ENROLLED
2014 Legislature CS for CS for SB 836, 1st Engrossed
2014836er
1
2 An act relating to medical gas; amending s. 499.001,
3 F.S.; conforming provisions to changes made by this
4 act; amending s. 499.003, F.S.; revising terms;
5 amending ss. 499.01 and 499.0121, F.S.; conforming
6 provisions to changes made by this act; amending s.
7 499.01211, F.S.; adding a member to the Drug Wholesale
8 Distributor Advisory Council; authorizing the
9 Compressed Gas Association to recommend one person to
10 the council for appointment; amending ss. 499.041,
11 499.05, 499.051, 499.066, 499.0661, and 499.067, F.S.;
12 conforming provisions to changes made by this act;
13 creating part III of ch. 499, F.S., entitled “Medical
14 Gas”; creating s. 499.81, F.S.; providing for the
15 administration and enforcement of this part; creating
16 s. 499.82, F.S.; defining terms; creating s. 499.83,
17 F.S.; requiring a person or entity that intends to
18 distribute medical gas within or into this state to
19 obtain an applicable permit before operating;
20 establishing categories of permits and setting
21 requirements for each; creating s. 499.831, F.S.;
22 requiring the Department of Business and Professional
23 Regulation to establish the form and content of an
24 application; authorizing the department to set fees
25 within certain parameters; creating s. 499.832, F.S.;
26 providing that a permit expires 2 years after the last
27 day of the month in which the permit was originally
28 issued; providing requirements for the renewal of a
29 permit; requiring the department to adopt rules for
30 the renewal of permits; creating s. 499.833, F.S.;
31 authorizing the department to approve certain
32 permitholder changes; creating s. 499.834, F.S.;
33 authorizing the department to consider certain factors
34 in determining the eligibility of an applicant;
35 creating s. 499.84, F.S.; setting the minimum
36 requirements for the storage and handling of medical
37 gas; creating s. 499.85, F.S.; setting facility
38 requirements for security purposes; authorizing a
39 vehicle used for on-call delivery of oxygen USP and
40 oxygen-related equipment to be parked at a place of
41 residence; requiring the department to adopt rules
42 governing the distribution of medical oxygen; creating
43 s. 499.86, F.S.; requiring a wholesale distributor of
44 medical gases to visually examine a medical gas
45 container upon receipt in order to identify the
46 medical gas stored within and to determine if the
47 container has been damaged or is otherwise unfit for
48 distribution; requiring a medical gas container that
49 is damaged or otherwise unfit for distribution to be
50 quarantined; requiring outgoing shipments of medical
51 gas to be inspected; requiring wholesale distributors
52 to review certain records; creating s. 499.87, F.S.;
53 authorizing the return of medical gas that has left
54 the control of a wholesale distributor; requiring that
55 medical gas that is damaged, misbranded, or
56 adulterated be quarantined from other medical gases
57 until it is destroyed or returned to the manufacturer
58 or wholesale distributor from which it was acquired;
59 creating s. 499.88, F.S.; requiring a wholesale
60 distributor to obtain certain information before the
61 initial acquisition of a medical gas; providing
62 certain exemptions; creating s. 499.89, F.S.;
63 requiring a permitholder under this part to establish
64 and maintain transactional records; providing a
65 retention period for certain records and requiring
66 that such records be available for inspection during
67 that period; creating s. 499.90, F.S.; requiring a
68 wholesale distributor to establish, maintain, and
69 adhere to certain written policies and procedures;
70 creating s. 499.91, F.S.; prohibiting certain acts;
71 creating s. 499.92, F.S.; establishing criminal
72 penalties; authorizing property or assets subject to
73 forfeiture to be seized pursuant to a warrant;
74 creating s. 499.93, F.S.; authorizing the department
75 to require a facility that engages in the manufacture,
76 retail sale, or wholesale distribution of medical gas
77 to undergo an inspection; authorizing the department
78 to authorize a third party to inspect such facilities;
79 creating s. 499.931, F.S.; providing that trade secret
80 information required to be submitted pursuant to this
81 part must be maintained by the department; creating s.
82 499.94, F.S.; requiring fees collected pursuant to
83 this part to be deposited into the Professional
84 Regulation Trust Fund; amending ss. 409.9201, 460.403,
85 465.0265, 499.01212, 499.015, and 499.024, F.S.;
86 conforming cross-references; providing an effective
87 date.
88
89 Be It Enacted by the Legislature of the State of Florida:
90
91 Section 1. Section 499.001, Florida Statutes, is amended to
92 read:
93 499.001 Florida Drug and Cosmetic Act; short title.
