Bill Text: FL S1604 | 2016 | Regular Session | Engrossed
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Drugs, Devices, and Cosmetics
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2016-04-08 - Chapter No. 2016-212 [S1604 Detail]
Download: Florida-2016-S1604-Engrossed.html
Bill Title: Drugs, Devices, and Cosmetics
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2016-04-08 - Chapter No. 2016-212 [S1604 Detail]
Download: Florida-2016-S1604-Engrossed.html
CS for CS for SB 1604 First Engrossed 20161604e1 1 A bill to be entitled 2 An act relating to drugs, devices, and cosmetics; 3 amending s. 499.003, F.S.; providing, revising, and 4 deleting definitions for purposes of the Florida Drug 5 and Cosmetic Act; requiring rulemaking; specifying a 6 default rule until the Department of Business and 7 Professional Regulation adopts a rule; amending s. 8 499.005, F.S.; revising prohibited acts related to the 9 distribution of prescription drugs; conforming a 10 cross-reference; amending s. 499.0051, F.S.; 11 prohibiting the distribution of prescription drugs 12 without delivering a transaction history, transaction 13 information, and transaction statement; providing 14 penalties; deleting provisions and revising 15 terminology related to pedigree papers, to conform to 16 changes made by the act; amending s. 499.006, F.S.; 17 conforming provisions; amending s. 499.01, F.S.; 18 requiring nonresident prescription drug repackagers to 19 obtain an operating permit; authorizing a manufacturer 20 to engage in the wholesale distribution of 21 prescription drugs; providing for the issuance of 22 virtual prescription drug manufacturer permits and 23 virtual nonresident prescription drug manufacturer 24 permits to certain persons; providing exceptions from 25 certain virtual manufacturer requirements; requiring a 26 nonresident prescription drug repackager permit for 27 certain persons; deleting surety bond requirements for 28 prescription drug wholesale distributors; requiring 29 that certain persons obtain an out-of-state 30 prescription drug wholesale distributor permit; 31 providing that a restricted prescription drug 32 distributor permit is not required for distributions 33 between certain pharmacies; requiring the Department 34 of Business and Professional Regulation to establish 35 by rule when such distribution constitutes regular and 36 systematic supplying of a prescription drug; requiring 37 certain third party logistic providers to be licensed; 38 requiring research and development labeling on certain 39 prescription drug active pharmaceutical ingredient 40 packaging; requiring certain manufacturers to create 41 and maintain certain records; requiring certain 42 prescription drug distributors to provide certain 43 information to health care entities for which they 44 repackage prescription drugs; requiring the department 45 to adopt rules concerning repackaged prescription drug 46 safety and integrity; amending s. 499.012, F.S.; 47 providing for issuance of a prescription drug 48 manufacturer permit or retail pharmacy drug wholesale 49 distributor permit when an applicant at the same 50 address is a licensed nuclear pharmacy or community 51 pharmacy; providing for the expiration of deficient 52 permit applications; requiring trade secret 53 information submitted by an applicant to be maintained 54 as a trade secret; authorizing the quadrennial renewal 55 of permits; providing for calculation of fees for such 56 permit renewals; revising procedures and application 57 requirements for permit renewals; providing for late 58 renewal fees; allowing a permittee who submits a 59 renewal application to continue operations; removing 60 certain application requirements for renewal of a 61 permit; requiring bonds or other surety of a specified 62 amount; requiring proof of inspection of 63 establishments used in wholesale distribution; 64 authorizing the Department of Business and 65 Professional Regulation to contract for the collection 66 of electronic fingerprints under certain 67 circumstances; providing information that may be 68 submitted in lieu of certain application requirements 69 for specified permits and certifications; removing 70 provisions relating to annual renewal and expiration 71 of permits; conforming cross-references; amending s. 72 499.01201, F.S.; conforming provisions; amending s. 73 499.0121, F.S.; revising prescription drug 74 recordkeeping requirements; specifying recordkeeping 75 requirements for manufacturers and repackagers of 76 medical devices, over-the-counter drugs, and 77 cosmetics; increasing the quantity of unit doses of a 78 controlled substance that may be ordered in any given 79 month by a customer without triggering a requirement 80 that a wholesale distributor perform a reasonableness 81 assessment; conforming provisions; amending s. 82 499.015, F.S.; providing for the expiration, renewal, 83 and issuance of certain drug, device, and cosmetic 84 product registrations; providing for product 85 registration fees; amending ss. 499.03, 499.05, and 86 499.051, F.S.; conforming provisions to changes made 87 by the act; amending s. 499.066, F.S.; authorizing the 88 issuance of nondisciplinary citations; authorizing the 89 department to adopt rules designating violations for 90 which a citation may be issued; authorizing the 91 department to recover investigative costs pursuant to 92 the citation; specifying a time limitation for 93 issuance of a citation; providing for service of a 94 citation; amending s. 499.82, F.S.; revising the 95 definition of “wholesale distribution” for purposes of 96 medical gas requirements; amending s. 499.83, F.S.; 97 authorizing licensed hospices to obtain on behalf of, 98 and sell medical oxygen to, their patients without 99 obtaining a medical oxygen retail establishment permit 100 in certain circumstances; specifying recordkeeping 101 requirements; amending s. 499.89, F.S.; conforming 102 provisions; repealing s. 499.01212, F.S., relating to 103 pedigree papers; amending ss. 409.9201, 499.067, 104 794.075, and 921.0022, F.S.; conforming cross 105 references; providing an effective date. 106 107 Be It Enacted by the Legislature of the State of Florida: 108 109 Section 1. Section 499.003, Florida Statutes, is amended to 110 read: 111 499.003 Definitions of terms used in this part.—As used in 112 this part, the term: 113 (1) “Active pharmaceutical ingredient” includes any 114 substance or mixture of substances intended, represented, or 115 labeled for use in drug manufacturing that furnishes or is 116 intended to furnish, in a finished dosage form, any 117 pharmacological activity or other direct effect in the 118 diagnosis, cure, mitigation, treatment, therapy, or prevention 119 of disease in humans or other animals, or to affect the 120 structure or any function of the body of humans or animals. 121 (2)(1)“Advertisement” means any representation 122 disseminated in any manner or by any means, other than by 123 labeling, for the purpose of inducing, or which is likely to 124 induce, directly or indirectly, the purchase of drugs, devices, 125 or cosmetics. 126 (3) “Affiliate” means a business entity that has a 127 relationship with another business entity in which, directly or 128 indirectly: 129 (a) The business entity controls, or has the power to 130 control, the other business entity; or 131 (b) A third party controls, or has the power to control, 132 both business entities. 133(2)“Affiliated group” means an affiliated group as defined134by s. 1504 of the Internal Revenue Code of 1986, as amended,135which is composed of chain drug entities, including at least 50136retail pharmacies, warehouses, or repackagers, which are members137of the same affiliated group. The affiliated group must disclose138the names of all its members to the department.139 (4)(3)“Affiliated party” means: 140 (a) A director, officer, trustee, partner, or committee 141 member of a permittee or applicant or a subsidiary or service 142 corporation of the permittee or applicant; 143 (b) A person who, directly or indirectly, manages, 144 controls, or oversees the operation of a permittee or applicant, 145 regardless of whether such person is a partner, shareholder, 146 manager, member, officer, director, independent contractor, or 147 employee of the permittee or applicant; 148 (c) A person who has filed or is required to file a 149 personal information statement pursuant to s. 499.012(9) or is 150 required to be identified in an application for a permit or to 151 renew a permit pursuant to s. 499.012(8); or 152 (d) The five largest natural shareholders that own at least 153 5 percent of the permittee or applicant. 154 (5)(4)“Applicant” means a person applying for a permit or 155 certification under this part. 156(5)“Authenticate” means to affirmatively verify upon157receipt of a prescription drug that each transaction listed on158the pedigree paper has occurred.159(a)A wholesale distributor is not required to open a160sealed, medical convenience kit to authenticate a pedigree paper161for a prescription drug contained within the kit.162(b)Authentication of a prescription drug included in a163sealed, medical convenience kit shall be limited to verifying164the transaction and pedigree information received.165 (6) “Certificate of free sale” means a document prepared by 166 the department which certifies a drug, device, or cosmetic, that 167 is registered with the department, as one that can be legally 168 sold in the state. 169 (7) “Chain pharmacy warehouse” means awholesale170 distributor permitted pursuant to s. 499.01 that maintains a 171 physical location for prescription drugs that functions solely 172 as a central warehouse to perform intracompany transfers of such 173 drugs between members of an affiliateto a member of its174affiliated group. 175 (8) “Closed pharmacy” means a pharmacy that is licensed 176 under chapter 465 and purchases prescription drugs for use by a 177 limited patient population and not for wholesale distribution or 178 sale to the public. The term does not include retail pharmacies. 179 (9) “Color” includes black, white, and intermediate grays. 180 (10) “Color additive” means, with the exception of any 181 material that has been or hereafter is exempt under the federal 182 act, a material that: 183 (a) Is a dye pigment, or other substance, made by a process 184 of synthesis or similar artifice, or extracted, isolated, or 185 otherwise derived, with or without intermediate or final change 186 of identity from a vegetable, animal, mineral, or other source; 187 or 188 (b) When added or applied to a drug or cosmetic or to the 189 human body, or any part thereof, is capable alone, or through 190 reaction with other substances, of imparting color thereto. 191 (11) “Contraband prescription drug” means any adulterated 192 drug, as defined in s. 499.006, any counterfeit drug, as defined 193 in this section, and also means any prescription drug for which 194 a transaction history, transaction information, or transaction 195 statementpedigree paperdoes not exist, or for which the 196 transaction history, transaction information, or transaction 197 statementpedigree paperin existence has been forged, 198 counterfeited, falsely created, or contains any altered, false, 199 or misrepresented matter. 200 (12) “Cosmetic” means an article, with the exception of 201 soap, that is: 202 (a) Intended to be rubbed, poured, sprinkled, or sprayed 203 on; introduced into; or otherwise applied to the human body or 204 any part thereof for cleansing, beautifying, promoting 205 attractiveness, or altering the appearance; or 206 (b) Intended for use as a component of any such article. 207 (13) “Counterfeit drug,” “counterfeit device,” or 208 “counterfeit cosmetic” means a drug, device, or cosmetic which, 209 or the container, seal, or labeling of which, without 210 authorization, bears the trademark, trade name, or other 211 identifying mark, imprint, or device, or any likeness thereof, 212 of a drug, device, or cosmetic manufacturer, processor, packer, 213 or distributor other than the person that in fact manufactured, 214 processed, packed, or distributed that drug, device, or cosmetic 215 and which thereby falsely purports or is represented to be the 216 product of, or to have been packed or distributed by, that other 217 drug, device, or cosmetic manufacturer, processor, packer, or 218 distributor. 219 (14) “Department” means the Department of Business and 220 Professional Regulation. 221 (15) “Device” means any instrument, apparatus, implement, 222 machine, contrivance, implant, in vitro reagent, or other 223 similar or related article, including its components, parts, or 224 accessories, which is: 225 (a) Recognized in the current edition of the United States 226 Pharmacopoeia and National Formulary, or any supplement thereof, 227 (b) Intended for use in the diagnosis, cure, mitigation, 228 treatment, therapy, or prevention of disease in humans or other 229 animals, or 230 (c) Intended to affect the structure or any function of the 231 body of humans or other animals, 232 233 and that does not achieve any of its principal intended purposes 234 through chemical action within or on the body of humans or other 235 animals and which is not dependent upon being metabolized for 236 the achievement of any of its principal intended purposes. 237 (16) “Distribute” or “distribution” means to sell, 238 purchase, trade, deliver, handle, store, or receiveto sell;239offer to sell; give away; transfer, whether by passage of title,240physical movement, or both; deliver; or offer to deliver. The 241 term does not mean to administer or dispenseand does not242include the billing and invoicing activities that commonly243follow a wholesale distribution transaction. 244(17)“Drop shipment” means the sale of a prescription drug245from a manufacturer to a wholesale distributor, where the246wholesale distributor takes title to, but not possession of, the247prescription drug, and the manufacturer of the prescription drug248ships the prescription drug directly to a chain pharmacy249warehouse or a person authorized by law to purchase prescription250drugs for the purpose of administering or dispensing the drug,251as defined in s. 465.003.252 (17)(18)“Drug” means an article that is: 253 (a) Recognized in the current edition of the United States 254 Pharmacopoeia and National Formulary, official Homeopathic 255 Pharmacopoeia of the United States, or any supplement to any of 256 those publications; 257 (b) Intended for use in the diagnosis, cure, mitigation, 258 treatment, therapy, or prevention of disease in humans or other 259 animals; 260 (c) Intended to affect the structure or any function of the 261 body of humans or other animals; or 262 (d) Intended for use as a component of any article 263 specified in paragraph (a), paragraph (b), or paragraph (c), and 264 includes active pharmaceutical ingredients, but does not include 265 devices or their nondrug components, parts, or accessories.For266purposes of this paragraph, an “active pharmaceutical267ingredient” includes any substance or mixture of substances268intended, represented, or labeled for use in drug manufacturing269that furnishes or is intended to furnish, in a finished dosage270form, any pharmacological activity or other direct effect in the271diagnosis, cure, mitigation, treatment, therapy, or prevention272of disease in humans or other animals, or to affect the273structure or any function of the body of humans or other274animals.275 (18)(19)“Establishment” means a place of business which is 276 at one general physical location and may extend to one or more 277 contiguous suites, units, floors, or buildings operated and 278 controlled exclusively by entities under common operation and 279 control. Where multiple buildings are under common exclusive 280 ownership, operation, and control, an intervening thoroughfare 281 does not affect the contiguous nature of the buildings. For 282 purposes of permitting, each suite, unit, floor, or building 283 must be identified in the most recent permit application. 284 (19)(20)“Federal act” means the Federal Food, Drug, and 285 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. 286 (20)(21)“Freight forwarder” means a person who receives 287 prescription drugs which are owned by another person and 288 designated by that person for export, and exports those 289 prescription drugs. 290 (21)(22)“Health care entity” means a closed pharmacy or 291 any person, organization, or business entity that provides 292 diagnostic, medical, surgical, or dental treatment or care, or 293 chronic or rehabilitative care, but does not include any 294 wholesale distributor or retail pharmacy licensed under state 295 law to deal in prescription drugs. However, a blood 296 establishment is a health care entity that may engage in the 297 wholesale distribution of prescription drugs under s. 298 499.01(2)(h)1.c.499.01(2)(g)1.c.299 (22)(23)“Health care facility” means a health care 300 facility licensed under chapter 395. 301 (23)(24)“Hospice” means a corporation licensed under part 302 IV of chapter 400. 303 (24)(25)“Hospital” means a facility as defined in s. 304 395.002 and licensed under chapter 395. 305 (25)(26)“Immediate container” does not include package 306 liners. 307 (26)(27)“Label” means a display of written, printed, or 308 graphic matter upon the immediate container of any drug, device, 309 or cosmetic. A requirement made by or under authority of this 310 part or rules adopted under this part that any word, statement, 311 or other information appear on the label is not complied with 312 unless such word, statement, or other information also appears 313 on the outside container or wrapper, if any, of the retail 314 package of such drug, device, or cosmetic or is easily legible 315 through the outside container or wrapper. 316 (27)(28)“Labeling” means all labels and other written, 317 printed, or graphic matters: 318 (a) Upon a drug, device, or cosmetic, or any of its 319 containers or wrappers; or 320 (b) Accompanying or related to such drug, device, or 321 cosmetic. 322 (28)(29)“Manufacture” means the preparation, deriving, 323 compounding, propagation, processing, producing, or fabrication 324 of any drug, device, or cosmetic. 325 (29)(30)“Manufacturer” means: 326 (a) A person who holds a New Drug Application, an 327 Abbreviated New Drug Application, a Biologics License 328 Application, or a New Animal Drug Application approved under the 329 federal act or a license issued under s. 351 of the Public 330 Health Service Act, 42 U.S.C. s. 262, for such drug or 331 biologics, or if such drug or biologics are not the subject of 332 an approved application or license, the person who manufactured 333 the drug or biologicsprepares, derives, manufactures, or334produces a drug, device, or cosmetic; 335 (b) A co-licensed partner of the person described in 336 paragraph (a) who obtains the drug or biologics directly from a 337 person described in paragraph (a), paragraph (c), or this 338 paragraphThe holder or holders of a New Drug Application (NDA),339an Abbreviated New Drug Application (ANDA), a Biologics License340Application (BLA), or a New Animal Drug Application (NADA),341provided such application has become effective or is otherwise342approved consistent with s. 499.023; 343 (c) An affiliate of a person described in paragraph (a), 344 paragraph (b), or this paragraph that receives the drug or 345 biologics directly from a person described in paragraph (a), 346 paragraph (b), or this paragraphA private label distributor for347whom the private label distributor’s prescription drugs are348originally manufactured and labeled for the distributor and have349not been repackaged; or 350 (d) A person who manufactures a device or a cosmetic.A351person registered under the federal act as a manufacturer of a352prescription drug, who is described in paragraph (a), paragraph353(b), or paragraph (c), who has entered into a written agreement354with another prescription drug manufacturer that authorizes355either manufacturer to distribute the prescription drug356identified in the agreement as the manufacturer of that drug357consistent with the federal act and its implementing358regulations;359(e)A member of an affiliated group that includes, but is360not limited to, persons described in paragraph (a), paragraph361(b), paragraph (c), or paragraph (d), which member distributes362prescription drugs, whether or not obtaining title to the drugs,363only for the manufacturer of the drugs who is also a member of364the affiliated group. As used in this paragraph, the term365“affiliated group” means an affiliated group as defined in s.3661504 of the Internal Revenue Code of 1986, as amended. The367manufacturer must disclose the names of all of its affiliated368group members to the department; or369(f)A person permitted as a third party logistics provider,370only while providing warehousing, distribution, or other371logistics services on behalf of a person described in paragraph372(a), paragraph (b), paragraph (c), paragraph (d), or paragraph373(e).374 375 The term does not include a pharmacy that is operating in 376 compliance with pharmacy practice standards as defined in 377 chapter 465 and rules adopted under that chapter. 378 (30)(31)“Medical convenience kit” means packages or units 379 that contain combination products as defined in 21 C.F.R. s. 380 3.2(e)(2). 381 (31)(32)“Medical gas” means any liquefied or vaporized gas 382 that is a prescription drug, whether alone or in combination 383 with other gases, and as defined in the federal act. 384 (32)(33)“New drug” means: 385 (a) Any drug the composition of which is such that the drug 386 is not generally recognized, among experts qualified by 387 scientific training and experience to evaluate the safety and 388 effectiveness of drugs, as safe and effective for use under the 389 conditions prescribed, recommended, or suggested in the labeling 390 of that drug; or 391 (b) Any drug the composition of which is such that the 392 drug, as a result of investigations to determine its safety and 393 effectiveness for use under certain conditions, has been 394 recognized for use under such conditions, but which drug has 395 not, other than in those investigations, been used to a material 396 extent or for a material time under such conditions. 