Full Text of SB0509 95th General Assembly
SB0509sam002 95TH GENERAL ASSEMBLY
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Sen. Terry Link
Filed: 3/22/2007
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| AMENDMENT TO SENATE BILL 509
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| AMENDMENT NO. ______. Amend Senate Bill 509, AS AMENDED, by | 3 |
| replacing everything after the enacting clause with the | 4 |
| following:
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| "Section 1. Short title. This Act may be cited as the | 6 |
| Wholesale Licensure and Prescription Medication Integrity Act. | 7 |
| Section 5. Definitions.
In this Act: | 8 |
| "Authentication" means to affirmatively verify, before any | 9 |
| wholesale distribution of a prescription drug occurs, that each | 10 |
| transaction listed on the pedigree has occurred. | 11 |
| "Authorized distributor of record" means a wholesale | 12 |
| distributor with whom a manufacturer has established an ongoing | 13 |
| relationship to distribute the manufacturer's prescription | 14 |
| drug. An ongoing relationship is deemed to exist between a | 15 |
| wholesale distributor and a manufacturer when the wholesale | 16 |
| distributor, including any affiliated group of the wholesale |
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| distributor, as defined in Section 1504 of the Internal Revenue | 2 |
| Code, complies with either of the following: | 3 |
| (1) the wholesale distributor has a written agreement | 4 |
| currently in effect with the manufacturer evidencing the | 5 |
| ongoing relationship; or | 6 |
| (2) the wholesale distributor is listed on the | 7 |
| manufacturer's current list of authorized distributors of | 8 |
| record, which is updated by the manufacturer on no less | 9 |
| than a monthly basis. | 10 |
| "Chain pharmacy warehouse" means a physical location for | 11 |
| prescription drugs that acts as a central warehouse and | 12 |
| performs intracompany sales or transfers of the drugs to a | 13 |
| group of chain pharmacies that have the same common ownership | 14 |
| and control. Notwithstanding any other provision of this Act, a | 15 |
| chain pharmacy warehouse shall be considered part of the normal | 16 |
| distribution channel. | 17 |
| "Co-licensed partner or product" means an instance where 2 | 18 |
| or more parties have the right to engage in the manufacturing | 19 |
| or marketing of a prescription drug, consistent with the FDA's | 20 |
| implementation of the Prescription Drug Marketing Act. | 21 |
| "Department" means the Department of Financial and | 22 |
| Professional Regulation. | 23 |
| "Drop shipment" means the sale of a prescription drug to a | 24 |
| wholesale distributor by the manufacturer of the prescription | 25 |
| drug, or that manufacturer's co-licensed product partner, that | 26 |
| manufacturer's third party logistics provider, or that |
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| manufacturer's exclusive distributor, whereby the wholesale | 2 |
| distributor or chain pharmacy warehouse takes title but not | 3 |
| physical possession of such prescription drug and the wholesale | 4 |
| distributor invoices the pharmacy, chain pharmacy warehouse, | 5 |
| or other person authorized by law to dispense or administer | 6 |
| such drug to a patient and the pharmacy, chain pharmacy | 7 |
| warehouse or other authorized person receives delivery of the | 8 |
| prescription drug directly from the manufacturer, that | 9 |
| manufacturer's third party logistics provider, or that | 10 |
| manufacturer's exclusive distributor. | 11 |
| "Facility" means a facility of a wholesale distributor | 12 |
| where prescription drugs are stored, handled, repackaged, or | 13 |
| offered for sale.
