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





                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)

                            CHAMBER ACTION
              Senate                               House
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 4                                                                

 5                                           ORIGINAL STAMP BELOW

 6

 7

 8

 9

10                                                                

11  Representative(s) Kelly offered the following:

12

13         Amendment (with title amendment) 

14         On page 17, between lines 7 and 8, of the bill

15

16  insert:

17         Section 13.  Effective July 1, 1998, subsection (12) of

18  section 465.003, Florida Statutes, is amended, subsections (4)

19  through (14) are renumbered as subsections (5) through (15),

20  respectively, and a new subsection (4) is added to said

21  section, to read:

22         465.003  Definitions.--As used in this chapter, the

23  term:

24         (4)  "Data communication device" means an electronic

25  device that receives electronic information from one source

26  and transmits or routes it to another, including, but not

27  limited to, any such bridge, router, switch, or gateway.

28         (13)(12)  "Practice of the profession of pharmacy"

29  includes compounding, dispensing, and consulting concerning

30  contents, therapeutic values, and uses of any medicinal drug;

31  and consulting concerning therapeutic values and interactions

                                  1

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  of patent or proprietary preparations, whether pursuant to

 2  prescriptions or in the absence and entirely independent of

 3  such prescriptions or orders; and other pharmaceutical

 4  services. For purposes of this subsection, "other

 5  pharmaceutical services" means the evaluation and monitoring

 6  of the patient's health as it relates to drug therapy and

 7  assisting the patient in the management of his or her drug

 8  therapy, and includes the assessment of the patient's drug

 9  therapy and communication with the patient and the patient's

10  prescribing health care provider as licensed under chapter

11  458, chapter 459, chapter 461, or chapter 466, or similar

12  statutory provision in another jurisdiction, or such

13  provider's agent or such other persons as specifically

14  authorized by the patient, regarding the drug therapy.

15  "Practice of the profession of pharmacy" The phrase also

16  includes any other act, service, operation, research, or

17  transaction incidental to, or forming a part of, any of the

18  foregoing acts, requiring, involving, or employing the science

19  or art of any branch of the pharmaceutical profession, study,

20  or training, and shall expressly permit a pharmacist to

21  transmit information from persons authorized to prescribe

22  medicinal drugs to their patients. In addition to the

23  authority to order and dispense medicinal drugs independently

24  of an established protocol as set forth in s. 465.186, a

25  pharmacist may also administer immunizations within the

26  framework of an established protocol under a supervisory

27  practitioner who is a physician licensed under chapter 458 or

28  chapter 459 or by written agreement with a county health

29  department. Each protocol must contain specific procedures to

30  address any unforeseen allergic reaction to an immunization. A

31  pharmacist may not enter into a protocol unless he or she

                                  2

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  maintains at least $200,000 of professional liability

 2  insurance, and not until the pharmacist has completed training

 3  in immunizations as may be required by the board. The decision

 4  by a supervisory practitioner to enter into such a protocol is

 5  a professional decision of the practitioner, and no person may

 6  interfere with a supervisory practitioner's decision as to

 7  whether to enter into such a protocol. A pharmacist may not

 8  enter into a protocol that is to be performed while acting as

 9  an employee without the written approval of the owner of the

10  pharmacy.

11         Section 14.  Effective July 1, 1998, a new paragraph

12  (q) is added to subsection (1) of section 465.016, Florida

13  Statutes, to read:

14         465.016  Disciplinary actions.--

15         (1)  The following acts shall be grounds for

16  disciplinary action set forth in this section:

17         (q)  Using or releasing a patient's records except as

18  authorized by this chapter and chapter 455.

19         Section 15.  Effective July 1, 1998, subsection (2) of

20  section 465.017, Florida Statutes, is amended to read:

21         465.017  Authority to inspect.--

22         (2)  Except as permitted by this chapter, and chapters

23  406, 409, 455, 499, and 893, records maintained by in a

24  pharmacy relating to the filling of prescriptions and the

25  dispensing of medicinal drugs shall not be furnished, except

26  upon the written authorization of the patient, to any person

27  other than to the patient for whom the drugs were dispensed,

28  or her or his legal representative, or to the department

29  pursuant to existing law, or, in the event that the patient is

30  incapacitated or unable to request said records, her or his

31  spouse; to the department pursuant to existing law; to health

                                  3

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  care practitioners and pharmacists consulting or dispensing to

