Full Text of SB2935 97th General Assembly
SB2935 97TH GENERAL ASSEMBLY |
| | 97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012 SB2935 Introduced 2/1/2012, by Sen. Iris Y. Martinez SYNOPSIS AS INTRODUCED: |
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Amends the Wholesale Drug Distribution Licensing Act. Provides that any person who practices, offers to practice, attempts to practice, or
holds oneself out to practice as a wholesale drug distributor or pharmacy
distributor without being licensed under the Act shall pay a civil penalty to the
Department of Financial and Professional Regulation in an amount not to exceed $10,000 (instead of $5,000) per violation for each offense. Provides that any pharmacy investigator authorized by the Department
has the right of entry that includes the business premises of a person licensed pursuant to the Act. Permits the authorized pharmacy investigator unfettered access to the entire business premises. Provides that the most recent 12 months of record must be kept on the premises where the drugs are stored. Allows the Department to take action, including imposing fines not to exceed $10,000 per violation, if the individual meets the requirements for grounds for disciplinary action. Provides that if any person violates the provisions of the Act, the Secretary may petition for an order enjoining the violation or for an order enforcing compliance with the Act. Provides that the Department may issue a rule to show cause why an order to cease and desist shall not be entered against that person. Makes other changes. Amends the Regulatory Sunset Act to extend the repeal of the Wholesale Drug Distribution Licensing Act from January 1, 2013 to January 1, 2023. Effective immediately.
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| | | FISCAL NOTE ACT MAY APPLY | |
| | A BILL FOR |
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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 Acts and Sections repealed on January 1,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repealed on January | 9 | | 1, 2013: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 licensed under the
laws of | 19 | | this State or the state of domicile except where otherwise
| 20 | | provided . A person or entity licensed under the laws of this | 21 | | State shall
include, but is not limited to, a wholesale | 22 | | distributor, manufacturer,
pharmacy distributor, or pharmacy. | 23 | | Any person violating
this Section shall, upon conviction, be | 24 | | adjudged guilty of a Class C
misdemeanor. A second violation | 25 | | shall constitute a Class 4 felony.
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| 1 | | (Source: P.A. 87-594.)
| 2 | | (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
| 3 | | (Section scheduled to be repealed on January 1, 2013)
| 4 | | Sec. 25. Wholesale drug distributor licensing | 5 | | requirements.
| 6 | | (a) Every resident wholesale distributor who engages in the | 7 | | wholesale distribution of prescription drugs must be licensed | 8 | | by the Department, and every non-resident wholesale | 9 | | distributor must be licensed in this State if it ships | 10 | | prescription drugs into this State, in accordance with this | 11 | | Act, before engaging in wholesale distributions of wholesale | 12 | | prescription drugs.
| 13 | | (b) The Department shall require without limitation all of | 14 | | the following information from each applicant for licensure | 15 | | under this Act: | 16 | | (1) The name, full business address, and telephone | 17 | | number of the licensee. | 18 | | (2) All trade or business names used by the licensee. | 19 | | (3) Addresses, telephone numbers, and the names of | 20 | | contact persons for all facilities used by the licensee for | 21 | | the storage, handling, and distribution of prescription | 22 | | drugs. | 23 | | (4) The type of ownership or operation, such as a | 24 | | partnership, corporation, or sole proprietorship. | 25 | | (5) The name of the owner or operator of the wholesale |
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| 1 | | distributor, including: | 2 | | (A) if a natural person, the name of the natural | 3 | | person; | 4 | | (B) if a partnership, the name of each partner and | 5 | | the name of the partnership; | 6 | | (C) if a corporation, the name and title of each | 7 | | corporate officer and director, the corporate names, | 8 | | and the name of the state of incorporation; and | 9 | | (D) if a sole proprietorship, the full name of the | 10 | | sole proprietor and the name of the business entity. | 11 | | (6) A list of all licenses and permits issued to the | 12 | | applicant by any other state that authorizes the applicant | 13 | | to purchase or possess prescription drugs. | 14 | | (7) The name of the designated representative for the | 15 | | wholesale distributor, together with the personal | 16 | | information statement and fingerprints, as required under
| 17 | | subsection (c) of this Section. | 18 | | (8) Minimum liability insurance and other insurance as | 19 | | defined by rule. | 20 | | (9) Any additional information required by the | 21 | | Department.
