Senate Bill sb0518c1
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Florida Senate - 2007 CS for SB 518
By the Committee on Criminal Justice; and Senators Saunders,
Bennett and Deutch
591-2354-07
1 A bill to be entitled
2 An act relating to controlled substances;
3 creating s. 831.311, F.S.; prohibiting the
4 sale, manufacture, alteration, delivery,
5 uttering, or possession of
6 counterfeit-resistant prescription blanks for
7 controlled substances; providing penalties;
8 amending s. 893.04, F.S.; providing additional
9 requirements for the dispensing of a controlled
10 substance listed in Schedule II, Schedule III,
11 or Schedule IV; specifying circumstances under
12 which a pharmacist who dispenses controlled
13 substances by mail is exempt from certain
14 requirements governing patient identification;
15 providing requirements and limitations for
16 dispensing controlled substances upon an oral
17 prescription; creating s. 893.055, F.S.;
18 defining terms; requiring the Agency for Health
19 Care Administration to contract for the
20 creation of a website to provide private-sector
21 medication history to certain pharmacies and
22 health care practitioners; providing
23 limitations on use; providing for liability for
24 the improper release of any confidential
25 information; precluding the use of specified
26 legal defenses by defendants in certain
27 actions; providing penalties; creating s.
28 893.065, F.S.; requiring the department to
29 develop and adopt by rule the form and content
30 for a counterfeit-proof prescription blank for
31 voluntary use by physicians in prescribing a
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Florida Senate - 2007 CS for SB 518
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1 controlled substance listed in Schedule II,
2 Schedule III, or Schedule IV; providing an
3 appropriation and authorizing additional
4 positions; providing for the contingent
5 applicability of penalties; providing a
6 contingent effective date.
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8 Be It Enacted by the Legislature of the State of Florida:
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10 Section 1. Section 831.311, Florida Statutes, is
11 created to read:
12 831.311 Unlawful sale, manufacture, alteration,
13 delivery, uttering, or possession of counterfeit-resistant
14 prescription blanks for controlled substances.--
15 (1) It is unlawful for any person having the intent to
16 injure or defraud any person or to facilitate any violation of
17 s. 893.13 to sell, manufacture, alter, deliver, utter, or
18 possess any counterfeit-resistant prescription blanks for
19 controlled substances, the form and content of which are
20 adopted by rule of the Department of Health pursuant to s.
21 893.065.
22 (2) Any person who violates this section commits a
23 felony of the third degree, punishable as provided in s.
24 775.082, s. 775.083, or s. 775.084.
25 Section 2. Section 893.04, Florida Statutes, is
26 amended to read:
27 893.04 Pharmacist and practitioner.--
28 (1) A pharmacist, in good faith and in the course of
29 professional practice only, may dispense controlled substances
30 upon a written or oral prescription of a practitioner, under
31 the following conditions:
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Florida Senate - 2007 CS for SB 518
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1 (a) Oral prescriptions must be promptly reduced to
2 writing by the pharmacist or recorded electronically if
3 permitted by federal law.
4 (b) The written prescription must be dated and signed
5 by the prescribing practitioner on the day when issued.
6 (c) There shall appear on the face of the prescription
7 or written record thereof for the controlled substance the
8 following information:
9 1. The full name and address of the person for whom,
10 or the owner of the animal for which, the controlled substance
11 is dispensed.
12 2. The full name and address of the prescribing
13 practitioner and the practitioner's federal controlled
14 substance registry number shall be printed thereon.
15 3. If the prescription is for an animal, the species
16 of animal for which the controlled substance is prescribed.
17 4. The name of the controlled substance prescribed and
18 the strength, quantity, and directions for use thereof.
19 5. The number of the prescription, as recorded in the
20 prescription files of the pharmacy in which it is filled.
21 6. The initials of the pharmacist filling the
22 prescription and the date filled.
