Bill Text: FL H7095 | 2011 | Regular Session | Comm Sub

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Prescription Drugs

Spectrum: Slight Partisan Bill (? 3-1)

Status: (Engrossed - Dead) 2011-05-06 - In returning messages [H7095 Detail]

Download: Florida-2011-H7095-Comm_Sub.html
CS/HB 7095

1
A bill to be entitled
2An act relating to controlled substances; amending ss.
3456.037 and 456.057, F.S.; conforming provisions to
4changes made by the act; amending s. 456.42, F.S.;
5requiring prescriptions for controlled substances to be
6written on a counterfeit-resistant pad produced by an
7approved vendor or electronically prescribed; repealing s.
8458.3265, F.S., relating to regulation of pain-management
9clinics and medical doctors; amending s. 458.327, F.S.;
10providing that dispensing certain controlled substances in
11violation of specified provisions is a third-degree
12felony; deleting references to felonies for certain
13activities related to pain-management clinics and medical
14doctors; amending s. 458.331, F.S.; deleting grounds for
15disciplinary actions against physicians relating to pain-
16management clinics and advertising controlled substances;
17repealing s. 459.0137, F.S., relating to pain-management
18clinics and osteopathic physicians; amending s. 459.013,
19F.S., relating to penalties for violations; providing that
20dispensing certain controlled substances in violation of
21specified provisions is a third-degree felony; deleting
22provisions relating to felonies for certain activities
23related to pain-management clinics and osteopathic
24physicians; amending s. 459.015, F.S.; deleting grounds
25for disciplinary actions against osteopathic physicians
26relating to pain-management clinics and advertising
27controlled substances; amending s. 465.015, F.S.;
28requiring a pharmacist, pharmacy intern, or other person
29employed by or at a pharmacy to report to the sheriff
30within a specified period any instance in which a person
31fraudulently obtained or attempted to fraudulently obtain
32a controlled substance; providing criminal penalties;
33providing requirements for reports; amending s. 465.018,
34F.S.; limiting the community pharmacies that may dispense
35controlled substances; providing an exemption; amending s.
36465.0276, F.S.; prohibiting registered dispensing
37practitioners from dispensing certain controlled
38substances; providing an exception; repealing a 72-hour
39supply limit on dispensing certain controlled substances
40to certain patients in registered pain-management clinics;
41providing an exception for dispensing controlled
42substances in the health care system of the Department of
43Corrections; amending s. 499.012, F.S.; requiring
44wholesale distributor permit applicants to submit
45documentation of credentialing policies; amending s.
46499.0121, F.S.; providing reporting requirements for
47wholesale distributors of certain controlled substances;
48requiring the Department of Health to share the reported
49data with law enforcement agencies; requiring the
50Department of Law Enforcement to make investigations based
51on the reported data; providing credentialing requirements
52for distribution of controlled substances to certain
53entities by wholesale distributors; limiting monthly
54distribution amounts of controlled substances to retail
55pharmacies; prohibiting distribution to entities with
56certain criminal backgrounds; amending s. 499.05, F.S.;
57authorizing rulemaking concerning specified controlled
58substance wholesale distributor reporting requirements and
59credentialing requirements; amending s. 499.067, F.S.;
60requiring the Department of Health to take disciplinary
61action against wholesale distributors failing to comply
62with specified credentialing requirements; amending s.
63810.02, F.S.; authorizing separate judgments and sentences
64for burglary with the intent to commit theft of a
65controlled substance under specified provisions and for
66any applicable possession of controlled substance offense
67under specified provisions in certain circumstances;
68amending s. 812.014, F.S.; authorizing separate judgments
69and sentences for theft of a controlled substance under
70specified provisions and for any applicable possession of
71controlled substance offense under specified provisions in
72certain circumstances; amending s. 893.07, F.S.; providing
73that law enforcement officers are not required to obtain a
74subpoena, court order, or search warrant in order to
75obtain access to or copies of specified controlled
76substance inventory records; requiring reporting discovery
77of the theft or loss of controlled substances to the
78sheriff within a specified period; providing criminal
79penalties; repealing s. 2 of chapter 2009-198, Laws of
80Florida, relating to Program Implementation and Oversight
81Task Force in the Executive Office of the Governor
82concerning the electronic system established for the
83prescription drug monitoring program; providing a buyback
84program for undispensed controlled substance inventory
85held by specified licensed physicians; requiring reports
86of program; providing for a declaration of a public health
87emergency; requiring certain actions relating to
88dispensing practitioners identified as posing the greatest
89threat to public health; providing an appropriation;
90providing for future repeal of program provisions;
91providing an effective date.
92
93Be It Enacted by the Legislature of the State of Florida:
94
95     Section 1.  Subsection (5) of section 456.037, Florida
96Statutes, is amended to read:
97     456.037  Business establishments; requirements for active
98status licenses; delinquency; discipline; applicability.-
99     (5)  This section applies to any business establishment
100registered, permitted, or licensed by the department to do
101business. Business establishments include, but are not limited
102to, dental laboratories, electrology facilities, massage
103establishments, and pharmacies, and pain-management clinics
104required to be registered under s. 458.3265 or s. 459.0137.
