CODING: Words stricken are deletions; words underlined are additions.
HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
CHAMBER ACTION
Senate House
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5 ORIGINAL STAMP BELOW
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11 Representative(s) Johnson, Gay, and Kelly offered the
12 following:
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14 Amendment (with title amendment)
15 Remove from the bill: Everything after the enacting clause
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17 and insert in lieu thereof:
18 Section 1. This act may be cited as the "Pharmacy
19 Patient Privacy Act of 1999."
20 Section 2. Subsection (12) of section 465.003, Florida
21 Statutes, is amended, subsections (4) through (14) of said
22 section are renumbered as subsections (5) through (15),
23 respectively, and a new subsection (4) is added to said
24 section, to read:
25 465.003 Definitions.--As used in this chapter, the
26 term:
27 (4) "Data communication device" means an electronic
28 device that receives electronic information from one source
29 and transmits or routes it to another, including, but not
30 limited to, any such bridge, router, switch, or gateway.
31 (13)(12) "Practice of the profession of pharmacy"
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 includes compounding, dispensing, and consulting concerning
2 contents, therapeutic values, and uses of any medicinal drug;
3 and consulting concerning therapeutic values and interactions
4 of patent or proprietary preparations, whether pursuant to
5 prescriptions or in the absence and entirely independent of
6 such prescriptions or orders; and other pharmaceutical
7 services. For purposes of this subsection, "other
8 pharmaceutical services" means the monitoring of the patient's
9 drug therapy and assisting the patient in the management of
10 his or her drug therapy, and includes review of the patient's
11 drug therapy and communication with the patient's prescribing
12 health care provider as licensed under chapter 458, chapter
13 459, chapter 461, or chapter 466, or similar statutory
14 provision in another jurisdiction, or such provider's agent or
15 such other persons as specifically authorized by the patient,
16 regarding the drug therapy. However, nothing in this
17 subsection may be interpreted to permit an alteration of a
18 prescriber's directions, the diagnosis or treatment of any
19 disease, the initiation of any drug therapy, the practice of
20 medicine, or the practice of osteopathic medicine, unless
21 otherwise permitted by law. "Practice of the profession of
22 pharmacy" The phrase also includes any other act, service,
23 operation, research, or transaction incidental to, or forming
24 a part of, any of the foregoing acts, requiring, involving, or
25 employing the science or art of any branch of the
26 pharmaceutical profession, study, or training, and shall
27 expressly permit a pharmacist to transmit information from
28 persons authorized to prescribe medicinal drugs to their
29 patients.
30 Section 3. Effective upon this act becoming a law,
31 paragraph (l) of subsection (1) of section 465.016, Florida
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 Statutes, is amended to read:
2 465.016 Disciplinary actions.--
3 (1) The following acts shall be grounds for
4 disciplinary action set forth in this section:
5 (l) Placing in the stock of any pharmacy any part of
6 any prescription compounded or dispensed which is returned by
7 a patient; however, in a hospital, nursing home, correctional
8 facility, or extended care facility in which unit-dose
9 medication is dispensed to inpatients, each dose being
10 individually sealed and the individual unit dose or unit-dose
11 system labeled with the name of the drug, dosage strength,
12 manufacturer's control number, and expiration date, if any,
13 the unused unit dose of medication may be returned to the
14 pharmacy for redispensing. Each pharmacist shall maintain
15 appropriate records for any unused or returned medicinal
16 drugs.
17 Section 4. Paragraph (q) is added to subsection (1) of
18 section 465.016, Florida Statutes, to read:
19 465.016 Disciplinary actions.--
20 (1) The following acts shall be grounds for
21 disciplinary action set forth in this section:
22 (q) Using or releasing a patient's records except as
23 authorized by this chapter and chapter 455.