397(34)“Normal distribution chain” means a wholesale398distribution of a prescription drug in which the wholesale399distributor or its wholly owned subsidiary purchases and400receives the specific unit of the prescription drug directly401from the manufacturer and distributes the prescription drug402directly, or through up to two intracompany transfers, to a403chain pharmacy warehouse or a person authorized by law to404purchase prescription drugs for the purpose of administering or405dispensing the drug, as defined in s. 465.003. For purposes of406this subsection, the term “intracompany” means any transaction407or transfer between any parent, division, or subsidiary wholly408owned by a corporate entity.409 (33)(35)“Nursing home” means a facility licensed under 410 part II of chapter 400. 411 (34)(36)“Official compendium” means the current edition of 412 the official United States Pharmacopoeia and National Formulary, 413 or any supplement thereto. 414(37)“Pedigree paper” means a document in written or415electronic form approved by the department which contains416information required by s. 499.01212 regarding the sale and417distribution of any given prescription drug.418 (35)(38)“Permittee” means any person holding a permit 419 issued under this chapterpursuant to s. 499.012. 420 (36)(39)“Person” means any individual, child, joint 421 venture, syndicate, fiduciary, partnership, corporation, 422 division of a corporation, firm, trust, business trust, company, 423 estate, public or private institution, association, 424 organization, group, city, county, city and county, political 425 subdivision of this state, other governmental agency within this 426 state, and any representative, agent, or agency of any of the 427 foregoing, or any other group or combination of the foregoing. 428 (37)(40)“Pharmacist” means a person licensed under chapter 429 465. 430 (38)(41)“Pharmacy” means an entity licensed under chapter 431 465. 432 (39)(42)“Prepackaged drug product” means a drug that 433 originally was in finished packaged form sealed by a 434 manufacturer and that is placed in a properly labeled container 435 by a pharmacy or practitioner authorized to dispense pursuant to 436 chapter 465 for the purpose of dispensing in the establishment 437 in which the prepackaging occurred. 438 (40)(43)“Prescription drug” means a prescription, 439 medicinal, or legend drug, including, but not limited to, 440 finished dosage forms or active pharmaceutical ingredients 441 subject to, defined by, or described by s. 503(b) of the federal 442 act or s. 465.003(8), s. 499.007(13), subsection (31)(32), or 443 subsection (47)(52), except that an active pharmaceutical 444 ingredient is a prescription drug only if substantially all 445 finished dosage forms in which it may be lawfully dispensed or 446 administered in this state are also prescription drugs. 447 (41)(44)“Prescription drug label” means any display of 448 written, printed, or graphic matter upon the immediate container 449 of any prescription drug before it is dispensedprior to its450dispensingto an individual patient pursuant to a prescription 451 of a practitioner authorized by law to prescribe. 452 (42)(45)“Prescription label” means any display of written, 453 printed, or graphic matter upon the immediate container of any 454 prescription drug dispensed pursuant to a prescription of a 455 practitioner authorized by law to prescribe. 456(46)“Primary wholesale distributor” means any wholesale457distributor that:458(a)Purchased 90 percent or more of the total dollar volume459of its purchases of prescription drugs directly from460manufacturers in the previous year; and461(b)1.Directly purchased prescription drugs from not fewer462than 50 different prescription drug manufacturers in the463previous year; or4642.Has, or the affiliated group, as defined in s. 1504 of465the Internal Revenue Code, of which the wholesale distributor is466a member has, not fewer than 250 employees.467(c)For purposes of this subsection, “directly from468manufacturers” means:4691.Purchases made by the wholesale distributor directly470from the manufacturer of prescription drugs; and4712.Transfers from a member of an affiliated group, as472defined in s. 1504 of the Internal Revenue Code, of which the473wholesale distributor is a member, if:474a.The affiliated group purchases 90 percent or more of the475total dollar volume of its purchases of prescription drugs from476the manufacturer in the previous year; and477b.The wholesale distributor discloses to the department478the names of all members of the affiliated group of which the479wholesale distributor is a member and the affiliated group480agrees in writing to provide records on prescription drug481purchases by the members of the affiliated group not later than48248 hours after the department requests access to such records,483regardless of the location where the records are stored.484 (43)(47)“Proprietary drug,” or “OTC drug,” means a patent 485 or over-the-counter drug in its unbroken, original package, 486 which drug is sold to the public by, or under the authority of, 487 the manufacturer or primary distributor thereof, is not 488 misbranded under the provisions of this part, and can be 489 purchased without a prescription. 490 (44)(48)“Repackage” includes repacking or otherwise 491 changing the container, wrapper, or labeling to further the 492 distribution of the drug, device, or cosmetic. 493 (45)(49)“Repackager” means a person who repackages. The 494 term excludes pharmacies that are operating in compliance with 495 pharmacy practice standards as defined in chapter 465 and rules 496 adopted under that chapter. 497 (46)(50)“Retail pharmacy” means a community pharmacy 498 licensed under chapter 465 that purchases prescription drugs at 499 fair market prices and provides prescription services to the 500 public. 501(51)“Secondary wholesale distributor” means a wholesale502distributor that is not a primary wholesale distributor.503 (47)(52)“Veterinary prescription drug” means a 504 prescription drug intended solely for veterinary use. The label 505 of the drug must bear the statement, “Caution: Federal law 506 restricts this drug to sale by or on the order of a licensed 507 veterinarian.” 508 (48)(53)“Wholesale distribution” means the distribution of 509 a prescription drug to a persondrugs to personsother than a 510 consumer or patient, or the receipt of a prescription drug by a 511 person other than the consumer or patient, but does not include: 512 (a) Any of the following activities, which is not a 513 violation of s. 499.005(21) if such activity is conducted in 514 accordance with s. 499.01(2)(h)499.01(2)(g): 515 1. The purchase or other acquisition by a hospital or other 516 health care entity that is a member of a group purchasing 517 organization of a prescription drug for its own use from the 518 group purchasing organization or from other hospitals or health 519 care entities that are members of that organization. 520 2. The distributionsale, purchase, or tradeof a 521 prescription drug or an offer to distributesell, purchase, or522tradea prescription drug by a charitable organization described 523 in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended 524 and revised, to a nonprofit affiliate of the organization to the 525 extent otherwise permitted by law. 526 3. The distributionsale, purchase, or tradeof a 527 prescription drugor an offer to sell, purchase, or trade a528prescription drugamong hospitals or other health care entities 529 that are under common control. For purposes of this 530 subparagraph, “common control” means the power to direct or 531 cause the direction of the management and policies of a person 532 or an organization, whether by ownership of stock, by voting 533 rights, by contract, or otherwise. 534 4. The distributionsale, purchase, trade, or other535transferof a prescription drug from or for any federal, state, 536 or local government agency or any entity eligible to purchase 537 prescription drugs at public health services prices pursuant to 538 Pub. L. No. 102-585, s. 602 to a contract provider or its 539 subcontractor for eligible patients of the agency or entity 540 under the following conditions: 541 a. The agency or entity must obtain written authorization 542 for the distributionsale, purchase, trade, or other transferof 543 a prescription drug under this subparagraph from the Secretary 544 of Business and Professional Regulation or his or her designee. 545 b. The contract provider or subcontractor must be 546 authorized by law to administer or dispense prescription drugs. 547 c. In the case of a subcontractor, the agency or entity 548 must be a party to and execute the subcontract. 549 d. The contract provider and subcontractor must maintain 550 and produce immediately for inspection all records of movement 551 or transfer of all the prescription drugs belonging to the 552 agency or entity, including, but not limited to, the records of 553 receipt and disposition of prescription drugs. Each contractor 554 and subcontractor dispensing or administering these drugs must 555 maintain and produce records documenting the dispensing or 556 administration. Records that are required to be maintained 557 include, but are not limited to, a perpetual inventory itemizing 558 drugs received and drugs dispensed by prescription number or 559 administered by patient identifier, which must be submitted to 560 the agency or entity quarterly. 561 e. The contract provider or subcontractor may administer or 562 dispense the prescription drugs only to the eligible patients of 563 the agency or entity or must return the prescription drugs for 564 or to the agency or entity. The contract provider or 565 subcontractor must require proof from each person seeking to 566 fill a prescription or obtain treatment that the person is an 567 eligible patient of the agency or entity and must, at a minimum, 568 maintain a copy of this proof as part of the records of the 569 contractor or subcontractor required under sub-subparagraph d. 570 f. In addition to the departmental inspection authority set 571 forth in s. 499.051, the establishment of the contract provider 572 and subcontractor and all records pertaining to prescription 573 drugs subject to this subparagraph shall be subject to 574 inspection by the agency or entity. All records relating to 575 prescription drugs of a manufacturer under this subparagraph 576 shall be subject to audit by the manufacturer of those drugs, 577 without identifying individual patient information. 578 (b) Any of the following activities, which is not a 579 violation of s. 499.005(21) if such activity is conducted in 580 accordance with rules established by the department: 581 1. The distributionsale, purchase, or tradeof a 582 prescription drug among federal, state, or local government 583 health care entities that are under common control and are 584 authorized to purchase such prescription drug. 585 2. The distributionsale, purchase, or tradeof a 586 prescription drug oranoffer to distributesell, purchase, or587tradea prescription drug for emergency medical reasons, which 588 may include. For purposes of this subparagraph, The term589“emergency medical reasons” includestransfers of prescription 590 drugs by a retail pharmacy to another retail pharmacy to 591 alleviate a temporary shortage. For purposes of this 592 subparagraph, a drug shortage not caused by a public health 593 emergency does not constitute an emergency medical reason. 594 3. The distributiontransferof a prescription drug 595 acquired by a medical director on behalf of a licensed emergency 596 medical services provider to that emergency medical services 597 provider and its transport vehicles for use in accordance with 598 the provider’s license under chapter 401. 5994.The revocation of a sale or the return of a prescription600drug to the person’s prescription drug wholesale supplier.601 4.5.The donation of a prescription drug by a health care 602 entity to a charitable organization that has been granted an 603 exemption under s. 501(c)(3) of the Internal Revenue Code of 604 1986, as amended, and that is authorized to possess prescription 605 drugs. 606 5.6.The distributiontransferof a prescription drug by a 607 person authorized to purchase or receive prescription drugs to a 608 person licensed or permitted to handle reverse distributions or 609 destruction under the laws of the jurisdiction in which the 610 person handling the reverse distribution or destruction receives 611 the drug. 612 6.7.The distributiontransferof a prescription drug by a 613 hospital or other health care entity to a person licensed under 614 this part to repackage prescription drugs for the purpose of 615 repackaging the prescription drug for use by that hospital, or 616 other health care entity and other health care entities that are 617 under common control, if ownership of the prescription drugs 618 remains with the hospital or other health care entity at all 619 times. In addition to the recordkeeping requirements of s. 620 499.0121(6), the hospital or health care entity that distributes 621transfersprescription drugs pursuant to this subparagraph must 622 reconcile all drugs distributedtransferredand returned and 623 resolve any discrepancies in a timely manner. 624 (c) Intracompany distribution of any drug between members 625 of an affiliate or within a manufacturer. 626 (d) The distribution of a prescription drug by the 627 manufacturer of the prescription drug. 628 (e)(c)The distribution of prescription drug samples by 629 manufacturers’ representatives or distributors’ representatives 630 conducted in accordance with s. 499.028. 631 (f) The distribution of a prescription drug by a third 632 party logistics provider permitted or licensed pursuant to and 633 operating in compliance with the laws of this state and federal 634 law if such third-party logistics provider does not take 635 ownership of the prescription drug. 636 (g) The distribution of a prescription drug, or an offer to 637 distribute a prescription drug by a repackager registered as a 638 drug establishment with the United States Food and Drug 639 Administration that has taken ownership or possession of the 640 prescription drug and repacks it in accordance with this part. 641 (h) The purchase or other acquisition by a dispenser, 642 hospital, or other health care entity of a prescription drug for 643 use by such dispenser, hospital, or other health care entity. 644 (i) The distribution of a prescription drug by a hospital 645 or other health care entity, or by a wholesale distributor or 646 manufacturer operating at the direction of the hospital or other 647 health care entity, to a repackager for the purpose of 648 repackaging the prescription drug for use by that hospital, or 649 other health care entity and other health care entities that are 650 under common control, if ownership of the prescription drug 651 remains with the hospital or other health care entity at all 652 times. 653 (j)(d)The distributionsale, purchase, or tradeof blood 654 and blood components intended for transfusion. As used in this 655 paragraph, the term “blood” means whole blood collected from a 656 single donor and processed for transfusion or further 657 manufacturing, and the term “blood components” means that part 658 of the blood separated by physical or mechanical means. 659 (k)(e)The lawful dispensing of a prescription drug in 660 accordance with chapter 465. 661 (l)(f)The distributionsale, purchase, or tradeof a 662 prescription drug between pharmacies as a result of a sale, 663 transfer, merger, or consolidation of all or part of the 664 business of the pharmacies from or with another pharmacy, 665 whether accomplished as a purchase and sale of stock or of 666 business assets. 667 (m) The distribution of minimal quantities of prescription 668 drugs by a licensed retail pharmacy to a licensed practitioner 669 for office use in compliance with chapter 465 and rules adopted 670 thereunder. The department shall adopt rules specifying the 671 quantities of prescription drugs which are considered to be 672 minimal quantities. However, until such rules are adopted, 673 minimal quantities distributed may not exceed 3 percent of the 674 retail pharmacy’s total annual purchases of prescription drugs. 675 (n) The distribution of an intravenous prescription drug 676 that, by its formulation, is intended for the replenishment of 677 fluids and electrolytes, such as sodium, chloride, and potassium 678 or calories, such as dextrose and amino acids. 679 (o) The distribution of an intravenous prescription drug 680 used to maintain the equilibrium of water and minerals in the 681 body, such as dialysis solutions. 682 (p) The distribution of a prescription drug that is 683 intended for irrigation or sterile water, whether intended for 684 such purposes or for injection. 685 (q) The distribution of an exempt medical convenience kit 686 pursuant to 21 U.S.C. s. 353(e)(4)(M). 687 (r) A common carrier that transports a prescription drug, 688 if the common carrier does not take ownership of the 689 prescription drug. 690 (s) Saleable drug returns when conducted by a dispenser. 691 (t) Facilitating the distribution of a prescription drug by 692 providing solely administrative services, including processing 693 of orders and payments. 694 (u) The distribution by a charitable organization described 695 in s. 501(c)(3) of the Internal Revenue Code of prescription 696 drugs donated to or supplied at a reduced price to the 697 charitable organization to: 698 1. A licensed health care practitioner, as defined in s. 699 456.001, who is authorized under the appropriate practice act to 700 prescribe and administer prescription drugs; 701 2. A health care clinic establishment permitted pursuant to 702 chapter 499; or 703 3. The Department of Health or the licensed medical 704 director of a government agency health care entity, authorized 705 to possess prescription drugs, for storage and use in the 706 treatment of persons in need of emergency medical services, 707 including controlling communicable diseases or providing 708 protection from unsafe conditions that pose an imminent threat 709 to public health, 710 711 if the distributor and the receiving entity receive no direct or 712 indirect financial benefit other than tax benefits related to 713 charitable contributions. Distributions under this section that 714 involve controlled substances must comply with all state and 715 federal regulations pertaining to the handling of controlled 716 substances. 717 (v) The distribution of medical gas pursuant to part III of 718 this chapter. 719 (49)(54)“Wholesale distributor” means aanyperson, other 720 than a manufacturer, a manufacturer’s co-licensed partner, a 721 third-party logistics provider, or a repackager, who is engaged 722 in wholesale distributionof prescription drugs in or into this723state, including, but not limited to, manufacturers;724repackagers; own-label distributors; jobbers; private-label725distributors; brokers; warehouses, including manufacturers’ and726distributors’ warehouses, chain drug warehouses, and wholesale727drug warehouses; independent wholesale drug traders; exporters;728retail pharmacies; and the agents thereof that conduct wholesale729distributions. 730 Section 2. Subsections (21), (28), and (29) of section 731 499.005, Florida Statutes, are amended to read: 732 499.005 Prohibited acts.—It is unlawful for a person to 733 perform or cause the performance of any of the following acts in 734 this state: 735 (21) The wholesale distribution of any prescription drug 736 that was: 737 (a) Purchased by a public or private hospital or other 738 health care entity; or 739 (b) Donated or supplied at a reduced price to a charitable 740 organization, 741 742 unless the wholesale distribution of the prescription drug is 743 authorized in s. 499.01(2)(h)1.c.499.01(2)(g)1.c.744 (28) Failure to acquire or deliver a transaction history, 745 transaction information, or transaction statementpedigree paper746 as required under this part and rules adopted under this part. 747(29)The receipt of a prescription drug pursuant to a748wholesale distribution without having previously received or749simultaneously receiving a pedigree paper that was attested to750as accurate and complete by the wholesale distributor as751required under this part.752 Section 3. Subsections (4) through (17) of section 753 499.0051, Florida Statutes, are renumbered as subsections (3) 754 through (16), respectively, and subsections (1) and (2), present 755 subsection (3), paragraphs (h) and (i) of present subsection 756 (12), paragraph (d) of present subsection (13), and present 757 subsection (15) of that section are amended, to read: 758 499.0051 Criminal acts.— 759 (1) FAILURE TO MAINTAIN OR DELIVER TRANSACTION HISTORY, 760 TRANSACTION INFORMATION, OR TRANSACTION STATEMENTPEDIGREE761PAPERS.— 762 (a) A person, other than a manufacturer,engaged in the 763wholesaledistribution of prescription drugs who fails to 764 deliver to another person a complete and accurate transaction 765 history, transaction information, or transaction statement 766pedigree papersconcerning a prescription drug or contraband 767 prescription drug, as required by this chapter and rules adopted 768 under this chapter, beforeprior to, or simultaneous with, the 769 transfer of the prescription drug or contraband prescription 770 drug to another person commits a felony of the third degree, 771 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 772 (b) A person engaged in thewholesaledistribution of 773 prescription drugs who fails to acquire a complete and accurate 774 transaction history, transaction information, or transaction 775 statementpedigree papersconcerning a prescription drug or 776 contraband prescription drug, as required by this chapter and 777 rules adopted under this chapter, beforeprior to, or 778 simultaneous with, the receipt of the prescription drug or 779 contraband prescription drug from another person commits a 780 felony of the third degree, punishable as provided in s. 781 775.082, s. 775.083, or s. 775.084. 