105     Section 2.  Subsection (9) of section 456.057, Florida
106Statutes, is amended to read:
107     456.057  Ownership and control of patient records; report
108or copies of records to be furnished.-
109     (9)(a)1.  The department may obtain patient records
110pursuant to a subpoena without written authorization from the
111patient if the department and the probable cause panel of the
112appropriate board, if any, find reasonable cause to believe that
113a health care practitioner has excessively or inappropriately
114prescribed any controlled substance specified in chapter 893 in
115violation of this chapter or any professional practice act or
116that a health care practitioner has practiced his or her
117profession below that level of care, skill, and treatment
118required as defined by this chapter or any professional practice
119act and also find that appropriate, reasonable attempts were
120made to obtain a patient release. Notwithstanding the foregoing,
121the department need not attempt to obtain a patient release when
122investigating an offense involving the inappropriate
123prescribing, overprescribing, or diversion of controlled
124substances and the offense involves a pain-management clinic.
125The department may obtain patient records without patient
126authorization or subpoena from any pain-management clinic
127required to be licensed if the department has probable cause to
128believe that a violation of any provision of s. 458.3265 or s.
129459.0137 is occurring or has occurred and reasonably believes
130that obtaining such authorization is not feasible due to the
131volume of the dispensing and prescribing activity involving
132controlled substances and that obtaining patient authorization
133or the issuance of a subpoena would jeopardize the
134investigation.
135     2.  The department may obtain patient records and insurance
136information pursuant to a subpoena without written authorization
137from the patient if the department and the probable cause panel
138of the appropriate board, if any, find reasonable cause to
139believe that a health care practitioner has provided inadequate
140medical care based on termination of insurance and also find
141that appropriate, reasonable attempts were made to obtain a
142patient release.
143     3.  The department may obtain patient records, billing
144records, insurance information, provider contracts, and all
145attachments thereto pursuant to a subpoena without written
146authorization from the patient if the department and probable
147cause panel of the appropriate board, if any, find reasonable
148cause to believe that a health care practitioner has submitted a
149claim, statement, or bill using a billing code that would result
150in payment greater in amount than would be paid using a billing
151code that accurately describes the services performed, requested
152payment for services that were not performed by that health care
153practitioner, used information derived from a written report of
154an automobile accident generated pursuant to chapter 316 to
155solicit or obtain patients personally or through an agent
156regardless of whether the information is derived directly from
157the report or a summary of that report or from another person,
158solicited patients fraudulently, received a kickback as defined
159in s. 456.054, violated the patient brokering provisions of s.
160817.505, or presented or caused to be presented a false or
161fraudulent insurance claim within the meaning of s.
162817.234(1)(a), and also find that, within the meaning of s.
163817.234(1)(a), patient authorization cannot be obtained because
164the patient cannot be located or is deceased, incapacitated, or
165suspected of being a participant in the fraud or scheme, and if
166the subpoena is issued for specific and relevant records.
167     4.  Notwithstanding subparagraphs 1.-3., when the
168department investigates a professional liability claim or
169undertakes action pursuant to s. 456.049 or s. 627.912, the
170department may obtain patient records pursuant to a subpoena
171without written authorization from the patient if the patient
172refuses to cooperate or if the department attempts to obtain a
173patient release and the failure to obtain the patient records
174would be detrimental to the investigation.
175     Section 3.  Section 456.42, Florida Statutes, is amended to
176read:
177     456.42  Written prescriptions for medicinal drugs.-
178     (1)  A written prescription for a medicinal drug issued by
179a health care practitioner licensed by law to prescribe such
180drug must be legibly printed or typed so as to be capable of
181being understood by the pharmacist filling the prescription;
182must contain the name of the prescribing practitioner, the name
183and strength of the drug prescribed, the quantity of the drug
184prescribed, and the directions for use of the drug; must be
185dated; and must be signed by the prescribing practitioner on the
186day when issued. A written prescription for a controlled
187substance listed in chapter 893 must have the quantity of the
188drug prescribed in both textual and numerical formats and must
189be dated with the abbreviated month written out on the face of
190the prescription. However, a prescription that is electronically
191generated and transmitted must contain the name of the
192prescribing practitioner, the name and strength of the drug
193prescribed, the quantity of the drug prescribed in numerical
194format, and the directions for use of the drug and must be dated
195and signed by the prescribing practitioner only on the day
196issued, which signature may be in an electronic format as
197defined in s. 668.003(4).
198     (2)  A written prescription for a controlled substance
199listed in chapter 893 must have the quantity of the drug
200prescribed in both textual and numerical formats and must be
201dated with the abbreviated month written out on the face of the
202prescription. A prescription for a controlled substance listed
203in chapter 893 must be written on a counterfeit-proof
204prescription pad produced by a vendor approved by the
205department, or must be electronically prescribed, as that term
206is used in s. 408.0611.
207     Section 4.  Section 458.3265, Florida Statutes, is
208repealed.
