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A BILL TO BE ENTITLED
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AN ACT
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relating to the licensing and regulation of wholesale distributors |
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of prescription drugs; providing penalties. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 431.401, Health and Safety Code, is |
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amended by amending Subdivisions (2), (5), (7), and (11) and adding |
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Subdivisions (3-a), (3-b), (4-a), (4-b), (10-a), and (12) to read |
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as follows: |
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(2) "Authorized distributor of record" means a |
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wholesale distributor with whom a manufacturer has established an |
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ongoing relationship to distribute the manufacturer's products in |
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accordance with Section 431.4011. |
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(3-a) "Co-licensed product" means a prescription drug |
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that two or more parties have the right to engage in the |
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manufacturing or marketing of. |
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(3-b) "Drop shipment" means the sale of a prescription |
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drug to a wholesale distributor by the manufacturer of the |
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prescription drug, or by the manufacturer's co-licensed product |
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partner, third-party logistics provider, or exclusive distributor, |
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in which: |
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(A) the wholesale distributor or chain pharmacy |
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warehouse takes title but not physical possession of the |
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prescription drug; |
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(B) the wholesale distributor invoices the |
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pharmacy, chain pharmacy warehouse, or other person authorized by |
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law to dispense or administer the drug to a patient; and |
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(C) the pharmacy, chain pharmacy warehouse, or |
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other authorized person receives delivery of the prescription drug |
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directly from the manufacturer or the manufacturer's third-party |
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logistics provider or exclusive distributor. |
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(4-a) "Manufacturer" means a person licensed or |
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approved by the United States Food and Drug Administration to |
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engage in the manufacture of drugs or devices. |
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(4-b) "Manufacturer's exclusive distributor" means a |
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person who holds a wholesale distributor license under this |
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subchapter, who contracts with a manufacturer to provide or |
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coordinate warehousing, distribution, or other services on behalf |
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of the manufacturer, and who takes title to, but does not have |
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general responsibility to direct the sale or disposition of, the |
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manufacturer's prescription drug. A manufacturer's exclusive |
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distributor must be an authorized distributor of record to be |
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considered part of the normal distribution channel. |
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(5) "Normal distribution channel [chain]" means: |
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(A) a drop shipment; or |
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(B) a chain of custody for a prescription drug |
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from the manufacturer of the prescription drug, the manufacturer to |
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the manufacturer's co-licensed product partner, the manufacturer |
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to the manufacturer's third-party logistics provider, or the |
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manufacturer to the manufacturer's exclusive distributor, to: |
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(i) [(A) a manufacturer to an authorized
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distributor of record or to a wholesale distributor licensed under
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this subchapter to] a pharmacy or other designated person |
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authorized by law to dispense or administer the drug [practitioner] |
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to a patient; |
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(ii) a wholesale distributor to a pharmacy |
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or other designated person authorized by law to dispense or |
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administer the drug [(B) a manufacturer to an authorized
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distributor of record to one other authorized distributor of record
|
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to a pharmacy or practitioner] to a patient; [or] |
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(iii) a wholesale distributor [(C) a
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manufacturer to an authorized distributor of record] to a chain |
