CS/CS/HB 7095

1	A bill to be entitled
2	An act relating to prescription drugs; 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; redefining the term "pain-
25	management clinic"; providing definitions; providing an
26	exemption from registration for clinics owned and operated
27	by physicians or medical specialists meeting certain
28	criteria; revising responsibilities of physicians in pain-
29	management clinics; allowing physician assistants and
30	advanced registered nurse practitioners to perform
31	physical examinations; requiring physicians in pain-
32	management clinics to ensure compliance with certain
33	requirements; imposing facility and physical operations
34	requirements; imposing infection control requirements;
35	imposing health and safety requirements; imposing quality
36	assurance requirements; imposing data collection and
37	reporting requirements; revising rulemaking authority;
38	conforming provisions to changes made by the act;
39	providing for future expiration of provisions; amending s.
40	458.327, F.S.; providing that dispensing certain
41	controlled substances in violation of specified provisions
42	is a third-degree felony; providing penalties; amending s.
43	458.331, F.S.; providing that dispensing certain
44	controlled substances in violation of specified provisions
45	is grounds for disciplinary action; providing penalties;
46	amending s. 459.0137, F.S., relating to regulation of
47	pain-management clinics and osteopathic physicians;
48	providing definitions; providing an exemption from
49	registration for clinics owned and operated by physicians
50	meeting certain criteria; revising responsibilities of
51	osteopathic physicians in pain-management clinics;
52	allowing physician assistants and advanced registered
53	nurse practitioners to perform physical examinations;
54	requiring osteopathic physicians in pain-management
55	clinics to ensure compliance with certain requirements;
56	imposing facility and physical operations requirements;
57	imposing infection control requirements; imposing health
58	and safety requirements; imposing quality assurance
59	requirements; imposing data collection and reporting
60	requirements; revising rulemaking authority; conforming
61	provisions to changes made by the act; providing for
62	future expiration of provisions; amending s. 459.013,
63	F.S.; providing that dispensing certain controlled
64	substances in violation of specified provisions is a
65	third-degree felony; providing penalties; amending s.
66	459.015, F.S.; providing that dispensing certain
67	controlled substances in violation of specified provisions
68	is grounds for disciplinary action; providing penalties;
69	amending s. 465.015, F.S.; requiring a pharmacist to
70	report to the sheriff within a specified period any
71	instance in which a person fraudulently obtained or
72	attempted to fraudulently obtain a controlled substance;
73	providing criminal penalties; providing suggested criteria
74	for the reports; amending s. 465.016, F.S.; providing
75	additional grounds for denial of or disciplinary action
76	against a pharmacist license; amending s. 465.018, F.S.;
77	providing grounds for permit denial or discipline;
78	requiring applicants to pay or make arrangements to pay
79	amounts owed to the Department of Health; requiring an
80	inspection; requiring permittees to maintain certain
81	records; requiring a community pharmacy to be permitted
82	under ch. 465, F.S., on or after a specified date in order
83	to dispense Schedule II or Schedule III controlled
84	substances; amending s. 465.022, F.S.; requiring the
85	Department of Health to adopt rules related to procedures
86	for dispensing controlled substances; providing
87	requirements for the issuance of a pharmacy permit;
88	requiring disclosure of financial interests; requiring
89	submission of policies and procedures and providing for
90	grounds for permit denial based on such policies and
91	procedures; authorizing the Department of Health to phase
92	in the policies and procedures requirement over an 18-
93	month period beginning July 1, 2011; requiring the
94	Department of Health to deny a permit to applicants under
95	certain circumstances; requiring permittees to provide
96	notice of certain management changes; requiring
97	prescription department managers to meet certain criteria;
98	imposing duties on prescription department managers;
99	limiting the number of locations a prescription department
100	manager may manage; requiring the board to adopt rules
101	related to recordkeeping; providing that permits are not
102	transferable; amending s. 465.0276, F.S.; deleting a
103	provision establishing a 72-hour supply limit on
104	dispensing certain controlled substances; prohibiting
105	registered dispensing practitioners from dispensing
106	certain controlled substances; revising the list of
107	exceptions that allow registered dispensing practitioners
108	to dispense certain controlled substances; amending s.
109	499.0051, F.S.; providing criminal penalties for
110	violations of certain provisions of s. 499.0121, F.S.;
111	amending s. 499.012, F.S.; requiring wholesale distributor
112	permit applicants to submit documentation of credentialing
113	policies; amending s. 499.0121, F.S.; providing reporting
114	requirements regarding certain controlled substances for
115	prescription drug wholesale distributors, out-of-state
116	prescription drug wholesale distributors, retail pharmacy
117	drug wholesale distributors, manufacturers, or repackagers
118	that engage in the wholesale distribution of controlled
119	substances to a retail pharmacy; requiring the Department
120	of Health to share the reported data with law enforcement
121	agencies; requiring the Department of Law Enforcement to
122	make investigations based on the reported data; providing
123	credentialing requirements for distribution of controlled
124	substances to certain entities by wholesale distributors;
125	requiring distributors to identify suspicious
126	transactions; requiring distributors to determine the
127	reasonableness of orders for controlled substances over
128	certain amounts; requiring distributors to maintain
129	documents that support the report submitted to the
130	Department of Health; requiring the department to assess
131	data; requiring the department to report certain data to
132	the Governor, President of the Senate, and Speaker of the
133	House of Representatives by certain dates; prohibiting
134	distribution to entities with certain criminal
135	backgrounds; amending s. 499.05, F.S.; authorizing
136	rulemaking concerning specified controlled substance
137	wholesale distributor reporting requirements and
138	credentialing requirements; amending s. 499.067, F.S.;
139	authorizing the Department of Health to take disciplinary
140	action against wholesale distributors failing to comply
141	with specified credentialing or reporting requirements;
142	amending s. 810.02, F.S.; authorizing separate judgments
143	and sentences for burglary with the intent to commit theft
144	of a controlled substance under specified provisions and
145	for any applicable possession of controlled substance
146	offense under specified provisions in certain
147	circumstances; amending s. 812.014, F.S.; authorizing
148	separate judgments and sentences for theft of a controlled
149	substance under specified provisions and for any
150	applicable possession of controlled substance offense
151	under specified provisions in certain circumstances;
152	amending s. 893.055, F.S., relating to the prescription
153	drug monitoring program; deleting obsolete dates; deleting
154	references to the Office of Drug Control; requiring
155	reports to the prescription drug monitoring system to be
156	made in 7 days rather than 15 days; prohibiting the use of
157	certain funds to implement the program; requiring criminal
158	background screening for those persons who have direct
159	access to the prescription drug monitoring program's
160	database; requiring the State Surgeon General to appoint a
161	board of directors for the direct-support organization;
162	conforming provisions to changes made by the act; amending
163	s. 893.065, F.S.; conforming provisions to changes made by
164	the act; amending s. 893.07, F.S.; providing that law
165	enforcement officers are not required to obtain a
166	subpoena, court order, or search warrant in order to
167	obtain access to or copies of specified controlled
168	substance inventory records; requiring reporting of the
169	discovery of the theft or loss of controlled substances to
170	the sheriff within a specified period; providing criminal
171	penalties; amending s. 893.13, F.S.; prohibiting a person
172	from obtaining or attempting to obtain from a practitioner
173	a controlled substance or a prescription for a controlled
174	substance by misrepresentation, fraud, forgery, deception,
175	subterfuge, or concealment of a material fact; prohibiting
176	a health care provider from providing a controlled
177	substance or a prescription for a controlled substance by
178	misrepresentation, fraud, forgery, deception, subterfuge,
179	or concealment of a material fact; prohibiting a person
180	from adulterating a controlled substance for certain use
181	without authorization by a prescribing physician;
182	providing penalties; amending s. 893.138, F.S.; providing
183	circumstances in which a pain-management clinic may be
184	declared a public nuisance; providing for the disposition
185	of certain controlled substance inventory held by
186	specified licensed physicians; providing certain
187	requirements for a physician returning inventory to a
188	distributor; requiring wholesale distributors to buy back
189	certain undispensed inventory of controlled substances;
190	providing for a declaration of a public health emergency;
191	requiring certain actions relating to dispensing
192	practitioners identified as posing the greatest threat to
193	public health; providing an appropriation; providing for
194	future expiration of program provisions; requiring the
195	Department of Health to establish a practitioner profile
196	for dentists; providing for severability; providing an
197	effective date.
198
199	Be It Enacted by the Legislature of the State of Florida:
200
201	Section 1.  Paragraph (mm) is added to subsection (1) of
202	section 456.072, Florida Statutes, subsection (7) is
203	redesignated as subsection (8), and a new subsection (7) is
204	added to that section, to read:
205	456.072  Grounds for discipline; penalties; enforcement.-
206	(1)  The following acts shall constitute grounds for which
207	the disciplinary actions specified in subsection (2) may be
208	taken:
209	(mm)  Failure to comply with controlled substance
210	prescribing requirements of s. 456.44.
211	(7)  Notwithstanding subsection (2), upon a finding that a
212	physician has prescribed or dispensed a controlled substance, or
213	caused a controlled substance to be prescribed or dispensed, in
214	a manner that violates the standard of practice set forth in s.
215	458.331(1)(q) or (t), s. 459.015(1)(t) or (x), s. 461.013(1)(o)
216	or (s), or s. 466.028(1)(p) or (x), the physician shall be
217	suspended for a period of not less than 6 months and pay a fine
218	of not less than $10,000 per count. Repeated violations shall
219	result in increased penalties.
220	Section 2.  Section 456.42, Florida Statutes, is amended to
221	read:
222	456.42  Written prescriptions for medicinal drugs.-
223	(1)  A written prescription for a medicinal drug issued by
224	a health care practitioner licensed by law to prescribe such
225	drug must be legibly printed or typed so as to be capable of
226	being understood by the pharmacist filling the prescription;
227	must contain the name of the prescribing practitioner, the name
228	and strength of the drug prescribed, the quantity of the drug
229	prescribed, and the directions for use of the drug; must be
230	dated; and must be signed by the prescribing practitioner on the
231	day when issued. A written prescription for a controlled
232	substance listed in chapter 893 must have the quantity of the
233	drug prescribed in both textual and numerical formats and must
234	be dated with the abbreviated month written out on the face of
235	the prescription. However, a prescription that is electronically
236	generated and transmitted must contain the name of the
237	prescribing practitioner, the name and strength of the drug
238	prescribed, the quantity of the drug prescribed in numerical
239	format, and the directions for use of the drug and must be dated
240	and signed by the prescribing practitioner only on the day
241	issued, which signature may be in an electronic format as
242	defined in s. 668.003(4).
243	(2)  A written prescription for a controlled substance
244	listed in chapter 893 must have the quantity of the drug
245	prescribed in both textual and numerical formats, must be dated
246	with the abbreviated month written out on the face of the
247	prescription, and must be either written on a standardized
248	counterfeit-proof prescription pad produced by a vendor approved
249	by the department or electronically prescribed as that term is
250	used in s. 408.0611. As a condition of being an approved vendor,
251	a prescription pad vendor must submit a monthly report to the
252	department which, at a minimum, documents the number of
253	prescription pads sold and identifies the purchasers. The
254	department may, by rule, require the reporting of additional
255	information.
256	Section 3.  Section 456.44, Florida Statutes, is created to
257	read:
258	456.44  Controlled substance prescribing.-
259	(1)  DEFINITIONS.-
260	(a)  "Addiction medicine specialist" means a board-
261	certified physiatrist with a subspecialty certification in
262	addiction medicine or who is eligible for such subspecialty
263	certification in addiction medicine, an addiction medicine
264	physician certified or eligible for certification by the
265	American Society of Addiction Medicine, or an osteopathic
266	physician who holds a certificate of added qualification in
267	Addiction Medicine through the American Osteopathic Association.
268	(b)  "Adverse incident" means any incident set forth in s.
269	458.351(4)(a)-(e) or s. 459.026(4)(a)-(e).
270	(c)  "Board-certified pain management physician" means a
271	physician who possesses board certification in pain medicine by
272	the American Board of Pain Medicine, board certification by the
273	American Board of Interventional Pain Physicians, or board
274	certification or subcertification in pain management by a
275	specialty board recognized by the American Association of
276	Physician Specialists or an osteopathic physician who holds a
277	certificate in Pain Management by the American Osteopathic
278	Association.
279	(d)  "Chronic nonmalignant pain" means pain unrelated to
280	cancer or rheumatoid arthritis which persists beyond the usual
281	course of disease or the injury that is the cause of the pain or
282	more than 90 days after surgery.
283	(e)  "Mental health addiction facility" means a facility
284	licensed under chapter 394 or chapter 397.
285	(2)  REGISTRATION.-Effective January 1, 2012, a physician
286	licensed under chapter 458, chapter 459, chapter 461, or chapter
287	466 who prescribes any controlled substance, as defined in s.
288	893.03, for the treatment of chronic nonmalignant pain, must:
289	(a)  Designate himself or herself as a controlled substance
290	prescribing practitioner on the physician's practitioner
291	profile.
292	(b)  Comply with the requirements of this section and
293	applicable board rules.
294	(3)  STANDARDS OF PRACTICE.-The standards of practice in
295	this section do not supersede the level of care, skill, and
296	treatment recognized in general law related to healthcare
297	licensure.
298	(a)  A complete medical history and a physical examination
299	must be conducted before beginning any treatment and must be
300	documented in the medical record. The exact components of the
301	physical examination shall be left to the judgment of the
302	clinician who is expected to perform a physical examination
303	proportionate to the diagnosis that justifies a treatment. The
304	medical record must, at a minimum, document the nature and
305	intensity of the pain, current and past treatments for pain,
306	underlying or coexisting diseases or conditions, the effect of
307	the pain on physical and psychological function, a review of
308	previous medical records, previous diagnostic studies, and
309	history of alcohol and substance abuse. The medical record shall
310	also document the presence of one or more recognized medical
311	indications for the use of a controlled substance. Each
312	registrant must develop a written plan for assessing each
313	patient's risk of aberrant drug-related behavior, which may
314	include patient drug testing. Registrants must assess each
315	patient's risk for aberrant drug-related behavior and monitor
316	that risk on an ongoing basis in accordance with the plan.
317	(b)  Each registrant must develop a written individualized
318	treatment plan for each patient. The treatment plan shall state
319	objectives that will be used to determine treatment success,
320	such as pain relief and improved physical and psychosocial
321	function, and shall indicate if any further diagnostic
322	evaluations or other treatments are planned. After treatment
323	begins, the physician shall adjust drug therapy to the
324	individual medical needs of each patient. Other treatment
325	modalities, including a rehabilitation program, shall be
326	considered depending on the etiology of the pain and the extent
327	to which the pain is associated with physical and psychosocial
328	impairment. The interdisciplinary nature of the treatment plan
329	shall be documented.
330	(c)  The physician shall discuss the risks and benefits of
331	the use of controlled substances, including the risks of abuse
332	and addiction, as well as physical dependence and its
333	consequences, with the patient, persons designated by the
334	patient, or the patient's surrogate or guardian if the patient
335	is incompetent. The physician shall use a written controlled
336	substance agreement between the physician and the patient
337	outlining the patient's responsibilities, including, but not
338	limited to:
339	1.  Number and frequency of controlled substance
340	prescriptions and refills.
341	2.  Patient compliance and reasons for which drug therapy
342	may be discontinued, such as a violation of the agreement.
343	3.  An agreement that controlled substances for the
344	treatment of chronic nonmalignant pain shall be prescribed by a
345	single treating physician unless otherwise authorized by the
346	treating physician and documented in the medical record.
347	(d)  The patient shall be seen by the physician at regular
348	intervals, not to exceed 3 months, to assess the efficacy of
349	treatment, ensure that controlled substance therapy remains
350	indicated, evaluate the patient's progress toward treatment
351	objectives, consider adverse drug effects, and review the
352	etiology of the pain. Continuation or modification of therapy
353	shall depend on the physician's evaluation of the patient's
354	progress. If treatment goals are not being achieved, despite
355	medication adjustments, the physician shall reevaluate the
356	appropriateness of continued treatment. The physician shall
357	monitor patient compliance in medication usage, related
358	treatment plans, controlled substance agreements, and
359	indications of substance abuse or diversion at a minimum of 3-
360	month intervals.
361	(e)  The physician shall refer the patient as necessary for
362	additional evaluation and treatment in order to achieve
363	treatment objectives. Special attention shall be given to those
364	patients who are at risk for misusing their medications and
365	those whose living arrangements pose a risk for medication
366	misuse or diversion. The management of pain in patients with a
367	history of substance abuse or with a comorbid psychiatric
368	disorder requires extra care, monitoring, and documentation and
369	requires consultation with or referral to an addictionologist or
370	physiatrist.