782 (c) Any person who knowingly destroys, alters, conceals, or 783 fails to maintain a complete and accurate transaction history, 784 transaction information, or transaction statementpedigree785papersconcerning any prescription drug or contraband 786 prescription drug, as required by this chapter and rules adopted 787 under this chapter, in his or her possession commits a felony of 788 the third degree, punishable as provided in s. 775.082, s. 789 775.083, or s. 775.084. 790(2)FAILURE TO AUTHENTICATE PEDIGREE PAPERS.—Effective July7911, 2006:792(a)A person engaged in the wholesale distribution of793prescription drugs who is in possession of pedigree papers794concerning prescription drugs or contraband prescription drugs795and who fails to authenticate the matters contained in the796pedigree papers and who nevertheless attempts to further797distribute prescription drugs or contraband prescription drugs798commits a felony of the third degree, punishable as provided in799s. 775.082, s. 775.083, or s. 775.084.800(b)A person in possession of pedigree papers concerning801prescription drugs or contraband prescription drugs who falsely802swears or certifies that he or she has authenticated the matters803contained in the pedigree papers commits a felony of the third804degree, punishable as provided in s. 775.082, s. 775.083, or s.805775.084.806 (2)(3)KNOWING FORGERY OF TRANSACTION HISTORY, TRANSACTION 807 INFORMATION, OR TRANSACTION STATEMENTPEDIGREE PAPERS.—A person 808 who knowingly forges, counterfeits, or falsely creates any 809 transaction history, transaction information, or transaction 810 statementpedigree paper; who falsely represents any factual 811 matter contained on any transaction history, transaction 812 information, or transaction statementpedigree paper; or who 813 knowingly omits to record material information required to be 814 recorded in a transaction history, transaction information, or 815 transaction statementpedigree paper, commits a felony of the 816 second degree, punishable as provided in s. 775.082, s. 775.083, 817 or s. 775.084. 818 (11)(12)ADULTERATED AND MISBRANDED DRUGS; FALSE 819 ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS. 820 Any person who violates any of the following provisions commits 821 a misdemeanor of the second degree, punishable as provided in s. 822 775.082 or s. 775.083; but, if the violation is committed after 823 a conviction of such person under this subsection has become 824 final, such person commits a misdemeanor of the first degree, 825 punishable as provided in s. 775.082 or s. 775.083, or as 826 otherwise provided in this part: 827 (h) The failure to maintain records related to a drug as 828 required by this part and rules adopted under this part, except 829 for transaction histories, transaction information, or 830 transaction statementspedigree papers, invoices, or shipping 831 documents related to prescription drugs. 832 (i) The possession of any drug in violation of this part, 833 except if the violation relates to a deficiency in transaction 834 histories, transaction information, or transaction statements 835pedigree papers. 836 (12)(13)REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, 837 OR TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO 838 PRESCRIPTION DRUGS.—Any person who violates any of the following 839 provisions commits a felony of the third degree, punishable as 840 provided in s. 775.082, s. 775.083, or s. 775.084, or as 841 otherwise provided in this part: 842 (d) The failure to receive, maintain, or provide invoices 843 and shipping documents, other than pedigree papers,if 844 applicable, related to the distribution of a prescription drug. 845 (15) FALSE ADVERTISEMENT.—A publisher, radio broadcast 846 licensee, or agency or medium for the dissemination of an 847 advertisement, except the manufacturer, repackager, wholesale 848 distributor, or seller of the article to which a false 849 advertisement relates, is not liable under subsection (11)(12), 850 subsection (12)(13), or subsection (13)(14)by reason of the 851 dissemination by him or her of such false advertisement, unless 852 he or she has refused, on the request of the department, to 853 furnish to the department the name and post office address of 854 the manufacturer, repackager, wholesale distributor, seller, or 855 advertising agency that asked him or her to disseminate such 856 advertisement. 857 Section 4. Section 499.006, Florida Statutes, is amended to 858 read: 859 499.006 Adulterated drug or device.—A drug or device is 860 adulterated, if any of the following apply: 861 (1)IfIt consists in whole or in part of any filthy, 862 putrid, or decomposed substance.;863 (2)IfIt has been produced, prepared, packed, or held 864 under conditions whereby it could have been contaminated with 865 filth or rendered injurious to health.;866 (3)IfIt is a drug and the methods used in, or the 867 facilities or controls used for, its manufacture, processing, 868 packing, or holding do not conform to, or are not operated or 869 administered in conformity with, current good manufacturing 870 practices to assure that the drug meets the requirements of this 871 part and that the drug has the identity and strength, and meets 872 the standard of quality and purity, which it purports or is 873 represented to possess.;874 (4)IfIt is a drug and its container is composed, in whole 875 or in part, of any poisonous or deleterious substance which 876 could render the contents injurious to health.;877 (5)IfIt is a drug and it bears or contains, for the 878 purpose of coloring only, a color additive that is unsafe within 879 the meaning of the federal act; or, if it is a color additive, 880 the intended use of which in or on drugs is for the purpose of 881 coloring only, and it is unsafe within the meaning of the 882 federal act.;883 (6)IfIt purports to be, or is represented as, a drug the 884 name of which is recognized in the official compendium, and its 885 strength differs from, or its quality or purity falls below, the 886 standard set forth in such compendium. The determination as to 887 strength, quality, or purity must be made in accordance with the 888 tests or methods of assay set forth in such compendium, or, when 889 such tests or methods of assay are absent or inadequate, in 890 accordance with those tests or methods of assay prescribed under 891 authority of the federal act. A drug defined in the official 892 compendium is not adulterated under this subsection merely 893 because it differs from the standard of strength, quality, or 894 purity set forth for that drug in such compendium if its 895 difference in strength, quality, or purity from such standard is 896 plainly stated on its label.;897 (7)IfIt is not subject to subsection (6) and its strength 898 differs from, or its purity or quality falls below the standard 899 of, that which it purports or is represented to possess.;900 (8)IfIt is a drug: 901 (a) With which any substance has been mixed or packed so as 902 to reduce the quality or strength of the drug; or 903 (b) For which any substance has been substituted wholly or 904 in part.;905 (9)IfIt is a drug or device for which the expiration date 906 has passed.;907 (10)IfIt is a prescription drug for which the required 908 transaction history, transaction information, or transaction 909 statementpedigree paperis nonexistent, fraudulent, or 910 incomplete under the requirements of this part or applicable 911 rules, or that has been purchased, held, sold, or distributed at 912 any time by a person not authorized under federal or state law 913 to do so.; or914 (11)IfIt is a prescription drug subject to, defined by, 915 or described by s. 503(b) of the Federal Food, Drug, and 916 Cosmetic Act which has been returned by a veterinarian to a 917 limited prescription drug veterinary wholesale distributor. 918 Section 5. Section 499.01, Florida Statutes, is amended to 919 read: 920 499.01 Permits.— 921 (1) BeforePrior tooperating, a permit is required for 922 each person and establishment that intends to operate as: 923 (a) A prescription drug manufacturer; 924 (b) A prescription drug repackager; 925 (c) A nonresident prescription drug manufacturer; 926 (d) A nonresident prescription drug repackager; 927 (e)(d)A prescription drug wholesale distributor; 928 (f)(e)An out-of-state prescription drug wholesale 929 distributor; 930 (g)(f)A retail pharmacy drug wholesale distributor; 931 (h)(g)A restricted prescription drug distributor; 932 (i)(h)A complimentary drug distributor; 933 (j)(i)A freight forwarder; 934 (k)(j)A veterinary prescription drug retail establishment; 935 (l)(k)A veterinary prescription drug wholesale 936 distributor; 937 (m)(l)A limited prescription drug veterinary wholesale 938 distributor; 939 (n)(m)An over-the-counter drug manufacturer; 940 (o)(n)A device manufacturer; 941 (p)(o)A cosmetic manufacturer; 942 (q)(p)A third party logistics provider; or 943 (r)(q)A health care clinic establishment. 944 (2) The following permits are established: 945 (a) Prescription drug manufacturer permit.—A prescription 946 drug manufacturer permit is required for any person that is a 947 manufacturer of a prescription drug and that manufactures or 948 distributes such prescription drugs in this state. 949 1. A person that operates an establishment permitted as a 950 prescription drug manufacturer may engage inwholesale951 distribution of prescription drugs for which the person is the 952 manufacturermanufactured at that establishmentand must comply 953 with s. 499.0121 and all otherof theprovisions of this part,954except s. 499.01212,andtherules adopted under this part,955except s. 499.01212, which apply to a wholesale distributor. The 956 department shall adopt rules for issuing a virtual prescription 957 drug manufacturer permit to a person who engages in the 958 manufacture of prescription drugs but does not make or take 959 physical possession of any prescription drugs. The rules adopted 960 by the department under this section may exempt virtual 961 manufacturers from certain establishment, security, and storage 962 requirements set forth in s. 499.0121. 963 2. A prescription drug manufacturer must comply with all 964 appropriate state and federal good manufacturing practices. 965 3. A blood establishment, as defined in s. 381.06014, 966 operating in a manner consistent with the provisions of 21 967 C.F.R. parts 211 and 600-640, and manufacturing only the 968 prescription drugs described in s. 499.003(48)(j)499.003(53)(d)969 is not required to be permitted as a prescription drug 970 manufacturer under this paragraph or to register products under 971 s. 499.015. 972 (b) Prescription drug repackager permit.—A prescription 973 drug repackager permit is required for any person that 974 repackages a prescription drug in this state. 975 1. A person that operates an establishment permitted as a 976 prescription drug repackager may engage inwholesale977 distribution of prescription drugs repackaged at that 978 establishment and must comply with all of the provisions of this 979 part and the rules adopted under this part that apply to a 980 prescription drug manufacturerwholesale distributor. 981 2. A prescription drug repackager must comply with all 982 appropriate state and federal good manufacturing practices. 983 (c) Nonresident prescription drug manufacturer permit.—A 984 nonresident prescription drug manufacturer permit is required 985 for any person that is a manufacturer of prescription drugs, 986 unless permitted as a third party logistics provider, located 987 outside of this state or outside the United States and that 988 engages in thewholesaledistribution in this state of such 989 prescription drugs. Each such manufacturer must be permitted by 990 the department and comply with all of the provisions required of 991 a prescription drug manufacturerwholesale distributorunder 992 this part, except s. 499.01212. The department shall adopt rules 993 for issuing a virtual nonresident prescription drug manufacturer 994 permit to a person who engages in the manufacture of 995 prescription drugs but does not make or take physical possession 996 of any prescription drugs. The rules adopted by the department 997 under this section may exempt virtual nonresident manufacturers 998 from certain establishment, security, and storage requirements 999 set forth in s. 499.0121. 1000 1. A person that distributes prescription drugs for which 1001 the person is not the manufacturer must also obtain an out-of 1002 state prescription drug wholesale distributor permit or third 1003 party logistics provider permit pursuant to this section to 1004 engage in thewholesaledistribution of such prescription drugs 1005 when required by this part. This subparagraph does not apply to 1006 a manufacturer that distributes prescription drugs only for the 1007 manufacturer of the prescription drugs where both manufacturers 1008 are affiliatesas defined in s. 499.003(30)(e). 1009 2. Any such person must comply with the licensing or 1010 permitting requirements of the jurisdiction in which the 1011 establishment is located and the federal act, and any 1012 prescription drug distributedproduct wholesaledinto this state 1013 must comply with this part. If a person intends to import 1014 prescription drugs from a foreign country into this state, the 1015 nonresident prescription drug manufacturer must provide to the 1016 department a list identifying each prescription drug it intends 1017 to import and document approval by the United States Food and 1018 Drug Administration for such importation. 1019 (d) Nonresident prescription drug repackager permit.–A 1020 nonresident prescription drug repackager permit is required for 1021 any person located outside of this state, but within the United 1022 States or its territories, that repackages prescription drugs 1023 and engages in the distribution of such prescription drugs into 1024 this state. 1025 1. A nonresident prescription drug repackager must comply 1026 with all of the provisions of this section and the rules adopted 1027 under this section that apply to a prescription drug 1028 manufacturer. 1029 2. A nonresident prescription drug repackager must be 1030 permitted by the department and comply with all appropriate 1031 state and federal good manufacturing practices. 1032 3. A nonresident prescription drug repackager must be 1033 registered as a drug establishment with the United States Food 1034 and Drug Administration. 1035 (e)(d)Prescription drug wholesale distributor permit.—A 1036 prescription drug wholesale distributor permit is required for 1037 any person who is a wholesale distributor of prescription drugs 1038 and thatmay engage in thewholesale distributes such 1039distribution ofprescription drugs in this state.A prescription1040drug wholesale distributor that applies to the department for a1041new permit or the renewal of a permit must submit a bond of1042$100,000, or other equivalent means of security acceptable to1043the department, such as an irrevocable letter of credit or a1044deposit in a trust account or financial institution, payable to1045the Professional Regulation Trust Fund. The purpose of the bond1046is to secure payment of any administrative penalties imposed by1047the department and any fees and costs incurred by the department1048regarding that permit which are authorized under state law and1049which the permittee fails to pay 30 days after the fine or costs1050become final. The department may make a claim against such bond1051or security until 1 year after the permittee’s license ceases to1052be valid or until 60 days after any administrative or legal1053proceeding authorized in this part which involves the permittee1054is concluded, including any appeal, whichever occurs later.The 1055 department may adopt rules for issuing a prescription drug 1056 wholesale distributor-broker permit to a person who engages in 1057 the wholesale distribution of prescription drugs and does not 1058 take physical possession of any prescription drugs. 1059 (f)(e)Out-of-state prescription drug wholesale distributor 1060 permit.—An out-of-state prescription drug wholesale distributor 1061 permit is required for any person that is a wholesale 1062 distributor located outside this state, but within the United 1063 States or its territories, which engages in the wholesale 1064 distribution of prescription drugs into this stateand which1065must be permitted by the department and comply with all the1066provisions required of a wholesale distributor under this part. 1067An out-of-state prescription drug wholesale distributor that1068applies to the department for a new permit or the renewal of a1069permit must submit a bond of $100,000, or other equivalent means1070of security acceptable to the department, such as an irrevocable1071letter of credit or a deposit in a trust account or financial1072institution, payable to the Professional Regulation Trust Fund.1073The purpose of the bond is to secure payment of any1074administrative penalties imposed by the department and any fees1075and costs incurred by the department regarding that permit which1076are authorized under state law and which the permittee fails to1077pay 30 days after the fine or costs become final. The department1078may make a claim against such bond or security until 1 year1079after the permittee’s license ceases to be valid or until 601080days after any administrative or legal proceeding authorized in1081this part which involves the permittee is concluded, including1082any appeal, whichever occurs later.The out-of-state 1083 prescription drug wholesale distributor must maintain at all 1084 times a license or permit to engage in the wholesale 1085 distribution of prescription drugs in compliance with laws of 1086 the state in which it is a resident. If the state from which the 1087 wholesale distributor distributes prescription drugs does not 1088 require a license to engage in the wholesale distribution of 1089 prescription drugs, the distributor must be licensed as a 1090 wholesale distributor as required by the federal act. 1091 (g)(f)Retail pharmacy drug wholesale distributor permit.—A 1092 retail pharmacy drug wholesale distributor is a retail pharmacy 1093 engaged in wholesale distribution of prescription drugs within 1094 this state under the following conditions: 1095 1. The pharmacy must obtain a retail pharmacy drug 1096 wholesale distributor permit pursuant to this part andtherules 1097 adopted under this part. 1098 2. The wholesale distribution activity does not exceed 30 1099 percent of the total annual purchases of prescription drugs. If 1100 the wholesale distribution activity exceeds the 30-percent 1101 maximum, the pharmacy must obtain a prescription drug wholesale 1102 distributor permit. 1103 3. The transfer of prescription drugs that appear in any 1104 schedule contained in chapter 893 is subject to chapter 893 and 1105 the federal Comprehensive Drug Abuse Prevention and Control Act 1106 of 1970. 1107 4. The transfer is between a retail pharmacy and another 1108 retail pharmacy, or a Modified Class II institutional pharmacy, 1109 or a health care practitioner licensed in this state and 1110 authorized by law to dispense or prescribe prescription drugs. 1111 5. All records of sales of prescription drugs subject to 1112 this section must be maintained separate and distinct from other 1113 records and comply with the recordkeeping requirements of this 1114 part. 1115 (h)(g)Restricted prescription drug distributor permit.— 1116 1. A restricted prescription drug distributor permit is 1117 required for: 1118 a. Any person located in this state who engages in the 1119 distribution of a prescription drug, which distribution is not 1120 considered “wholesale distribution” under s. 499.003(48)(a) 1121499.003(53)(a). 1122 b. Any person located in this state who engages in the 1123 receipt or distribution of a prescription drug in this state for 1124 the purpose of processing its return or its destruction if such 1125 person is not the person initiating the return, the prescription 1126 drug wholesale supplier of the person initiating the return, or 1127 the manufacturer of the drug. 1128 c. A blood establishment located in this state which 1129 collects blood and blood components only from volunteer donors 1130 as defined in s. 381.06014 or pursuant to an authorized 1131 practitioner’s order for medical treatment or therapy and 1132 engages in the wholesale distribution of a prescription drug not 1133 described in s. 499.003(48)(j)499.003(53)(d)to a health care 1134 entity. A mobile blood unit operated by a blood establishment 1135 permitted under this sub-subparagraph is not required to be 1136 separately permitted. The health care entity receiving a 1137 prescription drug distributed under this sub-subparagraph must 1138 be licensed as a closed pharmacy or provide health care services 1139 at that establishment. The blood establishment must operate in 1140 accordance with s. 381.06014 and may distribute only: 1141 (I) Prescription drugs indicated for a bleeding or clotting 1142 disorder or anemia; 1143 (II) Blood-collection containers approved under s. 505 of 1144 the federal act; 1145 (III) Drugs that are blood derivatives, or a recombinant or 1146 synthetic form of a blood derivative; 1147 (IV) Prescription drugs that are identified in rules 1148 adopted by the department and that are essential to services 1149 performed or provided by blood establishments and authorized for 1150 distribution by blood establishments under federal law; or 1151 (V) To the extent authorized by federal law, drugs 1152 necessary to collect blood or blood components from volunteer 1153 blood donors; for blood establishment personnel to perform 1154 therapeutic procedures under the direction and supervision of a 1155 licensed physician; and to diagnose, treat, manage, and prevent 1156 any reaction of a volunteer blood donor or a patient undergoing 1157 a therapeutic procedure performed under the direction and 1158 supervision of a licensed physician, 1159 1160 as long as all of the health care services provided by the blood 1161 establishment are related to its activities as a registered 1162 blood establishment or the health care services consist of 1163 collecting, processing, storing, or administering human 1164 hematopoietic stem cells or progenitor cells or performing 1165 diagnostic testing of specimens if such specimens are tested 1166 together with specimens undergoing routine donor testing. The 1167 blood establishment may purchase and possess the drugs described 1168 in this sub-subparagraph without a health care clinic 1169 establishment permit. 