1 | A bill to be entitled |
2 | An act relating to controlled substances; amending ss. |
3 | 456.037 and 456.057, F.S.; conforming provisions to |
4 | changes made by the act; amending s. 456.42, F.S.; |
5 | requiring prescriptions for controlled substances to be |
6 | written on a counterfeit-resistant pad produced by an |
7 | approved vendor or electronically prescribed; repealing s. |
8 | 458.3265, F.S., relating to regulation of pain-management |
9 | clinics and medical doctors; amending s. 458.327, F.S.; |
10 | providing that dispensing certain controlled substances in |
11 | violation of specified provisions is a third-degree |
12 | felony; deleting references to felonies for certain |
13 | activities related to pain-management clinics and medical |
14 | doctors; amending s. 458.331, F.S.; deleting grounds for |
15 | disciplinary actions against physicians relating to pain- |
16 | management clinics and advertising controlled substances; |
17 | repealing s. 459.0137, F.S., relating to pain-management |
18 | clinics and osteopathic physicians; amending s. 459.013, |
19 | F.S., relating to penalties for violations; providing that |
20 | dispensing certain controlled substances in violation of |
21 | specified provisions is a third-degree felony; deleting |
22 | provisions relating to felonies for certain activities |
23 | related to pain-management clinics and osteopathic |
24 | physicians; amending s. 459.015, F.S.; deleting grounds |
25 | for disciplinary actions against osteopathic physicians |
26 | relating to pain-management clinics and advertising |
27 | controlled substances; amending s. 465.015, F.S.; |
28 | requiring a pharmacist, pharmacy intern, or other person |
29 | employed by or at a pharmacy to report to the sheriff |
30 | within a specified period any instance in which a person |
31 | fraudulently obtained or attempted to fraudulently obtain |
32 | a controlled substance; providing criminal penalties; |
33 | providing requirements for reports; amending s. 465.018, |
34 | F.S.; limiting the community pharmacies that may dispense |
35 | controlled substances; providing an exemption; amending s. |
36 | 465.0276, F.S.; prohibiting registered dispensing |
37 | practitioners from dispensing certain controlled |
38 | substances; providing an exception; repealing a 72-hour |
39 | supply limit on dispensing certain controlled substances |
40 | to certain patients in registered pain-management clinics; |
41 | providing an exception for dispensing controlled |
42 | substances in the health care system of the Department of |
43 | Corrections; amending s. 499.012, F.S.; requiring |
44 | wholesale distributor permit applicants to submit |
45 | documentation of credentialing policies; amending s. |
46 | 499.0121, F.S.; providing reporting requirements for |
47 | wholesale distributors of certain controlled substances; |
48 | requiring the Department of Health to share the reported |
49 | data with law enforcement agencies; requiring the |
50 | Department of Law Enforcement to make investigations based |
51 | on the reported data; providing credentialing requirements |
52 | for distribution of controlled substances to certain |
53 | entities by wholesale distributors; limiting monthly |
54 | distribution amounts of controlled substances to retail |
55 | pharmacies; prohibiting distribution to entities with |
56 | certain criminal backgrounds; amending s. 499.05, F.S.; |
57 | authorizing rulemaking concerning specified controlled |
58 | substance wholesale distributor reporting requirements and |
59 | credentialing requirements; amending s. 499.067, F.S.; |
60 | requiring the Department of Health to take disciplinary |
61 | action against wholesale distributors failing to comply |
62 | with specified credentialing requirements; amending s. |
63 | 810.02, F.S.; authorizing separate judgments and sentences |
64 | for burglary with the intent to commit theft of a |
65 | controlled substance under specified provisions and for |
66 | any applicable possession of controlled substance offense |
67 | under specified provisions in certain circumstances; |
68 | amending s. 812.014, F.S.; authorizing separate judgments |
69 | and sentences for theft of a controlled substance under |
70 | specified provisions and for any applicable possession of |
71 | controlled substance offense under specified provisions in |
72 | certain circumstances; amending s. 893.07, F.S.; providing |
73 | that law enforcement officers are not required to obtain a |
74 | subpoena, court order, or search warrant in order to |
75 | obtain access to or copies of specified controlled |
76 | substance inventory records; requiring reporting discovery |
77 | of the theft or loss of controlled substances to the |
78 | sheriff within a specified period; providing criminal |
79 | penalties; repealing s. 2 of chapter 2009-198, Laws of |
80 | Florida, relating to Program Implementation and Oversight |
81 | Task Force in the Executive Office of the Governor |
82 | concerning the electronic system established for the |
83 | prescription drug monitoring program; providing a buyback |
84 | program for undispensed controlled substance inventory |
85 | held by specified licensed physicians; requiring reports |
86 | of program; providing for a declaration of a public health |
87 | emergency; requiring certain actions relating to |
88 | dispensing practitioners identified as posing the greatest |
89 | threat to public health; providing an appropriation; |
90 | providing for future repeal of program provisions; |
91 | providing an effective date. |
92 |
|
93 | Be It Enacted by the Legislature of the State of Florida: |
94 |
|
95 | Section 1. Subsection (5) of section 456.037, Florida |
96 | Statutes, is amended to read: |
97 | 456.037 Business establishments; requirements for active |
98 | status licenses; delinquency; discipline; applicability.- |
99 | (5) This section applies to any business establishment |
100 | registered, permitted, or licensed by the department to do |
101 | business. Business establishments include, but are not limited |
102 | to, dental laboratories, electrology facilities, massage |
103 | establishments, and pharmacies, and pain-management clinics |
104 | required to be registered under s. 458.3265 or s. 459.0137. |
105 | Section 2. Subsection (9) of section 456.057, Florida |
106 | Statutes, is amended to read: |
