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 Third Engrossed 20161604e3 1 A bill to be entitled 2 An act relating to drugs, devices, and cosmetics; 3 amending s. 385.211, F.S.; authorizing a certain type 4 of specialty hospital to conduct research on 5 cannabidiol and low-THC cannabis if contracted with 6 the Department of Health to perform such research; 7 amending s. 499.003, F.S.; providing, revising, and 8 deleting definitions for purposes of the Florida Drug 9 and Cosmetic Act; requiring rulemaking; specifying a 10 default rule until the Department of Business and 11 Professional Regulation adopts a rule; amending s. 12 499.005, F.S.; revising prohibited acts related to the 13 distribution of prescription drugs; conforming a 14 cross-reference; amending s. 499.0051, F.S.; 15 prohibiting the distribution of prescription drugs 16 without delivering a transaction history, transaction 17 information, and transaction statement; providing 18 penalties; deleting provisions and revising 19 terminology related to pedigree papers, to conform to 20 changes made by the act; amending s. 499.006, F.S.; 21 conforming provisions; amending s. 499.01, F.S.; 22 requiring nonresident prescription drug repackagers to 23 obtain an operating permit; authorizing a manufacturer 24 to engage in the wholesale distribution of 25 prescription drugs; providing for the issuance of 26 virtual prescription drug manufacturer permits and 27 virtual nonresident prescription drug manufacturer 28 permits to certain persons; providing exceptions from 29 certain virtual manufacturer requirements; requiring a 30 nonresident prescription drug repackager permit for 31 certain persons; deleting surety bond requirements for 32 prescription drug wholesale distributors; requiring 33 that certain persons obtain an out-of-state 34 prescription drug wholesale distributor permit; 35 providing that a restricted prescription drug 36 distributor permit is not required for distributions 37 between certain pharmacies; requiring the Department 38 of Business and Professional Regulation to establish 39 by rule when such distribution constitutes regular and 40 systematic supplying of a prescription drug; requiring 41 certain third party logistic providers to be licensed; 42 requiring research and development labeling on certain 43 prescription drug active pharmaceutical ingredient 44 packaging; requiring certain manufacturers to create 45 and maintain certain records; requiring certain 46 prescription drug distributors to provide certain 47 information to health care entities for which they 48 repackage prescription drugs; requiring the department 49 to adopt rules concerning repackaged prescription drug 50 safety and integrity; amending s. 499.012, F.S.; 51 providing for issuance of a prescription drug 52 manufacturer permit or retail pharmacy drug wholesale 53 distributor permit when an applicant at the same 54 address is a licensed nuclear pharmacy or community 55 pharmacy; providing for the expiration of deficient 56 permit applications; requiring trade secret 57 information submitted by an applicant to be maintained 58 as a trade secret; authorizing the quadrennial renewal 59 of permits; providing for calculation of fees for such 60 permit renewals; revising procedures and application 61 requirements for permit renewals; providing for late 62 renewal fees; allowing a permittee who submits a 63 renewal application to continue operations; removing 64 certain application requirements for renewal of a 65 permit; requiring bonds or other surety of a specified 66 amount; requiring proof of inspection of 67 establishments used in wholesale distribution; 68 authorizing the Department of Business and 69 Professional Regulation to contract for the collection 70 of electronic fingerprints under certain 71 circumstances; providing information that may be 72 submitted in lieu of certain application requirements 73 for specified permits and certifications; removing 74 provisions relating to annual renewal and expiration 75 of permits; conforming cross-references; amending s. 76 499.01201, F.S.; conforming provisions; amending s. 77 499.0121, F.S.; revising prescription drug 78 recordkeeping requirements; specifying recordkeeping 79 requirements for manufacturers and repackagers of 80 medical devices, over-the-counter drugs, and 81 cosmetics; increasing the quantity of unit doses of a 82 controlled substance that may be ordered in any given 83 month by a customer without triggering a requirement 84 that a wholesale distributor perform a reasonableness 85 assessment; conforming provisions; amending s. 86 499.015, F.S.; providing for the expiration, renewal, 87 and issuance of certain drug, device, and cosmetic 88 product registrations; providing for product 89 registration fees; amending ss. 499.03, 499.05, and 90 499.051, F.S.; conforming provisions to changes made 91 by the act; amending s. 499.82, F.S.; revising the 92 definition of “wholesale distribution” for purposes of 93 medical gas requirements; amending s. 499.83, F.S.; 94 authorizing licensed hospices to obtain on behalf of, 95 and sell medical oxygen to, their patients without 96 obtaining a medical oxygen retail establishment permit 97 in certain circumstances; specifying recordkeeping 98 requirements; amending s. 499.89, F.S.; conforming 99 provisions; repealing s. 499.01212, F.S., relating to 100 pedigree papers; amending ss. 409.9201, 499.067, 101 794.075, and 921.0022, F.S.; conforming cross 102 references; creating s. 893.30, F.S.; creating the 103 “Victoria Siegel Controlled Substances Safety 104 Education and Awareness Act”; requiring the Department 105 of Health to develop an educational pamphlet relating 106 to certain controlled substance issues; requiring the 107 department to encourage health care providers to 108 disseminate certain educational information; requiring 109 the department to encourage consumers to discuss 110 controlled substance risks with certain health care 111 providers; requiring the State Surgeon General to 112 provide certain educational resources on the 113 department’s website; requiring the department to fund 114 controlled substance safety education and awareness 115 with certain grants; encouraging the department to 116 collaborate with other entities to create a systematic 117 approach to increasing public awareness regarding 118 controlled substance safety; providing an effective 119 date. 120 121 Be It Enacted by the Legislature of the State of Florida: 122 123 Section 1. Subsection (2) of section 385.211, Florida 124 Statutes, is amended to read: 125 385.211 Refractory and intractable epilepsy treatment and 126 research at recognized medical centers.— 127 (2) Notwithstanding chapter 893, medical centers recognized 128 pursuant to s. 381.925, or an academic medical research 129 institution legally affiliated with a licensed children’s 130 specialty hospital as defined in s. 395.002(28) that contracts 131 with the Department of Health, may conduct research on 132 cannabidiol and low-THC cannabis. This research may include, but 133 is not limited to, the agricultural development, production, 134 clinical research, and use of liquid medical derivatives of 135 cannabidiol and low-THC cannabis for the treatment for 136 refractory or intractable epilepsy. The authority for recognized 137 medical centers to conduct this research is derived from 21 138 C.F.R. parts 312 and 316. Current state or privately obtained 139 research funds may be used to support the activities described 140 in this section. 141 Section 2. Section 499.003, Florida Statutes, is amended to 142 read: 143 499.003 Definitions of terms used in this part.—As used in 144 this part, the term: 145 (1) “Active pharmaceutical ingredient” includes any 146 substance or mixture of substances intended, represented, or 147 labeled for use in drug manufacturing that furnishes or is 148 intended to furnish, in a finished dosage form, any 149 pharmacological activity or other direct effect in the 150 diagnosis, cure, mitigation, treatment, therapy, or prevention 151 of disease in humans or other animals, or to affect the 152 structure or any function of the body of humans or animals. 153 (2)(1)“Advertisement” means any representation 154 disseminated in any manner or by any means, other than by 155 labeling, for the purpose of inducing, or which is likely to 156 induce, directly or indirectly, the purchase of drugs, devices, 157 or cosmetics. 158 (3) “Affiliate” means a business entity that has a 159 relationship with another business entity in which, directly or 160 indirectly: 161 (a) The business entity controls, or has the power to 162 control, the other business entity; or 163 (b) A third party controls, or has the power to control, 164 both business entities. 165(2)“Affiliated group” means an affiliated group as defined166by s. 1504 of the Internal Revenue Code of 1986, as amended,167which is composed of chain drug entities, including at least 50168retail pharmacies, warehouses, or repackagers, which are members169of the same affiliated group. The affiliated group must disclose170the names of all its members to the department.171 (4)(3)“Affiliated party” means: 172 (a) A director, officer, trustee, partner, or committee 173 member of a permittee or applicant or a subsidiary or service 174 corporation of the permittee or applicant; 175 (b) A person who, directly or indirectly, manages, 176 controls, or oversees the operation of a permittee or applicant, 177 regardless of whether such person is a partner, shareholder, 178 manager, member, officer, director, independent contractor, or 179 employee of the permittee or applicant; 180 (c) A person who has filed or is required to file a 181 personal information statement pursuant to s. 499.012(9) or is 182 required to be identified in an application for a permit or to 183 renew a permit pursuant to s. 499.012(8); or 184 (d) The five largest natural shareholders that own at least 185 5 percent of the permittee or applicant. 186 (5)(4)“Applicant” means a person applying for a permit or 187 certification under this part. 188(5)“Authenticate” means to affirmatively verify upon189receipt of a prescription drug that each transaction listed on190the pedigree paper has occurred.191(a)A wholesale distributor is not required to open a192sealed, medical convenience kit to authenticate a pedigree paper193for a prescription drug contained within the kit.194(b)Authentication of a prescription drug included in a195sealed, medical convenience kit shall be limited to verifying196the transaction and pedigree information received.197 (6) “Certificate of free sale” means a document prepared by 198 the department which certifies a drug, device, or cosmetic, that 199 is registered with the department, as one that can be legally 200 sold in the state. 201 (7) “Chain pharmacy warehouse” means awholesale202 distributor permitted pursuant to s. 499.01 that maintains a 203 physical location for prescription drugs that functions solely 204 as a central warehouse to perform intracompany transfers of such 205 drugs between members of an affiliateto a member of its206affiliated group. 207 (8) “Closed pharmacy” means a pharmacy that is licensed 208 under chapter 465 and purchases prescription drugs for use by a 209 limited patient population and not for wholesale distribution or 210 sale to the public. The term does not include retail pharmacies. 211 (9) “Color” includes black, white, and intermediate grays. 212 (10) “Color additive” means, with the exception of any 213 material that has been or hereafter is exempt under the federal 214 act, a material that: 215 (a) Is a dye pigment, or other substance, made by a process 216 of synthesis or similar artifice, or extracted, isolated, or 217 otherwise derived, with or without intermediate or final change 218 of identity from a vegetable, animal, mineral, or other source; 219 or 220 (b) When added or applied to a drug or cosmetic or to the 221 human body, or any part thereof, is capable alone, or through 222 reaction with other substances, of imparting color thereto. 223 (11) “Contraband prescription drug” means any adulterated 224 drug, as defined in s. 499.006, any counterfeit drug, as defined 225 in this section, and also means any prescription drug for which 226 a transaction history, transaction information, or transaction 227 statementpedigree paperdoes not exist, or for which the 228 transaction history, transaction information, or transaction 229 statementpedigree paperin existence has been forged, 230 counterfeited, falsely created, or contains any altered, false, 231 or misrepresented matter. 232 (12) “Cosmetic” means an article, with the exception of 233 soap, that is: 234 (a) Intended to be rubbed, poured, sprinkled, or sprayed 235 on; introduced into; or otherwise applied to the human body or 236 any part thereof for cleansing, beautifying, promoting 237 attractiveness, or altering the appearance; or 238 (b) Intended for use as a component of any such article. 239 (13) “Counterfeit drug,” “counterfeit device,” or 240 “counterfeit cosmetic” means a drug, device, or cosmetic which, 241 or the container, seal, or labeling of which, without 242 authorization, bears the trademark, trade name, or other 243 identifying mark, imprint, or device, or any likeness thereof, 244 of a drug, device, or cosmetic manufacturer, processor, packer, 245 or distributor other than the person that in fact manufactured, 246 processed, packed, or distributed that drug, device, or cosmetic 247 and which thereby falsely purports or is represented to be the 248 product of, or to have been packed or distributed by, that other 249 drug, device, or cosmetic manufacturer, processor, packer, or 250 distributor. 251 (14) “Department” means the Department of Business and 252 Professional Regulation. 253 (15) “Device” means any instrument, apparatus, implement, 254 machine, contrivance, implant, in vitro reagent, or other 255 similar or related article, including its components, parts, or 256 accessories, which is: 257 (a) Recognized in the current edition of the United States 258 Pharmacopoeia and National Formulary, or any supplement thereof, 259 (b) Intended for use in the diagnosis, cure, mitigation, 260 treatment, therapy, or prevention of disease in humans or other 261 animals, or 262 (c) Intended to affect the structure or any function of the 263 body of humans or other animals, 264 265 and that does not achieve any of its principal intended purposes 266 through chemical action within or on the body of humans or other 267 animals and which is not dependent upon being metabolized for 268 the achievement of any of its principal intended purposes. 269 (16) “Distribute” or “distribution” means to sell, 270 purchase, trade, deliver, handle, store, or receiveto sell;271offer to sell; give away; transfer, whether by passage of title,272physical movement, or both; deliver; or offer to deliver. The 273 term does not mean to administer or dispenseand does not274include the billing and invoicing activities that commonly275follow a wholesale distribution transaction. 276(17)“Drop shipment” means the sale of a prescription drug277from a manufacturer to a wholesale distributor, where the278wholesale distributor takes title to, but not possession of, the279prescription drug, and the manufacturer of the prescription drug280ships the prescription drug directly to a chain pharmacy281warehouse or a person authorized by law to purchase prescription282drugs for the purpose of administering or dispensing the drug,283as defined in s. 465.003.284 (17)(18)“Drug” means an article that is: 285 (a) Recognized in the current edition of the United States 286 Pharmacopoeia and National Formulary, official Homeopathic 287 Pharmacopoeia of the United States, or any supplement to any of 288 those publications; 289 (b) Intended for use in the diagnosis, cure, mitigation, 290 treatment, therapy, or prevention of disease in humans or other 291 animals; 292 (c) Intended to affect the structure or any function of the 293 body of humans or other animals; or 294 (d) Intended for use as a component of any article 295 specified in paragraph (a), paragraph (b), or paragraph (c), and 296 includes active pharmaceutical ingredients, but does not include 297 devices or their nondrug components, parts, or accessories.For298purposes of this paragraph, an “active pharmaceutical299ingredient” includes any substance or mixture of substances300intended, represented, or labeled for use in drug manufacturing301that furnishes or is intended to furnish, in a finished dosage302form, any pharmacological activity or other direct effect in the303diagnosis, cure, mitigation, treatment, therapy, or prevention304of disease in humans or other animals, or to affect the305structure or any function of the body of humans or other306animals.307 (18)(19)“Establishment” means a place of business which is 308 at one general physical location and may extend to one or more 309 contiguous suites, units, floors, or buildings operated and 310 controlled exclusively by entities under common operation and 311 control. Where multiple buildings are under common exclusive 312 ownership, operation, and control, an intervening thoroughfare 313 does not affect the contiguous nature of the buildings. For 314 purposes of permitting, each suite, unit, floor, or building 315 must be identified in the most recent permit application. 316 (19)(20)“Federal act” means the Federal Food, Drug, and 317 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. 318 (20)(21)“Freight forwarder” means a person who receives 319 prescription drugs which are owned by another person and 320 designated by that person for export, and exports those 321 prescription drugs. 322 (21)(22)“Health care entity” means a closed pharmacy or 323 any person, organization, or business entity that provides 324 diagnostic, medical, surgical, or dental treatment or care, or 325 chronic or rehabilitative care, but does not include any 326 wholesale distributor or retail pharmacy licensed under state 327 law to deal in prescription drugs. However, a blood 328 establishment is a health care entity that may engage in the 329 wholesale distribution of prescription drugs under s. 330 499.01(2)(h)1.c.499.01(2)(g)1.c.331 (22)(23)“Health care facility” means a health care 332 facility licensed under chapter 395. 333 (23)(24)“Hospice” means a corporation licensed under part 334 IV of chapter 400. 335 (24)(25)“Hospital” means a facility as defined in s. 336 395.002 and licensed under chapter 395. 337 (25)(26)“Immediate container” does not include package 338 liners. 339 (26)(27)“Label” means a display of written, printed, or 340 graphic matter upon the immediate container of any drug, device, 341 or cosmetic. A requirement made by or under authority of this 342 part or rules adopted under this part that any word, statement, 343 or other information appear on the label is not complied with 344 unless such word, statement, or other information also appears 345 on the outside container or wrapper, if any, of the retail 346 package of such drug, device, or cosmetic or is easily legible 347 through the outside container or wrapper. 348 (27)(28)“Labeling” means all labels and other written, 349 printed, or graphic matters: 350 (a) Upon a drug, device, or cosmetic, or any of its 351 containers or wrappers; or 352 (b) Accompanying or related to such drug, device, or 353 cosmetic. 354 (28)(29)“Manufacture” means the preparation, deriving, 355 compounding, propagation, processing, producing, or fabrication 356 of any drug, device, or cosmetic. 357 (29)(30)“Manufacturer” means: 358 (a) A person who holds a New Drug Application, an 359 Abbreviated New Drug Application, a Biologics License 360 Application, or a New Animal Drug Application approved under the 361 federal act or a license issued under s. 351 of the Public 362 Health Service Act, 42 U.S.C. s. 262, for such drug or 363 biologics, or if such drug or biologics are not the subject of 364 an approved application or license, the person who manufactured 365 the drug or biologicsprepares, derives, manufactures, or366produces a drug, device, or cosmetic; 367 (b) A co-licensed partner of the person described in 368 paragraph (a) who obtains the drug or biologics directly from a 369 person described in paragraph (a), paragraph (c), or this 370 paragraphThe holder or holders of a New Drug Application (NDA),371an Abbreviated New Drug Application (ANDA), a Biologics License372Application (BLA), or a New Animal Drug Application (NADA),373provided such application has become effective or is otherwise374approved consistent with s. 499.023; 375 (c) An affiliate of a person described in paragraph (a), 376 paragraph (b), or this paragraph that receives the drug or 377 biologics directly from a person described in paragraph (a), 378 paragraph (b), or this paragraphA private label distributor for379whom the private label distributor’s prescription drugs are380originally manufactured and labeled for the distributor and have381not been repackaged; or 382 (d) A person who manufactures a device or a cosmetic.A383person registered under the federal act as a manufacturer of a384prescription drug, who is described in paragraph (a), paragraph385(b), or paragraph (c), who has entered into a written agreement386with another prescription drug manufacturer that authorizes387either manufacturer to distribute the prescription drug388identified in the agreement as the manufacturer of that drug389consistent with the federal act and its implementing390regulations;391(e)A member of an affiliated group that includes, but is392not limited to, persons described in paragraph (a), paragraph393(b), paragraph (c), or paragraph (d), which member distributes394prescription drugs, whether or not obtaining title to the drugs,395only for the manufacturer of the drugs who is also a member of396the affiliated group. As used in this paragraph, the term397“affiliated group” means an affiliated group as defined in s.3981504 of the Internal Revenue Code of 1986, as amended. The399manufacturer must disclose the names of all of its affiliated400group members to the department; or401(f)A person permitted as a third party logistics provider,402only while providing warehousing, distribution, or other403logistics services on behalf of a person described in paragraph404(a), paragraph (b), paragraph (c), paragraph (d), or paragraph405(e).406 407 The term does not include a pharmacy that is operating in 408 compliance with pharmacy practice standards as defined in 409 chapter 465 and rules adopted under that chapter. 