1170 2. Storage, handling, and recordkeeping of these 1171 distributions by a person required to be permitted as a 1172 restricted prescription drug distributor must be in accordance 1173 with the requirements for wholesale distributors under s. 1174 499.0121, but not those set forth in s. 499.01212 if the1175distribution occurs pursuant to sub-subparagraph 1.a. or sub1176subparagraph 1.b. 1177 3. A person who applies for a permit as a restricted 1178 prescription drug distributor, or for the renewal of such a 1179 permit, must provide to the department the information required 1180 under s. 499.012. 1181 4. The department may adopt rules regarding the 1182 distribution of prescription drugs by hospitals, health care 1183 entities, charitable organizations, other persons not involved 1184 in wholesale distribution, and blood establishments, which rules 1185 are necessary for the protection of the public health, safety, 1186 and welfare. 1187 5. A restricted prescription drug distributor permit is not 1188 required for distributions between pharmacies that each hold an 1189 active permit under chapter 465, have a common ownership, and 1190 are operating in a freestanding end-stage renal dialysis clinic, 1191 if such distributions are made to meet the immediate emergency 1192 medical needs of specifically identified patients and do not 1193 occur with such frequency as to amount to the regular and 1194 systematic supplying of that drug between the pharmacies. The 1195 department shall adopt rules establishing when the distribution 1196 of a prescription drug under this subparagraph amounts to the 1197 regular and systematic supplying of that drug. 1198 (i)(h)Complimentary drug distributor permit.—A 1199 complimentary drug distributor permit is required for any person 1200 that engages in the distribution of a complimentary drug, 1201 subject to the requirements of s. 499.028. 1202 (j)(i)Freight forwarder permit.—A freight forwarder permit 1203 is required for any person that engages in the distribution of a 1204 prescription drug as a freight forwarder unless the person is a 1205 common carrier. The storage, handling, and recordkeeping of such 1206 distributions must comply with the requirements for wholesale 1207 distributors under s. 499.0121, but not those set forth in s.1208499.01212. A freight forwarder must provide the source of the 1209 prescription drugs with a validated airway bill, bill of lading, 1210 or other appropriate documentation to evidence the exportation 1211 of the product. 1212 (k)(j)Veterinary prescription drug retail establishment 1213 permit.—A veterinary prescription drug retail establishment 1214 permit is required for any person that sells veterinary 1215 prescription drugs to the public but does not include a pharmacy 1216 licensed under chapter 465. 1217 1. The sale to the public must be based on a valid written 1218 order from a veterinarian licensed in this state who has a valid 1219 client-veterinarian relationship with the purchaser’s animal. 1220 2. Veterinary prescription drugs may not be sold in excess 1221 of the amount clearly indicated on the order or beyond the date 1222 indicated on the order. 1223 3. An order may not be valid for more than 1 year. 1224 4. A veterinary prescription drug retail establishment may 1225 not purchase, sell, trade, or possess human prescription drugs 1226 or any controlled substance as defined in chapter 893. 1227 5. A veterinary prescription drug retail establishment must 1228 sell a veterinary prescription drug in the original, sealed 1229 manufacturer’s container with all labeling intact and legible. 1230 The department may adopt by rule additional labeling 1231 requirements for the sale of a veterinary prescription drug. 1232 6. A veterinary prescription drug retail establishment must 1233 comply with all of the wholesale distribution requirements of s. 1234 499.0121. 1235 7. Prescription drugs sold by a veterinary prescription 1236 drug retail establishment pursuant to a practitioner’s order may 1237 not be returned into the retail establishment’s inventory. 1238 (l)(k)Veterinary prescription drug wholesale distributor 1239 permit.—A veterinary prescription drug wholesale distributor 1240 permit is required for any person that engages in the 1241 distribution of veterinary prescription drugs in or into this 1242 state. A veterinary prescription drug wholesale distributor that 1243 also distributes prescription drugs subject to, defined by, or 1244 described by s. 503(b) of the Federal Food, Drug, and Cosmetic 1245 Act which it did not manufacture must obtain a permit as a 1246 prescription drug wholesale distributor, an out-of-state 1247 prescription drug wholesale distributor, or a limited 1248 prescription drug veterinary wholesale distributor in lieu of 1249 the veterinary prescription drug wholesale distributor permit. A 1250 veterinary prescription drug wholesale distributor must comply 1251 with the requirements for wholesale distributors under s. 1252 499.0121, but not those set forth in s. 499.01212. 1253 (m)(l)Limited prescription drug veterinary wholesale 1254 distributor permit.—Unless engaging in the activities of and 1255 permitted as a prescription drug manufacturer, nonresident 1256 prescription drug manufacturer, prescription drug wholesale 1257 distributor, or out-of-state prescription drug wholesale 1258 distributor, a limited prescription drug veterinary wholesale 1259 distributor permit is required for any person that engages in 1260 the distribution in or into this state of veterinary 1261 prescription drugs and prescription drugs subject to, defined 1262 by, or described by s. 503(b) of the Federal Food, Drug, and 1263 Cosmetic Act under the following conditions: 1264 1. The person is engaged in the business of wholesaling 1265 prescription and veterinary prescription drugs to persons: 1266 a. Licensed as veterinarians practicing on a full-time 1267 basis; 1268 b. Regularly and lawfully engaged in instruction in 1269 veterinary medicine; 1270 c. Regularly and lawfully engaged in law enforcement 1271 activities; 1272 d. For use in research not involving clinical use; or 1273 e. For use in chemical analysis or physical testing or for 1274 purposes of instruction in law enforcement activities, research, 1275 or testing. 1276 2. No more than 30 percent of total annual prescription 1277 drug sales may be prescription drugs approved for human use 1278 which are subject to, defined by, or described by s. 503(b) of 1279 the Federal Food, Drug, and Cosmetic Act. 1280 3. The person does not distribute in any jurisdiction 1281 prescription drugs subject to, defined by, or described by s. 1282 503(b) of the Federal Food, Drug, and Cosmetic Act to any person 1283 who is authorized to sell, distribute, purchase, trade, or use 1284 these drugs on or for humans. 1285 4. A limited prescription drug veterinary wholesale 1286 distributor that applies to the department for a new permit or 1287 the renewal of a permit must submit a bond of $20,000, or other 1288 equivalent means of security acceptable to the department, such 1289 as an irrevocable letter of credit or a deposit in a trust 1290 account or financial institution, payable to the Professional 1291 Regulation Trust Fund. The purpose of the bond is to secure 1292 payment of any administrative penalties imposed by the 1293 department and any fees and costs incurred by the department 1294 regarding that permit which are authorized under state law and 1295 which the permittee fails to pay 30 days after the fine or costs 1296 become final. The department may make a claim against such bond 1297 or security until 1 year after the permittee’s license ceases to 1298 be valid or until 60 days after any administrative or legal 1299 proceeding authorized in this part which involves the permittee 1300 is concluded, including any appeal, whichever occurs later. 1301 5. A limited prescription drug veterinary wholesale 1302 distributor must maintain at all times a license or permit to 1303 engage in the wholesale distribution of prescription drugs in 1304 compliance with laws of the state in which it is a resident. 1305 6. A limited prescription drug veterinary wholesale 1306 distributor must comply with the requirements for wholesale 1307 distributors under s.ss.499.0121and 499.01212, except that a1308limited prescription drug veterinary wholesale distributor is1309not required to provide a pedigree paper as required by s.1310499.01212 upon the wholesale distribution of a prescription drug1311to a veterinarian. 1312 7. A limited prescription drug veterinary wholesale 1313 distributor may not return to inventory for subsequent wholesale 1314 distribution any prescription drug subject to, defined by, or 1315 described by s. 503(b) of the Federal Food, Drug, and Cosmetic 1316 Act which has been returned by a veterinarian. 1317 8. A limited prescription drug veterinary wholesale 1318 distributor permit is not required for an intracompany sale or 1319 transfer of a prescription drug from an out-of-state 1320 establishment that is duly licensed to engage in the wholesale 1321 distribution of prescription drugs in its state of residence to 1322 a licensed limited prescription drug veterinary wholesale 1323 distributor in this state if both wholesale distributors conduct 1324 wholesale distributions of prescription drugs under the same 1325 business name. The recordkeeping requirements of s.ss.1326 499.0121(6)and 499.01212must be followed for this transaction. 1327 (n)(m)Over-the-counter drug manufacturer permit.—An over 1328 the-counter drug manufacturer permit is required for any person 1329 that engages in the manufacture or repackaging of an over-the 1330 counter drug. 1331 1. An over-the-counter drug manufacturer may not possess or 1332 purchase prescription drugs. 1333 2. A pharmacy is exempt from obtaining an over-the-counter 1334 drug manufacturer permit if it is operating in compliance with 1335 pharmacy practice standards as defined in chapter 465 andthe1336 rules adopted under that chapter. 1337 3. An over-the-counter drug manufacturer must comply with 1338 all appropriate state and federal good manufacturing practices. 1339 (o)(n)Device manufacturer permit.— 1340 1. A device manufacturer permit is required for any person 1341 that engages in the manufacture, repackaging, or assembly of 1342 medical devices for human use in this state, except that a 1343 permit is not required if: 1344 a. The person is engaged only in manufacturing, 1345 repackaging, or assembling a medical device pursuant to a 1346 practitioner’s order for a specific patient; or 1347 b. The person does not manufacture, repackage, or assemble 1348 any medical devices or components for such devices, except those 1349 devices or components which are exempt from registration 1350 pursuant to s. 499.015(8). 1351 2. A manufacturer or repackager of medical devices in this 1352 state must comply with all appropriate state and federal good 1353 manufacturing practices and quality system rules. 1354 3. The department shall adopt rules related to storage, 1355 handling, and recordkeeping requirements for manufacturers of 1356 medical devices for human use. 1357 (p)(o)Cosmetic manufacturer permit.—A cosmetic 1358 manufacturer permit is required for any person that manufactures 1359 or repackages cosmetics in this state. A person that only labels 1360 or changes the labeling of a cosmetic but does not open the 1361 container sealed by the manufacturer of the product is exempt 1362 from obtaining a permit under this paragraph. 1363 (q)(p)Third party logistics provider permit.—A third party 1364 logistics provider permit is required for any person that 1365 contracts with a prescription drug wholesale distributor or 1366 prescription drug manufacturer to provide warehousing, 1367 distribution, or other logistics services on behalf of a 1368 manufacturer,orwholesale distributor, or dispenser, but who 1369 does not take title to the prescription drug or have 1370 responsibility to direct the sale or disposition of the 1371 prescription drug. A third party logistics provider located 1372 outside of this state, must be licensed in the state or 1373 territory from which the prescription drug is distributed by the 1374 third party logistics provider. If the state or territory from 1375 which the third party logistics provider originates does not 1376 require a license to operate as a third party logistics 1377 provider, the third party logistics provider must be licensed as 1378 a third party logistics provider as required by the federal act. 1379 Each third party logistics provider permittee shall comply with 1380 s.the requirements for wholesale distributors under ss.1381 499.0121and 499.01212, with the exception of those wholesale1382distributions described in s. 499.01212(3)(a),and other rules 1383 that the department requires. 1384 (r)(q)Health care clinic establishment permit.—Effective1385January 1, 2009,A health care clinic establishment permit is 1386 required for the purchase of a prescription drug by a place of 1387 business at one general physical location that provides health 1388 care or veterinary services, which is owned and operated by a 1389 business entity that has been issued a federal employer tax 1390 identification number. For the purpose of this paragraph, the 1391 term “qualifying practitioner” means a licensed health care 1392 practitioner defined in s. 456.001, or a veterinarian licensed 1393 under chapter 474, who is authorized under the appropriate 1394 practice act to prescribe and administer a prescription drug. 1395 1. An establishment must provide, as part of the 1396 application required under s. 499.012, designation of a 1397 qualifying practitioner who will be responsible for complying 1398 with all legal and regulatory requirements related to the 1399 purchase, recordkeeping, storage, and handling of the 1400 prescription drugs. In addition, the designated qualifying 1401 practitioner shall be the practitioner whose name, establishment 1402 address, and license number is used on all distribution 1403 documents for prescription drugs purchased or returned by the 1404 health care clinic establishment. Upon initial appointment of a 1405 qualifying practitioner, the qualifying practitioner and the 1406 health care clinic establishment shall notify the department on 1407 a form furnished by the department within 10 days after such 1408 employment. In addition, the qualifying practitioner and health 1409 care clinic establishment shall notify the department within 10 1410 days after any subsequent change. 1411 2. The health care clinic establishment must employ a 1412 qualifying practitioner at each establishment. 1413 3. In addition to the remedies and penalties provided in 1414 this part, a violation of this chapter by the health care clinic 1415 establishment or qualifying practitioner constitutes grounds for 1416 discipline of the qualifying practitioner by the appropriate 1417 regulatory board. 1418 4. The purchase of prescription drugs by the health care 1419 clinic establishment is prohibited during any period of time 1420 when the establishment does not comply with this paragraph. 1421 5. A health care clinic establishment permit is not a 1422 pharmacy permit or otherwise subject to chapter 465. A health 1423 care clinic establishment that meets the criteria of a modified 1424 Class II institutional pharmacy under s. 465.019 is not eligible 1425 to be permitted under this paragraph. 1426 6. This paragraph does not apply to the purchase of a 1427 prescription drug by a licensed practitioner under his or her 1428 license. 1429 (3) A nonresident prescription drug manufacturer permit is 1430 not required for a manufacturer to distribute a prescription 1431 drug active pharmaceutical ingredient that it manufactures to a 1432 prescription drug manufacturer permitted in this statein1433limited quantitiesintended for research and development and not 1434 for resale or human use other than lawful clinical trials and 1435 biostudies authorized and regulated by federal law. A 1436 manufacturer claiming to be exempt from the permit requirements 1437 of this subsection and the prescription drug manufacturer 1438 purchasing and receiving the active pharmaceutical ingredient 1439 shall comply with the recordkeeping requirements of s. 1440 499.0121(6), but not the requirements of s. 499.01212. The 1441 prescription drug manufacturer purchasing and receiving the 1442 active pharmaceutical ingredient shall maintain on file a record 1443 of the FDA registration number; if available, the out-of-state 1444 license, permit, or registration number; and, if available, a 1445 copy of the most current FDA inspection report, for all 1446 manufacturers from whom they purchase active pharmaceutical 1447 ingredients under this section.The department shall define the1448term “limited quantities” by rule, and may include the allowable1449number of transactions within a given period of time and the1450amount of prescription drugs distributed into the state for1451purposes of this exemption.The failure to comply with the 1452 requirements of this subsection, or rules adopted by the 1453 department to administer this subsection, for the purchase of 1454 prescription drug active pharmaceutical ingredients is a 1455 violation of s. 499.005(14), and a knowing failure is a 1456 violation of s. 499.0051(3)499.0051(4). 1457 (a) The immediate package or container of a prescription 1458 drug active pharmaceutical ingredient distributed into the state 1459 that is intended for research and development under this 1460 subsection shall bear a label prominently displaying the 1461 statement: “Caution: Research and Development Only—Not for 1462 Manufacturing, Compounding, or Resale.” 1463 (b) A prescription drug manufacturer that obtains a 1464 prescription drug active pharmaceutical ingredient under this 1465 subsection for use in clinical trials and or biostudies 1466 authorized and regulated by federal law must create and maintain 1467 records detailing the specific clinical trials or biostudies for 1468 which the prescription drug active pharmaceutical ingredient was 1469 obtained. 1470 (4)(a) A permit issued under this part is not required to 1471 distribute a prescription drug active pharmaceutical ingredient 1472 from an establishment located in the United States to an 1473 establishment located in this state permitted as a prescription 1474 drug manufacturer under this part for use by the recipient in 1475 preparing, deriving, processing, producing, or fabricating a 1476 prescription drug finished dosage form at the establishment in 1477 this state where the product is received under an approved and 1478 otherwise valid New Drug Approval Application, Abbreviated New 1479 Drug Application, New Animal Drug Application, or Therapeutic 1480 Biologic Application, provided that the application, active 1481 pharmaceutical ingredient, or finished dosage form has not been 1482 withdrawn or removed from the market in this country for public 1483 health reasons. 1484 1. Any distributor claiming exemption from permitting 1485 requirements pursuant to this paragraph shall maintain a 1486 license, permit, or registration to engage in the wholesale 1487 distribution of prescription drugs under the laws of the state 1488 from which the product is distributed. If the state from which 1489 the prescription drugs are distributed does not require a 1490 license to engage in the wholesale distribution of prescription 1491 drugs, the distributor must be licensed as a wholesale 1492 distributor as required by the federal act. 1493 2. Any distributor claiming exemption from permitting 1494 requirements pursuant to this paragraph and the prescription 1495 drug manufacturer purchasing and receiving the active 1496 pharmaceutical ingredient shall comply with the recordkeeping 1497 requirements of s. 499.0121(6), but not the requirements of s.1498499.01212. 1499 (b) A permit issued under this part is not required to 1500 distributelimited quantities ofa prescription drug that has 1501 not been repackaged from an establishment located in the United 1502 States to an establishment located in this state permitted as a 1503 prescription drug manufacturer under this part for research and 1504 development or to a holder of a letter of exemption issued by 1505 the department under s. 499.03(4) for research, teaching, or 1506 testing.The department shall define “limited quantities” by1507rule and may include the allowable number of transactions within1508a given period of time and the amounts of prescription drugs1509distributed into the state for purposes of this exemption.1510 1. Any distributor claiming exemption from permitting 1511 requirements pursuant to this paragraph shall maintain a 1512 license, permit, or registration to engage in the wholesale 1513 distribution of prescription drugs under the laws of the state 1514 from which the product is distributed. If the state from which 1515 the prescription drugs are distributed does not require a 1516 license to engage in the wholesale distribution of prescription 1517 drugs, the distributor must be licensed as a wholesale 1518 distributor as required by the federal act. 1519 2. All purchasers and recipients of any prescription drugs 1520 distributed pursuant to this paragraph shall ensure that the 1521 products are not resold or used, directly or indirectly, on 1522 humans except in lawful clinical trials and biostudies 1523 authorized and regulated by federal law. 1524 3. Any distributor claiming exemption from permitting 1525 requirements pursuant to this paragraph, and the purchaser and 1526 recipient of the prescription drug, shall comply with the 1527 recordkeeping requirements of s. 499.0121(6), but not the1528requirements of s. 499.01212. 