371	(f)  A physician registered under this section must
372	maintain accurate, current, and complete records that are
373	accessible and readily available for review and comply with the
374	requirements of this section, the applicable practice act, and
375	applicable board rules. The medical records must include, but
376	are not limited to:
377	1.  The complete medical history and a physical
378	examination, including history of drug abuse or dependence.
379	2.  Diagnostic, therapeutic, and laboratory results.
380	3.  Evaluations and consultations.
381	4.  Treatment objectives.
382	5.  Discussion of risks and benefits.
383	6.  Treatments.
384	7.  Medications, including date, type, dosage, and quantity
385	prescribed.
386	8.  Instructions and agreements.
387	9.  Periodic reviews.
388	10.  Results of any drug testing.
389	11.  A photocopy of the patient's government-issued photo
390	identification.
391	12.  If a written prescription for a controlled substance
392	is given to the patient, a duplicate of the prescription.
393	13.  The physician's full name presented in a legible
394	manner.
395	(g)  Patients with signs or symptoms of substance abuse
396	shall be immediately referred to a board-certified pain
397	management physician, an addiction medicine specialist, or a
398	mental health addiction facility as it pertains to drug abuse or
399	addiction unless the physician is board-certified or board-
400	eligible in pain management. Throughout the period of time
401	before receiving the consultant's report, a prescribing
402	physician shall clearly and completely document medical
403	justification for continued treatment with controlled substances
404	and those steps taken to ensure medically appropriate use of
405	controlled substances by the patient. Upon receipt of the
406	consultant's written report, the prescribing physician shall
407	incorporate the consultant's recommendations for continuing,
408	modifying, or discontinuing controlled substance therapy. The
409	resulting changes in treatment shall be specifically documented
410	in the patient's medical record. Evidence or behavioral
411	indications of diversion shall be followed by discontinuation of
412	controlled substance therapy and the patient shall be discharged
413	and all results of testing and actions taken by the physician
414	shall be documented in the patient's medical record.
415
416	This subsection does not apply to a board-certified
417	anesthesiologist, physiatrist, or neurologist, or to a board-
418	certified physician who has surgical privileges at a hospital or
419	ambulatory surgery center and primarily provides surgical
420	services. This subsection does not apply to a board-certified
421	medical specialist who has also completed a fellowship in pain
422	medicine approved by the Accreditation Council for Graduate
423	Medical Education or the American Osteopathic Association, or
424	who is board certified in pain medicine by a board approved by
425	the American Board of Medical Specialties or the American
426	Osteopathic Association and performs interventional pain
427	procedures of the type routinely billed using surgical codes.
428	Section 4.  Section 458.3265, Florida Statutes, is amended
429	to read:
430	458.3265  Pain-management clinics.-
431	(1)  REGISTRATION.-
432	(a)1.  As used in this section, the term:
433	a.  "Chronic nonmalignant pain" means pain unrelated to
434	cancer or rheumatoid arthritis which persists beyond the usual
435	course of disease or the injury that is the cause of the pain or
436	more than 90 days after surgery.
437	b.  "Pain-management clinic" or "clinic" means any publicly
438	or privately owned facility:
439	(I)  That advertises in any medium for any type of pain-
440	management services; or
441	(II)  Where in any month a majority of patients are
442	prescribed opioids, benzodiazepines, barbiturates, or
443	carisoprodol for the treatment of chronic nonmalignant pain. All
444	privately owned pain-management clinics, facilities, or offices,
445	hereinafter referred to as "clinics," which advertise in any
446	medium for any type of pain-management services, or employ a
447	physician who is primarily engaged in the treatment of pain by
448	prescribing or dispensing controlled substance medications,
449	2.  Each pain-management clinic must register with the
450	department unless:
451	a.1.  That clinic is licensed as a facility pursuant to
452	chapter 395;
453	b.2.  The majority of the physicians who provide services
454	in the clinic primarily provide surgical services;
455	c.3.  The clinic is owned by a publicly held corporation
456	whose shares are traded on a national exchange or on the over-
457	the-counter market and whose total assets at the end of the
458	corporation's most recent fiscal quarter exceeded $50 million;
459	d.4.  The clinic is affiliated with an accredited medical
460	school at which training is provided for medical students,
461	residents, or fellows;
462	e.5.  The clinic does not prescribe or dispense controlled
463	substances for the treatment of pain; or
464	f.6.  The clinic is owned by a corporate entity exempt from
465	federal taxation under 26 U.S.C. s. 501(c)(3);.
466	g.  The clinic is wholly owned and operated by one or more
467	board-certified anesthesiologists, physiatrists, or
468	neurologists; or
469	h.  The clinic is wholly owned and operated by one or more
470	board-certified medical specialists who have also completed
471	fellowships in pain medicine approved by the Accreditation
472	Council for Graduate Medical Education, or who are also board-
473	certified in pain medicine by a board approved by the American
474	Board of Medical Specialties and perform interventional pain
475	procedures of the type routinely billed using surgical codes.
476	(b)  Each clinic location shall be registered separately
477	regardless of whether the clinic is operated under the same
478	business name or management as another clinic.
479	(c)  As a part of registration, a clinic must designate a
480	physician who is responsible for complying with all requirements
481	related to registration and operation of the clinic in
482	compliance with this section. Within 10 days after termination
483	of a designated physician, the clinic must notify the department
484	of the identity of another designated physician for that clinic.
485	The designated physician shall have a full, active, and
486	unencumbered license under this chapter or chapter 459 and shall
487	practice at the clinic location for which the physician has
488	assumed responsibility. Failing to have a licensed designated
489	physician practicing at the location of the registered clinic
490	may be the basis for a summary suspension of the clinic
491	registration certificate as described in s. 456.073(8) for a
492	license or s. 120.60(6).
493	(d)  The department shall deny registration to any clinic
494	that is not fully owned by a physician licensed under this
495	chapter or chapter 459 or a group of physicians, each of whom is
496	licensed under this chapter or chapter 459; or that is not a
497	health care clinic licensed under part X of chapter 400.
498	(e)  The department shall deny registration to any pain-
499	management clinic owned by or with any contractual or employment
500	relationship with a physician:
501	1.  Whose Drug Enforcement Administration number has ever
502	been revoked.
503	2.  Whose application for a license to prescribe, dispense,
504	or administer a controlled substance has been denied by any
505	jurisdiction.
506	3.  Who has been convicted of or pleaded guilty or nolo
507	contendere to, regardless of adjudication, an offense that
508	constitutes a felony for receipt of illicit and diverted drugs,
509	including a controlled substance listed in Schedule I, Schedule
510	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
511	this state, any other state, or the United States.
512	(f)  If the department finds that a pain-management clinic
513	does not meet the requirement of paragraph (d) or is owned,
514	directly or indirectly, by a person meeting any criteria listed
515	in paragraph (e), the department shall revoke the certificate of
516	registration previously issued by the department. As determined
517	by rule, the department may grant an exemption to denying a
518	registration or revoking a previously issued registration if
519	more than 10 years have elapsed since adjudication. As used in
520	this subsection, the term "convicted" includes an adjudication
521	of guilt following a plea of guilty or nolo contendere or the
522	forfeiture of a bond when charged with a crime.
523	(g)  The department may revoke the clinic's certificate of
524	registration and prohibit all physicians associated with that
525	pain-management clinic from practicing at that clinic location
526	based upon an annual inspection and evaluation of the factors
527	described in subsection (3).
528	(h)  If the registration of a pain-management clinic is
529	revoked or suspended, the designated physician of the pain-
530	management clinic, the owner or lessor of the pain-management
531	clinic property, the manager, and the proprietor shall cease to
532	operate the facility as a pain-management clinic as of the
533	effective date of the suspension or revocation.
534	(i)  If a pain-management clinic registration is revoked or
535	suspended, the designated physician of the pain-management
536	clinic, the owner or lessor of the clinic property, the manager,
537	or the proprietor is responsible for removing all signs and
538	symbols identifying the premises as a pain-management clinic.
539	(j)  Upon the effective date of the suspension or
540	revocation, the designated physician of the pain-management
541	clinic shall advise the department of the disposition of the
542	medicinal drugs located on the premises. The disposition is
543	subject to the supervision and approval of the department.
544	Medicinal drugs that are purchased or held by a pain-management
545	clinic that is not registered may be deemed adulterated pursuant
546	to s. 499.006.
547	(k)  If the clinic's registration is revoked, any person
548	named in the registration documents of the pain-management
549	clinic, including persons owning or operating the pain-
550	management clinic, may not, as an individual or as a part of a
551	group, apply to operate a pain-management clinic for 5 years
552	after the date the registration is revoked.
553	(l)  The period of suspension for the registration of a
554	pain-management clinic shall be prescribed by the department,
555	but may not exceed 1 year.
556	(m)  A change of ownership of a registered pain-management
557	clinic requires submission of a new registration application.
558	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
559	apply to any physician who provides professional services in a
560	pain-management clinic that is required to be registered in
561	subsection (1).
562	(a)  A physician may not practice medicine in a pain-
563	management clinic, as described in subsection (4), if:
564	1.  The pain-management clinic is not registered with the
565	department as required by this section.; or
566	2.  Effective July 1, 2012, the physician has not
567	successfully completed a pain-medicine fellowship that is
568	accredited by the Accreditation Council for Graduate Medical
569	Education or a pain-medicine residency that is accredited by the
570	Accreditation Council for Graduate Medical Education or, prior
571	to July 1, 2012, does not comply with rules adopted by the
572	board.
573
574	Any physician who qualifies to practice medicine in a pain-
575	management clinic pursuant to rules adopted by the Board of
576	Medicine as of July 1, 2012, may continue to practice medicine
577	in a pain-management clinic as long as the physician continues
578	to meet the qualifications set forth in the board rules. A
579	physician who violates this paragraph is subject to disciplinary
580	action by his or her appropriate medical regulatory board.
581	(b)  A person may not dispense any medication, including a
582	controlled substance, on the premises of a registered pain-
583	management clinic unless he or she is a physician licensed under
584	this chapter or chapter 459.
585	(c)  A physician, a physician assistant, or an advanced
586	registered nurse practitioner must perform a physical
587	examination of a patient on the same day that the physician he
588	or she dispenses or prescribes a controlled substance to a
589	patient at a pain-management clinic. If the physician prescribes
590	or dispenses more than a 72-hour dose of controlled substances
591	for the treatment of chronic nonmalignant pain, the physician
592	must document in the patient's record the reason for prescribing
593	or dispensing that quantity.
594	(d)  A physician authorized to prescribe controlled
595	substances who practices at a pain-management clinic is
596	responsible for maintaining the control and security of his or
597	her prescription blanks and any other method used for
598	prescribing controlled substance pain medication. The physician
599	shall comply with the requirements for counterfeit-resistant
600	prescription blanks in s. 893.065 and the rules adopted pursuant
601	to that section. The physician shall notify, in writing, the
602	department within 24 hours following any theft or loss of a
603	prescription blank or breach of any other method for prescribing
604	pain medication.
605	(e)  The designated physician of a pain-management clinic
606	shall notify the applicable board in writing of the date of
607	termination of employment within 10 days after terminating his
608	or her employment with a pain-management clinic that is required
609	to be registered under subsection (1). Each physician practicing
610	in a pain-management clinic shall advise the Board of Medicine,
611	in writing, within 10 calendar days after beginning or ending
612	his or her practice at a pain-management clinic.
613	(f)  Each physician practicing in a pain-management clinic
614	is responsible for ensuring compliance with the following
615	facility and physical operations requirements:
616	1.  A pain-management clinic shall be located and operated
617	at a publicly accessible fixed location and must:
618	a.  Display a sign that can be viewed by the public that
619	contains the clinic name, hours of operations, and a street
620	address.
621	b.  Have a publicly listed telephone number and a dedicated
622	phone number to send and receive faxes with a fax machine that
623	shall be operational 24 hours per day.
624	c.  Have emergency lighting and communications.
625	d.  Have a reception and waiting area.
626	e.  Provide a restroom.
627	f.  Have an administrative area, including room for storage
628	of medical records, supplies, and equipment.
629	g.  Have private patient examination rooms.
630	h.  Have treatment rooms, if treatment is being provided to
631	the patients.
632	i.  Display a printed sign located in a conspicuous place
633	in the waiting room viewable by the public with the name and
634	contact information of the clinic's designated physician and the
635	names of all physicians practicing in the clinic.
636	j.  If the clinic stores and dispenses prescription drugs,
637	comply with ss. 499.0121 and 893.07.
638	2.  This section does not excuse a physician from providing
639	any treatment or performing any medical duty without the proper
640	equipment and materials as required by the standard of care.
641	This section does not supersede the level of care, skill, and
642	treatment recognized in general law related to healthcare
643	licensure.
644	(g)  Each physician practicing in a pain-management clinic
645	is responsible for ensuring compliance with the following
646	infection control requirements.
647	1.  The clinic shall maintain equipment and supplies to
648	support infection prevention and control activities.
649	2.  The clinic shall identify infection risks based on the
650	following:
651	a.  Geographic location, community, and population served.
652	b.  The care, treatment, and services it provides.
653	c.  An analysis of its infection surveillance and control
654	data.
655	3.  The clinic shall maintain written infection prevention
656	policies and procedures that address the following:
657	a.  Prioritized risks.
658	b.  Limiting unprotected exposure to pathogens.
659	c.  Limiting the transmission of infections associated with
660	procedures performed in the clinic.
661	d.  Limiting the transmission of infections associated with
662	the clinic's use of medical equipment, devices, and supplies.
663	(h)  Each physician practicing in a pain-management clinic
664	is responsible for ensuring compliance with the following health
665	and safety requirements:
666	1.  The clinic, including its grounds, buildings,
667	furniture, appliances, and equipment shall be structurally
668	sound, in good repair, clean, and free from health and safety
669	hazards.
670	2.  The clinic shall have evacuation procedures in the
671	event of an emergency, which shall include provisions for the
672	evacuation of disabled patients and employees.
673	3.  The clinic shall have a written facility-specific
674	disaster plan setting forth actions that will be taken in the
675	event of clinic closure due to unforeseen disasters and shall
676	include provisions for the protection of medical records and any
677	controlled substances.
678	4.  Each clinic shall have at least one employee on the
679	premises during patient care hours who is certified in Basic
680	Life Support and is trained in reacting to accidents and medical
681	emergencies until emergency medical personnel arrive.
682	(i)  The designated physician is responsible for ensuring
683	compliance with the following quality assurance requirements.
684	Each pain-management clinic shall have an ongoing quality
685	assurance program that objectively and systematically monitors
686	and evaluates the quality and appropriateness of patient care,
687	evaluates methods to improve patient care, identifies and
688	corrects deficiencies within the facility, alerts the designated
689	physician to identify and resolve recurring problems, and
690	provides for opportunities to improve the facility's performance
691	and to enhance and improve the quality of care provided to the
692	public. The designated physician shall establish a quality
693	assurance program that includes the following components:
694	1.  The identification, investigation, and analysis of the
695	frequency and causes of adverse incidents to patients.
696	2.  The identification of trends or patterns of incidents.
697	3.  The development of measures to correct, reduce,
698	minimize, or eliminate the risk of adverse incidents to
699	patients.
700	4.  The documentation of these functions and periodic
701	review no less than quarterly of such information by the
702	designated physician.
703	(j)  The designated physician is responsible for ensuring
704	compliance with the following data collection and reporting
705	requirements:
706	1.  The designated physician for each pain-management
707	clinic shall report all adverse incidents to the department as
708	set forth in s. 458.351.
709	2.  The designated physician shall also report to the Board
710	of Medicine, in writing, on a quarterly basis the following
711	data:
712	a.  Number of new and repeat patients seen and treated at
713	the clinic who are prescribed controlled substance medications
714	for the treatment of chronic, nonmalignant pain.
715	b.  The number of patients discharged due to drug abuse.
716	c.  The number of patients discharged due to drug
717	diversion.
718	d.  The number of patients treated at the pain clinic whose
719	domicile is located somewhere other than in this state. A
720	patient's domicile is the patient's fixed or permanent home to
721	which he or she intends to return even though he or she may
722	temporarily reside elsewhere.
723	(3)  INSPECTION.-
724	(a)  The department shall inspect the pain-management
725	clinic annually, including a review of the patient records, to
726	ensure that it complies with this section and the rules of the
727	Board of Medicine adopted pursuant to subsection (4) unless the
728	clinic is accredited by a nationally recognized accrediting
729	agency approved by the Board of Medicine.
730	(b)  During an onsite inspection, the department shall make
731	a reasonable attempt to discuss each violation with the owner or
732	designated physician of the pain-management clinic before
733	issuing a formal written notification.
734	(c)  Any action taken to correct a violation shall be
735	documented in writing by the owner or designated physician of
736	the pain-management clinic and verified by followup visits by
737	departmental personnel.
