Florida Senate - 2008 SENATOR AMENDMENT

Bill No. HB 7049, 1st Eng.

286928

CHAMBER ACTION

Senate

Floor: 1/AD/3R

4/28/2008 4:08 PM

House

Floor: C

5/1/2008 9:29 PM

Senator Peaden moved the following amendment:

Senate Amendment (with title amendment)

Delete everything after the enacting clause

and insert:

Section 1. Section 499.002, Florida Statutes, is amended;

section 499.004, Florida Statutes, is redesignated as subsection

(2) of that section and amended; section 499.0053, Florida

Statutes, is redesignated as subsection (3) of that section and

amended; section 499.07, Florida Statutes, is redesignated as

subsection (4) of that section and amended; section 499.071,

Florida Statutes, is redesignated as subsection (5) of that

section and amended; and section 499.081, Florida Statutes, is

redesignated as subsection (6) of that section and amended, to

read:

499.002 Purpose, administration, and enforcement of and

exemption from this part ss. 499.001-499.081.--

(1) This part is Sections 499.001-499.081 are intended to:

(a)(1) Safeguard the public health and promote the public

welfare by protecting the public from injury by product use and

by merchandising deceit involving drugs, devices, and cosmetics.

(b)(2) Provide uniform legislation to be administered so

far as practicable in conformity with the provisions of, and

regulations issued under the authority of, the Federal Food,

Drug, and Cosmetic Act and that portion of the Federal Trade

Commission Act which expressly prohibits the false advertisement

of drugs, devices, and cosmetics.

(c)(3) Promote thereby uniformity of such state and federal

laws, and their administration and enforcement, throughout the

United States.

(2) 499.004 Administration and enforcement by

department.--The department of Health shall administer and

enforce this part ss. 499.001-499.081 to prevent fraud,

adulteration, misbranding, or false advertising in the

preparation, manufacture, repackaging, or distribution of drugs,

devices, and cosmetics.

(3) 499.0053 Power to administer oaths, take depositions,

and issue and serve subpoenas.--For the purpose of any

investigation or proceeding conducted by the department under

this part ss. 499.001-499.081, the department may administer

oaths, take depositions, issue and serve subpoenas, and compel

the attendance of witnesses and the production of books, papers,

documents, or other evidence. The department shall exercise this

power on its own initiative. Challenges to, and enforcement of,

the subpoenas and orders shall be handled as provided in s.

120.569.

(4) 499.07 Duty of prosecuting officer.--Each state

attorney, county attorney, or municipal attorney to whom the

department or its designated agent reports any violation of this

part ss. 499.001-499.081 shall cause appropriate proceedings to

be instituted in the proper courts without delay and to be

prosecuted in the manner required by law.

(5) 499.071 Issuance of warnings for minor

violations.--This part does Sections 499.001-499.081 do not

require the department to report, for the institution of

proceedings under this part ss. 499.001-499.081, minor violations

of this part ss. 499.001-499.081 when it believes that the public

interest will be adequately served in the circumstances by a

suitable written notice or warning.

(6) 499.081 Carriers in interstate commerce exempted from

ss. 499.001-499.081.--Common carriers engaged in interstate

commerce are not subject to this part ss. 499.001-499.081 if they

are engaged in the usual course of business as common carriers.

Section 2. Section 499.003, Florida Statutes, is amended;

paragraphs (a) through (f) of subsection (1) of section 499.012,

Florida Statutes, are redesignated as subsections (55), (56),

(52), and (48), paragraph (c) of subsection (48), and subsection

(53), respectively, of that section and amended; paragraphs (f)

through (j) and (l) through (m) of subsection (3) of section

499.029, Florida Statutes, are redesignated as subsections (25),

(26), (27), (35), (40), and (41), and, respectively, of that

section and amended; and subsection (1) of section 499.0661,

Florida Statutes, is redesignated as subsection (38) of that

section and amended, to read:

499.003 Definitions of terms used in this part ss. 499.001-

499.081.--As used in this part ss. 499.001-499.081, the term:

(1) "Advertisement" means any representation disseminated

in any manner or by any means, other than by labeling, for the

purpose of inducing, or which is likely to induce, directly or

indirectly, the purchase of drugs, devices, or cosmetics.

(2) "Affiliated group" means an affiliated group as defined

by s. 1504 of the Internal Revenue Code of 1986, as amended,

which is composed of chain drug entities, including at least 50

retail pharmacies, warehouses, or repackagers, which are members

of the same affiliated group. The affiliated group must disclose

the names of all its members to the department.

(3)(2) "Affiliated party" means:

(a) A director, officer, trustee, partner, or committee

member of a permittee or applicant or a subsidiary or service

corporation of the permittee or applicant;

(b) A person who, directly or indirectly, manages,

controls, or oversees the operation of a permittee or applicant,

regardless of whether such person is a partner, shareholder,

manager, member, officer, director, independent contractor, or

employee of the permittee or applicant;

personal information statement pursuant to s. 499.012(9) s.

499.012(4) or is required to be identified in an application for

a permit or to renew a permit pursuant to s. 499.012(8) s.

100

499.012(3); or

101

(d) The five largest natural shareholders that own at least

102

5 percent of the permittee or applicant.

103

(4)(3) "Applicant" means a person applying for a permit or

104

certification under this part ss. 499.001-499.081.

105

(5)(4) "Authenticate" means to affirmatively verify upon

106

receipt before any distribution of a prescription legend drug

107

occurs that each transaction listed on the pedigree paper has

108

occurred.

109

(a) A wholesale distributor is not required to open a

110

sealed, medical convenience kit to authenticate a pedigree paper

111

for a prescription drug contained within the kit.

112

(b) Authentication of a prescription drug included in a

113

sealed, medical convenience kit shall be limited to verifying the

114

transaction and pedigree information received.

115

(6)(5) "Certificate of free sale" means a document prepared

116

by the department which certifies a drug, device, or cosmetic,

117

that is registered with the department, as one that can be

118

legally sold in the state.

119

(7) "Chain pharmacy warehouse" means a wholesale

120

distributor permitted pursuant to s. 499.01 that maintains a

121

physical location for prescription drugs that functions solely as

122

a central warehouse to perform intracompany transfers of such

123

drugs to a member of its affiliated group.

124

(8)(6) "Closed pharmacy" means a pharmacy that is licensed

125

under chapter 465 and purchases prescription drugs for use by a

126

limited patient population and not for wholesale distribution or

127

sale to the public. The term does not include retail pharmacies.

128

(9)(7) "Color" includes black, white, and intermediate

129

grays.

130

(10)(8) "Color additive" means, with the exception of any

131

material that has been or hereafter is exempt under the federal

132

act, a material that:

133

(a) Is a dye pigment, or other substance, made by a process

134

of synthesis or similar artifice, or extracted, isolated, or

135

otherwise derived, with or without intermediate or final change

136

of identity from a vegetable, animal, mineral, or other source;

137

138

(b) When added or applied to a drug or cosmetic or to the

139

human body, or any part thereof, is capable alone, or through

140

reaction with other substances, of imparting color thereto;

141

142

except that the term does not include any material which has been

143

or hereafter is exempt under the federal act.

144

(11)(9) "Compressed medical gas" means any liquefied or

145

vaporized gas that is a prescription drug, whether it is alone or

146

in combination with other gases.

147

(12)(10) "Contraband prescription legend drug" means any

148

adulterated drug, as defined in s. 499.006, any counterfeit drug,

149

as defined in this section, and also means any prescription

150

legend drug for which a pedigree paper does not exist, or for

151

which the pedigree paper in existence has been forged,

152

counterfeited, falsely created, or contains any altered, false,

153

or misrepresented matter.

154

(13)(11) "Cosmetic" means an article, with the exception of

155

soap, that is:

156

(a) Intended to be rubbed, poured, sprinkled, or sprayed

157

on; introduced into; or otherwise applied to the human body or

158

any part thereof for cleansing, beautifying, promoting

159

attractiveness, or altering the appearance; or

160

(b) Intended for use as a component of any such article;

161

162

except that the term does not include soap.

163

(14)(12) "Counterfeit drug," "counterfeit device," or

164

"counterfeit drug, counterfeit device, or counterfeit cosmetic"

165

means a drug, device, or cosmetic which, or the container, seal,

166

or labeling of which, without authorization, bears the trademark,

167

trade name, or other identifying mark, imprint, or device, or any

168

likeness thereof, of a drug, device, or cosmetic manufacturer,

169

processor, packer, or distributor other than the person that in

170

fact manufactured, processed, packed, or distributed that drug,

171

device, or cosmetic and which thereby falsely purports or is

172

represented to be the product of, or to have been packed or

173

distributed by, that other drug, device, or cosmetic

174

manufacturer, processor, packer, or distributor.

175

(15)(13) "Department" means the Department of Health.

176

(16)(14) "Device" means any instrument, apparatus,

177

implement, machine, contrivance, implant, in vitro reagent, or

178

other similar or related article, including its components,

179

parts, or accessories, which is:

180

(a) Recognized in the current edition of the United States

181

Pharmacopoeia and National Formulary, or any supplement thereof,

182

(b) Intended for use in the diagnosis, cure, mitigation,

183

treatment, therapy, or prevention of disease in humans or other

184

animals, or

185

186

body of humans or other animals,

187

188

and that which does not achieve any of its principal intended

189

purposes through chemical action within or on the body of humans

190

or other animals and which is not dependent upon being

191

metabolized for the achievement of any of its principal intended

192

purposes.

193

(17)(15) "Distribute or distribution" or "distribution"

194

means to sell; offer to sell; give away; transfer, whether by

195

passage of title, physical movement, or both; deliver; or offer

196

to deliver. The term does not mean to administer or dispense.

197

(18) "Drop shipment" means the sale of a prescription drug

198

from a manufacturer to a wholesale distributor, where the

199

wholesale distributor takes title to, but not possession of, the

200

prescription drug and the manufacturer of the prescription drug

201

ships the prescription drug directly to a chain pharmacy

202

warehouse or a person authorized by law to purchase prescription

203

drugs for the purpose of administering or dispensing the drug, as

204

defined in s. 465.003.

205

(16) "Diverted from the legal channels of distribution for

206

prescription drugs" means an adulterated drug pursuant to s.

207

499.006(10).

208

(19)(17) "Drug" means an article that is:

209

(a) Recognized in the current edition of the United States

210

Pharmacopoeia and National Formulary, official Homeopathic

211

Pharmacopoeia of the United States, or any supplement to any of

212

those publications;

213

(b) Intended for use in the diagnosis, cure, mitigation,

214

treatment, therapy, or prevention of disease in humans or other

215

animals;

216

217

body of humans or other animals; or

218

(d) Intended for use as a component of any article

219

specified in paragraph (a), paragraph (b), or paragraph (c), but

220

does not include devices or their components, parts, or

221

accessories.

222

(20)(18) "Establishment" means a place of business at one

223

general physical location.

224

(21)(19) "Federal act" means the Federal Food, Drug, and

225

Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.

226

(22)(20) "Freight forwarder" means a person who receives

227

prescription legend drugs which are owned by another person and

228

designated by that person for export, and exports those

229

prescription legend drugs.

230

(23)(21) "Health care entity" means a closed pharmacy or

231

any person, organization, or business entity that provides

232

diagnostic, medical, surgical, or dental treatment or care, or

233

chronic or rehabilitative care, but does not include any

234

wholesale distributor or retail pharmacy licensed under state law

235

to deal in prescription drugs.

236

(24)(f) "Health care facility" means a health care facility

237

licensed under chapter 395.

238

(25)(h) "Hospice" means a corporation licensed under part

239

IV of chapter 400.

240

(26)(i) "Hospital" means a facility as defined in s.

241

395.002 and licensed under chapter 395.

242

(27)(22) "Immediate container" does not include package

243

liners.

244

(28)(23) "Label" means a display of written, printed, or

245

graphic matter upon the immediate container of any drug, device,

246

or cosmetic. A requirement made by or under authority of this

247

part ss. 499.001-499.081 or rules adopted under this part those

248

sections that any word, statement, or other information appear on

249

the label is not complied with unless such word, statement, or

250

other information also appears on the outside container or

251

wrapper, if any, of the retail package of such drug, device, or

252

cosmetic or is easily legible through the outside container or

253

wrapper.

254

(29)(24) "Labeling" means all labels and other written,

255

printed, or graphic matters:

256

(a) Upon a drug, device, or cosmetic, or any of its

257

containers or wrappers; or

258

(b) Accompanying or related to such drug, device, or

259

cosmetic.

260

(25) "Legend drug," "prescription drug," or "medicinal

261

drug" means any drug, including, but not limited to, finished

262

dosage forms, or active ingredients subject to, defined by, or

263

described by s. 503(b) of the Federal Food, Drug, and Cosmetic

264

Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or

265

(c).

266

(26) "Legend drug label" means any display of written,

267

printed, or graphic matter upon the immediate container of any

268

legend drug prior to its dispensing to an individual patient

269

pursuant to a prescription of a practitioner authorized by law to

270

prescribe.

271

(30)(27) "Manufacture" means the preparation, deriving,

272

compounding, propagation, processing, producing, or fabrication

273

of any drug, device, or cosmetic.

274

(31)(28) "Manufacturer" means:

275

(a) A person who prepares, derives, manufactures, or

276

produces a drug, device, or cosmetic.

277

(b) The holder or holders of a New Drug Application (NDA),

278

an Abbreviated New Drug Application (ANDA), a Biologics License

279

Application (BLA), or a New Animal Drug Application (NADA),

280

provided such application has become effective or is otherwise

281

approved consistent with s. 499.023; a private label distributor

282

for whom the private label distributor's prescription drugs are

283

originally manufactured and labeled for the distributor and have

284

not been repackaged; or the distribution point for the

285

manufacturer, contract manufacturer, or private label distributor

286

whether the establishment is a member of the manufacturer's

287

affiliated group or is a contract distribution site.

288

289

The term excludes pharmacies that are operating in compliance

290

with pharmacy practice standards as defined in chapter 465 and

291

rules adopted under that chapter.

292

(32)(29) "New drug" means:

293

(a) Any drug the composition of which is such that the drug

294

is not generally recognized, among experts qualified by

295

scientific training and experience to evaluate the safety and

296

effectiveness of drugs, as safe and effective for use under the

297

conditions prescribed, recommended, or suggested in the labeling

298

of that drug; or

299

(b) Any drug the composition of which is such that the

300

drug, as a result of investigations to determine its safety and

301

effectiveness for use under certain conditions, has been

302

recognized for use under such conditions, but which drug has not,

303

other than in those investigations, been used to a material

304

extent or for a material time under such conditions.

305

(33) "Normal distribution chain" means a wholesale

306

distribution of a prescription drug in which the wholesale

307

distributor or its wholly owned subsidiary purchases and receives

308

the specific unit of the prescription drug directly from the

309

manufacturer and distributes the prescription drug directly, or

310

through up to two intracompany transfers, to a chain pharmacy

311

warehouse or a person authorized by law to purchase prescription

312

drugs for the purpose of administering or dispensing the drug, as

313

defined in s. 465.003. For purposes of this subsection, the term

314

"intracompany" means any transaction or transfer between any

315

parent, division, or subsidiary wholly owned by a corporate

316

entity.

317

(34)(j) "Nursing home" means a facility licensed under part

318

II of chapter 400.

319

(35)(30) "Official compendium" means the current edition of

320

the official United States Pharmacopoeia and National Formulary,

321

or any supplement thereto.

