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Sen. Terry Link
Filed: 3/22/2007
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LRB095 10560 RAS 34198 a |
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| AMENDMENT TO SENATE BILL 509
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| AMENDMENT NO. ______. Amend Senate Bill 509, AS AMENDED, by |
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| replacing everything after the enacting clause with the |
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| following:
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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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| than a monthly basis. |
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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. Notwithstanding any other provision of this Act, a |
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| chain pharmacy warehouse shall be considered part of the normal |
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| distribution channel. |
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| "Co-licensed partner or product" means an instance where 2 |
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| or more parties have the right to engage in the manufacturing |
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| or marketing of a prescription drug, consistent with the FDA's |
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| implementation of the Prescription Drug Marketing Act. |
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| "Department" means the Department of Financial and |
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| Professional Regulation. |
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| "Drop shipment" means the sale of a prescription drug to a |
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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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| "Facility" means a facility of a wholesale distributor |
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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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| FDA to engage in the manufacture of drugs or devices, |
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| consistent with the definition of "manufacturer" set forth in |
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| the FDA's regulations and guidances implementing the |
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| Prescription Drug Marketing Act. |
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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, directly or by drop shipment, |
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| from (i) a manufacturer of the prescription drug, (ii) that |
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| manufacturer to that manufacturer's co-licensed partner, (iii) |
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| that manufacturer to that manufacturer's third-party logistics |
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| provider, or (iv) that manufacturer to that manufacturer's |
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| exclusive distributor to: |
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| (1) a pharmacy or to other designated persons |
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| authorized by law to dispense or administer the drug to a |
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| patient; |
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| (2) a wholesale distributor to a pharmacy or other |
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| designated persons authorized by law to dispense or |
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| administer the 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 the drug; or |
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| (4) a chain pharmacy warehouse to the chain pharmacy |
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| warehouse's intracompany pharmacy or other designated |
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| persons authorized by law to dispense or administer the |
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| drug.
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| "Pedigree" means a document or electronic file containing |
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| information that records each wholesale distribution of any |
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| given 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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| "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 the distribution of |
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| prescription drugs to persons other than a consumer or patient, |
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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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| (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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| prescription drugs into this State, in accordance with this |
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| Act, 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 without limitation all of |
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| the following information from each applicant for licensure |
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| 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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| (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 the designated representative for the |
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| wholesale distributor, together with the personal |
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| information statement and fingerprints, as required under |
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| 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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| 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 misdemeanor or felony criminal |
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| offense of which the person, as an adult, was found guilty, |
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| regardless of whether adjudication of guilt was withheld or |
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| whether the person pled guilty or nolo contendere. If the |
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| person indicates that a criminal conviction is under appeal |
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| and submits a copy of the notice of appeal of that criminal |
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| offense, the applicant must, within 15 days after the |
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| disposition of the appeal, submit to the Department a copy |
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| of the final written order of disposition. |
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| (8) A photograph of the person taken within the |
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| previous 180 days. |
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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 subsections (b) and (c) of this Section shall |
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| 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 facility at |
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| the address provided by the applicant as required under |
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| item (1) of subsection (b) of 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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| 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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| under federal, State, or local laws. |
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| (f) 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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| (g) 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 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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| 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 not engaged in |
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| wholesale distribution 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. Returns of expired, damaged, recalled, or otherwise |
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| non-saleable pharmaceutical products shall be distributed by |
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| the receiving wholesale distributor only to either the original |
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| manufacturer or a third party returns processor, and such |
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| returns or exchanges, including any redistribution by a |
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| receiving wholesaler, shall not be subject to the pedigree |
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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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| (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.