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pharmacy warehouse to the chain pharmacy warehouse's intracompany |
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pharmacy or other designated person authorized by law to dispense |
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or administer the drug [a pharmacy or practitioner] to a patient; |
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or |
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(iv) an authorized prescriber of a drug |
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that, by law, may be administered only under the supervision of the |
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prescriber. |
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(7) "Place of business" means a facility of a [each
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location at which a drug for] wholesale distributor in which |
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prescription drugs are stored, handled, repackaged, or offered for |
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sale [distribution is located]. |
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(10-a) "Third-party logistics provider" means a |
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person who holds a wholesale distributor license under this |
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subchapter, who contracts with a prescription drug manufacturer to |
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provide or coordinate warehousing, distribution, or other services |
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on behalf of the manufacturer, and who 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 logistics |
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provider must be an authorized distributor of record to be |
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considered part of the normal distribution channel. |
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(11) "Wholesale distribution" means distribution of |
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prescription drugs to a person other than a consumer or patient[,
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and includes distribution by a manufacturer, repackager, own label
|
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distributor, broker, jobber, warehouse, retail pharmacy that
|
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conducts wholesale distribution, or wholesaler]. The term does not |
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include: |
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(A) intracompany sales of prescription drugs, |
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which means transactions or transfers of prescription drugs between |
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a division, subsidiary, parent, or affiliated or related company |
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that is under common ownership and control of a corporate entity, or |
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any transaction or transfer between co-license holders of a |
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co-licensed product; |
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(B) the sale, purchase, distribution, trade, or |
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transfer of prescription drugs or the offer to sell, purchase, |
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distribute, trade, or transfer a prescription drug for emergency |
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medical reasons; |
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(C) the distribution of prescription drug |
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samples by a representative of a manufacturer; |
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(D) the return of drugs by a hospital, health |
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care entity, retail pharmacy, chain pharmacy warehouse, or |
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charitable institution in accordance with 21 C.F.R. Section 203.23; |
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[or] |
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(E) the sale of minimal quantities [delivery] by |
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a retail pharmacy of a prescription drug to [a patient or a
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patient's agent under the lawful order of] a licensed practitioner |
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for office use; |
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(F) the sale, purchase, or trade of a drug, an |
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offer to sell, purchase, or trade a drug, or the dispensing of a |
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drug under a prescription; |
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(G) the sale, transfer, merger, or consolidation |
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of all or part of the business of a pharmacy from or with another |
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pharmacy, whether accomplished as a purchase and sale of stock or |
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business assets; |
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(H) the sale, purchase, distribution, trade, or |
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transfer of a prescription drug from one authorized distributor of |
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record to one additional authorized distributor of record if: |
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(i) the manufacturer states in writing to |
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the receiving distributor that the manufacturer is unable to supply |
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the prescription drug; and |
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(ii) the supplying distributor states in |
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writing that the prescription drug being supplied had until that |
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time been exclusively in the normal distribution channel; |
