Senate Bill sb0636e1

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  1                      A bill to be entitled

  2         An act relating to controlled substances;

  3         providing for specified licensing boards to

  4         adopt rules governing the prescribing of

  5         controlled substances; requiring certain health

  6         care providers to complete education courses

  7         relating to the prescription of controlled

  8         substances; providing penalties and requiring a

  9         report; providing for the emergency suspension

10         of certain licenses for prescribing violations;

11         requiring the Department of Health, the

12         Department of Law Enforcement, the Statewide

13         Prosecutor, and State Attorneys to share

14         certain information regarding health care

15         practitioners; requiring a report; requiring

16         the Department of Legal Affairs to establish an

17         electronic system to monitor the prescribing of

18         certain controlled substances; establishing an

19         advisory council and providing for its

20         membership, duties, staff, and compensation;

21         amending s. 456.033, F.S.; eliminating certain

22         requirements for HIV and AIDS education

23         courses; amending s. 456.072, F.S., revising

24         penalties; amending s. 458.345, F.S.; requiring

25         certain resident physicians, interns, and

26         fellows to complete an educational course in

27         prescribing controlled substances; amending s.

28         461.013, F.S.; prohibiting the presigning of

29         blank prescription forms and providing

30         penalties; amending s. 893.04, F.S.; providing

31         additional requirements for pharmacists


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  1         regarding the identification of persons to whom

  2         controlled substances are dispensed;

  3         prohibiting certain prescribing practitioners

  4         from possessing, administering, dispensing, or

  5         prescribing controlled substances; creating s.

  6         893.065, F.S., establishing requirements for

  7         the design, issuance, and prescription forms

  8         developed by the Department of Legal Affairs

  9         for certain controlled substances and drugs;

10         granting rulemaking authority to the Department

11         of Legal Affairs; providing inspection of such

12         forms by the Department of Legal Affairs;

13         providing an effective date.

14

15  Be It Enacted by the Legislature of the State of Florida:

16

17         Section 1.  Physicians; rules establishing prescribing

18  guidelines.--To minimize the diversion and resultant abuse of

19  controlled substances, the Board of Medicine and the Board of

20  Osteopathic Medicine shall adopt rules to establish guidelines

21  for prescribing controlled substances to patients in

22  emergency-department settings. Such guidelines must allow

23  physicians to provide legitimate medical treatment of acute

24  and chronic pain and require them to recognize and prevent

25  abuse of pain medications prescribed in emergency-department

26  settings. The guidelines must also consider requirements of

27  state and federal law and of the Joint Commission on the

28  Accreditation of Healthcare Organizations. Each board shall

29  consult with the Florida College of Emergency Physicians in

30  developing these guidelines.

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  1         Section 2.  Instruction required for certain licensees

  2  in prescribing and pharmacology.--

  3         (1)  The appropriate professional licensing board shall

  4  require each person licensed under chapter 458, chapter 459,

  5  chapter 461, chapter 462, or chapter 466, Florida Statutes, to

  6  complete a 1-hour educational course, approved by the board,

  7  on appropriate prescribing and pharmacology of controlled

  8  substances, as part of the licensee's initial license renewal

  9  after January 1, 2003. The course shall provide education in

10  the state and federal laws and rules governing the prescribing

11  and dispensing of controlled substances; in appropriate

12  evaluation of patients for any risk of drug diversion and the

13  resulting abuse of controlled substances; in the use of

14  informed consent and other protocols, such as discussing the

15  risks and benefits of using controlled substances, with

16  patients to prevent drug diversion; in the need to keep

17  accurate and complete medical records to justify treatment

18  with controlled substances; in addiction and substance-abuse

19  issues with respect to patients; in the appropriate use of

20  recognized pain-management guidelines; and in the need for

21  consultation and referral of patients who are at risk for

22  misuse of medication or diversion of controlled substances,

23  when appropriate.

24         (2)  The board may approve additional equivalent

25  courses that satisfy the requirements of subsection (1). Each

26  licensing board that requires a licensee to complete an

27  educational course pursuant to this section shall include the

28  hours required to complete the course in the total required

29  continuing educational requirements.

