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

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