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Public Act 097-0804 Public Act 0804 97TH GENERAL ASSEMBLY |
Public Act 097-0804 | SB2935 Enrolled | LRB097 16822 CEL 62004 b |
|
| AN ACT concerning regulation.
| Be it enacted by the People of the State of Illinois,
| represented in the General Assembly:
| Section 1. The Regulatory Sunset Act is amended by changing | Section 4.23 and by adding Section 4.33 as follows:
| (5 ILCS 80/4.23)
| Sec. 4.23. Acts and Sections repealed on January 1,
2013. | The following Acts and Sections of Acts are
repealed on January | 1, 2013:
| The Dietetic and Nutrition Services Practice Act.
| The Elevator Safety and Regulation Act.
| The Fire Equipment Distributor and Employee Regulation Act | of 2011. | The Funeral Directors and Embalmers Licensing Code.
| The Naprapathic Practice Act.
| The Professional Counselor and Clinical Professional | Counselor
Licensing Act.
| The Wholesale Drug Distribution Licensing Act.
| Section 2.5 of the Illinois Plumbing License Law.
| (Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
| (5 ILCS 80/4.33 new) | Sec. 4.33. Act repealed on January 1,
2023. The following |
| Act is
repealed on January 1, 2023: | The Wholesale Drug Distribution Licensing Act. | Section 5. The Wholesale Drug Distribution Licensing Act is | amended by changing Sections 15, 20, 25, 26, 50, 55, and 59 and | by adding Section 173 as follows:
| (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 15. Definitions. As used in this Act:
| "Authentication" means the affirmative verification, | before any wholesale distribution of a prescription drug | occurs, that each transaction listed on the pedigree has | occurred. | "Authorized distributor of record" means a wholesale | distributor with whom a manufacturer has established an ongoing | relationship to distribute the manufacturer's prescription | drug. An ongoing relationship is deemed to exist between a | wholesale distributor and a manufacturer when the wholesale | distributor, including any affiliated group of the wholesale | distributor, as defined in Section 1504 of the Internal Revenue | Code, complies with the following: | (1) The wholesale distributor has a written agreement | currently in effect with the manufacturer evidencing the | ongoing relationship; and | (2) The wholesale distributor is listed on the |
| manufacturer's current list of authorized distributors of | record, which is updated by the manufacturer on no less | than a monthly basis.
| "Blood" means whole blood collected from a single donor and | processed
either for transfusion or further manufacturing.
| "Blood component" means that part of blood separated by | physical or
mechanical means.
| "Board" means the State Board of Pharmacy of the Department | of
Professional Regulation.
| "Chain pharmacy warehouse" means a physical location for | prescription drugs that acts as a central warehouse and | performs intracompany sales or transfers of the drugs to a | group of chain or mail order pharmacies that have the same | common ownership and control. Notwithstanding any other | provision of this Act, a chain pharmacy warehouse shall be | considered part of the normal distribution channel. | "Co-licensed partner or product" means an instance where | one or more parties have the right to engage in the | manufacturing or marketing of a prescription drug, consistent | with the FDA's implementation of the Prescription Drug | Marketing Act.
| "Department" means the Department of Financial and
| Professional Regulation.
| "Drop shipment" means the sale of a prescription drug to a | wholesale distributor by the manufacturer of the prescription | drug or that manufacturer's co-licensed product partner, that |
| manufacturer's third party logistics provider, or that | manufacturer's exclusive distributor or by an authorized | distributor of record that purchased the product directly from | the manufacturer or one of these entities whereby the wholesale | distributor or chain pharmacy warehouse takes title but not | physical possession of such prescription drug and the wholesale | distributor invoices the pharmacy, chain pharmacy warehouse, | or other person authorized by law to dispense or administer | such drug to a patient and the pharmacy, chain pharmacy | warehouse, or other authorized person receives delivery of the | prescription drug directly from the manufacturer, that | manufacturer's third party logistics provider, or that | manufacturer's exclusive distributor or from an authorized | distributor of record that purchased the product directly from | the manufacturer or one of these entities.