209     Section 5.  Section 458.327, Florida Statutes, is amended
210to read:
211     458.327  Penalty for violations.-
212     (1)  Each of the following acts constitutes a felony of the
213third degree, punishable as provided in s. 775.082, s. 775.083,
214or s. 775.084:
215     (a)  The practice of medicine or an attempt to practice
216medicine without a license to practice in Florida.
217     (b)  The use or attempted use of a license which is
218suspended or revoked to practice medicine.
219     (c)  Attempting to obtain or obtaining a license to
220practice medicine by knowing misrepresentation.
221     (d)  Attempting to obtain or obtaining a position as a
222medical practitioner or medical resident in a clinic or hospital
223through knowing misrepresentation of education, training, or
224experience.
225     (e)  Dispensing a controlled substance listed in Schedule
226II or Schedule III in violation of s. 465.0276. Knowingly
227operating, owning, or managing a nonregistered pain-management
228clinic that is required to be registered with the Department of
229Health pursuant to s. 458.3265(1).
230     (2)  Each of the following acts constitutes a misdemeanor
231of the first degree, punishable as provided in s. 775.082 or s.
232775.083:
233     (a)  Knowingly concealing information relating to
234violations of this chapter.
235     (b)  Making any willfully false oath or affirmation
236whenever an oath or affirmation is required by this chapter.
237     (c)  Referring any patient, for health care goods or
238services, to a partnership, firm, corporation, or other business
239entity in which the physician or the physician's employer has an
240equity interest of 10 percent or more unless, prior to such
241referral, the physician notifies the patient of his or her
242financial interest and of the patient's right to obtain such
243goods or services at the location of the patient's choice. This
244section does not apply to the following types of equity
245interest:
246     1.  The ownership of registered securities issued by a
247publicly held corporation or the ownership of securities issued
248by a publicly held corporation, the shares of which are traded
249on a national exchange or the over-the-counter market;
250     2.  A physician's own practice, whether he or she is a sole
251practitioner or part of a group, when the health care good or
252service is prescribed or provided solely for the physician's own
253patients and is provided or performed by the physician or under
254the physician's supervision; or
255     3.  An interest in real property resulting in a landlord-
256tenant relationship between the physician and the entity in
257which the equity interest is held, unless the rent is
258determined, in whole or in part, by the business volume or
259profitability of the tenant or is otherwise unrelated to fair
260market value.
261     (d)  Leading the public to believe that one is licensed as
262a medical doctor, or is engaged in the licensed practice of
263medicine, without holding a valid, active license.
264     (e)  Practicing medicine or attempting to practice medicine
265with an inactive or delinquent license.
266     (f)  Knowingly prescribing or dispensing, or causing to be
267prescribed or dispensed, controlled substances in a
268nonregistered pain-management clinic that is required to be
269registered with the Department of Health pursuant to s.
270458.3265(1).
271     Section 6.  Paragraphs (oo), (pp), and (qq) of subsection
272(1) of section 458.331, Florida Statutes, are amended to read:
273     458.331  Grounds for disciplinary action; action by the
274board and department.-
275     (1)  The following acts constitute grounds for denial of a
276license or disciplinary action, as specified in s. 456.072(2):
277     (oo)  Dispensing a controlled substance listed in Schedule
278II or Schedule III in violation of s. 465.0276. Applicable to a
279licensee who serves as the designated physician of a pain-
280management clinic as defined in s. 458.3265 or s. 459.0137:
281     1.  Registering a pain-management clinic through
282misrepresentation or fraud;
283     2.  Procuring, or attempting to procure, the registration
284of a pain-management clinic for any other person by making or
285causing to be made, any false representation;
286     3.  Failing to comply with any requirement of chapter 499,
287the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
288Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
289the Drug Abuse Prevention and Control Act; or chapter 893, the
290Florida Comprehensive Drug Abuse Prevention and Control Act;
291     4.  Being convicted or found guilty of, regardless of
292adjudication to, a felony or any other crime involving moral
293turpitude, fraud, dishonesty, or deceit in any jurisdiction of
294the courts of this state, of any other state, or of the United
295States;
296     5.  Being convicted of, or disciplined by a regulatory
297agency of the Federal Government or a regulatory agency of
298another state for, any offense that would constitute a violation
299of this chapter;
300     6.  Being convicted of, or entering a plea of guilty or
301nolo contendere to, regardless of adjudication, a crime in any
302jurisdiction of the courts of this state, of any other state, or
303of the United States which relates to the practice of, or the
304ability to practice, a licensed health care profession;
305     7.  Being convicted of, or entering a plea of guilty or
306nolo contendere to, regardless of adjudication, a crime in any
307jurisdiction of the courts of this state, of any other state, or
308of the United States which relates to health care fraud;
309     8.  Dispensing any medicinal drug based upon a
310communication that purports to be a prescription as defined in
311s. 465.003(14) or s. 893.02 if the dispensing practitioner knows
312or has reason to believe that the purported prescription is not
313based upon a valid practitioner-patient relationship; or
314     9.  Failing to timely notify the board of the date of his
315or her termination from a pain-management clinic as required by
316s. 458.3265(2).