1529 4. The immediate package or container of any active 1530 pharmaceutical ingredient distributed into the state that is 1531 intended for teaching, testing, research, and development shall 1532 bear a label prominently displaying the statement: “Caution: 1533 Research, Teaching, or Testing Only – Not for Manufacturing, 1534 Compounding, or Resale.” 1535 (c) An out-of-state prescription drug wholesale distributor 1536 permit is not required for an intracompany sale or transfer of a 1537 prescription drug from an out-of-state establishment that is 1538 duly licensed as a prescription drug wholesale distributor in 1539 its state of residence to a licensed prescription drug wholesale 1540 distributor in this state, if both wholesale distributors 1541 conduct wholesale distributions of prescription drugs under the 1542 same business name. The recordkeeping requirements of s.ss.1543 499.0121(6)and 499.01212must be followed for such 1544 transactions. 1545 (d) Persons receiving prescription drugs from a source 1546 claimed to be exempt from permitting requirements under this 1547 subsection shall maintain on file: 1548 1. A record of the FDA establishment registration number, 1549 if any; 1550 2. The resident state or federal license, registration, or 1551 permit that authorizes the source to distribute prescription 1552 drugsdrug wholesale distribution license, permit, or1553registration number; and 1554 3. A copy of the most recent resident state or FDA 1555 inspection report, for all distributors and establishments from 1556 whom they purchase or receive prescription drugs under this 1557 subsection. 1558 (e) All persons claiming exemption from permitting 1559 requirements pursuant to this subsection who engage in the 1560 distribution of prescription drugs within or into the state are 1561 subject to this part, including ss. 499.005 and 499.0051, and 1562 shall make available, within 48 hours, to the department on 1563 request all records related to any prescription drugs 1564 distributed under this subsection, including those records 1565 described in s. 499.051(4), regardless of the location where the 1566 records are stored. 1567 (f) A person purchasing and receiving a prescription drug 1568 from a person claimed to be exempt from licensing requirements 1569 pursuant to this subsection shall report to the department in 1570 writing within 14 days after receiving any product that is 1571 misbranded or adulterated or that fails to meet minimum 1572 standards set forth in the official compendium or state or 1573 federal good manufacturing practices for identity, purity, 1574 potency, or sterility, regardless of whether the product is 1575 thereafter rehabilitated, quarantined, returned, or destroyed. 1576 (g) The department may adopt rules to administer this 1577 subsection which are necessary for the protection of the public 1578 health, safety, and welfare. Failure to comply with the 1579 requirements of this subsection, or rules adopted by the 1580 department to administer this subsection, is a violation of s. 1581 499.005(14), and a knowing failure is a violation of s. 1582 499.0051(3)499.0051(4). 1583 (h) This subsection does not relieve any person from any 1584 requirement prescribed by law with respect to controlled 1585 substances as defined in the applicable federal and state laws. 1586 (5) A prescription drug repackager permit issued under this 1587 part is not required for a restricted prescription drug 1588 distributor permitholder that is a health care entity to 1589 repackage prescription drugs in this state for its own use or 1590 for distribution to hospitals or other health care entities in 1591 the state for their own use, pursuant to s. 499.003(48)(a)3. 1592499.003(53)(a)3., if: 1593 (a) The prescription drug distributor notifies the 1594 department, in writing, of its intention to engage in 1595 repackaging under this exemption, 30 days before engaging in the 1596 repackaging of prescription drugs at the permitted 1597 establishment; 1598 (b) The prescription drug distributor is under common 1599 control with the hospitals or other health care entities to 1600 which the prescription drug distributor is distributing 1601 prescription drugs. As used in this paragraph, “common control” 1602 means the power to direct or cause the direction of the 1603 management and policies of a person or an organization, whether 1604 by ownership of stock, voting rights, contract, or otherwise; 1605 (c) The prescription drug distributor repackages the 1606 prescription drugs in accordance with current state and federal 1607 good manufacturing practices; and 1608 (d) The prescription drug distributor labels the 1609 prescription drug it repackages in accordance with state and 1610 federal laws and rules. 1611 1612 The prescription drug distributor is exempt from the product 1613 registration requirements of s. 499.015 with regard to the 1614 prescription drugs that it repackages and distributes under this 1615 subsection. A prescription drug distributor that repackages and 1616 distributes prescription drugs under this subsection to a not 1617 for-profit rural hospital, as defined in s. 395.602, is not 1618 required to comply with paragraph (c) or paragraph (d), but must 1619 provide to each health care entity for which it repackages, for 1620 each prescription drug that is repackaged and distributed, the 1621 information required by department rule for labeling 1622 prescription drugs. The department shall adopt rules to ensure 1623 the safety and integrity of prescription drugs repackaged and 1624 distributed under this subsection, including rules regarding 1625 prescription drug manufacturing and labeling requirements. 1626 Section 6. Section 499.012, Florida Statutes, is amended to 1627 read: 1628 499.012 Permit application requirements.— 1629 (1)(a) A permit issued pursuant to this part may be issued 1630 only to a natural person who is at least 18 years of age or to 1631 an applicant that is not a natural person if each person who, 1632 directly or indirectly, manages, controls, or oversees the 1633 operation of that applicant is at least 18 years of age. 1634 (b) An establishment that is a place of residence may not 1635 receive a permit and may not operate under this part. 1636 (c) A person that applies for or renews a permit to 1637 manufacture or distribute prescription drugs may not use a name 1638 identical to the name used by any other establishment or 1639 licensed person authorized to purchase prescription drugs in 1640 this state, except that a restricted drug distributor permit 1641 issued to a health care entity will be issued in the name in 1642 which the institutional pharmacy permit is issued and a retail 1643 pharmacy drug wholesale distributor will be issued a permit in 1644 the name of its retail pharmacy permit. 1645 (d) A permit for a prescription drug manufacturer, 1646 prescription drug repackager, prescription drug wholesale 1647 distributor, limited prescription drug veterinary wholesale 1648 distributor, or retail pharmacy drug wholesale distributor may 1649 not be issued to the address of a health care entity or to a 1650 pharmacy licensed under chapter 465, except as provided in this 1651 paragraph. The department may issue a prescription drug 1652 manufacturer permit to an applicant at the same address as a 1653 licensed nuclear pharmacy, which is a health care entity, even 1654 if the nuclear pharmacy holds a special sterile compounding 1655 permit under chapter 465, for the purpose of manufacturing 1656 prescription drugs used in positron emission tomography or other 1657 radiopharmaceuticals, as listed in a rule adopted by the 1658 department pursuant to this paragraph. The purpose of this 1659 exemption is to assure availability of state-of-the-art 1660 pharmaceuticals that would pose a significant danger to the 1661 public health if manufactured at a separate establishment 1662 address from the nuclear pharmacy from which the prescription 1663 drugs are dispensed. The department may also issue a retail 1664 pharmacy drug wholesale distributor permit to the address of a 1665 community pharmacy licensed under chapter 465, even if the 1666 community pharmacy holds a special sterile compounding permit 1667 under chapter 465, as long as the community pharmacywhichdoes 1668 not meet the definition of a closed pharmacy in s. 499.003. 1669 (e) A county or municipality may not issue an occupational 1670 license forany licensing period beginning on or after October16711, 2003, forany establishment that requires a permit pursuant 1672 to this part, unless the establishment exhibits a current permit 1673 issued by the department for the establishment. Upon 1674 presentation of the requisite permit issued by the department, 1675 an occupational license may be issued by the municipality or 1676 county in which application is made. The department shall 1677 furnish to local agencies responsible for issuing occupational 1678 licenses a current list of all establishments licensed pursuant 1679 to this part. 1680 (2) Notwithstanding subsection (6), a permitted person in 1681 good standing may change the type of permit issued to that 1682 person by completing a new application for the requested permit, 1683 paying the amount of the difference in the permit fees if the 1684 fee for the new permit is more than the fee for the original 1685 permit, and meeting the applicable permitting conditions for the 1686 new permit type. The new permit expires on the expiration date 1687 of the original permit being changed; however, a new permit for 1688 a prescription drug wholesale distributor, an out-of-state 1689 prescription drug wholesale distributor, or a retail pharmacy 1690 drug wholesale distributor shall expire on the expiration date 1691 of the original permit or 1 year after the date of issuance of 1692 the new permit, whichever is earlier. A refund may not be issued 1693 if the fee for the new permit is less than the fee that was paid 1694 for the original permit. 1695 (3)(a) A written application for a permit or to renew a 1696 permit must be filed with the department on forms furnished by 1697 the department. The department shall establish, by rule, the 1698 form and content of the application to obtain or renew a permit. 1699 The applicant must submit to the department with the application 1700 a statement that swears or affirms that the information is true 1701 and correct. 1702 (b) Upon a determination that 2 years have elapsed since 1703 the department notified an applicant for permit, certification, 1704 or product registration of a deficiency in the application and 1705 that the applicant has failed to cure the deficiency, the 1706 application shall expire. The determination regarding the 2-year 1707 lapse of time shall be based on documentation that the 1708 department notified the applicant of the deficiency in 1709 accordance with s. 120.60. 1710 (c) Information submitted by an applicant on an application 1711 required pursuant to this subsection which is a trade secret, as 1712 defined in s. 812.081, shall be maintained by the department as 1713 trade secret information pursuant to s. 499.051(7). 1714 (4)(a) Except for a permit for a prescription drug 1715 wholesale distributor or an out-of-state prescription drug 1716 wholesale distributor, an application for a permit must include: 1717 1. The name, full business address, and telephone number of 1718 the applicant; 1719 2. All trade or business names used by the applicant; 1720 3. The address, telephone numbers, and the names of contact 1721 persons for each facility used by the applicant for the storage, 1722 handling, and distribution of prescription drugs; 1723 4. The type of ownership or operation, such as a 1724 partnership, corporation, or sole proprietorship; and 1725 5. The names of the owner and the operator of the 1726 establishment, including: 1727 a. If an individual, the name of the individual; 1728 b. If a partnership, the name of each partner and the name 1729 of the partnership; 1730 c. If a corporation, the name and title of each corporate 1731 officer and director, the corporate names, and the name of the 1732 state of incorporation; 1733 d. If a sole proprietorship, the full name of the sole 1734 proprietor and the name of the business entity; 1735 e. If a limited liability company, the name of each member, 1736 the name of each manager, the name of the limited liability 1737 company, and the name of the state in which the limited 1738 liability company was organized; and 1739 f. Any other relevant information that the department 1740 requires. 1741 (b) Upon approval of the application by the department and 1742 payment of the required fee, the department shall issue a permit 1743 to the applicant, if the applicant meets the requirements of 1744 this part and rules adopted under this part. 1745 (c) Any change in information required under paragraph (a) 1746 must be submitted to the department before the change occurs. 1747 (d) The department shall consider, at a minimum, the 1748 following factors in reviewing the qualifications of persons to 1749 be permitted under this part: 1750 1. The applicant’s having been found guilty, regardless of 1751 adjudication, in a court of this state or other jurisdiction, of 1752 a violation of a law that directly relates to a drug, device, or 1753 cosmetic. A plea of nolo contendere constitutes a finding of 1754 guilt for purposes of this subparagraph. 1755 2. The applicant’s having been disciplined by a regulatory 1756 agency in any state for any offense that would constitute a 1757 violation of this part. 1758 3. Any felony conviction of the applicant under a federal, 1759 state, or local law; 1760 4. The applicant’s past experience in manufacturing or 1761 distributing drugs, devices, or cosmetics; 1762 5. The furnishing by the applicant of false or fraudulent 1763 material in any application made in connection with 1764 manufacturing or distributing drugs, devices, or cosmetics; 1765 6. Suspension or revocation by a federal, state, or local 1766 government of any permit currently or previously held by the 1767 applicant for the manufacture or distribution of any drugs, 1768 devices, or cosmetics; 1769 7. Compliance with permitting requirements under any 1770 previously granted permits; 1771 8. Compliance with requirements to maintain or make 1772 available to the state permitting authority or to federal, 1773 state, or local law enforcement officials those records required 1774 under this section; and 1775 9. Any other factors or qualifications the department 1776 considers relevant to and consistent with the public health and 1777 safety. 1778 (5)Except for a permit for a prescription drug wholesale1779distributor or an out-of-state prescription drug wholesale1780distributor:1781 (a) The department shall adopt rules for the biennial 1782 renewal of permits; however, the department may issue up to a 4 1783 year permit to selected permittees notwithstanding any other 1784 provision of law. Fees for such renewal may not exceed the fee 1785 caps set forth in s. 499.041 on an annualized basis as 1786 authorized by law. 1787 (b) The department shall renew a permit upon receipt of the 1788 renewal application and renewal fee if the applicant meets the 1789 requirements established under this part andtherules adopted 1790 under this part. 1791 (c) At least 90 days before the expiration date of a 1792 permit, the department shall forward a permit renewal 1793 notification to the permittee at the mailing address of the 1794 permitted establishment on file with the department. The permit 1795 renewal notification must state conspicuously the date on which 1796 the permit for the establishment will expire and that the 1797 establishment may not operate unless the permit for the 1798 establishment is renewed timely.A permit, unless sooner1799suspended or revoked, automatically expires 2 years after the1800last day of the anniversary month in which the permit was1801originally issued.1802 (d) A permit issued under this part may be renewed by 1803 making application for renewal on forms furnished by the 1804 department and paying the appropriate fees. 1805 1. If a prescription drug wholesale distributor or an out 1806 of-state prescription drug wholesale distributor renewal 1807 application and fee are submitted and postmarked later than 45 1808 days before the expiration date of the permit, the permit may be 1809 renewed only upon payment of a late renewal fee of $100, plus 1810 the required renewal fee. 1811 2. If any otherarenewal application and fee are submitted 1812 and postmarked after the expiration date of the permit, the 1813 permit may be renewed only upon payment of a late renewal 1814 delinquent fee of $100, plus the required renewal fee, not later 1815 than 60 days after the expiration date. 1816 3. A permittee who submits a renewal application in 1817 accordance with this paragraph may continue to operate under its 1818 permit, unless the permit is suspended or revoked, until final 1819 disposition of the renewal application. 1820 4.(d)Failure to renew a permit in accordance with this 1821 section precludes any future renewal of that permit. If a permit 1822 issued pursuant to this part has expired and cannot be renewed, 1823 before an establishment may engage in activities that require a 1824 permit under this part, the establishment must submit an 1825 application for a new permit, pay the applicable application 1826 fee, the initial permit fee, and all applicable penalties, and 1827 be issued a new permit by the department. 1828 (6) A permit issued by the department is nontransferable. 1829 Each permit is valid only for the person or governmental unit to 1830 which it is issued and is not subject to sale, assignment, or 1831 other transfer, voluntarily or involuntarily; nor is a permit 1832 valid for any establishment other than the establishment for 1833 which it was originally issued. 1834 (a) A person permitted under this part must notify the 1835 department before making a change of address. The department 1836 shall set a change of location fee not to exceed $100. 1837 (b)1. An application for a new permit is required when a 1838 majority of the ownership or controlling interest of a permitted 1839 establishment is transferred or assigned or when a lessee agrees 1840 to undertake or provide services to the extent that legal 1841 liability for operation of the establishment will rest with the 1842 lessee. The application for the new permit must be made before 1843 the date of the sale, transfer, assignment, or lease. 1844 2. A permittee that is authorized to distribute 1845 prescription drugs may transfer such drugs to the new owner or 1846 lessee under subparagraph 1. only after the new owner or lessee 1847 has been approved for a permit to distribute prescription drugs. 1848 (c) If an establishment permitted under this part closes, 1849 the owner must notify the department in writing before the 1850 effective date of closure and must: 1851 1. Return the permit to the department; 1852 2. If the permittee is authorized to distribute 1853 prescription drugs, indicate the disposition of such drugs, 1854 including the name, address, and inventory, and provide the name 1855 and address of a person to contact regarding access to records 1856 that are required to be maintained under this part. Transfer of 1857 ownership of prescription drugs may be made only to persons 1858 authorized to possess prescription drugs under this part. 1859 1860 The department may revoke the permit of any person that fails to 1861 comply with the requirements of this subsection. 1862 (7) A permit must be posted in a conspicuous place on the 1863 licensed premises. 1864 (8) An application for a permit or to renew a permit for a 1865 prescription drug wholesale distributor or an out-of-state 1866 prescription drug wholesale distributor submitted to the 1867 department must include: 1868 (a) The name, full business address, and telephone number 1869 of the applicant. 1870 (b) All trade or business names used by the applicant. 1871 (c) The address, telephone numbers, and the names of 1872 contact persons for each facility used by the applicant for the 1873 storage, handling, and distribution of prescription drugs. 1874 (d) The type of ownership or operation, such as a 1875 partnership, corporation, or sole proprietorship. 1876 (e) The names of the owner and the operator of the 1877 establishment, including: 1878 1. If an individual, the name of the individual. 1879 2. If a partnership, the name of each partner and the name 1880 of the partnership. 1881 3. If a corporation: 1882 a. The name, address, and title of each corporate officer 1883 and director. 1884 b. The name and address of the corporation, resident agent 1885 of the corporation, the resident agent’s address, and the 1886 corporation’s state of incorporation. 1887 c. The name and address of each shareholder of the 1888 corporation that owns 5 percent or more of the outstanding stock 1889 of the corporation. 1890 4. If a sole proprietorship, the full name of the sole 1891 proprietor and the name of the business entity. 1892 5. If a limited liability company: 1893 a. The name and address of each member. 