107 | 456.057 Ownership and control of patient records; report |
108 | or copies of records to be furnished.- |
109 | (9)(a)1. The department may obtain patient records |
110 | pursuant to a subpoena without written authorization from the |
111 | patient if the department and the probable cause panel of the |
112 | appropriate board, if any, find reasonable cause to believe that |
113 | a health care practitioner has excessively or inappropriately |
114 | prescribed any controlled substance specified in chapter 893 in |
115 | violation of this chapter or any professional practice act or |
116 | that a health care practitioner has practiced his or her |
117 | profession below that level of care, skill, and treatment |
118 | required as defined by this chapter or any professional practice |
119 | act and also find that appropriate, reasonable attempts were |
120 | made to obtain a patient release. Notwithstanding the foregoing, |
121 | the department need not attempt to obtain a patient release when |
122 | investigating an offense involving the inappropriate |
123 | prescribing, overprescribing, or diversion of controlled |
124 | substances and the offense involves a pain-management clinic. |
125 | The department may obtain patient records without patient |
126 | authorization or subpoena from any pain-management clinic |
127 | required to be licensed if the department has probable cause to |
128 | believe that a violation of any provision of s. 458.3265 or s. |
129 | 459.0137 is occurring or has occurred and reasonably believes |
130 | that obtaining such authorization is not feasible due to the |
131 | volume of the dispensing and prescribing activity involving |
132 | controlled substances and that obtaining patient authorization |
133 | or the issuance of a subpoena would jeopardize the |
134 | investigation. |
135 | 2. The department may obtain patient records and insurance |
136 | information pursuant to a subpoena without written authorization |
137 | from the patient if the department and the probable cause panel |
138 | of the appropriate board, if any, find reasonable cause to |
139 | believe that a health care practitioner has provided inadequate |
140 | medical care based on termination of insurance and also find |
141 | that appropriate, reasonable attempts were made to obtain a |
142 | patient release. |
143 | 3. The department may obtain patient records, billing |
144 | records, insurance information, provider contracts, and all |
145 | attachments thereto pursuant to a subpoena without written |
146 | authorization from the patient if the department and probable |
147 | cause panel of the appropriate board, if any, find reasonable |
148 | cause to believe that a health care practitioner has submitted a |
149 | claim, statement, or bill using a billing code that would result |
150 | in payment greater in amount than would be paid using a billing |
151 | code that accurately describes the services performed, requested |
152 | payment for services that were not performed by that health care |
153 | practitioner, used information derived from a written report of |
154 | an automobile accident generated pursuant to chapter 316 to |
155 | solicit or obtain patients personally or through an agent |
156 | regardless of whether the information is derived directly from |
157 | the report or a summary of that report or from another person, |
158 | solicited patients fraudulently, received a kickback as defined |
159 | in s. 456.054, violated the patient brokering provisions of s. |
160 | 817.505, or presented or caused to be presented a false or |
161 | fraudulent insurance claim within the meaning of s. |
162 | 817.234(1)(a), and also find that, within the meaning of s. |
163 | 817.234(1)(a), patient authorization cannot be obtained because |
164 | the patient cannot be located or is deceased, incapacitated, or |
165 | suspected of being a participant in the fraud or scheme, and if |
166 | the subpoena is issued for specific and relevant records. |
167 | 4. Notwithstanding subparagraphs 1.-3., when the |
168 | department investigates a professional liability claim or |
169 | undertakes action pursuant to s. 456.049 or s. 627.912, the |
170 | department may obtain patient records pursuant to a subpoena |
171 | without written authorization from the patient if the patient |
172 | refuses to cooperate or if the department attempts to obtain a |
173 | patient release and the failure to obtain the patient records |
174 | would be detrimental to the investigation. |
175 | Section 3. Section 456.42, Florida Statutes, is amended to |
176 | read: |
177 | 456.42 Written prescriptions for medicinal drugs.- |
178 | (1) A written prescription for a medicinal drug issued by |
179 | a health care practitioner licensed by law to prescribe such |
180 | drug must be legibly printed or typed so as to be capable of |
181 | being understood by the pharmacist filling the prescription; |
182 | must contain the name of the prescribing practitioner, the name |
183 | and strength of the drug prescribed, the quantity of the drug |
184 | prescribed, and the directions for use of the drug; must be |
185 | dated; and must be signed by the prescribing practitioner on the |
186 | day when issued. A written prescription for a controlled |
187 | substance listed in chapter 893 must have the quantity of the |
188 | drug prescribed in both textual and numerical formats and must |
189 | be dated with the abbreviated month written out on the face of |
190 | the prescription. However, a prescription that is electronically |
191 | generated and transmitted must contain the name of the |
192 | prescribing practitioner, the name and strength of the drug |
193 | prescribed, the quantity of the drug prescribed in numerical |
194 | format, and the directions for use of the drug and must be dated |
195 | and signed by the prescribing practitioner only on the day |
196 | issued, which signature may be in an electronic format as |
197 | defined in s. 668.003(4). |
198 | (2) A written prescription for a controlled substance |
199 | listed in chapter 893 must have the quantity of the drug |
200 | prescribed in both textual and numerical formats and must be |
201 | dated with the abbreviated month written out on the face of the |
202 | prescription. A prescription for a controlled substance listed |
203 | in chapter 893 must be written on a counterfeit-proof |
