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A bill to be entitled |
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An act relating to controlled substances; creating s. |
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831.311, F.S.; prohibiting the sale, manufacture, |
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alteration, delivery, uttering, or possession of |
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counterfeit-resistant prescription blanks for controlled |
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substances; providing penalties; amending s. 893.04, F.S.; |
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providing additional requirements for the dispensing of a |
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controlled substance listed in Schedule II, Schedule III, |
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or Schedule IV; providing rulemaking authority to the |
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Board of Pharmacy; creating s. 893.055, F.S.; requiring |
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the Department of Health to establish an electronic system |
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to monitor the prescribing of controlled substances listed |
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in Schedules II, III, and IV; requiring the dispensing of |
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such controlled substances to be reported through the |
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system; providing exceptions; providing reporting |
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requirements; providing penalties; requiring the |
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department and regulatory boards to adopt rules; requiring |
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the department to cover all costs for the system, subject |
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to availability of funds; providing a continuing |
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appropriation; providing that a certain trust fund may not |
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be used to fund the program; providing for future |
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legislative review and repeal; creating s. 893.065, F.S.; |
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requiring the department to develop and adopt by rule the |
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form and content for a counterfeit-proof prescription |
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blank for voluntary use by physicians to prescribe a |
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controlled substance listed in Schedule II, Schedule III, |
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or Schedule IV; providing an appropriation and authorizing |
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positions; providing contingent applicability of |
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penalties; providing contingent effective dates. |
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Be It Enacted by the Legislature of the State of Florida: |
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Section 1. Section 831.311, Florida Statutes, is created |
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to read: |
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831.311 Unlawful sale, manufacture, alteration, delivery, |
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uttering, or possession of counterfeit-resistant prescription |
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blanks for controlled substances listed in Schedules II, III, |
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and IV.-- |
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(1) It is unlawful for any person with the intent to |
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injure or defraud any person or to facilitate any violation of |
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s. 893.13 to sell, manufacture, alter, deliver, utter, or |
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possess any counterfeit-resistant prescription blanks for |
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controlled substances adopted by rule of the Department of |
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Health pursuant to s. 893.065. |
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(2) Any person who violates this section commits a felony |
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of the third degree, punishable as provided in s. 775.082, s. |
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775.083, or s. 775.084. |
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Section 2. Section 893.04, Florida Statutes, is amended to |
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read: |
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893.04 Pharmacist and practitioner.-- |
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(1) A pharmacist, in good faith and in the course of |
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professional practice only, may dispense controlled substances |
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upon a written or oral prescription of a practitioner, under the |
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following conditions: |
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(a) Oral prescriptions must be promptly reduced to writing |
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by the pharmacist or recorded electronically. |
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(b) The written prescription must be dated and signed by |
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the prescribing practitioner on the day when issued. |
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(c) There shall appear on the face of the prescription or |
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written record thereof for the controlled substance the |
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following information: |
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1. The full name and address of the person for whom, or |
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the owner of the animal for which, the controlled substance is |
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dispensed. |
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2. The full name and address of the prescribing |
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practitioner and the practitioner's federal controlled substance |
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registry number shall be printed thereon. |
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3. If the prescription is for an animal, the species of |
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animal for which the controlled substance is prescribed. |
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4. The name of the controlled substance prescribed and the |
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strength, quantity, and directions for use thereof. |
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5. The number of the prescription, as recorded in the |
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prescription files of the pharmacy in which it is filled. |
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6. The initials of the pharmacist filling the prescription |
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and the date filled. |
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(d) The prescription shall be retained on file by the |
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proprietor of the pharmacy in which it is filled for a period of |
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2 years. |
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(e) Affixed to the original container in which a |
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controlled substance is delivered upon a prescription or |
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authorized refill thereof, as hereinafter provided, there shall |
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be a label bearing the following information: |
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1. The name and address of the pharmacy from which such |
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controlled substance was dispensed. |
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2. The date on which the prescription for such controlled |
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substance was filled. |
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3. The number of such prescription, as recorded in the |
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prescription files of the pharmacy in which it is filled. |
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4. The name of the prescribing practitioner. |
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5. The name of the patient for whom, or of the owner and |
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species of the animal for which, the controlled substance is |
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prescribed. |
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6. The directions for the use of the controlled substance |
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prescribed in the prescription. |
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7. A clear, concise warning that it is a crime to transfer |
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the controlled substance to any person other than the patient |
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for whom prescribed. |
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(f) A prescription for a controlled substance listed in |
