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95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008 SB0509
Introduced 2/8/2007, by Sen. Terry Link SYNOPSIS AS INTRODUCED: |
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New Act |
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5 ILCS 80/4.28 new |
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225 ILCS 85/10 |
from Ch. 111, par. 4130 |
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Creates the Wholesale Licensure and Prescription Medication Integrity Act. Provides that 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. Sets forth provisions concerning licensure, bond requirements, restrictions on transactions, a pedigree, prohibited acts, enforcement, and penalties. Amends the Regulatory Sunset Act to set a repeal date for the new Act of January 1, 2018. Amends the Pharmacy Practice Act of 1987 to make a related change. Effective immediately.
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CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY | |
FISCAL NOTE ACT MAY APPLY |
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A BILL FOR
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SB0509 |
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LRB095 10560 RAS 30780 b |
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| AN ACT concerning regulation.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| Section 1. Short title. This Act may be cited as the |
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| Wholesale Licensure and Prescription Medication Integrity Act. |
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| Section 5. Definitions.
In this Act: |
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| "Authentication" means to affirmatively verify, before any |
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| wholesale distribution of a prescription drug occurs, that each |
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| transaction listed on the pedigree has occurred. |
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| "Authorized distributor of record" means a wholesale |
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| distributor with whom a manufacturer has established an ongoing |
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| relationship to distribute the manufacturer's prescription |
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| drug. An ongoing relationship is deemed to exist between a |
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| wholesale distributor and a manufacturer when the wholesale |
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| distributor, including any affiliated group of the wholesale |
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| distributor, as defined in Section 1504 of the Internal Revenue |
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| Code, complies with either of the following: |
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| (1) the wholesale distributor has a written agreement |
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| currently in effect with the manufacturer evidencing the |
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| ongoing relationship; or |
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| (2) the wholesale distributor is listed on the |
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| manufacturer's current list of authorized distributors of |
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| record, which is updated by the manufacturer on no less |
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LRB095 10560 RAS 30780 b |
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| than a monthly basis. |
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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 |
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| wholesale distributor by the manufacturer of the prescription |
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| drug, or that manufacturer's co-licensed product partner, that |
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| manufacturer's third party logistics provider, or that |
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| manufacturer's exclusive distributor, whereby the wholesale |
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| distributor or chain pharmacy warehouse takes title but not |
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| physical possession of such prescription drug and the wholesale |
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| distributor invoices the pharmacy, chain pharmacy warehouse, |
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| or other person authorized by law to dispense or administer |
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| such drug to a patient and the pharmacy, chain pharmacy |
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| warehouse or other authorized person receives delivery of the |
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| prescription drug directly from the manufacturer, that |
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| manufacturer's third party logistics provider, or that |
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| manufacturer's exclusive distributor. |
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| "Chain pharmacy warehouse" means a physical location for |
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| prescription drugs that acts as a central warehouse and |
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| performs intracompany sales or transfers of the drugs to a |
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| group of chain pharmacies that have the same common ownership |
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| and control. |
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| "Co-licensed product" means a prescription drug in which 2 |
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| or more parties have the right to engage in the manufacturing |
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| or marketing of such drug. |
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| "Facility" means a facility of a wholesale distributor |
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LRB095 10560 RAS 30780 b |
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| where prescription drugs are stored, handled, repackaged, or |
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| offered for sale.
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| "FDA" means the United States Food and Drug Administration. |
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| "Manufacturer" means a person licensed or approved by the |
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| federal Food and Drug Administration to engage in the |
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| manufacture of drugs or devices. |
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| "Manufacturer's exclusive distributor" means anyone who |
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| contracts with a manufacturer to provide or coordinate |
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| warehousing, distribution, or other services on behalf of a |
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| manufacturer and who takes title to that manufacturer's |
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| prescription drug, but who does not have general responsibility |
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| to direct the sale or disposition of the manufacturer's |
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| prescription drug. A manufacturer's exclusive distributor must |
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| be licensed as a wholesale distributor under this Act and, in |
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| order to be considered part of the normal distribution channel, |
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| must also be an authorized distributor of record. |
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| "Normal distribution channel" means a chain of custody for |
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| a prescription drug that goes (i) from a manufacturer of the |
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| prescription drug, (ii) from that manufacturer to that |
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| manufacturer's co-licensed partner, (iii)from that |
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| manufacturer to that manufacturer's third-party logistics |
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| provider, or (iv) from that manufacturer to that manufacturer's |
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| exclusive distributor to: |
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| (1) a pharmacy to a patient or other designated persons |
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| authorized by law to dispense or administer such drug to a |
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| patient; |
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LRB095 10560 RAS 30780 b |
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| (2) a wholesale distributor to a pharmacy to a patient |
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| or other designated persons authorized by law to dispense |
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| or administer such drug to a patient; |
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| (3) a wholesale distributor to a chain pharmacy |
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| warehouse to that chain pharmacy warehouse's intracompany |
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| pharmacy to a patient or other designated persons |
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| authorized by law to dispense or administer such drug to a |
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| patient; or |
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| (4) a chain pharmacy warehouse to the chain pharmacy |
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| warehouse's intracompany pharmacy to a patient or other |
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| designated persons authorized by law to dispense or |
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| administer such drug to a patient.