| 22 | | (c) Each wholesale distributor must designate an | 23 | | individual representative who shall serve as the contact person | 24 | | for the Department. This representative must provide the
| 25 | | Department with all of the following information:
| 26 | | (1) Information concerning whether the person has been |
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| 1 | | enjoined, either temporarily or permanently, by a court of | 2 | | competent jurisdiction from violating any federal or State | 3 | | law regulating the possession, control, or distribution of | 4 | | prescription drugs or criminal violations, together with | 5 | | details concerning any such event. | 6 | | (2) A description of any involvement by the person with | 7 | | any business, including any investments, other than the | 8 | | ownership of stock in a publicly traded company or mutual | 9 | | fund which manufactured, administered, prescribed, | 10 | | distributed, or stored pharmaceutical products and any | 11 | | lawsuits in which such businesses were named as a party. | 12 | | (3) A description of any misdemeanor or felony criminal | 13 | | offense of which the person, as an adult, was found guilty, | 14 | | regardless of whether adjudication of guilt was withheld or | 15 | | whether the person pled guilty or nolo contendere. If the | 16 | | person indicates that a criminal conviction is under appeal | 17 | | and submits a copy of the notice of appeal of that criminal | 18 | | offense, the applicant must, within 15 days after the | 19 | | disposition of the appeal, submit to the Department a copy | 20 | | of the final written order of disposition. | 21 | | (4) The designated representative of an applicant for | 22 | | licensure as a wholesale drug distributor shall have his or | 23 | | her fingerprints submitted to the Department of State | 24 | | Police in an electronic format that complies with the form | 25 | | and manner for requesting and furnishing criminal history | 26 | | record information as prescribed by the Department of State |
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| 1 | | Police. These fingerprints shall be checked against the | 2 | | Department of State Police and Federal Bureau of | 3 | | Investigation criminal history record databases now and | 4 | | hereafter filed. The Department of State Police shall | 5 | | charge applicants a fee for conducting the criminal history | 6 | | records check, which shall be deposited into the State | 7 | | Police Services Fund and shall not exceed the actual cost | 8 | | of the records check. The Department of State Police shall | 9 | | furnish, pursuant to positive identification, records of | 10 | | Illinois convictions to the Department. The Department may | 11 | | require applicants to pay a separate fingerprinting fee, | 12 | | either to the Department or to a vendor. The Department, in | 13 | | its discretion, may allow an applicant who does not have | 14 | | reasonable access to a designated vendor to provide his or | 15 | | her fingerprints in an alternative manner. The Department | 16 | | may adopt any rules necessary to implement this Section. | 17 | | The designated representative of a licensee shall | 18 | | receive and complete continuing training in applicable | 19 | | federal and State laws governing the wholesale | 20 | | distribution of prescription drugs.
| 21 | | (d) The Department may not issue a wholesale distributor | 22 | | license to an applicant, unless the Department first: | 23 | | (1) ensures that a physical inspection of the facility | 24 | | satisfactory to the Department has occurred at the address | 25 | | provided by the applicant, as required under item (1) of | 26 | | subsection (b) of this Section; and |
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| 1 | | (2) determines that the designated representative | 2 | | meets each of the following qualifications: | 3 | | (A) He or she is at least 21 years of age. | 4 | | (B) He or she has been employed full-time for at | 5 | | least 3 years in a pharmacy or with a wholesale | 6 | | distributor in a capacity related to the dispensing and | 7 | | distribution of, and recordkeeping relating to, | 8 | | prescription drugs. | 9 | | (C) He or she is employed by the applicant full | 10 | | time in a managerial level position. | 11 | | (D) He or she is actively involved in and aware of | 12 | | the actual daily operation of the wholesale | 13 | | distributor. | 14 | | (E) He or she is physically present at the facility | 15 | | of the applicant during regular business hours, except | 16 | | when the absence of the designated representative is | 17 | | authorized, including without limitation sick leave | 18 | | and vacation leave. | 19 | | (F) He or she is serving in the capacity of a | 20 | | designated representative for only one applicant at a | 21 | | time, except where more than one licensed wholesale | 22 | | distributor is co-located in the same facility and such | 23 | | wholesale distributors are members of an affiliated | 24 | | group, as defined in Section 1504 of the Internal | 25 | | Revenue Code.
| 26 | | (e) If a wholesale distributor distributes prescription |
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| 1 | | drugs from more than one facility, the wholesale distributor | 2 | | shall obtain a license for each facility.
| 3 | | (f) The information provided under this Section may not be | 4 | | disclosed to any person or entity other than the Department or | 5 | | another government entity in need of such information for | 6 | | licensing or monitoring purposes.