410 (30)(31)“Medical convenience kit” means packages or units 411 that contain combination products as defined in 21 C.F.R. s. 412 3.2(e)(2). 413 (31)(32)“Medical gas” means any liquefied or vaporized gas 414 that is a prescription drug, whether alone or in combination 415 with other gases, and as defined in the federal act. 416 (32)(33)“New drug” means: 417 (a) Any drug the composition of which is such that the drug 418 is not generally recognized, among experts qualified by 419 scientific training and experience to evaluate the safety and 420 effectiveness of drugs, as safe and effective for use under the 421 conditions prescribed, recommended, or suggested in the labeling 422 of that drug; or 423 (b) Any drug the composition of which is such that the 424 drug, as a result of investigations to determine its safety and 425 effectiveness for use under certain conditions, has been 426 recognized for use under such conditions, but which drug has 427 not, other than in those investigations, been used to a material 428 extent or for a material time under such conditions. 429(34)“Normal distribution chain” means a wholesale430distribution of a prescription drug in which the wholesale431distributor or its wholly owned subsidiary purchases and432receives the specific unit of the prescription drug directly433from the manufacturer and distributes the prescription drug434directly, or through up to two intracompany transfers, to a435chain pharmacy warehouse or a person authorized by law to436purchase prescription drugs for the purpose of administering or437dispensing the drug, as defined in s. 465.003. For purposes of438this subsection, the term “intracompany” means any transaction439or transfer between any parent, division, or subsidiary wholly440owned by a corporate entity.441 (33)(35)“Nursing home” means a facility licensed under 442 part II of chapter 400. 443 (34)(36)“Official compendium” means the current edition of 444 the official United States Pharmacopoeia and National Formulary, 445 or any supplement thereto. 446(37)“Pedigree paper” means a document in written or447electronic form approved by the department which contains448information required by s. 499.01212 regarding the sale and449distribution of any given prescription drug.450 (35)(38)“Permittee” means any person holding a permit 451 issued under this chapterpursuant to s. 499.012. 452 (36)(39)“Person” means any individual, child, joint 453 venture, syndicate, fiduciary, partnership, corporation, 454 division of a corporation, firm, trust, business trust, company, 455 estate, public or private institution, association, 456 organization, group, city, county, city and county, political 457 subdivision of this state, other governmental agency within this 458 state, and any representative, agent, or agency of any of the 459 foregoing, or any other group or combination of the foregoing. 460 (37)(40)“Pharmacist” means a person licensed under chapter 461 465. 462 (38)(41)“Pharmacy” means an entity licensed under chapter 463 465. 464 (39)(42)“Prepackaged drug product” means a drug that 465 originally was in finished packaged form sealed by a 466 manufacturer and that is placed in a properly labeled container 467 by a pharmacy or practitioner authorized to dispense pursuant to 468 chapter 465 for the purpose of dispensing in the establishment 469 in which the prepackaging occurred. 470 (40)(43)“Prescription drug” means a prescription, 471 medicinal, or legend drug, including, but not limited to, 472 finished dosage forms or active pharmaceutical ingredients 473 subject to, defined by, or described by s. 503(b) of the federal 474 act or s. 465.003(8), s. 499.007(13), subsection (31)(32), or 475 subsection (47)(52), except that an active pharmaceutical 476 ingredient is a prescription drug only if substantially all 477 finished dosage forms in which it may be lawfully dispensed or 478 administered in this state are also prescription drugs. 479 (41)(44)“Prescription drug label” means any display of 480 written, printed, or graphic matter upon the immediate container 481 of any prescription drug before it is dispensedprior to its482dispensingto an individual patient pursuant to a prescription 483 of a practitioner authorized by law to prescribe. 484 (42)(45)“Prescription label” means any display of written, 485 printed, or graphic matter upon the immediate container of any 486 prescription drug dispensed pursuant to a prescription of a 487 practitioner authorized by law to prescribe. 488(46)“Primary wholesale distributor” means any wholesale489distributor that:490(a)Purchased 90 percent or more of the total dollar volume491of its purchases of prescription drugs directly from492manufacturers in the previous year; and493(b)1.Directly purchased prescription drugs from not fewer494than 50 different prescription drug manufacturers in the495previous year; or4962.Has, or the affiliated group, as defined in s. 1504 of497the Internal Revenue Code, of which the wholesale distributor is498a member has, not fewer than 250 employees.499(c)For purposes of this subsection, “directly from500manufacturers” means:5011.Purchases made by the wholesale distributor directly502from the manufacturer of prescription drugs; and5032.Transfers from a member of an affiliated group, as504defined in s. 1504 of the Internal Revenue Code, of which the505wholesale distributor is a member, if:506a.The affiliated group purchases 90 percent or more of the507total dollar volume of its purchases of prescription drugs from508the manufacturer in the previous year; and509b.The wholesale distributor discloses to the department510the names of all members of the affiliated group of which the511wholesale distributor is a member and the affiliated group512agrees in writing to provide records on prescription drug513purchases by the members of the affiliated group not later than51448 hours after the department requests access to such records,515regardless of the location where the records are stored.516 (43)(47)“Proprietary drug,” or “OTC drug,” means a patent 517 or over-the-counter drug in its unbroken, original package, 518 which drug is sold to the public by, or under the authority of, 519 the manufacturer or primary distributor thereof, is not 520 misbranded under the provisions of this part, and can be 521 purchased without a prescription. 522 (44)(48)“Repackage” includes repacking or otherwise 523 changing the container, wrapper, or labeling to further the 524 distribution of the drug, device, or cosmetic. 525 (45)(49)“Repackager” means a person who repackages. The 526 term excludes pharmacies that are operating in compliance with 527 pharmacy practice standards as defined in chapter 465 and rules 528 adopted under that chapter. 529 (46)(50)“Retail pharmacy” means a community pharmacy 530 licensed under chapter 465 that purchases prescription drugs at 531 fair market prices and provides prescription services to the 532 public. 533(51)“Secondary wholesale distributor” means a wholesale534distributor that is not a primary wholesale distributor.535 (47)(52)“Veterinary prescription drug” means a 536 prescription drug intended solely for veterinary use. The label 537 of the drug must bear the statement, “Caution: Federal law 538 restricts this drug to sale by or on the order of a licensed 539 veterinarian.” 540 (48)(53)“Wholesale distribution” means the distribution of 541 a prescription drug to a persondrugs to personsother than a 542 consumer or patient, or the receipt of a prescription drug by a 543 person other than the consumer or patient, but does not include: 544 (a) Any of the following activities, which is not a 545 violation of s. 499.005(21) if such activity is conducted in 546 accordance with s. 499.01(2)(h)499.01(2)(g): 547 1. The purchase or other acquisition by a hospital or other 548 health care entity that is a member of a group purchasing 549 organization of a prescription drug for its own use from the 550 group purchasing organization or from other hospitals or health 551 care entities that are members of that organization. 552 2. The distributionsale, purchase, or tradeof a 553 prescription drug or an offer to distributesell, purchase, or554tradea prescription drug by a charitable organization described 555 in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended 556 and revised, to a nonprofit affiliate of the organization to the 557 extent otherwise permitted by law. 558 3. The distributionsale, purchase, or tradeof a 559 prescription drugor an offer to sell, purchase, or trade a560prescription drugamong hospitals or other health care entities 561 that are under common control. For purposes of this 562 subparagraph, “common control” means the power to direct or 563 cause the direction of the management and policies of a person 564 or an organization, whether by ownership of stock, by voting 565 rights, by contract, or otherwise. 566 4. The distributionsale, purchase, trade, or other567transferof a prescription drug from or for any federal, state, 568 or local government agency or any entity eligible to purchase 569 prescription drugs at public health services prices pursuant to 570 Pub. L. No. 102-585, s. 602 to a contract provider or its 571 subcontractor for eligible patients of the agency or entity 572 under the following conditions: 573 a. The agency or entity must obtain written authorization 574 for the distributionsale, purchase, trade, or other transferof 575 a prescription drug under this subparagraph from the Secretary 576 of Business and Professional Regulation or his or her designee. 577 b. The contract provider or subcontractor must be 578 authorized by law to administer or dispense prescription drugs. 579 c. In the case of a subcontractor, the agency or entity 580 must be a party to and execute the subcontract. 581 d. The contract provider and subcontractor must maintain 582 and produce immediately for inspection all records of movement 583 or transfer of all the prescription drugs belonging to the 584 agency or entity, including, but not limited to, the records of 585 receipt and disposition of prescription drugs. Each contractor 586 and subcontractor dispensing or administering these drugs must 587 maintain and produce records documenting the dispensing or 588 administration. Records that are required to be maintained 589 include, but are not limited to, a perpetual inventory itemizing 590 drugs received and drugs dispensed by prescription number or 591 administered by patient identifier, which must be submitted to 592 the agency or entity quarterly. 593 e. The contract provider or subcontractor may administer or 594 dispense the prescription drugs only to the eligible patients of 595 the agency or entity or must return the prescription drugs for 596 or to the agency or entity. The contract provider or 597 subcontractor must require proof from each person seeking to 598 fill a prescription or obtain treatment that the person is an 599 eligible patient of the agency or entity and must, at a minimum, 600 maintain a copy of this proof as part of the records of the 601 contractor or subcontractor required under sub-subparagraph d. 602 f. In addition to the departmental inspection authority set 603 forth in s. 499.051, the establishment of the contract provider 604 and subcontractor and all records pertaining to prescription 605 drugs subject to this subparagraph shall be subject to 606 inspection by the agency or entity. All records relating to 607 prescription drugs of a manufacturer under this subparagraph 608 shall be subject to audit by the manufacturer of those drugs, 609 without identifying individual patient information. 610 (b) Any of the following activities, which is not a 611 violation of s. 499.005(21) if such activity is conducted in 612 accordance with rules established by the department: 613 1. The distributionsale, purchase, or tradeof a 614 prescription drug among federal, state, or local government 615 health care entities that are under common control and are 616 authorized to purchase such prescription drug. 617 2. The distributionsale, purchase, or tradeof a 618 prescription drug oranoffer to distributesell, purchase, or619tradea prescription drug for emergency medical reasons, which 620 may include. For purposes of this subparagraph, The term621“emergency medical reasons” includestransfers of prescription 622 drugs by a retail pharmacy to another retail pharmacy to 623 alleviate a temporary shortage. For purposes of this 624 subparagraph, a drug shortage not caused by a public health 625 emergency does not constitute an emergency medical reason. 626 3. The distributiontransferof a prescription drug 627 acquired by a medical director on behalf of a licensed emergency 628 medical services provider to that emergency medical services 629 provider and its transport vehicles for use in accordance with 630 the provider’s license under chapter 401. 6314.The revocation of a sale or the return of a prescription632drug to the person’s prescription drug wholesale supplier.633 4.5.The donation of a prescription drug by a health care 634 entity to a charitable organization that has been granted an 635 exemption under s. 501(c)(3) of the Internal Revenue Code of 636 1986, as amended, and that is authorized to possess prescription 637 drugs. 638 5.6.The distributiontransferof a prescription drug by a 639 person authorized to purchase or receive prescription drugs to a 640 person licensed or permitted to handle reverse distributions or 641 destruction under the laws of the jurisdiction in which the 642 person handling the reverse distribution or destruction receives 643 the drug. 644 6.7.The distributiontransferof a prescription drug by a 645 hospital or other health care entity to a person licensed under 646 this part to repackage prescription drugs for the purpose of 647 repackaging the prescription drug for use by that hospital, or 648 other health care entity and other health care entities that are 649 under common control, if ownership of the prescription drugs 650 remains with the hospital or other health care entity at all 651 times. In addition to the recordkeeping requirements of s. 652 499.0121(6), the hospital or health care entity that distributes 653transfersprescription drugs pursuant to this subparagraph must 654 reconcile all drugs distributedtransferredand returned and 655 resolve any discrepancies in a timely manner. 656 (c) Intracompany distribution of any drug between members 657 of an affiliate or within a manufacturer. 658 (d) The distribution of a prescription drug by the 659 manufacturer of the prescription drug. 660 (e)(c)The distribution of prescription drug samples by 661 manufacturers’ representatives or distributors’ representatives 662 conducted in accordance with s. 499.028. 663 (f) The distribution of a prescription drug by a third 664 party logistics provider permitted or licensed pursuant to and 665 operating in compliance with the laws of this state and federal 666 law if such third-party logistics provider does not take 667 ownership of the prescription drug. 668 (g) The distribution of a prescription drug, or an offer to 669 distribute a prescription drug by a repackager registered as a 670 drug establishment with the United States Food and Drug 671 Administration that has taken ownership or possession of the 672 prescription drug and repacks it in accordance with this part. 673 (h) The purchase or other acquisition by a dispenser, 674 hospital, or other health care entity of a prescription drug for 675 use by such dispenser, hospital, or other health care entity. 676 (i) The distribution of a prescription drug by a hospital 677 or other health care entity, or by a wholesale distributor or 678 manufacturer operating at the direction of the hospital or other 679 health care entity, to a repackager for the purpose of 680 repackaging the prescription drug for use by that hospital, or 681 other health care entity and other health care entities that are 682 under common control, if ownership of the prescription drug 683 remains with the hospital or other health care entity at all 684 times. 685 (j)(d)The distributionsale, purchase, or tradeof blood 686 and blood components intended for transfusion. As used in this 687 paragraph, the term “blood” means whole blood collected from a 688 single donor and processed for transfusion or further 689 manufacturing, and the term “blood components” means that part 690 of the blood separated by physical or mechanical means. 691 (k)(e)The lawful dispensing of a prescription drug in 692 accordance with chapter 465. 693 (l)(f)The distributionsale, purchase, or tradeof a 694 prescription drug between pharmacies as a result of a sale, 695 transfer, merger, or consolidation of all or part of the 696 business of the pharmacies from or with another pharmacy, 697 whether accomplished as a purchase and sale of stock or of 698 business assets. 699 (m) The distribution of minimal quantities of prescription 700 drugs by a licensed retail pharmacy to a licensed practitioner 701 for office use in compliance with chapter 465 and rules adopted 702 thereunder. The department shall adopt rules specifying the 703 quantities of prescription drugs which are considered to be 704 minimal quantities. However, until such rules are adopted, 705 minimal quantities distributed may not exceed 3 percent of the 706 retail pharmacy’s total annual purchases of prescription drugs. 707 (n) The distribution of an intravenous prescription drug 708 that, by its formulation, is intended for the replenishment of 709 fluids and electrolytes, such as sodium, chloride, and potassium 710 or calories, such as dextrose and amino acids. 711 (o) The distribution of an intravenous prescription drug 712 used to maintain the equilibrium of water and minerals in the 713 body, such as dialysis solutions. 714 (p) The distribution of a prescription drug that is 715 intended for irrigation or sterile water, whether intended for 716 such purposes or for injection. 717 (q) The distribution of an exempt medical convenience kit 718 pursuant to 21 U.S.C. s. 353(e)(4)(M). 719 (r) A common carrier that transports a prescription drug, 720 if the common carrier does not take ownership of the 721 prescription drug. 722 (s) Saleable drug returns when conducted by a dispenser. 723 (t) Facilitating the distribution of a prescription drug by 724 providing solely administrative services, including processing 725 of orders and payments. 726 (u) The distribution by a charitable organization described 727 in s. 501(c)(3) of the Internal Revenue Code of prescription 728 drugs donated to or supplied at a reduced price to the 729 charitable organization to: 730 1. A licensed health care practitioner, as defined in s. 731 456.001, who is authorized under the appropriate practice act to 732 prescribe and administer prescription drugs; 733 2. A health care clinic establishment permitted pursuant to 734 chapter 499; or 735 3. The Department of Health or the licensed medical 736 director of a government agency health care entity, authorized 737 to possess prescription drugs, for storage and use in the 738 treatment of persons in need of emergency medical services, 739 including controlling communicable diseases or providing 740 protection from unsafe conditions that pose an imminent threat 741 to public health, 742 743 if the distributor and the receiving entity receive no direct or 744 indirect financial benefit other than tax benefits related to 745 charitable contributions. Distributions under this section that 746 involve controlled substances must comply with all state and 747 federal regulations pertaining to the handling of controlled 748 substances. 749 (v) The distribution of medical gas pursuant to part III of 750 this chapter. 751 (49)(54)“Wholesale distributor” means aanyperson, other 752 than a manufacturer, a manufacturer’s co-licensed partner, a 753 third-party logistics provider, or a repackager, who is engaged 754 in wholesale distributionof prescription drugs in or into this755state, including, but not limited to, manufacturers;756repackagers; own-label distributors; jobbers; private-label757distributors; brokers; warehouses, including manufacturers’ and758distributors’ warehouses, chain drug warehouses, and wholesale759drug warehouses; independent wholesale drug traders; exporters;760retail pharmacies; and the agents thereof that conduct wholesale761distributions. 762 Section 3. Subsections (21), (28), and (29) of section 763 499.005, Florida Statutes, are amended to read: 764 499.005 Prohibited acts.—It is unlawful for a person to 765 perform or cause the performance of any of the following acts in 766 this state: 767 (21) The wholesale distribution of any prescription drug 768 that was: 769 (a) Purchased by a public or private hospital or other 770 health care entity; or 771 (b) Donated or supplied at a reduced price to a charitable 772 organization, 773 774 unless the wholesale distribution of the prescription drug is 775 authorized in s. 499.01(2)(h)1.c.499.01(2)(g)1.c.776 (28) Failure to acquire or deliver a transaction history, 777 transaction information, or transaction statementpedigree paper778 as required under this part and rules adopted under this part. 779(29)The receipt of a prescription drug pursuant to a780wholesale distribution without having previously received or781simultaneously receiving a pedigree paper that was attested to782as accurate and complete by the wholesale distributor as783required under this part.784 Section 4. Subsections (4) through (17) of section 785 499.0051, Florida Statutes, are renumbered as subsections (3) 786 through (16), respectively, and subsections (1) and (2), present 787 subsection (3), paragraphs (h) and (i) of present subsection 788 (12), paragraph (d) of present subsection (13), and present 789 subsection (15) of that section are amended, to read: 790 499.0051 Criminal acts.— 791 (1) FAILURE TO MAINTAIN OR DELIVER TRANSACTION HISTORY, 792 TRANSACTION INFORMATION, OR TRANSACTION STATEMENTPEDIGREE793PAPERS.