1894 b. The name and address of each manager. 1895 c. The name and address of the limited liability company, 1896 the resident agent of the limited liability company, and the 1897 name of the state in which the limited liability company was 1898 organized. 1899 (f) If applicable, the name and address of each affiliate 1900 ofmember of the affiliated group of whichthe applicantis a1901member. 1902 (g)1.The applicant’s gross annual receipts attributable to 1903 prescription drug wholesale distribution activities for the 1904 previous tax year.For an application for a new permit, the1905estimated annual dollar volume of prescription drug sales of the1906applicant, the estimated annual percentage of the applicant’s1907total company sales that are prescription drugs, the applicant’s1908estimated annual total dollar volume of purchases of1909prescription drugs, and the applicant’s estimated annual total1910dollar volume of prescription drug purchases directly from1911manufacturers.19122.For an application to renew a permit, the total dollar1913volume of prescription drug sales in the previous year, the1914total dollar volume of prescription drug sales made in the1915previous 6 months, the percentage of total company sales that1916were prescription drugs in the previous year, the total dollar1917volume of purchases of prescription drugs in the previous year,1918and the total dollar volume of prescription drug purchases1919directly from manufacturers in the previous year.1920 1921Such portions of the information required pursuant to this1922paragraph which are a trade secret, as defined in s. 812.081,1923shall be maintained by the department as trade secret1924information is required to be maintained under s. 499.051.1925 (h) The tax year of the applicant. 1926 (i) A copy of the deed for the property on which 1927 applicant’s establishment is located, if the establishment is 1928 owned by the applicant, or a copy of the applicant’s lease for 1929 the property on which applicant’s establishment is located that 1930 has an original term of not less than 1 calendar year, if the 1931 establishment is not owned by the applicant. 1932 (j) A list of all licenses and permits issued to the 1933 applicant by any other state which authorize the applicant to 1934 purchase or possess prescription drugs. 1935 (k) The name of the manager of the establishment that is 1936 applying for the permit or to renew the permit, the next four 1937 highest ranking employees responsible for prescription drug 1938 wholesale operations for the establishment, and the name of all 1939 affiliated parties for the establishment, together with the 1940 personal information statement and fingerprints required 1941 pursuant to subsection (9) for each of such persons. 1942 (l) The name of each of the applicant’s designated 1943 representatives as required by subsection (15)(16), together 1944 with the personal information statement and fingerprints 1945 required pursuant to subsection (9) for each such person. 1946 (m) Evidence of a surety bond in this state or any other 1947 state in the United States in the amount of $100,000. If the 1948 annual gross receipts of the applicant’s previous tax year is 1949 $10 million or less, evidence of a surety bond in the amount of 1950 $25,000. The specific language of the surety bond must include 1951 the State of Florida as a beneficiary, payable to the 1952 Professional Regulation Trust Fund. In lieu of the surety bond, 1953 the applicant may provide other equivalent security such as an 1954 irrevocable letter of credit, or a deposit in a trust account or 1955 financial institution, which includes the State of Florida as a 1956 beneficiary, payable to the Professional Regulation Trust Fund. 1957 The purpose of the bond or other security is to secure payment 1958 of any administrative penalties imposed by the department and 1959 any fees and costs incurred by the department regarding that 1960 permit which are authorized under state law and which the 1961 permittee fails to pay 30 days after the fine or costs become 1962 final. The department may make a claim against such bond or 1963 security until 1 year after the permittee’s license ceases to be 1964 valid or until 60 days after any administrative or legal 1965 proceeding authorized in this part which involves the permittee 1966 is concluded, including any appeal, whichever occurs later.For1967an applicant that is a secondary wholesale distributor, each of1968the following:19691.A personal background information statement containing1970the background information and fingerprints required pursuant to1971subsection (9) for each person named in the applicant’s response1972to paragraphs (k) and (l) and for each affiliated party of the1973applicant.19742.If any of the five largest shareholders of the1975corporation seeking the permit is a corporation, the name,1976address, and title of each corporate officer and director of1977each such corporation; the name and address of such corporation;1978the name of such corporation’s resident agent, such1979corporation’s resident agent’s address, and such corporation’s1980state of its incorporation; and the name and address of each1981shareholder of such corporation that owns 5 percent or more of1982the stock of such corporation.19833.The name and address of all financial institutions in1984which the applicant has an account which is used to pay for the1985operation of the establishment or to pay for drugs purchased for1986the establishment, together with the names of all persons that1987are authorized signatories on such accounts. The portions of the1988information required pursuant to this subparagraph which are a1989trade secret, as defined in s. 812.081, shall be maintained by1990the department as trade secret information is required to be1991maintained under s. 499.051.19924.The sources of all funds and the amounts of such funds1993used to purchase or finance purchases of prescription drugs or1994to finance the premises on which the establishment is to be1995located.19965.If any of the funds identified in subparagraph 4. were1997borrowed, copies of all promissory notes or loans used to obtain1998such funds.1999 (n) For establishments used in wholesale distribution, 2000 proof of an inspection conducted by the department, the United 2001 States Food and Drug Administration, or another governmental 2002 entity charged with the regulation of good manufacturing 2003 practices related to wholesale distribution of prescription 2004 drugs, within timeframes set forth by the department in 2005 departmental rules, which demonstrates substantial compliance 2006 with current good manufacturing practices applicable to 2007 wholesale distribution of prescription drugs. The department may 2008 recognize another state’s inspection of a wholesale distributor 2009 located in that state if such state’s laws are deemed to be 2010 substantially equivalent to the law of this state by the 2011 department. The department may accept an inspection by a third 2012 party accreditation or inspection service which meets the 2013 criteria set forth in department rule. 2014 (o)(n)Any other relevant information that the department 2015 requires, including, but not limited to, any information related2016to whether the applicant satisfies the definition of a primary2017wholesale distributor or a secondary wholesale distributor. 2018 (p)(o)Documentation of the credentialing policies and 2019 procedures required by s. 499.0121(15). 2020 (9)(a) Each person required by subsection (8) or subsection 2021 (15) to provide a personal information statement and 2022 fingerprints shall provide the following information to the 2023 department on forms prescribed by the department: 2024 1. The person’s places of residence for the past 7 years. 2025 2. The person’s date and place of birth. 2026 3. The person’s occupations, positions of employment, and 2027 offices held during the past 7 years. 2028 4. The principal business and address of any business, 2029 corporation, or other organization in which each such office of 2030 the person was held or in which each such occupation or position 2031 of employment was carried on. 2032 5. Whether the person has been, during the past 7 years, 2033 the subject of any proceeding for the revocation of any license 2034 and, if so, the nature of the proceeding and the disposition of 2035 the proceeding. 2036 6. Whether, during the past 7 years, the person has been 2037 enjoined, temporarily or permanently, by a court of competent 2038 jurisdiction from violating any federal or state law regulating 2039 the possession, control, or distribution of prescription drugs, 2040 together with details concerning any such event. 2041 7. A description of any involvement by the person with any 2042 business, including any investments, other than the ownership of 2043 stock in a publicly traded company or mutual fund, during the 2044 past 47years, which manufactured, administered, prescribed, 2045 distributed, or stored pharmaceutical products and any lawsuits 2046 in which such businesses were named as a party. 2047 8. A description of any felony criminal offense of which 2048 the person, as an adult, was found guilty, regardless of whether 2049 adjudication of guilt was withheld or whether the person pled 2050 guilty or nolo contendere. A criminal offense committed in 2051 another jurisdiction which would have been a felony in this 2052 state must be reported. If the person indicates that a criminal 2053 conviction is under appeal and submits a copy of the notice of 2054 appeal of that criminal offense, the applicant must, within 15 2055 days after the disposition of the appeal, submit to the 2056 department a copy of the final written order of disposition. 2057 9. A photograph of the person taken in the previous 180302058 days. 2059 10. A set of fingerprints for the person on a form and 2060 under procedures specified by the department, together with 2061 payment of an amount equal to the costs incurred by the 2062 department for the criminal record check of the person. 2063 11. The name, address, occupation, and date and place of 2064 birth for each member of the person’s immediate family who is 18 2065 years of age or older. As used in this subparagraph, the term 2066 “member of the person’s immediate family” includes the person’s 2067 spouse, children, parents, siblings, the spouses of the person’s 2068 children, and the spouses of the person’s siblings. 2069 12. Any other relevant information that the department 2070 requires. 2071 (b) The information required pursuant to paragraph (a) 2072 shall be provided under oath. 2073 (c) The department shall submit the fingerprints provided 2074 by a person for initial licensure to the Department of Law 2075 Enforcement for a statewide criminal record check and for 2076 forwarding to the Federal Bureau of Investigation for a national 2077 criminal record check of the person. The department shall submit 2078 the fingerprints provided by a person as a part of a renewal 2079 application to the Department of Law Enforcement for a statewide 2080 criminal record check, and for forwarding to the Federal Bureau 2081 of Investigation for a national criminal record check, for the 2082 initial renewal of a permit after January 1, 2004; for any 2083 subsequent renewal of a permit, the department shall submit the 2084 required information for a statewide and national criminal 2085 record check of the person. Any person who as a part of an 2086 initial permit application or initial permit renewal after 2087 January 1, 2004, submits to the department a set of fingerprints 2088 required for the criminal record check required in this 2089 paragraph areshallnotberequired to provide a subsequent set 2090 of fingerprints for a criminal record check to the department, 2091 if the person has undergone a criminal record check as a 2092 condition of the issuance of an initial permit or the initial 2093 renewal of a permit of an applicant after January 1, 2004. The 2094 department is authorized to contract with private vendors, or 2095 enter into interagency agreements, to collect electronic 2096 fingerprints where fingerprints are required for registration, 2097 certification, or the licensure process or where criminal 2098 history record checks are required. 2099 (d) For purposes of applying for renewal of a permit under 2100 subsection (8) or certification under subsection (16), a person 2101 may submit the following in lieu of satisfying the requirements 2102 of paragraphs (a), (b), and (c): 2103 1. A photograph of the individual taken within 180 days; 2104 and 2105 2. A copy of the personal information statement form most 2106 recently submitted to the department and a certification under 2107 oath, on a form specified by the department, that the individual 2108 has reviewed the previously submitted personal information 2109 statement form and that the information contained therein 2110 remains unchanged. 2111 (10) The department may deny an application for a permit or 2112 refuse to renew a permit for a prescription drug wholesale 2113 distributor or an out-of-state prescription drug wholesale 2114 distributor if: 2115 (a) The applicant has not met the requirements for the 2116 permit. 2117 (b) The management, officers, or directors of the applicant 2118 or any affiliated party are found by the department to be 2119 incompetent or untrustworthy. 2120 (c) The applicant is so lacking in experience in managing a 2121 wholesale distributor as to make the issuance of the proposed 2122 permit hazardous to the public health. 2123 (d) The applicant is so lacking in experience in managing a 2124 wholesale distributor as to jeopardize the reasonable promise of 2125 successful operation of the wholesale distributor. 2126 (e) The applicant is lacking in experience in the 2127 distribution of prescription drugs. 2128 (f) The applicant’s past experience in manufacturing or 2129 distributing prescription drugs indicates that the applicant 2130 poses a public health risk. 2131 (g) The applicant is affiliated directly or indirectly 2132 through ownership, control, or other business relations, with 2133 any person or persons whose business operations are or have been 2134 detrimental to the public health. 2135 (h) The applicant, or any affiliated party, has been found 2136 guilty of or has pleaded guilty or nolo contendere to any felony 2137 or crime punishable by imprisonment for 1 year or more under the 2138 laws of the United States, any state, or any other country, 2139 regardless of whether adjudication of guilt was withheld. 2140 (i) The applicant or any affiliated party has been charged 2141 with a felony in a state or federal court and the disposition of 2142 that charge is pending during the application review or renewal 2143 review period. 2144 (j) The applicant has furnished false or fraudulent 2145 information or material in any application made in this state or 2146 any other state in connection with obtaining a permit or license 2147 to manufacture or distribute drugs, devices, or cosmetics. 2148 (k) That a federal, state, or local government permit 2149 currently or previously held by the applicant, or any affiliated 2150 party, for the manufacture or distribution of any drugs, 2151 devices, or cosmetics has been disciplined, suspended, or 2152 revoked and has not been reinstated. 2153 (l) The applicant does not possess the financial or 2154 physical resources to operate in compliance with the permit 2155 being sought, this chapter, and the rules adopted under this 2156 chapter. 2157 (m) The applicant or any affiliated party receives, 2158 directly or indirectly, financial support and assistance from a 2159 person who was an affiliated party of a permittee whose permit 2160 was subject to discipline or was suspended or revoked, other 2161 than through the ownership of stock in a publicly traded company 2162 or a mutual fund. 2163 (n) The applicant or any affiliated party receives, 2164 directly or indirectly, financial support and assistance from a 2165 person who has been found guilty of any violation of this part 2166 or chapter 465, chapter 501, or chapter 893, any rules adopted 2167 under this part or those chapters, any federal or state drug 2168 law, or any felony where the underlying facts related to drugs, 2169 regardless of whether the person has been pardoned, had her or 2170 his civil rights restored, or had adjudication withheld, other 2171 than through the ownership of stock in a publicly traded company 2172 or a mutual fund. 2173 (o) The applicant for renewal of a permit under s. 2174 499.01(2)(e) or (f)499.01(2)(d) or (e)has not actively engaged 2175 in the wholesale distribution of prescription drugs, as 2176 demonstrated by the regular and systematic distribution of 2177 prescription drugs throughout the year as evidenced by not fewer 2178 than 12 wholesale distributions in the previous year and not 2179 fewer than three wholesale distributions in the previous 6 2180 months. 2181 (p) Information obtained in response to s. 499.01(2)(e) or 2182 (f)499.01(2)(d) or (e)demonstrates it would not be in the best 2183 interest of the public health, safety, and welfare to issue a 2184 permit. 2185 (q) The applicant does not possess the financial standing 2186 and business experience for the successful operation of the 2187 applicant. 2188 (r) The applicant or any affiliated party has failed to 2189 comply with the requirements for manufacturing or distributing 2190 prescription drugs under this part, similar federal laws, 2191 similar laws in other states, or the rules adopted under such 2192 laws. 2193 (11) Upon approval of the application by the department and 2194 payment of the required fee, the department shall issue or renew 2195 a prescription drug wholesale distributor or an out-of-state 2196 prescription drug wholesale distributor permit to the applicant. 2197(12)For a permit for a prescription drug wholesale2198distributor or an out-of-state prescription drug wholesale2199distributor:2200(a)The department shall adopt rules for the annual renewal2201of permits. At least 90 days before the expiration of a permit,2202the department shall forward a permit renewal notification and2203renewal application to the prescription drug wholesale2204distributor or out-of-state prescription drug wholesale2205distributor at the mailing address of the permitted2206establishment on file with the department. The permit renewal2207notification must state conspicuously the date on which the2208permit for the establishment will expire and that the2209establishment may not operate unless the permit for the2210establishment is renewed timely.2211(b)A permit, unless sooner suspended or revoked,2212automatically expires 1 year after the last day of the2213anniversary month in which the permit was originally issued. A2214permit may be renewed by making application for renewal on forms2215furnished by the department and paying the appropriate fees. If2216a renewal application and fee are submitted and postmarked after221745 days prior to the expiration date of the permit, the permit2218may be renewed only upon payment of a late renewal fee of $100,2219plus the required renewal fee. A permittee that has submitted a2220renewal application in accordance with this paragraph may2221continue to operate under its permit, unless the permit is2222suspended or revoked, until final disposition of the renewal2223application.2224(c)Failure to renew a permit in accordance with this2225section precludes any future renewal of that permit. If a permit2226issued pursuant to this section has expired and cannot be2227renewed, before an establishment may engage in activities that2228require a permit under this part, the establishment must submit2229an application for a new permit; pay the applicable application2230fee, initial permit fee, and all applicable penalties; and be2231issued a new permit by the department.2232 (12)(13)A person that engages in wholesale distribution of 2233 prescription drugs in this state must have a wholesale 2234 distributor’s permit issued by the department, except as noted 2235 in this section. Each establishment must be separately permitted 2236 except as noted in this subsection. 2237 (a) A separate establishment permit is not required when a 2238 permitted prescription drug wholesale distributor consigns a 2239 prescription drug to a pharmacy that is permitted under chapter 2240 465 and located in this state, provided that: 2241 1. The consignor wholesale distributor notifies the 2242 department in writing of the contract to consign prescription 2243 drugs to a pharmacy along with the identity and location of each 2244 consignee pharmacy; 2245 2. The pharmacy maintains its permit under chapter 465; 2246 3. The consignor wholesale distributor, which has no legal 2247 authority to dispense prescription drugs, complies with all 2248 wholesale distribution requirements of s.ss.499.0121and2249499.01212with respect to the consigned drugs and maintains 2250 records documenting the transfer of title or other completion of 2251 the wholesale distribution of the consigned prescription drugs; 2252 4. The distribution of the prescription drug is otherwise 2253 lawful under this chapter and other applicable law; 2254 5. Open packages containing prescription drugs within a 2255 pharmacy are the responsibility of the pharmacy, regardless of 2256 how the drugs are titled; and 2257 6. The pharmacy dispenses the consigned prescription drug 2258 in accordance with the limitations of its permit under chapter 2259 465 or returns the consigned prescription drug to the consignor 2260 wholesale distributor. In addition, a person who holds title to 2261 prescription drugs may transfer the drugs to a person permitted 2262 or licensed to handle the reverse distribution or destruction of 2263 drugs. Any other distribution by and means of the consigned 2264 prescription drug by any person, not limited to the consignor 2265 wholesale distributor or consignee pharmacy, to any other person 2266 is prohibited. 