(225 ILCS 120/1) (from Ch. 111, par. 8301-1)
(Section scheduled to be repealed on January 1, 2028)
Sec. 1.
Short title.
This Act may be cited as the Wholesale Drug Distribution Licensing Act.
(Source: P.A. 87-594.)
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(225 ILCS 120/3)
Sec. 3. (Repealed).
(Source: P.A. 95-689, eff. 10-29-07. Repealed by P.A. 102-879, eff. 1-1-23.) |
(225 ILCS 120/5) (from Ch. 111, par. 8301-5)
(Section scheduled to be repealed on January 1, 2028)
Sec. 5.
Scope.
This Act applies to any person, partnership,
corporation, or business firm engaging in the wholesale distribution of
human prescription drugs within this State.
(Source: P.A. 87-594.)
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(225 ILCS 120/10) (from Ch. 111, par. 8301-10)
(Section scheduled to be repealed on January 1, 2028)
Sec. 10.
Purpose.
The purpose of this Act is to implement the
Federal Prescription Drug Marketing Act of 1987 (PDMA), U.S. Pub. L.
100-293, 102 Stat. 95, codified at U.S.C. Sec. 321 et seq.; and
particularly PDMA requirements that no person or entity may engage in the
wholesale distribution of human prescription drugs in any state unless the
person or entity is licensed by that state in accordance with federally
prescribed minimum standards, terms, and conditions as set forth in
guidelines issued by United States Food and Drug Administration (FDA)
regulations.
(Source: P.A. 87-594.)
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(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
(Section scheduled to be repealed on January 1, 2028)
Sec. 15. Definitions. As used in this Act:
"Address of record" means the designated address recorded by the Department in the applicant's application file or licensee's license file maintained by the Department's licensure maintenance unit. "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 | ||
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(2) The wholesale distributor is listed on the | ||
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"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 Financial and
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.
"Email address of record" means the designated email address recorded by the Department in the applicant's application file or the licensee's license file, as maintained by the Department's licensure maintenance unit. "Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale, or a facility of a third-party logistics provider where prescription drugs are stored or handled. "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" does not
include anyone who is engaged in the packaging, repackaging, or
labeling of drugs only to the extent permitted
under the Illinois Drug Reuse Opportunity Program 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 | ||
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(2) a wholesale distributor to a pharmacy or other | ||
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(3) a wholesale distributor to a chain pharmacy | ||
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(4) a chain pharmacy warehouse to the chain pharmacy | ||
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(5) an authorized distributor of record to one other | ||
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(6) an authorized distributor to a pharmacy or other | ||
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"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,
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 the Department of Financial and Professional Regulation. "Suspicious order" includes, but is not limited to, an order of a controlled substance of unusual size, an order of a controlled substance deviating substantially from a normal pattern, and orders of controlled substances of unusual frequency as defined by 21 U.S.C. 802. "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. "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, | ||
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(2) The sale, purchase, distribution, trade, or | ||
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(3) The distribution of prescription drug samples by | ||
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(4) Drug returns, when conducted by a hospital, | ||
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(5) The sale of minimal quantities of prescription | ||
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(6) The sale, purchase, or trade of a drug, an offer | ||
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(7) The sale, transfer, merger, or consolidation of | ||
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(8) The sale, purchase, distribution, trade, or | ||
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(9) The delivery of or the offer to deliver a | ||
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(10) The sale or transfer from a retail pharmacy, | ||
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(11) The donation of drugs to the extent permitted | ||
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"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; 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. 102-389, eff. 1-1-22; 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)
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(225 ILCS 120/15.5) (Section scheduled to be repealed on January 1, 2028) Sec. 15.5. Address of record; email address of record. All applicants and licensees shall: (1) provide a valid address and email address to | ||
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(2) inform the Department of any change of address | ||
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(Source: P.A. 102-879, eff. 1-1-23.) |
(225 ILCS 120/20) (from Ch. 111, par. 8301-20)
(Section scheduled to be repealed on January 1, 2028)
Sec. 20. Prohibited drug purchases or receipt. It shall be unlawful
for any person or entity located in this State to knowingly 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. A person or entity licensed under the laws of this State shall
include, but is not limited to, a wholesale distributor, manufacturer, third-party logistics provider,
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. 101-420, eff. 8-16-19.)
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(225 ILCS 120/21) (Section scheduled to be repealed on January 1, 2028) Sec. 21. Reports to Department. Each licensee that is required to report suspicious orders under 21 U.S.C. 832 shall also submit such suspicions order reports to the Department.
(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.) |
(225 ILCS 120/24)
Sec. 24. (Repealed).
(Source: P.A. 95-689, eff. 10-29-07. Repealed by P.A. 98-692, eff. 7-1-14.)