30         (3)  Any person who holds two or more licenses subject

31  to this section may satisfy the requirements of this section


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  1  by taking only one such board-approved course for relicensure

  2  of all such licenses.

  3         (4)  A licensee who fails to comply with this section

  4  is subject to disciplinary action under each respective

  5  practice act and section 456.072(1)(k), Florida Statutes. In

  6  addition to discipline by the board, the licensee must

  7  complete the course.

  8         (5)  The board shall require, as a condition of

  9  granting a license under the chapter specified in subsection

10  (1), that an applicant for initial licensure complete an

11  educational course set forth in subsection (1). An applicant

12  who has not taken a course at the time of licensure shall be

13  allowed 6 months within which to complete this requirement.

14         (6)  The board may adopt rules necessary to administer

15  this section.

16         Section 3.  Emergency suspension orders; controlled

17  substances.--Upon receipt of sufficient evidence from any

18  agency authorized to enforce chapter 893, Florida Statutes,

19  regarding a violation of section 458.331(1)(q), section

20  458.331(1)(r), section 458.331(1)(aa), section 459.015(1)(t),

21  section 459.015(1)(u), section 459.015(1)(ee), section

22  461.013(1)(o), section 461.013(1)(p), section 461.013(1)(dd),

23  section 462.14(1)(q), section 462.14(1)(r), section

24  462.14(1)(aa), section 464.018(1)(i), section 465.016(1)(e),

25  section 465.016(1)(i), section 466.028(1)(p), section

26  466.028(1)(q), section 466.028(1)(r), or section

27  466.028(1)(dd) or of chapter 893, Florida Statutes, by a

28  licensed health care practitioner who is authorized to

29  prescribe, dispense, or administer controlled substances, the

30  Department of Health shall review the case and if the

31  practitioner is a danger to the public health, safety, or


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  1  welfare of the public as set forth in section 120.60(6),

  2  Florida Statutes, recommend the suspension or restriction of

  3  the practitioner's license to the Secretary of Health within

  4  10 working days after receiving such evidence. The Secretary

  5  of Health may suspend or restrict the license of the

  6  practitioner in accordance with section 120.60(6), Florida

  7  Statutes.

  8         Section 4.  Sharing of arrest, formal-charging, and

  9  other information regarding health care practitioners.--

10         (1)  In order to facilitate the efficiency of the

11  Department of Health's investigation of applicable violations

12  involving the diversion of controlled substances by such

13  practitioners, or other violations of criminal law that may

14  adversely affect a practitioner's licensed practice, any law

15  enforcement agency that arrests a person known or suspected to

16  be a health care practitioner licensed by the state shall

17  promptly notify the Department of Health and provide it with:

18         (a)  Notice of the arrest, including the name of the

19  arresting agency and lead investigator, detective, or officer

20  in the case;

21         (b)  The name of the person charged;

22         (c)  All known personal identifying information related

23  to the person arrested;

24         (d)  The date of the arrest;

25         (e)  The charges for which the person is arrested;

26         (f)  The agency case number assigned to the arrest; and

27         (g)  The arrest report, investigative report, or

28  statement of the allegations supporting the arrest.

29         (2)  A state attorney or the Statewide Prosecutor, upon

30  the filing of an indictment or information against a person

31  known or suspected to be a health care practitioner licensed


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  1  by the state, shall forward a copy of the indictment or

  2  information to the Department of Health.

  3         (3)  The Medical Examiners Commission within the

  4  Department of Law Enforcement shall report to the Department

  5  of Health quarterly any information in its possession

  6  regarding the deaths of persons who had lethal levels of

  7  controlled substances in their bodies as such information has

  8  been reported to the commission by the medical examiners

  9  within the state.

10         (4)  Upon receipt of arrest information from a law

11  enforcement agency or notice of formal charging by a

12  prosecuting entity, the Department of Health or the board

13  having regulatory authority over the practitioner shall

14  investigate any information received and determine whether it

15  has reasonable grounds to believe that the practitioner has

16  violated any law relating to the practitioner's practice and

17  shall take appropriate licensure action as provided by law or

18  rule. If the Department of Health receives information

19  pursuant to this section which suggests that the person

20  arrested or charged is also licensed by the state in another

21  field or profession, the Department of Health shall forward

22  such information to the appropriate licensing entity for

23  review and appropriate licensure action as provided by law or

24  rule.