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| "FDA" means the United States Food and Drug Administration. | 15 |
| "Manufacturer" means a person licensed or approved by the | 16 |
| FDA to engage in the manufacture of drugs or devices, | 17 |
| consistent with the definition of "manufacturer" set forth in | 18 |
| the FDA's regulations and guidances implementing the | 19 |
| Prescription Drug Marketing Act. | 20 |
| "Manufacturer's exclusive distributor" means anyone who | 21 |
| contracts with a manufacturer to provide or coordinate | 22 |
| warehousing, distribution, or other services on behalf of a | 23 |
| manufacturer and who takes title to that manufacturer's | 24 |
| prescription drug, but who does not have general responsibility | 25 |
| to direct the sale or disposition of the manufacturer's | 26 |
| prescription drug. A manufacturer's exclusive distributor must |
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| be licensed as a wholesale distributor under this Act and, in | 2 |
| order to be considered part of the normal distribution channel, | 3 |
| must also be an authorized distributor of record. | 4 |
| "Normal distribution channel" means a chain of custody for | 5 |
| a prescription drug that goes, directly or by drop shipment, | 6 |
| from (i) a manufacturer of the prescription drug, (ii) that | 7 |
| manufacturer to that manufacturer's co-licensed partner, (iii) | 8 |
| that manufacturer to that manufacturer's third-party logistics | 9 |
| provider, or (iv) that manufacturer to that manufacturer's | 10 |
| exclusive distributor to: | 11 |
| (1) a pharmacy or to other designated persons | 12 |
| authorized by law to dispense or administer the drug to a | 13 |
| patient; | 14 |
| (2) a wholesale distributor to a pharmacy or other | 15 |
| designated persons authorized by law to dispense or | 16 |
| administer the drug to a patient; | 17 |
| (3) a wholesale distributor to a chain pharmacy | 18 |
| warehouse to that chain pharmacy warehouse's intracompany | 19 |
| pharmacy to a patient or other designated persons | 20 |
| authorized by law to dispense or administer the drug; or | 21 |
| (4) a chain pharmacy warehouse to the chain pharmacy | 22 |
| warehouse's intracompany pharmacy or other designated | 23 |
| persons authorized by law to dispense or administer the | 24 |
| drug.
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| "Pedigree" means a document or electronic file containing | 26 |
| 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 | 3 |
| biological product (except for blood and blood components | 4 |
| intended for transfusion or biological products that are also | 5 |
| medical devices), required by federal law or regulation to be | 6 |
| dispensed only by a prescription, including finished dosage | 7 |
| forms and bulk drug substances subject to Section 503(b) of the | 8 |
| federal Food, Drug and Cosmetic Act. | 9 |
| "Repackage" means repackaging or otherwise changing the | 10 |
| container, wrapper, or labeling to further the distribution of | 11 |
| a prescription drug, excluding that completed by the pharmacist | 12 |
| responsible for dispensing product to a patient. | 13 |
| "Third party logistics provider" means anyone who | 14 |
| contracts with a prescription drug manufacturer to provide or | 15 |
| coordinate warehousing, distribution, or other services on | 16 |
| behalf of a manufacturer, but does not take title to the | 17 |
| prescription drug or have general responsibility to direct the | 18 |
| prescription drug's sale or disposition. A third party | 19 |
| logistics provider must be licensed as a wholesale distributor | 20 |
| under this Act and, in order to be considered part of the | 21 |
| normal distribution channel, must also be an authorized | 22 |
| distributor of record. | 23 |
| "Wholesale distributor" means anyone engaged in the | 24 |
| wholesale distribution of prescription drugs, including | 25 |
| without limitation manufacturers; repackagers; own-label | 26 |
| distributors; private-label distributors; jobbers; brokers; |
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| warehouses, including manufacturers' and distributors' | 2 |