204 | prescription pad produced by a vendor approved by the |
205 | department, or must be electronically prescribed, as that term |
206 | is used in s. 408.0611. |
207 | Section 4. Section 458.3265, Florida Statutes, is |
208 | repealed. |
209 | Section 5. Section 458.327, Florida Statutes, is amended |
210 | to read: |
211 | 458.327 Penalty for violations.- |
212 | (1) Each of the following acts constitutes a felony of the |
213 | third degree, punishable as provided in s. 775.082, s. 775.083, |
214 | or s. 775.084: |
215 | (a) The practice of medicine or an attempt to practice |
216 | medicine without a license to practice in Florida. |
217 | (b) The use or attempted use of a license which is |
218 | suspended or revoked to practice medicine. |
219 | (c) Attempting to obtain or obtaining a license to |
220 | practice medicine by knowing misrepresentation. |
221 | (d) Attempting to obtain or obtaining a position as a |
222 | medical practitioner or medical resident in a clinic or hospital |
223 | through knowing misrepresentation of education, training, or |
224 | experience. |
225 | (e) Dispensing a controlled substance listed in Schedule |
226 | II or Schedule III in violation of s. 465.0276. Knowingly |
227 | operating, owning, or managing a nonregistered pain-management |
228 | clinic that is required to be registered with the Department of |
229 | Health pursuant to s. 458.3265(1). |
230 | (2) Each of the following acts constitutes a misdemeanor |
231 | of the first degree, punishable as provided in s. 775.082 or s. |
232 | 775.083: |
233 | (a) Knowingly concealing information relating to |
234 | violations of this chapter. |
235 | (b) Making any willfully false oath or affirmation |
236 | whenever an oath or affirmation is required by this chapter. |
237 | (c) Referring any patient, for health care goods or |
238 | services, to a partnership, firm, corporation, or other business |
239 | entity in which the physician or the physician's employer has an |
240 | equity interest of 10 percent or more unless, prior to such |
241 | referral, the physician notifies the patient of his or her |
242 | financial interest and of the patient's right to obtain such |
243 | goods or services at the location of the patient's choice. This |
244 | section does not apply to the following types of equity |
245 | interest: |
246 | 1. The ownership of registered securities issued by a |
247 | publicly held corporation or the ownership of securities issued |
248 | by a publicly held corporation, the shares of which are traded |
249 | on a national exchange or the over-the-counter market; |
250 | 2. A physician's own practice, whether he or she is a sole |
251 | practitioner or part of a group, when the health care good or |
252 | service is prescribed or provided solely for the physician's own |
253 | patients and is provided or performed by the physician or under |
254 | the physician's supervision; or |
255 | 3. An interest in real property resulting in a landlord- |
256 | tenant relationship between the physician and the entity in |
257 | which the equity interest is held, unless the rent is |
258 | determined, in whole or in part, by the business volume or |
259 | profitability of the tenant or is otherwise unrelated to fair |
260 | market value. |
261 | (d) Leading the public to believe that one is licensed as |
262 | a medical doctor, or is engaged in the licensed practice of |
263 | medicine, without holding a valid, active license. |
264 | (e) Practicing medicine or attempting to practice medicine |
265 | with an inactive or delinquent license. |
266 | (f) Knowingly prescribing or dispensing, or causing to be |
267 | prescribed or dispensed, controlled substances in a |
268 | nonregistered pain-management clinic that is required to be |
269 | registered with the Department of Health pursuant to s. |
270 | 458.3265(1). |
271 | Section 6. Paragraphs (oo), (pp), and (qq) of subsection |
272 | (1) of section 458.331, Florida Statutes, are amended to read: |
273 | 458.331 Grounds for disciplinary action; action by the |
274 | board and department.- |
275 | (1) The following acts constitute grounds for denial of a |
276 | license or disciplinary action, as specified in s. 456.072(2): |
277 | (oo) Dispensing a controlled substance listed in Schedule |
278 | II or Schedule III in violation of s. 465.0276. Applicable to a |
279 | licensee who serves as the designated physician of a pain- |
280 | management clinic as defined in s. 458.3265 or s. 459.0137: |
281 | 1. Registering a pain-management clinic through |
282 | misrepresentation or fraud; |
283 | 2. Procuring, or attempting to procure, the registration |
284 | of a pain-management clinic for any other person by making or |
285 | causing to be made, any false representation; |
286 | 3. Failing to comply with any requirement of chapter 499, |
287 | the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the |
288 | Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., |
289 | the Drug Abuse Prevention and Control Act; or chapter 893, the |
290 | Florida Comprehensive Drug Abuse Prevention and Control Act; |
291 | 4. Being convicted or found guilty of, regardless of |
292 | adjudication to, a felony or any other crime involving moral |
293 | turpitude, fraud, dishonesty, or deceit in any jurisdiction of |
294 | the courts of this state, of any other state, or of the United |
295 | States; |
296 | 5. Being convicted of, or disciplined by a regulatory |
297 | agency of the Federal Government or a regulatory agency of |
298 | another state for, any offense that would constitute a violation |
299 | of this chapter; |
300 | 6. Being convicted of, or entering a plea of guilty or |
301 | nolo contendere to, regardless of adjudication, a crime in any |
302 | jurisdiction of the courts of this state, of any other state, or |
303 | of the United States which relates to the practice of, or the |
304 | ability to practice, a licensed health care profession; |
305 | 7. Being convicted of, or entering a plea of guilty or |
306 | nolo contendere to, regardless of adjudication, a crime in any |
307 | jurisdiction of the courts of this state, of any other state, or |
308 | of the United States which relates to health care fraud; |
309 | 8. Dispensing any medicinal drug based upon a |
310 | communication that purports to be a prescription as defined in |
