Sen. Thomas Cullerton

Filed: 4/9/2019





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2    AMENDMENT NO. ______. Amend Senate Bill 1839, AS AMENDED,
3by replacing everything after the enacting clause with the
5    "Section 3. The Pharmacy Practice Act is amended by
6changing Section 4 as follows:
7    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
8    (Section scheduled to be repealed on January 1, 2020)
9    Sec. 4. Exemptions. Nothing contained in any Section of
10this Act shall apply to, or in any manner interfere with:
11        (a) the lawful practice of any physician licensed to
12    practice medicine in all of its branches, dentist,
13    podiatric physician, veterinarian, or therapeutically or
14    diagnostically certified optometrist within the limits of
15    his or her license, or prevent him or her from supplying to
16    his or her bona fide patients such drugs, medicines, or



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1    poisons as may seem to him appropriate;
2        (b) the sale of compressed gases;
3        (c) the sale of patent or proprietary medicines and
4    household remedies when sold in original and unbroken
5    packages only, if such patent or proprietary medicines and
6    household remedies be properly and adequately labeled as to
7    content and usage and generally considered and accepted as
8    harmless and nonpoisonous when used according to the
9    directions on the label, and also do not contain opium or
10    coca leaves, or any compound, salt or derivative thereof,
11    or any drug which, according to the latest editions of the
12    following authoritative pharmaceutical treatises and
13    standards, namely, The United States
14    Pharmacopoeia/National Formulary (USP/NF), the United
15    States Dispensatory, and the Accepted Dental Remedies of
16    the Council of Dental Therapeutics of the American Dental
17    Association or any or either of them, in use on the
18    effective date of this Act, or according to the existing
19    provisions of the Federal Food, Drug, and Cosmetic Act and
20    Regulations of the Department of Health and Human Services,
21    Food and Drug Administration, promulgated thereunder now
22    in effect, is designated, described or considered as a
23    narcotic, hypnotic, habit forming, dangerous, or poisonous
24    drug;
25        (d) the sale of poultry and livestock remedies in
26    original and unbroken packages only, labeled for poultry



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1    and livestock medication;
2        (e) the sale of poisonous substances or mixture of
3    poisonous substances, in unbroken packages, for
4    nonmedicinal use in the arts or industries or for
5    insecticide purposes; provided, they are properly and
6    adequately labeled as to content and such nonmedicinal
7    usage, in conformity with the provisions of all applicable
8    federal, state and local laws and regulations promulgated
9    thereunder now in effect relating thereto and governing the
10    same, and those which are required under such applicable
11    laws and regulations to be labeled with the word "Poison",
12    are also labeled with the word "Poison" printed thereon in
13    prominent type and the name of a readily obtainable
14    antidote with directions for its administration;
15        (f) the delegation of limited prescriptive authority
16    by a physician licensed to practice medicine in all its
17    branches to a physician assistant under Section 7.5 of the
18    Physician Assistant Practice Act of 1987. This delegated
19    authority under Section 7.5 of the Physician Assistant
20    Practice Act of 1987 may, but is not required to, include
21    prescription of controlled substances, as defined in
22    Article II of the Illinois Controlled Substances Act, in
23    accordance with a written supervision agreement;
24        (g) the delegation of prescriptive authority by a
25    physician licensed to practice medicine in all its branches
26    or a licensed podiatric physician to an advanced practice



