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Sen. Thomas Cullerton
Filed: 3/5/2019
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1 | | AMENDMENT TO SENATE BILL 1839
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2 | | AMENDMENT NO. ______. Amend Senate Bill 1839 by replacing |
3 | | everything after the enacting clause with the following:
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4 | | "Section 5. The Wholesale Drug Distribution Licensing Act |
5 | | is amended by changing Sections 15, 57, and 200 and adding |
6 | | Section 28 as follows:
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7 | | (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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8 | | (Section scheduled to be repealed on January 1, 2023)
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9 | | Sec. 15. Definitions. As used in this Act:
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10 | | "Authentication" means the affirmative verification, |
11 | | before any wholesale distribution of a prescription drug |
12 | | occurs, that each transaction listed on the pedigree has |
13 | | occurred. |
14 | | "Authorized distributor of record" means a wholesale |
15 | | distributor with whom a manufacturer has established an ongoing |
16 | | relationship to distribute the manufacturer's prescription |
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1 | | drug. An ongoing relationship is deemed to exist between a |
2 | | wholesale distributor and a manufacturer when the wholesale |
3 | | distributor, including any affiliated group of the wholesale |
4 | | distributor, as defined in Section 1504 of the Internal Revenue |
5 | | Code, complies with the following: |
6 | | (1) The wholesale distributor has a written agreement |
7 | | currently in effect with the manufacturer evidencing the |
8 | | ongoing relationship; and |
9 | | (2) The wholesale distributor is listed on the |
10 | | manufacturer's current list of authorized distributors of |
11 | | record, which is updated by the manufacturer on no less |
12 | | than a monthly basis.
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13 | | "Blood" means whole blood collected from a single donor and |
14 | | processed
either for transfusion or further manufacturing.
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15 | | "Blood component" means that part of blood separated by |
16 | | physical or
mechanical means.
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17 | | "Board" means the State Board of Pharmacy of the Department |
18 | | of
Professional Regulation.
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19 | | "Chain pharmacy warehouse" means a physical location for |
20 | | prescription drugs that acts as a central warehouse and |
21 | | performs intracompany sales or transfers of the drugs to a |
22 | | group of chain or mail order pharmacies that have the same |
23 | | common ownership and control. Notwithstanding any other |
24 | | provision of this Act, a chain pharmacy warehouse shall be |
25 | | considered part of the normal distribution channel. |
26 | | "Co-licensed partner or product" means an instance where |
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1 | | one or more parties have the right to engage in the |
2 | | manufacturing or marketing of a prescription drug, consistent |
3 | | with the FDA's implementation of the Prescription Drug |
4 | | Marketing Act.
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5 | | "Department" means the Department of Financial and
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6 | | Professional Regulation.
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7 | | "Drop shipment" means the sale of a prescription drug to a |
8 | | wholesale distributor by the manufacturer of the prescription |
9 | | drug or that manufacturer's co-licensed product partner, that |
10 | | manufacturer's third-party third party logistics provider, or |
11 | | that manufacturer's exclusive distributor or by an authorized |
12 | | distributor of record that purchased the product directly from |
13 | | the manufacturer or one of these entities whereby the wholesale |
14 | | distributor or chain pharmacy warehouse takes title but not |
15 | | physical possession of such prescription drug and the wholesale |
16 | | distributor invoices the pharmacy, chain pharmacy warehouse, |
17 | | or other person authorized by law to dispense or administer |
18 | | such drug to a patient and the pharmacy, chain pharmacy |
19 | | warehouse, or other authorized person receives delivery of the |
20 | | prescription drug directly from the manufacturer, that |
21 | | manufacturer's third-party third party logistics provider, or |
22 | | that manufacturer's exclusive distributor or from an |
23 | | authorized distributor of record that purchased the product |
24 | | directly from the manufacturer or one of these entities.
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25 | | "Drug sample" means a unit of a prescription drug that is |
26 | | not intended to
be sold and is intended to promote the sale of |
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1 | | the drug.
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2 | | "Facility" means a facility of a wholesale distributor |
3 | | where prescription drugs are stored, handled, repackaged, or |
4 | | offered for sale. |
5 | | "FDA" means the United States Food and Drug Administration.
