CS/CS/HB 7095

1	A bill to be entitled
2	An act relating to controlled substances; amending s.
3	456.072, F.S.; making failure to comply with the
4	requirements of s. 456.44, F.S., grounds for disciplinary
5	action; providing mandatory administrative penalties for
6	certain violations related to prescribing; amending s.
7	456.42, F.S.; requiring prescriptions for controlled
8	substances to be written on a counterfeit-resistant pad
9	produced by an approved vendor or electronically
10	prescribed; providing conditions for being an approved
11	vendor; creating s. 456.44, F.S.; providing definitions;
12	requiring certain physicians to designate themselves as
13	controlled substance prescribing practitioners on their
14	practitioner profiles; providing an effective date;
15	requiring registered physicians to meet certain standards
16	of practice; requiring a physical examination; requiring a
17	written protocol; requiring an assessment of risk for
18	aberrant behavior; requiring a treatment plan; requiring
19	specified informed consent; requiring consultation and
20	referral in certain circumstances; requiring medical
21	records meeting certain criteria; providing an exemption
22	for physicians meeting certain criteria; amending s.
23	458.3265, F.S., relating to regulation of pain-management
24	clinics and medical doctors; amending the definition of a
25	pain-management clinic; providing definitions; providing
26	an exemption from registration for clinics owned and
27	operated by physicians or medical specialists meeting
28	certain criteria; allowing physician assistants and
29	advanced registered nurse practitioners to perform medical
30	examinations; requiring physicians in pain-management
31	clinics to ensure compliance with certain requirements;
32	imposing facility and physical operations requirements;
33	imposing infection control requirements; imposing health
34	and safety requirements; imposing quality assurance
35	requirements; imposing data collection and reporting
36	requirements; amending rulemaking authority; conforming
37	provisions to changes made by the act; providing for
38	future expiration of provisions; amending s. 458.327,
39	F.S.; providing that dispensing certain controlled
40	substances in violation of specified provisions is a
41	third-degree felony; providing penalties; amending s.
42	458.331, F.S.; providing that dispensing certain
43	controlled substances in violation of specified provisions
44	is grounds for disciplinary action; providing penalties;
45	amending s. 459.0137, F.S., relating to regulation of
46	pain-management clinics and osteopathic physicians;
47	providing definitions; providing an exemption from
48	registration for clinics owned and operated by physicians
49	meeting certain criteria; allowing physician assistants
50	and advanced registered nurse practitioners to perform
51	medical examinations; requiring osteopathic physicians in
52	pain-management clinics to ensure compliance with certain
53	requirements; imposing facility and physical operations
54	requirements; imposing infection control requirements;
55	imposing health and safety requirements; imposing quality
56	assurance requirements; imposing data collection and
57	reporting requirements; amending rulemaking authority;
58	conforming provisions to changes made by the act;
59	providing for future expiration of provisions; amending s.
60	459.013, F.S.; providing that dispensing certain
61	controlled substances in violation of specified provisions
62	is a third-degree felony; providing penalties; amending s.
63	459.015, F.S.; providing that dispensing certain
64	controlled substances in violation of specified provisions
65	is grounds for disciplinary action; providing penalties;
66	amending s. 465.015, F.S.; requiring a pharmacist to
67	report to the sheriff within a specified period any
68	instance in which a person fraudulently obtained or
69	attempted to fraudulently obtain a controlled substance;
70	providing criminal penalties; providing requirements for
71	reports; amending s. 465.016, F.S.; providing additional
72	grounds for denial of or disciplinary action against a
73	pharmacist license; amending s. 465.018, F.S.; providing
74	grounds for permit denial or discipline; requiring
75	applicants to pay or make arrangements to pay amounts owed
76	to the Department of Health; requiring an inspection;
77	requiring permittees to maintain certain records;
78	requiring community pharmacies to obtain a permit under
79	chapter 465, F.S., as amended by the act by March 1, 2012,
80	in order to dispense Schedule II and III controlled
81	substances; amending s. 465.022, F.S.; requiring the
82	Department of Health to adopt rules related to procedures
83	for dispensing controlled substances; providing
84	requirements for the issuance of a pharmacy permit;
85	requiring disclosure of financial interests; requiring
86	submission of policies and procedures and providing for
87	grounds for permit denial based on them; allowing the
88	Department of Health to phase-in the policies and
89	procedures requirement over an 18-month period beginning
90	July 1, 2011; requiring the Department of Health to deny a
91	permit to applicants under certain circumstances;
92	requiring permittees to provide notice of certain
93	management changes; requiring prescription department
94	managers to meet certain criteria; imposing duties on
95	prescription department managers; limiting the number of
96	locations a prescription department manager may manage;
97	requiring the board to adopt rules related to
98	recordkeeping; providing that permits are not
99	transferable; increasing the fee for a change of location;
100	amending s. 465.0276, F.S.; prohibiting registered
101	dispensing practitioners from dispensing certain
102	controlled substances; providing an exception for
103	dispensing controlled substances in the health care system
104	of the Department of Corrections; providing an exception
105	for dispensing within 7 days after surgery which used
106	general anesthesia; deleting a provision establishing a
107	72-hour supply limit on dispensing certain controlled
108	substances to certain patients in registered pain-
109	management clinics; amending s. 499.0051, F.S.; providing
110	criminal penalties for violations of certain provisions of
111	s. 499.0121, F.S.; amending s. 499.012, F.S.; requiring
112	wholesale distributor permit applicants to submit
113	documentation of credentialing policies; amending s.
114	499.0121, F.S.; providing reporting requirements for
115	wholesale distributors of certain controlled substances;
116	requiring the Department of Health to share the reported
117	data with law enforcement agencies; requiring the
118	Department of Law Enforcement to make investigations based
119	on the reported data; providing credentialing requirements
120	for distribution of controlled substances to certain
121	entities by wholesale distributors; requiring distributors
122	to identify suspicious transactions; requiring
123	distributors to determine the reasonableness of orders for
124	controlled substances over certain amounts; requiring
125	distributors to report certain transactions to the
126	Department of Health; prohibiting distribution to entities
127	with certain criminal histories; limiting monthly
128	distribution amounts of certain controlled substances to
129	retail pharmacies; requiring the department to assess
130	data; requiring the department to report certain data to
131	the Governor, President of the Senate, and Speaker of the
132	House of Representatives by certain dates; prohibiting
133	distribution to entities with certain criminal
134	backgrounds; amending s. 499.05, F.S.; authorizing
135	rulemaking concerning specified controlled substance
136	wholesale distributor reporting requirements and
137	credentialing requirements; amending s. 499.067, F.S.;
138	authorizing the Department of Health to take disciplinary
139	action against wholesale distributors failing to comply
140	with specified credentialing or reporting requirements;
141	amending s. 810.02, F.S.; authorizing separate judgments
142	and sentences for burglary with the intent to commit theft
143	of a controlled substance under specified provisions and
144	for any applicable possession of controlled substance
145	offense under specified provisions in certain
146	circumstances; amending s. 812.014, F.S.; authorizing
147	separate judgments and sentences for theft of a controlled
148	substance under specified provisions and for any
149	applicable possession of controlled substance offense
150	under specified provisions in certain circumstances;
151	amending s. 893.055, F.S., relating to the prescription
152	drug monitoring program; deleting obsolete dates; deleting
153	references to the Office of Drug Control; requiring
154	reports to the prescription drug monitoring system to be
155	made in 7 days rather than 15 days; prohibiting the use of
156	certain funds to implement the program; requiring the
157	State Surgeon General to appoint a board of directors for
158	the direct-support organization; conforming provisions to
159	changes made by the act; amending s. 893.065, F.S.;
160	conforming provisions to changes made by the act; amending
161	s. 893.07, F.S.; providing that law enforcement officers
162	are not required to obtain a subpoena, court order, or
163	search warrant in order to obtain access to or copies of
164	specified controlled substance inventory records;
165	requiring reporting of the discovery of the theft or loss
166	of controlled substances to the sheriff within a specified
167	period; providing criminal penalties; repealing s. 2 of
168	chapter 2009-198, Laws of Florida, relating to the Program
169	Implementation and Oversight Task Force in the Executive
170	Office of the Governor concerning the electronic system
171	established for the prescription drug monitoring program;
172	providing a buyback program for undispensed controlled
173	substance inventory held by specified licensed physicians;
174	requiring certain certifications by the physician
175	returning inventory to a distributor; providing an
176	exemption to pedigree paper requirements; requiring
177	reports of the program; providing for a declaration of a
178	public health emergency; requiring certain actions
179	relating to dispensing practitioners identified as posing
180	the greatest threat to public health; providing an
181	appropriation; providing for future repeal of program
182	provisions; providing an effective date.
183
184	Be It Enacted by the Legislature of the State of Florida:
185
186	Section 1.  Paragraph (mm) is added to subsection (1) of
187	section 456.072, Florida Statutes, subsection (7) is
188	redesignated as subsection (8), and a new subsection (7) is
189	added to that section, to read:
190	456.072  Grounds for discipline; penalties; enforcement.-
191	(1)  The following acts shall constitute grounds for which
192	the disciplinary actions specified in subsection (2) may be
193	taken:
194	(mm)  Failure to comply with controlled substance
195	prescribing requirements of s. 456.44.
196	(7)  Any licensee who has been found to overprescribe or
197	inappropriately prescribe controlled substances in violation of
198	s. 456.44, s. 458.331(1)(q) or (t), s. 459.015(t) or (x), s.
199	461.013(1)(o) or (s), or s. 466.028(1)(p) or (x) shall be
200	suspended for a period of not less than 6 months and pay a fine
201	of not less than $10,000 per count. Repeated violations shall
202	result in increased penalties.
203	Section 2.  Section 456.42, Florida Statutes, is amended to
204	read:
205	456.42  Written prescriptions for medicinal drugs.-
206	(1)  A written prescription for a medicinal drug issued by
207	a health care practitioner licensed by law to prescribe such
208	drug must be legibly printed or typed so as to be capable of
209	being understood by the pharmacist filling the prescription;
210	must contain the name of the prescribing practitioner, the name
211	and strength of the drug prescribed, the quantity of the drug
212	prescribed, and the directions for use of the drug; must be
213	dated; and must be signed by the prescribing practitioner on the
214	day when issued. A written prescription for a controlled
215	substance listed in chapter 893 must have the quantity of the
216	drug prescribed in both textual and numerical formats and must
217	be dated with the abbreviated month written out on the face of
218	the prescription. However, a prescription that is electronically
219	generated and transmitted must contain the name of the
220	prescribing practitioner, the name and strength of the drug
221	prescribed, the quantity of the drug prescribed in numerical
222	format, and the directions for use of the drug and must be dated
223	and signed by the prescribing practitioner only on the day
224	issued, which signature may be in an electronic format as
225	defined in s. 668.003(4).
226	(2)  A written prescription for a controlled substance
227	listed in chapter 893 must have the quantity of the drug
228	prescribed in both textual and numerical formats, must be dated
229	with the abbreviated month written out on the face of the
230	prescription, and must be either written on a standardized
231	counterfeit-proof prescription pad produced by a vendor approved
232	by the department or electronically prescribed as that term is
233	used in s. 408.0611. As a condition of being an approved vendor,
234	a prescription pad vendor must submit a monthly report to the
235	department which, at a minimum, documents the number of
236	prescription pads sold and identifies the purchasers. The
237	department may, by rule, require the reporting of additional
238	information.
239	Section 3.  Section 456.44, Florida Statutes, is created to
240	read:
241	456.44  Controlled substance prescribing.-
242	(1)  DEFINITIONS.-
243	(a)  "Addiction medicine specialist" means a board-
244	certified physiatrist with a subspecialty certification in
245	addiction medicine or who is eligible for such subspecialty
246	certification in addiction medicine, an addiction medicine
247	physician certified or eligible for certification by the
248	American Society of Addiction Medicine, or an osteopathic
249	physician who holds a certificate of added qualification in
250	Addiction Medicine through the American Osteopathic Association.
251
252	(b)  "Adverse incident" means any incident set forth in s.
253	458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
254	(c)  "Board-certified pain management physician" means a
255	physician who possesses board certification in pain medicine by
256	the American Board of Pain Medicine, board certification by the
257	American Board of Interventional Pain Physicians, or board
258	certification or subcertification in pain management by a
259	specialty board recognized by the American Association of
260	Physician Specialists or an osteopathic physician who holds a
261	certificate in Pain Management by the American Osteopathic
262	Association.
263	(d)  "Chronic nonmalignant pain" means pain unrelated to
264	cancer or rheumatoid arthritis which persists beyond the usual
265	course of disease or the injury that is the cause of the pain or
266	more than 90 days after surgery.
267	(e)  "Mental health addiction facility" means a facility
268	licensed under chapter 394 or chapter 397.
269	(2)  REGISTRATION.-Effective January 1, 2012, a physician
270	licensed under chapter 458, chapter 459, chapter 461, or chapter
271	466 who prescribes any controlled substance, as defined in s.
272	893.03, for the treatment of chronic nonmalignant pain, must:
273	(a)  Designate himself or herself as a controlled substance
274	prescribing practitioner on the physician's practitioner
275	profile.
276	(b)  Comply with the requirements of this section and
277	applicable board rules.
278	(3)  STANDARDS OF PRACTICE.-The standards of practice in
279	this section do not supersede the level of care, skill, and
280	treatment recognized in general law related to healthcare
281	licensure.
282	(a)  A complete medical history and a physical examination
283	must be conducted before beginning any treatment and must be
284	documented in the medical record. The exact components of the
285	physical examination shall be left to the judgment of the
286	clinician who is expected to perform a physical examination
287	proportionate to the diagnosis that justifies a treatment. The
288	medical record must, at a minimum, document the nature and
289	intensity of the pain, current and past treatments for pain,
290	underlying or coexisting diseases or conditions, the effect of
291	the pain on physical and psychological function, a review of
292	previous medical records, previous diagnostic studies, and
293	history of alcohol and substance abuse. The medical record shall
294	also document the presence of one or more recognized medical
295	indications for the use of a controlled substance. Each
296	registrant must develop a written plan for assessing each
297	patient's risk of aberrant drug-related behavior, which may
298	include patient drug testing. Registrants must assess each
299	patient's risk for aberrant drug-related behavior and monitor
300	that risk on an ongoing basis in accordance with the plan.
301	(b)  Each registrant must develop a written individualized
302	treatment plan for each patient. The treatment plan shall state
303	objectives that will be used to determine treatment success,
304	such as pain relief and improved physical and psychosocial
305	function, and shall indicate if any further diagnostic
306	evaluations or other treatments are planned. After treatment
307	begins, the physician shall adjust drug therapy to the
308	individual medical needs of each patient. Other treatment
309	modalities, including a rehabilitation program, shall be
310	considered depending on the etiology of the pain and the extent
311	to which the pain is associated with physical and psychosocial
312	impairment. The interdisciplinary nature of the treatment plan
313	shall be documented.
314	(c)  The physician shall discuss the risks and benefits of
315	the use of controlled substances, including the risks of abuse
316	and addiction, as well as physical dependence and its
317	consequences, with the patient, persons designated by the
318	patient, or the patient's surrogate or guardian if the patient
319	is incompetent. The physician shall use a written controlled
320	substance agreement between the physician and the patient
321	outlining the patient's responsibilities, including, but not
322	limited to:
323	1.  Number and frequency of controlled substance
324	prescriptions and refills.
325	2.  Patient compliance and reasons for which drug therapy
326	may be discontinued, such as a violation of the agreement.
327	3.  An agreement that controlled substances for the
328	treatment of chronic nonmalignant pain shall be prescribed by a
329	single treating physician unless otherwise authorized by the
330	treating physician and documented in the medical record.