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(I) the delivery of, or 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 prescription |
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drugs, if the common carrier does not store, warehouse, or take |
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legal ownership of the prescription drug; or |
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(J) the sale or transfer from a retail pharmacy |
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or chain pharmacy warehouse of expired, damaged, returned, or |
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recalled prescription drugs to the original manufacturer or to a |
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third-party returns processor. |
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(12) "Wholesale distributor" means a person engaged in |
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the wholesale distribution of prescription drugs, including a |
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manufacturer, repackager, own-label distributor, private-label |
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distributor, jobber, broker, manufacturer warehouse, distributor |
|
warehouse, or other warehouse, manufacturer's exclusive |
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distributor, authorized distributor of record, drug wholesaler or |
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distributor, independent wholesale drug trader, specialty |
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wholesale distributor, third-party logistics provider, retail |
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pharmacy that conducts wholesale distribution, and chain pharmacy |
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warehouse that conducts wholesale distribution. A wholesale |
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distributor must be an authorized distributor of record to be |
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considered part of the normal distribution channel. |
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SECTION 2. Section 431.4011, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 431.4011. ONGOING RELATIONSHIP. In this subchapter, |
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"ongoing relationship" means an association that exists when: |
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(1) a manufacturer and wholesale distributor, |
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including any affiliated group of the wholesale distributor, as |
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defined by Section 1504, Internal Revenue Code of 1986, enter into a |
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written agreement currently in effect that evidences the ongoing |
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relationship; or |
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(2) a wholesale distributor, including any affiliated |
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group of the distributor described by Subdivision (1), is listed on |
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a manufacturer's current list of authorized distributors of record, |
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which must be updated by the manufacturer at least monthly [under
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which the distributor is authorized to distribute the
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manufacturer's products for a period of time or for a number of
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shipments. If the distributor is not authorized to distribute the
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manufacturer's entire product line, the agreement must identify the
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specific drug products that the distributor is authorized to
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distribute]. |
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SECTION 3. Section 431.402(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) A person may not engage in wholesale distribution of |
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prescription drugs in this state unless the person holds a |
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wholesale drug distribution license under this subchapter for each |
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separate place of business. |
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SECTION 4. Section 431.403, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 431.403. EXEMPTION FROM LICENSING. (a) A person who |
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engages in wholesale distribution of prescription drugs in this |
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state for use in humans is exempt from this subchapter if the person |
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is distributing the person's own drugs and devices that have been |
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approved by the United States Food and Drug Administration and the |
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person is not required to obtain a license [exempt] under federal |
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law[:
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[(1) the Prescription Drug Marketing Act of 1987 (21
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U.S.C. Section 353(c)(3)(B));
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[(2) the regulations adopted by the secretary to
|
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administer and enforce that Act; or
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[(3) the interpretations of that Act set out in the
|
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compliance policy manual of the United States Food and Drug
|
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Administration]. |
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(b) An exemption from the licensing requirements under this |
|
section does not constitute an exemption from compliance with any |
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other requirement under this subchapter that the department by rule |