317     (pp)  Failing to timely notify the department of the theft
318of prescription blanks from a pain-management clinic or a breach
319of other methods for prescribing within 24 hours as required by
320s. 458.3265(2).
321     (qq)  Promoting or advertising through any communication
322media the use, sale, or dispensing of any controlled substance
323appearing on any schedule in chapter 893.
324     Section 7.  Section 459.0137, Florida Statutes, is
325repealed.
326     Section 8.  Paragraph (e) of subsection (1) and paragraph
327(d) of subsection (2) of section 459.013, Florida Statutes, are
328amended to read:
329     459.013  Penalty for violations.-
330     (1)  Each of the following acts constitutes a felony of the
331third degree, punishable as provided in s. 775.082, s. 775.083,
332or s. 775.084:
333     (e)  Dispensing a controlled substance listed in Schedule
334II or Schedule III in violation of s. 465.0276. Knowingly
335operating, owning, or managing a nonregistered pain-management
336clinic that is required to be registered with the Department of
337Health pursuant to s. 459.0137(1).
338     (2)  Each of the following acts constitutes a misdemeanor
339of the first degree, punishable as provided in s. 775.082 or s.
340775.083:
341     (d)  Knowingly prescribing or dispensing, or causing to be
342prescribed or dispensed, controlled substances in a
343nonregistered pain-management clinic that is required to be
344registered with the Department of Health pursuant to s.
345459.0137(1).
346     Section 9.  Paragraphs (qq), (rr), and (ss) of subsection
347(1) of section 459.015, Florida Statutes, are amended to read:
348     459.015  Grounds for disciplinary action; action by the
349board and department.-
350     (1)  The following acts constitute grounds for denial of a
351license or disciplinary action, as specified in s. 456.072(2):
352     (qq)  Dispensing a controlled substance listed in Schedule
353II or Schedule III in violation of s. 465.0276. Applicable to a
354licensee who serves as the designated physician of a pain-
355management clinic as defined in s. 458.3265 or s. 459.0137:
356     1.  Registering a pain-management clinic through
357misrepresentation or fraud;
358     2.  Procuring, or attempting to procure, the registration
359of a pain-management clinic for any other person by making or
360causing to be made, any false representation;
361     3.  Failing to comply with any requirement of chapter 499,
362the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the
363Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq.,
364the Drug Abuse Prevention and Control Act; or chapter 893, the
365Florida Comprehensive Drug Abuse Prevention and Control Act;
366     4.  Being convicted or found guilty of, regardless of
367adjudication to, a felony or any other crime involving moral
368turpitude, fraud, dishonesty, or deceit in any jurisdiction of
369the courts of this state, of any other state, or of the United
370States;
371     5.  Being convicted of, or disciplined by a regulatory
372agency of the Federal Government or a regulatory agency of
373another state for, any offense that would constitute a violation
374of this chapter;
375     6.  Being convicted of, or entering a plea of guilty or
376nolo contendere to, regardless of adjudication, a crime in any
377jurisdiction of the courts of this state, of any other state, or
378of the United States which relates to the practice of, or the
379ability to practice, a licensed health care profession;
380     7.  Being convicted of, or entering a plea of guilty or
381nolo contendere to, regardless of adjudication, a crime in any
382jurisdiction of the courts of this state, of any other state, or
383of the United States which relates to health care fraud;
384     8.  Dispensing any medicinal drug based upon a
385communication that purports to be a prescription as defined in
386s. 465.003(14) or s. 893.02 if the dispensing practitioner knows
387or has reason to believe that the purported prescription is not
388based upon a valid practitioner-patient relationship; or
389     9.  Failing to timely notify the board of the date of his
390or her termination from a pain-management clinic as required by
391s. 459.0137(2).
392     (rr)  Failing to timely notify the department of the theft
393of prescription blanks from a pain-management clinic or a breach
394of other methods for prescribing within 24 hours as required by
395s. 459.0137(2).
396     (ss)  Promoting or advertising through any communication
397media the use, sale, or dispensing of any controlled substance
398appearing on any schedule in chapter 893.
399     Section 10.  Subsections (3) and (4) of section 465.015,
400Florida Statutes, are renumbered as subsections (4) and (5),
401respectively, a new subsection (3) is added to that section, and
402present subsection (4) of that section is amended, to read:
403     465.015  Violations and penalties.-
404     (3)  It is unlawful for any pharmacist, pharmacy intern, or
405other person employed by or at a pharmacy to fail to report to
406the sheriff of the county where the pharmacy is located within
40724 hours after learning of any instance in which a person
408obtained or attempted to obtain a controlled substance, as
409defined in s. 893.02, that the pharmacist, pharmacy intern, or
410other person employed by or at the pharmacy knew or reasonably
411should have known was obtained or attempted to be obtained from
412the pharmacy though fraudulent methods or representations. Any
413pharmacist, pharmacy intern, or other person employed by or at a
414pharmacy who fails to make such a report within 24 hours after
415learning of the fraud or attempted fraud commits a misdemeanor
416of the first degree, punishable as provided in s. 775.082 or s.