738	(4)  RULEMAKING.-
739	(a)  The department shall adopt rules necessary to
740	administer the registration and inspection of pain-management
741	clinics which establish the specific requirements, procedures,
742	forms, and fees.
743	(b)  The department shall adopt a rule defining what
744	constitutes practice by a designated physician at the clinic
745	location for which the physician has assumed responsibility, as
746	set forth in subsection (1). When adopting the rule, the
747	department shall consider the number of clinic employees, the
748	location of the pain-management clinic, the clinic's hours of
749	operation, and the amount of controlled substances being
750	prescribed, dispensed, or administered at the pain-management
751	clinic.
752	(c)  The Board of Medicine shall adopt a rule establishing
753	the maximum number of prescriptions for Schedule II or Schedule
754	III controlled substances or the controlled substance Alprazolam
755	which may be written at any one registered pain-management
756	clinic during any 24-hour period.
757	(b)(d)  The Board of Medicine shall adopt rules setting
758	forth standards of practice for physicians practicing in
759	privately owned pain-management clinics that primarily engage in
760	the treatment of pain by prescribing or dispensing controlled
761	substance medications. Such rules shall address, but need not be
762	limited to:
763	1.  Facility operations;
764	2.  Physical operations;
765	3.  Infection control requirements;
766	4.  Health and safety requirements;
767	5.  Quality assurance requirements;
768	6.  Patient records;
769	7.  training requirements for all facility health care
770	practitioners who are not regulated by another board.;
771	8.  Inspections; and
772	9.  Data collection and reporting requirements.
773
774	A physician is primarily engaged in the treatment of pain by
775	prescribing or dispensing controlled substance medications when
776	the majority of the patients seen are prescribed or dispensed
777	controlled substance medications for the treatment of chronic
778	nonmalignant pain. Chronic nonmalignant pain is pain unrelated
779	to cancer which persists beyond the usual course of the disease
780	or the injury that is the cause of the pain or more than 90 days
781	after surgery.
782	(5)  PENALTIES; ENFORCEMENT.-
783	(a)  The department may impose an administrative fine on
784	the clinic of up to $5,000 per violation for violating the
785	requirements of this section; chapter 499, the Florida Drug and
786	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
787	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
788	Abuse Prevention and Control Act; chapter 893, the Florida
789	Comprehensive Drug Abuse Prevention and Control Act; or the
790	rules of the department. In determining whether a penalty is to
791	be imposed, and in fixing the amount of the fine, the department
792	shall consider the following factors:
793	1.  The gravity of the violation, including the probability
794	that death or serious physical or emotional harm to a patient
795	has resulted, or could have resulted, from the pain-management
796	clinic's actions or the actions of the physician, the severity
797	of the action or potential harm, and the extent to which the
798	provisions of the applicable laws or rules were violated.
799	2.  What actions, if any, the owner or designated physician
800	took to correct the violations.
801	3.  Whether there were any previous violations at the pain-
802	management clinic.
803	4.  The financial benefits that the pain-management clinic
804	derived from committing or continuing to commit the violation.
805	(b)  Each day a violation continues after the date fixed
806	for termination of the violation as ordered by the department
807	constitutes an additional, separate, and distinct violation.
808	(c)  The department may impose a fine and, in the case of
809	an owner-operated pain-management clinic, revoke or deny a pain-
810	management clinic's registration, if the clinic's designated
811	physician knowingly and intentionally misrepresents actions
812	taken to correct a violation.
813	(d)  An owner or designated physician of a pain-management
814	clinic who concurrently operates an unregistered pain-management
815	clinic is subject to an administrative fine of $5,000 per day.
816	(e)  If the owner of a pain-management clinic that requires
817	registration fails to apply to register the clinic upon a change
818	of ownership and operates the clinic under the new ownership,
819	the owner is subject to a fine of $5,000.
820	(6)  EXPIRATION.-This section expires January 1, 2016.
821	Section 5.  Paragraph (f) is added to subsection (1) of
822	section 458.327, Florida Statutes, to read:
823	458.327  Penalty for violations.-
824	(1)  Each of the following acts constitutes a felony of the
825	third degree, punishable as provided in s. 775.082, s. 775.083,
826	or s. 775.084:
827	(f)  Dispensing a controlled substance listed in Schedule
828	II or Schedule III in violation of s. 465.0276.
829	Section 6.  Paragraph (rr) is added to subsection (1) of
830	section 458.331, Florida Statutes, to read:
831	458.331  Grounds for disciplinary action; action by the
832	board and department.-
833	(1)  The following acts constitute grounds for denial of a
834	license or disciplinary action, as specified in s. 456.072(2):
835	(rr)  Dispensing a controlled substance listed in Schedule
836	II or Schedule III in violation of s. 465.0276.
837	Section 7.  Section 459.0137, Florida Statutes, is amended
838	to read:
839	459.0137  Pain-management clinics.-
840	(1)  REGISTRATION.-
841	(a)1.  As used in this section, the term:
842	a.  "Chronic nonmalignant pain" means pain unrelated to
843	cancer or rheumatoid arthritis which persists beyond the usual
844	course of disease or the injury that is the cause of the pain or
845	more than 90 days after surgery.
846	b.  "Pain-management clinic" or "clinic" means any publicly
847	or privately owned facility:
848	(I)  That advertises in any medium for any type of pain-
849	management services; or
850	(II)  Where in any month a majority of patients are
851	prescribed opioids, benzodiazepines, barbiturates, or
852	carisoprodol for the treatment of chronic nonmalignant pain. All
853	privately owned pain-management clinics, facilities, or offices,
854	hereinafter referred to as "clinics," which advertise in any
855	medium for any type of pain-management services, or employ an
856	osteopathic physician who is primarily engaged in the treatment
857	of pain by prescribing or dispensing controlled substance
858	medications,
859	2.  Each pain-management clinic must register with the
860	department unless:
861	a.1.  That clinic is licensed as a facility pursuant to
862	chapter 395;
863	b.2.  The majority of the physicians who provide services
864	in the clinic primarily provide surgical services;
865	c.3.  The clinic is owned by a publicly held corporation
866	whose shares are traded on a national exchange or on the over-
867	the-counter market and whose total assets at the end of the
868	corporation's most recent fiscal quarter exceeded $50 million;
869	d.4.  The clinic is affiliated with an accredited medical
870	school at which training is provided for medical students,
871	residents, or fellows;
872	e.5.  The clinic does not prescribe or dispense controlled
873	substances for the treatment of pain; or
874	f.6.  The clinic is owned by a corporate entity exempt from
875	federal taxation under 26 U.S.C. s. 501(c)(3);.
876	g.  The clinic is wholly owned and operated by one or more
877	board-certified anesthesiologists, physiatrists, or
878	neurologists; or
879	h.  The clinic is wholly owned and operated by one or more
880	board-certified medical specialists who have also completed
881	fellowships in pain medicine approved by the Accreditation
882	Council for Graduate Medical Education or the American
883	Osteopathic Association, or who are also board-certified in pain
884	medicine by a board approved by the American Board of Medical
885	Specialties or the American Osteopathic Association and perform
886	interventional pain procedures of the type routinely billed
887	using surgical codes.
888	(b)  Each clinic location shall be registered separately
889	regardless of whether the clinic is operated under the same
890	business name or management as another clinic.
891	(c)  As a part of registration, a clinic must designate an
892	osteopathic physician who is responsible for complying with all
893	requirements related to registration and operation of the clinic
894	in compliance with this section. Within 10 days after
895	termination of a designated osteopathic physician, the clinic
896	must notify the department of the identity of another designated
897	physician for that clinic. The designated physician shall have a
898	full, active, and unencumbered license under chapter 458 or this
899	chapter and shall practice at the clinic location for which the
900	physician has assumed responsibility. Failing to have a licensed
901	designated osteopathic physician practicing at the location of
902	the registered clinic may be the basis for a summary suspension
903	of the clinic registration certificate as described in s.
904	456.073(8) for a license or s. 120.60(6).
905	(d)  The department shall deny registration to any clinic
906	that is not fully owned by a physician licensed under chapter
907	458 or this chapter or a group of physicians, each of whom is
908	licensed under chapter 458 or this chapter; or that is not a
909	health care clinic licensed under part X of chapter 400.
910	(e)  The department shall deny registration to any pain-
911	management clinic owned by or with any contractual or employment
912	relationship with a physician:
913	1.  Whose Drug Enforcement Administration number has ever
914	been revoked.
915	2.  Whose application for a license to prescribe, dispense,
916	or administer a controlled substance has been denied by any
917	jurisdiction.
918	3.  Who has been convicted of or pleaded guilty or nolo
919	contendere to, regardless of adjudication, an offense that
920	constitutes a felony for receipt of illicit and diverted drugs,
921	including a controlled substance listed in Schedule I, Schedule
922	II, Schedule III, Schedule IV, or Schedule V of s. 893.03, in
923	this state, any other state, or the United States.
924	(f)  If the department finds that a pain-management clinic
925	does not meet the requirement of paragraph (d) or is owned,
926	directly or indirectly, by a person meeting any criteria listed
927	in paragraph (e), the department shall revoke the certificate of
928	registration previously issued by the department. As determined
929	by rule, the department may grant an exemption to denying a
930	registration or revoking a previously issued registration if
931	more than 10 years have elapsed since adjudication. As used in
932	this subsection, the term "convicted" includes an adjudication
933	of guilt following a plea of guilty or nolo contendere or the
934	forfeiture of a bond when charged with a crime.
935	(g)  The department may revoke the clinic's certificate of
936	registration and prohibit all physicians associated with that
937	pain-management clinic from practicing at that clinic location
938	based upon an annual inspection and evaluation of the factors
939	described in subsection (3).
940	(h)  If the registration of a pain-management clinic is
941	revoked or suspended, the designated physician of the pain-
942	management clinic, the owner or lessor of the pain-management
943	clinic property, the manager, and the proprietor shall cease to
944	operate the facility as a pain-management clinic as of the
945	effective date of the suspension or revocation.
946	(i)  If a pain-management clinic registration is revoked or
947	suspended, the designated physician of the pain-management
948	clinic, the owner or lessor of the clinic property, the manager,
949	or the proprietor is responsible for removing all signs and
950	symbols identifying the premises as a pain-management clinic.
951	(j)  Upon the effective date of the suspension or
952	revocation, the designated physician of the pain-management
953	clinic shall advise the department of the disposition of the
954	medicinal drugs located on the premises. The disposition is
955	subject to the supervision and approval of the department.
956	Medicinal drugs that are purchased or held by a pain-management
957	clinic that is not registered may be deemed adulterated pursuant
958	to s. 499.006.
959	(k)  If the clinic's registration is revoked, any person
960	named in the registration documents of the pain-management
961	clinic, including persons owning or operating the pain-
962	management clinic, may not, as an individual or as a part of a
963	group, make application for a permit to operate a pain-
964	management clinic for 5 years after the date the registration is
965	revoked.
966	(l)  The period of suspension for the registration of a
967	pain-management clinic shall be prescribed by the department,
968	but may not exceed 1 year.
969	(m)  A change of ownership of a registered pain-management
970	clinic requires submission of a new registration application.
971	(2)  PHYSICIAN RESPONSIBILITIES.-These responsibilities
972	apply to any osteopathic physician who provides professional
973	services in a pain-management clinic that is required to be
974	registered in subsection (1).
975	(a)  An osteopathic physician may not practice medicine in
976	a pain-management clinic, as described in subsection (4), if:
977	1.  the pain-management clinic is not registered with the
978	department as required by this section.; or
979	2.  Effective July 1, 2012, the physician has not
980	successfully completed a pain-medicine fellowship that is
981	accredited by the Accreditation Council for Graduate Medical
982	Education or the American Osteopathic Association or a pain-
983	medicine residency that is accredited by the Accreditation
984	Council for Graduate Medical Education or the American
985	Osteopathic Association or, prior to July 1, 2012, does not
986	comply with rules adopted by the board.
987
988	Any physician who qualifies to practice medicine in a pain-
989	management clinic pursuant to rules adopted by the Board of
990	Osteopathic Medicine as of July 1, 2012, may continue to
991	practice medicine in a pain-management clinic as long as the
992	physician continues to meet the qualifications set forth in the
993	board rules. An osteopathic physician who violates this
994	paragraph is subject to disciplinary action by his or her
995	appropriate medical regulatory board.
996	(b)  A person may not dispense any medication, including a
997	controlled substance, on the premises of a registered pain-
998	management clinic unless he or she is a physician licensed under
999	this chapter or chapter 458.
1000	(c)  An osteopathic physician, a physician assistant, or an
1001	advanced registered nurse practitioner must perform a physical
1002	examination of a patient on the same day that the physician he
1003	or she dispenses or prescribes a controlled substance to a
1004	patient at a pain-management clinic. If the osteopathic
1005	physician prescribes or dispenses more than a 72-hour dose of
1006	controlled substances for the treatment of chronic nonmalignant
1007	pain, the osteopathic physician must document in the patient's
1008	record the reason for prescribing or dispensing that quantity.
1009	(d)  An osteopathic physician authorized to prescribe
1010	controlled substances who practices at a pain-management clinic
1011	is responsible for maintaining the control and security of his
1012	or her prescription blanks and any other method used for
1013	prescribing controlled substance pain medication. The
1014	osteopathic physician shall comply with the requirements for
1015	counterfeit-resistant prescription blanks in s. 893.065 and the
1016	rules adopted pursuant to that section. The osteopathic
1017	physician shall notify, in writing, the department within 24
1018	hours following any theft or loss of a prescription blank or
1019	breach of any other method for prescribing pain medication.
1020	(e)  The designated osteopathic physician of a pain-
1021	management clinic shall notify the applicable board in writing
1022	of the date of termination of employment within 10 days after
1023	terminating his or her employment with a pain-management clinic
1024	that is required to be registered under subsection (1). Each
1025	osteopathic physician practicing in a pain-management clinic
1026	shall advise the Board of Osteopathic Medicine in writing within
1027	10 calendar days after beginning or ending his or her practice
1028	at a pain-management clinic.
1029	(f)  Each osteopathic physician practicing in a pain-
1030	management clinic is responsible for ensuring compliance with
1031	the following facility and physical operations requirements:
1032	1.  A pain-management clinic shall be located and operated
1033	at a publicly accessible fixed location and must:
1034	a.  Display a sign that can be viewed by the public that
1035	contains the clinic name, hours of operations, and a street
1036	address.
1037	b.  Have a publicly listed telephone number and a dedicated
1038	phone number to send and receive faxes with a fax machine that
1039	shall be operational 24 hours per day.
1040	c.  Have emergency lighting and communications.
1041	d.  Have a reception and waiting area.
1042	e.  Provide a restroom.
1043	f.  Have an administrative area including room for storage
1044	of medical records, supplies and equipment.
1045	g.  Have private patient examination rooms.
1046	h.  Have treatment rooms, if treatment is being provided to
1047	the patient.
1048	i.  Display a printed sign located in a conspicuous place
1049	in the waiting room viewable by the public with the name and
1050	contact information of the clinic-designated physician and the
1051	names of all physicians practicing in the clinic.
1052	j.  If the clinic stores and dispenses prescription drug,
1053	comply with ss. 499.0121 and 893.07.
1054	2.  This section does not excuse an osteopathic physician
1055	from providing any treatment or performing any medical duty
1056	without the proper equipment and materials as required by the
1057	standard of care. This section does not supersede the level of
1058	care, skill, and treatment recognized in general law related to
1059	healthcare licensure.
1060	(g)  Each osteopathic physician practicing in a pain-
1061	management clinic is responsible for ensuring compliance with
1062	the following infection control requirements.
1063	1.  The clinic shall maintain equipment and supplies to
1064	support infection prevention and control activities.
1065	2.  The clinic shall identify infection risks based on the
1066	following:
1067	a.  Geographic location, community, and population served.
1068	b.  The care, treatment and services it provides.
1069	c.  An analysis of its infection surveillance and control
1070	data.
1071	3.  The clinic shall maintain written infection prevention
1072	policies and procedures that address the following:
1073	a.  Prioritized risks.
1074	b.  Limiting unprotected exposure to pathogen.
1075	c.  Limiting the transmission of infections associated with
1076	procedures performed in the clinic.
1077	d.  Limiting the transmission of infections associated with
1078	the clinic's use of medical equipment, devices, and supplies.
1079	(h)  Each osteopathic physician practicing in a pain-
1080	management clinic is responsible for ensuring compliance with
1081	the following health and safety requirements.
1082	1.  The clinic, including its grounds, buildings,
1083	furniture, appliances, and equipment shall be structurally
1084	sound, in good repair, clean, and free from health and safety
1085	hazards.
