Florida Senate - 2010 SB 2722
By Senator Gardiner
9-01263-10 20102722__
1 A bill to be entitled
2 An act relating to controlled substances; amending ss.
3 458.309 and 459.005, F.S.; requiring the Department of
4 Health to deny registration to any clinic that is not
5 fully owned by a physician or group of physicians;
6 requiring the department to deny registration to any
7 clinic that is owned by or under any contractual or
8 employment relationship with a physician whose Drug
9 Enforcement Administration number has ever been
10 suspended or revoked, or against whom the Board of
11 Medicine or the Board of Osteopathic Medicine has
12 taken final administrative action related to the
13 physician’s impairment due to the misuse or abuse of
14 alcohol or drugs; requiring the department to deny
15 registration to any clinic in which the ownership or
16 any controlling interest is held by a person who has
17 been convicted of, or has entered a plea of guilty or
18 nolo contendere to, regardless of adjudication, a
19 felony; requiring the department to deny registration
20 to any clinic that has a medical director who is not
21 board-certified in pain medicine; amending ss. 458.331
22 and 459.015, F.S.; providing that the practice of
23 medicine or osteopathic medicine in an unregistered
24 pain-management clinic is grounds for denial of
25 licensure or disciplinary action; providing that the
26 advertisement of the use, sale, or dispensing of
27 controlled substances is grounds for denial of
28 licensure or disciplinary action; amending s. 465.018,
29 F.S.; prohibiting the department from issuing a permit
30 to operate a community pharmacy unless the applicant
31 demonstrates the ability to participate in a
32 multistate electronic prescribing network; amending
33 465.023, F.S.; authorizing the department to
34 discipline a pharmacy permittee for failing to
35 participate in a multistate electronic prescribing
36 network; amending s. 465.0276, F.S.; prohibiting
37 registered dispensing practitioners from dispensing
38 more than a specified amount of certain controlled
39 substances; providing an exception; providing an
40 effective date.
41
42 Be It Enacted by the Legislature of the State of Florida:
43
44 Section 1. Subsection (4) of section 458.309, Florida
45 Statutes, is amended to read:
46 458.309 Rulemaking authority.—
47 (4) All privately owned pain-management clinics,
48 facilities, or offices, hereinafter referred to as “clinics,”
49 which advertise in any medium for any type of pain-management
50 services, or employ a physician who is primarily engaged in the
51 treatment of pain by prescribing or dispensing controlled
52 substance medications, must register with the department by
53 January 4, 2010, unless that clinic is licensed as a facility
54 pursuant to chapter 395. The department shall deny registration
55 to any clinic that is not fully owned by a physician or group of
56 physicians. The department shall deny registration to any clinic
57 owned by or under any contractual or employment relationship
58 with a physician whose Drug Enforcement Administration number
59 has ever been suspended or revoked, or against whom the board
60 has taken final administrative action related to the physician’s
61 impairment due to the misuse or abuse of alcohol or drugs. The
62 department shall deny registration to any clinic in which the
63 ownership or any controlling interest is held by a person who
64 has been convicted of, or has entered a plea of guilty or nolo
65 contendere to, regardless of adjudication, a felony under
66 chapter 893. The department shall deny registration to any
67 clinic that has a medical director who is not board-certified in
68 pain medicine. A physician may not practice medicine in a pain
69 management clinic that is required to but has not registered
70 with the department. Each clinic location shall be registered
71 separately regardless of whether the clinic is operated under
72 the same business name or management as another clinic. If the
73 clinic is licensed as a health care clinic under chapter 400,
74 the medical director is responsible for registering the facility
75 with the department. If the clinic is not registered pursuant to
76 chapter 395 or chapter 400, the clinic shall, upon registration
77 with the department, designate a physician who is responsible
78 for complying with all requirements related to registration of
79 the clinic. The designated physician shall be licensed under
80 this chapter or chapter 459 and shall practice at the office
81 location for which the physician has assumed responsibility. The
82 department shall inspect the clinic annually to ensure that it
83 complies with rules of the Board of Medicine adopted pursuant to
84 this subsection and subsection (5) unless the office is
85 accredited by a nationally recognized accrediting agency
86 approved by the Board of Medicine. The actual costs for
87 registration and inspection or accreditation shall be paid by
88 the physician seeking to register the clinic.