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1    registered nurse in accordance with a written
2    collaborative agreement under Sections 65-35 and 65-40 of
3    the Nurse Practice Act; and
4        (h) the sale or distribution of dialysate or devices
5    necessary to perform home peritoneal renal dialysis for
6    patients with end-stage renal disease, provided that all of
7    the following conditions are met:
8            (1) the dialysate, comprised of dextrose or
9        icodextrin, or devices are approved or cleared by the
10        federal Food and Drug Administration, as required by
11        federal law;
12            (2) the dialysate or devices are lawfully held by a
13        manufacturer or the manufacturer's agent, which is
14        properly registered with the Board as a manufacturer,
15        third-party logistics provider, or wholesaler;
16            (3) the dialysate or devices are held and delivered
17        to the manufacturer or the manufacturer's agent in the
18        original, sealed packaging from the manufacturing
19        facility;
20            (4) the dialysate or devices are delivered only
21        upon receipt of a physician's prescription by a
22        licensed pharmacy in which the prescription is
23        processed in accordance with provisions set forth in
24        this Act, and the transmittal of an order from the
25        licensed pharmacy to the manufacturer or the
26        manufacturer's agent; and



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1            (5) the manufacturer or the manufacturer's agent
2        delivers the dialysate or devices directly to: (i) a
3        patient with end-stage renal disease, or his or her
4        designee, for the patient's self-administration of the
5        dialysis therapy or (ii) a health care provider or
6        institution for administration or delivery of the
7        dialysis therapy to a patient with end-stage renal
8        disease.
9        This paragraph (h) does not include any other drugs for
10    peritoneal dialysis, except dialysate, as described in
11    item (1) of this paragraph (h). All records of sales and
12    distribution of dialysate to patients made pursuant to this
13    paragraph (h) must be retained in accordance with Section
14    18 of this Act.
15(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
16100-863, eff. 8-14-18.)
17    Section 10. The Wholesale Drug Distribution Licensing Act
18is amended by changing Sections 15, 20, 26, 30, 35, 40, 57, 80,
19and 155 and by adding Section 25.5 as follows:
20    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
21    (Section scheduled to be repealed on January 1, 2023)
22    Sec. 15. Definitions. As used in this Act:
23    "Authentication" means the affirmative verification,
24before any wholesale distribution of a prescription drug



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1occurs, that each transaction listed on the pedigree has
3    "Authorized distributor of record" means a wholesale
4distributor with whom a manufacturer has established an ongoing
5relationship to distribute the manufacturer's prescription
6drug. An ongoing relationship is deemed to exist between a
7wholesale distributor and a manufacturer when the wholesale
8distributor, including any affiliated group of the wholesale
9distributor, as defined in Section 1504 of the Internal Revenue
10Code, complies with the following:
11        (1) The wholesale distributor has a written agreement
12    currently in effect with the manufacturer evidencing the
13    ongoing relationship; and
14        (2) The wholesale distributor is listed on the
15    manufacturer's current list of authorized distributors of
16    record, which is updated by the manufacturer on no less
17    than a monthly basis.
18    "Blood" means whole blood collected from a single donor and
19processed either for transfusion or further manufacturing.
20    "Blood component" means that part of blood separated by
21physical or mechanical means.
22    "Board" means the State Board of Pharmacy of the Department
23of Professional Regulation.
24    "Chain pharmacy warehouse" means a physical location for
25prescription drugs that acts as a central warehouse and
26performs intracompany sales or transfers of the drugs to a



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1group of chain or mail order pharmacies that have the same
2common ownership and control. Notwithstanding any other
3provision of this Act, a chain pharmacy warehouse shall be
4considered part of the normal distribution channel.
5    "Co-licensed partner or product" means an instance where
6one or more parties have the right to engage in the
7manufacturing or marketing of a prescription drug, consistent
8with the FDA's implementation of the Prescription Drug
9Marketing Act.
10    "Department" means the Department of Financial and
11Professional Regulation.
12    "Drop shipment" means the sale of a prescription drug to a
13wholesale distributor by the manufacturer of the prescription
14drug or that manufacturer's co-licensed product partner, that
15manufacturer's third party logistics provider, or that
16manufacturer's exclusive distributor or by an authorized
17distributor of record that purchased the product directly from
18the manufacturer or one of these entities whereby the wholesale
19distributor or chain pharmacy warehouse takes title but not
20physical possession of such prescription drug and the wholesale
21distributor invoices the pharmacy, chain pharmacy warehouse,
22or other person authorized by law to dispense or administer
23such drug to a patient and the pharmacy, chain pharmacy
24warehouse, or other authorized person receives delivery of the
25prescription drug directly from the manufacturer, that
26manufacturer's third party logistics provider, or that



