Florida Senate - 2008 COMMITTEE AMENDMENT

Bill No. CS for SB 2756

836536

CHAMBER ACTION

Senate

Comm: RCS

4/21/2008

House

The Committee on Judiciary (Fasano) recommended 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

100

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

101

499.012(3); or

102

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

103

5 percent of the permittee or applicant.

104

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

105

certification under this part ss. 499.001-499.081.

106

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

107

receipt before any distribution of a prescription legend drug

108

occurs that each transaction listed on the pedigree paper has

109

occurred.

110

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

111

sealed, medical convenience kit to authenticate a pedigree paper

112

for a prescription drug contained within the kit.

113

(b) Authentication of a prescription drug included in a

114

sealed, medical convenience kit shall be limited to verifying the

115

transaction and pedigree information received.

116

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

117

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

118

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

119

legally sold in the state.

120

(7) "Chain pharmacy warehouse" means a wholesale

121

distributor permitted pursuant to s. 499.01 that maintains a

122

physical location for prescription drugs that functions solely as

123

a central warehouse to perform intracompany transfers of such

124

drugs to a member of its affiliated group.

125

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

126

under chapter 465 and purchases prescription drugs for use by a

127

limited patient population and not for wholesale distribution or

128

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

129

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

130

grays.

131

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

132

material that has been or hereafter is exempt under the federal

133

act, a material that:

134

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

135

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

136

otherwise derived, with or without intermediate or final change

137

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

138

139

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

140

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

141

reaction with other substances, of imparting color thereto;

142

143

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

144

or hereafter is exempt under the federal act.

145

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

146

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

147

in combination with other gases.

148

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

149

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

150

as defined in this section, and also means any prescription

151

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

152

which the pedigree paper in existence has been forged,

153

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

154

or misrepresented matter.

155

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

156

soap, that is:

157

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

158

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

159

any part thereof for cleansing, beautifying, promoting

160

attractiveness, or altering the appearance; or

161

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

162

163

except that the term does not include soap.

164

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

165

"counterfeit drug, counterfeit device, or counterfeit cosmetic"

166

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

167

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

168

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

169

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

170

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

171

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

172

device, or cosmetic and which thereby falsely purports or is

173

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

174

distributed by, that other drug, device, or cosmetic

175

manufacturer, processor, packer, or distributor.

176

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

177

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

178

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

179

other similar or related article, including its components,

180

parts, or accessories, which is:

181

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

182

Pharmacopoeia and National Formulary, or any supplement thereof,

183

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

184

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

185

animals, or

186

187

body of humans or other animals,

188

189

and that which does not achieve any of its principal intended

190

purposes through chemical action within or on the body of humans

191

or other animals and which is not dependent upon being

192

metabolized for the achievement of any of its principal intended

193

purposes.

194

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

195

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

196

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

197

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

198

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

199

from a manufacturer to a wholesale distributor, where the

200

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

201

prescription drug and the manufacturer of the prescription drug

202

ships the prescription drug directly to a chain pharmacy

203

warehouse or a person authorized by law to purchase prescription

204

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

205

defined in s. 465.003.

206

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

207

prescription drugs" means an adulterated drug pursuant to s.

208

499.006(10).

209

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

210

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

211

Pharmacopoeia and National Formulary, official Homeopathic

212

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

213

those publications;

214

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

215

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

216

animals;

217

218

body of humans or other animals; or

219

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

220

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

221

does not include devices or their components, parts, or

222

accessories.

223

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

224

general physical location.

225

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

226

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

227

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

228

prescription legend drugs which are owned by another person and

229

designated by that person for export, and exports those

230

prescription legend drugs.

231

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

232

any person, organization, or business entity that provides

233

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

234

chronic or rehabilitative care, but does not include any

235

wholesale distributor or retail pharmacy licensed under state law

236

to deal in prescription drugs.

237

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

238

licensed under chapter 395.

239

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

240

IV of chapter 400.

241

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

242

395.002 and licensed under chapter 395.

243

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

244

liners.

245

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

246

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

247

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

248

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

249

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

250

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

251

other information also appears on the outside container or

252

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

253

cosmetic or is easily legible through the outside container or

254

wrapper.

255

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

256

printed, or graphic matters:

257

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

258

containers or wrappers; or

259

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

260

cosmetic.

261

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

262

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

263

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

264

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

265

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

266

(c).

267

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

268

printed, or graphic matter upon the immediate container of any

269

legend drug prior to its dispensing to an individual patient

270

pursuant to a prescription of a practitioner authorized by law to

271

prescribe.

272

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

273

compounding, propagation, processing, producing, or fabrication

274

of any drug, device, or cosmetic.

275

(31)(28) "Manufacturer" means:

276

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

277

produces a drug, device, or cosmetic.

278

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

279

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

280

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

281

provided such application has become effective or is otherwise

282

approved consistent with s. 499.023; a private label distributor

283

for whom the private label distributor's prescription drugs are

284

originally manufactured and labeled for the distributor and have

285

not been repackaged; or the distribution point for the

286

manufacturer, contract manufacturer, or private label distributor

287

whether the establishment is a member of the manufacturer's

288

affiliated group or is a contract distribution site.

289

290

The term excludes pharmacies that are operating in compliance

291

with pharmacy practice standards as defined in chapter 465 and

292

rules adopted under that chapter.

293

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

294

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

295

is not generally recognized, among experts qualified by

296

scientific training and experience to evaluate the safety and

297

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

298

conditions prescribed, recommended, or suggested in the labeling

299

of that drug; or

300

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

301

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

302

effectiveness for use under certain conditions, has been

303

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

304

other than in those investigations, been used to a material

305

extent or for a material time under such conditions.

306

(33) "Normal distribution chain" means a wholesale

307

distribution of a prescription drug in which the wholesale

308

distributor or its wholly owned subsidiary purchases and receives

309

the specific unit of the prescription drug directly from the

310

manufacturer and distributes the prescription drug directly, or

311

through up to two intracompany transfers, to a chain pharmacy

312

warehouse or a person authorized by law to purchase prescription

313

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

314

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

315

"intracompany" means any transaction or transfer between any

316

parent, division, or subsidiary wholly owned by a corporate

317

entity.

318

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

319

II of chapter 400.

320

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

321

the official United States Pharmacopoeia and National Formulary,

322

or any supplement thereto.

323

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

324

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

325

electronic form approved by the department which contains of

326

Health and containing information required by s. 499.01212

327

regarding the sale and that records each distribution of any

328

given prescription legend drug, from sale by a pharmaceutical

329

manufacturer, through acquisition and sale by any wholesaler or

330

repackager, until final sale to a pharmacy or other person

331

administering or dispensing the drug. The information required to

332

be included on the form approved by the department pursuant to

333

this paragraph must at least detail the amount of the legend

334

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

335

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

336

signature; its shipping information, including the name and

337

address of each person certifying delivery or receipt of the

338

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

339

another number uniquely identifying the transaction; and a

340

certification that the recipient wholesaler has authenticated the

341

pedigree papers. If the manufacturer or repackager has uniquely

342

serialized the individual legend drug unit, that identifier must

343

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

344

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

345

available, e-mail contact information of each wholesaler involved

346

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

347

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

348

confirming that a wholesale distributor purchases and receives

349

the specific unit of the prescription drug directly from the

350

manufacturer of the prescription drug and distributes the

351

prescription drug directly, or through an intracompany transfer,

352

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

353

purchase prescription drugs for the purpose of administering or

354

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

355

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

356

wholesale distributor permitted pursuant to s. 499.01 that

357

maintains a physical location for prescription drugs that

358

functions solely as a central warehouse to perform intracompany

359

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

360

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

361

1. The information required to be included pursuant to this

362

paragraph must include:

363

a. The following statement: "This wholesale distributor

364

purchased the specific unit of the prescription drug directly

365

from the manufacturer."

366

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

367

name and address of the wholesaler and the purchaser of the

368

prescription drug.

369

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

370

label.

371

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

372

prescription drug.

373

2. The wholesale distributor must also maintain and make

374

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

375

the prescription drugs, including intracompany transfers; the

376

date of the shipment from the manufacturer to the wholesale

377

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

378

numbers from the manufacturer.

379

380

The department may adopt rules and forms relating to the

381

requirements of this subsection.

382

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

383

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

384

s. 499.012.

385

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

386

venture, syndicate, fiduciary, partnership, corporation, division

387

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

388

public or private institution, association, organization, group,

389

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

390

state, other governmental agency within this state, and any

391

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

392

other group or combination of the foregoing.

393

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

394

465.

395

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

396

465.

397

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

398

originally was in finished packaged form sealed by a manufacturer

399

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

400

or practitioner authorized to dispense pursuant to chapter 465

401

for the purpose of dispensing in the establishment in which the

402

prepackaging occurred.

403

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

404

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

405

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

406

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

407

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

408

or subsection (54).

409

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

410

written, printed, or graphic matter upon the immediate container

411

of any prescription drug prior to its dispensing to an individual

412

patient pursuant to a prescription of a practitioner authorized

413

by law to prescribe.

414

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

415

printed, or graphic matter upon the immediate container of any

416

prescription legend drug dispensed pursuant to a prescription of

417

a practitioner authorized by law to prescribe.

418

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

419

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

420

prescription of a practitioner authorized by law to prescribe.

421

The label of prescription medical oxygen must comply with current

422

labeling requirements for oxygen under the Federal Food, Drug,

423

and Cosmetic Act.

424

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

425

any wholesale distributor that:

426

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

427

volume of its purchases of prescription drugs directly from

428

manufacturers in the previous year; and

429

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

430

fewer than 50 different prescription drug manufacturers in the

431

previous year; or

432

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

433

the Internal Revenue Code, of which the wholesale distributor is

434

a member has, not fewer than 250 employees.

435

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

436

manufacturers a manufacturer" means:

437

1. Purchases made by the wholesale distributor directly

438

from the manufacturer of prescription drugs; and

439

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

440

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

441

wholesale distributor is a member, if:

442

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

443

total dollar volume of its purchases of prescription drugs from

444

the manufacturer in the previous year; and

445

b. The wholesale distributor discloses to the department

446

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

447

wholesale distributor is a member and the affiliated group agrees

448

in writing to provide records on prescription drug purchases by

449

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

450

the department requests access to such records, regardless of the

451

location where the records are stored.

452

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

453

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

454

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

455

manufacturer or primary distributor thereof, is not misbranded

456

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

457

purchased without a prescription.

458

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

459

changing the container, wrapper, or labeling to further the

460

distribution of the drug, device, or cosmetic.

461

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

462

term excludes pharmacies that are operating in compliance with

463

pharmacy practice standards as defined in chapter 465 and rules

464

adopted under that chapter.

465

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

466

licensed under chapter 465 that purchases prescription drugs at

467

fair market prices and provides prescription services to the

468

public.

