Bill Text: FL S1180 | 2015 | Regular Session | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Practice of Pharmacy
Spectrum:
Status: (Introduced - Dead) 2015-04-27 - Laid on Table, companion bill(s) passed, see CS/CS/HB 1049 (Ch. 2015-127) [S1180 Detail]
Download: Florida-2015-S1180-Introduced.html
Bill Title: Practice of Pharmacy
Spectrum:
Status: (Introduced - Dead) 2015-04-27 - Laid on Table, companion bill(s) passed, see CS/CS/HB 1049 (Ch. 2015-127) [S1180 Detail]
Download: Florida-2015-S1180-Introduced.html
Florida Senate - 2015 SB 1180 By Senator Latvala 20-01281B-15 20151180__ 1 A bill to be entitled 2 An act relating to the practice of pharmacy; amending 3 s. 465.003, F.S.; defining a term; amending s. 4 465.0276, F.S.; providing that the Florida Pharmacy 5 Act does not prohibit the dispensing of a compounded 6 drug by a veterinarian; amending ss. 409.9201, 7 458.331, 459.015, 465.014, 465.015, 465.0156, 465.016, 8 465.0197, 465.022, 465.023, 465.1901, 499.003, and 9 893.02; conforming cross references; providing an 10 effective date. 11 12 Be It Enacted by the Legislature of the State of Florida: 13 14 Section 1. Section 465.003, Florida Statutes, is reordered 15 and amended, to read: 16 465.003 Definitions.—As used in this chapter, the term: 17 (1) “Administration” means the obtaining and giving of a 18 single dose of medicinal drugs by a legally authorized person to 19 a patient for her or his consumption. 20 (3)(2)“Board” means the Board of Pharmacy. 21 (7)(3)“Consultant pharmacist” means a pharmacist licensed 22 by the department and certified as a consultant pharmacist 23 pursuant to s. 465.0125. 24 (8)(4)“Data communication device” means an electronic 25 device that receives electronic information from one source and 26 transmits or routes it to another, including, but not limited 27 to, any such bridge, router, switch, or gateway. 28 (9)(5)“Department” means the Department of Health. 29 (10)(6)“Dispense” means the transfer of possession of one 30 or more doses of a medicinal drug by a pharmacist to the 31 ultimate consumer or her or his agent. As an element of 32 dispensing, the pharmacist shall, prior to the actual physical 33 transfer, interpret and assess the prescription order for 34 potential adverse reactions, interactions, and dosage regimen 35 she or he deems appropriate in the exercise of her or his 36 professional judgment, and the pharmacist shall certify that the 37 medicinal drug called for by the prescription is ready for 38 transfer. The pharmacist shall also provide counseling on proper 39 drug usage, either orally or in writing, if in the exercise of 40 her or his professional judgment counseling is necessary. The 41 actual sales transaction and delivery of such drug shall not be 42 considered dispensing. The administration shall not be 43 considered dispensing. 44 (11)(7)“Institutional formulary system” means a method 45 whereby the medical staff evaluates, appraises, and selects 46 those medicinal drugs or proprietary preparations which in the 47 medical staff’s clinical judgment are most useful in patient 48 care, and which are available for dispensing by a practicing 49 pharmacist in a Class II institutional pharmacy. 50 (12)(8)“Medicinal drugs” or “drugs” means those substances 51 or preparations commonly known as “prescription” or “legend” 52 drugs which are required by federal or state law to be dispensed 53 only on a prescription, but shall not include patents or 54 proprietary preparations as hereafter defined. 55 (16)(9)“Patent or proprietary preparation” means a 56 medicine in its unbroken, original package which is sold to the 57 public by, or under the authority of, the manufacturer or 58 primary distributor thereof and which is not misbranded under 59 the provisions of the Florida Drug and Cosmetic Act. 60 (17)(10)“Pharmacist” means any person licensed pursuant to 61 this chapter to practice the profession of pharmacy. 62 (18)(11)(a) “Pharmacy” includes a community pharmacy, an 63 institutional pharmacy, a nuclear pharmacy, a special pharmacy, 64 and an Internet pharmacy. 65 1. The term “community pharmacy” includes every location 66 where medicinal drugs are compounded, dispensed, stored, or sold 67 or where prescriptions are filled or dispensed on an outpatient 68 basis. 