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(225 ILCS 120/25) (from Ch. 111, par. 8301-25)
(Section scheduled to be repealed on January 1, 2028)
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 | ||
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(2) All trade or business names used by the licensee. (3) Addresses, telephone numbers, and the names of | ||
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(4) The type of ownership or operation, such as a | ||
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(5) The name of the owner or operator of the | ||
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(A) if a natural person, the name of the natural | ||
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(B) if a partnership, the name of each partner | ||
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(C) if a corporation, the name and title of each | ||
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(D) if a sole proprietorship, the full name of | ||
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(6) A list of all licenses and permits issued to the | ||
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(7) The name of the designated representative for the | ||
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(8) Minimum liability insurance and other insurance | ||
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(9) Any additional information required by the | ||
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(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 | ||
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(2) A description of any involvement by the person | ||
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(3) A description of any misdemeanor or felony | ||
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(4) The designated representative of an applicant for | ||
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The designated representative of a licensee shall | ||
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(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 | ||
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(2) determines that the designated representative | ||
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(A) He or she is at least 21 years of age. (B) He or she has been employed full-time for at | ||
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(C) He or she is employed by the applicant full | ||
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(D) He or she is actively involved in and aware | ||
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(E) He or she is physically present at the | ||
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(F) He or she is serving in the capacity of a | ||
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(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. 102-538, eff. 8-20-21.)
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(225 ILCS 120/25.5) (Section scheduled to be repealed on January 1, 2028) Sec. 25.5. Third-party logistics providers. (a) Each resident third-party logistics provider must be licensed by the Department, and every non-resident third-party logistics provider must be licensed in this State, in accordance with this Act, prior to shipping a prescription drug into this State. (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 | ||
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(2) All trade or business names used by the licensee. (3) Addresses, telephone numbers, and the names of | ||
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(4) The type of ownership or operation, such as a | ||
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(5) The name of the owner or operator of the | ||
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(A) if a natural person, the name of the natural | ||
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(B) if a partnership, the name of each partner | ||
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(C) if a corporation, the name and title of each | ||
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(D) if a sole proprietorship, the full name of | ||
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(6) A list of all licenses and permits issued to the | ||
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(7) The name of the designated representative for the | ||
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(8) Minimum liability insurance and other insurance | ||
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(9) Any additional information required by the | ||
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(c) Each third-party logistics provider 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 | ||
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(2) A description of any involvement by the person | ||
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(3) A description of any misdemeanor or felony | ||
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(4) The designated representative of an applicant for | ||
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(d) A third-party logistics provider shall not operate from a place of residence. (e) A third-party logistics provider facility shall be located apart and separate from any retail pharmacy licensed by the Department. (f) The Department may not issue a third-party logistics provider license to an applicant, unless the Department first: (1) ensures that a physical inspection of the | ||
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(2) determines that the designated representative | ||
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(A) He or she is at least 21 years of age. (B) He or she is employed by the applicant full | ||
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(C) He or she is actively involved in and aware | ||
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(g) A third-party logistics provider shall publicly display all licenses and have the most recent state and federal inspection reports readily available.
(Source: P.A. 101-420, eff. 8-16-19.) |
(225 ILCS 120/26)
(Section scheduled to be repealed on January 1, 2028)
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, pharmacy
distributor, or third-party logistics provider 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 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. 101-420, eff. 8-16-19.)
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(225 ILCS 120/27)
(Section scheduled to be repealed on January 1, 2028)
Sec. 27. Social security number, individual taxpayer identification number, or unique identifying number on license application. In addition
to any other information required to be contained in the application, every
application for an original license under this Act shall
include the applicant's social security number, individual taxpayer identification number, or other unique identifying number deemed appropriate by the Department, which shall be retained in the agency's records pertaining to the license. As soon as practical, the Department shall assign a customer's identification number to each applicant for a license. Every application for a renewal or restored license shall require the applicant's customer identification number.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/30) (from Ch. 111, par. 8301-30)
(Section scheduled to be repealed on January 1, 2028)
Sec. 30. License applications; renewal procedures. An application for an original license or renewal shall be made to the Department in writing or electronically on forms prescribed by the Department and shall be accompanied by the required fee, which shall not be refundable. Any such application shall require such information as in the judgment of the Department will enable the Board and Department to pass on the qualifications of the applicant for a license. If the application
for renewal with the required fee is not received by the Department before
the expiration date, the existing license shall lapse and become null and
void. Failure to renew before the expiration date is cause for a late
payment penalty, discipline, or both.
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
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(225 ILCS 120/31) (Section scheduled to be repealed on January 1, 2028) Sec. 31. Expiration of license; renewal. (a) The expiration date and renewal period for each license issued under this Act shall be set by rule. (b) Any licensee who shall engage in the practice for which the license was issued while the license is expired or on inactive status shall be considered to be practicing without a license which shall be grounds for discipline under this Act. (c) A wholesale drug distributor or third-party logistics provider whose license has been expired for one year or more may not have its license restored but must apply for a new license and meet all requirements for licensure. Any wholesale drug distributor or third-party logistics provider whose license has been expired for less than one year may apply for restoration of its license and shall have its license restored. (d) Anyone operating on an expired license is engaged in unlawful practice and subject to discipline under this Act.
(Source: P.A. 102-879, eff. 1-1-23.) |
(225 ILCS 120/35) (from Ch. 111, par. 8301-35)
(Section scheduled to be repealed on January 1, 2028)
Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
(a) The Department shall provide by rule for a schedule of fees for the
administration and
enforcement of this Act, including, but not limited to, original licensure,
renewal, and
restoration. The fees shall be nonrefundable.