469

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

470

a wholesale distributor that is not a primary wholesale

471

distributor wholesaler.

472

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

473

prescription legend drug intended solely for veterinary use. The

474

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

475

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

476

veterinarian."

477

(40) "Veterinary prescription drug wholesaler" means any

478

person engaged in wholesale distribution of veterinary

479

prescription drugs in or into this state.

480

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

481

prescription drugs to persons other than a consumer or patient,

482

but does not include:

483

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

484

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

485

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

486

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

487

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

488

organization of a prescription drug for its own use from the

489

group purchasing organization or from other hospitals or health

490

care entities that are members of that organization.

491

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

492

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

493

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

494

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

495

affiliate of the organization to the extent otherwise permitted

496

by law.

497

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

498

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

499

hospitals or other health care entities that are under common

500

control. For purposes of this subparagraph section, "common

501

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

502

management and policies of a person or an organization, whether

503

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

504

otherwise.

505

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

506

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

507

government agency or any entity eligible to purchase prescription

508

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

509

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

510

eligible patients of the agency or entity under the following

511

conditions:

512

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

513

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

514

a prescription drug under this subparagraph sub-subparagraph from

515

the State Surgeon General or his or her designee.

516

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

517

authorized by law to administer or dispense prescription drugs.

518

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

519

entity must be a party to and execute the subcontract.

520

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

521

separate and apart from other prescription drug inventory any

522

prescription drugs of the agency or entity in its possession.

523

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

524

and produce immediately for inspection all records of movement or

525

transfer of all the prescription drugs belonging to the agency or

526

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

527

disposition of prescription drugs. Each contractor and

528

subcontractor dispensing or administering these drugs must

529

maintain and produce records documenting the dispensing or

530

administration. Records that are required to be maintained

531

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

532

drugs received and drugs dispensed by prescription number or

533

administered by patient identifier, which must be submitted to

534

the agency or entity quarterly.

535

f.(VI) The contract provider or subcontractor may

536

administer or dispense the prescription drugs only to the

537

eligible patients of the agency or entity or must return the

538

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

539

provider or subcontractor must require proof from each person

540

seeking to fill a prescription or obtain treatment that the

541

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

542

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

543

records of the contractor or subcontractor required under sub-

544

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

545

g.(VII) In addition to the departmental inspection

546

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

547

contract provider and subcontractor and all records pertaining to

548

prescription drugs subject to this subparagraph sub-subparagraph

549

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

550

records relating to prescription drugs of a manufacturer under

551

this subparagraph sub-subparagraph shall be subject to audit by

552

the manufacturer of those drugs, without identifying individual

553

patient information.

554

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

555

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

556

accordance with rules established by the department:

557

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

558

among federal, state, or local government health care entities

559

that are under common control and are authorized to purchase such

560

prescription drug.

561

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

562

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

563

emergency medical reasons. For purposes of this subparagraph sub-

564

subparagraph, the term "emergency medical reasons" includes

565

transfers of prescription drugs by a retail pharmacy to another

566

retail pharmacy to alleviate a temporary shortage.

567

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

568

medical director on behalf of a licensed emergency medical

569

services provider to that emergency medical services provider and

570

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

571

license under chapter 401.

572

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

573

prescription drug to the person's prescription drug wholesale

574

supplier.

575

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

576

entity to a charitable organization that has been granted an

577

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

578

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

579

drugs.

580

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

581

authorized to purchase or receive prescription drugs to a person

582

licensed or permitted to handle reverse distributions or

583

destruction under the laws of the jurisdiction in which the

584

person handling the reverse distribution or destruction receives

585

the drug.

586

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

587

other health care entity to a person licensed under this part

588

chapter to repackage prescription drugs for the purpose of

589

repackaging the prescription drug for use by that hospital, or

590

other health care entity and other health care entities that are

591

under common control, if ownership of the prescription drugs

592

remains with the hospital or other health care entity at all

593

times. In addition to the recordkeeping requirements of s.

594

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

595

prescription drugs pursuant to this subparagraph sub-subparagraph

596

must reconcile all drugs transferred and returned and resolve any

597

discrepancies in a timely manner.

598

599

manufacturers' representatives or distributors' representatives

600

conducted in accordance with s. 499.028.

601

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

602

components intended for transfusion. As used in this paragraph

603

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

604

single donor and processed either for transfusion or further

605

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

606

the blood separated by physical or mechanical means.

607

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

608

accordance with chapter 465.

609

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

610

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

611

consolidation of all or part of the business of the pharmacies

612

from or with another pharmacy, whether accomplished as a purchase

613

and sale of stock or of business assets.

614

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

615

wholesale distribution of prescription drugs in or into this

616

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

617

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

618

brokers; warehouses, including manufacturers' and distributors'

619

warehouses, chain drug warehouses, and wholesale drug warehouses;

620

independent wholesale drug traders; exporters; retail pharmacies;

621

and the agents thereof that conduct wholesale distributions.

622

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

623

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

624

Florida Statutes, are amended to read:

625

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

626

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

627

this state:

628

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

629

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

630

part ss. 499.001-499.081.

631

(10) Forging; counterfeiting; simulating; falsely

632

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

633

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

634

or other identification device authorized or required by rules

635

adopted under this part ss. 499.001-499.081.

636

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

637

advertisement relating to such drug, of any representation or

638

suggestion that an application of the drug is effective when it

639

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

640

499.081 when it does not.

641

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

642

ss. 499.001-499.081.

643

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

644

from a person that is not authorized under this chapter to

645

distribute prescription legend drugs to that purchaser or

646

recipient.

647

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

648

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

649

in which the person receives the drug to purchase or possess

650

prescription legend drugs from the person selling or transferring

651

the prescription legend drug.

652

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

653

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

654

sections.

655

(19) Providing the department with false or fraudulent

656

records, or making false or fraudulent statements, regarding any

657

matter within the provisions of this part chapter.

658

(20) The importation of a prescription legend drug except

659

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

660

Act.

661

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

662

operating without a valid permit when a permit or registration is

663

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

664

(24) The distribution of a prescription legend device to

665

the patient or ultimate consumer without a prescription or order

666

from a practitioner licensed by law to use or prescribe the

667

device.

668

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

669

pedigree paper as required under this part.

670

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

671

wholesale distribution without having previously received or

672

simultaneously either first receiving a pedigree paper that was

673

attested to as accurate and complete by the wholesale distributor

674

as required under this part or complying with the provisions of

675

s. 499.0121(6)(d)5.

676

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

677

section 499.0052, Florida Statutes, is redesignated as subsection

678

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

679

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

680

amended; section 499.00545, Florida Statutes, is redesignated as

681

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

682

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

683

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

684

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

685

amended, to read:

686

499.0051 Criminal acts involving contraband or adulterated

687

drugs.--

688

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

689

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

690

wholesale distribution of prescription legend drugs who fails to

691

deliver to another person complete and accurate pedigree papers

692

concerning a prescription legend drug or contraband prescription

693

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

694

transferring the prescription legend drug or contraband

695

prescription legend drug to another person commits a felony of

696

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

697

775.083, or s. 775.084.

698

(b) A person engaged in the wholesale distribution of

699

prescription legend drugs who fails to acquire complete and

700

accurate pedigree papers concerning a prescription legend drug or

701

contraband prescription legend drug prior to, or simultaneous

702

with, the receipt of obtaining the prescription legend drug or

703

contraband prescription legend drug from another person commits a

704

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

705

s. 775.083, or s. 775.084.

706

707

fails to maintain complete and accurate pedigree papers

708

concerning any prescription legend drug or contraband

709

prescription legend drug in his or her possession commits a

710

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

711

s. 775.083, or s. 775.084.

712

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

713

July 1, 2006:

714

(a) A person engaged in the wholesale distribution of

715

prescription legend drugs who is in possession of pedigree papers

716

concerning prescription legend drugs or contraband prescription

717

legend drugs and who fails to authenticate the matters contained

718

in the pedigree papers and who nevertheless attempts to further

719

distribute prescription legend drugs or contraband prescription

720

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

721

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

722

(b) A person in possession of pedigree papers concerning

723

prescription legend drugs or contraband prescription legend drugs

724

who falsely swears or certifies that he or she has authenticated

725

the matters contained in the pedigree papers commits a felony of

726

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

727

775.083, or s. 775.084.

728

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

729

knowingly forges, counterfeits, or falsely creates any pedigree

730

paper; who falsely represents any factual matter contained on any

731

pedigree paper; or who knowingly omits to record material

732

information required to be recorded in a pedigree paper, commits

733

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

734

775.082, s. 775.083, or s. 775.084.

735

(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG

736

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

737

receives from a person not authorized to distribute prescription

738

legend drugs under this chapter a prescription legend drug in a

739

wholesale distribution transaction commits a felony of the second

740

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

741

775.084.

742

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

743

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

744

to a person not authorized to purchase or possess prescription

745

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

746

person receives the drug, a prescription legend drug in a

747

wholesale distribution transaction commits a felony of the second

748

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

749

775.084.

750

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

751

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

752

knowingly in actual or constructive possession of any amount of

753

contraband prescription legend drugs, who knowingly sells or

754

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

755

amount of contraband prescription legend drugs, commits a felony

756

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

757

775.083, or s. 775.084.

758

(7)499.0052 KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION

759

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

760

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

761

knowingly in actual or constructive possession of any amount of

762

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

763

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

764

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

765

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

766

a mandatory fine according to the following schedule:

767

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

768

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

769

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

770

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

771

shall pay a mandatory fine of $75,000.

772

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

773

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

774

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

775

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

776

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

777

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

778

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

779

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

780

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

781

fine of $600,000.

782

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

783

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

784

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

785

cost of replacement of the property within a reasonable time

786

after the offense. Amounts of value of separate contraband

787

prescription legend drugs involved in distinct transactions for

788

the distribution of the contraband prescription legend drugs

789

committed pursuant to one scheme or course of conduct, whether

790

involving the same person or several persons, may be aggregated

791

in determining the punishment of the offense.

792

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

793

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

794

or falsely creates any prescription label or prescription legend

795

drug label, or who falsely represents any factual matter

796

contained on any prescription label or prescription legend drug

797

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

798

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

799

(9)499.00535 KNOWING Sale or purchase of contraband

800

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

801

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

802

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

803

constructive possession of any amount of contraband prescription

804

legend drugs, and whose acts in violation of this subsection

805

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

806

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

807

775.084.

808

(10)499.00545 Knowing Sale or purchase of contraband

809

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

810

knowingly manufactures, sells, purchases, delivers, or brings

811

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

812

possession of any amount of contraband prescription legend drugs,

813

and whose acts in violation of this subsection section result in

814

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

815

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

816

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

817

(11)499.069 Criminal punishment for violations of s.