322

(36)(31) "Pedigree paper" means:

323

(a) Effective July 1, 2006, A document in written or

324

electronic form approved by the department which contains of

325

Health and containing information required by s. 499.01212

326

regarding the sale and that records each distribution of any

327

given prescription legend drug, from sale by a pharmaceutical

328

manufacturer, through acquisition and sale by any wholesaler or

329

repackager, until final sale to a pharmacy or other person

330

administering or dispensing the drug. The information required to

331

be included on the form approved by the department pursuant to

332

this paragraph must at least detail the amount of the legend

333

drug; its dosage form and strength; its lot numbers; the name and

334

address of each owner of the legend drug and his or her

335

signature; its shipping information, including the name and

336

address of each person certifying delivery or receipt of the

337

legend drug; an invoice number, a shipping document number, or

338

another number uniquely identifying the transaction; and a

339

certification that the recipient wholesaler has authenticated the

340

pedigree papers. If the manufacturer or repackager has uniquely

341

serialized the individual legend drug unit, that identifier must

342

also be included on the form approved pursuant to this paragraph.

343

It must also include the name, address, telephone number and, if

344

available, e-mail contact information of each wholesaler involved

345

in the chain of the legend drug's custody; or

346

(b) A statement, under oath, in written or electronic form,

347

confirming that a wholesale distributor purchases and receives

348

the specific unit of the prescription drug directly from the

349

manufacturer of the prescription drug and distributes the

350

prescription drug directly, or through an intracompany transfer,

351

to a chain pharmacy warehouse or a person authorized by law to

352

purchase prescription drugs for the purpose of administering or

353

dispensing the drug, as defined in s. 465.003. For purposes of

354

this subsection, the term "chain pharmacy warehouse" means a

355

wholesale distributor permitted pursuant to s. 499.01 that

356

maintains a physical location for prescription drugs that

357

functions solely as a central warehouse to perform intracompany

358

transfers of such drugs to a member of its affiliated group as

359

described in s. 499.0121(6)(f)1.

360

1. The information required to be included pursuant to this

361

paragraph must include:

362

a. The following statement: "This wholesale distributor

363

purchased the specific unit of the prescription drug directly

364

from the manufacturer."

365

b. The manufacturer's national drug code identifier and the

366

name and address of the wholesaler and the purchaser of the

367

prescription drug.

368

c. The name of the prescription drug as it appears on the

369

label.

370

d. The quantity, dosage form, and strength of the

371

prescription drug.

372

2. The wholesale distributor must also maintain and make

373

available to the department, upon request, the point of origin of

374

the prescription drugs, including intracompany transfers; the

375

date of the shipment from the manufacturer to the wholesale

376

distributor; the lot numbers of such drugs; and the invoice

377

numbers from the manufacturer.

378

379

The department may adopt rules and forms relating to the

380

requirements of this subsection.

381

(37)(1) DEFINITION.--As used in this section, the term

382

"Permittee" means any person holding a permit issued pursuant to

383

s. 499.012.

384

(38)(32) "Person" means any individual, child, joint

385

venture, syndicate, fiduciary, partnership, corporation, division

386

of a corporation, firm, trust, business trust, company, estate,

387

public or private institution, association, organization, group,

388

city, county, city and county, political subdivision of this

389

state, other governmental agency within this state, and any

390

representative, agent, or agency of any of the foregoing, or any

391

other group or combination of the foregoing.

392

(39)(l) "Pharmacist" means a person licensed under chapter

393

465.

394

(40)(m) "Pharmacy" means an entity licensed under chapter

395

465.

396

(41)(33) "Prepackaged drug product" means a drug that

397

originally was in finished packaged form sealed by a manufacturer

398

and that is placed in a properly labeled container by a pharmacy

399

or practitioner authorized to dispense pursuant to chapter 465

400

for the purpose of dispensing in the establishment in which the

401

prepackaging occurred.

402

(42) "Prescription drug" means a prescription, medicinal,

403

or legend drug, including, but not limited to, finished dosage

404

forms or active ingredients subject to, defined by, or described

405

by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.

406

465.003(8), s. 499.007(13), or subsection (11), subsection (47),

407

or subsection (54).

408

(43) "Prescription drug label" means any display of

409

written, printed, or graphic matter upon the immediate container

410

of any prescription drug prior to its dispensing to an individual

411

patient pursuant to a prescription of a practitioner authorized

412

by law to prescribe.

413

(44)(34) "Prescription label" means any display of written,

414

printed, or graphic matter upon the immediate container of any

415

prescription legend drug dispensed pursuant to a prescription of

416

a practitioner authorized by law to prescribe.

417

(45)(35) "Prescription medical oxygen" means oxygen USP

418

which is a drug that can only be sold on the order or

419

prescription of a practitioner authorized by law to prescribe.

420

The label of prescription medical oxygen must comply with current

421

labeling requirements for oxygen under the Federal Food, Drug,

422

and Cosmetic Act.

423

(46)(d) "Primary wholesale distributor wholesaler" means

424

any wholesale distributor that:

425

(a)1. Purchased 90 percent or more of the total dollar

426

volume of its purchases of prescription drugs directly from

427

manufacturers in the previous year; and

428

(b)1.2.a. Directly purchased prescription drugs from not

429

fewer than 50 different prescription drug manufacturers in the

430

previous year; or

431

2.b. Has, or the affiliated group, as defined in s. 1504 of

432

the Internal Revenue Code, of which the wholesale distributor is

433

a member has, not fewer than 250 employees.

434

(c)(e) For purposes of this subsection, "directly from

435

manufacturers a manufacturer" means:

436

1. Purchases made by the wholesale distributor directly

437

from the manufacturer of prescription drugs; and

438

2. Transfers from a member of an affiliated group, as

439

defined in s. 1504 of the Internal Revenue Code, of which the

440

wholesale distributor is a member, if:

441

a. The affiliated group purchases 90 percent or more of the

442

total dollar volume of its purchases of prescription drugs from

443

the manufacturer in the previous year; and

444

b. The wholesale distributor discloses to the department

445

the names of all members of the affiliated group of which the

446

wholesale distributor is a member and the affiliated group agrees

447

in writing to provide records on prescription drug purchases by

448

the members of the affiliated group not later than 48 hours after

449

the department requests access to such records, regardless of the

450

location where the records are stored.

451

(47)(36) "Proprietary drug," or "OTC drug," means a patent

452

or over-the-counter drug in its unbroken, original package, which

453

drug is sold to the public by, or under the authority of, the

454

manufacturer or primary distributor thereof, is not misbranded

455

under the provisions of this part ss. 499.001-499.081, and can be

456

purchased without a prescription.

457

(48)(37) "Repackage" includes repacking or otherwise

458

changing the container, wrapper, or labeling to further the

459

distribution of the drug, device, or cosmetic.

460

(49)(38) "Repackager" means a person who repackages. The

461

term excludes pharmacies that are operating in compliance with

462

pharmacy practice standards as defined in chapter 465 and rules

463

adopted under that chapter.

464

(50)(c) "Retail pharmacy" means a community pharmacy

465

licensed under chapter 465 that purchases prescription drugs at

466

fair market prices and provides prescription services to the

467

public.

468

(51)(f) "Secondary wholesale distributor wholesaler" means

469

a wholesale distributor that is not a primary wholesale

470

distributor wholesaler.

471

(53)(39) "Veterinary prescription drug" means a

472

prescription legend drug intended solely for veterinary use. The

473

label of the drug must bear the statement, "Caution: Federal law

474

restricts this drug to sale by or on the order of a licensed

475

veterinarian."

476

(40) "Veterinary prescription drug wholesaler" means any

477

person engaged in wholesale distribution of veterinary

478

prescription drugs in or into this state.

479

(54)(a) "Wholesale distribution" means distribution of

480

prescription drugs to persons other than a consumer or patient,

481

but does not include:

482

(a)1. Any of the following activities, which is not a

483

violation of s. 499.005(21) if such activity is conducted in

484

accordance with s. 499.01(2)(g) s. 499.014:

485

1.a. The purchase or other acquisition by a hospital or

486

other health care entity that is a member of a group purchasing

487

organization of a prescription drug for its own use from the

488

group purchasing organization or from other hospitals or health

489

care entities that are members of that organization.

490

2.b. The sale, purchase, or trade of a prescription drug or

491

an offer to sell, purchase, or trade a prescription drug by a

492

charitable organization described in s. 501(c)(3) of the Internal

493

Revenue Code of 1986, as amended and revised, to a nonprofit

494

affiliate of the organization to the extent otherwise permitted

495

by law.

496

3.c. The sale, purchase, or trade of a prescription drug or

497

an offer to sell, purchase, or trade a prescription drug among

498

hospitals or other health care entities that are under common

499

control. For purposes of this subparagraph section, "common

500

control" means the power to direct or cause the direction of the

501

management and policies of a person or an organization, whether

502

by ownership of stock, by voting rights, by contract, or

503

otherwise.

504

4.d. The sale, purchase, trade, or other transfer of a

505

prescription drug from or for any federal, state, or local

506

government agency or any entity eligible to purchase prescription

507

drugs at public health services prices pursuant to Pub. L. No.

508

102-585, s. 602 to a contract provider or its subcontractor for

509

eligible patients of the agency or entity under the following

510

conditions:

511

a.(I) The agency or entity must obtain written

512

authorization for the sale, purchase, trade, or other transfer of

513

a prescription drug under this subparagraph sub-subparagraph from

514

the State Surgeon General or his or her designee.

515

b.(II) The contract provider or subcontractor must be

516

authorized by law to administer or dispense prescription drugs.

517

c.(III) In the case of a subcontractor, the agency or

518

entity must be a party to and execute the subcontract.

519

d.(IV) A contract provider or subcontractor must maintain

520

separate and apart from other prescription drug inventory any

521

prescription drugs of the agency or entity in its possession.

522

e.(V) The contract provider and subcontractor must maintain

523

and produce immediately for inspection all records of movement or

524

transfer of all the prescription drugs belonging to the agency or

525

entity, including, but not limited to, the records of receipt and

526

disposition of prescription drugs. Each contractor and

527

subcontractor dispensing or administering these drugs must

528

maintain and produce records documenting the dispensing or

529

administration. Records that are required to be maintained

530

include, but are not limited to, a perpetual inventory itemizing

531

drugs received and drugs dispensed by prescription number or

532

administered by patient identifier, which must be submitted to

533

the agency or entity quarterly.

534

f.(VI) The contract provider or subcontractor may

535

administer or dispense the prescription drugs only to the

536

eligible patients of the agency or entity or must return the

537

prescription drugs for or to the agency or entity. The contract

538

provider or subcontractor must require proof from each person

539

seeking to fill a prescription or obtain treatment that the

540

person is an eligible patient of the agency or entity and must,

541

at a minimum, maintain a copy of this proof as part of the

542

records of the contractor or subcontractor required under sub-

543

subparagraph e. sub-sub-subparagraph (V).

544

g.(VII) In addition to the departmental inspection

545

authority set forth in s. 499.051, the establishment of the

546

contract provider and subcontractor and all records pertaining to

547

prescription drugs subject to this subparagraph sub-subparagraph

548

shall be subject to inspection by the agency or entity. All

549

records relating to prescription drugs of a manufacturer under

550

this subparagraph sub-subparagraph shall be subject to audit by

551

the manufacturer of those drugs, without identifying individual

552

patient information.

553

(b)2. Any of the following activities, which is not a

554

violation of s. 499.005(21) if such activity is conducted in

555

accordance with rules established by the department:

556

1.a. The sale, purchase, or trade of a prescription drug

557

among federal, state, or local government health care entities

558

that are under common control and are authorized to purchase such

559

prescription drug.

560

2.b. The sale, purchase, or trade of a prescription drug or

561

an offer to sell, purchase, or trade a prescription drug for

562

emergency medical reasons. For purposes of this subparagraph sub-

563

subparagraph, the term "emergency medical reasons" includes

564

transfers of prescription drugs by a retail pharmacy to another

565

retail pharmacy to alleviate a temporary shortage.

566

3.c. The transfer of a prescription drug acquired by a

567

medical director on behalf of a licensed emergency medical

568

services provider to that emergency medical services provider and

569

its transport vehicles for use in accordance with the provider's

570

license under chapter 401.

571

4.d. The revocation of a sale or the return of a

572

prescription drug to the person's prescription drug wholesale

573

supplier.

574

5.e. The donation of a prescription drug by a health care

575

entity to a charitable organization that has been granted an

576

exemption under s. 501(c)(3) of the Internal Revenue Code of

577

1986, as amended, and that is authorized to possess prescription

578

drugs.

579

6.f. The transfer of a prescription drug by a person

580

authorized to purchase or receive prescription drugs to a person

581

licensed or permitted to handle reverse distributions or

582

destruction under the laws of the jurisdiction in which the

583

person handling the reverse distribution or destruction receives

584

the drug.

585

7.g. The transfer of a prescription drug by a hospital or

586

other health care entity to a person licensed under this part

587

chapter to repackage prescription drugs for the purpose of

588

repackaging the prescription drug for use by that hospital, or

589

other health care entity and other health care entities that are

590

under common control, if ownership of the prescription drugs

591

remains with the hospital or other health care entity at all

592

times. In addition to the recordkeeping requirements of s.

593

499.0121(6), the hospital or health care entity that transfers

594

prescription drugs pursuant to this subparagraph sub-subparagraph

595

must reconcile all drugs transferred and returned and resolve any

596

discrepancies in a timely manner.

597

598

manufacturers' representatives or distributors' representatives

599

conducted in accordance with s. 499.028.

600

(d)4. The sale, purchase, or trade of blood and blood

601

components intended for transfusion. As used in this paragraph

602

subparagraph, the term "blood" means whole blood collected from a

603

single donor and processed either for transfusion or further

604

manufacturing, and the term "blood components" means that part of

605

the blood separated by physical or mechanical means.

606

(e)5. The lawful dispensing of a prescription drug in

607

accordance with chapter 465.

608

(f)6. The sale, purchase, or trade of a prescription drug

609

between pharmacies as a result of a sale, transfer, merger, or

610

consolidation of all or part of the business of the pharmacies

611

from or with another pharmacy, whether accomplished as a purchase

612

and sale of stock or of business assets.

613

(54)(b) "Wholesale distributor" means any person engaged in

614

wholesale distribution of prescription drugs in or into this

615

state, including, but not limited to, manufacturers; repackagers;

616

own-label distributors; jobbers; private-label distributors;

617

brokers; warehouses, including manufacturers' and distributors'

618

warehouses, chain drug warehouses, and wholesale drug warehouses;

619

independent wholesale drug traders; exporters; retail pharmacies;

620

and the agents thereof that conduct wholesale distributions.

621

Section 3. Subsections (4), (10), (11), (12), (14), (15),

622

(18), (19), (20), (22), (24), (28), and (29) of section 499.005,

623

Florida Statutes, are amended to read:

624

499.005 Prohibited acts.--It is unlawful for a person to

625

perform or cause the performance of any of the following acts in

626

this state:

627

(4) The sale, distribution, purchase, trade, holding, or

628

offering of any drug, device, or cosmetic in violation of this

629

part ss. 499.001-499.081.

630

(10) Forging; counterfeiting; simulating; falsely

631

representing any drug, device, or cosmetic; or, without the

632

authority of the manufacturer, using any mark, stamp, tag, label,

633

or other identification device authorized or required by rules

634

adopted under this part ss. 499.001-499.081.

635

(11) The use, on the labeling of any drug or in any

636

advertisement relating to such drug, of any representation or

637

suggestion that an application of the drug is effective when it

638

is not or that the drug complies with this part ss. 499.001-

639

499.081 when it does not.

640

(12) The possession of any drug in violation of this part

641

ss. 499.001-499.081.

642

(14) The purchase or receipt of a prescription legend drug

643

from a person that is not authorized under this chapter to

644

distribute prescription legend drugs to that purchaser or

645

recipient.

646

(15) The sale or transfer of a prescription legend drug to

647

a person that is not authorized under the law of the jurisdiction

648

in which the person receives the drug to purchase or possess

649

prescription legend drugs from the person selling or transferring

650

the prescription legend drug.

651

(18) Failure to maintain records as required by this part

652

ss. 499.001-499.081 and rules adopted under this part those

653

sections.