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considers necessary and appropriate to protect the public health or |
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safety [the other provisions of this chapter or the rules adopted
|
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under this chapter to administer and enforce the other provisions
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of this chapter]. |
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SECTION 5. Sections 431.404(a), (b), and (d), Health and |
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Safety Code, are amended to read as follows: |
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(a) An applicant for a license under this subchapter must |
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submit an application to the department on the form prescribed by |
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the department. The application must contain: |
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(1) the name, full business address, and telephone |
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number of the applicant; |
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(2) all trade or business names under which the |
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business is conducted; |
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(3) [(2)] the address, [and] telephone number, and |
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name of a contact person for each of the applicant's places of |
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business [of each place of business that is licensed]; |
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(4) [(3)] the type of business entity and: |
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(A) if the business is a sole proprietorship, the |
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name of the proprietor; |
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(B) if the business is a partnership, the name of |
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the partnership and each of the partners; or |
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(C) if the business is a corporation, the name of |
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the corporation, the place of incorporation, and the name and title |
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of each corporate officer and director [the name and residence
|
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address of:
|
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[(A) the proprietor, if the business is a
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proprietorship;
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[(B) all partners, if the business is a
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partnership; or
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[(C) all principals, if the business is an
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association]; |
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[(4) the date and place of incorporation, if the
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business is a corporation;] |
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(5) [the names and business addresses of the
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individuals in an administrative capacity showing:
|
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[(A) the managing proprietor, if the business is
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a proprietorship;
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[(B) the managing partner, if the business is a
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partnership;
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[(C) the officers and directors, if the business
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is a corporation; or
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[(D) the persons in a managerial capacity, if the
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business is an association;
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[(6)] the name and[,] telephone number of, and any |
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information necessary to complete a criminal history record check |
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on, a designated representative of each place of business; and |
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(6) [(7) the state of incorporation, if the business
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is a corporation;
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[(8)] a list of all licenses and permits issued to the |
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applicant by any other state under which the applicant is permitted |
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to purchase or possess prescription drugs[; and
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[(9) the name of the manager for each place of
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business]. |
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(b) Each person listed in Subsection (a)(5) [Subsections
|
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(a)(6) and (a)(9)] shall provide the following to the department: |
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(1) the person's places of residence for the past seven |
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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 seven years; |
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(4) the business name and address of any business, |
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corporation, or other organization in which the person held an |
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office under Subdivision (3) or in which the person conducted an |
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occupation or held a position of employment; |
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(5) a statement of whether during the preceding seven |
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years the person was the subject of a proceeding to revoke a license |
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or a criminal proceeding and the nature and disposition of the |