331	(d)  The patient shall be seen by the physician at regular
332	intervals, not to exceed 3 months, to assess the efficacy of
333	treatment, ensure that controlled substance therapy remains
334	indicated, evaluate the patient's progress toward treatment
335	objectives, consider adverse drug effects, and review the
336	etiology of the pain. Continuation or modification of therapy
337	shall depend on the physician's evaluation of the patient's
338	progress. If treatment goals are not being achieved, despite
339	medication adjustments, the physician shall reevaluate the
340	appropriateness of continued treatment. The physician shall
341	monitor patient compliance in medication usage, related
342	treatment plans, controlled substance agreements, and
343	indications of substance abuse or diversion at a minimum of 3-
344	month intervals.
345	(e)  The physician shall refer the patient as necessary for
346	additional evaluation and treatment in order to achieve
347	treatment objectives. Special attention shall be given to those
348	patients who are at risk for misusing their medications and
349	those whose living arrangements pose a risk for medication
350	misuse or diversion. The management of pain in patients with a
351	history of substance abuse or with a comorbid psychiatric
352	disorder requires extra care, monitoring, and documentation and
353	requires consultation with or referral to an addictionologist or
354	physiatrist.
355	(f)  A physician registered under this section must
356	maintain accurate, current, and complete records that are
357	accessible and readily available for review and comply with the
358	requirements of this section, the applicable practice act, and
359	applicable board rules. The medical records must include, but
360	are not limited to:
361	1.  The complete medical history and a physical
362	examination, including history of drug abuse or dependence.
363	2.  Diagnostic, therapeutic, and laboratory results.
364	3.  Evaluations and consultations.
365	4.  Treatment objectives.
366	5.  Discussion of risks and benefits.
367	6.  Treatments.
368	7.  Medications, including date, type, dosage, and quantity
369	prescribed.
370	8.  Instructions and agreements.
371	9.  Periodic reviews.
372	10.  Results of any drug testing.
373	11.  A photocopy of the patient's government-issued photo
374	identification.
375	12.  If a written prescription for a controlled substance
376	is given to the patient, a duplicate of the prescription.
377	13.  The physician's full name presented in a legible
378	manner.
379	(g)  Patients with signs or symptoms of substance abuse
380	shall be immediately referred to a board-certified pain
381	management physician, an addiction medicine specialist, or a
382	mental health addiction facility as it pertains to drug abuse or
383	addiction unless the physician is board-certified or board-
384	eligible in pain management. Throughout the period of time
385	before receiving the consultant's report, a prescribing
386	physician shall clearly and completely document medical
387	justification for continued treatment with controlled substances
388	and those steps taken to ensure medically appropriate use of
389	controlled substances by the patient. Upon receipt of the
390	consultant's written report, the prescribing physician shall
391	incorporate the consultant's recommendations for continuing,
392	modifying, or discontinuing controlled substance therapy. The
393	resulting changes in treatment shall be specifically documented
394	in the patient's medical record. Evidence or behavioral
395	indications of diversion shall be followed by discontinuation of
396	controlled substance therapy and the patient shall be discharged
397	and all results of testing and actions taken by the physician
398	shall be documented in the patient's medical record.
399
400	This subsection does not apply to a board-certified
401	anesthesiologist, physiatrist, or neurologist, or to a board-
402	certified physician who has surgical privileges at a hospital or
403	ambulatory surgery center and primarily provides surgical
404	services. This subsection does not apply to a board-certified
405	medical specialist who has also completed a fellowship in pain
406	medicine approved by the Accreditation Council for Graduate
407	Medical Education or the American Osteopathic Association, or
408	who is also board certified in pain medicine by a board approved
409	by the American Board of Medical Specialties or the American
410	Osteopathic Association and performs interventional pain
411	procedures of the type routinely billed using surgical codes.
412	Section 4.  Section 458.3265, Florida Statutes, is amended
413	to read:
414	458.3265  Pain-management clinics.-
415	(1)  REGISTRATION.-
416	(a)1.  As used in this section, the term:
417	a.  "Chronic nonmalignant pain" means pain unrelated to
418	cancer or rheumatoid arthritis which persists beyond the usual
419	course of disease or the injury that is the cause of the pain or
420	more than 90 days after surgery.
421	b.  "Pain-management clinic" or "clinic" means a publicly
422	or privately owned facility where in any month a majority of
423	patients are prescribed opioids, benzodiazepines, barbiturates,
424	or carisoprodol for the treatment of chronic nonmalignant pain.
425	All privately owned pain-management clinics, facilities, or
426	offices, hereinafter referred to as "clinics," which advertise
427	in any medium for any type of pain-management services, or
428	employ a physician who is primarily engaged in the treatment of
429	pain by prescribing or dispensing controlled substance
430	medications,
431	2.  Each pain-management clinic must register with the
432	department unless:
433	a.1.  That clinic is licensed as a facility pursuant to
434	chapter 395;
435	b.2.  The majority of the physicians who provide services
436	in the clinic primarily provide surgical services;
437	c.3.  The clinic is owned by a publicly held corporation
438	whose shares are traded on a national exchange or on the over-
439	the-counter market and whose total assets at the end of the
440	corporation's most recent fiscal quarter exceeded $50 million;
441	d.4.  The clinic is affiliated with an accredited medical
442	school at which training is provided for medical students,
443	residents, or fellows;
444	e.5.  The clinic does not prescribe or dispense controlled
445	substances for the treatment of pain; or
446	f.6.  The clinic is owned by a corporate entity exempt from
447	federal taxation under 26 U.S.C. s. 501(c)(3);
448	g.  The clinic is wholly owned and operated by one or more
449	board-certified anesthesiologists, physiatrists or neurologists;
450	or
451	h.  The clinic is wholly owned and operated by one or more
452	board-certified medical specialists who have also completed
453	fellowships in pain medicine approved by the Accreditation
454	Council for Graduate Medical Education, or who are also board
455	certified in pain medicine by a board approved by the American
456	Board of Medical Specialties and perform interventional pain
457	procedures of the type routinely billed using surgical codes.
458	(b)  Each clinic location shall be registered separately
459	regardless of whether the clinic is operated under the same
460	business name or management as another clinic.
461	(c)  As a part of registration, a clinic must designate a
462	physician who is responsible for complying with all requirements
463	related to registration and operation of the clinic in
464	compliance with this section. Within 10 days after termination
465	of a designated physician, the clinic must notify the department
466	of the identity of another designated physician for that clinic.
467	The designated physician shall have a full, active, and
468	unencumbered license under this chapter or chapter 459 and shall
469	practice at the clinic location for which the physician has
470	assumed responsibility. Failing to have a licensed designated
471	physician practicing at the location of the registered clinic
472	may be the basis for a summary suspension of the clinic
473	registration certificate as described in s. 456.073(8) for a
474	license or s. 120.60(6).
475	(d)  The department shall deny registration to any clinic
476	that is not fully owned by a physician licensed under this
477	chapter or chapter 459 or a group of physicians, each of whom is
478	licensed under this chapter or chapter 459; or that is not a
479	health care clinic licensed under part X of chapter 400.
480	(e)  The department shall deny registration to any pain-
481	management clinic owned by or with any contractual or employment
482	relationship with a physician:
483	1.  Whose Drug Enforcement Administration number has ever
484	been revoked.
485	2.  Whose application for a license to prescribe, dispense,
486	or administer a controlled substance has been denied by any
487	jurisdiction.
488	3.  Who has been convicted of or pleaded guilty or nolo
489	contendere to, regardless of adjudication, an offense that
490	constitutes a felony for receipt of illicit and diverted drugs,
491	including a controlled substance listed in Schedule I, Schedule
492	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
493	this state, any other state, or the United States.
494	(f)  If the department finds that a pain-management clinic
495	does not meet the requirement of paragraph (d) or is owned,
496	directly or indirectly, by a person meeting any criteria listed
497	in paragraph (e), the department shall revoke the certificate of
498	registration previously issued by the department. As determined
499	by rule, the department may grant an exemption to denying a
500	registration or revoking a previously issued registration if
501	more than 10 years have elapsed since adjudication. As used in
502	this subsection, the term "convicted" includes an adjudication
503	of guilt following a plea of guilty or nolo contendere or the
504	forfeiture of a bond when charged with a crime.
505	(g)  The department may revoke the clinic's certificate of
506	registration and prohibit all physicians associated with that
507	pain-management clinic from practicing at that clinic location
508	based upon an annual inspection and evaluation of the factors
509	described in subsection (3).
510	(h)  If the registration of a pain-management clinic is
511	revoked or suspended, the designated physician of the pain-
512	management clinic, the owner or lessor of the pain-management
513	clinic property, the manager, and the proprietor shall cease to
514	operate the facility as a pain-management clinic as of the
515	effective date of the suspension or revocation.
516	(i)  If a pain-management clinic registration is revoked or
517	suspended, the designated physician of the pain-management
518	clinic, the owner or lessor of the clinic property, the manager,
519	or the proprietor is responsible for removing all signs and
520	symbols identifying the premises as a pain-management clinic.
521	(j)  Upon the effective date of the suspension or
522	revocation, the designated physician of the pain-management
523	clinic shall advise the department of the disposition of the
524	medicinal drugs located on the premises. The disposition is
525	subject to the supervision and approval of the department.
526	Medicinal drugs that are purchased or held by a pain-management
527	clinic that is not registered may be deemed adulterated pursuant
528	to s. 499.006.
529	(k)  If the clinic's registration is revoked, any person
530	named in the registration documents of the pain-management
531	clinic, including persons owning or operating the pain-
532	management clinic, may not, as an individual or as a part of a
533	group, apply to operate a pain-management clinic for 5 years
534	after the date the registration is revoked.
535	(l)  The period of suspension for the registration of a
536	pain-management clinic shall be prescribed by the department,
537	but may not exceed 1 year.
538	(m)  A change of ownership of a registered pain-management
539	clinic requires submission of a new registration application.
540	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
541	apply to any physician who provides professional services in a
542	pain-management clinic that is required to be registered in
543	subsection (1).
544	(a)  A physician may not practice medicine in a pain-
545	management clinic, as described in subsection (4), if:
546	1.  The pain-management clinic is not registered with the
547	department as required by this section; or
548	2.  Effective July 1, 2012, the physician has not
549	successfully completed a pain-medicine fellowship that is
550	accredited by the Accreditation Council for Graduate Medical
551	Education or a pain-medicine residency that is accredited by the
552	Accreditation Council for Graduate Medical Education or, prior
553	to July 1, 2012, does not comply with rules adopted by the
554	board.
555
556	Any physician who qualifies to practice medicine in a pain-
557	management clinic pursuant to rules adopted by the Board of
558	Medicine as of July 1, 2012, may continue to practice medicine
559	in a pain-management clinic as long as the physician continues
560	to meet the qualifications set forth in the board rules. A
561	physician who violates this paragraph is subject to disciplinary
562	action by his or her appropriate medical regulatory board.
563	(b)  A person may not dispense any medication, including a
564	controlled substance, on the premises of a registered pain-
565	management clinic unless he or she is a physician licensed under
566	this chapter or chapter 459.
567	(c)  A physician, a physician assistant, or an advanced
568	registered nurse practitioner must perform an appropriate
569	medical a physical examination of a patient on the same day that
570	the physician he or she dispenses or prescribes a controlled
571	substance to a patient at a pain-management clinic. If the
572	physician prescribes or dispenses more than a 72-hour dose of
573	controlled substances for the treatment of chronic nonmalignant
574	pain, the physician must document in the patient's record the
575	reason for prescribing or dispensing that quantity.
576	(d)  A physician authorized to prescribe controlled
577	substances who practices at a pain-management clinic is
578	responsible for maintaining the control and security of his or
579	her prescription blanks and any other method used for
580	prescribing controlled substance pain medication. The physician
581	shall comply with the requirements for counterfeit-resistant
582	prescription blanks in s. 893.065 and the rules adopted pursuant
583	to that section. The physician shall notify, in writing, the
584	department within 24 hours following any theft or loss of a
585	prescription blank or breach of any other method for prescribing
586	pain medication.
587	(e)  The designated physician of a pain-management clinic
588	shall notify the applicable board in writing of the date of
589	termination of employment within 10 days after terminating his
590	or her employment with a pain-management clinic that is required
591	to be registered under subsection (1). Each physician practicing
592	in a pain-management clinic shall advise the Board of Medicine,
593	in writing, within 10 calendar days after beginning or ending
594	his or her practice at a pain-management clinic.
595	(f)  Each physician practicing in a pain management clinic
596	is responsible for ensuring compliance with the following
597	facility and physical operations requirements:
598	1.  A pain management clinic shall be located and operated
599	at a publicly accessible fixed location and must:
600	a.  Display a sign that can be viewed by the public that
601	contains the clinic name, hours of operations, and a street
602	address.
603	b.  Have a publicly listed telephone number and a dedicated
604	phone number to send and receive faxes with a fax machine that
605	shall be operational 24 hours per day.
606	c.  Have emergency lighting and communications.
607	d.  Have a reception and waiting area.
608	e.  Provide a restroom.
609	f.  Have an administrative area, including room for storage
610	of medical records, supplies, and equipment.
611	g.  Have private patient examination rooms.
612	h.  Have treatment rooms, if treatment is being provided to
613	the patients.
614	i.  Display a printed sign located in a conspicuous place
615	in the waiting room viewable by the public with the name and
616	contact information of the clinic's designated physician and the
617	names of all physicians practicing in the clinic.
618	j.  If the clinic stores and dispenses prescription drugs,
619	comply with ss. 499.0121 and 893.07.
620	2.  This section does not excuse a physician from providing
621	any treatment or performing any medical duty without the proper
622	equipment and materials as required by the standard of care.
623	This section does not supersede the level of care, skill, and
624	treatment recognized in general law related to healthcare
625	licensure.
626	(g)  Each physician practicing in a pain management clinic
627	is responsible for ensuring compliance with the following
628	infection control requirements.
629	1.  The clinic shall maintain equipment and supplies to
630	support infection prevention and control activities.
631	2.  The clinic shall identify infection risks based on the
632	following:
633	a.  Geographic location, community, and population served.
634	b.  The care, treatment, and services it provides.
635	c.  An analysis of its infection surveillance and control
636	data.
637	3.  The clinic shall maintain written infection prevention
638	policies and procedures that address the following:
639	a.  Prioritized risks.
640	b.  Limiting unprotected exposure to pathogens.
641	c.  Limiting the transmission of infections associated with
642	procedures performed in the clinic.
643	d.  Limiting the transmission of infections associated with
644	the clinic's use of medical equipment, devices, and supplies.
645	(h)  Each physician practicing in a pain management clinic
646	is responsible for ensuring compliance with the following health
647	and safety requirements:
648	1.  The clinic, including its grounds, buildings,
649	furniture, appliances, and equipment shall be structurally
650	sound, in good repair, clean, and free from health and safety
651	hazards.
652	2.  The clinic shall have evacuation procedures in the
653	event of an emergency, which shall include provisions for the
654	evacuation of disabled patients and employees.
655	3.  The clinic shall have a written facility-specific
656	disaster plan setting forth actions that will be taken in the
657	event of clinic closure due to unforeseen disasters and shall
658	include provisions for the protection of medical records and any
659	controlled substances.
660	4.  Each clinic shall have at least one employee on the
661	premises during patient care hours who is certified in Basic
662	Life Support and is trained in reacting to accidents and medical
663	emergencies until emergency medical personnel arrive.
664	(i)  The designated physician is responsible for ensuring
665	compliance with the following quality assurance requirements.