654

(19) Providing the department with false or fraudulent

655

records, or making false or fraudulent statements, regarding any

656

matter within the provisions of this part chapter.

657

(20) The importation of a prescription legend drug except

658

as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic

659

Act.

660

(22) Failure to obtain a permit or registration, or

661

operating without a valid permit when a permit or registration is

662

required by this part ss. 499.001-499.081 for that activity.

663

(24) The distribution of a prescription legend device to

664

the patient or ultimate consumer without a prescription or order

665

from a practitioner licensed by law to use or prescribe the

666

device.

667

(28) Failure to acquire obtain or deliver pass on a

668

pedigree paper as required under this part.

669

(29) The receipt of a prescription drug pursuant to a

670

wholesale distribution without having previously received or

671

simultaneously either first receiving a pedigree paper that was

672

attested to as accurate and complete by the wholesale distributor

673

as required under this part or complying with the provisions of

674

s. 499.0121(6)(d)5.

675

Section 4. Section 499.0051, Florida Statutes, is amended;

676

section 499.0052, Florida Statutes, is redesignated as subsection

677

(7) of that section and amended; section 499.00535, Florida

678

Statutes, is redesignated as subsection (9) of that section and

679

amended; section 499.00545, Florida Statutes, is redesignated as

680

subsection (10) of that section and amended; section 499.069,

681

Florida Statutes, is redesignated as subsection (11) of that

682

section and amended; and section 499.0691, Florida Statutes, is

683

redesignated as subsections (12) through (15) of that section and

684

amended, to read:

685

499.0051 Criminal acts involving contraband or adulterated

686

drugs.--

687

(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--

688

(a) A person, other than a manufacturer, engaged in the

689

wholesale distribution of prescription legend drugs who fails to

690

deliver to another person complete and accurate pedigree papers

691

concerning a prescription legend drug or contraband prescription

692

legend drug prior to, or simultaneous with, the transfer of

693

transferring the prescription legend drug or contraband

694

prescription legend drug to another person commits a felony of

695

the third degree, punishable as provided in s. 775.082, s.

696

775.083, or s. 775.084.

697

(b) A person engaged in the wholesale distribution of

698

prescription legend drugs who fails to acquire complete and

699

accurate pedigree papers concerning a prescription legend drug or

700

contraband prescription legend drug prior to, or simultaneous

701

with, the receipt of obtaining the prescription legend drug or

702

contraband prescription legend drug from another person commits a

703

felony of the third degree, punishable as provided in s. 775.082,

704

s. 775.083, or s. 775.084.

705

706

fails to maintain complete and accurate pedigree papers

707

concerning any prescription legend drug or contraband

708

prescription legend drug in his or her possession commits a

709

felony of the third degree, punishable as provided in s. 775.082,

710

s. 775.083, or s. 775.084.

711

(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective

712

July 1, 2006:

713

(a) A person engaged in the wholesale distribution of

714

prescription legend drugs who is in possession of pedigree papers

715

concerning prescription legend drugs or contraband prescription

716

legend drugs and who fails to authenticate the matters contained

717

in the pedigree papers and who nevertheless attempts to further

718

distribute prescription legend drugs or contraband prescription

719

legend drugs commits a felony of the third degree, punishable as

720

provided in s. 775.082, s. 775.083, or s. 775.084.

721

(b) A person in possession of pedigree papers concerning

722

prescription legend drugs or contraband prescription legend drugs

723

who falsely swears or certifies that he or she has authenticated

724

the matters contained in the pedigree papers commits a felony of

725

the third degree, punishable as provided in s. 775.082, s.

726

775.083, or s. 775.084.

727

(3) KNOWING FORGERY OF PEDIGREE PAPERS.--A person who

728

knowingly forges, counterfeits, or falsely creates any pedigree

729

paper; who falsely represents any factual matter contained on any

730

pedigree paper; or who knowingly omits to record material

731

information required to be recorded in a pedigree paper, commits

732

a felony of the second degree, punishable as provided in s.

733

775.082, s. 775.083, or s. 775.084.

734

(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG

735

FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or

736

receives from a person not authorized to distribute prescription

737

legend drugs under this chapter a prescription legend drug in a

738

wholesale distribution transaction commits a felony of the second

739

degree, punishable as provided in s. 775.082, s. 775.083, or s.

740

775.084.

741

(5) KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG TO

742

UNAUTHORIZED PERSON.--A person who knowingly sells or transfers

743

to a person not authorized to purchase or possess prescription

744

legend drugs, under the law of the jurisdiction in which the

745

person receives the drug, a prescription legend drug in a

746

wholesale distribution transaction commits a felony of the second

747

degree, punishable as provided in s. 775.082, s. 775.083, or s.

748

775.084.

749

(6) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO

750

SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is

751

knowingly in actual or constructive possession of any amount of

752

contraband prescription legend drugs, who knowingly sells or

753

delivers, or who possesses with intent to sell or deliver any

754

amount of contraband prescription legend drugs, commits a felony

755

of the second degree, punishable as provided in s. 775.082, s.

756

775.083, or s. 775.084.

757

(7)499.0052 KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION

758

LEGEND DRUGS.--A person who knowingly sells, purchases,

759

manufactures, delivers, or brings into this state, or who is

760

knowingly in actual or constructive possession of any amount of

761

contraband prescription legend drugs valued at $25,000 or more

762

commits a felony of the first degree, punishable as provided in

763

s. 775.082, s. 775.083, or s. 775.084.

764

(a) Upon conviction, each defendant shall be ordered to pay

765

a mandatory fine according to the following schedule:

766

1.(1) If the value of contraband prescription legend drugs

767

involved is $25,000 or more, but less than $100,000, the

768

defendant shall pay a mandatory fine of $25,000. If the defendant

769

is a corporation or other person that is not a natural person, it

770

shall pay a mandatory fine of $75,000.

771

2.(2) If the value of contraband prescription legend drugs

772

involved is $100,000 or more, but less than $250,000, the

773

defendant shall pay a mandatory fine of $100,000. If the

774

defendant is a corporation or other person that is not a natural

775

person, it shall pay a mandatory fine of $300,000.

776

3.(3) If the value of contraband prescription legend drugs

777

involved is $250,000 or more, the defendant shall pay a mandatory

778

fine of $200,000. If the defendant is a corporation or other

779

person that is not a natural person, it shall pay a mandatory

780

fine of $600,000.

781

(b) As used in this subsection section, the term "value"

782

means the market value of the property at the time and place of

783

the offense or, if such cannot be satisfactorily ascertained, the

784

cost of replacement of the property within a reasonable time

785

after the offense. Amounts of value of separate contraband

786

prescription legend drugs involved in distinct transactions for

787

the distribution of the contraband prescription legend drugs

788

committed pursuant to one scheme or course of conduct, whether

789

involving the same person or several persons, may be aggregated

790

in determining the punishment of the offense.

791

(8)(7) KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION

792

LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits,

793

or falsely creates any prescription label or prescription legend

794

drug label, or who falsely represents any factual matter

795

contained on any prescription label or prescription legend drug

796

label, commits a felony of the first degree, punishable as

797

provided in s. 775.082, s. 775.083, or s. 775.084.

798

(9)499.00535 KNOWING Sale or purchase of contraband

799

prescription legend drugs resulting in great bodily harm.--A

800

person who knowingly sells, purchases, manufactures, delivers, or

801

brings into this state, or who is knowingly in actual or

802

constructive possession of any amount of contraband prescription

803

legend drugs, and whose acts in violation of this subsection

804

section result in great bodily harm to a person, commits a felony

805

of the first degree, as provided in s. 775.082, s. 775.083, or s.

806

775.084.

807

(10)499.00545 Knowing Sale or purchase of contraband

808

prescription legend drugs resulting in death.--A person who

809

knowingly manufactures, sells, purchases, delivers, or brings

810

into this state, or who is knowingly in actual or constructive

811

possession of any amount of contraband prescription legend drugs,

812

and whose acts in violation of this subsection section result in

813

the death of a person, commits a felony of the first degree,

814

punishable by a term of years not exceeding life, as provided in

815

s. 775.082, s. 775.083, or s. 775.084.

816

(11)499.069 Criminal punishment for violations of s.

817

499.005 related to devices and cosmetics; dissemination of false

818

advertisement.--

819

(a)(1) Any person who violates any of the provisions of s.

820

499.005 with respect to a device or cosmetic commits a

821

misdemeanor of the second degree, punishable as provided in s.

822

775.082 or s. 775.083; but, if the violation is committed after a

823

conviction of such person under this subsection section has

824

become final, such person is guilty of a misdemeanor of the first

825

degree, punishable as provided in s. 775.082 or s. 775.083 or as

826

otherwise provided in this part ss. 499.001-499.081, except that

827

any person who violates s. 499.005(8) or (10) subsection (8) or

828

subsection (10) of s. 499.005 with respect to a device or

829

cosmetic commits a felony of the third degree, punishable as

830

provided in s. 775.082, s. 775.083, or s. 775.084, or as

831

otherwise provided in this part ss. 499.001-499.081.

832

(b)(2) A publisher, radio broadcast licensee, or agency or

833

medium for the dissemination of an advertisement, except the

834

manufacturer, wholesaler, or seller of the article to which a

835

false advertisement relates, is not liable under this subsection

836

section by reason of the dissemination by him or her of such

837

false advertisement, unless he or she has refused, on the request

838

of the department, to furnish to the department the name and post

839

office address of the manufacturer, wholesaler, seller, or

840

advertising agency that asked him or her to disseminate such

841

advertisement.

842

(12)499.0691 ADULTERATED AND MISBRANDED DRUGS; FALSE

843

ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS

844

Criminal punishment for violations related to drugs;

845

dissemination of false advertisement.--(1) Any person who

846

violates any of the following provisions commits a misdemeanor of

847

the second degree, punishable as provided in s. 775.082 or s.

848

775.083; but, if the violation is committed after a conviction of

849

such person under this subsection section has become final, such

850

person commits a misdemeanor of the first degree, punishable as

851

provided in s. 775.082 or s. 775.083, or as otherwise provided in

852

this part ss. 499.001-499.081:

853

(a) The manufacture, repackaging, sale, delivery, or

854

holding or offering for sale of any drug that is adulterated or

855

misbranded or has otherwise been rendered unfit for human or

856

animal use.

857

(b) The adulteration or misbranding of any drug intended

858

for further distribution.

859

860

misbranded, and the delivery or proffered delivery of such drug,

861

for pay or otherwise.

862

(d) The dissemination of any false or misleading

863

advertisement of a drug.

864

(e) The use, on the labeling of any drug or in any

865

advertisement relating to such drug, of any representation or

866

suggestion that an application of the drug is effective when it

867

is not or that the drug complies with this part ss. 499.001-

868

499.081 when it does not.

869

(f) The purchase or receipt of a compressed medical gas

870

from a person that is not authorized under this chapter to

871

distribute compressed medical gases.

872

(g) Charging a dispensing fee for dispensing,

873

administering, or distributing a prescription drug sample.

874

(h) The failure to maintain records related to a drug as

875

required by this part ss. 499.001-499.081 and rules adopted under

876

this part those sections, except for pedigree papers, invoices,

877

or shipping documents related to prescription legend drugs.

878

(i) The possession of any drug in violation of this part

879

ss. 499.001-499.081, except if the violation relates to a

880

deficiency in pedigree papers.

881

(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR

882

TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO

883

PRESCRIPTION DRUGS.--(2) Any person who violates any of the

884

following provisions commits a felony of the third degree,

885

punishable as provided in s. 775.082, s. 775.083, or s. 775.084,

886

or as otherwise provided in this part: ss. 499.001-499.081.

887

(a) The refusal or constructive refusal to allow:

888

1. The department to enter or inspect an establishment in

889

which drugs are manufactured, processed, repackaged, sold,

890

brokered, or held;

891

2. Inspection of any record of that establishment;

892

3. The department to enter and inspect any vehicle that is

893

being used to transport drugs; or

894

4. The department to take samples of any drug.

895

(b) The sale, purchase, or trade, or the offer to sell,

896

purchase, or trade, a drug sample as defined in s. 499.028; the

897

distribution of a drug sample in violation of s. 499.028; or the

898

failure to otherwise comply with s. 499.028.

899

900

records, or making false or fraudulent statements, regarding any

901

matter within the provisions of this part chapter related to a

902

drug.

903

(d) The failure to receive, maintain, or provide invoices

904

and shipping documents, other than pedigree papers, if

905

applicable, related to the distribution of a prescription legend

906

drug.

907

(e) The importation of a prescription legend drug for

908

wholesale distribution, except as provided by s. 801(d) of the

909

Federal Food, Drug, and Cosmetic Act.

910

(f) The wholesale distribution of a any prescription drug

911

that was:

912

1. Purchased by a public or private hospital or other

913

health care entity; or

914

2. Donated or supplied at a reduced price to a charitable

915

organization.

916

(g) The failure to obtain a permit as a prescription drug

917

wholesale distributor wholesaler when a permit is required by

918

this part ss. 499.001-499.081 for that activity.

919

(h) Knowingly possessing any adulterated or misbranded

920

prescription legend drug outside of a designated quarantine area.

921

(i) The purchase or sale of a prescription drug drugs for

922

wholesale distribution in exchange for currency, as defined in s.

923

560.103(6).

924

(14) OTHER VIOLATIONS.--(3) Any person who violates any of

925

the following provisions commits a felony of the second degree,

926

punishable as provided in s. 775.082, s. 775.083, or s. 775.084,

927

or as otherwise provided in this part: ss. 499.001-499.081.

928

(a) Knowingly manufacturing, repackaging, selling,

929

delivering, or holding or offering for sale any drug that is

930

adulterated or misbranded or has otherwise been rendered unfit

931

for human or animal use.

932

(b) Knowingly adulterating a drug that is intended for

933

further distribution.

934

935

delivering or proffering delivery of such drug for pay or

936

otherwise.

937

(d) Committing any act that causes a drug to be a

938

counterfeit drug, or selling, dispensing, or knowingly holding

939

for sale a counterfeit drug.

940

(e) Forging, counterfeiting, simulating, or falsely

941

representing any drug, or, without the authority of the

942

manufacturer, using any mark, stamp, tag, label, or other

943

identification device authorized or required by rules adopted

944

under this part ss. 499.001-499.081.

945

(f) Knowingly obtaining or attempting to obtain a

946

prescription drug for wholesale distribution by fraud, deceit,

947

misrepresentation, or subterfuge, or engaging in

948

misrepresentation or fraud in the distribution of a drug.

949

(g) Removing a pharmacy's dispensing label from a dispensed

950

prescription drug with the intent to further distribute the

951

prescription drug.

952

(h) Knowingly distributing a prescription drug that was

953

previously dispensed by a licensed pharmacy, unless such

954

distribution was authorized in chapter 465 or the rules adopted

955

under chapter 465.

956

(15) FALSE ADVERTISEMENT.--(4) A publisher, radio

957

broadcast licensee, or agency or medium for the dissemination of

958

an advertisement, except the manufacturer, repackager, wholesale

959

distributor wholesaler, or seller of the article to which a false

960

advertisement relates, is not liable under subsection (12),

961

subsection (13), or subsection (14) this section by reason of the

962

dissemination by him or her of such false advertisement, unless

963

he or she has refused, on the request of the department, to

964

furnish to the department the name and post office address of the

965

manufacturer, repackager, wholesale distributor wholesaler,

966

seller, or advertising agency that asked him or her to

967

disseminate such advertisement.

