| 1 | A bill to be entitled |
| 2 | An act relating to controlled substances; amending ss. |
| 3 | 456.037 and 456.057, F.S.; conforming provisions to |
| 4 | changes made by the act; amending s. 456.42, F.S.; |
| 5 | requiring prescriptions for controlled substances to be |
| 6 | written on a counterfeit-resistant pad produced by an |
| 7 | approved vendor or electronically prescribed; repealing s. |
| 8 | 458.3265, F.S., relating to regulation of pain-management |
| 9 | clinics and medical doctors; amending s. 458.327, F.S.; |
| 10 | providing that dispensing certain controlled substances in |
| 11 | violation of specified provisions is a third-degree |
| 12 | felony; deleting references to felonies for certain |
| 13 | activities related to pain-management clinics and medical |
| 14 | doctors; amending s. 458.331, F.S.; deleting grounds for |
| 15 | disciplinary actions against physicians relating to pain- |
| 16 | management clinics and advertising controlled substances; |
| 17 | repealing s. 459.0137, F.S., relating to pain-management |
| 18 | clinics and osteopathic physicians; amending s. 459.013, |
| 19 | F.S., relating to penalties for violations; providing that |
| 20 | dispensing certain controlled substances in violation of |
| 21 | specified provisions is a third-degree felony; deleting |
| 22 | provisions relating to felonies for certain activities |
| 23 | related to pain-management clinics and osteopathic |
| 24 | physicians; amending s. 459.015, F.S.; deleting grounds |
| 25 | for disciplinary actions against osteopathic physicians |
| 26 | relating to pain-management clinics and advertising |
| 27 | controlled substances; amending s. 465.015, F.S.; |
| 28 | requiring a pharmacist, pharmacy intern, or other person |
| 29 | employed by or at a pharmacy to report to the sheriff |
| 30 | within a specified period any instance in which a person |
| 31 | fraudulently obtained or attempted to fraudulently obtain |
| 32 | a controlled substance; providing criminal penalties; |
| 33 | providing requirements for reports; amending s. 465.018, |
| 34 | F.S.; limiting the community pharmacies that may dispense |
| 35 | controlled substances; providing an exemption; amending s. |
| 36 | 465.0276, F.S.; prohibiting registered dispensing |
| 37 | practitioners from dispensing certain controlled |
| 38 | substances; providing an exception; repealing a 72-hour |
| 39 | supply limit on dispensing certain controlled substances |
| 40 | to certain patients in registered pain-management clinics; |
| 41 | providing an exception for dispensing controlled |
| 42 | substances in the health care system of the Department of |
| 43 | Corrections; amending s. 499.012, F.S.; requiring |
| 44 | wholesale distributor permit applicants to submit |
| 45 | documentation of credentialing policies; amending s. |
| 46 | 499.0121, F.S.; providing reporting requirements for |
| 47 | wholesale distributors of certain controlled substances; |
| 48 | requiring the Department of Health to share the reported |
| 49 | data with law enforcement agencies; requiring the |
| 50 | Department of Law Enforcement to make investigations based |
| 51 | on the reported data; providing credentialing requirements |
| 52 | for distribution of controlled substances to certain |
| 53 | entities by wholesale distributors; limiting monthly |
| 54 | distribution amounts of controlled substances to retail |
| 55 | pharmacies; prohibiting distribution to entities with |
| 56 | certain criminal backgrounds; amending s. 499.05, F.S.; |
| 57 | authorizing rulemaking concerning specified controlled |
| 58 | substance wholesale distributor reporting requirements and |
| 59 | credentialing requirements; amending s. 499.067, F.S.; |
| 60 | requiring the Department of Health to take disciplinary |
| 61 | action against wholesale distributors failing to comply |
| 62 | with specified credentialing requirements; amending s. |
| 63 | 810.02, F.S.; authorizing separate judgments and sentences |
| 64 | for burglary with the intent to commit theft of a |
| 65 | controlled substance under specified provisions and for |
| 66 | any applicable possession of controlled substance offense |
| 67 | under specified provisions in certain circumstances; |
| 68 | amending s. 812.014, F.S.; authorizing separate judgments |
| 69 | and sentences for theft of a controlled substance under |
| 70 | specified provisions and for any applicable possession of |
| 71 | controlled substance offense under specified provisions in |
| 72 | certain circumstances; amending s. 893.07, F.S.; providing |
| 73 | that law enforcement officers are not required to obtain a |
| 74 | subpoena, court order, or search warrant in order to |
| 75 | obtain access to or copies of specified controlled |
| 76 | substance inventory records; requiring reporting discovery |
| 77 | of the theft or loss of controlled substances to the |
| 78 | sheriff within a specified period; providing criminal |
| 79 | penalties; repealing s. 2 of chapter 2009-198, Laws of |
| 80 | Florida, relating to Program Implementation and Oversight |
| 81 | Task Force in the Executive Office of the Governor |
| 82 | concerning the electronic system established for the |
| 83 | prescription drug monitoring program; providing a buyback |
| 84 | program for undispensed controlled substance inventory |
| 85 | held by specified licensed physicians; requiring reports |
| 86 | of program; providing for a declaration of a public health |
| 87 | emergency; requiring certain actions relating to |
| 88 | dispensing practitioners identified as posing the greatest |
| 89 | threat to public health; providing an appropriation; |
| 90 | providing for future repeal of program provisions; |
| 91 | providing an effective date. |
| 92 |
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| 93 | Be It Enacted by the Legislature of the State of Florida: |
| 94 |
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| 95 | Section 1. Subsection (5) of section 456.037, Florida |
| 96 | Statutes, is amended to read: |
| 97 | 456.037 Business establishments; requirements for active |
| 98 | status licenses; delinquency; discipline; applicability.- |
| 99 | (5) This section applies to any business establishment |
| 100 | registered, permitted, or licensed by the department to do |
| 101 | business. Business establishments include, but are not limited |
| 102 | to, dental laboratories, electrology facilities, massage |
| 103 | establishments, and pharmacies, and pain-management clinics |
| 104 | required to be registered under s. 458.3265 or s. 459.0137. |