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proceeding; |
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(6) a statement of whether during the preceding seven |
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years the person has been enjoined, either temporarily or |
|
permanently, by a court from violating any federal or state law |
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regulating the possession, control, or distribution of |
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prescription drugs, including the details concerning the event; |
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(7) a written description of any involvement by the |
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person as an officer or director with any business, including any |
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investments, other than the ownership of stock in a publicly traded |
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company or mutual fund during the past seven years, that |
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manufactured, administered, prescribed, distributed, or stored |
|
pharmaceutical products and any lawsuits in which the businesses |
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were named as a party; |
|
(8) a description of any misdemeanor or felony offense |
|
for which the person, as an adult, was found guilty, regardless of |
|
whether adjudication of guilt was withheld or whether the person |
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pled guilty or nolo contendere; |
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(9) a description of any criminal conviction of the |
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person under appeal, a copy of the notice of appeal for that |
|
criminal offense, and a copy of the final written order of an appeal |
|
not later than the 15th day after the date of the appeal's |
|
disposition; and |
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(10) a photograph of the person taken not earlier than |
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30 days before the date the application was submitted. |
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(d) An applicant or license holder shall submit to [file
|
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with] the department [a written notice of] any change in or |
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correction to the information required under this section in the |
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form and manner prescribed by the department. |
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SECTION 6. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Section 431.4045 to read as follows: |
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Sec. 431.4045. INSPECTION REQUIRED. The department may not |
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issue a wholesale distributor license to an applicant under this |
|
subchapter unless the department: |
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(1) conducts a physical inspection of the place of |
|
business at the address provided by the applicant under Section |
|
431.404; and |
|
(2) determines that the designated representative of |
|
the place of business meets the qualifications required by Section |
|
431.405. |
|
SECTION 7. Section 431.405, Health and Safety Code, is |
|
amended to read as follows: |
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Sec. 431.405. QUALIFICATIONS FOR LICENSE. To qualify for |
|
the issuance or renewal of a wholesale distributor license under |
|
this subchapter, the designated representative of an applicant or |
|
license holder must: |
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(1) be at least 21 years of age; |
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(2) have been employed full-time for at least three |
|
years by a pharmacy or a wholesale distributor in a capacity related |
|
to the dispensing or distributing of prescription drugs, including |
|
recordkeeping for the dispensing or distributing of prescription |
|
drugs; |
|
(3) be employed by the applicant full-time in a |
|
managerial-level position; |
|
(4) be actively involved in and aware of the actual |
|
daily operation of the wholesale distributor; |
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(5) be physically present at the applicant's place of |
|
business during regular business hours, except when the absence of |
|
the designated representative is authorized, including sick leave |
|
and vacation leave; |
|
(6) serve as a designated representative for only one |
|
applicant at any one time, except in a circumstance in which more |
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than one licensed wholesale distributor is colocated in the same |
|
place of business and the wholesale distributors are members of an |
|
affiliated group, as defined by Section 1504, Internal Revenue Code |
|
of 1986; |
|
(7) not have been convicted of a violation of any |
|
federal, state, or local laws relating to wholesale or retail |
|
prescription drug distribution or the distribution of controlled |
|
substances; and |
|
(8) not have been convicted of a felony under a |
|
federal, state, or local law. |
|
SECTION 8. Section 431.408, Health and Safety Code, is |
|
amended by adding Subsections (a-1) and (c-1) to read as follows: |
|
(a-1) A chain pharmacy warehouse that engages only in |
|
intracompany transfers is exempt from the bond requirement under |
|
Subsection (a). |
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(c-1) A single bond is sufficient to cover all places of |
|
business operated by a wholesale distributor in this state. |
|
SECTION 9. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Section 431.4095 to read as follows: |
|
Sec. 431.4095. RENEWAL NOTIFICATION; CHANGE OR RENEWAL. |
|
(a) Before the expiration of a license issued under this |
|
subchapter, the department shall send to each licensed wholesale |
|
distributor a form containing a copy of the information the |
|
distributor provided to the department under Section 431.404. |
|
(b) Not later than the 30th day after the date the wholesale |
|
distributor receives the form under Subsection (a), the wholesale |
|