(b) All fees collected under this Act shall be deposited into the Illinois
State
Pharmacy
Disciplinary Fund and shall be appropriated to the Department for the ordinary
and
contingent expenses of the Department in the administration of this Act. Moneys in the Fund may be transferred to the Professions
Indirect Cost Fund as authorized by Section 2105-300 of the
Department of Professional Regulation Law.
The moneys deposited into the Illinois State Pharmacy Disciplinary Fund shall
be invested to earn interest which shall accrue to the Fund.
(c) Any person who delivers a check or other payment to the Department that
is returned to the Department unpaid by the financial institution upon
which it is drawn shall pay to the Department, in addition to the amount
already owed to the Department, a fine of $50. The fines imposed by this Section are in addition
to any other discipline provided under this Act for unlicensed
practice or practice on a nonrenewed license. The Department shall notify
the person that payment of fees and fines shall be paid to the Department
by certified check or money order within 30 calendar days of the
notification. If, after the expiration of 30 days from the date of the
notification, the person has failed to submit the necessary remittance, the
Department shall automatically terminate the license or certificate or deny
the application, without hearing. If, after termination or denial, the
person seeks a license or certificate, he or she shall apply to the
Department for restoration or issuance of the license or certificate and
pay all fees and fines due to the Department. The Department may establish
a fee for the processing of an application for restoration of a license or
certificate to pay all expenses of processing this application. The Secretary
may waive the fines due under this Section in individual cases where the Secretary
finds that the fines would be unreasonable or unnecessarily
burdensome.
(d) (Blank).
(e) A manufacturer of controlled substances, wholesale distributor of controlled substances, or third-party logistics provider that is licensed under this Act and owned and operated by the State is exempt from licensure, registration, renewal, and other fees required under this Act. Nothing in this subsection (e) shall be construed to prohibit the Department
from imposing any fine or other penalty allowed under this Act.
(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)
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(225 ILCS 120/40) (from Ch. 111, par. 8301-40)
(Section scheduled to be repealed on January 1, 2028)
Sec. 40. Rules and regulations. The Department shall
make any rules and regulations, not inconsistent with law, as may be
necessary to carry out the purposes and enforce the provisions of this Act.
All rules and regulations promulgated under this Section shall
conform to wholesale drug distributor licensing guidelines formally adopted
by the FDA at 21 C.F.R. Part 205. In case of conflict between any rule
or regulation adopted by the Department and any FDA wholesale drug
distributor or third-party logistics provider guideline, the FDA guideline shall control.
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
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(225 ILCS 120/45)
Sec. 45. (Repealed).
(Source: P.A. 87-594. Repealed by P.A. 95-689, eff. 10-29-07.)
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(225 ILCS 120/50) (from Ch. 111, par. 8301-50)
(Section scheduled to be repealed on January 1, 2028)
Sec. 50. Inspection powers; access to records.
(a) Any pharmacy investigator authorized by the Department
has the right of entry for inspection
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.
(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 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. 102-879, eff. 1-1-23.)
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(225 ILCS 120/55) (from Ch. 111, par. 8301-55)
(Section scheduled to be repealed on January 1, 2028)
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 for any one or a combination of the following reasons:
(1) Violation of this Act or of the rules adopted | ||
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(2) Aiding or assisting another person in violating | ||
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(3) Failing, within 60 days, to provide information | ||
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(4) Engaging in dishonorable, unethical, or | ||
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(5) Discipline by another U.S. jurisdiction or | ||
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(6) Selling or engaging in the sale of drug samples | ||
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(7) Conviction by plea of guilty or nolo contendere, | ||
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(8) Habitual or excessive use or addiction to | ||
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(9) Material misstatement in furnishing information | ||
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(10) A finding by the Department that the licensee, | ||
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(11) Fraud or misrepresentation in applying for, or | ||
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(12) Willfully making or filing false records or | ||
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(13) A finding of a substantial discrepancy in a | ||
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(14) Falsifying a pedigree or selling, distributing, | ||
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(15) Interfering with a Department investigation. (16) Failing to adequately secure controlled | ||
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(17) Acquiring or distributing prescription drugs not | ||
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(18) Failing to properly store drugs. (19) Failing to maintain the licensed premises with | ||
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(b) 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) 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 (c) shall be prohibited from engaging in the practice of
pharmacy in this State.
(Source: P.A. 97-804, eff. 1-1-13; 97-813, eff. 7-13-12; 98-463, eff. 8-16-13.)
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(225 ILCS 120/56)
(Section scheduled to be repealed on January 1, 2028) Sec. 56. Restrictions on transactions. (a) A licensee shall receive prescription drug returns or exchanges from a pharmacy or other persons authorized to administer or dispense drugs or a chain pharmacy warehouse pursuant to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or chain pharmacy warehouse. Returns of expired, damaged, recalled, or otherwise non-saleable pharmaceutical products shall be distributed by the receiving wholesale distributor only to either the original manufacturer or a third party returns processor. Returns or exchanges of prescription drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, shall not be subject to the pedigree requirements of Section 57 of this Act, so long as they are exempt from the pedigree requirement of the FDA's currently applicable Prescription Drug Marketing Act guidance. Both licensees under this Act and pharmacies or other persons authorized to administer or dispense drugs shall be accountable for administering their returns process and ensuring that the aspects of this operation are secure and do not permit the entry of adulterated and counterfeit product. (b) A manufacturer or wholesale distributor licensed under this Act may furnish prescription drugs only to a person licensed by the appropriate state licensing authorities.