666	Each pain management clinic shall have an ongoing quality
667	assurance program that objectively and systematically monitors
668	and evaluates the quality and appropriateness of patient care,
669	evaluates methods to improve patient care, identifies and
670	corrects deficiencies within the facility, alerts the designated
671	physician to identify and resolve recurring problems, and
672	provides for opportunities to improve the facility's performance
673	and to enhance and improve the quality of care provided to the
674	public. The designated physician shall establish a quality
675	assurance program that includes the following components:
676	1.  The identification, investigation, and analysis of the
677	frequency and causes of adverse incidents to patients.
678	2.  The identification of trends or patterns of incidents.
679	3.  The development of measures to correct, reduce,
680	minimize, or eliminate the risk of adverse incidents to
681	patients.
682	4.  The documentation of these functions and periodic
683	review no less than quarterly of such information by the
684	designated physician.
685	(j)  The designated physician is responsible for ensuring
686	compliance with the following data collection and reporting
687	requirements:
688	1.  The designated physician for each pain-management
689	clinic shall report all adverse incidents to the department as
690	set forth in s. 458.351.
691	2.  The designated physician shall also report to the Board
692	of Medicine, in writing, on a quarterly basis the following
693	data:
694	a.  Number of new and repeat patients seen and treated at
695	the clinic who are prescribed controlled substance medications
696	for the treatment of chronic, nonmalignant pain.
697	b.  The number of patients discharged due to drug abuse.
698	c.  The number of patients discharged due to drug
699	diversion.
700	d.  The number of patients treated at the pain clinic whose
701	domicile is located somewhere other than in this state. A
702	patient's domicile is the patient's fixed or permanent home to
703	which he or she intends to return even though he or she may
704	temporarily reside elsewhere.
705	(3)  INSPECTION.-
706	(a)  The department shall inspect the pain-management
707	clinic annually, including a review of the patient records, to
708	ensure that it complies with this section and the rules of the
709	Board of Medicine adopted pursuant to subsection (4) unless the
710	clinic is accredited by a nationally recognized accrediting
711	agency approved by the Board of Medicine.
712	(b)  During an onsite inspection, the department shall make
713	a reasonable attempt to discuss each violation with the owner or
714	designated physician of the pain-management clinic before
715	issuing a formal written notification.
716	(c)  Any action taken to correct a violation shall be
717	documented in writing by the owner or designated physician of
718	the pain-management clinic and verified by followup visits by
719	departmental personnel.
720	(4)  RULEMAKING.-
721	(a)  The department shall adopt rules necessary to
722	administer the registration and inspection of pain-management
723	clinics which establish the specific requirements, procedures,
724	forms, and fees.
725	(b)  The department shall adopt a rule defining what
726	constitutes practice by a designated physician at the clinic
727	location for which the physician has assumed responsibility, as
728	set forth in subsection (1). When adopting the rule, the
729	department shall consider the number of clinic employees, the
730	location of the pain-management clinic, the clinic's hours of
731	operation, and the amount of controlled substances being
732	prescribed, dispensed, or administered at the pain-management
733	clinic.
734	(c)  The Board of Medicine shall adopt a rule establishing
735	the maximum number of prescriptions for Schedule II or Schedule
736	III controlled substances or the controlled substance Alprazolam
737	which may be written at any one registered pain-management
738	clinic during any 24-hour period.
739	(b)(d)  The Board of Medicine shall adopt rules setting
740	forth standards of practice for physicians practicing in
741	privately owned pain-management clinics that primarily engage in
742	the treatment of pain by prescribing or dispensing controlled
743	substance medications. Such rules shall address, but need not be
744	limited to:
745	1.  Facility operations;
746	2.  Physical operations;
747	3.  Infection control requirements;
748	4.  Health and safety requirements;
749	5.  Quality assurance requirements;
750	6.  Patient records;
751	7.  training requirements for all facility health care
752	practitioners who are not regulated by another board.;
753	8.  Inspections; and
754	9.  Data collection and reporting requirements.
755
756	A physician is primarily engaged in the treatment of pain by
757	prescribing or dispensing controlled substance medications when
758	the majority of the patients seen are prescribed or dispensed
759	controlled substance medications for the treatment of chronic
760	nonmalignant pain. Chronic nonmalignant pain is pain unrelated
761	to cancer which persists beyond the usual course of the disease
762	or the injury that is the cause of the pain or more than 90 days
763	after surgery.
764	(5)  PENALTIES; ENFORCEMENT.-
765	(a)  The department may impose an administrative fine on
766	the clinic of up to $5,000 per violation for violating the
767	requirements of this section; chapter 499, the Florida Drug and
768	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
769	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
770	Abuse Prevention and Control Act; chapter 893, the Florida
771	Comprehensive Drug Abuse Prevention and Control Act; or the
772	rules of the department. In determining whether a penalty is to
773	be imposed, and in fixing the amount of the fine, the department
774	shall consider the following factors:
775	1.  The gravity of the violation, including the probability
776	that death or serious physical or emotional harm to a patient
777	has resulted, or could have resulted, from the pain-management
778	clinic's actions or the actions of the physician, the severity
779	of the action or potential harm, and the extent to which the
780	provisions of the applicable laws or rules were violated.
781	2.  What actions, if any, the owner or designated physician
782	took to correct the violations.
783	3.  Whether there were any previous violations at the pain-
784	management clinic.
785	4.  The financial benefits that the pain-management clinic
786	derived from committing or continuing to commit the violation.
787	(b)  Each day a violation continues after the date fixed
788	for termination of the violation as ordered by the department
789	constitutes an additional, separate, and distinct violation.
790	(c)  The department may impose a fine and, in the case of
791	an owner-operated pain-management clinic, revoke or deny a pain-
792	management clinic's registration, if the clinic's designated
793	physician knowingly and intentionally misrepresents actions
794	taken to correct a violation.
795	(d)  An owner or designated physician of a pain-management
796	clinic who concurrently operates an unregistered pain-management
797	clinic is subject to an administrative fine of $5,000 per day.
798	(e)  If the owner of a pain-management clinic that requires
799	registration fails to apply to register the clinic upon a change
800	of ownership and operates the clinic under the new ownership,
801	the owner is subject to a fine of $5,000.
802	(6)  EXPIRATION.-This section expires January 1, 2016.
803	Section 5.  Paragraph (f) is added to subsection (1) of
804	section 458.327, Florida Statutes, to read:
805	458.327  Penalty for violations.-
806	(1)  Each of the following acts constitutes a felony of the
807	third degree, punishable as provided in s. 775.082, s. 775.083,
808	or s. 775.084:
809	(f)  Dispensing a controlled substance listed in Schedule
810	II or Schedule III in violation of s. 465.0276.
811	Section 6.  Paragraph (rr) is added to subsection (1) of
812	section 458.331, Florida Statutes, to read:
813	458.331  Grounds for disciplinary action; action by the
814	board and department.-
815	(1)  The following acts constitute grounds for denial of a
816	license or disciplinary action, as specified in s. 456.072(2):
817	(rr)  Dispensing a controlled substance listed in Schedule
818	II or Schedule III in violation of s. 465.0276.
819	Section 7.  Section 459.0137, Florida Statutes, is amended
820	to read:
821	459.0137  Pain-management clinics.-
822	(1)  REGISTRATION.-
823	(a)1.  As used in this section, the term:
824	a.  "Chronic nonmalignant pain" means pain unrelated to
825	cancer or rheumatoid arthritis which persists beyond the usual
826	course of disease or the injury that is the cause of the pain or
827	more than 90 days after surgery.
828	b.  "Pain-management clinic" or "clinic" means a publicly
829	or privately owned facility where in any month a majority of
830	patients are prescribed opioids, benzodiazepines, barbiturates,
831	or carisoprodol for the treatment of chronic nonmalignant pain.
832	All privately owned pain-management clinics, facilities, or
833	offices, hereinafter referred to as "clinics," which advertise
834	in any medium for any type of pain-management services, or
835	employ an osteopathic physician who is primarily engaged in the
836	treatment of pain by prescribing or dispensing controlled
837	substance medications,
838	2.  Each pain-management clinic must register with the
839	department unless:
840	a.1.  That clinic is licensed as a facility pursuant to
841	chapter 395;
842	b.2.  The majority of the physicians who provide services
843	in the clinic primarily provide surgical services;
844	c.3.  The clinic is owned by a publicly held corporation
845	whose shares are traded on a national exchange or on the over-
846	the-counter market and whose total assets at the end of the
847	corporation's most recent fiscal quarter exceeded $50 million;
848	d.4.  The clinic is affiliated with an accredited medical
849	school at which training is provided for medical students,
850	residents, or fellows;
851	e.5.  The clinic does not prescribe or dispense controlled
852	substances for the treatment of pain; or
853	f.6.  The clinic is owned by a corporate entity exempt from
854	federal taxation under 26 U.S.C. s. 501(c)(3);
855	g.  The clinic is wholly owned and operated by one or more
856	board-certified anesthesiologists, physiatrists, or
857	neurologists; or
858	h.  The clinic is wholly owned and operated by one or more
859	board-certified medical specialists who have also completed
860	fellowships in pain medicine approved by the Accreditation
861	Council for Graduate Medical Education or the American
862	Osteopathic Association, or who are also board certified in pain
863	medicine by a board approved by the American Board of Medical
864	Specialties or the American Osteopathic Association and perform
865	interventional pain procedures of the type routinely billed
866	using surgical codes.
867	(b)  Each clinic location shall be registered separately
868	regardless of whether the clinic is operated under the same
869	business name or management as another clinic.
870	(c)  As a part of registration, a clinic must designate an
871	osteopathic physician who is responsible for complying with all
872	requirements related to registration and operation of the clinic
873	in compliance with this section. Within 10 days after
874	termination of a designated osteopathic physician, the clinic
875	must notify the department of the identity of another designated
876	physician for that clinic. The designated physician shall have a
877	full, active, and unencumbered license under chapter 458 or this
878	chapter and shall practice at the clinic location for which the
879	physician has assumed responsibility. Failing to have a licensed
880	designated osteopathic physician practicing at the location of
881	the registered clinic may be the basis for a summary suspension
882	of the clinic registration certificate as described in s.
883	456.073(8) for a license or s. 120.60(6).
884	(d)  The department shall deny registration to any clinic
885	that is not fully owned by a physician licensed under chapter
886	458 or this chapter or a group of physicians, each of whom is
887	licensed under chapter 458 or this chapter; or that is not a
888	health care clinic licensed under part X of chapter 400.
889	(e)  The department shall deny registration to any pain-
890	management clinic owned by or with any contractual or employment
891	relationship with a physician:
892	1.  Whose Drug Enforcement Administration number has ever
893	been revoked.
894	2.  Whose application for a license to prescribe, dispense,
895	or administer a controlled substance has been denied by any
896	jurisdiction.
897	3.  Who has been convicted of or pleaded guilty or nolo
898	contendere to, regardless of adjudication, an offense that
899	constitutes a felony for receipt of illicit and diverted drugs,
900	including a controlled substance listed in Schedule I, Schedule
901	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
902	this state, any other state, or the United States.
903	(f)  If the department finds that a pain-management clinic
904	does not meet the requirement of paragraph (d) or is owned,
905	directly or indirectly, by a person meeting any criteria listed
906	in paragraph (e), the department shall revoke the certificate of
907	registration previously issued by the department. As determined
908	by rule, the department may grant an exemption to denying a
909	registration or revoking a previously issued registration if
910	more than 10 years have elapsed since adjudication. As used in
911	this subsection, the term "convicted" includes an adjudication
912	of guilt following a plea of guilty or nolo contendere or the
913	forfeiture of a bond when charged with a crime.
914	(g)  The department may revoke the clinic's certificate of
915	registration and prohibit all physicians associated with that
916	pain-management clinic from practicing at that clinic location
917	based upon an annual inspection and evaluation of the factors
918	described in subsection (3).
919	(h)  If the registration of a pain-management clinic is
920	revoked or suspended, the designated physician of the pain-
921	management clinic, the owner or lessor of the pain-management
922	clinic property, the manager, and the proprietor shall cease to
923	operate the facility as a pain-management clinic as of the
924	effective date of the suspension or revocation.
925	(i)  If a pain-management clinic registration is revoked or
926	suspended, the designated physician of the pain-management
927	clinic, the owner or lessor of the clinic property, the manager,
928	or the proprietor is responsible for removing all signs and
929	symbols identifying the premises as a pain-management clinic.
930	(j)  Upon the effective date of the suspension or
931	revocation, the designated physician of the pain-management
932	clinic shall advise the department of the disposition of the
933	medicinal drugs located on the premises. The disposition is
934	subject to the supervision and approval of the department.
935	Medicinal drugs that are purchased or held by a pain-management
936	clinic that is not registered may be deemed adulterated pursuant
937	to s. 499.006.
938	(k)  If the clinic's registration is revoked, any person
939	named in the registration documents of the pain-management
940	clinic, including persons owning or operating the pain-
941	management clinic, may not, as an individual or as a part of a
942	group, make application for a permit to operate a pain-
943	management clinic for 5 years after the date the registration is
944	revoked.
945	(l)  The period of suspension for the registration of a
946	pain-management clinic shall be prescribed by the department,
947	but may not exceed 1 year.
948	(m)  A change of ownership of a registered pain-management
949	clinic requires submission of a new registration application.
950	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
951	apply to any osteopathic physician who provides professional
952	services in a pain-management clinic that is required to be
953	registered in subsection (1).
954	(a)  An osteopathic physician may not practice medicine in
955	a pain-management clinic, as described in subsection (4), if:
956	1.  The pain-management clinic is not registered with the
957	department as required by this section; or
958	2.  Effective July 1, 2012, the physician has not
959	successfully completed a pain-medicine fellowship that is
960	accredited by the Accreditation Council for Graduate Medical
961	Education or the American Osteopathic Association or a pain-
962	medicine residency that is accredited by the Accreditation
963	Council for Graduate Medical Education or the American
964	Osteopathic Association or, prior to July 1, 2012, does not
965	comply with rules adopted by the board.
966
967	Any physician who qualifies to practice medicine in a pain-
968	management clinic pursuant to rules adopted by the Board of
969	Osteopathic Medicine as of July 1, 2012, may continue to
970	practice medicine in a pain-management clinic as long as the
971	physician continues to meet the qualifications set forth in the
972	board rules. An osteopathic physician who violates this
973	paragraph is subject to disciplinary action by his or her
974	appropriate medical regulatory board.
975	(b)  A person may not dispense any medication, including a
976	controlled substance, on the premises of a registered pain-
977	management clinic unless he or she is a physician licensed under
978	this chapter or chapter 458.
979	(c)  An osteopathic physician, a physician assistant, or an
980	advanced registered nurse practitioner must perform an a
981	appropriate medical physical examination of a patient on the
982	same day that the physician he or she dispenses or prescribes a
983	controlled substance to a patient at a pain-management clinic.
984	If the osteopathic physician prescribes or dispenses more than a
985	72-hour dose of controlled substances for the treatment of
986	chronic nonmalignant pain, the osteopathic physician must
987	document in the patient's record the reason for prescribing or
988	dispensing that quantity.
989	(d)  An osteopathic physician authorized to prescribe
990	controlled substances who practices at a pain-management clinic
991	is responsible for maintaining the control and security of his
992	or her prescription blanks and any other method used for
993	prescribing controlled substance pain medication. The
994	osteopathic physician shall comply with the requirements for
995	counterfeit-resistant prescription blanks in s. 893.065 and the
996	rules adopted pursuant to that section. The osteopathic
997	physician shall notify, in writing, the department within 24
998	hours following any theft or loss of a prescription blank or
999	breach of any other method for prescribing pain medication.