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Schedule II may be dispensed only upon a written prescription of |
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a practitioner, except that in an emergency situation, as |
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defined by regulation of the Department of Health, such |
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controlled substance may be dispensed upon oral prescription but |
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is limited to a 72-hour supply. No prescription for a controlled |
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substance listed in Schedule II may be refilled. |
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(g) No prescription for a controlled substance listed in |
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Schedule Schedules III, Schedule IV, or ScheduleV may be filled |
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or refilled more than five times within a period of 6 months |
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after the date on which the prescription was written unless the |
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prescription is renewed by a practitioner. |
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(2)(a) A pharmacist may not dispense a controlled |
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substance listed in Schedule II, Schedule III, or Schedule IV to |
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any patient or patient's agent without first determining, in the |
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exercise of her or his professional judgment, that the order is |
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valid. The pharmacist or pharmacist's agent must also obtain |
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the patient or patient's agent identification information, in |
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writing, electronic format, or other approved manner prior to |
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dispensing any controlled substance. If the patient or patient's |
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agent does not have appropriate identification, the pharmacist |
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may dispense the controlled substance only when the pharmacist |
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determines, in the exercise of her or his professional judgment, |
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that the order is valid and includes such information in the |
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patient's record. The Board of Pharmacy may adopt, by rule, |
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required patient identification information for controlled |
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substances and procedures for a pharmacist to verify the |
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validity of a prescription for controlled substances for |
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circumstances in which the pharmacist was not provided required |
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identification information. |
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(b) Any pharmacist that dispenses by mail a controlled |
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substance listed in Schedule II, Schedule III, or Schedule IV |
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shall be exempt from the requirement to obtain suitable |
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identification for the prescription dispensed by mail. |
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(c) Any controlled substance listed in Schedule III or |
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Schedule IV may be dispensed by a pharmacist upon an oral |
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prescription if, before filling the prescription, the pharmacist |
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reduces it to writing or records the prescription |
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electronically. Such prescriptions must contain the date of the |
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oral authorization. |
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(d) Each written prescription prescribed by a practitioner |
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in this state for a controlled substance listed in Schedule II, |
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Schedule III, or Schedule IV must include both a written and a |
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numerical notation of the quantity on the face of the |
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prescription and a notation of the date with the abbreviated |
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month written out on the face of the prescription. A pharmacist |
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shall be permitted, upon verification by the prescriber, to |
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document any information required by this paragraph. |
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(e) A pharmacist may not dispense more than a 30-day |
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supply of a controlled substance listed in Schedule III upon an |
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oral prescription issued in this state. |
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(f) A pharmacist may not knowingly fill a prescription |
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that has been forged for a controlled substance listed in |
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Schedule II, Schedule III, or Schedule IV. |
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(3)(2)Notwithstanding the provisions of subsection (1), a |
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pharmacist may dispense a one-time emergency refill of up to a |
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72-hour supply of the prescribed medication for any medicinal |
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drug other than a medicinal drug listed in Schedule II, in |
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compliance with the provisions of s. 465.0275. |
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(4)(3)The legal owner of any stock of controlled |
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substances in a pharmacy, upon discontinuance of dealing in |
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controlled substances, may sell said stock to a manufacturer, |
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wholesaler, or pharmacy. Such controlled substances may be sold |
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only upon an order form, when such an order form is required for |
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sale by the drug abuse laws of the United States or this state, |
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or regulations pursuant thereto. |
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Section 3. Effective July 1, 2004, subsection (1) of |
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section 893.055, Florida Statutes, is created, and effective |
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July 1, 2005, subsections (2) through (9) of said section are |
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created, to read: |
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893.055 Electronic monitoring system for prescription of |
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controlled substances listed in Schedules II, III, and IV.-- |
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(1) By June 30, 2005, the Department of Health shall |
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design and establish an electronic system consistent with the |
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American Society for Automation in Pharmacy (ASAP) standards to |
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monitor the prescribing and dispensing of controlled substances |
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listed in Schedules II, III, and IV by health care practitioners |
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within the state and the dispensing of such controlled |
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substances to an individual at a specific address within the |
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state by a pharmacy permitted or registered by the Board of |
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Pharmacy. The system shall be put into operation on July 1, |
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2005. |
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(2) Any controlled substance listed in Schedule II, |
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Schedule III, or Schedule IV which is dispensed to an individual |
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in this state must be reported to the Department of Health |
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through the system, as soon thereafter as possible but not more |
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than 35 days after the date the controlled substance is |
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dispensed, each time the controlled substance is dispensed. A |
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pharmacy may meet the reporting requirements of this section by |
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providing the Department of Health an exchangeable electronic |
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disc or tape of each controlled substance listed in Schedules |