69 2. The term “institutional pharmacy” includes every 70 location in a hospital, clinic, nursing home, dispensary, 71 sanitarium, extended care facility, or other facility, 72 hereinafter referred to as “health care institutions,” where 73 medicinal drugs are compounded, dispensed, stored, or sold. 74 3. The term “nuclear pharmacy” includes every location 75 where radioactive drugs and chemicals within the classification 76 of medicinal drugs are compounded, dispensed, stored, or sold. 77 The term “nuclear pharmacy” does not include hospitals licensed 78 under chapter 395 or the nuclear medicine facilities of such 79 hospitals. 80 4. The term “special pharmacy” includes every location 81 where medicinal drugs are compounded, dispensed, stored, or sold 82 if such locations are not otherwise defined in this subsection. 83 5. The term “Internet pharmacy” includes locations not 84 otherwise licensed or issued a permit under this chapter, within 85 or outside this state, which use the Internet to communicate 86 with or obtain information from consumers in this state and use 87 such communication or information to fill or refill 88 prescriptions or to dispense, distribute, or otherwise engage in 89 the practice of pharmacy in this state. Any act described in 90 this definition constitutes the practice of pharmacy as defined 91 in subsection (20)(13). 92 (b) The pharmacy department of any permittee shall be 93 considered closed whenever a Florida licensed pharmacist is not 94 present and on duty. The term “not present and on duty” shall 95 not be construed to prevent a pharmacist from exiting the 96 prescription department for the purposes of consulting or 97 responding to inquiries or providing assistance to patients or 98 customers, attending to personal hygiene needs, or performing 99 any other function for which the pharmacist is responsible, 100 provided that such activities are conducted in a manner 101 consistent with the pharmacist’s responsibility to provide 102 pharmacy services. 103 (19)(12)“Pharmacy intern” means a person who is currently 104 registered in, and attending, a duly accredited college or 105 school of pharmacy, or who is a graduate of such a school or 106 college of pharmacy, and who is duly and properly registered 107 with the department as provided for under its rules. 108 (20)(13)“Practice of the profession of pharmacy” includes 109 compounding, dispensing, and consulting concerning contents, 110 therapeutic values, and uses of any medicinal drug; consulting 111 concerning therapeutic values and interactions of patent or 112 proprietary preparations, whether pursuant to prescriptions or 113 in the absence and entirely independent of such prescriptions or 114 orders; and other pharmaceutical services. For purposes of this 115 subsection, “other pharmaceutical services” means the monitoring 116 of the patient’s drug therapy and assisting the patient in the 117 management of his or her drug therapy, and includes review of 118 the patient’s drug therapy and communication with the patient’s 119 prescribing health care provider as licensed under chapter 458, 120 chapter 459, chapter 461, or chapter 466, or similar statutory 121 provision in another jurisdiction, or such provider’s agent or 122 such other persons as specifically authorized by the patient, 123 regarding the drug therapy. However, nothing in this subsection 124 may be interpreted to permit an alteration of a prescriber’s 125 directions, the diagnosis or treatment of any disease, the 126 initiation of any drug therapy, the practice of medicine, or the 127 practice of osteopathic medicine, unless otherwise permitted by 128 law. “Practice of the profession of pharmacy” also includes any 129 other act, service, operation, research, or transaction 130 incidental to, or forming a part of, any of the foregoing acts, 131 requiring, involving, or employing the science or art of any 132 branch of the pharmaceutical profession, study, or training, and 133 shall expressly permit a pharmacist to transmit information from 134 persons authorized to prescribe medicinal drugs to their 135 patients. The practice of the profession of pharmacy also 136 includes the administration of vaccines to adults pursuant to s. 137 465.189. 138 (21)(14)“Prescription” includes any order for drugs or 139 medicinal supplies written or transmitted by any means of 140 communication by a duly licensed practitioner authorized by the 141 laws of the state to prescribe such drugs or medicinal supplies 142 and intended to be dispensed by a pharmacist. The term also 143 includes an orally transmitted order by the lawfully designated 144 agent of such practitioner. The term also includes an order 145 written or transmitted by a practitioner licensed to practice in 146 a jurisdiction other than this state, but only if the pharmacist 147 called upon to dispense such order determines, in the exercise 148 of her or his professional judgment, that the order is valid and 149 necessary for the treatment of a chronic or recurrent illness. 