Public Act 101-0420
 
SB1839 EnrolledLRB101 09712 JRG 54811 b

    AN ACT concerning regulation.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    Section 3. The Pharmacy Practice Act is amended by changing
Section 4 as follows:
 
    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
    (Section scheduled to be repealed on January 1, 2020)
    Sec. 4. Exemptions. Nothing contained in any Section of
this Act shall apply to, or in any manner interfere with:
        (a) the lawful practice of any physician licensed to
    practice medicine in all of its branches, dentist,
    podiatric physician, veterinarian, or therapeutically or
    diagnostically certified optometrist within the limits of
    his or her license, or prevent him or her from supplying to
    his or her bona fide patients such drugs, medicines, or
    poisons as may seem to him appropriate;
        (b) the sale of compressed gases;
        (c) the sale of patent or proprietary medicines and
    household remedies when sold in original and unbroken
    packages only, if such patent or proprietary medicines and
    household remedies be properly and adequately labeled as to
    content and usage and generally considered and accepted as
    harmless and nonpoisonous when used according to the
    directions on the label, and also do not contain opium or
    coca leaves, or any compound, salt or derivative thereof,
    or any drug which, according to the latest editions of the
    following authoritative pharmaceutical treatises and
    standards, namely, The United States
    Pharmacopoeia/National Formulary (USP/NF), the United
    States Dispensatory, and the Accepted Dental Remedies of
    the Council of Dental Therapeutics of the American Dental
    Association or any or either of them, in use on the
    effective date of this Act, or according to the existing
    provisions of the Federal Food, Drug, and Cosmetic Act and
    Regulations of the Department of Health and Human Services,
    Food and Drug Administration, promulgated thereunder now
    in effect, is designated, described or considered as a
    narcotic, hypnotic, habit forming, dangerous, or poisonous
    drug;
        (d) the sale of poultry and livestock remedies in
    original and unbroken packages only, labeled for poultry
    and livestock medication;
        (e) the sale of poisonous substances or mixture of
    poisonous substances, in unbroken packages, for
    nonmedicinal use in the arts or industries or for
    insecticide purposes; provided, they are properly and
    adequately labeled as to content and such nonmedicinal
    usage, in conformity with the provisions of all applicable
    federal, state and local laws and regulations promulgated
    thereunder now in effect relating thereto and governing the
    same, and those which are required under such applicable
    laws and regulations to be labeled with the word "Poison",
    are also labeled with the word "Poison" printed thereon in
    prominent type and the name of a readily obtainable
    antidote with directions for its administration;
        (f) the delegation of limited prescriptive authority
    by a physician licensed to practice medicine in all its
    branches to a physician assistant under Section 7.5 of the
    Physician Assistant Practice Act of 1987. This delegated
    authority under Section 7.5 of the Physician Assistant
    Practice Act of 1987 may, but is not required to, include
    prescription of controlled substances, as defined in
    Article II of the Illinois Controlled Substances Act, in
    accordance with a written supervision agreement;
        (g) the delegation of prescriptive authority by a
    physician licensed to practice medicine in all its branches
    or a licensed podiatric physician to an advanced practice
    registered nurse in accordance with a written
    collaborative agreement under Sections 65-35 and 65-40 of
    the Nurse Practice Act; and
        (h) the sale or distribution of dialysate or devices
    necessary to perform home peritoneal renal dialysis for
    patients with end-stage renal disease, provided that all of
    the following conditions are met:
            (1) the dialysate, comprised of dextrose or
        icodextrin, or devices are approved or cleared by the
        federal Food and Drug Administration, as required by
        federal law;
            (2) the dialysate or devices are lawfully held by a
        manufacturer or the manufacturer's agent, which is
        properly registered with the Board as a manufacturer,
        third-party logistics provider, or wholesaler;
            (3) the dialysate or devices are held and delivered
        to the manufacturer or the manufacturer's agent in the
        original, sealed packaging from the manufacturing
        facility;
            (4) the dialysate or devices are delivered only
        upon receipt of a physician's prescription by a
        licensed pharmacy in which the prescription is
        processed in accordance with provisions set forth in
        this Act, and the transmittal of an order from the
        licensed pharmacy to the manufacturer or the
        manufacturer's agent; and
            (5) the manufacturer or the manufacturer's agent
        delivers the dialysate or devices directly to: (i) a
        patient with end-stage renal disease, or his or her
        designee, for the patient's self-administration of the
        dialysis therapy or (ii) a health care provider or
        institution for administration or delivery of the
        dialysis therapy to a patient with end-stage renal
        disease.
        This paragraph (h) does not include any other drugs for
    peritoneal dialysis, except dialysate, as described in
    item (1) of this paragraph (h). All records of sales and
    distribution of dialysate to patients made pursuant to this
    paragraph (h) must be retained in accordance with Section
    18 of this Act.
(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
100-863, eff. 8-14-18.)
 