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1manufacturer's exclusive distributor or from an authorized
2distributor of record that purchased the product directly from
3the manufacturer or one of these entities.
4    "Drug sample" means a unit of a prescription drug that is
5not intended to be sold and is intended to promote the sale of
6the drug.
7    "Facility" means a facility of a wholesale distributor
8where prescription drugs are stored, handled, repackaged, or
9offered for sale, or a facility of a third-party logistics
10provider where prescription drugs are stored or handled.
11    "FDA" means the United States Food and Drug Administration.
12    "Manufacturer" means a person licensed or approved by the
13FDA to engage in the manufacture of drugs or devices,
14consistent with the definition of "manufacturer" set forth in
15the FDA's regulations and guidances implementing the
16Prescription Drug Marketing Act.
17    "Manufacturer's exclusive distributor" means anyone who
18contracts with a manufacturer to provide or coordinate
19warehousing, distribution, or other services on behalf of a
20manufacturer and who takes title to that manufacturer's
21prescription drug, but who does not have general responsibility
22to direct the sale or disposition of the manufacturer's
23prescription drug. A manufacturer's exclusive distributor must
24be licensed as a wholesale distributor under this Act and, in
25order to be considered part of the normal distribution channel,
26must also be an authorized distributor of record.



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1    "Normal distribution channel" means a chain of custody for
2a prescription drug that goes, directly or by drop shipment,
3from (i) a manufacturer of the prescription drug, (ii) that
4manufacturer to that manufacturer's co-licensed partner, (iii)
5that manufacturer to that manufacturer's third party logistics
6provider, or (iv) that manufacturer to that manufacturer's
7exclusive distributor to:
8        (1) a pharmacy or to other designated persons
9    authorized by law to dispense or administer the drug to a
10    patient;
11        (2) a wholesale distributor to a pharmacy or other
12    designated persons authorized by law to dispense or
13    administer the drug to a patient;
14        (3) a wholesale distributor to a chain pharmacy
15    warehouse to that chain pharmacy warehouse's intracompany
16    pharmacy to a patient or other designated persons
17    authorized by law to dispense or administer the drug to a
18    patient;
19        (4) a chain pharmacy warehouse to the chain pharmacy
20    warehouse's intracompany pharmacy or other designated
21    persons authorized by law to dispense or administer the
22    drug to the patient;
23        (5) an authorized distributor of record to one other
24    authorized distributor of record to an office-based health
25    care practitioner authorized by law to dispense or
26    administer the drug to the patient; or



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1        (6) an authorized distributor to a pharmacy or other
2    persons licensed to dispense or administer the drug.
3    "Pedigree" means a document or electronic file containing
4information that records each wholesale distribution of any
5given prescription drug from the point of origin to the final
6wholesale distribution point of any given prescription drug.
7    "Person" means and includes a natural person, partnership,
8association, corporation, or any other legal business entity.
9    "Pharmacy distributor" means any pharmacy licensed in this
10State or hospital pharmacy that is engaged in the delivery or
11distribution of prescription drugs either to any other pharmacy
12licensed in this State or to any other person or entity
13including, but not limited to, a wholesale drug distributor
14engaged in the delivery or distribution of prescription drugs
15who is involved in the actual, constructive, or attempted
16transfer of a drug in this State to other than the ultimate
17consumer except as otherwise provided for by law.
18    "Prescription drug" means any human drug, including any
19biological product (except for blood and blood components
20intended for transfusion or biological products that are also
21medical devices), required by federal law or regulation to be
22dispensed only by a prescription, including finished dosage
23forms and bulk drug substances subject to Section 503 of the
24Federal Food, Drug and Cosmetic Act.
25    "Repackage" means repackaging or otherwise changing the
26container, wrapper, or labeling to further the distribution of