150 The term “prescription” also includes a pharmacist’s order for a 151 product selected from the formulary created pursuant to s. 152 465.186. Prescriptions may be retained in written form or the 153 pharmacist may cause them to be recorded in a data processing 154 system, provided that such order can be produced in printed form 155 upon lawful request. 156 (13)(15)“Nuclear pharmacist” means a pharmacist licensed 157 by the department and certified as a nuclear pharmacist pursuant 158 to s. 465.0126. 159 (14) “Office use compounding” means the provision and 160 administration of a compounded drug to a patient by a 161 practitioner in the practitioner’s office or other treatment 162 setting. In the case of veterinary drugs, office use compounding 163 includes compounding for a veterinarian to dispense to the owner 164 or caretaker of the animal patient. 165 (4)(16)“Centralized prescription filling” means the 166 filling of a prescription by one pharmacy upon request by 167 another pharmacy to fill or refill the prescription. The term 168 includes the performance by one pharmacy for another pharmacy of 169 other pharmacy duties such as drug utilization review, 170 therapeutic drug utilization review, claims adjudication, and 171 the obtaining of refill authorizations. 172 (2)(17)“Automated pharmacy system” means a mechanical 173 system that delivers prescription drugs received from a Florida 174 licensed pharmacy and maintains related transaction information. 175 (6)(18)“Compounding” means combining, mixing, or altering 176 the ingredients of one or more drugs or products to create 177 another drug or product. 178 (15)(19)“Outsourcing facility” means a single physical 179 location registered as an outsourcing facility under the federal 180 Drug Quality and Security Act, Pub. L. No. 113-54, at which 181 sterile compounding of a drug or product is conducted. 182 (5)(20)“Compounded sterile product” means a drug that is 183 intended for parenteral administration, an ophthalmic or oral 184 inhalation drug in aqueous format, or a drug or product that is 185 required to be sterile under federal or state law or rule, which 186 is produced through compounding, but is not approved by the 187 United States Food and Drug Administration. 188 Section 2. A new subsection (6) is added to section 189 465.0276, Florida Statutes, to read: 190 465.0276 Dispensing practitioner.— 191 (6) Nothing in this chapter or the rules adopted thereunder 192 prohibit a veterinarian from dispensing a compounded drug to an 193 animal patient or its owner or caretaker. 194 Section 3. Paragraph (a) of subsection (1) of section 195 409.9201, Florida Statutes, is amended to read: 196 409.9201 Medicaid fraud.— 197 (1) As used in this section, the term: 198 (a) “Prescription drug” means any drug, including, but not 199 limited to, finished dosage forms or active ingredients that are 200 subject to, defined in, or described in s. 503(b) of the Federal 201 Food, Drug, and Cosmetic Act or in s. 465.003s. 465.003(8), s. 202 499.003(52), s. 499.007(13), or s. 499.82(10). 203 204 The value of individual items of the legend drugs or goods or 205 services involved in distinct transactions committed during a 206 single scheme or course of conduct, whether involving a single 207 person or several persons, may be aggregated when determining 208 the punishment for the offense. 209 Section 4. Paragraph (pp) of subsection (1) of section 210 458.331, Florida Statutes, is amended to read: 211 458.331 Grounds for disciplinary action; action by the 212 board and department.— 213 (1) The following acts constitute grounds for denial of a 214 license or disciplinary action, as specified in s. 456.072(2): 215 (pp) Applicable to a licensee who serves as the designated 216 physician of a pain-management clinic as defined in s. 458.3265 217 or s. 459.0137: 218 1. Registering a pain-management clinic through 219 misrepresentation or fraud; 220 2. Procuring, or attempting to procure, the registration of 221 a pain-management clinic for any other person by making or 222 causing to be made, any false representation; 223 3. Failing to comply with any requirement of chapter 499, 224 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 225 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 226 the Drug Abuse Prevention and Control Act; or chapter 893, the 227 