968

Section 5. Section 499.0054, Florida Statutes, is amended;

969

section 499.0055, Florida Statutes, is redesignated as subsection

970

(2) of that section and amended; and section 499.0057, Florida

971

Statutes, is redesignated as subsection (3) of that section and

972

amended, to read:

973

499.0054 Advertising and labeling of drugs, devices, and

974

cosmetics; exemptions.--

975

(1) It is a violation of the Florida Drug and Cosmetic Act

976

to perform or cause the performance of any of the following acts:

977

(a)(1) The dissemination of any false advertisement of any

978

drug, device, or cosmetic. An advertisement is false if it is

979

false or misleading in any way.

980

(b)(2) The distribution in commerce of any drug, device, or

981

cosmetic, if its labeling or advertising is in violation of this

982

part ss. 499.001-499.081.

983

(c)(3) The manufacturing, repackaging, packaging, selling,

984

delivery, holding, or offering for sale of any drug, device, or

985

cosmetic for which the advertising or labeling is false or

986

misleading.

987

(d)(4) The advertising of any drug, device, or cosmetic

988

that is adulterated or misbranded.

989

(e)(5) The receiving in commerce of any drug, device, or

990

cosmetic that is falsely advertised or labeled or the delivering

991

or proffering for delivery of any such drug, device, or cosmetic.

992

(f)(6) The advertising or labeling of any product

993

containing ephedrine, a salt of ephedrine, an isomer of

994

ephedrine, or a salt of an isomer of ephedrine, for the

995

indication of stimulation, mental alertness, weight loss,

996

appetite control, energy, or other indications not approved by

997

the pertinent United States Food and Drug Administration Over-

998

the-Counter Final or Tentative Final Monograph or approved new

999

drug application under the federal act. In determining compliance

1000

with this requirement, the department may consider the following

1001

factors:

1002

1.(a) The packaging of the product.

1003

2.(b) The name and labeling of the product.

1004

3.(c) The manner of distribution, advertising, and

1005

promotion of the product, including verbal representations at the

1006

point of sale.

1007

4.(d) The duration, scope, and significance of abuse of the

1008

particular product.

1009

(g)(7) The advertising of any drug or device represented to

1010

have any effect in any of the following conditions, disorders,

1011

diseases, or processes:

1012

1.(a) Blood disorders.

1013

2.(b) Bone or joint diseases.

1014

3.(c) Kidney diseases or disorders.

1015

4.(d) Cancer.

1016

5.(e) Diabetes.

1017

6.(f) Gall bladder diseases or disorders.

1018

7.(g) Heart and vascular diseases.

1019

8.(h) High blood pressure.

1020

9.(i) Diseases or disorders of the ear or auditory

1021

apparatus, including hearing loss or deafness.

1022

10.(j) Mental disease or mental retardation.

1023

11.(k) Paralysis.

1024

12.(l) Prostate gland disorders.

1025

13.(m) Conditions of the scalp affecting hair loss.

1026

14.(n) Baldness.

1027

15.(o) Endocrine disorders.

1028

16.(p) Sexual impotence.

1029

17.(q) Tumors.

1030

18.(r) Venereal diseases.

1031

19.(s) Varicose ulcers.

1032

20.(t) Breast enlargement.

1033

21.(u) Purifying blood.

1034

22.(v) Metabolic disorders.

1035

23.(w) Immune system disorders or conditions affecting the

1036

immune system.

1037

24.(x) Extension of life expectancy.

1038

25.(y) Stress and tension.

1039

26.(z) Brain stimulation or performance.

1040

27.(aa) The body's natural defense mechanisms.

1041

28.(bb) Blood flow.

1042

29.(cc) Depression.

1043

30.(dd) Human immunodeficiency virus or acquired immune

1044

deficiency syndrome or related disorders or conditions.

1045

(h)(8) The representation or suggestion in labeling or

1046

advertising that an article is approved under this part ss.

1047

499.001-499.081, when such is not the case.

1048

(2)499.0055 False or misleading advertisement.--In

1049

determining whether an advertisement is false or misleading, the

1050

department shall review the representations made or suggested by

1051

statement, word, design, device, sound, or any combination

1052

thereof within the advertisement and the extent to which the

1053

advertisement fails to reveal material facts with respect to

1054

consequences that can result from the use of the drug, device, or

1055

cosmetic to which the advertisement relates under the conditions

1056

of use prescribed in the labeling or advertisement.

1057

(3)499.0057 Advertisement exemptions.--

1058

(a)(1) An advertisement that is not prohibited under

1059

paragraph (1)(a) s. 499.0054(1) is not prohibited under paragraph

1060

(1)(g) s. 499.0054(7) if it is disseminated:

1061

1. To the public solely to advertise the product for those

1062

indications that are safe and effective indications and the

1063

product is safe and effective for self-medication, as established

1064

by the United States Food and Drug Administration; or

1065

2. if it is disseminated Only to members of the medical,

1066

dental, pharmaceutical, or veterinary professions or appears only

1067

in the scientific periodicals of these professions.

1068

(b)(2) Compliance with this part ss. 499.001-499.081 and

1069

the rules adopted under this part those sections creates no legal

1070

presumption that a drug or device is safe or effective.

1071

Section 6. Subsections (3), (10), and (11) of section

1072

499.006, Florida Statutes, are amended to read:

1073

499.006 Adulterated drug or device.--A drug or device is

1074

adulterated:

1075

(3) If it is a drug and the methods used in, or the

1076

facilities or controls used for, its manufacture, processing,

1077

packing, or holding do not conform to, or are not operated or

1078

administered in conformity with, current good manufacturing

1079

practices to assure that the drug meets the requirements of this

1080

part ss. 499.001-499.081 and that the drug has the identity and

1081

strength, and meets the standard of quality and purity, which it

1082

purports or is represented to possess;

1083

(10) If it is a prescription legend drug for which the

1084

required pedigree paper is nonexistent, fraudulent, or incomplete

1085

under the requirements of this part ss. 499.001-499.081 or

1086

applicable rules, or that has been purchased, held, sold, or

1087

distributed at any time by a person not authorized under federal

1088

or state law to do so; or

1089

(11) If it is a prescription drug subject to, defined by,

1090

or described by s. 503(b) of the Federal Food, Drug, and Cosmetic

1091

Act which has been returned by a veterinarian to a limited

1092

prescription drug veterinary wholesale distributor wholesaler.

1093

Section 7. Section 499.007, Florida Statutes, is amended to

1094

read:

1095

499.007 Misbranded drug or device.--A drug or device is

1096

misbranded:

1097

(1) If its labeling is in any way false or misleading.

1098

(2) Unless, If in package form, it does not bear bears a

1099

label containing:

1100

(a) The name and place of business of the manufacturer,

1101

repackager, or distributor of the finished dosage form of the

1102

drug. For the purpose of this paragraph, the finished dosage form

1103

of a prescription medicinal drug is that form of the drug which

1104

is, or is intended to be, dispensed or administered to the

1105

patient and requires no further manufacturing or processing other

1106

than packaging, reconstitution, and labeling; and

1107

(b) An accurate statement of the quantity of the contents

1108

in terms of weight, measure, or numerical count.; However, under

1109

this section, reasonable variations are permitted, and the

1110

department shall establish by rule exemptions for small packages.

1111

(3) If it is an active pharmaceutical ingredient in bulk

1112

form and does not bear a label containing:

1113

(a) The name and place of business of the manufacturer,

1114

repackager, or distributor; and

1115

(b) An accurate statement of the quantity of the contents

1116

in terms of weight, measure, or numerical count.

1117

(4)(3) If any word, statement, or other information

1118

required by or under this part ss. 499.001-499.081 to appear on

1119

the label or labeling is not prominently placed thereon with such

1120

conspicuousness as compared with other words, statements,

1121

designs, or devices in the labeling, and in such terms, as to

1122

render the word, statement, or other information likely to be

1123

read and understood under customary conditions of purchase and

1124

use.

1125

(5)(4) If it is a drug and is not designated solely by a

1126

name recognized in an official compendium and, unless its label

1127

does not bear bears:

1128

(a) The common or usual name of the drug, if any; and

1129

(b) In case it is fabricated from two or more ingredients,

1130

the common or usual name and quantity of each active ingredient.

1131

(6)(5) If Unless its labeling does not bear bears:

1132

(a) Adequate directions for use; and

1133

(b) Adequate warnings against use in those pathological

1134

conditions in which its use may be dangerous to health or against

1135

use by children if its use may be dangerous to health, or against

1136

unsafe dosage or methods or duration of administration or

1137

application, in such manner and form as are necessary for the

1138

protection of users.

1139

(7)(6) If it purports to be a drug the name of which is

1140

recognized in the official compendium and, unless it is not

1141

packaged and labeled as prescribed therein.; However, the method

1142

of packaging may be modified with the consent of the department.

1143

(8)(7) If it has been found by the department to be a drug

1144

liable to deterioration and, unless it is not packaged in such

1145

form and manner, and its label bears a statement of such

1146

precautions, as the department by rule requires as necessary to

1147

protect the public health. Such rule may not be established for

1148

any drug recognized in an official compendium until the

1149

department has informed the appropriate body charged with the

1150

revision of such compendium of the need for such packaging or

1151

labeling requirements and that body has failed within a

1152

reasonable time to prescribe such requirements.

1153

(9)(8) If it is:

1154

(a) A drug and its container or finished dosage form is so

1155

made, formed, or filled as to be misleading;

1156

(b) An imitation of another drug; or

1157

1158

(10)(9) If it is dangerous to health when used in the

1159

dosage or with the frequency or duration prescribed, recommended,

1160

or suggested in the labeling of the drug.

1161

(11)(10) If it is, purports to be, or is represented as a

1162

drug composed wholly or partly of insulin and, unless:

1163

(a) it is not from a batch with respect to which a

1164

certificate has been issued pursuant to s. 506 of the federal

1165

act, which; and

1166

(b) The certificate is in effect with respect to the drug.

1167

(12)(11) If it is, purports to be, or is represented as a

1168

drug composed wholly or partly of any kind of antibiotic

1169

requiring certification under the federal act and unless:

1170

(a) it is not from a batch with respect to which a

1171

certificate has been issued pursuant to s. 507 of the federal

1172

act, which; and

1173

(b) the certificate is in effect with respect to the drug.;

1174

1175

However, this subsection does not apply to any drug or class of

1176

drugs exempted by regulations adopted under s. 507(c) or (d) of

1177

the federal act.

1178

(13)(12) If it is a drug intended for use by humans which

1179

is a habit-forming drug or which, because of its toxicity or

1180

other potentiality for harmful effect, or the method of its use,

1181

or the collateral measures necessary to its use, is not safe for

1182

use except under the supervision of a practitioner licensed by

1183

law to administer such drugs,; or which is limited by an

1184

effective application under s. 505 of the federal act to use

1185

under the professional supervision of a practitioner licensed by

1186

law to prescribe such drug, if unless it is not dispensed only:

1187

(a) Upon the written prescription of a practitioner

1188

licensed by law to prescribe such drug;

1189

(b) Upon an oral prescription of such practitioner, which

1190

is reduced promptly to writing and filled by the pharmacist; or

1191

1192

such refilling is authorized by the prescriber either in the

1193

original prescription or by oral order which is reduced promptly

1194

to writing and filled by the pharmacist.

1195

1196

This subsection does not relieve any person from any requirement

1197

prescribed by law with respect to controlled substances as

1198

defined in the applicable federal and state laws.

1199

(14)(13) If it is a drug that is subject to paragraph

1200

(13)(12)(a), and if, at any time before it is dispensed, its

1201

label does not fails to bear the statement:

1202

(a) "Caution: Federal Law Prohibits Dispensing Without

1203

Prescription";

1204

(b) "Rx Only";

1205

1206

(d) "Caution: State Law Prohibits Dispensing Without

1207

Prescription."

1208

(15)(14) If it is a drug that is not subject to paragraph

1209

(13)(12)(a), if at any time before it is dispensed its label

1210

bears the statement of caution required in subsection (14) (13).

1211

(16)(15) If it is a color additive, the intended use of

1212

which in or on drugs is for the purpose of coloring only and,

1213

unless its packaging and labeling are not in conformity with the

1214

packaging and labeling requirements that apply to such color

1215

additive and are prescribed under the federal act.

1216

(17) A drug dispensed by filling or refilling a written or

1217

oral prescription of a practitioner licensed by law to prescribe

1218

such drug is exempt from the requirements of this section, except

1219

subsections (1), (9) (8), (11) (10), and (12) (11) and the

1220

packaging requirements of subsections (7) (6) and (8) (7), if the

1221

drug bears a label that contains the name and address of the

1222

dispenser or seller, the prescription number and the date the

1223

prescription was written or filled, the name of the prescriber

1224

and the name of the patient, and the directions for use and

1225

cautionary statements. This exemption does not apply to any drug

1226

dispensed in the course of the conduct of a business of

1227

dispensing drugs pursuant to diagnosis by mail or to any drug

1228

dispensed in violation of subsection (13) (12). The department

1229

may, by rule, exempt drugs subject to s. 499.062 ss. 499.062-

1230

499.064 from subsection (13) (12) if compliance with that

1231

subsection is not necessary to protect the public health, safety,

1232

and welfare.

1233

Section 8. Subsection (1) of section 499.008, Florida

1234

Statutes, is amended and subsection (5) is added to that section

1235

to read:

1236

499.008 Adulterated cosmetics.--A cosmetic is adulterated:

1237

(1) If it bears or contains any poisonous or deleterious

1238

substance that is injurious to users under the conditions of use

1239

prescribed in the labeling or advertisement thereof or under such

1240

conditions of use as are customary or usual; however, this

1241

subsection does not apply to coal-tar hair dye:

1242

(a) The label of which bears the following legend

1243

conspicuously displayed thereon: "Caution: This product contains

1244

ingredients which may cause skin irritation on certain

1245

individuals, and a preliminary test according to accompanying

1246

directions should first be made. This product must not be used

1247

for dyeing the eyelashes or eyebrows; to do so may cause

1248

blindness"; and

1249

(b) The labeling of which bears adequate directions for

1250

such preliminary testing.

1251

1252

For the purposes of this subsection and subsection (4), the term

1253

"hair dye" does not include eyelash dyes or eyebrow dyes.

1254

(5) For the purposes of subsections (1) and (4), the term

1255

"hair dye" does not include eyelash dyes or eyebrow dyes.

1256

Section 9. Subsections (2), (3), and (5) of section

1257

499.009, Florida Statutes, are amended to read:

1258

499.009 Misbranded cosmetics.--A cosmetic is misbranded:

1259

(2) Unless, If in package form, it does not bear bears a

1260

label containing:

1261

(a) The name and place of business of the manufacturer,

1262

packer, or distributor;

1263

(b) An accurate statement of the quantity of the contents

1264

in terms of weight, measure, or numerical count; however, under

1265

this paragraph reasonable variations are permitted, and the

1266

department shall establish by rule exemptions for small packages;

1267

and

1268

1269

predominance, or as otherwise required by federal law.

1270

(3) If any word, statement, or other information required

1271

by or under authority of this part ss. 499.001-499.081 to appear

1272

on the label or labeling is not prominently placed thereon with

1273

such conspicuousness as compared with other words, statements,

1274

designs, or devices in the labeling, and in such terms, as to

1275

render the word, statement, or other information likely to be

1276

read and understood by an individual under customary conditions

1277

of purchase and use.

1278

(5) Unless, If it is a color additive, its packaging and

1279

labeling are not in conformity with the packaging and labeling

1280

requirements applicable to that color additive prescribed under

1281

the federal act. This subsection does not apply to packages of

1282

color additives that, with respect to their use for cosmetics,

1283

are marketed and intended for use only in or on hair dyes.

