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A BILL TO BE ENTITLED
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AN ACT
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relating to the prescription of tamper-resistant opioid analgesic |
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drugs; providing an administrative penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter A, Chapter 562, Occupations Code, is |
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amended by adding Section 562.0143 to read as follows: |
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Sec. 562.0143. TAMPER-RESISTANT OPIOID ANALGESIC DRUG |
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SELECTION RESTRICTED. (a) In this section: |
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(1) "Interchange" means the substitution of an opioid |
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analgesic drug, whether brand name or generic, for a prescribed |
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tamper-resistant opioid analgesic drug. |
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(2) "Opioid analgesic drug" means a drug in the opioid |
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analgesic drug class that is prescribed to treat moderate to severe |
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pain or other conditions, including a drug in immediate release or |
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extended release form and a drug combined with other drug |
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substances to form a single tablet or other dosage form. |
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(3) "Tamper-resistant opioid analgesic drug" means an |
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opioid analgesic drug included on the list created and maintained |
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by the board under Subsection (e). |
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(b) Except as provided by Subsection (c), a pharmacist may |
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not interchange an opioid analgesic drug for a tamper-resistant |
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opioid analgesic drug, regardless of whether: |
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(1) the substituted drug is rated as pharmaceutically |
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equivalent and therapeutically equivalent to the prescribed drug by |
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the United States Food and Drug Administration or the board; or |
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(2) the prescribed drug bears a labeling claim with |
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respect to reduction of tampering, abuse, or abuse potential. |
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(c) A pharmacist may interchange an opioid analgesic drug |
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for a tamper-resistant opioid analgesic drug if: |
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(1) the substituted drug is a tamper-resistant opioid |
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analgesic drug included on the list created by the board under |
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Subsection (e) and the board has determined under Subsection (f) |
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that the substituted drug provides substantially similar |
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tamper-resistant properties as the prescribed drug; or |
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(2) the pharmacist obtains prior written consent to |
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the interchange from the prescribing physician. |
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(d) To comply with Subsection (c)(2), a pharmacist shall |
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notify the prescribing practitioner orally or electronically to |
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secure permission to interchange a tamper-resistant opioid |
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analgesic drug. The practitioner's authorization or denial of |
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authorization must be documented in writing and signed by the |
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practitioner. |
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(e) The board shall create and maintain a list of |
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tamper-resistant opioid analgesic drugs based on evidence |
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submitted by drug manufacturers or distributors. To qualify for |
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inclusion on the list, a drug: |
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(1) must incorporate a tamper-resistant technology; |
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and |
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(2) be approved by the United States Food and Drug |
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Administration pursuant to an application including at least one |
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human tampering or abuse potential study or laboratory study |
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comparing the tamper-resistant or abuse-resistant properties of |
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the drug to one or more opioid analgesic drugs approved by the |
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administration and serving as a positive control. |
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(f) Based solely on evidence submitted by drug |
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manufacturers and distributors described by Subsection (e), the |
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board shall determine which tamper-resistant opioid analgesic |
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drugs included on the list required by Subsection (e) provide |
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substantially similar tamper-resistant properties. The board |
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shall include such information on the list. |
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(g) A drug is not required to bear a labeling claim with |
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respect to reduction of tampering, abuse, or abuse potential in |
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order to be included on the list required by Subsection (e). |
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SECTION 2. (a) The Texas State Board of Pharmacy shall |
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adopt rules necessary to administer the changes in law made by this |
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Act and shall create the list required by Subsection (e), Section |
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562.0143, Occupations Code, as added by this Act, not later than |
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December 1, 2011. |
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(b) The changes in law made by this Act apply only to an |
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opioid analgesic drug dispensed on or after January 1, 2012. An |
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opioid analgesic drug dispensed before January 1, 2012, is governed |
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by the law as it existed immediately before that date, and that law |
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is continued in effect for that purpose. |
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SECTION 3. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2011. |