Bill Text: FL S0818 | 2011 | Regular Session | Engrossed
Bill Title: Controlled Substances
Spectrum:
Status: (Introduced - Dead) 2011-05-06 - Read 3rd time -SJ 1092 [S0818 Detail]
Download: Florida-2011-S0818-Engrossed.html
CS for CS for SB 818 First Engrossed 2011818e1 1 A bill to be entitled 2 An act relating to controlled substances; amending s. 3 400.9905, F.S.; redefining the terms “clinic” and 4 “portable equipment provider” within the Health Care 5 Clinic Act; amending s. 456.013, F.S.; authorizing 6 certain health care practitioners to complete a 7 continuing education course relating to the 8 prescription drug monitoring program; providing 9 requirements for the course; requiring the Department 10 of Health or a board that is authorized to exercise 11 regulatory or rulemaking functions within the 12 department to approve the course offered through a 13 facility licensed under ch. 395, F.S., under certain 14 circumstances; providing for application of the course 15 requirements; requiring a board or the Department of 16 Health to adopt rules; amending s. 458.305, F.S.; 17 defining the term “dispensing physician” as it relates 18 to the practice of medicine in this state; prohibiting 19 certain persons from using titles or displaying signs 20 that would lead the public to believe that they engage 21 in the dispensing of controlled substances; 22 prohibiting certain persons, firms, or corporations 23 from using a trade name, sign, letter, or 24 advertisement that implies that the persons, firms, or 25 corporations are licensed or registered to dispense 26 prescription drugs; prohibiting certain persons, 27 firms, or corporations from holding themselves out to 28 the public as licensed or registered to dispense 29 controlled substances; providing penalties; amending 30 s. 458.3191, F.S.; revising the information in the 31 physician survey that is submitted by persons who 32 apply for licensure renewal as a physician under ch. 33 458 or ch. 459, F.S.; amending s. 458.3192, F.S.; 34 requiring the Department of Health to provide 35 nonidentifying information to the prescription drug 36 monitoring program’s Implementation and Oversight Task 37 Force regarding the number of physicians that are 38 registered with the prescription drug monitoring 39 program and that use the database from the program in 40 their practice; amending s. 458.3265, F.S.; redefining 41 the term “pain-management clinic” and defining the 42 term “chronic nonmalignant pain”; revising the list of 43 entities that are not required to register as a pain 44 management clinic; authorizing the department to 45 revoke the certificate of registration of a pain 46 management clinic based upon a finding by a probable 47 cause panel of a board that the clinic does not meet 48 certain requirements; authorizing the department to 49 revoke a clinic’s certificate of registration and 50 prohibit all physicians associated with that clinic 51 from practicing at that clinic location based upon an 52 annual inspection and evaluation and upon a final 53 determination by the probable cause panel of the 54 appropriate board that any physician associated with 55 that pain-management clinic knew or should have known 56 of certain violations; prohibiting the department from 57 revoking or suspending a clinic’s registration if the 58 clinic appoints another designated physician; 59 prohibiting persons owning or operating a pain 60 management clinic that has a revoked registration from 61 applying to operate another pain-management clinic 62 within a specified number of years upon a finding by 63 the probable cause panel of the appropriate board, and 64 an opportunity to be heard, that the persons operating 65 such clinic knew or should have known of violations 66 causing such revocation; deleting certain requirements 67 for a physician to practice medicine in a pain 68 management clinic; requiring a physician, an advanced 69 registered nurse practitioner, or a physician 70 assistant to perform an appropriate medical 71 examination of a patient on the same day that the 72 physician dispenses or prescribes a controlled 73 substance to the patient at a pain-management clinic; 74 requiring a physician who works in a pain-management 75 clinic to document the reason a prescription for a 76 certain dosage of a controlled substance is within the 77 proper standard of care; creating a felony of the 78 third degree for any person to register or attempt to 79 register a pain-management clinic through 80 misrepresentation or fraud; amending s. 458.327, F.S.; 81 providing additional penalties; amending s. 458.331, 82 F.S.; providing additional grounds for disciplinary 83 action by the Board of Medicine; amending s. 459.003, 84 F.S.; defining the term “dispensing physician” as it 85 relates to the practice of osteopathic medicine in 86 this state; amending s. 459.0081, F.S.; revising the 87 information that must be furnished in a physician 88 survey to the Department of Health in order to renew a 89 license to practice osteopathic medicine; amending s. 90 459.0082, F.S.; requiring the department to provide 91 certain nonidentifying information to the 92 Implementation and Oversight Task Force of the 93 prescription drug monitoring program; amending s. 94 459.013, F.S.; providing additional penalties; 95 amending s. 459.0137, F.S.; redefining the term “pain 96 management clinic” and defining the term “chronic 97 nonmalignant pain”; providing an exemption from the 98 requirement that all privately owned pain-management 99 clinics, facilities, or offices that advertise in any 100 medium for any type of pain-management services, or 101 employ an osteopathic physician who is primarily 102 engaged in the treatment of pain by prescribing or 103 dispensing controlled substance medications, must 104 register with the Department of Health; authorizing 105 the department to revoke the certificate of 106 registration of a pain-management clinic based upon a 107 finding by a probable cause panel of a board that the 108 clinic does not meet certain requirements; authorizing 109 the department to revoke a clinic’s certificate of 110 registration and prohibit all physicians associated 111 with that clinic from practicing at that clinic 112 location based upon an annual inspection and 113 evaluation and upon a final determination by the 114 probable cause panel of the appropriate board that any 115 physician associated with that pain-management clinic 116 knew or should have known of certain violations; 117 prohibiting the department from revoking or suspending 118 a clinic’s registration if the clinic appoints another 119 designated physician; prohibiting persons owning or 120 operating a pain-management clinic that has a revoked 121 registration from applying to operate another pain 122 management clinic within a specified number of years 123 upon a finding by the probable cause panel of the 124 appropriate board, and an opportunity to be heard, 125 when the persons operating such clinic knew or should 126 have known of violations causing such revocation; 127 revising the responsibilities of an osteopathic 128 physician who provides professional services in a 129 pain-management clinic; requiring an osteopathic 130 physician, an advanced registered nurse practitioner, 131 or a physician assistant to perform an appropriate 132 medical examination of a patient on the same day that 133 the physician dispenses or prescribes a controlled 134 substance to the patient at a pain-management clinic; 135 requiring an osteopathic physician who works in a 136 pain-management clinic to document the reason a 137 prescription for a certain dosage of a controlled 138 substance is within the proper standard of care; 139 creating a felony of the third degree for a licensee 140 or other person who serves as the designated physician 141 of a pain-management clinic to register a pain 142 management clinic through misrepresentation or fraud; 143 amending s. 459.015, F.S.; providing additional 144 grounds for disciplinary action by the Board of 145 Osteopathic Medicine; amending s. 465.015, F.S.; 146 prohibiting a licensed pharmacist from knowingly 147 failing to report to the local county sheriff’s office 148 the commission of a felony involving a person who 149 acquires or obtains possession of a controlled 150 substance by misrepresentation, fraud, forgery, 151 deception, or subterfuge under certain conditions; 152 providing penalties; providing suggested criteria for 153 reporting the commission of a felony that involves a 154 person who acquires or obtains possession of a 155 controlled substance by misrepresentation, fraud, 156 forgery, deception, or subterfuge; providing that a 157 licensed pharmacist is not subject to disciplinary 158 action for reporting; amending s. 465.0276, F.S.; 159 requiring a practitioner to register as a dispensing 160 practitioner in order to dispense controlled 161 substances; amending s. 499.01, F.S.; authorizing 162 certain business entities to pay for prescription 163 drugs obtained by practitioners licensed under ch. 164 466, F.S.; amending s. 766.101, F.S.; conforming a 165 cross-reference; amending s. 810.02, F.S.; redefining 166 the offense of burglary to include the theft of a 167 controlled substance within a structure or conveyance; 168 amending s. 812.014, F.S.; redefining the offense of 169 theft to include the theft of a controlled substance; 170 creating s. 893.021, F.S.; providing conditions in 171 which a drug is considered adulterated; providing that 172 a physician is not prevented from directing or 173 prescribing a change to the recognized manufactured 174 recommendations for use of any controlled substance 175 for a patient under certain circumstances; requiring a 176 prescribing physician to indicate on the original 177 prescription any deviation of the recognized 178 manufacturer’s recommended use of a controlled 179 substance; requiring a pharmacist or physician to 180 indicate such deviation on the label of the 181 prescription upon dispensing; amending s. 893.04, 182 F.S.; revising the required information that must 183 appear on the face of a prescription or written record 184 of a controlled substance before it is dispensed by a 185 pharmacist; amending s. 893.055, F.S.; requiring that 186 the prescription drug monitoring program comply with 187 the minimum requirements established by the Department 188 of Health; requiring the Department of Health to 189 establish a method to allow corrections to the 190 database of the prescription drug monitoring program; 191 requiring the number of refills ordered and whether 192 the drug was dispensed as a refill or a first-time 193 request to be included in the database of the 194 prescription drug monitoring program; revising the 195 number of days in which a dispensed controlled 196 substance must be reported to the department through 197 the prescription drug monitoring program; revising the 198 list of acts of dispensing or administering which are 199 exempt from reporting; requiring a pharmacy, 200 prescriber, practitioner, or dispenser to register 201 with the department by submitting a registering 202 document in order to have access to certain 203 information in the prescription drug monitoring 204 program’s database; requiring the department to 205 approve the registering document before granting 206 access to information in the prescription drug 207 monitoring program’s database; requiring criminal 208 background screening for those persons who have direct 209 access to the prescription drug monitoring program’s 210 database; authorizing the Attorney General to obtain 211 confidential and exempt information for Medicaid fraud 212 cases and Medicaid investigations; requiring certain 213 documentation to be provided to the program manager in 214 order to release confidential and exempt information 215 from the prescription drug monitoring program’s 216 database to a patient, legal guardian, or a designated 217 health care surrogate; authorizing the Agency for 218 Health Care Administration to obtain confidential and 219 exempt information from the prescription drug 220 monitoring program’s database for Medicaid fraud cases 221 and Medicaid investigations involving controlled 222 substances; deleting a provision requiring that 223 administrative costs of the prescription drug 224 monitoring program be funded through federal grants 225 and private sources; requiring the State Surgeon 226 General to enter into reciprocal agreements for the 227 sharing of information in the prescription drug 228 monitoring program with other states that have a 229 similar prescription drug monitoring program; 230 requiring the State Surgeon General to annually review 231 a reciprocal agreement to determine its compatibility; 232 providing requirements for compatibility; prohibiting 233 the sharing of certain information; providing an 234 appropriation; amending s. 893.0551, F.S.; requiring 235 the Department of Health to disclose confidential and 236 exempt information pertaining to the prescription drug 237 monitoring program to the Attorney General and 238 designee when working on Medicaid fraud cases and 239 Medicaid investigations involving prescribed 240 controlled substances or when the Attorney General has 241 initiated a review of specific identifiers that 242 warrant a Medicaid investigation regarding prescribed 243 controlled substances; prohibiting the Attorney 244 General’s Medicaid investigators from direct access to 245 the prescription drug monitoring program’s database; 246 authorizing the Department of Health to disclose 247 certain confidential and exempt information in the 248 prescription drug monitoring program’s database under 249 certain circumstances involving reciprocal agreements 250 with other states; prohibiting the sharing of 251 information from the prescription drug monitoring 252 program’s database which is not for the purpose that 253 is statutorily authorized or according to the State 254 Surgeon General’s determination of compatibility; 255 amending s. 893.07, F.S.; requiring that a person 256 report to the local sheriff’s office the theft or 257 significant loss of a controlled substance within a 258 specified time; providing penalties; providing 259 legislative intent; amending s. 893.13, F.S.; 260 prohibiting a person from obtaining or attempting to 261 obtain from a practitioner a controlled substance or a 262 prescription for a controlled substance by 263 misrepresentation, fraud, forgery, deception, 264 subterfuge, or concealment of a material fact; 265 prohibiting a health care provider from providing a 266 controlled substance or a prescription for a 267 controlled substance by misrepresentation, fraud, 268 forgery, deception, subterfuge, or concealment of a 269 material fact; prohibiting a person from adulterating 270 a controlled substance for certain use without 271 authorization by a prescribing physician; authorizing 272 a law enforcement officer to seize as evidence the 273 adulteration or off-label use of a prescribed 274 controlled substance; providing that such adulterated 275 or off-label use of the controlled substance may be 276 returned to its owner only under certain conditions; 277 providing penalties; prohibiting a prescribing 278 practitioner from writing a prescription for a 279 controlled substance and authorizing or directing the 280 adulteration of the dispensed form of the controlled 281 substance for the purpose of ingestion by means not 282 medically necessary; amending s. 893.138, F.S.; 283 providing circumstances in which a pain-management 284 clinic may be declared a public nuisance; amending s. 285 465.025, F.S.; requiring the Board of Pharmacy to 286 create a list of opioid analgesic drugs; providing 287 requirements for the list of opioid analgesic drugs; 288 prohibiting a pharmacist from substituting an opioid 289 analgesic drug for an opioid analgesic drug that 290 incorporates a tamper-resistant technology; providing 291 an effective date. 292 293 Be It Enacted by the Legislature of the State of Florida: 294 295 Section 1. Subsections (4) and (7) of section 400.9905, 296 Florida Statutes, are amended to read: 297 400.9905 Definitions.