1000	(e)  The designated osteopathic physician of a pain-
1001	management clinic shall notify the applicable board in writing
1002	of the date of termination of employment within 10 days after
1003	terminating his or her employment with a pain-management clinic
1004	that is required to be registered under subsection (1). Each
1005	osteopathic physician practicing in a pain-management clinic
1006	shall advise the Board of Osteopathic Medicine in writing within
1007	10 calendar days after beginning or ending his or her practice
1008	at a pain-management clinic.
1009	(f)  Each osteopathic physician practicing in a pain
1010	management clinic is responsible for ensuring compliance with
1011	the following facility and physical operations requirements:
1012	1.  A pain-management clinic shall be located and operated
1013	at a publicly accessible fixed location and must:
1014	a.  Display a sign that can be viewed by the public that
1015	contains the clinic name, hours of operations, and a street
1016	address.
1017	b.  Have a publicly listed telephone number and a dedicated
1018	phone number to send and receive faxes with a fax machine that
1019	shall be operational 24 hours per day.
1020	c.  Have emergency lighting and communications.
1021	d.  Have a reception and waiting area.
1022	e.  Provide a restroom.
1023	f.  Have an administrative area including room for storage
1024	of medical records, supplies and equipment.
1025	g.  Have private patient examination rooms.
1026	h.  Have treatment rooms, if treatment is being provided to
1027	the patient.
1028	i.  Display a printed sign located in a conspicuous place
1029	in the waiting room viewable by the public with the name and
1030	contact information of the clinic-designated physician and the
1031	names of all physicians practicing in the clinic.
1032	j.  If the clinic stores and dispenses prescription drug,
1033	comply with ss. 499.0121 and 893.07.
1034	2.  This section does not excuse an osteopathic physician
1035	from providing any treatment or performing any medical duty
1036	without the proper equipment and materials as required by the
1037	standard of care. This section does not supersede the level of
1038	care, skill, and treatment recognized in general law related to
1039	healthcare licensure.
1040	(g)  Each osteopathic physician practicing in a pain
1041	management clinic is responsible for ensuring compliance with
1042	the following infection control requirements.
1043	1.  The clinic shall maintain equipment and supplies to
1044	support infection prevention and control activities.
1045	2.  The clinic shall identify infection risks based on the
1046	following:
1047	a.  Geographic location, community, and population served.
1048	b.  The care, treatment and services it provides.
1049	c.  An analysis of its infection surveillance and control
1050	data.
1051	3.  The clinic shall maintain written infection prevention
1052	policies and procedures that address the following:
1053	a.  Prioritized risks.
1054	b.  Limiting unprotected exposure to pathogen.
1055	c.  Limiting the transmission of infections associated with
1056	procedures performed in the clinic.
1057	d.  Limiting the transmission of infections associated with
1058	the clinic's use of medical equipment, devices, and supplies.
1059	(h)  Each osteopathic physician practicing in a pain
1060	management clinic is responsible for ensuring compliance with
1061	the following health and safety requirements.
1062	1.  The clinic, including its grounds, buildings,
1063	furniture, appliances, and equipment shall be structurally
1064	sound, in good repair, clean, and free from health and safety
1065	hazards.
1066	2.  The clinic shall have evacuation procedures in the
1067	event of an emergency which shall include provisions for the
1068	evacuation of disabled patients and employees.
1069	3.  The clinic shall have a written facility-specific
1070	disaster plan which sets forth actions that will be taken in the
1071	event of clinic closure due to unforeseen disasters and shall
1072	include provisions for the protection of medical records and any
1073	controlled substances.
1074	4.  Each clinic shall have at least one employee on the
1075	premises during patient care hours who is certified in Basic
1076	Life Support and is trained in reacting to accidents and medical
1077	emergencies until emergency medical personnel arrive.
1078	(i)  The designated physician is responsible for ensuring
1079	compliance with the following quality assurance requirements.
1080	Each pain management clinic shall have an ongoing quality
1081	assurance program that objectively and systematically monitors
1082	and evaluates the quality and appropriateness of patient care,
1083	evaluates methods to improve patient care, identifies and
1084	corrects deficiencies within the facility, alerts the designated
1085	physician to identify and resolve recurring problems, and
1086	provides for opportunities to improve the facility's performance
1087	and to enhance and improve the quality of care provided to the
1088	public. The designated physician shall establish a quality
1089	assurance program that includes the following components:
1090	1.  The identification, investigation, and analysis of the
1091	frequency and causes of adverse incidents to patients.
1092	2.  The identification of trends or patterns of incidents.
1093	3.  The development of measures to correct, reduce,
1094	minimize, or eliminate the risk of adverse incidents to
1095	patients.
1096	4.  The documentation of these functions and periodic
1097	review no less than quarterly of such information by the
1098	designated physician.
1099	(j)  The designated physician is responsible for ensuring
1100	compliance with the following data collection and reporting
1101	requirements:
1102	1.  The designated physician for each pain-management
1103	clinic shall report all adverse incidents to the department as
1104	set forth in s. 459.026.
1105	2.  The designated physician shall also report to the Board
1106	of Osteopathic Medicine, in writing, on a quarterly basis, the
1107	following data:
1108	a.  Number of new and repeat patients seen and treated at
1109	the clinic who are prescribed controlled substance medications
1110	for the treatment of chronic, nonmalignant pain.
1111	b.  The number of patients discharged due to drug abuse.
1112	c.  The number of patients discharged due to drug
1113	diversion.
1114	d.  The number of patients treated at the pain clinic whose
1115	domicile is located somewhere other than in this state. A
1116	patient's domicile is the patient's fixed or permanent home to
1117	which he or she intends to return even though he or she may
1118	temporarily reside elsewhere.
1119	(3)  INSPECTION.-
1120	(a)  The department shall inspect the pain-management
1121	clinic annually, including a review of the patient records, to
1122	ensure that it complies with this section and the rules of the
1123	Board of Osteopathic Medicine adopted pursuant to subsection (4)
1124	unless the clinic is accredited by a nationally recognized
1125	accrediting agency approved by the Board of Osteopathic
1126	Medicine.
1127	(b)  During an onsite inspection, the department shall make
1128	a reasonable attempt to discuss each violation with the owner or
1129	designated physician of the pain-management clinic before
1130	issuing a formal written notification.
1131	(c)  Any action taken to correct a violation shall be
1132	documented in writing by the owner or designated physician of
1133	the pain-management clinic and verified by followup visits by
1134	departmental personnel.
1135	(4)  RULEMAKING.-
1136	(a)  The department shall adopt rules necessary to
1137	administer the registration and inspection of pain-management
1138	clinics which establish the specific requirements, procedures,
1139	forms, and fees.
1140	(b)  The department shall adopt a rule defining what
1141	constitutes practice by a designated osteopathic physician at
1142	the clinic location for which the physician has assumed
1143	responsibility, as set forth in subsection (1). When adopting
1144	the rule, the department shall consider the number of clinic
1145	employees, the location of the pain-management clinic, the
1146	clinic's hours of operation, and the amount of controlled
1147	substances being prescribed, dispensed, or administered at the
1148	pain-management clinic.
1149	(c)  The Board of Osteopathic Medicine shall adopt a rule
1150	establishing the maximum number of prescriptions for Schedule II
1151	or Schedule III controlled substances or the controlled
1152	substance Alprazolam which may be written at any one registered
1153	pain-management clinic during any 24-hour period.
1154	(b)(d)  The Board of Osteopathic Medicine shall adopt rules
1155	setting forth standards of practice for osteopathic physicians
1156	practicing in privately owned pain-management clinics that
1157	primarily engage in the treatment of pain by prescribing or
1158	dispensing controlled substance medications. Such rules shall
1159	address, but need not be limited to:
1160	1.  Facility operations;
1161	2.  Physical operations;
1162	3.  Infection control requirements;
1163	4.  Health and safety requirements;
1164	5.  Quality assurance requirements;
1165	6.  Patient records;
1166	7.  training requirements for all facility health care
1167	practitioners who are not regulated by another board.;
1168	8.  Inspections; and
1169	9.  Data collection and reporting requirements.
1170
1171	An osteopathic physician is primarily engaged in the treatment
1172	of pain by prescribing or dispensing controlled substance
1173	medications when the majority of the patients seen are
1174	prescribed or dispensed controlled substance medications for the
1175	treatment of chronic nonmalignant pain. Chronic nonmalignant
1176	pain is pain unrelated to cancer which persists beyond the usual
1177	course of the disease or the injury that is the cause of the
1178	pain or more than 90 days after surgery.
1179	(5)  PENALTIES; ENFORCEMENT.-
1180	(a)  The department may impose an administrative fine on
1181	the clinic of up to $5,000 per violation for violating the
1182	requirements of this section; chapter 499, the Florida Drug and
1183	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
1184	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
1185	Abuse Prevention and Control Act; chapter 893, the Florida
1186	Comprehensive Drug Abuse Prevention and Control Act; or the
1187	rules of the department. In determining whether a penalty is to
1188	be imposed, and in fixing the amount of the fine, the department
1189	shall consider the following factors:
1190	1.  The gravity of the violation, including the probability
1191	that death or serious physical or emotional harm to a patient
1192	has resulted, or could have resulted, from the pain-management
1193	clinic's actions or the actions of the osteopathic physician,
1194	the severity of the action or potential harm, and the extent to
1195	which the provisions of the applicable laws or rules were
1196	violated.
1197	2.  What actions, if any, the owner or designated
1198	osteopathic physician took to correct the violations.
1199	3.  Whether there were any previous violations at the pain-
1200	management clinic.
1201	4.  The financial benefits that the pain-management clinic
1202	derived from committing or continuing to commit the violation.
1203	(b)  Each day a violation continues after the date fixed
1204	for termination of the violation as ordered by the department
1205	constitutes an additional, separate, and distinct violation.
1206	(c)  The department may impose a fine and, in the case of
1207	an owner-operated pain-management clinic, revoke or deny a pain-
1208	management clinic's registration, if the clinic's designated
1209	osteopathic physician knowingly and intentionally misrepresents
1210	actions taken to correct a violation.
1211	(d)  An owner or designated osteopathic physician of a
1212	pain-management clinic who concurrently operates an unregistered
1213	pain-management clinic is subject to an administrative fine of
1214	$5,000 per day.
1215	(e)  If the owner of a pain-management clinic that requires
1216	registration fails to apply to register the clinic upon a change
1217	of ownership and operates the clinic under the new ownership,
1218	the owner is subject to a fine of $5,000.
1219	(6)  EXPIRATION.-This section expires January 1, 2016.
1220	Section 8.  Paragraph (f) is added to subsection (1) of
1221	section 459.013, Florida Statutes, to read:
1222	459.013  Penalty for violations.-
1223	(1)  Each of the following acts constitutes a felony of the
1224	third degree, punishable as provided in s. 775.082, s. 775.083,
1225	or s. 775.084:
1226	(f)  Dispensing a controlled substance listed in Schedule
1227	II or Schedule III in violation of s. 465.0276.
1228	Section 9.  Paragraph (tt) is added to subsection (1) of
1229	section 459.015, Florida Statutes, to read:
1230	459.015  Grounds for disciplinary action; action by the
1231	board and department.-
1232	(1)  The following acts constitute grounds for denial of a
1233	license or disciplinary action, as specified in s. 456.072(2):
1234	(tt)  Dispensing a controlled substance listed in Schedule
1235	II or Schedule III in violation of s. 465.0276.
1236	Section 10.  Subsections (3) and (4) of section 465.015,
1237	Florida Statutes, are renumbered as subsections (4) and (5),
1238	respectively, a new subsection (3) is added to that section, and
1239	present subsection (4) of that section is amended, to read:
1240	465.015  Violations and penalties.-
1241	(3)  It is unlawful for any pharmacist to fail to report to
1242	the sheriff of the county where the pharmacy is located within
1243	24 hours after learning of any instance in which a person
1244	obtained or attempted to obtain a controlled substance, as
1245	defined in s. 893.02, that the pharmacist knew or reasonably
1246	should have known was obtained or attempted to be obtained from
1247	the pharmacy through fraudulent methods or representations. Any
1248	pharmacist who fails to make such a report within 24 hours after
1249	learning of the fraud or attempted fraud commits a misdemeanor
1250	of the first degree, punishable as provided in s. 775.082 or s.
1251	775.083. A sufficient report of the fraudulent obtaining of
1252	controlled substances under this subsection shall contain, at a
1253	minimum, a copy of the prescription used or presented and a
1254	narrative, including all information available to the pharmacy
1255	concerning the transaction, such as the name and telephone
1256	number of the prescribing physician; the name, description, and
1257	any personal identification information pertaining to the person
1258	who presented the prescription; and all other material
1259	information, such as photographic or video surveillance of the
1260	transaction.
1261	(5)(4)  Any person who violates any provision of subsection
1262	(1) or subsection (4) (3) commits a misdemeanor of the first
1263	degree, punishable as provided in s. 775.082 or s. 775.083. Any
1264	person who violates any provision of subsection (2) commits a
1265	felony of the third degree, punishable as provided in s.
1266	775.082, s. 775.083, or s. 775.084. In any warrant, information,
1267	or indictment, it shall not be necessary to negative any
1268	exceptions, and the burden of any exception shall be upon the
1269	defendant.
1270	Section 11.  Paragraph (t) is added to subsection (1) of
1271	section 465.016, Florida Statutes, to read:
1272	465.016  Disciplinary actions.-
1273	(1)  The following acts constitute grounds for denial of a
1274	license or disciplinary action, as specified in s. 456.072(2):
1275	(t)  Committing an error or omission during the performance
1276	of a specific function of prescription drug processing, which
1277	includes, for purposes of this paragraph:
1278	1.  Receiving, interpreting, or clarifying a prescription.
1279	2.  Entering prescription data into the pharmacy's record.
1280	3.  Verifying or validating a prescription.
1281	4.  Performing pharmaceutical calculations.
1282	5.  Performing prospective drug review as defined by the
1283	board.
1284	6.  Obtaining refill and substitution authorizations.
1285	7.  Interpreting or acting on clinical data.
1286	8.  Performing therapeutic interventions.
1287	9.  Providing drug information concerning a patient's
1288	prescription.
1289	10.  Providing patient counseling.
1290	Section 12.  Section 465.018, Florida Statutes, is amended
1291	to read:
1292	465.018  Community pharmacies; permits.-
1293	(1)  Any person desiring a permit to operate a community
1294	pharmacy shall apply to the department.
1295	(2)  If the board office certifies that the application
1296	complies with the laws of the state and the rules of the board
1297	governing pharmacies, the department shall issue the permit. No
1298	permit shall be issued unless a licensed pharmacist is
1299	designated as the prescription department manager responsible
1300	for maintaining all drug records, providing for the security of
1301	the prescription department, and following such other rules as
1302	relate to the practice of the profession of pharmacy. The
1303	permittee and the newly designated prescription department
1304	manager shall notify the department within 10 days of any change
1305	in prescription department manager.
1306	(3)  The board may suspend or revoke the permit of, or may
1307	refuse to issue a permit to:
1308	(a)  Any person who has been disciplined or who has
1309	abandoned a permit or allowed a permit to become void after
1310	written notice that disciplinary proceedings had been or would
1311	be brought against the permit;
1312	(b)  Any person who is an officer, director, or person
1313	interested directly or indirectly in a person or business entity
1314	that has had a permit disciplined or abandoned or become void
1315	after written notice that disciplinary proceedings had been or
1316	would be brought against the permit; or
1317	(c)  Any person who is or has been an officer of a business
1318	entity, or who was interested directly or indirectly in a
1319	business entity, the permit of which has been disciplined or
1320	abandoned or become null and void after written notice that
1321	disciplinary proceedings had been or would be brought against
1322	the permit.