| 7 | | (Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
| 8 | | (225 ILCS 120/26)
| 9 | | (Section scheduled to be repealed on January 1, 2013)
| 10 | | Sec. 26. Unlicensed practice; violation; civil penalty.
| 11 | | (a) Any person who practices, offers to practice, attempts | 12 | | to practice, or
holds oneself out to practice as a wholesale | 13 | | drug distributor or pharmacy
distributor without being | 14 | | licensed under this Act shall, in
addition to any other penalty | 15 | | provided by law, pay a civil penalty to the
Department in an | 16 | | amount not to exceed $10,000 $5,000 for each offense as | 17 | | determined by
the Department. The civil penalty shall be | 18 | | assessed by the Department after a
hearing is held in | 19 | | accordance with the provisions set forth in this Act
regarding | 20 | | the provision of a hearing for the discipline of a licensee.
| 21 | | (b) The Department has the authority and power to | 22 | | investigate any and all
unlicensed activity.
| 23 | | (c) The civil penalty shall be paid within 60 days after | 24 | | the effective date
of the order imposing the civil penalty. The | 25 | | order shall constitute a judgment
and may be filed and |
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| 1 | | execution had thereon in the same manner as any judgment
from | 2 | | any court of record.
| 3 | | (Source: P.A. 89-474, eff. 6-18-96.)
| 4 | | (225 ILCS 120/50) (from Ch. 111, par. 8301-50)
| 5 | | (Section scheduled to be repealed on January 1, 2013)
| 6 | | Sec. 50. Inspection powers; access to records.
| 7 | | (a) Any pharmacy investigator authorized by the Department
| 8 | | has the right of entry for inspection during normal business | 9 | | hours
of premises purporting or appearing to be used by a | 10 | | wholesale
drug distributor in this State , including the | 11 | | business premises of a person licensed pursuant to this Act. | 12 | | This right of entry shall permit the authorized pharmacy | 13 | | investigator unfettered access to the entire business | 14 | | premises. Any attempt to hinder an authorized pharmacy | 15 | | investigator from inspecting the business premises and | 16 | | documenting the inspection shall be a violation of this Act . | 17 | | The duly authorized investigators shall be
required to show | 18 | | appropriate identification before being given access to a
| 19 | | wholesale drug distributor's premises and delivery vehicles. | 20 | | Any wholesale
drug distributor providing adequate | 21 | | documentation of the most recent
satisfactory inspection less | 22 | | than 3 years old of the distributor's
wholesale drug | 23 | | distribution activities and facilities by either the U.S.
FDA, | 24 | | a State agency, or any person or entity lawfully designated by | 25 | | a State
agency to perform an inspection determined to be |
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| 1 | | comparable by the
Department shall be exempt from further | 2 | | inspection for a period of time to
be determined by the | 3 | | Department. The exemption shall not bar the
Department from | 4 | | initiating an investigation of a public or governmental
| 5 | | complaint received by the Department regarding a wholesale drug
| 6 | | distributor. Wholesale drug distributors shall be given an | 7 | | opportunity to
correct minor violations determined by these | 8 | | investigations.
| 9 | | (b) With the exception of the most recent 12 months of | 10 | | records that must be kept on the premises where the drugs are | 11 | | stored, wholesale Wholesale drug distributors may keep records | 12 | | regarding purchase and
sales transactions at a central location | 13 | | apart from the principal office of
the wholesale drug | 14 | | distributor or the location at which the drugs were
stored and | 15 | | from which they were shipped, provided that the records shall
| 16 | | be made available for inspection within 2 working days of a | 17 | | request by the
Department. The records may be kept in any form | 18 | | permissible under federal
law applicable to prescription drugs | 19 | | record keeping.
| 20 | | (c) (Blank).
| 21 | | (Source: P.A. 94-942, eff. 1-1-07.)
| 22 | | (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
| 23 | | (Section scheduled to be repealed on January 1, 2013)
| 24 | | Sec. 55. Discipline; grounds.
| 25 | | (a) The Department may refuse to issue, restore, or renew, |
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| 1 | | or may revoke,
suspend, place on probation, reprimand or take | 2 | | other disciplinary or non-disciplinary action as
the | 3 | | Department may deem appropriate, including imposing fines not | 4 | | to exceed $10,000 for each violation, with regard to any | 5 | | applicant or licensee or any officer, director, manager, or | 6 | | shareholder who owns 5% or more interest in the business that | 7 | | holds the license proper for any one or a combination of the | 8 | | following reasons:
| 9 | | (1) Violation of this Act or of the its rules adopted | 10 | | under this Act .