23 (d) The prescription shall be retained on file by the
24 proprietor of the pharmacy in which it is filled for a period
25 of 2 years.
26 (e) Affixed to the original container in which a
27 controlled substance is delivered upon a prescription or
28 authorized refill thereof, as hereinafter provided, there
29 shall be a label bearing the following information:
30 1. The name and address of the pharmacy from which
31 such controlled substance was dispensed.
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Florida Senate - 2007 CS for SB 518
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1 2. The date on which the prescription for such
2 controlled substance was filled.
3 3. The number of such prescription, as recorded in the
4 prescription files of the pharmacy in which it is filled.
5 4. The name of the prescribing practitioner.
6 5. The name of the patient for whom, or of the owner
7 and species of the animal for which, the controlled substance
8 is prescribed.
9 6. The directions for the use of the controlled
10 substance prescribed in the prescription.
11 7. A clear, concise warning that it is a crime to
12 transfer the controlled substance to any person other than the
13 patient for whom prescribed.
14 (f) A prescription for a controlled substance listed
15 in Schedule II may be dispensed only upon a written
16 prescription of a practitioner, except that in an emergency
17 situation, as defined by regulation of the Department of
18 Health, such controlled substance may be dispensed upon oral
19 prescription but is limited to a 72-hour supply. A No
20 prescription for a controlled substance listed in Schedule II
21 may not be refilled.
22 (g) A No prescription for a controlled substance
23 listed in Schedule Schedules III, Schedule IV, or Schedule V
24 may not be filled or refilled more than five times within a
25 period of 6 months after the date on which the prescription
26 was written unless the prescription is renewed by a
27 practitioner.
28 (2)(a) A pharmacist may not dispense a controlled
29 substance listed in Schedule II, Schedule III, or Schedule IV
30 to any patient or patient's agent without first determining,
31 in the exercise of her or his professional judgment, that the
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1 order is valid. The pharmacist may dispense the controlled
2 substance, in the exercise of her or his professional
3 judgment, when the pharmacist or pharmacist's agent has
4 obtained satisfactory patient information from the patient or
5 the patient's agent.
6 (b) Any pharmacist who dispenses by mail a controlled
7 substance listed in Schedule II, Schedule III, or Schedule IV
8 is exempt from the requirement to obtain suitable
9 identification for the prescription dispensed by mail if the
10 pharmacist has obtained the patient's identification through
11 the patient's prescription benefit plan.
12 (c) Any controlled substance listed in Schedule III or
13 Schedule IV may be dispensed by a pharmacist upon an oral
14 prescription if, before filling the prescription, the
15 pharmacist reduces it to writing or records the prescription
16 electronically if permitted by federal law. Such prescriptions
17 must contain the date of the oral authorization.
18 (d) Each written prescription prescribed by a
19 practitioner in this state for a controlled substance listed
20 in Schedule II, Schedule III, or Schedule IV must include both
21 a written and a numerical notation of the quantity on the face
22 of the prescription and a notation of the date, with the
23 abbreviated month written out on the face of the prescription.
24 A pharmacist may, upon verification by the prescriber,
25 document any information required by this paragraph.
26 (e) A pharmacist may not dispense more than a 30-day
27 supply of a controlled substance listed in Schedule III upon
28 an oral prescription issued in this state.
29 (f) A pharmacist may not knowingly fill a prescription
30 that has been forged for a controlled substance listed in
31 Schedule II, Schedule III, or Schedule IV.
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1 (3)(2) Notwithstanding the provisions of subsection
2 (1), a pharmacist may dispense a one-time emergency refill of
3 up to a 72-hour supply of the prescribed medication for any
4 medicinal drug other than a medicinal drug listed in Schedule
5 II, in compliance with the provisions of s. 465.0275.
6 (4)(3) The legal owner of any stock of controlled
7 substances in a pharmacy, upon discontinuance of dealing in
8 controlled substances, may sell said stock to a manufacturer,
9 wholesaler, or pharmacy. Such controlled substances may be
10 sold only upon an order form, when such an order form is
11 required for sale by the drug abuse laws of the United States
12 or this state, or regulations pursuant thereto.
