House Bill hb0701c1
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Florida House of Representatives - 2002 CS/HB 701
By the Committee on State Administration and
Representative Crow
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 in emergency department
6 settings; requiring certain health care
7 providers to complete education courses
8 relating to the prescription and pharmacology
9 of controlled substances; providing penalties
10 and requiring a report; providing for the
11 emergency suspension of certain licenses for
12 prescribing violations; requiring law
13 enforcement agencies, the Department of Health,
14 the Medical Examiners Commission within the
15 Department of Law Enforcement, the statewide
16 prosecutor, and state attorneys to share
17 certain information regarding health care
18 practitioners; requiring a study and report by
19 the Department of Health and the Department of
20 Law Enforcement; requiring the Department of
21 Legal Affairs to establish an electronic system
22 to monitor the prescribing of certain
23 controlled substances; establishing an advisory
24 council and providing for its membership,
25 duties, and staff; authorizing reimbursement
26 for per diem and travel expenses in the
27 performance of official duties; providing
28 rulemaking authority; amending s. 458.345,
29 F.S.; requiring certain resident physicians,
30 interns, and fellows to complete an educational
31 course in prescribing and pharmacology of
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1 controlled substances; amending s. 461.013,
2 F.S.; prohibiting the presigning of blank
3 prescription forms and providing penalties;
4 amending s. 893.04, F.S.; providing additional
5 requirements for pharmacists regarding the
6 identification of persons to whom controlled
7 substances are dispensed; prohibiting certain
8 prescribing practitioners from possessing,
9 administering, dispensing, or prescribing
10 controlled substances; creating s. 893.065,
11 F.S.; establishing protocols requiring
12 prescriptions for certain controlled substances
13 to be issued on special forms developed by the
14 Department of Legal Affairs; establishing
15 requirements for the design, issuance, and
16 control of such forms; providing recordkeeping
17 requirements; providing other requirements for
18 the use of such forms; providing an effective
19 date.
20
21 Be It Enacted by the Legislature of the State of Florida:
22
23 Section 1. Physicians; rules establishing prescribing
24 guidelines.--To minimize the diversion and resultant abuse of
25 controlled substances, the Board of Medicine and the Board of
26 Osteopathic Medicine shall adopt rules pursuant to ss.
27 120.536(1) and 120.54 to establish guidelines for prescribing
28 controlled substances to patients in emergency department
29 settings. Such guidelines must allow physicians to provide
30 legitimate medical treatment of acute and chronic pain and
31 require them to recognize and prevent abuse of pain
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1 medications prescribed in emergency department settings. The
2 guidelines must also consider requirements of state and
3 federal law and of the Joint Commission on Accreditation of
4 Healthcare Organizations. Each board shall consult with the
5 Florida College of Emergency Physicians in developing these
6 guidelines.
7 Section 2. Instruction required for certain licensees
8 in prescribing and pharmacology.--
9 (1) The appropriate professional licensing board shall
10 require each person licensed under chapter 458, chapter 459,
11 chapter 461, chapter 462, or chapter 466, Florida Statutes, to
12 complete a 1-hour educational course, approved by the board,
13 on appropriate prescribing and pharmacology of controlled
14 substances, as part of the licensee's initial license renewal
15 after January 1, 2003. The course shall provide education in
16 the state and federal laws and rules governing the prescribing
17 and dispensing of controlled substances; in appropriate
18 evaluation of patients for any risk of drug diversion and the
19 resulting abuse of controlled substances; in the use of
20 informed consent and other protocols, such as discussing the
21 risks and benefits of using controlled substances, with
22 patients to prevent drug diversion; in the need to keep
23 accurate and complete medical records to justify treatment
24 with controlled substances; in addiction and substance abuse
25 issues with respect to patients; in the appropriate use of
26 recognized pain management guidelines; and in the need for
27 consultation and referral of patients who are at risk for
28 misuse of medication or diversion of controlled substances,
29 when appropriate.