1086	2.  The clinic shall have evacuation procedures in the
1087	event of an emergency which shall include provisions for the
1088	evacuation of disabled patients and employees.
1089	3.  The clinic shall have a written facility-specific
1090	disaster plan which sets forth actions that will be taken in the
1091	event of clinic closure due to unforeseen disasters and shall
1092	include provisions for the protection of medical records and any
1093	controlled substances.
1094	4.  Each clinic shall have at least one employee on the
1095	premises during patient care hours who is certified in Basic
1096	Life Support and is trained in reacting to accidents and medical
1097	emergencies until emergency medical personnel arrive.
1098	(i)  The designated physician is responsible for ensuring
1099	compliance with the following quality assurance requirements.
1100	Each pain-management clinic shall have an ongoing quality
1101	assurance program that objectively and systematically monitors
1102	and evaluates the quality and appropriateness of patient care,
1103	evaluates methods to improve patient care, identifies and
1104	corrects deficiencies within the facility, alerts the designated
1105	physician to identify and resolve recurring problems, and
1106	provides for opportunities to improve the facility's performance
1107	and to enhance and improve the quality of care provided to the
1108	public. The designated physician shall establish a quality
1109	assurance program that includes the following components:
1110	1.  The identification, investigation, and analysis of the
1111	frequency and causes of adverse incidents to patients.
1112	2.  The identification of trends or patterns of incidents.
1113	3.  The development of measures to correct, reduce,
1114	minimize, or eliminate the risk of adverse incidents to
1115	patients.
1116	4.  The documentation of these functions and periodic
1117	review no less than quarterly of such information by the
1118	designated physician.
1119	(j)  The designated physician is responsible for ensuring
1120	compliance with the following data collection and reporting
1121	requirements:
1122	1.  The designated physician for each pain-management
1123	clinic shall report all adverse incidents to the department as
1124	set forth in s. 459.026.
1125	2.  The designated physician shall also report to the Board
1126	of Osteopathic Medicine, in writing, on a quarterly basis, the
1127	following data:
1128	a.  Number of new and repeat patients seen and treated at
1129	the clinic who are prescribed controlled substance medications
1130	for the treatment of chronic, nonmalignant pain.
1131	b.  The number of patients discharged due to drug abuse.
1132	c.  The number of patients discharged due to drug
1133	diversion.
1134	d.  The number of patients treated at the pain clinic whose
1135	domicile is located somewhere other than in this state. A
1136	patient's domicile is the patient's fixed or permanent home to
1137	which he or she intends to return even though he or she may
1138	temporarily reside elsewhere.
1139	(3)  INSPECTION.-
1140	(a)  The department shall inspect the pain-management
1141	clinic annually, including a review of the patient records, to
1142	ensure that it complies with this section and the rules of the
1143	Board of Osteopathic Medicine adopted pursuant to subsection (4)
1144	unless the clinic is accredited by a nationally recognized
1145	accrediting agency approved by the Board of Osteopathic
1146	Medicine.
1147	(b)  During an onsite inspection, the department shall make
1148	a reasonable attempt to discuss each violation with the owner or
1149	designated physician of the pain-management clinic before
1150	issuing a formal written notification.
1151	(c)  Any action taken to correct a violation shall be
1152	documented in writing by the owner or designated physician of
1153	the pain-management clinic and verified by followup visits by
1154	departmental personnel.
1155	(4)  RULEMAKING.-
1156	(a)  The department shall adopt rules necessary to
1157	administer the registration and inspection of pain-management
1158	clinics which establish the specific requirements, procedures,
1159	forms, and fees.
1160	(b)  The department shall adopt a rule defining what
1161	constitutes practice by a designated osteopathic physician at
1162	the clinic location for which the physician has assumed
1163	responsibility, as set forth in subsection (1). When adopting
1164	the rule, the department shall consider the number of clinic
1165	employees, the location of the pain-management clinic, the
1166	clinic's hours of operation, and the amount of controlled
1167	substances being prescribed, dispensed, or administered at the
1168	pain-management clinic.
1169	(c)  The Board of Osteopathic Medicine shall adopt a rule
1170	establishing the maximum number of prescriptions for Schedule II
1171	or Schedule III controlled substances or the controlled
1172	substance Alprazolam which may be written at any one registered
1173	pain-management clinic during any 24-hour period.
1174	(b)(d)  The Board of Osteopathic Medicine shall adopt rules
1175	setting forth standards of practice for osteopathic physicians
1176	practicing in privately owned pain-management clinics that
1177	primarily engage in the treatment of pain by prescribing or
1178	dispensing controlled substance medications. Such rules shall
1179	address, but need not be limited to:
1180	1.  Facility operations;
1181	2.  Physical operations;
1182	3.  Infection control requirements;
1183	4.  Health and safety requirements;
1184	5.  Quality assurance requirements;
1185	6.  Patient records;
1186	7.  training requirements for all facility health care
1187	practitioners who are not regulated by another board.;
1188	8.  Inspections; and
1189	9.  Data collection and reporting requirements.
1190
1191	An osteopathic physician is primarily engaged in the treatment
1192	of pain by prescribing or dispensing controlled substance
1193	medications when the majority of the patients seen are
1194	prescribed or dispensed controlled substance medications for the
1195	treatment of chronic nonmalignant pain. Chronic nonmalignant
1196	pain is pain unrelated to cancer which persists beyond the usual
1197	course of the disease or the injury that is the cause of the
1198	pain or more than 90 days after surgery.
1199	(5)  PENALTIES; ENFORCEMENT.-
1200	(a)  The department may impose an administrative fine on
1201	the clinic of up to $5,000 per violation for violating the
1202	requirements of this section; chapter 499, the Florida Drug and
1203	Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and
1204	Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug
1205	Abuse Prevention and Control Act; chapter 893, the Florida
1206	Comprehensive Drug Abuse Prevention and Control Act; or the
1207	rules of the department. In determining whether a penalty is to
1208	be imposed, and in fixing the amount of the fine, the department
1209	shall consider the following factors:
1210	1.  The gravity of the violation, including the probability
1211	that death or serious physical or emotional harm to a patient
1212	has resulted, or could have resulted, from the pain-management
1213	clinic's actions or the actions of the osteopathic physician,
1214	the severity of the action or potential harm, and the extent to
1215	which the provisions of the applicable laws or rules were
1216	violated.
1217	2.  What actions, if any, the owner or designated
1218	osteopathic physician took to correct the violations.
1219	3.  Whether there were any previous violations at the pain-
1220	management clinic.
1221	4.  The financial benefits that the pain-management clinic
1222	derived from committing or continuing to commit the violation.
1223	(b)  Each day a violation continues after the date fixed
1224	for termination of the violation as ordered by the department
1225	constitutes an additional, separate, and distinct violation.
1226	(c)  The department may impose a fine and, in the case of
1227	an owner-operated pain-management clinic, revoke or deny a pain-
1228	management clinic's registration, if the clinic's designated
1229	osteopathic physician knowingly and intentionally misrepresents
1230	actions taken to correct a violation.
1231	(d)  An owner or designated osteopathic physician of a
1232	pain-management clinic who concurrently operates an unregistered
1233	pain-management clinic is subject to an administrative fine of
1234	$5,000 per day.
1235	(e)  If the owner of a pain-management clinic that requires
1236	registration fails to apply to register the clinic upon a change
1237	of ownership and operates the clinic under the new ownership,
1238	the owner is subject to a fine of $5,000.
1239	(6)  EXPIRATION.-This section expires January 1, 2016.
1240	Section 8.  Paragraph (f) is added to subsection (1) of
1241	section 459.013, Florida Statutes, to read:
1242	459.013  Penalty for violations.-
1243	(1)  Each of the following acts constitutes a felony of the
1244	third degree, punishable as provided in s. 775.082, s. 775.083,
1245	or s. 775.084:
1246	(f)  Dispensing a controlled substance listed in Schedule
1247	II or Schedule III in violation of s. 465.0276.
1248	Section 9.  Paragraph (tt) is added to subsection (1) of
1249	section 459.015, Florida Statutes, to read:
1250	459.015  Grounds for disciplinary action; action by the
1251	board and department.-
1252	(1)  The following acts constitute grounds for denial of a
1253	license or disciplinary action, as specified in s. 456.072(2):
1254	(tt)  Dispensing a controlled substance listed in Schedule
1255	II or Schedule III in violation of s. 465.0276.
1256	Section 10.  Subsections (3) and (4) of section 465.015,
1257	Florida Statutes, are renumbered as subsections (4) and (5),
1258	respectively, a new subsection (3) is added to that section, and
1259	present subsection (4) of that section is amended, to read:
1260	465.015  Violations and penalties.-
1261	(3)  It is unlawful for any pharmacist to knowingly fail to
1262	report to the sheriff or other chief law enforcement agency of
1263	the county where the pharmacy is located within 24 hours after
1264	learning of any instance in which a person obtained or attempted
1265	to obtain a controlled substance, as defined in s. 893.02, or at
1266	the close of business on the next business day, whichever is
1267	later, that the pharmacist knew or believed was obtained or
1268	attempted to be obtained through fraudulent methods or
1269	representations from the pharmacy at which the pharmacist
1270	practiced pharmacy. Any pharmacist who knowingly fails to make
1271	such a report within 24 hours after learning of the fraud or
1272	attempted fraud or at the close of business on the next business
1273	day, whichever is later, commits a misdemeanor of the first
1274	degree, punishable as provided in s. 775.082 or s. 775.083. A
1275	sufficient report of the fraudulent obtaining of controlled
1276	substances under this subsection must contain, at a minimum, a
1277	copy of the prescription used or presented and a narrative,
1278	including all information available to the pharmacist concerning
1279	the transaction, such as the name and telephone number of the
1280	prescribing physician; the name, description, and any personal
1281	identification information pertaining to the person who
1282	presented the prescription; and all other material information,
1283	such as photographic or video surveillance of the transaction.
1284	(5)(4)  Any person who violates any provision of subsection
1285	(1) or subsection (4) (3) commits a misdemeanor of the first
1286	degree, punishable as provided in s. 775.082 or s. 775.083. Any
1287	person who violates any provision of subsection (2) commits a
1288	felony of the third degree, punishable as provided in s.
1289	775.082, s. 775.083, or s. 775.084. In any warrant, information,
1290	or indictment, it shall not be necessary to negative any
1291	exceptions, and the burden of any exception shall be upon the
1292	defendant.
1293	Section 11.  Paragraph (t) is added to subsection (1) of
1294	section 465.016, Florida Statutes, to read:
1295	465.016  Disciplinary actions.-
1296	(1)  The following acts constitute grounds for denial of a
1297	license or disciplinary action, as specified in s. 456.072(2):
1298	(t)  Committing an error or omission during the performance
1299	of a specific function of prescription drug processing, which
1300	includes, for purposes of this paragraph:
1301	1.  Receiving, interpreting, or clarifying a prescription.
1302	2.  Entering prescription data into the pharmacy's record.
1303	3.  Verifying or validating a prescription.
1304	4.  Performing pharmaceutical calculations.
1305	5.  Performing prospective drug review as defined by the
1306	board.
1307	6.  Obtaining refill and substitution authorizations.
1308	7.  Interpreting or acting on clinical data.
1309	8.  Performing therapeutic interventions.
1310	9.  Providing drug information concerning a patient's
1311	prescription.
1312	10.  Providing patient counseling.
1313	Section 12.  Section 465.018, Florida Statutes, is amended
1314	to read:
1315	465.018  Community pharmacies; permits.-
1316	(1)  Any person desiring a permit to operate a community
1317	pharmacy shall apply to the department.
1318	(2)  If the board office certifies that the application
1319	complies with the laws of the state and the rules of the board
1320	governing pharmacies, the department shall issue the permit. No
1321	permit shall be issued unless a licensed pharmacist is
1322	designated as the prescription department manager responsible
1323	for maintaining all drug records, providing for the security of
1324	the prescription department, and following such other rules as
1325	relate to the practice of the profession of pharmacy. The
1326	permittee and the newly designated prescription department
1327	manager shall notify the department within 10 days of any change
1328	in prescription department manager.
1329	(3)  The board may suspend or revoke the permit of, or may
1330	refuse to issue a permit to:
1331	(a)  Any person who has been disciplined or who has
1332	abandoned a permit or allowed a permit to become void after
1333	written notice that disciplinary proceedings had been or would
1334	be brought against the permit;
1335	(b)  Any person who is an officer, director, or person
1336	interested directly or indirectly in a person or business entity
1337	that has had a permit disciplined or abandoned or become void
1338	after written notice that disciplinary proceedings had been or
1339	would be brought against the permit; or
1340	(c)  Any person who is or has been an officer of a business
1341	entity, or who was interested directly or indirectly in a
1342	business entity, the permit of which has been disciplined or
1343	abandoned or become null and void after written notice that
1344	disciplinary proceedings had been or would be brought against
1345	the permit.
1346	(4)  In addition to any other remedies provided by law, the
1347	board may deny the application or suspend or revoke the license,
1348	registration, or certificate of any entity regulated or licensed
1349	by it if the applicant, licensee, registrant, or licenseholder,
1350	or, in the case of a corporation, partnership, or other business
1351	entity, if any officer, director, agent, or managing employee of
1352	that business entity or any affiliated person, partner, or
1353	shareholder having an ownership interest equal to 5 percent or
1354	greater in that business entity, has failed to pay all
1355	outstanding fines, liens, or overpayments assessed by final
1356	order of the department, unless a repayment plan is approved by
1357	the department, or has failed to comply with any repayment plan.
1358	(5)  In reviewing any application requesting a change of
1359	ownership or a change of licensee or registrant, the transferor
1360	shall, before board approval of the change, repay or make
1361	arrangements to repay any amounts owed to the department. If the
1362	transferor fails to repay or make arrangements to repay the
1363	amounts owed to the department, the license or registration may
1364	not be issued to the transferee until repayment or until
1365	arrangements for repayment are made.
1366	(6)  Passing an onsite inspection is a prerequisite to the
1367	issuance of an initial permit or a permit for a change of
1368	location. The department must make the inspection within 90 days
1369	before issuance of the permit.
1370	(7)  Community pharmacies that dispense controlled
1371	substances must maintain a record of all controlled substance
1372	dispensing consistent with the requirements of s. 893.07 and
1373	must make the record available to the department and law
1374	enforcement agencies upon request.
1375	Section 13.  In order to dispense controlled substances
1376	listed in Schedule II or Schedule III, as provided in s. 893.03,
1377	Florida Statutes, on or after July 1, 2012, a community pharmacy
1378	permittee must be permitted pursuant to chapter 465, Florida
1379	Statutes, as amended by this act and any rules adopted
1380	thereunder.
1381	Section 14.  Section 465.022, Florida Statutes, is amended
1382	to read:
1383	465.022  Pharmacies; general requirements; fees.-
1384	(1)  The board shall adopt rules pursuant to ss. 120.536(1)
1385	and 120.54 to implement the provisions of this chapter. Such
1386	rules shall include, but shall not be limited to, rules relating
1387	to:
1388	(a)  General drug safety measures.
1389	(b)  Minimum standards for the physical facilities of
1390	pharmacies.
1391	(c)  Safe storage of floor-stock drugs.
1392	(d)  Functions of a pharmacist in an institutional
1393	pharmacy, consistent with the size and scope of the pharmacy.
1394	(e)  Procedures for the safe storage and handling of
1395	radioactive drugs.
1396	(f)  Procedures for the distribution and disposition of
1397	medicinal drugs distributed pursuant to s. 499.028.
1398	(g)  Procedures for transfer of prescription files and
1399	medicinal drugs upon the change of ownership or closing of a
1400	pharmacy.
1401	(h)  Minimum equipment which a pharmacy shall at all times
1402	possess to fill prescriptions properly.
1403	(i)  Procedures for the dispensing of controlled substances
1404	to minimize dispensing based on fraudulent representations or
1405	invalid practitioner-patient relationships.
1406	(2)  A pharmacy permit may shall be issued only to a
1407	natural person who is at least 18 years of age, to a partnership
1408	comprised of at least one natural person and all of whose
1409	partners are all at least 18 years of age, to a governmental
1410	agency, or to a business entity that is properly registered with
1411	the Secretary of State, if required by law, and has been issued
1412	a federal employer tax identification number corporation that is
1413	registered pursuant to chapter 607 or chapter 617 whose
1414	officers, directors, and shareholders are at least 18 years of
1415	age. Permits issued to business entities may be issued only to
1416	entities whose affiliated persons, members, partners, officers,
1417	directors, and agents, including persons required to be
1418	fingerprinted under subsection (3), are not less than 18 years
1419	of age.
1420	(3)  Any person or business entity, partnership, or
1421	corporation before engaging in the operation of a pharmacy,
1422	shall file with the board a sworn application on forms provided
1423	by the department. For purposes of this section, any person
1424	required to provide fingerprints under this subsection is an
1425	affiliated person within the meaning of s. 465.023(1).