1284

Section 10. Section 499.01, Florida Statutes, is amended;

1285

the introductory paragraph and paragraphs (a) through (h) of

1286

subsection (2) of section 499.012, Florida Statutes, are

1287

redesignated as the introductory paragraph and paragraphs (d),

1288

(n), (e), (f), (c), (i), (k), and (l), respectively, of

1289

subsection (2) of that section and amended; paragraphs (b)

1290

through (e) of subsection (2) of section 499.013, Florida

1291

Statutes, are redesignated as paragraphs (p), (o), (q), and (r),

1292

respectively, of subsection (2) of that section and amended; and

1293

section 499.014, Florida Statutes, is redesignated as paragraph

1294

(g) of subsection (2) of that section and amended, to read:

1295

499.01 Permits; applications; renewal; general

1296

requirements.--

1297

(1) Prior to operating, a permit is required for each

1298

person and establishment that intends to operate as:

1299

(a) A prescription drug manufacturer;

1300

(b) A prescription drug repackager;

1301

1302

(d) A prescription drug wholesale distributor;

1303

(e) An out-of-state prescription drug wholesale

1304

distributor;

1305

(f) A retail pharmacy drug wholesale distributor;

1306

(g) A restricted prescription drug distributor;

1307

(h) A complimentary drug distributor;

1308

(i) A freight forwarder;

1309

(j) A veterinary prescription drug retail establishment;

1310

(k) A veterinary prescription drug wholesale distributor;

1311

(l) A limited prescription drug veterinary wholesale

1312

distributor;

1313

(m) A medical oxygen retail establishment;

1314

(n) A compressed medical gas wholesale distributor;

1315

(o) A compressed medical gas manufacturer;

1316

(p)(c) An over-the-counter drug manufacturer;

1317

(d) A compressed medical gas manufacturer;

1318

(q)(e) A device manufacturer;

1319

(r)(f) A cosmetic manufacturer;

1320

(s) A third party logistic provider; or

1321

(t) A health care clinic establishment.

1322

(g) A prescription drug wholesaler;

1323

(h) A veterinary prescription drug wholesaler;

1324

(i) A compressed medical gas wholesaler;

1325

(j) An out-of-state prescription drug wholesaler;

1326

(k) A nonresident prescription drug manufacturer;

1327

(l) A freight forwarder;

1328

(m) A retail pharmacy drug wholesaler;

1329

(n) A veterinary legend drug retail establishment;

1330

(o) A medical oxygen retail establishment;

1331

(p) A complimentary drug distributor;

1332

(q) A restricted prescription drug distributor; or

1333

(r) A limited prescription drug veterinary wholesaler.

1334

(2) The following types of wholesaler permits are

1335

established:

1336

(a) Prescription drug manufacturer permit.--A prescription

1337

drug manufacturer permit is required for any person that

1338

manufactures a prescription drug in this state.

1339

1. A person that operates an establishment permitted as a

1340

prescription drug manufacturer may engage in wholesale

1341

distribution of prescription drugs manufactured at that

1342

establishment and must comply with all the provisions of this

1343

part and the rules adopted under this part that apply to a

1344

wholesale distributor.

1345

2. A prescription drug manufacturer must comply with all

1346

appropriate state and federal good manufacturing practices.

1347

(b) Prescription drug repackager permit.--A prescription

1348

drug repackager permit is required for any person that repackages

1349

a prescription drug in this state.

1350

1. A person that operates an establishment permitted as a

1351

prescription drug repackager may engage in wholesale distribution

1352

of prescription drugs repackaged at that establishment and must

1353

comply with all the provisions of this part and the rules adopted

1354

under this part that apply to a wholesale distributor.

1355

2. A prescription drug repackager must comply with all

1356

appropriate state and federal good manufacturing practices.

1357

(c)(e) Nonresident prescription drug manufacturer

1358

permit.--A nonresident prescription drug manufacturer permit is

1359

required for any person that is a manufacturer of prescription

1360

drugs, or the distribution point for a manufacturer of

1361

prescription drugs unless permitted as a third party logistics

1362

provider, and located outside of this state, or that is an entity

1363

to whom an approved new drug application has been issued by the

1364

United States Food and Drug Administration, or the contracted

1365

manufacturer of the approved new drug application holder, and

1366

located outside the United States, which engages in the wholesale

1367

distribution in this state of the prescription drugs it

1368

manufactures or is responsible for manufacturing. Each such

1369

manufacturer or entity must be permitted by the department and

1370

comply with all the provisions required of a wholesale

1371

distributor under this part ss. 499.001-499.081, except s.

1372

499.01212 s. 499.0121(6)(d).

1373

1. A person that distributes prescription drugs that it did

1374

not manufacture must also obtain an out-of-state prescription

1375

drug wholesale distributor wholesaler permit pursuant to this

1376

section to engage in the wholesale distribution of the

1377

prescription drugs manufactured by another person and comply with

1378

the requirements of an out-of-state prescription drug wholesale

1379

distributor wholesaler.

1380

2. Any such person must comply with the licensing or

1381

permitting requirements of the jurisdiction in which the

1382

establishment is located and the federal act, and any product

1383

wholesaled into this state must comply with this part ss.

1384

499.001-499.081. If a person intends to import prescription drugs

1385

from a foreign country into this state, the nonresident

1386

prescription drug manufacturer must provide to the department a

1387

list identifying each prescription drug it intends to import and

1388

document approval by the United States Food and Drug

1389

Administration for such importation.

1390

3. A nonresident prescription drug manufacturer permit is

1391

not required for a manufacturer to distribute a prescription drug

1392

active pharmaceutical ingredient that it manufactures to a

1393

prescription drug manufacturer permitted in this state in limited

1394

quantities intended for research and development and not for

1395

resale, or human use other than lawful clinical trials and

1396

biostudies authorized and regulated by federal law. A

1397

manufacturer claiming to be exempt from the permit requirements

1398

of this subparagraph and the prescription drug manufacturer

1399

purchasing and receiving the active pharmaceutical ingredient

1400

shall comply with the recordkeeping requirements of s.

1401

499.0121(6), but not the requirements of s. 499.01212. The

1402

prescription drug manufacturer purchasing and receiving the

1403

active pharmaceutical ingredient shall maintain on file a record

1404

of the FDA registration number; the out-of-state license, permit,

1405

or registration number; and, if available, a copy of the most

1406

current FDA inspection report, for all manufacturers from whom

1407

they purchase active pharmaceutical ingredients under this

1408

section. The department shall specify by rule the allowable

1409

number of transactions within a given period of time and the

1410

amount of active pharmaceutical ingredients that qualify as

1411

limited quantities for purposes of this exemption. The failure to

1412

comply with the requirements of this subparagraph, or rules

1413

adopted by the department to administer this subparagraph, for

1414

the purchase of prescription drug active pharmaceutical

1415

ingredients is a violation of s. 499.005(14).

1416

(d)(a) A Prescription drug wholesale distributor

1417

wholesaler's permit.--A prescription drug wholesale distributor

1418

wholesaler is a wholesale distributor that may engage in the

1419

wholesale distribution of prescription drugs. A prescription drug

1420

wholesale distributor wholesaler that applies to the department

1421

for a new permit or the renewal of a permit must submit a bond of

1422

$100,000, or other equivalent means of security acceptable to the

1423

department, such as an irrevocable letter of credit or a deposit

1424

in a trust account or financial institution, payable to the

1425

Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the

1426

bond is to secure payment of any administrative penalties imposed

1427

by the department and any fees and costs incurred by the

1428

department regarding that permit which are authorized under state

1429

law and which the permittee fails to pay 30 days after the fine

1430

or costs become final. The department may make a claim against

1431

such bond or security until 1 year after the permittee's license

1432

ceases to be valid or until 60 days after any administrative or

1433

legal proceeding authorized in this part ss. 499.001-499.081

1434

which involves the permittee is concluded, including any appeal,

1435

whichever occurs later. The department may adopt rules for

1436

issuing a prescription drug wholesale distributor-broker

1437

wholesaler-broker permit to a person who engages in the wholesale

1438

distribution of prescription drugs and does not take physical

1439

possession of any prescription drugs.

1440

(e)(c) An Out-of-state prescription drug wholesale

1441

distributor wholesaler's permit.--An out-of-state prescription

1442

drug wholesale distributor wholesaler is a wholesale distributor

1443

located outside this state which engages in the wholesale

1444

distribution of prescription drugs into this state and which must

1445

be permitted by the department and comply with all the provisions

1446

required of a wholesale distributor under this part ss. 499.001-

1447

499.081. An out-of-state prescription drug wholesale distributor

1448

wholesaler that applies to the department for a new permit or the

1449

renewal of a permit must submit a bond of $100,000, or other

1450

equivalent means of security acceptable to the department, such

1451

as an irrevocable letter of credit or a deposit in a trust

1452

account or financial institution, payable to the Florida Drug,

1453

Device, and Cosmetic Trust Fund. The purpose of the bond is to

1454

secure payment of any administrative penalties imposed by the

1455

department and any fees and costs incurred by the department

1456

regarding that permit which are authorized under state law and

1457

which the permittee fails to pay 30 days after the fine or costs

1458

become final. The department may make a claim against such bond

1459

or security until 1 year after the permittee's license ceases to

1460

be valid or until 60 days after any administrative or legal

1461

proceeding authorized in this part ss. 499.001-499.081 which

1462

involves the permittee is concluded, including any appeal,

1463

whichever occurs later.

1464

1. The out-of-state prescription drug wholesale distributor

1465

wholesaler must maintain at all times a license or permit to

1466

engage in the wholesale distribution of prescription drugs in

1467

compliance with laws of the state in which it is a resident.

1468

2. An out-of-state prescription drug wholesale distributor

1469

wholesaler's permit is not required for an intracompany sale or

1470

transfer of a prescription drug from an out-of-state

1471

establishment that is duly licensed as a prescription drug

1472

wholesale distributor wholesaler, in its state of residence, to a

1473

licensed prescription drug wholesale distributor wholesaler in

1474

this state, if both wholesale distributors wholesalers conduct

1475

wholesale distributions of prescription drugs under the same

1476

business name. The recordkeeping requirements of ss. s.

1477

499.0121(6) and 499.01212 must be followed for this transaction.

1478

(f)(d) A Retail pharmacy drug wholesale distributor

1479

wholesaler's permit.--A retail pharmacy drug wholesale

1480

distributor wholesaler is a retail pharmacy engaged in wholesale

1481

distribution of prescription drugs within this state under the

1482

following conditions:

1483

1. The pharmacy must obtain a retail pharmacy drug

1484

wholesale distributor wholesaler's permit pursuant to this part

1485

ss. 499.001-499.081 and the rules adopted under this part those

1486

sections.

1487

2. The wholesale distribution activity does not exceed 30

1488

percent of the total annual purchases of prescription drugs. If

1489

the wholesale distribution activity exceeds the 30-percent

1490

maximum, the pharmacy must obtain a prescription drug wholesale

1491

distributor wholesaler's permit.

1492

3. The transfer of prescription drugs that appear in any

1493

schedule contained in chapter 893 is subject to chapter 893 and

1494

the federal Comprehensive Drug Abuse Prevention and Control Act

1495

of 1970.

1496

4. The transfer is between a retail pharmacy and another

1497

retail pharmacy, or a Modified Class II institutional pharmacy,

1498

or a health care practitioner licensed in this state and

1499

authorized by law to dispense or prescribe prescription drugs.

1500

5. All records of sales of prescription drugs subject to

1501

this section must be maintained separate and distinct from other

1502

records and comply with the recordkeeping requirements of this

1503

part ss. 499.001-499.081.

1504

(g)499.014 Restricted prescription drug distributor permit

1505

Distribution of legend drugs by hospitals, health care entities,

1506

charitable organizations, and return or destruction companies;

1507

permits, general requirements.--

1508

(1) A restricted prescription drug distributor permit is

1509

required for any person that engages in the distribution of a

1510

prescription legend drug, which distribution is not considered

1511

"wholesale distribution" under s. 499.003(53)(a) s.

1512

499.012(1)(a)1.

1513

1.(2) A person who engages in the receipt or distribution

1514

of a prescription legend drug in this state for the purpose of

1515

processing its return or its destruction must obtain a permit as

1516

a restricted prescription drug distributor if such person is not

1517

the person initiating the return, the prescription drug wholesale

1518

supplier of the person initiating the return, or the manufacturer

1519

of the drug.

1520

2.(3) Storage, handling, and recordkeeping of these

1521

distributions must comply with the requirements for wholesale

1522

distributors under s. 499.0121, but not except those set forth in

1523

s. 499.01212 s. 499.0121(6)(d).

1524

3.(4) A person who applies for a permit as a restricted

1525

prescription drug distributor, or for the renewal of such a

1526

permit, must provide to the department the information required

1527

under s. 499.012 s. 499.01.

1528

4.(5) The department may issue permits to restricted

1529

prescription drug distributors and may adopt rules regarding the

1530

distribution of prescription drugs by hospitals, health care

1531

entities, charitable organizations, or other persons not involved

1532

in wholesale distribution, which rules are necessary for the

1533

protection of the public health, safety, and welfare.

1534

(h) Complimentary drug distributor permit.--A complimentary

1535

drug distributor permit is required for any person that engages

1536

in the distribution of a complimentary drug, subject to the

1537

requirements of s. 499.028.

1538

(i)(f) Freight forwarder permit.--A freight forwarder

1539

permit is required for any person that engages in the

1540

distribution of a prescription legend drug as a freight forwarder

1541

unless the person is a common carrier. The storage, handling, and

1542

recordkeeping of such distributions must comply with the

1543

requirements for wholesale distributors under s. 499.0121, but

1544

not except those set forth in s. 499.01212 s. 499.0121(6)(d). A

1545

freight forwarder must provide the source of the prescription

1546

legend drugs with a validated airway bill, bill of lading, or

1547

other appropriate documentation to evidence the exportation of

1548

the product.

1549

(j) Veterinary prescription drug retail establishment

1550

permit.--A veterinary prescription drug retail establishment

1551

permit is required for any person that sells veterinary

1552

prescription drugs to the public but does not include a pharmacy

1553

licensed under chapter 465.

1554

1. The sale to the public must be based on a valid written

1555

order from a veterinarian licensed in this state who has a valid

1556

client-veterinarian relationship with the purchaser's animal.

1557

2. Veterinary prescription drugs may not be sold in excess

1558

of the amount clearly indicated on the order or beyond the date

1559

indicated on the order.

1560

3. An order may not be valid for more than 1 year.

1561

4. A veterinary prescription drug retail establishment may

1562

not purchase, sell, trade, or possess human prescription drugs or

1563

any controlled substance as defined in chapter 893.

1564

5. A veterinary prescription drug retail establishment must

1565

sell a veterinary prescription drug in the original, sealed

1566

manufacturer's container with all labeling intact and legible.

1567

The department may adopt by rule additional labeling requirements

1568

for the sale of a veterinary prescription drug.

1569

6. A veterinary prescription drug retail establishment must

1570

comply with all of the wholesale distribution requirements of s.

1571

499.0121.

1572

7. Prescription drugs sold by a veterinary prescription

1573

drug retail establishment pursuant to a practitioner's order may

1574

not be returned into the retail establishment's inventory.

1575

(k)(g) A veterinary prescription drug wholesale distributor

1576

wholesaler permit.--A veterinary prescription drug wholesale

1577

distributor wholesaler permit is required for any person that

1578

engages in the distribution of veterinary prescription drugs in

1579

or into this state. A veterinary prescription drug wholesale

1580

distributor wholesaler that also distributes prescription drugs

1581

subject to, defined by, or described by s. 503(b) of the Federal

1582

Food, Drug, and Cosmetic Act which it did not manufacture must

1583

obtain a permit as a prescription drug wholesale distributor

1584

wholesaler, an out-of-state prescription drug wholesale

1585

distributor wholesaler, or a limited prescription drug veterinary

1586

wholesale distributor wholesaler in lieu of the veterinary

1587

prescription drug wholesale distributor wholesaler permit. A

1588

veterinary prescription drug wholesale distributor wholesaler

1589

must comply with the requirements for wholesale distributors

1590

under s. 499.0121, but not except those set forth in s. 499.01212

1591

s. 499.0121(6)(d).