89 Section 2. Subsection (3) of section 459.005, Florida
90 Statutes, is amended to read:
91 459.005 Rulemaking authority.—
92 (3) All privately owned pain-management clinics,
93 facilities, or offices, hereinafter referred to as “clinics,”
94 which advertise in any medium for any type of pain-management
95 services, or employ a physician who is licensed under this
96 chapter and who is primarily engaged in the treatment of pain by
97 prescribing or dispensing controlled substance medications, must
98 register with the department by January 4, 2010, unless that
99 clinic is licensed as a facility under chapter 395. The
100 department shall deny registration to any clinic that is not
101 fully owned by a physician or group of physicians. The
102 department shall deny registration to any clinic owned by or
103 under any contractual or employment relationship with a
104 physician whose Drug Enforcement Administration number has ever
105 been suspended or revoked, or against whom the board has taken
106 final administrative action related to the physician’s
107 impairment due to the misuse or abuse of alcohol or drugs. The
108 department shall deny registration to any clinic in which the
109 ownership or any controlling interest is held by a person who
110 has been convicted of, or has entered a plea of guilty or nolo
111 contendere to, regardless of adjudication, a felony under
112 chapter 893. The department shall deny registration to any
113 clinic that has a medical director who is not board-certified in
114 pain medicine. A physician may not practice osteopathic medicine
115 in a pain-management clinic that is required to but has not
116 registered with the department. Each clinic location shall be
117 registered separately regardless of whether the clinic is
118 operated under the same business name or management as another
119 clinic. If the clinic is licensed as a health care clinic under
120 chapter 400, the medical director is responsible for registering
121 the facility with the department. If the clinic is not
122 registered under chapter 395 or chapter 400, the clinic shall,
123 upon registration with the department, designate a physician who
124 is responsible for complying with all requirements related to
125 registration of the clinic. The designated physician shall be
126 licensed under chapter 458 or this chapter and shall practice at
127 the office location for which the physician has assumed
128 responsibility. The department shall inspect the clinic annually
129 to ensure that it complies with rules of the Board of
130 Osteopathic Medicine adopted pursuant to this subsection and
131 subsection (4) unless the office is accredited by a nationally
132 recognized accrediting agency approved by the Board of
133 Osteopathic Medicine. The actual costs for registration and
134 inspection or accreditation shall be paid by the physician
135 seeking to register the clinic.
136 Section 3. Present paragraph (nn) of subsection (1) of
137 section 458.331, Florida Statutes, is redesignated as paragraph
138 (pp), and new paragraphs (nn) and (oo) are added to that
139 subsection, to read:
140 458.331 Grounds for disciplinary action; action by the
141 board and department.—
142 (1) The following acts constitute grounds for denial of a
143 license or disciplinary action, as specified in s. 456.072(2):
144 (nn) Practicing medicine in a pain-management clinic that
145 is required to register, but that has not registered, with the
146 department pursuant to s. 458.309.
147 (oo) Using any communication media to promote or advertise
148 the use, sale, or dispensing of any controlled substance
149 appearing in any schedule in chapter 893.
150 Section 4. Present paragraph (pp) of subsection (1) of
151 section 459.015, Florida Statutes, is redesignated as paragraph
152 (rr), and new paragraphs (pp) and (qq) are added to that
153 subsection, to read:
154 459.015 Grounds for disciplinary action; action by the
155 board and department.—
156 (1) The following acts constitute grounds for denial of a
157 license or disciplinary action, as specified in s. 456.072(2):
158 (pp) Practicing osteopathic medicine in a pain-management
159 clinic that is required to register, but that has not
160 registered, with the department pursuant to s. 459.005.
161 (qq) Using any communication media to promote or advertise
162 the use, sale, or dispensing of any controlled substance
163 appearing in any schedule in chapter 893.