1426	(a)  An application for a pharmacy permit must include a
1427	set of fingerprints from each person having an ownership
1428	interest of 5 percent or greater and from any person who,
1429	directly or indirectly, manages, oversees, or controls the
1430	operation of the applicant, including officers and members of
1431	the board of directors of an applicant that is a corporation.
1432	The applicant must provide payment in the application for the
1433	cost of state and national criminal history records checks.
1434	1.  For corporations having more than $100 million of
1435	business taxable assets in this state, in lieu of these
1436	fingerprint requirements, the department shall require the
1437	prescription department manager or consultant pharmacist of
1438	record who will be directly involved in the management and
1439	operation of the pharmacy to submit a set of fingerprints.
1440	2.  A representative of a corporation described in
1441	subparagraph 1. satisfies the requirement to submit a set of his
1442	or her fingerprints if the fingerprints are on file with the
1443	department or the Agency for Health Care Administration, meet
1444	the fingerprint specifications for submission by the Department
1445	of Law Enforcement, and are available to the department.
1446	(b)  The department shall annually submit the fingerprints
1447	provided by the applicant to the Department of Law Enforcement
1448	for a state criminal history records check. The Department of
1449	Law Enforcement shall annually forward the fingerprints to the
1450	Federal Bureau of Investigation for a national criminal history
1451	records check. The department shall report the results of annual
1452	criminal history records checks to wholesale distributors
1453	permitted under chapter 499 for the purposes of s. 499.0121(15).
1454	(c)  In addition to those documents required by the
1455	department or board, each applicant having any financial or
1456	ownership interest greater than 5 percent in the subject of the
1457	application must submit a signed affidavit disclosing any
1458	financial or ownership interest greater than 5 percent in any
1459	pharmacy permitted in the past 5 years, which pharmacy has
1460	closed voluntarily or involuntarily, has filed a voluntary
1461	relinquishment of its permit, has had its permit suspended or
1462	revoked, or has had an injunction issued against it by a
1463	regulatory agency. The affidavit must disclose the reason such
1464	entity was closed, whether voluntary or involuntary.
1465	(4)  An application for a pharmacy permit must include the
1466	applicant's written policies and procedures for preventing
1467	controlled substance dispensing based on fraudulent
1468	representations or invalid practitioner-patient relationships.
1469	The board must review the policies and procedures and may deny a
1470	permit if the policies and procedures are insufficient to
1471	reasonably prevent such dispensing. The department may phase in
1472	the submission and review of policies and procedures over one
1473	18-month period beginning July 1, 2011.
1474	(5)(4)  The department or board shall deny an application
1475	for a pharmacy permit if the applicant or an affiliated person,
1476	partner, officer, director, or prescription department manager
1477	or consultant pharmacist of record of the applicant has:
1478	(a)  Has obtained a permit by misrepresentation or fraud.;
1479	(b)  Has attempted to procure, or has procured, a permit
1480	for any other person by making, or causing to be made, any false
1481	representation.;
1482	(c)  Has been convicted of, or entered a plea of guilty or
1483	nolo contendere to, regardless of adjudication, a crime in any
1484	jurisdiction which relates to the practice of, or the ability to
1485	practice, the profession of pharmacy.;
1486	(d)  Has been convicted of, or entered a plea of guilty or
1487	nolo contendere to, regardless of adjudication, a crime in any
1488	jurisdiction which relates to health care fraud.;
1489	(e)  Has been convicted of, or entered a plea of guilty or
1490	nolo contendere to, regardless of adjudication, a felony under
1491	chapter 409, chapter 817, or chapter 893, or a similar felony
1492	offense committed in another state or jurisdiction, since July
1493	1, 2009. Been terminated for cause, pursuant to the appeals
1494	procedures established by the state or Federal Government, from
1495	any state Medicaid program or the federal Medicare program,
1496	unless the applicant has been in good standing with a state
1497	Medicaid program or the federal Medicare program for the most
1498	recent 5 years and the termination occurred at least 20 years
1499	ago; or
1500	(f)  Has been convicted of, or entered a plea of guilty or
1501	nolo contendere to, regardless of adjudication, a felony under
1502	21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1,
1503	2009.
1504	(g)  Has been terminated for cause from the Florida
1505	Medicaid program pursuant to s. 409.913, unless the applicant
1506	has been in good standing with the Florida Medicaid program for
1507	the most recent 5-year period.
1508	(h)  Has been terminated for cause, pursuant to the appeals
1509	procedures established by the state, from any other state
1510	Medicaid program, unless the applicant has been in good standing
1511	with a state Medicaid program for the most recent 5-year period
1512	and the termination occurred at least 20 years before the date
1513	of the application.
1514	(i)  Is currently listed on the United States Department of
1515	Health and Human Services Office of Inspector General's List of
1516	Excluded Individuals and Entities.
1517	(j)(f)  Has dispensed any medicinal drug based upon a
1518	communication that purports to be a prescription as defined by
1519	s. 465.003(14) or s. 893.02 when the pharmacist knows or has
1520	reason to believe that the purported prescription is not based
1521	upon a valid practitioner-patient relationship that includes a
1522	documented patient evaluation, including history and a physical
1523	examination adequate to establish the diagnosis for which any
1524	drug is prescribed and any other requirement established by
1525	board rule under chapter 458, chapter 459, chapter 461, chapter
1526	463, chapter 464, or chapter 466.
1527
1528	For felonies in which the defendant entered a plea of guilty or
1529	nolo contendere in an agreement with the court to enter a
1530	pretrial intervention or drug diversion program, the department
1531	shall deny the application if upon final resolution of the case
1532	the licensee has failed to successfully complete the program.
1533	(6)  The department or board may deny an application for a
1534	pharmacy permit if the applicant or an affiliated person,
1535	partner, officer, director, or prescription department manager
1536	or consultant pharmacist of record of the applicant has violated
1537	or failed to comply with any provision of this chapter; chapter
1538	499, the Florida Drug and Cosmetic Act; chapter 893; 21 U.S.C.
1539	ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C.
1540	ss. 821 et seq., the Comprehensive Drug Abuse Prevention and
1541	Control Act; or any rules or regulations promulgated thereunder
1542	unless the violation or noncompliance is technical.
1543	(7)(5)  After the application has been filed with the board
1544	and the permit fee provided in this section has been received,
1545	the board shall cause the application to be fully investigated,
1546	both as to the qualifications of the applicant and the
1547	prescription department manager or consultant pharmacist
1548	designated to be in charge and as to the premises and location
1549	described in the application.
1550	(8)(6)  The Board of Pharmacy shall have the authority to
1551	determine whether a bona fide transfer of ownership is present
1552	and that the sale of a pharmacy is not being accomplished for
1553	the purpose of avoiding an administrative prosecution.
1554	(9)(7)  Upon the completion of the investigation of an
1555	application, the board shall approve or deny disapprove the
1556	application. If approved, the permit shall be issued by the
1557	department.
1558	(10)(8)  A permittee must notify the department, on a form
1559	approved by the board, within 10 days after any change in
1560	prescription department manager or consultant pharmacist of
1561	record. Permits issued by the department are not transferable.
1562	(11)  A permittee must notify the department of the
1563	identity of the prescription department manager within 10 days
1564	after employment. The prescription department manager must
1565	comply with the following requirements:
1566	(a)  The prescription department manager of a permittee
1567	must obtain and maintain all drug records required by any state
1568	or federal law to be obtained by a pharmacy, including, but not
1569	limited to, records required by or under this chapter, chapter
1570	499, or chapter 893. The prescription department manager must
1571	ensure the permittee's compliance with all rules adopted under
1572	those chapters as they relate to the practice of the profession
1573	of pharmacy and the sale of prescription drugs.
1574	(b)  The prescription department manager must ensure the
1575	security of the prescription department. The prescription
1576	department manager must notify the board of any theft or
1577	significant loss of any controlled substances within 1 business
1578	day after discovery of the theft or loss.
1579	(c)  A registered pharmacist may not serve as the
1580	prescription department manager in more than one location unless
1581	approved by the board.
1582	(12)  The board shall adopt rules that require the keeping
1583	of such records of prescription drugs as are necessary for the
1584	protection of public health, safety, and welfare.
1585	(a)  All required records documenting prescription drug
1586	distributions shall be readily available or immediately
1587	retrievable during an inspection by the department.
1588	(b)  The records must be maintained for 4 years after the
1589	creation or receipt of the record, whichever is later.
1590	(13)  Permits issued by the department are not
1591	transferable.
1592	(14)(9)  The board shall set the fees for the following:
1593	(a)  Initial permit fee not to exceed $250.
1594	(b)  Biennial permit renewal not to exceed $250.
1595	(c)  Delinquent fee not to exceed $100.
1596	(d)  Change of location fee not to exceed $100.
1597	Section 15.  Paragraph (b) of subsection (1) of section
1598	465.0276, Florida Statutes, is amended to read:
1599	465.0276  Dispensing practitioner.-
1600	(1)
1601	(b)1.  A practitioner registered under this section may not
1602	dispense more than a 72-hour supply of a controlled substance
1603	listed in Schedule II or, Schedule III as provided in, Schedule
1604	IV, or Schedule V of s. 893.03 for any patient who pays for the
1605	medication by cash, check, or credit card in a clinic registered
1606	under s. 458.3265 or s. 459.0137. A practitioner who violates
1607	this paragraph commits a felony of the third degree, punishable
1608	as provided in s. 775.082, s. 775.083, or s. 775.084. This
1609	paragraph does not apply to:
1610	1.  A practitioner who dispenses medication to a workers'
1611	compensation patient pursuant to chapter 440.
1612	2.  A practitioner who dispenses medication to an insured
1613	patient who pays by cash, check, or credit card to cover any
1614	applicable copayment or deductible.
1615	1.3.  The dispensing of complimentary packages of medicinal
1616	drugs which are labeled as a drug sample or complimentary drug
1617	as defined in s. 499.028 to the practitioner's own patients in
1618	the regular course of her or his practice without the payment of
1619	a fee or remuneration of any kind, whether direct or indirect,
1620	as provided in subsection (5).
1621	2.  The dispensing of controlled substances in the health
1622	care system of the Department of Corrections.
1623	3.  The dispensing of a controlled substance listed in
1624	Schedule II or Schedule III in connection with the performance
1625	of a surgical procedure. The amount dispensed pursuant to the
1626	subparagraph may not exceed a 14-day supply. This exception does
1627	not allow for the dispensing of a controlled substance listed in
1628	Schedule II or Schedule III more than 14 days after the
1629	performance of the surgical procedure. For purposes of this
1630	subparagraph, the term "surgical procedure" means any procedure
1631	in any setting which involves, or reasonably should involve:
1632	a.  Perioperative medication and sedation that allows the
1633	patient to tolerate unpleasant procedures while maintaining
1634	adequate cardiorespiratory function and the ability to respond
1635	purposefully to verbal or tactile stimulation and makes intra-
1636	and post-operative monitoring necessary; or
1637	b.  The use of general anesthesia or major conduction
1638	anesthesia and preoperative sedation.
1639	4.  The dispensing of a controlled substance listed in
1640	Schedule II or Schedule III pursuant to an approved clinical
1641	trial. For purposes of this subparagraph, the term "approved
1642	clinical trial" means a clinical research study or clinical
1643	investigation that, in whole or in part, is state or federally
1644	funded or is conducted under an investigational new drug
1645	application that is reviewed by the United States Food and Drug
1646	Administration.
1647	5.  The dispensing of methadone in a facility licensed
1648	under s. 397.427 where medication-assisted treatment for opiate
1649	addiction is provided.
1650	6.  The dispensing of a controlled substance listed in
1651	Schedule II or Schedule III to a patient of a facility licensed
1652	under part IV of chapter 400.
1653	Section 16.  Subsections (16) and (17) are added to section
1654	499.0051, Florida Statutes, to read:
1655	499.0051  Criminal acts.-
1656	(16)  FALSE REPORT.-Any person who submits a report
1657	required by s. 499.0121(14) knowing that such report contains a
1658	false statement commits a felony of the third degree, punishable
1659	as provided in s. 775.082, s. 775.083, or s. 775.084.
1660	(17)  CONTROLLED SUBSTANCE DISTRIBUTION.-Any person who
1661	engages in the wholesale distribution of prescription drugs and
1662	who knowingly distributes controlled substances in violation of
1663	s. 499.0121(14) commits a felony of the third degree, punishable
1664	as provided in s. 775.082, s. 775.083, or s. 775.084. In
1665	addition to any other fine that may be imposed, a person
1666	convicted of such a violation may be sentenced to pay a fine
1667	that does not exceed three times the gross monetary value gained
1668	from such violation, plus court costs and the reasonable costs
1669	of investigation and prosecution.
1670	Section 17.  Paragraph (o) is added to subsection (8) of
1671	section 499.012, Florida Statutes, to read:
1672	499.012  Permit application requirements.-
1673	(8)  An application for a permit or to renew a permit for a
1674	prescription drug wholesale distributor or an out-of-state
1675	prescription drug wholesale distributor submitted to the
1676	department must include:
1677	(o)  Documentation of the credentialing policies and
1678	procedures required by s. 499.0121(14).
1679	Section 18.  Subsections (14) and (15) are added to section
1680	499.0121, Florida Statutes, to read:
1681	499.0121  Storage and handling of prescription drugs;
1682	recordkeeping.-The department shall adopt rules to implement
1683	this section as necessary to protect the public health, safety,
1684	and welfare. Such rules shall include, but not be limited to,
1685	requirements for the storage and handling of prescription drugs
1686	and for the establishment and maintenance of prescription drug
1687	distribution records.
1688	(14)  DISTRIBUTION REPORTING.-Each prescription drug
1689	wholesale distributor, out-of-state prescription drug wholesale
1690	distributor, retail pharmacy drug wholesale distributor,
1691	manufacturer, or repackager that engages in the wholesale
1692	distribution of controlled substances as defined in s. 893.02
1693	shall submit a report to the department of its receipts and
1694	distributions of controlled substances listed in Schedule II,
1695	Schedule III, Schedule IV, or Schedule V as provided in s.
1696	893.03. Wholesale distributor facilities located within this
1697	state shall report all transactions involving controlled
1698	substances, and wholesale distributor facilities located outside
1699	this state shall report all distributions to entities located in
1700	this state. If the prescription drug wholesale distributor, out-
1701	of-state prescription drug wholesale distributor, retail
1702	pharmacy drug wholesale distributor, manufacturer, or repackager
1703	does not have any controlled substance distributions for the
1704	month, a report shall be sent indicating that no distributions
1705	occurred in the period. The report shall be submitted monthly by
1706	the 20th of the next month, in the electronic format used for
1707	controlled substance reporting to the Automation of Reports and
1708	Consolidated Orders System division of the federal Drug
1709	Enforcement Administration. Submission of electronic data must
1710	be made in a secured Internet environment that allows for manual
1711	or automated transmission. Upon successful transmission, an
1712	acknowledgement page must be displayed to confirm receipt. The
1713	report must contain the following information:
1714	(a)  The federal Drug Enforcement Administration
1715	registration number of the wholesale distributing location.
1716	(b)  The federal Drug Enforcement Administration
1717	registration number of the entity to which the drugs are
1718	distributed or from which the drugs are received.
1719	(c)  The transaction code that indicates the type of
1720	transaction.
1721	(d)  The National Drug Code identifier of the product and
1722	the quantity distributed or received.
1723	(e)  The Drug Enforcement Administration Form 222 number or
1724	Controlled Substance Ordering System Identifier on all schedule
1725	II transactions.
1726	(f)  The date of the transaction.
1727
1728	The department must share the reported data with the Department
1729	of Law Enforcement and local law enforcement agencies upon
1730	request and must monitor purchasing to identify purchasing
1731	levels that are inconsistent with the purchasing entity's
1732	clinical needs. The Department of Law Enforcement shall
1733	investigate purchases at levels that are inconsistent with the
1734	purchasing entity's clinical needs to determine whether
1735	violations of chapter 893 have occurred.
1736	(15)  DUE DILIGENCE OF PURCHASERS.-
1737	(a)  Each prescription drug wholesale distributor, out-of-
1738	state prescription drug wholesale distributor, and retail
1739	pharmacy drug wholesale distributor must establish and maintain
1740	policies and procedures to credential physicians licensed under
1741	chapter 458, chapter 459, chapter 461, or chapter 466 and
1742	pharmacies that purchase or otherwise receive from the wholesale
1743	distributor controlled substances listed in Schedule II or
1744	Schedule III as provided in s. 893.03. The prescription drug
1745	wholesale distributor, out-of-state prescription drug wholesale
1746	distributor, or retail pharmacy drug wholesale distributor shall
1747	maintain records of such credentialing and make the records
1748	available to the department upon request. Such credentialing
1749	must, at a minimum, include:
1750	1.  A determination of the clinical nature of the receiving
1751	entity, including any specialty practice area.
