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A BILL TO BE ENTITLED
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AN ACT
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relating to the regulation of controlled substances. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Section 481.002, Health and Safety Code, is |
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amended by adding Subdivision (2-a) and amending Subdivision (22) |
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to read as follows: |
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(2-a) "Board" means the Texas State Board of Pharmacy. |
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(22) "Immediate precursor" means a substance |
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designated [the director finds to be and] by rule under this chapter |
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[designates] as being: |
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(A) a principal compound commonly used or |
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produced primarily for use in the manufacture of a controlled |
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substance; |
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(B) a substance that is an immediate chemical |
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intermediary used or likely to be used in the manufacture of a |
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controlled substance; and |
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(C) a substance the control of which is necessary |
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to prevent, curtail, or limit the manufacture of a controlled |
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substance. |
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SECTION 2. Section 481.003(a), Health and Safety Code, is |
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amended to read as follows: |
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(a) The director may adopt rules to administer and enforce |
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this chapter, except that the board may adopt rules relating to the |
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issuance of prescriptions and information submitted in connection |
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with those prescriptions. The department and the board by rule |
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shall adopt a memorandum of understanding outlining the |
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responsibilities of each agency in regulating controlled |
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substances under this chapter. |
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SECTION 3. Section 481.034(h), Health and Safety Code, is |
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amended to read as follows: |
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(h) Not later than the 10th day after the date on which the |
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commissioner designates, deletes, or reschedules a substance under |
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Subsection (a), the commissioner shall give written notice of that |
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action to the director, the board, and [to] each state licensing |
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agency having jurisdiction over practitioners. |
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SECTION 4. Section 481.064(c), Health and Safety Code, is |
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amended to read as follows: |
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(c) The director shall deposit the collected fees to the |
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credit of the [operator's and chauffeur's license account in the] |
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general revenue fund. The fees may be used only by the department |
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and the board in the administration or enforcement of this |
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subchapter. |
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SECTION 5. Section 481.074, Health and Safety Code, is |
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amended by amending Subsections (b), (c), (d), (f), (k), (p), and |
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(q), and reenacting and amending Subsection (o), as amended by |
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Chapters 349 (S.B. 1188) and 1345 (S.B. 410), Acts of the 79th |
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Legislature, Regular Session, 2005, to read as follows: |
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(b) Except in an emergency as defined by rule of the board |
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[director] or as provided by Subsection (o) [or Section 481.075(j)
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or (m)], a person may not dispense or administer a controlled |
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substance listed in Schedule II without the written prescription of |
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a practitioner [on an official prescription form that meets the
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requirements of and is completed by the practitioner in accordance
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with Section 481.075]. In an emergency, a person may dispense or |
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administer a controlled substance listed in Schedule II on the oral |
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or telephonically communicated prescription of a practitioner. The |
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person who administers or dispenses the substance shall: |
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(1) if the person is a prescribing practitioner or a |
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pharmacist, promptly comply with Subsection (c); or |
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(2) if the person is not a prescribing practitioner or |
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a pharmacist, promptly write the oral or telephonically |
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communicated prescription and include in the written record of the |
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prescription the name, address, [department registration number,] |
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and Federal Drug Enforcement Administration number of the |
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prescribing practitioner[, all information required to be provided
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by a practitioner under Section 481.075(e)(1), and all information