| 11 | | (2) Aiding or assisting another person in violating any | 12 | | provision of
this Act or the its rules adopted under this | 13 | | Act .
| 14 | | (3) Failing, within 60 days, to provide information in | 15 | | response respond to a written requirement made by
the | 16 | | Department for information .
| 17 | | (4) Engaging in dishonorable, unethical, or | 18 | | unprofessional conduct of a
character likely to deceive, | 19 | | defraud, or harm the public. This includes
violations of | 20 | | "good faith" as defined by the Illinois Controlled | 21 | | Substances
Act and applies to all prescription drugs.
| 22 | | (5) Discipline by another U.S. jurisdiction or foreign | 23 | | nation, if at
least one of the grounds for the discipline | 24 | | is the same or substantially
equivalent to those set forth | 25 | | in this Act.
| 26 | | (6) Selling or engaging in the sale of drug samples |
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| 1 | | provided at no cost
by drug manufacturers.
| 2 | | (7) Conviction by of or entry of a plea of guilty or | 3 | | nolo contendere , finding of guilt, jury verdict, or entry | 4 | | of judgment or by sentencing of any crime, including, but | 5 | | not limited to, convictions, preceding sentences of | 6 | | supervision, conditional discharge, or first offender | 7 | | probation, under the laws of any jurisdiction of the United | 8 | | States (i) by the applicant or licensee, or any officer, | 9 | | director,
manager or shareholder who owns more than 5% of | 10 | | stock, to any crime under the laws of the United States or | 11 | | any state or territory of the United States that is a | 12 | | felony or (ii) a misdemeanor, of which an essential element | 13 | | of which is dishonesty , or any crime that is directly | 14 | | related to the practice of this profession.
| 15 | | (8) Habitual or excessive use or addiction to alcohol, | 16 | | narcotics,
stimulants, or any other chemical agent or drug | 17 | | by the designated representative, as provided for in item | 18 | | (7) of subsection (b) of Section 25 of this Act, any | 19 | | officer, or director that results in the
inability to | 20 | | function with reasonable judgment, skill, or safety.
| 21 | | (b) The Department may refuse to issue, restore, or renew, | 22 | | or may
revoke, suspend, place on probation, reprimand or take | 23 | | other disciplinary
action as the Department may deem property | 24 | | including fines not to exceed
$10,000 per offense
for any of | 25 | | the following reasons:
| 26 | | (9) (1) Material misstatement in furnishing |
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| 1 | | information to the Department.
| 2 | | (2) Making any misrepresentation for the purpose of | 3 | | obtaining a license.
| 4 | | (10) (3) A finding by the Department that the licensee, | 5 | | after having his
or her license placed on probationary | 6 | | status, has violated the terms of
probation.
| 7 | | (11) Fraud or misrepresentation in applying for, or | 8 | | procuring, a license under this Act or in connection with | 9 | | applying for renewal of a license under this Act. (4) A | 10 | | finding that licensure or registration has been applied for | 11 | | or
obtained by fraudulent means.
| 12 | | (12) (5) Willfully making or filing false records or | 13 | | reports.
| 14 | | (13) (6) A finding of a substantial discrepancy in a | 15 | | Department audit
of a prescription drug, including a | 16 | | controlled substance as that term is
defined in this Act or | 17 | | in the Illinois Controlled Substances Act.
| 18 | | (14) Falsifying a pedigree or selling, distributing, | 19 | | transferring, manufacturing, repackaging, handling, or | 20 | | holding a counterfeit prescription drug intended for human | 21 | | use. | 22 | | (15) Interfering with a Department investigation. | 23 | | (16) Failing to adequately secure controlled | 24 | | substances or other prescription drugs from diversion. | 25 | | (17) Acquiring or distributing prescription drugs not | 26 | | obtained from a licensed source. |
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| 1 | | (18) Failing to properly store drugs. | 2 | | (19) Failing to maintain the licensed premises with | 3 | | proper storage and security controls. | 4 | | (b) (c) The Department may refuse to issue or may suspend | 5 | | the license or
registration of any person who fails to file a | 6 | | return, or to pay the tax,
penalty or interest shown in a filed | 7 | | return, or to pay any final assessment
of tax, penalty or | 8 | | interest, as required by any tax Act administered by the
| 9 | | Illinois Department of Revenue, until the time the requirements | 10 | | of
the tax Act are satisfied.