818

499.005 related to devices and cosmetics; dissemination of false

819

advertisement.--

820

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

821

499.005 with respect to a device or cosmetic commits a

822

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

823

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

824

conviction of such person under this subsection section has

825

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

826

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

827

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

828

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

829

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

830

cosmetic commits a felony of the third degree, punishable as

831

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

832

otherwise provided in this part ss. 499.001-499.081.

833

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

834

medium for the dissemination of an advertisement, except the

835

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

836

false advertisement relates, is not liable under this subsection

837

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

838

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

839

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

840

office address of the manufacturer, wholesaler, seller, or

841

advertising agency that asked him or her to disseminate such

842

advertisement.

843

(12)499.0691 ADULTERATED AND MISBRANDED DRUGS; FALSE

844

ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS

845

Criminal punishment for violations related to drugs;

846

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

847

violates any of the following provisions commits a misdemeanor of

848

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

849

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

850

such person under this subsection section has become final, such

851

person commits a misdemeanor of the first degree, punishable as

852

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

853

this part ss. 499.001-499.081:

854

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

855

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

856

misbranded or has otherwise been rendered unfit for human or

857

animal use.

858

(b) The adulteration or misbranding of any drug intended

859

for further distribution.

860

861

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

862

for pay or otherwise.

863

(d) The dissemination of any false or misleading

864

advertisement of a drug.

865

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

866

advertisement relating to such drug, of any representation or

867

suggestion that an application of the drug is effective when it

868

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

869

499.081 when it does not.

870

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

871

from a person that is not authorized under this chapter to

872

distribute compressed medical gases.

873

(g) Charging a dispensing fee for dispensing,

874

administering, or distributing a prescription drug sample.

875

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

876

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

877

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

878

or shipping documents related to prescription legend drugs.

879

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

880

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

881

deficiency in pedigree papers.

882

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

883

TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO

884

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

885

following provisions commits a felony of the third degree,

886

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

887

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

888

(a) The refusal or constructive refusal to allow:

889

1. The department to enter or inspect an establishment in

890

which drugs are manufactured, processed, repackaged, sold,

891

brokered, or held;

892

2. Inspection of any record of that establishment;

893

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

894

being used to transport drugs; or

895

4. The department to take samples of any drug.

896

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

897

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

898

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

899

failure to otherwise comply with s. 499.028.

900

901

records, or making false or fraudulent statements, regarding any

902

matter within the provisions of this part chapter related to a

903

drug.

904

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

905

and shipping documents, other than pedigree papers, if

906

applicable, related to the distribution of a prescription legend

907

drug.

908

(e) The importation of a prescription legend drug for

909

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

910

Federal Food, Drug, and Cosmetic Act.

911

(f) The wholesale distribution of a any prescription drug

912

that was:

913

1. Purchased by a public or private hospital or other

914

health care entity; or

915

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

916

organization.

917

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

918

wholesale distributor wholesaler when a permit is required by

919

this part ss. 499.001-499.081 for that activity.

920

(h) Knowingly possessing any adulterated or misbranded

921

prescription legend drug outside of a designated quarantine area.

922

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

923

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

924

560.103(6).

925

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

926

the following provisions commits a felony of the second degree,

927

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

928

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

929

(a) Knowingly manufacturing, repackaging, selling,

930

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

931

adulterated or misbranded or has otherwise been rendered unfit

932

for human or animal use.

933

(b) Knowingly adulterating a drug that is intended for

934

further distribution.

935

936

delivering or proffering delivery of such drug for pay or

937

otherwise.

938

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

939

counterfeit drug, or selling, dispensing, or knowingly holding

940

for sale a counterfeit drug.

941

(e) Forging, counterfeiting, simulating, or falsely

942

representing any drug, or, without the authority of the

943

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

944

identification device authorized or required by rules adopted

945

under this part ss. 499.001-499.081.

946

(f) Knowingly obtaining or attempting to obtain a

947

prescription drug for wholesale distribution by fraud, deceit,

948

misrepresentation, or subterfuge, or engaging in

949

misrepresentation or fraud in the distribution of a drug.

950

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

951

prescription drug with the intent to further distribute the

952

prescription drug.

953

(h) Knowingly distributing a prescription drug that was

954

previously dispensed by a licensed pharmacy, unless such

955

distribution was authorized in chapter 465 or the rules adopted

956

under chapter 465.

957

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

958

broadcast licensee, or agency or medium for the dissemination of

959

an advertisement, except the manufacturer, repackager, wholesale

960

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

961

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

962

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

963

dissemination by him or her of such false advertisement, unless

964

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

965

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

966

manufacturer, repackager, wholesale distributor wholesaler,

967

seller, or advertising agency that asked him or her to

968

disseminate such advertisement.

969

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

970

section 499.0055, Florida Statutes, is redesignated as subsection

971

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

972

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

973

amended, to read:

974

499.0054 Advertising and labeling of drugs, devices, and

975

cosmetics; exemptions.--

976

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

977

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

978

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

979

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

980

false or misleading in any way.

981

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

982

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

983

part ss. 499.001-499.081.

984

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

985

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

986

cosmetic for which the advertising or labeling is false or

987

misleading.

988

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

989

that is adulterated or misbranded.

990

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

991

cosmetic that is falsely advertised or labeled or the delivering

992

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

993

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

994

containing ephedrine, a salt of ephedrine, an isomer of

995

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

996

indication of stimulation, mental alertness, weight loss,

997

appetite control, energy, or other indications not approved by

998

the pertinent United States Food and Drug Administration Over-

999

the-Counter Final or Tentative Final Monograph or approved new

1000

drug application under the federal act. In determining compliance

1001

with this requirement, the department may consider the following

1002

factors:

1003

1.(a) The packaging of the product.

1004

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

1005

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

1006

promotion of the product, including verbal representations at the

1007

point of sale.

1008

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

1009

particular product.

1010

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

1011

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

1012

diseases, or processes:

1013

1.(a) Blood disorders.

1014

2.(b) Bone or joint diseases.

1015

3.(c) Kidney diseases or disorders.

1016

4.(d) Cancer.

1017

5.(e) Diabetes.

1018

6.(f) Gall bladder diseases or disorders.

1019

7.(g) Heart and vascular diseases.

1020

8.(h) High blood pressure.

1021

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

1022

apparatus, including hearing loss or deafness.

1023

10.(j) Mental disease or mental retardation.

1024

11.(k) Paralysis.

1025

12.(l) Prostate gland disorders.

1026

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

1027

14.(n) Baldness.

1028

15.(o) Endocrine disorders.

1029

16.(p) Sexual impotence.

1030

17.(q) Tumors.

1031

18.(r) Venereal diseases.

1032

19.(s) Varicose ulcers.

1033

20.(t) Breast enlargement.

1034

21.(u) Purifying blood.

1035

22.(v) Metabolic disorders.

1036

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

1037

immune system.

1038

24.(x) Extension of life expectancy.

1039

25.(y) Stress and tension.

1040

26.(z) Brain stimulation or performance.

1041

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

1042

28.(bb) Blood flow.

1043

29.(cc) Depression.

1044

30.(dd) Human immunodeficiency virus or acquired immune

1045

deficiency syndrome or related disorders or conditions.

1046

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

1047

advertising that an article is approved under this part ss.

1048

499.001-499.081, when such is not the case.

1049

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

1050

determining whether an advertisement is false or misleading, the

1051

department shall review the representations made or suggested by

1052

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

1053

thereof within the advertisement and the extent to which the

1054

advertisement fails to reveal material facts with respect to

1055

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

1056

cosmetic to which the advertisement relates under the conditions

1057

of use prescribed in the labeling or advertisement.

1058

(3)499.0057 Advertisement exemptions.--

1059

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

1060

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

1061

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

1062

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

1063

indications that are safe and effective indications and the

1064

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

1065

by the United States Food and Drug Administration; or

1066

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

1067

dental, pharmaceutical, or veterinary professions or appears only

1068

in the scientific periodicals of these professions.

1069

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

1070

the rules adopted under this part those sections creates no legal

1071

presumption that a drug or device is safe or effective.

1072

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

1073

499.006, Florida Statutes, are amended to read:

1074

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

1075

adulterated:

1076

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

1077

facilities or controls used for, its manufacture, processing,

1078

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

1079

administered in conformity with, current good manufacturing

1080

practices to assure that the drug meets the requirements of this

1081

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

1082

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

1083

purports or is represented to possess;

1084

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

1085

required pedigree paper is nonexistent, fraudulent, or incomplete

1086

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

1087

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

1088

distributed at any time by a person not authorized under federal

1089

or state law to do so; or

1090

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

1091

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

1092

Act which has been returned by a veterinarian to a limited

1093

prescription drug veterinary wholesale distributor wholesaler.

1094

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

1095

read:

1096

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

1097

misbranded:

1098

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

1099

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

1100

label containing:

1101

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

1102

repackager, or distributor of the finished dosage form of the

1103

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

1104

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

1105

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

1106

patient and requires no further manufacturing or processing other

1107

than packaging, reconstitution, and labeling; and

1108

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

1109

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

1110

this section, reasonable variations are permitted, and the

1111

department shall establish by rule exemptions for small packages.

1112

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

1113

form and does not bear a label containing:

1114

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

1115

repackager, or distributor; and

1116

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

1117

in terms of weight, measure, or numerical count.

1118

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

1119

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

1120

the label or labeling is not prominently placed thereon with such

1121

conspicuousness as compared with other words, statements,

1122

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

1123

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

1124

read and understood under customary conditions of purchase and

1125

use.

1126

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

1127

name recognized in an official compendium and, unless its label

1128

does not bear bears:

1129

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

1130

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

1131

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

1132

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

1133

(a) Adequate directions for use; and

1134

(b) Adequate warnings against use in those pathological

1135

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

1136

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

1137

unsafe dosage or methods or duration of administration or

1138

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

1139

protection of users.

1140

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

1141

recognized in the official compendium and, unless it is not

1142

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

1143

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

1144

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

1145

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

1146

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

1147

precautions, as the department by rule requires as necessary to

1148

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

1149

any drug recognized in an official compendium until the

1150

department has informed the appropriate body charged with the

1151

revision of such compendium of the need for such packaging or

1152

labeling requirements and that body has failed within a

1153

reasonable time to prescribe such requirements.

1154

(9)(8) If it is:

1155

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

1156

made, formed, or filled as to be misleading;

1157

(b) An imitation of another drug; or

1158

1159

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

1160

dosage or with the frequency or duration prescribed, recommended,

1161

or suggested in the labeling of the drug.

1162

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

1163

drug composed wholly or partly of insulin and, unless:

1164

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

1165

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

1166

act, which; and

1167

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

1168

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

1169

drug composed wholly or partly of any kind of antibiotic

1170

requiring certification under the federal act and unless:

1171

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

1172

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

1173

act, which; and

1174

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

1175

1176

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

1177

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

1178

the federal act.

