CODING: Words stricken are deletions; words underlined are additions.
SENATE AMENDMENT
Bill No. HB 4119, 1st Eng.
Amendment No.
CHAMBER ACTION
Senate House
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11 Senators Jones and Hargrett moved the following amendment to
12 amendment (974800):
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14 Senate Amendment (with title amendment)
15 On page 14, between lines 15 and 16,
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17 insert:
18 Section 11. Effective July 1, 1998, subsection (12) of
19 section 465.003, Florida Statutes, is amended, subsections (4)
20 through (14) are renumbered as subsections (5) through (15),
21 respectively, and a new subsection (4) is added to said
22 section, to read:
23 465.003 Definitions.--As used in this chapter, the
24 term:
25 (4) "Data communication device" means an electronic
26 device that receives electronic information from one source
27 and transmits or routes it to another, including, but not
28 limited to, any such bridge, router, switch, or gateway.
29 (13)(12) "Practice of the profession of pharmacy"
30 includes compounding, dispensing, and consulting concerning
31 contents, therapeutic values, and uses of any medicinal drug;
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Amendment No.
1 and consulting concerning therapeutic values and interactions
2 of patent or proprietary preparations, whether pursuant to
3 prescriptions or in the absence and entirely independent of
4 such prescriptions or orders; and other pharmaceutical
5 services. For purposes of this subsection, "other
6 pharmaceutical services" means the evaluation and monitoring
7 of the patient's health as it relates to drug therapy and
8 assisting the patient in the management of his or her drug
9 therapy, and includes the review of the patient's drug therapy
10 and communication with the patient and the patient's
11 prescribing health care provider as licensed under chapter
12 458, chapter 459, chapter 461, or chapter 466, or similar
13 statutory provision in another jurisdiction, or such
14 provider's agent or such other persons as specifically
15 authorized by the patient, regarding the drug therapy.Nothing
16 herein shall be interpreted to permit an alteration of a
17 prescriber's directions, unless otherwise permitted by law.
18 "Practice of the profession of pharmacy" The phrase also
19 includes any other act, service, operation, research, or
20 transaction incidental to, or forming a part of, any of the
21 foregoing acts, requiring, involving, or employing the science
22 or art of any branch of the pharmaceutical profession, study,
23 or training, and shall expressly permit a pharmacist to
24 transmit information from persons authorized to prescribe
25 medicinal drugs to their patients. A pharmacist may also
26 administer immunizations within the framework of an
27 established protocol under a supervisory practitioner who is a
28 physician licensed under chapter 458 or chapter 459 or by
29 written agreement with a county health department. Each
30 protocol must contain specific procedures to address any
31 unforeseen allergic reaction to an immunization. A pharmacist
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 may not enter into a protocol unless he or she maintains at
2 least $200,000 of professional liability insurance, and not
3 until the pharmacist has completed training in immunizations
4 as may be required by the board. The decision by a supervisory
5 practitioner to enter into such a protocol is a professional
6 decision of the practitioner, and no person may interfere with
7 a supervisory practitioner's decision as to whether to enter
8 into such a protocol. A pharmacist may not enter into a
9 protocol that is to be performed while acting as an employee
10 without the written approval of the owner of the pharmacy.
11 Section 12. Paragraph (l) of subsection (1) of section
12 465.016, Florida Statutes, is amended to read:
13 465.016 Disciplinary actions.--
14 (1) The following acts shall be grounds for
15 disciplinary action set forth in this section:
16 (l) Placing in the stock of any pharmacy any part of
17 any prescription compounded or dispensed which is returned by
18 a patient; however, in a hospital, nursing home, correctional
19 facility, or extended care facility in which unit-dose
20 medication is dispensed to inpatients, each dose being
21 individually sealed and the individual unit dose or unit-dose
22 system labeled with the name of the drug, dosage strength,
23 manufacturer's control number, and expiration date, if any,
24 the unused unit dose of medication may be returned to the
25 pharmacy for redispensing. Each pharmacist shall maintain
26 appropriate records for any unused or returned medicinal
27 drugs.
28 Section 13. Effective July 1, 1998, a new paragraph
29 (q) is added to subsection (1) of section 465.016, Florida
30 Statutes, to read:
31 465.016 Disciplinary actions.--
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 (1) The following acts shall be grounds for
2 disciplinary action set forth in this section:
3 (q) Using or releasing a patient's records except as
4 authorized by this chapter and chapter 455.