| "Drug sample" means a unit of a prescription drug that is | not intended to
be sold and is intended to promote the sale of | the drug.
| "Facility" means a facility of a wholesale distributor | where prescription drugs are stored, handled, repackaged, or | offered for sale. | "FDA" means the United States Food and Drug Administration.
| "Manufacturer" means a person licensed or approved by the | FDA to engage in the manufacture of drugs or devices, | consistent with the definition of "manufacturer" set forth in | the FDA's regulations and guidances implementing the |
| Prescription Drug Marketing Act. | "Manufacturer's exclusive distributor" means anyone who | contracts with a manufacturer to provide or coordinate | warehousing, distribution, or other services on behalf of a | manufacturer and who takes title to that manufacturer's | prescription drug, but who does not have general responsibility | to direct the sale or disposition of the manufacturer's | prescription drug. A manufacturer's exclusive distributor must | be licensed as a wholesale distributor under this Act and, in | order to be considered part of the normal distribution channel, | must also be an authorized distributor of record.
| "Normal distribution channel" means a chain of custody for | a prescription drug that goes, directly or by drop shipment, | from (i) a manufacturer of the prescription drug, (ii) that | manufacturer to that manufacturer's co-licensed partner, (iii) | that manufacturer to that manufacturer's third party logistics | provider, or (iv) that manufacturer to that manufacturer's | exclusive distributor to: | (1) a pharmacy or to other designated persons | authorized by law to dispense or administer the drug to a | patient; | (2) a wholesale distributor to a pharmacy or other | designated persons authorized by law to dispense or | administer the drug to a patient; | (3) a wholesale distributor to a chain pharmacy | warehouse to that chain pharmacy warehouse's intracompany |
| pharmacy to a patient or other designated persons | authorized by law to dispense or administer the drug to a | patient; | (4) a chain pharmacy warehouse to the chain pharmacy | warehouse's intracompany pharmacy or other designated | persons authorized by law to dispense or administer the | drug to the patient; | (5) an authorized distributor of record to one other | authorized distributor of record to an office-based health | care practitioner authorized by law to dispense or | administer the drug to the patient; or | (6) an authorized distributor to a pharmacy or other | persons licensed to dispense or administer the drug. | "Pedigree" means a document or electronic file containing | information that records each wholesale distribution of any | given prescription drug from the point of origin to the final | wholesale distribution point of any given prescription drug.
| "Person" means and includes a natural person, partnership, | association , or
corporation , or any other legal business | entity .
| "Pharmacy distributor" means any pharmacy licensed in this | State or
hospital pharmacy that is engaged in the delivery or | distribution of
prescription drugs either to any other pharmacy | licensed in this State or
to any other person or entity | including, but not limited to, a wholesale
drug distributor | engaged in the delivery or distribution of prescription
drugs |
| who is involved in the actual, constructive, or attempted | transfer of
a drug in this State to other than the ultimate | consumer except as
otherwise provided for by law.
| "Prescription drug" means any human drug, including any | biological product (except for blood and blood components | intended for transfusion or biological products that are also | medical devices), required by federal law or
regulation to be | dispensed only by a prescription, including finished
dosage | forms and bulk drug substances
subject to Section
503 of the | Federal Food, Drug and Cosmetic Act.
| "Repackage" means repackaging or otherwise changing the | container, wrapper, or labeling to further the distribution of | a prescription drug, excluding that completed by the pharmacist | responsible for dispensing the product to a patient. | "Secretary" means the Secretary of Financial and | Professional Regulation. | "Third party logistics provider" means anyone who | contracts with a prescription drug manufacturer to provide or | coordinate warehousing, distribution, or other services on | behalf of a manufacturer, but does not take title to the | prescription drug or have general responsibility to direct the | prescription drug's sale or disposition. A third party | logistics provider must be licensed as a wholesale distributor | under this Act and, in order to be considered part of the | normal distribution channel, must also be an authorized | distributor of record. |
| "Wholesale distribution"
means the distribution
of | prescription drugs to persons other than a consumer or patient, | but does
not include any of the following:
| (1)
Intracompany sales of prescription drugs, meaning | (i) any transaction or transfer
between any division, | subsidiary, parent, or affiliated or related company
under | the common ownership and control of a corporate entity or | (ii) any transaction or transfer between co-licensees of a | co-licensed product.