1592

(l)(h) Limited prescription drug veterinary wholesale

1593

distributor wholesaler permit.--Unless engaging in the activities

1594

of and permitted as a prescription drug manufacturer, nonresident

1595

prescription drug manufacturer, prescription drug wholesale

1596

distributor wholesaler, or out-of-state prescription drug

1597

wholesale distributor wholesaler, a limited prescription drug

1598

veterinary wholesale distributor wholesaler permit is required

1599

for any person that engages in the distribution in or into this

1600

state of veterinary prescription drugs and prescription drugs

1601

subject to, defined by, or described by s. 503(b) of the Federal

1602

Food, Drug, and Cosmetic Act under the following conditions:

1603

1. The person is engaged in the business of wholesaling

1604

prescription and veterinary prescription legend drugs to persons:

1605

a. Licensed as veterinarians practicing on a full-time

1606

basis;

1607

b. Regularly and lawfully engaged in instruction in

1608

veterinary medicine;

1609

c. Regularly and lawfully engaged in law enforcement

1610

activities;

1611

d. For use in research not involving clinical use; or

1612

e. For use in chemical analysis or physical testing or for

1613

purposes of instruction in law enforcement activities, research,

1614

or testing.

1615

2. No more than 30 percent of total annual prescription

1616

drug sales may be prescription drugs approved for human use which

1617

are subject to, defined by, or described by s. 503(b) of the

1618

Federal Food, Drug, and Cosmetic Act.

1619

3. The person does not distribute is not permitted,

1620

licensed, or otherwise authorized in any jurisdiction state to

1621

wholesale prescription drugs subject to, defined by, or described

1622

by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any

1623

person who is authorized to sell, distribute, purchase, trade, or

1624

use these drugs on or for humans.

1625

4. A limited prescription drug veterinary wholesale

1626

distributor wholesaler that applies to the department for a new

1627

permit or the renewal of a permit must submit a bond of $20,000,

1628

or other equivalent means of security acceptable to the

1629

department, such as an irrevocable letter of credit or a deposit

1630

in a trust account or financial institution, payable to the

1631

Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the

1632

bond is to secure payment of any administrative penalties imposed

1633

by the department and any fees and costs incurred by the

1634

department regarding that permit which are authorized under state

1635

law and which the permittee fails to pay 30 days after the fine

1636

or costs become final. The department may make a claim against

1637

such bond or security until 1 year after the permittee's license

1638

ceases to be valid or until 60 days after any administrative or

1639

legal proceeding authorized in this part ss. 499.001-499.081

1640

which involves the permittee is concluded, including any appeal,

1641

whichever occurs later.

1642

5. A limited prescription drug veterinary wholesale

1643

distributor wholesaler must maintain at all times a license or

1644

permit to engage in the wholesale distribution of prescription

1645

drugs in compliance with laws of the state in which it is a

1646

resident.

1647

6. A limited prescription drug veterinary wholesale

1648

distributor wholesaler must comply with the requirements for

1649

wholesale distributors under ss. s. 499.0121 and 499.01212,

1650

except that a limited prescription drug veterinary wholesale

1651

distributor wholesaler is not required to provide a pedigree

1652

paper as required by s. 499.01212 s. 499.0121(6)(d) upon the

1653

wholesale distribution of a prescription drug to a veterinarian.

1654

7. A limited prescription drug veterinary wholesale

1655

distributor wholesaler may not return to inventory for subsequent

1656

wholesale distribution any prescription drug subject to, defined

1657

by, or described by s. 503(b) of the Federal Food, Drug, and

1658

Cosmetic Act which has been returned by a veterinarian.

1659

8. An out-of-state prescription drug wholesaler's permit or

1660

A limited prescription drug veterinary wholesale distributor

1661

wholesaler permit is not required for an intracompany sale or

1662

transfer of a prescription drug from an out-of-state

1663

establishment that is duly licensed to engage in the wholesale

1664

distribution of prescription drugs in its state of residence to a

1665

licensed limited prescription drug veterinary wholesale

1666

distributor wholesaler in this state if both wholesale

1667

distributors wholesalers conduct wholesale distributions of

1668

prescription drugs under the same business name. The

1669

recordkeeping requirements of ss. s. 499.0121(6) and 499.01212

1670

must be followed for this transaction.

1671

(m) Medical oxygen retail establishment permit.--A medical

1672

oxygen retail establishment permit is required for any person

1673

that sells medical oxygen to patients only. The sale must be

1674

based on an order from a practitioner authorized by law to

1675

prescribe. The term does not include a pharmacy licensed under

1676

chapter 465.

1677

1. A medical oxygen retail establishment may not possess,

1678

purchase, sell, or trade any prescription drug other than medical

1679

oxygen.

1680

2. A medical oxygen retail establishment may refill medical

1681

oxygen for an individual patient based on an order from a

1682

practitioner authorized by law to prescribe. A medical oxygen

1683

retail establishment that refills medical oxygen must comply with

1684

all appropriate state and federal good manufacturing practices.

1685

3. A medical oxygen retail establishment must comply with

1686

all of the wholesale distribution requirements of s. 499.0121.

1687

4. Prescription medical oxygen sold by a medical oxygen

1688

retail establishment pursuant to a practitioner's order may not

1689

be returned into the retail establishment's inventory.

1690

(n)(b) A compressed medical gas wholesale distributor

1691

wholesaler's permit.--A compressed medical gas wholesale

1692

distributor wholesaler is a wholesale distributor that is limited

1693

to the wholesale distribution of compressed medical gases to

1694

other than the consumer or patient. The compressed medical gas

1695

must be in the original sealed container that was purchased by

1696

that wholesale distributor wholesaler. A compressed medical gas

1697

wholesale distributor wholesaler may not possess or engage in the

1698

wholesale distribution of any prescription drug other than

1699

compressed medical gases. The department shall adopt rules that

1700

govern the wholesale distribution of prescription medical oxygen

1701

for emergency use. With respect to the emergency use of

1702

prescription medical oxygen, those rules may not be inconsistent

1703

with rules and regulations of federal agencies unless the

1704

Legislature specifically directs otherwise.

1705

(o)(c) Compressed medical gas manufacturer permit.--A

1706

compressed medical gas manufacturer manufacturer's permit is

1707

required for any person that engages in the manufacture of

1708

compressed medical gases or repackages compressed medical gases

1709

from one container to another.

1710

1. A compressed medical gas manufacturer permittee may not

1711

manufacture or possess any prescription drug other than

1712

compressed medical gases.

1713

2. A compressed medical gas manufacturer permittee may

1714

engage in wholesale distribution of compressed medical gases

1715

manufactured at that establishment and must comply with all the

1716

provisions of this part ss. 499.001-499.081 and the rules adopted

1717

under this part those sections that apply to a wholesale

1718

distributor.

1719

3. A compressed medical gas manufacturer permittee must

1720

comply with all appropriate state and federal good manufacturing

1721

practices.

1722

(p)(b) Over-the-counter drug manufacturer permit.--An over-

1723

the-counter drug manufacturer manufacturer's permit is required

1724

for any person that engages in the manufacture or repackaging of

1725

an over-the-counter drug.

1726

1. An over-the-counter drug manufacturer permittee may not

1727

possess or purchase prescription drugs.

1728

2. A pharmacy is exempt from obtaining an over-the-counter

1729

drug manufacturer manufacturer's permit if it is operating in

1730

compliance with pharmacy practice standards as defined in chapter

1731

465 and the rules adopted under that chapter.

1732

3. An over-the-counter drug manufacturer permittee must

1733

comply with all appropriate state and federal good manufacturing

1734

practices.

1735

(q)(d) Device manufacturer permit.--A device manufacturer

1736

manufacturer's permit is required for any person that engages in

1737

the manufacture, repackaging, or assembly of medical devices for

1738

human use in this state, except that a permit is not required if

1739

the person is engaged only in manufacturing, repackaging, or

1740

assembling a medical device pursuant to a practitioner's order

1741

for a specific patient.

1742

1. A manufacturer or repackager of medical devices in this

1743

state must comply with all appropriate state and federal good

1744

manufacturing practices and quality system rules.

1745

2. The department shall adopt rules related to storage,

1746

handling, and recordkeeping requirements for manufacturers of

1747

medical devices for human use.

1748

(r)(e) Cosmetic manufacturer permit.--A cosmetic

1749

manufacturer manufacturer's permit is required for any person

1750

that manufactures or repackages cosmetics in this state. A person

1751

that only labels or changes the labeling of a cosmetic but does

1752

not open the container sealed by the manufacturer of the product

1753

is exempt from obtaining a permit under this paragraph.

1754

(s) Third party logistics provider permit.--A third party

1755

logistics provider permit is required for any person that

1756

contracts with a prescription drug wholesale distributor or

1757

prescription drug manufacturer to provide warehousing,

1758

distribution, or other logistics services on behalf of a

1759

manufacturer or wholesale distributor, but who does not take

1760

title to the prescription drug or have responsibility to direct

1761

the sale or disposition of the prescription drug. Each third

1762

party logistics provider permittee shall comply with the

1763

requirements for wholesale distributors under ss. 499.0121 and

1764

499.01212, with the exception of those wholesale distributions

1765

described in s. 499.01212(3)(a), and other rules that the

1766

department requires.

1767

(t) Health care clinic establishment permit.--Effective

1768

January 1, 2009, a health care clinic establishment permit is

1769

required for the purchase of a prescription drug by a place of

1770

business at one general physical location owned and operated by a

1771

professional corporation or professional limited liability

1772

company described in chapter 621, or a corporation that employs a

1773

veterinarian as a qualifying practitioner. For the purpose of

1774

this paragraph, the term "qualifying practitioner" means a

1775

licensed health care practitioner defined in s. 456.001 or a

1776

veterinarian licensed under chapter 474, who is authorized under

1777

the appropriate practice act to prescribe and administer a

1778

prescription drug.

1779

1. An establishment must provide, as part of the

1780

application required under s. 499.012, designation of a

1781

qualifying practitioner who will be responsible for complying

1782

with all legal and regulatory requirements related to the

1783

purchase, recordkeeping, storage, and handling of the

1784

prescription drugs. In addition, the designated qualifying

1785

practitioner shall be the practitioner whose name, establishment

1786

address, and license number is used on all distribution documents

1787

for prescription drugs purchased or returned by the health care

1788

clinic establishment. Upon initial appointment of a qualifying

1789

practitioner, the qualifying practitioner and the health care

1790

clinic establishment shall notify the department on a form

1791

furnished by the department within 10 days after such employment.

1792

In addition, the qualifying practitioner and health care clinic

1793

establishment shall notify the department within 10 days after

1794

any subsequent change.

1795

2. The health care clinic establishment must employ a

1796

qualifying practitioner at each establishment.

1797

3. In addition to the remedies and penalties provided in

1798

this part, a violation of this chapter by the health care clinic

1799

establishment or qualifying practitioner constitutes grounds for

1800

discipline of the qualifying practitioner by the appropriate

1801

regulatory board.

1802

4. The purchase of prescription drugs by the health care

1803

clinic establishment is prohibited during any period of time when

1804

the establishment does not comply with this paragraph.

1805

5. A health care clinic establishment permit is not a

1806

pharmacy permit or otherwise subject to chapter 465. A health

1807

care clinic establishment that meets the criteria of a modified

1808

Class II institutional pharmacy under s. 465.019 is not eligible

1809

to be permitted under this paragraph.

1810

6. This paragraph does not prohibit a qualifying

1811

practitioner from purchasing prescription drugs.

1812

Section 11. Section 499.012, Florida Statutes, is amended

1813

and subsections (2) through (8) of section 499.01, Florida

1814

States, are redesignated as subsections (1) through (7) of that

1815

section and amended, to read:

1816

499.012 Permit application Wholesale distribution;

1817

definitions; permits; applications; general requirements.--

1818

(1) As used in this section, the term:

1819

(2)(a) A permit issued pursuant to this part ss. 499.001-

1820

499.081 may be issued only to a natural person who is at least 18

1821

years of age or to an applicant that is not a natural person if

1822

each person who, directly or indirectly, manages, controls, or

1823

oversees the operation of that applicant is at least 18 years of

1824

age.

1825

(b) An establishment that is a place of residence may not

1826

receive a permit and may not operate under this part ss. 499.001-

1827

499.081.

1828

1829

manufacture or distribute prescription legend drugs may not use a

1830

name identical to the name used by any other establishment or

1831

licensed person authorized to purchase prescription drugs in this

1832

state, except that a restricted drug distributor permit issued to

1833

a health care entity will be issued in the name in which the

1834

institutional pharmacy permit is issued and a retail pharmacy

1835

drug wholesale distributor wholesaler will be issued a permit in

1836

the name of its retail pharmacy permit.

1837

(d) A permit for a prescription drug manufacturer,

1838

prescription drug repackager, prescription drug wholesale

1839

distributor wholesaler, limited prescription drug veterinary

1840

wholesale distributor wholesaler, or retail pharmacy drug

1841

wholesale distributor wholesaler may not be issued to the address

1842

of a health care entity or to a pharmacy licensed under chapter

1843

465, except as provided in this paragraph. The department may

1844

issue a prescription drug manufacturer permit to an applicant at

1845

the same address as a licensed nuclear pharmacy, which is a

1846

health care entity, for the purpose of manufacturing prescription

1847

drugs used in positron emission tomography or other

1848

radiopharmaceuticals, as listed in a rule adopted by the

1849

department pursuant to this paragraph. The purpose of this

1850

exemption is to assure availability of state-of-the-art

1851

pharmaceuticals that would pose a significant danger to the

1852

public health if manufactured at a separate establishment address

1853

from the nuclear pharmacy from which the prescription drugs are

1854

dispensed. The department may also issue a retail pharmacy drug

1855

wholesale distributor wholesaler permit to the address of a

1856

community pharmacy licensed under chapter 465 which does not meet

1857

the definition of a closed pharmacy in s. 499.003.

1858

(e) A county or municipality may not issue an occupational

1859

license for any licensing period beginning on or after October 1,

1860

2003, for any establishment that requires a permit pursuant to

1861

this part ss. 499.001-499.081, unless the establishment exhibits

1862

a current permit issued by the department for the establishment.

1863

Upon presentation of the requisite permit issued by the

1864

department, an occupational license may be issued by the

1865

municipality or county in which application is made. The

1866

department shall furnish to local agencies responsible for

1867

issuing occupational licenses a current list of all

1868

establishments licensed pursuant to this part ss. 499.001-

1869

499.081.

1870

(2)(3) Notwithstanding subsection (6) (7), a permitted

1871

person in good standing may change the type of permit issued to

1872

that person by completing a new application for the requested

1873

permit, paying the amount of the difference in the permit fees if

1874

the fee for the new permit is more than the fee for the original

1875

permit, and meeting the applicable permitting conditions for the

1876

new permit type. The new permit expires on the expiration date of

1877

the original permit being changed; however, a new permit for a

1878

prescription drug wholesale distributor wholesaler, an out-of-

1879

state prescription drug wholesale distributor wholesaler, or a

1880

retail pharmacy drug wholesale distributor wholesaler shall

1881

expire on the expiration date of the original permit or 1 year

1882

after the date of issuance of the new permit, whichever is

1883

earlier. A refund may not be issued if the fee for the new permit

1884

is less than the fee that was paid for the original permit.

1885

(3)(4) A written application for a permit or to renew a

1886

permit must be filed with the department on forms furnished by

1887

the department. The department shall establish, by rule, the form

1888

and content of the application to obtain or renew a permit. The

1889

applicant must submit to the department with the application a

1890

statement that swears or affirms that the information is true and

1891

correct.