13 Section 3. Section 893.055, Florida Statutes, is
14 created to read:
15 893.055 Prescription drug history.--
16 (1) As used in this section, the term:
17 (a) "Agency" means the Agency for Health Care
18 Administration.
19 (b) "Department" means the Department of Health.
20 (c) "Federal privacy laws" means the provisions
21 relating to the disclosure of patient privacy information
22 under federal law, including, but not limited to, the Health
23 Insurance Portability and Accountability Act of 1996 (HIPAA),
24 Pub. L. No. 104-91, and its implementing regulations, the
25 Federal Privacy Act, 5 U.S.C. s. 552(a), and its implementing
26 regulations, and any other federal law, including, but not
27 limited to, federal common law and decisional law that would
28 prohibit the disclosure of patient privacy information.
29 (d) "Health care practitioner" means, with the
30 exception of a pharmacist, a practitioner licensed under
31 chapter 456 and authorized by law to prescribe drugs.
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1 (e) "Pharmacy" means a pharmacy subject to licensure
2 or regulation by the department under chapter 465 which
3 dispenses or delivers a controlled substance listed in
4 Schedule II, Schedule III, or Schedule IV to a patient in this
5 state.
6 (2)(a) By June 30, 2008, the agency shall contract
7 with a vendor for the design and operation of a secure,
8 privacy-protected website that provides a health care
9 practitioner, pharmacy, or pharmacist access to comprehensive
10 patient medication history. In order to provide comprehensive
11 patient medication history, the agency shall require the
12 contracted vendor to subcontract with private-sector
13 organizations that currently operate electronic prescribing
14 networks that provide such medication history.
15 (b) The contracted vendor shall comply with all
16 applicable state and federal privacy laws and maintain the
17 website within the United States.
18 (c) The contracted vendor must create a system to
19 verify with the department that each health care practitioner,
20 pharmacy, or pharmacist requesting access to the website holds
21 a valid, active license.
22 (3) A health care practitioner authorized to access
23 the website may use only the website to obtain medication
24 history for a current patient for prescribing purposes with
25 the written permission of the patient.
26 (4) A pharmacy or pharmacist authorized to access the
27 website may use only the website to obtain medication history
28 in dispensing a current prescription for Schedule II, Schedule
29 III, or Schedule IV medicinal drugs with the written
30 permission of the patient. The pharmacy or pharmacist may not
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Florida Senate - 2007 CS for SB 518
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1 have access to pharmacy-identifying information within a
2 patient's medication history.
3 (5) Recovery is not allowed in any court in this state
4 against a health care practitioner, pharmacy, or pharmacist
5 authorized to obtain information under this section for
6 accessing or failing to access such information.
7 (6) A violation of this section by a health care
8 practitioner, pharmacy, or pharmacist constitutes grounds for
9 disciplinary action under each respective licensing chapter
10 and s. 456.072(1)(k).
11 (7) Any contractor entering into a contract under this
12 section is liable in tort for the improper release of any
13 confidential information received, in addition to any breach
14 of contract liability. Sovereign immunity may not be raised by
15 the contractor, or the insurer of that contractor on the
16 contractor's behalf, as a defense in any action arising out of
17 the performance of any contract entered into under this
18 section, as a defense in tort, in any other application
19 regarding the maintenance of confidentiality of information,
20 or for any breach of contract.