Florida Comprehensive Drug Abuse Prevention and Control Act; 228 4. Being convicted or found guilty of, regardless of 229 adjudication to, a felony or any other crime involving moral 230 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 231 the courts of this state, of any other state, or of the United 232 States; 233 5. Being convicted of, or disciplined by a regulatory 234 agency of the Federal Government or a regulatory agency of 235 another state for, any offense that would constitute a violation 236 of this chapter; 237 6. Being convicted of, or entering a plea of guilty or nolo 238 contendere to, regardless of adjudication, a crime in any 239 jurisdiction of the courts of this state, of any other state, or 240 of the United States which relates to the practice of, or the 241 ability to practice, a licensed health care profession; 242 7. Being convicted of, or entering a plea of guilty or nolo 243 contendere to, regardless of adjudication, a crime in any 244 jurisdiction of the courts of this state, of any other state, or 245 of the United States which relates to health care fraud; 246 8. Dispensing any medicinal drug based upon a communication 247 that purports to be a prescription as defined in s. 465.003s.248465.003(14)or s. 893.02 if the dispensing practitioner knows or 249 has reason to believe that the purported prescription is not 250 based upon a valid practitioner-patient relationship; or 251 9. Failing to timely notify the board of the date of his or 252 her termination from a pain-management clinic as required by s. 253 458.3265(2). 254 Section 5. Paragraph (rr) of subsection (1) of section 255 459.015, Florida Statutes, is amended to read: 256 459.015 Grounds for disciplinary action; action by the 257 board and department.— 258 (1) The following acts constitute grounds for denial of a 259 license or disciplinary action, as specified in s. 456.072(2): 260 (rr) Applicable to a licensee who serves as the designated 261 physician of a pain-management clinic as defined in s. 458.3265 262 or s. 459.0137: 263 1. Registering a pain-management clinic through 264 misrepresentation or fraud; 265 2. Procuring, or attempting to procure, the registration of 266 a pain-management clinic for any other person by making or 267 causing to be made, any false representation; 268 3. Failing to comply with any requirement of chapter 499, 269 the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the 270 Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., 271 the Drug Abuse Prevention and Control Act; or chapter 893, the 272 Florida Comprehensive Drug Abuse Prevention and Control Act; 273 4. Being convicted or found guilty of, regardless of 274 adjudication to, a felony or any other crime involving moral 275 turpitude, fraud, dishonesty, or deceit in any jurisdiction of 276 the courts of this state, of any other state, or of the United 277 States; 278 5. Being convicted of, or disciplined by a regulatory 279 agency of the Federal Government or a regulatory agency of 280 another state for, any offense that would constitute a violation 281 of this chapter; 282 6. Being convicted of, or entering a plea of guilty or nolo 283 contendere to, regardless of adjudication, a crime in any 284 jurisdiction of the courts of this state, of any other state, or 285 of the United States which relates to the practice of, or the 286 ability to practice, a licensed health care profession; 287 7. Being convicted of, or entering a plea of guilty or nolo 288 contendere to, regardless of adjudication, a crime in any 289 jurisdiction of the courts of this state, of any other state, or 290 of the United States which relates to health care fraud; 291 8. Dispensing any medicinal drug based upon a communication 292 that purports to be a prescription as defined in s. 465.003s.293465.003(14)or s. 893.02 if the dispensing practitioner knows or 294 has reason to believe that the purported prescription is not 295 based upon a valid practitioner-patient relationship; or 296 9. Failing to timely notify the board of the date of his or 297 her termination from a pain-management clinic as required by s. 298 459.0137(2). 299 Section 6. Subsection (1) of section 465.014, Florida 300 Statutes, is amended to read: 301 465.014 Pharmacy technician.