| warehouses; manufacturer's exclusive distributors; and | 3 |
| authorized distributors of record; drug wholesalers or | 4 |
| distributors; independent wholesale drug traders; specialty | 5 |
| wholesale distributors; third party logistics providers; and | 6 |
| retail pharmacies that conduct wholesale distribution; and | 7 |
| chain pharmacy warehouses that conduct wholesale distribution. | 8 |
| In order to be considered part of the normal distribution | 9 |
| channel, a wholesale distributor must also be an authorized | 10 |
| distributor of record. | 11 |
| "Wholesale distribution" means the distribution of | 12 |
| prescription drugs to persons other than a consumer or patient, | 13 |
| but does not include any of the following: | 14 |
| (1) Intracompany sales of prescription drugs, meaning | 15 |
| (i) any transaction or transfer between any division, | 16 |
| subsidiary, parent or affiliated or related company under | 17 |
| common ownership and control of a corporate entity or (ii) | 18 |
| any transaction or transfer between co-licensees of a | 19 |
| co-licensed product. | 20 |
| (2) The sale, purchase, distribution, trade, or | 21 |
| transfer of a prescription drug or offer to sell, purchase, | 22 |
| distribute, trade, or transfer a prescription drug for | 23 |
| emergency medical reasons. | 24 |
| (3) The distribution of prescription drug samples by | 25 |
| manufacturers' representatives. | 26 |
| (4) Drug returns, when conducted by a hospital, health |
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| care entity, or charitable institution in accordance with | 2 |
| federal regulation. | 3 |
| (5) The sale of minimal quantities of prescription | 4 |
| drugs by retail pharmacies to licensed practitioners for | 5 |
| office use. | 6 |
| (6) The sale, purchase, or trade of a drug, an offer to | 7 |
| sell, purchase, or trade a drug, or the dispensing of a | 8 |
| drug pursuant to a prescription. | 9 |
| (7) The sale, transfer, merger, or consolidation of all | 10 |
| or part of the business of a pharmacy or pharmacies from or | 11 |
| with another pharmacy or pharmacies, whether accomplished | 12 |
| as a purchase and sale of stock or business assets. | 13 |
| (8) The sale, purchase, distribution, trade, or | 14 |
| transfer of a prescription drug from one authorized | 15 |
| distributor of record to one additional authorized | 16 |
| distributor of record when the manufacturer has stated in | 17 |
| writing to the receiving authorized distributor of record | 18 |
| that the manufacturer is unable to supply the prescription | 19 |
| drug and the supplying authorized distributor of record | 20 |
| states in writing that the prescription drug being supplied | 21 |
| had until that time been exclusively in the normal | 22 |
| distribution channel. | 23 |
| (9) The delivery of or the offer to deliver a | 24 |
| prescription drug by a common carrier solely in the common | 25 |
| carrier's usual course of business of transporting | 26 |
| prescription drugs when the common carrier does not store, |
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| warehouse, or take legal ownership of the prescription | 2 |
| drug. | 3 |
| (10) The sale or transfer from a retail pharmacy or | 4 |
| chain pharmacy warehouse of expired, damaged, returned, or | 5 |
| recalled prescription drugs to the original manufacturer | 6 |
| or to a third party returns processor. | 7 |
| Section 10. Licensure required. | 8 |
| (a) Every resident wholesale distributor who engages in the | 9 |
| wholesale distribution of prescription drugs must be licensed | 10 |
| by the Department, and every non-resident wholesale | 11 |
| distributor must be licensed in this State if it ships | 12 |
| prescription drugs into this State, in accordance with this | 13 |
| Act, before engaging in wholesale distributions of wholesale | 14 |
| prescription drugs. The Department shall exempt manufacturers | 15 |
| distributing their own FDA-approved drugs and devices from the | 16 |
| requirements of this Section, to the extent not required by | 17 |
| federal law or regulation, unless particular requirements are | 18 |
| deemed necessary and appropriate following rulemaking.