— 298 (4) “Clinic” means an entity at which health care services 299 are provided to individuals and which tenders charges for 300 reimbursement or payment for such services, including a mobile 301 clinic and a portable equipment provider. For purposes of this 302 part, the term does not include and the licensure requirements 303 of this part do not apply to: 304 (a) Entities licensed or registered by the state under 305 chapter 395; or entities licensed or registered by the state and 306 providing only health care services within the scope of services 307 authorized under their respective licenses granted under ss. 308 383.30-383.335, chapter 390, chapter 394, chapter 397, this 309 chapter except part X, chapter 429, chapter 463, chapter 465, 310 chapter 466, chapter 478, part I of chapter 483, chapter 484, or 311 chapter 651; end-stage renal disease providers authorized under 312 42 C.F.R. part 405, subpart U; or providers certified under 42 313 C.F.R. part 485, subpart B or subpart H; or any entity that 314 provides neonatal or pediatric hospital-based health care 315 services or other health care services by licensed practitioners 316 solely within a hospital licensed under chapter 395. 317 (b) Entities that own, directly or indirectly, entities 318 licensed or registered by the state pursuant to chapter 395; or 319 entities that own, directly or indirectly, entities licensed or 320 registered by the state and providing only health care services 321 within the scope of services authorized pursuant to their 322 respective licenses granted under ss. 383.30-383.335, chapter 323 390, chapter 394, chapter 397, this chapter except part X, 324 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 325 part I of chapter 483, chapter 484, chapter 651; end-stage renal 326 disease providers authorized under 42 C.F.R. part 405, subpart 327 U; or providers certified under 42 C.F.R. part 485, subpart B or 328 subpart H; or any entity that provides neonatal or pediatric 329 hospital-based health care services by licensed practitioners 330 solely within a hospital licensed under chapter 395. 331 (c) Entities that are owned, directly or indirectly, by an 332 entity licensed or registered by the state pursuant to chapter 333 395; or entities that are owned, directly or indirectly, by an 334 entity licensed or registered by the state and providing only 335 health care services within the scope of services authorized 336 pursuant to their respective licenses granted under ss. 383.30 337 383.335, chapter 390, chapter 394, chapter 397, this chapter 338 except part X, chapter 429, chapter 463, chapter 465, chapter 339 466, chapter 478, part I of chapter 483, chapter 484, or chapter 340 651; end-stage renal disease providers authorized under 42 341 C.F.R. part 405, subpart U; or providers certified under 42 342 C.F.R. part 485, subpart B or subpart H; or any entity that 343 provides neonatal or pediatric hospital-based health care 344 services by licensed practitioners solely within a hospital 345 under chapter 395. 346 (d) Entities that are under common ownership, directly or 347 indirectly, with an entity licensed or registered by the state 348 pursuant to chapter 395; or entities that are under common 349 ownership, directly or indirectly, with an entity licensed or 350 registered by the state and providing only health care services 351 within the scope of services authorized pursuant to their 352 respective licenses granted under ss. 383.30-383.335, chapter 353 390, chapter 394, chapter 397, this chapter except part X, 354 chapter 429, chapter 463, chapter 465, chapter 466, chapter 478, 355 part I of chapter 483, chapter 484, or chapter 651; end-stage 356 renal disease providers authorized under 42 C.F.R. part 405, 357 subpart U; or providers certified under 42 C.F.R. part 485, 358 subpart B or subpart H; or any entity that provides neonatal or 359 pediatric hospital-based health care services by licensed 360 practitioners solely within a hospital licensed under chapter 361 395. 362 (e) An entity that is exempt from federal taxation under 26 363 U.S.C. s. 501(c)(3) or (4), an employee stock ownership plan 364 under 26 U.S.C. s. 409 that has a board of trustees not less 365 than two-thirds of which are Florida-licensed health care 366 practitioners and provides only physical therapy services under 367 physician orders, any community college or university clinic, 368 and any entity owned or operated by the federal or state 369 government, including agencies, subdivisions, or municipalities 370 thereof. 371 (f) A sole proprietorship, group practice, partnership, or 372 corporation that provides health care services by physicians 373 covered by s. 627.419, that is directly supervised by one or 374 more of such physicians, and that is wholly owned by one or more 375 of those physicians or by a physician and the spouse, parent, 376 child, or sibling of that physician. 377 (g) A sole proprietorship, group practice, partnership, or 378 corporation that provides health care services by licensed 379 health care practitioners under chapter 457, chapter 458, 380 chapter 459, chapter 460, chapter 461, chapter 462, chapter 463, 381 chapter 466, chapter 467, chapter 480, chapter 484, chapter 486, 382 chapter 490, chapter 491, or part I, part III, part X, part 383 XIII, or part XIV of chapter 468, or s. 464.012, which are 384 wholly owned by one or more licensed health care practitioners, 385 or the licensed health care practitioners set forth in this 386 paragraph and the spouse, parent, child, or sibling of a 387 licensed health care practitioner, so long as one of the owners 388 who is a licensed health care practitioner is supervising the 389 business activities and is legally responsible for the entity’s 390 compliance with all federal and state laws. However, a health 391 care practitioner may not supervise services beyond the scope of 392 the practitioner’s license, except that, for the purposes of 393 this part, a clinic owned by a licensee in s. 456.053(3)(b) that 394 provides only services authorized pursuant to s. 456.053(3)(b) 395 may be supervised by a licensee specified in s. 456.053(3)(b). 396 (h) Clinical facilities affiliated with an accredited 397 medical school at which training is provided for medical 398 students, residents, or fellows. 399 (i) Entities that provide only oncology or radiation 400 therapy services by physicians licensed under chapter 458 or 401 chapter 459 or entities that provide oncology or radiation 402 therapy services by physicians licensed under chapter 458 or 403 chapter 459 which are owned by a corporation whose shares are 404 publicly traded on a recognized stock exchange. 405 (j) Clinical facilities affiliated with a college of 406 chiropractic accredited by the Council on Chiropractic Education 407 at which training is provided for chiropractic students. 408 (k) Entities that provide licensed practitioners to staff 409 emergency departments or to deliver anesthesia services in 410 facilities licensed under chapter 395 and that derive at least 411 90 percent of their gross annual revenues from the provision of 412 such services. Entities claiming an exemption from licensure 413 under this paragraph must provide documentation demonstrating 414 compliance. 415 (l) Orthotic or prosthetic clinical facilities that are a 416 publicly traded corporation or that are wholly owned, directly 417 or indirectly, by a publicly traded corporation. As used in this 418 paragraph, a publicly traded corporation is a corporation that 419 issues securities traded on an exchange registered with the 420 United States Securities and Exchange Commission as a national 421 securities exchange. 422 (7) “Portable equipment provider” means an entity that 423 contracts with or employs persons to provide portable equipment 424 to multiple locations performing treatment or diagnostic testing 425 of individuals, that bills third-party payors for those426services,and that otherwise meets the definition of a clinic in 427 subsection (4). 428 Section 2. Subsection (7) of section 456.013, Florida 429 Statutes, is amended to read: 430 456.013 Department; general licensing provisions.— 431 (7)(a) The boards, or the department when there is no 432 board, shall require the completion of a 2-hour course relating 433 to prevention of medical errors as part of the licensure and 434 renewal process. The 2-hour course countsshall counttowards 435 the total number of continuing education hours required for the 436 profession. The board or department shall approve the course 437shall be approved by the board or department, as appropriate, 438 which mustand shallinclude a study of root-cause analysis, 439 error reduction and prevention, and patient safety. In addition, 440 the course approved by the Board of Medicine and the Board of 441 Osteopathic Medicine mustshallinclude information relating to 442 the five most misdiagnosed conditions during the previous 443 biennium, as determined by the board. If the course is being 444 offered by a facility licensed underpursuant tochapter 395 for 445 its employees, the board may approve up to 1 hour of the 2-hour 446 course to be specifically related to error reduction and 447 prevention methods used in that facility. 448 (b) As a condition of initial licensure and at each 449 subsequent license renewal, the boards, or the department if 450 there is no board, shall allow each practitioner licensed under 451 chapter 458, chapter 459, chapter 461, chapter 465, or chapter 452 466 whose lawful scope of practice authorizes the practitioner 453 to prescribe, administer, or dispense controlled substances to 454 complete a 1-hour continuing education course relating to the 455 prescription drug monitoring program. The course must include, 456 but need not be limited to: 457 1. The purpose of the prescription drug monitoring program. 458 2. The practitioners’ capabilities for improving the 459 standard of care for patients by using the prescription drug 460 monitoring program. 461 3. How the prescription drug monitoring program can help 462 practitioners detect doctor shopping. 463 4. The involvement of law enforcement personnel, the 464 Attorney General’s Medicaid Fraud Unit, and medical regulatory 465 investigators with the prescription drug monitoring program. 466 5. The procedures for registering for access to the 467 prescription drug monitoring program. 468 469 The course hours may be included in the total number of hours of 470 continuing education required by the profession and must be 471 approved by the board or by the department if there is no board. 472 The boards, or the department if there is no board, shall 473 approve the course offered through a facility licensed under 474 chapter 395 for its employees if the course is at least 3 hours 475 and covers the education requirements. 476 (c) The course requirements in paragraph (b) apply to each 477 licensee renewing his or her license on or after July 1, 2012, 478 and to each applicant approved for licensure on or after January 479 1, 2013. 480 (d) By October 1, 2011, the boards, or the department if 481 there is no board, shall adopt rules as necessary to administer 482 this subsection. 483 Section 3. Section 458.305, Florida Statutes, is amended to 484 read: 485 458.305 Definitions.—As used in this chapter: 486 (1) “Board” means the Board of Medicine. 487 (2) “Department” means the Department of Health. 488 (3) “Dispensing physician” means a physician who is 489 registered as a dispensing practitioner under s. 465.0276. 490 (4)(3)“Practice of medicine” means the diagnosis, 491 treatment, operation, or prescription for any human disease, 492 pain, injury, deformity, or other physical or mental condition. 493 (5)(4)“Physician” means a person who is licensed to 494 practice medicine in this state. 495 Section 4. Advertising of controlled substances by a 496 dispensing physician.— 497 (1)(a) Only a dispensing physician licensed under chapter 498 458 or chapter 459, Florida Statutes, may use the title 499 “dispensing physician” or “dispenser” or otherwise lead the 500 public to believe that he or she is engaged in the dispensing of 501 controlled substances. 502 (b) A person, other than an owner of a: 503 1. Pain-management clinic registered under chapter 458 or 504 chapter 459, Florida Statutes; or 505 2. Health clinic licensed under chapter 400, Florida 506 Statutes, 507 508 may not display any sign or take any other action that would 509 lead the public to believe that such person is engaged in the 510 business of dispensing a controlled substance. Any advertisement 511 that states “dispensing onsite” or “onsite pharmacy” violates 512 this paragraph. This paragraph does not preclude a person who is 513 not licensed as a medical practitioner from owning a pain 514 management clinic. 515 (c) A person, firm, or corporation, unless licensed under 516 chapter 465, Florida Statutes, may not use in a trade name, 517 sign, letter, or advertisement any term, including “drug,” 518 “pharmacy,” “onsite pharmacy,” “dispensing,” “dispensing 519 onsite,” “prescription drugs,” “Rx,” or “apothecary,” which 520 implies that the person, firm, or corporation is licensed or 521 registered to dispense prescription drugs in this state. 522 (2) A person who violates paragraph (1)(a) or paragraph 523 (1)(b) commits a misdemeanor of the first degree, punishable as 524 provided in s. 775.082 or s. 775.083, Florida Statutes. A person 525 who violates paragraph (1)(c) commits a felony of the third 526 degree, punishable as provided in s. 775.082, s. 775.083, or s. 527 775.084, Florida Statutes. In any warrant, information, or 528 indictment, it is not necessary to negate any exceptions, and 529 the burden of any exception is upon the defendant. 530 Section 5. Paragraph (a) of subsection (1) of section 531 458.3191, Florida Statutes, is amended to read: 532 458.3191 Physician survey.— 533 (1) Each person who applies for licensure renewal as a 534 physician under this chapter or chapter 459 must, in conjunction 535 with the renewal of such license under procedures adopted by the 536 Department of Health and in addition to any other information 537 that may be required from the applicant, furnish the following 538 to the Department of Health in a physician survey: 539 (a) Licensee information, including, but not limited to: 540 1. Frequency and geographic location of practice within the 541 state. 542 2. Practice setting. 543 3. Percentage of time spent in direct patient care. 544 4. Anticipated change to license or practice status. 545 5. Areas of specialty or certification. 546 6. Whether the department has ever approved or denied the 547 physician’s registration for access to a patient’s information 548 in the prescription drug monitoring program’s database. 549 7. Whether the physician uses the prescription drug 550 monitoring program with patients in his or her medical practice. 551 Section 6. Subsection (3) is added to section 458.3192, 552 Florida Statutes, to read: 553 458.3192 Analysis of survey results; report.— 554 (3) By November 1 each year, the Department of Health shall 555 provide nonidentifying information to the prescription drug 556 monitoring program’s Implementation and Oversight Task Force 557 regarding the number of physicians who are registered with the 558 prescription drug monitoring program and who also use the 559 database from the prescription drug monitoring program for their 560 patients in their medical practice. 561 Section 7. Paragraphs (a), (f), (g), (h), and (k) of 562 subsection (1) and paragraphs (a) and (c) of subsection (2) of 563 section 458.3265, Florida Statutes, are amended, and paragraphs 564 (f) and (g) are added to subsection (5) of that section, to 565 read: 566 458.3265 Pain-management clinics.— 567 (1) REGISTRATION.— 568 (a) “Pain-management clinic,” hereinafter referred to as 569 “clinic,” means a publicly or privately owned facility where in 570 any month a majority of patients are prescribed opioids, 571 benzodiazepines, barbiturates, or carisoprodol, for the 572 treatment of chronic nonmalignant pain. “Chronic nonmalignant 573 pain” means pain unrelated to cancer or rheumatoid arthritis 574 which persists beyond the usual course of disease or the injury 575 that is the cause of the pain or more than 90 days after 576 surgery. Allprivately ownedpain-management clinics,577facilities, or offices, hereinafter referred to as “clinics,”578which advertise in any medium for any type of pain-management579services, or employ a physician who is primarily engaged in the580treatment of pain by prescribing or dispensing controlled581substance medications,must register with the department unless: 582 1. That clinic is licensed as a facility pursuant to 583 chapter 395; 584 2. The majority of the physicians who provide services in 585 the clinic primarily provide surgical services or interventional 586 pain procedures of the type routinely billed using surgical 587 codes; 588 3. The clinic is owned, directly or indirectly, by a 589 publicly held corporation whose shares are traded on a national 590 exchange or on the over-the-counter market and whose total 591 assets at the end of the corporation’s most recent fiscal 592 quarter exceeded $50 million; 593 4. The clinic is affiliated with an accredited medical 594 school at which training is provided for medical students, 595 residents, or fellows; 596 5. The clinic does not prescribe or dispense controlled 597 substances for the treatment of pain; or 598 6. The clinic is owned by a corporate entity exempt from 599 federal taxation under 26 U.S.C. s. 501(c)(3). 