24 Section 5. Subsection (2) of section 465.017, Florida
25 Statutes, is amended to read:
26 465.017 Authority to inspect.--
27 (2) Except as permitted by this chapter, and chapters
28 406, 409, 455, 499, and 893, records maintained by in a
29 pharmacy relating to the filling of prescriptions and the
30 dispensing of medicinal drugs shall not be furnished, except
31 upon the written authorization of the patient, to any person
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 other than to the patient for whom the drugs were dispensed,
2 or her or his legal representative, or to the department
3 pursuant to existing law, or, in the event that the patient is
4 incapacitated or unable to request such said records, her or
5 his spouse; to the department pursuant to law; to health care
6 practitioners and pharmacists consulting with or dispensing to
7 the patient, including physicians who are part of independent
8 practice associations, physician hospital organizations, or
9 other such organized provider groups; to entities that provide
10 compliance services; to insurance carriers or other payors
11 authorized by the patient to receive such records; or to a
12 health care researcher, investigator, or sponsor investigator
13 where use of the information is for a research project or
14 clinical investigation regulated under 21 C.F.R. ss. 50 and 56
15 or 45 C.F.R s. 46. For purposes of this section, records held
16 in a pharmacy shall be considered owned by the owner of the
17 pharmacy. The pharmacy owner may use such records in the
18 aggregate without patient identification data, regardless of
19 where such records are held, for purposes reasonably related
20 to the business and practice of pharmacy or health care
21 research that meets the requirements of s. 455.667(5)(d)
22 except upon the written authorization of such patient. Such
23 records may be furnished in any civil or criminal proceeding,
24 upon the issuance of a subpoena from a court of competent
25 jurisdiction and proper notice to the patient or her or his
26 legal representative by the party seeking such records. Such
27 records or any part thereof, if transmitted through a data
28 communication device not under the control or ownership of a
29 pharmacy or affiliated company or not directly between a
30 pharmacy and a treating practitioner, may not be accessed,
31 used, or maintained by the operator or owner of the data
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 communication device unless specifically authorized by this
2 section. It is the intent of this subsection to allow the use
3 and sharing of such records to improve patient care, provided
4 the pharmacist acts in the best interests of her or his
5 patient. Nothing in this subsection may be construed to
6 authorize or expand solicitation or marketing to patients or
7 potential patients in any manner not otherwise specifically
8 authorized by law.
9 Section 6. Section 465.014, Florida Statutes, is
10 amended to read:
11 465.014 Pharmacy technician.--No person other than a
12 licensed pharmacist or pharmacy intern may engage in the
13 practice of the profession of pharmacy, except that a licensed
14 pharmacist may delegate to nonlicensed pharmacy technicians
15 those duties, tasks, and functions which do not fall within
16 the purview of s. 465.003(13)(12). All such delegated acts
17 shall be performed under the direct supervision of a licensed
18 pharmacist who shall be responsible for all such acts
19 performed by persons under his or her supervision. A pharmacy
20 technician, under the supervision of a pharmacist, may
21 initiate or receive communications with a practitioner or his
22 or her agent, on behalf of a patient, regarding refill
23 authorization requests. No licensed pharmacist shall
24 supervise more than one pharmacy technician unless otherwise
25 permitted by the guidelines adopted by the board. The board
26 shall establish guidelines to be followed by licensees or
27 permittees in determining the circumstances under which a
28 licensed pharmacist may supervise more than one but not more
29 than three pharmacy technicians.
30 Section 7. Paragraph (c) of subsection (2) of section
31 465.015, Florida Statutes, is amended to read:
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 465.015 Violations and penalties.--
2 (2) It is unlawful for any person:
3 (c) To sell or dispense drugs as defined in s.
4 465.003(8)(7) without first being furnished with a
5 prescription.
6 Section 8. Section 465.0196, Florida Statutes, is
7 amended to read:
8 465.0196 Special pharmacy permits.--Any person
9 desiring a permit to operate a pharmacy which does not fall
10 within the definitions set forth in s. 465.003(11)(10)(a)1.,
11 2., and 3. shall apply to the department for a special
12 pharmacy permit. If the board certifies that the application
13 complies with the applicable laws and rules of the board
14 governing the practice of the profession of pharmacy, the
15 department shall issue the permit. No permit shall be issued
16 unless a licensed pharmacist is designated to undertake the
17 professional supervision of the compounding and dispensing of
18 all drugs dispensed by the pharmacy. The licensed pharmacist
19 shall be responsible for maintaining all drug records and for
20 providing for the security of the area in the facility in
21 which the compounding, storing, and dispensing of medicinal
22 drugs occurs. The permittee shall notify the department
23 within 10 days of any change of the licensed pharmacist
24 responsible for such duties.
25 Section 9. Subsection (3) of section 468.812, Florida
26 Statutes, is amended to read:
27 468.812 Exemptions from licensure.--
28 (3) The provisions of this act relating to orthotics
29 or pedorthics do not apply to any licensed pharmacist or to
30 any person acting under the supervision of a licensed
31 pharmacist. The practice of orthotics or pedorthics by a
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 pharmacist or any of the pharmacist's employees acting under
2 the supervision of a pharmacist shall be construed to be
3 within the meaning of the term "practice of the profession of
4 pharmacy" as set forth in s. 465.003(13)(12), and shall be
5 subject to regulation in the same manner as any other pharmacy
6 practice. The Board of Pharmacy shall develop rules regarding
7 the practice of orthotics and pedorthics by a pharmacist. Any
8 pharmacist or person under the supervision of a pharmacist
9 engaged in the practice of orthotics or pedorthics shall not
10 be precluded from continuing that practice pending adoption of
11 these rules.