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1a prescription drug, excluding that completed by the pharmacist
2responsible for dispensing the product to a patient.
3    "Secretary" means the Secretary of Financial and
4Professional Regulation.
5    "Third-party Third party logistics provider" means anyone
6who contracts with a prescription drug manufacturer to provide
7or coordinate warehousing, distribution, or other services on
8behalf of a manufacturer, but does not take title to the
9prescription drug or have general responsibility to direct the
10prescription drug's sale or disposition. A third party
11logistics provider must be licensed as a wholesale distributor
12under this Act and, in order to be considered part of the
13normal distribution channel, must also be an authorized
14distributor of record.
15    "Wholesale distribution" means the distribution of
16prescription drugs to persons other than a consumer or patient,
17but does not include any of the following:
18        (1) Intracompany sales of prescription drugs, meaning
19    (i) any transaction or transfer between any division,
20    subsidiary, parent, or affiliated or related company under
21    the common ownership and control of a corporate entity or
22    (ii) any transaction or transfer between co-licensees of a
23    co-licensed product.
24        (2) The sale, purchase, distribution, trade, or
25    transfer of a prescription drug or offer to sell, purchase,
26    distribute, trade, or transfer a prescription drug for



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1    emergency medical reasons.
2        (3) The distribution of prescription drug samples by
3    manufacturers' representatives.
4        (4) Drug returns, when conducted by a hospital, health
5    care entity, or charitable institution in accordance with
6    federal regulation.
7        (5) The sale of minimal quantities of prescription
8    drugs by licensed pharmacies to licensed practitioners for
9    office use or other licensed pharmacies.
10        (6) The sale, purchase, or trade of a drug, an offer to
11    sell, purchase, or trade a drug, or the dispensing of a
12    drug pursuant to a prescription.
13        (7) The sale, transfer, merger, or consolidation of all
14    or part of the business of a pharmacy or pharmacies from or
15    with another pharmacy or pharmacies, whether accomplished
16    as a purchase and sale of stock or business assets.
17        (8) The sale, purchase, distribution, trade, or
18    transfer of a prescription drug from one authorized
19    distributor of record to one additional authorized
20    distributor of record when the manufacturer has stated in
21    writing to the receiving authorized distributor of record
22    that the manufacturer is unable to supply the prescription
23    drug and the supplying authorized distributor of record
24    states in writing that the prescription drug being supplied
25    had until that time been exclusively in the normal
26    distribution channel.



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1        (9) The delivery of or the offer to deliver a
2    prescription drug by a common carrier solely in the common
3    carrier's usual course of business of transporting
4    prescription drugs when the common carrier does not store,
5    warehouse, or take legal ownership of the prescription
6    drug.
7        (10) The sale or transfer from a retail pharmacy, mail
8    order pharmacy, or chain pharmacy warehouse of expired,
9    damaged, returned, or recalled prescription drugs to the
10    original manufacturer, the originating wholesale
11    distributor, or a third party returns processor.
12    "Wholesale drug distributor" means anyone engaged in the
13wholesale distribution of prescription drugs into, out of, or
14within the State, including without limitation manufacturers;
15repackers; own label distributors; jobbers; private label
16distributors; brokers; warehouses, including manufacturers'
17and distributors' warehouses; manufacturer's exclusive
18distributors; and authorized distributors of record; drug
19wholesalers or distributors; independent wholesale drug
20traders; specialty wholesale distributors; third party
21logistics providers; and retail pharmacies that conduct
22wholesale distribution; and chain pharmacy warehouses that
23conduct wholesale distribution. In order to be considered part
24of the normal distribution channel, a wholesale distributor
25must also be an authorized distributor of record.
26(Source: P.A. 97-804, eff. 1-1-13.)