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| "Pedigree" means a document or electronic file containing |
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| information that records each distribution of any given |
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| prescription drug.
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| "Prescription drug" means any drug, including any |
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| biological product (except for blood and blood components |
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| intended for transfusion or biological products that are also |
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| medical devices), required by federal law or regulation to be |
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| dispensed only by a prescription, including finished dosage |
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| forms and bulk drug substances subject to Section 503(b) of the |
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| federal Food, Drug and Cosmetic Act. |
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| "Repackage" means repackaging or otherwise changing the |
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| container, wrapper, or labeling to further the distribution of |
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| a prescription drug, excluding that completed by the pharmacist |
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| responsible for dispensing product to a patient. |
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LRB095 10560 RAS 30780 b |
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| "Third party logistics provider" means anyone who |
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| contracts with a prescription drug manufacturer to provide or |
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| coordinate warehousing, distribution, or other services on |
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| behalf of a manufacturer, but does not take title to the |
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| prescription drug or have general responsibility to direct the |
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| prescription drug's sale or disposition. A third party |
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| logistics provider must be licensed as a wholesale distributor |
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| under this Act and, in order to be considered part of the |
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| normal distribution channel, must also be an authorized |
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| distributor of record. |
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| "Wholesale distributor" means anyone engaged in the |
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| wholesale distribution of prescription drugs, including |
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| without limitation manufacturers; repackagers; own-label |
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| distributors; private-label distributors; jobbers; brokers; |
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| warehouses, including manufacturers' and distributors' |
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| warehouses; manufacturer's exclusive distributors; and |
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| authorized distributors of record; drug wholesalers or |
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| distributors; independent wholesale drug traders; specialty |
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| wholesale distributors; third party logistics providers; and |
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| retail pharmacies that conduct wholesale distribution; and |
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| chain pharmacy warehouses that conduct wholesale distribution. |
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| In order to be considered part of the normal distribution |
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| channel, a wholesale distributor must also be an authorized |
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| distributor of record. |
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| "Wholesale distribution" means distribution of |
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| prescription drugs to persons other than a consumer or patient, |
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LRB095 10560 RAS 30780 b |
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| but does not include any of the following: |
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| (1) Intracompany sales of prescription drugs, meaning |
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| (i) any transaction or transfer between any division, |
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| subsidiary, parent or affiliated or related company under |
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| common ownership and control of a corporate entity, or (ii) |
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| any transaction or transfer between co-licensees of a |
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| co-licensed product. |
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| (2) The sale, purchase, distribution, trade, or |
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| transfer of a prescription drug or offer to sell, purchase, |
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| distribute, trade, or transfer a prescription drug for |
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| emergency medical reasons. |
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| (3) The distribution of prescription drug samples by |
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| manufacturers' representatives. |
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| (4) Drug returns, when conducted by a hospital, health |
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| care entity, or charitable institution in accordance with |
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| federal regulation. |
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| (5) The sale of minimal quantities of prescription |
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| drugs by retail pharmacies to licensed practitioners for |
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| office use. |
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| (6) The sale, purchase, or trade of a drug, an offer to |
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| sell, purchase, or trade a drug, or the dispensing of a |
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| drug pursuant to a prescription. |
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| (7) The sale, transfer, merger or consolidation of all |
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| or part of the business of a pharmacy or pharmacies from or |
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| with another pharmacy or pharmacies, whether accomplished |
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| as a purchase and sale of stock or business assets. |
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LRB095 10560 RAS 30780 b |
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| (8) The sale, purchase, distribution, trade, or |
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| transfer of a prescription drug from one authorized |
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| distributor of record to one additional authorized |
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| distributor of record when the manufacturer has stated in |
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| writing to the receiving authorized distributor of record |
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| that the manufacturer is unable to supply the prescription |
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| drug and the supplying authorized distributor of record |
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| states in writing that the prescription drug being supplied |
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| had until that time been exclusively in the normal |
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| distribution channel. |
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| (9) The delivery of or the offer to deliver a |
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| prescription drug by a common carrier solely in the common |
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| carrier's usual course of business of transporting |
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| prescription drugs when the common carrier does not store, |
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| warehouse, or take legal ownership of the prescription |
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| drug. |
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| (10) The sale or transfer from a retail pharmacy or |
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| chain pharmacy warehouse of expired, damaged, returned, or |
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| recalled prescription drugs to the original manufacturer |
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| or to a third party returns processor. |
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| Section 10. Licensure required. |
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| (a) Every resident wholesale distributor who engages in the |
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| wholesale distribution of prescription drugs must be licensed |
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| by the Department, and every non-resident wholesale |
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| distributor must be licensed in this State if it ships |
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LRB095 10560 RAS 30780 b |
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| prescription drugs into this State, in accordance with this Act |
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| before engaging in wholesale distributions of wholesale |
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| prescription drugs. The Department shall exempt manufacturers |
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| distributing their own FDA-approved drugs and devices from the |
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| requirements of this Section, to the extent not required by |
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| federal law or regulation, unless particular requirements are |
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| deemed necessary and appropriate following rulemaking.