21 Section 4. Section 893.065, Florida Statutes, is
22 created to read:
23 893.065 Counterfeit-resistant prescription blanks for
24 controlled substances listed in Schedule II, Schedule III, or
25 Schedule IV.--The Department of Health shall develop and adopt
26 by rule the form and content for a counterfeit-resistant
27 prescription blank which may be used by practitioners for the
28 purpose of prescribing a controlled substance listed in
29 Schedule II, Schedule III, or Schedule IV. The Department of
30 Health may require the prescription blanks to be printed on
31 distinctive, watermarked paper and to bear the preprinted
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Florida Senate - 2007 CS for SB 518
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1 name, address, and category of professional licensure of the
2 practitioner and that practitioner's federal registry number
3 for controlled substances. The prescription blanks may not be
4 transferred.
5 Section 5. The sum of $2,564,670 in recurring general
6 revenue funds and $1,837,677 in nonrecurring general revenue
7 funds are appropriated to the Department of Health to
8 implement the provisions of this bill. Three additional
9 full-time equivalent positions are authorized for the
10 2007-2008 fiscal year to implement the provisions of ss.
11 893.055 and 893.065, Florida Statutes, as created by this act.
12 Section 6. The penalties created in ss. 831.311(2) and
13 893.055(7), Florida Statutes, by this act shall take effect
14 only upon the adoption by the Department of Health and each
15 applicable professional regulatory board of the rules required
16 pursuant to ss. 893.055(8) and 893.065, Florida Statutes, as
17 created by this act.
18 Section 7. Except as otherwise expressly provided in
19 this act, this act shall take effect July 1, 2007, if Senate
20 Bill 520, or similar legislation, is adopted in the same
21 legislative session or an extension thereof and becomes law.
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Florida Senate - 2007 CS for SB 518
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1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 Senate Bill 518
3
4 - Precludes a pharmacist from dispensing a controlled
substance listed in Schedule II, III, or IV to any
5 patient or patient's agent without first determining, in
the exercise of her or his professional judgment, that
6 the order is valid, but authorizes a pharmacist to
dispense the controlled substance, in the exercise of her
7 or his professional judgment, when the pharmacist or
pharmacist's agent has obtained satisfactory patient
8 information from the patient or the patient's agent.
9 - Provides that, by June 30, 2008, the Agency for Health
Care Administration (AHCA) must contract with a vendor
10 for the design and operation of a secure,
privacy-protected website that provides a health care
11 practitioner, pharmacy, or pharmacist access to
comprehensive patient medication history, which is
12 provided by the AHCA requiring the contracted vendor to
subcontract with private-sector organizations that
13 currently operate electronic prescribing networks that
provide such medication history.
14
- Requires the contracted vendor to comply with all
15 applicable state and federal privacy laws and maintain
the website within the United States, and create a system
16 to verify with the Department of Health that each health
care practitioner, pharmacy, or pharmacist requesting
17 access to the website holds a valid, active license.
18 - Provides that a health care practitioner authorized to
access the website may use only the website to obtain
19 medication history for a current patient for prescribing
purposes with the written permission of the patient, and
20 a pharmacy or pharmacist with this authorization may use
only the website to obtain medication history in
21 dispensing a current prescription for Schedule II, III,
or IV medicinal drugs with the written permission of the
22 patient.
23 - Precludes the pharmacy or pharmacist from access to
pharmacy-identifying information within a patient's
24 medication history.
25 - Disallows recovery in any Florida court against a health
care practitioner, pharmacy, or pharmacist authorized to
26 obtain information for accessing or failing to access
such information.
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- Provides that a health care practitioner, pharmacy, or
28 pharmacist who violates requirements pertaining to the
website constitutes grounds for disciplinary action.
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- Provides that any contractor entering into a contract is
30 liable in tort for the improper release of any
confidential information received, in addition to any
31 breach of contract liability.
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Florida Senate - 2007 CS for SB 518
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1 - Provides that sovereign immunity may not be raised by the
contractor or the insurer of that contractor on the
2 contractor's behalf as a defense in any action arising
out of the performance of any contract, as a defense in
3 tort, in any other application regarding the maintenance
of confidentiality of information, or for any breach of
4 contract.
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