| 11 | | (c) (d) The Department shall revoke the license or | 12 | | certificate of
registration issued under this Act or any prior | 13 | | Act of
this State of any person who has been convicted a second | 14 | | time of committing
any felony under the Illinois Controlled | 15 | | Substances Act or the Methamphetamine Control and Community | 16 | | Protection Act
or who
has been convicted a second time of | 17 | | committing a Class 1 felony under
Sections 8A-3 and 8A-6 of the | 18 | | Illinois Public Aid Code. A
person whose license or certificate | 19 | | of registration issued under
this Act or any prior Act of this | 20 | | State is revoked under this
subsection (b) (c) shall be | 21 | | prohibited from engaging in the practice of
pharmacy in this | 22 | | State.
| 23 | | (Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07; | 24 | | revised 11-18-11.)
| 25 | | (225 ILCS 120/59)
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| 1 | | (Section scheduled to be repealed on January 1, 2013) | 2 | | Sec. 59. Injunctive action; cease and desist order. | 3 | | Enforcement; order to cease distribution of a drug. | 4 | | (a) If any person violates the provisions of this Act, the | 5 | | Secretary, in the name of the People of the State of Illinois, | 6 | | through the Attorney General or the State's Attorney of the | 7 | | county where the violation is alleged to have occurred, may | 8 | | petition for an order enjoining the violation or for an order | 9 | | enforcing compliance with this Act. Upon the filing of a | 10 | | verified petition, the court with appropriate jurisdiction may | 11 | | issue a temporary restraining order, without notice or bond, | 12 | | and may preliminarily and permanently enjoin the violation. If | 13 | | it is established that the person has violated or is violating | 14 | | the injunction, then the court may punish the offender for | 15 | | contempt of court. Proceedings under this Section are in | 16 | | addition to, and not in lieu of, all other remedies and | 17 | | penalties provided by this Act. The Department shall issue an | 18 | | order requiring the appropriate person, including the | 19 | | distributors or retailers of a drug, to immediately cease | 20 | | distribution of the drug within this State, if the Department | 21 | | finds that there is a reasonable probability that: | 22 | | (1) a wholesale distributor has (i) violated a | 23 | | provision in this Act or (ii) falsified a pedigree or sold, | 24 | | distributed, transferred, manufactured, repackaged, | 25 | | handled, or held a counterfeit prescription drug intended | 26 | | for human use; |
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| 1 | | (2) the prescription drug at issue, as a result of a | 2 | | violation in paragraph (1) of this subsection (a), could | 3 | | cause serious, adverse health consequences or death; and | 4 | | (3) other procedures would result in unreasonable | 5 | | delay. | 6 | | (b) Whenever, in the opinion of the Department, a person | 7 | | violates any provision of this Act, the Department may issue a | 8 | | rule to show cause why an order to cease and desist shall not | 9 | | be entered against that person. The rule shall clearly set | 10 | | forth the grounds relied upon by the Department and shall allow | 11 | | a person at least 7 days after the date of the rule to file an | 12 | | answer satisfactory to the Department. Failure to answer to the | 13 | | satisfaction of the Department shall cause an order to cease | 14 | | and desist to be issued. An order issued under this Section | 15 | | shall provide the person subject to the order with an | 16 | | opportunity for an informal hearing, to be held not later than | 17 | | 10 days after the date of the issuance of the order, on the | 18 | | actions required by the order. If, after providing an | 19 | | opportunity for a hearing, the Department determines that | 20 | | inadequate grounds exist to support the actions required by the | 21 | | order, the Department shall vacate the order.
| 22 | | (Source: P.A. 95-689, eff. 10-29-07.) | 23 | | (225 ILCS 120/173 new) | 24 | | Sec. 173. Confidentiality. All information collected by | 25 | | the Department in the course of an examination or investigation |
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| 1 | | of a licensee or applicant, including, but not limited to, any | 2 | | complaint against a licensee filed with the Department and | 3 | | information collected to investigate any such complaint, shall | 4 | | be maintained for the confidential use of the Department and | 5 | | shall not be disclosed. The Department may not disclose the | 6 | | information to anyone other than law enforcement officials, | 7 | | other regulatory agencies that have an appropriate regulatory | 8 | | interest as determined by the Secretary, or a party presenting | 9 | | a lawful subpoena to the Department. Information and documents | 10 | | disclosed to a federal, State, county, or local law enforcement | 11 | | agency shall not be disclosed by the agency for any purpose to | 12 | | any other agency or person. A formal complaint filed against a | 13 | | licensee by the Department or any order issued by the | 14 | | Department against a licensee or applicant shall be a public | 15 | | record, except as otherwise prohibited by law.
| 16 | | Section 99. Effective date. This Act takes effect upon | 17 | | becoming law.
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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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