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required to be provided by a dispensing pharmacist under Section
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481.075(e)(2)]. |
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(c) Not later than the seventh day after the date a |
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prescribing practitioner authorizes an emergency oral or |
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telephonically communicated prescription, the prescribing |
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practitioner shall cause a written prescription[, completed in the
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manner required by Section 481.075,] to be delivered in person or |
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mailed to the dispensing pharmacist at the pharmacy where the |
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prescription was dispensed. The envelope of a prescription |
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delivered by mail must be postmarked not later than the seventh day |
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after the date the prescription was authorized. [On receipt of the
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prescription, the dispensing pharmacy shall file the transcription
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of the telephonically communicated prescription and the pharmacy
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copy and shall send information to the director as required by
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Section 481.075.] |
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(d) Except as specified in Subsections (e) and (f), the |
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board [director], by rule and in consultation with the Texas |
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Medical Board and the department [Texas State Board of Pharmacy], |
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shall establish the period after the date on which the prescription |
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is issued that a person may fill a prescription for a controlled |
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substance listed in Schedule II. A person may not refill a |
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prescription for a substance listed in Schedule II. |
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(f) A prescription for a Schedule II controlled substance |
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written for a patient in a long-term care facility (LTCF) or for a |
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patient with a medical diagnosis documenting a terminal illness may |
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be filled in partial quantities to include individual dosage units. |
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If there is any question about whether a patient may be classified |
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as having a terminal illness, the pharmacist must contact the |
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practitioner before partially filling the prescription. Both the |
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pharmacist and the practitioner have a corresponding |
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responsibility to assure that the controlled substance is for a |
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terminally ill patient. The pharmacist must record [the
|
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prescription on an official prescription form and must indicate] on |
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the prescription [form] whether the patient is "terminally ill" or |
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an "LTCF patient." A prescription that is partially filled and does |
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not contain the notation "terminally ill" or "LTCF patient" is |
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considered to have been filled in violation of this chapter. For |
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each partial filling, the dispensing pharmacist shall record on the |
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back of the [official] prescription [form] the date of the partial |
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filling, the quantity dispensed, the remaining quantity authorized |
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to be dispensed, and the identification of the dispensing |
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pharmacist. Before any subsequent partial filling, the pharmacist |
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must determine that the additional partial filling is necessary. |
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The total quantity of Schedule II controlled substances dispensed |
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in all partial fillings may not exceed the total quantity |
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prescribed. Schedule II prescriptions for patients in a long-term |
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care facility or patients with a medical diagnosis documenting a |
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terminal illness are valid for a period not to exceed 60 days |
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following the issue date unless sooner terminated by discontinuance |
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of the medication. |
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(k) A prescription for a controlled substance must show: |
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(1) the quantity of the substance prescribed: |
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(A) numerically, followed by the number written |
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as a word, if the prescription is written; or |
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(B) if the prescription is communicated orally or |
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telephonically, as transcribed by the receiving pharmacist; |
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(2) the date of issue; |
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(3) the name, address, and date of birth or age of the |
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patient or, if the controlled substance is prescribed for an |
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animal, the species of the animal and the name and address of its |
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owner; |
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(4) the name and strength of the controlled substance |
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prescribed; |
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(5) the directions for use of the controlled |