5 Section 14. Effective July 1, 1998, subsection (2) of
6 section 465.017, Florida Statutes, is amended to read:
7 465.017 Authority to inspect.--
8 (2) Except as permitted by this chapter, and chapters
9 406, 409, 455, 499, and 893, records maintained by in a
10 pharmacy relating to the filling of prescriptions and the
11 dispensing of medicinal drugs shall not be furnished, except
12 upon the written authorization of the patient, to any person
13 other than to the patient for whom the drugs were dispensed,
14 or her or his legal representative, or to the department
15 pursuant to existing law, or, in the event that the patient is
16 incapacitated or unable to request said records, her or his
17 spouse; or to the department pursuant to existing law; or to
18 health care practitioners and pharmacists consulting or
19 dispensing to the patient; or to insurance carriers or other
20 payors authorized by the patient to receive such records. For
21 purposes of this section, records held in a pharmacy shall be
22 considered owned by the owner of the pharmacy. The pharmacy
23 owner may use such records in the aggregate without patient
24 identification data, regardless of where such records are
25 held, for purposes reasonably related to the business and
26 practice of pharmacy except upon the written authorization of
27 such patient. Such records may be furnished in any civil or
28 criminal proceeding, upon the issuance of a subpoena from a
29 court of competent jurisdiction and proper notice to the
30 patient or her or his legal representative by the party
31 seeking such records. Such records or any part thereof, if
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 transmitted through a data communication device not under the
2 control or ownership of a pharmacy or affiliated company or
3 not directly between a pharmacy and a treating practitioner,
4 may not be accessed, used, or maintained by the operator or
5 owner of the data communication device unless specifically
6 authorized by this section. It is the intent of this
7 subsection to allow the use and sharing of such records to
8 improve patient care, provided the pharmacist acts in the best
9 interests of their patient. Nothing herein shall be construed
10 to authorize or expand solicitation or marketing to patients
11 or potential patients in any manner not otherwise specifically
12 authorized by law.
13 Section 15. Effective July 1, 1998, subsection (4) of
14 section 465.019, Florida Statutes, is amended to read:
15 465.019 Institutional pharmacies; permits.--
16 (4) Medicinal drugs shall be dispensed in an
17 institutional pharmacy to outpatients only when that
18 institution has secured a community pharmacy permit from the
19 department. However, an individual licensed to prescribe
20 medicinal drugs in this state may dispense up to a 24-hour
21 supply of a medicinal drug to any patient of an emergency
22 department of a hospital that operates a Class II
23 institutional pharmacy, provided the physician treating the
24 patient in such hospital's emergency department determines
25 that the medicinal drug is warranted and that community
26 pharmacy services are not readily accessible, geographically
27 or otherwise, to the patient. Such dispensing from the
28 emergency department shall be in accordance with the
29 procedures of the hospital. For any such patient for whom a
30 medicinal drug is warranted for a period to exceed 24 hours,
31 an individual licensed to prescribe such drug shall dispense a
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Amendment No.
1 24-hour supply of such drug to the patient and shall provide
2 the patient a prescription for such drug for use after the
3 initial 24-hour period. The board may adopt rules necessary to
4 carry out the provisions of this subsection.
5 Section 16. Effective July 1, 1998, section 465.014,
6 Florida Statutes, is amended to read:
7 465.014 Pharmacy technician.--No person other than a
8 licensed pharmacist or pharmacy intern may engage in the
9 practice of the profession of pharmacy, except that a licensed
10 pharmacist may delegate to nonlicensed pharmacy technicians
11 those duties, tasks, and functions which do not fall within
12 the purview of s. 465.003(13)(12). All such delegated acts
13 shall be performed under the direct supervision of a licensed
14 pharmacist who shall be responsible for all such acts
15 performed by persons under his or her supervision. A pharmacy
16 technician, under the supervision of a pharmacist, may
17 initiate or receive communications with a practitioner or his
18 or her agent, on behalf of a patient, regarding refill
19 authorization requests. No licensed pharmacist shall supervise
20 more than one pharmacy technician unless otherwise permitted
21 by the guidelines adopted by the board. The board shall
22 establish guidelines to be followed by licensees or permittees
23 in determining the circumstances under which a licensed
24 pharmacist may supervise more than one but not more than three
25 pharmacy technicians.