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1    (225 ILCS 120/20)  (from Ch. 111, par. 8301-20)
2    (Section scheduled to be repealed on January 1, 2023)
3    Sec. 20. Prohibited drug purchases or receipt. It shall be
4unlawful for any person or entity located in this State to
5knowingly receive any prescription drug from any source other
6than a person or entity required by the laws of this State to
7be licensed to ship into, out of, or within this State. A
8person or entity licensed under the laws of this State shall
9include, but is not limited to, a wholesale distributor,
10manufacturer, third-party logistics provider, pharmacy
11distributor, or pharmacy. Any person violating this Section
12shall, upon conviction, be adjudged guilty of a Class C
13misdemeanor. A second violation shall constitute a Class 4
15(Source: P.A. 97-804, eff. 1-1-13.)
16    (225 ILCS 120/25.5 new)
17    Sec. 25.5. Third-party logistics providers.
18    (a) Each resident third-party logistics provider must be
19licensed by the Department, and every non-resident third-party
20logistics provider must be licensed in this State, in
21accordance with this Act, prior to shipping a prescription drug
22into this State.
23    (b) The Department shall require, without limitation, all
24of the following information from each applicant for licensure



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1under this Act:
2        (1) The name, full business address, and telephone
3    number of the licensee.
4        (2) All trade or business names used by the licensee.
5        (3) Addresses, telephone numbers, and the names of
6    contact persons for all facilities used by the licensee for
7    the storage, handling, and distribution of prescription
8    drugs.
9        (4) The type of ownership or operation, such as a
10    partnership, corporation, or sole proprietorship.
11        (5) The name of the owner or operator of the
12    third-party logistics provider, including:
13            (A) if a natural person, the name of the natural
14        person;
15            (B) if a partnership, the name of each partner and
16        the name of the partnership;
17            (C) if a corporation, the name and title of each
18        corporate officer and director, the corporate names,
19        and the name of the state of incorporation; and
20            (D) if a sole proprietorship, the full name of the
21        sole proprietor and the name of the business entity.
22        (6) A list of all licenses and permits issued to the
23    applicant by any other state that authorizes the applicant
24    to purchase or possess prescription drugs.
25        (7) The name of the designated representative for the
26    third-party logistics provider, together with the personal



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1    information statement and fingerprints, as required under
2    subsection (c) of this Section.
3        (8) Minimum liability insurance and other insurance as
4    defined by rule.
5        (9) Any additional information required by the
6    Department.
7    (c) Each third-party logistics provider must designate an
8individual representative who shall serve as the contact person
9for the Department. This representative must provide the
10Department with all of the following information:
11        (1) Information concerning whether the person has been
12    enjoined, either temporarily or permanently, by a court of
13    competent jurisdiction from violating any federal or State
14    law regulating the possession, control, or distribution of
15    prescription drugs or criminal violations, together with
16    details concerning any such event.
17        (2) A description of any involvement by the person with
18    any business, including any investments, other than the
19    ownership of stock in a publicly traded company or mutual
20    fund, that manufactured, administered, prescribed,
21    distributed, or stored pharmaceutical products and any
22    lawsuits in which such businesses were named as a party.
23        (3) A description of any misdemeanor or felony criminal
24    offense of which the person, as an adult, was found guilty,
25    regardless of whether adjudication of guilt was withheld or
26    whether the person pled guilty or nolo contendere. If the



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1    person indicates that a criminal conviction is under appeal
2    and submits a copy of the notice of appeal of that criminal
3    offense, the applicant must, within 15 days after the
4    disposition of the appeal, submit to the Department a copy
5    of the final written order of disposition.
6        (4) The designated representative of an applicant for
7    licensure as a third-party logistics provider shall have
8    his or her fingerprints submitted to the Department of
9    State Police in an electronic format that complies with the
10    form and manner for requesting and furnishing criminal
11    history record information as prescribed by the Department
12    of State Police. These fingerprints shall be checked
13    against the Department of State Police and Federal Bureau
14    of Investigation criminal history record databases now and
15    hereafter filed. The Department of State Police shall
16    charge applicants a fee for conducting the criminal history
17    records check, which shall be deposited into the State
18    Police Services Fund and shall not exceed the actual cost
19    of the records check. The Department of State Police shall
20    furnish, pursuant to positive identification, records of
21    Illinois convictions to the Department. The Department may
22    require applicants to pay a separate fingerprinting fee,
23    either to the Department or to a vendor. The Department, in
24    its discretion, may allow an applicant who does not have
25    reasonable access to a designated vendor to provide his or
26    her fingerprints in an alternative manner. The Department



