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1    AN ACT concerning regulation.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 3. The Pharmacy Practice Act is amended by changing
5Section 4 as follows:
6    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
7    (Section scheduled to be repealed on January 1, 2020)
8    Sec. 4. Exemptions. Nothing contained in any Section of
9this Act shall apply to, or in any manner interfere with:
10        (a) the lawful practice of any physician licensed to
11    practice medicine in all of its branches, dentist,
12    podiatric physician, veterinarian, or therapeutically or
13    diagnostically certified optometrist within the limits of
14    his or her license, or prevent him or her from supplying to
15    his or her bona fide patients such drugs, medicines, or
16    poisons as may seem to him appropriate;
17        (b) the sale of compressed gases;
18        (c) the sale of patent or proprietary medicines and
19    household remedies when sold in original and unbroken
20    packages only, if such patent or proprietary medicines and
21    household remedies be properly and adequately labeled as to
22    content and usage and generally considered and accepted as
23    harmless and nonpoisonous when used according to the



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1    directions on the label, and also do not contain opium or
2    coca leaves, or any compound, salt or derivative thereof,
3    or any drug which, according to the latest editions of the
4    following authoritative pharmaceutical treatises and
5    standards, namely, The United States
6    Pharmacopoeia/National Formulary (USP/NF), the United
7    States Dispensatory, and the Accepted Dental Remedies of
8    the Council of Dental Therapeutics of the American Dental
9    Association or any or either of them, in use on the
10    effective date of this Act, or according to the existing
11    provisions of the Federal Food, Drug, and Cosmetic Act and
12    Regulations of the Department of Health and Human Services,
13    Food and Drug Administration, promulgated thereunder now
14    in effect, is designated, described or considered as a
15    narcotic, hypnotic, habit forming, dangerous, or poisonous
16    drug;
17        (d) the sale of poultry and livestock remedies in
18    original and unbroken packages only, labeled for poultry
19    and livestock medication;
20        (e) the sale of poisonous substances or mixture of
21    poisonous substances, in unbroken packages, for
22    nonmedicinal use in the arts or industries or for
23    insecticide purposes; provided, they are properly and
24    adequately labeled as to content and such nonmedicinal
25    usage, in conformity with the provisions of all applicable
26    federal, state and local laws and regulations promulgated



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1    thereunder now in effect relating thereto and governing the
2    same, and those which are required under such applicable
3    laws and regulations to be labeled with the word "Poison",
4    are also labeled with the word "Poison" printed thereon in
5    prominent type and the name of a readily obtainable
6    antidote with directions for its administration;
7        (f) the delegation of limited prescriptive authority
8    by a physician licensed to practice medicine in all its
9    branches to a physician assistant under Section 7.5 of the
10    Physician Assistant Practice Act of 1987. This delegated
11    authority under Section 7.5 of the Physician Assistant
12    Practice Act of 1987 may, but is not required to, include
13    prescription of controlled substances, as defined in
14    Article II of the Illinois Controlled Substances Act, in
15    accordance with a written supervision agreement;
16        (g) the delegation of prescriptive authority by a
17    physician licensed to practice medicine in all its branches
18    or a licensed podiatric physician to an advanced practice
19    registered nurse in accordance with a written
20    collaborative agreement under Sections 65-35 and 65-40 of
21    the Nurse Practice Act; and
22        (h) the sale or distribution of dialysate or devices
23    necessary to perform home peritoneal renal dialysis for
24    patients with end-stage renal disease, provided that all of
25    the following conditions are met:
26            (1) the dialysate, comprised of dextrose or



