Sen. Terry Link

Filed: 3/22/2007

 

 


 

 


 
09500SB0509sam002 LRB095 10560 RAS 34198 a

1
AMENDMENT TO SENATE BILL 509

2     AMENDMENT NO. ______. Amend Senate Bill 509, AS AMENDED, by
3 replacing everything after the enacting clause with the
4 following:
 
5     "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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1 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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1 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.
14     "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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1 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.
25     "Pedigree" means a document or electronic file containing
26 information that records each wholesale distribution of any

 

 

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1 given prescription drug.
2     "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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1 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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1     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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1     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.
19     (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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1     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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1 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.
17         (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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1     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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1     (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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1         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.
 
18     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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1 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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1     Section 25. Restrictions on transactions.
2     (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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1     (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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1 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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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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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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1     (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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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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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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1 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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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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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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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.".