| 105 | Section 2. Subsection (9) of section 456.057, Florida |
| 106 | Statutes, is amended to read: |
| 107 | 456.057 Ownership and control of patient records; report |
| 108 | or copies of records to be furnished.- |
| 109 | (9)(a)1. The department may obtain patient records |
| 110 | pursuant to a subpoena without written authorization from the |
| 111 | patient if the department and the probable cause panel of the |
| 112 | appropriate board, if any, find reasonable cause to believe that |
| 113 | a health care practitioner has excessively or inappropriately |
| 114 | prescribed any controlled substance specified in chapter 893 in |
| 115 | violation of this chapter or any professional practice act or |
| 116 | that a health care practitioner has practiced his or her |
| 117 | profession below that level of care, skill, and treatment |
| 118 | required as defined by this chapter or any professional practice |
| 119 | act and also find that appropriate, reasonable attempts were |
| 120 | made to obtain a patient release. Notwithstanding the foregoing, |
| 121 | the department need not attempt to obtain a patient release when |
| 122 | investigating an offense involving the inappropriate |
| 123 | prescribing, overprescribing, or diversion of controlled |
| 124 | substances and the offense involves a pain-management clinic. |
| 125 | The department may obtain patient records without patient |
| 126 | authorization or subpoena from any pain-management clinic |
| 127 | required to be licensed if the department has probable cause to |
| 128 | believe that a violation of any provision of s. 458.3265 or s. |
| 129 | 459.0137 is occurring or has occurred and reasonably believes |
| 130 | that obtaining such authorization is not feasible due to the |
| 131 | volume of the dispensing and prescribing activity involving |
| 132 | controlled substances and that obtaining patient authorization |
| 133 | or the issuance of a subpoena would jeopardize the |
| 134 | investigation. |
| 135 | 2. The department may obtain patient records and insurance |
| 136 | information pursuant to a subpoena without written authorization |
| 137 | from the patient if the department and the probable cause panel |
| 138 | of the appropriate board, if any, find reasonable cause to |
| 139 | believe that a health care practitioner has provided inadequate |
| 140 | medical care based on termination of insurance and also find |
| 141 | that appropriate, reasonable attempts were made to obtain a |
| 142 | patient release. |
| 143 | 3. The department may obtain patient records, billing |
| 144 | records, insurance information, provider contracts, and all |
| 145 | attachments thereto pursuant to a subpoena without written |
| 146 | authorization from the patient if the department and probable |
| 147 | cause panel of the appropriate board, if any, find reasonable |
| 148 | cause to believe that a health care practitioner has submitted a |
| 149 | claim, statement, or bill using a billing code that would result |
| 150 | in payment greater in amount than would be paid using a billing |
| 151 | code that accurately describes the services performed, requested |
| 152 | payment for services that were not performed by that health care |
| 153 | practitioner, used information derived from a written report of |
| 154 | an automobile accident generated pursuant to chapter 316 to |
| 155 | solicit or obtain patients personally or through an agent |
| 156 | regardless of whether the information is derived directly from |
| 157 | the report or a summary of that report or from another person, |
| 158 | solicited patients fraudulently, received a kickback as defined |
| 159 | in s. 456.054, violated the patient brokering provisions of s. |
| 160 | 817.505, or presented or caused to be presented a false or |
| 161 | fraudulent insurance claim within the meaning of s. |
| 162 | 817.234(1)(a), and also find that, within the meaning of s. |
| 163 | 817.234(1)(a), patient authorization cannot be obtained because |
| 164 | the patient cannot be located or is deceased, incapacitated, or |
| 165 | suspected of being a participant in the fraud or scheme, and if |
| 166 | the subpoena is issued for specific and relevant records. |
| 167 | 4. Notwithstanding subparagraphs 1.-3., when the |
| 168 | department investigates a professional liability claim or |
| 169 | undertakes action pursuant to s. 456.049 or s. 627.912, the |
| 170 | department may obtain patient records pursuant to a subpoena |
| 171 | without written authorization from the patient if the patient |
| 172 | refuses to cooperate or if the department attempts to obtain a |
| 173 | patient release and the failure to obtain the patient records |
| 174 | would be detrimental to the investigation. |
| 175 | Section 3. Section 456.42, Florida Statutes, is amended to |
| 176 | read: |
| 177 | 456.42 Written prescriptions for medicinal drugs.- |
| 178 | (1) A written prescription for a medicinal drug issued by |
| 179 | a health care practitioner licensed by law to prescribe such |
| 180 | drug must be legibly printed or typed so as to be capable of |
| 181 | being understood by the pharmacist filling the prescription; |
| 182 | must contain the name of the prescribing practitioner, the name |
| 183 | and strength of the drug prescribed, the quantity of the drug |
| 184 | prescribed, and the directions for use of the drug; must be |
| 185 | dated; and must be signed by the prescribing practitioner on the |
| 186 | day when issued. A written prescription for a controlled |
| 187 | substance listed in chapter 893 must have the quantity of the |
| 188 | drug prescribed in both textual and numerical formats and must |
| 189 | be dated with the abbreviated month written out on the face of |
| 190 | the prescription. However, a prescription that is electronically |
| 191 | generated and transmitted must contain the name of the |
| 192 | prescribing practitioner, the name and strength of the drug |
| 193 | prescribed, the quantity of the drug prescribed in numerical |
| 194 | format, and the directions for use of the drug and must be dated |
| 195 | and signed by the prescribing practitioner only on the day |
| 196 | issued, which signature may be in an electronic format as |
| 197 | defined in s. 668.003(4). |
| 198 | (2) A written prescription for a controlled substance |
| 199 | listed in chapter 893 must have the quantity of the drug |
| 200 | prescribed in both textual and numerical formats and must be |
| 201 | dated with the abbreviated month written out on the face of the |
| 202 | prescription. A prescription for a controlled substance listed |