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II, III, and IV which it dispenses. |
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(3) This section does not apply to controlled substances: |
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(a) Administered by a health care practitioner directly to |
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a patient. |
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(b) Dispensed by a health care practitioner authorized to |
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prescribe controlled substances directly to a patient and |
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limited to an amount adequate to treat the patient for a period |
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of no more than 72 hours. |
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(c) Dispensed by a health care practitioner or a |
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pharmacist to an inpatient of a facility with an institutional |
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pharmacy permit. |
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(d) Ordered from an institutional pharmacy permitted under |
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s. 465.019 in accordance with the institutional policy for such |
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controlled substances or drugs. |
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(e) Either dispensed by a pharmacist or administered by a |
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health care practitioner to a patient or resident receiving care |
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from a hospital, nursing home, assisted living facility, home |
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health agency, hospice, or intermediate care facility for the |
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developmentally disabled which is licensed in this state. |
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(f) Prescribed by a health care practitioner for a patient |
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younger than 16 years of age. |
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(4) The data required to be reported under this section |
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shall be determined by the Department of Health by rule but may |
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include any data required under s. 893.04. |
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(5) A practitioner or pharmacist who dispenses a |
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controlled substance under this section must submit the |
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information required by this section in an electronic or other |
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format approved by rule of the Department of Health. The cost to |
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the dispenser in submitting the information required by this |
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subsection may not be material or extraordinary. Costs not |
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considered to be material or extraordinary include, but are not |
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limited to, regular postage, compact discs, zip drive storage, |
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regular electronic mail, magnetic tapes, diskettes, and |
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facsimile charges. The information submitted to the Department |
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of Health under this section may be transmitted to any person or |
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agency authorized to receive it pursuant to House Bill 399, or |
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similar legislation, and that person or agency may maintain the |
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information received for up to 24 months before purging it from |
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its records. All transmissions required by this paragraph must |
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comply with relevant federal and state privacy and security |
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laws. However, any authorized agency receiving such information |
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may maintain it longer than 24 months if the information is |
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pertinent to an ongoing investigation or prosecution. |
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(6) Any person who knowingly fails to report the |
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dispensing of a controlled substance listed in Schedule II, |
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Schedule III, or Schedule IV as required by this section commits |
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a misdemeanor of the first degree, punishable as provided in s. |
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775.082 or s. 775.083. |
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(7) The Department of Health and the regulatory boards for |
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the health care practitioners subject to this section shall |
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adopt rules pursuant to ss. 120.536(1) and 120.54 necessary to |
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implement and administer this section. |
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(8) All costs incurred by the Department of Health in |
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implementing the prescription monitoring system shall be borne |
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by the department, subject to the availability of funds, and |
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there is appropriated annually from the Grants and Donations |
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Trust Fund an amount necessary to cover such costs. The Medical |
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Quality Assurance Trust Fund may not be used to implement or |
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otherwise fund this program. |
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(9) This section is repealed June 30, 2008, unless |
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reviewed and saved from repeal through reenactment by the |
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Legislature.
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Section 4. Section 893.065, Florida Statutes, is created |
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to read: |
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893.065 Counterfeit-resistant prescription blanks for |
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controlled substances listed in Schedules II, III, and IV.--The |
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Department of Health shall develop and adopt by rule the form |
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and content for a counterfeit-resistant prescription blank which |
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may be used by practitioners to prescribe a controlled substance |
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listed in Schedule II, Schedule III, or Schedule IV. The |
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Department of Health may require the prescription blanks to be |
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printed on distinctive, watermarked paper and to bear the |
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preprinted name, address, and category of professional licensure |
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of the practitioner and that practitioner's federal registry |
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number for controlled substances. The prescription blanks may |
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not be transferred. |
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Section 5. Effective July 1, 2004, there is appropriated |
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$2,196,352 from the Grants and Donations Trust Fund to the |
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Department of Health, and three full-time equivalent positions |
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are authorized for fiscal year 2004-2005, to implement the |
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provisions of ss. 893.055 and 893.065, Florida Statutes, as |
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created by this act. |
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Section 6. The penalties created in ss. 831.311(2) and |
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893.055(6), Florida Statutes, by this act shall be effective |
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only upon the adoption by the Department of Health and each |
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applicable professional regulatory board of the rules required |
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pursuant to ss. 893.055(7) and 893.065, Florida Statutes, as |
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created by this act. |
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Section 7. Except as otherwise expressly provided in this |
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act, this act shall take effect July 1, 2005, if House Bill 399 |
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or similar legislation is adopted in the same legislative |
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session or an extension thereof and becomes law. |