Before furnishing prescription drugs to a person not known to the manufacturer or wholesale distributor, the manufacturer or wholesale distributor must affirmatively verify that the person is legally authorized to receive the prescription drugs by contacting the appropriate state licensing authorities. (c) Prescription drugs furnished by a manufacturer or wholesale distributor licensed under this Act may be delivered only to the premises listed on the license, provided that the manufacturer or wholesale distributor may furnish prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if: (1) the identity and authorization of the recipient | ||
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(2) this method of receipt is employed only to meet | ||
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(d) Prescription drugs may be furnished to a hospital pharmacy receiving area, provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor by the next business day after the delivery to the pharmacy receiving area. (e) A manufacturer or wholesale distributor licensed under this Act may not accept payment for, or allow the use of, a person or entity's credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial officer listed on the license of a person or entity legally authorized to receive the prescription drugs. Any account established for the purchase of prescription drugs must bear the name of the licensee. This subsection (e) shall not be construed to prohibit a pharmacy or chain pharmacy warehouse from receiving prescription drugs if payment for the prescription drugs is processed through the pharmacy's or chain pharmacy warehouse's contractual drug manufacturer or wholesale distributor.
(Source: P.A. 95-689, eff. 10-29-07.) |
(225 ILCS 120/57) (Section scheduled to be repealed on January 1, 2028) Sec. 57. Pedigree. (a) Each person who is engaged in the wholesale distribution of prescription drugs, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, that leave or have ever left the normal distribution channel shall, before each wholesale distribution of the drug, provide a pedigree to the person who receives the
drug. A retail pharmacy, mail order pharmacy, or chain pharmacy warehouse must comply with the requirements of this Section only if the pharmacy or chain pharmacy warehouse engages in the wholesale distribution of prescription drugs. On or before July 1, 2009, the Department shall determine a targeted implementation date for electronic track and trace pedigree technology. This targeted implementation date shall not be sooner than July 1, 2010. Beginning on the date established by the Department, pedigrees may be implemented through an approved and readily available system that electronically tracks and traces the wholesale distribution of each prescription drug starting with the sale by the manufacturer through acquisition and sale by any wholesale distributor and until final sale to a pharmacy or other authorized person administering or dispensing the prescription drug. This electronic tracking system shall be deemed to be readily available only upon there being available a standardized system originating with the manufacturers and capable of being used on a wide scale across the entire pharmaceutical chain, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. Consideration must also be given to the large-scale implementation of this technology across the supply chain and the technology must be proven to have no negative impact on the safety and efficacy of the pharmaceutical product. (b) Each person who is engaged in the wholesale distribution of a prescription drug who is provided a pedigree for a prescription drug and attempts to further distribute that prescription drug, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, must affirmatively verify before any distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred. (c) The pedigree must include all necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer or the manufacturer's third-party logistics provider, co-licensed product partner, or exclusive distributor through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. This necessary chain of distribution information shall include, without limitation all of the following: (1) The name, address, telephone number and, if | ||
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(2) The name and address of each location from which | ||
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(3) Transaction dates. (4) Certification that each recipient has | ||
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(d) The pedigree must also include without limitation all of the following information concerning the prescription drug: (1) The name and national drug code number of the | ||
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(2) The dosage form and strength of the prescription | ||
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(3) The size of the container. (4) The number of containers. (5) The lot number of the prescription drug. (6) The name of the manufacturer of the finished | ||
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(e) Each pedigree or electronic file shall be maintained by the purchaser and the wholesale distributor for at least 3 years from the date of sale or transfer and made available for inspection or use within 5 business days upon a request of the Department.
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.) |
(225 ILCS 120/58)
(Section scheduled to be repealed on January 1, 2028) Sec. 58. Prohibited acts. It is unlawful for a person to perform or cause the performance of or aid and abet any of the following acts: (1) Failure to obtain a license in accordance with | ||
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(2) If the requirements of subsection (a) of Section | ||
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(3) If licensure is required pursuant to subsection | ||
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(4) Failure to deliver prescription drugs to | ||
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(5) Accepting payment or credit for the sale of | ||
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(6) Failure to maintain or provide pedigrees as | ||
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(7) Failure to obtain, pass, or authenticate a | ||
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(8) Providing the Department or any federal official | ||
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(9) Obtaining or attempting to obtain a prescription | ||
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(10) The manufacture, repacking, sale, transfer, | ||
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(11) The adulteration, misbranding, or counterfeiting | ||
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(12) The receipt of any prescription drug that is | ||
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(13) The alteration, mutilation, destruction, | ||
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(Source: P.A. 95-689, eff. 10-29-07.) |
(225 ILCS 120/59)
(Section scheduled to be repealed on January 1, 2028) Sec. 59. Injunctive action; cease and desist order. (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. (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.