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1        icodextrin, or devices are approved or cleared by the
2        federal Food and Drug Administration, as required by
3        federal law;
4            (2) the dialysate or devices are lawfully held by a
5        manufacturer or the manufacturer's agent, which is
6        properly registered with the Board as a manufacturer,
7        third-party logistics provider, or wholesaler;
8            (3) the dialysate or devices are held and delivered
9        to the manufacturer or the manufacturer's agent in the
10        original, sealed packaging from the manufacturing
11        facility;
12            (4) the dialysate or devices are delivered only
13        upon receipt of a physician's prescription by a
14        licensed pharmacy in which the prescription is
15        processed in accordance with provisions set forth in
16        this Act, and the transmittal of an order from the
17        licensed pharmacy to the manufacturer or the
18        manufacturer's agent; and
19            (5) the manufacturer or the manufacturer's agent
20        delivers the dialysate or devices directly to: (i) a
21        patient with end-stage renal disease, or his or her
22        designee, for the patient's self-administration of the
23        dialysis therapy or (ii) a health care provider or
24        institution for administration or delivery of the
25        dialysis therapy to a patient with end-stage renal
26        disease.



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1        This paragraph (h) does not include any other drugs for
2    peritoneal dialysis, except dialysate, as described in
3    item (1) of this paragraph (h). All records of sales and
4    distribution of dialysate to patients made pursuant to this
5    paragraph (h) must be retained in accordance with Section
6    18 of this Act.
7(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
8100-863, eff. 8-14-18.)
9    Section 10. The Wholesale Drug Distribution Licensing Act
10is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80,
11and 155 and by adding Section 25.5 as follows:
12    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
13    (Section scheduled to be repealed on January 1, 2023)
14    Sec. 15. Definitions. As used in this Act:
15    "Authentication" means the affirmative verification,
16before any wholesale distribution of a prescription drug
17occurs, that each transaction listed on the pedigree has
19    "Authorized distributor of record" means a wholesale
20distributor with whom a manufacturer has established an ongoing
21relationship to distribute the manufacturer's prescription
22drug. An ongoing relationship is deemed to exist between a
23wholesale distributor and a manufacturer when the wholesale
24distributor, including any affiliated group of the wholesale



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1distributor, as defined in Section 1504 of the Internal Revenue
2Code, complies with the following:
3        (1) The wholesale distributor has a written agreement
4    currently in effect with the manufacturer evidencing the
5    ongoing relationship; and
6        (2) The wholesale distributor is listed on the
7    manufacturer's current list of authorized distributors of
8    record, which is updated by the manufacturer on no less
9    than a monthly basis.
10    "Blood" means whole blood collected from a single donor and
11processed either for transfusion or further manufacturing.
12    "Blood component" means that part of blood separated by
13physical or mechanical means.
14    "Board" means the State Board of Pharmacy of the Department
15of Professional Regulation.
16    "Chain pharmacy warehouse" means a physical location for
17prescription drugs that acts as a central warehouse and
18performs intracompany sales or transfers of the drugs to a
19group of chain or mail order pharmacies that have the same
20common ownership and control. Notwithstanding any other
21provision of this Act, a chain pharmacy warehouse shall be
22considered part of the normal distribution channel.
23    "Co-licensed partner or product" means an instance where
24one or more parties have the right to engage in the
25manufacturing or marketing of a prescription drug, consistent
26with the FDA's implementation of the Prescription Drug



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1Marketing Act.
2    "Department" means the Department of Financial and
3Professional Regulation.
4    "Drop shipment" means the sale of a prescription drug to a
5wholesale distributor by the manufacturer of the prescription
6drug or that manufacturer's co-licensed product partner, that
7manufacturer's third party logistics provider, or that
8manufacturer's exclusive distributor or by an authorized
9distributor of record that purchased the product directly from
10the manufacturer or one of these entities whereby the wholesale
11distributor or chain pharmacy warehouse takes title but not
12physical possession of such prescription drug and the wholesale
13distributor invoices the pharmacy, chain pharmacy warehouse,
14or other person authorized by law to dispense or administer
15such drug to a patient and the pharmacy, chain pharmacy
16warehouse, or other authorized person receives delivery of the
17prescription drug directly from the manufacturer, that
18manufacturer's third party logistics provider, or that
19manufacturer's exclusive distributor or from an authorized
20distributor of record that purchased the product directly from
21the manufacturer or one of these entities.
22    "Drug sample" means a unit of a prescription drug that is
23not intended to be sold and is intended to promote the sale of
24the drug.
25    "Facility" means a facility of a wholesale distributor
26where prescription drugs are stored, handled, repackaged, or