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1    may adopt any rules necessary to implement this paragraph
2    (4).
3    (d) A third-party logistics provider shall not operate from
4a place of residence.
5    (e) A third-party logistics provider facility shall be
6located apart and separate from any retail pharmacy licensed by
7the Department.
8    (f) The Department may not issue a third-party logistics
9provider license to an applicant, unless the Department first:
10        (1) ensures that a physical inspection of the facility
11    satisfactory to the Department has occurred at the address
12    provided by the applicant, as required under item (1) of
13    subsection (b) of this Section; such inspection is not
14    required if the resident state of the third-party logistics
15    provider facility does not license third-party logistics
16    providers or if the resident state does not inspect
17    third-party logistics providers. If the resident state
18    does not inspect third-party logistics providers, a
19    Verified Accredited Wholesale Distributors Accreditation
20    or other inspection approved by the Department meets this
21    requirement; and
22        (2) determines that the designated representative
23    meets each of the following qualifications:
24            (A) He or she is at least 21 years of age.
25            (B) He or she is employed by the applicant full
26        time in a managerial level position.



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1            (C) He or she is actively involved in and aware of
2        the actual daily operation of third-party logistics
3        provider.
4    (g) A third-party logistics provider shall publicly
5display all licenses and have the most recent state and federal
6inspection reports readily available.
7    (225 ILCS 120/26)
8    (Section scheduled to be repealed on January 1, 2023)
9    Sec. 26. Unlicensed practice; violation; civil penalty.
10    (a) Any person who practices, offers to practice, attempts
11to practice, or holds oneself out to practice as a wholesale
12drug distributor, or pharmacy distributor, or third-party
13logistics provider without being licensed to ship into, out of,
14or within the State under this Act shall, in addition to any
15other penalty provided by law, pay a civil penalty to the
16Department in an amount not to exceed $10,000 for each offense
17as determined by the Department. The civil penalty shall be
18assessed by the Department after a hearing is held in
19accordance with the provisions set forth in this Act regarding
20the provision of a hearing for the discipline of a licensee.
21    (b) The Department has the authority and power to
22investigate any and all unlicensed activity.
23    (c) The civil penalty shall be paid within 60 days after
24the effective date of the order imposing the civil penalty. The
25order shall constitute a judgment and may be filed and



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1execution had thereon in the same manner as any judgment from
2any court of record.
3(Source: P.A. 97-804, eff. 1-1-13.)
4    (225 ILCS 120/30)  (from Ch. 111, par. 8301-30)
5    (Section scheduled to be repealed on January 1, 2023)
6    Sec. 30. License renewal application procedures.
7Application blanks for renewal of any license required by this
8Act shall be mailed or emailed to each licensee at least 60
9days before the license expires. If the application for renewal
10with the required fee is not received by the Department before
11the expiration date, the existing license shall lapse and
12become null and void. Failure to renew before the expiration
13date is cause for a late payment penalty, discipline, or both.
14(Source: P.A. 87-594.)
15    (225 ILCS 120/35)  (from Ch. 111, par. 8301-35)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
18    (a) The Department shall provide by rule for a schedule of
19fees for the administration and enforcement of this Act,
20including but not limited to original licensure, renewal, and
21restoration. The fees shall be nonrefundable.
22    (b) All fees collected under this Act shall be deposited
23into the Illinois State Pharmacy Disciplinary Fund and shall be
24appropriated to the Department for the ordinary and contingent