| 203 | in chapter 893 must be written on a counterfeit-proof |
| 204 | prescription pad produced by a vendor approved by the |
| 205 | department, or must be electronically prescribed, as that term |
| 206 | is used in s. 408.0611. |
| 207 | Section 4. Section 458.3265, Florida Statutes, is |
| 208 | repealed. |
| 209 | Section 5. Section 458.327, Florida Statutes, is amended |
| 210 | to read: |
| 211 | 458.327 Penalty for violations.- |
| 212 | (1) Each of the following acts constitutes a felony of the |
| 213 | third degree, punishable as provided in s. 775.082, s. 775.083, |
| 214 | or s. 775.084: |
| 215 | (a) The practice of medicine or an attempt to practice |
| 216 | medicine without a license to practice in Florida. |
| 217 | (b) The use or attempted use of a license which is |
| 218 | suspended or revoked to practice medicine. |
| 219 | (c) Attempting to obtain or obtaining a license to |
| 220 | practice medicine by knowing misrepresentation. |
| 221 | (d) Attempting to obtain or obtaining a position as a |
| 222 | medical practitioner or medical resident in a clinic or hospital |
| 223 | through knowing misrepresentation of education, training, or |
| 224 | experience. |
| 225 | (e) Dispensing a controlled substance listed in Schedule |
| 226 | II or Schedule III in violation of s. 465.0276. Knowingly |
| 227 | operating, owning, or managing a nonregistered pain-management |
| 228 | clinic that is required to be registered with the Department of |
| 229 | Health pursuant to s. 458.3265(1). |
| 230 | (2) Each of the following acts constitutes a misdemeanor |
| 231 | of the first degree, punishable as provided in s. 775.082 or s. |
| 232 | 775.083: |
| 233 | (a) Knowingly concealing information relating to |
| 234 | violations of this chapter. |
| 235 | (b) Making any willfully false oath or affirmation |
| 236 | whenever an oath or affirmation is required by this chapter. |
| 237 | (c) Referring any patient, for health care goods or |
| 238 | services, to a partnership, firm, corporation, or other business |
| 239 | entity in which the physician or the physician's employer has an |
| 240 | equity interest of 10 percent or more unless, prior to such |
| 241 | referral, the physician notifies the patient of his or her |
| 242 | financial interest and of the patient's right to obtain such |
| 243 | goods or services at the location of the patient's choice. This |
| 244 | section does not apply to the following types of equity |
| 245 | interest: |
| 246 | 1. The ownership of registered securities issued by a |
| 247 | publicly held corporation or the ownership of securities issued |
| 248 | by a publicly held corporation, the shares of which are traded |
| 249 | on a national exchange or the over-the-counter market; |
| 250 | 2. A physician's own practice, whether he or she is a sole |
| 251 | practitioner or part of a group, when the health care good or |
| 252 | service is prescribed or provided solely for the physician's own |
| 253 | patients and is provided or performed by the physician or under |
| 254 | the physician's supervision; or |
| 255 | 3. An interest in real property resulting in a landlord- |
| 256 | tenant relationship between the physician and the entity in |
| 257 | which the equity interest is held, unless the rent is |
| 258 | determined, in whole or in part, by the business volume or |
| 259 | profitability of the tenant or is otherwise unrelated to fair |
| 260 | market value. |
| 261 | (d) Leading the public to believe that one is licensed as |
| 262 | a medical doctor, or is engaged in the licensed practice of |
| 263 | medicine, without holding a valid, active license. |
| 264 | (e) Practicing medicine or attempting to practice medicine |
| 265 | with an inactive or delinquent license. |
| 266 | (f) Knowingly prescribing or dispensing, or causing to be |
| 267 | prescribed or dispensed, controlled substances in a |
| 268 | nonregistered pain-management clinic that is required to be |
| 269 | registered with the Department of Health pursuant to s. |
| 270 | 458.3265(1). |
| 271 | Section 6. Paragraphs (oo), (pp), and (qq) of subsection |
| 272 | (1) of section 458.331, Florida Statutes, are amended to read: |
| 273 | 458.331 Grounds for disciplinary action; action by the |
| 274 | board and department.- |
| 275 | (1) The following acts constitute grounds for denial of a |
| 276 | license or disciplinary action, as specified in s. 456.072(2): |
| 277 | (oo) Dispensing a controlled substance listed in Schedule |
| 278 | II or Schedule III in violation of s. 465.0276. Applicable to a |
| 279 | licensee who serves as the designated physician of a pain- |
| 280 | management clinic as defined in s. 458.3265 or s. 459.0137: |
| 281 | 1. Registering a pain-management clinic through |
| 282 | misrepresentation or fraud; |
| 283 | 2. Procuring, or attempting to procure, the registration |
| 284 | of a pain-management clinic for any other person by making or |
| 285 | causing to be made, any false representation; |
| 286 | 3. Failing to comply with any requirement of chapter 499, |
| 287 | the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the |
| 288 | Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., |
| 289 | the Drug Abuse Prevention and Control Act; or chapter 893, the |
| 290 | Florida Comprehensive Drug Abuse Prevention and Control Act; |
| 291 | 4. Being convicted or found guilty of, regardless of |
| 292 | adjudication to, a felony or any other crime involving moral |
| 293 | turpitude, fraud, dishonesty, or deceit in any jurisdiction of |
| 294 | the courts of this state, of any other state, or of the United |
| 295 | States; |
| 296 | 5. Being convicted of, or disciplined by a regulatory |
| 297 | agency of the Federal Government or a regulatory agency of |
| 298 | another state for, any offense that would constitute a violation |
| 299 | of this chapter; |
| 300 | 6. Being convicted of, or entering a plea of guilty or |
| 301 | nolo contendere to, regardless of adjudication, a crime in any |
| 302 | jurisdiction of the courts of this state, of any other state, or |
| 303 | of the United States which relates to the practice of, or the |
| 304 | ability to practice, a licensed health care profession; |
| 305 | 7. Being convicted of, or entering a plea of guilty or |
| 306 | nolo contendere to, regardless of adjudication, a crime in any |
| 307 | jurisdiction of the courts of this state, of any other state, or |
| 308 | of the United States which relates to health care fraud; |
| 309 | 8. Dispensing any medicinal drug based upon a |
| 310 | communication that purports to be a prescription as defined in |