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1offered for sale, or a facility of a third-party logistics
2provider where prescription drugs are stored or handled.
3    "FDA" means the United States Food and Drug Administration.
4    "Manufacturer" means a person licensed or approved by the
5FDA to engage in the manufacture of drugs or devices,
6consistent with the definition of "manufacturer" set forth in
7the FDA's regulations and guidances implementing the
8Prescription Drug Marketing Act.
9    "Manufacturer's exclusive distributor" means anyone who
10contracts with a manufacturer to provide or coordinate
11warehousing, distribution, or other services on behalf of a
12manufacturer and who takes title to that manufacturer's
13prescription drug, but who does not have general responsibility
14to direct the sale or disposition of the manufacturer's
15prescription drug. A manufacturer's exclusive distributor must
16be licensed as a wholesale distributor under this Act and, in
17order to be considered part of the normal distribution channel,
18must also be an authorized distributor of record.
19    "Normal distribution channel" means a chain of custody for
20a prescription drug that goes, directly or by drop shipment,
21from (i) a manufacturer of the prescription drug, (ii) that
22manufacturer to that manufacturer's co-licensed partner, (iii)
23that manufacturer to that manufacturer's third party logistics
24provider, or (iv) that manufacturer to that manufacturer's
25exclusive distributor to:
26        (1) a pharmacy or to other designated persons



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1    authorized by law to dispense or administer the drug to a
2    patient;
3        (2) a wholesale distributor to a pharmacy or other
4    designated persons authorized by law to dispense or
5    administer the drug to a patient;
6        (3) a wholesale distributor to a chain pharmacy
7    warehouse to that chain pharmacy warehouse's intracompany
8    pharmacy to a patient or other designated persons
9    authorized by law to dispense or administer the drug to a
10    patient;
11        (4) a chain pharmacy warehouse to the chain pharmacy
12    warehouse's intracompany pharmacy or other designated
13    persons authorized by law to dispense or administer the
14    drug to the patient;
15        (5) an authorized distributor of record to one other
16    authorized distributor of record to an office-based health
17    care practitioner authorized by law to dispense or
18    administer the drug to the patient; or
19        (6) an authorized distributor to a pharmacy or other
20    persons licensed to dispense or administer the drug.
21    "Pedigree" means a document or electronic file containing
22information that records each wholesale distribution of any
23given prescription drug from the point of origin to the final
24wholesale distribution point of any given prescription drug.
25    "Person" means and includes a natural person, partnership,
26association, corporation, or any other legal business entity.



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1    "Pharmacy distributor" means any pharmacy licensed in this
2State or hospital pharmacy that is engaged in the delivery or
3distribution of prescription drugs either to any other pharmacy
4licensed in this State or to any other person or entity
5including, but not limited to, a wholesale drug distributor
6engaged in the delivery or distribution of prescription drugs
7who is involved in the actual, constructive, or attempted
8transfer of a drug in this State to other than the ultimate
9consumer except as otherwise provided for by law.
10    "Prescription drug" means any human drug, including any
11biological product (except for blood and blood components
12intended for transfusion or biological products that are also
13medical devices), required by federal law or regulation to be
14dispensed only by a prescription, including finished dosage
15forms and bulk drug substances subject to Section 503 of the
16Federal Food, Drug and Cosmetic Act.
17    "Repackage" means repackaging or otherwise changing the
18container, wrapper, or labeling to further the distribution of
19a prescription drug, excluding that completed by the pharmacist
20responsible for dispensing the product to a patient.
21    "Secretary" means the Secretary of Financial and
22Professional Regulation.
23    "Third-party Third party logistics provider" means anyone
24who contracts with a prescription drug manufacturer to provide
25or coordinate warehousing, distribution, or other services on
26behalf of a manufacturer, but does not take title to the



