(225 ILCS 120/15)
(from Ch. 111, par. 8301-15)
(Section scheduled to be repealed on January 1, 2023)
As used in this Act:
"Authentication" means the affirmative verification, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree has occurred.
"Authorized distributor of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to exist between a wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with the following:
(1) The wholesale distributor has a written agreement
currently in effect with the manufacturer evidencing the ongoing relationship; and
(2) The wholesale distributor is listed on the
manufacturer's current list of authorized distributors of record, which is updated by the manufacturer on no less than a monthly basis.
"Blood" means whole blood collected from a single donor and processed
either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by physical or
"Board" means the State Board of Pharmacy of the Department of
"Chain pharmacy warehouse" means a physical location for prescription drugs that acts as a central warehouse and performs intracompany sales or transfers of the drugs to a group of chain or mail order pharmacies that have the same common ownership and control. Notwithstanding any other provision of this Act, a chain pharmacy warehouse shall be considered part of the normal distribution channel.
"Co-licensed partner or product" means an instance where one or more parties have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the FDA's implementation of the Prescription Drug Marketing Act.
"Department" means the Department of Financial and
"Drop shipment" means the sale of a prescription drug to a wholesale distributor by the manufacturer of the prescription drug or that manufacturer's co-licensed product partner, that manufacturer's third party logistics provider, or that manufacturer's exclusive distributor or by an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities whereby the wholesale distributor or chain pharmacy warehouse takes title but not physical possession of such prescription drug and the wholesale distributor invoices the pharmacy, chain pharmacy warehouse, or other person authorized by law to dispense or administer such drug to a patient and the pharmacy, chain pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer, that manufacturer's third party logistics provider, or that manufacturer's exclusive distributor or from an authorized distributor of record that purchased the product directly from the manufacturer or one of these entities.
"Drug sample" means a unit of a prescription drug that is not intended to
be sold and is intended to promote the sale of the drug.
"Facility" means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale.
"FDA" means the United States Food and Drug Administration.
"Manufacturer" means a person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" set forth in the FDA's regulations and guidances implementing the Prescription Drug Marketing Act.
"Manufacturer's exclusive distributor" means anyone who contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug. A manufacturer's exclusive distributor must be licensed as a wholesale distributor under this Act and, in order to be considered part of the normal distribution channel, must also be an authorized distributor of record.
"Normal distribution channel" means a chain of custody for a prescription drug that goes, directly or by drop shipment, from (i) a manufacturer of the prescription drug, (ii) that manufacturer to that manufacturer's co-licensed partner, (iii) that manufacturer to that manufacturer's third party logistics provider, or (iv) that manufacturer to that manufacturer's exclusive distributor to:
(1) a pharmacy or to other designated persons
authorized by law to dispense or administer the drug to a patient;
(2) a wholesale distributor to a pharmacy or other
designated persons authorized by law to dispense or administer the drug to a patient;
(3) a wholesale distributor to a chain pharmacy
warehouse to that chain pharmacy warehouse's intracompany pharmacy to a patient or other designated persons authorized by law to dispense or administer the drug to a patient;
(4) a chain pharmacy warehouse to the chain pharmacy
warehouse's intracompany pharmacy or other designated persons authorized by law to dispense or administer the drug to the patient;
(5) an authorized distributor of record to one other
authorized distributor of record to an office-based health care practitioner authorized by law to dispense or administer the drug to the patient; or
(6) an authorized distributor to a pharmacy or other
persons licensed to dispense or administer the drug.
"Pedigree" means a document or electronic file containing information that records each wholesale distribution of any given prescription drug from the point of origin to the final wholesale distribution point of any given prescription drug.
"Person" means and includes a natural person, partnership, association,
corporation, or any other legal business entity.
"Pharmacy distributor" means any pharmacy licensed in this State or
hospital pharmacy that is engaged in the delivery or distribution of
prescription drugs either to any other pharmacy licensed in this State or
to any other person or entity including, but not limited to, a wholesale
drug distributor engaged in the delivery or distribution of prescription
drugs who is involved in the actual, constructive, or attempted transfer of
a drug in this State to other than the ultimate consumer except as
otherwise provided for by law.