26 Section 17. Effective July 1, 1998, paragraph (c) of
27 subsection (2) of section 465.015, Florida Statutes, is
28 amended to read:
29 465.015 Violations and penalties.--
30 (2) It is unlawful for any person:
31 (c) To sell or dispense drugs as defined in s.
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Amendment No.
1 465.003(8)(7) without first being furnished with a
2 prescription.
3 Section 18. Effective July 1, 1998, section 465.0196,
4 Florida Statutes, is amended to read:
5 465.0196 Special pharmacy permits.--Any person
6 desiring a permit to operate a pharmacy which does not fall
7 within the definitions set forth in s. 465.003(11)(10)(a)1.,
8 2., and 3. shall apply to the department for a special
9 pharmacy permit. If the board certifies that the application
10 complies with the applicable laws and rules of the board
11 governing the practice of the profession of pharmacy, the
12 department shall issue the permit. No permit shall be issued
13 unless a licensed pharmacist is designated to undertake the
14 professional supervision of the compounding and dispensing of
15 all drugs dispensed by the pharmacy. The licensed pharmacist
16 shall be responsible for maintaining all drug records and for
17 providing for the security of the area in the facility in
18 which the compounding, storing, and dispensing of medicinal
19 drugs occurs. The permittee shall notify the department
20 within 10 days of any change of the licensed pharmacist
21 responsible for such duties.
22 Section 19. Effective July 1, 1998, subsection (3) of
23 section 468.812, Florida Statutes, is amended to read:
24 468.812 Exemptions from licensure.--
25 (3) The provisions of this act relating to orthotics
26 or pedorthics do not apply to any licensed pharmacist or to
27 any person acting under the supervision of a licensed
28 pharmacist. The practice of orthotics or pedorthics by a
29 pharmacist or any of the pharmacist's employees acting under
30 the supervision of a pharmacist shall be construed to be
31 within the meaning of the term "practice of the profession of
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Amendment No.
1 pharmacy" as set forth in s. 465.003(13)(12), and shall be
2 subject to regulation in the same manner as any other pharmacy
3 practice. The Board of Pharmacy shall develop rules regarding
4 the practice of orthotics and pedorthics by a pharmacist. Any
5 pharmacist or person under the supervision of a pharmacist
6 engaged in the practice of orthotics or pedorthics shall not
7 be precluded from continuing that practice pending adoption of
8 these rules.
9 Section 20. Effective July 1, 1998, subsection (19) of
10 section 499.003, Florida Statutes, is amended to read:
11 499.003 Definitions of terms used in ss.
12 499.001-499.081.--As used in ss. 499.001-499.081, the term:
13 (19) "Legend drug," "prescription drug," or "medicinal
14 drug" means any drug, including, but not limited to, finished
15 dosage forms, or active ingredients subject to, defined by, or
16 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
17 Act or s. 465.003(8)(7), s. 499.007(12), or s. 499.0122(1)(b)
18 or (c).
19 Section 21. Effective July 1, 1998, paragraph (a) of
20 subsection (1) of section 499.012, Florida Statutes, is
21 amended to read:
22 499.012 Wholesale distribution; definitions; permits;
23 general requirements.--
24 (1) As used in this section, the term:
25 (a) "Wholesale distribution" means distribution of
26 prescription drugs to persons other than a consumer or
27 patient, but does not include lawful dispensing of a
28 prescription drug in accordance with chapter 465; however:
29 1. As used in s. 499.005(21), the term "wholesale
30 distribution" does not include any of the following activities
31 if the activity is conducted in accordance with s. 499.014:
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Amendment No.
1 a.1. The purchase or other acquisition by a hospital
2 or other health care entity that is a member of a group
3 purchasing organization of a prescription drug for its own use
4 from the group purchasing organization or from other hospitals
5 or health care entities that are members of that organization;
6 b.2. The sale, purchase, or trade of a prescription
7 drug or an offer to sell, purchase, or trade a prescription
8 drug by a charitable organization described in s. 501(c)(3) of
9 the Internal Revenue Code of 1986, as amended and revised, to
10 a nonprofit affiliate of the organization to the extent
11 otherwise permitted by law;
12 c.3. The sale, purchase, or trade of a prescription
13 drug or an offer to sell, purchase, or trade a prescription
14 drug among hospitals or other health care entities that are
15 under common control. For purposes of this section, "common
16 control" means the power to direct or cause the direction of
17 the management and policies of a person or an organization,
18 whether by ownership of stock, by voting rights, by contract,
19 or otherwise.