| 311 | s. 465.003(14) or s. 893.02 if the dispensing practitioner knows |
| 312 | or has reason to believe that the purported prescription is not |
| 313 | based upon a valid practitioner-patient relationship; or |
| 314 | 9. Failing to timely notify the board of the date of his |
| 315 | or her termination from a pain-management clinic as required by |
| 316 | s. 458.3265(2). |
| 317 | (pp) Failing to timely notify the department of the theft |
| 318 | of prescription blanks from a pain-management clinic or a breach |
| 319 | of other methods for prescribing within 24 hours as required by |
| 320 | s. 458.3265(2). |
| 321 | (qq) Promoting or advertising through any communication |
| 322 | media the use, sale, or dispensing of any controlled substance |
| 323 | appearing on any schedule in chapter 893. |
| 324 | Section 7. Section 459.0137, Florida Statutes, is |
| 325 | repealed. |
| 326 | Section 8. Paragraph (e) of subsection (1) and paragraph |
| 327 | (d) of subsection (2) of section 459.013, Florida Statutes, are |
| 328 | amended to read: |
| 329 | 459.013 Penalty for violations.- |
| 330 | (1) Each of the following acts constitutes a felony of the |
| 331 | third degree, punishable as provided in s. 775.082, s. 775.083, |
| 332 | or s. 775.084: |
| 333 | (e) Dispensing a controlled substance listed in Schedule |
| 334 | II or Schedule III in violation of s. 465.0276. Knowingly |
| 335 | operating, owning, or managing a nonregistered pain-management |
| 336 | clinic that is required to be registered with the Department of |
| 337 | Health pursuant to s. 459.0137(1). |
| 338 | (2) Each of the following acts constitutes a misdemeanor |
| 339 | of the first degree, punishable as provided in s. 775.082 or s. |
| 340 | 775.083: |
| 341 | (d) Knowingly prescribing or dispensing, or causing to be |
| 342 | prescribed or dispensed, controlled substances in a |
| 343 | nonregistered pain-management clinic that is required to be |
| 344 | registered with the Department of Health pursuant to s. |
| 345 | 459.0137(1). |
| 346 | Section 9. Paragraphs (qq), (rr), and (ss) of subsection |
| 347 | (1) of section 459.015, Florida Statutes, are amended to read: |
| 348 | 459.015 Grounds for disciplinary action; action by the |
| 349 | board and department.- |
| 350 | (1) The following acts constitute grounds for denial of a |
| 351 | license or disciplinary action, as specified in s. 456.072(2): |
| 352 | (qq) Dispensing a controlled substance listed in Schedule |
| 353 | II or Schedule III in violation of s. 465.0276. Applicable to a |
| 354 | licensee who serves as the designated physician of a pain- |
| 355 | management clinic as defined in s. 458.3265 or s. 459.0137: |
| 356 | 1. Registering a pain-management clinic through |
| 357 | misrepresentation or fraud; |
| 358 | 2. Procuring, or attempting to procure, the registration |
| 359 | of a pain-management clinic for any other person by making or |
| 360 | causing to be made, any false representation; |
| 361 | 3. Failing to comply with any requirement of chapter 499, |
| 362 | the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the |
| 363 | Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., |
| 364 | the Drug Abuse Prevention and Control Act; or chapter 893, the |
| 365 | Florida Comprehensive Drug Abuse Prevention and Control Act; |
| 366 | 4. Being convicted or found guilty of, regardless of |
| 367 | adjudication to, a felony or any other crime involving moral |
| 368 | turpitude, fraud, dishonesty, or deceit in any jurisdiction of |
| 369 | the courts of this state, of any other state, or of the United |
| 370 | States; |
| 371 | 5. Being convicted of, or disciplined by a regulatory |
| 372 | agency of the Federal Government or a regulatory agency of |
| 373 | another state for, any offense that would constitute a violation |
| 374 | of this chapter; |
| 375 | 6. Being convicted of, or entering a plea of guilty or |
| 376 | nolo contendere to, regardless of adjudication, a crime in any |
| 377 | jurisdiction of the courts of this state, of any other state, or |
| 378 | of the United States which relates to the practice of, or the |
| 379 | ability to practice, a licensed health care profession; |
| 380 | 7. Being convicted of, or entering a plea of guilty or |
| 381 | nolo contendere to, regardless of adjudication, a crime in any |
| 382 | jurisdiction of the courts of this state, of any other state, or |
| 383 | of the United States which relates to health care fraud; |
| 384 | 8. Dispensing any medicinal drug based upon a |
| 385 | communication that purports to be a prescription as defined in |
| 386 | s. 465.003(14) or s. 893.02 if the dispensing practitioner knows |
| 387 | or has reason to believe that the purported prescription is not |
| 388 | based upon a valid practitioner-patient relationship; or |
| 389 | 9. Failing to timely notify the board of the date of his |
| 390 | or her termination from a pain-management clinic as required by |
| 391 | s. 459.0137(2). |
| 392 | (rr) Failing to timely notify the department of the theft |
| 393 | of prescription blanks from a pain-management clinic or a breach |
| 394 | of other methods for prescribing within 24 hours as required by |
| 395 | s. 459.0137(2). |
| 396 | (ss) Promoting or advertising through any communication |
| 397 | media the use, sale, or dispensing of any controlled substance |
| 398 | appearing on any schedule in chapter 893. |
| 399 | Section 10. Subsections (3) and (4) of section 465.015, |
| 400 | Florida Statutes, are renumbered as subsections (4) and (5), |
| 401 | respectively, a new subsection (3) is added to that section, and |
| 402 | present subsection (4) of that section is amended, to read: |
| 403 | 465.015 Violations and penalties.- |
| 404 | (3) It is unlawful for any pharmacist, pharmacy intern, or |
| 405 | other person employed by or at a pharmacy to fail to report to |
| 406 | the sheriff of the county where the pharmacy is located within |
| 407 | 24 hours after learning of any instance in which a person |
| 408 | obtained or attempted to obtain a controlled substance, as |
| 409 | defined in s. 893.02, that the pharmacist, pharmacy intern, or |
| 410 | other person employed by or at the pharmacy knew or reasonably |
| 411 | should have known was obtained or attempted to be obtained from |
| 412 | the pharmacy though fraudulent methods or representations. Any |
| 413 | pharmacist, pharmacy intern, or other person employed by or at a |
| 414 | pharmacy who fails to make such a report within 24 hours after |
| 415 | learning of the fraud or attempted fraud commits a misdemeanor |