164 Section 5. Section 465.018, Florida Statutes, is amended to
165 read:
166 465.018 Community pharmacies; permits.—Any person desiring
167 a permit to operate a community pharmacy shall apply to the
168 department. If the board office certifies that the application
169 complies with the laws of the state and the rules of the board
170 governing pharmacies, the department shall issue the permit. The
171 department may not issue the permit No permit shall be issued
172 unless a licensed pharmacist is designated as the prescription
173 department manager responsible for maintaining all drug records,
174 providing for the security of the prescription department, and
175 following such other rules as relate to the practice of the
176 profession of pharmacy. The permittee and the newly designated
177 prescription department manager shall notify the department
178 within 10 days of any change in prescription department manager.
179 The department may not issue the permit unless the applicant
180 demonstrates the ability to participate in a multistate
181 electronic prescribing network.
182 Section 6. Subsection (1) of section 465.023, Florida
183 Statutes, is amended to read:
184 465.023 Pharmacy permittee; disciplinary action.—
185 (1) The department or the board may revoke or suspend the
186 permit of any pharmacy permittee, and may fine, place on
187 probation, or otherwise discipline any pharmacy permittee if the
188 permittee, or any affiliated person, partner, officer, director,
189 or agent of the permittee, including a person fingerprinted
190 under s. 465.022(3), has:
191 (a) Obtained a permit by misrepresentation or fraud or
192 through an error of the department or the board;
193 (b) Attempted to procure, or has procured, a permit for any
194 other person by making, or causing to be made, any false
195 representation;
196 (c) Violated any of the requirements of this chapter or any
197 of the rules of the Board of Pharmacy; of chapter 499, known as
198 the “Florida Drug and Cosmetic Act”; of 21 U.S.C. ss. 301-392,
199 known as the “Federal Food, Drug, and Cosmetic Act”; of 21
200 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse
201 Prevention and Control Act; or of chapter 893;
202 (d) Been convicted or found guilty, regardless of
203 adjudication, of a felony or any other crime involving moral
204 turpitude in any of the courts of this state, of any other
205 state, or of the United States;
206 (e) Been convicted or disciplined by a regulatory agency of
207 the Federal Government or a regulatory agency of another state
208 for any offense that would constitute a violation of this
209 chapter;
210 (f) Been convicted of, or entered a plea of guilty or nolo
211 contendere to, regardless of adjudication, a crime in any
212 jurisdiction which relates to the practice of, or the ability to
213 practice, the profession of pharmacy;
214 (g) Been convicted of, or entered a plea of guilty or nolo
215 contendere to, regardless of adjudication, a crime in any
216 jurisdiction which relates to health care fraud; or
217 (h) Dispensed any medicinal drug based upon a communication
218 that purports to be a prescription as defined by s. 465.003(14)
219 or s. 893.02 when the pharmacist knows or has reason to believe
220 that the purported prescription is not based upon a valid
221 practitioner-patient relationship that includes a documented
222 patient evaluation, including history and a physical examination
223 adequate to establish the diagnosis for which any drug is
224 prescribed and any other requirement established by board rule
225 under chapter 458, chapter 459, chapter 461, chapter 463,
226 chapter 464, or chapter 466; or.
227 (i) Failed to participate in a multistate electronic
228 prescribing network.
229 Section 7. Subsection (1) of section 465.0276, Florida
230 Statutes, is amended to read:
231 465.0276 Dispensing practitioner.—
232 (1)(a) A person may not dispense medicinal drugs unless
233 licensed as a pharmacist or otherwise authorized under this
234 chapter to do so, except that a practitioner authorized by law
235 to prescribe drugs may dispense such drugs to her or his
236 patients in the regular course of her or his practice in
237 compliance with this section.
238 (b) A practitioner registered under this section may not
239 dispense more than a 72-hour supply of a controlled substance
240 listed in Schedule II, Schedule III, or Schedule IV as provided
241 in s. 893.03. This paragraph does not apply to controlled
242 substances dispensed in the health care system of the Department
243 of Corrections.
244 Section 8. This act shall take effect July 1, 2010.