311 | s. 465.003(14) or s. 893.02 if the dispensing practitioner knows |
312 | or has reason to believe that the purported prescription is not |
313 | based upon a valid practitioner-patient relationship; or |
314 | 9. Failing to timely notify the board of the date of his |
315 | or her termination from a pain-management clinic as required by |
316 | s. 458.3265(2). |
317 | (pp) Failing to timely notify the department of the theft |
318 | of prescription blanks from a pain-management clinic or a breach |
319 | of other methods for prescribing within 24 hours as required by |
320 | s. 458.3265(2). |
321 | (qq) Promoting or advertising through any communication |
322 | media the use, sale, or dispensing of any controlled substance |
323 | appearing on any schedule in chapter 893. |
324 | Section 7. Section 459.0137, Florida Statutes, is |
325 | repealed. |
326 | Section 8. Paragraph (e) of subsection (1) and paragraph |
327 | (d) of subsection (2) of section 459.013, Florida Statutes, are |
328 | amended to read: |
329 | 459.013 Penalty for violations.- |
330 | (1) Each of the following acts constitutes a felony of the |
331 | third degree, punishable as provided in s. 775.082, s. 775.083, |
332 | or s. 775.084: |
333 | (e) Dispensing a controlled substance listed in Schedule |
334 | II or Schedule III in violation of s. 465.0276. Knowingly |
335 | operating, owning, or managing a nonregistered pain-management |
336 | clinic that is required to be registered with the Department of |
337 | Health pursuant to s. 459.0137(1). |
338 | (2) Each of the following acts constitutes a misdemeanor |
339 | of the first degree, punishable as provided in s. 775.082 or s. |
340 | 775.083: |
341 | (d) Knowingly prescribing or dispensing, or causing to be |
342 | prescribed or dispensed, controlled substances in a |
343 | nonregistered pain-management clinic that is required to be |
344 | registered with the Department of Health pursuant to s. |
345 | 459.0137(1). |
346 | Section 9. Paragraphs (qq), (rr), and (ss) of subsection |
347 | (1) of section 459.015, Florida Statutes, are amended to read: |
348 | 459.015 Grounds for disciplinary action; action by the |
349 | board and department.- |
350 | (1) The following acts constitute grounds for denial of a |
351 | license or disciplinary action, as specified in s. 456.072(2): |
352 | (qq) Dispensing a controlled substance listed in Schedule |
353 | II or Schedule III in violation of s. 465.0276. Applicable to a |
354 | licensee who serves as the designated physician of a pain- |
355 | management clinic as defined in s. 458.3265 or s. 459.0137: |
356 | 1. Registering a pain-management clinic through |
357 | misrepresentation or fraud; |
358 | 2. Procuring, or attempting to procure, the registration |
359 | of a pain-management clinic for any other person by making or |
360 | causing to be made, any false representation; |
361 | 3. Failing to comply with any requirement of chapter 499, |
362 | the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the |
363 | Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., |
364 | the Drug Abuse Prevention and Control Act; or chapter 893, the |
365 | Florida Comprehensive Drug Abuse Prevention and Control Act; |
366 | 4. Being convicted or found guilty of, regardless of |
367 | adjudication to, a felony or any other crime involving moral |
368 | turpitude, fraud, dishonesty, or deceit in any jurisdiction of |
369 | the courts of this state, of any other state, or of the United |
370 | States; |
371 | 5. Being convicted of, or disciplined by a regulatory |
372 | agency of the Federal Government or a regulatory agency of |
373 | another state for, any offense that would constitute a violation |
374 | of this chapter; |
375 | 6. Being convicted of, or entering a plea of guilty or |
376 | nolo contendere to, regardless of adjudication, a crime in any |
377 | jurisdiction of the courts of this state, of any other state, or |
378 | of the United States which relates to the practice of, or the |
379 | ability to practice, a licensed health care profession; |
380 | 7. Being convicted of, or entering a plea of guilty or |
381 | nolo contendere to, regardless of adjudication, a crime in any |
382 | jurisdiction of the courts of this state, of any other state, or |
383 | of the United States which relates to health care fraud; |
384 | 8. Dispensing any medicinal drug based upon a |
385 | communication that purports to be a prescription as defined in |
386 | s. 465.003(14) or s. 893.02 if the dispensing practitioner knows |
387 | or has reason to believe that the purported prescription is not |
388 | based upon a valid practitioner-patient relationship; or |
389 | 9. Failing to timely notify the board of the date of his |
390 | or her termination from a pain-management clinic as required by |
391 | s. 459.0137(2). |
392 | (rr) Failing to timely notify the department of the theft |
393 | of prescription blanks from a pain-management clinic or a breach |
394 | of other methods for prescribing within 24 hours as required by |
395 | s. 459.0137(2). |
396 | (ss) Promoting or advertising through any communication |
397 | media the use, sale, or dispensing of any controlled substance |
398 | appearing on any schedule in chapter 893. |
399 | Section 10. Subsections (3) and (4) of section 465.015, |
400 | Florida Statutes, are renumbered as subsections (4) and (5), |
401 | respectively, a new subsection (3) is added to that section, and |
402 | present subsection (4) of that section is amended, to read: |
403 | 465.015 Violations and penalties.- |
404 | (3) It is unlawful for any pharmacist, pharmacy intern, or |
405 | other person employed by or at a pharmacy to fail to report to |
406 | the sheriff of the county where the pharmacy is located within |
407 | 24 hours after learning of any instance in which a person |
408 | obtained or attempted to obtain a controlled substance, as |
409 | defined in s. 893.02, that the pharmacist, pharmacy intern, or |
410 | other person employed by or at the pharmacy knew or reasonably |
411 | should have known was obtained or attempted to be obtained from |
412 | the pharmacy though fraudulent methods or representations. Any |
413 | pharmacist, pharmacy intern, or other person employed by or at a |
414 | pharmacy who fails to make such a report within 24 hours after |
415 | learning of the fraud or attempted fraud commits a misdemeanor |