— 794 (a) A person, other than a manufacturer,engaged in the 795wholesaledistribution of prescription drugs who fails to 796 deliver to another person a complete and accurate transaction 797 history, transaction information, or transaction statement 798pedigree papersconcerning a prescription drug or contraband 799 prescription drug, as required by this chapter and rules adopted 800 under this chapter, beforeprior to, or simultaneous with, the 801 transfer of the prescription drug or contraband prescription 802 drug to another person commits a felony of the third degree, 803 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 804 (b) A person engaged in thewholesaledistribution of 805 prescription drugs who fails to acquire a complete and accurate 806 transaction history, transaction information, or transaction 807 statementpedigree papersconcerning a prescription drug or 808 contraband prescription drug, as required by this chapter and 809 rules adopted under this chapter, beforeprior to, or 810 simultaneous with, the receipt of the prescription drug or 811 contraband prescription drug from another person commits a 812 felony of the third degree, punishable as provided in s. 813 775.082, s. 775.083, or s. 775.084. 814 (c) Any person who knowingly destroys, alters, conceals, or 815 fails to maintain a complete and accurate transaction history, 816 transaction information, or transaction statementpedigree817papersconcerning any prescription drug or contraband 818 prescription drug, as required by this chapter and rules adopted 819 under this chapter, in his or her possession commits a felony of 820 the third degree, punishable as provided in s. 775.082, s. 821 775.083, or s. 775.084. 822(2)FAILURE TO AUTHENTICATE PEDIGREE PAPERS.—Effective July8231, 2006:824(a)A person engaged in the wholesale distribution of825prescription drugs who is in possession of pedigree papers826concerning prescription drugs or contraband prescription drugs827and who fails to authenticate the matters contained in the828pedigree papers and who nevertheless attempts to further829distribute prescription drugs or contraband prescription drugs830commits a felony of the third degree, punishable as provided in831s. 775.082, s. 775.083, or s. 775.084.832(b)A person in possession of pedigree papers concerning833prescription drugs or contraband prescription drugs who falsely834swears or certifies that he or she has authenticated the matters835contained in the pedigree papers commits a felony of the third836degree, punishable as provided in s. 775.082, s. 775.083, or s.837775.084.838 (2)(3)KNOWING FORGERY OF TRANSACTION HISTORY, TRANSACTION 839 INFORMATION, OR TRANSACTION STATEMENTPEDIGREE PAPERS.—A person 840 who knowingly forges, counterfeits, or falsely creates any 841 transaction history, transaction information, or transaction 842 statementpedigree paper; who falsely represents any factual 843 matter contained on any transaction history, transaction 844 information, or transaction statementpedigree paper; or who 845 knowingly omits to record material information required to be 846 recorded in a transaction history, transaction information, or 847 transaction statementpedigree paper, commits a felony of the 848 second degree, punishable as provided in s. 775.082, s. 775.083, 849 or s. 775.084. 850 (11)(12)ADULTERATED AND MISBRANDED DRUGS; FALSE 851 ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS. 852 Any person who violates any of the following provisions commits 853 a misdemeanor of the second degree, punishable as provided in s. 854 775.082 or s. 775.083; but, if the violation is committed after 855 a conviction of such person under this subsection has become 856 final, such person commits a misdemeanor of the first degree, 857 punishable as provided in s. 775.082 or s. 775.083, or as 858 otherwise provided in this part: 859 (h) The failure to maintain records related to a drug as 860 required by this part and rules adopted under this part, except 861 for transaction histories, transaction information, or 862 transaction statementspedigree papers, invoices, or shipping 863 documents related to prescription drugs. 864 (i) The possession of any drug in violation of this part, 865 except if the violation relates to a deficiency in transaction 866 histories, transaction information, or transaction statements 867pedigree papers. 868 (12)(13)REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, 869 OR TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO 870 PRESCRIPTION DRUGS.—Any person who violates any of the following 871 provisions commits a felony of the third degree, punishable as 872 provided in s. 775.082, s. 775.083, or s. 775.084, or as 873 otherwise provided in this part: 874 (d) The failure to receive, maintain, or provide invoices 875 and shipping documents, other than pedigree papers,if 876 applicable, related to the distribution of a prescription drug. 877 (14)(15)FALSE ADVERTISEMENT.—A publisher, radio broadcast 878 licensee, or agency or medium for the dissemination of an 879 advertisement, except the manufacturer, repackager, wholesale 880 distributor, or seller of the article to which a false 881 advertisement relates, is not liable under subsection (11)(12), 882 subsection (12)(13), or subsection (13)(14)by reason of the 883 dissemination by him or her of such false advertisement, unless 884 he or she has refused, on the request of the department, to 885 furnish to the department the name and post office address of 886 the manufacturer, repackager, wholesale distributor, seller, or 887 advertising agency that asked him or her to disseminate such 888 advertisement. 889 Section 5. Section 499.006, Florida Statutes, is amended to 890 read: 891 499.006 Adulterated drug or device.—A drug or device is 892 adulterated, if any of the following apply: 893 (1)IfIt consists in whole or in part of any filthy, 894 putrid, or decomposed substance.;895 (2)IfIt has been produced, prepared, packed, or held 896 under conditions whereby it could have been contaminated with 897 filth or rendered injurious to health.;898 (3)IfIt is a drug and the methods used in, or the 899 facilities or controls used for, its manufacture, processing, 900 packing, or holding do not conform to, or are not operated or 901 administered in conformity with, current good manufacturing 902 practices to assure that the drug meets the requirements of this 903 part and that the drug has the identity and strength, and meets 904 the standard of quality and purity, which it purports or is 905 represented to possess.;906 (4)IfIt is a drug and its container is composed, in whole 907 or in part, of any poisonous or deleterious substance which 908 could render the contents injurious to health.;909 (5)IfIt is a drug and it bears or contains, for the 910 purpose of coloring only, a color additive that is unsafe within 911 the meaning of the federal act; or, if it is a color additive, 912 the intended use of which in or on drugs is for the purpose of 913 coloring only, and it is unsafe within the meaning of the 914 federal act.;915 (6)IfIt purports to be, or is represented as, a drug the 916 name of which is recognized in the official compendium, and its 917 strength differs from, or its quality or purity falls below, the 918 standard set forth in such compendium. The determination as to 919 strength, quality, or purity must be made in accordance with the 920 tests or methods of assay set forth in such compendium, or, when 921 such tests or methods of assay are absent or inadequate, in 922 accordance with those tests or methods of assay prescribed under 923 authority of the federal act. A drug defined in the official 924 compendium is not adulterated under this subsection merely 925 because it differs from the standard of strength, quality, or 926 purity set forth for that drug in such compendium if its 927 difference in strength, quality, or purity from such standard is 928 plainly stated on its label.;929 (7)IfIt is not subject to subsection (6) and its strength 930 differs from, or its purity or quality falls below the standard 931 of, that which it purports or is represented to possess.;932 (8)IfIt is a drug: 933 (a) With which any substance has been mixed or packed so as 934 to reduce the quality or strength of the drug; or 935 (b) For which any substance has been substituted wholly or 936 in part.;937 (9)IfIt is a drug or device for which the expiration date 938 has passed.;939 (10)IfIt is a prescription drug for which the required 940 transaction history, transaction information, or transaction 941 statementpedigree paperis nonexistent, fraudulent, or 942 incomplete under the requirements of this part or applicable 943 rules, or that has been purchased, held, sold, or distributed at 944 any time by a person not authorized under federal or state law 945 to do so.; or946 (11)IfIt is a prescription drug subject to, defined by, 947 or described by s. 503(b) of the Federal Food, Drug, and 948 Cosmetic Act which has been returned by a veterinarian to a 949 limited prescription drug veterinary wholesale distributor. 950 Section 6. Section 499.01, Florida Statutes, is amended to 951 read: 952 499.01 Permits.— 953 (1) BeforePrior tooperating, a permit is required for 954 each person and establishment that intends to operate as: 955 (a) A prescription drug manufacturer; 956 (b) A prescription drug repackager; 957 (c) A nonresident prescription drug manufacturer; 958 (d) A nonresident prescription drug repackager; 959 (e)(d)A prescription drug wholesale distributor; 960 (f)(e)An out-of-state prescription drug wholesale 961 distributor; 962 (g)(f)A retail pharmacy drug wholesale distributor; 963 (h)(g)A restricted prescription drug distributor; 964 (i)(h)A complimentary drug distributor; 965 (j)(i)A freight forwarder; 966 (k)(j)A veterinary prescription drug retail establishment; 967 (l)(k)A veterinary prescription drug wholesale 968 distributor; 969 (m)(l)A limited prescription drug veterinary wholesale 970 distributor; 971 (n)(m)An over-the-counter drug manufacturer; 972 (o)(n)A device manufacturer; 973 (p)(o)A cosmetic manufacturer; 974 (q)(p)A third party logistics provider; or 975 (r)(q)A health care clinic establishment. 976 (2) The following permits are established: 977 (a) Prescription drug manufacturer permit.—A prescription 978 drug manufacturer permit is required for any person that is a 979 manufacturer of a prescription drug and that manufactures or 980 distributes such prescription drugs in this state. 981 1. A person that operates an establishment permitted as a 982 prescription drug manufacturer may engage inwholesale983 distribution of prescription drugs for which the person is the 984 manufacturermanufactured at that establishmentand must comply 985 with s. 499.0121 and all otherof theprovisions of this part,986except s. 499.01212,andtherules adopted under this part,987except s. 499.01212, which apply to a wholesale distributor. The 988 department shall adopt rules for issuing a virtual prescription 989 drug manufacturer permit to a person who engages in the 990 manufacture of prescription drugs but does not make or take 991 physical possession of any prescription drugs. The rules adopted 992 by the department under this section may exempt virtual 993 manufacturers from certain establishment, security, and storage 994 requirements set forth in s. 499.0121. 995 2. A prescription drug manufacturer must comply with all 996 appropriate state and federal good manufacturing practices. 997 3. A blood establishment, as defined in s. 381.06014, 998 operating in a manner consistent with the provisions of 21 999 C.F.R. parts 211 and 600-640, and manufacturing only the 1000 prescription drugs described in s. 499.003(48)(j)499.003(53)(d)1001 is not required to be permitted as a prescription drug 1002 manufacturer under this paragraph or to register products under 1003 s. 499.015. 1004 (b) Prescription drug repackager permit.—A prescription 1005 drug repackager permit is required for any person that 1006 repackages a prescription drug in this state. 1007 1. A person that operates an establishment permitted as a 1008 prescription drug repackager may engage inwholesale1009 distribution of prescription drugs repackaged at that 1010 establishment and must comply with all of the provisions of this 1011 part and the rules adopted under this part that apply to a 1012 prescription drug manufacturerwholesale distributor. 1013 2. A prescription drug repackager must comply with all 1014 appropriate state and federal good manufacturing practices. 1015 (c) Nonresident prescription drug manufacturer permit.—A 1016 nonresident prescription drug manufacturer permit is required 1017 for any person that is a manufacturer of prescription drugs, 1018 unless permitted as a third party logistics provider, located 1019 outside of this state or outside the United States and that 1020 engages in thewholesaledistribution in this state of such 1021 prescription drugs. Each such manufacturer must be permitted by 1022 the department and comply with all of the provisions required of 1023 a prescription drug manufacturerwholesale distributorunder 1024 this part, except s. 499.01212. The department shall adopt rules 1025 for issuing a virtual nonresident prescription drug manufacturer 1026 permit to a person who engages in the manufacture of 1027 prescription drugs but does not make or take physical possession 1028 of any prescription drugs. The rules adopted by the department 1029 under this section may exempt virtual nonresident manufacturers 1030 from certain establishment, security, and storage requirements 1031 set forth in s. 499.0121. 1032 1. A person that distributes prescription drugs for which 1033 the person is not the manufacturer must also obtain an out-of 1034 state prescription drug wholesale distributor permit or third 1035 party logistics provider permit pursuant to this section to 1036 engage in thewholesaledistribution of such prescription drugs 1037 when required by this part. This subparagraph does not apply to 1038 a manufacturer that distributes prescription drugs only for the 1039 manufacturer of the prescription drugs where both manufacturers 1040 are affiliatesas defined in s. 499.003(30)(e). 1041 2. Any such person must comply with the licensing or 1042 permitting requirements of the jurisdiction in which the 1043 establishment is located and the federal act, and any 1044 prescription drug distributedproduct wholesaledinto this state 1045 must comply with this part. If a person intends to import 1046 prescription drugs from a foreign country into this state, the 1047 nonresident prescription drug manufacturer must provide to the 1048 department a list identifying each prescription drug it intends 1049 to import and document approval by the United States Food and 1050 Drug Administration for such importation. 1051 (d) Nonresident prescription drug repackager permit.–A 1052 nonresident prescription drug repackager permit is required for 1053 any person located outside of this state, but within the United 1054 States or its territories, that repackages prescription drugs 1055 and engages in the distribution of such prescription drugs into 1056 this state. 1057 1. A nonresident prescription drug repackager must comply 1058 with all of the provisions of this section and the rules adopted 1059 under this section that apply to a prescription drug 1060 manufacturer. 1061 2. A nonresident prescription drug repackager must be 1062 permitted by the department and comply with all appropriate 1063 state and federal good manufacturing practices. 1064 3. A nonresident prescription drug repackager must be 1065 registered as a drug establishment with the United States Food 1066 and Drug Administration. 1067 (e)(d)Prescription drug wholesale distributor permit.—A 1068 prescription drug wholesale distributor permit is required for 1069 any person who is a wholesale distributor of prescription drugs 1070 and thatmay engage in thewholesale distributes such 1071distribution ofprescription drugs in this state.A prescription1072drug wholesale distributor that applies to the department for a1073new permit or the renewal of a permit must submit a bond of1074$100,000, or other equivalent means of security acceptable to1075the department, such as an irrevocable letter of credit or a1076deposit in a trust account or financial institution, payable to1077the Professional Regulation Trust Fund. The purpose of the bond1078is to secure payment of any administrative penalties imposed by1079the department and any fees and costs incurred by the department1080regarding that permit which are authorized under state law and1081which the permittee fails to pay 30 days after the fine or costs1082become final. The department may make a claim against such bond1083or security until 1 year after the permittee’s license ceases to1084be valid or until 60 days after any administrative or legal1085proceeding authorized in this part which involves the permittee1086is concluded, including any appeal, whichever occurs later.The 1087 department may adopt rules for issuing a prescription drug 1088 wholesale distributor-broker permit to a person who engages in 1089 the wholesale distribution of prescription drugs and does not 1090 take physical possession of any prescription drugs. 1091 (f)(e)Out-of-state prescription drug wholesale distributor 1092 permit.—An out-of-state prescription drug wholesale distributor 1093 permit is required for any person that is a wholesale 1094 distributor located outside this state, but within the United 1095 States or its territories, which engages in the wholesale 1096 distribution of prescription drugs into this stateand which1097must be permitted by the department and comply with all the1098provisions required of a wholesale distributor under this part. 1099An out-of-state prescription drug wholesale distributor that1100applies to the department for a new permit or the renewal of a1101permit must submit a bond of $100,000, or other equivalent means1102of security acceptable to the department, such as an irrevocable1103letter of credit or a deposit in a trust account or financial1104institution, payable to the Professional Regulation Trust Fund.1105The purpose of the bond is to secure payment of any1106administrative penalties imposed by the department and any fees1107and costs incurred by the department regarding that permit which1108are authorized under state law and which the permittee fails to1109pay 30 days after the fine or costs become final. The department1110may make a claim against such bond or security until 1 year1111after the permittee’s license ceases to be valid or until 601112days after any administrative or legal proceeding authorized in1113this part which involves the permittee is concluded, including1114any appeal, whichever occurs later.The out-of-state 1115 prescription drug wholesale distributor must maintain at all 1116 times a license or permit to engage in the wholesale 1117 distribution of prescription drugs in compliance with laws of 1118 the state in which it is a resident. If the state from which the 1119 wholesale distributor distributes prescription drugs does not 1120 require a license to engage in the wholesale distribution of 1121 prescription drugs, the distributor must be licensed as a 1122 wholesale distributor as required by the federal act. 1123 (g)(f)Retail pharmacy drug wholesale distributor permit.—A 1124 retail pharmacy drug wholesale distributor is a retail pharmacy 1125 engaged in wholesale distribution of prescription drugs within 1126 this state under the following conditions: 1127 1. The pharmacy must obtain a retail pharmacy drug 1128 wholesale distributor permit pursuant to this part andtherules 1129 adopted under this part. 1130 2. The wholesale distribution activity does not exceed 30 1131 percent of the total annual purchases of prescription drugs. If 1132 the wholesale distribution activity exceeds the 30-percent 1133 maximum, the pharmacy must obtain a prescription drug wholesale 1134 distributor permit. 1135 3. The transfer of prescription drugs that appear in any 1136 schedule contained in chapter 893 is subject to chapter 893 and 1137 the federal Comprehensive Drug Abuse Prevention and Control Act 1138 of 1970. 1139 4. The transfer is between a retail pharmacy and another 1140 retail pharmacy, or a Modified Class II institutional pharmacy, 1141 or a health care practitioner licensed in this state and 1142 authorized by law to dispense or prescribe prescription drugs. 1143 5. All records of sales of prescription drugs subject to 1144 this section must be maintained separate and distinct from other 1145 records and comply with the recordkeeping requirements of this 1146 part. 1147 (h)(g)Restricted prescription drug distributor permit.— 1148 1. A restricted prescription drug distributor permit is 1149 required for: 1150 a. Any person located in this state who engages in the 1151 distribution of a prescription drug, which distribution is not 1152 considered “wholesale distribution” under s. 499.003(48)(a) 1153499.003(53)(a). 