 2  the patient; or to insurance carriers or other payors

 3  authorized by the patient to receive such records. For

 4  purposes of this section, records held in a pharmacy shall be

 5  considered owned by the owner of the pharmacy. The pharmacy

 6  owner may use such records in the aggregate without patient

 7  identification data, regardless of where such records are

 8  held, for purposes reasonably related to the business and

 9  practice of pharmacy except upon the written authorization of

10  such patient. Such records may be furnished in any civil or

11  criminal proceeding, upon the issuance of a subpoena from a

12  court of competent jurisdiction and proper notice to the

13  patient or her or his legal representative by the party

14  seeking such records. Such records or any part thereof, if

15  transmitted through a data communication device and not

16  directly between a pharmacy and a treating practitioner, may

17  not be accessed, used, or maintained by the operator or owner

18  of the data communication device unless specifically

19  authorized by this section. It is the intent of this

20  subsection to allow the use and sharing of such records to

21  improve patient care, provided the pharmacist acts in the best

22  interests of their patient. Nothing herein shall be construed

23  to authorize or expand solicitation or marketing to patients

24  or potential patients in any manner not otherwise specifically

25  authorized by law.

26         Section 16.  Effective July 1, 1998, subsection (4) of

27  section 465.019, Florida Statutes, is amended to read:

28         465.019  Institutional pharmacies; permits.--

29         (4)  Medicinal drugs shall be dispensed in an

30  institutional pharmacy to outpatients only when that

31  institution has secured a community pharmacy permit from the

                                  4

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  department. However, an individual licensed to prescribe

 2  medicinal drugs in this state may dispense up to a 24-hour

 3  supply of a medicinal drug to any patient of an emergency

 4  department of a hospital that operates a Class II

 5  institutional pharmacy, provided the physician treating the

 6  patient in such hospital's emergency department determines

 7  that the medicinal drug is warranted and that community

 8  pharmacy services are not readily accessible, geographically

 9  or otherwise, to the patient. Such dispensing from the

10  emergency department shall be in accordance with the

11  procedures of the hospital. For any such patient for whom a

12  medicinal drug is warranted for a period to exceed 24 hours,

13  an individual licensed to prescribe such drug shall dispense a

14  24-hour supply of such drug to the patient and shall provide

15  the patient a prescription for such drug for use after the

16  initial 24-hour period. The board may adopt rules necessary to

17  carry out the provisions of this subsection.

18         Section 17.  Effective July 1, 1998, section 465.014,

19  Florida Statutes, is amended to read:

20         465.014  Pharmacy technician.--No person other than a

21  licensed pharmacist or pharmacy intern may engage in the

22  practice of the profession of pharmacy, except that a licensed

23  pharmacist may delegate to nonlicensed pharmacy technicians

24  those duties, tasks, and functions which do not fall within

25  the purview of s. 465.003(13)(12).  All such delegated acts

26  shall be performed under the direct supervision of a licensed

27  pharmacist who shall be responsible for all such acts

28  performed by persons under his or her supervision. A pharmacy

29  technician, under the supervision of a pharmacist, may

30  initiate or receive communications with a practitioner or his

31  or her agent, on behalf of a patient, regarding refill

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  authorization requests. No licensed pharmacist shall supervise

 2  more than one pharmacy technician unless otherwise permitted

 3  by the guidelines adopted by the board. The board shall

 4  establish guidelines to be followed by licensees or permittees

 5  in determining the circumstances under which a licensed

 6  pharmacist may supervise more than one but not more than three

 7  pharmacy technicians.

 8         Section 18.  Effective July 1, 1998, paragraph (c) of

 9  subsection (2) of section 465.015, Florida Statutes, is

10  amended to read:

11         465.015  Violations and penalties.--

12         (2)  It is unlawful for any person:

13         (c)  To sell or dispense drugs as defined in s.

14  465.003(8)(7) without first being furnished with a

15  prescription.