25         (5)  To help the Department of Health and regulatory

26  boards control the diversion and resultant abuse of controlled

27  substances, the Department of Health and the Department of Law

28  Enforcement shall study the feasibility of expanding the

29  electronic exchange of information to facilitate the transfer

30  to the Department of Health of criminal-history information

31  involving licensed health care practitioners who are


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  1  authorized to prescribe, administer, or dispense controlled

  2  substances. The study must address whether the collection and

  3  retention of fingerprint information concerning licensed

  4  health care practitioners subject to the profiling provisions

  5  of sections 456.039 and 456.0391, Florida Statutes, is

  6  advisable as a means of better regulating such practitioners

  7  and guarding against abuse of the privileges of such licensure

  8  with respect to controlling the diversion and resultant abuse

  9  of controlled substances. The Department of Law Enforcement

10  shall investigate the feasibility of the electronic

11  transmission of information from medical examiners within this

12  state to the Department of Health regarding autopsies and

13  other public reports that attribute death to

14  controlled-substance abuse. The Department of Law Enforcement,

15  in consultation with the Department of Health, must submit a

16  report of its findings to the Legislature by November 1, 2002.

17         Section 5.  Electronic monitoring system for

18  prescriptions.--

19         (1)  By July 1, 2003, the Department of Legal Affairs

20  shall design and establish an electronic system consistent

21  with the National Council of Prescription Drug Programs

22  (NCPDP) standards or the American Society for Automation in

23  Pharmacy (ASAP) standards to monitor the prescribing of

24  Schedule II controlled substances, other drugs designated by

25  rule by the Attorney General under this section, and codeine,

26  hydrocodone, dihydrocodeine, ethylmorphine, and morphine, as

27  scheduled in Schedule II and Schedule III, by health care

28  practitioners within the state or the dispensing of such

29  controlled substances to an address within the state by a

30  pharmacy permitted or registered by the Board of Pharmacy.

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  1         (2)  All Schedule II controlled substances, and codeine

  2  hydrocodone, dihydrocodeine, ethylmorphine, and morphine as

  3  scheduled in Schedule II and Schedule III, and any other drug

  4  designated by the Attorney General under this section shall be

  5  included in the electronic monitoring system. The Attorney

  6  General may, by rule, designate any other drug for inclusion

  7  in such system after making a determination that the drug is a

  8  drug of abuse. The Attorney General must consider the

  9  recommendations of the prescription-monitoring advisory

10  council created by this section before designating a drug of

11  abuse for inclusion in the electronic monitoring system and

12  only after he or she determines that the current level of

13  regulation over the prescribing and dispensing of such drug is

14  inadequate and that the drug has a high potential for abuse or

15  is being excessively misused, abused, or diverted into illicit

16  drug trafficking.

17         (3)  Each controlled substance or drug subject to this

18  section which is dispensed in this state must be timely

19  reported to the Department of Legal Affairs. Such data must be

20  reported each time that:

21         (a)  A Schedule II controlled substance is dispensed;

22         (b)  A drug that is designated by the Attorney General

23  under subsection (2) is dispensed; or

24         (c)  Codeine, hydrocodone, dihydrocodeine,

25  ethylmorphine, or morphine as scheduled in Schedule II and

26  Schedule III is dispensed.

27         (4)  This section does not apply to controlled

28  substances or drugs:

29         (a)  Ordered from an institutional pharmacy licensed

30  under section 465.019(2), Florida Statutes, in accordance with

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  1  the institutional policy for such controlled substances or

  2  drugs; or

  3         (b)  Administered by a health care practitioner to a

  4  patient or resident receiving care from a hospital, nursing

  5  home, assisted living facility, home health agency, hospice,

  6  or intermediate care facility for the developmentally disabled

  7  which is licensed in this state.

  8         (5)  The data required under this section includes:

  9         (a)  The patient's name.

10         (b)  The patient's address.

11         (c)  The national drug code number of the substance

12  dispensed.

13         (d)  The date that the substance is dispensed.

14         (e)  The quantity of substance dispensed.