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1expenses of the Department in the administration of this Act.
2Moneys in the Fund may be transferred to the Professions
3Indirect Cost Fund as authorized by Section 2105-300 of the
4Department of Professional Regulation Law (20 ILCS
6    The moneys deposited into the Illinois State Pharmacy
7Disciplinary Fund shall be invested to earn interest which
8shall accrue to the Fund.
9    The Department shall present to the Board for its review
10and comment all appropriation requests from the Illinois State
11Pharmacy Disciplinary Fund. The Department shall give due
12consideration to any comments of the Board in making
13appropriation requests.
14    (c) Any person who delivers a check or other payment to the
15Department that is returned to the Department unpaid by the
16financial institution upon which it is drawn shall pay to the
17Department, in addition to the amount already owed to the
18Department, a fine of $50. The fines imposed by this Section
19are in addition to any other discipline provided under this Act
20for unlicensed practice or practice on a nonrenewed license.
21The Department shall notify the person that payment of fees and
22fines shall be paid to the Department by certified check or
23money order within 30 calendar days of the notification. If,
24after the expiration of 30 days from the date of the
25notification, the person has failed to submit the necessary
26remittance, the Department shall automatically terminate the



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1license or certificate or deny the application, without
2hearing. If, after termination or denial, the person seeks a
3license or certificate, he or she shall apply to the Department
4for restoration or issuance of the license or certificate and
5pay all fees and fines due to the Department. The Department
6may establish a fee for the processing of an application for
7restoration of a license or certificate to pay all expenses of
8processing this application. The Director may waive the fines
9due under this Section in individual cases where the Director
10finds that the fines would be unreasonable or unnecessarily
12    (d) The Department shall maintain a roster of the names and
13addresses of all registrants and of all persons whose licenses
14have been suspended or revoked. This roster shall be available
15upon written request and payment of the required fee.
16    (e) A manufacturer of controlled substances, or wholesale
17distributor of controlled substances, or third-party logistics
18provider that is licensed under this Act and owned and operated
19by the State is exempt from licensure, registration, renewal,
20and other fees required under this Act. Nothing in this
21subsection (e) shall be construed to prohibit the Department
22from imposing any fine or other penalty allowed under this Act.
23(Source: P.A. 95-689, eff. 10-29-07.)
24    (225 ILCS 120/40)  (from Ch. 111, par. 8301-40)
25    (Section scheduled to be repealed on January 1, 2023)



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1    Sec. 40. Rules and regulations. The Department shall make
2any rules and regulations, not inconsistent with law, as may be
3necessary to carry out the purposes and enforce the provisions
4of this Act. Rules and regulations that incorporate and set
5detailed standards for meeting each of the license
6prerequisites set forth in Section 25 of this Act shall be
7adopted no later than September 14, 1992. All rules and
8regulations promulgated under this Section shall conform to
9wholesale drug distributor licensing guidelines formally
10adopted by the FDA at 21 C.F.R. Part 205. In case of conflict
11between any rule or regulation adopted by the Department and
12any FDA wholesale drug distributor or third-party logistics
13provider guideline, the FDA guideline shall control.
14(Source: P.A. 87-594.)
15    (225 ILCS 120/57)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 57. Pedigree.
18    (a) Each person who is engaged in the wholesale
19distribution of prescription drugs, including repackagers, but
20excluding the original manufacturer of the finished form of the
21prescription drug, that leave or have ever left the normal
22distribution channel shall, before each wholesale distribution
23of the drug, provide a pedigree to the person who receives the
24drug. A retail pharmacy, mail order pharmacy, or chain pharmacy
25warehouse must comply with the requirements of this Section