1323	(4)  In addition to any other remedies provided by law, the
1324	board may deny the application or suspend or revoke the license,
1325	registration, or certificate of any entity regulated or licensed
1326	by it if the applicant, licensee, registrant, or licenseholder,
1327	or, in the case of a corporation, partnership, or other business
1328	entity, if any officer, director, agent, or managing employee of
1329	that business entity or any affiliated person, partner, or
1330	shareholder having an ownership interest equal to 5 percent or
1331	greater in that business entity, has failed to pay all
1332	outstanding fines, liens, or overpayments assessed by final
1333	order of the department, unless a repayment plan is approved by
1334	the department; or for failure to comply with any repayment
1335	plan.
1336	(5)  In reviewing any application requesting a change of
1337	ownership or a change of licensee or registrant, the transferor
1338	shall, before board approval of the change, repay or make
1339	arrangements to repay any amounts owed to the department. If the
1340	transferor fails to repay or make arrangements to repay the
1341	amounts owed to the department, the license or registration may
1342	not be issued to the transferee until repayment or until
1343	arrangements for repayment are made.
1344	(6)  Passing an onsite inspection is a prerequisite to the
1345	issuance of an initial permit or a permit for a change of
1346	location. The department must make the inspection within 90 days
1347	before issuance of the permit.
1348	(7)  Community pharmacies that dispense controlled
1349	substances must maintain a record of all controlled substance
1350	dispensing consistent with the requirements of s. 893.07 and
1351	must make the record available to the department and law
1352	enforcement agencies upon request.
1353	Section 13.  In order to dispense controlled substances
1354	listed in Schedule II or Schedule III, as provided in s. 893.03,
1355	Florida Statutes, on or after March 1, 2012, a community
1356	pharmacy permittee must be permitted pursuant to chapter 465,
1357	Florida Statutes, as amended by this act and any rules adopted
1358	thereunder.
1359	Section 14.  Section 465.022, Florida Statutes, is amended
1360	to read:
1361	465.022  Pharmacies; general requirements; fees.-
1362	(1)  The board shall adopt rules pursuant to ss. 120.536(1)
1363	and 120.54 to implement the provisions of this chapter. Such
1364	rules shall include, but shall not be limited to, rules relating
1365	to:
1366	(a)  General drug safety measures.
1367	(b)  Minimum standards for the physical facilities of
1368	pharmacies.
1369	(c)  Safe storage of floor-stock drugs.
1370	(d)  Functions of a pharmacist in an institutional
1371	pharmacy, consistent with the size and scope of the pharmacy.
1372	(e)  Procedures for the safe storage and handling of
1373	radioactive drugs.
1374	(f)  Procedures for the distribution and disposition of
1375	medicinal drugs distributed pursuant to s. 499.028.
1376	(g)  Procedures for transfer of prescription files and
1377	medicinal drugs upon the change of ownership or closing of a
1378	pharmacy.
1379	(h)  Minimum equipment which a pharmacy shall at all times
1380	possess to fill prescriptions properly.
1381	(i)  Procedures for the dispensing of controlled substances
1382	to minimize dispensing based on fraudulent representations or
1383	invalid practitioner-patient relationships.
1384	(2)  A pharmacy permit may shall be issued only to a
1385	natural person who is at least 18 years of age, to a partnership
1386	comprised of at least one natural person and all of whose
1387	partners are all at least 18 years of age, to a government
1388	agency, or to a business entity that is properly registered with
1389	the Secretary of State, if required by law, and has been issued
1390	a federal employer tax identification number corporation that is
1391	registered pursuant to chapter 607 or chapter 617 whose
1392	officers, directors, and shareholders are at least 18 years of
1393	age. Permits issued to business entities may be issued only to
1394	entities whose affiliated persons, members, partners, officers,
1395	directors, and agents, including persons required to be
1396	fingerprinted under subsection (3), are not less than 18 years
1397	of age.
1398	(3)  Any person or business entity, partnership, or
1399	corporation before engaging in the operation of a pharmacy,
1400	shall file with the board a sworn application on forms provided
1401	by the department. For purposes of this section, any person
1402	required to provide fingerprints under this subsection is an
1403	affiliated person within the meaning of s. 465.023(1).
1404	(a)  An application for a pharmacy permit must include a
1405	set of fingerprints from each person having an ownership
1406	interest of 5 percent or greater and from any person who,
1407	directly or indirectly, manages, oversees, or controls the
1408	operation of the applicant, including officers and members of
1409	the board of directors of an applicant that is a corporation.
1410	The applicant must provide payment in the application for the
1411	cost of state and national criminal history records checks.
1412	1.  For corporations having more than $100 million of
1413	business taxable assets in this state, in lieu of these
1414	fingerprint requirements, the department shall require the
1415	prescription department manager or consultant pharmacist of
1416	record who will be directly involved in the management and
1417	operation of the pharmacy to submit a set of fingerprints.
1418	2.  A representative of a corporation described in
1419	subparagraph 1. satisfies the requirement to submit a set of his
1420	or her fingerprints if the fingerprints are on file with the
1421	department or the Agency for Health Care Administration, meet
1422	the fingerprint specifications for submission by the Department
1423	of Law Enforcement, and are available to the department.
1424	(b)  The department shall submit the fingerprints provided
1425	by the applicant to the Department of Law Enforcement for a
1426	state criminal history records check. The Department of Law
1427	Enforcement shall forward the fingerprints to the Federal Bureau
1428	of Investigation for a national criminal history records check.
1429	(c)  In addition to those documents required by the
1430	department or board, each applicant with any financial or
1431	ownership interest greater than 5 percent in the subject of the
1432	application must submit a signed affidavit disclosing any
1433	financial or ownership interest greater than 5 percent in any
1434	pharmacy permitted in the past 5 years, which pharmacy has
1435	closed voluntarily or involuntarily, has filed a voluntary
1436	relinquishment of its permit, has had its permit suspended or
1437	revoked, or has had an injunction issued against it by a
1438	regulatory agency. The affidavit must disclose the reason such
1439	entity was closed, whether voluntary or involuntary.
1440	(4)  An application for a pharmacy permit must include the
1441	applicant's written policies and procedures for preventing
1442	controlled substance dispensing based on fraudulent
1443	representations or invalid practitioner-patient relationships.
1444	The board must review the policies and procedures and may deny a
1445	permit if the policies and procedures are insufficient to
1446	reasonably prevent such dispensing. The department may phase in
1447	the submission and review of policies and procedures over one
1448	18-month period beginning July 1, 2011.
1449	(5)(4)  The department or board shall deny an application
1450	for a pharmacy permit if the applicant or an affiliated person,
1451	partner, officer, director, or prescription department manager
1452	or consultant pharmacist of record of the applicant has:
1453	(a)  Has obtained a permit by misrepresentation or fraud.;
1454	(b)  Has attempted to procure, or has procured, a permit
1455	for any other person by making, or causing to be made, any false
1456	representation.;
1457	(c)  Has been convicted of, or entered a plea of guilty or
1458	nolo contendere to, regardless of adjudication, a crime in any
1459	jurisdiction which relates to the practice of, or the ability to
1460	practice, the profession of pharmacy.;
1461	(d)  Has been convicted of, or entered a plea of guilty or
1462	nolo contendere to, regardless of adjudication, a crime in any
1463	jurisdiction which relates to health care fraud.;
1464	(e)  Has been convicted of, or entered a plea of guilty or
1465	nolo contendere to, regardless of adjudication, a felony under
1466	chapter 409, chapter 817, or chapter 893, or a similar felony
1467	offense committed in another state or jurisdiction, since July
1468	1, 2009. Been terminated for cause, pursuant to the appeals
1469	procedures established by the state or Federal Government, from
1470	any state Medicaid program or the federal Medicare program,
1471	unless the applicant has been in good standing with a state
1472	Medicaid program or the federal Medicare program for the most
1473	recent 5 years and the termination occurred at least 20 years
1474	ago; or
1475	(f)  Has been convicted of, or entered a plea of guilty or
1476	nolo contendere to, regardless of adjudication, a felony under
1477	21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
1478	2009.
1479	(g)  Has been terminated for cause from the Florida
1480	Medicaid program pursuant to s. 409.913, unless the applicant
1481	has been in good standing with the Florida Medicaid program for
1482	the most recent 5-year period.
1483	(h)  Has been terminated for cause, pursuant to the appeals
1484	procedures established by the state, from any other state
1485	Medicaid program, unless the applicant has been in good standing
1486	with a state Medicaid program for the most recent 5-year period
1487	and the termination occurred at least 20 years before the date
1488	of the application.
1489	(i)  Is currently listed on the United States Department of
1490	Health and Human Services Office of Inspector General's List of
1491	Excluded Individuals and Entities.
1492	(j)(f)  Has dispensed any medicinal drug based upon a
1493	communication that purports to be a prescription as defined by
1494	s. 465.003(14) or s. 893.02 when the pharmacist knows or has
1495	reason to believe that the purported prescription is not based
1496	upon a valid practitioner-patient relationship that includes a
1497	documented patient evaluation, including history and a physical
1498	examination adequate to establish the diagnosis for which any
1499	drug is prescribed and any other requirement established by
1500	board rule under chapter 458, chapter 459, chapter 461, chapter
1501	463, chapter 464, or chapter 466.
1502	(k)  Has violated or failed to comply with any provision of
1503	this chapter; chapter 499, the Florida Drug and Cosmetic Act;
1504	chapter 893; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
1505	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
1506	Abuse Prevention and Control Act; or any rules or regulations
1507	promulgated thereunder.
1508
1509	For felonies in which the defendant entered a plea of guilty or
1510	nolo contendere in an agreement with the court to enter a
1511	pretrial intervention or drug diversion program, the department
1512	may not approve or deny the application for a renewal of a
1513	license, certificate, or registration until the final resolution
1514	of the case.
1515	(6)(5)  After the application has been filed with the board
1516	and the permit fee provided in this section has been received,
1517	the board shall cause the application to be fully investigated,
1518	both as to the qualifications of the applicant and the
1519	prescription department manager or consultant pharmacist
1520	designated to be in charge and as to the premises and location
1521	described in the application.
1522	(7)(6)  The Board of Pharmacy shall have the authority to
1523	determine whether a bona fide transfer of ownership is present
1524	and that the sale of a pharmacy is not being accomplished for
1525	the purpose of avoiding an administrative prosecution.
1526	(8)(7)  Upon the completion of the investigation of an
1527	application, the board shall approve or deny disapprove the
1528	application. If approved, the permit shall be issued by the
1529	department.
1530	(9)(8)  A permittee must notify the department, on a form
1531	approved by the board, within 10 days after any change in
1532	prescription department manager or consultant pharmacist of
1533	record. Permits issued by the department are not transferable.
1534	(10)  A permittee must notify the department of the
1535	identity of the prescription department manager within 10 days
1536	after employment. The prescription department manager must
1537	comply with the following requirements:
1538	(a)  The prescription department manager of a permittee
1539	must obtain and maintain all drug records required by any state
1540	or federal law to be obtained by a pharmacy, including, but not
1541	limited to, records required by or under this chapter, chapter
1542	499, or chapter 893. The prescription department manager must
1543	ensure the permittee's compliance with all rules adopted under
1544	those chapters as they relate to the practice of the profession
1545	of pharmacy and the sale of prescription drugs.
1546	(b)  The prescription department manager must ensure the
1547	security of the prescription department. The prescription
1548	department manager must notify the board of any theft or
1549	significant loss of any controlled substances within 1 business
1550	day after discovery of the theft or loss.
1551	(c)  A registered pharmacist may not serve as the
1552	prescription department manager in more than one location unless
1553	approved by the board.
1554	(11)  The board shall adopt rules that require the keeping
1555	of such records of prescription drugs as are necessary for the
1556	protection of public health, safety, and welfare.
1557	(a)  All required records documenting prescription drug
1558	distributions shall be readily available or immediately
1559	retrievable during an inspection by the department.
1560	(b)  The records must be maintained for 4 years after the
1561	creation or receipt of the record, whichever is later.
1562	(12)  Permits issued by the department are not
1563	transferable.
1564	(13)(9)  The board shall set the fees for the following:
1565	(a)  Initial permit fee not to exceed $250.
1566	(b)  Biennial permit renewal not to exceed $250.
1567	(c)  Delinquent fee not to exceed $100.
1568	(d)  Change of location fee not to exceed $250 $100.
1569	Section 15.  Paragraph (b) of subsection (1) of section
1570	465.0276, Florida Statutes, is amended to read:
1571	465.0276  Dispensing practitioner.-
1572	(1)
1573	(b)  A practitioner registered under this section may not
1574	dispense a controlled substance listed in Schedule II or
1575	Schedule III as provided in s. 893.03 A practitioner registered
1576	under this section may not dispense more than a 72-hour supply
1577	of a controlled substance listed in Schedule II, Schedule III,
1578	Schedule IV, or Schedule V of s. 893.03 for any patient who pays
1579	for the medication by cash, check, or credit card in a clinic
1580	registered under s. 458.3265 or s. 459.0137. A practitioner who
1581	violates this paragraph commits a felony of the third degree,
1582	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1583	This paragraph does not apply to:
1584	1.  A practitioner who dispenses medication to a workers'
1585	compensation patient pursuant to chapter 440.
1586	2.  A practitioner who dispenses medication to an insured
1587	patient who pays by cash, check, or credit card to cover any
1588	applicable copayment or deductible.
1589	1.3.  The dispensing of complimentary packages of medicinal
1590	drugs to the practitioner's own patients in the regular course
1591	of her or his practice without the payment of a fee or
1592	remuneration of any kind, whether direct or indirect, as
1593	provided in subsection (5).
1594	2.  The dispensing of controlled substances in the health
1595	care system of the Department of Corrections.
1596	3.  Controlled substances dispensed within 7 days after
1597	surgery for which general anesthesia was used.
1598	Section 16.  Subsections (16) and (17) are added to section
1599	499.0051, Florida Statutes, to read:
1600	499.0051  Criminal acts.-
1601	(16)  FALSE REPORT.-Any person who submits a report
1602	required by s. 499.0121(14) knowing that such report contains a
1603	false statement commits a felony of the third degree, punishable
1604	as provided in s. 775.082, s. 775.083, or s. 775.084.
1605	(17)  CONTROLLED SUBSTANCE DISTRIBUTION.-Any wholesale
1606	distributor who distributes controlled substances in violation
1607	of s. 499.0121(14) commits a felony of the third degree,
1608	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
1609	In addition to any other fine that may be imposed, a wholesale
1610	distributor convicted of such a violation may be sentenced to
1611	pay a fine that does not exceed three times the gross monetary
1612	value gained from such violation, plus court costs and the
1613	reasonable costs of investigation and prosecution.
1614	Section 17.  Paragraph (o) is added to subsection (8) of
1615	section 499.012, Florida Statutes, to read:
1616	499.012  Permit application requirements.-
1617	(8)  An application for a permit or to renew a permit for a
1618	prescription drug wholesale distributor or an out-of-state
1619	prescription drug wholesale distributor submitted to the
1620	department must include:
1621	(o)  Documentation of the credentialing policies and
1622	procedures required by s. 499.0121(14).
1623	Section 18.  Subsections (14) and (15) are added to section
1624	499.0121, Florida Statutes, to read:
1625	499.0121  Storage and handling of prescription drugs;
1626	recordkeeping.-The department shall adopt rules to implement
1627	this section as necessary to protect the public health, safety,
1628	and welfare. Such rules shall include, but not be limited to,
1629	requirements for the storage and handling of prescription drugs
1630	and for the establishment and maintenance of prescription drug
1631	distribution records.
1632	(14)  DISTRIBUTION REPORTING.-Each wholesale distributor
1633	shall submit a report to the department of its receipts and
1634	distributions of controlled substances listed in Schedule II,
1635	Schedule III, Schedule IV, or Schedule V as provided in s.
1636	893.03. Wholesale distributor facilities located within this
1637	state shall report all transactions involving controlled
1638	substances, and wholesale distributor facilities located outside
1639	this state shall report all distributions to entities located in
1640	this state. If the wholesale distributor did not have any
1641	controlled substance distributions for the month, a report shall
1642	be sent indicating that no distributions occurred in the period.