| (2) The sale, purchase, distribution, trade, or | transfer of a prescription drug or offer to sell, purchase, | distribute, trade, or transfer a prescription drug for | emergency medical reasons.
| (3) The distribution of prescription drug samples by | manufacturers' representatives. | (4) Drug returns, when conducted by a hospital, health | care entity, or charitable institution in accordance with | federal regulation. | (5) The sale of minimal quantities of prescription | drugs by licensed retail pharmacies to licensed | practitioners for office use or other licensed pharmacies . | (6) The sale, purchase, or trade of a drug, an offer to | sell, purchase, or trade a drug, or the dispensing of a | drug pursuant to a prescription. | (7) The sale, transfer, merger, or consolidation of all | or part of the business of a pharmacy or pharmacies from or |
| with another pharmacy or pharmacies, whether accomplished | as a purchase and sale of stock or business assets. | (8) The sale, purchase, distribution, trade, or | transfer of a prescription drug from one authorized | distributor of record to one additional authorized | distributor of record when the manufacturer has stated in | writing to the receiving authorized distributor of record | that the manufacturer is unable to supply the prescription | drug and the supplying authorized distributor of record | states in writing that the prescription drug being supplied | had until that time been exclusively in the normal | distribution channel. | (9) The delivery of or the offer to deliver a | prescription drug by a common carrier solely in the common | carrier's usual course of business of transporting | prescription drugs when the common carrier does not store, | warehouse, or take legal ownership of the prescription | drug. | (10) The sale or transfer from a retail pharmacy, mail | order pharmacy, or chain pharmacy warehouse of expired, | damaged, returned, or recalled prescription drugs to the | original manufacturer, the originating wholesale | distributor, or a third party returns processor.
| "Wholesale drug distributor" means anyone
engaged in the
| wholesale distribution of prescription drugs into, out of, or | within the State , including without limitation
manufacturers; |
| repackers; own label distributors; jobbers; private
label | distributors; brokers; warehouses, including manufacturers' | and
distributors' warehouses; manufacturer's exclusive | distributors; and authorized distributors of record; drug | wholesalers or distributors; independent wholesale drug | traders; specialty wholesale distributors; third party | logistics providers; and retail pharmacies that conduct | wholesale distribution; and chain pharmacy warehouses that | conduct wholesale distribution. In order to be considered part | of the normal distribution channel, a wholesale distributor | must also be an authorized distributor of record.
| (Source: P.A. 95-689, eff. 10-29-07.)
| (225 ILCS 120/20) (from Ch. 111, par. 8301-20)
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 20. Prohibited drug purchases or receipt. It shall be | unlawful
for any person or entity located in this State to | knowingly purchase or receive any prescription
drug from any | source other than a person or entity required by the laws of | this State to be licensed to ship into, out of, or within this | State licensed under the
laws of this State or the state of | domicile except where otherwise
provided . A person or entity | licensed under the laws of this State shall
include, but is not | limited to, a wholesale distributor, manufacturer,
pharmacy | distributor, or pharmacy. Any person violating
this Section | shall, upon conviction, be adjudged guilty of a Class C
|
| misdemeanor. A second violation shall constitute a Class 4 | felony.
| (Source: P.A. 87-594.)
| (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 25. Wholesale drug distributor licensing | requirements.
| (a) Every resident wholesale distributor who engages in the | wholesale distribution of prescription drugs must be licensed | by the Department, and every non-resident wholesale | distributor must be licensed in this State if it ships | prescription drugs into this State, in accordance with this | Act, before engaging in wholesale distributions of wholesale | prescription drugs.