| 416 | of the first degree, punishable as provided in s. 775.082 or s. |
| 417 | 775.083. A sufficient report of the fraudulent obtaining of |
| 418 | controlled substances under this subsection shall contain, at a |
| 419 | minimum, a copy of the prescription used or presented and a |
| 420 | narrative, including all information available to the pharmacy |
| 421 | concerning the transaction, such as the name and telephone |
| 422 | number of the prescribing physician; the name, description, and |
| 423 | any personal identification information pertaining to the person |
| 424 | who presented the prescription; and all other material |
| 425 | information, such as photographic or video surveillance of the |
| 426 | transaction. |
| 427 | (5)(4) Any person who violates any provision of subsection |
| 428 | (1) or subsection (4) (3) commits a misdemeanor of the first |
| 429 | degree, punishable as provided in s. 775.082 or s. 775.083. Any |
| 430 | person who violates any provision of subsection (2) commits a |
| 431 | felony of the third degree, punishable as provided in s. |
| 432 | 775.082, s. 775.083, or s. 775.084. In any warrant, information, |
| 433 | or indictment, it shall not be necessary to negative any |
| 434 | exceptions, and the burden of any exception shall be upon the |
| 435 | defendant. |
| 436 | Section 11. Section 465.018, Florida Statutes, is amended |
| 437 | to read: |
| 438 | 465.018 Community pharmacies; permits.- |
| 439 | (1) Any person desiring a permit to operate a community |
| 440 | pharmacy shall apply to the department. If the board office |
| 441 | certifies that the application complies with the laws of the |
| 442 | state and the rules of the board governing pharmacies, the |
| 443 | department shall issue the permit. No permit shall be issued |
| 444 | unless a licensed pharmacist is designated as the prescription |
| 445 | department manager responsible for maintaining all drug records, |
| 446 | providing for the security of the prescription department, and |
| 447 | following such other rules as relate to the practice of the |
| 448 | profession of pharmacy. The permittee and the newly designated |
| 449 | prescription department manager shall notify the department |
| 450 | within 10 days of any change in prescription department manager. |
| 451 | (2)(a) A pharmacy permitted under this section may not |
| 452 | dispense a controlled substance listed in Schedule II or |
| 453 | Schedule III as provided in s. 893.03 unless the pharmacy is: |
| 454 | 1. Wholly owned by a corporation whose shares are publicly |
| 455 | traded on a recognized stock exchange; or |
| 456 | 2. Wholly owned by a corporation having more than $100 |
| 457 | million of business taxable assets in this state. |
| 458 | (b) Community pharmacies that have been continuously |
| 459 | permitted for at least 10 years are exempt from this subsection. |
| 460 | Section 12. Paragraph (b) of subsection (1) of section |
| 461 | 465.0276, Florida Statutes, is amended to read: |
| 462 | 465.0276 Dispensing practitioner.- |
| 463 | (1) |
| 464 | (b) A practitioner registered under this section may not |
| 465 | dispense a controlled substance listed in Schedule II or |
| 466 | Schedule III as provided in s. 893.03. A practitioner registered |
| 467 | under this section may not dispense more than a 72-hour supply |
| 468 | of a controlled substance listed in Schedule II, Schedule III, |
| 469 | Schedule IV, or Schedule V of s. 893.03 for any patient who pays |
| 470 | for the medication by cash, check, or credit card in a clinic |
| 471 | registered under s. 458.3265 or s. 459.0137. A practitioner who |
| 472 | violates this paragraph commits a felony of the third degree, |
| 473 | punishable as provided in s. 775.082, s. 775.083, or s. 775.084. |
| 474 | This paragraph does not apply to: |
| 475 | 1. A practitioner who dispenses medication to a workers' |
| 476 | compensation patient pursuant to chapter 440. |
| 477 | 2. A practitioner who dispenses medication to an insured |
| 478 | patient who pays by cash, check, or credit card to cover any |
| 479 | applicable copayment or deductible. |
| 480 | 1.3. The dispensing of complimentary packages of medicinal |
| 481 | drugs to the practitioner's own patients in the regular course |
| 482 | of her or his practice without the payment of a fee or |
| 483 | remuneration of any kind, whether direct or indirect, as |
| 484 | provided in subsection (5). |
| 485 | 2. The dispensing of controlled substances in the health |
| 486 | care system of the Department of Corrections. |
| 487 | Section 13. Paragraph (o) is added to subsection (8) of |
| 488 | section 499.012, Florida Statutes, to read: |
| 489 | 499.012 Permit application requirements.- |
| 490 | (8) An application for a permit or to renew a permit for a |
| 491 | prescription drug wholesale distributor or an out-of-state |
| 492 | prescription drug wholesale distributor submitted to the |
| 493 | department must include: |
| 494 | (o) Documentation of the credentialing policies and |
| 495 | procedures required by s. 499.0121(14). |
| 496 | Section 14. Subsections (14) and (15) are added to section |
| 497 | 499.0121, Florida Statutes, to read: |
| 498 | 499.0121 Storage and handling of prescription drugs; |
| 499 | recordkeeping.-The department shall adopt rules to implement |
| 500 | this section as necessary to protect the public health, safety, |
| 501 | and welfare. Such rules shall include, but not be limited to, |
| 502 | requirements for the storage and handling of prescription drugs |
| 503 | and for the establishment and maintenance of prescription drug |
| 504 | distribution records. |
| 505 | (14) DISTRIBUTION REPORTING.-Each wholesale distributor |
| 506 | shall submit a report to the department of its receipts and |
| 507 | distributions of controlled substances listed in Schedule II, |
| 508 | Schedule III, Schedule IV, or Schedule V as provided in s. |
| 509 | 893.03. Wholesale distributor facilities located within this |
| 510 | state shall report all transactions involving controlled |
| 511 | substances and wholesale distributor facilities located outside |
| 512 | this state shall report all distributions to entities located in |
| 513 | this state. If the wholesale distributor did not have any |
| 514 | controlled substance distributions for the month, a report shall |
| 515 | be sent indicating no distributions occurred in the period. The |
| 516 | report shall be submitted monthly by the 20th of the next month, |
| 517 | in the electronic format used for controlled substance reporting |