1154 b. Any person located in this state who engages in the 1155 receipt or distribution of a prescription drug in this state for 1156 the purpose of processing its return or its destruction if such 1157 person is not the person initiating the return, the prescription 1158 drug wholesale supplier of the person initiating the return, or 1159 the manufacturer of the drug. 1160 c. A blood establishment located in this state which 1161 collects blood and blood components only from volunteer donors 1162 as defined in s. 381.06014 or pursuant to an authorized 1163 practitioner’s order for medical treatment or therapy and 1164 engages in the wholesale distribution of a prescription drug not 1165 described in s. 499.003(48)(j)499.003(53)(d)to a health care 1166 entity. A mobile blood unit operated by a blood establishment 1167 permitted under this sub-subparagraph is not required to be 1168 separately permitted. The health care entity receiving a 1169 prescription drug distributed under this sub-subparagraph must 1170 be licensed as a closed pharmacy or provide health care services 1171 at that establishment. The blood establishment must operate in 1172 accordance with s. 381.06014 and may distribute only: 1173 (I) Prescription drugs indicated for a bleeding or clotting 1174 disorder or anemia; 1175 (II) Blood-collection containers approved under s. 505 of 1176 the federal act; 1177 (III) Drugs that are blood derivatives, or a recombinant or 1178 synthetic form of a blood derivative; 1179 (IV) Prescription drugs that are identified in rules 1180 adopted by the department and that are essential to services 1181 performed or provided by blood establishments and authorized for 1182 distribution by blood establishments under federal law; or 1183 (V) To the extent authorized by federal law, drugs 1184 necessary to collect blood or blood components from volunteer 1185 blood donors; for blood establishment personnel to perform 1186 therapeutic procedures under the direction and supervision of a 1187 licensed physician; and to diagnose, treat, manage, and prevent 1188 any reaction of a volunteer blood donor or a patient undergoing 1189 a therapeutic procedure performed under the direction and 1190 supervision of a licensed physician, 1191 1192 as long as all of the health care services provided by the blood 1193 establishment are related to its activities as a registered 1194 blood establishment or the health care services consist of 1195 collecting, processing, storing, or administering human 1196 hematopoietic stem cells or progenitor cells or performing 1197 diagnostic testing of specimens if such specimens are tested 1198 together with specimens undergoing routine donor testing. The 1199 blood establishment may purchase and possess the drugs described 1200 in this sub-subparagraph without a health care clinic 1201 establishment permit. 1202 2. Storage, handling, and recordkeeping of these 1203 distributions by a person required to be permitted as a 1204 restricted prescription drug distributor must be in accordance 1205 with the requirements for wholesale distributors under s. 1206 499.0121, but not those set forth in s. 499.01212 if the1207distribution occurs pursuant to sub-subparagraph 1.a. or sub1208subparagraph 1.b. 1209 3. A person who applies for a permit as a restricted 1210 prescription drug distributor, or for the renewal of such a 1211 permit, must provide to the department the information required 1212 under s. 499.012. 1213 4. The department may adopt rules regarding the 1214 distribution of prescription drugs by hospitals, health care 1215 entities, charitable organizations, other persons not involved 1216 in wholesale distribution, and blood establishments, which rules 1217 are necessary for the protection of the public health, safety, 1218 and welfare. 1219 5. A restricted prescription drug distributor permit is not 1220 required for distributions between pharmacies that each hold an 1221 active permit under chapter 465, have a common ownership, and 1222 are operating in a freestanding end-stage renal dialysis clinic, 1223 if such distributions are made to meet the immediate emergency 1224 medical needs of specifically identified patients and do not 1225 occur with such frequency as to amount to the regular and 1226 systematic supplying of that drug between the pharmacies. The 1227 department shall adopt rules establishing when the distribution 1228 of a prescription drug under this subparagraph amounts to the 1229 regular and systematic supplying of that drug. 1230 (i)(h)Complimentary drug distributor permit.—A 1231 complimentary drug distributor permit is required for any person 1232 that engages in the distribution of a complimentary drug, 1233 subject to the requirements of s. 499.028. 1234 (j)(i)Freight forwarder permit.—A freight forwarder permit 1235 is required for any person that engages in the distribution of a 1236 prescription drug as a freight forwarder unless the person is a 1237 common carrier. The storage, handling, and recordkeeping of such 1238 distributions must comply with the requirements for wholesale 1239 distributors under s. 499.0121, but not those set forth in s.1240499.01212. A freight forwarder must provide the source of the 1241 prescription drugs with a validated airway bill, bill of lading, 1242 or other appropriate documentation to evidence the exportation 1243 of the product. 1244 (k)(j)Veterinary prescription drug retail establishment 1245 permit.—A veterinary prescription drug retail establishment 1246 permit is required for any person that sells veterinary 1247 prescription drugs to the public but does not include a pharmacy 1248 licensed under chapter 465. 1249 1. The sale to the public must be based on a valid written 1250 order from a veterinarian licensed in this state who has a valid 1251 client-veterinarian relationship with the purchaser’s animal. 1252 2. Veterinary prescription drugs may not be sold in excess 1253 of the amount clearly indicated on the order or beyond the date 1254 indicated on the order. 1255 3. An order may not be valid for more than 1 year. 1256 4. A veterinary prescription drug retail establishment may 1257 not purchase, sell, trade, or possess human prescription drugs 1258 or any controlled substance as defined in chapter 893. 1259 5. A veterinary prescription drug retail establishment must 1260 sell a veterinary prescription drug in the original, sealed 1261 manufacturer’s container with all labeling intact and legible. 1262 The department may adopt by rule additional labeling 1263 requirements for the sale of a veterinary prescription drug. 1264 6. A veterinary prescription drug retail establishment must 1265 comply with all of the wholesale distribution requirements of s. 1266 499.0121. 1267 7. Prescription drugs sold by a veterinary prescription 1268 drug retail establishment pursuant to a practitioner’s order may 1269 not be returned into the retail establishment’s inventory. 1270 (l)(k)Veterinary prescription drug wholesale distributor 1271 permit.—A veterinary prescription drug wholesale distributor 1272 permit is required for any person that engages in the 1273 distribution of veterinary prescription drugs in or into this 1274 state. A veterinary prescription drug wholesale distributor that 1275 also distributes prescription drugs subject to, defined by, or 1276 described by s. 503(b) of the Federal Food, Drug, and Cosmetic 1277 Act which it did not manufacture must obtain a permit as a 1278 prescription drug wholesale distributor, an out-of-state 1279 prescription drug wholesale distributor, or a limited 1280 prescription drug veterinary wholesale distributor in lieu of 1281 the veterinary prescription drug wholesale distributor permit. A 1282 veterinary prescription drug wholesale distributor must comply 1283 with the requirements for wholesale distributors under s. 1284 499.0121, but not those set forth in s. 499.01212. 1285 (m)(l)Limited prescription drug veterinary wholesale 1286 distributor permit.—Unless engaging in the activities of and 1287 permitted as a prescription drug manufacturer, nonresident 1288 prescription drug manufacturer, prescription drug wholesale 1289 distributor, or out-of-state prescription drug wholesale 1290 distributor, a limited prescription drug veterinary wholesale 1291 distributor permit is required for any person that engages in 1292 the distribution in or into this state of veterinary 1293 prescription drugs and prescription drugs subject to, defined 1294 by, or described by s. 503(b) of the Federal Food, Drug, and 1295 Cosmetic Act under the following conditions: 1296 1. The person is engaged in the business of wholesaling 1297 prescription and veterinary prescription drugs to persons: 1298 a. Licensed as veterinarians practicing on a full-time 1299 basis; 1300 b. Regularly and lawfully engaged in instruction in 1301 veterinary medicine; 1302 c. Regularly and lawfully engaged in law enforcement 1303 activities; 1304 d. For use in research not involving clinical use; or 1305 e. For use in chemical analysis or physical testing or for 1306 purposes of instruction in law enforcement activities, research, 1307 or testing. 1308 2. No more than 30 percent of total annual prescription 1309 drug sales may be prescription drugs approved for human use 1310 which are subject to, defined by, or described by s. 503(b) of 1311 the Federal Food, Drug, and Cosmetic Act. 1312 3. The person does not distribute in any jurisdiction 1313 prescription drugs subject to, defined by, or described by s. 1314 503(b) of the Federal Food, Drug, and Cosmetic Act to any person 1315 who is authorized to sell, distribute, purchase, trade, or use 1316 these drugs on or for humans. 1317 4. A limited prescription drug veterinary wholesale 1318 distributor that applies to the department for a new permit or 1319 the renewal of a permit must submit a bond of $20,000, or other 1320 equivalent means of security acceptable to the department, such 1321 as an irrevocable letter of credit or a deposit in a trust 1322 account or financial institution, payable to the Professional 1323 Regulation Trust Fund. The purpose of the bond is to secure 1324 payment of any administrative penalties imposed by the 1325 department and any fees and costs incurred by the department 1326 regarding that permit which are authorized under state law and 1327 which the permittee fails to pay 30 days after the fine or costs 1328 become final. The department may make a claim against such bond 1329 or security until 1 year after the permittee’s license ceases to 1330 be valid or until 60 days after any administrative or legal 1331 proceeding authorized in this part which involves the permittee 1332 is concluded, including any appeal, whichever occurs later. 1333 5. A limited prescription drug veterinary wholesale 1334 distributor must maintain at all times a license or permit to 1335 engage in the wholesale distribution of prescription drugs in 1336 compliance with laws of the state in which it is a resident. 1337 6. A limited prescription drug veterinary wholesale 1338 distributor must comply with the requirements for wholesale 1339 distributors under s.ss.499.0121and 499.01212, except that a1340limited prescription drug veterinary wholesale distributor is1341not required to provide a pedigree paper as required by s.1342499.01212 upon the wholesale distribution of a prescription drug1343to a veterinarian. 1344 7. A limited prescription drug veterinary wholesale 1345 distributor may not return to inventory for subsequent wholesale 1346 distribution any prescription drug subject to, defined by, or 1347 described by s. 503(b) of the Federal Food, Drug, and Cosmetic 1348 Act which has been returned by a veterinarian. 1349 8. A limited prescription drug veterinary wholesale 1350 distributor permit is not required for an intracompany sale or 1351 transfer of a prescription drug from an out-of-state 1352 establishment that is duly licensed to engage in the wholesale 1353 distribution of prescription drugs in its state of residence to 1354 a licensed limited prescription drug veterinary wholesale 1355 distributor in this state if both wholesale distributors conduct 1356 wholesale distributions of prescription drugs under the same 1357 business name. The recordkeeping requirements of s.ss.1358 499.0121(6)and 499.01212must be followed for this transaction. 1359 (n)(m)Over-the-counter drug manufacturer permit.—An over 1360 the-counter drug manufacturer permit is required for any person 1361 that engages in the manufacture or repackaging of an over-the 1362 counter drug. 1363 1. An over-the-counter drug manufacturer may not possess or 1364 purchase prescription drugs. 1365 2. A pharmacy is exempt from obtaining an over-the-counter 1366 drug manufacturer permit if it is operating in compliance with 1367 pharmacy practice standards as defined in chapter 465 andthe1368 rules adopted under that chapter. 1369 3. An over-the-counter drug manufacturer must comply with 1370 all appropriate state and federal good manufacturing practices. 1371 (o)(n)Device manufacturer permit.— 1372 1. A device manufacturer permit is required for any person 1373 that engages in the manufacture, repackaging, or assembly of 1374 medical devices for human use in this state, except that a 1375 permit is not required if: 1376 a. The person is engaged only in manufacturing, 1377 repackaging, or assembling a medical device pursuant to a 1378 practitioner’s order for a specific patient; or 1379 b. The person does not manufacture, repackage, or assemble 1380 any medical devices or components for such devices, except those 1381 devices or components which are exempt from registration 1382 pursuant to s. 499.015(8). 1383 2. A manufacturer or repackager of medical devices in this 1384 state must comply with all appropriate state and federal good 1385 manufacturing practices and quality system rules. 1386 3. The department shall adopt rules related to storage, 1387 handling, and recordkeeping requirements for manufacturers of 1388 medical devices for human use. 1389 (p)(o)Cosmetic manufacturer permit.—A cosmetic 1390 manufacturer permit is required for any person that manufactures 1391 or repackages cosmetics in this state. A person that only labels 1392 or changes the labeling of a cosmetic but does not open the 1393 container sealed by the manufacturer of the product is exempt 1394 from obtaining a permit under this paragraph. 1395 (q)(p)Third party logistics provider permit.—A third party 1396 logistics provider permit is required for any person that 1397 contracts with a prescription drug wholesale distributor or 1398 prescription drug manufacturer to provide warehousing, 1399 distribution, or other logistics services on behalf of a 1400 manufacturer,orwholesale distributor, or dispenser, but who 1401 does not take title to the prescription drug or have 1402 responsibility to direct the sale or disposition of the 1403 prescription drug. A third party logistics provider located 1404 outside of this state, must be licensed in the state or 1405 territory from which the prescription drug is distributed by the 1406 third party logistics provider. If the state or territory from 1407 which the third party logistics provider originates does not 1408 require a license to operate as a third party logistics 1409 provider, the third party logistics provider must be licensed as 1410 a third party logistics provider as required by the federal act. 1411 Each third party logistics provider permittee shall comply with 1412 s.the requirements for wholesale distributors under ss.1413 499.0121and 499.01212, with the exception of those wholesale1414distributions described in s. 499.01212(3)(a),and other rules 1415 that the department requires. 1416 (r)(q)Health care clinic establishment permit.—Effective1417January 1, 2009,A health care clinic establishment permit is 1418 required for the purchase of a prescription drug by a place of 1419 business at one general physical location that provides health 1420 care or veterinary services, which is owned and operated by a 1421 business entity that has been issued a federal employer tax 1422 identification number. For the purpose of this paragraph, the 1423 term “qualifying practitioner” means a licensed health care 1424 practitioner defined in s. 456.001, or a veterinarian licensed 1425 under chapter 474, who is authorized under the appropriate 1426 practice act to prescribe and administer a prescription drug. 1427 1. An establishment must provide, as part of the 1428 application required under s. 499.012, designation of a 1429 qualifying practitioner who will be responsible for complying 1430 with all legal and regulatory requirements related to the 1431 purchase, recordkeeping, storage, and handling of the 1432 prescription drugs. In addition, the designated qualifying 1433 practitioner shall be the practitioner whose name, establishment 1434 address, and license number is used on all distribution 1435 documents for prescription drugs purchased or returned by the 1436 health care clinic establishment. Upon initial appointment of a 1437 qualifying practitioner, the qualifying practitioner and the 1438 health care clinic establishment shall notify the department on 1439 a form furnished by the department within 10 days after such 1440 employment. In addition, the qualifying practitioner and health 1441 care clinic establishment shall notify the department within 10 1442 days after any subsequent change. 1443 2. The health care clinic establishment must employ a 1444 qualifying practitioner at each establishment. 1445 3. In addition to the remedies and penalties provided in 1446 this part, a violation of this chapter by the health care clinic 1447 establishment or qualifying practitioner constitutes grounds for 1448 discipline of the qualifying practitioner by the appropriate 1449 regulatory board. 1450 4. The purchase of prescription drugs by the health care 1451 clinic establishment is prohibited during any period of time 1452 when the establishment does not comply with this paragraph. 1453 5. A health care clinic establishment permit is not a 1454 pharmacy permit or otherwise subject to chapter 465. A health 1455 care clinic establishment that meets the criteria of a modified 1456 Class II institutional pharmacy under s. 465.019 is not eligible 1457 to be permitted under this paragraph. 1458 6. This paragraph does not apply to the purchase of a 1459 prescription drug by a licensed practitioner under his or her 1460 license. 1461 (3) A nonresident prescription drug manufacturer permit is 1462 not required for a manufacturer to distribute a prescription 1463 drug active pharmaceutical ingredient that it manufactures to a 1464 prescription drug manufacturer permitted in this statein1465limited quantitiesintended for research and development and not 1466 for resale or human use other than lawful clinical trials and 1467 biostudies authorized and regulated by federal law. A 1468 manufacturer claiming to be exempt from the permit requirements 1469 of this subsection and the prescription drug manufacturer 1470 purchasing and receiving the active pharmaceutical ingredient 1471 shall comply with the recordkeeping requirements of s. 1472 499.0121(6), but not the requirements of s. 499.01212. The 1473 prescription drug manufacturer purchasing and receiving the 1474 active pharmaceutical ingredient shall maintain on file a record 1475 of the FDA registration number; if available, the out-of-state 1476 license, permit, or registration number; and, if available, a 1477 copy of the most current FDA inspection report, for all 1478 manufacturers from whom they purchase active pharmaceutical 1479 ingredients under this section.The department shall define the1480term “limited quantities” by rule, and may include the allowable1481number of transactions within a given period of time and the1482amount of prescription drugs distributed into the state for1483purposes of this exemption.The failure to comply with the 1484 requirements of this subsection, or rules adopted by the 1485 department to administer this subsection, for the purchase of 1486 prescription drug active pharmaceutical ingredients is a 1487 violation of s. 499.005(14), and a knowing failure is a 1488 violation of s. 499.0051(3)499.0051(4). 1489 (a) The immediate package or container of a prescription 1490 drug active pharmaceutical ingredient distributed into the state 1491 that is intended for research and development under this 1492 subsection shall bear a label prominently displaying the 1493 statement: “Caution: Research and Development Only—Not for 1494 Manufacturing, Compounding, or Resale.” 1495 (b) A prescription drug manufacturer that obtains a 1496 prescription drug active pharmaceutical ingredient under this 1497 subsection for use in clinical trials and or biostudies 1498 authorized and regulated by federal law must create and maintain 1499 records detailing the specific clinical trials or biostudies for 1500 which the prescription drug active pharmaceutical ingredient was 1501 obtained. 1502 (4)(a) A permit issued under this part is not required to 1503 distribute a prescription drug active pharmaceutical ingredient 1504 from an establishment located in the United States to an 1505 establishment located in this state permitted as a prescription 1506 drug manufacturer under this part for use by the recipient in 1507 preparing, deriving, processing, producing, or fabricating a 1508 prescription drug finished dosage form at the establishment in 1509 this state where the product is received under an approved and 1510 otherwise valid New Drug Approval Application, Abbreviated New 1511 Drug Application, New Animal Drug Application, or Therapeutic 1512 Biologic Application, provided that the application, active 1513 pharmaceutical ingredient, or finished dosage form has not been 1514 withdrawn or removed from the market in this country for public 1515 health reasons. 1516 1. Any distributor claiming exemption from permitting 1517 requirements pursuant to this paragraph shall maintain a 1518 license, permit, or registration to engage in the wholesale 1519 distribution of prescription drugs under the laws of the state 1520 from which the product is distributed. If the state from which 1521 the prescription drugs are distributed does not require a 1522 license to engage in the wholesale distribution of prescription 1523 drugs, the distributor must be licensed as a wholesale 1524 distributor as required by the federal act. 1525 2. Any distributor claiming exemption from permitting 1526 requirements pursuant to this paragraph and the prescription 1527 drug manufacturer purchasing and receiving the active 1528 pharmaceutical ingredient shall comply with the recordkeeping 1529 requirements of s. 499.0121(6), but not the requirements of s.1530499.01212. 