(Source: P.A. 97-804, eff. 1-1-13.) |
(225 ILCS 120/60) (from Ch. 111, par. 8301-60)
(Section scheduled to be repealed on January 1, 2028)
Sec. 60.
Wholesaler licensing; complaints.
The Department may refuse
to issue a license to establish a new licensed wholesale drug
distributorship, if an owner of the wholesale drug distributorship applying
for a license was an owner of a wholesale drug distributorship that had its
license revoked, unless the owner presents sufficient evidence indicating
rehabilitation. Once a complaint has been filed by the Department against
a wholesale drug distributorship the Department may refuse to issue a
license to establish a new licensed wholesale drug distributorship,
until such time as the Department issues a decision on the complaint if an
owner of the new wholesale drug distributorship was also an owner of a
wholesale drug distributorship against which the complaint was filed.
Neither an application for change of ownership nor for a change of location
for any such wholesale drug distributorship shall be acted on by the
Department until such time as the Department issues a decision on the
complaint. In the event that the wholesale drug distributorship against
which the complaint has been filed ceases to be licensed by the Department,
for any reason, before the Department's decision on the complaint and an
owner or that wholesale drug distributorship applies for a license to
establish a new wholesale drug distributorship, the Department shall
conduct a hearing on the complaint earlier filed, regardless of whether
that wholesale drug distributorship is presently licensed by the
Department. If the conduct for which the complaint was originally filed
would have been sufficient to result in a revocation of a license to
operate a licensed wholesale drug distributorship, then the conduct shall
constitute sufficient grounds for denial of an application for a license.
(Source: P.A. 87-594.)
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(225 ILCS 120/65) (from Ch. 111, par. 8301-65)
(Section scheduled to be repealed on January 1, 2028)
Sec. 65.
Pending disciplinary proceeding.
The Department
shall render no final administrative decision relative to any
application for a license or certificate of registration under
this Act if the applicant for the license or certificate of
registration is the subject of a pending disciplinary proceeding
under this Act or another Act administered by the Department. For
purposes of this Section "applicant" means an individual or sole
proprietor, or an individual who is an officer, director, or owner
of a 5% or more beneficial interest in the applicant.
(Source: P.A. 87-594.)
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(225 ILCS 120/70) (from Ch. 111, par. 8301-70)
(Section scheduled to be repealed on January 1, 2028)
Sec. 70. Immediate suspension of license or registration; hearing.
The Secretary may, upon receipt of a written communication
from the Secretary of Human Services or the Director of Public Health that
continuation of practice
of a person licensed or registered under this Act constitutes an immediate
danger to the public, immediately suspend the license or registration of
that person without a hearing. In instances in which the Secretary
immediately suspends a license or registration under this Section, a hearing
upon the person's license must be convened by the Board within 15 days
after the suspension and completed without appreciable delay. The hearing
shall be held to determine whether to recommend to the Secretary that the
person's license be revoked, suspended, placed on probationary status, or
reinstated, or that the person be subject to other disciplinary action. In
the hearing, the written communication and any other evidence submitted
with the communication may be introduced as evidence
against the person. The person or his or her counsel shall
have the opportunity to discredit or impeach such evidence and submit
rebuttal evidence.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/75) (from Ch. 111, par. 8301-75)
(Section scheduled to be repealed on January 1, 2028)
Sec. 75. Automatic suspension. The determination by a
circuit court that a licensee is subject to involuntary
admission or judicial admission as provided in the Mental
Health and Developmental Disabilities Code operates as an
automatic suspension. The suspension shall end only upon (i)
a finding by a court that the patient is no longer subject
to involuntary admission or judicial admission and the issuance
of an order so finding and discharging the patient and (ii) the
recommendation of the Board to the Secretary that the licensee
be allowed to resume his or her practice.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/80) (from Ch. 111, par. 8301-80)
(Section scheduled to be repealed on January 1, 2028)
Sec. 80. Violations of Act.
(a) If any person violates the provisions of this Act, the Secretary
may, in the name of the People of the State of Illinois through
the Attorney General of the State of Illinois or the State's Attorney of
any county in which the action is brought, petition for an order enjoining
the violation or for an order enforcing compliance with this Act. Upon
the filing of a verified petition in the court, the court 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, the Court may punish
the offender for contempt of court. Proceedings under this Section shall
be in addition to, and not in lieu of, all other remedies and penalties
provided by this Act.
(b) Whoever knowingly conducts business as a wholesale drug distributor or third-party logistics provider
in this State without being appropriately licensed under this Act shall be
guilty of a Class A misdemeanor for a first violation and for each
subsequent conviction shall be guilty of a Class 4 felony.
(c) Whenever in the opinion of the Department any person not licensed in
good standing under this Act violates any provision of this Act, the
Department may issue a rule to show cause why an order to cease and desist
should not be entered against him. The rule shall clearly set forth the
grounds relied upon by the Department and shall provide a period of 7 days
from the date of the rule to file an answer to the satisfaction of the
Department. Failure to answer to the satisfaction of the Department shall
cause an order to cease and desist to be issued immediately.