— 302 (1) A person other than a licensed pharmacist or pharmacy 303 intern may not engage in the practice of the profession of 304 pharmacy, except that a licensed pharmacist may delegate to 305 pharmacy technicians who are registered pursuant to this section 306 those duties, tasks, and functions that do not fall within the 307 purview of s. 465.003s. 465.003(13). All such delegated acts 308 must be performed under the direct supervision of a licensed 309 pharmacist who is responsible for all such acts performed by 310 persons under his or her supervision. A registered pharmacy 311 technician, under the supervision of a pharmacist, may initiate 312 or receive communications with a practitioner or his or her 313 agent, on behalf of a patient, regarding refill authorization 314 requests. A licensed pharmacist may not supervise more than one 315 registered pharmacy technician unless otherwise permitted by the 316 guidelines adopted by the board. The board shall establish 317 guidelines to be followed by licensees or permittees in 318 determining the circumstances under which a licensed pharmacist 319 may supervise more than one pharmacy technician. 320 Section 7. Paragraph (c) of subsection (2) of section 321 465.015, Florida Statutes, is amended to read: 322 465.015 Violations and penalties.— 323 (2) It is unlawful for any person: 324 (c) To sell or dispense drugs as defined in s. 465.003s.325465.003(8)without first being furnished with a prescription. 326 Section 8. Subsection (9) of section 465.0156, Florida 327 Statutes, is amended to read: 328 465.0156 Registration of nonresident pharmacies.— 329 (9) Notwithstanding s. 465.003s. 465.003(10), for purposes 330 of this section, the registered pharmacy and the pharmacist 331 designated by the registered pharmacy as the prescription 332 department manager or the equivalent must be licensed in the 333 state of location in order to dispense into this state. 334 Section 9. Paragraph (s) of subsection (1) of section 335 465.016, Florida Statutes, is amended to read: 336 465.016 Disciplinary actions.— 337 (1) The following acts constitute grounds for denial of a 338 license or disciplinary action, as specified in s. 456.072(2): 339 (s) Dispensing any medicinal drug based upon a 340 communication that purports to be a prescription as defined by 341 s. 465.003s. 465.003(14)or s. 893.02 when the pharmacist knows 342 or has reason to believe that the purported prescription is not 343 based upon a valid practitioner-patient relationship. 344 Section 10. Subsection (4) of section 465.0197, Florida 345 Statutes, is amended to read: 346 465.0197 Internet pharmacy permits.— 347 (4) Notwithstanding s. 465.003s. 465.003(10), for purposes 348 of this section, the Internet pharmacy and the pharmacist 349 designated by the Internet pharmacy as the prescription 350 department manager or the equivalent must be licensed in the 351 state of location in order to dispense into this state. 352 Section 11. Paragraph (j) of subsection (5) of section 353 465.022, Florida Statutes, is amended to read: 354 465.022 Pharmacies; general requirements; fees.— 355 (5) The department or board shall deny an application for a 356 pharmacy permit if the applicant or an affiliated person, 357 partner, officer, director, or prescription department manager 358 or consultant pharmacist of record of the applicant: 359 (j) Has dispensed any medicinal drug based upon a 360 communication that purports to be a prescription as defined by 361 s. 465.003s. 465.003(14)or s. 893.02 when the pharmacist knows 362 or has reason to believe that the purported prescription is not 363 based upon a valid practitioner-patient relationship that 364 includes a documented patient evaluation, including history and 365 a physical examination adequate to establish the diagnosis for 366 which any drug is prescribed and any other requirement 367 established by board rule under chapter 458, chapter 459, 368 chapter 461, chapter 463, chapter 464, or chapter 466. 369 370 For felonies in which the defendant entered a plea of guilty or 371 nolo contendere in an agreement with the court to enter a 372 pretrial intervention or drug diversion program, the department 373 shall deny the application if upon final resolution of the case 374 the licensee has failed to successfully complete the program. 375 Section 12. Paragraph (h) of subsection (1) of section 376 465.023, Florida Statutes, is amended to read: 377 465.023 Pharmacy permittee; disciplinary action.