"Prescription drug" means any human drug, including any biological product (except for blood and blood components intended for transfusion or biological products that are also medical devices), required by federal law or
regulation to be dispensed only by a prescription, including finished
dosage forms and bulk drug substances
subject to Section
503 of the Federal Food, Drug and Cosmetic Act.
"Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug, excluding that completed by the pharmacist responsible for dispensing the product to a patient.
"Secretary" means the Secretary of Financial and Professional Regulation.
"Third party logistics provider" means anyone who contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition. A third party logistics provider must be licensed as a wholesale distributor under this Act and, in order to be considered part of the normal distribution channel, must also be an authorized distributor of record.
means the distribution
of prescription drugs to persons other than a consumer or patient, but does
not include any of the following:
(1) Intracompany sales of prescription drugs,
meaning (i) any transaction or transfer between any division, subsidiary, parent, or affiliated or related company under the common ownership and control of a corporate entity or (ii) any transaction or transfer between co-licensees of a co-licensed product.
(2) The sale, purchase, distribution, trade, or
transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.
(3) The distribution of prescription drug samples by
(4) Drug returns, when conducted by a hospital,
health care entity, or charitable institution in accordance with federal regulation.
(5) The sale of minimal quantities of prescription
drugs by licensed pharmacies to licensed practitioners for office use or other licensed pharmacies.
(6) The sale, purchase, or trade of a drug, an offer
to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.
(7) The sale, transfer, merger, or consolidation of
all or part of the business of a pharmacy or pharmacies from or with another pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets.
(8) The sale, purchase, distribution, trade, or
transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record when the manufacturer has stated in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the prescription drug and the supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel.
(9) The delivery of or the offer to deliver a
prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs when the common carrier does not store, warehouse, or take legal ownership of the prescription drug.
(10) The sale or transfer from a retail pharmacy,
mail order pharmacy, or chain pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original manufacturer, the originating wholesale distributor, or a third party returns processor.
"Wholesale drug distributor" means anyone
engaged in the
wholesale distribution of prescription drugs into, out of, or within the State, including without limitation
manufacturers; repackers; own label distributors; jobbers; private
label distributors; brokers; warehouses, including manufacturers' and
distributors' warehouses; manufacturer's exclusive distributors; and authorized distributors of record; drug wholesalers or distributors; independent wholesale drug traders; specialty wholesale distributors; third party logistics providers; and retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution. In order to be considered part of the normal distribution channel, a wholesale distributor must also be an authorized distributor of record.
(Source: P.A. 97-804, eff. 1-1-13.)
(225 ILCS 120/25)
(from Ch. 111, par. 8301-25)
(Section scheduled to be repealed on January 1, 2023)
Wholesale drug distributor licensing requirements.
(a) Every resident wholesale distributor who engages in the wholesale distribution of prescription drugs must be licensed by the Department, and every non-resident wholesale distributor must be licensed in this State if it ships prescription drugs into this State, in accordance with this Act, before engaging in wholesale distributions of wholesale prescription drugs.
(b) The Department shall require without limitation all of the following information from each applicant for licensure under this Act:
(1) The name, full business address, and telephone
(2) All trade or business names used by the licensee.
(3) Addresses, telephone numbers, and the names of
contact persons for all facilities used by the licensee for the storage, handling, and distribution of prescription drugs.
(4) The type of ownership or operation, such as a
partnership, corporation, or sole proprietorship.
(5) The name of the owner or operator of the
wholesale distributor, including:
(A) if a natural person, the name of the natural
(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
wholesale distributor, together with the personal information statement and fingerprints, as required under subsection (c) of this Section.