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| (b) The Department shall require all of the following |
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| information from each applicant for licensure under this Act: |
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| (1) The name, full business address, and telephone |
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| number of the licensee. |
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| (2) All trade or business names used by the licensee. |
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| (3) Addresses, telephone numbers, and the names of |
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| contact persons for all facilities used by the licensee for |
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| the storage, handling, and distribution of prescription |
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| drugs. |
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| (4) The type of ownership or operation, such as a |
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| partnership, corporation, or sole proprietorship. |
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| (5) The name of the owner or operator of the wholesale |
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| distributor, including: |
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| (A) if a person, the name of the person; |
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| (B) if a partnership, the name of each partner and |
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| the name of the partnership; |
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| (C) if a corporation, the name and title of each |
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| corporate officer and director, the corporate names, |
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| and the name of the state of incorporation; and |
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LRB095 10560 RAS 30780 b |
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| (D) if a sole proprietorship, the full name of the |
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| sole proprietor and the name of the business entity. |
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| (6) A list of all licenses and permits issued to the |
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| applicant by any other state that authorizes the applicant |
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| to purchase or possess prescription drugs. |
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| (7) The name of designated representative for the |
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| wholesale distributor, together with the personal |
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| information statement and fingerprints required of the |
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| person, as required under subsection (c) of this Section. |
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| (8) Any additional information required by the |
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| Department. |
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| (c) Each wholesale distributor must designate an |
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| individual representative who shall serve as the contact person |
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| for the Department. This representative must provide the |
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| Department with all of the following information: |
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| (1) The person's places of residence for the past 7 |
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| years. |
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| (2) The person's date and place of birth. |
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| (3) The person's occupations, positions of employment, |
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| and offices held during the past 7 years and the principal |
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| business and address of any business, corporation, or other |
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| organization in which each such office of the person was |
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| held or in which each such occupation or position of |
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| employment was carried on. |
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| (4) Information concerning whether the person has |
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| been, during the past 7 years, the subject of any |
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LRB095 10560 RAS 30780 b |
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| proceeding for the revocation of any license or any |
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| criminal violation and, if so, the nature of the proceeding |
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| and the disposition of the proceeding.