— 378 (1) The department or the board may revoke or suspend the 379 permit of any pharmacy permittee, and may fine, place on 380 probation, or otherwise discipline any pharmacy permittee if the 381 permittee, or any affiliated person, partner, officer, director, 382 or agent of the permittee, including a person fingerprinted 383 under s. 465.022(3), has: 384 (h) Dispensed any medicinal drug based upon a communication 385 that purports to be a prescription as defined by s. 465.003s.386465.003(14)or s. 893.02 when the pharmacist knows or has reason 387 to believe that the purported prescription is not based upon a 388 valid practitioner-patient relationship that includes a 389 documented patient evaluation, including history and a physical 390 examination adequate to establish the diagnosis for which any 391 drug is prescribed and any other requirement established by 392 board rule under chapter 458, chapter 459, chapter 461, chapter 393 463, chapter 464, or chapter 466. 394 Section 13. Section 465.1901, Florida Statutes, is amended 395 to read: 396 465.1901 Practice of orthotics and pedorthics.—The 397 provisions of chapter 468 relating to orthotics or pedorthics do 398 not apply to any licensed pharmacist or to any person acting 399 under the supervision of a licensed pharmacist. The practice of 400 orthotics or pedorthics by a pharmacist or any of the 401 pharmacist’s employees acting under the supervision of a 402 pharmacist shall be construed to be within the meaning of the 403 term “practice of the profession of pharmacy” as set forth in s. 404 465.003s. 465.003(13), and shall be subject to regulation in 405 the same manner as any other pharmacy practice. The Board of 406 Pharmacy shall develop rules regarding the practice of orthotics 407 and pedorthics by a pharmacist. Any pharmacist or person under 408 the supervision of a pharmacist engaged in the practice of 409 orthotics or pedorthics is not precluded from continuing that 410 practice pending adoption of these rules. 411 Section 14. Subsection (43) of section 499.003, Florida 412 Statutes, is amended to read: 413 499.003 Definitions of terms used in this part.—As used in 414 this part, the term: 415 (43) “Prescription drug” means a prescription, medicinal, 416 or legend drug, including, but not limited to, finished dosage 417 forms or active pharmaceutical ingredients subject to, defined 418 by, or described by s. 503(b) of the federal act or s. 465.003 419s. 465.003(8), s. 499.007(13), subsection (32), or subsection 420 (52), except that an active pharmaceutical ingredient is a 421 prescription drug only if substantially all finished dosage 422 forms in which it may be lawfully dispensed or administered in 423 this state are also prescription drugs. 424 Section 15. Subsection (22) of section 893.02, Florida 425 Statutes, is amended to read: 426 893.02 Definitions.—The following words and phrases as used 427 in this chapter shall have the following meanings, unless the 428 context otherwise requires: 429 (22) “Prescription” means and includes an order for drugs 430 or medicinal supplies written, signed, or transmitted by word of 431 mouth, telephone, telegram, or other means of communication by a 432 duly licensed practitioner licensed by the laws of the state to 433 prescribe such drugs or medicinal supplies, issued in good faith 434 and in the course of professional practice, intended to be 435 filled, compounded, or dispensed by another person licensed by 436 the laws of the state to do so, and meeting the requirements of 437 s. 893.04. The term also includes an order for drugs or 438 medicinal supplies so transmitted or written by a physician, 439 dentist, veterinarian, or other practitioner licensed to 440 practice in a state other than Florida, but only if the 441 pharmacist called upon to fill such an order determines, in the 442 exercise of his or her professional judgment, that the order was 443 issued pursuant to a valid patient-physician relationship, that 444 it is authentic, and that the drugs or medicinal supplies so 445 ordered are considered necessary for the continuation of 446 treatment of a chronic or recurrent illness. However, if the 447 physician writing the prescription is not known to the 448 pharmacist, the pharmacist shall obtain proof to a reasonable 449 certainty of the validity of said prescription. A prescription 450 order for a controlled substance shall not be issued on the same 451 prescription blank with another prescription order for a 452 controlled substance which is named or described in a different 453 schedule, nor shall any prescription order for a controlled 454 substance be issued on the same prescription blank as a 455 prescription order for a medicinal drug, as defined in s. 456 465.003s. 465.003(8), which does not fall within the definition 457 of a controlled substance as defined in this act. 458 Section 16. This act shall take effect July 1, 2015.