417775.083. A sufficient report of the fraudulent obtaining of
418controlled substances under this subsection shall contain, at a
419minimum, a copy of the prescription used or presented and a
420narrative, including all information available to the pharmacy
421concerning the transaction, such as the name and telephone
422number of the prescribing physician; the name, description, and
423any personal identification information pertaining to the person
424who presented the prescription; and all other material
425information, such as photographic or video surveillance of the
426transaction.
427     (5)(4)  Any person who violates any provision of subsection
428(1) or subsection (4) (3) commits a misdemeanor of the first
429degree, punishable as provided in s. 775.082 or s. 775.083. Any
430person who violates any provision of subsection (2) commits a
431felony of the third degree, punishable as provided in s.
432775.082, s. 775.083, or s. 775.084. In any warrant, information,
433or indictment, it shall not be necessary to negative any
434exceptions, and the burden of any exception shall be upon the
435defendant.
436     Section 11.  Section 465.018, Florida Statutes, is amended
437to read:
438     465.018  Community pharmacies; permits.-
439     (1)  Any person desiring a permit to operate a community
440pharmacy shall apply to the department. If the board office
441certifies that the application complies with the laws of the
442state and the rules of the board governing pharmacies, the
443department shall issue the permit. No permit shall be issued
444unless a licensed pharmacist is designated as the prescription
445department manager responsible for maintaining all drug records,
446providing for the security of the prescription department, and
447following such other rules as relate to the practice of the
448profession of pharmacy. The permittee and the newly designated
449prescription department manager shall notify the department
450within 10 days of any change in prescription department manager.
451     (2)(a)  A pharmacy permitted under this section may not
452dispense a controlled substance listed in Schedule II or
453Schedule III as provided in s. 893.03 unless the pharmacy is:
454     1.  Wholly owned by a corporation whose shares are publicly
455traded on a recognized stock exchange; or
456     2.  Wholly owned by a corporation having more than $100
457million of business taxable assets in this state.
458     (b)  Community pharmacies that have been continuously
459permitted for at least 10 years are exempt from this subsection.
460     Section 12.  Paragraph (b) of subsection (1) of section
461465.0276, Florida Statutes, is amended to read:
462     465.0276  Dispensing practitioner.-
463     (1)
464     (b)  A practitioner registered under this section may not
465dispense a controlled substance listed in Schedule II or
466Schedule III as provided in s. 893.03. A practitioner registered
467under this section may not dispense more than a 72-hour supply
468of a controlled substance listed in Schedule II, Schedule III,
469Schedule IV, or Schedule V of s. 893.03 for any patient who pays
470for the medication by cash, check, or credit card in a clinic
471registered under s. 458.3265 or s. 459.0137. A practitioner who
472violates this paragraph commits a felony of the third degree,
473punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
474This paragraph does not apply to:
475     1.  A practitioner who dispenses medication to a workers'
476compensation patient pursuant to chapter 440.
477     2.  A practitioner who dispenses medication to an insured
478patient who pays by cash, check, or credit card to cover any
479applicable copayment or deductible.
480     1.3.  The dispensing of complimentary packages of medicinal
481drugs to the practitioner's own patients in the regular course
482of her or his practice without the payment of a fee or
483remuneration of any kind, whether direct or indirect, as
484provided in subsection (5).
485     2.  The dispensing of controlled substances in the health
486care system of the Department of Corrections.
487     Section 13.  Paragraph (o) is added to subsection (8) of
488section 499.012, Florida Statutes, to read:
489     499.012  Permit application requirements.-
490     (8)  An application for a permit or to renew a permit for a
491prescription drug wholesale distributor or an out-of-state
492prescription drug wholesale distributor submitted to the
493department must include:
494     (o)  Documentation of the credentialing policies and
495procedures required by s. 499.0121(14).
496     Section 14.  Subsections (14) and (15) are added to section
497499.0121, Florida Statutes, to read:
498     499.0121  Storage and handling of prescription drugs;
499recordkeeping.-The department shall adopt rules to implement
500this section as necessary to protect the public health, safety,
501and welfare. Such rules shall include, but not be limited to,
502requirements for the storage and handling of prescription drugs
503and for the establishment and maintenance of prescription drug
504distribution records.
505     (14)  DISTRIBUTION REPORTING.-Each wholesale distributor
506shall submit a report to the department of its receipts and
507distributions of controlled substances listed in Schedule II,
508Schedule III, Schedule IV, or Schedule V as provided in s.
509893.03. Wholesale distributor facilities located within this
510state shall report all transactions involving controlled
511substances and wholesale distributor facilities located outside
512this state shall report all distributions to entities located in
513this state. If the wholesale distributor did not have any
514controlled substance distributions for the month, a report shall
515be sent indicating no distributions occurred in the period. The
516report shall be submitted monthly by the 20th of the next month,
517in the electronic format used for controlled substance reporting
518to the Automation of Reports and Consolidated Orders System
519division of the federal Drug Enforcement Administration.
520Submission of electronic data must be made in a secured web
521environment that allows for manual or automated transmission.