1892

(4)(5)(a) Except for a permit for a prescription drug

1893

wholesale distributor wholesaler or an out-of-state prescription

1894

drug wholesale distributor wholesaler, an application for a

1895

permit must include:

1896

1. The name, full business address, and telephone number of

1897

the applicant;

1898

2. All trade or business names used by the applicant;

1899

3. The address, telephone numbers, and the names of contact

1900

persons for each facility used by the applicant for the storage,

1901

handling, and distribution of prescription drugs;

1902

4. The type of ownership or operation, such as a

1903

partnership, corporation, or sole proprietorship; and

1904

5. The names of the owner and the operator of the

1905

establishment, including:

1906

a. If an individual, the name of the individual;

1907

b. If a partnership, the name of each partner and the name

1908

of the partnership;

1909

c. If a corporation, the name and title of each corporate

1910

officer and director, the corporate names, and the name of the

1911

state of incorporation;

1912

d. If a sole proprietorship, the full name of the sole

1913

proprietor and the name of the business entity;

1914

e. If a limited liability company, the name of each member,

1915

the name of each manager, the name of the limited liability

1916

company, and the name of the state in which the limited liability

1917

company was organized; and

1918

f. Any other relevant information that the department

1919

requires.

1920

(b) Upon approval of the application by the department and

1921

payment of the required fee, the department shall issue a permit

1922

to the applicant, if the applicant meets the requirements of this

1923

part ss. 499.001-499.081 and rules adopted under this part those

1924

sections.

1925

1926

must be submitted to the department before the change occurs.

1927

(d) The department shall consider, at a minimum, the

1928

following factors in reviewing the qualifications of persons to

1929

be permitted under this part ss. 499.001-499.081:

1930

1. The applicant's having been found guilty, regardless of

1931

adjudication, in a court of this state or other jurisdiction, of

1932

a violation of a law that directly relates to a drug, device, or

1933

cosmetic. A plea of nolo contendere constitutes a finding of

1934

guilt for purposes of this subparagraph.

1935

2. The applicant's having been disciplined by a regulatory

1936

agency in any state for any offense that would constitute a

1937

violation of this part ss. 499.001-499.081.

1938

3. Any felony conviction of the applicant under a federal,

1939

state, or local law;

1940

4. The applicant's past experience in manufacturing or

1941

distributing drugs, devices, or cosmetics;

1942

5. The furnishing by the applicant of false or fraudulent

1943

material in any application made in connection with manufacturing

1944

or distributing drugs, devices, or cosmetics;

1945

6. Suspension or revocation by a federal, state, or local

1946

government of any permit currently or previously held by the

1947

applicant for the manufacture or distribution of any drugs,

1948

devices, or cosmetics;

1949

7. Compliance with permitting requirements under any

1950

previously granted permits;

1951

8. Compliance with requirements to maintain or make

1952

available to the state permitting authority or to federal, state,

1953

or local law enforcement officials those records required under

1954

this section; and

1955

9. Any other factors or qualifications the department

1956

considers relevant to and consistent with the public health and

1957

safety.

1958

(5)(6) Except for a permit permits for a prescription drug

1959

wholesale distributor wholesalers or an out-of-state prescription

1960

drug wholesale distributor wholesalers:

1961

(a) The department shall adopt rules for the biennial

1962

renewal of permits.

1963

(b) The department shall renew a permit upon receipt of the

1964

renewal application and renewal fee if the applicant meets the

1965

requirements established under this part ss. 499.001-499.081 and

1966

the rules adopted under this part those sections.

1967

1968

automatically expires 2 years after the last day of the

1969

anniversary month in which the permit was originally issued. A

1970

permit issued under this part ss. 499.001-499.081 may be renewed

1971

by making application for renewal on forms furnished by the

1972

department and paying the appropriate fees. If a renewal

1973

application and fee are submitted and postmarked after the

1974

expiration date of the permit, the permit may be renewed only

1975

upon payment of a late renewal delinquent fee of $100, plus the

1976

required renewal fee, not later than 60 days after the expiration

1977

date.

1978

(d) Failure to renew a permit in accordance with this

1979

section precludes any future renewal of that permit. If a permit

1980

issued pursuant to this part section has expired and cannot be

1981

renewed, before an establishment may engage in activities that

1982

require a permit under this part ss. 499.001-499.081, the

1983

establishment must submit an application for a new permit, pay

1984

the applicable application fee, the initial permit fee, and all

1985

applicable penalties, and be issued a new permit by the

1986

department.

1987

(6)(7) A permit issued by the department is

1988

nontransferable. Each permit is valid only for the person or

1989

governmental unit to which it is issued and is not subject to

1990

sale, assignment, or other transfer, voluntarily or

1991

involuntarily; nor is a permit valid for any establishment other

1992

than the establishment for which it was originally issued.

1993

(a) A person permitted under this part ss. 499.001-499.081

1994

must notify the department before making a change of address. The

1995

department shall set a change of location fee not to exceed $100.

1996

(b)1. An application for a new permit is required when a

1997

majority of the ownership or controlling interest of a permitted

1998

establishment is transferred or assigned or when a lessee agrees

1999

to undertake or provide services to the extent that legal

2000

liability for operation of the establishment will rest with the

2001

lessee. The application for the new permit must be made before

2002

the date of the sale, transfer, assignment, or lease.

2003

2. A permittee that is authorized to distribute

2004

prescription legend drugs may transfer such drugs to the new

2005

owner or lessee under subparagraph 1. only after the new owner or

2006

lessee has been approved for a permit to distribute prescription

2007

legend drugs.

2008

2009

499.001-499.081 closes, the owner must notify the department in

2010

writing before the effective date of closure and must:

2011

1. Return the permit to the department;

2012

2. If the permittee is authorized to distribute

2013

prescription legend drugs, indicate the disposition of such

2014

drugs, including the name, address, and inventory, and provide

2015

the name and address of a person to contact regarding access to

2016

records that are required to be maintained under this part ss.

2017

499.001-499.081. Transfer of ownership of prescription legend

2018

drugs may be made only to persons authorized to possess

2019

prescription legend drugs under this part ss. 499.001-499.081.

2020

2021

The department may revoke the permit of any person that fails to

2022

comply with the requirements of this subsection.

2023

(7)(8) A permit must be posted in a conspicuous place on

2024

the licensed premises.

2025

(8)(3) An application for a permit or to renew a permit for

2026

a prescription drug wholesale distributor wholesaler or an out-

2027

of-state prescription drug wholesale distributor wholesaler

2028

submitted to the department must include:

2029

(a) The name, full business address, and telephone number

2030

of the applicant.

2031

(b) All trade or business names used by the applicant.

2032

2033

contact persons for each facility used by the applicant for the

2034

storage, handling, and distribution of prescription drugs.

2035

(d) The type of ownership or operation, such as a

2036

partnership, corporation, or sole proprietorship.

2037

(e) The names of the owner and the operator of the

2038

establishment, including:

2039

1. If an individual, the name of the individual.

2040

2. If a partnership, the name of each partner and the name

2041

of the partnership.

2042

3. If a corporation:

2043

a. The name, address, and title of each corporate officer

2044

and director.

2045

b. The name and address of the corporation, resident agent

2046

of the corporation, the resident agent's address, and the

2047

corporation's state of incorporation.

2048

c. The name and address of each shareholder of the

2049

corporation that owns 5 percent or more of the outstanding stock

2050

of the corporation.

2051

4. If a sole proprietorship, the full name of the sole

2052

proprietor and the name of the business entity.

2053

5. If a limited liability company:

2054

a. The name and address of each member.

2055

b. The name and address of each manager.

2056

c. The name and address of the limited liability company,

2057

the resident agent of the limited liability company, and the name

2058

of the state in which the limited liability company was

2059

organized.

2060

(f) If applicable, the name and address of each member of

2061

the affiliated group of which the applicant is a member.

2062

(g)1. For an application for a new permit, the estimated

2063

annual dollar volume of prescription drug sales of the applicant,

2064

the estimated annual percentage of the applicant's total company

2065

sales that are prescription drugs, the applicant's estimated

2066

annual total dollar volume of purchases of prescription drugs,

2067

and the applicant's estimated annual total dollar volume of

2068

prescription drug purchases directly from manufacturers.

2069

2. For an application to renew a permit, the total dollar

2070

volume of prescription drug sales in the previous year, the total

2071

dollar volume of prescription drug sales made in the previous 6

2072

months, the percentage of total company sales that were

2073

prescription drugs in the previous year, the total dollar volume

2074

of purchases of prescription drugs in the previous year, and the

2075

total dollar volume of prescription drug purchases directly from

2076

manufacturers in the previous year.

2077

2078

Such portions of the information required pursuant to this

2079

paragraph which are a trade secret, as defined in s. 812.081,

2080

shall be maintained by the department as trade secret information

2081

is required to be maintained under s. 499.051.

2082

(h) The tax year of the applicant.

2083

(i) A copy of the deed for the property on which

2084

applicant's establishment is located, if the establishment is

2085

owned by the applicant, or a copy of the applicant's lease for

2086

the property on which applicant's establishment is located that

2087

has an original term of not less than 1 calendar year, if the

2088

establishment is not owned by the applicant.

2089

(j) A list of all licenses and permits issued to the

2090

applicant by any other state which authorize the applicant to

2091

purchase or possess prescription drugs.

2092

(k) The name of the manager of the establishment that is

2093

applying for the permit or to renew the permit, the next four

2094

highest ranking employees responsible for prescription drug

2095

wholesale operations for the establishment, and the name of all

2096

affiliated parties for the establishment, together with the

2097

personal information statement and fingerprints required pursuant

2098

to subsection (9) (4) for each of such persons.

2099

(l) The name of each of the applicant's designated

2100

representatives as required by subsection (16) (11), together

2101

with the personal information statement and fingerprints required

2102

pursuant to subsection (9) (4) for each such person.

2103

(m) For an applicant that is a secondary wholesale

2104

distributor wholesaler, each of the following:

2105

1. A personal background information statement containing

2106

the background information and fingerprints required pursuant to

2107

subsection (9) (4) for each person named in the applicant's

2108

response to paragraphs (k) and (l) and for each affiliated party

2109

of the applicant.

2110

2. If any of the five largest shareholders of the

2111

corporation seeking the permit is a corporation, the name,

2112

address, and title of each corporate officer and director of each

2113

such corporation; the name and address of such corporation; the

2114

name of such corporation's resident agent, such corporation's

2115

resident agent's address, and such corporation's state of its

2116

incorporation; and the name and address of each shareholder of

2117

such corporation that owns 5 percent or more of the stock of such

2118

corporation.

2119

3. The name and address of all financial institutions in

2120

which the applicant has an account which is used to pay for the

2121

operation of the establishment or to pay for drugs purchased for

2122

the establishment, together with the names of all persons that

2123

are authorized signatories on such accounts. The portions of the

2124

information required pursuant to this subparagraph which are a

2125

trade secret, as defined in s. 812.081, shall be maintained by

2126

the department as trade secret information is required to be

2127

maintained under s. 499.051.

2128

4. The sources of all funds and the amounts of such funds

2129

used to purchase or finance purchases of prescription drugs or to

2130

finance the premises on which the establishment is to be located.

2131

5. If any of the funds identified in subparagraph 4. were

2132

borrowed, copies of all promissory notes or loans used to obtain

2133

such funds.

2134

(n) Any other relevant information that the department

2135

requires, including, but not limited to, any information related

2136

to whether the applicant satisfies the definition of a primary

2137

wholesale distributor wholesaler or a secondary wholesale

2138

distributor wholesaler.

2139

(9)(4)(a) Each person required by subsection (8) (3) to

2140

provide a personal information statement and fingerprints shall

2141

provide the following information to the department on forms

2142

prescribed by the department:

2143

1. The person's places of residence for the past 7 years.

2144

2. The person's date and place of birth.

2145

3. The person's occupations, positions of employment, and

2146

offices held during the past 7 years.

2147

4. The principal business and address of any business,

2148

corporation, or other organization in which each such office of

2149

the person was held or in which each such occupation or position

2150

of employment was carried on.

2151

5. Whether the person has been, during the past 7 years,

2152

the subject of any proceeding for the revocation of any license

2153

and, if so, the nature of the proceeding and the disposition of

2154

the proceeding.

2155

6. Whether, during the past 7 years, the person has been

2156

enjoined, either temporarily or permanently, by a court of

2157

competent jurisdiction from violating any federal or state law

2158

regulating the possession, control, or distribution of

2159

prescription drugs, together with details concerning any such

2160

event.

2161

7. A description of any involvement by the person with any

2162

business, including any investments, other than the ownership of

2163

stock in a publicly traded company or mutual fund, during the

2164

past 7 years, which manufactured, administered, prescribed,

2165

distributed, or stored pharmaceutical products and any lawsuits

2166

in which such businesses were named as a party.

2167

8. A description of any felony criminal offense of which

2168

the person, as an adult, was found guilty, regardless of whether

2169

adjudication of guilt was withheld or whether the person pled

2170

guilty or nolo contendere. A criminal offense committed in

2171

another jurisdiction which would have been a felony in this state

2172

must be reported. If the person indicates that a criminal

2173

conviction is under appeal and submits a copy of the notice of

2174

appeal of that criminal offense, the applicant must, within 15

2175

days after the disposition of the appeal, submit to the

2176

department a copy of the final written order of disposition.

2177

9. A photograph of the person taken in the previous 30

2178

days.

2179

10. A set of fingerprints for the person on a form and

2180

under procedures specified by the department, together with

2181

payment of an amount equal to the costs incurred by the

2182

department for the criminal record check of the person.

2183

11. The name, address, occupation, and date and place of

2184

birth for each member of the person's immediate family who is 18

2185

years of age or older. As used in this subparagraph, the term

2186

"member of the person's immediate family" includes the person's

2187

spouse, children, parents, siblings, the spouses of the person's

2188

children, and the spouses of the person's siblings.

2189

12. Any other relevant information that the department

2190

requires.

2191

(b) The information required pursuant to paragraph (a)

2192

shall be provided under oath.

2193

2194

by a person for initial licensure to the Department of Law

2195

Enforcement for a statewide criminal record check and for

2196

forwarding to the Federal Bureau of Investigation for a national

2197

criminal record check of the person. The department shall submit

2198

the fingerprints provided by a person as a part of a renewal

2199

application to the Department of Law Enforcement for a statewide

2200

criminal record check, and for forwarding to the Federal Bureau

2201

of Investigation for a national criminal record check, for the

2202

initial renewal of a permit after January 1, 2004; for any

2203

subsequent renewal of a permit, the department shall submit the

2204

required information for a statewide and national criminal record

2205

check of the person. Any person who as a part of an initial

2206

permit application or initial permit renewal after January 1,

2207

2004, submits to the department a set of fingerprints required

2208

for the criminal record check required in this paragraph shall

2209

not be required to provide a subsequent set of fingerprints for a

2210

criminal record check to the department, if the person has

2211

undergone a criminal record check as a condition of the issuance

2212

of an initial permit or the initial renewal of a permit of an

2213

applicant after January 1, 2004.

2214

(10)(5) The department may deny an application for a permit

2215

or refuse to renew a permit for a prescription drug wholesale

2216

distributor wholesaler or an out-of-state prescription drug

2217

wholesale distributor wholesaler if:

2218

(a) The applicant has not met the requirements for the

2219

permit.

2220

(b) The management, officers, or directors of the applicant

2221

or any affiliated party are found by the department to be

2222

incompetent or untrustworthy.

2223

2224

wholesale distributor as to make the issuance of the proposed

2225

permit hazardous to the public health.

2226

(d) The applicant is so lacking in experience in managing a

2227

wholesale distributor as to jeopardize the reasonable promise of

2228

successful operation of the wholesale distributor.

2229

(e) The applicant is lacking in experience in the

2230

distribution of prescription drugs.

2231

(f) The applicant's past experience in manufacturing or

2232

distributing prescription drugs indicates that the applicant

2233

poses a public health risk.