20 2. As used in s. 499.005(21), the term "wholesale
21 distribution" also does not include any of the following
22 activities if the activity is done in accordance with rules
23 established by the department:
24 a.4. The sale, purchase, or trade of a prescription
25 drug among federal, state, or local government health care
26 entities that are under common control and are authorized to
27 purchase such prescription drug.
28 b. The sale, purchase, trade, or other transfer of a
29 prescription drug from or for any of the following entities: a
30 federal, state, or local government agency or any entity
31 eligible to purchase prescription drugs at public health
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 services prices pursuant to s. 602 of Pub. L. No. 102-585 to a
2 contract provider or its subcontractor for eligible patients
3 of the entity if:
4 (I) The entity obtains written authorization for the
5 sale, purchase, trade, or other transfer of a prescription
6 drug under this paragraph from the Secretary of Health. This
7 written authorization must be based on a favorable
8 recommendation by the Drug Regulation Advisory Group after the
9 group has reviewed the entity's submission to the department
10 of a detailed plan and justification for the sale, purchase,
11 trade, or other transfer of a prescription drug under this
12 paragraph and must enhance the public's health by improving
13 needed access, quality, or safety because current patient drug
14 delivery systems are inadequate;
15 (II) The contract provider or subcontractor is
16 authorized by law to administer or dispense prescription
17 drugs;
18 (III) In the case of a subcontractor, the entity is a
19 party to and executes the subcontract;
20 (IV) A contract provider or subcontractor maintains
21 separate and apart any prescription drugs of the entity in its
22 possession from other prescription drug inventory;
23 (V) The contract provider and subcontractor maintains
24 and produces immediately for inspection all records of
25 movement or transfer of all the prescription drugs belonging
26 to the entity, including, but not limited to, the records of
27 receipt and disposition of prescription drugs. Each contractor
28 and subcontractor dispensing or administering these drugs must
29 maintain and produce records documenting the dispensing or
30 administration. Records that are required to be maintained
31 include, but are not limited to, a perpetual inventory
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Amendment No.
1 itemizing drugs received and drugs dispensed by prescription
2 number or administered by patient identifier, which must be
3 submitted to the entity monthly;
4 (VI) The contract provider or subcontractor either
5 administers or dispenses the prescription drugs only to the
6 eligible patients of the entity or returns the prescription
7 drug for or to the entity. The contract provider or
8 subcontractor must require proof from each person seeking to
9 fill a prescription or obtain treatment that the person is an
10 eligible patient of the entity and must, at a minimum,
11 maintain a copy of this proof as part of the records of the
12 contractor or subcontractor required under
13 sub-sub-subparagraph (V);
14 (VII) The prescription drugs transferred pursuant to
15 this paragraph may not be billed to Medicaid; and
16 (VIII) In addition to the departmental inspection
17 authority set forth in s. 499.051, the establishment of the
18 contract provider and subcontractor and all records pertaining
19 to prescription drugs subject to this sub-subparagraph are
20 subject to inspection by the entity. All records relating to
21 prescription drugs of a manufacturer under this
22 sub-subparagraph are subject to audit by the manufacturer of
23 those drugs, without identifying individual patient
24 information.
25 c.5. The sale, purchase, or trade of a prescription
26 drug or an offer to sell, purchase, or trade a prescription
27 drug for emergency medical reasons; for purposes of this
28 sub-subparagraph subparagraph, the term "emergency medical
29 reasons" includes transfers of prescription drugs by a retail
30 pharmacy to another retail pharmacy to alleviate a temporary
31 shortage.;
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 d.6. The transfer purchase or acquisition of a
2 prescription drug acquired by a medical director on behalf of
3 a licensed an emergency medical services provider to that
4 medical director for use by emergency medical services
5 provider and its transport vehicles for use in accordance with
6 the provider's license under providers acting within the scope
7 of their professional practice pursuant to chapter 401.
8 7. The dispensing of a prescription drug pursuant to a
9 prescription;
10 e.8. The distribution of prescription drug samples by
11 manufacturers' representatives or distributors'
12 representatives conducted in accordance with s. 499.028.; or
13 f.9. The sale, purchase, or trade of blood and blood
14 components intended for transfusion. As used in this section,
15 the term "blood" means whole blood collected from a single
16 donor and processed either for transfusion or further
17 manufacturing, and the term "blood components" means that part
18 of the blood separated by physical or mechanical means.