1179

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

1180

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

1181

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

1182

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

1183

use except under the supervision of a practitioner licensed by

1184

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

1185

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

1186

under the professional supervision of a practitioner licensed by

1187

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

1188

(a) Upon the written prescription of a practitioner

1189

licensed by law to prescribe such drug;

1190

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

1191

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

1192

1193

such refilling is authorized by the prescriber either in the

1194

original prescription or by oral order which is reduced promptly

1195

to writing and filled by the pharmacist.

1196

1197

This subsection does not relieve any person from any requirement

1198

prescribed by law with respect to controlled substances as

1199

defined in the applicable federal and state laws.

1200

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

1201

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

1202

label does not fails to bear the statement:

1203

(a) "Caution: Federal Law Prohibits Dispensing Without

1204

Prescription";

1205

(b) "Rx Only";

1206

1207

(d) "Caution: State Law Prohibits Dispensing Without

1208

Prescription."

1209

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

1210

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

1211

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

1212

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

1213

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

1214

unless its packaging and labeling are not in conformity with the

1215

packaging and labeling requirements that apply to such color

1216

additive and are prescribed under the federal act.

1217

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

1218

oral prescription of a practitioner licensed by law to prescribe

1219

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

1220

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

1221

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

1222

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

1223

dispenser or seller, the prescription number and the date the

1224

prescription was written or filled, the name of the prescriber

1225

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

1226

cautionary statements. This exemption does not apply to any drug

1227

dispensed in the course of the conduct of a business of

1228

dispensing drugs pursuant to diagnosis by mail or to any drug

1229

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

1230

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

1231

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

1232

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

1233

and welfare.

1234

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

1235

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

1236

to read:

1237

499.008 Adulterated cosmetics.--A cosmetic is adulterated:

1238

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

1239

substance that is injurious to users under the conditions of use

1240

prescribed in the labeling or advertisement thereof or under such

1241

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

1242

subsection does not apply to coal-tar hair dye:

1243

(a) The label of which bears the following legend

1244

conspicuously displayed thereon: "Caution: This product contains

1245

ingredients which may cause skin irritation on certain

1246

individuals, and a preliminary test according to accompanying

1247

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

1248

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

1249

blindness"; and

1250

(b) The labeling of which bears adequate directions for

1251

such preliminary testing.

1252

1253

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

1254

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

1255

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

1256

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

1257

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

1258

499.009, Florida Statutes, are amended to read:

1259

499.009 Misbranded cosmetics.--A cosmetic is misbranded:

1260

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

1261

label containing:

1262

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

1263

packer, or distributor;

1264

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

1265

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

1266

this paragraph reasonable variations are permitted, and the

1267

department shall establish by rule exemptions for small packages;

1268

and

1269

1270

predominance, or as otherwise required by federal law.

1271

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

1272

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

1273

on the label or labeling is not prominently placed thereon with

1274

such conspicuousness as compared with other words, statements,

1275

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

1276

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

1277

read and understood by an individual under customary conditions

1278

of purchase and use.

1279

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

1280

labeling are not in conformity with the packaging and labeling

1281

requirements applicable to that color additive prescribed under

1282

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

1283

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

1284

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

1285

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

1286

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

1287

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

1288

redesignated as the introductory paragraph and paragraphs (d),

1289

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

1290

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

1291

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

1292

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

1293

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

1294

section 499.014, Florida Statutes, is redesignated as paragraph

1295

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

1296

499.01 Permits; applications; renewal; general

1297

requirements.--

1298

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

1299

person and establishment that intends to operate as:

1300

(a) A prescription drug manufacturer;

1301

(b) A prescription drug repackager;

1302

1303

(d) A prescription drug wholesale distributor;

1304

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

1305

distributor;

1306

(f) A retail pharmacy drug wholesale distributor;

1307

(g) A restricted prescription drug distributor;

1308

(h) A complimentary drug distributor;

1309

(i) A freight forwarder;

1310

(j) A veterinary prescription drug retail establishment;

1311

(k) A veterinary prescription drug wholesale distributor;

1312

(l) A limited prescription drug veterinary wholesale

1313

distributor;

1314

(m) A medical oxygen retail establishment;

1315

(n) A compressed medical gas wholesale distributor;

1316

(o) A compressed medical gas manufacturer;

1317

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

1318

(d) A compressed medical gas manufacturer;

1319

(q)(e) A device manufacturer;

1320

(r)(f) A cosmetic manufacturer;

1321

(s) A third party logistic provider; or

1322

(t) A health care clinic establishment.

1323

(g) A prescription drug wholesaler;

1324

(h) A veterinary prescription drug wholesaler;

1325

(i) A compressed medical gas wholesaler;

1326

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

1327

(k) A nonresident prescription drug manufacturer;

1328

(l) A freight forwarder;

1329

(m) A retail pharmacy drug wholesaler;

1330

(n) A veterinary legend drug retail establishment;

1331

(o) A medical oxygen retail establishment;

1332

(p) A complimentary drug distributor;

1333

(q) A restricted prescription drug distributor; or

1334

(r) A limited prescription drug veterinary wholesaler.

1335

(2) The following types of wholesaler permits are

1336

established:

1337

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

1338

drug manufacturer permit is required for any person that

1339

manufactures a prescription drug in this state.

1340

1. A person that operates an establishment permitted as a

1341

prescription drug manufacturer may engage in wholesale

1342

distribution of prescription drugs manufactured at that

1343

establishment and must comply with all the provisions of this

1344

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

1345

wholesale distributor.

1346

2. A prescription drug manufacturer must comply with all

1347

appropriate state and federal good manufacturing practices.

1348

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

1349

drug repackager permit is required for any person that repackages

1350

a prescription drug in this state.

1351

1. A person that operates an establishment permitted as a

1352

prescription drug repackager may engage in wholesale distribution

1353

of prescription drugs repackaged at that establishment and must

1354

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

1355

under this part that apply to a wholesale distributor.

1356

2. A prescription drug repackager must comply with all

1357

appropriate state and federal good manufacturing practices.

1358

(c)(e) Nonresident prescription drug manufacturer

1359

permit.--A nonresident prescription drug manufacturer permit is

1360

required for any person that is a manufacturer of prescription

1361

drugs, or the distribution point for a manufacturer of

1362

prescription drugs, and located outside of this state, or that is

1363

an entity to whom an approved new drug application has been

1364

issued by the United States Food and Drug Administration, or the

1365

contracted manufacturer of the approved new drug application

1366

holder, and located outside the United States, which engages in

1367

the wholesale distribution in this state of the prescription

1368

drugs it manufactures or is responsible for manufacturing. Each

1369

such manufacturer or entity must be permitted by the department

1370

and 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). The prescription drug manufacturer purchasing and

1402

receiving the active pharmaceutical ingredient shall maintain on

1403

file a record of the FDA registration number; the out-of-state

1404

license, permit, or registration number; and, if available, a

1405

copy of the most current FDA inspection report, for all

1406

manufacturers from whom they purchase active pharmaceutical

1407

ingredients under this section. The department shall specify by

1408

rule the allowable number of transactions within a given period

1409

of time and the amount of active pharmaceutical ingredients that

1410

qualify as limited quantities for purposes of this exemption. The

1411

failure to comply with the requirements of this subparagraph, or

1412

rules adopted by the department to administer this subparagraph,

1413

for the purchase of prescription drug active pharmaceutical

1414

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

1415

(d)(a) A Prescription drug wholesale distributor

1416

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

1417

wholesaler is a wholesale distributor that may engage in the

1418

wholesale distribution of prescription drugs. A prescription drug

1419

wholesale distributor wholesaler that applies to the department

1420

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

1421

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

1422

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

1423

in a trust account or financial institution, payable to the

1424

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

1425

bond is to secure payment of any administrative penalties imposed

1426

by the department and any fees and costs incurred by the

1427

department regarding that permit which are authorized under state

1428

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

1429

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

1430

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

1431

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

1432

legal proceeding authorized in this part ss. 499.001-499.081

1433

which involves the permittee is concluded, including any appeal,

1434

whichever occurs later. The department may adopt rules for

1435

issuing a prescription drug wholesale distributor-broker

1436

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

1437

distribution of prescription drugs and does not take physical

1438

possession of any prescription drugs.

1439

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

1440

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

1441

drug wholesale distributor wholesaler is a wholesale distributor

1442

located outside this state which engages in the wholesale

1443

distribution of prescription drugs into this state and which must

1444

be permitted by the department and comply with all the provisions

1445

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

1446

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

1447

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

1448

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

1449

equivalent means of security acceptable to the department, such

1450

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

1451

account or financial institution, payable to the Florida Drug,

1452

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

1453

secure payment of any administrative penalties imposed by the

1454

department and any fees and costs incurred by the department

1455

regarding that permit which are authorized under state law and

1456

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

1457

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

1458

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

1459

be valid or until 60 days after any administrative or legal

1460

proceeding authorized in this part ss. 499.001-499.081 which

1461

involves the permittee is concluded, including any appeal,

1462

whichever occurs later.

1463

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

1464

wholesaler must maintain at all times a license or permit to

1465

engage in the wholesale distribution of prescription drugs in

1466

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

1467

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

1468

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

1469

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

1470

establishment that is duly licensed as a prescription drug

1471

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

1472

licensed prescription drug wholesale distributor wholesaler in

1473

this state, if both wholesale distributors wholesalers conduct

1474

wholesale distributions of prescription drugs under the same

1475

business name. The recordkeeping requirements of ss. s.

1476

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

1477

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

1478

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

1479

distributor wholesaler is a retail pharmacy engaged in wholesale

1480

distribution of prescription drugs within this state under the

1481

following conditions:

1482

1. The pharmacy must obtain a retail pharmacy drug

1483

wholesale distributor wholesaler's permit pursuant to this part

1484

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

1485

sections.

1486

2. The wholesale distribution activity does not exceed 30

1487

percent of the total annual purchases of prescription drugs. If

1488

the wholesale distribution activity exceeds the 30-percent

1489

maximum, the pharmacy must obtain a prescription drug wholesale

1490

distributor wholesaler's permit.

1491

3. The transfer of prescription drugs that appear in any

1492

schedule contained in chapter 893 is subject to chapter 893 and

1493

the federal Comprehensive Drug Abuse Prevention and Control Act

1494

of 1970.

1495

4. The transfer is between a retail pharmacy and another

1496

retail pharmacy, or a Modified Class II institutional pharmacy,

1497

or a health care practitioner licensed in this state and

1498

authorized by law to dispense or prescribe prescription drugs.

1499

5. All records of sales of prescription drugs subject to

1500

this section must be maintained separate and distinct from other

1501

records and comply with the recordkeeping requirements of this

1502

part ss. 499.001-499.081.