15         (f)  The dispenser's National Association of Board's of

16  Pharmacy (NABP) number.

17         (g)  The prescribing practitioner's United States Drug

18  Enforcement Administration Number.

19         (6)  The information must be reported within 30 days

20  after the date the controlled substance or drug is dispensed.

21         (7)  A dispenser must transmit the information required

22  by this section in an electronic format approved by rule of

23  the Board of Pharmacy after consultation with the advisory

24  council and the Department of Legal Affairs unless a specific

25  waiver is granted to that dispenser by the Department of Legal

26  Affairs. The information transmitted may be maintained by any

27  department receiving it for up to 12 months before purging it

28  from its records. Notwithstanding the foregoing, any

29  department receiving such information may maintain it longer

30  than 12 months if the information is pertinent to an ongoing

31  investigation arising under this act.


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  1         (8)  The Department of Legal Affairs shall establish a

  2  14-member prescription-monitoring program advisory council to

  3  assist it in identifying drugs of abuse for inclusion in the

  4  monitoring system and in implementing the system.

  5         (a)  The Governor shall appoint members to serve on the

  6  advisory council. The members of the council shall include the

  7  Attorney General or his or her designee who shall serve as the

  8  chairperson; the Secretary of Health or his or her designee;

  9  the executive director of the Department of Law Enforcement or

10  his or her designee; the director of the Office of Drug

11  Control within the Executive Office of Governor or his or her

12  designee; a physician who is licensed in this state under

13  chapter 458, Florida Statutes, who is recommended by the

14  Florida Medical Association; a physician who is licensed in

15  this state under chapter 458 or chapter 459, Florida Statutes,

16  who is recommended by the Florida Academy of Pain Medicine; a

17  physician who is licensed in this state under chapter 459,

18  Florida Statutes, who is recommended by the Florida

19  Osteopathic Medical Association; a podiatric physician who is

20  licensed in this state under chapter 461, Florida Statutes,

21  who is recommended by the Florida Podiatric Medical

22  Association; a pharmacist who is licensed in this state under

23  chapter 465, Florida Statutes, who is recommended by the

24  Florida Pharmacy Association; a pharmacist who is licensed in

25  this state under chapter 465, Florida Statutes, who is

26  recommended by the Florida Retail Federation; a pharmacist who

27  is licensed in this state under chapter 465, Florida Statutes,

28  who is recommended by the National Community Pharmacy

29  Association; a dentist who is licensed in this state under

30  chapter 466, Florida Statutes, who is recommended by the

31  Florida Dental Association; a veterinarian who is licensed in


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  1  this state under chapter 474, Florida Statutes, who is

  2  recommended by the Florida Veterinary Medical Association; and

  3  a prosecutor who has expertise in the criminal prosecution of

  4  drug-diversion cases.

  5         (b)  The advisory council members shall meet no more

  6  often than quarterly at the call of the chairperson, and serve

  7  without compensation. However, such members may receive

  8  reimbursement, as provided in section 112.061, Florida

  9  Statutes, for per diem and travel expenses incurred in the

10  performance of their official duties.

11         (c)  The Department of Legal Affairs shall provide

12  staff and other administrative assistance that is reasonably

13  necessary to assist the advisory council in carrying out its

14  responsibilities.

15         (9)  The Department of Legal Affairs shall adopt rules

16  pursuant to section 120.536(1) and section 120.574, Florida

17  Statutes, necessary to administer this section.

18         Section 6.  Subsections (1) and (9) of section 456.033,

19  Florida Statutes, are amended to read:

20         456.033  Requirement for instruction for certain

21  licensees on HIV and AIDS.--

22         (1)  The appropriate board shall require each person

23  licensed or certified under chapter 457; chapter 458; chapter

24  459; chapter 460; chapter 461; chapter 463; part I of chapter

25  464; chapter 465; chapter 466; part II, part III, part V, or

26  part X of chapter 468; or chapter 486 to complete a continuing

27  educational course, approved by the board, on human

28  immunodeficiency virus and acquired immune deficiency syndrome

29  as part of biennial relicensure or recertification. The course

30  shall consist of education on the modes of transmission,

31  infection control procedures, clinical management, and


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  1  prevention of human immunodeficiency virus and acquired immune

  2  deficiency syndrome. Such course shall include information on

  3  current Florida law on acquired immune deficiency syndrome and

  4  its impact on testing, confidentiality of test results,

  5  treatment of patients, and any protocols and procedures

  6  applicable to human immunodeficiency virus counseling and

  7  testing, reporting, the offering of HIV testing to pregnant

  8  women, and partner notification issues pursuant to ss. 381.004

  9  and 384.25.