416 | of the first degree, punishable as provided in s. 775.082 or s. |
417 | 775.083. A sufficient report of the fraudulent obtaining of |
418 | controlled substances under this subsection shall contain, at a |
419 | minimum, a copy of the prescription used or presented and a |
420 | narrative, including all information available to the pharmacy |
421 | concerning the transaction, such as the name and telephone |
422 | number of the prescribing physician; the name, description, and |
423 | any personal identification information pertaining to the person |
424 | who presented the prescription; and all other material |
425 | information, such as photographic or video surveillance of the |
426 | transaction. |
427 | (5)(4) Any person who violates any provision of subsection |
428 | (1) or subsection (4) (3) commits a misdemeanor of the first |
429 | degree, punishable as provided in s. 775.082 or s. 775.083. Any |
430 | person who violates any provision of subsection (2) commits a |
431 | felony of the third degree, punishable as provided in s. |
432 | 775.082, s. 775.083, or s. 775.084. In any warrant, information, |
433 | or indictment, it shall not be necessary to negative any |
434 | exceptions, and the burden of any exception shall be upon the |
435 | defendant. |
436 | Section 11. Section 465.018, Florida Statutes, is amended |
437 | to read: |
438 | 465.018 Community pharmacies; permits.- |
439 | (1) Any person desiring a permit to operate a community |
440 | pharmacy shall apply to the department. If the board office |
441 | certifies that the application complies with the laws of the |
442 | state and the rules of the board governing pharmacies, the |
443 | department shall issue the permit. No permit shall be issued |
444 | unless a licensed pharmacist is designated as the prescription |
445 | department manager responsible for maintaining all drug records, |
446 | providing for the security of the prescription department, and |
447 | following such other rules as relate to the practice of the |
448 | profession of pharmacy. The permittee and the newly designated |
449 | prescription department manager shall notify the department |
450 | within 10 days of any change in prescription department manager. |
451 | (2)(a) A pharmacy permitted under this section may not |
452 | dispense a controlled substance listed in Schedule II or |
453 | Schedule III as provided in s. 893.03 unless the pharmacy is: |
454 | 1. Wholly owned by a corporation whose shares are publicly |
455 | traded on a recognized stock exchange; or |
456 | 2. Wholly owned by a corporation having more than $100 |
457 | million of business taxable assets in this state. |
458 | (b) Community pharmacies that have been continuously |
459 | permitted for at least 10 years are exempt from this subsection. |
460 | Section 12. Paragraph (b) of subsection (1) of section |
461 | 465.0276, Florida Statutes, is amended to read: |
462 | 465.0276 Dispensing practitioner.- |
463 | (1) |
464 | (b) A practitioner registered under this section may not |
465 | dispense a controlled substance listed in Schedule II or |
466 | Schedule III as provided in s. 893.03. A practitioner registered |
467 | under this section may not dispense more than a 72-hour supply |
468 | of a controlled substance listed in Schedule II, Schedule III, |
469 | Schedule IV, or Schedule V of s. 893.03 for any patient who pays |
470 | for the medication by cash, check, or credit card in a clinic |
471 | registered under s. 458.3265 or s. 459.0137. A practitioner who |
472 | violates this paragraph commits a felony of the third degree, |
473 | punishable as provided in s. 775.082, s. 775.083, or s. 775.084. |
474 | This paragraph does not apply to: |
475 | 1. A practitioner who dispenses medication to a workers' |
476 | compensation patient pursuant to chapter 440. |
477 | 2. A practitioner who dispenses medication to an insured |
478 | patient who pays by cash, check, or credit card to cover any |
479 | applicable copayment or deductible. |
480 | 1.3. The dispensing of complimentary packages of medicinal |
481 | drugs to the practitioner's own patients in the regular course |
482 | of her or his practice without the payment of a fee or |
483 | remuneration of any kind, whether direct or indirect, as |
484 | provided in subsection (5). |
485 | 2. The dispensing of controlled substances in the health |
486 | care system of the Department of Corrections. |
487 | Section 13. Paragraph (o) is added to subsection (8) of |
488 | section 499.012, Florida Statutes, to read: |
489 | 499.012 Permit application requirements.- |
490 | (8) An application for a permit or to renew a permit for a |
491 | prescription drug wholesale distributor or an out-of-state |
492 | prescription drug wholesale distributor submitted to the |
493 | department must include: |
494 | (o) Documentation of the credentialing policies and |
495 | procedures required by s. 499.0121(14). |
496 | Section 14. Subsections (14) and (15) are added to section |
497 | 499.0121, Florida Statutes, to read: |
498 | 499.0121 Storage and handling of prescription drugs; |
499 | recordkeeping.-The department shall adopt rules to implement |
500 | this section as necessary to protect the public health, safety, |
501 | and welfare. Such rules shall include, but not be limited to, |
502 | requirements for the storage and handling of prescription drugs |
503 | and for the establishment and maintenance of prescription drug |
504 | distribution records. |
505 | (14) DISTRIBUTION REPORTING.-Each wholesale distributor |
506 | shall submit a report to the department of its receipts and |
507 | distributions of controlled substances listed in Schedule II, |
508 | Schedule III, Schedule IV, or Schedule V as provided in s. |
509 | 893.03. Wholesale distributor facilities located within this |
510 | state shall report all transactions involving controlled |
511 | substances and wholesale distributor facilities located outside |
512 | this state shall report all distributions to entities located in |
513 | this state. If the wholesale distributor did not have any |
514 | controlled substance distributions for the month, a report shall |
515 | be sent indicating no distributions occurred in the period. The |
516 | report shall be submitted monthly by the 20th of the next month, |
517 | in the electronic format used for controlled substance reporting |