12 Section 10. Subsection (19) of section 499.003,
13 Florida Statutes, is amended to read:
14 499.003 Definitions of terms used in ss.
15 499.001-499.081.--As used in ss. 499.001-499.081, the term:
16 (19) "Legend drug," "prescription drug," or "medicinal
17 drug" means any drug, including, but not limited to, finished
18 dosage forms, or active ingredients subject to, defined by, or
19 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
20 Act or s. 465.003(8)(7), s. 499.007(12), or s. 499.0122(1)(b)
21 or (c).
22 Section 11. Paragraph (a) of subsection (1) and
23 subsection (5) of section 499.012, Florida Statutes, 1998
24 Supplement, are amended to read:
25 499.012 Wholesale distribution; definitions; permits;
26 general requirements.--
27 (1) As used in this section, the term:
28 (a) "Wholesale distribution" means distribution of
29 prescription drugs to persons other than a consumer or
30 patient, but does not include:
31 1. Any of the following activities, which is not a
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 violation of s. 499.005(21) if such activity is conducted in
2 accordance with s. 499.014:
3 a. The purchase or other acquisition by a hospital or
4 other health care entity that is a member of a group
5 purchasing organization of a prescription drug for its own use
6 from the group purchasing organization or from other hospitals
7 or health care entities that are members of that organization.
8 b. The sale, purchase, or trade of a prescription drug
9 or an offer to sell, purchase, or trade a prescription drug by
10 a charitable organization described in s. 501(c)(3) of the
11 Internal Revenue Code of 1986, as amended and revised, to a
12 nonprofit affiliate of the organization to the extent
13 otherwise permitted by law.
14 c. The sale, purchase, or trade of a prescription drug
15 or an offer to sell, purchase, or trade a prescription drug
16 among hospitals or other health care entities that are under
17 common control. For purposes of this section, "common control"
18 means the power to direct or cause the direction of the
19 management and policies of a person or an organization,
20 whether by ownership of stock, by voting rights, by contract,
21 or otherwise.
22 d. The sale, purchase, trade, or other transfer of a
23 prescription drug from or for any federal, state, or local
24 government agency or any entity eligible to purchase
25 prescription drugs at public health services prices pursuant
26 to s. 602 of Pub. L. No. 102-585 to a contract provider or its
27 subcontractor for eligible patients of the agency or entity
28 under the following conditions:
29 (I) The agency or entity must obtain written
30 authorization for the sale, purchase, trade, or other transfer
31 of a prescription drug under this sub-subparagraph from the
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 Secretary of Health or his or her designee.
2 (II) The contract provider or subcontractor must be
3 authorized by law to administer or dispense prescription
4 drugs.
5 (III) In the case of a subcontractor, the agency or
6 entity must be a party to and execute the subcontract.
7 (IV) A contract provider or subcontractor must
8 maintain separate and apart from other prescription drug
9 inventory any prescription drugs of the agency or entity in
10 its possession.
11 (V) The contract provider and subcontractor must
12 maintain and produce immediately for inspection all records of
13 movement or transfer of all the prescription drugs belonging
14 to the agency or entity, including, but not limited to, the
15 records of receipt and disposition of prescription drugs.
16 Each contractor and subcontractor dispensing or administering
17 these drugs must maintain and produce records documenting the
18 dispensing or administration. Records that are required to be
19 maintained include, but are not limited to, a perpetual
20 inventory itemizing drugs received and drugs dispensed by
21 prescription number or administered by patient identifier,
22 which must be submitted to the agency or entity quarterly.
23 (VI) The contract provider or subcontractor may
24 administer or dispense the prescription drugs only to the
25 eligible patients of the agency or entity or must return the
26 prescription drugs for or to the agency or entity. The
27 contract provider or subcontractor must require proof from
28 each person seeking to fill a prescription or obtain treatment
29 that the person is an eligible patient of the agency or entity
30 and must, at a minimum, maintain a copy of this proof as part
31 of the records of the contractor or subcontractor required
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 under sub-sub-subparagraph (V).
2 (VII) The prescription drugs transferred pursuant to
3 this sub-subparagraph may not be billed to Medicaid.