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1prescription drug or have general responsibility to direct the
2prescription drug's sale or disposition. A third party
3logistics provider must be licensed as a wholesale distributor
4under this Act and, in order to be considered part of the
5normal distribution channel, must also be an authorized
6distributor of record.
7    "Wholesale distribution" means the distribution of
8prescription drugs to persons other than a consumer or patient,
9but does not include any of the following:
10        (1) Intracompany sales of prescription drugs, meaning
11    (i) any transaction or transfer between any division,
12    subsidiary, parent, or affiliated or related company under
13    the common ownership and control of a corporate entity or
14    (ii) any transaction or transfer between co-licensees of a
15    co-licensed product.
16        (2) The sale, purchase, distribution, trade, or
17    transfer of a prescription drug or offer to sell, purchase,
18    distribute, trade, or transfer a prescription drug for
19    emergency medical reasons.
20        (3) The distribution of prescription drug samples by
21    manufacturers' representatives.
22        (4) Drug returns, when conducted by a hospital, health
23    care entity, or charitable institution in accordance with
24    federal regulation.
25        (5) The sale of minimal quantities of prescription
26    drugs by licensed pharmacies to licensed practitioners for



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1    office use or other licensed pharmacies.
2        (6) The sale, purchase, or trade of a drug, an offer to
3    sell, purchase, or trade a drug, or the dispensing of a
4    drug pursuant to a prescription.
5        (7) The sale, transfer, merger, or consolidation of all
6    or part of the business of a pharmacy or pharmacies from or
7    with another pharmacy or pharmacies, whether accomplished
8    as a purchase and sale of stock or business assets.
9        (8) The sale, purchase, distribution, trade, or
10    transfer of a prescription drug from one authorized
11    distributor of record to one additional authorized
12    distributor of record when the manufacturer has stated in
13    writing to the receiving authorized distributor of record
14    that the manufacturer is unable to supply the prescription
15    drug and the supplying authorized distributor of record
16    states in writing that the prescription drug being supplied
17    had until that time been exclusively in the normal
18    distribution channel.
19        (9) The delivery of or the offer to deliver a
20    prescription drug by a common carrier solely in the common
21    carrier's usual course of business of transporting
22    prescription drugs when the common carrier does not store,
23    warehouse, or take legal ownership of the prescription
24    drug.
25        (10) The sale or transfer from a retail pharmacy, mail
26    order pharmacy, or chain pharmacy warehouse of expired,



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1    damaged, returned, or recalled prescription drugs to the
2    original manufacturer, the originating wholesale
3    distributor, or a third party returns processor.
4    "Wholesale drug distributor" means anyone engaged in the
5wholesale distribution of prescription drugs into, out of, or
6within the State, including without limitation manufacturers;
7repackers; own label distributors; jobbers; private label
8distributors; brokers; warehouses, including manufacturers'
9and distributors' warehouses; manufacturer's exclusive
10distributors; and authorized distributors of record; drug
11wholesalers or distributors; independent wholesale drug
12traders; specialty wholesale distributors; third party
13logistics providers; and retail pharmacies that conduct
14wholesale distribution; and chain pharmacy warehouses that
15conduct wholesale distribution. In order to be considered part
16of the normal distribution channel, a wholesale distributor
17must also be an authorized distributor of record.
18(Source: P.A. 97-804, eff. 1-1-13.)
19    (225 ILCS 120/20)  (from Ch. 111, par. 8301-20)
20    (Section scheduled to be repealed on January 1, 2023)
21    Sec. 20. Prohibited drug purchases or receipt. It shall be
22unlawful for any person or entity located in this State to
23knowingly receive any prescription drug from any source other
24than a person or entity required by the laws of this State to
25be licensed to ship into, out of, or within this State. A