16         Section 19.  Effective July 1, 1998, section 465.0196,

17  Florida Statutes, is amended to read:

18         465.0196  Special pharmacy permits.--Any person

19  desiring a permit to operate a pharmacy which does not fall

20  within the definitions set forth in s. 465.003(11)(10)(a)1.,

21  2., and 3. shall apply to the department for a special

22  pharmacy permit.  If the board certifies that the application

23  complies with the applicable laws and rules of the board

24  governing the practice of the profession of pharmacy, the

25  department shall issue the permit.  No permit shall be issued

26  unless a licensed pharmacist is designated to undertake the

27  professional supervision of the compounding and dispensing of

28  all drugs dispensed by the pharmacy.  The licensed pharmacist

29  shall be responsible for maintaining all drug records and for

30  providing for the security of the area in the facility in

31  which the compounding, storing, and dispensing of medicinal

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  drugs occurs.  The permittee shall notify the department

 2  within 10 days of any change of the licensed pharmacist

 3  responsible for such duties.

 4         Section 20.  Effective July 1, 1998, subsection (3) of

 5  section 468.812, Florida Statutes, is amended to read:

 6         468.812  Exemptions from licensure.--

 7         (3)  The provisions of this act relating to orthotics

 8  or pedorthics do not apply to any licensed pharmacist or to

 9  any person acting under the supervision of a licensed

10  pharmacist. The practice of orthotics or pedorthics by a

11  pharmacist or any of the pharmacist's employees acting under

12  the supervision of a pharmacist shall be construed to be

13  within the meaning of the term "practice of the profession of

14  pharmacy" as set forth in s. 465.003(13)(12), and shall be

15  subject to regulation in the same manner as any other pharmacy

16  practice. The Board of Pharmacy shall develop rules regarding

17  the practice of orthotics and pedorthics by a pharmacist. Any

18  pharmacist or person under the supervision of a pharmacist

19  engaged in the practice of orthotics or pedorthics shall not

20  be precluded from continuing that practice pending adoption of

21  these rules.

22         Section 21.  Effective July 1, 1998, subsection (19) of

23  section 499.003, Florida Statutes, is amended to read:

24         499.003  Definitions of terms used in ss.

25  499.001-499.081.--As used in ss. 499.001-499.081, the term:

26         (19)  "Legend drug," "prescription drug," or "medicinal

27  drug" means any drug, including, but not limited to, finished

28  dosage forms, or active ingredients subject to, defined by, or

29  described by s. 503(b) of the Federal Food, Drug, and Cosmetic

30  Act or s. 465.003(8)(7), s. 499.007(12), or s. 499.0122(1)(b)

31  or (c).

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1         Section 22.  Effective July 1, 1998, paragraph (a) of

 2  subsection (1) of section 499.012, Florida Statutes, is

 3  amended to read:

 4         499.012  Wholesale distribution; definitions; permits;

 5  general requirements.--

 6         (1)  As used in this section, the term:

 7         (a)  "Wholesale distribution" means distribution of

 8  prescription drugs to persons  other than a consumer or

 9  patient, but does not include lawful dispensing of a

10  prescription drug in accordance with chapter 465; however:

11         1.  As used in s. 499.005(21), the term "wholesale

12  distribution" does not include any of the following activities

13  if the activity is conducted in accordance with s. 499.014:

14         a.1.  The purchase or other acquisition by a hospital

15  or other health care entity that is a member of a group

16  purchasing organization of a prescription drug for its own use

17  from the group purchasing organization or from other hospitals

18  or health care entities that are members of that organization;

19         b.2.  The sale, purchase, or trade of a prescription

20  drug or an offer to sell, purchase, or trade a prescription

21  drug by a charitable organization described in s. 501(c)(3) of

22  the Internal Revenue Code of 1986, as amended and revised, to

23  a nonprofit affiliate of the organization to the extent

24  otherwise permitted by law;

25         c.3.  The sale, purchase, or trade of a prescription

26  drug or an offer to sell, purchase, or trade a prescription

27  drug among hospitals or other health care entities that are

28  under common control.  For purposes of this section, "common

29  control" means the power to direct or cause the direction of

30  the management and policies of a person or an organization,

31  whether by ownership of stock, by voting rights, by contract,

                                  8

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  or otherwise.

 2         2.  As used in s. 499.005(21), the term "wholesale

 3  distribution" also does not include any of the following

 4  activities if the activity is done in accordance with rules

 5  established by the department:

 6         a.4.  The sale, purchase, or trade of a prescription

 7  drug among federal, state, or local government health care

 8  entities that are under common control and are authorized to

 9  purchase such prescription drug.