| (b) The Department shall require without limitation all of | the following information from each applicant for licensure | under this Act: | (1) The name, full business address, and telephone | number of the licensee. | (2) All trade or business names used by the licensee. | (3) Addresses, telephone numbers, and the names of | contact persons for all facilities used by the licensee for | the storage, handling, and distribution of prescription | drugs. | (4) The type of ownership or operation, such as a |
| partnership, corporation, or sole proprietorship. | (5) The name of the owner or operator of the wholesale | distributor, including: | (A) if a natural person, the name of the natural | person; | (B) if a partnership, the name of each partner and | the name of the partnership; | (C) if a corporation, the name and title of each | corporate officer and director, the corporate names, | and the name of the state of incorporation; and | (D) if a sole proprietorship, the full name of the | sole proprietor and the name of the business entity. | (6) A list of all licenses and permits issued to the | applicant by any other state that authorizes the applicant | to purchase or possess prescription drugs. | (7) The name of the designated representative for the | wholesale distributor, together with the personal | information statement and fingerprints, as required under
| subsection (c) of this Section. | (8) Minimum liability insurance and other insurance as | defined by rule. | (9) Any additional information required by the | Department.
| (c) Each wholesale distributor must designate an | individual representative who shall serve as the contact person | for the Department. This representative must provide the
|
| Department with all of the following information:
| (1) Information concerning whether the person has been | enjoined, either temporarily or permanently, by a court of | competent jurisdiction from violating any federal or State | law regulating the possession, control, or distribution of | prescription drugs or criminal violations, together with | details concerning any such event. | (2) A description of any involvement by the person with | any business, including any investments, other than the | ownership of stock in a publicly traded company or mutual | fund which manufactured, administered, prescribed, | distributed, or stored pharmaceutical products and any | lawsuits in which such businesses were named as a party. | (3) A description of any misdemeanor or felony criminal | offense of which the person, as an adult, was found guilty, | regardless of whether adjudication of guilt was withheld or | whether the person pled guilty or nolo contendere. If the | person indicates that a criminal conviction is under appeal | and submits a copy of the notice of appeal of that criminal | offense, the applicant must, within 15 days after the | disposition of the appeal, submit to the Department a copy | of the final written order of disposition. | (4) The designated representative of an applicant for | licensure as a wholesale drug distributor shall have his or | her fingerprints submitted to the Department of State | Police in an electronic format that complies with the form |
| and manner for requesting and furnishing criminal history | record information as prescribed by the Department of State | Police. These fingerprints shall be checked against the | Department of State Police and Federal Bureau of | Investigation criminal history record databases now and | hereafter filed. The Department of State Police shall | charge applicants a fee for conducting the criminal history | records check, which shall be deposited into the State | Police Services Fund and shall not exceed the actual cost | of the records check. The Department of State Police shall | furnish, pursuant to positive identification, records of | Illinois convictions to the Department. The Department may | require applicants to pay a separate fingerprinting fee, | either to the Department or to a vendor. The Department, in | its discretion, may allow an applicant who does not have | reasonable access to a designated vendor to provide his or | her fingerprints in an alternative manner. The Department | may adopt any rules necessary to implement this Section. | The designated representative of a licensee shall | receive and complete continuing training in applicable | federal and State laws governing the wholesale | distribution of prescription drugs.
| (d) The Department may not issue a wholesale distributor | license to an applicant, unless the Department first: | (1) ensures that a physical inspection of the facility | satisfactory to the Department has occurred at the address |
| provided by the applicant, as required under item (1) of | subsection (b) of this Section; and | (2) determines that the designated representative | meets each of the following qualifications: | (A) He or she is at least 21 years of age. | (B) He or she has been employed full-time for at | least 3 years in a pharmacy or with a wholesale | distributor in a capacity related to the dispensing and | distribution of, and recordkeeping relating to, | prescription drugs. | (C) He or she is employed by the applicant full | time in a managerial level position. | (D) He or she is actively involved in and aware of | the actual daily operation of the wholesale | distributor. | (E) He or she is physically present at the facility | of the applicant during regular business hours, except | when the absence of the designated representative is | authorized, including without limitation sick leave | and vacation leave. | (F) He or she is serving in the capacity of a | designated representative for only one applicant at a | time, except where more than one licensed wholesale | distributor is co-located in the same facility and such | wholesale distributors are members of an affiliated | group, as defined in Section 1504 of the Internal |
| Revenue Code.