1752	2.  A review of the receiving entity's history of Schedule
1753	II and Schedule III controlled substance purchasing from the
1754	wholesale distributor.
1755	3.  A determination that the receiving entity's Schedule II
1756	and Schedule III controlled substance purchasing history, if
1757	any, is consistent with and reasonable for that entity's
1758	clinical business needs.
1759	(b)  A wholesale distributor must take reasonable measures
1760	to identify its customers, understand the normal and expected
1761	transactions conducted by those customers, and identify those
1762	transactions that are suspicious in nature. A wholesale
1763	distributor must establish internal policies and procedures for
1764	identifying suspicious orders and preventing suspicious
1765	transactions. A wholesale distributor must assess orders for
1766	greater than 5,000 unit doses of any one controlled substance in
1767	any one month to determine whether the purchase is reasonable.
1768	In making such assessments, a wholesale distributor may consider
1769	the purchasing entity's clinical business needs, location, and
1770	population served, in addition to other factors established in
1771	the distributor's policies and procedures. A wholesale
1772	distributor must report to the department any regulated
1773	transaction involving an extraordinary quantity of a listed
1774	chemical, an uncommon method of payment or delivery, or any
1775	other circumstance that the regulated person believes may
1776	indicate that the listed chemical will be used in violation of
1777	the law. The wholesale distributor shall maintain records that
1778	document the report submitted to the department in compliance
1779	with this paragraph.
1780	(c)  A wholesale distributor may not distribute controlled
1781	substances to an entity if any criminal history record check for
1782	any person associated with that entity shows that the person has
1783	been convicted of, or entered a plea of guilty or nolo
1784	contendere to, regardless of adjudication, a crime in any
1785	jurisdiction related to controlled substances, the practice of
1786	pharmacy, or the dispensing of medicinal drugs.
1787	(d)  The department shall assess national data from the
1788	Automation of Reports and Consolidated Orders System of the
1789	federal Drug Enforcement Administration, excluding Florida data,
1790	and identify the national average of grams of hydrocodone,
1791	morphine, oxycodone, and methadone distributed per pharmacy
1792	registrant per month in the most recent year for which data is
1793	available. The department shall report the average for each of
1794	these drugs to the Governor, the President of the Senate, and
1795	the Speaker of the House of Representatives by November 1, 2011.
1796	The department shall assess the data reported pursuant to
1797	subsection (14) and identify the statewide average of grams of
1798	each benzodiazapine distributed per community pharmacy per
1799	month. The department shall report the average for each
1800	benzodiazapine to the Governor, the President of the Senate, and
1801	the Speaker of the House of Representatives by November 1, 2011.
1802	Section 19.  Paragraphs (o) and (p) are added to subsection
1803	(1) of section 499.05, Florida Statutes, to read:
1804	499.05  Rules.-
1805	(1)  The department shall adopt rules to implement and
1806	enforce this part with respect to:
1807	(o)  Wholesale distributor reporting requirements of s.
1808	499.0121(14).
1809	(p)  Wholesale distributor credentialing and distribution
1810	requirements of s. 499.0121(15).
1811	Section 20.  Subsections (8) and (9) are added to section
1812	499.067, Florida Statutes, to read:
1813	499.067  Denial, suspension, or revocation of permit,
1814	certification, or registration.-
1815	(8)  The department may deny, suspend, or revoke a permit
1816	if it finds the permittee has not complied with the
1817	credentialing requirements of s. 499.0121(15).
1818	(9)  The department may deny, suspend, or revoke a permit
1819	if it finds the permittee has not complied with the reporting
1820	requirements of, or knowingly made a false statement in a report
1821	required by, s. 499.0121(14).
1822	Section 21.  Paragraph (f) is added to subsection (3) of
1823	section 810.02, Florida Statutes, to read:
1824	810.02  Burglary.-
1825	(3)  Burglary is a felony of the second degree, punishable
1826	as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
1827	course of committing the offense, the offender does not make an
1828	assault or battery and is not and does not become armed with a
1829	dangerous weapon or explosive, and the offender enters or
1830	remains in a:
1831	(f)  Structure or conveyance when the offense intended to
1832	be committed therein is theft of a controlled substance as
1833	defined in s. 893.02. Notwithstanding any other law, separate
1834	judgments and sentences for burglary with the intent to commit
1835	theft of a controlled substance under this paragraph and for any
1836	applicable possession of controlled substance offense under s.
1837	893.13 or trafficking in controlled substance offense under s.
1838	893.135 may be imposed when all such offenses involve the same
1839	amount or amounts of a controlled substance.
1840
1841	However, if the burglary is committed within a county that is
1842	subject to a state of emergency declared by the Governor under
1843	chapter 252 after the declaration of emergency is made and the
1844	perpetration of the burglary is facilitated by conditions
1845	arising from the emergency, the burglary is a felony of the
1846	first degree, punishable as provided in s. 775.082, s. 775.083,
1847	or s. 775.084. As used in this subsection, the term "conditions
1848	arising from the emergency" means civil unrest, power outages,
1849	curfews, voluntary or mandatory evacuations, or a reduction in
1850	the presence of or response time for first responders or
1851	homeland security personnel. A person arrested for committing a
1852	burglary within a county that is subject to such a state of
1853	emergency may not be released until the person appears before a
1854	committing magistrate at a first appearance hearing. For
1855	purposes of sentencing under chapter 921, a felony offense that
1856	is reclassified under this subsection is ranked one level above
1857	the ranking under s. 921.0022 or s. 921.0023 of the offense
1858	committed.
1859	Section 22.  Paragraph (c) of subsection (2) of section
1860	812.014, Florida Statutes, is amended to read:
1861	812.014  Theft.-
1862	(2)
1863	(c)  It is grand theft of the third degree and a felony of
1864	the third degree, punishable as provided in s. 775.082, s.
1865	775.083, or s. 775.084, if the property stolen is:
1866	1.  Valued at $300 or more, but less than $5,000.
1867	2.  Valued at $5,000 or more, but less than $10,000.
1868	3.  Valued at $10,000 or more, but less than $20,000.
1869	4.  A will, codicil, or other testamentary instrument.
1870	5.  A firearm.
1871	6.  A motor vehicle, except as provided in paragraph (a).
1872	7.  Any commercially farmed animal, including any animal of
1873	the equine, bovine, or swine class, or other grazing animal, and
1874	including aquaculture species raised at a certified aquaculture
1875	facility. If the property stolen is aquaculture species raised
1876	at a certified aquaculture facility, then a $10,000 fine shall
1877	be imposed.
1878	8.  Any fire extinguisher.
1879	9.  Any amount of citrus fruit consisting of 2,000 or more
1880	individual pieces of fruit.
1881	10.  Taken from a designated construction site identified
1882	by the posting of a sign as provided for in s. 810.09(2)(d).
1883	11.  Any stop sign.
1884	12.  Anhydrous ammonia.
1885	13.  Any amount of a controlled substance as defined in s.
1886	893.02. Notwithstanding any other law, separate judgments and
1887	sentences for theft of a controlled substance under this
1888	subparagraph and for any applicable possession of controlled
1889	substance offense under s. 893.13 or trafficking in controlled
1890	substance offense under s. 893.135 may be imposed when all such
1891	offenses involve the same amount or amounts of a controlled
1892	substance.
1893
1894	However, if the property is stolen within a county that is
1895	subject to a state of emergency declared by the Governor under
1896	chapter 252, the property is stolen after the declaration of
1897	emergency is made, and the perpetration of the theft is
1898	facilitated by conditions arising from the emergency, the
1899	offender commits a felony of the second degree, punishable as
1900	provided in s. 775.082, s. 775.083, or s. 775.084, if the
1901	property is valued at $5,000 or more, but less than $10,000, as
1902	provided under subparagraph 2., or if the property is valued at
1903	$10,000 or more, but less than $20,000, as provided under
1904	subparagraph 3. As used in this paragraph, the term "conditions
1905	arising from the emergency" means civil unrest, power outages,
1906	curfews, voluntary or mandatory evacuations, or a reduction in
1907	the presence of or the response time for first responders or
1908	homeland security personnel. For purposes of sentencing under
1909	chapter 921, a felony offense that is reclassified under this
1910	paragraph is ranked one level above the ranking under s.
1911	921.0022 or s. 921.0023 of the offense committed.
1912	Section 23.  Section 893.055, Florida Statutes, is amended
1913	to read:
1914	893.055  Prescription drug monitoring program.-
1915	(1)  As used in this section, the term:
1916	(a)  "Patient advisory report" or "advisory report" means
1917	information provided by the department in writing, or as
1918	determined by the department, to a prescriber, dispenser,
1919	pharmacy, or patient concerning the dispensing of controlled
1920	substances. All advisory reports are for informational purposes
1921	only and impose no obligations of any nature or any legal duty
1922	on a prescriber, dispenser, pharmacy, or patient. The patient
1923	advisory report shall be provided in accordance with s.
1924	893.13(7)(a)8. The advisory reports issued by the department are
1925	not subject to discovery or introduction into evidence in any
1926	civil or administrative action against a prescriber, dispenser,
1927	pharmacy, or patient arising out of matters that are the subject
1928	of the report; and a person who participates in preparing,
1929	reviewing, issuing, or any other activity related to an advisory
1930	report may not be permitted or required to testify in any such
1931	civil action as to any findings, recommendations, evaluations,
1932	opinions, or other actions taken in connection with preparing,
1933	reviewing, or issuing such a report.
1934	(b)  "Controlled substance" means a controlled substance
1935	listed in Schedule II, Schedule III, or Schedule IV in s.
1936	893.03.
1937	(c)  "Dispenser" means a pharmacy, dispensing pharmacist,
1938	or dispensing health care practitioner.
1939	(d)  "Health care practitioner" or "practitioner" means any
1940	practitioner who is subject to licensure or regulation by the
1941	department under chapter 458, chapter 459, chapter 461, chapter
1942	462, chapter 464, chapter 465, or chapter 466.
1943	(e)  "Health care regulatory board" means any board for a
1944	practitioner or health care practitioner who is licensed or
1945	regulated by the department.
1946	(f)  "Pharmacy" means any pharmacy that is subject to
1947	licensure or regulation by the department under chapter 465 and
1948	that dispenses or delivers a controlled substance to an
1949	individual or address in this state.
1950	(g)  "Prescriber" means a prescribing physician,
1951	prescribing practitioner, or other prescribing health care
1952	practitioner.
1953	(h)  "Active investigation" means an investigation that is
1954	being conducted with a reasonable, good faith belief that it
1955	could lead to the filing of administrative, civil, or criminal
1956	proceedings, or that is ongoing and continuing and for which
1957	there is a reasonable, good faith anticipation of securing an
1958	arrest or prosecution in the foreseeable future.
1959	(i)  "Law enforcement agency" means the Department of Law
1960	Enforcement, a Florida sheriff's department, a Florida police
1961	department, or a law enforcement agency of the Federal
1962	Government which enforces the laws of this state or the United
1963	States relating to controlled substances, and which its agents
1964	and officers are empowered by law to conduct criminal
1965	investigations and make arrests.
1966	(j)  "Program manager" means an employee of or a person
1967	contracted by the Department of Health who is designated to
1968	ensure the integrity of the prescription drug monitoring program
1969	in accordance with the requirements established in paragraphs
1970	(2)(a) and (b).
1971	(2)(a)  By December 1, 2010, The department shall design
1972	and establish a comprehensive electronic database system that
1973	has controlled substance prescriptions provided to it and that
1974	provides prescription information to a patient's health care
1975	practitioner and pharmacist who inform the department that they
1976	wish the patient advisory report provided to them. Otherwise,
1977	the patient advisory report will not be sent to the
1978	practitioner, pharmacy, or pharmacist. The system shall be
1979	designed to provide information regarding dispensed
1980	prescriptions of controlled substances and shall not infringe
1981	upon the legitimate prescribing or dispensing of a controlled
1982	substance by a prescriber or dispenser acting in good faith and
1983	in the course of professional practice. The system shall be
1984	consistent with standards of the American Society for Automation
1985	in Pharmacy (ASAP). The electronic system shall also comply with
1986	the Health Insurance Portability and Accountability Act (HIPAA)
1987	as it pertains to protected health information (PHI), electronic
1988	protected health information (EPHI), and all other relevant
1989	state and federal privacy and security laws and regulations. The
1990	department shall establish policies and procedures as
1991	appropriate regarding the reporting, accessing the database,
1992	evaluation, management, development, implementation, operation,
1993	storage, and security of information within the system. The
1994	reporting of prescribed controlled substances shall include a
1995	dispensing transaction with a dispenser pursuant to chapter 465
1996	or through a dispensing transaction to an individual or address
1997	in this state with a pharmacy that is not located in this state
1998	but that is otherwise subject to the jurisdiction of this state
1999	as to that dispensing transaction. The reporting of patient
2000	advisory reports refers only to reports to patients, pharmacies,
2001	and practitioners. Separate reports that contain patient
2002	prescription history information and that are not patient
2003	advisory reports are provided to persons and entities as
2004	authorized in paragraphs (7)(b) and (c) and s. 893.0551.
2005	(b)  The department, when the direct support organization
2006	receives at least $20,000 in nonstate moneys or the state
2007	receives at least $20,000 in federal grants for the prescription
2008	drug monitoring program, and in consultation with the Office of
2009	Drug Control, shall adopt rules as necessary concerning the
2010	reporting, accessing the database, evaluation, management,
2011	development, implementation, operation, security, and storage of
2012	information within the system, including rules for when patient
2013	advisory reports are provided to pharmacies and prescribers. The
2014	patient advisory report shall be provided in accordance with s.
2015	893.13(7)(a)8. The department shall work with the professional
2016	health care licensure boards, such as the Board of Medicine, the
2017	Board of Osteopathic Medicine, and the Board of Pharmacy; other
2018	appropriate organizations, such as the Florida Pharmacy
2019	Association, the Office of Drug Control, the Florida Medical
2020	Association, the Florida Retail Federation, and the Florida
2021	Osteopathic Medical Association, including those relating to
2022	pain management; and the Attorney General, the Department of Law
2023	Enforcement, and the Agency for Health Care Administration to
2024	develop rules appropriate for the prescription drug monitoring
2025	program.
2026	(c)  All dispensers and prescribers subject to these
2027	reporting requirements shall be notified by the department of
2028	the implementation date for such reporting requirements.
2029	(d)  The program manager shall work with professional
2030	health care licensure boards and the stakeholders listed in
2031	paragraph (b) to develop rules appropriate for identifying
2032	indicators of controlled substance abuse.
2033	(3)  The pharmacy dispensing the controlled substance and
2034	each prescriber who directly dispenses a controlled substance
2035	shall submit to the electronic system, by a procedure and in a
2036	format established by the department and consistent with an
2037	ASAP-approved format, the following information for inclusion in
2038	the database:
2039	(a)  The name of the prescribing practitioner, the
2040	practitioner's federal Drug Enforcement Administration
2041	registration number, the practitioner's National Provider
2042	Identification (NPI) or other appropriate identifier, and the
2043	date of the prescription.
2044	(b)  The date the prescription was filled and the method of
2045	payment, such as cash by an individual, insurance coverage
2046	through a third party, or Medicaid payment. This paragraph does
2047	not authorize the department to include individual credit card
2048	numbers or other account numbers in the database.
2049	(c)  The full name, address, and date of birth of the
2050	person for whom the prescription was written.
2051	(d)  The name, national drug code, quantity, and strength
2052	of the controlled substance dispensed.
2053	(e)  The full name, federal Drug Enforcement Administration
2054	registration number, and address of the pharmacy or other
2055	location from which the controlled substance was dispensed. If
2056	the controlled substance was dispensed by a practitioner other
2057	than a pharmacist, the practitioner's full name, federal Drug
2058	Enforcement Administration registration number, and address.
2059	(f)  The name of the pharmacy or practitioner, other than a
2060	pharmacist, dispensing the controlled substance and the
2061	practitioner's National Provider Identification (NPI).
2062	(g)  Other appropriate identifying information as
2063	determined by department rule.
2064	(4)  Each time a controlled substance is dispensed to an
2065	individual, the controlled substance shall be reported to the
2066	department through the system as soon thereafter as possible,
2067	but not more than 7 15 days after the date the controlled
2068	substance is dispensed unless an extension is approved by the
2069	department for cause as determined by rule. A dispenser must
2070	meet the reporting requirements of this section by providing the
2071	required information concerning each controlled substance that
2072	it dispensed in a department-approved, secure methodology and
2073	format. Such approved formats may include, but are not limited
2074	to, submission via the Internet, on a disc, or by use of regular
2075	mail.