1531 (b) A permit issued under this part is not required to 1532 distributelimited quantities ofa prescription drug that has 1533 not been repackaged from an establishment located in the United 1534 States to an establishment located in this state permitted as a 1535 prescription drug manufacturer under this part for research and 1536 development or to a holder of a letter of exemption issued by 1537 the department under s. 499.03(4) for research, teaching, or 1538 testing.The department shall define “limited quantities” by1539rule and may include the allowable number of transactions within1540a given period of time and the amounts of prescription drugs1541distributed into the state for purposes of this exemption.1542 1. Any distributor claiming exemption from permitting 1543 requirements pursuant to this paragraph shall maintain a 1544 license, permit, or registration to engage in the wholesale 1545 distribution of prescription drugs under the laws of the state 1546 from which the product is distributed. If the state from which 1547 the prescription drugs are distributed does not require a 1548 license to engage in the wholesale distribution of prescription 1549 drugs, the distributor must be licensed as a wholesale 1550 distributor as required by the federal act. 1551 2. All purchasers and recipients of any prescription drugs 1552 distributed pursuant to this paragraph shall ensure that the 1553 products are not resold or used, directly or indirectly, on 1554 humans except in lawful clinical trials and biostudies 1555 authorized and regulated by federal law. 1556 3. Any distributor claiming exemption from permitting 1557 requirements pursuant to this paragraph, and the purchaser and 1558 recipient of the prescription drug, shall comply with the 1559 recordkeeping requirements of s. 499.0121(6), but not the1560requirements of s. 499.01212. 1561 4. The immediate package or container of any active 1562 pharmaceutical ingredient distributed into the state that is 1563 intended for teaching, testing, research, and development shall 1564 bear a label prominently displaying the statement: “Caution: 1565 Research, Teaching, or Testing Only – Not for Manufacturing, 1566 Compounding, or Resale.” 1567 (c) An out-of-state prescription drug wholesale distributor 1568 permit is not required for an intracompany sale or transfer of a 1569 prescription drug from an out-of-state establishment that is 1570 duly licensed as a prescription drug wholesale distributor in 1571 its state of residence to a licensed prescription drug wholesale 1572 distributor in this state, if both wholesale distributors 1573 conduct wholesale distributions of prescription drugs under the 1574 same business name. The recordkeeping requirements of s.ss.1575 499.0121(6)and 499.01212must be followed for such 1576 transactions. 1577 (d) Persons receiving prescription drugs from a source 1578 claimed to be exempt from permitting requirements under this 1579 subsection shall maintain on file: 1580 1. A record of the FDA establishment registration number, 1581 if any; 1582 2. The resident state or federal license, registration, or 1583 permit that authorizes the source to distribute prescription 1584 drugsdrug wholesale distribution license, permit, or1585registration number; and 1586 3. A copy of the most recent resident state or FDA 1587 inspection report, for all distributors and establishments from 1588 whom they purchase or receive prescription drugs under this 1589 subsection. 1590 (e) All persons claiming exemption from permitting 1591 requirements pursuant to this subsection who engage in the 1592 distribution of prescription drugs within or into the state are 1593 subject to this part, including ss. 499.005 and 499.0051, and 1594 shall make available, within 48 hours, to the department on 1595 request all records related to any prescription drugs 1596 distributed under this subsection, including those records 1597 described in s. 499.051(4), regardless of the location where the 1598 records are stored. 1599 (f) A person purchasing and receiving a prescription drug 1600 from a person claimed to be exempt from licensing requirements 1601 pursuant to this subsection shall report to the department in 1602 writing within 14 days after receiving any product that is 1603 misbranded or adulterated or that fails to meet minimum 1604 standards set forth in the official compendium or state or 1605 federal good manufacturing practices for identity, purity, 1606 potency, or sterility, regardless of whether the product is 1607 thereafter rehabilitated, quarantined, returned, or destroyed. 1608 (g) The department may adopt rules to administer this 1609 subsection which are necessary for the protection of the public 1610 health, safety, and welfare. Failure to comply with the 1611 requirements of this subsection, or rules adopted by the 1612 department to administer this subsection, is a violation of s. 1613 499.005(14), and a knowing failure is a violation of s. 1614 499.0051(3)499.0051(4). 1615 (h) This subsection does not relieve any person from any 1616 requirement prescribed by law with respect to controlled 1617 substances as defined in the applicable federal and state laws. 1618 (5) A prescription drug repackager permit issued under this 1619 part is not required for a restricted prescription drug 1620 distributor permitholder that is a health care entity to 1621 repackage prescription drugs in this state for its own use or 1622 for distribution to hospitals or other health care entities in 1623 the state for their own use, pursuant to s. 499.003(48)(a)3. 1624499.003(53)(a)3., if: 1625 (a) The prescription drug distributor notifies the 1626 department, in writing, of its intention to engage in 1627 repackaging under this exemption, 30 days before engaging in the 1628 repackaging of prescription drugs at the permitted 1629 establishment; 1630 (b) The prescription drug distributor is under common 1631 control with the hospitals or other health care entities to 1632 which the prescription drug distributor is distributing 1633 prescription drugs. As used in this paragraph, “common control” 1634 means the power to direct or cause the direction of the 1635 management and policies of a person or an organization, whether 1636 by ownership of stock, voting rights, contract, or otherwise; 1637 (c) The prescription drug distributor repackages the 1638 prescription drugs in accordance with current state and federal 1639 good manufacturing practices; and 1640 (d) The prescription drug distributor labels the 1641 prescription drug it repackages in accordance with state and 1642 federal laws and rules. 1643 1644 The prescription drug distributor is exempt from the product 1645 registration requirements of s. 499.015 with regard to the 1646 prescription drugs that it repackages and distributes under this 1647 subsection. A prescription drug distributor that repackages and 1648 distributes prescription drugs under this subsection to a not 1649 for-profit rural hospital, as defined in s. 395.602, is not 1650 required to comply with paragraph (c) or paragraph (d), but must 1651 provide to each health care entity for which it repackages, for 1652 each prescription drug that is repackaged and distributed, the 1653 information required by department rule for labeling 1654 prescription drugs. The department shall adopt rules to ensure 1655 the safety and integrity of prescription drugs repackaged and 1656 distributed under this subsection, including rules regarding 1657 prescription drug manufacturing and labeling requirements. 1658 Section 7. Section 499.012, Florida Statutes, is amended to 1659 read: 1660 499.012 Permit application requirements.— 1661 (1)(a) A permit issued pursuant to this part may be issued 1662 only to a natural person who is at least 18 years of age or to 1663 an applicant that is not a natural person if each person who, 1664 directly or indirectly, manages, controls, or oversees the 1665 operation of that applicant is at least 18 years of age. 1666 (b) An establishment that is a place of residence may not 1667 receive a permit and may not operate under this part. 1668 (c) A person that applies for or renews a permit to 1669 manufacture or distribute prescription drugs may not use a name 1670 identical to the name used by any other establishment or 1671 licensed person authorized to purchase prescription drugs in 1672 this state, except that a restricted drug distributor permit 1673 issued to a health care entity will be issued in the name in 1674 which the institutional pharmacy permit is issued and a retail 1675 pharmacy drug wholesale distributor will be issued a permit in 1676 the name of its retail pharmacy permit. 1677 (d) A permit for a prescription drug manufacturer, 1678 prescription drug repackager, prescription drug wholesale 1679 distributor, limited prescription drug veterinary wholesale 1680 distributor, or retail pharmacy drug wholesale distributor may 1681 not be issued to the address of a health care entity or to a 1682 pharmacy licensed under chapter 465, except as provided in this 1683 paragraph. The department may issue a prescription drug 1684 manufacturer permit to an applicant at the same address as a 1685 licensed nuclear pharmacy, which is a health care entity, even 1686 if the nuclear pharmacy holds a special sterile compounding 1687 permit under chapter 465, for the purpose of manufacturing 1688 prescription drugs used in positron emission tomography or other 1689 radiopharmaceuticals, as listed in a rule adopted by the 1690 department pursuant to this paragraph. The purpose of this 1691 exemption is to assure availability of state-of-the-art 1692 pharmaceuticals that would pose a significant danger to the 1693 public health if manufactured at a separate establishment 1694 address from the nuclear pharmacy from which the prescription 1695 drugs are dispensed. The department may also issue a retail 1696 pharmacy drug wholesale distributor permit to the address of a 1697 community pharmacy licensed under chapter 465, even if the 1698 community pharmacy holds a special sterile compounding permit 1699 under chapter 465, as long as the community pharmacywhichdoes 1700 not meet the definition of a closed pharmacy in s. 499.003. 1701 (e) A county or municipality may not issue an occupational 1702 license forany licensing period beginning on or after October17031, 2003, forany establishment that requires a permit pursuant 1704 to this part, unless the establishment exhibits a current permit 1705 issued by the department for the establishment. Upon 1706 presentation of the requisite permit issued by the department, 1707 an occupational license may be issued by the municipality or 1708 county in which application is made. The department shall 1709 furnish to local agencies responsible for issuing occupational 1710 licenses a current list of all establishments licensed pursuant 1711 to this part. 1712 (2) Notwithstanding subsection (6), a permitted person in 1713 good standing may change the type of permit issued to that 1714 person by completing a new application for the requested permit, 1715 paying the amount of the difference in the permit fees if the 1716 fee for the new permit is more than the fee for the original 1717 permit, and meeting the applicable permitting conditions for the 1718 new permit type. The new permit expires on the expiration date 1719 of the original permit being changed; however, a new permit for 1720 a prescription drug wholesale distributor, an out-of-state 1721 prescription drug wholesale distributor, or a retail pharmacy 1722 drug wholesale distributor shall expire on the expiration date 1723 of the original permit or 1 year after the date of issuance of 1724 the new permit, whichever is earlier. A refund may not be issued 1725 if the fee for the new permit is less than the fee that was paid 1726 for the original permit. 1727 (3)(a) A written application for a permit or to renew a 1728 permit must be filed with the department on forms furnished by 1729 the department. The department shall establish, by rule, the 1730 form and content of the application to obtain or renew a permit. 1731 The applicant must submit to the department with the application 1732 a statement that swears or affirms that the information is true 1733 and correct. 1734 (b) Upon a determination that 2 years have elapsed since 1735 the department notified an applicant for permit, certification, 1736 or product registration of a deficiency in the application and 1737 that the applicant has failed to cure the deficiency, the 1738 application shall expire. The determination regarding the 2-year 1739 lapse of time shall be based on documentation that the 1740 department notified the applicant of the deficiency in 1741 accordance with s. 120.60. 1742 (c) Information submitted by an applicant on an application 1743 required pursuant to this subsection which is a trade secret, as 1744 defined in s. 812.081, shall be maintained by the department as 1745 trade secret information pursuant to s. 499.051(7). 1746 (4)(a) Except for a permit for a prescription drug 1747 wholesale distributor or an out-of-state prescription drug 1748 wholesale distributor, an application for a permit must include: 1749 1. The name, full business address, and telephone number of 1750 the applicant; 1751 2. All trade or business names used by the applicant; 1752 3. The address, telephone numbers, and the names of contact 1753 persons for each facility used by the applicant for the storage, 1754 handling, and distribution of prescription drugs; 1755 4. The type of ownership or operation, such as a 1756 partnership, corporation, or sole proprietorship; and 1757 5. The names of the owner and the operator of the 1758 establishment, including: 1759 a. If an individual, the name of the individual; 1760 b. If a partnership, the name of each partner and the name 1761 of the partnership; 1762 c. If a corporation, the name and title of each corporate 1763 officer and director, the corporate names, and the name of the 1764 state of incorporation; 1765 d. If a sole proprietorship, the full name of the sole 1766 proprietor and the name of the business entity; 1767 e. If a limited liability company, the name of each member, 1768 the name of each manager, the name of the limited liability 1769 company, and the name of the state in which the limited 1770 liability company was organized; and 1771 f. Any other relevant information that the department 1772 requires. 1773 (b) Upon approval of the application by the department and 1774 payment of the required fee, the department shall issue a permit 1775 to the applicant, if the applicant meets the requirements of 1776 this part and rules adopted under this part. 1777 (c) Any change in information required under paragraph (a) 1778 must be submitted to the department before the change occurs. 1779 (d) The department shall consider, at a minimum, the 1780 following factors in reviewing the qualifications of persons to 1781 be permitted under this part: 1782 1. The applicant’s having been found guilty, regardless of 1783 adjudication, in a court of this state or other jurisdiction, of 1784 a violation of a law that directly relates to a drug, device, or 1785 cosmetic. A plea of nolo contendere constitutes a finding of 1786 guilt for purposes of this subparagraph. 1787 2. The applicant’s having been disciplined by a regulatory 1788 agency in any state for any offense that would constitute a 1789 violation of this part. 1790 3. Any felony conviction of the applicant under a federal, 1791 state, or local law; 1792 4. The applicant’s past experience in manufacturing or 1793 distributing drugs, devices, or cosmetics; 1794 5. The furnishing by the applicant of false or fraudulent 1795 material in any application made in connection with 1796 manufacturing or distributing drugs, devices, or cosmetics; 1797 6. Suspension or revocation by a federal, state, or local 1798 government of any permit currently or previously held by the 1799 applicant for the manufacture or distribution of any drugs, 1800 devices, or cosmetics; 1801 7. Compliance with permitting requirements under any 1802 previously granted permits; 1803 8. Compliance with requirements to maintain or make 1804 available to the state permitting authority or to federal, 1805 state, or local law enforcement officials those records required 1806 under this section; and 1807 9. Any other factors or qualifications the department 1808 considers relevant to and consistent with the public health and 1809 safety. 1810 (5)Except for a permit for a prescription drug wholesale1811distributor or an out-of-state prescription drug wholesale1812distributor:1813 (a) The department shall adopt rules for the biennial 1814 renewal of permits; however, the department may issue up to a 4 1815 year permit to selected permittees notwithstanding any other 1816 provision of law. Fees for such renewal may not exceed the fee 1817 caps set forth in s. 499.041 on an annualized basis as 1818 authorized by law. 1819 (b) The department shall renew a permit upon receipt of the 1820 renewal application and renewal fee if the applicant meets the 1821 requirements established under this part andtherules adopted 1822 under this part. 1823 (c) At least 90 days before the expiration date of a 1824 permit, the department shall forward a permit renewal 1825 notification to the permittee at the mailing address of the 1826 permitted establishment on file with the department. The permit 1827 renewal notification must state conspicuously the date on which 1828 the permit for the establishment will expire and that the 1829 establishment may not operate unless the permit for the 1830 establishment is renewed timely.A permit, unless sooner1831suspended or revoked, automatically expires 2 years after the1832last day of the anniversary month in which the permit was1833originally issued.1834 (d) A permit issued under this part may be renewed by 1835 making application for renewal on forms furnished by the 1836 department and paying the appropriate fees. 1837 1. If a prescription drug wholesale distributor or an out 1838 of-state prescription drug wholesale distributor renewal 1839 application and fee are submitted and postmarked later than 45 1840 days before the expiration date of the permit, the permit may be 1841 renewed only upon payment of a late renewal fee of $100, plus 1842 the required renewal fee. 1843 2. If any otherarenewal application and fee are submitted 1844 and postmarked after the expiration date of the permit, the 1845 permit may be renewed only upon payment of a late renewal 1846 delinquent fee of $100, plus the required renewal fee, not later 1847 than 60 days after the expiration date. 1848 3. A permittee who submits a renewal application in 1849 accordance with this paragraph may continue to operate under its 1850 permit, unless the permit is suspended or revoked, until final 1851 disposition of the renewal application. 1852 4.(d)Failure to renew a permit in accordance with this 1853 section precludes any future renewal of that permit. If a permit 1854 issued pursuant to this part has expired and cannot be renewed, 1855 before an establishment may engage in activities that require a 1856 permit under this part, the establishment must submit an 1857 application for a new permit, pay the applicable application 1858 fee, the initial permit fee, and all applicable penalties, and 1859 be issued a new permit by the department. 1860 (6) A permit issued by the department is nontransferable. 1861 Each permit is valid only for the person or governmental unit to 1862 which it is issued and is not subject to sale, assignment, or 1863 other transfer, voluntarily or involuntarily; nor is a permit 1864 valid for any establishment other than the establishment for 1865 which it was originally issued. 1866 (a) A person permitted under this part must notify the 1867 department before making a change of address. The department 1868 shall set a change of location fee not to exceed $100. 1869 (b)1. An application for a new permit is required when a 1870 majority of the ownership or controlling interest of a permitted 1871 establishment is transferred or assigned or when a lessee agrees 1872 to undertake or provide services to the extent that legal 1873 liability for operation of the establishment will rest with the 1874 lessee. The application for the new permit must be made before 1875 the date of the sale, transfer, assignment, or lease. 1876 2. A permittee that is authorized to distribute 1877 prescription drugs may transfer such drugs to the new owner or 1878 lessee under subparagraph 1. only after the new owner or lessee 1879 has been approved for a permit to distribute prescription drugs. 1880 (c) If an establishment permitted under this part closes, 1881 the owner must notify the department in writing before the 1882 effective date of closure and must: 1883 1. Return the permit to the department; 1884 2. If the permittee is authorized to distribute 1885 prescription drugs, indicate the disposition of such drugs, 1886 including the name, address, and inventory, and provide the name 1887 and address of a person to contact regarding access to records 1888 that are required to be maintained under this part. Transfer of 1889 ownership of prescription drugs may be made only to persons 1890 authorized to possess prescription drugs under this part. 1891 1892 The department may revoke the permit of any person that fails to 1893 comply with the requirements of this subsection. 1894 (7) A permit must be posted in a conspicuous place on the 1895 licensed premises. 1896 (8) An application for a permit or to renew a permit for a 1897 prescription drug wholesale distributor or an out-of-state 1898 prescription drug wholesale distributor submitted to the 1899 department must include: 1900 (a) The name, full business address, and telephone number 1901 of the applicant. 1902 (b) All trade or business names used by the applicant. 1903 (c) The address, telephone numbers, and the names of 1904 contact persons for each facility used by the applicant for the 1905 storage, handling, and distribution of prescription drugs. 1906 (d) The type of ownership or operation, such as a 1907 partnership, corporation, or sole proprietorship. 1908 (e) The names of the owner and the operator of the 1909 establishment, including: 1910 1. If an individual, the name of the individual. 1911 2. If a partnership, the name of each partner and the name 1912 of the partnership. 1913 3. If a corporation: 1914 a. The name, address, and title of each corporate officer 1915 and director. 1916 b. The name and address of the corporation, resident agent 1917 of the corporation, the resident agent’s address, and the 1918 corporation’s state of incorporation. 1919 c. The name and address of each shareholder of the 1920 corporation that owns 5 percent or more of the outstanding stock 1921 of the corporation. 