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1person or entity licensed under the laws of this State shall
2include, but is not limited to, a wholesale distributor,
3manufacturer, third-party logistics provider, pharmacy
4distributor, or pharmacy. Any person violating this Section
5shall, upon conviction, be adjudged guilty of a Class C
6misdemeanor. A second violation shall constitute a Class 4
8(Source: P.A. 97-804, eff. 1-1-13.)
9    (225 ILCS 120/25.5 new)
10    Sec. 25.5. Third-party logistics providers.
11    (a) Each resident third-party logistics provider must be
12licensed by the Department, and every non-resident third-party
13logistics provider must be licensed in this State, in
14accordance with this Act, prior to shipping a prescription drug
15into this State.
16    (b) The Department shall require, without limitation, all
17of the following information from each applicant for licensure
18under this Act:
19        (1) The name, full business address, and telephone
20    number of the licensee.
21        (2) All trade or business names used by the licensee.
22        (3) Addresses, telephone numbers, and the names of
23    contact persons for all facilities used by the licensee for
24    the storage, handling, and distribution of prescription
25    drugs.



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1        (4) The type of ownership or operation, such as a
2    partnership, corporation, or sole proprietorship.
3        (5) The name of the owner or operator of the
4    third-party logistics provider, including:
5            (A) if a natural person, the name of the natural
6        person;
7            (B) if a partnership, the name of each partner and
8        the name of the partnership;
9            (C) if a corporation, the name and title of each
10        corporate officer and director, the corporate names,
11        and the name of the state of incorporation; and
12            (D) if a sole proprietorship, the full name of the
13        sole proprietor and the name of the business entity.
14        (6) A list of all licenses and permits issued to the
15    applicant by any other state that authorizes the applicant
16    to purchase or possess prescription drugs.
17        (7) The name of the designated representative for the
18    third-party logistics provider, together with the personal
19    information statement and fingerprints, as required under
20    subsection (c) of this Section.
21        (8) Minimum liability insurance and other insurance as
22    defined by rule.
23        (9) Any additional information required by the
24    Department.
25    (c) Each third-party logistics provider must designate an
26individual representative who shall serve as the contact person



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1for the Department. This representative must provide the
2Department with all of the following information:
3        (1) Information concerning whether the person has been
4    enjoined, either temporarily or permanently, by a court of
5    competent jurisdiction from violating any federal or State
6    law regulating the possession, control, or distribution of
7    prescription drugs or criminal violations, together with
8    details concerning any such event.
9        (2) A description of any involvement by the person with
10    any business, including any investments, other than the
11    ownership of stock in a publicly traded company or mutual
12    fund, that manufactured, administered, prescribed,
13    distributed, or stored pharmaceutical products and any
14    lawsuits in which such businesses were named as a party.
15        (3) A description of any misdemeanor or felony criminal
16    offense of which the person, as an adult, was found guilty,
17    regardless of whether adjudication of guilt was withheld or
18    whether the person pled guilty or nolo contendere. If the
19    person indicates that a criminal conviction is under appeal
20    and submits a copy of the notice of appeal of that criminal
21    offense, the applicant must, within 15 days after the
22    disposition of the appeal, submit to the Department a copy
23    of the final written order of disposition.
24        (4) The designated representative of an applicant for
25    licensure as a third-party logistics provider shall have
26    his or her fingerprints submitted to the Department of



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1    State Police in an electronic format that complies with the
2    form and manner for requesting and furnishing criminal
3    history record information as prescribed by the Department
4    of State Police. These fingerprints shall be checked
5    against the Department of State Police and Federal Bureau
6    of Investigation criminal history record databases now and
7    hereafter filed. The Department of State Police shall
8    charge applicants a fee for conducting the criminal history
9    records check, which shall be deposited into the State
10    Police Services Fund and shall not exceed the actual cost
11    of the records check. The Department of State Police shall
12    furnish, pursuant to positive identification, records of
13    Illinois convictions to the Department. The Department may
14    require applicants to pay a separate fingerprinting fee,
15    either to the Department or to a vendor. The Department, in
16    its discretion, may allow an applicant who does not have
17    reasonable access to a designated vendor to provide his or
18    her fingerprints in an alternative manner. The Department
19    may adopt any rules necessary to implement this paragraph
20    (4).
21    (d) A third-party logistics provider shall not operate from
22a place of residence.
23    (e) A third-party logistics provider facility shall be
24located apart and separate from any retail pharmacy licensed by
25the Department.
26    (f) The Department may not issue a third-party logistics