2076	(5)  When the following acts of dispensing or administering
2077	occur, the following are exempt from reporting under this
2078	section for that specific act of dispensing or administration:
2079	(a)  A health care practitioner when administering a
2080	controlled substance directly to a patient if the amount of the
2081	controlled substance is adequate to treat the patient during
2082	that particular treatment session.
2083	(b)  A pharmacist or health care practitioner when
2084	administering a controlled substance to a patient or resident
2085	receiving care as a patient at a hospital, nursing home,
2086	ambulatory surgical center, hospice, or intermediate care
2087	facility for the developmentally disabled which is licensed in
2088	this state.
2089	(c)  A practitioner when administering or dispensing a
2090	controlled substance in the health care system of the Department
2091	of Corrections.
2092	(d)  A practitioner when administering a controlled
2093	substance in the emergency room of a licensed hospital.
2094	(e)  A health care practitioner when administering or
2095	dispensing a controlled substance to a person under the age of
2096	16.
2097	(f)  A pharmacist or a dispensing practitioner when
2098	dispensing a one-time, 72-hour emergency resupply of a
2099	controlled substance to a patient.
2100	(6)  The department may establish when to suspend and when
2101	to resume reporting information during a state-declared or
2102	nationally declared disaster.
2103	(7)(a)  A practitioner or pharmacist who dispenses a
2104	controlled substance must submit the information required by
2105	this section in an electronic or other method in an ASAP format
2106	approved by rule of the department unless otherwise provided in
2107	this section. The cost to the dispenser in submitting the
2108	information required by this section may not be material or
2109	extraordinary. Costs not considered to be material or
2110	extraordinary include, but are not limited to, regular postage,
2111	electronic media, regular electronic mail, and facsimile
2112	charges.
2113	(b)  A pharmacy, prescriber, or dispenser shall have access
2114	to information in the prescription drug monitoring program's
2115	database which relates to a patient of that pharmacy,
2116	prescriber, or dispenser in a manner established by the
2117	department as needed for the purpose of reviewing the patient's
2118	controlled substance prescription history. Other access to the
2119	program's database shall be limited to the program's manager and
2120	to the designated program and support staff, who may act only at
2121	the direction of the program manager or, in the absence of the
2122	program manager, as authorized. Access by the program manager or
2123	such designated staff is for prescription drug program
2124	management only or for management of the program's database and
2125	its system in support of the requirements of this section and in
2126	furtherance of the prescription drug monitoring program.
2127	Confidential and exempt information in the database shall be
2128	released only as provided in paragraph (c) and s. 893.0551. The
2129	program manager, designated program and support staff who act at
2130	the direction of or in the absence of the program manager, and
2131	any individual who has similar access regarding the management
2132	of the database from the prescription drug monitoring program
2133	shall submit fingerprints to the department for background
2134	screening. The department shall follow the procedure established
2135	by the Department of Law Enforcement to request a statewide
2136	criminal history record check and to request that the Department
2137	of Law Enforcement forward the fingerprints to the Federal
2138	Bureau of Investigation for a national criminal history record
2139	check.
2140	(c)  The following entities shall not be allowed direct
2141	access to information in the prescription drug monitoring
2142	program database but may request from the program manager and,
2143	when authorized by the program manager, the program manager's
2144	program and support staff, information that is confidential and
2145	exempt under s. 893.0551. Prior to release, the request shall be
2146	verified as authentic and authorized with the requesting
2147	organization by the program manager, the program manager's
2148	program and support staff, or as determined in rules by the
2149	department as being authentic and as having been authorized by
2150	the requesting entity:
2151	1.  The department or its relevant health care regulatory
2152	boards responsible for the licensure, regulation, or discipline
2153	of practitioners, pharmacists, or other persons who are
2154	authorized to prescribe, administer, or dispense controlled
2155	substances and who are involved in a specific controlled
2156	substance investigation involving a designated person for one or
2157	more prescribed controlled substances.
2158	2.  The Attorney General for Medicaid fraud cases involving
2159	prescribed controlled substances.
2160	3.  A law enforcement agency during active investigations
2161	regarding potential criminal activity, fraud, or theft regarding
2162	prescribed controlled substances.
2163	4.  A patient or the legal guardian or designated health
2164	care surrogate of an incapacitated patient as described in s.
2165	893.0551 who, for the purpose of verifying the accuracy of the
2166	database information, submits a written and notarized request
2167	that includes the patient's full name, address, and date of
2168	birth, and includes the same information if the legal guardian
2169	or health care surrogate submits the request. The request shall
2170	be validated by the department to verify the identity of the
2171	patient and the legal guardian or health care surrogate, if the
2172	patient's legal guardian or health care surrogate is the
2173	requestor. Such verification is also required for any request to
2174	change a patient's prescription history or other information
2175	related to his or her information in the electronic database.
2176
2177	Information in the database for the electronic prescription drug
2178	monitoring system is not discoverable or admissible in any civil
2179	or administrative action, except in an investigation and
2180	disciplinary proceeding by the department or the appropriate
2181	regulatory board.
2182	(d)  The following entities shall not be allowed direct
2183	access to information in the prescription drug monitoring
2184	program database but may request from the program manager and,
2185	when authorized by the program manager, the program manager's
2186	program and support staff, information that contains no
2187	identifying information of any patient, physician, health care
2188	practitioner, prescriber, or dispenser and that is not
2189	confidential and exempt:
2190	1.  Department staff for the purpose of calculating
2191	performance measures pursuant to subsection (8).
2192	2.  The Program Implementation and Oversight Task Force for
2193	its reporting to the Governor, the President of the Senate, and
2194	the Speaker of the House of Representatives regarding the
2195	prescription drug monitoring program. This subparagraph expires
2196	July 1, 2012.
2197	(e)  All transmissions of data required by this section
2198	must comply with relevant state and federal privacy and security
2199	laws and regulations. However, any authorized agency or person
2200	under s. 893.0551 receiving such information as allowed by s.
2201	893.0551 may maintain the information received for up to 24
2202	months before purging it from his or her records or maintain it
2203	for longer than 24 months if the information is pertinent to
2204	ongoing health care or an active law enforcement investigation
2205	or prosecution.
2206	(f)  The program manager, upon determining a pattern
2207	consistent with the rules established under paragraph (2)(d) and
2208	having cause to believe a violation of s. 893.13(7)(a)8.,
2209	(8)(a), or (8)(b) has occurred, may provide relevant information
2210	to the applicable law enforcement agency.
2211	(8)  To assist in fulfilling program responsibilities,
2212	performance measures shall be reported annually to the Governor,
2213	the President of the Senate, and the Speaker of the House of
2214	Representatives by the department each December 1, beginning in
2215	2011. Data that does not contain patient, physician, health care
2216	practitioner, prescriber, or dispenser identifying information
2217	may be requested during the year by department employees so that
2218	the department may undertake public health care and safety
2219	initiatives that take advantage of observed trends. Performance
2220	measures may include, but are not limited to, efforts to achieve
2221	the following outcomes:
2222	(a)  Reduction of the rate of inappropriate use of
2223	prescription drugs through department education and safety
2224	efforts.
2225	(b)  Reduction of the quantity of pharmaceutical controlled
2226	substances obtained by individuals attempting to engage in fraud
2227	and deceit.
2228	(c)  Increased coordination among partners participating in
2229	the prescription drug monitoring program.
2230	(d)  Involvement of stakeholders in achieving improved
2231	patient health care and safety and reduction of prescription
2232	drug abuse and prescription drug diversion.
2233	(9)  Any person who willfully and knowingly fails to report
2234	the dispensing of a controlled substance as required by this
2235	section commits a misdemeanor of the first degree, punishable as
2236	provided in s. 775.082 or s. 775.083.
2237	(10)  All costs incurred by the department in administering
2238	the prescription drug monitoring program shall be funded through
2239	federal grants or private funding applied for or received by the
2240	state. The department may not commit funds for the monitoring
2241	program without ensuring funding is available. The prescription
2242	drug monitoring program and the implementation thereof are
2243	contingent upon receipt of the nonstate funding. The department
2244	and state government shall cooperate with the direct-support
2245	organization established pursuant to subsection (11) in seeking
2246	federal grant funds, other nonstate grant funds, gifts,
2247	donations, or other private moneys for the department so long as
2248	the costs of doing so are not considered material. Nonmaterial
2249	costs for this purpose include, but are not limited to, the
2250	costs of mailing and personnel assigned to research or apply for
2251	a grant. Notwithstanding the exemptions to competitive-
2252	solicitation requirements under s. 287.057(3)(f), the department
2253	shall comply with the competitive-solicitation requirements
2254	under s. 287.057 for the procurement of any goods or services
2255	required by this section. Funds provided, directly or
2256	indirectly, by prescription drug manufacturers may not be used
2257	to implement the program.
2258	(11)  The Office of Drug Control, in coordination with the
2259	department, may establish a direct-support organization that has
2260	a board consisting of at least five members to provide
2261	assistance, funding, and promotional support for the activities
2262	authorized for the prescription drug monitoring program.
2263	(a)  As used in this subsection, the term "direct-support
2264	organization" means an organization that is:
2265	1.  A Florida corporation not for profit incorporated under
2266	chapter 617, exempted from filing fees, and approved by the
2267	Department of State.
2268	2.  Organized and operated to conduct programs and
2269	activities; raise funds; request and receive grants, gifts, and
2270	bequests of money; acquire, receive, hold, and invest, in its
2271	own name, securities, funds, objects of value, or other
2272	property, either real or personal; and make expenditures or
2273	provide funding to or for the direct or indirect benefit of the
2274	department in the furtherance of the prescription drug
2275	monitoring program.
2276	(b)  The direct-support organization is not considered a
2277	lobbying firm within the meaning of s. 11.045.
2278	(c)  The State Surgeon General director of the Office of
2279	Drug Control shall appoint a board of directors for the direct-
2280	support organization. The director may designate employees of
2281	the Office of Drug Control, state employees other than state
2282	employees from the department, and any other nonstate employees
2283	as appropriate, to serve on the board. Members of the board
2284	shall serve at the pleasure of the director of the State Surgeon
2285	General Office of Drug Control. The State Surgeon General
2286	director shall provide guidance to members of the board to
2287	ensure that moneys received by the direct-support organization
2288	are not received from inappropriate sources. Inappropriate
2289	sources include, but are not limited to, donors, grantors,
2290	persons, or organizations that may monetarily or substantively
2291	benefit from the purchase of goods or services by the department
2292	in furtherance of the prescription drug monitoring program.
2293	(d)  The direct-support organization shall operate under
2294	written contract with the department Office of Drug Control. The
2295	contract must, at a minimum, provide for:
2296	1.  Approval of the articles of incorporation and bylaws of
2297	the direct-support organization by the department Office of Drug
2298	Control.
2299	2.  Submission of an annual budget for the approval of the
2300	department Office of Drug Control.
2301	3.  Certification by the department Office of Drug Control
2302	in consultation with the department that the direct-support
2303	organization is complying with the terms of the contract in a
2304	manner consistent with and in furtherance of the goals and
2305	purposes of the prescription drug monitoring program and in the
2306	best interests of the state. Such certification must be made
2307	annually and reported in the official minutes of a meeting of
2308	the direct-support organization.
2309	4.  The reversion, without penalty, to the Office of Drug
2310	Control, or to the state if the Office of Drug Control ceases to
2311	exist, of all moneys and property held in trust by the direct-
2312	support organization for the benefit of the prescription drug
2313	monitoring program if the direct-support organization ceases to
2314	exist or if the contract is terminated.
2315	5.  The fiscal year of the direct-support organization,
2316	which must begin July 1 of each year and end June 30 of the
2317	following year.
2318	6.  The disclosure of the material provisions of the
2319	contract to donors of gifts, contributions, or bequests,
2320	including such disclosure on all promotional and fundraising
2321	publications, and an explanation to such donors of the
2322	distinction between the department Office of Drug Control and
2323	the direct-support organization.
2324	7.  The direct-support organization's collecting,
2325	expending, and providing of funds to the department for the
2326	development, implementation, and operation of the prescription
2327	drug monitoring program as described in this section and s. 2,
2328	chapter 2009-198, Laws of Florida, as long as the task force is
2329	authorized. The direct-support organization may collect and
2330	expend funds to be used for the functions of the direct-support
2331	organization's board of directors, as necessary and approved by
2332	the department director of the Office of Drug Control. In
2333	addition, the direct-support organization may collect and
2334	provide funding to the department in furtherance of the
2335	prescription drug monitoring program by:
2336	a.  Establishing and administering the prescription drug
2337	monitoring program's electronic database, including hardware and
2338	software.
2339	b.  Conducting studies on the efficiency and effectiveness
2340	of the program to include feasibility studies as described in
2341	subsection (13).
2342	c.  Providing funds for future enhancements of the program
2343	within the intent of this section.
2344	d.  Providing user training of the prescription drug
2345	monitoring program, including distribution of materials to
2346	promote public awareness and education and conducting workshops
2347	or other meetings, for health care practitioners, pharmacists,
2348	and others as appropriate.
2349	e.  Providing funds for travel expenses.
2350	f.  Providing funds for administrative costs, including
2351	personnel, audits, facilities, and equipment.
2352	g.  Fulfilling all other requirements necessary to
2353	implement and operate the program as outlined in this section.
2354	(e)  The activities of the direct-support organization must
2355	be consistent with the goals and mission of the department
2356	Office of Drug Control, as determined by the office in
2357	consultation with the department, and in the best interests of
2358	the state. The direct-support organization must obtain a written
2359	approval from the department director of the Office of Drug
2360	Control for any activities in support of the prescription drug
2361	monitoring program before undertaking those activities.
2362	(f)  The Office of Drug Control, in consultation with the
2363	department, may permit, without charge, appropriate use of
2364	administrative services, property, and facilities of the Office
2365	of Drug Control and the department by the direct-support
2366	organization, subject to this section. The use must be directly
2367	in keeping with the approved purposes of the direct-support
2368	organization and may not be made at times or places that would
2369	unreasonably interfere with opportunities for the public to use
2370	such facilities for established purposes. Any moneys received
2371	from rentals of facilities and properties managed by the Office
2372	of Drug Control and the department may be held by the Office of
2373	Drug Control or in a separate depository account in the name of
2374	the direct-support organization and subject to the provisions of
2375	the letter of agreement with the department Office of Drug
2376	Control. The letter of agreement must provide that any funds
2377	held in the separate depository account in the name of the
2378	direct-support organization must revert to the department Office
2379	of Drug Control if the direct-support organization is no longer
2380	approved by the department Office of Drug Control to operate in
2381	the best interests of the state.
2382	(g)  The Office of Drug Control, in consultation with the
2383	department, may adopt rules under s. 120.54 to govern the use of
2384	administrative services, property, or facilities of the
2385	department or office by the direct-support organization.
2386	(h)  The department Office of Drug Control may not permit
2387	the use of any administrative services, property, or facilities
2388	of the state by a direct-support organization if that
2389	organization does not provide equal membership and employment
2390	opportunities to all persons regardless of race, color,
2391	religion, gender, age, or national origin.
2392	(i)  The direct-support organization shall provide for an
2393	independent annual financial audit in accordance with s.
2394	215.981. Copies of the audit shall be provided to the department
2395	Office of Drug Control and the Office of Policy and Budget in
2396	the Executive Office of the Governor.
2397	(j)  The direct-support organization may not exercise any
2398	power under s. 617.0302(12) or (16).
2399	(12)  A prescriber or dispenser may have access to the
2400	information under this section which relates to a patient of
2401	that prescriber or dispenser as needed for the purpose of
2402	reviewing the patient's controlled drug prescription history. A
2403	prescriber or dispenser acting in good faith is immune from any
2404	civil, criminal, or administrative liability that might
2405	otherwise be incurred or imposed for receiving or using
2406	information from the prescription drug monitoring program. This
2407	subsection does not create a private cause of action, and a
2408	person may not recover damages against a prescriber or dispenser
2409	authorized to access information under this subsection for
2410	accessing or failing to access such information.
2411	(13)  To the extent that funding is provided for such
2412	purpose through federal or private grants or gifts and other
2413	types of available moneys, the department, in collaboration with
2414	the Office of Drug Control, shall study the feasibility of
2415	enhancing the prescription drug monitoring program for the
2416	purposes of public health initiatives and statistical reporting
2417	that respects the privacy of the patient, the prescriber, and
2418	the dispenser. Such a study shall be conducted in order to
2419	further improve the quality of health care services and safety
2420	by improving the prescribing and dispensing practices for
2421	prescription drugs, taking advantage of advances in technology,
2422	reducing duplicative prescriptions and the overprescribing of
2423	prescription drugs, and reducing drug abuse. The requirements of
2424	the National All Schedules Prescription Electronic Reporting
2425	(NASPER) Act are authorized in order to apply for federal NASPER
2426	funding. In addition, the direct-support organization shall
2427	provide funding for the department, in collaboration with the
2428	Office of Drug Control, to conduct training for health care
2429	practitioners and other appropriate persons in using the
2430	monitoring program to support the program enhancements.