600 (f) If the department finds upon a hearing by the probable 601 cause panel of the appropriate board that a pain-management 602 clinic does not meet the requirement of paragraph (d) or is 603 owned, directly or indirectly, by a person meeting any criteria 604 listed in paragraph (e), the department shall revoke the 605 certificate of registration previously issued by the department. 606 As determined by rule, the department may grant an exemption to 607 denying a registration or revoking a previously issued 608 registration if more than 10 years have elapsed since 609 adjudication. As used in this subsection, the term “convicted” 610 includes an adjudication of guilt following a plea of guilty or 611 nolo contendere or the forfeiture of a bond when charged with a 612 crime. 613 (g) The department may revoke the clinic’s certificate of 614 registration and prohibit all physicians associated with that 615 pain-management clinic from practicing at that clinic location 616 based upon an annual inspection and evaluation of the factors 617 described in subsection (3) and upon a final determination by 618 the probable cause panel of the appropriate board that any 619 physician associated with that pain-management clinic knew or 620 should have known of any violations of the factors described in 621 subsection (3). 622 (h)1. If the registration of a pain-management clinic is 623 revoked or suspended, the designated physician of the pain 624 management clinic, the owner or lessor of the pain-management 625 clinic property, the manager, and the proprietor shall cease to 626 operate the facility as a pain-management clinic as of the 627 effective date of the suspension or revocation. 628 2. Notwithstanding subparagraph 1., the clinic’s 629 registration shall not be revoked or suspended if the clinic, 630 within 24 hours after notification of suspension or revocation, 631 appoints another designated physician who has a full, active, 632 and unencumbered license under this chapter or chapter 459 to 633 operate a pain-management clinic. 634 (k) If the clinic’s registration is revoked, any person 635 named in the registration documents of the pain-management 636 clinic, including persons owning or operating the pain 637 management clinic, may not, as an individual or as a part of a 638 group, apply to operate a pain-management clinic for 5 years 639 after the date the registration is revoked upon a finding by the 640 probable cause panel of the appropriate board, and an 641 opportunity to be heard, that the persons operating such clinic 642 knew or should have known of violations causing such revocation. 643 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 644 apply to any physician who provides professional services in a 645 pain-management clinic that is required to be registered in 646 subsection (1). 647 (a) A physician may not practice medicine in a pain 648 management clinic, as described in subsection (4), if:6491.the pain-management clinic is not registered with the 650 department as required by this section.; or6512. Effective July 1, 2012, the physician has not652successfully completed a pain-medicine fellowship that is653accredited by the Accreditation Council for Graduate Medical654Education or a pain-medicine residency that is accredited by the655Accreditation Council for Graduate Medical Education or, prior656to July 1, 2012, does not comply with rules adopted by the657board.658 659 Any physician who qualifies to practice medicine in a pain 660 management clinic pursuant to rules adopted by the Board of 661 Medicine as of July 1, 2012, may continue to practice medicine 662 in a pain-management clinic as long as the physician continues 663 to meet the qualifications set forth in the board rules. A 664 physician who violates this paragraph is subject to disciplinary 665 action by his or her appropriate medical regulatory board. 666 (c) A physician, an advanced registered nurse practitioner, 667 or a physician assistant must perform an appropriate medicala668physicalexamination of a patient on the same day that the 669 physicianhe or shedispenses or prescribes a controlled 670 substance to a patient at a pain-management clinic. If the 671 physician prescribes or dispenses more than a 72-hour dose of 672 controlled substances for the treatment of chronic nonmalignant 673 pain, the physician must document in the patient’s record the 674 reason such dosage is within the standard of care. For the 675 purpose of this paragraph, the standard of care is set forth in 676 rule 64B8-9.013(3), Florida Administrative Codefor prescribing677or dispensing that quantity. 678 (5) PENALTIES; ENFORCEMENT.— 679 (f) A licensee or other person who serves as the designated 680 physician of a pain-management clinic as defined in this section 681 or s. 459.0137 and registers a pain-management clinic through 682 misrepresentation or fraud or procures or attempts to procure 683 the registration of a pain-management clinic for any other 684 person by making or causing to be made any false or fraudulent 685 representation commits a felony of the third degree, punishable 686 as provided in s. 775.082, s. 775.083, or s. 775.084. 687 (g) Any person who registers a pain-management clinic 688 through misrepresentation or fraud or who procures or attempts 689 to procure the registration of a pain-management clinic for any 690 other person by making or causing to be made any false or 691 fraudulent representation, commits a felony of the third degree, 692 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 693 Section 8. Paragraphs (f) and (g) are added to subsection 694 (1), paragraphs (g) and (h) are added to subsection (2), and 695 subsection (3) is added to section 458.327, Florida Statutes, to 696 read: 697 458.327 Penalty for violations.— 698 (1) Each of the following acts constitutes a felony of the 699 third degree, punishable as provided in s. 775.082, s. 775.083, 700 or s. 775.084: 701 (f) Failing to perform a physical examination of a patient 702 by a physician or a licensed designee acting under the 703 physician’s supervision on the same day that the treating 704 physician dispenses or prescribes a controlled substance to the 705 patient at a pain-management clinic occurring three or more 706 times within a 6-month period, or failing to perform a physical 707 examination on three or more different patients on the same day 708 that the treating physician dispenses or prescribes a controlled 709 substance to each patient at a pain-management clinic within a 710 6-month period. 711 (g) Prescribing or dispensing in excess of a 72-hour dose 712 of controlled substances at a pain-management clinic for the 713 treatment of chronic nonmalignant pain of a patient occurring 714 three or more times within a 6-month period without documenting 715 in the patient’s record the reason that such dosage is within 716 the standard of care. For the purpose of this paragraph, the 717 standard of care is set forth in rule 64B8-9.013(3), Florida 718 Administrative Code. 719 (2) Each of the following acts constitutes a misdemeanor of 720 the first degree, punishable as provided in s. 775.082 or s. 721 775.083: 722 (g) Failing to perform a physical examination of a patient 723 on the same day that the treating physician dispenses or 724 prescribes a controlled substance to the patient at a pain 725 management clinic two times in a 6-month period, or failing to 726 perform a physical examination on two different patients on the 727 same day that the treating physician dispenses or prescribes a 728 controlled substance to each patient at a pain-management clinic 729 within a 6-month period. 730 (h) Prescribing or dispensing in excess of a 72-hour dose 731 of controlled substances at a pain-management clinic for the 732 treatment of chronic nonmalignant pain of a patient occurring 733 two times within a 6-month period without documenting in the 734 patient’s record the reason that such dosage is within the 735 standard of care. For the purpose of this paragraph, the 736 standard of care is set forth in rule 64B8-9.013(3), Florida 737 Administrative Code. 738 (3) Each of the following acts constitutes a misdemeanor of 739 the second degree, punishable as provided in s. 775.082 or s. 740 775.083: 741 (a) A first offense of failing to perform a physical 742 examination of a patient on the same day that the treating 743 physician dispenses or prescribes a controlled substance to the 744 patient at a pain-management clinic. 745 (b) A first offense of failing to document in a patient’s 746 record the reason that such dosage is within the standard of 747 care for prescribing or dispensing in excess of a 72-hour dose 748 of controlled substances at a pain-management clinic for the 749 treatment of chronic nonmalignant pain. 750 Section 9. Subsection (11) is added to section 458.331, 751 Florida Statutes, to read: 752 458.331 Grounds for disciplinary action; action by the 753 board and department.— 754 (11) Notwithstanding subsection (2), upon finding that a 755 physician has prescribed or dispensed, or caused to be 756 prescribed or dispensed, a controlled substance in a pain 757 management clinic in a manner that violates the standard of 758 practice as set forth in this chapter or rules adopted pursuant 759 to this chapter, the board shall, at a minimum, suspend the 760 physician’s license for at least 6 months and impose a fine of 761 at least $10,000 per count. Repeated violations shall result in 762 increased penalties. 763 Section 10. Present subsections (3), (4), and (5) of 764 section 459.003, Florida Statutes, are redesignated as 765 subsections (4), (5), and (6), respectively, and a new 766 subsection (3) is added to that section, to read: 767 459.003 Definitions.—As used in this chapter: 768 (3) “Dispensing physician” means an osteopathic physician 769 who is registered as a dispensing practitioner under s. 770 465.0276. 771 Section 11. Paragraph (a) of subsection (1) of section 772 459.0081, Florida Statutes, is amended to read: 773 459.0081 Physician survey.— 774 (1) Each person who applies for licensure renewal as a 775 physician under chapter 458 or this chapter must, in conjunction 776 with the renewal of such license under procedures adopted by the 777 Department of Health and in addition to any other information 778 that may be required from the applicant, furnish the following 779 to the Department of Health in a physician survey: 780 (a) Licensee information, including, but not limited to: 781 1. Frequency and geographic location of practice within the 782 state. 783 2. Practice setting. 784 3. Percentage of time spent in direct patient care. 785 4. Anticipated change to license or practice status. 786 5. Areas of specialty or certification. 787 6. Whether the department has ever approved or denied the 788 physician’s registration for access to a patient’s information 789 in the database of the prescription drug monitoring program. 790 7. Whether the physician uses the prescription drug 791 monitoring program with patients in his or her medical practice. 792 Section 12. Subsection (3) is added to section 459.0082, 793 Florida Statutes, to read: 794 459.0082 Analysis of survey results; report.— 795 (3) By November 1 of each year, the Department of Health 796 shall provide nonidentifying information to the Implementation 797 and Oversight Task Force of the prescription drug monitoring 798 program regarding the number of physicians who are registered 799 with the prescription drug monitoring program and who also use 800 the database from the prescription drug monitoring program for 801 their patients in their medical practice. 802 Section 13. Paragraphs (f) and (g) are added to subsection 803 (1), paragraphs (e) and (f) are added to subsection (2), and 804 paragraphs (d) and (e) are added to subsection (3) of section 805 459.013, Florida Statutes, to read: 806 459.013 Penalty for violations.— 807 (1) Each of the following acts constitutes a felony of the 808 third degree, punishable as provided in s. 775.082, s. 775.083, 809 or s. 775.084: 810 (f) Failing to perform a physical examination of a patient 811 on the same day that the osteopathic physician dispenses or 812 prescribes a controlled substance to the patient at a pain 813 management clinic occurring three or more times within a 6-month 814 period, or failing to perform a physical examination on three or 815 more different patients on the same day that the osteopathic 816 physician dispenses or prescribes a controlled substance to each 817 patient at a pain-management clinic within a 6-month period. 818 (g) Prescribing or dispensing in excess of a 72-hour dose 819 of controlled substances at a pain-management clinic for the 820 treatment of chronic nonmalignant pain of a patient occurring 821 three or more times within a 6-month period without documenting 822 in the patient’s record the reason that such dosage is within 823 the standard of care. For the purpose of this paragraph, the 824 standard of care is set forth in rule 64B15-14.005(3), Florida 825 Administrative Code. 826 (2) Each of the following acts constitutes a misdemeanor of 827 the first degree, punishable as provided in s. 775.082 or s. 828 775.083: 829 (e) Failing to perform a physical examination of a patient 830 on the same day that the osteopathic physician dispenses or 831 prescribes a controlled substance to the patient at a pain 832 management clinic occurring two times within a 6-month period, 833 or failing to perform a physical examination on two different 834 patients on the same day that the osteopathic physician 835 dispenses or prescribes a controlled substance to each patient 836 at a pain-management clinic within a 6-month period. 837 (f) Prescribing or dispensing in excess of a 72-hour dose 838 of controlled substances at a pain-management clinic for the 839 treatment of chronic nonmalignant pain of a patient occurring 840 two times within a 6-month period without documenting in the 841 patient’s record the reason that such dosage is within the 842 standard of care. For the purpose of this paragraph, the 843 standard of care is set forth in rule 64B15-14.005(3), Florida 844 Administrative Code. 845 (3) Each of the following constitutes a misdemeanor of the 846 second degree, punishable as provided in s. 775.082 or s. 847 775.083: 848 (d) A first offense of failing to perform a physical 849 examination of a patient on the same day that the osteopathic 850 physician dispenses or prescribes a controlled substance to the 851 patient at a pain-management clinic. 852 (e) A first offense of failing to document in a patient’s 853 record the reason that such dosage is within the standard of 854 care for prescribing or dispensing in excess of a 72-hour dose 855 of controlled substances at a pain-management clinic for the 856 treatment of chronic nonmalignant pain. For the purpose of this 857 paragraph, the standard of care is set forth in rule 64B15 858 14.005(3), Florida Administrative Code. 859 Section 14. Paragraphs (a), (f), (g), (h), and (k) of 860 subsection (1) and paragraphs (a) and (c) of subsection (2) of 861 section 459.0137, Florida Statutes, are amended, and paragraphs 862 (f) and (g) are added to subsection (5) of that section, to 863 read: 864 459.0137 Pain-management clinics.— 865 (1) REGISTRATION.— 866 (a) “Pain-management clinic,” hereinafter referred to as 867 “clinic,” means a publicly or privately owned facility where in 868 any month a majority of patients are prescribed opioids, 869 benzodiazepines, barbiturates, or carisoprodol for the treatment 870 of chronic nonmalignant pain. “Chronic nonmalignant pain” means 871 pain unrelated to cancer or rheumatoid arthritis which persists 872 beyond the usual course of a disease or the injury that is the 873 cause of the pain or more than 90 days after surgery. All 874privately ownedpain-management clinics, facilities, or offices,875hereinafter referred to as “clinics,” which advertise in any876medium for any type of pain-management services, or employ an877osteopathic physician who is primarily engaged in the treatment878of pain by prescribing or dispensing controlled substance879medications,must register with the department unless: 880 1. That clinic is licensed as a facility pursuant to 881 chapter 395; 882 2. The majority of the physicians who provide services in 883 the clinic primarily provide surgical services or interventional 884 pain procedures of the type routinely billed using surgical 885 codes; 886 3. The clinic is owned by a publicly held corporation whose 887 shares are traded on a national exchange or on the over-the 888 counter market and whose total assets at the end of the 889 corporation’s most recent fiscal quarter exceeded $50 million; 890 4. The clinic is affiliated with an accredited medical 891 school at which training is provided for medical students, 892 residents, or fellows; 893 5. The clinic does not prescribe or dispense controlled 894 substances for the treatment of pain; or 895 6. The clinic is owned by a corporate entity exempt from 896 federal taxation under 26 U.S.C. s. 501(c)(3). 