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6 | | "Manufacturer" means a person licensed or approved by the |
7 | | FDA to engage in the manufacture of drugs or devices, |
8 | | consistent with the definition of "manufacturer" set forth in |
9 | | the FDA's regulations and guidances implementing the |
10 | | Prescription Drug Marketing Act. |
11 | | "Manufacturer's exclusive distributor" means anyone who |
12 | | contracts with a manufacturer to provide or coordinate |
13 | | warehousing, distribution, or other services on behalf of a |
14 | | manufacturer and who takes title to that manufacturer's |
15 | | prescription drug, but who does not have general responsibility |
16 | | to direct the sale or disposition of the manufacturer's |
17 | | prescription drug. A manufacturer's exclusive distributor must |
18 | | be licensed as a wholesale distributor under this Act and, in |
19 | | order to be considered part of the normal distribution channel, |
20 | | must also be an authorized distributor of record.
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21 | | "Normal distribution channel" means a chain of custody for |
22 | | a prescription drug that goes, directly or by drop shipment, |
23 | | from (i) a manufacturer of the prescription drug, (ii) that |
24 | | manufacturer to that manufacturer's co-licensed partner, (iii) |
25 | | that manufacturer to that manufacturer's third-party third |
26 | | party logistics provider, or (iv) that manufacturer to that |
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1 | | manufacturer's exclusive distributor to: |
2 | | (1) a pharmacy or to other designated persons |
3 | | authorized by law to dispense or administer the drug to a |
4 | | patient; |
5 | | (2) a wholesale distributor to a pharmacy or other |
6 | | designated persons authorized by law to dispense or |
7 | | administer the drug to a patient; |
8 | | (3) a wholesale distributor to a chain pharmacy |
9 | | warehouse to that chain pharmacy warehouse's intracompany |
10 | | pharmacy to a patient or other designated persons |
11 | | authorized by law to dispense or administer the drug to a |
12 | | patient; |
13 | | (4) a chain pharmacy warehouse to the chain pharmacy |
14 | | warehouse's intracompany pharmacy or other designated |
15 | | persons authorized by law to dispense or administer the |
16 | | drug to the patient; |
17 | | (5) an authorized distributor of record to one other |
18 | | authorized distributor of record to an office-based health |
19 | | care practitioner authorized by law to dispense or |
20 | | administer the drug to the patient; or |
21 | | (6) an authorized distributor to a pharmacy or other |
22 | | persons licensed to dispense or administer the drug. |
23 | | "Pedigree" means a document or electronic file containing |
24 | | information that records each wholesale distribution of any |
25 | | given prescription drug from the point of origin to the final |
26 | | wholesale distribution point of any given prescription drug.
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1 | | "Person" means and includes a natural person, partnership, |
2 | | association,
corporation, or any other legal business entity.
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3 | | "Pharmacy distributor" means any pharmacy licensed in this |
4 | | State or
hospital pharmacy that is engaged in the delivery or |
5 | | distribution of
prescription drugs either to any other pharmacy |
6 | | licensed in this State or
to any other person or entity |
7 | | including, but not limited to, a wholesale
drug distributor |
8 | | engaged in the delivery or distribution of prescription
drugs |
9 | | who is involved in the actual, constructive, or attempted |
10 | | transfer of
a drug in this State to other than the ultimate |
11 | | consumer except as
otherwise provided for by law.
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12 | | "Prescription drug" means any human drug, including any |
13 | | biological product (except for blood and blood components |
14 | | intended for transfusion or biological products that are also |
15 | | medical devices), required by federal law or
regulation to be |
16 | | dispensed only by a prescription, including finished
dosage |
17 | | forms and bulk drug substances
subject to Section
503 of the |
18 | | Federal Food, Drug and Cosmetic Act.
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19 | | "Repackage" means repackaging or otherwise changing the |
20 | | container, wrapper, or labeling to further the distribution of |
21 | | a prescription drug, excluding that completed by the pharmacist |
22 | | responsible for dispensing the product to a patient. |
23 | | "Secretary" means the Secretary of Financial and |
24 | | Professional Regulation. |
25 | | " Third-party Third party logistics provider" means anyone |
26 | | who contracts with a prescription drug manufacturer to provide |
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1 | | or coordinate warehousing, distribution, or other services on |
2 | | behalf of a manufacturer, but does not take title to the |
3 | | prescription drug or have general responsibility to direct the |
4 | | prescription drug's sale or disposition. A third-party third |
5 | | party logistics provider must be licensed as a third-party |
6 | | logistics provider wholesale distributor under this Act and, in |
7 | | order to be considered part of the normal distribution channel, |
8 | | must also be an authorized distributor of record . |
9 | | "Wholesale distribution"
means the distribution
of |
10 | | prescription drugs to persons other than a consumer or patient, |
11 | | but does
not include any of the following:
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12 | | (1)
Intracompany sales of prescription drugs, meaning |
13 | | (i) any transaction or transfer
between any division, |
14 | | subsidiary, parent, or affiliated or related company
under |
15 | | the common ownership and control of a corporate entity or |
16 | | (ii) any transaction or transfer between co-licensees of a |
17 | | co-licensed product.