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1provider license to an applicant, unless the Department first:
2        (1) ensures that a physical inspection of the facility
3    satisfactory to the Department has occurred at the address
4    provided by the applicant, as required under item (1) of
5    subsection (b) of this Section; such inspection is not
6    required if the resident state of the third-party logistics
7    provider facility does not license third-party logistics
8    providers or if the resident state does not inspect
9    third-party logistics providers. If the resident state
10    does not inspect third-party logistics providers, a
11    Verified Accredited Wholesale Distributors Accreditation
12    or other inspection approved by the Department meets this
13    requirement; and
14        (2) determines that the designated representative
15    meets each of the following qualifications:
16            (A) He or she is at least 21 years of age.
17            (B) He or she is employed by the applicant full
18        time in a managerial level position.
19            (C) He or she is actively involved in and aware of
20        the actual daily operation of third-party logistics
21        provider.
22    (g) A third-party logistics provider shall publicly
23display all licenses and have the most recent state and federal
24inspection reports readily available.
25    (225 ILCS 120/26)



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1    (Section scheduled to be repealed on January 1, 2023)
2    Sec. 26. Unlicensed practice; violation; civil penalty.
3    (a) Any person who practices, offers to practice, attempts
4to practice, or holds oneself out to practice as a wholesale
5drug distributor, or pharmacy distributor, or third-party
6logistics provider without being licensed to ship into, out of,
7or within the State under this Act shall, in addition to any
8other penalty provided by law, pay a civil penalty to the
9Department in an amount not to exceed $10,000 for each offense
10as determined by the Department. The civil penalty shall be
11assessed by the Department after a hearing is held in
12accordance with the provisions set forth in this Act regarding
13the provision of a hearing for the discipline of a licensee.
14    (b) The Department has the authority and power to
15investigate any and all unlicensed activity.
16    (c) The civil penalty shall be paid within 60 days after
17the effective date of the order imposing the civil penalty. The
18order shall constitute a judgment and may be filed and
19execution had thereon in the same manner as any judgment from
20any court of record.
21(Source: P.A. 97-804, eff. 1-1-13.)
22    (225 ILCS 120/30)  (from Ch. 111, par. 8301-30)
23    (Section scheduled to be repealed on January 1, 2023)
24    Sec. 30. License renewal application procedures.
25Application blanks for renewal of any license required by this



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1Act shall be mailed or emailed to each licensee at least 60
2days before the license expires. If the application for renewal
3with the required fee is not received by the Department before
4the expiration date, the existing license shall lapse and
5become null and void. Failure to renew before the expiration
6date is cause for a late payment penalty, discipline, or both.
7(Source: P.A. 87-594.)
8    (225 ILCS 120/35)  (from Ch. 111, par. 8301-35)
9    (Section scheduled to be repealed on January 1, 2023)
10    Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
11    (a) The Department shall provide by rule for a schedule of
12fees for the administration and enforcement of this Act,
13including but not limited to original licensure, renewal, and
14restoration. The fees shall be nonrefundable.
15    (b) All fees collected under this Act shall be deposited
16into the Illinois State Pharmacy Disciplinary Fund and shall be
17appropriated to the Department for the ordinary and contingent
18expenses of the Department in the administration of this Act.
19Moneys in the Fund may be transferred to the Professions
20Indirect Cost Fund as authorized by Section 2105-300 of the
21Department of Professional Regulation Law (20 ILCS
23    The moneys deposited into the Illinois State Pharmacy
24Disciplinary Fund shall be invested to earn interest which
25shall accrue to the Fund.