1503

(g)499.014 Restricted prescription drug distributor permit

1504

Distribution of legend drugs by hospitals, health care entities,

1505

charitable organizations, and return or destruction companies;

1506

permits, general requirements.--

1507

(1) A restricted prescription drug distributor permit is

1508

required for any person that engages in the distribution of a

1509

prescription legend drug, which distribution is not considered

1510

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

1511

499.012(1)(a)1.

1512

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

1513

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

1514

processing its return or its destruction must obtain a permit as

1515

a restricted prescription drug distributor if such person is not

1516

the person initiating the return, the prescription drug wholesale

1517

supplier of the person initiating the return, or the manufacturer

1518

of the drug.

1519

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

1520

distributions must comply with the requirements for wholesale

1521

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

1522

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

1523

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

1524

prescription drug distributor, or for the renewal of such a

1525

permit, must provide to the department the information required

1526

under s. 499.012 s. 499.01.

1527

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

1528

prescription drug distributors and may adopt rules regarding the

1529

distribution of prescription drugs by hospitals, health care

1530

entities, charitable organizations, or other persons not involved

1531

in wholesale distribution, which rules are necessary for the

1532

protection of the public health, safety, and welfare.

1533

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

1534

drug distributor permit is required for any person that engages

1535

in the distribution of a complimentary drug, subject to the

1536

requirements of s. 499.028.

1537

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

1538

permit is required for any person that engages in the

1539

distribution of a prescription legend drug as a freight forwarder

1540

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

1541

recordkeeping of such distributions must comply with the

1542

requirements for wholesale distributors under s. 499.0121, but

1543

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

1544

freight forwarder must provide the source of the prescription

1545

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

1546

other appropriate documentation to evidence the exportation of

1547

the product.

1548

(j) Veterinary prescription drug retail establishment

1549

permit.--A veterinary prescription drug retail establishment

1550

permit is required for any person that sells veterinary

1551

prescription drugs to the public but does not include a pharmacy

1552

licensed under chapter 465.

1553

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

1554

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

1555

client-veterinarian relationship with the purchaser's animal.

1556

2. Veterinary prescription drugs may not be sold in excess

1557

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

1558

indicated on the order.

1559

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

1560

4. A veterinary prescription drug retail establishment may

1561

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

1562

any controlled substance as defined in chapter 893.

1563

5. A veterinary prescription drug retail establishment must

1564

sell a veterinary prescription drug in the original, sealed

1565

manufacturer's container with all labeling intact and legible.

1566

The department may adopt by rule additional labeling requirements

1567

for the sale of a veterinary prescription drug.

1568

6. A veterinary prescription drug retail establishment must

1569

comply with all of the wholesale distribution requirements of s.

1570

499.0121.

1571

7. Prescription drugs sold by a veterinary prescription

1572

drug retail establishment pursuant to a practitioner's order may

1573

not be returned into the retail establishment's inventory.

1574

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

1575

wholesaler permit.--A veterinary prescription drug wholesale

1576

distributor wholesaler permit is required for any person that

1577

engages in the distribution of veterinary prescription drugs in

1578

or into this state. A veterinary prescription drug wholesale

1579

distributor wholesaler that also distributes prescription drugs

1580

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

1581

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

1582

obtain a permit as a prescription drug wholesale distributor

1583

wholesaler, an out-of-state prescription drug wholesale

1584

distributor wholesaler, or a limited prescription drug veterinary

1585

wholesale distributor wholesaler in lieu of the veterinary

1586

prescription drug wholesale distributor wholesaler permit. A

1587

veterinary prescription drug wholesale distributor wholesaler

1588

must comply with the requirements for wholesale distributors

1589

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

1590

s. 499.0121(6)(d).

1591

(l)(h) Limited prescription drug veterinary wholesale

1592

distributor wholesaler permit.--Unless engaging in the activities

1593

of and permitted as a prescription drug manufacturer, nonresident

1594

prescription drug manufacturer, prescription drug wholesale

1595

distributor wholesaler, or out-of-state prescription drug

1596

wholesale distributor wholesaler, a limited prescription drug

1597

veterinary wholesale distributor wholesaler permit is required

1598

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

1599

state of veterinary prescription drugs and prescription drugs

1600

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

1601

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

1602

1. The person is engaged in the business of wholesaling

1603

prescription and veterinary prescription legend drugs to persons:

1604

a. Licensed as veterinarians practicing on a full-time

1605

basis;

1606

b. Regularly and lawfully engaged in instruction in

1607

veterinary medicine;

1608

c. Regularly and lawfully engaged in law enforcement

1609

activities;

1610

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

1611

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

1612

purposes of instruction in law enforcement activities, research,

1613

or testing.

1614

2. No more than 30 percent of total annual prescription

1615

drug sales may be prescription drugs approved for human use which

1616

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

1617

Federal Food, Drug, and Cosmetic Act.

1618

3. The person does not distribute is not permitted,

1619

licensed, or otherwise authorized in any jurisdiction state to

1620

wholesale prescription drugs subject to, defined by, or described

1621

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

1622

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

1623

use these drugs on or for humans.

1624

4. A limited prescription drug veterinary wholesale

1625

distributor wholesaler that applies to the department for a new

1626

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

1627

or other equivalent means of security acceptable to the

1628

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

1629

in a trust account or financial institution, payable to the

1630

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

1631

bond is to secure payment of any administrative penalties imposed

1632

by the department and any fees and costs incurred by the

1633

department regarding that permit which are authorized under state

1634

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

1635

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

1636

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

1637

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

1638

legal proceeding authorized in this part ss. 499.001-499.081

1639

which involves the permittee is concluded, including any appeal,

1640

whichever occurs later.

1641

5. A limited prescription drug veterinary wholesale

1642

distributor wholesaler must maintain at all times a license or

1643

permit to engage in the wholesale distribution of prescription

1644

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

1645

resident.

1646

6. A limited prescription drug veterinary wholesale

1647

distributor wholesaler must comply with the requirements for

1648

wholesale distributors under ss. s. 499.0121 and 499.01212,

1649

except that a limited prescription drug veterinary wholesale

1650

distributor wholesaler is not required to provide a pedigree

1651

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

1652

wholesale distribution of a prescription drug to a veterinarian.

1653

7. A limited prescription drug veterinary wholesale

1654

distributor wholesaler may not return to inventory for subsequent

1655

wholesale distribution any prescription drug subject to, defined

1656

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

1657

Cosmetic Act which has been returned by a veterinarian.

1658

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

1659

A limited prescription drug veterinary wholesale distributor

1660

wholesaler permit is not required for an intracompany sale or

1661

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

1662

establishment that is duly licensed to engage in the wholesale

1663

distribution of prescription drugs in its state of residence to a

1664

licensed limited prescription drug veterinary wholesale

1665

distributor wholesaler in this state if both wholesale

1666

distributors wholesalers conduct wholesale distributions of

1667

prescription drugs under the same business name. The

1668

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

1669

must be followed for this transaction.

1670

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

1671

oxygen retail establishment permit is required for any person

1672

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

1673

based on an order from a practitioner authorized by law to

1674

prescribe. The term does not include a pharmacy licensed under

1675

chapter 465.

1676

1. A medical oxygen retail establishment may not possess,

1677

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

1678

oxygen.

1679

2. A medical oxygen retail establishment may refill medical

1680

oxygen for an individual patient based on an order from a

1681

practitioner authorized by law to prescribe. A medical oxygen

1682

retail establishment that refills medical oxygen must comply with

1683

all appropriate state and federal good manufacturing practices.

1684

3. A medical oxygen retail establishment must comply with

1685

all of the wholesale distribution requirements of s. 499.0121.

1686

4. Prescription medical oxygen sold by a medical oxygen

1687

retail establishment pursuant to a practitioner's order may not

1688

be returned into the retail establishment's inventory.

1689

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

1690

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

1691

distributor wholesaler is a wholesale distributor that is limited

1692

to the wholesale distribution of compressed medical gases to

1693

other than the consumer or patient. The compressed medical gas

1694

must be in the original sealed container that was purchased by

1695

that wholesale distributor wholesaler. A compressed medical gas

1696

wholesale distributor wholesaler may not possess or engage in the

1697

wholesale distribution of any prescription drug other than

1698

compressed medical gases. The department shall adopt rules that

1699

govern the wholesale distribution of prescription medical oxygen

1700

for emergency use. With respect to the emergency use of

1701

prescription medical oxygen, those rules may not be inconsistent

1702

with rules and regulations of federal agencies unless the

1703

Legislature specifically directs otherwise.

1704

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

1705

compressed medical gas manufacturer manufacturer's permit is

1706

required for any person that engages in the manufacture of

1707

compressed medical gases or repackages compressed medical gases

1708

from one container to another.

1709

1. A compressed medical gas manufacturer permittee may not

1710

manufacture or possess any prescription drug other than

1711

compressed medical gases.

1712

2. A compressed medical gas manufacturer permittee may

1713

engage in wholesale distribution of compressed medical gases

1714

manufactured at that establishment and must comply with all the

1715

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

1716

under this part those sections that apply to a wholesale

1717

distributor.

1718

3. A compressed medical gas manufacturer permittee must

1719

comply with all appropriate state and federal good manufacturing

1720

practices.

1721

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

1722

the-counter drug manufacturer manufacturer's permit is required

1723

for any person that engages in the manufacture or repackaging of

1724

an over-the-counter drug.

1725

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

1726

possess or purchase prescription drugs.

1727

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

1728

drug manufacturer manufacturer's permit if it is operating in

1729

compliance with pharmacy practice standards as defined in chapter

1730

465 and the rules adopted under that chapter.

1731

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

1732

comply with all appropriate state and federal good manufacturing

1733

practices.

1734

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

1735

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

1736

the manufacture, repackaging, or assembly of medical devices for

1737

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

1738

the person is engaged only in manufacturing, repackaging, or

1739

assembling a medical device pursuant to a practitioner's order

1740

for a specific patient.

1741

1. A manufacturer or repackager of medical devices in this

1742

state must comply with all appropriate state and federal good

1743

manufacturing practices and quality system rules.

1744

2. The department shall adopt rules related to storage,

1745

handling, and recordkeeping requirements for manufacturers of

1746

medical devices for human use.

1747

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

1748

manufacturer manufacturer's permit is required for any person

1749

that manufactures or repackages cosmetics in this state. A person

1750

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

1751

not open the container sealed by the manufacturer of the product

1752

is exempt from obtaining a permit under this paragraph.

1753

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

1754

logistics provider permit is required for any person that

1755

contracts with a prescription drug wholesale distributor or

1756

prescription drug manufacturer to provide warehousing,

1757

distribution, or other logistics services on behalf of a

1758

manufacturer or wholesale distributor, but who does not take

1759

title to the prescription drug or have responsibility to direct

1760

the sale or disposition of the prescription drug. Each third

1761

party logistics provider permittee shall comply with all of the

1762

provisions required of a wholesale distributor under this part,

1763

with the exception of s. 499.01212 for those wholesale

1764

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

1765

that the department requires.