30 (2) The board may approve additional equivalent
31 courses that satisfy the requirements of subsection (1). Each
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1 licensing board that requires a licensee to complete an
2 educational course pursuant to this section shall include the
3 hours required to complete the course in the total required
4 continuing educational requirements.
5 (3) Any person who holds two or more licenses subject
6 to this section may satisfy the requirements of this section
7 by taking only one such board-approved course for relicensure
8 of all such licenses.
9 (4) A licensee who fails to comply with this section
10 is subject to disciplinary action under each respective
11 practice act and s. 456.072(1)(k), Florida Statutes. In
12 addition to discipline by the board, the licensee must
13 complete the course.
14 (5) The board shall require, as a condition of
15 granting a license under the chapter specified in subsection
16 (1), that an applicant for initial licensure complete an
17 educational course set forth in subsection (1). An applicant
18 who has not taken a course at the time of licensure shall be
19 allowed 6 months within which to complete this requirement.
20 (6) The board may adopt rules pursuant to ss.
21 120.536(1) and 120.54 necessary to administer this section.
22 Section 3. Emergency suspension orders; controlled
23 substances.--Upon receipt of sufficient evidence from any
24 agency authorized to enforce chapter 893, Florida Statutes,
25 regarding a violation of s. 458.331(1)(q), (r), or (aa), s.
26 459.015(1)(t), (u), or (ee), s. 461.013(1)(o), (p), or (cc),
27 s. 462.14(1)(q), (r), or (aa), s. 464.018(1)(i), s.
28 465.016(1)(e) or (i), or s. 466.028(1)(p), (q), (r), or (dd),
29 or of chapter 893, Florida Statutes, by a licensed health care
30 practitioner who is authorized to prescribe, dispense, or
31 administer controlled substances, the Department of Health
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1 shall review the case and if the practitioner is a danger to
2 the public health, safety, or welfare as set forth in s.
3 120.60(6), Florida Statutes, recommend the suspension or
4 restriction of the practitioner's license to the Secretary of
5 Health within 10 working days after receiving such evidence.
6 The Secretary of Health may suspend or restrict the license of
7 the practitioner in accordance with s. 120.60(6), Florida
8 Statutes.
9 Section 4. Sharing of arrest, formal charging, and
10 other information regarding health care practitioners.--
11 (1) In order to facilitate the efficiency of the
12 Department of Health's investigation of applicable violations
13 involving the diversion of controlled substances by health
14 care practitioners, or other violations of criminal law that
15 may adversely affect a health care practitioner's licensed
16 practice, any law enforcement agency that arrests a person
17 known or suspected to be a health care practitioner licensed
18 by the state shall promptly notify the Department of Health
19 and provide it with:
20 (a) Notice of the arrest, including the name of the
21 arresting agency and lead investigator, detective, or officer
22 in the case.
23 (b) The name of the person charged.
24 (c) All known personal identifying information related
25 to the person arrested.
26 (d) The date of the arrest.
27 (e) The charges for which the person is arrested.
28 (f) The agency case number assigned to 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, notice of formal charging by a prosecuting
12 entity, or information from the Medical Examiners Commission,
13 as provided in this section, the Department of Health or the
14 board having regulatory authority over the practitioner shall
15 investigate any information received and determine whether it
16 has reasonable grounds to believe that the practitioner has
17 violated any law relating to the practitioner's practice and
18 shall take appropriate licensure action as provided by law or
19 rule. If the Department of Health receives information
20 pursuant to this section which suggests the person arrested,
21 charged, or otherwise identified is also licensed by the state
22 in another field or profession, the Department of Health shall
23 forward such information to the appropriate licensing entity
24 for review and appropriate licensure action as provided by law
25 or rule.