897 (f) If the department finds upon a hearing by the probable 898 cause panel of the appropriate board that a pain-management 899 clinic does not meet the requirement of paragraph (d) or is 900 owned, directly or indirectly, by a person meeting any criteria 901 listed in paragraph (e), the department shall revoke the 902 certificate of registration previously issued by the department. 903 As determined by rule, the department may grant an exemption to 904 denying a registration or revoking a previously issued 905 registration if more than 10 years have elapsed since 906 adjudication. As used in this subsection, the term “convicted” 907 includes an adjudication of guilt following a plea of guilty or 908 nolo contendere or the forfeiture of a bond when charged with a 909 crime. 910 (g) The department may revoke the clinic’s certificate of 911 registration and prohibit all physicians associated with that 912 pain-management clinic from practicing at that clinic location 913 based upon an annual inspection and evaluation of the factors 914 described in subsection (3) and upon a final determination by 915 the probable cause panel of the appropriate board that any 916 physician associated with that pain-management clinic knew or 917 should have known of any violations of the factors described in 918 subsection (3). 919 (h)1. If the registration of a pain-management clinic is 920 revoked or suspended, the designated physician of the pain 921 management clinic, the owner or lessor of the pain-management 922 clinic property, the manager, and the proprietor shall cease to 923 operate the facility as a pain-management clinic as of the 924 effective date of the suspension or revocation. 925 2. Notwithstanding subparagraph 1., the clinic’s 926 registration shall not be revoked or suspended if the clinic, 927 within 24 hours after notification of suspension or revocation, 928 appoints another designated physician who has a full, active, 929 and unencumbered license under this chapter or chapter 458 to 930 operate a pain-management clinic. 931 (k) If the clinic’s registration is revoked, any person 932 named in the registration documents of the pain-management 933 clinic, including persons owning or operating the pain 934 management clinic, may not, as an individual or as a part of a 935 group, make application for a permit to operate a pain 936 management clinic for 5 years after the date the registration is 937 revoked upon a finding by the probable cause panel of the 938 appropriate board, and an opportunity to be heard, that the 939 persons operating such clinic knew or should have known of 940 violations causing such revocation. 941 (2) PHYSICIAN RESPONSIBILITIES.—These responsibilities 942 apply to any osteopathic physician who provides professional 943 services in a pain-management clinic that is required to be 944 registered in subsection (1). 945 (a) An osteopathic physician may not practice medicine in a 946 pain-management clinic, as described in subsection (4), if:9471.The pain-management clinic is not registered with the 948 department as required by this section.; or9492. Effective July 1, 2012, the physician has not950successfully completed a pain-medicine fellowship that is951accredited by the Accreditation Council for Graduate Medical952Education or the American Osteopathic Association or a pain953medicine residency that is accredited by the Accreditation954Council for Graduate Medical Education or the American955Osteopathic Association or, prior to July 1, 2012, does not956comply with rules adopted by the board.957 958 Any physician who qualifies to practice medicine in a pain 959 management clinic pursuant to rules adopted by the Board of 960 Osteopathic Medicine as of July 1, 2012, may continue to 961 practice medicine in a pain-management clinic as long as the 962 physician continues to meet the qualifications set forth in the 963 board rules. An osteopathic physician who violates this 964 paragraph is subject to disciplinary action by his or her 965 appropriate medical regulatory board. 966 (c) An osteopathic physician, an advanced registered nurse 967 practitioner, or a physician assistant must perform an 968 appropriate medicala physicalexamination of a patient on the 969 same day that the physicianhe or shedispenses or prescribes a 970 controlled substance to a patient at a pain-management clinic. 971 If the osteopathic physician prescribes or dispenses more than a 972 72-hour dose of controlled substances for the treatment of 973 chronic nonmalignant pain, the osteopathic physician must 974 document in the patient’s record the reason for which 975 prescribing or dispensing a dosage in excess of a 72-hour dose 976 of controlled substances for the treatment of chronic 977 nonmalignant pain is within the standard of carefor prescribing978or dispensing that quantity. 979 (5) PENALTIES; ENFORCEMENT.— 980 (f) A licensee or other person who serves as the designated 981 physician of a pain-management clinic as defined in s. 458.3265 982 or s. 459.0137 and registers a pain-management clinic through 983 intentional misrepresentation or fraud or procures or attempts 984 to procure the registration of a pain-management clinic for any 985 other person by making or causing to be made any false or 986 fraudulent representation commits a felony of the third degree, 987 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 988 (g) Any person who registers a pain-management clinic 989 through misrepresentation or fraud or who procures or attempts 990 to procure the registration of a pain-management clinic for any 991 other person by making or causing to be made any false or 992 fraudulent representation, commits a felony of the third degree, 993 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 994 Section 15. Subsection (11) is added to section 459.015, 995 Florida Statutes, to read: 996 459.015 Grounds for disciplinary action; action by the 997 board and department.— 998 (11) Notwithstanding subsection (2), upon finding that an 999 osteopathic physician has prescribed or dispensed, or caused to 1000 be prescribed or dispensed, a controlled substance in a pain 1001 management clinic in a manner that violates the standard of 1002 practice as set forth in this chapter or rules adopted pursuant 1003 to this chapter, the board shall, at a minimum, suspend the 1004 osteopathic physician’s license for at least 6 months and impose 1005 a fine of at least $10,000 per count. Repeated violations shall 1006 result in increased penalties. 1007 Section 16. Present subsections (3) and (4) of section 1008 465.015, Florida Statutes, are renumbered as subsections (4) and 1009 (5), respectively, and a new subsection (3) is added to that 1010 section, to read: 1011 465.015 Violations and penalties.— 1012 (3)(a) A licensed pharmacist may not knowingly fail to 1013 timely report to the local county sheriff’s office the name of 1014 any person who obtains or attempts to obtain a substance 1015 controlled by s. 893.03 which the licensed pharmacist knows or 1016 reasonably should have known was obtained or attempted to be 1017 obtained from the pharmacy through any fraudulent method or 1018 representation. A licensed pharmacist who fails to make such a 1019 report within 24 hours after learning of the fraud or attempted 1020 fraud commits a misdemeanor of the first degree, punishable as 1021 provided in s. 775.082 or s. 775.083. 1022 (b) A sufficient report of the fraudulent obtaining of or 1023 attempt to obtain a controlled substance under this subsection 1024 may contain, at a minimum, a copy of the prescription used or 1025 presented and a narrative, including all information available 1026 to the pharmacy regarding: 1027 1. The transaction, such as the name and telephone number 1028 of the prescribing physician; 1029 2. The name, description, and any personal identification 1030 information pertaining to the person presenting the 1031 prescription; and 1032 3. All other material information, such as photographic or 1033 video surveillance of the transaction. 1034 1035 A licensed pharmacist is not subject to disciplinary action for 1036 reporting under this subsection. 1037 Section 17. Subsection (6) is added to section 465.0276, 1038 Florida Statutes, to read: 1039 465.0276 Dispensing practitioner.— 1040 (6) In order to dispense a controlled substance listed in 1041 Schedule II, Schedule III, or Schedule IV in s. 893.03, a 1042 practitioner authorized by law to prescribe a controlled 1043 substance shall register with the Board of Pharmacy as a 1044 dispensing practitioner who dispenses controlled substances and 1045 pay a fee not to exceed $100. The department shall adopt rules 1046 establishing procedures for renewal of the registration every 4 1047 years. 1048 Section 18. Paragraph (t) of subsection (2) of section 1049 499.01, Florida Statutes, is amended to read: 1050 499.01 Permits.— 1051 (2) The following permits are established: 1052 (t) Health care clinic establishment permit.—Effective 1053 January 1, 2009, a health care clinic establishment permit is 1054 required for the purchase of a prescription drug by a place of 1055 business at one general physical location that provides health 1056 care or veterinary services, which is owned and operated by a 1057 business entity that has been issued a federal employer tax 1058 identification number. For the purpose of this paragraph, the 1059 term “qualifying practitioner” means a licensed health care 1060 practitioner defined in s. 456.001, or a veterinarian licensed 1061 under chapter 474, who is authorized under the appropriate 1062 practice act to prescribe and administer a prescription drug. 1063 1. An establishment must provide, as part of the 1064 application required under s. 499.012, designation of a 1065 qualifying practitioner who will be responsible for complying 1066 with all legal and regulatory requirements related to the 1067 purchase, recordkeeping, storage, and handling of the 1068 prescription drugs. In addition, the designated qualifying 1069 practitioner shall be the practitioner whose name, establishment 1070 address, and license number is used on all distribution 1071 documents for prescription drugs purchased or returned by the 1072 health care clinic establishment. Upon initial appointment of a 1073 qualifying practitioner, the qualifying practitioner and the 1074 health care clinic establishment shall notify the department on 1075 a form furnished by the department within 10 days after such 1076 employment. In addition, the qualifying practitioner and health 1077 care clinic establishment shall notify the department within 10 1078 days after any subsequent change. 1079 2. The health care clinic establishment must employ a 1080 qualifying practitioner at each establishment. 1081 3. In addition to the remedies and penalties provided in 1082 this part, a violation of this chapter by the health care clinic 1083 establishment or qualifying practitioner constitutes grounds for 1084 discipline of the qualifying practitioner by the appropriate 1085 regulatory board. 1086 4. The purchase of prescription drugs by the health care 1087 clinic establishment is prohibited during any period of time 1088 when the establishment does not comply with this paragraph. 1089 5. A health care clinic establishment permit is not a 1090 pharmacy permit or otherwise subject to chapter 465. A health 1091 care clinic establishment that meets the criteria of a modified 1092 Class II institutional pharmacy under s. 465.019 is not eligible 1093 to be permitted under this paragraph. 1094 6. This paragraph does not apply to the purchase of a 1095 prescription drug by a licensed practitioner under his or her 1096 license. A professional corporation or limited liability company 1097 composed of dentists and operating as authorized in s. 466.0285 1098 may pay for prescription drugs obtained by a practitioner 1099 licensed under chapter 466, and the licensed practitioner is 1100 deemed the purchaser and owner of the prescription drugs. 1101 Section 19. Paragraph (a) of subsection (1) of section 1102 766.101, Florida Statutes, is amended to read: 1103 766.101 Medical review committee, immunity from liability.— 1104 (1) As used in this section: 1105 (a) The term “medical review committee” or “committee” 1106 means: 1107 1.a. A committee of a hospital or ambulatory surgical 1108 center licensed under chapter 395 or a health maintenance 1109 organization certificated under part I of chapter 641, 1110 b. A committee of a physician-hospital organization, a 1111 provider-sponsored organization, or an integrated delivery 1112 system, 1113 c. A committee of a state or local professional society of 1114 health care providers, 1115 d. A committee of a medical staff of a licensed hospital or 1116 nursing home, provided the medical staff operates pursuant to 1117 written bylaws that have been approved by the governing board of 1118 the hospital or nursing home, 1119 e. A committee of the Department of Corrections or the 1120 Correctional Medical Authority as created under s. 945.602, or 1121 employees, agents, or consultants of either the department or 1122 the authority or both, 1123 f. A committee of a professional service corporation formed 1124 under chapter 621 or a corporation organized under chapter 607 1125 or chapter 617, which is formed and operated for the practice of 1126 medicine as defined in s. 458.305(4)s.458.305(3), and which 1127 has at least 25 health care providers who routinely provide 1128 health care services directly to patients, 1129 g. A committee of the Department of Children and Family 1130 Services which includes employees, agents, or consultants to the 1131 department as deemed necessary to provide peer review, 1132 utilization review, and mortality review of treatment services 1133 provided pursuant to chapters 394, 397, and 916, 1134 h. A committee of a mental health treatment facility 1135 licensed under chapter 394 or a community mental health center 1136 as defined in s. 394.907, provided the quality assurance program 1137 operates pursuant to the guidelines which have been approved by 1138 the governing board of the agency, 1139 i. A committee of a substance abuse treatment and education 1140 prevention program licensed under chapter 397 provided the 1141 quality assurance program operates pursuant to the guidelines 1142 which have been approved by the governing board of the agency, 1143 j. A peer review or utilization review committee organized 1144 under chapter 440, 1145 k. A committee of the Department of Health, a county health 1146 department, healthy start coalition, or certified rural health 1147 network, when reviewing quality of care, or employees of these 1148 entities when reviewing mortality records, or 1149 l. A continuous quality improvement committee of a pharmacy 1150 licensed pursuant to chapter 465, 1151 1152 which committee is formed to evaluate and improve the quality of 1153 health care rendered by providers of health service, to 1154 determine that health services rendered were professionally 1155 indicated or were performed in compliance with the applicable 1156 standard of care, or that the cost of health care rendered was 1157 considered reasonable by the providers of professional health 1158 services in the area; or 1159 2. A committee of an insurer, self-insurer, or joint 1160 underwriting association of medical malpractice insurance, or 1161 other persons conducting review under s. 766.106. 1162 Section 20. Subsection (3) of section 810.02, Florida 1163 Statutes, is amended to read: 1164 810.02 Burglary.