2267 (b) A wholesale distributor’s permit is not required for 2268 the one-time transfer of title of a pharmacy’s lawfully acquired 2269 prescription drug inventory by a pharmacy with a valid permit 2270 issued under chapter 465 to a consignor prescription drug 2271 wholesale distributor, permitted under this chapter, in 2272 accordance with a written consignment agreement between the 2273 pharmacy and that wholesale distributor if the permitted 2274 pharmacy and the permitted prescription drug wholesale 2275 distributor comply with all of the provisions of paragraph (a) 2276 and the prescription drugs continue to be within the permitted 2277 pharmacy’s inventory for dispensing in accordance with the 2278 limitations of the pharmacy permit under chapter 465. A 2279 consignor drug wholesale distributor may not use the pharmacy as 2280 a wholesale distributor through which it distributes the 2281 prescription drugs to other pharmacies. Nothing in this section 2282 is intended to prevent a wholesale distributor from obtaining 2283 this inventory in the event of nonpayment by the pharmacy. 2284 (c) A separate establishment permit is not required when a 2285 permitted prescription drug wholesale distributor operates 2286 temporary transit storage facilities for the sole purpose of 2287 storage, for up to 16 hours, of a delivery of prescription drugs 2288 when the wholesale distributor was temporarily unable to 2289 complete the delivery to the recipient. 2290 (d) The department shall require information from each 2291 wholesale distributor as part of the permit and renewal of such 2292 permit, as required under this section. 2293 (13)(14)Personnel employed in wholesale distribution must 2294 have appropriate education and experience to enable them to 2295 perform their duties in compliance with state permitting 2296 requirements. 2297 (14)(15)The name of a permittee or establishment on a 2298 prescription drug wholesale distributor permit or an out-of 2299 state prescription drug wholesale distributor permit may not 2300 include any indicia of attainment of any educational degree, any 2301 indicia that the permittee or establishment possesses a 2302 professional license, or any name or abbreviation that the 2303 department determines is likely to cause confusion or mistake or 2304 that the department determines is deceptive, including that of 2305 any other entity authorized to purchase prescription drugs. 2306 (15)(16)(a) Each establishment that is issued an initial or 2307 renewal permit as a prescription drug wholesale distributor or 2308 an out-of-state prescription drug wholesale distributor must 2309 designate in writing to the department at least one natural 2310 person to serve as the designated representative of the 2311 wholesale distributor. Such person must have an active 2312 certification as a designated representative from the 2313 department. 2314 (b) To be certified as a designated representative, a 2315 natural person must: 2316 1. Submit an application on a form furnished by the 2317 department and pay the appropriate fees. 2318 2. Be at least 18 years of age. 2319 3. Have at least 2 years of verifiable full-time: 2320 a. Work experience in a pharmacy licensed in this state or 2321 another state, where the person’s responsibilities included, but 2322 were not limited to, recordkeeping for prescription drugs; 2323 b. Managerial experience with a prescription drug wholesale 2324 distributor licensed in this state or in another state; or 2325 c. Managerial experience with the United States Armed 2326 Forces, where the person’s responsibilities included, but were 2327 not limited to, recordkeeping, warehousing, distributing, or 2328 other logistics services pertaining to prescription drugs. 2329 4. Receive a passing score of at least 75 percent on an 2330 examination given by the department regarding federal laws 2331 governing distribution of prescription drugs and this part and 2332 the rules adopted by the department governing the wholesale 2333 distribution of prescription drugs. This requirement shall be 2334 effective 1 year after the results of the initial examination 2335 are mailed to the persons that took the examination. The 2336 department shall offer such examinations at least four times 2337 each calendar year. 2338 5. Provide the department with a personal information 2339 statement and fingerprints pursuant to subsection (9). 2340 (c) The department may deny an application for 2341 certification as a designated representative or may suspend or 2342 revoke a certification of a designated representative pursuant 2343 to s. 499.067. 2344 (d) A designated representative: 2345 1. Must be actively involved in and aware of the actual 2346 daily operation of the wholesale distributor. 2347 2. Must be employed full time in a managerial position by 2348 the wholesale distributor. 2349 3. Must be physically present at the establishment during 2350 normal business hours, except for time periods when absent due 2351 to illness, family illness or death, scheduled vacation, or 2352 other authorized absence. 2353 4. May serve as a designated representative for only one 2354 wholesale distributor at any one time. 2355 (e) A wholesale distributor must notify the department when 2356 a designated representative leaves the employ of the wholesale 2357 distributor. Such notice must be provided to the department 2358 within 10 business days after the last day of designated 2359 representative’s employment with the wholesale distributor. 2360 (f) A wholesale distributor may not operate under a 2361 prescription drug wholesale distributor permit or an out-of 2362 state prescription drug wholesale distributor permit for more 2363 than 10 business days after the designated representative leaves 2364 the employ of the wholesale distributor, unless the wholesale 2365 distributor employs another designated representative and 2366 notifies the department within 10 business days of the identity 2367 of the new designated representative. 2368 Section 7. Section 499.01201, Florida Statutes, is amended 2369 to read: 2370 499.01201 Agency for Health Care Administration review and 2371 use of statute and rule violation or compliance data. 2372 Notwithstanding any other provisionprovisionsof lawto the2373contrary, the Agency for Health Care Administration may not: 2374 (1) Review or use any violation or alleged violation of s. 2375 499.0121(6)or s. 499.01212, or any rules adopted under that 2376 sectionthose sections, as a ground for denying or withholding 2377 any payment of a Medicaid reimbursement to a pharmacy licensed 2378 under chapter 465; or 2379 (2) Review or use compliance with s. 499.0121(6)or s.2380499.01212, or any rules adopted under that sectionthose2381sections, as the subject of any audit of Medicaid-related 2382 records held by a pharmacy licensed under chapter 465. 2383 Section 8. Paragraph (d) of subsection (4), subsection (6), 2384 and paragraph (b) of subsection (15) of section 499.0121, 2385 Florida Statutes, are amended to read: 2386 499.0121 Storage and handling of prescription drugs; 2387 recordkeeping.—The department shall adopt rules to implement 2388 this section as necessary to protect the public health, safety, 2389 and welfare. Such rules shall include, but not be limited to, 2390 requirements for the storage and handling of prescription drugs 2391 and for the establishment and maintenance of prescription drug 2392 distribution records. 2393 (4) EXAMINATION OF MATERIALS AND RECORDS.— 2394 (d) Upon receipt, a wholesale distributor must review 2395 records required under this section for the acquisition of 2396 prescription drugs for accuracy and completeness, considering 2397 the total facts and circumstances surrounding the transactions 2398 and the wholesale distributors involved.This includes2399authenticating each transaction listed on a pedigree paper, as2400defined in s. 499.003(37).2401 (6) RECORDKEEPING.—The department shall adopt rules that 2402 require keeping such records of prescription drugs, including 2403 active pharmaceutical ingredients, as are necessary for the 2404 protection of the public health. 2405 (a) The following persons must maintain business records 2406 that include the information specified in paragraph (b) 2407Wholesale distributors must establish and maintain inventories2408and records of all transactions regarding the receipt and2409distribution or other disposition of prescription drugs. These2410records must provide a complete audit trail from receipt to sale2411or other disposition, be readily retrievable for inspection, and2412include, at a minimum, the following information: 2413 1. Persons permitted or required to be permitted under 2414 chapter 499 to engage in the manufacture, repackaging, or 2415 distribution of active pharmaceutical ingredients or 2416 prescription drugs.The source of the drugs, including the name2417and principal address of the seller or transferor, and the2418address of the location from which the drugs were shipped;2419 2. Persons other than those set forth in subparagraph 1. 2420 that engage in the receipt of active pharmaceutical ingredients 2421 or prescription drugs.The name, principal address, and state2422license permit or registration number of the person authorized2423to purchase prescription drugs;24243. The name, strength, dosage form, and quantity of the2425drugs received and distributed or disposed of;24264. The dates of receipt and distribution or other2427disposition of the drugs; and24285.Any financial documentation supporting the transaction.2429 (b) Business records for persons specified in paragraph (a) 2430 must include: 2431 1. The name and address of the seller, and the Florida 2432 permit number of the seller if such seller is not exempt from 2433 Florida permitting requirements, of the active pharmaceutical 2434 ingredient or prescription drug. 2435 2. The address of the location the active pharmaceutical 2436 ingredient or prescription drug was shipped from. 2437 3. The distribution date of the active pharmaceutical 2438 ingredient or prescription drug. 2439 4. The name, strength, and quantity, and the National Drug 2440 Code if such code has been assigned, of the distributed active 2441 pharmaceutical ingredient or prescription drug. 2442 5. The name and Florida permit number of the person that 2443 purchased the active pharmaceutical ingredient or prescription 2444 drug. 2445 6. The financial data, including the unit type and unit 2446 price, for the distributions involving active pharmaceutical 2447 ingredients or prescription drugs. 2448 7. The date and method of disposition of the active 2449 pharmaceutical ingredient or prescription drug.Inventories and2450records must be made available for inspection and photocopying2451by authorized federal, state, or local officials for a period of24522 years following disposition of the drugs or 3 years after the2453creation of the records, whichever period is longer.2454 (c) Each manufacturer or repackager of medical devices, 2455 over-the-counter drugs, or cosmetics must maintain business 2456 records that include: 2457 1. The name and address of the seller or transferor of the 2458 product. 2459 2. The address of the location the product was shipped 2460 from. 2461 3. The date of the sale or distribution of the product. 2462 4. The name and quantity of the product involved. 2463 5. The name and address of the person who purchased the 2464 productRecords described in this section that are kept at the2465inspection site or that can be immediately retrieved by computer2466or other electronic means must be readily available for2467authorized inspection during the retention period. Records that2468are kept at a central location outside of this state and that2469are not electronically retrievable must be made available for2470inspection within 2 working days after a request by an2471authorized official of a federal, state, or local law2472enforcement agency. Records that are maintained at a central2473location within this state must be maintained at an2474establishment that is permitted pursuant to this part and must2475be readily available. 2476 (d) Persons permitted, or required to be permitted, under 2477 this chapter to engage in the manufacture, repackaging, or 2478 distribution of active pharmaceutical ingredients or 2479 prescription drugs; or the manufacture or repackaging of medical 2480 devices, over-the-counter drugs, and cosmetics; must establish, 2481 maintain, or have the capability to create a current inventory 2482 of the active pharmaceutical ingredients, prescription drugs, 2483 over-the-counter drugs, cosmetics, and devices at an 2484 establishment where activities specified in this paragraph are 2485 undertaken and must be able to produce such inventory for 2486 inspection by the department within 2 business daysEach2487manufacturer or repackager of medical devices, over-the-counter2488drugs, or cosmetics must maintain records that include the name2489and principal address of the seller or transferor of the2490product, the address of the location from which the product was2491shipped, the date of the transaction, the name and quantity of2492the product involved, and the name and principal address of the2493person who purchased the product. 2494 (e) Business records required to be kept pursuant to this 2495 section, and that are kept at the inspection site or can be 2496 immediately retrieved by computer or other electronic means, 2497 must be readily available for authorized inspection during the 2498 retention period. Records kept at a central location outside of 2499 this state which are not electronically retrievable must be made 2500 available for inspection within 2 working days after a request 2501 by an authorized official of a federal, state, or local law 2502 enforcement agency. Records maintained at a central location 2503 within this state must be maintained at an establishment that is 2504 permitted pursuant to this part and such records must be readily 2505 available for inspectionWhen pedigree papers are required by2506this part, a wholesale distributor must maintain the pedigree2507papers separate and distinct from other records required under2508this part. 2509 (f) Records required to be kept pursuant to this subsection 2510 must be maintained as specified for a period of not less than 6 2511 years from the date of disposition of the active pharmaceutical 2512 ingredients, prescription drugs, over-the-counter drugs, medical 2513 devices, or cosmetics. 2514 (g) To the extent that prescription drugs are also products 2515 as defined in the federal act, as amended, and the information 2516 required by the business records requirements of this section 2517 are also included in the tracking and tracing requirements of 2518 the federal act, as amended, and departmental rules, the 2519 manufacturer, wholesale distributor, repackager, or dispenser 2520 must follow both the requirements of the federal act, as 2521 amended, and departmental rules. 2522 (15) DUE DILIGENCE OF PURCHASERS.— 2523 (b) A wholesale distributor must take reasonable measures 2524 to identify its customers, understand the normal and expected 2525 transactions conducted by those customers, and identify those 2526 transactions that are suspicious in nature. A wholesale 2527 distributor must establish internal policies and procedures for 2528 identifying suspicious orders and preventing suspicious 2529 transactions. A wholesale distributor must assess orders for 2530 moregreaterthan 7,5005,000unit doses of any one controlled 2531 substance in any one month to determine whether the purchase is 2532 reasonable. In making such assessments, a wholesale distributor 2533 may consider the purchasing entity’s clinical business needs, 2534 location, and population served, in addition to other factors 2535 established in the distributor’s policies and procedures. A 2536 wholesale distributor must report to the department any 2537 regulated transaction involving an extraordinary quantity of a 2538 listed chemical, an uncommon method of payment or delivery, or 2539 any other circumstance that the regulated person believes may 2540 indicate that the listed chemical will be used in violation of 2541 the law. The wholesale distributor shall maintain records that 2542 document the report submitted to the department in compliance 2543 with this paragraph. 2544 Section 9. Subsection (4) of section 499.015, Florida 2545 Statues, is amended to read: 2546 499.015 Registration of drugs, devices, and cosmetics; 2547 issuance of certificates of free sale.— 2548 (4) Unless a registration is renewed, it expires 2 years 2549 after the last day of the month in which it was issued. Any 2550 product registration issued or renewed on or after July 1, 2016, 2551 shall expire on the same date as the manufacturer or repackager 2552 permit of the person seeking to register the product. If the 2553 first product registration issued to a person on or after July 2554 1, 2016, expires less than 366 days after issuance, the fee for 2555 product registration shall be $15. If the first product 2556 registration issued to a person on or after July 1, 2016, 2557 expires more than 365 days after issuance, the fee for product 2558 registration shall be $30. The department may issue a stop-sale 2559 notice or order against a person that is subject to the 2560 requirements of this section and that fails to comply with this 2561 section within 31 days after the date the registration expires. 2562 The notice or order shall prohibit such person from selling or 2563 causing to be sold any drugs, devices, or cosmetics covered by 2564 this part until he or she complies with the requirements of this 2565 section. 2566 Section 10. Subsection (1) of section 499.03, Florida 2567 Statutes, is amended to read: 2568 499.03 Possession of certain drugs without prescriptions 2569 unlawful; exemptions and exceptions.— 2570 (1) A person may not possess, or possess with intent to 2571 sell, dispense, or deliver, any habit-forming, toxic, harmful, 2572 or new drug subject to s. 499.003(32)499.003(33), or 2573 prescription drug as defined in s. 499.003(40)499.003(43), 2574 unless the possession of the drug has been obtained by a valid 2575 prescription of a practitioner licensed by law to prescribe the 2576 drug. However, this section does not apply to the delivery of 2577 such drugs to persons included in any of the classes named in 2578 this subsection, or to the agents or employees of such persons, 2579 for use in the usual course of their businesses or practices or 2580 in the performance of their official duties, as the case may be; 2581 nor does this section apply to the possession of such drugs by 2582 those persons or their agents or employees for such use: 2583 (a) A licensed pharmacist or any person under the licensed 2584 pharmacist’s supervision while acting within the scope of the 2585 licensed pharmacist’s practice; 2586 (b) A licensed practitioner authorized by law to prescribe 2587 prescription drugs or any person under the licensed 2588 practitioner’s supervision while acting within the scope of the 2589 licensed practitioner’s practice; 2590 (c) A qualified person who uses prescription drugs for 2591 lawful research, teaching, or testing, and not for resale; 2592 (d) A licensed hospital or other institution that procures 2593 such drugs for lawful administration or dispensing by 2594 practitioners; 2595 (e) An officer or employee of a federal, state, or local 2596 government; or 2597 (f) A person that holds a valid permit issued by the 2598 department pursuant to this part which authorizes that person to 2599 possess prescription drugs. 2600 Section 11. Paragraphs (i) through (p) of subsection (1) of 2601 section 499.05, Florida Statutes, are amended to read: 2602 499.05 Rules.— 2603 (1) The department shall adopt rules to implement and 2604 enforce this chapter with respect to: 2605 (i) Additional conditions that qualify as an emergency 2606 medical reason under s. 499.003(48)(b)2.499.003(53)(b)2.or s. 2607 499.82. 2608(j)Procedures and forms relating to the pedigree paper2609requirement of s. 499.01212.2610 (j)(k)The protection of the public health, safety, and 2611 welfare regarding good manufacturing practices that 2612 manufacturers and repackagers must follow to ensure the safety 2613 of the products. 2614 (k)(l)Information required from each retail establishment 2615 pursuant to s. 499.012(3) or s. 499.83(2)(c), including 2616 requirements for prescriptions or orders. 2617 (l)(m)The recordkeeping, storage, and handling with 2618 respect to each of the distributions of prescription drugs 2619 specified in s. 499.003(48)(a)-(v)499.003(53)(a)-(d)or s. 2620 499.82(14). 2621(n)Alternatives to compliance with s. 499.01212 for a2622prescription drug in the inventory of a permitted prescription2623drug wholesale distributor as of June 30, 2006, and the return2624of a prescription drug purchased prior to July 1, 2006. The2625department may specify time limits for such alternatives.2626 (m)(o)Wholesale distributor reporting requirements of s. 2627 499.0121(14). 2628 (n)(p)Wholesale distributor credentialing and distribution 2629 requirements of s. 499.0121(15). 2630 Section 12. Subsection (7) of section 499.051, Florida 2631 Statutes, is amended to read: 2632 499.051 Inspections and investigations.— 2633 (7) The complaint and all information obtained pursuant to 2634 the investigation by the department are confidential and exempt 2635 from s. 119.07(1) and s. 24(a), Art. I of the State Constitution 2636 until the investigation and the enforcement action are 2637 completed. However, trade secret information contained therein 2638 as defined by s. 812.081(1)(c) shall remain confidential and 2639 exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I 2640 of the State Constitution, as long as the information is 2641 retained by the department. This subsection does not prohibit 2642 the department from using such information for regulatory or 2643 enforcement proceedings under this chapter or from providing 2644 such information to any law enforcement agency or any other 2645 regulatory agency. However, the receiving agency shall keep such 2646 records confidential and exempt as provided in this subsection. 