26 (5) To help the Department of Health and regulatory
27 boards control the diversion and resultant abuse of controlled
28 substances, the Department of Health and the Department of Law
29 Enforcement shall study the feasibility of expanding the
30 electronic exchange of information to facilitate the transfer
31 to the Department of Health of criminal history information
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1 involving licensed health care practitioners who are
2 authorized to prescribe, administer, or dispense controlled
3 substances. The study shall address whether collection and
4 retention of fingerprint information concerning licensed
5 health care practitioners is advisable as a means of better
6 regulating such practitioners and guarding against abuse of
7 the privileges of such licensure. The Department of Law
8 Enforcement shall investigate the feasibility of the
9 electronic transmission of information from medical examiners
10 within this state to the Department of Health regarding
11 autopsies and other public reports that attribute death to
12 controlled substance abuse. The Department of Law Enforcement,
13 in consultation with the Department of Health, must submit a
14 report of its findings to the Legislature by November 1, 2002.
15 Section 5. Electronic monitoring system for
16 prescriptions.--
17 (1) By July 1, 2003, the Department of Legal Affairs
18 shall design and establish an electronic system consistent
19 with the National Council of Prescription Drug Programs
20 (NCPDP) standards or the American Society for Automation in
21 Pharmacy (ASAP) standards to monitor the prescribing of
22 Schedule II controlled substances, other drugs designated by
23 rule by the Attorney General under this section, and codeine,
24 hydrocodone, dihydrocodeine, ethylmorphine, and morphine, as
25 scheduled in Schedule II and Schedule III, by health care
26 practitioners within the state or the dispensing of such
27 controlled substances to an address within the state by a
28 pharmacy permitted or registered by the Board of Pharmacy.
29 (2) All Schedule II controlled substances, and codeine
30 hydrocodone, dihydrocodeine, ethylmorphine, and morphine, as
31 scheduled in Schedule II and Schedule III, and any other drug
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1 designated by the Attorney General under this section, shall
2 be included in the prescription monitoring system. The
3 Attorney General may, by rule, designate any other drug for
4 inclusion in such system after making a determination that the
5 drug is a drug of abuse. The Attorney General must consider
6 the recommendations of the prescription monitoring system
7 advisory council created by this section before designating a
8 drug of abuse for inclusion in the prescription monitoring
9 system and only after he or she determines that the current
10 level of regulation over the prescribing and dispensing of
11 such drug is inadequate and that the drug has a high potential
12 for abuse or is being excessively misused, abused, or diverted
13 into illicit drug trafficking.
14 (3) Each controlled substance or drug subject to this
15 section which is dispensed in this state must be timely
16 reported to the Department of Legal Affairs. Such data must be
17 reported each time that:
18 (a) A Schedule II controlled substance is dispensed;
19 (b) A drug that is designated by the Attorney General
20 under subsection (2) is dispensed; or
21 (c) Codeine, hydrocodone, dihydrocodeine,
22 ethylmorphine, or morphine, as scheduled in Schedule II and
23 Schedule III, is dispensed.
24 (4) This section does not apply to controlled
25 substances or drugs:
26 (a) Ordered from an institutional pharmacy licensed
27 under s. 465.019(2), Florida Statutes, in accordance with the
28 institutional policy for such controlled substances or drugs;
29 or
30 (b) Administered by a health care practitioner to a
31 patient or resident receiving care from a hospital, nursing
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1 home, assisted living facility, home health agency, hospice,
2 or intermediate care facility for the developmentally disabled
3 which is licensed in this state.
4 (5) The data required under this section includes:
5 (a) The patient's name.
6 (b) The patient's address.
7 (c) The national drug code number of the substance
8 dispensed.
9 (d) The date that the substance is dispensed.
10 (e) The quantity of substance dispensed.
11 (f) The dispenser's National Association of Boards of
12 Pharmacy (NABP) number.
13 (g) The prescribing practitioner's United States Drug
14 Enforcement Administration number.
15 (6) The information must be reported within 30 days
16 after the date the controlled substance or drug is dispensed.