— 1165 (3) Burglary is a felony of the second degree, punishable 1166 as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the 1167 course of committing the offense, the offender does not make an 1168 assault or battery and is not and does not become armed with a 1169 dangerous weapon or explosive, and the offender enters or 1170 remains in a: 1171 (a) Dwelling, and there is another person in the dwelling 1172 at the time the offender enters or remains; 1173 (b) Dwelling, and there is not another person in the 1174 dwelling at the time the offender enters or remains; 1175 (c) Structure, and there is another person in the structure 1176 at the time the offender enters or remains; 1177 (d) Conveyance, and there is another person in the 1178 conveyance at the time the offender enters or remains;or1179 (e) Authorized emergency vehicle, as defined in s. 316.003; 1180 or.1181 (f) Structure or conveyance when the offense intended to be 1182 committed is theft of a substance controlled by s. 893.03. 1183 Notwithstanding any contrary provisions of law, separate 1184 judgments and sentences for burglary with the intent to commit 1185 theft of a controlled substance under this paragraph and for any 1186 applicable offense for possession of a controlled substance 1187 under s. 893.13, or an offense for trafficking in a controlled 1188 substance under s. 893.135, may be imposed if all such offenses 1189 involve the same amount or amounts of a controlled substance. 1190 1191 However, if the burglary is committed within a county that is 1192 subject to a state of emergency declared by the Governor under 1193 chapter 252 after the declaration of emergency is made and the 1194 perpetration of the burglary is facilitated by conditions 1195 arising from the emergency, the burglary is a felony of the 1196 first degree, punishable as provided in s. 775.082, s. 775.083, 1197 or s. 775.084. As used in this subsection, the term “conditions 1198 arising from the emergency” means civil unrest, power outages, 1199 curfews, voluntary or mandatory evacuations, or a reduction in 1200 the presence of or response time for first responders or 1201 homeland security personnel. A person arrested for committing a 1202 burglary within a county that is subject to such a state of 1203 emergency may not be released until the person appears before a 1204 committing magistrate at a first appearance hearing. For 1205 purposes of sentencing under chapter 921, a felony offense that 1206 is reclassified under this subsection is ranked one level above 1207 the ranking under s. 921.0022 or s. 921.0023 of the offense 1208 committed. 1209 Section 21. Paragraph (c) of subsection (2) of section 1210 812.014, Florida Statutes, is amended to read: 1211 812.014 Theft.— 1212 (2) 1213 (c) It is grand theft of the third degree and a felony of 1214 the third degree, punishable as provided in s. 775.082, s. 1215 775.083, or s. 775.084, if the property stolen is: 1216 1. Valued at $300 or more, but less than $5,000. 1217 2. Valued at $5,000 or more, but less than $10,000. 1218 3. Valued at $10,000 or more, but less than $20,000. 1219 4. A will, codicil, or other testamentary instrument. 1220 5. A firearm. 1221 6. A motor vehicle, except as provided in paragraph (a). 1222 7. Any commercially farmed animal, including any animal of 1223 the equine, bovine, or swine class, or other grazing animal, and 1224 including aquaculture species raised at a certified aquaculture 1225 facility. If the property stolen is aquaculture species raised 1226 at a certified aquaculture facility, then a $10,000 fine shall 1227 be imposed. 1228 8. Any fire extinguisher. 1229 9. Any amount of citrus fruit consisting of 2,000 or more 1230 individual pieces of fruit. 1231 10. Taken from a designated construction site identified by 1232 the posting of a sign as provided for in s. 810.09(2)(d). 1233 11. Any stop sign. 1234 12. Anhydrous ammonia. 1235 13. Any amount of a substance controlled by s. 893.03. 1236 Notwithstanding any contrary provisions of law, separate 1237 judgments and sentences for theft of a controlled substance 1238 under this subparagraph, and for any applicable offense for 1239 possession of a controlled substance under s. 893.13, or an 1240 offense for trafficking in a controlled substance under s. 1241 893.135 may be imposed if all such offenses involve the same 1242 amount or amounts of controlled substance. 1243 1244 However, if the property is stolen within a county that is 1245 subject to a state of emergency declared by the Governor under 1246 chapter 252, the property is stolen after the declaration of 1247 emergency is made, and the perpetration of the theft is 1248 facilitated by conditions arising from the emergency, the 1249 offender commits a felony of the second degree, punishable as 1250 provided in s. 775.082, s. 775.083, or s. 775.084, if the 1251 property is valued at $5,000 or more, but less than $10,000, as 1252 provided under subparagraph 2., or if the property is valued at 1253 $10,000 or more, but less than $20,000, as provided under 1254 subparagraph 3. As used in this paragraph, the term “conditions 1255 arising from the emergency” means civil unrest, power outages, 1256 curfews, voluntary or mandatory evacuations, or a reduction in 1257 the presence of or the response time for first responders or 1258 homeland security personnel. For purposes of sentencing under 1259 chapter 921, a felony offense that is reclassified under this 1260 paragraph is ranked one level above the ranking under s. 1261 921.0022 or s. 921.0023 of the offense committed. 1262 Section 22. Section 893.021, Florida Statutes, is created 1263 to read: 1264 893.021 Adulterated drug.— 1265 (1) As used in this chapter, a drug is adulterated if it is 1266 a controlled substance that: 1267 (a) Has been produced, prepared, packed, and marketed for 1268 oral consumption by the manufacturer; and 1269 (b) Has had any change to its integrity or composition for 1270 use by means of inhalation, injection, or any other form of 1271 ingestion not in accordance with the manufacturer’s recommended 1272 use, and such mode of use has not been previously directed and 1273 approved by the prescribing physician. 1274 (2) A physician is not prevented from directing or 1275 prescribing a change to the recognized manufactured 1276 recommendations for use in a patient who presents a medical need 1277 for such a requirement change of any controlled substance. The 1278 prescribing physician shall clearly indicate any deviation of 1279 the recognized manufacturer’s recommended use of a controlled 1280 substance on the original prescription, and the licensed 1281 pharmacist shall clearly indicate such deviation on the label of 1282 the prescription upon dispensing the controlled substance. 1283 Section 23. Paragraphs (c), (d), and (e) of subsection (1) 1284 of section 893.04, Florida Statutes, are amended to read: 1285 893.04 Pharmacist and practitioner.— 1286 (1) A pharmacist, in good faith and in the course of 1287 professional practice only, may dispense controlled substances 1288 upon a written or oral prescription of a practitioner, under the 1289 following conditions: 1290 (c) The following information mustThere shallappear on 1291 the face of the prescription or written record of athereof for1292thecontrolled substancethe following information: 1293 1. The full name and address of the person for whom, or the 1294 owner of the animal for which, the controlled substance is 1295 dispensed. 1296 2. The full name and address of the prescribing 1297 practitioner and the practitioner’s federal controlled substance 1298 registry number shall be printed thereon. 1299 3. If the prescription is for an animal, the species of 1300 animal for which the controlled substance is prescribed. 1301 4. The name of the controlled substance prescribed and the 1302 strength, quantity, and directions for use thereof. The 1303 directions for use must specify the authorization by the 1304 physician, any instructions requiring the adulteration of the 1305 dispensed form of the medication, and the medical necessity for 1306 the adulteration in accordance with s. 893.021. 1307 5. The number of the prescription, as recorded in the 1308 prescription files of the pharmacy in which it is filled. 1309 6. The initials of the pharmacist filling the prescription 1310 and the date filled. 1311 (d) The prescription mustshallbe retained on file by the 1312 proprietor of the pharmacy in which it is filled for a period of 1313 2 years. 1314 (e) A label bearing the following information must be 1315 affixed to the original container in which a controlled 1316 substance is delivered asupona prescription or authorized 1317 refillthereof, as hereinafter provided, there shall be a label1318bearing the following information: 1319 1. The name and address of the pharmacy from which such 1320 controlled substance was dispensed. 1321 2. The date on which the prescription for such controlled 1322 substance was filled. 1323 3. The number of such prescription, as recorded in the 1324 prescription files of the pharmacy in which it is filled. 1325 4. The name of the prescribing practitioner. 1326 5. The name of the patient for whom, or of the owner and 1327 species of the animal for which, the controlled substance is 1328 prescribed. 1329 6. The directions for the use of the controlled substance 1330 prescribed in the prescription. 1331 7. A clear, concise warning that it is a crime to transfer 1332 the controlled substance to any person other than the patient 1333 for whom prescribed. 1334 Section 24. Section 893.055, Florida Statutes, is amended 1335 to read: 1336 893.055 Prescription drug monitoring program.— 1337 (1) As used in this section, the term: 1338 (a) “Patient advisory report” or “advisory report” means 1339 information provided by the department in writing, or as 1340 determined by the department, to a prescriber, dispenser, 1341 pharmacy, or patient concerning the dispensing of controlled 1342 substances. All advisory reports are for informational purposes 1343 only and impose no obligations of any nature or any legal duty 1344 on a prescriber, dispenser, pharmacy, or patient. The patient 1345 advisory report shall be provided in accordance with s. 1346 893.13(7)(a)8. The advisory reports issued by the department are 1347 not subject to discovery or introduction into evidence in any 1348 civil or administrative action against a prescriber, dispenser, 1349 pharmacy, or patient arising out of matters that are the subject 1350 of the report; and a person who participates in preparing, 1351 reviewing, issuing, or any other activity related to an advisory 1352 report may not be permitted or required to testify in any such 1353 civil action as to any findings, recommendations, evaluations, 1354 opinions, or other actions taken in connection with preparing, 1355 reviewing, or issuing such a report. 1356 (b) “Controlled substance” means a controlled substance 1357 listed in Schedule II, Schedule III, or Schedule IV in s. 1358 893.03. 1359 (c) “Dispenser” means a pharmacy, dispensing pharmacist, or 1360 dispensing health care practitioner. 1361 (d) “Health care practitioner” or “practitioner” means any 1362 practitioner who is subject to licensure or regulation by the 1363 department under chapter 458, chapter 459, chapter 461, chapter 1364 462, chapter 464, chapter 465, or chapter 466. 1365 (e) “Health care regulatory board” means any board for a 1366 practitioner or health care practitioner who is licensed or 1367 regulated by the department. 1368 (f) “Pharmacy” means any pharmacy that is subject to 1369 licensure or regulation by the department under chapter 465 and 1370 that dispenses or delivers a controlled substance to an 1371 individual or address in this state. 1372 (g) “Prescriber” means a prescribing physician, prescribing 1373 practitioner, or other prescribing health care practitioner. 1374 (h) “Active investigation” means an investigation that is 1375 being conducted with a reasonable, good faith belief that it 1376 could lead to the filing of administrative, civil, or criminal 1377 proceedings, or that is ongoing and continuing and for which 1378 there is a reasonable, good faith anticipation of securing an 1379 arrest or prosecution in the foreseeable future. 1380 (i) “Law enforcement agency” means the Department of Law 1381 Enforcement, a Florida sheriff’s department, a Florida police 1382 department, or a law enforcement agency of the Federal 1383 Government which enforces the laws of this state or the United 1384 States relating to controlled substances, and which its agents 1385 and officers are empowered by law to conduct criminal 1386 investigations and make arrests. 1387 (j) “Program manager” means an employee of or a person 1388 contracted by the Department of Health who is designated to 1389 ensure the integrity of the prescription drug monitoring program 1390 in accordance with the requirements established in paragraphs 1391 (2)(a) and (b). 1392 (2)(a) By December 1, 2010, the department shall design and 1393 establish a comprehensive electronic database system that has 1394 controlled substance prescriptions provided to it and that 1395 provides prescription information to a patient’s health care 1396 practitioner and pharmacist who inform the department that they 1397 wish the patient advisory report provided to them. Otherwise, 1398 the patient advisory report will not be sent to the 1399 practitioner, pharmacy, or pharmacist. The system shall be 1400 designed to provide information regarding dispensed 1401 prescriptions of controlled substances and shall not infringe 1402 upon the legitimate prescribing or dispensing of a controlled 1403 substance by a prescriber or dispenser acting in good faith and 1404 in the course of professional practice. The system shall be 1405 consistent with standards of the American Society for Automation 1406 in Pharmacy (ASAP). The electronic system shall also comply with 1407 the Health Insurance Portability and Accountability Act (HIPAA) 1408 as it pertains to protected health information (PHI), electronic 1409 protected health information (EPHI), minimum requirements as 1410 established by the department for authentication of a 1411 practitioner who requests information in the prescription drug 1412 monitoring program database and certification of the purpose for 1413 which information is requested, and all other relevant state and 1414 federal privacy and security laws and regulations. The 1415 department shall establish policies and procedures as 1416 appropriate regarding the reporting, accessing the database, 1417 evaluation, management, development, implementation, operation, 1418 storage, and security of information within the system. The 1419 reporting of prescribed controlled substances shall include a 1420 dispensing transaction with a dispenser pursuant to chapter 465 1421 or through a dispensing transaction to an individual or address 1422 in this state with a pharmacy that is not located in this state 1423 but that is otherwise subject to the jurisdiction of this state 1424 as to that dispensing transaction. The reporting of patient 1425 advisory reports refers only to reports to patients, pharmacies, 1426 and practitioners. Separate reports that contain patient 1427 prescription history information and that are not patient 1428 advisory reports are provided to persons and entities as 1429 authorized in paragraphs (7)(b) and (c) and s. 893.0551. 1430 (b) The department, when the direct support organization 1431 receives at least $20,000 in nonstate moneys or the state 1432 receives at least $20,000 in federal grants for the prescription 1433 drug monitoring program, and in consultation with the Office of 1434 Drug Control, shall adopt rules as necessary concerning the 1435 reporting, accessing the database, evaluation, management, 1436 development, implementation, operation, security, and storage of 1437 information within the system, including rules for when patient 1438 advisory reports are provided to pharmacies and prescribers. The 1439 patient advisory report shall be provided in accordance with s. 1440 893.13(7)(a)8. The department shall work with the professional 1441 health care licensure boards, such as the Board of Medicine, the 1442 Board of Osteopathic Medicine, and the Board of Pharmacy; other 1443 appropriate organizations, such as the Florida Pharmacy 1444 Association, the Office of Drug Control, the Florida Medical 1445 Association, the Florida Retail Federation, and the Florida 1446 Osteopathic Medical Association, including those relating to 1447 pain management; and the Attorney General, the Department of Law 1448 Enforcement, and the Agency for Health Care Administration to 1449 develop rules appropriate for the prescription drug monitoring 1450 program. 1451 (c) All dispensers and prescribers subject to these 1452 reporting requirements shall be notified by the department of 1453 the implementation date for such reporting requirements. 