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substance; |
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(6) the intended use of the substance prescribed |
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unless the practitioner determines the furnishing of this |
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information is not in the best interest of the patient; |
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(7) the legibly printed or stamped name, address, |
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Federal Drug Enforcement Administration registration number, and |
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telephone number of the practitioner at the practitioner's usual |
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place of business; and |
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(8) if the prescription is handwritten, the signature |
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of the prescribing practitioner[; and
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[(9)
if the prescribing practitioner is licensed in
|
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this state, the practitioner's department registration number]. |
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(o) A pharmacist may dispense a Schedule II controlled |
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substance pursuant to a facsimile copy of a [an official] |
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prescription completed in the manner required by board rule |
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[Section 481.075] and transmitted by the practitioner or the |
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practitioner's agent to the pharmacy if: |
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(1) the prescription is written for: |
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(A) a Schedule II narcotic or nonnarcotic |
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substance for a patient in a long-term care facility (LTCF), and the |
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practitioner notes on the prescription "LTCF patient"; |
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(B) a Schedule II narcotic product to be |
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compounded for the direct administration to a patient by |
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parenteral, intravenous, intramuscular, subcutaneous, or |
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intraspinal infusion; or |
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(C) a Schedule II narcotic substance for a |
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patient with a medical diagnosis documenting a terminal illness or |
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a patient enrolled in a hospice care program certified or paid for |
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by Medicare under Title XVIII, Social Security Act (42 U.S.C. |
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Section 1395 et seq.), as amended, by Medicaid, or by a hospice |
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program that is licensed under Chapter 142, and the practitioner or |
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the practitioner's agent notes on the prescription "terminally ill" |
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or "hospice patient"; and |
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(2) after transmitting the prescription, the |
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prescribing practitioner or the practitioner's agent: |
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(A) writes across the face of the [official] |
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prescription "VOID--sent by fax to (name and telephone number of |
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receiving pharmacy)"; and |
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(B) files the [official] prescription in the |
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patient's medical records instead of delivering it to the patient. |
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(p) On receipt of the prescription, the dispensing pharmacy |
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shall file the facsimile copy of the prescription and shall send |
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information relating to the prescription to the board [director] as |
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required by board rule [Section 481.075]. |
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(q) Each dispensing pharmacist shall send all information |
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required by the board [director], including any information |
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required to complete the Schedule III through V prescription forms, |
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to the board [director] by electronic transfer or another form |
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approved by the board [director] not later than the 15th day after |
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the last day of the month in which the prescription is completely |
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filled. The board shall submit any information received under this |
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section to the director on request. |
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SECTION 6. Section 481.076, Health and Safety Code, is |
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amended to read as follows: |
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Sec. 481.076. [OFFICIAL] PRESCRIPTION INFORMATION. (a) |
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The board [director] may not permit any person to have access to |
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information submitted to the board [director] under Section |
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481.074(q) [or 481.075] except: |
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(1) an investigator for the Texas Medical Board, the |
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Texas State Board of Podiatric Medical Examiners, the State Board |
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of Dental Examiners, or the State Board of Veterinary Medical |
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Examiners[, or the Texas State Board of Pharmacy]; |
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(2) an authorized officer or member of the department |
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engaged in the administration, investigation, or enforcement of |
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this chapter or another law governing illicit drugs in this state or |