10         (9)(a)  In lieu of completing a course as required in

11  subsection (1), the licensee may complete a course in

12  end-of-life care and palliative health care, so long as the

13  licensee completed an approved AIDS/HIV course in the

14  immediately preceding biennium.

15         (b)  In lieu of completing a course as required by

16  subsection (1), a person licensed under chapter 466 who has

17  completed an approved AIDS/HIV course in the immediately

18  preceding 2 years may complete a course approved by the Board

19  of Dentistry.

20         Section 7.  Paragraph (d) of subsection (2) of section

21  456.072, Florida Statutes, is amended to read:

22         456.072  Grounds for discipline; penalties;

23  enforcement.--

24         (2)  When the board, or the department when there is no

25  board, finds any person guilty of the grounds set forth in

26  subsection (1) or of any grounds set forth in the applicable

27  practice act, including conduct constituting a substantial

28  violation of subsection (1) or a violation of the applicable

29  practice act which occurred prior to obtaining a license, it

30  may enter an order imposing one or more of the following

31  penalties:


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  1         (d)  Imposition of an administrative fine not to exceed

  2  $25,000 $10,000 for each count or separate offense. If the

  3  violation is for fraud or making a false or fraudulent

  4  representation, the board, or the department if there is no

  5  board, must impose a fine of $10,000 per count or offense.

  6         Section 8.  Paragraph (d) is added to subsection (1) of

  7  section 458.345, Florida Statutes, to read:

  8         458.345  Registration of resident physicians, interns,

  9  and fellows; list of hospital employees; prescribing of

10  medicinal drugs; penalty.--

11         (1)  Any person desiring to practice as a resident

12  physician, assistant resident physician, house physician,

13  intern, or fellow in fellowship training which leads to

14  subspecialty board certification in this state, or any person

15  desiring to practice as a resident physician, assistant

16  resident physician, house physician, intern, or fellow in

17  fellowship training in a teaching hospital in this state as

18  defined in s. 408.07(44) or s. 395.805(2), who does not hold a

19  valid, active license issued under this chapter shall apply to

20  the department to be registered and shall remit a fee not to

21  exceed $300 as set by the board.  The department shall

22  register any applicant the board certifies has met the

23  following requirements:

24         (d)  Has completed, upon initial registration, the

25  1-hour educational course in the prescribing of controlled

26  substances as set forth in section 2 of this act. An applicant

27  who has not taken a course at the time of registration shall

28  be allowed up to 6 months within which to complete this

29  requirement.

30         Section 9.  Paragraph (dd) is added to subsection (1)

31  of section 461.013, Florida Statutes, to read:


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  1         461.013  Grounds for disciplinary action; action by the

  2  board; investigations by department.--

  3         (1)  The following acts constitute grounds for denial

  4  of a license or disciplinary action, as specified in s.

  5  456.072(2):

  6         (dd)  Presigning blank prescription forms.

  7         Section 10.  Paragraphs (h), (i), (j), (k), and (l) are

  8  added to subsection (1) of section 893.04, Florida Statutes,

  9  to read:

10         893.04  Pharmacist and practitioner.--

11         (1)  A pharmacist, in good faith and in the course of

12  professional practice only, may dispense controlled substances

13  upon a written or oral prescription of a practitioner, under

14  the following conditions:

15         (h)  A pharmacist may not dispense a Schedule II

16  controlled substance; codeine, hydrocodone, dihydrocodeine,

17  ethylmorphine, or morphine, as scheduled in Schedule II and

18  Schedule III; or a drug of abuse designated by the Attorney

19  General by rule under the prescription-monitoring system to

20  any individual not personally known to the pharmacist without

21  first obtaining suitable identification and documenting, in a

22  log book kept by the pharmacist, the identity of the

23  individual obtaining the controlled substance. The log book

24  entry must contain the printed name, address, telephone number

25  if available, and driver's license number or other suitable

26  identification number, and signature of the person obtaining

27  the controlled substance or drug. If the individual does not

28  have suitable identification or it is impracticable to obtain

29  such identification, the pharmacist may dispense the

30  controlled substance or drug only when the pharmacist

31  determines, in the exercise of her or his professional


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  1  judgment, that the order is valid and necessary for treatment.