| (e) If a wholesale distributor distributes prescription | drugs from more than one facility, the wholesale distributor | shall obtain a license for each facility.
| (f) The information provided under this Section may not be | disclosed to any person or entity other than the Department or | another government entity in need of such information for | licensing or monitoring purposes.
| (Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
| (225 ILCS 120/26)
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 26. Unlicensed practice; violation; civil penalty.
| (a) 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 to ship into, out of, or within the State under this | Act shall, in
addition to any other penalty provided by law, | pay a civil penalty to the
Department in an amount not to | exceed $10,000 $5,000 for each offense as determined by
the | Department. The civil penalty shall be assessed by the | Department after a
hearing is held in accordance with the | provisions set forth in this Act
regarding the provision of a | hearing for the discipline of a licensee.
| (b) The Department has the authority and power to | investigate any and all
unlicensed activity.
|
| (c) The civil penalty shall be paid within 60 days after | the effective date
of the order imposing the civil penalty. The | order shall constitute a judgment
and may be filed and | execution had thereon in the same manner as any judgment
from | any court of record.
| (Source: P.A. 89-474, eff. 6-18-96.)
| (225 ILCS 120/50) (from Ch. 111, par. 8301-50)
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 50. Inspection powers; access to records.
| (a) Any pharmacy investigator authorized by the Department
| has the right of entry for inspection during normal business | hours
of premises purporting or appearing to be used by a | wholesale
drug distributor in this State , including the | business premises of a person licensed pursuant to this Act. | This right of entry shall permit the authorized pharmacy | investigator unfettered access to the entire business | premises. Any attempt to hinder an authorized pharmacy | investigator from inspecting the business premises and | documenting the inspection shall be a violation of this Act . | The duly authorized investigators shall be
required to show | appropriate identification before being given access to a
| wholesale drug distributor's premises and delivery vehicles. | Any wholesale
drug distributor providing adequate | documentation of the most recent
satisfactory inspection less | than 3 years old of the distributor's
wholesale drug |
| distribution activities and facilities by either the U.S.
FDA, | a State agency, or any person or entity lawfully designated by | a State
agency to perform an inspection determined to be | comparable by the
Department shall be exempt from further | inspection for a period of time to
be determined by the | Department. The exemption shall not bar the
Department from | initiating an investigation of a public or governmental
| complaint received by the Department regarding a wholesale drug
| distributor. Wholesale drug distributors shall be given an | opportunity to
correct minor violations determined by these | investigations.
| (b) With the exception of the most recent 12 months of | records that must be kept on the premises where the drugs are | stored, wholesale Wholesale drug distributors may keep records | regarding purchase and
sales transactions electronically at a | central location apart from the principal office of
the | wholesale drug distributor or the location at which the drugs | were
stored and from which they were shipped, provided that the | records shall
be made readily available for inspection within 2 | working days of a request by the
Department. The records may be | kept in any form permissible under federal
law applicable to | prescription drugs record keeping.
| (c) (Blank).
| (Source: P.A. 94-942, eff. 1-1-07.)
| (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
|
| (Section scheduled to be repealed on January 1, 2013)
| Sec. 55. Discipline; grounds.
| (a) The Department may refuse to issue, restore, or renew, | or may revoke,
suspend, place on probation, reprimand or take | other disciplinary or non-disciplinary action as
the | Department may deem appropriate, including imposing fines not | to exceed $10,000 for each violation, with regard to any | applicant or licensee or any officer, director, manager, or | shareholder who owns 5% or more interest in the business that | holds the license proper for any one or a combination of the | following reasons:
| (1) Violation of this Act or of the its rules adopted | under this Act .