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1    The Department shall present to the Board for its review
2and comment all appropriation requests from the Illinois State
3Pharmacy Disciplinary Fund. The Department shall give due
4consideration to any comments of the Board in making
5appropriation requests.
6    (c) Any person who delivers a check or other payment to the
7Department that is returned to the Department unpaid by the
8financial institution upon which it is drawn shall pay to the
9Department, in addition to the amount already owed to the
10Department, a fine of $50. The fines imposed by this Section
11are in addition to any other discipline provided under this Act
12for unlicensed practice or practice on a nonrenewed license.
13The Department shall notify the person that payment of fees and
14fines shall be paid to the Department by certified check or
15money order within 30 calendar days of the notification. If,
16after the expiration of 30 days from the date of the
17notification, the person has failed to submit the necessary
18remittance, the Department shall automatically terminate the
19license or certificate or deny the application, without
20hearing. If, after termination or denial, the person seeks a
21license or certificate, he or she shall apply to the Department
22for restoration or issuance of the license or certificate and
23pay all fees and fines due to the Department. The Department
24may establish a fee for the processing of an application for
25restoration of a license or certificate to pay all expenses of
26processing this application. The Director may waive the fines



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1due under this Section in individual cases where the Director
2finds that the fines would be unreasonable or unnecessarily
4    (d) The Department shall maintain a roster of the names and
5addresses of all registrants and of all persons whose licenses
6have been suspended or revoked. This roster shall be available
7upon written request and payment of the required fee.
8    (e) A manufacturer of controlled substances, or wholesale
9distributor of controlled substances, or third-party logistics
10provider that is licensed under this Act and owned and operated
11by the State is exempt from licensure, registration, renewal,
12and other fees required under this Act. Nothing in this
13subsection (e) shall be construed to prohibit the Department
14from imposing any fine or other penalty allowed under this Act.
15(Source: P.A. 95-689, eff. 10-29-07.)
16    (225 ILCS 120/40)  (from Ch. 111, par. 8301-40)
17    (Section scheduled to be repealed on January 1, 2023)
18    Sec. 40. Rules and regulations. The Department shall make
19any rules and regulations, not inconsistent with law, as may be
20necessary to carry out the purposes and enforce the provisions
21of this Act. Rules and regulations that incorporate and set
22detailed standards for meeting each of the license
23prerequisites set forth in Section 25 of this Act shall be
24adopted no later than September 14, 1992. All rules and
25regulations promulgated under this Section shall conform to



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1wholesale drug distributor licensing guidelines formally
2adopted by the FDA at 21 C.F.R. Part 205. In case of conflict
3between any rule or regulation adopted by the Department and
4any FDA wholesale drug distributor or third-party logistics
5provider guideline, the FDA guideline shall control.
6(Source: P.A. 87-594.)
7    (225 ILCS 120/57)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 57. Pedigree.
10    (a) Each person who is engaged in the wholesale
11distribution of prescription drugs, including repackagers, but
12excluding the original manufacturer of the finished form of the
13prescription drug, that leave or have ever left the normal
14distribution channel shall, before each wholesale distribution
15of the drug, provide a pedigree to the person who receives the
16drug. A retail pharmacy, mail order pharmacy, or chain pharmacy
17warehouse must comply with the requirements of this Section
18only if the pharmacy or chain pharmacy warehouse engages in the
19wholesale distribution of prescription drugs. On or before July
201, 2009, the Department shall determine a targeted
21implementation date for electronic track and trace pedigree
22technology. This targeted implementation date shall not be
23sooner than July 1, 2010. Beginning on the date established by
24the Department, pedigrees may be implemented through an
25approved and readily available system that electronically



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1tracks and traces the wholesale distribution of each
2prescription drug starting with the sale by the manufacturer
3through acquisition and sale by any wholesale distributor and
4until final sale to a pharmacy or other authorized person
5administering or dispensing the prescription drug. This
6electronic tracking system shall be deemed to be readily
7available only upon there being available a standardized system
8originating with the manufacturers and capable of being used on
9a wide scale across the entire pharmaceutical chain, including
10manufacturers, wholesale distributors, third-party logistics
11providers, and pharmacies. Consideration must also be given to
12the large-scale implementation of this technology across the
13supply chain and the technology must be proven to have no
14negative impact on the safety and efficacy of the
15pharmaceutical product.
16    (b) Each person who is engaged in the wholesale
17distribution of a prescription drug who is provided a pedigree
18for a prescription drug and attempts to further distribute that
19prescription drug, including repackagers, but excluding the
20original manufacturer of the finished form of the prescription
21drug, must affirmatively verify before any distribution of a
22prescription drug occurs that each transaction listed on the
23pedigree has occurred.
24    (c) The pedigree must include all necessary identifying
25information concerning each sale in the chain of distribution
26of the product from the manufacturer or the manufacturer's