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| (5) Information concerning whether, during the past 7 |
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| years, the person has been enjoined, either temporarily or |
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| permanently, by a court of competent jurisdiction from |
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| violating any federal or State law regulating the |
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| possession, control, or distribution of prescription drugs |
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| or criminal violations, together with details concerning |
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| any such event. |
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| (6) A description of any involvement by the person with |
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| any business, including any investments, other than the |
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| ownership of stock in a publicly traded company or mutual |
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| fund, during the past 7 years, which manufactured, |
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| administered, prescribed, distributed, or stored |
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| pharmaceutical products and any lawsuits in which such |
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| businesses were named as a party. |
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| (7) A description of any felony criminal offense or |
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| offense involving moral turpitude or related to the |
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| qualifications, functions, or duties of that person in |
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| connection with the operation of the wholesale |
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| distributor, of which the person, as an adult, was found |
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| guilty, regardless of whether adjudication of guilt was |
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| withheld or whether the person pled guilty or nolo |
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| contendere. If the person indicates that a criminal |
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| conviction is under appeal and submits a copy of the notice |
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LRB095 10560 RAS 30780 b |
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| of appeal of that criminal offense, the applicant must, |
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| within 15 days after the disposition of the appeal, submit |
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| to the Department a copy of the final written order of |
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| disposition. |
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| (8) A photograph of the person taken within the |
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| previous year. |
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| The designated representative must also submit his or her |
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| fingerprints to the Department to be checked against the |
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| Department of State Police and Federal Bureau of Investigation |
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| criminal history record databases now and hereafter filed, in a |
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| manner prescribed by the Department and must receive and |
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| complete continuing training in applicable federal and State |
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| laws governing the wholesale distribution of prescription |
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| drugs. |
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| (d) Any information required to be submitted to the |
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| Department under this Section shall be provided under oath. |
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| (e) The Department may not issue a wholesale distributor |
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| license to an applicant, unless the Department first: |
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| (1) conducts a physical inspection of the wholesale |
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| distribution facility at the address provided by the |
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| applicant as required under item (1) of subsection (b) of |
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| this Section; and |
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| (2) determines that the designated representative |
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| meets each of the following qualifications: |
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| (A) He or she is at least 21 years of age. |
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| (B) He or she has been employed full-time for at |
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LRB095 10560 RAS 30780 b |
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| least 3 years in a pharmacy or with a wholesale |
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| distributor in a capacity related to the dispensing and |
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| distribution of, and recordkeeping relating to, |
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| prescription drugs. |
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| (C) He or she is employed by the applicant full |
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| time in a managerial level position. |
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| (D) He or she is actively involved in and aware of |
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| the actual daily operation of the wholesale |
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| distributor. |
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| (E) He or she is physically present at the facility |
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| of the applicant during regular business hours, except |
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| when the absence of the designated representative is |
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| authorized, including without limitation sick leave |
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| and vacation leave. |
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| (F) He or she is serving in the capacity of a |
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| designated representative for only one applicant at a |
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| time, except where more than one licensed wholesale |
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| distributor is co-located in the same facility and such |
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| wholesale distributors are members of an affiliated |
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| group, as defined in Section 1504 of the Internal |
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| Revenue Code. |
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| (G) He or she does not have any convictions under |
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| any federal, State, or local laws relating to wholesale |
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| or retail prescription drug distribution or |
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| distribution of controlled substances. |
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| (H) He or she does not have any felony convictions |
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LRB095 10560 RAS 30780 b |
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| under federal, State, or local laws. |
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| (h) If a wholesale distributor distributes prescription |
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| drugs from more than one facility, the wholesale distributor |
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| shall obtain a license for each facility. |
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| (i) The information provided under this Section may not be |
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| disclosed to any person or entity other than the Department or |
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| another government entity in need of such information for |
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| licensing or monitoring purposes.
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| Section 15. License renewal. In accordance with each |
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| license renewal, the Department shall send to each licensee a |
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| form setting forth the information that the licensee provided |
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| to the Department in the licensee's original application for |
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| licensure under Section 10 of this Act. Within 30 days after |
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| receiving the form, the wholesale distributor must identify and |
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| state under oath to the Department any and all changes or |
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| corrections to the information originally submitted to the |
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| Department. The Department may suspend or revoke the license of |
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| a licensee if the Department determines that the licensee no |
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| longer qualifies for the license originally issued under this |
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| Act. |
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| Section 20. Bond required. The Department shall require |
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| every wholesale distributor applying for a licensure under this |
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| Act to submit a bond of at least $100,000 or another equivalent |
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| means of security acceptable to the Department, such as an |
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LRB095 10560 RAS 30780 b |
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| irrevocable letter of credit or a deposit in a trust account or |
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| financial institution, payable to a fund established by the |
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| Department. Chain pharmacy warehouses that are engaged only in |
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| intracompany transfers are exempt from the bond requirement of |
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| this Section. The purpose of the bond is to secure payment of |
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| any fines or penalties imposed by the Department and any fees |
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| and costs incurred by the Department regarding that license, |
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| which are authorized under State law and which the licensee |
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| fails to pay 30 days after the fines, penalties, or costs |
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| become final. The Department may make a claim against the bond |
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| or security until one year after the licensee's license ceases |
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| to be valid. A single bond may suffice to cover all facilities |
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| operated by an applicant in this State. |
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| The Department shall establish a fund, separate from its |
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| other accounts, in which to deposit the wholesale distributor |
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| bonds required under this Section. |
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| Section 25. Restrictions on transactions.