1766

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

1767

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

1768

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

1769

business at one general physical location owned and operated by a

1770

professional corporation or professional limited liability

1771

company described in chapter 621. For the purpose of this

1772

paragraph, the term "qualifying practitioner" means a licensed

1773

health care practitioner defined in s. 456.001 or a veterinarian

1774

licensed under chapter 474, who is authorized under the

1775

appropriate practice act to prescribe and administer a

1776

prescription drug without supervision or a protocol.

1777

1. An establishment must provide, as part of the

1778

application required under s. 499.012, designation of a

1779

qualifying practitioner who will be responsible for complying

1780

with all legal and regulatory requirements related to the

1781

purchase, recordkeeping, storage, and handling of the

1782

prescription drugs. In addition, the designated qualifying

1783

practitioner shall be the practitioner whose name, establishment

1784

address, and license number is used on all distribution documents

1785

for prescription drugs purchased or returned by the health care

1786

clinic establishment.

1787

2. The health care clinic establishment must employ a

1788

qualifying practitioner who practices full-time at the

1789

establishment.

1790

3. Upon employment of a qualifying practitioner, the health

1791

care clinic establishment shall notify the department on a form

1792

furnished by the department within 10 days after such employment.

1793

In addition, the health care clinic establishment shall notify

1794

the department within 10 days after any subsequent changes in the

1795

licensure, employment, or practice status of the qualifying

1796

practitioner.

1797

4. 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

5. A health care clinic establishment may not purchase a

1803

controlled substance as defined under chapter 893.

1804

6. Administration of prescription drugs purchased by the

1805

health care clinic establishment is prohibited during any period

1806

of time when the establishment does not comply with this

1807

paragraph.

1808

Section 11. Section 499.012, Florida Statutes, is amended

1809

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

1810

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

1811

section and amended, to read:

1812

499.012 Permit application Wholesale distribution;

1813

definitions; permits; applications; general requirements.--

1814

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

1815

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

1816

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

1817

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

1818

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

1819

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

1820

age.

1821

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

1822

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

1823

499.081.

1824

1825

manufacture or distribute prescription legend drugs may not use a

1826

name identical to the name used by any other establishment or

1827

licensed person authorized to purchase prescription drugs in this

1828

state, except that a restricted drug distributor permit issued to

1829

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

1830

institutional pharmacy permit is issued and a retail pharmacy

1831

drug wholesale distributor wholesaler will be issued a permit in

1832

the name of its retail pharmacy permit.

1833

(d) A permit for a prescription drug manufacturer,

1834

prescription drug repackager, prescription drug wholesale

1835

distributor wholesaler, limited prescription drug veterinary

1836

wholesale distributor wholesaler, or retail pharmacy drug

1837

wholesale distributor wholesaler may not be issued to the address

1838

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

1839

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

1840

issue a prescription drug manufacturer permit to an applicant at

1841

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

1842

health care entity, for the purpose of manufacturing prescription

1843

drugs used in positron emission tomography or other

1844

radiopharmaceuticals, as listed in a rule adopted by the

1845

department pursuant to this paragraph. The purpose of this

1846

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

1847

pharmaceuticals that would pose a significant danger to the

1848

public health if manufactured at a separate establishment address

1849

from the nuclear pharmacy from which the prescription drugs are

1850

dispensed. The department may also issue a retail pharmacy drug

1851

wholesale distributor wholesaler permit to the address of a

1852

community pharmacy licensed under chapter 465 which does not meet

1853

the definition of a closed pharmacy in s. 499.003.

1854

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

1855

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

1856

2003, for any establishment that requires a permit pursuant to

1857

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

1858

a current permit issued by the department for the establishment.

1859

Upon presentation of the requisite permit issued by the

1860

department, an occupational license may be issued by the

1861

municipality or county in which application is made. The

1862

department shall furnish to local agencies responsible for

1863

issuing occupational licenses a current list of all

1864

establishments licensed pursuant to this part ss. 499.001-

1865

499.081.

1866

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

1867

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

1868

that person by completing a new application for the requested

1869

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

1870

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

1871

permit, and meeting the applicable permitting conditions for the

1872

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

1873

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

1874

prescription drug wholesale distributor wholesaler, an out-of-

1875

state prescription drug wholesale distributor wholesaler, or a

1876

retail pharmacy drug wholesale distributor wholesaler shall

1877

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

1878

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

1879

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

1880

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

1881

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

1882

permit must be filed with the department on forms furnished by

1883

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

1884

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

1885

applicant must submit to the department with the application a

1886

statement that swears or affirms that the information is true and

1887

correct.

1888

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

1889

wholesale distributor wholesaler or an out-of-state prescription

1890

drug wholesale distributor wholesaler, an application for a

1891

permit must include:

1892

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

1893

the applicant;

1894

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

1895

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

1896

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

1897

handling, and distribution of prescription drugs;

1898

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

1899

partnership, corporation, or sole proprietorship; and

1900

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

1901

establishment, including:

1902

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

1903

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

1904

of the partnership;

1905

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

1906

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

1907

state of incorporation;

1908

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

1909

proprietor and the name of the business entity;

1910

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

1911

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

1912

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

1913

company was organized; and

1914

f. Any other relevant information that the department

1915

requires.

1916

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

1917

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

1918

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

1919

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

1920

sections.

1921

1922

must be submitted to the department before the change occurs.

1923

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

1924

following factors in reviewing the qualifications of persons to

1925

be permitted under this part ss. 499.001-499.081:

1926

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

1927

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

1928

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

1929

cosmetic. A plea of nolo contendere constitutes a finding of

1930

guilt for purposes of this subparagraph.

1931

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

1932

agency in any state for any offense that would constitute a

1933

violation of this part ss. 499.001-499.081.

1934

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

1935

state, or local law;

1936

4. The applicant's past experience in manufacturing or

1937

distributing drugs, devices, or cosmetics;

1938

5. The furnishing by the applicant of false or fraudulent

1939

material in any application made in connection with manufacturing

1940

or distributing drugs, devices, or cosmetics;

1941

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

1942

government of any permit currently or previously held by the

1943

applicant for the manufacture or distribution of any drugs,

1944

devices, or cosmetics;

1945

7. Compliance with permitting requirements under any

1946

previously granted permits;

1947

8. Compliance with requirements to maintain or make

1948

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

1949

or local law enforcement officials those records required under

1950

this section; and

1951

9. Any other factors or qualifications the department

1952

considers relevant to and consistent with the public health and

1953

safety.

1954

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

1955

wholesale distributor wholesalers or an out-of-state prescription

1956

drug wholesale distributor wholesalers:

1957

(a) The department shall adopt rules for the biennial

1958

renewal of permits.

1959

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

1960

renewal application and renewal fee if the applicant meets the

1961

requirements established under this part ss. 499.001-499.081 and

1962

the rules adopted under this part those sections.

1963

1964

automatically expires 2 years after the last day of the

1965

anniversary month in which the permit was originally issued. A

1966

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

1967

by making application for renewal on forms furnished by the

1968

department and paying the appropriate fees. If a renewal

1969

application and fee are submitted and postmarked after the

1970

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

1971

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

1972

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

1973

date.

1974

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

1975

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

1976

issued pursuant to this part section has expired and cannot be

1977

renewed, before an establishment may engage in activities that

1978

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

1979

establishment must submit an application for a new permit, pay

1980

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

1981

applicable penalties, and be issued a new permit by the

1982

department.

1983

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

1984

nontransferable. Each permit is valid only for the person or

1985

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

1986

sale, assignment, or other transfer, voluntarily or

1987

involuntarily; nor is a permit valid for any establishment other

1988

than the establishment for which it was originally issued.

1989

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

1990

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

1991

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

1992

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

1993

majority of the ownership or controlling interest of a permitted

1994

establishment is transferred or assigned or when a lessee agrees

1995

to undertake or provide services to the extent that legal

1996

liability for operation of the establishment will rest with the

1997

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

1998

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

1999

2. A permittee that is authorized to distribute

2000

prescription legend drugs may transfer such drugs to the new

2001

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

2002

lessee has been approved for a permit to distribute prescription

2003

legend drugs.

2004

2005

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

2006

writing before the effective date of closure and must:

2007

1. Return the permit to the department;

2008

2. If the permittee is authorized to distribute

2009

prescription legend drugs, indicate the disposition of such

2010

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

2011

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

2012

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

2013

499.001-499.081. Transfer of ownership of prescription legend

2014

drugs may be made only to persons authorized to possess

2015

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

2016

2017

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

2018

comply with the requirements of this subsection.

2019

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

2020

the licensed premises.

2021

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

2022

a prescription drug wholesale distributor wholesaler or an out-

2023

of-state prescription drug wholesale distributor wholesaler

2024

submitted to the department must include:

2025

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

2026

of the applicant.

2027

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

2028

2029

contact persons for each facility used by the applicant for the

2030

storage, handling, and distribution of prescription drugs.

2031

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

2032

partnership, corporation, or sole proprietorship.

2033

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

2034

establishment, including:

2035

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

2036

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

2037

of the partnership.

2038

3. If a corporation:

2039

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

2040

and director.

2041

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

2042

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

2043

corporation's state of incorporation.

2044

c. The name and address of each shareholder of the

2045

corporation that owns 5 percent or more of the outstanding stock

2046

of the corporation.

2047

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

2048

proprietor and the name of the business entity.

2049

5. If a limited liability company:

2050

a. The name and address of each member.

2051

b. The name and address of each manager.

2052

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

2053

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

2054

of the state in which the limited liability company was

2055

organized.

2056

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

2057

the affiliated group of which the applicant is a member.

2058

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

2059

annual dollar volume of prescription drug sales of the applicant,

2060

the estimated annual percentage of the applicant's total company

2061

sales that are prescription drugs, the applicant's estimated

2062

annual total dollar volume of purchases of prescription drugs,

2063

and the applicant's estimated annual total dollar volume of

2064

prescription drug purchases directly from manufacturers.

2065

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

2066

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

2067

dollar volume of prescription drug sales made in the previous 6

2068

months, the percentage of total company sales that were

2069

prescription drugs in the previous year, the total dollar volume

2070

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

2071

total dollar volume of prescription drug purchases directly from

2072

manufacturers in the previous year.

2073

2074

Such portions of the information required pursuant to this

2075

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

2076

shall be maintained by the department as trade secret information

2077

is required to be maintained under s. 499.051.

2078

(h) The tax year of the applicant.

2079

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

2080

applicant's establishment is located, if the establishment is

2081

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

2082

the property on which applicant's establishment is located that

2083

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

2084

establishment is not owned by the applicant.

2085

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

2086

applicant by any other state which authorize the applicant to

2087

purchase or possess prescription drugs.