This subsection (e) shall not be |
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| construed to prohibit a pharmacy or chain pharmacy warehouse |
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| from receiving prescription drugs if payment for the |
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| prescription drugs is processed through the pharmacy's or chain |
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| pharmacy warehouse's contractual drug manufacturer or |
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| wholesale distributor. |
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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, that leave or have 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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| 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 |
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| chain pharmacy warehouse engages in the wholesale distribution |
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| of prescription drugs. |
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| The State Board of Pharmacy shall determine by July 1, |
22 |
| 2009, a targeted implementation date for electronic track and |
23 |
| trace technology. This determination shall be based on |
24 |
| consultation with manufacturers, distributors, and pharmacies |
25 |
| responsible for the sale and distribution of prescription drug |
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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1 |
| products in this State. After consultation with interested |
2 |
| stakeholders and prior to the implementation of the track and |
3 |
| trace technology, the State Board of Pharmacy shall deem that |
4 |
| the technology is universally available across the entire |
5 |
| prescription pharmaceutical supply chain. The implementation |
6 |
| date for the mandated electronic track and trace technology |
7 |
| shall be no sooner than July 1, 2010 and may be extended by the |
8 |
| State Board of Pharmacy in one year increments if it appears |
9 |
| that the technology is not universally available across the |
10 |
| entire prescription pharmaceutical supply chain. |
11 |
| (b) Each person who is engaged in the wholesale |
12 |
| distribution of a prescription drug, including repackagers, |
13 |
| but excluding the original manufacturer of the finished form of |
14 |
| the prescription drug, who is provided a pedigree for a |
15 |
| prescription drug and attempts to further distribute that |
16 |
| prescription drug, must affirmatively verify before any |
17 |
| distribution of a prescription drug occurs that each |
18 |
| transaction listed on the pedigree has occurred. |
19 |
| (c) The pedigree must include all necessary identifying |
20 |
| information concerning each sale in the chain of distribution |
21 |
| of the product from the manufacturer or the manufacturer's |
22 |
| third party logistics provider, co-licensed product partner, |
23 |
| or exclusive distributor through acquisition and sale by any |
24 |
| wholesale distributor or repackager, until final sale to a |
25 |
| pharmacy or other person dispensing or administering the drug. |
26 |
| This necessary chain of distribution information shall |
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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1 |
| include, without limitation all of the following: |
2 |
| (1) The name, address, telephone number and, if |
3 |
| available, the e-mail address of each owner of the |
4 |
| prescription drug and each wholesale distributor of the |
5 |
| prescription drug. |
6 |
| (2) The name and address of each location from which |
7 |
| the product was shipped, if different from the owner's. |
8 |
| (3) Transaction dates. |
9 |
| (4) Certification that each recipient has |
10 |
| authenticated the pedigree. |
11 |
| (d) The pedigree must also include without limitation all |
12 |
| of the following information concerning the prescription drug:
|
13 |
| (1) The name and national drug code number of the |
14 |
| prescription drug. |
15 |
| (2) The dosage form and strength of the prescription |
16 |
| drug. |
17 |
| (3) The size of the container. |
18 |
| (4) The number of containers.
|
19 |
| (5) The lot number of the prescription drug. |
20 |
| (6) The name of the manufacturer of the finished dosage |
21 |
| form. |
22 |
| (e) Each pedigree or electronic file shall be maintained by |
23 |
| the purchaser and the wholesale distributor for at least 3 |
24 |
| years from the date of sale or transfer and made available for |
25 |
| inspection or use within 5 business days upon a request of the |
26 |
| Department. |
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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| (f) The Department shall adopt rules and prescribe a form |
2 |
| relating to the requirements of this Section no later than 90 |
3 |
| days after the effective date of this Act.
|
4 |
| Section 35. Prohibited acts. It is unlawful for a person to |
5 |
| perform or cause the performance of or aid and abet any of the |
6 |
| following acts: |
7 |
| (1) Failure to obtain a license in accordance with this |
8 |
| Act or operating without a valid license when a license is |
9 |
| required by this Act. |
10 |
| (2) If the requirements of subsection (a) of Section 25 |
11 |
| are applicable and are not met, the purchasing or otherwise |
12 |
| receiving of a prescription drug from a pharmacy. |
13 |
| (3) If licensure is required pursuant to subsection (b) |
14 |
| of Section 25 of this Act, the sale, distribution, or |
15 |
| transfer of a prescription drug to a person that is not |
16 |
| authorized under the law of the jurisdiction in which the |
17 |
| person receives the prescription drug to receive the |
18 |
| prescription drug. |
19 |
| (4) Failure to deliver prescription drugs to specified |
20 |
| premises, as required by subsection (c) of Section 25 of |
21 |
| this Act. |
22 |
| (5) Accepting payment or credit for the sale of |
23 |
| prescription drugs in violation of subsection (e) of |
24 |
| Section 25 of this Act. |
25 |
| (6) Failure to maintain or provide pedigrees as |
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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| required by this Act; |
2 |
| (7) Failure to obtain, pass, or authenticate a pedigree |
3 |
| as required by this Act. |
4 |
| (8) Providing the Department or any federal official |
5 |
| with false or fraudulent records or making false or |
6 |
| fraudulent statements regarding any matter within the |
7 |
| provisions of this Act. |
8 |
| (9) Obtaining or attempting to obtain a prescription |
9 |
| drug by fraud, deceit, or misrepresentation or engaging in |
10 |
| misrepresentation or fraud in the distribution of a |
11 |
| prescription drug. |
12 |
| (10) The manufacture, repacking, sale, transfer, |
13 |
| delivery, holding, or offering for sale of any prescription |
14 |
| drug that is adulterated, misbranded, counterfeit, |
15 |
| suspected of being counterfeit, or that has otherwise been |
16 |
| rendered unfit for distribution. |
17 |
| (11) The adulteration, misbranding, or counterfeiting |
18 |
| of any prescription drug. |
19 |
| (12) The receipt of any prescription drug that is |
20 |
| adulterated, misbranded, stolen, obtained by fraud or |
21 |
| deceit, counterfeit, or suspected of being counterfeit and |
22 |
| the delivery or proffered delivery of such drug for pay or |
23 |
| otherwise. |
24 |
| (13) The alteration, mutilation, destruction, |
25 |
| obliteration, or removal of the whole or any part of the |
26 |
| labeling of a prescription drug or the commission of any |
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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|
1 |
| other act with respect to a prescription drug that results |
2 |
| in the prescription drug being misbranded. |
3 |
| The acts prohibited in this Section do not include the |
4 |
| obtaining or the attempt to obtain a prescription drug for the |
5 |
| sole purpose of testing the prescription drug for authenticity |
6 |
| performed by a prescription drug manufacturer or the agent of a |
7 |
| prescription drug manufacturer.