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| (a) A licensee shall receive prescription drug returns or |
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| exchanges from a pharmacy or chain pharmacy warehouse pursuant |
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| to the terms and conditions of the agreement between the |
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| wholesale distributor and the pharmacy or chain pharmacy |
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| warehouse, including the returns of expired, damaged, and |
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| recalled pharmaceutical products to either the original |
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| manufacturer or a third party returns processor, and such |
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| returns or exchanges shall not be subject to the pedigree |
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LRB095 10560 RAS 30780 b |
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| requirements of Section 30 of this Act, so long as they are |
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| exempt from the pedigree requirement of the FDA's currently |
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| applicable Prescription Drug Marketing Act guidance. Both |
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| licensees under this Act and pharmacies shall be accountable |
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| for administering their returns process and ensuring that the |
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| aspects of this operation are secure and do not permit the |
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| entry of adulterated and counterfeit product. |
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| (b) A manufacturer or wholesale distributor licensed under |
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| this Act may furnish prescription drugs only to a person |
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| licensed by the appropriate state licensing authorities. |
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| Before furnishing prescription drugs to a person not known to |
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| the manufacturer or wholesale distributor, the manufacturer or |
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| wholesale distributor must affirmatively verify that the |
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| person is legally authorized to receive the prescription drugs |
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| by contacting the appropriate state licensing authorities. |
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| (c) Prescription drugs furnished by a manufacturer or |
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| wholesale distributor licensed under this Act may be delivered |
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| only to the premises listed on the license, provided that the |
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| manufacturer or wholesale distributor may furnish prescription |
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| drugs to an authorized person or agent of that person at the |
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| premises of the manufacturer or wholesale distributor if: |
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| (1) the identity and authorization of the recipient is |
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| properly established; and |
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| (2) this method of receipt is employed only to meet the |
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| immediate needs of a particular patient of the authorized |
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| person. |
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LRB095 10560 RAS 30780 b |
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| (d) Prescription drugs may be furnished to a hospital |
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| pharmacy receiving area, provided that a pharmacist or |
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| authorized receiving personnel signs, at the time of delivery, |
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| a receipt showing the type and quantity of the prescription |
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| drug received. Any discrepancy between the receipt and the type |
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| and quantity of the prescription drug actually received shall |
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| be reported to the delivering manufacturer or wholesale |
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| distributor by the next business day after the delivery to the |
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| pharmacy receiving area. |
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| (e) A manufacturer or wholesale distributor licensed under |
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| this Act may not accept payment for, or allow the use of, a |
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| person or entity's credit to establish an account for the |
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| purchase of prescription drugs from any person other than the |
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| owner of record, the chief executive officer, or the chief |
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| financial officer listed on the license of a person or entity |
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| legally authorized to receive the prescription drugs. Any |
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| account established for the purchase of prescription drugs must |
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| bear the name of the licensee.
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| Section 30. Pedigree. |
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| (a) Each person who is engaged in the wholesale |
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| distribution of prescription drugs, including repackagers, but |
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| excluding the original manufacturer of the finished form of the |
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| prescription drug, who leaves or has ever left the normal |
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| distribution channel shall, before each wholesale distribution |
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| of the drug, provide a pedigree to the person who receives the |
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LRB095 10560 RAS 30780 b |
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| drug. |
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| A retail pharmacy or chain pharmacy warehouse must comply |
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| with the requirements of this Section only if the pharmacy or |
4 |
| chain pharmacy warehouse engages in the wholesale distribution |
5 |
| of prescription drugs. |
6 |
| The State Board of Pharmacy shall determine by July 1, |