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| (b) The Department shall require without limitation all of | 20 |
| the following information from each applicant for licensure | 21 |
| under this Act: | 22 |
| (1) The name, full business address, and telephone | 23 |
| number of the licensee. | 24 |
| (2) All trade or business names used by the licensee. | 25 |
| (3) Addresses, telephone numbers, and the names of |
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| contact persons for all facilities used by the licensee for | 2 |
| the storage, handling, and distribution of prescription | 3 |
| drugs. | 4 |
| (4) The type of ownership or operation, such as a | 5 |
| partnership, corporation, or sole proprietorship. | 6 |
| (5) The name of the owner or operator of the wholesale | 7 |
| distributor, including: | 8 |
| (A) if a person, the name of the person; | 9 |
| (B) if a partnership, the name of each partner and | 10 |
| the name of the partnership; | 11 |
| (C) if a corporation, the name and title of each | 12 |
| corporate officer and director, the corporate names, | 13 |
| and the name of the state of incorporation; and | 14 |
| (D) if a sole proprietorship, the full name of the | 15 |
| sole proprietor and the name of the business entity. | 16 |
| (6) A list of all licenses and permits issued to the | 17 |
| applicant by any other state that authorizes the applicant | 18 |
| to purchase or possess prescription drugs. | 19 |
| (7) The name of the designated representative for the | 20 |
| wholesale distributor, together with the personal | 21 |
| information statement and fingerprints, as required under | 22 |
| subsection (c) of this Section. | 23 |
| (8) Any additional information required by the | 24 |
| Department. | 25 |
| (c) Each wholesale distributor must designate an | 26 |
| individual representative who shall serve as the contact person |
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| for the Department. This representative must provide the | 2 |
| Department with all of the following information: | 3 |
| (1) The person's places of residence for the past 7 | 4 |
| years. | 5 |
| (2) The person's date and place of birth. | 6 |
| (3) The person's occupations, positions of employment, | 7 |
| and offices held during the past 7 years and the principal | 8 |
| business and address of any business, corporation, or other | 9 |
| organization in which each such office of the person was | 10 |
| held or in which each such occupation or position of | 11 |
| employment was carried on. | 12 |
| (4) Information concerning whether the person has | 13 |
| been, during the past 7 years, the subject of any | 14 |
| proceeding for the revocation of any license or any | 15 |
| criminal violation and, if so, the nature of the proceeding | 16 |
| and the disposition of the proceeding.
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| (5) Information concerning whether, during the past 7 | 18 |
| years, the person has been enjoined, either temporarily or | 19 |
| permanently, by a court of competent jurisdiction from | 20 |
| violating any federal or State law regulating the | 21 |
| possession, control, or distribution of prescription drugs | 22 |
| or criminal violations, together with details concerning | 23 |
| any such event. | 24 |
| (6) A description of any involvement by the person with | 25 |
| any business, including any investments, other than the | 26 |
| ownership of stock in a publicly traded company or mutual |
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| fund, during the past 7 years, which manufactured, | 2 |
| administered, prescribed, distributed, or stored | 3 |
| pharmaceutical products and any lawsuits in which such | 4 |
| businesses were named as a party. | 5 |
| (7) A description of any misdemeanor or felony criminal | 6 |
| offense of which the person, as an adult, was found guilty, | 7 |
| regardless of whether adjudication of guilt was withheld or | 8 |
| whether the person pled guilty or nolo contendere. If the | 9 |
| person indicates that a criminal conviction is under appeal | 10 |
| and submits a copy of the notice of appeal of that criminal | 11 |
| offense, the applicant must, within 15 days after the | 12 |
| disposition of the appeal, submit to the Department a copy | 13 |
| of the final written order of disposition. | 14 |
| (8) A photograph of the person taken within the | 15 |
| previous 180 days. | 16 |
| The designated representative must also submit his or her | 17 |
| fingerprints to the Department to be checked against the | 18 |
| Department of State Police and Federal Bureau of Investigation | 19 |
| criminal history record databases now and hereafter filed, in a | 20 |
| manner prescribed by the Department and must receive and | 21 |
| complete continuing training in applicable federal and State | 22 |
| laws governing the wholesale distribution of prescription | 23 |
| drugs. | 24 |
| (d) Any information required to be submitted to the | 25 |
| Department under subsections (b) and (c) of this Section shall | 26 |
| be provided under oath. |
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| (e) The Department may not issue a wholesale distributor | 2 |
| license to an applicant, unless the Department first: | 3 |