distributor shall identify and state under oath to the department |
|
any change in or correction to the information. |
|
SECTION 10. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Sections 431.4101 and 431.4102 to read as |
|
follows: |
|
Sec. 431.4101. CONTINUING EDUCATION. Designated |
|
representatives identified in Section 431.404(a)(5) shall |
|
successfully complete continuing education training regarding |
|
applicable federal and state laws governing the wholesale |
|
distribution of prescription drugs as required by department rule. |
|
Sec. 431.4102. CONFIDENTIALITY. Information provided |
|
under Section 431.404 may not be disclosed to any person other than |
|
the department for licensing or monitoring purposes. |
|
SECTION 11. Section 431.411, Health and Safety Code, is |
|
amended by amending Subsection (a) and adding Subsections (a-1) and |
|
(e) to read as follows: |
|
(a) A wholesale distributor shall receive prescription drug |
|
returns or exchanges from a pharmacy or chain pharmacy warehouse in |
|
accordance with the terms and conditions of the agreement between |
|
the wholesale distributor and the pharmacy or chain pharmacy |
|
warehouse, including the return of an expired, damaged, or recalled |
|
prescription drug to either the original manufacturer or a |
|
third-party returns processor. The returns or exchanges received |
|
by the wholesale distributor as provided by this subsection are not |
|
subject to the pedigree requirement under Section 431.412 if the |
|
returns or exchanges are exempt from pedigree under: |
|
(1) Section 503, Prescription Drug Marketing Act of |
|
1987 (21 U.S.C. Section 353(c)(3)(B)); |
|
(2) the regulations adopted by the secretary to |
|
administer and enforce that Act; or |
|
(3) the interpretations of that Act set out in the |
|
compliance policy manual of the United States Food and Drug |
|
Administration. |
|
(a-1) Each [In connection with the returned goods process,
|
|
a] wholesale distributor and pharmacy shall administer the process |
|
of drug returns and exchanges to ensure that the process is secure |
|
and does not permit [should establish appropriate business
|
|
practices and exercise due diligence designed to prevent] the entry |
|
of adulterated or counterfeit drugs into the distribution channel. |
|
(e) A manufacturer or wholesale distributor may not accept |
|
payment for, or allow the use of a person's credit to establish an |
|
account for the purchase of, prescription drugs from any person |
|
other than the owner of record, the chief executive officer, or the |
|
chief financial officer listed on the license of a person legally |
|
authorized to receive prescription drugs. Any account for the |
|
purchase of prescription drugs must be established in the name of |
|
the license holder. |
|
SECTION 12. Section 431.412, Health and Safety Code, is |
|
amended by amending Subsections (a) and (d) and adding Subsection |
|
(b-1) to read as follows: |
|
(a) A person who is engaged in the wholesale distribution of |
|
a prescription drug, including a repackager but excluding the |
|
original manufacturer [and the original labeler of a prescription
|
|
drug], shall provide a pedigree for each prescription drug that is |
|
not distributed through the normal distribution channel [chain] and |
|
is sold, traded, or transferred to any other person. |
|
(b-1) A retail pharmacy or chain pharmacy warehouse is |
|
required to comply with this section only if the pharmacy or |
|
warehouse engages in the wholesale distribution of a prescription |
|
drug. |
|
(d) A person who is engaged in the wholesale distribution of |
|
a prescription drug, including a repackager, but excluding the |
|
original manufacturer of the finished form of a prescription drug, |
|
and who is in possession of a pedigree for a prescription drug must |
|
verify before distributing the prescription drug that each |
|
transaction listed on the pedigree has occurred. |
|
SECTION 13. Section 431.413, Health and Safety Code, is |
|
amended by amending Subsections (a), (c), and (e) and adding |
|
Subsection (e-1) to read as follows: |
|
(a) A pedigree must include all necessary identifying |
|
information concerning each sale in the product's chain of |
|
distribution from the manufacturer, or from the manufacturer's |
|
third-party logistics provider, co-licensed product partner, or |
|
exclusive distributor, through acquisition and sale by a wholesale |
|
distributor or repackager, until final sale to a pharmacy or other |
|
person dispensing or administering the drug. At a minimum, the |
|
chain of distribution information must include: |
|
(1) the name, address, telephone number, and, if |
|
available, the e-mail address of each person who owns [or
|
|
possesses] the prescription drug and each wholesale distributor of |
|
the prescription drug[, except common carriers and logistics
|
|
providers]; |
|
(2) [the signature of each owner of the prescription
|
|
drug;
|
|
[(3)] the name and address of each location from which |
|
the product was shipped, if different from the owner's name and |
|
address; |
|
(3) [(4)] the transaction dates; and |
|
(4) [(5)] certification that each recipient has |
|
authenticated the pedigree. |
|
(c) Each pedigree statement must be: |
|
(1) maintained by the purchaser and the wholesale |
|
distributor for at least three years; and |
|
(2) available for inspection and photocopying not |
|
later than the fifth business day after the date [on] a request is |
|
submitted by the department or a peace officer in this state. |
|
(e) The department shall: |
|
(1) conduct a study on the implementation of |
|
electronic pedigrees; and |
|
(2) in conducting the study under Subdivision (1), |
|
consult with manufacturers, distributors, and pharmacies |
|
responsible for the sale and distribution of prescription drugs in |
|
this state[; and
|
|
[(3) based on the results of the study, establish an
|
|
implementation date, which may not be earlier than December 31,
|
|
2007, for electronic pedigrees]. |
|
(e-1) If, after consulting with manufacturers, |
|
distributors, and pharmacies responsible for the sale and |
|
distribution of prescription drugs in this state, the department |
|
determines that track and trace technology to implement electronic |
|
pedigrees is universally available across the entire prescription |
|
pharmaceutical supply chain, the department shall establish an |