1922 4. If a sole proprietorship, the full name of the sole 1923 proprietor and the name of the business entity. 1924 5. If a limited liability company: 1925 a. The name and address of each member. 1926 b. The name and address of each manager. 1927 c. The name and address of the limited liability company, 1928 the resident agent of the limited liability company, and the 1929 name of the state in which the limited liability company was 1930 organized. 1931 (f) If applicable, the name and address of each affiliate 1932 ofmember of the affiliated group of whichthe applicantis a1933member. 1934 (g)1.The applicant’s gross annual receipts attributable to 1935 prescription drug wholesale distribution activities for the 1936 previous tax year.For an application for a new permit, the1937estimated annual dollar volume of prescription drug sales of the1938applicant, the estimated annual percentage of the applicant’s1939total company sales that are prescription drugs, the applicant’s1940estimated annual total dollar volume of purchases of1941prescription drugs, and the applicant’s estimated annual total1942dollar volume of prescription drug purchases directly from1943manufacturers.19442.For an application to renew a permit, the total dollar1945volume of prescription drug sales in the previous year, the1946total dollar volume of prescription drug sales made in the1947previous 6 months, the percentage of total company sales that1948were prescription drugs in the previous year, the total dollar1949volume of purchases of prescription drugs in the previous year,1950and the total dollar volume of prescription drug purchases1951directly from manufacturers in the previous year.1952 1953Such portions of the information required pursuant to this1954paragraph which are a trade secret, as defined in s. 812.081,1955shall be maintained by the department as trade secret1956information is required to be maintained under s. 499.051.1957 (h) The tax year of the applicant. 1958 (i) A copy of the deed for the property on which 1959 applicant’s establishment is located, if the establishment is 1960 owned by the applicant, or a copy of the applicant’s lease for 1961 the property on which applicant’s establishment is located that 1962 has an original term of not less than 1 calendar year, if the 1963 establishment is not owned by the applicant. 1964 (j) A list of all licenses and permits issued to the 1965 applicant by any other state which authorize the applicant to 1966 purchase or possess prescription drugs. 1967 (k) The name of the manager of the establishment that is 1968 applying for the permit or to renew the permit, the next four 1969 highest ranking employees responsible for prescription drug 1970 wholesale operations for the establishment, and the name of all 1971 affiliated parties for the establishment, together with the 1972 personal information statement and fingerprints required 1973 pursuant to subsection (9) for each of such persons. 1974 (l) The name of each of the applicant’s designated 1975 representatives as required by subsection (15)(16), together 1976 with the personal information statement and fingerprints 1977 required pursuant to subsection (9) for each such person. 1978 (m) Evidence of a surety bond in this state or any other 1979 state in the United States in the amount of $100,000. If the 1980 annual gross receipts of the applicant’s previous tax year is 1981 $10 million or less, evidence of a surety bond in the amount of 1982 $25,000. The specific language of the surety bond must include 1983 the State of Florida as a beneficiary, payable to the 1984 Professional Regulation Trust Fund. In lieu of the surety bond, 1985 the applicant may provide other equivalent security such as an 1986 irrevocable letter of credit, or a deposit in a trust account or 1987 financial institution, which includes the State of Florida as a 1988 beneficiary, payable to the Professional Regulation Trust Fund. 1989 The purpose of the bond or other security is to secure payment 1990 of any administrative penalties imposed by the department and 1991 any fees and costs incurred by the department regarding that 1992 permit which are authorized under state law and which the 1993 permittee fails to pay 30 days after the fine or costs become 1994 final. The department may make a claim against such bond or 1995 security until 1 year after the permittee’s license ceases to be 1996 valid or until 60 days after any administrative or legal 1997 proceeding authorized in this part which involves the permittee 1998 is concluded, including any appeal, whichever occurs later.For1999an applicant that is a secondary wholesale distributor, each of2000the following:20011.A personal background information statement containing2002the background information and fingerprints required pursuant to2003subsection (9) for each person named in the applicant’s response2004to paragraphs (k) and (l) and for each affiliated party of the2005applicant.20062.If any of the five largest shareholders of the2007corporation seeking the permit is a corporation, the name,2008address, and title of each corporate officer and director of2009each such corporation; the name and address of such corporation;2010the name of such corporation’s resident agent, such2011corporation’s resident agent’s address, and such corporation’s2012state of its incorporation; and the name and address of each2013shareholder of such corporation that owns 5 percent or more of2014the stock of such corporation.20153.The name and address of all financial institutions in2016which the applicant has an account which is used to pay for the2017operation of the establishment or to pay for drugs purchased for2018the establishment, together with the names of all persons that2019are authorized signatories on such accounts. The portions of the2020information required pursuant to this subparagraph which are a2021trade secret, as defined in s. 812.081, shall be maintained by2022the department as trade secret information is required to be2023maintained under s. 499.051.20244.The sources of all funds and the amounts of such funds2025used to purchase or finance purchases of prescription drugs or2026to finance the premises on which the establishment is to be2027located.20285.If any of the funds identified in subparagraph 4. were2029borrowed, copies of all promissory notes or loans used to obtain2030such funds.2031 (n) For establishments used in wholesale distribution, 2032 proof of an inspection conducted by the department, the United 2033 States Food and Drug Administration, or another governmental 2034 entity charged with the regulation of good manufacturing 2035 practices related to wholesale distribution of prescription 2036 drugs, within timeframes set forth by the department in 2037 departmental rules, which demonstrates substantial compliance 2038 with current good manufacturing practices applicable to 2039 wholesale distribution of prescription drugs. The department may 2040 recognize another state’s inspection of a wholesale distributor 2041 located in that state if such state’s laws are deemed to be 2042 substantially equivalent to the law of this state by the 2043 department. The department may accept an inspection by a third 2044 party accreditation or inspection service which meets the 2045 criteria set forth in department rule. 2046 (o)(n)Any other relevant information that the department 2047 requires, including, but not limited to, any information related2048to whether the applicant satisfies the definition of a primary2049wholesale distributor or a secondary wholesale distributor. 2050 (p)(o)Documentation of the credentialing policies and 2051 procedures required by s. 499.0121(15). 2052 (9)(a) Each person required by subsection (8) or subsection 2053 (15) to provide a personal information statement and 2054 fingerprints shall provide the following information to the 2055 department on forms prescribed by the department: 2056 1. The person’s places of residence for the past 7 years. 2057 2. The person’s date and place of birth. 2058 3. The person’s occupations, positions of employment, and 2059 offices held during the past 7 years. 2060 4. The principal business and address of any business, 2061 corporation, or other organization in which each such office of 2062 the person was held or in which each such occupation or position 2063 of employment was carried on. 2064 5. Whether the person has been, during the past 7 years, 2065 the subject of any proceeding for the revocation of any license 2066 and, if so, the nature of the proceeding and the disposition of 2067 the proceeding. 2068 6. Whether, during the past 7 years, the person has been 2069 enjoined, temporarily or permanently, by a court of competent 2070 jurisdiction from violating any federal or state law regulating 2071 the possession, control, or distribution of prescription drugs, 2072 together with details concerning any such event. 2073 7. A description of any involvement by the person with any 2074 business, including any investments, other than the ownership of 2075 stock in a publicly traded company or mutual fund, during the 2076 past 47years, which manufactured, administered, prescribed, 2077 distributed, or stored pharmaceutical products and any lawsuits 2078 in which such businesses were named as a party. 2079 8. A description of any felony criminal offense of which 2080 the person, as an adult, was found guilty, regardless of whether 2081 adjudication of guilt was withheld or whether the person pled 2082 guilty or nolo contendere. A criminal offense committed in 2083 another jurisdiction which would have been a felony in this 2084 state must be reported. If the person indicates that a criminal 2085 conviction is under appeal and submits a copy of the notice of 2086 appeal of that criminal offense, the applicant must, within 15 2087 days after the disposition of the appeal, submit to the 2088 department a copy of the final written order of disposition. 2089 9. A photograph of the person taken in the previous 180302090 days. 2091 10. A set of fingerprints for the person on a form and 2092 under procedures specified by the department, together with 2093 payment of an amount equal to the costs incurred by the 2094 department for the criminal record check of the person. 2095 11. The name, address, occupation, and date and place of 2096 birth for each member of the person’s immediate family who is 18 2097 years of age or older. As used in this subparagraph, the term 2098 “member of the person’s immediate family” includes the person’s 2099 spouse, children, parents, siblings, the spouses of the person’s 2100 children, and the spouses of the person’s siblings. 2101 12. Any other relevant information that the department 2102 requires. 2103 (b) The information required pursuant to paragraph (a) 2104 shall be provided under oath. 2105 (c) The department shall submit the fingerprints provided 2106 by a person for initial licensure to the Department of Law 2107 Enforcement for a statewide criminal record check and for 2108 forwarding to the Federal Bureau of Investigation for a national 2109 criminal record check of the person. The department shall submit 2110 the fingerprints provided by a person as a part of a renewal 2111 application to the Department of Law Enforcement for a statewide 2112 criminal record check, and for forwarding to the Federal Bureau 2113 of Investigation for a national criminal record check, for the 2114 initial renewal of a permit after January 1, 2004; for any 2115 subsequent renewal of a permit, the department shall submit the 2116 required information for a statewide and national criminal 2117 record check of the person. Any person who as a part of an 2118 initial permit application or initial permit renewal after 2119 January 1, 2004, submits to the department a set of fingerprints 2120 required for the criminal record check required in this 2121 paragraph areshallnotberequired to provide a subsequent set 2122 of fingerprints for a criminal record check to the department, 2123 if the person has undergone a criminal record check as a 2124 condition of the issuance of an initial permit or the initial 2125 renewal of a permit of an applicant after January 1, 2004. The 2126 department is authorized to contract with private vendors, or 2127 enter into interagency agreements, to collect electronic 2128 fingerprints where fingerprints are required for registration, 2129 certification, or the licensure process or where criminal 2130 history record checks are required. 2131 (d) For purposes of applying for renewal of a permit under 2132 subsection (8) or certification under subsection (16), a person 2133 may submit the following in lieu of satisfying the requirements 2134 of paragraphs (a), (b), and (c): 2135 1. A photograph of the individual taken within 180 days; 2136 and 2137 2. A copy of the personal information statement form most 2138 recently submitted to the department and a certification under 2139 oath, on a form specified by the department, that the individual 2140 has reviewed the previously submitted personal information 2141 statement form and that the information contained therein 2142 remains unchanged. 2143 (10) The department may deny an application for a permit or 2144 refuse to renew a permit for a prescription drug wholesale 2145 distributor or an out-of-state prescription drug wholesale 2146 distributor if: 2147 (a) The applicant has not met the requirements for the 2148 permit. 2149 (b) The management, officers, or directors of the applicant 2150 or any affiliated party are found by the department to be 2151 incompetent or untrustworthy. 2152 (c) The applicant is so lacking in experience in managing a 2153 wholesale distributor as to make the issuance of the proposed 2154 permit hazardous to the public health. 2155 (d) The applicant is so lacking in experience in managing a 2156 wholesale distributor as to jeopardize the reasonable promise of 2157 successful operation of the wholesale distributor. 2158 (e) The applicant is lacking in experience in the 2159 distribution of prescription drugs. 2160 (f) The applicant’s past experience in manufacturing or 2161 distributing prescription drugs indicates that the applicant 2162 poses a public health risk. 2163 (g) The applicant is affiliated directly or indirectly 2164 through ownership, control, or other business relations, with 2165 any person or persons whose business operations are or have been 2166 detrimental to the public health. 2167 (h) The applicant, or any affiliated party, has been found 2168 guilty of or has pleaded guilty or nolo contendere to any felony 2169 or crime punishable by imprisonment for 1 year or more under the 2170 laws of the United States, any state, or any other country, 2171 regardless of whether adjudication of guilt was withheld. 2172 (i) The applicant or any affiliated party has been charged 2173 with a felony in a state or federal court and the disposition of 2174 that charge is pending during the application review or renewal 2175 review period. 2176 (j) The applicant has furnished false or fraudulent 2177 information or material in any application made in this state or 2178 any other state in connection with obtaining a permit or license 2179 to manufacture or distribute drugs, devices, or cosmetics. 2180 (k) That a federal, state, or local government permit 2181 currently or previously held by the applicant, or any affiliated 2182 party, for the manufacture or distribution of any drugs, 2183 devices, or cosmetics has been disciplined, suspended, or 2184 revoked and has not been reinstated. 2185 (l) The applicant does not possess the financial or 2186 physical resources to operate in compliance with the permit 2187 being sought, this chapter, and the rules adopted under this 2188 chapter. 2189 (m) The applicant or any affiliated party receives, 2190 directly or indirectly, financial support and assistance from a 2191 person who was an affiliated party of a permittee whose permit 2192 was subject to discipline or was suspended or revoked, other 2193 than through the ownership of stock in a publicly traded company 2194 or a mutual fund. 2195 (n) The applicant or any affiliated party receives, 2196 directly or indirectly, financial support and assistance from a 2197 person who has been found guilty of any violation of this part 2198 or chapter 465, chapter 501, or chapter 893, any rules adopted 2199 under this part or those chapters, any federal or state drug 2200 law, or any felony where the underlying facts related to drugs, 2201 regardless of whether the person has been pardoned, had her or 2202 his civil rights restored, or had adjudication withheld, other 2203 than through the ownership of stock in a publicly traded company 2204 or a mutual fund. 2205 (o) The applicant for renewal of a permit under s. 2206 499.01(2)(e) or (f)499.01(2)(d) or (e)has not actively engaged 2207 in the wholesale distribution of prescription drugs, as 2208 demonstrated by the regular and systematic distribution of 2209 prescription drugs throughout the year as evidenced by not fewer 2210 than 12 wholesale distributions in the previous year and not 2211 fewer than three wholesale distributions in the previous 6 2212 months. 2213 (p) Information obtained in response to s. 499.01(2)(e) or 2214 (f)499.01(2)(d) or (e)demonstrates it would not be in the best 2215 interest of the public health, safety, and welfare to issue a 2216 permit. 2217 (q) The applicant does not possess the financial standing 2218 and business experience for the successful operation of the 2219 applicant. 2220 (r) The applicant or any affiliated party has failed to 2221 comply with the requirements for manufacturing or distributing 2222 prescription drugs under this part, similar federal laws, 2223 similar laws in other states, or the rules adopted under such 2224 laws. 2225 (11) Upon approval of the application by the department and 2226 payment of the required fee, the department shall issue or renew 2227 a prescription drug wholesale distributor or an out-of-state 2228 prescription drug wholesale distributor permit to the applicant. 2229(12)For a permit for a prescription drug wholesale2230distributor or an out-of-state prescription drug wholesale2231distributor:2232(a)The department shall adopt rules for the annual renewal2233of permits. At least 90 days before the expiration of a permit,2234the department shall forward a permit renewal notification and2235renewal application to the prescription drug wholesale2236distributor or out-of-state prescription drug wholesale2237distributor at the mailing address of the permitted2238establishment on file with the department. The permit renewal2239notification must state conspicuously the date on which the2240permit for the establishment will expire and that the2241establishment may not operate unless the permit for the2242establishment is renewed timely.2243(b)A permit, unless sooner suspended or revoked,2244automatically expires 1 year after the last day of the2245anniversary month in which the permit was originally issued. A2246permit may be renewed by making application for renewal on forms2247furnished by the department and paying the appropriate fees. If2248a renewal application and fee are submitted and postmarked after224945 days prior to the expiration date of the permit, the permit2250may be renewed only upon payment of a late renewal fee of $100,2251plus the required renewal fee. A permittee that has submitted a2252renewal application in accordance with this paragraph may2253continue to operate under its permit, unless the permit is2254suspended or revoked, until final disposition of the renewal2255application.2256(c)Failure to renew a permit in accordance with this2257section precludes any future renewal of that permit. If a permit2258issued pursuant to this section has expired and cannot be2259renewed, before an establishment may engage in activities that2260require a permit under this part, the establishment must submit2261an application for a new permit; pay the applicable application2262fee, initial permit fee, and all applicable penalties; and be2263issued a new permit by the department.2264 (12)(13)A person that engages in wholesale distribution of 2265 prescription drugs in this state must have a wholesale 2266 distributor’s permit issued by the department, except as noted 2267 in this section. Each establishment must be separately permitted 2268 except as noted in this subsection. 2269 (a) A separate establishment permit is not required when a 2270 permitted prescription drug wholesale distributor consigns a 2271 prescription drug to a pharmacy that is permitted under chapter 2272 465 and located in this state, provided that: 2273 1. The consignor wholesale distributor notifies the 2274 department in writing of the contract to consign prescription 2275 drugs to a pharmacy along with the identity and location of each 2276 consignee pharmacy; 2277 2. The pharmacy maintains its permit under chapter 465; 2278 3. The consignor wholesale distributor, which has no legal 2279 authority to dispense prescription drugs, complies with all 2280 wholesale distribution requirements of s.ss.499.0121and2281499.01212with respect to the consigned drugs and maintains 2282 records documenting the transfer of title or other completion of 2283 the wholesale distribution of the consigned prescription drugs; 2284 4. The distribution of the prescription drug is otherwise 2285 lawful under this chapter and other applicable law; 2286 5. Open packages containing prescription drugs within a 2287 pharmacy are the responsibility of the pharmacy, regardless of 2288 how the drugs are titled; and 2289 6. The pharmacy dispenses the consigned prescription drug 2290 in accordance with the limitations of its permit under chapter 2291 465 or returns the consigned prescription drug to the consignor 2292 wholesale distributor. In addition, a person who holds title to 2293 prescription drugs may transfer the drugs to a person permitted 2294 or licensed to handle the reverse distribution or destruction of 2295 drugs. Any other distribution by and means of the consigned 2296 prescription drug by any person, not limited to the consignor 2297 wholesale distributor or consignee pharmacy, to any other person 2298 is prohibited. 