    Section 10. The Wholesale Drug Distribution Licensing Act
is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80,
and 155 and by adding Section 25.5 as follows:
 
    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
    (Section scheduled to be repealed on January 1, 2023)
    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, 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'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, 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 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 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. 97-804, eff. 1-1-13.)
 
    (225 ILCS 120/20)  (from Ch. 111, par. 8301-20)
    (Section scheduled to be repealed on January 1, 2023)
    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. 97-804, eff. 1-1-13.)
 
    (225 ILCS 120/25.5 new)
    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
    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
    third-party logistics provider, 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
    third-party logistics provider, 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 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 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, that 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 third-party logistics provider 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 paragraph
    (4).
    (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 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; such inspection is not
    required if the resident state of the third-party logistics
    provider facility does not license third-party logistics
    providers or if the resident state does not inspect
    third-party logistics providers. If the resident state
    does not inspect third-party logistics providers, a
    Verified Accredited Wholesale Distributors Accreditation
    or other inspection approved by the Department meets this
    requirement; 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 is employed by the applicant full
        time in a managerial level position.
            (C) He or she is actively involved in and aware of
        the actual daily operation of third-party logistics
        provider.
    (g) A third-party logistics provider shall publicly
display all licenses and have the most recent state and federal
inspection reports readily available.
 
    (225 ILCS 120/26)
    (Section scheduled to be repealed on January 1, 2023)
    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, 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. 97-804, eff. 1-1-13.)
 
    (225 ILCS 120/30)  (from Ch. 111, par. 8301-30)
    (Section scheduled to be repealed on January 1, 2023)
    Sec. 30. License renewal application procedures.
Application blanks for renewal of any license required by this
Act shall be mailed or emailed to each licensee at least 60
days before the license expires. 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. 87-594.)
 
    (225 ILCS 120/35)  (from Ch. 111, par. 8301-35)
    (Section scheduled to be repealed on January 1, 2023)
    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 (20 ILCS
2105/2105-300).
    The moneys deposited into the Illinois State Pharmacy
Disciplinary Fund shall be invested to earn interest which
shall accrue to the Fund.
    The Department shall present to the Board for its review
and comment all appropriation requests from the Illinois State
Pharmacy Disciplinary Fund. The Department shall give due
consideration to any comments of the Board in making
appropriation requests.
    (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 Director may waive the fines
due under this Section in individual cases where the Director
finds that the fines would be unreasonable or unnecessarily
burdensome.
    (d) The Department shall maintain a roster of the names and
addresses of all registrants and of all persons whose licenses
have been suspended or revoked. This roster shall be available
upon written request and payment of the required fee.
    (e) A manufacturer of controlled substances, or 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. 95-689, eff. 10-29-07.)
 
    (225 ILCS 120/40)  (from Ch. 111, par. 8301-40)
    (Section scheduled to be repealed on January 1, 2023)
    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. Rules and regulations that incorporate and set
detailed standards for meeting each of the license
prerequisites set forth in Section 25 of this Act shall be
adopted no later than September 14, 1992. 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. 87-594.)
 
    (225 ILCS 120/57)
    (Section scheduled to be repealed on January 1, 2023)
    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
    available, the e-mail address of each owner of the
    prescription drug and each wholesale distributor of the
    prescription drug.
        (2) The name and address of each location from which
    the product was shipped, if different from the owner's.
        (3) Transaction dates.
        (4) Certification that each recipient has
    authenticated the pedigree.
    (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
    prescription drug.
        (2) The dosage form and strength of the prescription
    drug.
        (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 dosage
    form.
    (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. 95-689, eff. 10-29-07.)
 
    (225 ILCS 120/80)  (from Ch. 111, par. 8301-80)
    (Section scheduled to be repealed on January 1, 2023)
    Sec. 80. Violations of Act.
    (a) If any person violates the provisions of this Act, the
Director 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. 87-594.)
 
    (225 ILCS 120/155)  (from Ch. 111, par. 8301-155)
    (Section scheduled to be repealed on January 1, 2023)
    Sec. 155. Temporary suspension of license; hearing. The
Director 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
Director 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 Director
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. 87-594.)
 
    Section 99. Effective date. This Act takes effect upon
becoming law.

Effective Date: 8/16/2019