7 |
| 2009, a targeted implementation date for electronic track and |
8 |
| trace pedigree technology. This determination shall be based on |
9 |
| consultation with manufacturers, distributors, and pharmacies |
10 |
| responsible for the sale and distribution of prescription drug |
11 |
| products in this State. After consultation with interested |
12 |
| stakeholders and prior to the implementation of the electronic |
13 |
| pedigree, the State Board of Pharmacy shall deem that the |
14 |
| technology is universally available across the entire |
15 |
| prescription pharmaceutical supply chain. The implementation |
16 |
| date for the mandated electronic track and trace pedigree |
17 |
| technology shall be no sooner than July 1, 2010 and may be |
18 |
| extended by the State Board of Pharmacy in one year increments |
19 |
| if it appears that the technology is not universally available |
20 |
| across the entire prescription pharmaceutical supply chain. |
21 |
| (b) Each person who is engaged in the wholesale |
22 |
| distribution of a prescription drug, including repackagers, |
23 |
| but excluding the original manufacturer of the finished form of |
24 |
| the prescription drug, who is provided a pedigree for a |
25 |
| prescription drug and attempts to further distribute that |
26 |
| prescription drug, must affirmatively verify before any |
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LRB095 10560 RAS 30780 b |
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| distribution of a prescription drug occurs that each |
2 |
| transaction listed on the pedigree has occurred. |
3 |
| (c) The pedigree must include all necessary identifying |
4 |
| information concerning each sale in the chain of distribution |
5 |
| of the product from the manufacturer or the manufacturer's |
6 |
| third party logistics provider, co-licensed product partner, |
7 |
| or exclusive distributor through acquisition and sale by any |
8 |
| wholesale distributor or repackager, until final sale to a |
9 |
| pharmacy or other person dispensing or administering the drug. |
10 |
| This necessary chain of distribution information shall |
11 |
| include, without limitation each of all of the following: |
12 |
| (1) The name, address, telephone number and, if |
13 |
| available, the e-mail address, of each owner of the |
14 |
| prescription drug and each wholesale distributor of the |
15 |
| prescription drug. |
16 |
| (2) The name and address of each location from which |
17 |
| the product was shipped, if different from the owner's. |
18 |
| (3) Transaction dates. |
19 |
| (4) Certification that each recipient has |
20 |
| authenticated the pedigree. |
21 |
| (d) The pedigree must also include all of the following |
22 |
| information concerning the prescription drug:
|
23 |
| (1) The name of the prescription drug. |
24 |
| (2) The dosage form and strength of the prescription |
25 |
| drug. |
26 |
| (3) The size of the container. |
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LRB095 10560 RAS 30780 b |
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| (4) The number of containers.
|
2 |
| (5) The lot number and National Drug Code number of the |
3 |
| prescription drug. |
4 |
| (6) The name of the manufacturer of the finished dosage |
5 |
| form. |
6 |
| (e) Each pedigree or electronic file shall be maintained by |
7 |
| the purchaser and the wholesale distributor for 3 years from |
8 |
| the date of sale or transfer and made available for inspection |
9 |
| or use within 5 business days upon a request of the Department. |
10 |
| (f) The Department shall adopt rules and prescribe a form |
11 |
| relating to the requirements of this Section no later than 90 |
12 |
| days after the effective date of this Act.
|
13 |
| Section 35. Prohibited acts. It is unlawful for a person to |
14 |
| perform or cause the performance of or aid and abet any of the |
15 |
| following acts: |
16 |
| (1) Failure to obtain a license in accordance with this |
17 |
| Act or operating without a valid license when a license is |
18 |
| required by this Act. |
19 |
| (2) If the requirements of subsection (a) of Section 25 |
20 |
| are applicable and are not met, the purchasing or otherwise |
21 |
| receiving of a prescription drug from a pharmacy. |
22 |
| (3) If a licensure is required pursuant to subsection |
23 |
| (b) of Section 25 of this Act, the sale, distribution, or |
24 |
| transfer of a prescription drug to a person that is not |
25 |
| authorized under the law of the jurisdiction in which the |
|
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| person receives the prescription drug to receive the |
2 |
| prescription drug. |
3 |
| (4) Failure to deliver prescription drugs to specified |
4 |
| premises, as required by subsection (c) of Section 25 of |
5 |
| this Act. |
6 |
| (5) Accepting payment or credit for the sale of |
7 |
| prescription drugs in violation of subsection (e) of |
8 |
| Section of this Act. |
9 |
| (6) Failure to maintain or provide pedigrees as |
10 |
| required by this Act; |
11 |
| (7) Failure to obtain, pass, or authenticate a pedigree |
12 |
| as required by this Act. |
13 |
| (8) Providing the Department with false or fraudulent |
14 |
| records or making false or fraudulent statements regarding |
15 |
| any matter within the provisions of this Act. |
16 |
| (9) Obtaining or attempting to obtain a prescription |
17 |
| drug by fraud, deceit, or misrepresentation or engaging in |
18 |
| misrepresentation or fraud in the distribution of a |
19 |
| prescription drug. |
20 |
| (10) Except for the wholesale distribution by |
21 |
| manufacturers of a prescription drug that has been |
22 |
| delivered into commerce pursuant to an application |
23 |
| approved under federal law by the FDA, the manufacture, |
24 |
| repacking, sale, transfer, delivery, holding, or offering |
25 |
| for sale of any prescription drug that is adulterated, |
26 |
| misbranded, counterfeit, suspected of being counterfeit, |
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| or that has otherwise been rendered unfit for distribution. |
2 |
| (11) Except for the wholesale distribution by |
3 |
| manufacturers of a prescription drug that has been |
4 |
| delivered into commerce pursuant to an application |
5 |
| approved under federal law by the FDA, the adulteration, |
6 |
| misbranding, or counterfeiting of any prescription drug. |
7 |
| (12) The receipt of any prescription drug that is |
8 |
| adulterated, misbranded, stolen, obtained by fraud or |
9 |
| deceit, counterfeit, or suspected of being counterfeit and |
10 |
| the delivery or proffered delivery of such drug for pay or |
11 |
| otherwise. |
12 |
| (13) The alteration, mutilation, destruction, |
13 |
| obliteration, or removal of the whole or any part of the |
14 |
| labeling of a prescription drug or the commission of any |
15 |
| other act with respect to a prescription drug that results |
16 |
| in the prescription drug being misbranded. |
17 |
| The acts prohibited in this Section do not include the |
18 |
| obtaining or the attempt to obtain a prescription drug for the |
19 |
| sole purpose of testing the prescription drug for authenticity |
20 |
| performed by a prescription drug manufacturer or the agent of a |
21 |
| prescription drug manufacturer.