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
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(225 ILCS 120/85) (from Ch. 111, par. 8301-85)
(Section scheduled to be repealed on January 1, 2028)
Sec. 85. Investigations; notice of disciplinary hearing. The
Department may investigate the actions of any applicant or of any person or
persons holding or claiming to hold a license or registration. Before
suspending, revoking, placing on probationary status, or taking any other
disciplinary action as the Department may deem proper with regard to any
license or certificate, at least 30 days before the date set for the
hearing, the Department shall (i) notify the accused in writing of any
charges made and the time and place for a hearing of the charges before
the Board, (ii) direct him or her to file a written answer to the charges
with the Board under oath within 20 days after the service of the notice,
and (iii) inform the accused that if he or she fails to file an answer
default will be taken against him or her and his or her license or
certificate may be suspended, revoked, placed on probationary
status, or have other disciplinary action, including limiting the scope,
nature or extent of business, as provided for in this Act. The written notice
may be served by personal delivery, email to the respondent's email address of record, or mail to the respondent's address of record. At
the time and place fixed in the notice, the Board shall proceed to hear the
charges and the parties or their counsel shall be accorded ample
opportunity to present any statements, testimony, evidence and argument
that may be pertinent to the charges or to their defense. The hearing may
be continued from time to time. In case the accused person, after
receiving notice, fails to file an answer, his or her license or
certificate may in the discretion of the Secretary, having received first
the recommendation of the Board, be suspended, revoked, placed on
probationary status, or the Secretary may take whatever disciplinary action
as he or she may deem proper as provided in this Act, including limiting
the scope, nature, or extent of the person's practice, without a hearing,
if the act or acts charged constitute sufficient grounds for such action
under this Act.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/90) (from Ch. 111, par. 8301-90)
(Section scheduled to be repealed on January 1, 2028)
Sec. 90.
Record of proceedings.
The Department, at its expense,
shall preserve a record of all proceedings at the formal hearing of any
case involving the refusal to issue or renew a license or discipline of a
licensee. The notice of hearing, complaint, and all other documents in the
nature of pleadings and written motions filed in the proceedings, the
transcript of testimony, the report of the Board or hearing officer, and
orders of the Department shall be the record of the proceeding.
(Source: P.A. 87-594.)
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(225 ILCS 120/95) (from Ch. 111, par. 8301-95)
(Section scheduled to be repealed on January 1, 2028)
Sec. 95.
Order requiring attendance of witnesses and production of
evidence. Any circuit court may, upon application of the Department or its
designee or of the applicant or licensee against whom proceedings of this
Act are pending, enter an order requiring the attendance of witnesses and
their testimony and the production of documents, papers, files, books and
records in connection with any hearing or investigation. The court may
compel obedience to its order by proceedings for contempt.
(Source: P.A. 87-594.)
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(225 ILCS 120/100) (from Ch. 111, par. 8301-100)
(Section scheduled to be repealed on January 1, 2028)
Sec. 100. Subpoena power; administration of oaths. The Department
shall have power to subpoena and bring before it any person in this State
and to take testimony, either orally or by deposition or both, with the
same fees and mileage and in the same manner as prescribed by law in
judicial proceedings in civil cases in circuit courts of this State. The Department may subpoena and compel the production of documents, papers, files, books, and records in connection with any hearing or investigation.
The Secretary, hearing officer, and any member of the Board shall each have power to
administer oaths to witnesses at any hearing which the Department is
authorized to conduct under this Act, and any other oaths required or
authorized to be administered by the Department under this Act.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/105) (from Ch. 111, par. 8301-105)
(Section scheduled to be repealed on January 1, 2028)
Sec. 105. Report of findings and recommendation. At the conclusion
of the hearing, the Board shall present to the Secretary a written report of
its findings of fact, conclusions of law, and recommendations. The report
shall contain a finding whether or not the accused person violated this Act
or failed to comply with the conditions required in this Act. The Board
shall specify the nature of the violation or failure to comply and shall
make its recommendations to the Secretary.
The report of findings of fact, conclusion of law, and recommendations of
the Board shall be the basis for the Department's order for refusal or for
the granting of a license or registration. The finding is not admissible
in evidence against the person in a criminal prosecution brought for the
violation of this Act, but the hearing and finding are not a bar to a
criminal prosecution brought for the violation of this Act.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/110) (from Ch. 111, par. 8301-110)
(Section scheduled to be repealed on January 1, 2028)
Sec. 110. Hearing officers; appointment. Notwithstanding any other
provision of this Act, the Secretary shall have the authority to appoint
any attorney duly licensed to practice law in the State of Illinois to
serve as the hearing officer in any action before the Board for refusal to
issue or renew a license, or the discipline of a licensee. The hearing officer
shall report his findings of fact, conclusions of law, and recommendations
to the Board and the Secretary. The Board shall have 60 days from receipt
of the report to review the report of the hearing officer and present its
findings of fact, conclusions of law, and recommendations to the Secretary.
If the Board fails to present its report within the 60-day period, the Secretary
may issue an order based on the report of the hearing officer and the record of the proceedings or issue an order remanding the matter back to the hearing officer for additional proceedings in accordance with the order. If the Secretary disagrees with the recommendation of the Board or the hearing officer, the Secretary may issue an order in contravention of the recommendation.
(Source: P.A. 102-879, eff. 1-1-23; 103-154, eff. 6-30-23.)