2234

(g) The applicant is affiliated directly or indirectly

2235

through ownership, control, or other business relations, with any

2236

person or persons whose business operations are or have been

2237

detrimental to the public health.

2238

(h) The applicant, or any affiliated party, has been found

2239

guilty of or has pleaded guilty or nolo contendere to any felony

2240

or crime punishable by imprisonment for 1 year or more under the

2241

laws of the United States, any state, or any other country,

2242

regardless of whether adjudication of guilt was withheld.

2243

(i) The applicant or any affiliated party has been charged

2244

with a felony in a state or federal court and the disposition of

2245

that charge is pending during the application review or renewal

2246

review period.

2247

(j) The applicant has furnished false or fraudulent

2248

information or material in any application made in this state or

2249

any other state in connection with obtaining a permit or license

2250

to manufacture or distribute drugs, devices, or cosmetics.

2251

(k) That a federal, state, or local government permit

2252

currently or previously held by the applicant, or any affiliated

2253

party, for the manufacture or distribution of any drugs, devices,

2254

or cosmetics has been disciplined, suspended, or revoked and has

2255

not been reinstated.

2256

(l) The applicant does not possess the financial or

2257

physical resources to operate in compliance with the permit being

2258

sought, this chapter, and the rules adopted under this chapter.

2259

(m) The applicant or any affiliated party receives,

2260

directly or indirectly, financial support and assistance from a

2261

person who was an affiliated party of a permittee whose permit

2262

was subject to discipline or was suspended or revoked, other than

2263

through the ownership of stock in a publicly traded company or a

2264

mutual fund.

2265

(n) The applicant or any affiliated party receives,

2266

directly or indirectly, financial support and assistance from a

2267

person who has been found guilty of any violation of this part

2268

ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893,

2269

any rules adopted under any of this part those sections or those

2270

chapters, any federal or state drug law, or any felony where the

2271

underlying facts related to drugs, regardless of whether the

2272

person has been pardoned, had her or his civil rights restored,

2273

or had adjudication withheld, other than through the ownership of

2274

stock in a publicly traded company or a mutual fund.

2275

(o) The applicant for renewal of a permit under s.

2276

499.01(2)(d) paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c)

2277

has not actively engaged in the wholesale distribution of

2278

prescription drugs, as demonstrated by the regular and systematic

2279

distribution of prescription drugs throughout the year as

2280

evidenced by not fewer than 12 wholesale distributions in the

2281

previous year and not fewer than three wholesale distributions in

2282

the previous 6 months.

2283

(p) Information obtained in response to s. 499.01(2)(d)

2284

paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates

2285

it would not be in the best interest of the public health,

2286

safety, and welfare to issue a permit.

2287

(q) The applicant does not possess the financial standing

2288

and business experience for the successful operation of the

2289

applicant.

2290

(r) The applicant or any affiliated party has failed to

2291

comply with the requirements for manufacturing or distributing

2292

prescription drugs under this part ss. 499.001-499.081, similar

2293

federal laws, similar laws in other states, or the rules adopted

2294

under such laws.

2295

(11)(6) Upon approval of the application by the department

2296

and payment of the required fee, the department shall issue or

2297

renew a prescription drug wholesale distributor wholesaler or an

2298

out-of-state prescription drug wholesale distributor wholesaler

2299

permit to the applicant.

2300

(12)(7) For a permit permits for a prescription drug

2301

wholesale distributor wholesalers or an out-of-state prescription

2302

drug wholesale distributor wholesalers:

2303

(a) The department shall adopt rules for the annual renewal

2304

of permits. At least 90 days before the expiration of a permit,

2305

the department shall forward a permit renewal notification and

2306

renewal application to the prescription drug wholesale

2307

distributor wholesaler or out-of-state prescription drug

2308

wholesale distributor wholesaler at the mailing address of the

2309

permitted establishment on file with the department. The permit

2310

renewal notification must state conspicuously the date on which

2311

the permit for the establishment will expire and that the

2312

establishment may not operate unless the permit for the

2313

establishment is renewed timely.

2314

(b) A permit, unless sooner suspended or revoked,

2315

automatically expires 1 year after the last day of the

2316

anniversary month in which the permit was originally issued. A

2317

permit may be renewed by making application for renewal on forms

2318

furnished by the department and paying the appropriate fees. If a

2319

renewal application and fee are submitted and postmarked after 45

2320

days prior to the expiration date of the permit, the permit may

2321

be renewed only upon payment of a late renewal fee of $100, plus

2322

the required renewal fee. A permittee that has submitted a

2323

renewal application in accordance with this paragraph may

2324

continue to operate under its permit, unless the permit is

2325

suspended or revoked, until final disposition of the renewal

2326

application.

2327

2328

section precludes any future renewal of that permit. If a permit

2329

issued pursuant to this section has expired and cannot be

2330

renewed, before an establishment may engage in activities that

2331

require a permit under this part ss. 499.001-499.081, the

2332

establishment must submit an application for a new permit; pay

2333

the applicable application fee, initial permit fee, and all

2334

applicable penalties; and be issued a new permit by the

2335

department.

2336

(13)(8) A person that engages in wholesale distribution of

2337

prescription drugs in this state must have a wholesale

2338

distributor's permit issued by the department, except as noted in

2339

this section. Each establishment must be separately permitted

2340

except as noted in this subsection.

2341

(a) A separate establishment permit is not required when a

2342

permitted prescription drug wholesale distributor wholesaler

2343

consigns a prescription drug to a pharmacy that is permitted

2344

under chapter 465 and located in this state, provided that:

2345

1. The consignor wholesale distributor wholesaler notifies

2346

the department in writing of the contract to consign prescription

2347

drugs to a pharmacy along with the identity and location of each

2348

consignee pharmacy;

2349

2. The pharmacy maintains its permit under chapter 465;

2350

3. The consignor wholesale distributor wholesaler, which

2351

has no legal authority to dispense prescription drugs, complies

2352

with all wholesale distribution requirements of ss. s. 499.0121

2353

and 499.01212 with respect to the consigned drugs and maintains

2354

records documenting the transfer of title or other completion of

2355

the wholesale distribution of the consigned prescription drugs;

2356

4. The distribution of the prescription drug is otherwise

2357

lawful under this chapter and other applicable law;

2358

5. Open packages containing prescription drugs within a

2359

pharmacy are the responsibility of the pharmacy, regardless of

2360

how the drugs are titled; and

2361

6. The pharmacy dispenses the consigned prescription drug

2362

in accordance with the limitations of its permit under chapter

2363

465 or returns the consigned prescription drug to the consignor

2364

wholesale distributor wholesaler. In addition, a person who holds

2365

title to prescription drugs may transfer the drugs to a person

2366

permitted or licensed to handle the reverse distribution or

2367

destruction of drugs. Any other distribution by and means of the

2368

consigned prescription drug by any person, not limited to the

2369

consignor wholesale distributor wholesaler or consignee pharmacy,

2370

to any other person is prohibited.

2371

(b) A wholesale distributor's permit is not required for

2372

the one-time transfer of title of a pharmacy's lawfully acquired

2373

prescription drug inventory by a pharmacy with a valid permit

2374

issued under chapter 465 to a consignor prescription drug

2375

wholesale distributor wholesaler, permitted under this chapter,

2376

in accordance with a written consignment agreement between the

2377

pharmacy and that wholesale distributor wholesaler if: the

2378

permitted pharmacy and the permitted prescription drug wholesale

2379

distributor wholesaler comply with all of the provisions of

2380

paragraph (a) and the prescription drugs continue to be within

2381

the permitted pharmacy's inventory for dispensing in accordance

2382

with the limitations of the pharmacy permit under chapter 465. A

2383

consignor drug wholesale distributor wholesaler may not use the

2384

pharmacy as a wholesale distributor through which it distributes

2385

the prescription legend drugs to other pharmacies. Nothing in

2386

this section is intended to prevent a wholesale drug distributor

2387

from obtaining this inventory in the event of nonpayment by the

2388

pharmacy.

2389

2390

permitted prescription drug wholesale distributor operates

2391

temporary transit storage facilities for the sole purpose of

2392

storage, for up to 16 hours, of a delivery of prescription drugs

2393

when the wholesale distributor was temporarily unable to complete

2394

the delivery to the recipient.

2395

(d)(c) The department shall require information from each

2396

wholesale distributor as part of the permit and renewal of such

2397

permit, as required under s. 499.01 or this section.

2398

(14)(9) Personnel employed in wholesale distribution must

2399

have appropriate education and experience to enable them to

2400

perform their duties in compliance with state permitting

2401

requirements.

2402

(15)(10) The name of a permittee or establishment on a

2403

prescription drug wholesale distributor wholesaler permit or an

2404

out-of-state prescription drug wholesale distributor wholesaler

2405

permit may not include any indicia of attainment of any

2406

educational degree, any indicia that the permittee or

2407

establishment possesses a professional license, or any name or

2408

abbreviation that the department determines is likely to cause

2409

confusion or mistake or that the department determines is

2410

deceptive, including that of any other entity authorized to

2411

purchase prescription drugs.

2412

(16)(11)(a) Each establishment that is issued an initial or

2413

renewal permit as a prescription drug wholesale distributor

2414

wholesaler or an out-of-state prescription drug wholesale

2415

distributor wholesaler must designate in writing to the

2416

department at least one natural person to serve as the designated

2417

representative of the wholesale distributor wholesaler. Such

2418

person must have an active certification as a designated

2419

representative from the department.

2420

(b) To be certified as a designated representative, a

2421

natural person must:

2422

1. Submit an application on a form furnished by the

2423

department and pay the appropriate fees;

2424

2. Be at least 18 years of age;

2425

3. Have not less than 2 years of verifiable full-time work

2426

experience in a pharmacy licensed in this state or another state,

2427

where the person's responsibilities included, but were not

2428

limited to, recordkeeping for prescription drugs, or have not

2429

less than 2 years of verifiable full-time managerial experience

2430

with a prescription drug wholesale distributor wholesaler

2431

licensed in this state or in another state;

2432

4. Receive a passing score of at least 75 percent on an

2433

examination given by the department regarding federal laws

2434

governing distribution of prescription drugs and this part ss.

2435

499.001-499.081 and the rules adopted by the department governing

2436

the wholesale distribution of prescription drugs. This

2437

requirement shall be effective 1 year after the results of the

2438

initial examination are mailed to the persons that took the

2439

examination. The department shall offer such examinations at

2440

least four times each calendar year; and

2441

5. Provide the department with a personal information

2442

statement and fingerprints pursuant to subsection (9)(4).

2443

2444

certification as a designated representative or may suspend or

2445

revoke a certification of a designated representative pursuant to

2446

s. 499.067.

2447

(d) A designated representative:

2448

1. Must be actively involved in and aware of the actual

2449

daily operation of the wholesale distributor.

2450

2. Must be employed full time in a managerial position by

2451

the wholesale distributor.

2452

3. Must be physically present at the establishment during

2453

normal business hours, except for time periods when absent due to

2454

illness, family illness or death, scheduled vacation, or other

2455

authorized absence.

2456

4. May serve as a designated representative for only one

2457

wholesale distributor at any one time.

2458

(e) A wholesale distributor must notify the department when

2459

a designated representative leaves the employ of the wholesale

2460

distributor. Such notice must be provided to the department

2461

within 10 business days after the last day of designated

2462

representative's employment with the wholesale distributor.

2463

(f) A wholesale distributor may not operate under a

2464

prescription drug wholesale distributor wholesaler permit or an

2465

out-of-state prescription drug wholesale distributor wholesaler

2466

permit for more than 10 business days after the designated

2467

representative leaves the employ of the wholesale distributor,

2468

unless the wholesale distributor employs another designated

2469

representative and notifies the department within 10 business

2470

days of the identity of the new designated representative.

2471

Section 12. Section 499.01201, Florida Statutes, is amended

2472

to read:

2473

499.01201 Agency for Health Care Administration review and

2474

use of statute and rule violation or compliance

2475

data.--Notwithstanding any other provisions of law to the

2476

contrary, the Agency for Health Care Administration may not:

2477

(1) Review or use any violation or alleged violation of s.

2478

499.0121(6) or s. 499.01212, or any rules adopted under those

2479

sections that section, as a ground for denying or withholding any

2480

payment of a Medicaid reimbursement to a pharmacy licensed under

2481

chapter 465; or

2482

(2) Review or use compliance with s. 499.0121(6) or s.

2483

499.01212, or any rules adopted under those sections that

2484

section, as the subject of any audit of Medicaid-related records

2485

held by a pharmacy licensed under chapter 465.

2486

Section 13. Section 499.0121, Florida Statutes, is amended,

2487

and subsection (4) of section 499.013, Florida Statutes, is

2488

redesignated as paragraph (d) of subsection (6) of that section

2489

and amended, to read:

2490

499.0121 Storage and handling of prescription drugs;

2491

recordkeeping.--The department shall adopt rules to implement

2492

this section as necessary to protect the public health, safety,

2493

and welfare. Such rules shall include, but not be limited to,

2494

requirements for the storage and handling of prescription drugs

2495

and for the establishment and maintenance of prescription drug

2496

distribution records.

2497

(1) ESTABLISHMENTS.--An establishment at which prescription

2498

drugs are stored, warehoused, handled, held, offered, marketed,

2499

or displayed must:

2500

(a) Be of suitable size and construction to facilitate

2501

cleaning, maintenance, and proper operations;

2502

(b) Have storage areas designed to provide adequate

2503

lighting, ventilation, temperature, sanitation, humidity, space,

2504

equipment, and security conditions;

2505

2506

drugs that are outdated, damaged, deteriorated, misbranded, or

2507

adulterated, or that are in immediate or sealed, secondary

2508

containers that have been opened;

2509

(d) Be maintained in a clean and orderly condition; and

2510

(e) Be free from infestation by insects, rodents, birds, or

2511

vermin of any kind.

2512

(2) SECURITY.--

2513

(a) An establishment that is used for wholesale drug

2514

distribution must be secure from unauthorized entry.

2515

1. Access from outside the premises must be kept to a

2516

minimum and be well-controlled.

2517

2. The outside perimeter of the premises must be well-

2518

lighted.

2519

3. Entry into areas where prescription drugs are held must

2520

be limited to authorized personnel.

2521

(b) An establishment that is used for wholesale drug

2522

distribution must be equipped with:

2523

1. An alarm system to detect entry after hours; however,

2524

the department may exempt by rule establishments that only hold a

2525

permit as prescription drug wholesale distributor-brokers

2526

wholesaler-brokers and establishments that only handle medical

2527

oxygen; and

2528

2. A security system that will provide suitable protection

2529

against theft and diversion. When appropriate, the security

2530

system must provide protection against theft or diversion that is

2531

facilitated or hidden by tampering with computers or electronic

2532

records.

2533

2534

secure from unauthorized access to the prescription drugs in the

2535

vehicle.

2536

(3) STORAGE.--All prescription drugs shall be stored at

2537

appropriate temperatures and under appropriate conditions in

2538

accordance with requirements, if any, in the labeling of such

2539

drugs, or with requirements in the official compendium.

2540

(a) If no storage requirements are established for a

2541

prescription drug, the drug may be held at "controlled" room

2542

temperature, as defined in the official compendium, to help

2543

ensure that its identity, strength, quality, and purity are not

2544

adversely affected.

2545

(b) Appropriate manual, electromechanical, or electronic

2546

temperature and humidity recording equipment, devices, or logs

2547

must be used to document proper storage of prescription drugs.

2548

2549

be followed for all stored prescription drugs.

2550

(4) EXAMINATION OF MATERIALS AND RECORDS.--

2551

(a) Upon receipt, each outside shipping container must be

2552

visually examined for identity and to prevent the acceptance of

2553

contaminated prescription drugs that are otherwise unfit for

2554

distribution. This examination must be adequate to reveal

2555

container damage that would suggest possible contamination or

2556