|
implementation date, which may not be earlier than July 1, 2010, for |
|
electronic pedigrees. |
|
SECTION 14. Section 431.414, Health and Safety Code, is |
|
amended by adding Subsection (a-1) to read as follows: |
|
(a-1) The commissioner of state health services may suspend |
|
or revoke a license if the license holder no longer meets the |
|
qualifications for obtaining a license under Section 431.405. |
|
SECTION 15. Section 431.415, Health and Safety Code, is |
|
amended by amending Subsection (a) and adding Subsection (a-1) to |
|
read as follows: |
|
(a) The commissioner of state health services shall issue an |
|
order requiring a person, including a [manufacturer,] |
|
distributor[,] or retailer of a prescription drug, to immediately |
|
cease distribution of the drug if the commissioner determines there |
|
is a reasonable probability that: |
|
(1) a wholesale distributor has: |
|
(A) violated this subchapter; |
|
(B) falsified a pedigree; or |
|
(C) sold, distributed, transferred, |
|
manufactured, repackaged, handled, or held a counterfeit |
|
prescription drug intended for human use that could cause serious |
|
adverse health consequences or death; and |
|
(2) other procedures would result in unreasonable |
|
delay. |
|
(a-1) This section does not authorize the commissioner of |
|
state health services to issue a cease and desist order against a |
|
manufacturer. |
|
SECTION 16. Subchapter N, Chapter 431, Health and Safety |
|
Code, is amended by adding Sections 431.416 and 431.417 to read as |
|
follows: |
|
Sec. 431.416. PROHIBITED ACTS. (a) The following acts and |
|
the causing of or aiding or abetting of the following acts within |
|
this state are unlawful and prohibited: |
|
(1) the failure to obtain a license in accordance with |
|
this subchapter; |
|
(2) operating without a valid license when a license |
|
is required by this subchapter; |
|
(3) the purchase or receipt of a prescription drug |
|
from a pharmacy in violation of Section 431.411(a) or (a-1); |
|
(4) if a license is required under Section 431.411(b), |
|
the sale, distribution, or transfer of a prescription drug to a |
|
person who is not authorized under the laws of the jurisdiction in |
|
which the person receives the prescription drug to receive the |
|
prescription drug; |
|
(5) the failure to deliver a prescription drug to a |
|
specified premise, as required by Section 431.411(c); |
|
(6) accepting payment or credit for the sale of a |
|
prescription drug in violation of Section 431.411(e); |
|
(7) the failure to maintain or provide a pedigree as |
|
required by this subchapter; |
|
(8) the failure to obtain, pass, or authenticate a |
|
pedigree as required by this subchapter; |
|
(9) providing this state or a representative of this |
|
state or a federal official with a false or fraudulent record |
|
regarding any matter covered under this subchapter; |
|
(10) making a false or fraudulent statement regarding |
|
any matter covered under this subchapter; |
|
(11) obtaining or attempting to obtain a prescription |
|
drug by fraud, deceit, or misrepresentation; |
|
(12) engaging in misrepresentation or fraud in the |
|
distribution of a prescription drug; |
|
(13) the manufacture, repacking, sale, transfer, |
|
delivery, or holding of, or offering for sale, any prescription |
|
drug that is adulterated, misbranded, counterfeit, or suspected of |
|
being counterfeit or has otherwise been rendered unfit for |
|
distribution; |
|
(14) the adulteration, misbranding, or counterfeiting |
|
of any prescription drug; |
|
(15) the receipt of a prescription drug that is |
|
adulterated, misbranded, stolen, obtained by fraud or deceit, |
|
counterfeit, or suspected of being counterfeit, and the delivery or |
|
proffered delivery of such a drug for payment or otherwise; and |
|
(16) the alteration, mutilation, destruction, |
|
obliteration, or removal of all or any part of the labeling of a |
|
prescription drug or the commission of any other act with respect to |
|
a prescription drug that results in the prescription drug being |
|
misbranded. |
|
(b) Subsection (a) does not apply to a prescription drug |
|
manufacturer, or an agent of a prescription drug manufacturer, who |
|
is obtaining or attempting to obtain a prescription drug for the |
|
sole purpose of testing the prescription drug for authenticity. |
|
(c) Subsections (a)(13) and (14) do not apply to a |
|
manufacturer's wholesale distribution of a prescription drug |
|
approved by the United States Food and Drug Administration. |
|
Sec. 431.417. CRIMINAL PENALTIES. (a) A person commits an |
|
offense if the person engages in the wholesale distribution of |
|
prescription drugs in violation of this subchapter. Except as |
|
otherwise provided by this section, an offense under this section |
|
is a felony punishable by imprisonment for a term not to exceed 15 |
|
years, a fine not to exceed $50,000, or both imprisonment and a |
|
fine. If it is shown on the trial of an offense under this section |
|
that the person knowingly engaged in the wholesale distribution of |
|
prescription drugs in violation of this subchapter, the offense is |
|
a felony punishable by imprisonment for a term of not more than 99 |
|
years or less than 15 years, a fine not to exceed $500,000, or both |
|
imprisonment and a fine. |
|
(b) If conduct constituting an offense under this section |
|
also constitutes an offense under any other law, the actor may be |
|
prosecuted under this section, the other law, or both. |
|
SECTION 17. Sections 431.059(a-1) and (a-2) and 431.412(b) |
|
and (c), Health and Safety Code, are repealed. |
|
SECTION 18. The executive commissioner of the Health and |
|
Human Services Commission shall adopt the rules necessary to |
|
implement the changes in law made by this Act not later than |
|
December 1, 2007. |
|
SECTION 19. The change in law made by this Act applies only |
|
to an offense committed on or after the effective date of this Act. |
|
An offense committed before the effective date of this Act is |
|
covered by the law in effect when the offense was committed, and the |
|
former law is continued in effect for that purpose. For purposes of |
|
this section, an offense was committed before the effective date of |
|
this Act if any element of the offense was committed before that |
|
date. |
|
SECTION 20. This Act takes effect September 1, 2007. |