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another state; [or] |
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(3) if the board [director] finds that proper need has |
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been shown to the board, [director:
|
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[(A)] a law enforcement or prosecutorial |
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official engaged in the administration, investigation, or |
|
enforcement of this chapter or another law governing illicit drugs |
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in this state or another state; |
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(4) [(B)] a pharmacist or practitioner who is a |
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physician, dentist, veterinarian, podiatrist, or advanced practice |
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nurse or physician assistant described by Section 481.002(39)(D) |
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and is inquiring about a recent Schedule II, III, IV, or V |
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prescription history of a particular patient of the practitioner; |
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or |
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(5) [(C)] a pharmacist or practitioner who is |
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inquiring about the person's own dispensing or prescribing |
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activity. |
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(b) This section does not prohibit the board [director] from |
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creating, using, or disclosing statistical data about information |
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received by the board [director] under this section if the board |
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[director] removes any information reasonably likely to reveal the |
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identity of each patient, practitioner, or other person who is a |
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subject of the information. |
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(c) The board [director] by rule shall design and implement |
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a system for submission of information to the board [director] by |
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electronic or other means and for retrieval of information |
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submitted to the board [director] under this section and Section |
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[Sections] 481.074 [and 481.075]. The board [director] shall use |
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automated information security techniques and devices to preclude |
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improper access to the information. The board [director] shall |
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submit the system design to the director [Texas State Board of
|
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Pharmacy] and the Texas Medical Board for review and approval or |
|
comment a reasonable time before implementation of the system and |
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shall comply with the comments of those agencies unless it is |
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unreasonable to do so. |
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(d) Information submitted to the board [director] under |
|
this section shall be released to the department upon request and |
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may be used by the department or the board only for: |
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(1) the administration, investigation, or enforcement |
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of this chapter or another law governing illicit drugs in this state |
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or another state; |
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(2) investigatory or evidentiary purposes in |
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connection with the functions of an agency listed in Subsection |
|
(a)(1); or |
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(3) dissemination [by the director] to the public in |
|
the form of a statistical tabulation or report if all information |
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reasonably likely to reveal the identity of each patient, |
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practitioner, or other person who is a subject of the information |
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has been removed. |
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(e) The board [director] shall remove from the information |
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retrieval system, destroy, and make irretrievable the record of the |
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identity of a patient submitted under this section to the board |
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[director] not later than the end of the 12th calendar month after |
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the month in which the identity is entered into the system. |
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However, the board or the director may retain a patient identity |
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that is necessary for use in a specific ongoing investigation |
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conducted by the department in accordance with this section until |
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the 30th day after the end of the month in which the necessity for |
|
retention of the identity ends. |
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(f) If the board or the director permits access to |
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information under Subsection (a)(2) relating to a person licensed |
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or regulated by an agency listed in Subsection (a)(1), the director |
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shall notify and cooperate with that agency regarding the |
|
disposition of the matter before taking action against the person, |
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unless the director determines that notification is reasonably |
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likely to interfere with an administrative or criminal |
|
investigation or prosecution. |
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(g) If the board or the director permits access to |
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information under Subsection (a)(3) [(a)(3)(A)] relating to a |
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person licensed or regulated by an agency listed in Subsection |