| (1) conducts a physical inspection of the facility at | 4 |
| the address provided by the applicant as required under | 5 |
| item (1) of subsection (b) of this Section; and | 6 |
| (2) determines that the designated representative | 7 |
| meets each of the following qualifications: | 8 |
| (A) He or she is at least 21 years of age. | 9 |
| (B) He or she has been employed full-time for at | 10 |
| least 3 years in a pharmacy or with a wholesale | 11 |
| distributor in a capacity related to the dispensing and | 12 |
| distribution of, and recordkeeping relating to, | 13 |
| prescription drugs. | 14 |
| (C) He or she is employed by the applicant full | 15 |
| time in a managerial level position. | 16 |
| (D) He or she is actively involved in and aware of | 17 |
| the actual daily operation of the wholesale | 18 |
| distributor. | 19 |
| (E) He or she is physically present at the facility | 20 |
| of the applicant during regular business hours, except | 21 |
| when the absence of the designated representative is | 22 |
| authorized, including without limitation sick leave | 23 |
| and vacation leave. | 24 |
| (F) He or she is serving in the capacity of a | 25 |
| designated representative for only one applicant at a | 26 |
| time, except where more than one licensed wholesale |
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| distributor is co-located in the same facility and such | 2 |
| wholesale distributors are members of an affiliated | 3 |
| group, as defined in Section 1504 of the Internal | 4 |
| Revenue Code. | 5 |
| (G) He or she does not have any convictions under | 6 |
| any federal, State, or local laws relating to wholesale | 7 |
| or retail prescription drug distribution or | 8 |
| distribution of controlled substances. | 9 |
| (H) He or she does not have any felony convictions | 10 |
| under federal, State, or local laws. | 11 |
| (f) If a wholesale distributor distributes prescription | 12 |
| drugs from more than one facility, the wholesale distributor | 13 |
| shall obtain a license for each facility. | 14 |
| (g) The information provided under this Section may not be | 15 |
| disclosed to any person or entity other than the Department or | 16 |
| another government entity in need of such information for | 17 |
| licensing or monitoring purposes.
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| Section 15. License renewal. In accordance with each | 19 |
| license renewal, the Department shall send to each licensee a | 20 |
| form setting forth the information that the licensee provided | 21 |
| to the Department in the licensee's original application for | 22 |
| licensure under Section 10 of this Act. Within 30 days after | 23 |
| receiving the form, the wholesale distributor must identify and | 24 |
| state under oath to the Department any and all changes or | 25 |
| corrections to the information originally submitted to the |
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| Department. The Department may suspend or revoke the license of | 2 |
| a licensee if the Department determines that the licensee no | 3 |
| longer qualifies for the license originally issued under this | 4 |
| Act. | 5 |
| Section 20. Bond required. The Department shall require | 6 |
| every wholesale distributor applying for licensure under this | 7 |
| Act to submit a bond of at least $100,000 or another equivalent | 8 |
| means of security acceptable to the Department, such as an | 9 |
| irrevocable letter of credit or a deposit in a trust account or | 10 |
| financial institution, payable to a fund established by the | 11 |
| Department. Chain pharmacy warehouses that are not engaged in | 12 |
| wholesale distribution are exempt from the bond requirement of | 13 |
| this Section. The purpose of the bond is to secure payment of | 14 |
| any fines or penalties imposed by the Department and any fees | 15 |
| and costs incurred by the Department regarding that license, | 16 |
| which are authorized under State law and which the licensee | 17 |
| fails to pay 30 days after the fines, penalties, or costs | 18 |
| become final. The Department may make a claim against the bond | 19 |
| or security until one year after the licensee's license ceases | 20 |
| to be valid. A single bond may suffice to cover all facilities | 21 |
| operated by an applicant in this State. | 22 |
| The Department shall establish a fund, separate from its | 23 |
| other accounts, in which to deposit the wholesale distributor | 24 |
| 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 | 3 |
| exchanges from a pharmacy or chain pharmacy warehouse pursuant | 4 |
| to the terms and conditions of the agreement between the | 5 |
| wholesale distributor and the pharmacy or chain pharmacy | 6 |
| warehouse. Returns of expired, damaged, recalled, or otherwise | 7 |
| non-saleable pharmaceutical products shall be distributed by | 8 |
| the receiving wholesale distributor only to either the original | 9 |
| manufacturer or a third party returns processor, and such | 10 |
| returns or exchanges, including any redistribution by a | 11 |
| receiving wholesaler, shall not be subject to the pedigree | 12 |
| requirements of Section 30 of this Act, so long as they are | 13 |
| exempt from the pedigree requirement of the FDA's currently | 14 |