518 | to the Automation of Reports and Consolidated Orders System |
519 | division of the federal Drug Enforcement Administration. |
520 | Submission of electronic data must be made in a secured web |
521 | environment that allows for manual or automated transmission. |
522 | Upon successful transmission, an acknowledgement page must be |
523 | displayed to confirm receipt. The report must contain the |
524 | following information: |
525 | (a) The federal Drug Enforcement Administration |
526 | registration number of the wholesale distributing location. |
527 | (b) The federal Drug Enforcement Administration |
528 | registration number of the entity to which the drugs are |
529 | distributed or from which the drugs are received. |
530 | (c) The transaction code that indicates the type of |
531 | transaction. |
532 | (d) The National Drug Code identifier of the product and |
533 | the quantity distributed or received. |
534 | (e) The Drug Enforcement Administration Form 222 number or |
535 | Controlled Substance Ordering System Identifier on all schedule |
536 | II transactions. |
537 | (f) The date of the transaction. |
538 |
|
539 | The department must share the reported data with the Department |
540 | of Law Enforcement and local law enforcement agencies upon |
541 | request, and must monitor purchasing to identify purchasing |
542 | levels that are inconsistent with the purchasing entity's |
543 | clinical needs. The Department of Law Enforcement shall |
544 | investigate purchases at levels that are inconsistent with the |
545 | purchasing entity's clinical needs to determine whether |
546 | violations of chapter 893 have occurred. |
547 | (15) DUE DILIGENCE.-Each wholesale distributor must |
548 | establish and maintain policies and procedures to credential |
549 | physicians licensed under chapter 459, chapter 459, chapter 461, |
550 | or chapter 466 and pharmacies that would purchase or otherwise |
551 | receive from the wholesale distributor controlled substances |
552 | listed in Schedule II or Schedule III as provided in s. 893.03. |
553 | The wholesale distributor shall maintain records of such |
554 | credentialing and make the records available to the department |
555 | upon request. Such credentialing must, at a minimum, include: |
556 | (a) A determination of the clinical nature of the |
557 | receiving entity, including any specialty practice area. |
558 | (b) A review of the receiving entity's history of Schedule |
559 | II and Schedule III controlled substance purchasing from the |
560 | wholesale distributor. |
561 | (c) A determination that the receiving entity's Schedule |
562 | II and Schedule III controlled substance purchasing history, if |
563 | any, is consistent with and reasonable for that entity's |
564 | clinical business needs. |
565 | (d) Documentation of a level 2 background screening |
566 | pursuant to chapter 435 through the department on any person who |
567 | owns a controlling interest in or, directly or indirectly, |
568 | manages, oversees, or controls the operation of the entity, |
569 | including officers and members of the board of directors of an |
570 | entity that is a corporation. |
571 |
|
572 | Wholesale distributors may not distribute more than 5,000 unit |
573 | doses of any one controlled substance to a retail pharmacy in |
574 | any given month. Wholesale distributors may not distribute |
575 | controlled substances to an entity if any criminal history |
576 | record check for any person associated with that entity shows |
577 | the person has been convicted of, or entered a plea of guilty or |
578 | nolo contendere to, regardless of adjudication, a crime in any |
579 | jurisdiction related to controlled substances, the practice of |
580 | pharmacy, or the dispensing of medicinal drugs. |
581 | Section 15. Paragraphs (o) and (p) are added to subsection |
582 | (1) of section 499.05, Florida Statutes, to read: |
583 | 499.05 Rules.- |
584 | (1) The department shall adopt rules to implement and |
585 | enforce this part with respect to: |
586 | (o) Wholesale distributor reporting requirements of s. |
587 | 499.0121(14). |
588 | (p) Wholesale distributor credentialing requirements of s. |
589 | 499.0121(15). |
590 | Section 16. Subsection (8) is added to section 499.067, |
591 | Florida Statutes, to read: |
592 | 499.067 Denial, suspension, or revocation of permit, |
593 | certification, or registration.- |
594 | (8) The department shall deny, suspend, or revoke a permit |
595 | if it finds the permittee has not complied with the |
596 | credentialing requirements of s. 499.0121(15). |
597 | Section 17. Paragraph (f) is added to subsection (3) of |
598 | section 810.02, Florida Statutes, to read: |
599 | 810.02 Burglary.- |
600 | (3) Burglary is a felony of the second degree, punishable |
601 | as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the |
602 | course of committing the offense, the offender does not make an |
603 | assault or battery and is not and does not become armed with a |
604 | dangerous weapon or explosive, and the offender enters or |
605 | remains in a: |
606 | (f) Structure or conveyance when the offense intended to |
607 | be committed therein is theft of a controlled substance as |
608 | defined in s. 893.02. Notwithstanding any other law, separate |
609 | judgments and sentences for burglary with the intent to commit |
610 | theft of a controlled substance under this paragraph and for any |
611 | applicable possession of controlled substance offense under s. |
612 | 893.13 or trafficking in controlled substance offense under s. |
613 | 893.135 may be imposed when all such offenses involve the same |
614 | amount or amounts of a controlled substance. |
615 |
|
616 | However, if the burglary is committed within a county that is |
617 | subject to a state of emergency declared by the Governor under |
618 | chapter 252 after the declaration of emergency is made and the |
619 | perpetration of the burglary is facilitated by conditions |
620 | arising from the emergency, the burglary is a felony of the |
621 | first degree, punishable as provided in s. 775.082, s. 775.083, |
622 | or s. 775.084. As used in this subsection, the term "conditions |
623 | arising from the emergency" means civil unrest, power outages, |
624 | curfews, voluntary or mandatory evacuations, or a reduction in |
625 | the presence of or response time for first responders or |