|
8 |
| Section 40. Enforcement; order to cease distribution of a |
9 |
| drug.
|
10 |
| (a) The Department shall issue an order requiring the |
11 |
| appropriate person, including the distributors or retailers of |
12 |
| a drug, to immediately cease distribution of the drug within |
13 |
| this State, if the Department finds that there is a reasonable |
14 |
| probability that: |
15 |
| (1) a wholesale distributor has (i) violated a |
16 |
| provision in this Act or (ii) falsified a pedigree or sold, |
17 |
| distributed, transferred, manufactured, repackaged, |
18 |
| handled, or held a counterfeit prescription drug intended |
19 |
| for human use; |
20 |
| (2) the prescription drug at issue, as a result of a |
21 |
| violation in paragraph (1) of this subsection (a), could |
22 |
| cause serious, adverse health consequences or death; and |
23 |
| (3) other procedures would result in unreasonable |
24 |
| delay. |
25 |
| (b) An order issued under this Section shall provide the |
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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| person subject to the order with an opportunity for an informal |
2 |
| hearing, to be held not later than 10 days after the date of |
3 |
| the issuance of the order, on the actions required by the |
4 |
| order. If, after providing an opportunity for a hearing, the |
5 |
| Department determines that inadequate grounds exist to support |
6 |
| the actions required by the order, the Department shall vacate |
7 |
| the order. |
8 |
| Section 45. Penalties. |
9 |
| (a) Any person who engages in the wholesale distribution of |
10 |
| prescription drugs in violation of this Act may be fined not |
11 |
| more than $10,000. |
12 |
| (b) Any person who engages in the wholesale distribution of |
13 |
| prescription drugs in violation of this Act and does so in a |
14 |
| grossly negligent manner may be imprisoned for not more than 15 |
15 |
| years, fined not more than $50,000, or both. |
16 |
| (c) Any person who knowingly engages in the wholesale |
17 |
| distribution of prescription drugs in violation of this Act may |
18 |
| be imprisoned for any term of years, fined not more than |
19 |
| $500,000, or both. |
20 |
| Section 90. The Regulatory Sunset Act is amended by adding |
21 |
| Section 4.28 as follows: |
22 |
| (5 ILCS 80/4.28 new) |
23 |
| Sec. 4.28. Act repealed on January 1, 2018. The following |
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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|
1 |
| Act is repealed on January 1, 2018: |
2 |
| The Wholesale Licensure and Prescription Medication |
3 |
| Integrity Act. |
4 |
| Section 95. The Pharmacy Practice Act of 1987 is amended by |
5 |
| changing Section 10 as follows:
|
6 |
| (225 ILCS 85/10) (from Ch. 111, par. 4130)
|
7 |
| (Section scheduled to be repealed on January 1, 2008)
|
8 |
| Sec. 10. State Board of Pharmacy. There is created in the |
9 |
| Department the
State Board of Pharmacy.
It shall consist of 9 |
10 |
| members, 7 of whom shall be licensed pharmacists.
Each of those |
11 |
| 7 members must be a licensed pharmacist in good standing
in |
12 |
| this State, a graduate of an accredited college of pharmacy or |
13 |
| hold
a Bachelor of Science degree in Pharmacy and have at least |
14 |
| 5 years'
practical experience in the practice of pharmacy |
15 |
| subsequent to the
date of his licensure as a licensed |
16 |
| pharmacist in the State of Illinois.