522Upon successful transmission, an acknowledgement page must be
523displayed to confirm receipt. The report must contain the
524following information:
525     (a)  The federal Drug Enforcement Administration
526registration number of the wholesale distributing location.
527     (b)  The federal Drug Enforcement Administration
528registration number of the entity to which the drugs are
529distributed or from which the drugs are received.
530     (c)  The transaction code that indicates the type of
531transaction.
532     (d)  The National Drug Code identifier of the product and
533the quantity distributed or received.
534     (e)  The Drug Enforcement Administration Form 222 number or
535Controlled Substance Ordering System Identifier on all schedule
536II transactions.
537     (f)  The date of the transaction.
538
539The department must share the reported data with the Department
540of Law Enforcement and local law enforcement agencies upon
541request, and must monitor purchasing to identify purchasing
542levels that are inconsistent with the purchasing entity's
543clinical needs. The Department of Law Enforcement shall
544investigate purchases at levels that are inconsistent with the
545purchasing entity's clinical needs to determine whether
546violations of chapter 893 have occurred.
547     (15)  DUE DILIGENCE.-Each wholesale distributor must
548establish and maintain policies and procedures to credential
549physicians licensed under chapter 459, chapter 459, chapter 461,
550or chapter 466 and pharmacies that would purchase or otherwise
551receive from the wholesale distributor controlled substances
552listed in Schedule II or Schedule III as provided in s. 893.03.
553The wholesale distributor shall maintain records of such
554credentialing and make the records available to the department
555upon request. Such credentialing must, at a minimum, include:
556     (a)  A determination of the clinical nature of the
557receiving entity, including any specialty practice area.
558     (b)  A review of the receiving entity's history of Schedule
559II and Schedule III controlled substance purchasing from the
560wholesale distributor.
561     (c)  A determination that the receiving entity's Schedule
562II and Schedule III controlled substance purchasing history, if
563any, is consistent with and reasonable for that entity's
564clinical business needs.
565     (d)  Documentation of a level 2 background screening
566pursuant to chapter 435 through the department on any person who
567owns a controlling interest in or, directly or indirectly,
568manages, oversees, or controls the operation of the entity,
569including officers and members of the board of directors of an
570entity that is a corporation.
571
572Wholesale distributors may not distribute more than 5,000 unit
573doses of any one controlled substance to a retail pharmacy in
574any given month. Wholesale distributors may not distribute
575controlled substances to an entity if any criminal history
576record check for any person associated with that entity shows
577the person has been convicted of, or entered a plea of guilty or
578nolo contendere to, regardless of adjudication, a crime in any
579jurisdiction related to controlled substances, the practice of
580pharmacy, or the dispensing of medicinal drugs.
581     Section 15.  Paragraphs (o) and (p) are added to subsection
582(1) of section 499.05, Florida Statutes, to read:
583     499.05  Rules.-
584     (1)  The department shall adopt rules to implement and
585enforce this part with respect to:
586     (o)  Wholesale distributor reporting requirements of s.
587499.0121(14).
588     (p)  Wholesale distributor credentialing requirements of s.
589499.0121(15).
590     Section 16.  Subsection (8) is added to section 499.067,
591Florida Statutes, to read:
592     499.067  Denial, suspension, or revocation of permit,
593certification, or registration.-
594     (8)  The department shall deny, suspend, or revoke a permit
595if it finds the permittee has not complied with the
596credentialing requirements of s. 499.0121(15).
597     Section 17.  Paragraph (f) is added to subsection (3) of
598section 810.02, Florida Statutes, to read:
599     810.02  Burglary.-
600     (3)  Burglary is a felony of the second degree, punishable
601as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the
602course of committing the offense, the offender does not make an
603assault or battery and is not and does not become armed with a
604dangerous weapon or explosive, and the offender enters or
605remains in a:
606     (f)  Structure or conveyance when the offense intended to
607be committed therein is theft of a controlled substance as
608defined in s. 893.02. Notwithstanding any other law, separate
609judgments and sentences for burglary with the intent to commit
610theft of a controlled substance under this paragraph and for any
611applicable possession of controlled substance offense under s.
612893.13 or trafficking in controlled substance offense under s.
613893.135 may be imposed when all such offenses involve the same
614amount or amounts of a controlled substance.
615
616However, if the burglary is committed within a county that is
617subject to a state of emergency declared by the Governor under
618chapter 252 after the declaration of emergency is made and the
619perpetration of the burglary is facilitated by conditions
620arising from the emergency, the burglary is a felony of the
621first degree, punishable as provided in s. 775.082, s. 775.083,
622or s. 775.084. As used in this subsection, the term "conditions
623arising from the emergency" means civil unrest, power outages,
624curfews, voluntary or mandatory evacuations, or a reduction in
625the presence of or response time for first responders or
626homeland security personnel. A person arrested for committing a
627burglary within a county that is subject to such a state of
628emergency may not be released until the person appears before a
629committing magistrate at a first appearance hearing. For
630purposes of sentencing under chapter 921, a felony offense that
631is reclassified under this subsection is ranked one level above
632the ranking under s. 921.0022 or s. 921.0023 of the offense
633committed.