626 | homeland security personnel. A person arrested for committing a |
627 | burglary within a county that is subject to such a state of |
628 | emergency may not be released until the person appears before a |
629 | committing magistrate at a first appearance hearing. For |
630 | purposes of sentencing under chapter 921, a felony offense that |
631 | is reclassified under this subsection is ranked one level above |
632 | the ranking under s. 921.0022 or s. 921.0023 of the offense |
633 | committed. |
634 | Section 18. Paragraph (c) of subsection (2) of section |
635 | 812.014, Florida Statutes, is amended to read: |
636 | 812.014 Theft.- |
637 | (2) |
638 | (c) It is grand theft of the third degree and a felony of |
639 | the third degree, punishable as provided in s. 775.082, s. |
640 | 775.083, or s. 775.084, if the property stolen is: |
641 | 1. Valued at $300 or more, but less than $5,000. |
642 | 2. Valued at $5,000 or more, but less than $10,000. |
643 | 3. Valued at $10,000 or more, but less than $20,000. |
644 | 4. A will, codicil, or other testamentary instrument. |
645 | 5. A firearm. |
646 | 6. A motor vehicle, except as provided in paragraph (a). |
647 | 7. Any commercially farmed animal, including any animal of |
648 | the equine, bovine, or swine class, or other grazing animal, and |
649 | including aquaculture species raised at a certified aquaculture |
650 | facility. If the property stolen is aquaculture species raised |
651 | at a certified aquaculture facility, then a $10,000 fine shall |
652 | be imposed. |
653 | 8. Any fire extinguisher. |
654 | 9. Any amount of citrus fruit consisting of 2,000 or more |
655 | individual pieces of fruit. |
656 | 10. Taken from a designated construction site identified |
657 | by the posting of a sign as provided for in s. 810.09(2)(d). |
658 | 11. Any stop sign. |
659 | 12. Anhydrous ammonia. |
660 | 13. Any amount of a controlled substance as defined in s. |
661 | 893.02. Notwithstanding any other law, separate judgments and |
662 | sentences for theft of a controlled substance under this |
663 | subparagraph and for any applicable possession of controlled |
664 | substance offense under s. 893.13 or trafficking in controlled |
665 | substance offense under s. 893.135 may be imposed when all such |
666 | offenses involve the same amount or amounts of a controlled |
667 | substance. |
668 |
|
669 | However, if the property is stolen within a county that is |
670 | subject to a state of emergency declared by the Governor under |
671 | chapter 252, the property is stolen after the declaration of |
672 | emergency is made, and the perpetration of the theft is |
673 | facilitated by conditions arising from the emergency, the |
674 | offender commits a felony of the second degree, punishable as |
675 | provided in s. 775.082, s. 775.083, or s. 775.084, if the |
676 | property is valued at $5,000 or more, but less than $10,000, as |
677 | provided under subparagraph 2., or if the property is valued at |
678 | $10,000 or more, but less than $20,000, as provided under |
679 | subparagraph 3. As used in this paragraph, the term "conditions |
680 | arising from the emergency" means civil unrest, power outages, |
681 | curfews, voluntary or mandatory evacuations, or a reduction in |
682 | the presence of or the response time for first responders or |
683 | homeland security personnel. For purposes of sentencing under |
684 | chapter 921, a felony offense that is reclassified under this |
685 | paragraph is ranked one level above the ranking under s. |
686 | 921.0022 or s. 921.0023 of the offense committed. |
687 | Section 19. Subsections (4) and (5) of section 893.07, |
688 | Florida Statutes, are amended to read: |
689 | 893.07 Records.- |
690 | (4) Every inventory or record required by this chapter, |
691 | including prescription records, shall be maintained: |
692 | (a) Separately from all other records of the registrant, |
693 | or |
694 | (b) Alternatively, in the case of Schedule III, IV, or V |
695 | controlled substances, in such form that information required by |
696 | this chapter is readily retrievable from the ordinary business |
697 | records of the registrant. |
698 |
|
699 | In either case, the records described in this subsection shall |
700 | be kept and made available for a period of at least 2 years for |
701 | inspection and copying by law enforcement officers whose duty it |
702 | is to enforce the laws of this state relating to controlled |
703 | substances. Law enforcement officers are not required to obtain |
704 | a subpoena, court order, or search warrant in order to obtain |
705 | access to or copies of such records. |
706 | (5) Each person described in subsection (1) shall: |
707 | (a) Maintain a record which shall contain a detailed list |
708 | of controlled substances lost, destroyed, or stolen, if any; the |
709 | kind and quantity of such controlled substances; and the date of |
710 | the discovering of such loss, destruction, or theft. |
711 | (b) In the event of the discovery of the theft or loss of |
712 | controlled substances, report such theft or loss to the sheriff |
713 | of that county within 48 hours after its discovery. A person who |
714 | fails to report a theft or loss of a substance listed in s. |
715 | 893.03(3), (4), or (5) within 48 hours after discovery as |
716 | required in this paragraph commits a misdemeanor of the second |
717 | degree, punishable as provided in s. 775.082 or s. 775.083. A |
718 | person who fails to report a theft or loss of a substance listed |
719 | in s. 893.03(2) within 48 hours after discovery as required in |
720 | this paragraph commits a misdemeanor of the first degree, |
721 | punishable as provided in s. 775.082 or s. 775.083. |
722 | Section 20. Section 2 of chapter 2009-198, Laws of |
723 | Florida, is repealed. |
724 | Section 21. |
725 | (1) BUY-BACK PROGRAM.-Within 10 days after the effective |
726 | date of this act, each physician licensed under chapter 458, |
727 | chapter 459, chapter 461, or chapter 466, Florida Statutes, |
728 | shall ensure that undispensed inventory of controlled substances |
729 | listed in Schedule II or Schedule III as provided in s. 893.03, |
730 | Florida Statutes, purchased under the physician's Drug |
731 | Enforcement Administration number for dispensing is: |
732 | (a) Returned to the wholesale distributor, as defined in |