(8) Minimum liability insurance and other insurance
(9) Any additional information required by the
(c) Each wholesale distributor must designate an individual representative who shall serve as the contact person for the Department. This representative must provide the
Department with all of the following information:
(1) Information concerning whether the person has
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 which 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 wholesale drug distributor shall have his or her fingerprints submitted to the Department of State Police in an electronic format that complies with the form and manner for requesting and furnishing criminal history record information as prescribed by the Department of State Police. These fingerprints shall be checked against the Department of State Police and Federal Bureau of Investigation criminal history record databases now and hereafter filed. The Department of State Police shall charge applicants a fee for conducting the criminal history records check, which shall be deposited into the State Police Services Fund and shall not exceed the actual cost of the records check. The Department of State Police shall furnish, pursuant to positive identification, records of Illinois convictions to the Department. The Department may require applicants to pay a separate fingerprinting fee, either to the Department or to a vendor. The Department, in its discretion, may allow an applicant who does not have reasonable access to a designated vendor to provide his or her fingerprints in an alternative manner. The Department may adopt any rules necessary to implement this Section.
The designated representative of a licensee shall
receive and complete continuing training in applicable federal and State laws governing the wholesale distribution of prescription drugs.
(d) The Department may not issue a wholesale distributor license to an applicant, unless the Department first:
(1) ensures that a physical inspection of the
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; 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 has been employed full-time for at
least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and recordkeeping relating to, prescription drugs.
(C) He or she is employed by the applicant full
time in a managerial level position.
(D) He or she is actively involved in and aware
of the actual daily operation of the wholesale distributor.
(E) He or she is physically present at the
facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including without limitation sick leave and vacation leave.
(F) He or she is serving in the capacity of a
designated representative for only one applicant at a time, except where more than one licensed wholesale distributor is co-located in the same facility and such wholesale distributors are members of an affiliated group, as defined in Section 1504 of the Internal Revenue Code.
(e) If a wholesale distributor distributes prescription drugs from more than one facility, the wholesale distributor shall obtain a license for each facility.
(f) The information provided under this Section may not be disclosed to any person or entity other than the Department or another government entity in need of such information for licensing or monitoring purposes.
(Source: P.A. 97-804, eff. 1-1-13.)
(225 ILCS 120/55)
(from Ch. 111, par. 8301-55)
(Section scheduled to be repealed on January 1, 2023)
(a) The Department may refuse to issue, restore, or renew, or may revoke,
suspend, place on probation, reprimand or take other disciplinary or non-disciplinary action as
the Department may deem appropriate, including imposing fines not to exceed $10,000 for each violation, with regard to any applicant or licensee or any officer, director, manager, or shareholder who owns 5% or more interest in the business that holds the license for any one or a combination of the following reasons:
(1) Violation of this Act or of the rules adopted
(2) Aiding or assisting another person in violating
any provision of this Act or the rules adopted under this Act.
(3) Failing, within 60 days, to provide information
in response to a written requirement made by the Department.
(4) Engaging in dishonorable, unethical, or
unprofessional conduct of a character likely to deceive, defraud, or harm the public. This includes violations of "good faith" as defined by the Illinois Controlled Substances Act and applies to all prescription drugs.
(5) Discipline by another U.S. jurisdiction or
foreign nation, if at least one of the grounds for the discipline is the same or substantially equivalent to those set forth in this Act.
(6) Selling or engaging in the sale of drug samples
provided at no cost by drug manufacturers.
(7) Conviction by plea of guilty or nolo contendere,
finding of guilt, jury verdict, or entry of judgment or by sentencing of any crime, including, but not limited to, convictions, preceding sentences of supervision, conditional discharge, or first offender probation, under the laws of any jurisdiction of the United States that is (i) a felony or (ii) a misdemeanor, an essential element of which is dishonesty or that is directly related to the practice of this profession.
(8) Habitual or excessive use or addiction to
alcohol, narcotics, stimulants, or any other chemical agent or drug by the designated representative, as provided for in item (7) of subsection (b) of Section 25 of this Act, any officer, or director that results in the inability to function with reasonable judgment, skill, or safety.
(9) Material misstatement in furnishing information
(10) A finding by the Department that the licensee,
after having his or her license placed on probationary status, has violated the terms of probation.
(11) Fraud or misrepresentation in applying for, or
procuring, a license under this Act or in connection with applying for renewal of a license under this Act.