634     Section 18.  Paragraph (c) of subsection (2) of section
635812.014, Florida Statutes, is amended to read:
636     812.014  Theft.-
637     (2)
638     (c)  It is grand theft of the third degree and a felony of
639the third degree, punishable as provided in s. 775.082, s.
640775.083, or s. 775.084, if the property stolen is:
641     1.  Valued at $300 or more, but less than $5,000.
642     2.  Valued at $5,000 or more, but less than $10,000.
643     3.  Valued at $10,000 or more, but less than $20,000.
644     4.  A will, codicil, or other testamentary instrument.
645     5.  A firearm.
646     6.  A motor vehicle, except as provided in paragraph (a).
647     7.  Any commercially farmed animal, including any animal of
648the equine, bovine, or swine class, or other grazing animal, and
649including aquaculture species raised at a certified aquaculture
650facility. If the property stolen is aquaculture species raised
651at a certified aquaculture facility, then a $10,000 fine shall
652be imposed.
653     8.  Any fire extinguisher.
654     9.  Any amount of citrus fruit consisting of 2,000 or more
655individual pieces of fruit.
656     10.  Taken from a designated construction site identified
657by the posting of a sign as provided for in s. 810.09(2)(d).
658     11.  Any stop sign.
659     12.  Anhydrous ammonia.
660     13.  Any amount of a controlled substance as defined in s.
661893.02. Notwithstanding any other law, separate judgments and
662sentences for theft of a controlled substance under this
663subparagraph and for any applicable possession of controlled
664substance offense under s. 893.13 or trafficking in controlled
665substance offense under s. 893.135 may be imposed when all such
666offenses involve the same amount or amounts of a controlled
667substance.
668
669However, if the property is stolen within a county that is
670subject to a state of emergency declared by the Governor under
671chapter 252, the property is stolen after the declaration of
672emergency is made, and the perpetration of the theft is
673facilitated by conditions arising from the emergency, the
674offender commits a felony of the second degree, punishable as
675provided in s. 775.082, s. 775.083, or s. 775.084, if the
676property is valued at $5,000 or more, but less than $10,000, as
677provided under subparagraph 2., or if the property is valued at
678$10,000 or more, but less than $20,000, as provided under
679subparagraph 3. As used in this paragraph, the term "conditions
680arising from the emergency" means civil unrest, power outages,
681curfews, voluntary or mandatory evacuations, or a reduction in
682the presence of or the response time for first responders or
683homeland security personnel. For purposes of sentencing under
684chapter 921, a felony offense that is reclassified under this
685paragraph is ranked one level above the ranking under s.
686921.0022 or s. 921.0023 of the offense committed.
687     Section 19.  Subsections (4) and (5) of section 893.07,
688Florida Statutes, are amended to read:
689     893.07  Records.-
690     (4)  Every inventory or record required by this chapter,
691including prescription records, shall be maintained:
692     (a)  Separately from all other records of the registrant,
693or
694     (b)  Alternatively, in the case of Schedule III, IV, or V
695controlled substances, in such form that information required by
696this chapter is readily retrievable from the ordinary business
697records of the registrant.
698
699In either case, the records described in this subsection shall
700be kept and made available for a period of at least 2 years for
701inspection and copying by law enforcement officers whose duty it
702is to enforce the laws of this state relating to controlled
703substances. Law enforcement officers are not required to obtain
704a subpoena, court order, or search warrant in order to obtain
705access to or copies of such records.
706     (5)  Each person described in subsection (1) shall:
707     (a)  Maintain a record which shall contain a detailed list
708of controlled substances lost, destroyed, or stolen, if any; the
709kind and quantity of such controlled substances; and the date of
710the discovering of such loss, destruction, or theft.
711     (b)  In the event of the discovery of the theft or loss of
712controlled substances, report such theft or loss to the sheriff
713of that county within 48 hours after its discovery. A person who
714fails to report a theft or loss of a substance listed in s.
715893.03(3), (4), or (5) within 48 hours after discovery as
716required in this paragraph commits a misdemeanor of the second
717degree, punishable as provided in s. 775.082 or s. 775.083. A
718person who fails to report a theft or loss of a substance listed
719in s. 893.03(2) within 48 hours after discovery as required in
720this paragraph commits a misdemeanor of the first degree,
721punishable as provided in s. 775.082 or s. 775.083.
722     Section 20.  Section 2 of chapter 2009-198, Laws of
723Florida, is repealed.
724     Section 21.  
725     (1)  BUY-BACK PROGRAM.-Within 10 days after the effective
726date of this act, each physician licensed under chapter 458,
727chapter 459, chapter 461, or chapter 466, Florida Statutes,
728shall ensure that undispensed inventory of controlled substances
729listed in Schedule II or Schedule III as provided in s. 893.03,
730Florida Statutes, purchased under the physician's Drug
731Enforcement Administration number for dispensing is:
732     (a)  Returned to the wholesale distributor, as defined in
733s. 499.003, Florida Statutes, which distributed them; or
734     (b)  Turned in to local law enforcement agencies and
735abandoned.