733 | s. 499.003, Florida Statutes, which distributed them; or |
734 | (b) Turned in to local law enforcement agencies and |
735 | abandoned. |
736 |
|
737 | Wholesale distributors shall buy back the undispensed inventory |
738 | of controlled substances listed in Schedule II or Schedule III |
739 | as provided in s. 893.03, Florida Statutes, at the purchase |
740 | price paid by the physician, physician practice, clinic, or |
741 | other paying entity. Each wholesale distributor shall submit a |
742 | report of its activities under this section to the Department of |
743 | Health by August 1, 2011. The report shall include the following |
744 | information: |
745 | 1. The name and address of the returning entity. |
746 | 2. The Florida license, registration, or permit number and |
747 | Drug Enforcement Administration number of the entity that |
748 | originally ordered the drugs. |
749 | 3. The drug name and number of unit doses returned. |
750 | 4. The date of return. |
751 | (2) PUBLIC HEALTH EMERGENCY.- |
752 | (a) The Legislature finds that: |
753 | 1. Prescription drug overdose has been declared a public |
754 | health epidemic by the United States Centers for Disease Control |
755 | and Prevention. |
756 | 2. Prescription drug abuse results in an average of 7 |
757 | deaths in this state each day. |
758 | 3. Physicians in this state purchased over 85 percent of |
759 | the oxycodone purchased by all practitioners in the United |
760 | States in 2006. |
761 | 4. Physicians in this state purchased over 93 percent of |
762 | the methadone purchased by all practitioners in the United |
763 | States in 2006. |
764 | 5. Some physicians in this state dispense medically |
765 | unjustifiable amounts of controlled substances to addicts and |
766 | people who intend to illegally sell the drugs. |
767 | 6. Physicians in this state who have purchased large |
768 | quantities of controlled substances may have significant |
769 | inventory on the effective date of this act. |
770 | 7. On the effective date of this act, the only legal |
771 | method for a dispensing practitioner to sell or otherwise |
772 | transfer controlled substances listed in Schedule II or Schedule |
773 | III as provided in s. 893.03, Florida Statutes, purchased for |
774 | dispensing is through the buy-back procedure or abandonment |
775 | procedures of subsection (1). |
776 | 8. It is likely that the same physicians who purchase and |
777 | dispense medically unjustifiable amounts of drugs will not |
778 | legally dispose of remaining inventory. |
779 | 9. The actions of such dispensing practitioners may result |
780 | in substantial injury to the public health. |
781 | (b) Immediately on the effective date of this act, the |
782 | State Health Officer shall declare a public health emergency |
783 | pursuant to s. 381.00315, Florida Statutes. Pursuant to that |
784 | declaration, the Department of Health, the Attorney General, the |
785 | Department of Law Enforcement, and local law enforcement |
786 | agencies shall take the following actions: |
787 | 1. Within 2 days after the effective date of this act, in |
788 | consultation with wholesale distributors as defined in s. |
789 | 499.003, Florida Statutes, the Department of Health shall |
790 | identify dispensing practitioners that purchased more than an |
791 | average of 2,000 unit doses of controlled substances listed in |
792 | Schedule II or Schedule III as provided in s. 893.03, Florida |
793 | Statutes, per month in the previous 6 months, and shall identify |
794 | the dispensing practitioners in that group who pose the greatest |
795 | threat to the public health based on an assessment of: |
796 | a. The risk of noncompliance with subsection (1). |
797 | b. Purchase amounts. |
798 | c. Manner of medical practice. |
799 | d. Any other factor set by the State Health Officer. |
800 |
|
801 | The Attorney General shall consult and coordinate with federal |
802 | law enforcement agencies. The Department of Law Enforcement |
803 | shall coordinate the efforts of local law enforcement agencies. |
804 | 2. On the 3rd day after the effective date of this act, |
805 | the Department of Law Enforcement or local law enforcement |
806 | agencies shall enter the business premises of the dispensing |
807 | practitioners identified as posing the greatest threat to public |
808 | health and quarantine the inventory of controlled substances |
809 | listed in Schedule II or Schedule III as provided in s. 893.03, |
810 | Florida Statutes, of such dispensing practitioners on site. |
811 | 3. The Department of Law Enforcement or local law |
812 | enforcement agencies shall ensure the security of such inventory |
813 | 24 hours a day through the 10th day after the effective date of |
814 | this act or until the inventory is validly transferred pursuant |
815 | to subsection (1), whichever is earlier. |
816 | 4. On the 11th day after the effective date of this act, |
817 | any remaining inventory of controlled substances listed in |
818 | Schedule II or Schedule III as provided in s. 893.03, Florida |
819 | Statutes, purchased for dispensing by practitioners is deemed |
820 | contraband under s. 893.12, Florida Statutes. The Department of |
821 | Law Enforcement or local law enforcement agencies shall seize |
822 | the inventory and comply with the provisions of s. 893.12, |
823 | Florida Statutes, to destroy it. |
824 | (c) In order to implement the provisions of this section, |
825 | the sum of $3 million of nonrecurring funds from the General |
826 | Revenue Fund is appropriated to the Department of Law |
827 | Enforcement for the 2010-2011 fiscal year. The Department of Law |
828 | Enforcement shall expend the appropriation by reimbursing local |
829 | law enforcement agencies for the overtime-hour costs associated |
830 | with securing the quarantined controlled substance inventory as |
831 | provided in paragraph (b) and activities related to |
832 | investigation and prosecution of crimes related to prescribed |
833 | controlled substances. If requests for reimbursement exceed the |
834 | amount appropriated, the reimbursements shall be prorated by the |
835 | hours of overtime per requesting agency at a maximum of one law |
836 | enforcement officer per quarantine site. |
837 | (3) This section is repealed January 1, 2013. |
838 | Section 22. This act shall take effect upon becoming a |
839 | law. |