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18 | | (2) The sale, purchase, distribution, trade, or |
19 | | transfer of a prescription drug or offer to sell, purchase, |
20 | | distribute, trade, or transfer a prescription drug for |
21 | | emergency medical reasons.
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22 | | (3) The distribution of prescription drug samples by |
23 | | manufacturers' representatives. |
24 | | (4) Drug returns, when conducted by a hospital, health |
25 | | care entity, or charitable institution in accordance with |
26 | | federal regulation. |
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1 | | (5) The sale of minimal quantities of prescription |
2 | | drugs by licensed pharmacies to licensed practitioners for |
3 | | office use or other licensed pharmacies. |
4 | | (6) The sale, purchase, or trade of a drug, an offer to |
5 | | sell, purchase, or trade a drug, or the dispensing of a |
6 | | drug pursuant to a prescription. |
7 | | (7) The sale, transfer, merger, or consolidation of all |
8 | | or part of the business of a pharmacy or pharmacies from or |
9 | | with another pharmacy or pharmacies, whether accomplished |
10 | | as a purchase and sale of stock or business assets. |
11 | | (8) The sale, purchase, distribution, trade, or |
12 | | transfer of a prescription drug from one authorized |
13 | | distributor of record to one additional authorized |
14 | | distributor of record when the manufacturer has stated in |
15 | | writing to the receiving authorized distributor of record |
16 | | that the manufacturer is unable to supply the prescription |
17 | | drug and the supplying authorized distributor of record |
18 | | states in writing that the prescription drug being supplied |
19 | | had until that time been exclusively in the normal |
20 | | distribution channel. |
21 | | (9) The delivery of or the offer to deliver a |
22 | | prescription drug by a common carrier solely in the common |
23 | | carrier's usual course of business of transporting |
24 | | prescription drugs when the common carrier does not store, |
25 | | warehouse, or take legal ownership of the prescription |
26 | | drug. |
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1 | | (10) The sale or transfer from a retail pharmacy, mail |
2 | | order pharmacy, or chain pharmacy warehouse of expired, |
3 | | damaged, returned, or recalled prescription drugs to the |
4 | | original manufacturer, the originating wholesale |
5 | | distributor, or a third party returns processor.
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6 | | "Wholesale drug distributor" means anyone
engaged in the
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7 | | wholesale distribution of prescription drugs into, out of, or |
8 | | within the State, including without limitation
manufacturers; |
9 | | repackers; own label distributors; jobbers; private
label |
10 | | distributors; brokers; warehouses, including manufacturers' |
11 | | and
distributors' warehouses; manufacturer's exclusive |
12 | | distributors; and authorized distributors of record; drug |
13 | | wholesalers or distributors; independent wholesale drug |
14 | | traders; specialty wholesale distributors; third party |
15 | | logistics providers; and retail pharmacies that conduct |
16 | | wholesale distribution; and chain pharmacy warehouses that |
17 | | conduct wholesale distribution. In order to be considered part |
18 | | of the normal distribution channel, a wholesale distributor |
19 | | must also be an authorized distributor of record.
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20 | | (Source: P.A. 97-804, eff. 1-1-13.)
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21 | | (225 ILCS 120/28 new) |
22 | | Sec. 28. Third-party logistics providers licensing |
23 | | requirements. |
24 | | (a) Each facility of a third-party logistics provider |
25 | | located within Illinois shall be licensed by the Department |
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1 | | prior to shipping a prescription drug: |
2 | | (1) within the borders of Illinois; or |
3 | | (2) to a location outside the borders of Illinois. |
4 | | (b) Each facility of a third-party logistics provider |
5 | | located within Illinois must provide, on a form provided by the |
6 | | Department, information that shall include, but is not limited |
7 | | to: |
8 | | (1) the name, business address, and social security |
9 | | number or federal tax identification number of each owner, |
10 | | officer, and stockholder owning more than 10% of the stock |
11 | | of the company, unless the stock of the company is publicly |
12 | | traded; |
13 | | (2) every trade or business name used by the applicant; |
14 | | and |
15 | | (3) any disciplinary action taken by any state or |
16 | | federal authority against the applicant or any other |
17 | | third-party logistics provider under common ownership or |
18 | | control, or any owner, principal, or designated |
19 | | representative of the applicant, in connection with the |
20 | | drug laws or regulations of any state or the federal |
21 | | government. |
22 | | (c) Licenses issued under subsection (b) of this Section |
23 | | shall be renewed annually upon: |
24 | | (1) completion of an application; and |
25 | | (2) payment of a renewal fee as established by |
26 | | administrative rules adopted by the Department. |