2299 (b) A wholesale distributor’s permit is not required for 2300 the one-time transfer of title of a pharmacy’s lawfully acquired 2301 prescription drug inventory by a pharmacy with a valid permit 2302 issued under chapter 465 to a consignor prescription drug 2303 wholesale distributor, permitted under this chapter, in 2304 accordance with a written consignment agreement between the 2305 pharmacy and that wholesale distributor if the permitted 2306 pharmacy and the permitted prescription drug wholesale 2307 distributor comply with all of the provisions of paragraph (a) 2308 and the prescription drugs continue to be within the permitted 2309 pharmacy’s inventory for dispensing in accordance with the 2310 limitations of the pharmacy permit under chapter 465. A 2311 consignor drug wholesale distributor may not use the pharmacy as 2312 a wholesale distributor through which it distributes the 2313 prescription drugs to other pharmacies. Nothing in this section 2314 is intended to prevent a wholesale distributor from obtaining 2315 this inventory in the event of nonpayment by the pharmacy. 2316 (c) A separate establishment permit is not required when a 2317 permitted prescription drug wholesale distributor operates 2318 temporary transit storage facilities for the sole purpose of 2319 storage, for up to 16 hours, of a delivery of prescription drugs 2320 when the wholesale distributor was temporarily unable to 2321 complete the delivery to the recipient. 2322 (d) The department shall require information from each 2323 wholesale distributor as part of the permit and renewal of such 2324 permit, as required under this section. 2325 (13)(14)Personnel employed in wholesale distribution must 2326 have appropriate education and experience to enable them to 2327 perform their duties in compliance with state permitting 2328 requirements. 2329 (14)(15)The name of a permittee or establishment on a 2330 prescription drug wholesale distributor permit or an out-of 2331 state prescription drug wholesale distributor permit may not 2332 include any indicia of attainment of any educational degree, any 2333 indicia that the permittee or establishment possesses a 2334 professional license, or any name or abbreviation that the 2335 department determines is likely to cause confusion or mistake or 2336 that the department determines is deceptive, including that of 2337 any other entity authorized to purchase prescription drugs. 2338 (15)(16)(a) Each establishment that is issued an initial or 2339 renewal permit as a prescription drug wholesale distributor or 2340 an out-of-state prescription drug wholesale distributor must 2341 designate in writing to the department at least one natural 2342 person to serve as the designated representative of the 2343 wholesale distributor. Such person must have an active 2344 certification as a designated representative from the 2345 department. 2346 (b) To be certified as a designated representative, a 2347 natural person must: 2348 1. Submit an application on a form furnished by the 2349 department and pay the appropriate fees. 2350 2. Be at least 18 years of age. 2351 3. Have at least 2 years of verifiable full-time: 2352 a. Work experience in a pharmacy licensed in this state or 2353 another state, where the person’s responsibilities included, but 2354 were not limited to, recordkeeping for prescription drugs; 2355 b. Managerial experience with a prescription drug wholesale 2356 distributor licensed in this state or in another state; or 2357 c. Managerial experience with the United States Armed 2358 Forces, where the person’s responsibilities included, but were 2359 not limited to, recordkeeping, warehousing, distributing, or 2360 other logistics services pertaining to prescription drugs. 2361 4. Receive a passing score of at least 75 percent on an 2362 examination given by the department regarding federal laws 2363 governing distribution of prescription drugs and this part and 2364 the rules adopted by the department governing the wholesale 2365 distribution of prescription drugs. This requirement shall be 2366 effective 1 year after the results of the initial examination 2367 are mailed to the persons that took the examination. The 2368 department shall offer such examinations at least four times 2369 each calendar year. 2370 5. Provide the department with a personal information 2371 statement and fingerprints pursuant to subsection (9). 2372 (c) The department may deny an application for 2373 certification as a designated representative or may suspend or 2374 revoke a certification of a designated representative pursuant 2375 to s. 499.067. 2376 (d) A designated representative: 2377 1. Must be actively involved in and aware of the actual 2378 daily operation of the wholesale distributor. 2379 2. Must be employed full time in a managerial position by 2380 the wholesale distributor. 2381 3. Must be physically present at the establishment during 2382 normal business hours, except for time periods when absent due 2383 to illness, family illness or death, scheduled vacation, or 2384 other authorized absence. 2385 4. May serve as a designated representative for only one 2386 wholesale distributor at any one time. 2387 (e) A wholesale distributor must notify the department when 2388 a designated representative leaves the employ of the wholesale 2389 distributor. Such notice must be provided to the department 2390 within 10 business days after the last day of designated 2391 representative’s employment with the wholesale distributor. 2392 (f) A wholesale distributor may not operate under a 2393 prescription drug wholesale distributor permit or an out-of 2394 state prescription drug wholesale distributor permit for more 2395 than 10 business days after the designated representative leaves 2396 the employ of the wholesale distributor, unless the wholesale 2397 distributor employs another designated representative and 2398 notifies the department within 10 business days of the identity 2399 of the new designated representative. 2400 Section 8. Section 499.01201, Florida Statutes, is amended 2401 to read: 2402 499.01201 Agency for Health Care Administration review and 2403 use of statute and rule violation or compliance data. 2404 Notwithstanding any other provisionprovisionsof lawto the2405contrary, the Agency for Health Care Administration may not: 2406 (1) Review or use any violation or alleged violation of s. 2407 499.0121(6)or s. 499.01212, or any rules adopted under that 2408 sectionthose sections, as a ground for denying or withholding 2409 any payment of a Medicaid reimbursement to a pharmacy licensed 2410 under chapter 465; or 2411 (2) Review or use compliance with s. 499.0121(6)or s.2412499.01212, or any rules adopted under that sectionthose2413sections, as the subject of any audit of Medicaid-related 2414 records held by a pharmacy licensed under chapter 465. 2415 Section 9. Paragraph (d) of subsection (4), subsection (6), 2416 and paragraph (b) of subsection (15) of section 499.0121, 2417 Florida Statutes, are amended to read: 2418 499.0121 Storage and handling of prescription drugs; 2419 recordkeeping.—The department shall adopt rules to implement 2420 this section as necessary to protect the public health, safety, 2421 and welfare. Such rules shall include, but not be limited to, 2422 requirements for the storage and handling of prescription drugs 2423 and for the establishment and maintenance of prescription drug 2424 distribution records. 2425 (4) EXAMINATION OF MATERIALS AND RECORDS.— 2426 (d) Upon receipt, a wholesale distributor must review 2427 records required under this section for the acquisition of 2428 prescription drugs for accuracy and completeness, considering 2429 the total facts and circumstances surrounding the transactions 2430 and the wholesale distributors involved.This includes2431authenticating each transaction listed on a pedigree paper, as2432defined in s. 499.003(37).2433 (6) RECORDKEEPING.—The department shall adopt rules that 2434 require keeping such records of prescription drugs, including 2435 active pharmaceutical ingredients, as are necessary for the 2436 protection of the public health. 2437 (a) The following persons must maintain business records 2438 that include the information specified in paragraph (b) 2439Wholesale distributors must establish and maintain inventories2440and records of all transactions regarding the receipt and2441distribution or other disposition of prescription drugs. These2442records must provide a complete audit trail from receipt to sale2443or other disposition, be readily retrievable for inspection, and2444include, at a minimum, the following information: 2445 1. Persons permitted or required to be permitted under 2446 chapter 499 to engage in the manufacture, repackaging, or 2447 distribution of active pharmaceutical ingredients or 2448 prescription drugs.The source of the drugs, including the name2449and principal address of the seller or transferor, and the2450address of the location from which the drugs were shipped;2451 2. Persons other than those set forth in subparagraph 1. 2452 that engage in the receipt of active pharmaceutical ingredients 2453 or prescription drugs.The name, principal address, and state2454license permit or registration number of the person authorized2455to purchase prescription drugs;24563. The name, strength, dosage form, and quantity of the2457drugs received and distributed or disposed of;24584. The dates of receipt and distribution or other2459disposition of the drugs; and24605.Any financial documentation supporting the transaction.2461 (b) Business records for persons specified in paragraph (a) 2462 must include: 2463 1. The name and address of the seller, and the Florida 2464 permit number of the seller if such seller is not exempt from 2465 Florida permitting requirements, of the active pharmaceutical 2466 ingredient or prescription drug. 2467 2. The address of the location the active pharmaceutical 2468 ingredient or prescription drug was shipped from. 2469 3. The distribution date of the active pharmaceutical 2470 ingredient or prescription drug. 2471 4. The name, strength, and quantity, and the National Drug 2472 Code if such code has been assigned, of the distributed active 2473 pharmaceutical ingredient or prescription drug. 2474 5. The name and Florida permit number of the person that 2475 purchased the active pharmaceutical ingredient or prescription 2476 drug. 2477 6. The financial data, including the unit type and unit 2478 price, for the distributions involving active pharmaceutical 2479 ingredients or prescription drugs. 2480 7. The date and method of disposition of the active 2481 pharmaceutical ingredient or prescription drug.Inventories and2482records must be made available for inspection and photocopying2483by authorized federal, state, or local officials for a period of24842 years following disposition of the drugs or 3 years after the2485creation of the records, whichever period is longer.2486 (c) Each manufacturer or repackager of medical devices, 2487 over-the-counter drugs, or cosmetics must maintain business 2488 records that include: 2489 1. The name and address of the seller or transferor of the 2490 product. 2491 2. The address of the location the product was shipped 2492 from. 2493 3. The date of the sale or distribution of the product. 2494 4. The name and quantity of the product involved. 2495 5. The name and address of the person who purchased the 2496 productRecords described in this section that are kept at the2497inspection site or that can be immediately retrieved by computer2498or other electronic means must be readily available for2499authorized inspection during the retention period. Records that2500are kept at a central location outside of this state and that2501are not electronically retrievable must be made available for2502inspection within 2 working days after a request by an2503authorized official of a federal, state, or local law2504enforcement agency. Records that are maintained at a central2505location within this state must be maintained at an2506establishment that is permitted pursuant to this part and must2507be readily available. 2508 (d) Persons permitted, or required to be permitted, under 2509 this chapter to engage in the manufacture, repackaging, or 2510 distribution of active pharmaceutical ingredients or 2511 prescription drugs; or the manufacture or repackaging of medical 2512 devices, over-the-counter drugs, and cosmetics; must establish, 2513 maintain, or have the capability to create a current inventory 2514 of the active pharmaceutical ingredients, prescription drugs, 2515 over-the-counter drugs, cosmetics, and devices at an 2516 establishment where activities specified in this paragraph are 2517 undertaken and must be able to produce such inventory for 2518 inspection by the department within 2 business daysEach2519manufacturer or repackager of medical devices, over-the-counter2520drugs, or cosmetics must maintain records that include the name2521and principal address of the seller or transferor of the2522product, the address of the location from which the product was2523shipped, the date of the transaction, the name and quantity of2524the product involved, and the name and principal address of the2525person who purchased the product. 2526 (e) Business records required to be kept pursuant to this 2527 section, and that are kept at the inspection site or can be 2528 immediately retrieved by computer or other electronic means, 2529 must be readily available for authorized inspection during the 2530 retention period. Records kept at a central location outside of 2531 this state which are not electronically retrievable must be made 2532 available for inspection within 2 working days after a request 2533 by an authorized official of a federal, state, or local law 2534 enforcement agency. Records maintained at a central location 2535 within this state must be maintained at an establishment that is 2536 permitted pursuant to this part and such records must be readily 2537 available for inspectionWhen pedigree papers are required by2538this part, a wholesale distributor must maintain the pedigree2539papers separate and distinct from other records required under2540this part. 2541 (f) Records required to be kept pursuant to this subsection 2542 must be maintained as specified for a period of not less than 6 2543 years from the date of disposition of the active pharmaceutical 2544 ingredients, prescription drugs, over-the-counter drugs, medical 2545 devices, or cosmetics. 2546 (g) To the extent that prescription drugs are also products 2547 as defined in the federal act, as amended, and the information 2548 required by the business records requirements of this section 2549 are also included in the tracking and tracing requirements of 2550 the federal act, as amended, and departmental rules, the 2551 manufacturer, wholesale distributor, repackager, or dispenser 2552 must follow both the requirements of the federal act, as 2553 amended, and departmental rules. 2554 (15) DUE DILIGENCE OF PURCHASERS.— 2555 (b) A wholesale distributor must take reasonable measures 2556 to identify its customers, understand the normal and expected 2557 transactions conducted by those customers, and identify those 2558 transactions that are suspicious in nature. A wholesale 2559 distributor must establish internal policies and procedures for 2560 identifying suspicious orders and preventing suspicious 2561 transactions. A wholesale distributor must assess orders for 2562 moregreaterthan 7,5005,000unit doses of any one controlled 2563 substance in any one month to determine whether the purchase is 2564 reasonable. In making such assessments, a wholesale distributor 2565 may consider the purchasing entity’s clinical business needs, 2566 location, and population served, in addition to other factors 2567 established in the distributor’s policies and procedures. A 2568 wholesale distributor must report to the department any 2569 regulated transaction involving an extraordinary quantity of a 2570 listed chemical, an uncommon method of payment or delivery, or 2571 any other circumstance that the regulated person believes may 2572 indicate that the listed chemical will be used in violation of 2573 the law. The wholesale distributor shall maintain records that 2574 document the report submitted to the department in compliance 2575 with this paragraph. 2576 Section 10. Subsection (4) of section 499.015, Florida 2577 Statutes, is amended to read: 2578 499.015 Registration of drugs, devices, and cosmetics; 2579 issuance of certificates of free sale.— 2580 (4) Unless a registration is renewed, it expires 2 years 2581 after the last day of the month in which it was issued. Any 2582 product registration issued or renewed on or after July 1, 2016, 2583 shall expire on the same date as the manufacturer or repackager 2584 permit of the person seeking to register the product. If the 2585 first product registration issued to a person on or after July 2586 1, 2016, expires less than 366 days after issuance, the fee for 2587 product registration shall be $15. If the first product 2588 registration issued to a person on or after July 1, 2016, 2589 expires more than 365 days after issuance, the fee for product 2590 registration shall be $30. The department may issue a stop-sale 2591 notice or order against a person that is subject to the 2592 requirements of this section and that fails to comply with this 2593 section within 31 days after the date the registration expires. 2594 The notice or order shall prohibit such person from selling or 2595 causing to be sold any drugs, devices, or cosmetics covered by 2596 this part until he or she complies with the requirements of this 2597 section. 2598 Section 11. Subsection (1) of section 499.03, Florida 2599 Statutes, is amended to read: 2600 499.03 Possession of certain drugs without prescriptions 2601 unlawful; exemptions and exceptions.— 2602 (1) A person may not possess, or possess with intent to 2603 sell, dispense, or deliver, any habit-forming, toxic, harmful, 2604 or new drug subject to s. 499.003(32)499.003(33), or 2605 prescription drug as defined in s. 499.003(40)499.003(43), 2606 unless the possession of the drug has been obtained by a valid 2607 prescription of a practitioner licensed by law to prescribe the 2608 drug. However, this section does not apply to the delivery of 2609 such drugs to persons included in any of the classes named in 2610 this subsection, or to the agents or employees of such persons, 2611 for use in the usual course of their businesses or practices or 2612 in the performance of their official duties, as the case may be; 2613 nor does this section apply to the possession of such drugs by 2614 those persons or their agents or employees for such use: 2615 (a) A licensed pharmacist or any person under the licensed 2616 pharmacist’s supervision while acting within the scope of the 2617 licensed pharmacist’s practice; 2618 (b) A licensed practitioner authorized by law to prescribe 2619 prescription drugs or any person under the licensed 2620 practitioner’s supervision while acting within the scope of the 2621 licensed practitioner’s practice; 2622 (c) A qualified person who uses prescription drugs for 2623 lawful research, teaching, or testing, and not for resale; 2624 (d) A licensed hospital or other institution that procures 2625 such drugs for lawful administration or dispensing by 2626 practitioners; 2627 (e) An officer or employee of a federal, state, or local 2628 government; or 2629 (f) A person that holds a valid permit issued by the 2630 department pursuant to this part which authorizes that person to 2631 possess prescription drugs. 2632 Section 12. Paragraphs (i) through (p) of subsection (1) of 2633 section 499.05, Florida Statutes, are amended to read: 2634 499.05 Rules.— 2635 (1) The department shall adopt rules to implement and 2636 enforce this chapter with respect to: 2637 (i) Additional conditions that qualify as an emergency 2638 medical reason under s. 499.003(48)(b)2.499.003(53)(b)2.or s. 2639 499.82. 2640(j)Procedures and forms relating to the pedigree paper2641requirement of s. 499.01212.2642 (j)(k)The protection of the public health, safety, and 2643 welfare regarding good manufacturing practices that 2644 manufacturers and repackagers must follow to ensure the safety 2645 of the products. 2646 (k)(l)Information required from each retail establishment 2647 pursuant to s. 499.012(3) or s. 499.83(2)(c), including 2648 requirements for prescriptions or orders. 2649 (l)(m)The recordkeeping, storage, and handling with 2650 respect to each of the distributions of prescription drugs 2651 specified in s. 499.003(48)(a)-(v)499.003(53)(a)-(d)or s. 2652 499.82(14). 2653(n)Alternatives to compliance with s. 499.01212 for a2654prescription drug in the inventory of a permitted prescription2655drug wholesale distributor as of June 30, 2006, and the return2656of a prescription drug purchased prior to July 1, 2006. The2657department may specify time limits for such alternatives.2658 (m)(o)Wholesale distributor reporting requirements of s. 2659 499.0121(14). 2660 (n)(p)Wholesale distributor credentialing and distribution 2661 requirements of s. 499.0121(15). 2662 Section 13. Subsection (7) of section 499.051, Florida 2663 Statutes, is amended to read: 2664 499.051 Inspections and investigations.— 2665 (7) The complaint and all information obtained pursuant to 2666 the investigation by the department are confidential and exempt 2667 from s. 119.07(1) and s. 24(a), Art. I of the State Constitution 2668 until the investigation and the enforcement action are 2669 completed. However, trade secret information contained therein 2670 as defined by s. 812.081(1)(c) shall remain confidential and 2671 exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I 2672 of the State Constitution, as long as the information is 2673 retained by the department. This subsection does not prohibit 2674 the department from using such information for regulatory or 2675 enforcement proceedings under this chapter or from providing 2676 such information to any law enforcement agency or any other 2677 regulatory agency. However, the receiving agency shall keep such 2678 records confidential and exempt as provided in this subsection. 