| applicable Prescription Drug Marketing Act guidance. Both | 15 |
| licensees under this Act and pharmacies shall be accountable | 16 |
| for administering their returns process and ensuring that the | 17 |
| aspects of this operation are secure and do not permit the | 18 |
| entry of adulterated and counterfeit product. | 19 |
| (b) A manufacturer or wholesale distributor licensed under | 20 |
| this Act may furnish prescription drugs only to a person | 21 |
| licensed by the appropriate state licensing authorities. | 22 |
| Before furnishing prescription drugs to a person not known to | 23 |
| the manufacturer or wholesale distributor, the manufacturer or | 24 |
| wholesale distributor must affirmatively verify that the | 25 |
| person is legally authorized to receive the prescription drugs | 26 |
| by contacting the appropriate state licensing authorities. |
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| (c) Prescription drugs furnished by a manufacturer or | 2 |
| wholesale distributor licensed under this Act may be delivered | 3 |
| only to the premises listed on the license, provided that the | 4 |
| manufacturer or wholesale distributor may furnish prescription | 5 |
| drugs to an authorized person or agent of that person at the | 6 |
| premises of the manufacturer or wholesale distributor if: | 7 |
| (1) the identity and authorization of the recipient is | 8 |
| properly established; and | 9 |
| (2) this method of receipt is employed only to meet the | 10 |
| immediate needs of a particular patient of the authorized | 11 |
| person. | 12 |
| (d) Prescription drugs may be furnished to a hospital | 13 |
| pharmacy receiving area, provided that a pharmacist or | 14 |
| authorized receiving personnel signs, at the time of delivery, | 15 |
| a receipt showing the type and quantity of the prescription | 16 |
| drug received. Any discrepancy between the receipt and the type | 17 |
| and quantity of the prescription drug actually received shall | 18 |
| be reported to the delivering manufacturer or wholesale | 19 |
| distributor by the next business day after the delivery to the | 20 |
| pharmacy receiving area. | 21 |
| (e) A manufacturer or wholesale distributor licensed under | 22 |
| this Act may not accept payment for, or allow the use of, a | 23 |
| person or entity's credit to establish an account for the | 24 |
| purchase of prescription drugs from any person other than the | 25 |
| owner of record, the chief executive officer, or the chief | 26 |
| financial officer listed on the license of a person or entity |
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| legally authorized to receive the prescription drugs. Any | 2 |
| account established for the purchase of prescription drugs must | 3 |
| bear the name of the licensee.
This subsection (e) shall not be | 4 |
| construed to prohibit a pharmacy or chain pharmacy warehouse | 5 |
| from receiving prescription drugs if payment for the | 6 |
| prescription drugs is processed through the pharmacy's or chain | 7 |
| pharmacy warehouse's contractual drug manufacturer or | 8 |
| wholesale distributor. | 9 |
| Section 30. Pedigree. | 10 |
| (a) Each person who is engaged in the wholesale | 11 |
| distribution of prescription drugs, including repackagers, but | 12 |
| excluding the original manufacturer of the finished form of the | 13 |
| prescription drug, that leave or have ever left the normal | 14 |
| distribution channel shall, before each wholesale distribution | 15 |
| of the drug, provide a pedigree to the person who receives the | 16 |
| drug. | 17 |
| A retail pharmacy or chain pharmacy warehouse must comply | 18 |
| with the requirements of this Section only if the pharmacy or | 19 |
| chain pharmacy warehouse engages in the wholesale distribution | 20 |
| of prescription drugs. | 21 |
| 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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| 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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| 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:
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| (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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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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LRB095 10560 RAS 34198 a |
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| 1 |
| 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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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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| 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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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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| 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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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 |
|
|
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LRB095 10560 RAS 34198 a |
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| 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.".
|
|