| 518 | to the Automation of Reports and Consolidated Orders System |
| 519 | division of the federal Drug Enforcement Administration. |
| 520 | Submission of electronic data must be made in a secured web |
| 521 | environment that allows for manual or automated transmission. |
| 522 | Upon successful transmission, an acknowledgement page must be |
| 523 | displayed to confirm receipt. The report must contain the |
| 524 | following information: |
| 525 | (a) The federal Drug Enforcement Administration |
| 526 | registration number of the wholesale distributing location. |
| 527 | (b) The federal Drug Enforcement Administration |
| 528 | registration number of the entity to which the drugs are |
| 529 | distributed or from which the drugs are received. |
| 530 | (c) The transaction code that indicates the type of |
| 531 | transaction. |
| 532 | (d) The National Drug Code identifier of the product and |
| 533 | the quantity distributed or received. |
| 534 | (e) The Drug Enforcement Administration Form 222 number or |
| 535 | Controlled Substance Ordering System Identifier on all schedule |
| 536 | II transactions. |
| 537 | (f) The date of the transaction. |
| 538 |
|
| 539 | The department must share the reported data with the Department |
| 540 | of Law Enforcement and local law enforcement agencies upon |
| 541 | request, and must monitor purchasing to identify purchasing |
| 542 | levels that are inconsistent with the purchasing entity's |
| 543 | clinical needs. The Department of Law Enforcement shall |
| 544 | investigate purchases at levels that are inconsistent with the |
| 545 | purchasing entity's clinical needs to determine whether |
| 546 | violations of chapter 893 have occurred. |
| 547 | (15) DUE DILIGENCE.-Each wholesale distributor must |
| 548 | establish and maintain policies and procedures to credential |
| 549 | physicians licensed under chapter 459, chapter 459, chapter 461, |
| 550 | or chapter 466 and pharmacies that would purchase or otherwise |
| 551 | receive from the wholesale distributor controlled substances |
| 552 | listed in Schedule II or Schedule III as provided in s. 893.03. |
| 553 | The wholesale distributor shall maintain records of such |
| 554 | credentialing and make the records available to the department |
| 555 | upon request. Such credentialing must, at a minimum, include: |
| 556 | (a) A determination of the clinical nature of the |
| 557 | receiving entity, including any specialty practice area. |
| 558 | (b) A review of the receiving entity's history of Schedule |
| 559 | II and Schedule III controlled substance purchasing from the |
| 560 | wholesale distributor. |
| 561 | (c) A determination that the receiving entity's Schedule |
| 562 | II and Schedule III controlled substance purchasing history, if |
| 563 | any, is consistent with and reasonable for that entity's |
| 564 | clinical business needs. |
| 565 | (d) Documentation of a level 2 background screening |
| 566 | pursuant to chapter 435 through the department on any person who |
| 567 | owns a controlling interest in or, directly or indirectly, |
| 568 | manages, oversees, or controls the operation of the entity, |
| 569 | including officers and members of the board of directors of an |
| 570 | entity that is a corporation. |
| 571 |
|
| 572 | Wholesale distributors may not distribute more than 5,000 unit |
| 573 | doses of any one controlled substance to a retail pharmacy in |
| 574 | any given month. Wholesale distributors may not distribute |
| 575 | controlled substances to an entity if any criminal history |
| 576 | record check for any person associated with that entity shows |
| 577 | the person has been convicted of, or entered a plea of guilty or |
| 578 | nolo contendere to, regardless of adjudication, a crime in any |
| 579 | jurisdiction related to controlled substances, the practice of |
| 580 | pharmacy, or the dispensing of medicinal drugs. |
| 581 | Section 15. Paragraphs (o) and (p) are added to subsection |
| 582 | (1) of section 499.05, Florida Statutes, to read: |
| 583 | 499.05 Rules.- |
| 584 | (1) The department shall adopt rules to implement and |
| 585 | enforce this part with respect to: |
| 586 | (o) Wholesale distributor reporting requirements of s. |
| 587 | 499.0121(14). |
| 588 | (p) Wholesale distributor credentialing requirements of s. |
| 589 | 499.0121(15). |
| 590 | Section 16. Subsection (8) is added to section 499.067, |
| 591 | Florida Statutes, to read: |
| 592 | 499.067 Denial, suspension, or revocation of permit, |
| 593 | certification, or registration.- |
| 594 | (8) The department shall deny, suspend, or revoke a permit |
| 595 | if it finds the permittee has not complied with the |
| 596 | credentialing requirements of s. 499.0121(15). |
| 597 | Section 17. Paragraph (f) is added to subsection (3) of |
| 598 | section 810.02, Florida Statutes, to read: |
| 599 | 810.02 Burglary.- |
| 600 | (3) Burglary is a felony of the second degree, punishable |
| 601 | as provided in s. 775.082, s. 775.083, or s. 775.084, if, in the |
| 602 | course of committing the offense, the offender does not make an |
| 603 | assault or battery and is not and does not become armed with a |
| 604 | dangerous weapon or explosive, and the offender enters or |
| 605 | remains in a: |
| 606 | (f) Structure or conveyance when the offense intended to |
| 607 | be committed therein is theft of a controlled substance as |
| 608 | defined in s. 893.02. Notwithstanding any other law, separate |
| 609 | judgments and sentences for burglary with the intent to commit |
| 610 | theft of a controlled substance under this paragraph and for any |
| 611 | applicable possession of controlled substance offense under s. |
| 612 | 893.13 or trafficking in controlled substance offense under s. |
| 613 | 893.135 may be imposed when all such offenses involve the same |
| 614 | amount or amounts of a controlled substance. |
| 615 |
|
| 616 | However, if the burglary is committed within a county that is |
| 617 | subject to a state of emergency declared by the Governor under |
| 618 | chapter 252 after the declaration of emergency is made and the |
| 619 | perpetration of the burglary is facilitated by conditions |
| 620 | arising from the emergency, the burglary is a felony of the |
| 621 | first degree, punishable as provided in s. 775.082, s. 775.083, |
| 622 | or s. 775.084. As used in this subsection, the term "conditions |
| 623 | arising from the emergency" means civil unrest, power outages, |
| 624 | curfews, voluntary or mandatory evacuations, or a reduction in |
| 625 | the presence of or response time for first responders or |
