law enforcement | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
14 | agency shall not be disclosed by the agency for any purpose to | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
15 | any other agency or person. A formal complaint filed against a | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
16 | licensee by the Department or any order issued by the | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
17 | Department against a licensee or applicant shall be a public | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
18 | record, except as otherwise prohibited by law.
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19 | Section 99. Effective date. This Act takes effect on | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
20 | January 1, 2013.
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