  2  In such a case, the pharmacist or his or her designee must

  3  obtain the other information required under this paragraph,

  4  and the pharmacist or pharmacist's designee must sign the log

  5  to indicate that suitable identification was not available and

  6  that the pharmacist's professional judgment was exercised

  7  prior to dispensing the controlled substance or drug. The

  8  Board of Pharmacy may adopt, by rule, procedures for a

  9  pharmacist to verify the validity of a prescription for a

10  Schedule II controlled substance; other drug designated by the

11  Attorney General under this section; or codeine, hydrocodone,

12  dihydrocodeine, ethylmorphine, or morphine, as scheduled in

13  Schedule II and Schedule III, for circumstances when it is

14  otherwise impracticable for the pharmacist or dispensing

15  practitioner to obtain suitable identification from the

16  patient or the patient's agent. For purposes of this section,

17  identification is suitable only if it contains the photograph,

18  the printed name, and the signature of the individual

19  obtaining the Schedule II controlled substance or drug of

20  abuse under the prescription-monitoring system.

21         (i)  Any pharmacist that dispenses a Schedule II

22  controlled substance or drug subject to the requirements of

23  this section when dispensed by mail shall be exempt from the

24  requirements to obtain suitable identification.

25         (j)  All prescriptions issued for a Schedule II

26  controlled substance; codeine, hydrocodone, dihydrocodeine,

27  ethylmorphine, or morphine, as scheduled in Schedule II and

28  Schedule III; or a drug of abuse under the

29  prescription-monitoring system which has been designated by

30  the Attorney General by rule, must include both a written and

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  1  numerical notation of quantity on the face of the

  2  prescription.

  3         (k)  A pharmacist may not dispense more than a 30-day

  4  supply of a controlled substance listed in Schedule III upon

  5  an oral prescription.

  6         (l)  A pharmacist may not knowingly fill a prescription

  7  that has been mutilated or forged for a Schedule II controlled

  8  substance; codeine, hydrocodone, dihydrocodeine,

  9  ethylmorphine, and morphine, as scheduled in Schedule II and

10  Schedule III; or a drug of abuse under the

11  prescription-monitoring system which has been designated by

12  the Attorney General by rule.

13         Section 11.  Section 893.065, Florida Statutes, is

14  created to read:

15         893.065  Voluntary program for counterfeit-resistant

16  prescription blanks.--The Department of Legal Affairs, may, by

17  rule, after consultation with the prescription monitoring

18  program advisory council established under this act, develop a

19  voluntary program for counterfeit-resistant prescription

20  blanks to be used by practitioners who prescribe controlled

21  substances or any drug of abuse under the electronic

22  prescription-monitoring system which has been designated by

23  the Attorney General. The Department of Legal Affairs may

24  develop, by rule, a counterfeit-resistant prescription blank

25  for voluntary use by practitioners who prescribe controlled

26  substances or any drug of abuse under the electronic

27  prescription monitoring system. The Department of Legal

28  Affairs may, by rule, require the blanks to be printed on

29  distinctive paper, serially numbered, and to bear the

30  preprinted name, address, and category of professional

31  licensure of the practitioner to whom they are issued and that


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  1  practitioner's federal registry number for controlled

  2  substances. The prescription blanks may be issued by the

  3  Department of Legal Affairs in serially numbered groups to

  4  prescribing practitioners. If such blanks are issued by the

  5  Department of Legal Affairs to implement a voluntary program

  6  for counterfeit-resistant prescription blanks, a copy must be

  7  available for inspection by the Department of Legal Affairs,

  8  and all costs of preparing, issuing, and tracking prescription

  9  blanks may be covered by the Department of Legal Affairs.

10         Section 12.  This act shall take effect July 1, 2002.

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CODING: Words stricken are deletions; words underlined are additions.