(12) Willfully making or filing false records or
(13) A finding of a substantial discrepancy in a
Department audit of a prescription drug, including a controlled substance as that term is defined in this Act or in the Illinois Controlled Substances Act.
(14) Falsifying a pedigree or selling, distributing,
transferring, manufacturing, repackaging, handling, or holding a counterfeit prescription drug intended for human use.
(15) Interfering with a Department investigation.
(16) Failing to adequately secure controlled
substances or other prescription drugs from diversion.
(17) Acquiring or distributing prescription drugs not
obtained from a source licensed by the Department.
(18) Failing to properly store drugs.
(19) Failing to maintain the licensed premises with
proper storage and security controls.
(b) The Department may refuse to issue or may suspend the license or
registration of any person who fails to file a return, or to pay the tax,
penalty or interest shown in a filed return, or to pay any final assessment
of tax, penalty or interest, as required by any tax Act administered by the
Illinois Department of Revenue, until the time the requirements of
the tax Act are satisfied.
(c) The Department shall revoke the license or certificate of
registration issued under this Act or any prior Act of
this State of any person who has been convicted a second time of committing
any felony under the Illinois Controlled Substances Act or the Methamphetamine Control and Community Protection Act
has been convicted a second time of committing a Class 1 felony under
Sections 8A-3 and 8A-6 of the Illinois Public Aid Code. A
person whose license or certificate of registration issued under
this Act or any prior Act of this State is revoked under this
subsection (c) shall be prohibited from engaging in the practice of
pharmacy in this State.
(Source: P.A. 97-804, eff. 1-1-13; 97-813, eff. 7-13-12; 98-463, eff. 8-16-13.)
(225 ILCS 120/57)
(Section scheduled to be repealed on January 1, 2023)
(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, 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
(2) The dosage form and strength of the prescription
(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
(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 120/58)
(Section scheduled to be repealed on January 1, 2023)
It is unlawful for a person to perform or cause the performance of or aid and abet any of the following acts:
(1) Failure to obtain a license in accordance with
this Act or operating without a valid license when a license is required by this Act.
(2) If the requirements of subsection (a) of Section
56 of this Act are applicable and are not met, the purchasing or otherwise receiving of a prescription drug from a pharmacy.
(3) If licensure is required pursuant to subsection
(b) of Section 56 of this Act, the sale, distribution, or transfer of a prescription drug to a person that is not authorized under the law of the jurisdiction in which the person receives the prescription drug to receive the prescription drug.
(4) Failure to deliver prescription drugs to
specified premises, as required by subsection (c) of Section 56 of this Act.
(5) Accepting payment or credit for the sale of
prescription drugs in violation of subsection (e) of Section 56 of this Act.
(6) Failure to maintain or provide pedigrees as
(7) Failure to obtain, pass, or authenticate a
pedigree as required by this Act.
(8) Providing the Department or any federal official
with false or fraudulent records or making false or fraudulent statements regarding any matter within the provisions of this Act.
(9) Obtaining or attempting to obtain a prescription
drug by fraud, deceit, or misrepresentation or engaging in misrepresentation or fraud in the distribution of a prescription drug.
(10) The manufacture, repacking, sale, transfer,
delivery, holding, or offering for sale of any prescription drug that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or that has otherwise been rendered unfit for distribution, except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved under federal law by the FDA.
(11) The adulteration, misbranding, or counterfeiting
of any prescription drug, except for the wholesale distribution by manufacturers of a prescription drug that has been delivered into commerce pursuant to an application approved under federal law by the FDA.
(12) The receipt of any prescription drug that is
adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit and the delivery or proffered delivery of such drug for pay or otherwise.
(13) The alteration, mutilation, destruction,
obliteration, or removal of the whole or any part of the labeling of a prescription drug or the commission of any other act with respect to a prescription drug that results in the prescription drug being misbranded. The acts prohibited in this Section do not include the obtaining or the attempt to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity performed by a prescription drug manufacturer or the agent of a prescription drug manufacturer.
(Source: P.A. 95-689, eff. 10-29-07