Full Text of SB2935 97th General Assembly
SB2935eng 97TH GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 2 | | Be it enacted by the People of the State of Illinois,
| 3 | | represented in the General Assembly:
| 4 | | Section 1. The Regulatory Sunset Act is amended by changing | 5 | | Section 4.23 and by adding Section 4.33 as follows:
| 6 | | (5 ILCS 80/4.23)
| 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 Acts and Sections repealed on January 1,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repealed on January | 9 | | 1, 2013: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.
| 18 | | The Wholesale Drug Distribution Licensing Act.
| 19 | | Section 2.5 of the Illinois Plumbing License Law.
| 20 | | (Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
| 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 Act repealed on January 1,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repealed on January 1, 2023: | 2 | | The Wholesale Drug Distribution Licensing Act.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)
| 7 | | (Section scheduled to be repealed on January 1, 2013)
| 8 | | Sec. 15. Definitions. As used in this Act:
| 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.
| 22 | | "Department" means the Department of Financial and
| 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.
| 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 |
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| 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 |
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| 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.
| 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)
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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.
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| 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
| 8 | | complaint received by the Department regarding a wholesale drug
| 9 | | distributor. Wholesale drug distributors shall be given an | 10 | | opportunity to
correct minor violations determined by these | 11 | | investigations.
| 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.
| 23 | | (c) (Blank).
| 24 | | (Source: P.A. 94-942, eff. 1-1-07.)
| 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)
| 2 | | Sec. 55. Discipline; grounds.
| 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:
| 12 | | (1) Violation of this Act or of the its rules adopted | 13 | | under this Act .
| 14 | | (2) Aiding or assisting another person in violating any | 15 | | provision of
this Act or the its rules adopted under this | 16 | | Act .
| 17 | | (3) Failing, within 60 days, to provide information in | 18 | | response respond to a written requirement made by
the | 19 | | Department for information .
| 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.
| 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.
| 3 | | (6) Selling or engaging in the sale of drug samples | 4 | | provided at no cost
by drug manufacturers.
| 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.
| 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.
| 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:
| 3 | | (9) (1) Material misstatement in furnishing | 4 | | information to the Department.
| 5 | | (2) Making any misrepresentation for the purpose of | 6 | | obtaining a license.
| 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.
| 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.
| 15 | | (12) (5) Willfully making or filing false records or | 16 | | reports.
| 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.
| 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
| 12 | | Illinois Department of Revenue, until the time the requirements | 13 | | of
the tax Act are satisfied.
| 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.
| 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.)
| 2 | | (225 ILCS 120/59)
| 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.
| 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.
| 19 | | Section 99. Effective date. This Act takes effect on | 20 | | January 1, 2013.
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| 1 | |
INDEX
| 2 | |
Statutes amended in order of appearance
| | 3 | | 5 ILCS 80/4.23 | | | 4 | | 5 ILCS 80/4.33 new | | | 5 | | 225 ILCS 120/15 | from Ch. 111, par. 8301-15 | | 6 | | 225 ILCS 120/20 | from Ch. 111, par. 8301-20 | | 7 | | 225 ILCS 120/25 | from Ch. 111, par. 8301-25 | | 8 | | 225 ILCS 120/26 | | | 9 | | 225 ILCS 120/50 | from Ch. 111, par. 8301-50 | | 10 | | 225 ILCS 120/55 | from Ch. 111, par. 8301-55 | | 11 | | 225 ILCS 120/59 | | | 12 | | 225 ILCS 120/173 new | |
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