2679In addition, this subsection is not intended to prevent2680compliance with the provisions of s. 499.01212, and the pedigree2681papers required in that section shall not be deemed a trade2682secret.2683 Section 14. Subsection (14) of section 499.82, Florida 2684 Statutes, is amended to read: 2685 499.82 Definitions.—As used in this part, the term: 2686 (14) “Wholesale distribution” means the distribution of 2687 medical gas to a person other than a consumer or patient. 2688 Wholesale distribution of medical gases does not include: 2689 (a) The sale, purchase, or trade of a medical gas; an offer 2690 to sell, purchase, or trade a medical gas; or the dispensing of 2691 a medical gas pursuant to a prescription; 2692 (b) Activities exempt from the definition of wholesale 2693 distribution in s. 499.003; or 2694 (c) The sale, purchase, or trade of a medical gas or an 2695 offer to sell, purchase, or trade a medical gas for emergency 2696 medical reasons; or2697(d)Other transactions excluded from the definition of2698wholesale distribution under the federal act or regulations2699implemented under the federal act related to medical gas. 2700 Section 15. Subsection (6) of section 499.83, Florida 2701 Statutes, is created to read: 2702 499.83 Permits.— 2703 (6) A hospice licensed by the Agency for Health Care 2704 Administration pursuant to part IV of chapter 400 is not 2705 required to obtain medical oxygen retail establishment permit to 2706 purchase on behalf of and sell medical oxygen to its hospice 2707 patients, if the hospice contracts for the purchase and delivery 2708 of medical oxygen from an establishment permitted pursuant to 2709 this part. Sale and delivery to patients by hospices pursuant to 2710 this subsection must be based upon on a prescription or an order 2711 from a practitioner authorized by law to prescribe medical 2712 oxygen. For sales to hospices pursuant to this subsection, the 2713 medical gas wholesale distributor or the medical gas 2714 manufacturer selling medical oxygen to a hospice shall reflect 2715 on its invoice the hospice license number provided by the Agency 2716 for Health Care Administration and shall maintain such record 2717 pursuant to s. 499.89. Both the hospice and the medical oxygen 2718 retailer delivering medical oxygen to the patient must maintain 2719 a copy of a valid order or prescription for medical oxygen in 2720 accordance with s. 499.89 and department rule, which copy must 2721 be readily available for inspection. 2722 Section 16. Subsection (4) of section 499.89, Florida 2723 Statutes, is amended to read: 2724 499.89 Recordkeeping.— 2725(4)A pedigree paper is not required for distributing or2726dispensing medical gas.2727 Section 17. Section 499.01212, Florida Statutes, is 2728 repealed. 2729 Section 18. Paragraph (a) of subsection (1) of section 2730 409.9201, Florida Statutes, is amended to read: 2731 409.9201 Medicaid fraud.— 2732 (1) As used in this section, the term: 2733 (a) “Prescription drug” means any drug, including, but not 2734 limited to, finished dosage forms or active ingredients that are 2735 subject to, defined in, or described in s. 503(b) of the Federal 2736 Food, Drug, and Cosmetic Act or in s. 465.003(8), s. 499.003(47) 2737499.003(52), s. 499.007(13), or s. 499.82(10). 2738 2739 The value of individual items of the legend drugs or goods or 2740 services involved in distinct transactions committed during a 2741 single scheme or course of conduct, whether involving a single 2742 person or several persons, may be aggregated when determining 2743 the punishment for the offense. 2744 Section 19. Paragraph (b) of subsection (1) of section 2745 499.067, Florida Statutes, is amended to read: 2746 499.067 Denial, suspension, or revocation of permit, 2747 certification, or registration.— 2748 (1) 2749 (b) The department may deny an application for a permit or 2750 certification, or suspend or revoke a permit or certification, 2751 if the department finds that: 2752 1. The applicant is not of good moral character or that it 2753 would be a danger or not in the best interest of the public 2754 health, safety, and welfare if the applicant were issued a 2755 permit or certification. 2756 2. The applicant has not met the requirements for the 2757 permit or certification. 2758 3. The applicant is not eligible for a permit or 2759 certification for any of the reasons enumerated in s. 499.012. 2760 4. The applicant, permittee, or person certified under s. 2761 499.012(15)s. 499.012(16)demonstrates any of the conditions 2762 enumerated in s. 499.012. 2763 5. The applicant, permittee, or person certified under s. 2764 499.012(15)s. 499.012(16)has committed any violation of this 2765 chapter. 2766 Section 20. Subsection (1) of section 794.075, Florida 2767 Statutes, is amended to read: 2768 794.075 Sexual predators; erectile dysfunction drugs.— 2769 (1) A person may not possess a prescription drug, as 2770 defined in s. 499.003(40)499.003(43), for the purpose of 2771 treating erectile dysfunction if the person is designated as a 2772 sexual predator under s. 775.21. 2773 Section 21. Paragraphs (d), (f), (i), and (j) of subsection 2774 (3) of section 921.0022, Florida Statutes, are amended to read: 2775 921.0022 Criminal Punishment Code; offense severity ranking 2776 chart.— 2777 (3) OFFENSE SEVERITY RANKING CHART 2778 (d) LEVEL 4 2779 2780 2781 FloridaStatute FelonyDegree Description 2782 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. 2783 499.0051(1) 3rd Failure to maintain or deliver transaction history, transaction information, or transaction statementspedigree papers. 2784499.0051(2)3rdFailure to authenticate pedigree papers.2785 499.0051(5)499.0051(6)2nd Knowing sale or delivery, or possession with intent to sell, contraband prescription drugs. 2786 517.07(1) 3rd Failure to register securities. 2787 517.12(1) 3rd Failure of dealer, associated person, or issuer of securities to register. 2788 784.07(2)(b) 3rd Battery of law enforcement officer, firefighter, etc. 2789 784.074(1)(c) 3rd Battery of sexually violent predators facility staff. 2790 784.075 3rd Battery on detention or commitment facility staff. 2791 784.078 3rd Battery of facility employee by throwing, tossing, or expelling certain fluids or materials. 2792 784.08(2)(c) 3rd Battery on a person 65 years of age or older. 2793 784.081(3) 3rd Battery on specified official or employee. 2794 784.082(3) 3rd Battery by detained person on visitor or other detainee. 2795 784.083(3) 3rd Battery on code inspector. 2796 784.085 3rd Battery of child by throwing, tossing, projecting, or expelling certain fluids or materials. 2797 787.03(1) 3rd Interference with custody; wrongly takes minor from appointed guardian. 2798 787.04(2) 3rd Take, entice, or remove child beyond state limits with criminal intent pending custody proceedings. 2799 787.04(3) 3rd Carrying child beyond state lines with criminal intent to avoid producing child at custody hearing or delivering to designated person. 2800 787.07 3rd Human smuggling. 2801 790.115(1) 3rd Exhibiting firearm or weapon within 1,000 feet of a school. 2802 790.115(2)(b) 3rd Possessing electric weapon or device, destructive device, or other weapon on school property. 2803 790.115(2)(c) 3rd Possessing firearm on school property. 2804 800.04(7)(c) 3rd Lewd or lascivious exhibition; offender less than 18 years. 2805 810.02(4)(a) 3rd Burglary, or attempted burglary, of an unoccupied structure; unarmed; no assault or battery. 2806 810.02(4)(b) 3rd Burglary, or attempted burglary, of an unoccupied conveyance; unarmed; no assault or battery. 2807 810.06 3rd Burglary; possession of tools. 2808 810.08(2)(c) 3rd Trespass on property, armed with firearm or dangerous weapon. 2809 812.014(2)(c)3. 3rd Grand theft, 3rd degree $10,000 or more but less than $20,000. 2810 812.014 (2)(c)4.-10. 3rd Grand theft, 3rd degree, a will, firearm, motor vehicle, livestock, etc. 2811 812.0195(2) 3rd Dealing in stolen property by use of the Internet; property stolen $300 or more. 2812 817.563(1) 3rd Sell or deliver substance other than controlled substance agreed upon, excluding s. 893.03(5) drugs. 2813 817.568(2)(a) 3rd Fraudulent use of personal identification information. 2814 817.625(2)(a) 3rd Fraudulent use of scanning device or reencoder. 2815 828.125(1) 2nd Kill, maim, or cause great bodily harm or permanent breeding disability to any registered horse or cattle. 2816 837.02(1) 3rd Perjury in official proceedings. 2817 837.021(1) 3rd Make contradictory statements in official proceedings. 2818 838.022 3rd Official misconduct. 2819 839.13(2)(a) 3rd Falsifying records of an individual in the care and custody of a state agency. 2820 839.13(2)(c) 3rd Falsifying records of the Department of Children and Families. 2821 843.021 3rd Possession of a concealed handcuff key by a person in custody. 2822 843.025 3rd Deprive law enforcement, correctional, or correctional probation officer of means of protection or communication. 2823 843.15(1)(a) 3rd Failure to appear while on bail for felony (bond estreature or bond jumping). 2824 847.0135(5)(c) 3rd Lewd or lascivious exhibition using computer; offender less than 18 years. 2825 874.05(1)(a) 3rd Encouraging or recruiting another to join a criminal gang. 2826 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). 2827 914.14(2) 3rd Witnesses accepting bribes. 2828 914.22(1) 3rd Force, threaten, etc., witness, victim, or informant. 2829 914.23(2) 3rd Retaliation against a witness, victim, or informant, no bodily injury. 2830 918.12 3rd Tampering with jurors. 2831 934.215 3rd Use of two-way communications device to facilitate commission of a crime. 2832 2833 (f) LEVEL 6 2834 2835 2836 FloridaStatute FelonyDegree Description 2837 316.027(2)(b) 2nd Leaving the scene of a crash involving serious bodily injury. 2838 316.193(2)(b) 3rd Felony DUI, 4th or subsequent conviction. 2839 400.9935(4)(c) 2nd Operating a clinic, or offering services requiring licensure, without a license. 2840 499.0051(2)499.0051(3)2nd Knowing forgery of transaction history, transaction information, or transaction statementpedigree papers. 2841 499.0051(3)499.0051(4)2nd Knowing purchase or receipt of prescription drug from unauthorized person. 2842 499.0051(4)499.0051(5)2nd Knowing sale or transfer of prescription drug to unauthorized person. 2843 775.0875(1) 3rd Taking firearm from law enforcement officer. 2844 784.021(1)(a) 3rd Aggravated assault; deadly weapon without intent to kill. 2845 784.021(1)(b) 3rd Aggravated assault; intent to commit felony. 2846 784.041 3rd Felony battery; domestic battery by strangulation. 2847 784.048(3) 3rd Aggravated stalking; credible threat. 2848 784.048(5) 3rd Aggravated stalking of person under 16. 2849 784.07(2)(c) 2nd Aggravated assault on law enforcement officer. 2850 784.074(1)(b) 2nd Aggravated assault on sexually violent predators facility staff. 2851 784.08(2)(b) 2nd Aggravated assault on a person 65 years of age or older. 2852 784.081(2) 2nd Aggravated assault on specified official or employee. 2853 784.082(2) 2nd Aggravated assault by detained person on visitor or other detainee. 2854 784.083(2) 2nd Aggravated assault on code inspector. 2855 787.02(2) 3rd False imprisonment; restraining with purpose other than those in s. 787.01. 2856 790.115(2)(d) 2nd Discharging firearm or weapon on school property. 2857 790.161(2) 2nd Make, possess, or throw destructive device with intent to do bodily harm or damage property. 2858 790.164(1) 2nd False report of deadly explosive, weapon of mass destruction, or act of arson or violence to state property. 2859 790.19 2nd Shooting or throwing deadly missiles into dwellings, vessels, or vehicles. 2860 794.011(8)(a) 3rd Solicitation of minor to participate in sexual activity by custodial adult. 2861 794.05(1) 2nd Unlawful sexual activity with specified minor. 2862 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. 2863 800.04(6)(b) 2nd Lewd or lascivious conduct; offender 18 years of age or older. 2864 806.031(2) 2nd Arson resulting in great bodily harm to firefighter or any other person. 2865 810.02(3)(c) 2nd Burglary of occupied structure; unarmed; no assault or battery. 2866 810.145(8)(b) 2nd Video voyeurism; certain minor victims; 2nd or subsequent offense. 2867 812.014(2)(b)1. 2nd Property stolen $20,000 or more, but less than $100,000, grand theft in 2nd degree. 2868 812.014(6) 2nd Theft; property stolen $3,000 or more; coordination of others. 2869 812.015(9)(a) 2nd Retail theft; property stolen $300 or more; second or subsequent conviction. 2870 812.015(9)(b) 2nd Retail theft; property stolen $3,000 or more; coordination of others. 2871 812.13(2)(c) 2nd Robbery, no firearm or other weapon (strong-arm robbery). 2872 817.4821(5) 2nd Possess cloning paraphernalia with intent to create cloned cellular telephones. 2873 825.102(1) 3rd Abuse of an elderly person or disabled adult. 2874 825.102(3)(c) 3rd Neglect of an elderly person or disabled adult. 2875 825.1025(3) 3rd Lewd or lascivious molestation of an elderly person or disabled adult. 2876 825.103(3)(c) 3rd Exploiting an elderly person or disabled adult and property is valued at less than $10,000. 2877 827.03(2)(c) 3rd Abuse of a child. 2878 827.03(2)(d) 3rd Neglect of a child. 2879 827.071(2) & (3) 2nd Use or induce a child in a sexual performance, or promote or direct such performance. 2880 836.05 2nd Threats; extortion. 2881 836.10 2nd Written threats to kill or do bodily injury. 2882 843.12 3rd Aids or assists person to escape. 2883 847.011 3rd Distributing, offering to distribute, or possessing with intent to distribute obscene materials depicting minors. 2884 847.012 3rd Knowingly using a minor in the production of materials harmful to minors. 2885 847.0135(2) 3rd Facilitates sexual conduct of or with a minor or the visual depiction of such conduct. 2886 914.23 2nd Retaliation against a witness, victim, or informant, with bodily injury. 2887 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. 2888 944.40 2nd Escapes. 2889 944.46 3rd Harboring, concealing, aiding escaped prisoners. 2890 944.47(1)(a)5. 2nd Introduction of contraband (firearm, weapon, or explosive) into correctional facility. 2891 951.22(1) 3rd Intoxicating drug, firearm, or weapon introduced into county facility. 2892 2893 (i) LEVEL 9 2894 2895 FloridaStatute FelonyDegree Description 2896 316.193 (3)(c)3.b. 1st DUI manslaughter; failing to render aid or give information. 2897 327.35 (3)(c)3.b. 1st BUI manslaughter; failing to render aid or give information. 2898 409.920 (2)(b)1.c. 1st Medicaid provider fraud; $50,000 or more. 2899 499.0051(8)499.0051(9)1st Knowing sale or purchase of contraband prescription drugs resulting in great bodily harm. 2900 560.123(8)(b)3. 1st Failure to report currency or payment instruments totaling or exceeding $100,000 by money transmitter. 2901 560.125(5)(c) 1st Money transmitter business by unauthorized person, currency, or payment instruments totaling or exceeding $100,000. 2902 655.50(10)(b)3. 1st Failure to report financial transactions totaling or exceeding $100,000 by financial institution. 2903 775.0844 1st Aggravated white collar crime. 2904 782.04(1) 1st Attempt, conspire, or solicit to commit premeditated murder. 2905 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. 2906 782.051(1) 1st Attempted felony murder while perpetrating or attempting to perpetrate a felony enumerated in s. 782.04(3). 2907 782.07(2) 1st Aggravated manslaughter of an elderly person or disabled adult. 2908 787.01(1)(a)1. 1st,PBL Kidnapping; hold for ransom or reward or as a shield or hostage. 2909 787.01(1)(a)2. 1st,PBL Kidnapping with intent to commit or facilitate commission of any felony. 2910 787.01(1)(a)4. 1st,PBL Kidnapping with intent to interfere with performance of any governmental or political function. 2911 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. 2912 787.06(3)(c)1. 1st Human trafficking for labor and services of an unauthorized alien child. 2913 787.06(3)(d) 1st Human trafficking using coercion for commercial sexual activity of an unauthorized adult alien. 2914 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. 2915 790.161 1st Attempted capital destructive device offense. 2916 790.166(2) 1st,PBL Possessing, selling, using, or attempting to use a weapon of mass destruction. 2917 794.011(2) 1st Attempted sexual battery; victim less than 12 years of age. 2918 794.011(2) Life Sexual battery; offender younger than 18 years and commits sexual battery on a person less than 12 years. 2919 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. 2920 794.011(4)(b) 1st Sexual battery, certain circumstances; victim and offender 18 years of age or older. 2921 794.011(4)(c) 1st Sexual battery, certain circumstances; victim 12 years of age or older; offender younger than 18 years. 2922 794.011(4)(d) 1st,PBL Sexual battery, certain circumstances; victim 12 years of age or older; prior conviction for specified sex offenses. 2923 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. 2924 794.08(2) 1st Female genital mutilation; victim younger than 18 years of age. 2925 800.04(5)(b) Life Lewd or lascivious molestation; victim less than 12 years; offender 18 years or older. 2926 812.13(2)(a) 1st,PBL Robbery with firearm or other deadly weapon. 2927 812.133(2)(a) 1st,PBL Carjacking; firearm or other deadly weapon. 2928 812.135(2)(b) 1st Home-invasion robbery with weapon. 2929 817.535(3)(b) 1st Filing false lien or other unauthorized document; second or subsequent offense; property owner is a public officer or employee. 2930 817.535(4)(a)2. 1st Filing false claim or other unauthorized document; defendant is incarcerated or under supervision. 2931 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. 2932 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. 2933 827.03(2)(a) 1st Aggravated child abuse. 2934 847.0145(1) 1st Selling, or otherwise transferring custody or control, of a minor. 2935 847.0145(2) 1st Purchasing, or otherwise obtaining custody or control, of a minor. 2936 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. 2937 893.135 1st Attempted capital trafficking offense. 2938 893.135(1)(a)3. 1st Trafficking in cannabis, more than 10,000 lbs. 2939 893.135 (1)(b)1.c. 1st Trafficking in cocaine, more than 400 grams, less than 150 kilograms. 2940 893.135 (1)(c)1.c. 1st Trafficking in illegal drugs, more than 28 grams, less than 30 kilograms. 2941 893.135 (1)(c)2.d. 1st Trafficking in hydrocodone, 200 grams or more, less than 30 kilograms. 2942 893.135 (1)(c)3.d. 1st Trafficking in oxycodone, 100 grams or more, less than 30 kilograms. 2943 893.135 (1)(d)1.c. 1st Trafficking in phencyclidine, more than 400 grams. 2944 893.135 (1)(e)1.c. 1st Trafficking in methaqualone, more than 25 kilograms. 2945 893.135 (1)(f)1.c. 1st Trafficking in amphetamine, more than 200 grams. 2946 893.135 (1)(h)1.c. 1st Trafficking in gamma-hydroxybutyric acid (GHB), 10 kilograms or more. 2947 893.135 (1)(j)1.c. 1st Trafficking in 1,4-Butanediol, 10 kilograms or more. 2948 893.135 (1)(k)2.c. 1st Trafficking in Phenethylamines, 400 grams or more. 2949 896.101(5)(c) 1st Money laundering, financial instruments totaling or exceeding $100,000. 2950 896.104(4)(a)3. 1st Structuring transactions to evade reporting or registration requirements, financial transactions totaling or exceeding $100,000. 2951 2952 (j) LEVEL 10 2953 2954 FloridaStatute FelonyDegree Description 2955 499.0051(9)499.0051(10)1st Knowing sale or purchase of contraband prescription drugs resulting in death. 2956 782.04(2) 1st,PBL Unlawful killing of human; act is homicide, unpremeditated. 2957 782.07(3) 1st Aggravated manslaughter of a child. 2958 787.01(1)(a)3. 1st,PBL Kidnapping; inflict bodily harm upon or terrorize victim. 2959 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. 2960 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. 2961 787.06(4)(a) Life Selling or buying of minors into human trafficking. 2962 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. 2963 812.135(2)(a) 1st,PBL Home-invasion robbery with firearm or other deadly weapon. 2964 876.32 1st Treason against the state. 2965 Section 22. Section 893.30, Florida Statutes, is created to 2966 read: 2967 893.30 Controlled substance safety education and 2968 awareness.— 2969 (1) This section may be cited as the “Victoria Siegel 2970 Controlled Substance Safety Education and Awareness Act.” 2971 (2) The department shall develop a written pamphlet 2972 relating to controlled substances which includes educational 2973 information about the following: 2974 (a) Precautions regarding the use of pain management 2975 prescriptions. 2976 (b) The potential for misuse and abuse of controlled 2977 substances by adults and children. 2978 (c) The risk of controlled substance dependency and 2979 addiction. 2980 (d) The proper storage and disposal of controlled 2981 substances. 2982 (e) Controlled substance addiction support and treatment 2983 resources. 2984 (f) Telephone helplines and website links that provide 2985 counseling and emergency assistance for individuals dealing with 2986 substance abuse. 2987 (3) The department shall encourage health care providers, 2988 including, but not limited to, hospitals, county health 2989 departments, physicians, and nurses, to disseminate and display 2990 information about controlled substance safety, including, but 2991 not limited to, the pamphlet created pursuant to subsection (2). 2992 (4) The department shall encourage consumers to discuss the 2993 risks of controlled substance use with their health care 2994 providers. 2995 (5) The State Surgeon General shall make publicly 2996 available, by posting on the department’s website, the pamphlet 2997 created pursuant to subsection (2) and additional resources as 2998 appropriate. 2999 (6) The department shall fund the promotion of controlled 3000 substance safety education and awareness under this section 3001 through grants from private or federal sources. 3002 (7) The department is encouraged to collaborate with other 3003 agencies, organizations, and institutions to create a systematic 3004 approach to increasing public awareness regarding controlled 3005 substance safety. 3006 Section 23. This act shall take effect July 1, 2016.