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(225 ILCS 120/115) (from Ch. 111, par. 8301-115)
(Section scheduled to be repealed on January 1, 2028)
Sec. 115. Motion for rehearing. In any case involving the refusal to
issue, renew, or discipline of a license or registration, a copy of the
Board's report shall be served upon the respondent by the Department, either
personally or as provided in this Act for the service of the notice of
hearing. Within 20 days after service, the respondent may present to
the Department a motion in writing for a rehearing, which shall
specify the particular grounds for rehearing. If no motion for rehearing is
filed, then upon the expiration of the time specified for filing a
motion, or if a motion for rehearing is denied, then upon denial the Secretary
may enter an order in accordance with recommendations of the Board.
If the respondent orders from the reporting service and
pays for a transcript of the record within the time for filing a motion
for rehearing, the 20-day period within which a motion may be filed shall
commence upon the delivery of the transcript to the respondent.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/120) (from Ch. 111, par. 8301-120)
(Section scheduled to be repealed on January 1, 2028)
Sec. 120. Rehearing by order of Secretary. Whenever the Secretary is
satisfied that substantial justice has not been done in the revocation,
suspension, or refusal to issue or renew a license or registration,
the Secretary may order a rehearing by the same hearing office or Board.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/125) (from Ch. 111, par. 8301-125)
(Section scheduled to be repealed on January 1, 2028)
Sec. 125. Duties of the Board. The Board shall exercise the rights, powers, and duties which have been vested in the Board under this Act, and any other duties conferred upon the Board by law.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/130) (from Ch. 111, par. 8301-130)
(Section scheduled to be repealed on January 1, 2028)
Sec. 130.
State liability for disciplinary action without reasonable
basis. In the event that the Department's order of revocation, suspension,
placing the licensee on probationary status, or other order or formal
disciplinary action is without any reasonable basis, then the State of
Illinois shall be liable to the injured party for those special damages
suffered as a direct result of such order.
(Source: P.A. 87-594.)
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(225 ILCS 120/135) (from Ch. 111, par. 8301-135)
(Section scheduled to be repealed on January 1, 2028)
Sec. 135. Disciplinary consent orders. Notwithstanding the provisions
of this Act concerning the conduct of hearings and recommendations for
disciplinary actions, the Secretary shall have the authority to negotiate
agreements with licensees resulting in disciplinary consent
orders. Consent orders may provide for any of the forms of discipline
otherwise provided in this Act. Consent orders shall provide that they were
not entered into a result of any coercion by the Department.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/140) (from Ch. 111, par. 8301-140)
(Section scheduled to be repealed on January 1, 2028)
Sec. 140. Orders; prima facie proof. An order or a certified copy
thereof, over the seal of the Department and purporting to be signed by the Secretary, shall be prima facie proof that:
(a) the signature is the genuine signature of the | ||
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(b) the Secretary is duly appointed and qualified; and
(c) the Board and its members are qualified to act.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/145) (from Ch. 111, par. 8301-145)
(Section scheduled to be repealed on January 1, 2028)
Sec. 145.
Restoration of certificate.
At any time after suspension
or revocation of any certificate, the Department may restore it to the
accused person upon the written recommendation of the Board.
(Source: P.A. 87-594.)
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(225 ILCS 120/150) (from Ch. 111, par. 8301-150)
(Section scheduled to be repealed on January 1, 2028)
Sec. 150.
Surrender of license or registration.
Upon the revocation
or suspension of any license or registration, the holder shall immediately
surrender the license or registration to the Department and if the
licensee fails to do so, the Department shall have the right to seize the
license or certificate.
(Source: P.A. 87-594.)
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(225 ILCS 120/155) (from Ch. 111, par. 8301-155)
(Section scheduled to be repealed on January 1, 2028)
Sec. 155. Temporary suspension of license; hearing. The Secretary
may temporarily suspend licensure as a wholesale drug distributor or third-party logistics provider,
without a hearing, simultaneously with the institution of proceedings for a
hearing provided for in Section 85 of this Act, if the Secretary finds that
evidence in his or her possession indicates that a continuation in business
would constitute an imminent danger to the public. In the event that the Secretary
temporarily suspends a license or certificate without a
hearing, a hearing by the Department must be held within 10 days after
the suspension has occurred and be concluded without appreciable delay.
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
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(225 ILCS 120/160) (from Ch. 111, par. 8301-160)
(Section scheduled to be repealed on January 1, 2028)
Sec. 160.
Administrative Review Law; venue.
All final
administrative decisions of the Department are subject to judicial
review under the Administrative Review Law and its rules. The
term "administrative decision" is defined as in Section 3-101
of the Code of Civil Procedure.
Proceedings for judicial review shall be commenced in the circuit
court of the county in which the party applying for review resides;
but if the party is not a resident of this State, the venue shall be
in Sangamon County.
(Source: P.A. 87-594.)