1454 (d) The program manager shall work with professional health 1455 care licensure boards and the stakeholders listed in paragraph 1456 (b) to develop rules appropriate for identifying indicators of 1457 controlled substance abuse. 1458 (e) The department shall establish a method to allow 1459 corrections to the database when notified by a health care 1460 practitioner or pharmacist. 1461 (3) The pharmacy dispensing the controlled substance and 1462 each prescriber who directly dispenses a controlled substance 1463 shall submit to the electronic system, by a procedure and in a 1464 format established by the department and consistent with an 1465 ASAP-approved format, the following information for inclusion in 1466 the database: 1467 (a) The name of the prescribing practitioner, the 1468 practitioner’s federal Drug Enforcement Administration 1469 registration number, the practitioner’s National Provider 1470 Identification (NPI) or other appropriate identifier, and the 1471 date of the prescription. 1472 (b) The date the prescription was filled and the method of 1473 payment, such as cash by an individual, insurance coverage 1474 through a third party, or Medicaid payment. This paragraph does 1475 not authorize the department to include individual credit card 1476 numbers or other account numbers in the database. 1477 (c) The full name, address, and date of birth of the person 1478 for whom the prescription was written. 1479 (d) The name, national drug code, quantity, and strength of 1480 the controlled substance dispensed. 1481 (e) The full name, federal Drug Enforcement Administration 1482 registration number, and address of the pharmacy or other 1483 location from which the controlled substance was dispensed. If 1484 the controlled substance was dispensed by a practitioner other 1485 than a pharmacist, the practitioner’s full name, federal Drug 1486 Enforcement Administration registration number, and address. 1487 (f) The name of the pharmacy or practitioner, other than a 1488 pharmacist, dispensing the controlled substance and the 1489 practitioner’s National Provider Identification (NPI). 1490 (g) Other appropriate identifying information as determined 1491 by department rule. 1492 (h) The number of refills ordered and whether the drug was 1493 dispensed as a refill of a prescription or was a first-time 1494 request. 1495 (4) Each time a controlled substance is dispensed to an 1496 individual, the controlled substance shall be reported to the 1497 department through the system as soon thereafter as possible, 1498 but not more than 715days after the date the controlled 1499 substance is dispensed unless an extension is approved by the 1500 department for cause as determined by rule. A dispenser must 1501 meet the reporting requirements of this section by providing the 1502 required information concerning each controlled substance that 1503 it dispensed in a department-approved, secure methodology and 1504 format. Such approved formats may include, but are not limited 1505 to, submission via the Internet, on a disc, or by use of regular 1506 mail. 1507 (5) When the following acts of dispensing or administering 1508 occur, the following are exempt from reporting under this 1509 section for that specific act of dispensing or administration: 1510 (a) A health care practitioner when administering a 1511 controlled substance directly to a patient if the amount of the 1512 controlled substance is adequate to treat the patient during 1513 that particular treatment session. 1514 (b) A pharmacist or health care practitioner when 1515 administering a controlled substance to a patient or resident 1516 receiving care as a patient at a hospital, nursing home, 1517 ambulatory surgical center, hospice, or intermediate care 1518 facility for the developmentally disabled which is licensed in 1519 this state. 1520(c) A practitioner when administering or dispensing a1521controlled substance in the health care system of the Department1522of Corrections.1523 (c)(d)A practitioner when administering a controlled 1524 substance in the emergency room of a licensed hospital. 1525 (d)(e)A health care practitioner when administering or 1526 dispensing a controlled substance to a person under the age of 1527 16 if the amount of the controlled substance is adequate to 1528 treat the patient during that particular treatment session. 1529 (e)(f)A pharmacist or a dispensing practitioner when 1530 dispensing a one-time, 48-hour72-houremergency resupply of a 1531 controlled substance to a patient. 1532 (6) The department may establish when to suspend and when 1533 to resume reporting information during a state-declared or 1534 nationally declared disaster. 1535 (7)(a) A practitioner or pharmacist who dispenses a 1536 controlled substance must submit the information required by 1537 this section in an electronic or other method in an ASAP format 1538 approved by rule of the department unless otherwise provided in 1539 this section. The cost to the dispenser in submitting the 1540 information required by this section may not be material or 1541 extraordinary. Costs not considered to be material or 1542 extraordinary include, but are not limited to, regular postage, 1543 electronic media, regular electronic mail, and facsimile 1544 charges. 1545 (b)1. In order for a pharmacy, prescriber, practitioner, or 1546 dispenser toshallhave access to information in the 1547 prescription drug monitoring program’s database which relates to 1548 a patient of that pharmacy, prescriber, practitioner, or 1549 dispenser, the pharmacy, prescriber, practitioner, or dispenser 1550 shall register with the department by submitting a registering 1551 document provided by the department. The document and validation 1552 of that document shall be determined by the department. Before a 1553 pharmacy, prescriber, practitioner, or dispenser is granted 1554 access to information in the database from the prescription drug 1555 monitoring program, the department shall approve the submitted 1556 document. Upon approval, the department shall grant the 1557 registrant access to the appropriate information in the 1558 prescription drug monitoring program’s databasein a manner1559established by the department as needed for the purpose of1560reviewing the patient’s controlled substance prescription1561history. 1562 2. Other access to the program’s database shall be limited 1563 to the program’s manager and to the designated program and 1564 support staff, who may act only at the direction of the program 1565 manager or, in the absence of the program manager, as 1566 authorized. Access by the program manager or such designated 1567 staff is for prescription drug program management only or for 1568 management of the program’s database and its system in support 1569 of the requirements of this section and in furtherance of the 1570 prescription drug monitoring program. Confidential and exempt 1571 information in the database shall be released only as provided 1572 in paragraph (c) and s. 893.0551. The program manager, 1573 designated program and support staff who act at the direction of 1574 or in the absence of the program manager, and any individual who 1575 has similar access regarding the management of the database from 1576 the prescription drug monitoring program shall submit 1577 fingerprints to the department for background screening. The 1578 department shall follow the procedure established by the 1579 Department of Law Enforcement to request a statewide criminal 1580 history record check and to request that the Department of Law 1581 Enforcement forward the fingerprints to the Federal Bureau of 1582 Investigation for a national criminal history record check. 1583 (c) The following entities mayshallnot havebe allowed1584 direct access to information in the prescription drug monitoring 1585 program database but may request from the program manager and, 1586 when authorized by the program manager, the program manager’s 1587 program and support staff, information that is confidential and 1588 exempt under s. 893.0551. Prior to release, the request shall be 1589 verified as authentic and authorized with the requesting 1590 organization by the program manager, the program manager’s 1591 program and support staff, or as determined in rules by the 1592 department as being authentic and as having been authorized by 1593 the requesting entity: 1594 1. The department or its relevant health care regulatory 1595 boards responsible for the licensure, regulation, or discipline 1596 of practitioners, pharmacists, or other persons who are 1597 authorized to prescribe, administer, or dispense controlled 1598 substances and who are involved in a specific controlled 1599 substance investigation involving a designated person for one or 1600 more prescribed controlled substances. 1601 2. The Attorney General for Medicaid fraud cases or 1602 Medicaid investigations involving prescribed controlled 1603 substances. 1604 3. A law enforcement agency during active investigations 1605 regarding potential criminal activity, fraud, or theft regarding 1606 prescribed controlled substances. 1607 4. A patient or the legal guardian or designated health 1608 care surrogate of an incapacitated patient as described in s. 1609 893.0551 who, for the purpose of verifying the accuracy of the 1610 database information, submits a written and notarized request 1611 that includes the patient’s full name, address, and date of 1612 birth, and includes the same information if the legal guardian 1613 or health care surrogate submits the request. The patient’s 1614 phone number, current address, and a copy of a government-issued 1615 photo identification must be provided in person to the program 1616 manager along with the notarized request. The request shall be 1617 validated by the department to verify the identity of the 1618 patient and the legal guardian or health care surrogate, if the 1619 patient’s legal guardian or health care surrogate is the 1620 requestor. Such verification is also required for any request to 1621 change a patient’s prescription history or other information 1622 related to his or her information in the electronic database. 1623 5. The Agency for Health Care Administration for Medicaid 1624 fraud cases or Medicaid investigations involving prescribed 1625 controlled substances. 1626 1627 Information in the database for the electronic prescription drug 1628 monitoring system is not discoverable or admissible in any civil 1629 or administrative action, except in an investigation and 1630 disciplinary proceeding by the department or the appropriate 1631 regulatory board. 1632 (d) The following entities mayshallnot havebe allowed1633 direct access to information in the prescription drug monitoring 1634 program database but may request from the program manager and, 1635 when authorized by the program manager, the program manager’s 1636 program and support staff, information that contains no 1637 identifying information of any patient, physician, health care 1638 practitioner, prescriber, or dispenser and that is not 1639 confidential and exempt: 1640 1. Department staff for the purpose of calculating 1641 performance measures pursuant to subsection (8). 1642 2. The Program Implementation and Oversight Task Force for 1643 its reporting to the Governor, the President of the Senate, and 1644 the Speaker of the House of Representatives regarding the 1645 prescription drug monitoring program. This subparagraph expires 1646 July 1, 2012. 1647 (e) All transmissions of data required by this section must 1648 comply with relevant state and federal privacy and security laws 1649 and regulations. However, any authorized agency or person under 1650 s. 893.0551 receiving such information as allowed by s. 893.0551 1651 may maintain the information received for up to 24 months before 1652 purging it from his or her records or maintain it for longer 1653 than 24 months if the information is pertinent to ongoing health 1654 care or an active law enforcement investigation or prosecution. 1655 (f) The program manager, upon determining a pattern 1656 consistent with the rules established under paragraph (2)(d) and 1657 having cause to believe a violation of s. 893.13(7)(a)8., 1658 (8)(a), or (8)(b) has occurred, may provide relevant information 1659 to the applicable law enforcement agency. 1660 (8) To assist in fulfilling program responsibilities, 1661 performance measures shall be reported annually to the Governor, 1662 the President of the Senate, and the Speaker of the House of 1663 Representatives by the department each December 1, beginning in 1664 2011. Data that does not contain patient, physician, health care 1665 practitioner, prescriber, or dispenser identifying information 1666 may be requested during the year by department employees so that 1667 the department may undertake public health care and safety 1668 initiatives that take advantage of observed trends. Performance 1669 measures may include, but are not limited to, efforts to achieve 1670 the following outcomes: 1671 (a) Reduction of the rate of inappropriate use of 1672 prescription drugs through department education and safety 1673 efforts. 1674 (b) Reduction of the quantity of pharmaceutical controlled 1675 substances obtained by individuals attempting to engage in fraud 1676 and deceit. 1677 (c) Increased coordination among partners participating in 1678 the prescription drug monitoring program. 1679 (d) Involvement of stakeholders in achieving improved 1680 patient health care and safety and reduction of prescription 1681 drug abuse and prescription drug diversion. 1682 (9) Any person who willfully and knowingly fails to report 1683 the dispensing of a controlled substance as required by this 1684 section commits a misdemeanor of the first degree, punishable as 1685 provided in s. 775.082 or s. 775.083. 1686 (10)All costs incurred by the department in administering1687the prescription drug monitoring program shall be funded through1688federal grants or private funding applied for or received by the1689state. The department may not commit funds for the monitoring1690program without ensuring funding is available. The prescription1691drug monitoring program and the implementation thereof are1692contingent upon receipt of the nonstate funding.The department 1693 and state government shall cooperate with the direct-support 1694 organization established pursuant to subsection (11) in seeking 1695 federal grant funds, other nonstate grant funds, gifts, 1696 donations, or other private moneys for the department so long as 1697 the costs of doing so are not considered material. Nonmaterial 1698 costs for this purpose include, but are not limited to, the 1699 costs of mailing and personnel assigned to research or apply for 1700 a grant. Notwithstanding the exemptions to competitive 1701 solicitation requirements under s. 287.057(3)(f), the department 1702 shall comply with the competitive-solicitation requirements 1703 under s. 287.057 for the procurement of any goods or services 1704 required by this section. 1705 (11) The Office of Drug Control, in coordination with the 1706 department, may establish a direct-support organization that has 1707 a board consisting of at least five members to provide 1708 assistance, funding, and promotional support for the activities 1709 authorized for the prescription drug monitoring program. 1710 (a) As used in this subsection, the term “direct-support 1711 organization” means an organization that is: 1712 1. A Florida corporation not for profit incorporated under 1713 chapter 617, exempted from filing fees, and approved by the 1714 Department of State. 1715 2. Organized and operated to conduct programs and 1716 activities; raise funds; request and receive grants, gifts, and 1717 bequests of money; acquire, receive, hold, and invest, in its 1718 own name, securities, funds, objects of value, or other 1719 property, either real or personal; and make expenditures or 1720 provide funding to or for the direct or indirect benefit of the 1721 department in the furtherance of the prescription drug 1722 monitoring program. 1723 (b) The direct-support organization is not considered a 1724 lobbying firm within the meaning of s. 11.045. 