17 (7) A dispenser must transmit the information required
18 by this section in an electronic format approved by rule of
19 the Board of Pharmacy, after consultation with the advisory
20 council and the Department of Legal Affairs, unless a specific
21 waiver is granted to that dispenser by the Department of Legal
22 Affairs.
23 (8) The Department of Legal Affairs shall establish a
24 13-member prescription monitoring system advisory council to
25 assist it in identifying drugs of abuse for inclusion in the
26 monitoring system and in implementing the system.
27 (a) The Governor shall appoint members to serve on the
28 advisory council. The members of the council shall include the
29 Attorney General or his or her designee, who shall serve as
30 the chairperson; the Secretary of Health or his or her
31 designee; the executive director of the Department of Law
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1 Enforcement or his or her designee; the director of the Office
2 of Drug Control within the Executive Office of the Governor or
3 his or her designee; a physician who is licensed in this state
4 under chapter 458, Florida Statutes, who is recommended by the
5 Florida Medical Association; a physician who is licensed in
6 this state under chapter 459, Florida Statutes, who is
7 recommended by the Florida Osteopathic Medical Association; a
8 podiatric physician who is licensed in this state under
9 chapter 461, Florida Statutes, who is recommended by the
10 Florida Podiatric Medical Association; a pharmacist who is
11 licensed in this state under chapter 465, Florida Statutes,
12 who is recommended by the Florida Pharmacy Association; a
13 pharmacist who is licensed in this state under chapter 465,
14 Florida Statutes, who is recommended by the Florida Retail
15 Federation; a pharmacist who is licensed in this state under
16 chapter 465, Florida Statutes, who is recommended by the
17 National Community Pharmacy Association; a dentist who is
18 licensed in this state under chapter 466, Florida Statutes,
19 who is recommended by the Florida Dental Association; a
20 veterinarian who is licensed in this state under chapter 474,
21 Florida Statutes, who is recommended by the Florida Veterinary
22 Medical Association; and a prosecutor who has expertise in the
23 criminal prosecution of drug diversion cases.
24 (b) The advisory council members shall meet no more
25 often than quarterly at the call of the chairperson and shall
26 serve without compensation. However, such members may receive
27 reimbursement, as provided in s. 112.061, Florida Statutes,
28 for per diem and travel expenses incurred in the performance
29 of their official duties.
30 (c) The Department of Legal Affairs shall provide
31 staff and other administrative assistance that is reasonably
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1 necessary to assist the advisory council in carrying out its
2 responsibilities.
3 (9) The Department of Legal Affairs shall adopt rules
4 pursuant to ss. 120.536(1) and 120.54, Florida Statutes,
5 necessary to administer this section.
6 Section 6. 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 and pharmacology
26 of controlled substances as set forth in section 2 of this
27 act. An applicant who has not taken a course at the time of
28 registration shall be allowed up to 6 months within which to
29 complete this requirement.
30 Section 7. Paragraph (cc) of subsection (1) of section
31 461.013, Florida Statutes, is redesignated as paragraph (dd)
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1 of said subsection, and a new paragraph (cc) is added to said
2 subsection, to read:
3 461.013 Grounds for disciplinary action; action by the
4 board; investigations by department.--
5 (1) The following acts constitute grounds for denial
6 of a license or disciplinary action, as specified in s.
7 456.072(2):
8 (cc) Presigning blank prescription forms.
9 (dd)(cc) Violating any provision of this chapter or
10 chapter 456, or any rules adopted pursuant thereto.