|
22 |
| Section 40. Enforcement; order to cease distribution of a |
23 |
| drug.
|
24 |
| (a) The Department shall issue an order requiring the |
25 |
| appropriate person, including the distributors or retailers of |
|
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| a drug, to immediately cease distribution of the drug within |
2 |
| this State, if the Department finds that there is a reasonable |
3 |
| probability that: |
4 |
| (1) a wholesale distributor, other than a |
5 |
| manufacturer, has (i) violated a provision in this Act or |
6 |
| (ii) falsified a pedigree or sold, distributed, |
7 |
| transferred, manufactured, repackaged, handled, or held a |
8 |
| counterfeit prescription drug intended for human use; |
9 |
| (2) the prescription drug at issue, as a result of a |
10 |
| violation in paragraph (1) of this subsection (a), could |
11 |
| cause serious, adverse health consequences or death; and |
12 |
| (3) other procedures would result in unreasonable |
13 |
| delay. |
14 |
| (b) An order issued under this Section shall provide the |
15 |
| person subject to the order with an opportunity for an informal |
16 |
| hearing, to be held not later than 10 days after the date of |
17 |
| the issuance of the order, on the actions required by the |
18 |
| order. If, after providing an opportunity for a hearing, the |
19 |
| Department determines that inadequate grounds exist to support |
20 |
| the actions required by the order, the Department shall vacate |
21 |
| the order. |
22 |
| Section 45. Penalties. |
23 |
| (a) Any person who engages in the wholesale distribution of |
24 |
| prescription drugs in violation of this Act may be fined not |
25 |
| more than $10,000. |
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| (b) Any person who knowingly engages in wholesale |
2 |
| distribution of prescription drugs in violation of this Act may |
3 |
| be imprisoned for any term of years, fined not more than |
4 |
| $500,000, or both. |
5 |
| Section 90. The Regulatory Sunset Act is amended by adding |
6 |
| Section 4.28 as follows: |
7 |
| (5 ILCS 80/4.28 new) |
8 |
| Sec. 4.28. Act repealed on January 1, 2018. The following |
9 |
| Act is repealed on January 1, 2018: |
10 |
| The Wholesale Licensure and Prescription Medication |
11 |
| Integrity Act. |
12 |
| Section 95. The Pharmacy Practice Act of 1987 is amended by |
13 |
| changing Section 10 as follows:
|
14 |
| (225 ILCS 85/10) (from Ch. 111, par. 4130)
|
15 |
| (Section scheduled to be repealed on January 1, 2008)
|
16 |
| Sec. 10. State Board of Pharmacy. There is created in the |
17 |
| Department the
State Board of Pharmacy.
It shall consist of 9 |
18 |
| members, 7 of whom shall be licensed pharmacists.
Each of those |
19 |
| 7 members must be a licensed pharmacist in good standing
in |
20 |
| this State, a graduate of an accredited college of pharmacy or |
21 |
| hold
a Bachelor of Science degree in Pharmacy and have at least |
22 |
| 5 years'
practical experience in the practice of pharmacy |
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| subsequent to the
date of his licensure as a licensed |
2 |
| pharmacist in the State of Illinois.