4 (VIII) In addition to the departmental inspection
5 authority set forth in s. 499.051, the establishment of the
6 contract provider and subcontractor and all records pertaining
7 to prescription drugs subject to this sub-subparagraph shall
8 be subject to inspection by the agency or entity. All records
9 relating to prescription drugs of a manufacturer under this
10 sub-subparagraph shall be subject to audit by the manufacturer
11 of those drugs, without identifying individual patient
12 information.
13 2. Any of the following activities, which is not a
14 violation of s. 499.005(21) if such activity is conducted in
15 accordance with rules established by the department:
16 a. The sale, purchase, or trade of a prescription drug
17 among federal, state, or local government health care entities
18 that are under common control and are authorized to purchase
19 such prescription drug.
20 b. The sale, purchase, or trade of a prescription drug
21 or an offer to sell, purchase, or trade a prescription drug
22 for emergency medical reasons.; For purposes of this
23 sub-subparagraph subparagraph, the term "emergency medical
24 reasons" includes transfers of prescription drugs by a retail
25 pharmacy to another retail pharmacy to alleviate a temporary
26 shortage.
27 c. The transfer purchase or acquisition of a
28 prescription drug acquired by a medical director on behalf of
29 a licensed an emergency medical services provider to that
30 medical director for use by emergency medical services
31 provider and its transport vehicles for use in accordance with
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 the provider's license under providers acting within the scope
2 of their professional practice pursuant to chapter 401.
3 d. The revocation of a sale or the return of a
4 prescription drug to the person's prescription drug wholesale
5 supplier.
6 e. The donation of a prescription drug by a health
7 care entity to a charitable organization that has been granted
8 an exemption under s. 501(c)(3) of the Internal Revenue Code
9 of 1986, as amended, and that is authorized to possess
10 prescription drugs.
11 f. The transfer of a prescription drug by a person
12 authorized to purchase or receive prescription drugs to a
13 person licensed or permitted to handle reverse distributions
14 or destruction under the laws of the jurisdiction in which the
15 person handling the reverse distribution or destruction
16 receives the drug.
17 3. The dispensing of a prescription drug pursuant to a
18 prescription;
19 3.4. The distribution of prescription drug samples by
20 manufacturers' representatives or distributors'
21 representatives conducted in accordance with s. 499.028.; or
22 4.5. The sale, purchase, or trade of blood and blood
23 components intended for transfusion. As used in this
24 subparagraph section, the term "blood" means whole blood
25 collected from a single donor and processed either for
26 transfusion or further manufacturing, and the term "blood
27 components" means that part of the blood separated by physical
28 or mechanical means.
29 5. The lawful dispensing of a prescription drug in
30 accordance with chapter 465.
31 (5) The department may adopt rules governing the
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 recordkeeping, storage, and handling with respect to each of
2 the distributions of prescription drugs specified in
3 subparagraphs (1)(a)1.-4.1., 2., 4., and 5.
4 Section 12. Except as otherwise provided herein, this
5 act shall take effect July 1, 1999.
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8 ================ T I T L E A M E N D M E N T ===============
9 And the title is amended as follows:
10 remove from the title of the bill: everything before the
11 enacting clause
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13 and insert in lieu thereof:
14 A bill to be entitled
15 An act relating to pharmacy practice; providing
16 a short title; amending s. 465.003, F.S.;
17 defining the term "data communication device";
18 revising the definition of the term "practice
19 of the profession of pharmacy"; amending s.
20 465.016, F.S.; authorizing the redispensing of
21 unused or returned unit-dose medication by
22 correctional facilities under certain
23 conditions; providing that using or releasing a
24 patient's records except as authorized by
25 chapter 455 or chapter 465, F.S., constitutes a
26 ground for disciplinary action against a
27 pharmacist, for which there are penalties;
28 amending s. 465.017, F.S.; providing additional
29 persons to whom and entities to which records
30 relating to the filling of prescriptions and
31 the dispensing of medicinal drugs that are
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HOUSE AMENDMENT
dhs-21 Bill No. CS/HB 287
Amendment No. (for drafter's use only)
1 maintained by a pharmacy may be furnished;
2 specifying authorized uses of patient records
3 by pharmacy owners; providing restrictions on
4 such records when transmitted through a data
5 communication device; amending ss. 465.014,
6 465.015, 465.0196, 468.812, and 499.003, F.S.;
7 correcting cross references, to conform;
8 amending s. 499.012, F.S.; redefining the term
9 "wholesale distribution," relating to the
10 distribution of prescription drugs, to provide
11 for the exclusion of certain activities;
12 providing effective dates.
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