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1 | | (d) A third-party logistics provider license shall be valid |
2 | | only for the name, ownership, and location listed on the |
3 | | license. |
4 | | The Department may require a criminal history and financial |
5 | | background check of each principal, owner, or officer of the |
6 | | applicant prior to initial registration and prior to any |
7 | | renewal unless the applicant is publicly traded. Any such |
8 | | checks shall be at the applicant's expense. |
9 | | Changes of name, ownership, or location shall require a new |
10 | | third-party logistics provider license. |
11 | | Changes in information required for licensure shall be |
12 | | reported to the Department, in writing, within 45 days after |
13 | | the change. |
14 | | (e) A third-party logistics provider that provides |
15 | | services in respect to controlled substances as defined in the |
16 | | Illinois Controlled Substances Act must also complete and |
17 | | submit the controlled substance registration form provided by |
18 | | the Department, with the appropriate fee. |
19 | | (f) Each third-party logistics provider must designate an |
20 | | individual representative who shall serve as the contact person |
21 | | for the Department. |
22 | | (g) An agent or employee of any licensed third-party |
23 | | logistics provider does not need a license and may lawfully |
24 | | possess pharmaceutical drugs when acting in the usual course of |
25 | | business or employment. |
26 | | (h) A third-party logistics provider shall not operate from |
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1 | | a place of residence. |
2 | | A third-party logistics provider facility shall be located |
3 | | apart and separate from any retail pharmacy licensed by the |
4 | | Department. |
5 | | The Department may require a physical inspection of each |
6 | | facility prior to initial registration and prior to any |
7 | | renewal. |
8 | | (i) A third-party logistics provider shall publicly |
9 | | display all licenses and have the most recent State and federal |
10 | | inspection reports readily available. |
11 | | (j) The Department shall adopt rules establishing |
12 | | requirements for a third-party logistics provider license, |
13 | | licensure fees, and other relevant matters. |
14 | | (k) The Department may waive any requirement of this |
15 | | Section if, in the Board's judgment, a waiver will further |
16 | | public health or safety. A waiver granted under this Section |
17 | | shall only be effective when issued in writing. |
18 | | (l) The Department may deny, suspend, or revoke a |
19 | | third-party logistics provider license or otherwise discipline |
20 | | a third-party logistics provider for failure to meet the |
21 | | applicable standards or for a violation of the laws of this |
22 | | State, another state, or the United States or for a violation |
23 | | of this Act or a rule of the Department. |
24 | | (225 ILCS 120/57)
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25 | | (Section scheduled to be repealed on January 1, 2023) |
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1 | | Sec. 57. Pedigree. |
2 | | (a) Each person who is engaged in the wholesale |
3 | | distribution of prescription drugs, including repackagers, but |
4 | | excluding the original manufacturer of the finished form of the |
5 | | prescription drug, that leave or have ever left the normal |
6 | | distribution channel shall, before each wholesale distribution |
7 | | of the drug, provide a pedigree to the person who receives the
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8 | | drug. A retail pharmacy, mail order pharmacy, or chain pharmacy |
9 | | warehouse must comply with the requirements of this Section |
10 | | only if the pharmacy or chain pharmacy warehouse engages in the |
11 | | wholesale distribution of prescription drugs. On or before July |
12 | | 1, 2009, the Department shall determine a targeted |
13 | | implementation date for electronic track and trace pedigree |
14 | | technology. This targeted implementation date shall not be |
15 | | sooner than July 1, 2010. Beginning on the date established by |
16 | | the Department, pedigrees may be implemented through an |
17 | | approved and readily available system that electronically |
18 | | tracks and traces the wholesale distribution of each |
19 | | prescription drug starting with the sale by the manufacturer |
20 | | through acquisition and sale by any wholesale distributor and |
21 | | until final sale to a pharmacy or other authorized person |
22 | | administering or dispensing the prescription drug. This |
23 | | electronic tracking system shall be deemed to be readily |
24 | | available only upon there being available a standardized system |
25 | | originating with the manufacturers and capable of being used on |
26 | | a wide scale across the entire pharmaceutical chain, including |
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1 | | manufacturers, wholesale distributors, and pharmacies. |
2 | | Consideration must also be given to the large-scale |
3 | | implementation of this technology across the supply chain and |
4 | | the technology must be proven to have no negative impact on the |
5 | | safety and efficacy of the pharmaceutical product. |
6 | | (b) Each person who is engaged in the wholesale |