1725 (c) The director of the Office of Drug Control shall 1726 appoint a board of directors for the direct-support 1727 organization. The director may designate employees of the Office 1728 of Drug Control, state employees other than state employees from 1729 the department, and any other nonstate employees as appropriate, 1730 to serve on the board. Members of the board shall serve at the 1731 pleasure of the director of the Office of Drug Control. The 1732 director shall provide guidance to members of the board to 1733 ensure that moneys received by the direct-support organization 1734 are not received from inappropriate sources. Inappropriate 1735 sources include, but are not limited to, donors, grantors, 1736 persons, or organizations that may monetarily or substantively 1737 benefit from the purchase of goods or services by the department 1738 in furtherance of the prescription drug monitoring program. 1739 (d) The direct-support organization shall operate under 1740 written contract with the Office of Drug Control. The contract 1741 must, at a minimum, provide for: 1742 1. Approval of the articles of incorporation and bylaws of 1743 the direct-support organization by the Office of Drug Control. 1744 2. Submission of an annual budget for the approval of the 1745 Office of Drug Control. 1746 3. Certification by the Office of Drug Control in 1747 consultation with the department that the direct-support 1748 organization is complying with the terms of the contract in a 1749 manner consistent with and in furtherance of the goals and 1750 purposes of the prescription drug monitoring program and in the 1751 best interests of the state. Such certification must be made 1752 annually and reported in the official minutes of a meeting of 1753 the direct-support organization. 1754 4. The reversion, without penalty, to the Office of Drug 1755 Control, or to the state if the Office of Drug Control ceases to 1756 exist, of all moneys and property held in trust by the direct 1757 support organization for the benefit of the prescription drug 1758 monitoring program if the direct-support organization ceases to 1759 exist or if the contract is terminated. 1760 5. The fiscal year of the direct-support organization, 1761 which must begin July 1 of each year and end June 30 of the 1762 following year. 1763 6. The disclosure of the material provisions of the 1764 contract to donors of gifts, contributions, or bequests, 1765 including such disclosure on all promotional and fundraising 1766 publications, and an explanation to such donors of the 1767 distinction between the Office of Drug Control and the direct 1768 support organization. 1769 7. The direct-support organization’s collecting, expending, 1770 and providing of funds to the department for the development, 1771 implementation, and operation of the prescription drug 1772 monitoring program as described in this section and s. 2, 1773 chapter 2009-198, Laws of Florida, as long as the task force is 1774 authorized. The direct-support organization may collect and 1775 expend funds to be used for the functions of the direct-support 1776 organization’s board of directors, as necessary and approved by 1777 the director of the Office of Drug Control. In addition, the 1778 direct-support organization may collect and provide funding to 1779 the department in furtherance of the prescription drug 1780 monitoring program by: 1781 a. Establishing and administering the prescription drug 1782 monitoring program’s electronic database, including hardware and 1783 software. 1784 b. Conducting studies on the efficiency and effectiveness 1785 of the program to include feasibility studies as described in 1786 subsection (13). 1787 c. Providing funds for future enhancements of the program 1788 within the intent of this section. 1789 d. Providing user training of the prescription drug 1790 monitoring program, including distribution of materials to 1791 promote public awareness and education and conducting workshops 1792 or other meetings, for health care practitioners, pharmacists, 1793 and others as appropriate. 1794 e. Providing funds for travel expenses. 1795 f. Providing funds for administrative costs, including 1796 personnel, audits, facilities, and equipment. 1797 g. Fulfilling all other requirements necessary to implement 1798 and operate the program as outlined in this section. 1799 (e) The activities of the direct-support organization must 1800 be consistent with the goals and mission of the Office of Drug 1801 Control, as determined by the office in consultation with the 1802 department, and in the best interests of the state. The direct 1803 support organization must obtain a written approval from the 1804 director of the Office of Drug Control for any activities in 1805 support of the prescription drug monitoring program before 1806 undertaking those activities. 1807 (f) The Office of Drug Control, in consultation with the 1808 department, may permit, without charge, appropriate use of 1809 administrative services, property, and facilities of the Office 1810 of Drug Control and the department by the direct-support 1811 organization, subject to this section. The use must be directly 1812 in keeping with the approved purposes of the direct-support 1813 organization and may not be made at times or places that would 1814 unreasonably interfere with opportunities for the public to use 1815 such facilities for established purposes. Any moneys received 1816 from rentals of facilities and properties managed by the Office 1817 of Drug Control and the department may be held by the Office of 1818 Drug Control or in a separate depository account in the name of 1819 the direct-support organization and subject to the provisions of 1820 the letter of agreement with the Office of Drug Control. The 1821 letter of agreement must provide that any funds held in the 1822 separate depository account in the name of the direct-support 1823 organization must revert to the Office of Drug Control if the 1824 direct-support organization is no longer approved by the Office 1825 of Drug Control to operate in the best interests of the state. 1826 (g) The Office of Drug Control, in consultation with the 1827 department, may adopt rules under s. 120.54 to govern the use of 1828 administrative services, property, or facilities of the 1829 department or office by the direct-support organization. 1830 (h) The Office of Drug Control may not permit the use of 1831 any administrative services, property, or facilities of the 1832 state by a direct-support organization if that organization does 1833 not provide equal membership and employment opportunities to all 1834 persons regardless of race, color, religion, gender, age, or 1835 national origin. 1836 (i) The direct-support organization shall provide for an 1837 independent annual financial audit in accordance with s. 1838 215.981. Copies of the audit shall be provided to the Office of 1839 Drug Control and the Office of Policy and Budget in the 1840 Executive Office of the Governor. 1841 (j) The direct-support organization may not exercise any 1842 power under s. 617.0302(12) or (16). 1843 (12) A prescriber or dispenser may have access to the 1844 information under this section which relates to a patient of 1845 that prescriber or dispenser as needed for the purpose of 1846 reviewing the patient’s controlled drug prescription history. A 1847 prescriber or dispenser acting in good faith is immune from any 1848 civil, criminal, or administrative liability that might 1849 otherwise be incurred or imposed for receiving or using 1850 information from the prescription drug monitoring program. This 1851 subsection does not create a private cause of action, and a 1852 person may not recover damages against a prescriber or dispenser 1853 authorized to access information under this subsection for 1854 accessing or failing to access such information. 1855 (13) To the extent that funding is provided for such 1856 purpose through federal or private grants or gifts and other 1857 types of available moneys, the department, in collaboration with 1858 the Office of Drug Control, shall study the feasibility of 1859 enhancing the prescription drug monitoring program for the 1860 purposes of public health initiatives and statistical reporting 1861 that respects the privacy of the patient, the prescriber, and 1862 the dispenser. Such a study shall be conducted in order to 1863 further improve the quality of health care services and safety 1864 by improving the prescribing and dispensing practices for 1865 prescription drugs, taking advantage of advances in technology, 1866 reducing duplicative prescriptions and the overprescribing of 1867 prescription drugs, and reducing drug abuse. The requirements of 1868 the National All Schedules Prescription Electronic Reporting 1869 (NASPER) Act are authorized in order to apply for federal NASPER 1870 funding. In addition, the direct-support organization shall 1871 provide funding for the department, in collaboration with the 1872 Office of Drug Control, to conduct training for health care 1873 practitioners and other appropriate persons in using the 1874 monitoring program to support the program enhancements. 1875 (14) A pharmacist, pharmacy, or dispensing health care 1876 practitioner or his or her agent, before releasing a controlled 1877 substance to any person not known to such dispenser, shall 1878 require the person purchasing, receiving, or otherwise acquiring 1879 the controlled substance to present valid photographic 1880 identification or other verification of his or her identity to 1881 the dispenser. If the person does not have proper 1882 identification, the dispenser may verify the validity of the 1883 prescription and the identity of the patient with the prescriber 1884 or his or her authorized agent. Verification of health plan 1885 eligibility through a real-time inquiry or adjudication system 1886 will be considered to be proper identification. This subsection 1887 does not apply in an institutional setting or to a long-term 1888 care facility, including, but not limited to, an assisted living 1889 facility or a hospital to which patients are admitted. As used 1890 in this subsection, the term “proper identification” means an 1891 identification that is issued by a state or the Federal 1892 Government containing the person’s photograph, printed name, and 1893 signature or a document considered acceptable under 8 C.F.R. s. 1894 274a.2(b)(1)(v)(A) and (B). 1895 (15) The Agency for Health Care Administration shall 1896 continue the promotion of electronic prescribing by health care 1897 practitioners, health care facilities, and pharmacies under s. 1898 408.0611. 1899 (16) By October 1, 2010, the department shall adopt rules 1900 pursuant to ss. 120.536(1) and 120.54 to administer the 1901 provisions of this section, which shall include as necessary the 1902 reporting, accessing, evaluation, management, development, 1903 implementation, operation, and storage of information within the 1904 monitoring program’s system. 1905 (17) After the prescription drug monitoring program’s 1906 database has been operational for 12 months, the State Surgeon 1907 General shall enter into reciprocal agreements for the sharing 1908 of prescription drug monitoring information with any other state 1909 that has a compatible prescription drug monitoring program. If 1910 the State Surgeon General evaluates the prescription drug 1911 monitoring program of another state as authorized in this 1912 subsection, priority shall be given to a state that is 1913 contiguous with the borders of this state. 1914 (a) In determining compatibility, the State Surgeon General 1915 shall consider: 1916 1. The essential purposes of the program and the success of 1917 the program in fulfilling those purposes. 1918 2. The safeguards for privacy of patient records and the 1919 success of the program in protecting patient privacy. 1920 3. The persons authorized to view the data collected by the 1921 program. Comparable organizations and professions for 1922 practitioners in other states, law enforcement agencies, the 1923 Attorney General’s Medicaid Fraud Unit, medical regulatory 1924 boards, and, as needed, management staff who have similar duties 1925 as management staff who work with the prescription drug 1926 monitoring program as authorized in s. 893.0551 are authorized 1927 access upon approval by the State Surgeon General. 1928 4. The schedules of the controlled substances that are 1929 monitored. 1930 5. The data required to be submitted for each prescription. 1931 6. Any implementing criteria deemed essential for a 1932 thorough comparison. 1933 (b) The State Surgeon General shall annually review any 1934 agreement to determine its continued compatibility with the 1935 prescription drug monitoring program in this state. 1936 (c) Any agreement between the State Surgeon General and 1937 another state shall prohibit the sharing of information 1938 concerning a resident of this state or a practitioner, 1939 pharmacist, or other prescriber for any purpose that is not 1940 otherwise authorized by this section or s. 893.0551. 1941 Section 25. The sum of $1.75 million is appropriated from 1942 the General Revenue Fund to the Department of Health for the 1943 purpose of paying salaries and other administrative expenses 1944 necessary to carry out the implementation of the prescription 1945 drug monitoring program. 1946 Section 26. Paragraph (a) of subsection (3) of section 1947 893.0551, Florida Statutes, is amended, present subsections (4), 1948 (5), (6), and (7) of that section are redesignated as 1949 subsections (5), (6), (7), and (8), respectively, and a new 1950 subsection (4) is added to that section, to read: 1951 893.0551 Public records exemption for the prescription drug 1952 monitoring program.— 1953 (3) The department shall disclose such confidential and 1954 exempt information to the following entities after using a 1955 verification process to ensure the legitimacy of that person’s 1956 or entity’s request for the information: 1957 (a) The Attorney General and his or her designee when 1958 working on Medicaid fraud cases and Medicaid investigations 1959 involving prescribed controlled substancesprescription drugsor 1960 when the Attorney General has initiated a review of specific 1961 identifiers of Medicaid fraud or specific identifiers that 1962 warrant a Medicaid investigation regarding prescribed controlled 1963 substancesprescription drugs. The Attorney General or his or 1964 her designee may disclose the confidential and exempt 1965 information received from the department to a criminal justice 1966 agency as defined in s. 119.011 as part of an active 1967 investigation that is specific to a violation of prescription 1968 drug abuse or prescription drug diversion law as it relates to 1969 controlled substances. The Attorney General’s Medicaid fraud 1970 investigators and Medicaid investigators may not have direct 1971 access to the department’s database. 1972 (4) The department may disclose confidential and exempt 1973 information contained in records held by the department under s. 1974 893.055 if the State Surgeon General has entered into a 1975 reciprocal agreement for the sharing of prescription drug 1976 monitoring information with any other state that has a 1977 compatible prescription drug monitoring program. 1978 (a) The reciprocal agreement may allow the following 1979 persons from another state to receive information from the 1980 prescription drug monitoring program if approved by the State 1981 Surgeon General: 1982 1. A designated representative of a state professional 1983 licensing, certification, or regulatory agency charged with 1984 oversight of those persons authorized to prescribe or dispense 1985 controlled substances for the purpose of a bona fide, specific 1986 investigation of a prescription of a controlled substance which 1987 involves a designated person. As required in s. 893.055, this 1988 authorization does not preclude the requirement for the program 1989 manager to review the request for information and validate it. 1990 2. A health care practitioner or pharmacist licensed in the 1991 state from which the request originates. Such health care 1992 practitioner or pharmacist shall certify that the requested 1993 information is for the purpose of providing medical or 1994 pharmaceutical treatment to a bona fide, current patient. The 1995 health care practitioner or pharmacist shall follow all the 1996 procedures required in s. 893.055 and rules established by the 1997 department for a health care practitioner or pharmacist to 1998 request information from the database. 1999 3. A law enforcement officer from another state: 2000 a. Who is a member of a sheriff’s department or a police 2001 department; 2002 b. Who is authorized by law to conduct criminal 2003 investigations and make arrests; 2004 c. Whose duty it is to enforce the laws of his or her state 2005 relating to controlled substances; and 2006 d. Who is engaged in a bona fide specific, active 2007 investigation involving a designated person regarding 2008 prescriptions for controlled substances. 