736
737Wholesale distributors shall buy back the undispensed inventory
738of controlled substances listed in Schedule II or Schedule III
739as provided in s. 893.03, Florida Statutes, at the purchase
740price paid by the physician, physician practice, clinic, or
741other paying entity. Each wholesale distributor shall submit a
742report of its activities under this section to the Department of
743Health by August 1, 2011. The report shall include the following
744information:
745     1.  The name and address of the returning entity.
746     2.  The Florida license, registration, or permit number and
747Drug Enforcement Administration number of the entity that
748originally ordered the drugs.
749     3.  The drug name and number of unit doses returned.
750     4.  The date of return.
751     (2)  PUBLIC HEALTH EMERGENCY.-
752     (a)  The Legislature finds that:
753     1.  Prescription drug overdose has been declared a public
754health epidemic by the United States Centers for Disease Control
755and Prevention.
756     2.  Prescription drug abuse results in an average of 7
757deaths in this state each day.
758     3.  Physicians in this state purchased over 85 percent of
759the oxycodone purchased by all practitioners in the United
760States in 2006.
761     4.  Physicians in this state purchased over 93 percent of
762the methadone purchased by all practitioners in the United
763States in 2006.
764     5.  Some physicians in this state dispense medically
765unjustifiable amounts of controlled substances to addicts and
766people who intend to illegally sell the drugs.
767     6.  Physicians in this state who have purchased large
768quantities of controlled substances may have significant
769inventory on the effective date of this act.
770     7.  On the effective date of this act, the only legal
771method for a dispensing practitioner to sell or otherwise
772transfer controlled substances listed in Schedule II or Schedule
773III as provided in s. 893.03, Florida Statutes, purchased for
774dispensing is through the buy-back procedure or abandonment
775procedures of subsection (1).
776     8.  It is likely that the same physicians who purchase and
777dispense medically unjustifiable amounts of drugs will not
778legally dispose of remaining inventory.
779     9.  The actions of such dispensing practitioners may result
780in substantial injury to the public health.
781     (b)  Immediately on the effective date of this act, the
782State Health Officer shall declare a public health emergency
783pursuant to s. 381.00315, Florida Statutes. Pursuant to that
784declaration, the Department of Health, the Attorney General, the
785Department of Law Enforcement, and local law enforcement
786agencies shall take the following actions:
787     1.  Within 2 days after the effective date of this act, in
788consultation with wholesale distributors as defined in s.
789499.003, Florida Statutes, the Department of Health shall
790identify dispensing practitioners that purchased more than an
791average of 2,000 unit doses of controlled substances listed in
792Schedule II or Schedule III as provided in s. 893.03, Florida
793Statutes, per month in the previous 6 months, and shall identify
794the dispensing practitioners in that group who pose the greatest
795threat to the public health based on an assessment of:
796     a.  The risk of noncompliance with subsection (1).
797     b.  Purchase amounts.
798     c.  Manner of medical practice.
799     d.  Any other factor set by the State Health Officer.
800
801The Attorney General shall consult and coordinate with federal
802law enforcement agencies. The Department of Law Enforcement
803shall coordinate the efforts of local law enforcement agencies.
804     2.  On the 3rd day after the effective date of this act,
805the Department of Law Enforcement or local law enforcement
806agencies shall enter the business premises of the dispensing
807practitioners identified as posing the greatest threat to public
808health and quarantine the inventory of controlled substances
809listed in Schedule II or Schedule III as provided in s. 893.03,
810Florida Statutes, of such dispensing practitioners on site.
811     3.  The Department of Law Enforcement or local law
812enforcement agencies shall ensure the security of such inventory
81324 hours a day through the 10th day after the effective date of
814this act or until the inventory is validly transferred pursuant
815to subsection (1), whichever is earlier.
816     4.  On the 11th day after the effective date of this act,
817any remaining inventory of controlled substances listed in
818Schedule II or Schedule III as provided in s. 893.03, Florida
819Statutes, purchased for dispensing by practitioners is deemed
820contraband under s. 893.12, Florida Statutes. The Department of
821Law Enforcement or local law enforcement agencies shall seize
822the inventory and comply with the provisions of s. 893.12,
823Florida Statutes, to destroy it.
824     (c)  In order to implement the provisions of this section,
825the sum of $3 million of nonrecurring funds from the General
826Revenue Fund is appropriated to the Department of Law
827Enforcement for the 2010-2011 fiscal year. The Department of Law
828Enforcement shall expend the appropriation by reimbursing local
829law enforcement agencies for the overtime-hour costs associated
830with securing the quarantined controlled substance inventory as
831provided in paragraph (b) and activities related to
832investigation and prosecution of crimes related to prescribed
833controlled substances. If requests for reimbursement exceed the
834amount appropriated, the reimbursements shall be prorated by the
835hours of overtime per requesting agency at a maximum of one law
836enforcement officer per quarantine site.
837     (3)  This section is repealed January 1, 2013.
838     Section 22.  This act shall take effect upon becoming a
839law.


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