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(225 ILCS 120/165) (from Ch. 111, par. 8301-165)
(Section scheduled to be repealed on January 1, 2028)
Sec. 165. Certification of record. The Department shall not be required to certify any record to the court, to file an answer in court, or to otherwise appear in any court in a judicial review proceeding unless and until the Department has received from the plaintiff payment of the costs of furnishing and certifying the record, which costs shall be determined by the Department. Failure on the part of the plaintiff to file a receipt in court shall be grounds for dismissal of the action. During the pendency and hearing of any and all judicial proceedings incident to the disciplinary action, the sanctions imposed upon the accused by the Department because of acts or omissions related to the delivery of direct patient care as specified in the Department's final administrative decision, shall, as a matter of public policy, remain in full force and effect in order to protect the public pending final resolution of any of the proceedings.
(Source: P.A. 102-879, eff. 1-1-23.)
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(225 ILCS 120/170) (from Ch. 111, par. 8301-170)
(Section scheduled to be repealed on January 1, 2028)
Sec. 170. Penalties. Any person who is found to have violated
any provision of this Act is guilty of a Class A misdemeanor. On
conviction of a second or subsequent offense, the violator shall
be guilty of a Class 4 felony. All criminal fines, monies, or
property collected or received by the Department under this Section
or any other State or federal statute, including, but not limited
to, property forfeited to the Department under Section 505 of the
Illinois Controlled Substances Act or Section 85 of the Methamphetamine Control and Community Protection Act, shall be deposited into the
Professional Regulation Evidence Fund.
(Source: P.A. 94-556, eff. 9-11-05.)
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(225 ILCS 120/173) (Section scheduled to be repealed on January 1, 2028) 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.
(Source: P.A. 97-804, eff. 1-1-13.) |
(225 ILCS 120/175) (from Ch. 111, par. 8301-175)
(Section scheduled to be repealed on January 1, 2028)
Sec. 175.
Administrative procedure.
The Illinois Administrative
Procedure Act is hereby expressly adopted and incorporated as if the
provisions of that Act were included in this Act, except that the
provision of paragraph (d) of Section 10-65 of the
Illinois Administrative Procedure Act, which provides that at hearings the
licensee has the right to show compliance with all lawful requirements for
retention, continuation, or renewal of the license, is
specifically excluded. For the purpose of this Act, the notice required
under Section 10-25 of the Administrative Procedure Act is
deemed sufficient when mailed to the last known address of a party.
(Source: P.A. 87-594; 88-670, eff. 12-2-94.)
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(225 ILCS 120/180) (from Ch. 111, par. 8301-180)
(Section scheduled to be repealed on January 1, 2028)
Sec. 180.
Conflict of laws.
In the event of a conflict between any
provision of this Act and the Mental Health and Developmental Disabilities
Confidentiality Act, the provisions of this Act shall govern.
(Source: P.A. 87-594.)
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(225 ILCS 120/185) (from Ch. 111, par. 8301-185)
(Section scheduled to be repealed on January 1, 2028)
Sec. 185.
Home rule preemption.
The regulation and licensing of
wholesale drug distributors are exclusive powers and functions of the
State. A home rule unit may not regulate or license wholesale drug
distributors. This Section is a denial and limitation of home rule powers
and functions under subsection (h) of Section 6 of Article VII of the
Illinois Constitution.
(Source: P.A. 87-594.)
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(225 ILCS 120/195) (from Ch. 111, par. 8301-195)
(Section scheduled to be repealed on January 1, 2028)
Sec. 195.
Effective date.
This Act shall take effect upon becoming law.
(Source: P.A. 87-594.)
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(225 ILCS 120/200) (Section scheduled to be repealed on January 1, 2028) Sec. 200. Drugs in shortage. (a) For the purpose of this Section, "drug in shortage" means a drug, as defined in Section 356c of the Federal Food, Drug, and Cosmetic Act, listed on the drug shortage list maintained by the U.S. Food and Drug Administration in accordance with Section 356e of the Federal Food, Drug, and Cosmetic Act. (b) Any person engaged in the wholesale distribution of a drug in shortage in this State must be licensed by the Department. (c) It is unlawful for any person, other than a manufacturer, a manufacturer's exclusive distributor, a third-party logistics provider, or an authorized distributor of record, to purchase or receive a drug in shortage from any person not licensed by the Department. This subsection (c) does not apply to the return of drugs or the purchase or receipt of drugs pursuant to any of the distributions that are specifically excluded from the definition of "wholesale distribution" in Section 15 of the Wholesale Drug Distribution Licensing Act. (d) A person found to have violated a provision of this Section shall be subject to administrative fines, orders for restitution, and orders for disgorgement. (e) The Department shall create a centralized, searchable database of those entities licensed to engage in wholesale distribution, including manufacturers, wholesale distributors, and pharmacy distributors, to enable purchasers of a drug in shortage to easily verify the licensing status of an entity offering such drugs. (f) The Department shall establish a system for reporting the reasonable suspicion that a violation of this Act has been committed by a distributor of a drug in shortage. Reports made through this system shall be referred to the Office of the Attorney General and the appropriate State's Attorney's office for further investigation and prosecution. (g) The Department shall adopt rules to carry out the provisions of this Section. (h) Nothing in this Section prohibits one hospital pharmacy from purchasing or receiving a drug in shortage from another hospital pharmacy in the event of a medical emergency.
(Source: P.A. 102-879, eff. 1-1-23.) |