|
(a)(1), the board or the director shall notify that agency of the |
|
disclosure of the information not later than the 10th working day |
|
after the date the information is disclosed. |
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(h) If the board or the director withholds notification to |
|
an agency under Subsection (f), the board or the director shall |
|
notify the agency of the disclosure of the information and the |
|
reason for withholding notification when the director determines |
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that notification is no longer likely to interfere with an |
|
administrative or criminal investigation or prosecution. |
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(i) Information submitted to the board or the director under |
|
Section 481.074(q) [481.075] is confidential and remains |
|
confidential regardless of whether the board or the director |
|
permits access to the information under this section. |
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SECTION 7. Sections 481.0761(a), (c), and (e), Health and |
|
Safety Code, are amended to read as follows: |
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(a) The board [director] shall consult with the director and |
|
the Texas Medical [State] Board [of Pharmacy] and by rule establish |
|
and revise as necessary a standardized database format that may be |
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used by a pharmacy to transmit the information required by Sections |
|
481.074 [481.074(q)] and 481.076 [481.075(i)] to the board |
|
[director] electronically or to deliver the information on storage |
|
media, including disks, tapes, and cassettes. |
|
(c) The board [director] by rule may: |
|
(1) permit more than one prescription to be |
|
administered or dispensed and recorded on one prescription form for |
|
a Schedule III through V controlled substance; |
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(2) [remove from or return to the official
|
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prescription program any aspect of a practitioner's or pharmacist's
|
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hospital practice, including administering or dispensing;
|
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[(3)] waive or delay any requirement relating to the |
|
time or manner of reporting; |
|
(3) [(4)] establish compatibility protocols for |
|
electronic data transfer hardware, software, or format; |
|
(4) [(5)] establish a procedure to control the release |
|
of information under Sections 481.074[, 481.075,] and 481.076; and |
|
(5) [(6)] establish a minimum level of prescription |
|
activity below which a reporting activity may be modified or |
|
deleted. |
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(e) In adopting a rule relating to the electronic transfer |
|
of information under this subchapter, the board [director] shall |
|
consider the economic impact of the rule on practitioners and |
|
pharmacists and, to the extent permitted by law, act to minimize any |
|
negative economic impact, including the imposition of costs related |
|
to computer hardware or software or to the transfer of |
|
information. The board [director] may not adopt a rule relating to |
|
the electronic transfer of information under this subchapter that |
|
imposes a fee in addition to the fees authorized by Section 481.064. |
|
SECTION 8. Section 481.127(a), Health and Safety Code, is |
|
amended to read as follows: |
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(a) A person commits an offense if the person knowingly |
|
gives, permits, or obtains unauthorized access to information |
|
submitted to the board [director] under Section 481.074 [481.075]. |
|
SECTION 9. Section 481.128(a), Health and Safety Code, is |
|
amended to read as follows: |
|
(a) A registrant or dispenser commits an offense if the |
|
registrant or dispenser knowingly: |
|
(1) distributes, delivers, administers, or dispenses |
|
a controlled substance in violation of Sections 481.070-481.074 |
|
[481.070-481.075]; |
|
(2) manufactures a controlled substance not |
|
authorized by the person's registration or distributes or dispenses |
|
a controlled substance not authorized by the person's registration |
|
to another registrant or other person; |
|
(3) refuses or fails to make, keep, or furnish a |
|
record, report, notification, order form, statement, invoice, or |
|
information required by this chapter; |
|
(4) prints, manufactures, possesses, or produces an |
|
official prescription form without the approval of the director; |
|
(5) delivers or possesses a counterfeit official |
|
prescription form; |
|
(6) refuses an entry into a premise for an inspection |
|
authorized by this chapter; |
|
(7) [refuses or fails to return an official
|
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prescription form as required by Section 481.075(k);
|
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[(8)] refuses or fails to make, keep, or furnish a |
|
record, report, notification, order form, statement, invoice, or |
|
information required by a rule adopted by the director; or |
|
(8) [(9)] refuses or fails to maintain security |
|
required by this chapter or a rule adopted under this chapter. |
|
SECTION 10. Section 552.118, Government Code, is amended to |
|
read as follows: |
|
Sec. 552.118. EXCEPTION: [OFFICIAL] PRESCRIPTION |
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INFORMATION [FORM]. Information is excepted from the requirements |
|
of Section 552.021 if it is: |
|
(1) information on or derived from an official |
|
prescription form filed with the director of the Department of |
|
Public Safety under Section 481.075, Health and Safety Code, as |
|
that section existed before September 1, 2010; or |
|
(2) other information collected under Section |
|
481.074(q) or 481.075, Health and Safety Code, as that section |
|
existed before September 1, 2010 [of that code]. |
|
SECTION 11. Section 565.003(b), Occupations Code, is |
|
amended to read as follows: |
|
(b) Unless compliance would violate the pharmacy or drug |
|
statutes or rules in the state in which the pharmacy is located the |
|
board may discipline an applicant for or the holder of a Class E |
|
pharmacy license if the board finds that the applicant or license |
|
holder has failed to comply with: |
|
(1) Section 481.074 [or 481.075], Health and Safety |
|
Code; |
|
(2) Texas substitution requirements regarding: |
|
(A) the practitioner's directions concerning |
|
generic substitution; |
|
(B) the patient's right to refuse generic |
|
substitution; or |
|
(C) notification to the patient of the patient's |
|
right to refuse substitution; |
|
(3) any board rule relating to providing drug |
|
information to the patient or the patient's agent in written form or |
|
by telephone; or |
|
(4) any board rule adopted under Section 554.051(a) |
|
and determined by the board to be applicable under Section |
|
554.051(b). |
|
SECTION 12. The following provisions are repealed: |