2431	(14)  A pharmacist, pharmacy, or dispensing health care
2432	practitioner or his or her agent, before releasing a controlled
2433	substance to any person not known to such dispenser, shall
2434	require the person purchasing, receiving, or otherwise acquiring
2435	the controlled substance to present valid photographic
2436	identification or other verification of his or her identity to
2437	the dispenser. If the person does not have proper
2438	identification, the dispenser may verify the validity of the
2439	prescription and the identity of the patient with the prescriber
2440	or his or her authorized agent. Verification of health plan
2441	eligibility through a real-time inquiry or adjudication system
2442	will be considered to be proper identification. This subsection
2443	does not apply in an institutional setting or to a long-term
2444	care facility, including, but not limited to, an assisted living
2445	facility or a hospital to which patients are admitted. As used
2446	in this subsection, the term "proper identification" means an
2447	identification that is issued by a state or the Federal
2448	Government containing the person's photograph, printed name, and
2449	signature or a document considered acceptable under 8 C.F.R. s.
2450	274a.2(b)(1)(v)(A) and (B).
2451	(15)  The Agency for Health Care Administration shall
2452	continue the promotion of electronic prescribing by health care
2453	practitioners, health care facilities, and pharmacies under s.
2454	408.0611.
2455	(16)  By October 1, 2010, The department shall adopt rules
2456	pursuant to ss. 120.536(1) and 120.54 to administer the
2457	provisions of this section, which shall include as necessary the
2458	reporting, accessing, evaluation, management, development,
2459	implementation, operation, and storage of information within the
2460	monitoring program's system.
2461	Section 24.  Section 893.065, Florida Statutes, is amended
2462	to read:
2463	893.065  Counterfeit-resistant prescription blanks for
2464	controlled substances listed in Schedule II, Schedule III, or
2465	Schedule IV.-The Department of Health shall develop and adopt by
2466	rule the form and content for a counterfeit-resistant
2467	prescription blank which must may be used by practitioners for
2468	the purpose of prescribing a controlled substance listed in
2469	Schedule II, Schedule III, or Schedule IV, or Schedule V
2470	pursuant to s. 456.42. The Department of Health may require the
2471	prescription blanks to be printed on distinctive, watermarked
2472	paper and to bear the preprinted name, address, and category of
2473	professional licensure of the practitioner and that
2474	practitioner's federal registry number for controlled
2475	substances. The prescription blanks may not be transferred.
2476	Section 25.  Subsections (4) and (5) of section 893.07,
2477	Florida Statutes, are amended to read:
2478	893.07  Records.-
2479	(4)  Every inventory or record required by this chapter,
2480	including prescription records, shall be maintained:
2481	(a)  Separately from all other records of the registrant,
2482	or
2483	(b)  Alternatively, in the case of Schedule III, IV, or V
2484	controlled substances, in such form that information required by
2485	this chapter is readily retrievable from the ordinary business
2486	records of the registrant.
2487
2488	In either case, the records described in this subsection shall
2489	be kept and made available for a period of at least 2 years for
2490	inspection and copying by law enforcement officers whose duty it
2491	is to enforce the laws of this state relating to controlled
2492	substances. Law enforcement officers are not required to obtain
2493	a subpoena, court order, or search warrant in order to obtain
2494	access to or copies of such records.
2495	(5)  Each person described in subsection (1) shall:
2496	(a)  Maintain a record which shall contain a detailed list
2497	of controlled substances lost, destroyed, or stolen, if any; the
2498	kind and quantity of such controlled substances; and the date of
2499	the discovering of such loss, destruction, or theft.
2500	(b)  In the event of the discovery of the theft or
2501	significant loss of controlled substances, report such theft or
2502	significant loss to the sheriff of that county within 24 hours
2503	after discovery. A person who fails to report a theft or
2504	significant loss of a substance listed in s. 893.03(3), (4), or
2505	(5) within 24 hours after discovery as required in this
2506	paragraph commits a misdemeanor of the second degree, punishable
2507	as provided in s. 775.082 or s. 775.083. A person who fails to
2508	report a theft or significant loss of a substance listed in s.
2509	893.03(2) within 24 hours after discovery as required in this
2510	paragraph commits a misdemeanor of the first degree, punishable
2511	as provided in s. 775.082 or s. 775.083.
2512	Section 26.  Subsection (7) of section 893.13, Florida
2513	Statutes, is amended to read:
2514	893.13  Prohibited acts; penalties.-
2515	(7)(a)  A It is unlawful for any person may not:
2516	1.  To Distribute or dispense a controlled substance in
2517	violation of this chapter.
2518	2.  To Refuse or fail to make, keep, or furnish any record,
2519	notification, order form, statement, invoice, or information
2520	required under this chapter.
2521	3.  To Refuse an entry into any premises for any inspection
2522	or to refuse to allow any inspection authorized by this chapter.
2523	4.  To Distribute a controlled substance named or described
2524	in s. 893.03(1) or (2) except pursuant to an order form as
2525	required by s. 893.06.
2526	5.  To Keep or maintain any store, shop, warehouse,
2527	dwelling, building, vehicle, boat, aircraft, or other structure
2528	or place which is resorted to by persons using controlled
2529	substances in violation of this chapter for the purpose of using
2530	these substances, or which is used for keeping or selling them
2531	in violation of this chapter.
2532	6.  To Use to his or her own personal advantage, or to
2533	reveal, any information obtained in enforcement of this chapter
2534	except in a prosecution or administrative hearing for a
2535	violation of this chapter.
2536	7.  To Possess a prescription form which has not been
2537	completed and signed by the practitioner whose name appears
2538	printed thereon, unless the person is that practitioner, is an
2539	agent or employee of that practitioner, is a pharmacist, or is a
2540	supplier of prescription forms who is authorized by that
2541	practitioner to possess those forms.
2542	8.  To Withhold information from a practitioner from whom
2543	the person seeks to obtain a controlled substance or a
2544	prescription for a controlled substance that the person making
2545	the request has received a controlled substance or a
2546	prescription for a controlled substance of like therapeutic use
2547	from another practitioner within the previous 30 days.
2548	9.  To Acquire or obtain, or attempt to acquire or obtain,
2549	possession of a controlled substance by misrepresentation,
2550	fraud, forgery, deception, or subterfuge.
2551	10.  To Affix any false or forged label to a package or
2552	receptacle containing a controlled substance.
2553	11.  To Furnish false or fraudulent material information
2554	in, or omit any material information from, any report or other
2555	document required to be kept or filed under this chapter or any
2556	record required to be kept by this chapter.
2557	12.  To Store anhydrous ammonia in a container that is not
2558	approved by the United States Department of Transportation to
2559	hold anhydrous ammonia or is not constructed in accordance with
2560	sound engineering, agricultural, or commercial practices.
2561	13.  With the intent to obtain a controlled substance or
2562	combination of controlled substances that are not medically
2563	necessary for the person or an amount of a controlled substance
2564	or substances that are not medically necessary for the person,
2565	obtain or attempt to obtain from a practitioner a controlled
2566	substance or a prescription for a controlled substance by
2567	misrepresentation, fraud, forgery, deception, subterfuge, or
2568	concealment of a material fact. For purposes of this
2569	subparagraph, a material fact includes whether the person has an
2570	existing prescription for a controlled substance issued for the
2571	same period of time by another practitioner or as described in
2572	subparagraph 8.
2573	(b)  A health care practitioner, with the intent to provide
2574	a controlled substance or combination of controlled substances
2575	that are not medically necessary to his or her patient or an
2576	amount of controlled substances that are not medically necessary
2577	for his or her patient, may not provide a controlled substance
2578	or a prescription for a controlled substance by
2579	misrepresentation, fraud, forgery, deception, subterfuge, or
2580	concealment of a material fact. For purposes of this paragraph,
2581	a material fact includes whether the patient has an existing
2582	prescription for a controlled substance issued for the same
2583	period of time by another practitioner or as described in
2584	subparagraph (a)8.
2585	(c)(b)  Any person who violates the provisions of
2586	subparagraphs (a)1.-7. commits a misdemeanor of the first
2587	degree, punishable as provided in s. 775.082 or s. 775.083;
2588	except that, upon a second or subsequent violation, the person
2589	commits a felony of the third degree, punishable as provided in
2590	s. 775.082, s. 775.083, or s. 775.084.
2591	(d)(c)  Any person who violates the provisions of
2592	subparagraphs (a)8.-12. commits a felony of the third degree,
2593	punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
2594	(e)  A person or health care practitioner who violates the
2595	provisions of paragraph (b) or subparagraph (a)13. commits a
2596	felony of the third degree, punishable as provided in s.
2597	775.082, s. 775.083, or s. 775.084, if any controlled substance
2598	that is the subject of the offense is listed in Schedule II,
2599	Schedule III, or Schedule IV.
2600	Section 27.  Present subsections (3) through (10) of
2601	section 893.138, Florida Statutes, are redesignated as
2602	subsections (4) through (11), respectively, and a new subsection
2603	(3) is added to that section, to read:
2604	893.138  Local administrative action to abate drug-related,
2605	prostitution-related, or stolen-property-related public
2606	nuisances and criminal gang activity.-
2607	(3)  Any pain-management clinic, as described in s.
2608	458.3265 or s. 459.0137, which has been used on more than two
2609	occasions within a 6-month period as the site of a violation of:
2610	(a)  Section 784.011, s. 784.021, s. 784.03, or s. 784.045,
2611	relating to assault and battery;
2612	(b)  Section 810.02, relating to burglary;
2613	(c)  Section 812.014, relating to dealing in theft;
2614	(d)  Section 812.131, relating to robbery by sudden
2615	snatching; or
2616	(e)  Section 893.13, relating to the unlawful distribution
2617	of controlled substances,
2618
2619	may be declared to be a public nuisance, and such nuisance may
2620	be abated pursuant to the procedures provided in this section.
2621	Section 28.  (1)  DISPOSITION OF CONTROLLED SUBSTANCES.-
2622	(a)  Within 10 days after the effective date of this act,
2623	each physician licensed under chapter 458, chapter 459, chapter
2624	461, or chapter 466, Florida Statutes, unless he or she meets
2625	one of the exceptions for physician who dispenses under s.
2626	465.0276, Florida Statutes, shall ensure that the undispensed
2627	inventory of controlled substances listed in Schedule II or
2628	Schedule III as provided in s. 893.03, Florida Statutes,
2629	purchased under the physician's Drug Enforcement Administration
2630	number for dispensing is:
2631	1.  Returned in compliance with the laws and rules adopted
2632	under chapter 499, Florida Statutes, to the wholesale
2633	distributor, as defined in s. 499.003, Florida Statutes, which
2634	distributed the controlled substances to the physician; or
2635	2.  Turned in to local law enforcement agencies and
2636	abandoned.
2637	(b)  Wholesale distributors shall buy back the undispensed
2638	inventory of controlled substances listed in Schedule II or
2639	Schedule III as provided in s. 893.03, Florida Statutes, which
2640	are in the manufacturer's original packing, unopened, and in
2641	date, in accordance with the established policies of the
2642	wholesale distributor or the contractual terms between the
2643	wholesale distributor and the physician concerning returns.
2644	(2)  PUBLIC HEALTH EMERGENCY.-
2645	(a)  The Legislature finds that:
2646	1.  Prescription drug overdose has been declared a public
2647	health epidemic by the United States Centers for Disease Control
2648	and Prevention.
2649	2.  Prescription drug abuse results in an average of seven
2650	deaths in this state each day.
2651	3.  Physicians in this state purchased more than 85 percent
2652	of the oxycodone purchased by all practitioners in the United
2653	States in 2006.
2654	4.  Physicians in this state purchased more than 93 percent
2655	of the methadone purchased by all practitioners in the United
2656	States in 2006.
2657	5.  Some physicians in this state dispense medically
2658	unjustifiable amounts of controlled substances to addicts and to
2659	people who intend to illegally sell the drugs.
2660	6.  Physicians in this state who have purchased large
2661	quantities of controlled substances may have significant
2662	inventory 30 days after the effective date of this act.
2663	7.  Thirty days after the effective date of this act, the
2664	only legal method for a dispensing practitioner to sell or
2665	otherwise transfer controlled substances listed in Schedule II
2666	or Schedule III as provided in s. 893.03, Florida Statutes,
2667	purchased for dispensing, is through the abandonment procedures
2668	of subsection (1) or as authorized under s. 465.0276, Florida
2669	Statutes.
2670	8.  It is likely that the same physicians who purchase and
2671	dispense medically unjustifiable amounts of drugs will not
2672	legally dispose of the remaining inventory.
2673	9.  The actions of such dispensing practitioners may result
2674	in substantial injury to the public health.
2675	(b)  Immediately upon the effective date of this act, the
2676	State Health Officer shall declare a public health emergency
2677	pursuant to s. 381.00315, Florida Statutes. Pursuant to that
2678	declaration, the Department of Health, the Attorney General, the
2679	Department of Law Enforcement, and local law enforcement
2680	agencies shall take the following actions:
2681	1.  Within 2 days after the effective date of this act, in
2682	consultation with wholesale distributors as defined in s.
2683	499.003, Florida Statutes, the Department of Health shall
2684	identify dispensing practitioners who purchased more than an
2685	average of 2,000 unit doses of controlled substances listed in
2686	Schedule II or Schedule III as provided in s. 893.03, Florida
2687	Statutes, per month in the previous 6 months, and shall identify
2688	the dispensing practitioners in that group who pose the greatest
2689	threat to the public health based on an assessment of:
2690	a.  The risk of noncompliance with subsection (1).
2691	b.  The purchase amounts.
2692	c.  The manner of medical practice.
2693	d.  Any other factor set by the State Health Officer.
2694
2695	The Attorney General shall consult and coordinate with federal
2696	law enforcement agencies. The Department of Law Enforcement
2697	shall coordinate the efforts of local law enforcement agencies.
2698	2.  On the 3rd day after the effective date of this act,
2699	the Department of Law Enforcement or local law enforcement
2700	agencies shall enter the business premises of the dispensing
2701	practitioners identified as posing the greatest threat to public
2702	health and quarantine any inventory of controlled substances
2703	listed in Schedule II or Schedule III as provided in s. 893.03,
2704	Florida Statutes, of such dispensing practitioners on site.
2705	3.  The Department of Law Enforcement or local law
2706	enforcement agencies shall ensure the security of such inventory
2707	24 hours a day until the inventory is seized as contraband or
2708	deemed to be lawfully possessed for dispensing by the physician
2709	in accordance with s. 465.0276, Florida Statutes.
2710	4.  On the 31st day after the effective date of this act,
2711	any remaining inventory of controlled substances listed in
2712	Schedule II or Schedule III as provided in s. 893.03, Florida
2713	Statutes, purchased for dispensing by practitioners is deemed
2714	contraband under s. 893.12, Florida Statutes. The Department of
2715	Law Enforcement or local law enforcement agencies shall seize
2716	the inventory and comply with the provisions of s. 893.12,
2717	Florida Statutes, to destroy it.
2718	(c)  In order to implement this subsection, the sum of $3
2719	million of nonrecurring funds from the General Revenue Fund is
2720	appropriated to the Department of Law Enforcement for the 2010-
2721	2011 fiscal year. The Department of Law Enforcement shall expend
2722	the appropriation by reimbursing local law enforcement agencies
2723	for the overtime-hour costs associated with securing the
2724	quarantined controlled substance inventory as provided in
2725	paragraph (b) and activities related to investigation and
2726	prosecution of crimes related to prescribed controlled
2727	substances. If requests for reimbursement exceed the amount
2728	appropriated, the reimbursements shall be prorated by the hours
2729	of overtime per requesting agency at a maximum of one law
2730	enforcement officer per quarantine site.
2731	(3)  REPEAL.-This section expires January 1, 2013.
2732	Section 29.  The Department of Health shall establish a
2733	practitioner profile for dentists licensed under chapter 466,
2734	Florida Statutes, for a practitioner's designation as a
2735	controlled substance prescribing practitioner as provided in s.
2736	456.44, Florida Statutes.
2737	Section 30.  If any provision of this act or its
2738	application to any person or circumstance is held invalid, the
2739	invalidity does not affect other provisions or applications of
2740	the act which can be given effect without the invalid provision
2741	or application, and to this end the provisions of this act are
2742	severable.
2743	Section 31.  This act shall take effect July 1, 2011.

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