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| Public Act 101-0420
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| SB1839 Enrolled | LRB101 09712 JRG 54811 b |
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AN ACT concerning regulation.
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Be it enacted by the People of the State of Illinois, |
represented in the General Assembly:
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Section 3. The Pharmacy Practice Act is amended by changing |
Section 4 as follows:
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(225 ILCS 85/4) (from Ch. 111, par. 4124)
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(Section scheduled to be repealed on January 1, 2020)
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Sec. 4. Exemptions. Nothing contained in any Section of |
this Act shall
apply
to, or in any manner interfere with:
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(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
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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;
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(b) the sale of compressed gases;
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(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 |
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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;
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(d) the sale of poultry and livestock remedies in |
original and unbroken
packages only, labeled for poultry |
and livestock medication;
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(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 |
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thereunder now in effect relating thereto
and governing the |
same, and those which are required under such applicable
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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;
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(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;
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(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
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registered nurse in accordance with a written |
collaborative
agreement under Sections 65-35 and 65-40 of |
the Nurse Practice Act; and
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(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 |
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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. |
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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.)
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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:
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(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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(Section scheduled to be repealed on January 1, 2023)
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Sec. 15. Definitions. As used in this Act:
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"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 |
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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.
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"Blood" means whole blood collected from a single donor and |
processed
either for transfusion or further manufacturing.
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"Blood component" means that part of blood separated by |
physical or
mechanical means.
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"Board" means the State Board of Pharmacy of the Department |
of
Professional Regulation.
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"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 |
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Marketing Act.
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"Department" means the Department of Financial and
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Professional Regulation.
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"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.
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"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.
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"Facility" means a facility of a wholesale distributor |
where prescription drugs are stored, handled, repackaged, or |
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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.
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"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.
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"Normal distribution channel" means a chain of custody for |
a prescription drug that goes, directly or by drop shipment, |
from (i) a manufacturer of the prescription drug, (ii) that |
manufacturer to that manufacturer's co-licensed partner, (iii) |
that manufacturer to that manufacturer's third party logistics |
provider, or (iv) that manufacturer to that manufacturer's |
exclusive distributor to: |
(1) a pharmacy or to other designated persons |
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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.
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"Person" means and includes a natural person, partnership, |
association,
corporation, or any other legal business entity.
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"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.
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"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.
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"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 |
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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:
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(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.
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(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.
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(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 |
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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, |
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damaged, returned, or recalled prescription drugs to the |
original manufacturer, the originating wholesale |
distributor, or a third party returns processor.
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"Wholesale drug distributor" means anyone
engaged in the
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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.
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(Source: P.A. 97-804, eff. 1-1-13.)
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(225 ILCS 120/20) (from Ch. 111, par. 8301-20)
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(Section scheduled to be repealed on January 1, 2023)
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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 |
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person or entity licensed under the laws of this State shall
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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
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misdemeanor. A second violation shall constitute a Class 4 |
felony.
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(Source: P.A. 97-804, eff. 1-1-13.)
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(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. |
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(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 |
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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 |
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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 |
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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.
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(225 ILCS 120/26)
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(Section scheduled to be repealed on January 1, 2023)
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Sec. 26. Unlicensed practice; violation; civil penalty.
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(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
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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.
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(b) The Department has the authority and power to |
investigate any and all
unlicensed activity.
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(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.
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(Source: P.A. 97-804, eff. 1-1-13.)
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(225 ILCS 120/30) (from Ch. 111, par. 8301-30)
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(Section scheduled to be repealed on January 1, 2023)
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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
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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.
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(Source: P.A. 87-594.)
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(225 ILCS 120/35) (from Ch. 111, par. 8301-35)
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(Section scheduled to be repealed on January 1, 2023)
|
Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
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(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
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restoration. The fees shall be nonrefundable.
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(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
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Department of Professional Regulation Law (20 ILCS |
2105/2105-300).
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The moneys deposited into the Illinois State Pharmacy |
Disciplinary Fund shall
be invested to earn interest which |
shall accrue to the Fund.
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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.
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(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
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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 |
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due under this Section in individual cases where the
Director |
finds that the fines would be unreasonable or unnecessarily
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burdensome.
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(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.
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(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.
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(Source: P.A. 95-689, eff. 10-29-07.)
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(225 ILCS 120/40) (from Ch. 111, par. 8301-40)
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(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 |
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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
|