1643	The report shall be submitted monthly by the 20th of the next
1644	month, in the electronic format used for controlled substance
1645	reporting to the Automation of Reports and Consolidated Orders
1646	System division of the federal Drug Enforcement Administration.
1647	Submission of electronic data must be made in a secured web
1648	environment that allows for manual or automated transmission.
1649	Upon successful transmission, an acknowledgement page must be
1650	displayed to confirm receipt. The report must contain the
1651	following information:
1652	(a)  The federal Drug Enforcement Administration
1653	registration number of the wholesale distributing location.
1654	(b)  The federal Drug Enforcement Administration
1655	registration number of the entity to which the drugs are
1656	distributed or from which the drugs are received.
1657	(c)  The transaction code that indicates the type of
1658	transaction.
1659	(d)  The National Drug Code identifier of the product and
1660	the quantity distributed or received.
1661	(e)  The Drug Enforcement Administration Form 222 number or
1662	Controlled Substance Ordering System Identifier on all schedule
1663	II transactions.
1664	(f)  The date of the transaction.
1665
1666	The department must share the reported data with the Department
1667	of Law Enforcement and local law enforcement agencies upon
1668	request and must monitor purchasing to identify purchasing
1669	levels that are inconsistent with the purchasing entity's
1670	clinical needs. The Department of Law Enforcement shall
1671	investigate purchases at levels that are inconsistent with the
1672	purchasing entity's clinical needs to determine whether
1673	violations of chapter 893 have occurred.
1674	(15)  DUE DILIGENCE OF PURCHASERS.-
1675	(a)  Each wholesale distributor must establish and maintain
1676	policies and procedures to credential physicians licensed under
1677	chapter 458, chapter 459, chapter 459, chapter 461, or chapter
1678	466 and pharmacies that would purchase or otherwise receive from
1679	the wholesale distributor controlled substances listed in
1680	Schedule II or Schedule III as provided in s. 893.03. The
1681	wholesale distributor shall maintain records of such
1682	credentialing and make the records available to the department
1683	upon request. Such credentialing must, at a minimum, include:
1684	1.  A determination of the clinical nature of the receiving
1685	entity, including any specialty practice area.
1686	2.  A review of the receiving entity's history of Schedule
1687	II and Schedule III controlled substance purchasing from the
1688	wholesale distributor.
1689	3.  A determination that the receiving entity's Schedule II
1690	and Schedule III controlled substance purchasing history, if
1691	any, is consistent with and reasonable for that entity's
1692	clinical business needs.
1693	4.  Conduct of a level 2 background screening pursuant to
1694	chapter 435 through the department on any person who owns a
1695	controlling interest in or, directly or indirectly, manages,
1696	oversees, or controls the operation of the entity, including
1697	officers and members of the board of directors of an entity that
1698	is a corporation. This requirement does not apply to publicly
1699	traded entities or entities having more than $100 million of
1700	business taxable assets in this state. For such entities,
1701	wholesale distributors must require current documentation of all
1702	state and federal licenses and permits.
1703	(b)  A wholesale distributor must take reasonable measures
1704	to identify its customers, understand the normal and expected
1705	transactions conducted by those customers, and identify those
1706	transactions that are suspicious in nature. A wholesale
1707	distributor must establish internal policies and procedures for
1708	identifying suspicious orders and preventing suspicious
1709	transactions. A wholesale distributor must assess orders for
1710	greater than 5,000 unit doses of any one controlled substance in
1711	any one month to determine whether the purchase is reasonable.
1712	In making such assessments, a wholesale distributor may consider
1713	the purchasing entity's clinical business needs, location, and
1714	population served, in addition to other factors established in
1715	the distributor's policies and procedures. A wholesale
1716	distributor must report to the department any regulated
1717	transaction involving an extraordinary quantity of a listed
1718	chemical, an uncommon method of payment or delivery, or any
1719	other circumstance that the regulated person believes may
1720	indicate that the listed chemical will be used in violation of
1721	the law. For each reported transaction that is completed, the
1722	wholesale distributor must document the basis for determining
1723	the transaction was reasonable.
1724	(c)  A wholesale distributor may not distribute controlled
1725	substances to an entity if any criminal history record check for
1726	any person associated with that entity shows the person has been
1727	convicted of, or entered a plea of guilty or nolo contendere to,
1728	regardless of adjudication, a crime in any jurisdiction related
1729	to controlled substances, the practice of pharmacy, or the
1730	dispensing of medicinal drugs.
1731	(d)  A wholesale distributor may not distribute more than
1732	5,000 unit doses each of hydrocodone, morphine, oxycodone,
1733	methadone, or any one benzodiazepine, or any derivative,
1734	precursor, or component of these drugs to a retail pharmacy in
1735	any given month. The department shall assess national data from
1736	the Automation of Reports and Consolidated Orders System of the
1737	federal Drug Enforcement Administration, excluding Florida data,
1738	and identify the national average of grams of hydrocodone,
1739	morphine, oxycodone, and methadone distributed per pharmacy
1740	registrant per month in the most recent year for which data is
1741	available. The department shall report the average for each of
1742	these drugs to the Governor, the President of the Senate, and
1743	the Speaker of the House of Representatives by January 1, 2012.
1744	The department shall assess the data reported pursuant to
1745	subsection (14) and identify the statewide average of grams of
1746	each benzodiazapine distributed per community pharmacy per
1747	month. The department shall report the average for each
1748	benzodiazapine to the Governor, the President of the Senate, and
1749	the Speaker of the House of Representatives by January 1, 2012.
1750	Section 19.  Paragraphs (o) and (p) are added to subsection
1751	(1) of section 499.05, Florida Statutes, to read:
1752	499.05  Rules.-
1753	(1)  The department shall adopt rules to implement and
1754	enforce this part with respect to:
1755	(o)  Wholesale distributor reporting requirements of s.
1756	499.0121(14).
1757	(p)  Wholesale distributor credentialing and distribution
1758	requirements of s. 499.0121(15).
1759	Section 20.  Subsections (8) and (9) are added to section
1760	499.067, Florida Statutes, to read:
1761	499.067  Denial, suspension, or revocation of permit,
1762	certification, or registration.-
1763	(8)  The department may deny, suspend, or revoke a permit
1764	if it finds the permittee has not complied with the
1765	credentialing requirements of s. 499.0121(15).
1766	(9)  The department may deny, suspend, or revoke a permit
1767	if it finds the permittee has not complied with the reporting
1768	requirements of, or knowingly made a false statement in a report
1769	required by, s. 499.0121(14).
1770	Section 21.  Paragraph (f) is added to subsection (3) of
1771	section 810.02, Florida Statutes, to read:
1772	810.02  Burglary.-
1773	(3)  Burglary is a felony of the second degree, punishable
1774	as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
1775	course of committing the offense, the offender does not make an
1776	assault or battery and is not and does not become armed with a
1777	dangerous weapon or explosive, and the offender enters or
1778	remains in a:
1779	(f)  Structure or conveyance when the offense intended to
1780	be committed therein is theft of a controlled substance as
1781	defined in s. 893.02. Notwithstanding any other law, separate
1782	judgments and sentences for burglary with the intent to commit
1783	theft of a controlled substance under this paragraph and for any
1784	applicable possession of controlled substance offense under s.
1785	893.13 or trafficking in controlled substance offense under s.
1786	893.135 may be imposed when all such offenses involve the same
1787	amount or amounts of a controlled substance.
1788
1789	However, if the burglary is committed within a county that is
1790	subject to a state of emergency declared by the Governor under
1791	chapter 252 after the declaration of emergency is made and the
1792	perpetration of the burglary is facilitated by conditions
1793	arising from the emergency, the burglary is a felony of the
1794	first degree, punishable as provided in s. 775.082, s. 775.083,
1795	or s. 775.084. As used in this subsection, the term "conditions
1796	arising from the emergency" means civil unrest, power outages,
1797	curfews, voluntary or mandatory evacuations, or a reduction in
1798	the presence of or response time for first responders or
1799	homeland security personnel. A person arrested for committing a
1800	burglary within a county that is subject to such a state of
1801	emergency may not be released until the person appears before a
1802	committing magistrate at a first appearance hearing. For
1803	purposes of sentencing under chapter 921, a felony offense that
1804	is reclassified under this subsection is ranked one level above
1805	the ranking under s. 921.0022 or s. 921.0023 of the offense
1806	committed.
1807	Section 22.  Paragraph (c) of subsection (2) of section
1808	812.014, Florida Statutes, is amended to read:
1809	812.014  Theft.-
1810	(2)
1811	(c)  It is grand theft of the third degree and a felony of
1812	the third degree, punishable as provided in s. 775.082, s.
1813	775.083, or s. 775.084, if the property stolen is:
1814	1.  Valued at $300 or more, but less than $5,000.
1815	2.  Valued at $5,000 or more, but less than $10,000.
1816	3.  Valued at $10,000 or more, but less than $20,000.
1817	4.  A will, codicil, or other testamentary instrument.
1818	5.  A firearm.
1819	6.  A motor vehicle, except as provided in paragraph (a).
1820	7.  Any commercially farmed animal, including any animal of
1821	the equine, bovine, or swine class, or other grazing animal, and
1822	including aquaculture species raised at a certified aquaculture
1823	facility. If the property stolen is aquaculture species raised
1824	at a certified aquaculture facility, then a $10,000 fine shall
1825	be imposed.
1826	8.  Any fire extinguisher.
1827	9.  Any amount of citrus fruit consisting of 2,000 or more
1828	individual pieces of fruit.
1829	10.  Taken from a designated construction site identified
1830	by the posting of a sign as provided for in s. 810.09(2)(d).
1831	11.  Any stop sign.
1832	12.  Anhydrous ammonia.
1833	13.  Any amount of a controlled substance as defined in s.
1834	893.02. Notwithstanding any other law, separate judgments and
1835	sentences for theft of a controlled substance under this
1836	subparagraph and for any applicable possession of controlled
1837	substance offense under s. 893.13 or trafficking in controlled
1838	substance offense under s. 893.135 may be imposed when all such
1839	offenses involve the same amount or amounts of a controlled
1840	substance.
1841
1842	However, if the property is stolen within a county that is
1843	subject to a state of emergency declared by the Governor under
1844	chapter 252, the property is stolen after the declaration of
1845	emergency is made, and the perpetration of the theft is
1846	facilitated by conditions arising from the emergency, the
1847	offender commits a felony of the second degree, punishable as
1848	provided in s. 775.082, s. 775.083, or s. 775.084, if the
1849	property is valued at $5,000 or more, but less than $10,000, as
1850	provided under subparagraph 2., or if the property is valued at
1851	$10,000 or more, but less than $20,000, as provided under
1852	subparagraph 3. As used in this paragraph, the term "conditions
1853	arising from the emergency" means civil unrest, power outages,
1854	curfews, voluntary or mandatory evacuations, or a reduction in
1855	the presence of or the response time for first responders or
1856	homeland security personnel. For purposes of sentencing under
1857	chapter 921, a felony offense that is reclassified under this
1858	paragraph is ranked one level above the ranking under s.
1859	921.0022 or s. 921.0023 of the offense committed.
1860	Section 23.  Section 893.055, Florida Statutes, is amended
1861	to read:
1862	893.055  Prescription drug monitoring program.-
1863	(1)  As used in this section, the term:
1864	(a)  "Patient advisory report" or "advisory report" means
1865	information provided by the department in writing, or as
1866	determined by the department, to a prescriber, dispenser,
1867	pharmacy, or patient concerning the dispensing of controlled
1868	substances. All advisory reports are for informational purposes
1869	only and impose no obligations of any nature or any legal duty
1870	on a prescriber, dispenser, pharmacy, or patient. The patient
1871	advisory report shall be provided in accordance with s.
1872	893.13(7)(a)8. The advisory reports issued by the department are
1873	not subject to discovery or introduction into evidence in any
1874	civil or administrative action against a prescriber, dispenser,
1875	pharmacy, or patient arising out of matters that are the subject
1876	of the report; and a person who participates in preparing,
1877	reviewing, issuing, or any other activity related to an advisory
1878	report may not be permitted or required to testify in any such
1879	civil action as to any findings, recommendations, evaluations,
1880	opinions, or other actions taken in connection with preparing,
1881	reviewing, or issuing such a report.
1882	(b)  "Controlled substance" means a controlled substance
1883	listed in Schedule II, Schedule III, or Schedule IV in s.
1884	893.03.
1885	(c)  "Dispenser" means a pharmacy, dispensing pharmacist,
1886	or dispensing health care practitioner.
1887	(d)  "Health care practitioner" or "practitioner" means any
1888	practitioner who is subject to licensure or regulation by the
1889	department under chapter 458, chapter 459, chapter 461, chapter
1890	462, chapter 464, chapter 465, or chapter 466.
1891	(e)  "Health care regulatory board" means any board for a
1892	practitioner or health care practitioner who is licensed or
1893	regulated by the department.
1894	(f)  "Pharmacy" means any pharmacy that is subject to
1895	licensure or regulation by the department under chapter 465 and
1896	that dispenses or delivers a controlled substance to an
1897	individual or address in this state.
1898	(g)  "Prescriber" means a prescribing physician,
1899	prescribing practitioner, or other prescribing health care
1900	practitioner.
1901	(h)  "Active investigation" means an investigation that is
1902	being conducted with a reasonable, good faith belief that it
1903	could lead to the filing of administrative, civil, or criminal
1904	proceedings, or that is ongoing and continuing and for which
1905	there is a reasonable, good faith anticipation of securing an
1906	arrest or prosecution in the foreseeable future.
1907	(i)  "Law enforcement agency" means the Department of Law
1908	Enforcement, a Florida sheriff's department, a Florida police
1909	department, or a law enforcement agency of the Federal
1910	Government which enforces the laws of this state or the United
1911	States relating to controlled substances, and which its agents
1912	and officers are empowered by law to conduct criminal
1913	investigations and make arrests.
1914	(j)  "Program manager" means an employee of or a person
1915	contracted by the Department of Health who is designated to
1916	ensure the integrity of the prescription drug monitoring program
1917	in accordance with the requirements established in paragraphs
1918	(2)(a) and (b).
1919	(2)(a)  By December 1, 2010, The department shall design
1920	and establish a comprehensive electronic database system that
1921	has controlled substance prescriptions provided to it and that
1922	provides prescription information to a patient's health care
1923	practitioner and pharmacist who inform the department that they
1924	wish the patient advisory report provided to them. Otherwise,
1925	the patient advisory report will not be sent to the
1926	practitioner, pharmacy, or pharmacist. The system shall be
1927	designed to provide information regarding dispensed
1928	prescriptions of controlled substances and shall not infringe
1929	upon the legitimate prescribing or dispensing of a controlled
1930	substance by a prescriber or dispenser acting in good faith and
1931	in the course of professional practice. The system shall be
1932	consistent with standards of the American Society for Automation
1933	in Pharmacy (ASAP). The electronic system shall also comply with
1934	the Health Insurance Portability and Accountability Act (HIPAA)
1935	as it pertains to protected health information (PHI), electronic
1936	protected health information (EPHI), and all other relevant
1937	state and federal privacy and security laws and regulations. The
1938	department shall establish policies and procedures as
1939	appropriate regarding the reporting, accessing the database,
1940	evaluation, management, development, implementation, operation,
1941	storage, and security of information within the system. The
1942	reporting of prescribed controlled substances shall include a
1943	dispensing transaction with a dispenser pursuant to chapter 465
1944	or through a dispensing transaction to an individual or address
1945	in this state with a pharmacy that is not located in this state
1946	but that is otherwise subject to the jurisdiction of this state
1947	as to that dispensing transaction. The reporting of patient
1948	advisory reports refers only to reports to patients, pharmacies,
1949	and practitioners. Separate reports that contain patient
1950	prescription history information and that are not patient
1951	advisory reports are provided to persons and entities as
1952	authorized in paragraphs (7)(b) and (c) and s. 893.0551.