19 Section 22. Effective July 1, 1998, section 499.0722,
20 Florida Statutes, is created to read:
21 499.0722 Drug Regulation Advisory Group; exemptions.--
22 (1) There is created the Drug Regulation Advisory
23 Group, which is an independent advisory group composed of at
24 least 11 members appointed by the Secretary of Health and
25 including:
26 (a) One member representing the prescription drug
27 wholesale industry in this state;
28 (b) One member representing pharmaceutical
29 manufacturers, who may represent pharmaceutical manufacturers
30 nationwide;
31 (c) One member who is a practicing pharmacist;
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 (d) One member representing the Agency for Health Care
2 Administration;
3 (e) One member who is a physician licensed under
4 chapter 458 or chapter 459;
5 (f) One consumer representative;
6 (g) One member representing the cosmetic industry;
7 (h) One member representing the compressed medical gas
8 industry;
9 (i) One member representing the medical device
10 manufacturing industry;
11 (j) The Executive Director of the Board of Pharmacy,
12 who shall be an ex officio member; and
13 (k) One member representing the department, who shall
14 chair group meetings.
15 (l) One member representing hospitals.
16 (m) One member representing the long-term care
17 industry.
18 (2) Members shall be appointed for terms of 4 years,
19 except for the Executive Director of the Board of Pharmacy and
20 the departmental representative, who may serve indefinitely.
21 Members of the group may be reappointed. A vacancy in
22 membership which occurs before the expiration of a term shall
23 be filled by a member appointed by the Secretary of Health for
24 a full term.
25 (3) The group shall meet upon request of the
26 department, but no more than four times a year. Members of the
27 group shall serve without compensation, but may be reimbursed
28 for per diem and travel expenses as provided in s. 112.061.
29 (4) The purposes and duties of the Drug Regulation
30 Advisory Group include, but are not limited to:
31 (a) Making recommendations to the Secretary of Health
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 regarding authorizations for the sale, purchase, trade, or
2 other transfer of a prescription drug under s. 499.012(1)(b)2.
3 (b) Making recommendations to the department regarding
4 enforcement priorities under this chapter.
5 (c) Briefing the department on industry trends that
6 affect this chapter.
7 (d) Providing information and guidance on issues
8 submitted by the department to the group.
9 (e) Facilitating the dissemination of relevant
10 information concerning current issues affecting the public
11 health within the scope and responsibility of this chapter.
12 (5) The department may publish compliance policy
13 guidelines that set forth enforcement priorities or other
14 recommendations of the Drug Regulation Advisory Group when
15 that is in the best interest of the public health.
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17
18 ================ T I T L E A M E N D M E N T ===============
19 And the title is amended as follows:
20 On page 15, line 16, after the semicolon
21
22 insert:
23 amending s. 465.003, F.S.; defining the term
24 "data communication device"; revising the
25 definition of the term "practice of the
26 profession of pharmacy"; amending s. 465.016,
27 F.S.; authorizing the redispensing of unused or
28 returned unit-dose medication by correctional
29 facilities under certain conditions; amending
30 s. 465.016, F.S.; providing a ground for which
31 a pharmacist may be subject to discipline by
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Bill No. HB 4119, 1st Eng.
Amendment No.
1 the Board of Pharmacy; amending s. 465.017,
2 F.S.; providing additional persons and entities
3 to whom records relating to the filling of
4 prescriptions and the dispensing of medicinal
5 drugs that are maintained by a pharmacy may be
6 furnished; specifying authorized uses of
7 patient records by pharmacy owners; providing
8 restrictions on such records when transmitted
9 through a data communication device; amending
10 s. 465.019, F.S.; providing for certain
11 dispensing of medicinal drugs to patients in
12 emergency departments of certain hospitals;
13 amending ss. 465.014, 465.015, 465.0196,
14 468.812, and 499.003, F.S.; correcting cross
15 references, to conform; amending s. 499.012,
16 F.S.; redefining the term "wholesale
17 distribution," relating to the distribution of
18 prescription drugs, by providing for the
19 exclusion of certain activities; creating s.
20 499.0722, F.S.; creating the Drug Regulation
21 Advisory Group; providing membership; providing
22 terms of office; providing for meetings, for
23 reimbursement of expenses, and for purposes and
24 duties of the group; allowing the Department of
25 Health to publish compliance policy guidelines
26 that include recommendations of the group;
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31
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