| (2) Aiding or assisting another person in violating any | provision of
this Act or the its rules adopted under this | Act .
| (3) Failing, within 60 days, to provide information in | response respond to a written requirement made by
the | Department for information .
| (4) Engaging in dishonorable, unethical, or | unprofessional conduct of a
character likely to deceive, | defraud, or harm the public. This includes
violations of | "good faith" as defined by the Illinois Controlled | Substances
Act and applies to all prescription drugs.
| (5) Discipline by another U.S. jurisdiction or foreign | nation, if at
least one of the grounds for the discipline |
| is the same or substantially
equivalent to those set forth | in this Act.
| (6) Selling or engaging in the sale of drug samples | provided at no cost
by drug manufacturers.
| (7) Conviction by of or entry of a plea of guilty or | nolo contendere , finding of guilt, jury verdict, or entry | of judgment or by sentencing of any crime, including, but | not limited to, convictions, preceding sentences of | supervision, conditional discharge, or first offender | probation, under the laws of any jurisdiction of the United | States (i) by the applicant or licensee, or any officer, | director,
manager or shareholder who owns more than 5% of | stock, to any crime under the laws of the United States or | any state or territory of the United States that is a | felony or (ii) a misdemeanor, of which an essential element | of which is dishonesty , or any crime that is directly | related to the practice of this profession.
| (8) Habitual or excessive use or addiction to alcohol, | narcotics,
stimulants, or any other chemical agent or drug | by the designated representative, as provided for in item | (7) of subsection (b) of Section 25 of this Act, any | officer, or director that results in the
inability to | function with reasonable judgment, skill, or safety.
| (b) The Department may refuse to issue, restore, or renew, | or may
revoke, suspend, place on probation, reprimand or take | other disciplinary
action as the Department may deem property |
| including fines not to exceed
$10,000 per offense
for any of | the following reasons:
| (9) (1) Material misstatement in furnishing | information to the Department.
| (2) Making any misrepresentation for the purpose of | obtaining a license.
| (10) (3) A finding by the Department that the licensee, | after having his
or her license placed on probationary | status, has violated the terms of
probation.
| (11) Fraud or misrepresentation in applying for, or | procuring, a license under this Act or in connection with | applying for renewal of a license under this Act. (4) A | finding that licensure or registration has been applied for | or
obtained by fraudulent means.
| (12) (5) Willfully making or filing false records or | reports.
| (13) (6) A finding of a substantial discrepancy in a | Department audit
of a prescription drug, including a | controlled substance as that term is
defined in this Act or | in the Illinois Controlled Substances Act.
| (14) Falsifying a pedigree or selling, distributing, | transferring, manufacturing, repackaging, handling, or | holding a counterfeit prescription drug intended for human | use. | (15) Interfering with a Department investigation. | (16) Failing to adequately secure controlled |
| substances or other prescription drugs from diversion. | (17) Acquiring or distributing prescription drugs not | obtained from a source licensed by the Department. | (18) Failing to properly store drugs. | (19) Failing to maintain the licensed premises with | proper storage and security controls. | (b) (c) The Department may refuse to issue or may suspend | the license or
registration of any person who fails to file a | return, or to pay the tax,
penalty or interest shown in a filed | return, or to pay any final assessment
of tax, penalty or | interest, as required by any tax Act administered by the
| Illinois Department of Revenue, until the time the requirements | of
the tax Act are satisfied.
| (c) (d) The Department shall revoke the license or | certificate of
registration issued under this Act or any prior | Act of
this State of any person who has been convicted a second | time of committing
any felony under the Illinois Controlled | Substances Act or the Methamphetamine Control and Community | Protection Act
or who
has been convicted a second time of | committing a Class 1 felony under
Sections 8A-3 and 8A-6 of the | Illinois Public Aid Code. A
person whose license or certificate | of registration issued under
this Act or any prior Act of this | State is revoked under this
subsection (b) (c) shall be | prohibited from engaging in the practice of
pharmacy in this | State.