1953	(b)  The department, when the direct support organization
1954	receives at least $20,000 in nonstate moneys or the state
1955	receives at least $20,000 in federal grants for the prescription
1956	drug monitoring program, and in consultation with the Office of
1957	Drug Control, shall adopt rules as necessary concerning the
1958	reporting, accessing the database, evaluation, management,
1959	development, implementation, operation, security, and storage of
1960	information within the system, including rules for when patient
1961	advisory reports are provided to pharmacies and prescribers. The
1962	patient advisory report shall be provided in accordance with s.
1963	893.13(7)(a)8. The department shall work with the professional
1964	health care licensure boards, such as the Board of Medicine, the
1965	Board of Osteopathic Medicine, and the Board of Pharmacy; other
1966	appropriate organizations, such as the Florida Pharmacy
1967	Association, the Office of Drug Control, the Florida Medical
1968	Association, the Florida Retail Federation, and the Florida
1969	Osteopathic Medical Association, including those relating to
1970	pain management; and the Attorney General, the Department of Law
1971	Enforcement, and the Agency for Health Care Administration to
1972	develop rules appropriate for the prescription drug monitoring
1973	program.
1974	(c)  All dispensers and prescribers subject to these
1975	reporting requirements shall be notified by the department of
1976	the implementation date for such reporting requirements.
1977	(d)  The program manager shall work with professional
1978	health care licensure boards and the stakeholders listed in
1979	paragraph (b) to develop rules appropriate for identifying
1980	indicators of controlled substance abuse.
1981	(3)  The pharmacy dispensing the controlled substance and
1982	each prescriber who directly dispenses a controlled substance
1983	shall submit to the electronic system, by a procedure and in a
1984	format established by the department and consistent with an
1985	ASAP-approved format, the following information for inclusion in
1986	the database:
1987	(a)  The name of the prescribing practitioner, the
1988	practitioner's federal Drug Enforcement Administration
1989	registration number, the practitioner's National Provider
1990	Identification (NPI) or other appropriate identifier, and the
1991	date of the prescription.
1992	(b)  The date the prescription was filled and the method of
1993	payment, such as cash by an individual, insurance coverage
1994	through a third party, or Medicaid payment. This paragraph does
1995	not authorize the department to include individual credit card
1996	numbers or other account numbers in the database.
1997	(c)  The full name, address, and date of birth of the
1998	person for whom the prescription was written.
1999	(d)  The name, national drug code, quantity, and strength
2000	of the controlled substance dispensed.
2001	(e)  The full name, federal Drug Enforcement Administration
2002	registration number, and address of the pharmacy or other
2003	location from which the controlled substance was dispensed. If
2004	the controlled substance was dispensed by a practitioner other
2005	than a pharmacist, the practitioner's full name, federal Drug
2006	Enforcement Administration registration number, and address.
2007	(f)  The name of the pharmacy or practitioner, other than a
2008	pharmacist, dispensing the controlled substance and the
2009	practitioner's National Provider Identification (NPI).
2010	(g)  Other appropriate identifying information as
2011	determined by department rule.
2012	(4)  Each time a controlled substance is dispensed to an
2013	individual, the controlled substance shall be reported to the
2014	department through the system as soon thereafter as possible,
2015	but not more than 7 15 days after the date the controlled
2016	substance is dispensed unless an extension is approved by the
2017	department for cause as determined by rule. A dispenser must
2018	meet the reporting requirements of this section by providing the
2019	required information concerning each controlled substance that
2020	it dispensed in a department-approved, secure methodology and
2021	format. Such approved formats may include, but are not limited
2022	to, submission via the Internet, on a disc, or by use of regular
2023	mail.
2024	(5)  When the following acts of dispensing or administering
2025	occur, the following are exempt from reporting under this
2026	section for that specific act of dispensing or administration:
2027	(a)  A health care practitioner when administering a
2028	controlled substance directly to a patient if the amount of the
2029	controlled substance is adequate to treat the patient during
2030	that particular treatment session.
2031	(b)  A pharmacist or health care practitioner when
2032	administering a controlled substance to a patient or resident
2033	receiving care as a patient at a hospital, nursing home,
2034	ambulatory surgical center, hospice, or intermediate care
2035	facility for the developmentally disabled which is licensed in
2036	this state.
2037	(c)  A practitioner when administering or dispensing a
2038	controlled substance in the health care system of the Department
2039	of Corrections.
2040	(d)  A practitioner when administering a controlled
2041	substance in the emergency room of a licensed hospital.
2042	(e)  A health care practitioner when administering or
2043	dispensing a controlled substance to a person under the age of
2044	16.
2045	(f)  A pharmacist or a dispensing practitioner when
2046	dispensing a one-time, 72-hour emergency resupply of a
2047	controlled substance to a patient.
2048	(6)  The department may establish when to suspend and when
2049	to resume reporting information during a state-declared or
2050	nationally declared disaster.
2051	(7)(a)  A practitioner or pharmacist who dispenses a
2052	controlled substance must submit the information required by
2053	this section in an electronic or other method in an ASAP format
2054	approved by rule of the department unless otherwise provided in
2055	this section. The cost to the dispenser in submitting the
2056	information required by this section may not be material or
2057	extraordinary. Costs not considered to be material or
2058	extraordinary include, but are not limited to, regular postage,
2059	electronic media, regular electronic mail, and facsimile
2060	charges.
2061	(b)  A pharmacy, prescriber, or dispenser shall have access
2062	to information in the prescription drug monitoring program's
2063	database which relates to a patient of that pharmacy,
2064	prescriber, or dispenser in a manner established by the
2065	department as needed for the purpose of reviewing the patient's
2066	controlled substance prescription history. Other access to the
2067	program's database shall be limited to the program's manager and
2068	to the designated program and support staff, who may act only at
2069	the direction of the program manager or, in the absence of the
2070	program manager, as authorized. Access by the program manager or
2071	such designated staff is for prescription drug program
2072	management only or for management of the program's database and
2073	its system in support of the requirements of this section and in
2074	furtherance of the prescription drug monitoring program.
2075	Confidential and exempt information in the database shall be
2076	released only as provided in paragraph (c) and s. 893.0551.
2077	(c)  The following entities shall not be allowed direct
2078	access to information in the prescription drug monitoring
2079	program database but may request from the program manager and,
2080	when authorized by the program manager, the program manager's
2081	program and support staff, information that is confidential and
2082	exempt under s. 893.0551. Prior to release, the request shall be
2083	verified as authentic and authorized with the requesting
2084	organization by the program manager, the program manager's
2085	program and support staff, or as determined in rules by the
2086	department as being authentic and as having been authorized by
2087	the requesting entity:
2088	1.  The department or its relevant health care regulatory
2089	boards responsible for the licensure, regulation, or discipline
2090	of practitioners, pharmacists, or other persons who are
2091	authorized to prescribe, administer, or dispense controlled
2092	substances and who are involved in a specific controlled
2093	substance investigation involving a designated person for one or
2094	more prescribed controlled substances.
2095	2.  The Attorney General for Medicaid fraud cases involving
2096	prescribed controlled substances.
2097	3.  A law enforcement agency during active investigations
2098	regarding potential criminal activity, fraud, or theft regarding
2099	prescribed controlled substances.
2100	4.  A patient or the legal guardian or designated health
2101	care surrogate of an incapacitated patient as described in s.
2102	893.0551 who, for the purpose of verifying the accuracy of the
2103	database information, submits a written and notarized request
2104	that includes the patient's full name, address, and date of
2105	birth, and includes the same information if the legal guardian
2106	or health care surrogate submits the request. The request shall
2107	be validated by the department to verify the identity of the
2108	patient and the legal guardian or health care surrogate, if the
2109	patient's legal guardian or health care surrogate is the
2110	requestor. Such verification is also required for any request to
2111	change a patient's prescription history or other information
2112	related to his or her information in the electronic database.
2113
2114	Information in the database for the electronic prescription drug
2115	monitoring system is not discoverable or admissible in any civil
2116	or administrative action, except in an investigation and
2117	disciplinary proceeding by the department or the appropriate
2118	regulatory board.
2119	(d)  Department staff are The following entities shall not
2120	be allowed direct access to information in the prescription drug
2121	monitoring program database but may request from the program
2122	manager and, when authorized by the program manager, the program
2123	manager's program and support staff, information that contains
2124	no identifying information of any patient, physician, health
2125	care practitioner, prescriber, or dispenser and that is not
2126	confidential and exempt,:
2127	1.  Department staff for the purpose of calculating
2128	performance measures pursuant to subsection (8).
2129	2.  The Program Implementation and Oversight Task Force for
2130	its reporting to the Governor, the President of the Senate, and
2131	the Speaker of the House of Representatives regarding the
2132	prescription drug monitoring program. This subparagraph expires
2133	July 1, 2012.
2134	(e)  All transmissions of data required by this section
2135	must comply with relevant state and federal privacy and security
2136	laws and regulations. However, any authorized agency or person
2137	under s. 893.0551 receiving such information as allowed by s.
2138	893.0551 may maintain the information received for up to 24
2139	months before purging it from his or her records or maintain it
2140	for longer than 24 months if the information is pertinent to
2141	ongoing health care or an active law enforcement investigation
2142	or prosecution.
2143	(f)  The program manager, upon determining a pattern
2144	consistent with the rules established under paragraph (2)(d) and
2145	having cause to believe a violation of s. 893.13(7)(a)8.,
2146	(8)(a), or (8)(b) has occurred, may provide relevant information
2147	to the applicable law enforcement agency.
2148	(8)  To assist in fulfilling program responsibilities,
2149	performance measures shall be reported annually to the Governor,
2150	the President of the Senate, and the Speaker of the House of
2151	Representatives by the department each December 1, beginning in
2152	2011. Data that does not contain patient, physician, health care
2153	practitioner, prescriber, or dispenser identifying information
2154	may be requested during the year by department employees so that
2155	the department may undertake public health care and safety
2156	initiatives that take advantage of observed trends. Performance
2157	measures may include, but are not limited to, efforts to achieve
2158	the following outcomes:
2159	(a)  Reduction of the rate of inappropriate use of
2160	prescription drugs through department education and safety
2161	efforts.
2162	(b)  Reduction of the quantity of pharmaceutical controlled
2163	substances obtained by individuals attempting to engage in fraud
2164	and deceit.
2165	(c)  Increased coordination among partners participating in
2166	the prescription drug monitoring program.
2167	(d)  Involvement of stakeholders in achieving improved
2168	patient health care and safety and reduction of prescription
2169	drug abuse and prescription drug diversion.
2170	(9)  Any person who willfully and knowingly fails to report
2171	the dispensing of a controlled substance as required by this
2172	section commits a misdemeanor of the first degree, punishable as
2173	provided in s. 775.082 or s. 775.083.
2174	(10)  All costs incurred by the department in administering
2175	the prescription drug monitoring program shall be funded through
2176	federal grants or private funding applied for or received by the
2177	state. The department may not commit funds for the monitoring
2178	program without ensuring funding is available. The prescription
2179	drug monitoring program and the implementation thereof are
2180	contingent upon receipt of the nonstate funding. The department
2181	and state government shall cooperate with the direct-support
2182	organization established pursuant to subsection (11) in seeking
2183	federal grant funds, other nonstate grant funds, gifts,
2184	donations, or other private moneys for the department so long as
2185	the costs of doing so are not considered material. Nonmaterial
2186	costs for this purpose include, but are not limited to, the
2187	costs of mailing and personnel assigned to research or apply for
2188	a grant. Notwithstanding the exemptions to competitive-
2189	solicitation requirements under s. 287.057(3)(f), the department
2190	shall comply with the competitive-solicitation requirements
2191	under s. 287.057 for the procurement of any goods or services
2192	required by this section. Funds provided, directly or
2193	indirectly, by prescription drug manufacturers may not be used
2194	to implement the program.
2195	(11)  The Office of Drug Control, in coordination with the
2196	department, may establish a direct-support organization that has
2197	a board consisting of at least five members to provide
2198	assistance, funding, and promotional support for the activities
2199	authorized for the prescription drug monitoring program.
2200	(a)  As used in this subsection, the term "direct-support
2201	organization" means an organization that is:
2202	1.  A Florida corporation not for profit incorporated under
2203	chapter 617, exempted from filing fees, and approved by the
2204	Department of State.
2205	2.  Organized and operated to conduct programs and
2206	activities; raise funds; request and receive grants, gifts, and
2207	bequests of money; acquire, receive, hold, and invest, in its
2208	own name, securities, funds, objects of value, or other
2209	property, either real or personal; and make expenditures or
2210	provide funding to or for the direct or indirect benefit of the
2211	department in the furtherance of the prescription drug
2212	monitoring program.
2213	(b)  The direct-support organization is not considered a
2214	lobbying firm within the meaning of s. 11.045.
2215	(c)  The State Surgeon General director of the Office of
2216	Drug Control shall appoint a board of directors for the direct-
2217	support organization. The director may designate employees of
2218	the Office of Drug Control, state employees other than state
2219	employees from the department, and any other nonstate employees
2220	as appropriate, to serve on the board. Members of the board
2221	shall serve at the pleasure of the director of the State Surgeon
2222	General Office of Drug Control. The State Surgeon General
2223	director shall provide guidance to members of the board to
2224	ensure that moneys received by the direct-support organization
2225	are not received from inappropriate sources. Inappropriate
2226	sources include, but are not limited to, donors, grantors,
2227	persons, or organizations that may monetarily or substantively
2228	benefit from the purchase of goods or services by the department
2229	in furtherance of the prescription drug monitoring program.
2230	(d)  The direct-support organization shall operate under
2231	written contract with the department Office of Drug Control. The
2232	contract must, at a minimum, provide for:
2233	1.  Approval of the articles of incorporation and bylaws of
2234	the direct-support organization by the department Office of Drug
2235	Control.
2236	2.  Submission of an annual budget for the approval of the
2237	department Office of Drug Control.
2238	3.  Certification by the department Office of Drug Control
2239	in consultation with the department that the direct-support
2240	organization is complying with the terms of the contract in a
2241	manner consistent with and in furtherance of the goals and
2242	purposes of the prescription drug monitoring program and in the
2243	best interests of the state. Such certification must be made
2244	annually and reported in the official minutes of a meeting of
2245	the direct-support organization.
2246	4.  The reversion, without penalty, to the Office of Drug
2247	Control, or to the state if the Office of Drug Control ceases to
2248	exist, of all moneys and property held in trust by the direct-
2249	support organization for the benefit of the prescription drug
2250	monitoring program if the direct-support organization ceases to
2251	exist or if the contract is terminated.
2252	5.  The fiscal year of the direct-support organization,
2253	which must begin July 1 of each year and end June 30 of the
2254	following year.
2255	6.  The disclosure of the material provisions of the
2256	contract to donors of gifts, contributions, or bequests,
2257	including such disclosure on all promotional and fundraising
2258	publications, and an explanation to such donors of the
2259	distinction between the department Office of Drug Control and
2260	the direct-support organization.