2647In addition, this subsection is not intended to prevent2648compliance with the provisions of s. 499.01212, and the pedigree2649papers required in that section shall not be deemed a trade2650secret.2651 Section 13. Subsection (8) is added to section 499.066, 2652 Florida Statutes, to read: 2653 499.066 Penalties; remedies.—In addition to other penalties 2654 and other enforcement provisions: 2655 (8)(a) The department shall adopt rules to permit the 2656 issuance of remedial, nondisciplinary citations. A citation 2657 shall be issued to the person alleged to have committed a 2658 violation and contain the person’s name, address, and license 2659 number, if applicable, a brief factual statement, the sections 2660 of the law allegedly violated, and the monetary assessment and 2661 or other remedial measures imposed. The citation must clearly 2662 state that the person may choose, in lieu of accepting the 2663 citation, to have the department rescind the citation and 2664 conduct an investigation pursuant to s. 499.051. If the person 2665 does not dispute the matter in the citation with the department 2666 within 30 days after the citation is served, the citation 2667 becomes a final order and does not constitute discipline. 2668 (b) The department shall adopt rules designating violations 2669 for which a citation may be issued. The rules shall designate as 2670 citable those violations for which there is no substantial 2671 threat to the public health, safety, or welfare. 2672 (c) The department is entitled to recover the costs of 2673 investigation, in addition to any penalty provided according to 2674 department rule, as part of the penalty levied pursuant to the 2675 citation. 2676 (d) A citation must be issued within 12 months after the 2677 filing of the complaint that is the basis for the citation. 2678 (e) Service of a citation may be made by personal service 2679 or certified mail, restricted delivery, to the person at the 2680 person’s last known address of record with the department or to 2681 the person’s Florida registered agent. 2682 (f) The department has authority to, and shall adopt rules 2683 to, designate those violations for which a person is subject to 2684 the issuance of a citation and designate the monetary 2685 assessments and or other remedial measures that must be taken 2686 for those violations. The department has continuous authority to 2687 amend its rules adopted pursuant to this section. 2688 Section 14. Subsection (14) of section 499.82, Florida 2689 Statutes, is amended to read: 2690 499.82 Definitions.—As used in this part, the term: 2691 (14) “Wholesale distribution” means the distribution of 2692 medical gas to a person other than a consumer or patient. 2693 Wholesale distribution of medical gases does not include: 2694 (a) The sale, purchase, or trade of a medical gas; an offer 2695 to sell, purchase, or trade a medical gas; or the dispensing of 2696 a medical gas pursuant to a prescription; 2697 (b) Activities exempt from the definition of wholesale 2698 distribution in s. 499.003; or 2699 (c) The sale, purchase, or trade of a medical gas or an 2700 offer to sell, purchase, or trade a medical gas for emergency 2701 medical reasons; or2702(d)Other transactions excluded from the definition of2703wholesale distribution under the federal act or regulations2704implemented under the federal act related to medical gas. 2705 Section 15. Subsection (6) of section 499.83, Florida 2706 Statutes, is created to read: 2707 499.83 Permits.— 2708 (6) A hospice licensed by the Agency for Health Care 2709 Administration pursuant to part IV of chapter 400 is not 2710 required to obtain medical oxygen retail establishment permit to 2711 purchase on behalf of and sell medical oxygen to its hospice 2712 patients, if the hospice contracts for the purchase and delivery 2713 of medical oxygen from an establishment permitted pursuant to 2714 this part. Sale and delivery to patients by hospices pursuant to 2715 this subsection must be based upon on a prescription or an order 2716 from a practitioner authorized by law to prescribe medical 2717 oxygen. For sales to hospices pursuant to this subsection, the 2718 medical gas wholesale distributor or the medical gas 2719 manufacturer selling medical oxygen to a hospice shall reflect 2720 on its invoice the hospice license number provided by the Agency 2721 for Health Care Administration and shall maintain such record 2722 pursuant to s. 499.89. Both the hospice and the medical oxygen 2723 retailer delivering medical oxygen to the patient must maintain 2724 a copy of a valid order or prescription for medical oxygen in 2725 accordance with s. 499.89 and department rule, which copy must 2726 be readily available for inspection. 2727 Section 16. Subsection (4) of section 499.89, Florida 2728 Statutes, is amended to read: 2729 499.89 Recordkeeping.— 2730(4)A pedigree paper is not required for distributing or2731dispensing medical gas.2732 Section 17. Section 499.01212, Florida Statutes, is 2733 repealed. 2734 Section 18. Paragraph (a) of subsection (1) of section 2735 409.9201, Florida Statutes, is amended to read: 2736 409.9201 Medicaid fraud.— 2737 (1) As used in this section, the term: 2738 (a) “Prescription drug” means any drug, including, but not 2739 limited to, finished dosage forms or active ingredients that are 2740 subject to, defined in, or described in s. 503(b) of the Federal 2741 Food, Drug, and Cosmetic Act or in s. 465.003(8), s. 499.003(47) 2742499.003(52), s. 499.007(13), or s. 499.82(10). 2743 2744 The value of individual items of the legend drugs or goods or 2745 services involved in distinct transactions committed during a 2746 single scheme or course of conduct, whether involving a single 2747 person or several persons, may be aggregated when determining 2748 the punishment for the offense. 2749 Section 19. Paragraph (b) of subsection (1) of section 2750 499.067, Florida Statutes, is amended to read: 2751 499.067 Denial, suspension, or revocation of permit, 2752 certification, or registration.— 2753 (1) 2754 (b) The department may deny an application for a permit or 2755 certification, or suspend or revoke a permit or certification, 2756 if the department finds that: 2757 1. The applicant is not of good moral character or that it 2758 would be a danger or not in the best interest of the public 2759 health, safety, and welfare if the applicant were issued a 2760 permit or certification. 2761 2. The applicant has not met the requirements for the 2762 permit or certification. 2763 3. The applicant is not eligible for a permit or 2764 certification for any of the reasons enumerated in s. 499.012. 2765 4. The applicant, permittee, or person certified under s. 2766 499.012(15)s. 499.012(16)demonstrates any of the conditions 2767 enumerated in s. 499.012. 2768 5. The applicant, permittee, or person certified under s. 2769 499.012(15)s. 499.012(16)has committed any violation of this 2770 chapter. 2771 Section 20. Subsection (1) of section 794.075, Florida 2772 Statutes, is amended to read: 2773 794.075 Sexual predators; erectile dysfunction drugs.— 2774 (1) A person may not possess a prescription drug, as 2775 defined in s. 499.003(40)499.003(43), for the purpose of 2776 treating erectile dysfunction if the person is designated as a 2777 sexual predator under s. 775.21. 2778 Section 21. Paragraphs (d), (f), (i), and (j) of subsection 2779 (3) of section 921.0022, Florida Statutes, are amended to read: 2780 921.0022 Criminal Punishment Code; offense severity ranking 2781 chart.— 2782 (3) OFFENSE SEVERITY RANKING CHART 2783 (d) LEVEL 4 2784 2785 2786 FloridaStatute FelonyDegree Description 2787 316.1935(3)(a) 2nd Driving at high speed or with wanton disregard for safety while fleeing or attempting to elude law enforcement officer who is in a patrol vehicle with siren and lights activated. 2788 499.0051(1) 3rd Failure to maintain or deliver transaction history, transaction information, or transaction statementspedigree papers. 2789499.0051(2)3rdFailure to authenticate pedigree papers.2790 499.0051(5)499.0051(6)2nd Knowing sale or delivery, or possession with intent to sell, contraband prescription drugs. 2791 517.07(1) 3rd Failure to register securities. 2792 517.12(1) 3rd Failure of dealer, associated person, or issuer of securities to register. 2793 784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, etc. 2794 784.074(1)(c) 3rd Battery of sexually violent predators facility staff. 2795 784.075 3rd Battery on detention or commitment facility staff. 2796 784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials. 2797 784.08(2)(c) 3rd Battery on a person 65 years of age or older. 2798 784.081(3) 3rd Battery on specified official or employee. 2799 784.082(3) 3rd Battery by detained person on visitor or other detainee. 2800 784.083(3) 3rd Battery on code inspector. 2801 784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials. 2802 787.03(1) 3rd Interference with custody; wrongly takes minor from appointed guardian. 2803 787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings. 2804 787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person. 2805 787.07 3rd Human smuggling. 2806 790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school. 2807 790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property. 2808 790.115(2)(c) 3rd Possessing firearm on school property. 2809 800.04(7)(c) 3rd Lewd or lascivious exhibition; offender less than 18 years. 2810 810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery. 2811 810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery. 2812 810.06 3rd Burglary; possession of tools. 2813 810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon. 2814 812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000. 2815 812.014 (2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc. 2816 812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more. 2817 817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs. 2818 817.568(2)(a) 3rd Fraudulent use of personal identification information. 2819 817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder. 2820 828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle. 2821 837.02(1) 3rd Perjury in official proceedings. 2822 837.021(1) 3rd Make contradictory statements in official proceedings. 2823 838.022 3rd Official misconduct. 2824 839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency. 2825 839.13(2)(c) 3rd Falsifying records of the Department of Children and Families. 2826 843.021 3rd Possession of a concealed handcuff key by a person in custody. 2827 843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication. 2828 843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping). 2829 847.0135(5)(c) 3rd Lewd or lascivious exhibition using computer; offender less than 18 years. 2830 874.05(1)(a) 3rd Encouraging or recruiting another to join a criminal gang. 2831 893.13(2)(a)1. 2nd Purchase of cocaine (or other s. 893.03(1)(a), (b), or (d), (2)(a), (2)(b), or (2)(c)4. drugs). 2832 914.14(2) 3rd Witnesses accepting bribes. 2833 914.22(1) 3rd Force, threaten, etc., witness, victim, or informant. 2834 914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury. 2835 918.12 3rd Tampering with jurors. 2836 934.215 3rd Use of two-way communications device to facilitate commission of a crime. 2837 2838 (f) LEVEL 6 2839 2840 2841 FloridaStatute FelonyDegree Description 2842 316.027(2)(b) 2nd Leaving the scene of a crash involving serious bodily injury. 2843 316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction. 2844 400.9935(4)(c) 2nd Operating a clinic, or offering services requiring licensure, without a license. 2845 499.0051(2)499.0051(3)2nd Knowing forgery of transaction history, transaction information, or transaction statementpedigree papers. 2846 499.0051(3)499.0051(4)2nd Knowing purchase or receipt of prescription drug from unauthorized person. 2847 499.0051(4)499.0051(5)2nd Knowing sale or transfer of prescription drug to unauthorized person. 2848 775.0875(1) 3rd Taking firearm from law enforcement officer. 2849 784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill. 2850 784.021(1)(b) 3rd Aggravated assault; intent to commit felony. 2851 784.041 3rd Felony battery; domestic battery by strangulation. 2852 784.048(3) 3rd Aggravated stalking; credible threat. 2853 784.048(5) 3rd Aggravated stalking of person under 16. 2854 784.07(2)(c) 2nd Aggravated assault on law enforcement officer. 2855 784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff. 2856 784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older. 2857 784.081(2) 2nd Aggravated assault on specified official or employee. 2858 784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee. 2859 784.083(2) 2nd Aggravated assault on code inspector. 2860 787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01. 2861 790.115(2)(d) 2nd Discharging firearm or weapon on school property. 2862 790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property. 2863 790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property. 2864 790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles. 2865 794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult. 2866 794.05(1) 2nd Unlawful sexual activity with specified minor. 2867 800.04(5)(d) 3rd Lewd or lascivious molestation; victim 12 years of age or older but less than 16 years of age; offender less than 18 years. 2868 800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older. 2869 806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person. 2870 810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery. 2871 810.145(8)(b) 2nd Video voyeurism; certain minor victims; 2nd or subsequent offense. 2872 812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree. 2873 812.014(6) 2nd Theft; property stolen $3,000 or more; coordination of others. 2874 812.015(9)(a) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction. 2875 812.015(9)(b) 2nd Retail theft; property stolen $3,000 or more; coordination of others. 2876 812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery). 2877 817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones. 2878 825.102(1) 3rd Abuse of an elderly person or disabled adult. 2879 825.102(3)(c) 3rd Neglect of an elderly person or disabled adult. 2880 825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult. 2881 825.103(3)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $10,000. 2882 827.03(2)(c) 3rd Abuse of a child. 2883 827.03(2)(d) 3rd Neglect of a child. 2884 827.071(2) & (3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance. 2885 836.05 2nd Threats; extortion. 2886 836.10 2nd Written threats to kill or do bodily injury. 2887 843.12 3rd Aids or assists person to escape. 2888 847.011 3rd Distributing, offering to distribute, or possessing with intent to distribute obscene materials depicting minors. 2889 847.012 3rd Knowingly using a minor in the production of materials harmful to minors. 2890 847.0135(2) 3rd Facilitates sexual conduct of or with a minor or the visual depiction of such conduct. 2891 914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury. 2892 944.35(3)(a)2. 3rd Committing malicious battery upon or inflicting cruel or inhuman treatment on an inmate or offender on community supervision, resulting in great bodily harm. 2893 944.40 2nd Escapes. 2894 944.46 3rd Harboring, concealing, aiding escaped prisoners. 2895 944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility. 2896 951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility. 2897 2898 (i) LEVEL 9 2899 2900 FloridaStatute FelonyDegree Description 2901 316.193 (3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information. 2902 327.35 (3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information. 2903 409.920 (2)(b)1.c. 1st Medicaid provider fraud; $50,000 or more. 2904 499.0051(8)499.0051(9)1st Knowing sale or purchase of contraband prescription drugs resulting in great bodily harm. 2905 560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter. 2906 560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000. 2907 655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution. 2908 775.0844 1st Aggravated white collar crime. 2909 782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder. 2910 782.04(3) 1st,PBL Accomplice to murder in connection with arson, sexual battery, robbery, burglary, aggravated fleeing or eluding with serious bodily injury or death, and other specified felonies. 2911 782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3). 2912 782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult. 2913 787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage. 2914 787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony. 2915 787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function. 2916 787.02(3)(a) 1st,PBL False imprisonment; child under age 13; perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. 2917 787.06(3)(c)1. 1st Human trafficking for labor and services of an unauthorized alien child. 2918 787.06(3)(d) 1st Human trafficking using coercion for commercial sexual activity of an unauthorized adult alien. 2919 787.06(3)(f)1. 1st,PBL Human trafficking for commercial sexual activity by the transfer or transport of any child from outside Florida to within the state. 2920 790.161 1st Attempted capital destructive device offense. 2921 790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction. 2922 794.011(2) 1st Attempted sexual battery; victim less than 12 years of age. 2923 794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years. 2924 794.011(4)(a) 1st,PBL Sexual battery, certain circumstances; victim 12 years of age or older but younger than 18 years; offender 18 years or older. 2925 794.011(4)(b) 1st Sexual battery, certain circumstances; victim and offender 18 years of age or older. 2926 794.011(4)(c) 1st Sexual battery, certain circumstances; victim 12 years of age or older; offender younger than 18 years. 2927 794.011(4)(d) 1st,PBL Sexual battery, certain circumstances; victim 12 years of age or older; prior conviction for specified sex offenses. 2928 794.011(8)(b) 1st,PBL Sexual battery; engage in sexual conduct with minor 12 to 18 years by person in familial or custodial authority. 2929 794.08(2) 1st Female genital mutilation; victim younger than 18 years of age. 2930 800.04(5)(b) Life Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older. 2931 812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon. 2932 812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon. 2933 812.135(2)(b) 1st Home-invasion robbery with weapon. 2934 817.535(3)(b) 1st Filing false lien or other unauthorized document; second or subsequent offense; property owner is a public officer or employee. 2935 817.535(4)(a)2. 1st Filing false claim or other unauthorized document; defendant is incarcerated or under supervision. 2936 817.535(5)(b) 1st Filing false lien or other unauthorized document; second or subsequent offense; owner of the property incurs financial loss as a result of the false instrument. 2937 817.568(7) 2nd,PBL Fraudulent use of personal identification information of an individual under the age of 18 by his or her parent, legal guardian, or person exercising custodial authority. 2938 827.03(2)(a) 1st Aggravated child abuse. 2939 847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor. 2940 847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor. 2941 859.01 1st Poisoning or introducing bacteria, radioactive materials, viruses, or chemical compounds into food, drink, medicine, or water with intent to kill or injure another person. 2942 893.135 1st Attempted capital trafficking offense. 2943 893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs. 2944 893.135 (1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms. 2945 893.135 (1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms. 2946 893.135 (1)(c)2.d. 1st Trafficking in hydrocodone, 200 grams or more, less than 30 kilograms. 2947 893.135 (1)(c)3.d. 1st Trafficking in oxycodone, 100 grams or more, less than 30 kilograms. 2948 893.135 (1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams. 2949 893.135 (1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms. 2950 893.135 (1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams. 2951 893.135 (1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more. 2952 893.135 (1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more. 2953 893.135 (1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more. 2954 896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000. 2955 896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000. 2956 2957 (j) LEVEL 10 2958 2959 FloridaStatute FelonyDegree Description 2960 499.0051(9)499.0051(10)1st Knowing sale or purchase of contraband prescription drugs resulting in death. 2961 782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated. 2962 782.07(3) 1st Aggravated manslaughter of a child. 2963 787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim. 2964 787.01(3)(a) Life Kidnapping; child under age 13, perpetrator also commits aggravated child abuse, sexual battery, or lewd or lascivious battery, molestation, conduct, or exhibition. 2965 787.06(3)(g) Life Human trafficking for commercial sexual activity of a child under the age of 18 or mentally defective or incapacitated person. 2966 787.06(4)(a) Life Selling or buying of minors into human trafficking. 2967 794.011(3) Life Sexual battery; victim 12 years or older, offender uses or threatens to use deadly weapon or physical force to cause serious injury. 2968 812.135(2)(a) 1st,PBL Home-invasion robbery with firearm or other deadly weapon. 2969 876.32 1st Treason against the state. 2970 2971 2972 Section 22. This act shall take effect July 1, 2016.