There shall be 2 public |
3 |
| members, who shall be voting members, who
shall not be licensed |
4 |
| pharmacists in this State or any other state.
|
5 |
| Each member shall be appointed by the Governor.
|
6 |
| The terms of all members serving as of March 31, 1999 shall |
7 |
| expire on that
date. The Governor shall appoint 3 persons to |
8 |
| serve one-year terms, 3 persons
to serve 3-year terms, and 3 |
9 |
| persons to serve 5-year terms to begin April 1,
1999. |
10 |
| Otherwise, members shall be appointed to 5 year terms. No |
11 |
| member shall
be eligible to serve more than 12 consecutive |
12 |
| years.
|
13 |
| In making the appointment of members on the Board, the |
14 |
| Governor shall
give due consideration to recommendations by the |
15 |
| members of the profession
of pharmacy and by pharmaceutical |
16 |
| organizations therein. The Governor
shall notify the |
17 |
| pharmaceutical organizations promptly of any vacancy
of |
18 |
| members on the Board and in appointing members shall give |
19 |
| consideration
to individuals engaged in all types and settings |
20 |
| of pharmacy practice.
|
21 |
| The Governor may remove any member of the Board for |
22 |
| misconduct, incapacity
or neglect of duty and he shall be the |
23 |
| sole judge of the sufficiency of the
cause for removal.
|
24 |
| Every person appointed a member of the Board shall take and |
25 |
| subscribe
the constitutional oath of office and file it with |
26 |
| the Secretary of
State. Each member of the Board shall be |
|
|
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SB0509 |
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| reimbursed for such actual
and legitimate expenses as he may |
2 |
| incur in going to and from the place
of meeting and remaining |
3 |
| thereat during sessions of the Board. In
addition, each member |
4 |
| of the Board shall receive a per diem payment
in an amount |
5 |
| determined from time to time by the Director for attendance
at |
6 |
| meetings of the Board and conducting other official business of
|
7 |
| the Board.
|
8 |
| The Board shall hold quarterly meetings and an annual |
9 |
| meeting in January
of each year and such other meetings at such |
10 |
| times and places and upon
such notice as the Board may |
11 |
| determine and as its business may require.
Five members of the |
12 |
| Board shall constitute a quorum for the transaction
of |
13 |
| business. The Director shall appoint a pharmacy coordinator, |
14 |
| who shall be
someone other than a member of the Board. The |
15 |
| pharmacy coordinator shall be a
registered pharmacist in good |
16 |
| standing in this State, shall be a graduate of
an accredited |
17 |
| college of pharmacy, or hold at a minimum a Bachelor of Science
|
18 |
| degree in Pharmacy and shall have at least 5 years' experience |
19 |
| in the practice
of pharmacy immediately prior to his |
20 |
| appointment. The pharmacy coordinator
shall be the executive |
21 |
| administrator and the chief enforcement officer of the
Pharmacy |
22 |
| Practice Act of 1987.
|
23 |
| The Board shall exercise the rights, powers and duties |
24 |
| which have been
vested in the Board under this Act, and any |
25 |
| other duties conferred
upon the Board by law , including those |
26 |
| set forth in Section 30 of the Wholesale Licensure and |
|
|
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LRB095 10560 RAS 30780 b |
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|
1 |
| Prescription Medication Integrity Act .
|
2 |
| The Director shall, in conformity with the Personnel Code, |
3 |
| employ not
less than 7 pharmacy investigators and 2 pharmacy |
4 |
| supervisors. Each pharmacy
investigator and each supervisor |
5 |
| shall be a registered pharmacist in good
standing in this |
6 |
| State, and shall be a graduate of an accredited college of
|
7 |
| pharmacy and have at least 5 years of experience in the |
8 |
| practice of pharmacy.
The Department shall also employ at least |
9 |
| one attorney who is a pharmacist
to prosecute violations of |
10 |
| this Act and its rules. The Department may, in
conformity with |
11 |
| the Personnel Code, employ such clerical and other employees
as |
12 |
| are necessary to carry out the duties of the Board.
|
13 |
| The duly authorized pharmacy investigators of the |
14 |
| Department shall have the
right to enter and inspect during |
15 |
| business hours any pharmacy or any other
place in the State of |
16 |
| Illinois holding itself out to be a pharmacy where
medicines or |
17 |
| drugs or drug products or proprietary medicines are sold, |
18 |
| offered
for sale, exposed for sale, or kept for sale. The |
19 |
| pharmacy investigators shall
be the only Department |
20 |
| investigators authorized to inspect, investigate, and
monitor |
21 |
| probation compliance of pharmacists, pharmacies, and
pharmacy |
22 |
| technicians.
|
23 |
| (Source: P.A. 91-827, eff. 6-13-00; 92-651, eff. 7-11-02; |
24 |
| 92-880, eff. 1-1-04.)
|
25 |
| Section 99. Effective date. This Act takes effect upon |
26 |
| becoming law.
|