| (Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07; |
| revised 11-18-11.)
| (225 ILCS 120/59)
| (Section scheduled to be repealed on January 1, 2013) | Sec. 59. Injunctive action; cease and desist order. | Enforcement; order to cease distribution of a drug. | (a) If any person violates the provisions of this Act, the | Secretary, in the name of the People of the State of Illinois, | through the Attorney General or the State's Attorney of the | county where the violation is alleged to have occurred, may | petition for an order enjoining the violation or for an order | enforcing compliance with this Act. Upon the filing of a | verified petition, the court with appropriate jurisdiction may | issue a temporary restraining order, without notice or bond, | and may preliminarily and permanently enjoin the violation. If | it is established that the person has violated or is violating | the injunction, then the court may punish the offender for | contempt of court. Proceedings under this Section are in | addition to, and not in lieu of, all other remedies and | penalties provided by this Act. The Department shall issue an | order requiring the appropriate person, including the | distributors or retailers of a drug, to immediately cease | distribution of the drug within this State, if the Department | finds that there is a reasonable probability that: | (1) a wholesale distributor has (i) violated a | provision in this Act or (ii) falsified a pedigree or sold, |
| distributed, transferred, manufactured, repackaged, | handled, or held a counterfeit prescription drug intended | for human use; | (2) the prescription drug at issue, as a result of a | violation in paragraph (1) of this subsection (a), could | cause serious, adverse health consequences or death; and | (3) other procedures would result in unreasonable | delay. | (b) Whenever, in the opinion of the Department, a person | violates any provision of this Act, the Department may issue a | rule to show cause why an order to cease and desist shall not | be entered against that person. The rule shall clearly set | forth the grounds relied upon by the Department and shall allow | a person at least 7 days after the date of the rule to file an | answer satisfactory to the Department. Failure to answer to the | satisfaction of the Department shall cause an order to cease | and desist to be issued. An order issued under this Section | shall provide the person subject to the order with an | opportunity for an informal hearing, to be held not later than | 10 days after the date of the issuance of the order, on the | actions required by the order. If, after providing an | opportunity for a hearing, the Department determines that | inadequate grounds exist to support the actions required by the | order, the Department shall vacate the order.
| (Source: P.A. 95-689, eff. 10-29-07.) |
| (225 ILCS 120/173 new) | Sec. 173. Confidentiality. All information collected by | the Department in the course of an examination or investigation | of a licensee or applicant, including, but not limited to, any | complaint against a licensee filed with the Department and | information collected to investigate any such complaint, shall | be maintained for the confidential use of the Department and | shall not be disclosed. The Department may not disclose the | information to anyone other than law enforcement officials, | other regulatory agencies that have an appropriate regulatory | interest as determined by the Secretary, or a party presenting | a lawful subpoena to the Department. Information and documents | disclosed to a federal, State, county, or local law enforcement | agency shall not be disclosed by the agency for any purpose to | any other agency or person. A formal complaint filed against a | licensee by the Department or any order issued by the | Department against a licensee or applicant shall be a public | record, except as otherwise prohibited by law.
| Section 99. Effective date. This Act takes effect on | January 1, 2013.
| |
INDEX
|
Statutes amended in order of appearance
| | 5 ILCS 80/4.23 | | | 5 ILCS 80/4.33 new | | | 225 ILCS 120/15 | from Ch. 111, par. 8301-15 | | 225 ILCS 120/20 | from Ch. 111, par. 8301-20 | | 225 ILCS 120/25 | from Ch. 111, par. 8301-25 | | 225 ILCS 120/26 | | | 225 ILCS 120/50 | from Ch. 111, par. 8301-50 | | 225 ILCS 120/55 | from Ch. 111, par. 8301-55 | | 225 ILCS 120/59 | | | 225 ILCS 120/173 new | |
| |
Effective Date: 1/1/2013
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