| 626 | homeland security personnel. A person arrested for committing a |
| 627 | burglary within a county that is subject to such a state of |
| 628 | emergency may not be released until the person appears before a |
| 629 | committing magistrate at a first appearance hearing. For |
| 630 | purposes of sentencing under chapter 921, a felony offense that |
| 631 | is reclassified under this subsection is ranked one level above |
| 632 | the ranking under s. 921.0022 or s. 921.0023 of the offense |
| 633 | committed. |
| 634 | Section 18. Paragraph (c) of subsection (2) of section |
| 635 | 812.014, Florida Statutes, is amended to read: |
| 636 | 812.014 Theft.- |
| 637 | (2) |
| 638 | (c) It is grand theft of the third degree and a felony of |
| 639 | the third degree, punishable as provided in s. 775.082, s. |
| 640 | 775.083, or s. 775.084, if the property stolen is: |
| 641 | 1. Valued at $300 or more, but less than $5,000. |
| 642 | 2. Valued at $5,000 or more, but less than $10,000. |
| 643 | 3. Valued at $10,000 or more, but less than $20,000. |
| 644 | 4. A will, codicil, or other testamentary instrument. |
| 645 | 5. A firearm. |
| 646 | 6. A motor vehicle, except as provided in paragraph (a). |
| 647 | 7. Any commercially farmed animal, including any animal of |
| 648 | the equine, bovine, or swine class, or other grazing animal, and |
| 649 | including aquaculture species raised at a certified aquaculture |
| 650 | facility. If the property stolen is aquaculture species raised |
| 651 | at a certified aquaculture facility, then a $10,000 fine shall |
| 652 | be imposed. |
| 653 | 8. Any fire extinguisher. |
| 654 | 9. Any amount of citrus fruit consisting of 2,000 or more |
| 655 | individual pieces of fruit. |
| 656 | 10. Taken from a designated construction site identified |
| 657 | by the posting of a sign as provided for in s. 810.09(2)(d). |
| 658 | 11. Any stop sign. |
| 659 | 12. Anhydrous ammonia. |
| 660 | 13. Any amount of a controlled substance as defined in s. |
| 661 | 893.02. Notwithstanding any other law, separate judgments and |
| 662 | sentences for theft of a controlled substance under this |
| 663 | subparagraph and for any applicable possession of controlled |
| 664 | substance offense under s. 893.13 or trafficking in controlled |
| 665 | substance offense under s. 893.135 may be imposed when all such |
| 666 | offenses involve the same amount or amounts of a controlled |
| 667 | substance. |
| 668 |
|
| 669 | However, if the property is stolen within a county that is |
| 670 | subject to a state of emergency declared by the Governor under |
| 671 | chapter 252, the property is stolen after the declaration of |
| 672 | emergency is made, and the perpetration of the theft is |
| 673 | facilitated by conditions arising from the emergency, the |
| 674 | offender commits a felony of the second degree, punishable as |
| 675 | provided in s. 775.082, s. 775.083, or s. 775.084, if the |
| 676 | property is valued at $5,000 or more, but less than $10,000, as |
| 677 | provided under subparagraph 2., or if the property is valued at |
| 678 | $10,000 or more, but less than $20,000, as provided under |
| 679 | subparagraph 3. As used in this paragraph, the term "conditions |
| 680 | arising from the emergency" means civil unrest, power outages, |
| 681 | curfews, voluntary or mandatory evacuations, or a reduction in |
| 682 | the presence of or the response time for first responders or |
| 683 | homeland security personnel. For purposes of sentencing under |
| 684 | chapter 921, a felony offense that is reclassified under this |
| 685 | paragraph is ranked one level above the ranking under s. |
| 686 | 921.0022 or s. 921.0023 of the offense committed. |
| 687 | Section 19. Subsections (4) and (5) of section 893.07, |
| 688 | Florida Statutes, are amended to read: |
| 689 | 893.07 Records.- |
| 690 | (4) Every inventory or record required by this chapter, |
| 691 | including prescription records, shall be maintained: |
| 692 | (a) Separately from all other records of the registrant, |
| 693 | or |
| 694 | (b) Alternatively, in the case of Schedule III, IV, or V |
| 695 | controlled substances, in such form that information required by |
| 696 | this chapter is readily retrievable from the ordinary business |
| 697 | records of the registrant. |
| 698 |
|
| 699 | In either case, the records described in this subsection shall |
| 700 | be kept and made available for a period of at least 2 years for |
| 701 | inspection and copying by law enforcement officers whose duty it |
| 702 | is to enforce the laws of this state relating to controlled |
| 703 | substances. Law enforcement officers are not required to obtain |
| 704 | a subpoena, court order, or search warrant in order to obtain |
| 705 | access to or copies of such records. |
| 706 | (5) Each person described in subsection (1) shall: |
| 707 | (a) Maintain a record which shall contain a detailed list |
| 708 | of controlled substances lost, destroyed, or stolen, if any; the |
| 709 | kind and quantity of such controlled substances; and the date of |
| 710 | the discovering of such loss, destruction, or theft. |
| 711 | (b) In the event of the discovery of the theft or loss of |
| 712 | controlled substances, report such theft or loss to the sheriff |
| 713 | of that county within 48 hours after its discovery. A person who |
| 714 | fails to report a theft or loss of a substance listed in s. |
| 715 | 893.03(3), (4), or (5) within 48 hours after discovery as |
| 716 | required in this paragraph commits a misdemeanor of the second |
| 717 | degree, punishable as provided in s. 775.082 or s. 775.083. A |
| 718 | person who fails to report a theft or loss of a substance listed |
| 719 | in s. 893.03(2) within 48 hours after discovery as required in |
| 720 | this paragraph commits a misdemeanor of the first degree, |
| 721 | punishable as provided in s. 775.082 or s. 775.083. |
| 722 | Section 20. Section 2 of chapter 2009-198, Laws of |
| 723 | Florida, is repealed. |
| 724 | Section 21. |
| 725 | (1) BUY-BACK PROGRAM.-Within 10 days after the effective |
| 726 | date of this act, each physician licensed under chapter 458, |
| 727 | chapter 459, chapter 461, or chapter 466, Florida Statutes, |
| 728 | shall ensure that undispensed inventory of controlled substances |
| 729 | listed in Schedule II or Schedule III as provided in s. 893.03, |
| 730 | Florida Statutes, purchased under the physician's Drug |
| 731 | Enforcement Administration number for dispensing is: |
| 732 | (a) Returned to the wholesale distributor, as defined in |