10         b.  The sale, purchase, trade, or other transfer of a

11  prescription drug from or for any of the following entities: a

12  federal, state, or local government agency or any entity

13  eligible to purchase prescription drugs at public health

14  services prices pursuant to s. 602 of Pub. L. No. 102-585 to a

15  contract provider or its subcontractor for eligible patients

16  of the entity if:

17         (I)  The entity obtains written authorization for the

18  sale, purchase, trade, or other transfer of a prescription

19  drug under this paragraph from the Secretary of Health. This

20  written authorization must be based on a favorable

21  recommendation by the Drug Regulation Advisory Group after the

22  group has reviewed the entity's submission to the department

23  of a detailed plan and justification for the sale, purchase,

24  trade, or other transfer of a prescription drug under this

25  paragraph and must enhance the public's health by improving

26  needed access, quality, or safety because current patient drug

27  delivery systems are inadequate;

28         (II)  The contract provider or subcontractor is

29  authorized by law to administer or dispense prescription

30  drugs;

31         (III)  In the case of a subcontractor, the entity is a

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  party to and executes the subcontract;

 2         (IV)  A contract provider or subcontractor maintains

 3  separate and apart any prescription drugs of the entity in its

 4  possession from other prescription drug inventory;

 5         (V)  The contract provider and subcontractor maintains

 6  and produces immediately for inspection all records of

 7  movement or transfer of all the prescription drugs belonging

 8  to the entity, including, but not limited to, the records of

 9  receipt and disposition of prescription drugs. Each contractor

10  and subcontractor dispensing or administering these drugs must

11  maintain and produce records documenting the dispensing or

12  administration. Records that are required to be maintained

13  include, but are not limited to, a perpetual inventory

14  itemizing drugs received and drugs dispensed by prescription

15  number or administered by patient identifier, which must be

16  submitted to the entity monthly;

17         (VI)  The contract provider or subcontractor either

18  administers or dispenses the prescription drugs only to the

19  eligible patients of the entity or returns the prescription

20  drug for or to the entity. The contract provider or

21  subcontractor must require proof from each person seeking to

22  fill a prescription or obtain treatment that the person is an

23  eligible patient of the entity and must, at a minimum,

24  maintain a copy of this proof as part of the records of the

25  contractor or subcontractor required under

26  sub-sub-subparagraph (V);

27         (VII)  The prescription drugs transferred pursuant to

28  this paragraph may not be billed to Medicaid; and

29         (VIII)  In addition to the departmental inspection

30  authority set forth in s. 499.051, the establishment of the

31  contract provider and subcontractor and all records pertaining

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  to prescription drugs subject to this sub-subparagraph are

 2  subject to inspection by the entity. All records relating to

 3  prescription drugs of a manufacturer under this

 4  sub-subparagraph are subject to audit by the manufacturer of

 5  those drugs, without identifying individual patient

 6  information.

 7         c.5.  The sale, purchase, or trade of a prescription

 8  drug or an offer to sell, purchase, or trade a prescription

 9  drug for emergency medical reasons; for purposes of this

10  sub-subparagraph subparagraph, the term "emergency medical

11  reasons" includes transfers of prescription drugs by a retail

12  pharmacy to another retail pharmacy to alleviate a temporary

13  shortage.;

14         d.6.  The transfer purchase or acquisition of a

15  prescription drug acquired by a medical director on behalf of

16  a licensed an emergency medical services provider to that

17  medical director for use by emergency medical services

18  provider and its transport vehicles for use in accordance with

19  the provider's license under providers acting within the scope

20  of their professional practice pursuant to chapter 401.

21         7.  The dispensing of a prescription drug pursuant to a

22  prescription;

23         e.8.  The distribution of prescription drug samples by

24  manufacturers' representatives or distributors'

25  representatives conducted in accordance with s. 499.028.; or

26         f.9.  The sale, purchase, or trade of blood and blood

27  components intended for transfusion.  As used in this section,

28  the term "blood" means whole blood collected from a single

29  donor and processed either for transfusion or further

30  manufacturing, and the term "blood components" means that part

31  of the blood separated by physical or mechanical means.