11 Section 8. Paragraphs (h), (i), (j), (k), and (l) are
12 added to subsection (1) of section 893.04, Florida Statutes,
13 to read:
14 893.04 Pharmacist and practitioner.--
15 (1) A pharmacist, in good faith and in the course of
16 professional practice only, may dispense controlled substances
17 upon a written or oral prescription of a practitioner, under
18 the following conditions:
19 (h) A pharmacist may not dispense a Schedule II
20 controlled substance; codeine, hydrocodone, dihydrocodeine,
21 ethylmorphine, or morphine, as scheduled in Schedule II and
22 Schedule III; or a drug of abuse designated by the Attorney
23 General under the prescription monitoring system, to any
24 individual not personally known to the pharmacist, without
25 first obtaining suitable identification and documenting, in a
26 log book kept by the pharmacist, the identity of the
27 individual obtaining the controlled substance. The log book
28 entry shall contain the printed name, address, phone number
29 (if available), driver's license number or other suitable
30 identification number, and signature of the person obtaining
31 the controlled substance or drug. If the individual does not
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1 have suitable identification or it is impracticable to obtain
2 such identification, the pharmacist may dispense the
3 controlled substance or drug only when the pharmacist
4 determines, in the exercise of her or his professional
5 judgment, that the order is valid and necessary for treatment.
6 In such case, the pharmacist or his or her designee must
7 obtain the other information required by this paragraph and
8 must sign the log book to indicate that suitable
9 identification was not available and that the pharmacist's
10 professional judgment was exercised prior to dispensing the
11 controlled substance or drug. The Board of Pharmacy may adopt,
12 by rule, procedures for a pharmacist to verify the validity of
13 a prescription for a Schedule II controlled substance; a drug
14 of abuse designated by the Attorney General under the
15 prescription monitoring system; or codeine, hydrocodone,
16 dihydrocodeine, ethylmorphine, or morphine, as scheduled in
17 Schedule II and Schedule III, for circumstances when it is
18 otherwise impracticable for the pharmacist or dispensing
19 practitioner to obtain suitable identification from the
20 patient or the patient's agent. For purposes of this
21 paragraph, identification is suitable only if it contains the
22 photograph, printed name, and signature of the individual
23 obtaining the Schedule II controlled substance or drug of
24 abuse under the prescription monitoring system.
25 (i) Any pharmacist that dispenses by mail a Schedule
26 II controlled substance or drug subject to the requirements of
27 this section shall be exempt from the requirements to obtain
28 suitable identification.
29 (j) All prescriptions issued for a Schedule II
30 controlled substance; codeine, hydrocodone, dihydrocodeine,
31 ethylmorphine, or morphine, as scheduled in Schedule II and
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1 Schedule III; or a drug of abuse designated by the Attorney
2 General under the prescription monitoring system, must include
3 both a written and numerical notation of quantity on the face
4 of the prescription.
5 (k) A pharmacist may not dispense more than a 30-day
6 supply of a controlled substance listed in Schedule III upon
7 an oral prescription.
8 (l) A pharmacist may not knowingly fill a prescription
9 that has been mutilated or forged for a Schedule II controlled
10 substance; codeine, hydrocodone, dihydrocodeine,
11 ethylmorphine, and morphine, as scheduled in Schedule II and
12 Schedule III; or a drug of abuse designated by the Attorney
13 General under the prescription monitoring system.
14 Section 9. Section 893.065, Florida Statutes, is
15 created to read:
16 893.065 Prescriptions required for certain controlled
17 substances.--
18 (1) On or after July 1, 2002, a person may not issue a
19 prescription for a Schedule II controlled substance; codeine,
20 hydrocodone, dihydrocodeine, ethylmorphine, or morphine, as
21 scheduled in Schedule II and Schedule III; or any drug of
22 abuse designated by the Attorney General under the
23 prescription monitoring system, unless the prescription meets
24 the requirements of this section.
25 (2) The Department of Legal Affairs shall develop a
26 counterfeit-proof prescription blank for use by practitioners
27 who prescribe:
28 (a) A Schedule II controlled substance.
29 (b) Any drug of abuse designated by the Attorney
30 General under the prescription monitoring system.
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1 (c) Codeine, hydrocodone, dihydrocodeine,
2 ethylmorphine, or morphine, as scheduled in Schedule II or
3 Schedule III.
4 (3) Prescription blanks shall be issued by the
5 Department of Legal Affairs to such practitioners. The
6 prescription blanks must be printed on distinctive paper and
7 must bear the preprinted full name, address, and category of
8 professional licensure of the practitioner to whom they are
9 issued and that practitioner's federal registry number for
10 controlled substances. The prescription blanks may not be
11 transferred.