| 733 | s. 499.003, Florida Statutes, which distributed them; or |
| 734 | (b) Turned in to local law enforcement agencies and |
| 735 | abandoned. |
| 736 |
|
| 737 | Wholesale distributors shall buy back the undispensed inventory |
| 738 | of controlled substances listed in Schedule II or Schedule III |
| 739 | as provided in s. 893.03, Florida Statutes, at the purchase |
| 740 | price paid by the physician, physician practice, clinic, or |
| 741 | other paying entity. Each wholesale distributor shall submit a |
| 742 | report of its activities under this section to the Department of |
| 743 | Health by August 1, 2011. The report shall include the following |
| 744 | information: |
| 745 | 1. The name and address of the returning entity. |
| 746 | 2. The Florida license, registration, or permit number and |
| 747 | Drug Enforcement Administration number of the entity that |
| 748 | originally ordered the drugs. |
| 749 | 3. The drug name and number of unit doses returned. |
| 750 | 4. The date of return. |
| 751 | (2) PUBLIC HEALTH EMERGENCY.- |
| 752 | (a) The Legislature finds that: |
| 753 | 1. Prescription drug overdose has been declared a public |
| 754 | health epidemic by the United States Centers for Disease Control |
| 755 | and Prevention. |
| 756 | 2. Prescription drug abuse results in an average of 7 |
| 757 | deaths in this state each day. |
| 758 | 3. Physicians in this state purchased over 85 percent of |
| 759 | the oxycodone purchased by all practitioners in the United |
| 760 | States in 2006. |
| 761 | 4. Physicians in this state purchased over 93 percent of |
| 762 | the methadone purchased by all practitioners in the United |
| 763 | States in 2006. |
| 764 | 5. Some physicians in this state dispense medically |
| 765 | unjustifiable amounts of controlled substances to addicts and |
| 766 | people who intend to illegally sell the drugs. |
| 767 | 6. Physicians in this state who have purchased large |
| 768 | quantities of controlled substances may have significant |
| 769 | inventory on the effective date of this act. |
| 770 | 7. On the effective date of this act, the only legal |
| 771 | method for a dispensing practitioner to sell or otherwise |
| 772 | transfer controlled substances listed in Schedule II or Schedule |
| 773 | III as provided in s. 893.03, Florida Statutes, purchased for |
| 774 | dispensing is through the buy-back procedure or abandonment |
| 775 | procedures of subsection (1). |
| 776 | 8. It is likely that the same physicians who purchase and |
| 777 | dispense medically unjustifiable amounts of drugs will not |
| 778 | legally dispose of remaining inventory. |
| 779 | 9. The actions of such dispensing practitioners may result |
| 780 | in substantial injury to the public health. |
| 781 | (b) Immediately on the effective date of this act, the |
| 782 | State Health Officer shall declare a public health emergency |
| 783 | pursuant to s. 381.00315, Florida Statutes. Pursuant to that |
| 784 | declaration, the Department of Health, the Attorney General, the |
| 785 | Department of Law Enforcement, and local law enforcement |
| 786 | agencies shall take the following actions: |
| 787 | 1. Within 2 days after the effective date of this act, in |
| 788 | consultation with wholesale distributors as defined in s. |
| 789 | 499.003, Florida Statutes, the Department of Health shall |
| 790 | identify dispensing practitioners that purchased more than an |
| 791 | average of 2,000 unit doses of controlled substances listed in |
| 792 | Schedule II or Schedule III as provided in s. 893.03, Florida |
| 793 | Statutes, per month in the previous 6 months, and shall identify |
| 794 | the dispensing practitioners in that group who pose the greatest |
| 795 | threat to the public health based on an assessment of: |
| 796 | a. The risk of noncompliance with subsection (1). |
| 797 | b. Purchase amounts. |
| 798 | c. Manner of medical practice. |
| 799 | d. Any other factor set by the State Health Officer. |
| 800 |
|
| 801 | The Attorney General shall consult and coordinate with federal |
| 802 | law enforcement agencies. The Department of Law Enforcement |
| 803 | shall coordinate the efforts of local law enforcement agencies. |
| 804 | 2. On the 3rd day after the effective date of this act, |
| 805 | the Department of Law Enforcement or local law enforcement |
| 806 | agencies shall enter the business premises of the dispensing |
| 807 | practitioners identified as posing the greatest threat to public |
| 808 | health and quarantine the inventory of controlled substances |
| 809 | listed in Schedule II or Schedule III as provided in s. 893.03, |
| 810 | Florida Statutes, of such dispensing practitioners on site. |
| 811 | 3. The Department of Law Enforcement or local law |
| 812 | enforcement agencies shall ensure the security of such inventory |
| 813 | 24 hours a day through the 10th day after the effective date of |
| 814 | this act or until the inventory is validly transferred pursuant |
| 815 | to subsection (1), whichever is earlier. |
| 816 | 4. On the 11th day after the effective date of this act, |
| 817 | any remaining inventory of controlled substances listed in |
| 818 | Schedule II or Schedule III as provided in s. 893.03, Florida |
| 819 | Statutes, purchased for dispensing by practitioners is deemed |
| 820 | contraband under s. 893.12, Florida Statutes. The Department of |
| 821 | Law Enforcement or local law enforcement agencies shall seize |
| 822 | the inventory and comply with the provisions of s. 893.12, |
| 823 | Florida Statutes, to destroy it. |
| 824 | (c) In order to implement the provisions of this section, |
| 825 | the sum of $3 million of nonrecurring funds from the General |
| 826 | Revenue Fund is appropriated to the Department of Law |
| 827 | Enforcement for the 2010-2011 fiscal year. The Department of Law |
| 828 | Enforcement shall expend the appropriation by reimbursing local |
| 829 | law enforcement agencies for the overtime-hour costs associated |
| 830 | with securing the quarantined controlled substance inventory as |
| 831 | provided in paragraph (b) and activities related to |
| 832 | investigation and prosecution of crimes related to prescribed |
| 833 | controlled substances. If requests for reimbursement exceed the |
| 834 | amount appropriated, the reimbursements shall be prorated by the |
| 835 | hours of overtime per requesting agency at a maximum of one law |
| 836 | enforcement officer per quarantine site. |
| 837 | (3) This section is repealed January 1, 2013. |
| 838 | Section 22. This act shall take effect upon becoming a |
| 839 | law. |