2088

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

2089

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

2090

highest ranking employees responsible for prescription drug

2091

wholesale operations for the establishment, and the name of all

2092

affiliated parties for the establishment, together with the

2093

personal information statement and fingerprints required pursuant

2094

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

2095

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

2096

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

2097

with the personal information statement and fingerprints required

2098

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

2099

(m) For an applicant that is a secondary wholesale

2100

distributor wholesaler, each of the following:

2101

1. A personal background information statement containing

2102

the background information and fingerprints required pursuant to

2103

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

2104

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

2105

of the applicant.

2106

2. If any of the five largest shareholders of the

2107

corporation seeking the permit is a corporation, the name,

2108

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

2109

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

2110

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

2111

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

2112

incorporation; and the name and address of each shareholder of

2113

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

2114

corporation.

2115

3. The name and address of all financial institutions in

2116

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

2117

operation of the establishment or to pay for drugs purchased for

2118

the establishment, together with the names of all persons that

2119

are authorized signatories on such accounts. The portions of the

2120

information required pursuant to this subparagraph which are a

2121

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

2122

the department as trade secret information is required to be

2123

maintained under s. 499.051.

2124

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

2125

used to purchase or finance purchases of prescription drugs or to

2126

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

2127

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

2128

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

2129

such funds.

2130

(n) Any other relevant information that the department

2131

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

2132

to whether the applicant satisfies the definition of a primary

2133

wholesale distributor wholesaler or a secondary wholesale

2134

distributor wholesaler.

2135

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

2136

provide a personal information statement and fingerprints shall

2137

provide the following information to the department on forms

2138

prescribed by the department:

2139

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

2140

2. The person's date and place of birth.

2141

3. The person's occupations, positions of employment, and

2142

offices held during the past 7 years.

2143

4. The principal business and address of any business,

2144

corporation, or other organization in which each such office of

2145

the person was held or in which each such occupation or position

2146

of employment was carried on.

2147

5. Whether the person has been, during the past 7 years,

2148

the subject of any proceeding for the revocation of any license

2149

and, if so, the nature of the proceeding and the disposition of

2150

the proceeding.

2151

6. Whether, during the past 7 years, the person has been

2152

enjoined, either temporarily or permanently, by a court of

2153

competent jurisdiction from violating any federal or state law

2154

regulating the possession, control, or distribution of

2155

prescription drugs, together with details concerning any such

2156

event.

2157

7. A description of any involvement by the person with any

2158

business, including any investments, other than the ownership of

2159

stock in a publicly traded company or mutual fund, during the

2160

past 7 years, which manufactured, administered, prescribed,

2161

distributed, or stored pharmaceutical products and any lawsuits

2162

in which such businesses were named as a party.

2163

8. A description of any felony criminal offense of which

2164

the person, as an adult, was found guilty, regardless of whether

2165

adjudication of guilt was withheld or whether the person pled

2166

guilty or nolo contendere. A criminal offense committed in

2167

another jurisdiction which would have been a felony in this state

2168

must be reported. If the person indicates that a criminal

2169

conviction is under appeal and submits a copy of the notice of

2170

appeal of that criminal offense, the applicant must, within 15

2171

days after the disposition of the appeal, submit to the

2172

department a copy of the final written order of disposition.

2173

9. A photograph of the person taken in the previous 30

2174

days.

2175

10. A set of fingerprints for the person on a form and

2176

under procedures specified by the department, together with

2177

payment of an amount equal to the costs incurred by the

2178

department for the criminal record check of the person.

2179

11. The name, address, occupation, and date and place of

2180

birth for each member of the person's immediate family who is 18

2181

years of age or older. As used in this subparagraph, the term

2182

"member of the person's immediate family" includes the person's

2183

spouse, children, parents, siblings, the spouses of the person's

2184

children, and the spouses of the person's siblings.

2185

12. Any other relevant information that the department

2186

requires.

2187

(b) The information required pursuant to paragraph (a)

2188

shall be provided under oath.

2189

2190

by a person for initial licensure to the Department of Law

2191

Enforcement for a statewide criminal record check and for

2192

forwarding to the Federal Bureau of Investigation for a national

2193

criminal record check of the person. The department shall submit

2194

the fingerprints provided by a person as a part of a renewal

2195

application to the Department of Law Enforcement for a statewide

2196

criminal record check, and for forwarding to the Federal Bureau

2197

of Investigation for a national criminal record check, for the

2198

initial renewal of a permit after January 1, 2004; for any

2199

subsequent renewal of a permit, the department shall submit the

2200

required information for a statewide and national criminal record

2201

check of the person. Any person who as a part of an initial

2202

permit application or initial permit renewal after January 1,

2203

2004, submits to the department a set of fingerprints required

2204

for the criminal record check required in this paragraph shall

2205

not be required to provide a subsequent set of fingerprints for a

2206

criminal record check to the department, if the person has

2207

undergone a criminal record check as a condition of the issuance

2208

of an initial permit or the initial renewal of a permit of an

2209

applicant after January 1, 2004.

2210

(10)(5) The department may deny an application for a permit

2211

or refuse to renew a permit for a prescription drug wholesale

2212

distributor wholesaler or an out-of-state prescription drug

2213

wholesale distributor wholesaler if:

2214

(a) The applicant has not met the requirements for the

2215

permit.

2216

(b) The management, officers, or directors of the applicant

2217

or any affiliated party are found by the department to be

2218

incompetent or untrustworthy.

2219

2220

wholesale distributor as to make the issuance of the proposed

2221

permit hazardous to the public health.

2222

(d) The applicant is so lacking in experience in managing a

2223

wholesale distributor as to jeopardize the reasonable promise of

2224

successful operation of the wholesale distributor.

2225

(e) The applicant is lacking in experience in the

2226

distribution of prescription drugs.

2227

(f) The applicant's past experience in manufacturing or

2228

distributing prescription drugs indicates that the applicant

2229

poses a public health risk.

2230

(g) The applicant is affiliated directly or indirectly

2231

through ownership, control, or other business relations, with any

2232

person or persons whose business operations are or have been

2233

detrimental to the public health.

2234

(h) The applicant, or any affiliated party, has been found

2235

guilty of or has pleaded guilty or nolo contendere to any felony

2236

or crime punishable by imprisonment for 1 year or more under the

2237

laws of the United States, any state, or any other country,

2238

regardless of whether adjudication of guilt was withheld.

2239

(i) The applicant or any affiliated party has been charged

2240

with a felony in a state or federal court and the disposition of

2241

that charge is pending during the application review or renewal

2242

review period.

2243

(j) The applicant has furnished false or fraudulent

2244

information or material in any application made in this state or

2245

any other state in connection with obtaining a permit or license

2246

to manufacture or distribute drugs, devices, or cosmetics.

2247

(k) That a federal, state, or local government permit

2248

currently or previously held by the applicant, or any affiliated

2249

party, for the manufacture or distribution of any drugs, devices,

2250

or cosmetics has been disciplined, suspended, or revoked and has

2251

not been reinstated.

2252

(l) The applicant does not possess the financial or

2253

physical resources to operate in compliance with the permit being

2254

sought, this chapter, and the rules adopted under this chapter.

2255

(m) The applicant or any affiliated party receives,

2256

directly or indirectly, financial support and assistance from a

2257

person who was an affiliated party of a permittee whose permit

2258

was subject to discipline or was suspended or revoked, other than

2259

through the ownership of stock in a publicly traded company or a

2260

mutual fund.

2261

(n) The applicant or any affiliated party receives,

2262

directly or indirectly, financial support and assistance from a

2263

person who has been found guilty of any violation of this part

2264

ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893,

2265

any rules adopted under any of this part those sections or those

2266

chapters, any federal or state drug law, or any felony where the

2267

underlying facts related to drugs, regardless of whether the

2268

person has been pardoned, had her or his civil rights restored,

2269

or had adjudication withheld, other than through the ownership of

2270

stock in a publicly traded company or a mutual fund.

2271

(o) The applicant for renewal of a permit under s.

2272

499.01(2)(d) paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c)

2273

has not actively engaged in the wholesale distribution of

2274

prescription drugs, as demonstrated by the regular and systematic

2275

distribution of prescription drugs throughout the year as

2276

evidenced by not fewer than 12 wholesale distributions in the

2277

previous year and not fewer than three wholesale distributions in

2278

the previous 6 months.

2279

(p) Information obtained in response to s. 499.01(2)(d)

2280

paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates

2281

it would not be in the best interest of the public health,

2282

safety, and welfare to issue a permit.

2283

(q) The applicant does not possess the financial standing

2284

and business experience for the successful operation of the

2285

applicant.

2286

(r) The applicant or any affiliated party has failed to

2287

comply with the requirements for manufacturing or distributing

2288

prescription drugs under this part ss. 499.001-499.081, similar

2289

federal laws, similar laws in other states, or the rules adopted

2290

under such laws.

2291

(11)(6) Upon approval of the application by the department

2292

and payment of the required fee, the department shall issue or

2293

renew a prescription drug wholesale distributor wholesaler or an

2294

out-of-state prescription drug wholesale distributor wholesaler

2295

permit to the applicant.

2296

(12)(7) For a permit permits for a prescription drug

2297

wholesale distributor wholesalers or an out-of-state prescription

2298

drug wholesale distributor wholesalers:

2299

(a) The department shall adopt rules for the annual renewal

2300

of permits. At least 90 days before the expiration of a permit,

2301

the department shall forward a permit renewal notification and

2302

renewal application to the prescription drug wholesale

2303

distributor wholesaler or out-of-state prescription drug

2304

wholesale distributor wholesaler at the mailing address of the

2305

permitted establishment on file with the department. The permit

2306

renewal notification must state conspicuously the date on which

2307

the permit for the establishment will expire and that the

2308

establishment may not operate unless the permit for the

2309

establishment is renewed timely.

2310

(b) A permit, unless sooner suspended or revoked,

2311

automatically expires 1 year after the last day of the

2312

anniversary month in which the permit was originally issued. A

2313

permit may be renewed by making application for renewal on forms

2314

furnished by the department and paying the appropriate fees. If a

2315

renewal application and fee are submitted and postmarked after 45

2316

days prior to the expiration date of the permit, the permit may

2317

be renewed only upon payment of a late renewal fee of $100, plus

2318

the required renewal fee. A permittee that has submitted a

2319

renewal application in accordance with this paragraph may

2320

continue to operate under its permit, unless the permit is

2321

suspended or revoked, until final disposition of the renewal

2322

application.

2323

2324

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

2325

issued pursuant to this section has expired and cannot be

2326

renewed, before an establishment may engage in activities that

2327

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

2328

establishment must submit an application for a new permit; pay

2329

the applicable application fee, initial permit fee, and all

2330

applicable penalties; and be issued a new permit by the

2331

department.

2332

(13)(8) A person that engages in wholesale distribution of

2333

prescription drugs in this state must have a wholesale

2334

distributor's permit issued by the department, except as noted in

2335

this section. Each establishment must be separately permitted

2336

except as noted in this subsection.