|
(1) Section 481.002(47), Health and Safety Code; |
|
(2) Section 481.075, Health and Safety Code; |
|
(3) Sections 481.0761(b), (d), and (f), Health and |
|
Safety Code; |
|
(4) Subchapter H, Chapter 481, Health and Safety Code; |
|
(5) Section 157.059(c), Occupations Code; and |
|
(6) Sections 7 and 8, Chapter 1391 (S.B. 1879), Acts of |
|
the 80th Legislature, Regular Session, 2007. |
|
SECTION 13. (a) An advisory committee is created to advise |
|
the Texas State Board of Pharmacy on the implementation of this Act. |
|
(b) The advisory committee is composed of: |
|
(1) the executive director of the Texas State Board of |
|
Pharmacy or the executive director's designee; |
|
(2) the public safety director of the Department of |
|
Public Safety or the director's designee; |
|
(3) a physician appointed by the governor; |
|
(4) a pharmacist appointed by the governor; |
|
(5) a physician appointed by the lieutenant governor; |
|
(6) a pharmacist appointed by the lieutenant governor; |
|
(7) a physician appointed by the governor from a list |
|
of names submitted by the speaker of the house of representatives; |
|
(8) a pharmacist appointed by the governor from a list |
|
of names submitted by the speaker of the house of representatives; |
|
and |
|
(9) one member from each of the following boards: |
|
(A) the Texas Medical Board; |
|
(B) the Texas State Board of Pharmacy; |
|
(C) the State Board of Dental Examiners; and |
|
(D) the Texas Board of Nursing. |
|
(c) The executive director of the Texas State Board of |
|
Pharmacy or the executive director's designee is the presiding |
|
officer of the advisory committee. The committee shall meet at the |
|
call of the presiding officer or at the request of any three members |
|
other than the presiding officer. |
|
(d) The advisory committee shall: |
|
(1) develop recommendations regarding the |
|
implementation of an electronic controlled substance monitoring |
|
system that would be used for prescriptions of controlled |
|
substances listed in Schedule II through V as established under |
|
Subchapter B, Chapter 481, Health and Safety Code; |
|
(2) develop recommendations as to which data should be |
|
provided to the Texas State Board of Pharmacy to support a |
|
controlled substance monitoring system recommended under |
|
Subdivision (1), including provider identification information; |
|
(3) monitor and develop recommendations regarding the |
|
implementation and enforcement of a controlled substance |
|
monitoring system recommended under Subdivision (1); |
|
(4) develop recommended procedures necessary for |
|
real-time point-of-service access for a practitioner authorized to |
|
prescribe or dispense controlled substances listed in Schedule II |
|
through V to enable the practitioner to obtain: |
|
(A) the prescription history for a particular |
|
patient; or |
|
(B) the practitioner's own dispensing or |
|
prescribing activity; and |
|
(5) develop recommended procedures that should be |
|
followed by the Texas State Board of Pharmacy and the applicable |
|
licensing authority of this state, another state, or the United |
|
States when: |
|
(A) the Texas State Board of Pharmacy shares |
|
information related to the diversion of controlled substances with |
|
a licensing authority for the purpose of licensing enforcement; or |
|
(B) a licensing authority shares information |
|
related to diversion of controlled substances with the department |
|
for the purpose of criminal enforcement. |
|
(e) The executive director or the executive director's |
|
designee of the Texas State Board of Pharmacy shall report the |
|
recommendations developed under Subsection (d) of this section to |
|
the governor, the lieutenant governor, speaker of the house of |
|
representatives, and appropriate committees of the senate and the |
|
house of representatives not later than July 1, 2011. |
|
(f) This section expires and the advisory committee is |
|
abolished on September 1, 2011. |
|
SECTION 14. (a) The Department of Public Safety, Texas |
|
Medical Board, Texas State Board of Pharmacy, State Board of Dental |
|
Examiners, and Texas Board of Nursing shall submit to the presiding |
|
officers of the Senate Committee on Health and Human Services and |
|
the House Committee on Public Health a report that details the |
|
number and type of actions relating to the prosecution of |
|
violations of Chapter 481, Health and Safety Code, as amended by |
|
this Act. |
|
(b) Each agency shall submit its initial report under |
|
Subsection (a) of this section not later than November 1, 2009. |
|
Each agency shall submit an update of its initial report not later |
|
than May 1 and November 1 of each year. |
|
(c) This section expires November 1, 2013. |
|
SECTION 15. (a) The Texas State Board of Pharmacy and the |
|
public safety director of the Department of Public Safety shall |
|
enter into the memorandum of understanding required by Section |
|
481.003, Health and Safety Code, as amended by this Act, not later |
|
than January 1, 2010. |
|
(b) The Texas State Board of Pharmacy shall adopt any rules |
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required by Chapter 481, Health and Safety Code, as amended by this |
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Act, not later than September 1, 2010. |
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(c) Not later than September 1, 2010, the Department of |
|
Public Safety shall transfer the records received under Sections |
|
481.074, 481.076, and 481.0761, Health and Safety Code, to the |
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Texas State Board of Pharmacy. |
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(d) A rule, form, policy, procedure, or decision adopted |
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under Chapter 481, Health and Safety Code, as it existed before |
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amendment by this Act, continues in effect as a rule, form, policy, |
|
procedure, or decision and remains in effect until amended or |
|
replaced. |
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(e) A reference in law or an administrative rule to the |
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public safety director of the Department of Public Safety relating |
|
to rulemaking authority given and duties transferred to the Texas |
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State Board of Pharmacy by this Act is a reference to the Texas |
|
State Board of Pharmacy. |
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SECTION 16. The changes in law made by this Act in amending |
|
Sections 481.074, 481.076, and 481.127, Health and Safety Code, and |
|
in repealing Sections 481.002(47) and 481.075, Health and Safety |
|
Code, and Section 157.059(c), Occupations Code, take effect |
|
September 1, 2010. |
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SECTION 17. Except as otherwise provided by this Act, this |
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Act takes effect September 1, 2009. |