7 | | distribution of a prescription drug who is provided a pedigree |
8 | | for a prescription drug and attempts to further distribute that |
9 | | prescription drug, including repackagers, but excluding the |
10 | | original manufacturer of the finished form of the prescription |
11 | | drug, must affirmatively verify before any distribution of a |
12 | | prescription drug occurs that each transaction listed on the |
13 | | pedigree has occurred. |
14 | | (c) The pedigree must include all necessary identifying |
15 | | information concerning each sale in the chain of distribution |
16 | | of the product from the manufacturer or the manufacturer's |
17 | | third-party third party logistics provider, co-licensed |
18 | | product partner, or exclusive distributor through acquisition |
19 | | and sale by any wholesale distributor or repackager, until |
20 | | final sale to a pharmacy or other person dispensing or |
21 | | administering the drug. This necessary chain of distribution |
22 | | information shall include, without limitation all of the |
23 | | following: |
24 | | (1) The name, address, telephone number and, if |
25 | | available, the e-mail address of each owner of the |
26 | | prescription drug and each wholesale distributor of the |
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1 | | prescription drug. |
2 | | (2) The name and address of each location from which |
3 | | the product was shipped, if different from the owner's. |
4 | | (3) Transaction dates. |
5 | | (4) Certification that each recipient has |
6 | | authenticated the pedigree. |
7 | | (d) The pedigree must also include without limitation all |
8 | | of the following information concerning the prescription drug: |
9 | | (1) The name and national drug code number of the |
10 | | prescription drug. |
11 | | (2) The dosage form and strength of the prescription |
12 | | drug. |
13 | | (3) The size of the container. |
14 | | (4) The number of containers. |
15 | | (5) The lot number of the prescription drug. |
16 | | (6) The name of the manufacturer of the finished dosage |
17 | | form. |
18 | | (e) Each pedigree or electronic file shall be maintained by |
19 | | the purchaser and the wholesale distributor for at least 3 |
20 | | years from the date of sale or transfer and made available for |
21 | | inspection or use within 5 business days upon a request of the |
22 | | Department.
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23 | | (Source: P.A. 95-689, eff. 10-29-07 .) |
24 | | (225 ILCS 120/200) |
25 | | (Section scheduled to be repealed on January 1, 2023) |
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1 | | Sec. 200. Drugs in shortage. |
2 | | (a) For the purpose of this Section, "drug in shortage" |
3 | | means a drug, as defined in Section 356c of the Federal Food, |
4 | | Drug, and Cosmetic Act, listed on the drug shortage list |
5 | | maintained by the U.S. Food and Drug Administration in |
6 | | accordance with Section 356e of the Federal Food, Drug, and |
7 | | Cosmetic Act. |
8 | | (b) Any person engaged in the wholesale distribution of a |
9 | | drug in shortage in this State must be licensed by the |
10 | | Department. |
11 | | (c) It is unlawful for any person, other than a |
12 | | manufacturer, a manufacturer's exclusive distributor, a |
13 | | third-party third party logistics provider, or an authorized |
14 | | distributor of record, to purchase or receive a drug in |
15 | | shortage from any person not licensed by the Department. This |
16 | | subsection (c) does not apply to the return of drugs or the |
17 | | purchase or receipt of drugs pursuant to any of the |
18 | | distributions that are specifically excluded from the |
19 | | definition of "wholesale distribution" in Section 15 of the |
20 | | Wholesale Drug Distribution Licensing Act. |
21 | | (d) A person found to have violated a provision of this |
22 | | Section shall be subject to administrative fines, orders for |
23 | | restitution, and orders for disgorgement. |
24 | | (e) The Department shall create a centralized, searchable |
25 | | database of those entities licensed to engage in wholesale |
26 | | distribution, including manufacturers, wholesale distributors, |
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1 | | and pharmacy distributors, to enable purchasers of a drug in |
2 | | shortage to easily verify the licensing status of an entity |
3 | | offering such drugs. |
4 | | (f) The Department shall establish a system for reporting |
5 | | the reasonable suspicion that a violation of this Act has been |
6 | | committed by a distributor of a drug in shortage. Reports made |
7 | | through this system shall be referred to the Office of the |
8 | | Attorney General and the appropriate State's Attorney's office |
9 | | for further investigation and prosecution. |
10 | | (g) The Department shall adopt rules to carry out the |
11 | | provisions of this Section. |
12 | | (h) Nothing in this Section prohibits one hospital pharmacy |
13 | | from purchasing or receiving a drug in shortage from another |
14 | | hospital pharmacy in the event of a medical emergency.
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15 | | (Source: P.A. 98-355, eff. 8-16-13.)
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16 | | Section 99. Effective date. This Act takes effect upon |
17 | | becoming law.".
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