2337

(a) A separate establishment permit is not required when a

2338

permitted prescription drug wholesale distributor wholesaler

2339

consigns a prescription drug to a pharmacy that is permitted

2340

under chapter 465 and located in this state, provided that:

2341

1. The consignor wholesale distributor wholesaler notifies

2342

the department in writing of the contract to consign prescription

2343

drugs to a pharmacy along with the identity and location of each

2344

consignee pharmacy;

2345

2. The pharmacy maintains its permit under chapter 465;

2346

3. The consignor wholesale distributor wholesaler, which

2347

has no legal authority to dispense prescription drugs, complies

2348

with all wholesale distribution requirements of ss. s. 499.0121

2349

and 499.01212 with respect to the consigned drugs and maintains

2350

records documenting the transfer of title or other completion of

2351

the wholesale distribution of the consigned prescription drugs;

2352

4. The distribution of the prescription drug is otherwise

2353

lawful under this chapter and other applicable law;

2354

5. Open packages containing prescription drugs within a

2355

pharmacy are the responsibility of the pharmacy, regardless of

2356

how the drugs are titled; and

2357

6. The pharmacy dispenses the consigned prescription drug

2358

in accordance with the limitations of its permit under chapter

2359

465 or returns the consigned prescription drug to the consignor

2360

wholesale distributor wholesaler. In addition, a person who holds

2361

title to prescription drugs may transfer the drugs to a person

2362

permitted or licensed to handle the reverse distribution or

2363

destruction of drugs. Any other distribution by and means of the

2364

consigned prescription drug by any person, not limited to the

2365

consignor wholesale distributor wholesaler or consignee pharmacy,

2366

to any other person is prohibited.

2367

(b) A wholesale distributor's permit is not required for

2368

the one-time transfer of title of a pharmacy's lawfully acquired

2369

prescription drug inventory by a pharmacy with a valid permit

2370

issued under chapter 465 to a consignor prescription drug

2371

wholesale distributor wholesaler, permitted under this chapter,

2372

in accordance with a written consignment agreement between the

2373

pharmacy and that wholesale distributor wholesaler if: the

2374

permitted pharmacy and the permitted prescription drug wholesale

2375

distributor wholesaler comply with all of the provisions of

2376

paragraph (a) and the prescription drugs continue to be within

2377

the permitted pharmacy's inventory for dispensing in accordance

2378

with the limitations of the pharmacy permit under chapter 465. A

2379

consignor drug wholesale distributor wholesaler may not use the

2380

pharmacy as a wholesale distributor through which it distributes

2381

the prescription legend drugs to other pharmacies. Nothing in

2382

this section is intended to prevent a wholesale drug distributor

2383

from obtaining this inventory in the event of nonpayment by the

2384

pharmacy.

2385

2386

permitted prescription drug wholesale distributor operates

2387

temporary transit storage facilities for the sole purpose of

2388

storage, for a period not to exceed 12 hours, of a delivery of

2389

prescription drugs when the wholesale distributor was temporarily

2390

unable to complete the delivery to the recipient.

2391

(d)(c) The department shall require information from each

2392

wholesale distributor as part of the permit and renewal of such

2393

permit, as required under s. 499.01 or this section.

2394

(14)(9) Personnel employed in wholesale distribution must

2395

have appropriate education and experience to enable them to

2396

perform their duties in compliance with state permitting

2397

requirements.

2398

(15)(10) The name of a permittee or establishment on a

2399

prescription drug wholesale distributor wholesaler permit or an

2400

out-of-state prescription drug wholesale distributor wholesaler

2401

permit may not include any indicia of attainment of any

2402

educational degree, any indicia that the permittee or

2403

establishment possesses a professional license, or any name or

2404

abbreviation that the department determines is likely to cause

2405

confusion or mistake or that the department determines is

2406

deceptive, including that of any other entity authorized to

2407

purchase prescription drugs.

2408

(16)(11)(a) Each establishment that is issued an initial or

2409

renewal permit as a prescription drug wholesale distributor

2410

wholesaler or an out-of-state prescription drug wholesale

2411

distributor wholesaler must designate in writing to the

2412

department at least one natural person to serve as the designated

2413

representative of the wholesale distributor wholesaler. Such

2414

person must have an active certification as a designated

2415

representative from the department.

2416

(b) To be certified as a designated representative, a

2417

natural person must:

2418

1. Submit an application on a form furnished by the

2419

department and pay the appropriate fees;

2420

2. Be at least 18 years of age;

2421

3. Have not less than 2 years of verifiable full-time work

2422

experience in a pharmacy licensed in this state or another state,

2423

where the person's responsibilities included, but were not

2424

limited to, recordkeeping for prescription drugs, or have not

2425

less than 2 years of verifiable full-time managerial experience

2426

with a prescription drug wholesale distributor wholesaler

2427

licensed in this state or in another state;

2428

4. Receive a passing score of at least 75 percent on an

2429

examination given by the department regarding federal laws

2430

governing distribution of prescription drugs and this part ss.

2431

499.001-499.081 and the rules adopted by the department governing

2432

the wholesale distribution of prescription drugs. This

2433

requirement shall be effective 1 year after the results of the

2434

initial examination are mailed to the persons that took the

2435

examination. The department shall offer such examinations at

2436

least four times each calendar year; and

2437

5. Provide the department with a personal information

2438

statement and fingerprints pursuant to subsection (9)(4).

2439

2440

certification as a designated representative or may suspend or

2441

revoke a certification of a designated representative pursuant to

2442

s. 499.067.

2443

(d) A designated representative:

2444

1. Must be actively involved in and aware of the actual

2445

daily operation of the wholesale distributor.

2446

2. Must be employed full time in a managerial position by

2447

the wholesale distributor.

2448

3. Must be physically present at the establishment during

2449

normal business hours, except for time periods when absent due to

2450

illness, family illness or death, scheduled vacation, or other

2451

authorized absence.

2452

4. May serve as a designated representative for only one

2453

wholesale distributor at any one time.

2454

(e) A wholesale distributor must notify the department when

2455

a designated representative leaves the employ of the wholesale

2456

distributor. Such notice must be provided to the department

2457

within 10 business days after the last day of designated

2458

representative's employment with the wholesale distributor.

2459

(f) A wholesale distributor may not operate under a

2460

prescription drug wholesale distributor wholesaler permit or an

2461

out-of-state prescription drug wholesale distributor wholesaler

2462

permit for more than 10 business days after the designated

2463

representative leaves the employ of the wholesale distributor,

2464

unless the wholesale distributor employs another designated

2465

representative and notifies the department within 10 business

2466

days of the identity of the new designated representative.

2467

Section 12. Section 499.01201, Florida Statutes, is amended

2468

to read:

2469

499.01201 Agency for Health Care Administration review and

2470

use of statute and rule violation or compliance

2471

data.--Notwithstanding any other provisions of law to the

2472

contrary, the Agency for Health Care Administration may not:

2473

(1) Review or use any violation or alleged violation of s.

2474

499.0121(6) or s. 499.01212, or any rules adopted under those

2475

sections that section, as a ground for denying or withholding any

2476

payment of a Medicaid reimbursement to a pharmacy licensed under

2477

chapter 465; or

2478

(2) Review or use compliance with s. 499.0121(6) or s.

2479

499.01212, or any rules adopted under those sections that

2480

section, as the subject of any audit of Medicaid-related records

2481

held by a pharmacy licensed under chapter 465.

2482

Section 13. Section 499.0121, Florida Statutes, is amended,

2483

and subsection (4) of section 499.013, Florida Statutes, is

2484

redesignated as paragraph (d) of subsection (6) of that section

2485

and amended, to read:

2486

499.0121 Storage and handling of prescription drugs;

2487

recordkeeping.--The department shall adopt rules to implement

2488

this section as necessary to protect the public health, safety,

2489

and welfare. Such rules shall include, but not be limited to,

2490

requirements for the storage and handling of prescription drugs

2491

and for the establishment and maintenance of prescription drug

2492

distribution records.

2493

(1) ESTABLISHMENTS.--An establishment at which prescription

2494

drugs are stored, warehoused, handled, held, offered, marketed,

2495

or displayed must:

2496

(a) Be of suitable size and construction to facilitate

2497

cleaning, maintenance, and proper operations;

2498

(b) Have storage areas designed to provide adequate

2499

lighting, ventilation, temperature, sanitation, humidity, space,

2500

equipment, and security conditions;

2501

2502

drugs that are outdated, damaged, deteriorated, misbranded, or

2503

adulterated, or that are in immediate or sealed, secondary

2504

containers that have been opened;

2505

(d) Be maintained in a clean and orderly condition; and

2506

(e) Be free from infestation by insects, rodents, birds, or

2507

vermin of any kind.

2508

(2) SECURITY.--

2509

(a) An establishment that is used for wholesale drug

2510

distribution must be secure from unauthorized entry.

2511

1. Access from outside the premises must be kept to a

2512

minimum and be well-controlled.

2513

2. The outside perimeter of the premises must be well-

2514

lighted.

2515

3. Entry into areas where prescription drugs are held must

2516

be limited to authorized personnel.

2517

(b) An establishment that is used for wholesale drug

2518

distribution must be equipped with:

2519

1. An alarm system to detect entry after hours; however,

2520

the department may exempt by rule establishments that only hold a

2521

permit as prescription drug wholesale distributor-brokers

2522

wholesaler-brokers and establishments that only handle medical

2523

oxygen; and

2524

2. A security system that will provide suitable protection

2525

against theft and diversion. When appropriate, the security

2526

system must provide protection against theft or diversion that is

2527

facilitated or hidden by tampering with computers or electronic

2528

records.

2529

2530

secure from unauthorized access to the prescription drugs in the

2531

vehicle.

2532

(3) STORAGE.--All prescription drugs shall be stored at

2533

appropriate temperatures and under appropriate conditions in

2534

accordance with requirements, if any, in the labeling of such

2535

drugs, or with requirements in the official compendium.

2536

(a) If no storage requirements are established for a

2537

prescription drug, the drug may be held at "controlled" room

2538

temperature, as defined in the official compendium, to help

2539

ensure that its identity, strength, quality, and purity are not

2540

adversely affected.

2541

(b) Appropriate manual, electromechanical, or electronic

2542

temperature and humidity recording equipment, devices, or logs

2543

must be used to document proper storage of prescription drugs.

2544

2545

be followed for all stored prescription drugs.

2546

(4) EXAMINATION OF MATERIALS AND RECORDS.--

2547

(a) Upon receipt, each outside shipping container must be

2548

visually examined for identity and to prevent the acceptance of

2549

contaminated prescription drugs that are otherwise unfit for

2550

distribution. This examination must be adequate to reveal

2551

container damage that would suggest possible contamination or

2552