There shall be 2 public |
17 |
| members, who shall be voting members, who
shall not be licensed |
18 |
| pharmacists in this State or any other state.
|
19 |
| Each member shall be appointed by the Governor.
|
20 |
| The terms of all members serving as of March 31, 1999 shall |
21 |
| expire on that
date. The Governor shall appoint 3 persons to |
22 |
| serve one-year terms, 3 persons
to serve 3-year terms, and 3 |
23 |
| persons to serve 5-year terms to begin April 1,
1999. |
24 |
| Otherwise, members shall be appointed to 5 year terms. No |
|
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|
09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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|
1 |
| member shall
be eligible to serve more than 12 consecutive |
2 |
| years.
|
3 |
| In making the appointment of members on the Board, the |
4 |
| Governor shall
give due consideration to recommendations by the |
5 |
| members of the profession
of pharmacy and by pharmaceutical |
6 |
| organizations therein. The Governor
shall notify the |
7 |
| pharmaceutical organizations promptly of any vacancy
of |
8 |
| members on the Board and in appointing members shall give |
9 |
| consideration
to individuals engaged in all types and settings |
10 |
| of pharmacy practice.
|
11 |
| The Governor may remove any member of the Board for |
12 |
| misconduct, incapacity
or neglect of duty and he shall be the |
13 |
| sole judge of the sufficiency of the
cause for removal.
|
14 |
| Every person appointed a member of the Board shall take and |
15 |
| subscribe
the constitutional oath of office and file it with |
16 |
| the Secretary of
State. Each member of the Board shall be |
17 |
| reimbursed for such actual
and legitimate expenses as he may |
18 |
| incur in going to and from the place
of meeting and remaining |
19 |
| thereat during sessions of the Board. In
addition, each member |
20 |
| of the Board shall receive a per diem payment
in an amount |
21 |
| determined from time to time by the Director for attendance
at |
22 |
| meetings of the Board and conducting other official business of
|
23 |
| the Board.
|
24 |
| The Board shall hold quarterly meetings and an annual |
25 |
| meeting in January
of each year and such other meetings at such |
26 |
| times and places and upon
such notice as the Board may |
|
|
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09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
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|
1 |
| determine and as its business may require.
Five members of the |
2 |
| Board shall constitute a quorum for the transaction
of |
3 |
| business. The Director shall appoint a pharmacy coordinator, |
4 |
| who shall be
someone other than a member of the Board. The |
5 |
| pharmacy coordinator shall be a
registered pharmacist in good |
6 |
| standing in this State, shall be a graduate of
an accredited |
7 |
| college of pharmacy, or hold at a minimum a Bachelor of Science
|
8 |
| degree in Pharmacy and shall have at least 5 years' experience |
9 |
| in the practice
of pharmacy immediately prior to his |
10 |
| appointment. The pharmacy coordinator
shall be the executive |
11 |
| administrator and the chief enforcement officer of the
Pharmacy |
12 |
| Practice Act of 1987.
|
13 |
| The Board shall exercise the rights, powers and duties |
14 |
| which have been
vested in the Board under this Act, and any |
15 |
| other duties conferred
upon the Board by law , including those |
16 |
| set forth in Section 30 of the Wholesale Licensure and |
17 |
| Prescription Medication Integrity Act .
|
18 |
| The Director shall, in conformity with the Personnel Code, |
19 |
| employ not
less than 7 pharmacy investigators and 2 pharmacy |
20 |
| supervisors. Each pharmacy
investigator and each supervisor |
21 |
| shall be a registered pharmacist in good
standing in this |
22 |
| State, and shall be a graduate of an accredited college of
|
23 |
| pharmacy and have at least 5 years of experience in the |
24 |
| practice of pharmacy.
The Department shall also employ at least |
25 |
| one attorney who is a pharmacist
to prosecute violations of |
26 |
| this Act and its rules. The Department may, in
conformity with |
|
|
|
09500SB0509sam002 |
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LRB095 10560 RAS 34198 a |
|
|
1 |
| the Personnel Code, employ such clerical and other employees
as |
2 |
| are necessary to carry out the duties of the Board.
|
3 |
| The duly authorized pharmacy investigators of the |
4 |
| Department shall have the
right to enter and inspect during |
5 |
| business hours any pharmacy or any other
place in the State of |
6 |
| Illinois holding itself out to be a pharmacy where
medicines or |
7 |
| drugs or drug products or proprietary medicines are sold, |
8 |
| offered
for sale, exposed for sale, or kept for sale. The |
9 |
| pharmacy investigators shall
be the only Department |
10 |
| investigators authorized to inspect, investigate, and
monitor |
11 |
| probation compliance of pharmacists, pharmacies, and
pharmacy |
12 |
| technicians.
|
13 |
| (Source: P.A. 91-827, eff. 6-13-00; 92-651, eff. 7-11-02; |
14 |
| 92-880, eff. 1-1-04.)
|
15 |
| Section 99. Effective date. This Act takes effect upon |
16 |
| becoming law.".
|