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1third party logistics provider, co-licensed product partner,
2or exclusive distributor through acquisition and sale by any
3wholesale distributor or repackager, until final sale to a
4pharmacy or other person dispensing or administering the drug.
5This necessary chain of distribution information shall
6include, without limitation all of the following:
7        (1) The name, address, telephone number and, if
8    available, the e-mail address of each owner of the
9    prescription drug and each wholesale distributor of the
10    prescription drug.
11        (2) The name and address of each location from which
12    the product was shipped, if different from the owner's.
13        (3) Transaction dates.
14        (4) Certification that each recipient has
15    authenticated the pedigree.
16    (d) The pedigree must also include without limitation all
17of the following information concerning the prescription drug:
18        (1) The name and national drug code number of the
19    prescription drug.
20        (2) The dosage form and strength of the prescription
21    drug.
22        (3) The size of the container.
23        (4) The number of containers.
24        (5) The lot number of the prescription drug.
25        (6) The name of the manufacturer of the finished dosage
26    form.



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1    (e) Each pedigree or electronic file shall be maintained by
2the purchaser and the wholesale distributor for at least 3
3years from the date of sale or transfer and made available for
4inspection or use within 5 business days upon a request of the
6(Source: P.A. 95-689, eff. 10-29-07.)
7    (225 ILCS 120/80)  (from Ch. 111, par. 8301-80)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 80. Violations of Act.
10    (a) If any person violates the provisions of this Act, the
11Director may, in the name of the People of the State of
12Illinois through the Attorney General of the State of Illinois
13or the State's Attorney of any county in which the action is
14brought, petition for an order enjoining the violation or for
15an order enforcing compliance with this Act. Upon the filing of
16a verified petition in the court, the court may issue a
17temporary restraining order, without notice or bond, and may
18preliminarily and permanently enjoin the violation. If it is
19established that the person has violated or is violating the
20injunction, the Court may punish the offender for contempt of
21court. Proceedings under this Section shall be in addition to,
22and not in lieu of, all other remedies and penalties provided
23by this Act.
24    (b) Whoever knowingly conducts business as a wholesale drug
25distributor or third-party logistics provider in this State



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1without being appropriately licensed under this Act shall be
2guilty of a Class A misdemeanor for a first violation and for
3each subsequent conviction shall be guilty of a Class 4 felony.
4    (c) Whenever in the opinion of the Department any person
5not licensed in good standing under this Act violates any
6provision of this Act, the Department may issue a rule to show
7cause why an order to cease and desist should not be entered
8against him. The rule shall clearly set forth the grounds
9relied upon by the Department and shall provide a period of 7
10days from the date of the rule to file an answer to the
11satisfaction of the Department. Failure to answer to the
12satisfaction of the Department shall cause an order to cease
13and desist to be issued immediately.
14(Source: P.A. 87-594.)
15    (225 ILCS 120/155)  (from Ch. 111, par. 8301-155)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 155. Temporary suspension of license; hearing. The
18Director may temporarily suspend licensure as a wholesale drug
19distributor or third-party logistics provider, without a
20hearing, simultaneously with the institution of proceedings
21for a hearing provided for in Section 85 of this Act, if the
22Director finds that evidence in his or her possession indicates
23that a continuation in business would constitute an imminent
24danger to the public. In the event that the Director
25temporarily suspends a license or certificate without a



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1hearing, a hearing by the Department must be held within 10
2days after the suspension has occurred and be concluded without
3appreciable delay.
4(Source: P.A. 87-594.)
5    Section 99. Effective date. This Act takes effect upon
6becoming law.