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1only if the pharmacy or chain pharmacy warehouse engages in the
2wholesale distribution of prescription drugs. On or before July
31, 2009, the Department shall determine a targeted
4implementation date for electronic track and trace pedigree
5technology. This targeted implementation date shall not be
6sooner than July 1, 2010. Beginning on the date established by
7the Department, pedigrees may be implemented through an
8approved and readily available system that electronically
9tracks and traces the wholesale distribution of each
10prescription drug starting with the sale by the manufacturer
11through acquisition and sale by any wholesale distributor and
12until final sale to a pharmacy or other authorized person
13administering or dispensing the prescription drug. This
14electronic tracking system shall be deemed to be readily
15available only upon there being available a standardized system
16originating with the manufacturers and capable of being used on
17a wide scale across the entire pharmaceutical chain, including
18manufacturers, wholesale distributors, third-party logistics
19providers, and pharmacies. Consideration must also be given to
20the large-scale implementation of this technology across the
21supply chain and the technology must be proven to have no
22negative impact on the safety and efficacy of the
23pharmaceutical product.
24    (b) Each person who is engaged in the wholesale
25distribution of a prescription drug who is provided a pedigree
26for a prescription drug and attempts to further distribute that



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



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1    prescription drug.
2        (2) The dosage form and strength of the prescription
3    drug.
4        (3) The size of the container.
5        (4) The number of containers.
6        (5) The lot number of the prescription drug.
7        (6) The name of the manufacturer of the finished dosage
8    form.
9    (e) Each pedigree or electronic file shall be maintained by
10the purchaser and the wholesale distributor for at least 3
11years from the date of sale or transfer and made available for
12inspection or use within 5 business days upon a request of the
14(Source: P.A. 95-689, eff. 10-29-07.)
15    (225 ILCS 120/80)  (from Ch. 111, par. 8301-80)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 80. Violations of Act.
18    (a) If any person violates the provisions of this Act, the
19Director may, in the name of the People of the State of
20Illinois through the Attorney General of the State of Illinois
21or the State's Attorney of any county in which the action is
22brought, petition for an order enjoining the violation or for
23an order enforcing compliance with this Act. Upon the filing of
24a verified petition in the court, the court may issue a
25temporary restraining order, without notice or bond, and may



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1preliminarily and permanently enjoin the violation. If it is
2established that the person has violated or is violating the
3injunction, the Court may punish the offender for contempt of
4court. Proceedings under this Section shall be in addition to,
5and not in lieu of, all other remedies and penalties provided
6by this Act.
7    (b) Whoever knowingly conducts business as a wholesale drug
8distributor or third-party logistics provider in this State
9without being appropriately licensed under this Act shall be
10guilty of a Class A misdemeanor for a first violation and for
11each subsequent conviction shall be guilty of a Class 4 felony.
12    (c) Whenever in the opinion of the Department any person
13not licensed in good standing under this Act violates any
14provision of this Act, the Department may issue a rule to show
15cause why an order to cease and desist should not be entered
16against him. The rule shall clearly set forth the grounds
17relied upon by the Department and shall provide a period of 7
18days from the date of the rule to file an answer to the
19satisfaction of the Department. Failure to answer to the
20satisfaction of the Department shall cause an order to cease
21and desist to be issued immediately.
22(Source: P.A. 87-594.)
23    (225 ILCS 120/155)  (from Ch. 111, par. 8301-155)
24    (Section scheduled to be repealed on January 1, 2023)
25    Sec. 155. Temporary suspension of license; hearing. The



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1Director may temporarily suspend licensure as a wholesale drug
2distributor or third-party logistics provider, without a
3hearing, simultaneously with the institution of proceedings
4for a hearing provided for in Section 85 of this Act, if the
5Director finds that evidence in his or her possession indicates
6that a continuation in business would constitute an imminent
7danger to the public. In the event that the Director
8temporarily suspends a license or certificate without a
9hearing, a hearing by the Department must be held within 10
10days after the suspension has occurred and be concluded without
11appreciable delay.
12(Source: P.A. 87-594.)
13    Section 99. Effective date. This Act takes effect upon
14becoming law.".