                                  11

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1         Section 23.  Effective July 1, 1998, section 499.0722,

 2  Florida Statutes, is created to read:

 3         499.0722  Drug Regulation Advisory Group; exemptions.--

 4         (1)  There is created the Drug Regulation Advisory

 5  Group, which is an independent advisory group composed of at

 6  least 11 members appointed by the Secretary of Health and

 7  including:

 8         (a)  One member representing the prescription drug

 9  wholesale industry in this state;

10         (b)  One member representing pharmaceutical

11  manufacturers, who may represent pharmaceutical manufacturers

12  nationwide;

13         (c)  One member who is a practicing pharmacist;

14         (d)  One member representing the Agency for Health Care

15  Administration;

16         (e)  One member who is a physician licensed under

17  chapter 458 or chapter 459;

18         (f)  One consumer representative;

19         (g)  One member representing the cosmetic industry;

20         (h)  One member representing the compressed medical gas

21  industry;

22         (i)  One member representing the medical device

23  manufacturing industry;

24         (j)  The Executive Director of the Board of Pharmacy,

25  who shall be an ex officio member; and

26         (k)  One member representing the department, who shall

27  chair group meetings.

28         (l)  One member representing hospitals.

29         (m)  One member representing the long-term care

30  industry.

31         (2)  Members shall be appointed for terms of 4 years,

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  except for the Executive Director of the Board of Pharmacy and

 2  the departmental representative, who may serve indefinitely.

 3  Members of the group may be reappointed. A vacancy in

 4  membership which occurs before the expiration of a term shall

 5  be filled by a member appointed by the Secretary of Health for

 6  a full term.

 7         (3)  The group shall meet upon request of the

 8  department, but no more than four times a year. Members of the

 9  group shall serve without compensation, but may be reimbursed

10  for per diem and travel expenses as provided in s. 112.061.

11         (4)  The purposes and duties of the Drug Regulation

12  Advisory Group include, but are not limited to:

13         (a)  Making recommendations to the Secretary of Health

14  regarding authorizations for the sale, purchase, trade, or

15  other transfer of a prescription drug under s. 499.012(1)(b)2.

16         (b)  Making recommendations to the department regarding

17  enforcement priorities under this chapter.

18         (c)  Briefing the department on industry trends that

19  affect this chapter.

20         (d)  Providing information and guidance on issues

21  submitted by the department to the group.

22         (e)  Facilitating the dissemination of relevant

23  information concerning current issues affecting the public

24  health within the scope and responsibility of this chapter.

25         (5)  The department may publish compliance policy

26  guidelines that set forth enforcement priorities or other

27  recommendations of the Drug Regulation Advisory Group when

28  that is in the best interest of the public health.

29

30

31

                                  13

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1  ================ T I T L E   A M E N D M E N T ===============

 2  And the title is amended as follows:

 3         On page 2, line 2, after the semicolon

 4

 5  insert:

 6         amending s. 465.003, F.S.; defining the term

 7         "data communication device"; revising the

 8         definition of the term "practice of the

 9         profession of pharmacy"; amending s. 465.016,

10         F.S.; providing a ground for which a pharmacist

11         may be subject to discipline by the Board of

12         Pharmacy; amending s. 465.017, F.S.; providing

13         additional persons and entities to whom records

14         relating to the filling of prescriptions and

15         the dispensing of medicinal drugs that are

16         maintained by a pharmacy may be furnished;

17         specifying authorized uses of patient records

18         by pharmacy owners; providing restrictions on

19         such records when transmitted through a data

20         communication device; amending s. 465.019,

21         F.S.; providing for certain dispensing of

22         medicinal drugs to patients in emergency

23         departments of certain hospitals; amending ss.

24         465.014, 465.015, 465.0196, 468.812, and

25         499.003, F.S.; correcting cross references, to

26         conform; amending s. 499.012, F.S.; redefining

27         the term "wholesale distribution," relating to

28         the distribution of prescription drugs, by

29         providing for the exclusion of certain

30         activities; creating s. 499.0722, F.S.;

31         creating the Drug Regulation Advisory Group;

                                  14

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                                                   HOUSE AMENDMENT

    hbd-21                              Bill No. HB 4119, 1st Eng.

    Amendment No.     (for drafter's use only)





 1         providing membership; providing terms of

 2         office; providing for meetings, for

 3         reimbursement of expenses, and for purposes and

 4         duties of the group; allowing the Department of

 5         Health to publish compliance policy guidelines

 6         that include recommendations of the group;

 7

 8

 9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

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31

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