2009 2010 As required in s. 893.055, this authorization does not preclude 2011 the requirement for the program manager to review the request 2012 for information and validate it. This authorization also does 2013 not preclude the ability to provide a report to a law 2014 enforcement agency in another state under s. 893.055(7) or this 2015 subsection. 2016 (b) Any agreement between the State Surgeon General and 2017 another state shall prohibit the sharing of information 2018 concerning a resident of this state, a patient whose information 2019 is in the program’s database, or a practitioner, pharmacy, 2020 pharmacist, health care practitioner, or other prescriber for 2021 any purpose that is not otherwise authorized by this section or 2022 s. 893.055, and the information must be provided according to 2023 the State Surgeon General’s determination of compatibility as 2024 described in s. 893.055(17). 2025 Section 27. Subsections (1), (4), and (5) of section 2026 893.07, Florida Statutes, are amended, and subsection (6) is 2027 added to that section, to read: 2028 893.07 Records.— 2029 (1) Notwithstanding any other provision of law and in 2030 consonance with the authority of State v. Carter, 23 So. 3d 798 2031 (Fla. 1st DCA 2009) and State v. Tamulonis, 39 So. 3d 524 (Fla. 2032 2d DCA 2010), every person who engages in the manufacture, 2033 compounding, mixing, cultivating, growing, or by any other 2034 process producing or preparing, or in the dispensing, 2035 importation, or, as a wholesaler, distribution, of controlled 2036 substances shall: 2037 (a) On January 1, 1974, or as soon thereafter as any person 2038 first engages in such activity, and every second year 2039 thereafter, make a complete and accurate record of all stocks of 2040 controlled substances on hand. The inventory may be prepared on 2041 the regular physical inventory date which is nearest to, and 2042 does not vary by more than 6 months from, the biennial date that 2043 would otherwise apply. As additional substances are designated 2044 for control under this chapter, they shall be inventoried as 2045 provided for in this subsection. 2046 (b) On and after January 1, 1974, maintain, on a current 2047 basis, a complete and accurate record of each substance 2048 manufactured, received, sold, delivered, or otherwise disposed 2049 of by him or her, except that this subsection shall not require 2050 the maintenance of a perpetual inventory. 2051 2052 Compliance with the provisions of federal law pertaining to the 2053 keeping of records of controlled substances shall be deemed a 2054 compliance with the requirements of this subsection. 2055 (4) Every inventory or record required by this chapter, 2056 including prescription records, shall be maintained: 2057 (a) Separately from all other records of the registrant, or 2058 (b) Alternatively, in the case of Schedule III, IV, or V 2059 controlled substances, in such form that information required by 2060 this chapter is readily retrievable from the ordinary business 2061 records of the registrant. 2062 2063 In either case, such records described in this subsection shall 2064 be kept and made available for a period of at least 2 years for 2065 inspection and copying by law enforcement officers whose duty it 2066 is to enforce the laws of this state relating to controlled 2067 substances. This subsection does not require a law enforcement 2068 officer to obtain a subpoena, court order, or search warrant in 2069 order to obtain access to or copies of such records. 2070 (5) Each person shall maintain a record that containswhich2071shall containa detailed list of controlled substances lost, 2072 destroyed, or stolen, if any; the kind and quantity of such 2073 controlled substances; and the date of the discovering of such 2074 loss, destruction, or theft. If a person discovers the theft or 2075 significant loss of a controlled substance, such person shall 2076 report the theft or significant loss to a local county sheriff’s 2077 office within 48 hours after the discovery of such theft or 2078 loss. A person who fails to report the theft or significant loss 2079 of a controlled substance under this subsection commits a 2080 misdemeanor of the second degree, punishable as provided in s. 2081 775.082 or s. 775.083. However, a person who fails to report the 2082 theft or significant loss of a Schedule II controlled substance 2083 commits a misdemeanor of the first degree, punishable as 2084 provided in s. 775.082 or s. 775.083. 2085 (6) The Legislature finds that the opinions rendered in 2086 State v. Carter, 23 So. 3d 798 (Fla. 1st DCA 2009), and State v. 2087 Tamulonis, 39 So. 3d 524 (Fla. 2d DCA 2010), correctly construe 2088 this Legislature’s intent that the inspection powers previously 2089 conferred upon law enforcement officers which allow such 2090 officers to access and review pharmacy records concerning 2091 controlled substances are to be exercised properly by such law 2092 enforcement officers without the requirement of a subpoena or 2093 search warrant being sought or issued to examine and copy such 2094 records, and without the requirement that those persons to whom 2095 particular pharmacy records refer be given notice of the 2096 records’ examination and copying under this section. 2097 Section 28. Subsections (7) and (8) of section 893.13, 2098 Florida Statutes, are amended to read: 2099 893.13 Prohibited acts; penalties.— 2100 (7)(a) AIt is unlawful for anyperson may not: 2101 1.ToDistribute or dispense a controlled substance in 2102 violation of this chapter. 2103 2.ToRefuse or fail to make, keep, or furnish any record, 2104 notification, order form, statement, invoice, or information 2105 required under this chapter. 2106 3.ToRefuseanentry into any premises for any inspection 2107 ortorefuse to allow any inspection authorized by this chapter. 2108 4.ToDistribute a controlled substance named or described 2109 in s. 893.03(1) or (2) except pursuant to an order form as 2110 required by s. 893.06. 2111 5.ToKeep or maintain any store, shop, warehouse, 2112 dwelling, building, vehicle, boat, aircraft, or other structure 2113 or place which is resorted to by persons using controlled 2114 substances in violation of this chapter for the purpose of using 2115 these substances, or which is used for keeping or selling them 2116 in violation of this chapter. 2117 6.ToUse to his or her own personal advantage, orto2118 reveal, any information obtained in enforcement of this chapter 2119 except in a prosecution or administrative hearing for a 2120 violation of this chapter. 2121 7.ToPossess a prescription form which has not been 2122 completed and signed by the practitioner whose name appears 2123 printed thereon, unless the person is that practitioner, is an 2124 agent or employee of that practitioner, is a pharmacist, or is a 2125 supplier of prescription forms who is authorized by that 2126 practitioner to possess those forms. 2127 8.ToWithhold information from a practitioner from whom 2128 the person seeks to obtain a controlled substance or a 2129 prescription for a controlled substance that the person making 2130 the request has received a controlled substance or a 2131 prescription for a controlled substance of like therapeutic use 2132 from another practitioner within the previous 30 days. 2133 9.ToAcquire or obtain, or attempt to acquire or obtain, 2134 possession of a controlled substance by misrepresentation, 2135 fraud, forgery, deception, or subterfuge. 2136 10.ToAffix any false or forged label to a package or 2137 receptacle containing a controlled substance. 2138 11.ToFurnish false or fraudulent material information in, 2139 or omit any material information from, any report or other 2140 document required to be kept or filed under this chapter or any 2141 record required to be kept by this chapter. 2142 12.ToStore anhydrous ammonia in a container that is not 2143 approved by the United States Department of Transportation to 2144 hold anhydrous ammonia or is not constructed in accordance with 2145 sound engineering, agricultural, or commercial practices. 2146 13. With the intent to obtain a controlled substance or 2147 combination of controlled substances that are not medically 2148 necessary for the person or an amount of a controlled substance 2149 or substances that are not medically necessary for the person, 2150 obtain or attempt to obtain from a practitioner a controlled 2151 substance or a prescription for a controlled substance by 2152 misrepresentation, fraud, forgery, deception, subterfuge, or 2153 concealment of a material fact. For purposes of this 2154 subparagraph, a material fact includes whether the person has an 2155 existing prescription for a controlled substance issued for the 2156 same period of time by another practitioner or as described in 2157 subparagraph 8. 2158 (b) A health care practitioner, with the intent to provide 2159 a controlled substance or combination of controlled substances 2160 that are not medically necessary to his or her patient or an 2161 amount of controlled substances that are not medically necessary 2162 for his or her patient, may not provide a controlled substance 2163 or a prescription for a controlled substance by 2164 misrepresentation, fraud, forgery, deception, subterfuge, or 2165 concealment of a material fact. For purposes of this paragraph, 2166 a material fact includes whether the patient has an existing 2167 prescription for a controlled substance issued for the same 2168 period of time by another practitioner or as described in 2169 subparagraph (a)8. 2170 (c) Any person who adulterates a controlled substance for 2171 directed off-label use without authorization by a prescribing 2172 physician violates the provisions of subparagraph (a)1. and 2173 causes the issuance of the entire prescription for the 2174 controlled substance to become invalid. A law enforcement 2175 officer in the performance of his or her official duties may 2176 seize the adulterated or off-label prescribed controlled 2177 substance as evidence. The controlled substance may be returned 2178 to the owner only with a notarized affidavit from the original 2179 prescribing practitioner who has knowledge and gave 2180 authorization and explicit directions for the adulteration or 2181 off-label use of the controlled substance. 2182 (d)(b)Any person who violates the provisions of 2183 subparagraphs (a)1.-7. commits a misdemeanor of the first 2184 degree, punishable as provided in s. 775.082 or s. 775.083; 2185 except that, upon a second or subsequent violation, the person 2186 commits a felony of the third degree, punishable as provided in 2187 s. 775.082, s. 775.083, or s. 775.084. 2188 (e)(c)Any person who violates the provisions of 2189 subparagraphs (a)8.-12. commits a felony of the third degree, 2190 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 2191 (f) A person or health care practitioner who violates the 2192 provisions of paragraph (b) or subparagraph (a)13. commits a 2193 felony of the third degree, punishable as provided in s. 2194 775.082, s. 775.083, or s. 775.084, if any controlled substance 2195 that is the subject of the offense is listed in Schedule II, 2196 Schedule III, or Schedule IV. 2197 (8)(a) Notwithstanding subsection (9), a prescribing 2198 practitioner may not: 2199 1. Knowingly assist a patient, other person, or the owner 2200 of an animal in obtaining a controlled substance through 2201 deceptive, untrue, or fraudulent representations in or related 2202 to the practice of the prescribing practitioner’s professional 2203 practice; 2204 2. Employ a trick or scheme in the practice of the 2205 prescribing practitioner’s professional practice to assist a 2206 patient, other person, or the owner of an animal in obtaining a 2207 controlled substance; 2208 3. Knowingly write a prescription for a controlled 2209 substance for a fictitious person;or2210 4. Write a prescription for a controlled substance for a 2211 patient, other person, or an animal if the sole purpose of 2212 writing such prescription is to provide a monetary benefit to, 2213 or obtain a monetary benefit for, the prescribing practitioner; 2214 or.2215 5. Write a prescription for a controlled substance for a 2216 patient, other person, or an animal and authorize or direct the 2217 adulteration of the dispensed form of the controlled substance 2218 for the purpose of ingestion by means of inhalation, injection, 2219 or any other means not medically necessary for the treatment of 2220 the patient. 2221 (b) If the prescribing practitioner wrote a prescription or 2222 multiple prescriptions for a controlled substance for the 2223 patient, other person, or animal for which there was no medical 2224 necessity, or which was in excess of what was medically 2225 necessary to treat the patient, other person, or animal, that 2226 fact does not give rise to any presumption that the prescribing 2227 practitioner violated subparagraph (a)1., but may be considered 2228 with other competent evidence in determining whether the 2229 prescribing practitioner knowingly assisted a patient, other 2230 person, or the owner of an animal to obtain a controlled 2231 substance in violation of subparagraph (a)1. 2232 (c) A person who violates paragraph (a) commits a felony of 2233 the third degree, punishable as provided in s. 775.082, s. 2234 775.083, or s. 775.084. 2235 (d) Notwithstanding paragraph (c), if a prescribing 2236 practitioner has violated paragraph (a) and received $1,000 or 2237 more in payment for writing one or more prescriptions or, in the 2238 case of a prescription written for a controlled substance 2239 described in s. 893.135, has written one or more prescriptions 2240 for a quantity of a controlled substance which, individually or 2241 in the aggregate, meets the threshold for the offense of 2242 trafficking in a controlled substance under s. 893.15, the 2243 violation is reclassified as a felony of the second degree and 2244 ranked in level 4 of the Criminal Punishment Code. 2245 Section 29. Present subsections (3) through (10) of section 2246 893.138, Florida Statutes, are redesignated as subsections (4) 2247 through (11), respectively, and a new subsection (3) is added to 2248 that section, to read: 2249 893.138 Local administrative action to abate drug-related, 2250 prostitution-related, or stolen-property-related public 2251 nuisances and criminal gang activity.— 2252 (3) Any pain-management clinic, as described in s. 458.3265 2253 or s. 459.0137, which has been used on more than two occasions 2254 within a 6-month period as the site of a violation of: 2255 (a) Section 784.011, s. 784.021, s. 784.03, or s. 784.045, 2256 relating to assault and battery; 2257 (b) Section 810.02, relating to burglary; 2258 (c) Section 812.014, relating to dealing in theft; 2259 (d) Section 812.131, relating to robbery by sudden 2260 snatching; or 2261 (e) Section 893.13, relating to the unlawful distribution 2262 of controlled substances, 2263 2264 may be declared to be a public nuisance, and such nuisance may 2265 be abated pursuant to the procedures provided in this section. 2266 Section 30. Subsection (9) is added to section 465.025, 2267 Florida Statutes, to read: 2268 465.025 Substitution of drugs.— 2269 (9) The board shall establish by rule a list of opioid 2270 drugs that incorporate tamper-resistant technology. Inclusion of 2271 a drug on the list does not require that the drug bear a 2272 labeling claim with respect to reduction of tampering, abuse, or 2273 abuse potential at the time of listing. The board shall make a 2274 determination whether to include a drug on the list based on a 2275 submission of evidence by the drug manufacturer or distributor 2276 that the drug: 2277 (a) Incorporates a tamper-resistance technology; and 2278 (b) Has been approved by the United States Food and Drug 2279 Administration pursuant to an application that includes at least 2280 one study on human tampering or abuse potential or a laboratory 2281 study comparing the tamper-resistant or abuse-resistant 2282 properties of the drug to one or more opioid drugs that have 2283 been approved by the United States Food and Drug Administration 2284 and serve as a positive control. 2285 2286 Notwithstanding subsection (2), a pharmacist may not substitute 2287 an opioid analgesic drug, either the brand name drug or generic 2288 drug, for an opioid analgesic drug incorporating a tamper 2289 resistance technology which was originally prescribed and is 2290 listed by the board pursuant to this subsection. 2291 Section 31. This act shall take effect October 1, 2011.