2261	7.  The direct-support organization's collecting,
2262	expending, and providing of funds to the department for the
2263	development, implementation, and operation of the prescription
2264	drug monitoring program as described in this section and s. 2,
2265	chapter 2009-198, Laws of Florida, as long as the task force is
2266	authorized. The direct-support organization may collect and
2267	expend funds to be used for the functions of the direct-support
2268	organization's board of directors, as necessary and approved by
2269	the department director of the Office of Drug Control. In
2270	addition, the direct-support organization may collect and
2271	provide funding to the department in furtherance of the
2272	prescription drug monitoring program by:
2273	a.  Establishing and administering the prescription drug
2274	monitoring program's electronic database, including hardware and
2275	software.
2276	b.  Conducting studies on the efficiency and effectiveness
2277	of the program to include feasibility studies as described in
2278	subsection (13).
2279	c.  Providing funds for future enhancements of the program
2280	within the intent of this section.
2281	d.  Providing user training of the prescription drug
2282	monitoring program, including distribution of materials to
2283	promote public awareness and education and conducting workshops
2284	or other meetings, for health care practitioners, pharmacists,
2285	and others as appropriate.
2286	e.  Providing funds for travel expenses.
2287	f.  Providing funds for administrative costs, including
2288	personnel, audits, facilities, and equipment.
2289	g.  Fulfilling all other requirements necessary to
2290	implement and operate the program as outlined in this section.
2291	(e)  The activities of the direct-support organization must
2292	be consistent with the goals and mission of the department
2293	Office of Drug Control, as determined by the office in
2294	consultation with the department, and in the best interests of
2295	the state. The direct-support organization must obtain a written
2296	approval from the department director of the Office of Drug
2297	Control for any activities in support of the prescription drug
2298	monitoring program before undertaking those activities.
2299	(f)  The Office of Drug Control, in consultation with the
2300	department, may permit, without charge, appropriate use of
2301	administrative services, property, and facilities of the Office
2302	of Drug Control and the department by the direct-support
2303	organization, subject to this section. The use must be directly
2304	in keeping with the approved purposes of the direct-support
2305	organization and may not be made at times or places that would
2306	unreasonably interfere with opportunities for the public to use
2307	such facilities for established purposes. Any moneys received
2308	from rentals of facilities and properties managed by the Office
2309	of Drug Control and the department may be held by the Office of
2310	Drug Control or in a separate depository account in the name of
2311	the direct-support organization and subject to the provisions of
2312	the letter of agreement with the department Office of Drug
2313	Control. The letter of agreement must provide that any funds
2314	held in the separate depository account in the name of the
2315	direct-support organization must revert to the department Office
2316	of Drug Control if the direct-support organization is no longer
2317	approved by the department Office of Drug Control to operate in
2318	the best interests of the state.
2319	(g)  The Office of Drug Control, in consultation with the
2320	department, may adopt rules under s. 120.54 to govern the use of
2321	administrative services, property, or facilities of the
2322	department or office by the direct-support organization.
2323	(h)  The department Office of Drug Control may not permit
2324	the use of any administrative services, property, or facilities
2325	of the state by a direct-support organization if that
2326	organization does not provide equal membership and employment
2327	opportunities to all persons regardless of race, color,
2328	religion, gender, age, or national origin.
2329	(i)  The direct-support organization shall provide for an
2330	independent annual financial audit in accordance with s.
2331	215.981. Copies of the audit shall be provided to the department
2332	Office of Drug Control and the Office of Policy and Budget in
2333	the Executive Office of the Governor.
2334	(j)  The direct-support organization may not exercise any
2335	power under s. 617.0302(12) or (16).
2336	(12)  A prescriber or dispenser may have access to the
2337	information under this section which relates to a patient of
2338	that prescriber or dispenser as needed for the purpose of
2339	reviewing the patient's controlled drug prescription history. A
2340	prescriber or dispenser acting in good faith is immune from any
2341	civil, criminal, or administrative liability that might
2342	otherwise be incurred or imposed for receiving or using
2343	information from the prescription drug monitoring program. This
2344	subsection does not create a private cause of action, and a
2345	person may not recover damages against a prescriber or dispenser
2346	authorized to access information under this subsection for
2347	accessing or failing to access such information.
2348	(13)  To the extent that funding is provided for such
2349	purpose through federal or private grants or gifts and other
2350	types of available moneys, the department, in collaboration with
2351	the Office of Drug Control, shall study the feasibility of
2352	enhancing the prescription drug monitoring program for the
2353	purposes of public health initiatives and statistical reporting
2354	that respects the privacy of the patient, the prescriber, and
2355	the dispenser. Such a study shall be conducted in order to
2356	further improve the quality of health care services and safety
2357	by improving the prescribing and dispensing practices for
2358	prescription drugs, taking advantage of advances in technology,
2359	reducing duplicative prescriptions and the overprescribing of
2360	prescription drugs, and reducing drug abuse. The requirements of
2361	the National All Schedules Prescription Electronic Reporting
2362	(NASPER) Act are authorized in order to apply for federal NASPER
2363	funding. In addition, the direct-support organization shall
2364	provide funding for the department, in collaboration with the
2365	Office of Drug Control, to conduct training for health care
2366	practitioners and other appropriate persons in using the
2367	monitoring program to support the program enhancements.
2368	(14)  A pharmacist, pharmacy, or dispensing health care
2369	practitioner or his or her agent, before releasing a controlled
2370	substance to any person not known to such dispenser, shall
2371	require the person purchasing, receiving, or otherwise acquiring
2372	the controlled substance to present valid photographic
2373	identification or other verification of his or her identity to
2374	the dispenser. If the person does not have proper
2375	identification, the dispenser may verify the validity of the
2376	prescription and the identity of the patient with the prescriber
2377	or his or her authorized agent. Verification of health plan
2378	eligibility through a real-time inquiry or adjudication system
2379	will be considered to be proper identification. This subsection
2380	does not apply in an institutional setting or to a long-term
2381	care facility, including, but not limited to, an assisted living
2382	facility or a hospital to which patients are admitted. As used
2383	in this subsection, the term "proper identification" means an
2384	identification that is issued by a state or the Federal
2385	Government containing the person's photograph, printed name, and
2386	signature or a document considered acceptable under 8 C.F.R. s.
2387	274a.2(b)(1)(v)(A) and (B).
2388	(15)  The Agency for Health Care Administration shall
2389	continue the promotion of electronic prescribing by health care
2390	practitioners, health care facilities, and pharmacies under s.
2391	408.0611.
2392	(16)  By October 1, 2010, The department shall adopt rules
2393	pursuant to ss. 120.536(1) and 120.54 to administer the
2394	provisions of this section, which shall include as necessary the
2395	reporting, accessing, evaluation, management, development,
2396	implementation, operation, and storage of information within the
2397	monitoring program's system.
2398	Section 24.  Section 893.065, Florida Statutes, is amended
2399	to read:
2400	893.065  Counterfeit-resistant prescription blanks for
2401	controlled substances listed in Schedule II, Schedule III, or
2402	Schedule IV.-The Department of Health shall develop and adopt by
2403	rule the form and content for a counterfeit-resistant
2404	prescription blank which must may be used by practitioners for
2405	the purpose of prescribing a controlled substance listed in
2406	Schedule II, Schedule III, or Schedule IV, or Schedule V
2407	pursuant to s. 456.42. The Department of Health may require the
2408	prescription blanks to be printed on distinctive, watermarked
2409	paper and to bear the preprinted name, address, and category of
2410	professional licensure of the practitioner and that
2411	practitioner's federal registry number for controlled
2412	substances. The prescription blanks may not be transferred.
2413	Section 25.  Subsections (4) and (5) of section 893.07,
2414	Florida Statutes, are amended to read:
2415	893.07  Records.-
2416	(4)  Every inventory or record required by this chapter,
2417	including prescription records, shall be maintained:
2418	(a)  Separately from all other records of the registrant,
2419	or
2420	(b)  Alternatively, in the case of Schedule III, IV, or V
2421	controlled substances, in such form that information required by
2422	this chapter is readily retrievable from the ordinary business
2423	records of the registrant.
2424
2425	In either case, the records described in this subsection shall
2426	be kept and made available for a period of at least 2 years for
2427	inspection and copying by law enforcement officers whose duty it
2428	is to enforce the laws of this state relating to controlled
2429	substances. Law enforcement officers are not required to obtain
2430	a subpoena, court order, or search warrant in order to obtain
2431	access to or copies of such records.
2432	(5)  Each person described in subsection (1) shall:
2433	(a)  Maintain a record which shall contain a detailed list
2434	of controlled substances lost, destroyed, or stolen, if any; the
2435	kind and quantity of such controlled substances; and the date of
2436	the discovering of such loss, destruction, or theft.
2437	(b)  In the event of the discovery of the theft or loss of
2438	controlled substances, report such theft or loss to the sheriff
2439	of that county within 24 hours after its discovery. A person who
2440	fails to report a theft or loss of a substance listed in s.
2441	893.03(3), (4), or (5) within 24 hours after discovery as
2442	required in this paragraph commits a misdemeanor of the second
2443	degree, punishable as provided in s. 775.082 or s. 775.083. A
2444	person who fails to report a theft or loss of a substance listed
2445	in s. 893.03(2) within 24 hours after discovery as required in
2446	this paragraph commits a misdemeanor of the first degree,
2447	punishable as provided in s. 775.082 or s. 775.083.
2448	Section 26.  Section 2 of chapter 2009-198, Laws of
2449	Florida, is repealed.
2450	Section 27.  (1)  BUY-BACK PROGRAM.-
2451	(a)  Within 10 days after the effective date of this act,
2452	each physician licensed under chapter 458, chapter 459, chapter
2453	461, or chapter 466, Florida Statutes, shall ensure that
2454	undispensed inventory of controlled substances listed in
2455	Schedule II or Schedule III as provided in s. 893.03, Florida
2456	Statutes, purchased under the physician's Drug Enforcement
2457	Administration number for dispensing is:
2458	1.  Returned to the wholesale distributor, as defined in s.
2459	499.003, Florida Statutes, which distributed them, with a
2460	written certification by the physician that, from the time such
2461	products were received by the physician until they are received
2462	by the wholesale distributor, the products have been properly
2463	stored, handled, and shipped in accordance with all applicable
2464	laws, rules, regulations, and standards; and that the specific
2465	units being returned were purchased from the wholesale
2466	distributor; and identifying the corresponding sales invoice
2467	number and date of sale from that wholesale distributor; or
2468	2.  Turned in to local law enforcement agencies and
2469	abandoned.
2470	(b)  Wholesale distributors shall buy back the undispensed
2471	inventory of controlled substances listed in Schedule II or
2472	Schedule III as provided in s. 893.03, Florida Statutes, at the
2473	purchase price paid by the physician, physician practice,
2474	clinic, or other paying entity. A wholesale distributor may
2475	resell the inventory bought back under this section without
2476	documenting the original sale or return in the pedigree paper.
2477	Each wholesale distributor shall submit a report of its buy-back
2478	activities under this section to the Department of Health by
2479	August 1, 2011. The report shall include the following
2480	information:
2481	1.  The name and address of the returning entity.
2482	2.  The Florida license, registration, or permit number and
2483	Drug Enforcement Administration number of the entity that
2484	originally ordered the drugs.
2485	3.  The drug name and number of unit doses returned.
2486	4.  The date of return.
2487	(2)  PUBLIC HEALTH EMERGENCY.-
2488	(a)  The Legislature finds that:
2489	1.  Prescription drug overdose has been declared a public
2490	health epidemic by the United States Centers for Disease Control
2491	and Prevention.
2492	2.  Prescription drug abuse results in an average of seven
2493	deaths in this state each day.
2494	3.  Physicians in this state purchased over 85 percent of
2495	the oxycodone purchased by all practitioners in the United
2496	States in 2006.
2497	4.  Physicians in this state purchased over 93 percent of
2498	the methadone purchased by all practitioners in the United
2499	States in 2006.
2500	5.  Some physicians in this state dispense medically
2501	unjustifiable amounts of controlled substances to addicts and
2502	people who intend to illegally sell the drugs.
2503	6.  Physicians in this state who have purchased large
2504	quantities of controlled substances may have significant
2505	inventory on the effective date of this act.
2506	7.  On the effective date of this act, the only legal
2507	method for a dispensing practitioner to sell or otherwise
2508	transfer controlled substances listed in Schedule II or Schedule
2509	III as provided in s. 893.03, Florida Statutes, purchased for
2510	dispensing is through the buy-back procedure or abandonment
2511	procedures of subsection (1).
2512	8.  It is likely that the same physicians who purchase and
2513	dispense medically unjustifiable amounts of drugs will not
2514	legally dispose of remaining inventory.
2515	9.  The actions of such dispensing practitioners may result
2516	in substantial injury to the public health.
2517	(b)  Immediately on the effective date of this act, the
2518	State Health Officer shall declare a public health emergency
2519	pursuant to s. 381.00315, Florida Statutes. Pursuant to that
2520	declaration, the Department of Health, the Attorney General, the
2521	Department of Law Enforcement, and local law enforcement
2522	agencies shall take the following actions:
2523	1.  Within 2 days after the effective date of this act, in
2524	consultation with wholesale distributors as defined in s.
2525	499.003, Florida Statutes, the Department of Health shall
2526	identify dispensing practitioners that purchased more than an
2527	average of 2,000 unit doses of controlled substances listed in
2528	Schedule II or Schedule III as provided in s. 893.03, Florida
2529	Statutes, per month in the previous 6 months, and shall identify
2530	the dispensing practitioners in that group who pose the greatest
2531	threat to the public health based on an assessment of:
2532	a.  The risk of noncompliance with subsection (1).
2533	b.  Purchase amounts.
2534	c.  Manner of medical practice.
2535	d.  Any other factor set by the State Health Officer.
2536
2537	The Attorney General shall consult and coordinate with federal
2538	law enforcement agencies. The Department of Law Enforcement
2539	shall coordinate the efforts of local law enforcement agencies.
2540	2.  On the 3rd day after the effective date of this act,
2541	the Department of Law Enforcement or local law enforcement
2542	agencies shall enter the business premises of the dispensing
2543	practitioners identified as posing the greatest threat to public
2544	health and quarantine the inventory of controlled substances
2545	listed in Schedule II or Schedule III as provided in s. 893.03,
2546	Florida Statutes, of such dispensing practitioners on site.
2547	3.  The Department of Law Enforcement or local law
2548	enforcement agencies shall ensure the security of such inventory
2549	24 hours a day through the 10th day after the effective date of
2550	this act or until the inventory is validly transferred pursuant
2551	to subsection (1), whichever is earlier.
2552	4.  On the 11th day after the effective date of this act,
2553	any remaining inventory of controlled substances listed in
2554	Schedule II or Schedule III as provided in s. 893.03, Florida
2555	Statutes, purchased for dispensing by practitioners is deemed
2556	contraband under s. 893.12, Florida Statutes. The Department of
2557	Law Enforcement or local law enforcement agencies shall seize
2558	the inventory and comply with the provisions of s. 893.12,
2559	Florida Statutes, to destroy it.
2560	(c)  In order to implement the provisions of this
2561	subsection, the sum of $3 million of nonrecurring funds from the
2562	General Revenue Fund is appropriated to the Department of Law
2563	Enforcement for the 2010-2011 fiscal year. The Department of Law
2564	Enforcement shall expend the appropriation by reimbursing local
2565	law enforcement agencies for the overtime-hour costs associated
2566	with securing the quarantined controlled substance inventory as
2567	provided in paragraph (b) and activities related to
2568	investigation and prosecution of crimes related to prescribed
2569	controlled substances. If requests for reimbursement exceed the
2570	amount appropriated, the reimbursements shall be prorated by the
2571	hours of overtime per requesting agency at a maximum of one law
2572	enforcement officer per quarantine site.
2573	(3)  REPEAL.-This section is repealed January 1, 2013.
2574	Section 28.  This act shall take effect July 1, 2011.

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