12 (4) The Department of Legal Affairs must cover all
13 costs for the prescription monitoring system, including the
14 department's actual costs of preparing, issuing, and tracking
15 prescription blanks.
16 (5) Notwithstanding s. 893.04(1)(a)-(d), a person may
17 not prescribe a Schedule II controlled substance; codeine,
18 hydrocodone, dihydrocodeine, ethylmorphine, or morphine, as
19 scheduled in Schedule II and Schedule III; or any drug of
20 abuse designated by the Attorney General under the
21 prescription monitoring system; nor may any person fill,
22 compound, or dispense such a prescription, unless it complies
23 with this section.
24 (a) The signature on each such prescription form must
25 be wholly written in ink or indelible pencil in the
26 handwriting of the prescribing practitioner. Each prescription
27 must be prepared, dated, and signed by the prescribing
28 practitioner on the day when issued and must contain,
29 typewritten or handwritten by the physician or an employee of
30 the physician, the full name and address of the person for
31 whom, or the owner of the animal for which, the controlled
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1 substance is prescribed; the name, quantity, and strength of
2 the controlled substance; directions for use; and the address,
3 category of professional licensure, and federal controlled
4 substance registration number of the prescribing practitioner.
5 If the prescription is for an animal, the prescription must
6 state the species of animal for which it is prescribed. If the
7 prescribing practitioner does not specify the address of the
8 person for whom, or animal for which, the prescription is
9 prescribed, the pharmacist filling the prescription or an
10 employee acting under the direction of the pharmacist must
11 write or type the address on the prescription or maintain the
12 information in a readily retrievable form in the pharmacy.
13 (b) The original of the prescription must be delivered
14 to the pharmacist filling the prescription. The original must
15 be retained on file by the proprietor of the pharmacy in which
16 it is filled for a period of 2 years, properly endorsed by the
17 pharmacist with the name and address of the pharmacy, the
18 pharmacy's state permit number, the date that the prescription
19 was filled, and the signature of the pharmacist, and a copy
20 must be available for inspection by the Department of Legal
21 Affairs. Notwithstanding any provision of this section, the
22 prescribing practitioner's address, category of professional
23 licensure, or federal controlled substances registration
24 number need not appear on the prescription if that information
25 is readily retrievable in the pharmacy.
26 (c) All prescriptions issued for a Schedule II
27 controlled substance; codeine, hydrocodone, dihydrocodeine,
28 ethylmorphine, or morphine, as scheduled in Schedule II and
29 Schedule III; or any drug of abuse designated by the Attorney
30 General under the prescription monitoring system, must include
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1 both a written and numerical notation of quantity on the face
2 of the prescription.
3 (d) 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 (e) 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, or morphine, as scheduled in Schedule II and
10 Schedule III; or any drug of abuse designated by the Attorney
11 General under the prescription monitoring system.
12 (f) Any controlled substance listed in Schedule III;
13 codeine, hydrocodone, dihydrocodeine, ethylmorphine, or
14 morphine, as scheduled in Schedule II and Schedule III; or any
15 drug of abuse designated by the Attorney General under the
16 prescription monitoring system, may be dispensed by a
17 pharmacist upon an oral prescription, if, before filling the
18 prescription, the pharmacist reduces it to writing in ink or
19 indelible pencil in the handwriting of the pharmacist, upon an
20 official form issued by the Department of Legal Affairs for
21 that purpose. Such prescriptions must contain the date of the
22 oral authorization and the information required by paragraph
23 (a).
24 (6) Any pharmacist that dispenses by mail a Schedule
25 II controlled substance or other drug subject to the
26 requirements of this section shall be exempt from the
27 requirements to use the required prescription blanks.
28 Section 10. This act shall take effect July 1, 2002.
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