94 Sections 499.001-499.94 499.001-499.081 may be cited as the
95 “Florida Drug and Cosmetic Act.”
96 Section 2. Subsections (12) through (32) and subsections
97 (47) through (55) of section 499.003, Florida Statutes, are
98 renumbered as subsections (11) through (31) and subsections (46)
99 through (54), respectively, and present subsections (11), (43),
100 and (46) of that section are amended, to read:
101 499.003 Definitions of terms used in this part.—As used in
102 this part, the term:
103 (32)(11) “Compressed Medical gas” means any liquefied or
104 vaporized gas that is a prescription drug, whether it is alone
105 or in combination with other gases, and as defined in the
106 federal act.
107 (43) “Prescription drug” means a prescription, medicinal,
108 or legend drug, including, but not limited to, finished dosage
109 forms or active pharmaceutical ingredients subject to, defined
110 by, or described by s. 503(b) of the federal Food, Drug, and
111 Cosmetic act or s. 465.003(8), s. 499.007(13), or subsection
112 (32) (11), subsection (46), or subsection (52) (53), except that
113 an active pharmaceutical ingredient is a prescription drug only
114 if substantially all finished dosage forms in which it may be
115 lawfully dispensed or administered in this state are also
116 prescription drugs.
117 (46) “Prescription medical oxygen” means oxygen USP which
118 is a drug that can only be sold on the order or prescription of
119 a practitioner authorized by law to prescribe. The label of
120 prescription medical oxygen must comply with current labeling
121 requirements for oxygen under the Federal Food, Drug, and
122 Cosmetic Act.
123 Section 3. Subsection (1), paragraphs (a), (c), (g), (m),
124 (n), and (o) of subsection (2), and subsection (5) of section
125 499.01, Florida Statutes, are amended to read:
126 499.01 Permits.—
127 (1) Prior to operating, a permit is required for each
128 person and establishment that intends to operate as:
129 (a) A prescription drug manufacturer;
130 (b) A prescription drug repackager;
131 (c) A nonresident prescription drug manufacturer;
132 (d) A prescription drug wholesale distributor;
133 (e) An out-of-state prescription drug wholesale
134 distributor;
135 (f) A retail pharmacy drug wholesale distributor;
136 (g) A restricted prescription drug distributor;
137 (h) A complimentary drug distributor;
138 (i) A freight forwarder;
139 (j) A veterinary prescription drug retail establishment;
140 (k) A veterinary prescription drug wholesale distributor;
141 (l) A limited prescription drug veterinary wholesale
142 distributor;
143 (m) A medical oxygen retail establishment;
144 (n) A compressed medical gas wholesale distributor;
145 (o) A compressed medical gas manufacturer;
146 (m)(p) An over-the-counter drug manufacturer;
147 (n)(q) A device manufacturer;
148 (o)(r) A cosmetic manufacturer;
149 (p)(s) A third party logistics provider; or
150 (q)(t) A health care clinic establishment.
151 (2) The following permits are established:
152 (a) Prescription drug manufacturer permit.—A prescription
153 drug manufacturer permit is required for any person that is a
154 manufacturer of a prescription drug and that manufactures or
155 distributes such prescription drugs in this state.
156 1. A person that operates an establishment permitted as a
157 prescription drug manufacturer may engage in wholesale
158 distribution of prescription drugs manufactured at that
159 establishment and must comply with all of the provisions of this
160 part, except s. 499.01212, and the rules adopted under this
161 part, except s. 499.01212, which apply to a wholesale
162 distributor.
163 2. A prescription drug manufacturer must comply with all
164 appropriate state and federal good manufacturing practices.
165 3. A blood establishment, as defined in s. 381.06014,
166 operating in a manner consistent with the provisions of 21
167 C.F.R. parts 211 and 600-640, and manufacturing only the
168 prescription drugs described in s. 499.003(53)(d) s.
169 499.003(54)(d) is not required to be permitted as a prescription
170 drug manufacturer under this paragraph or to register products
171 under s. 499.015.
172 (c) Nonresident prescription drug manufacturer permit.—A
173 nonresident prescription drug manufacturer permit is required
174 for any person that is a manufacturer of prescription drugs,
175 unless permitted as a third party logistics provider, located
176 outside of this state or outside the United States and that
177 engages in the wholesale distribution in this state of such
178 prescription drugs. Each such manufacturer must be permitted by
179 the department and comply with all of the provisions required of
180 a wholesale distributor under this part, except s. 499.01212.
181 1. A person that distributes prescription drugs for which
182 the person is not the manufacturer must also obtain an out-of
183 state prescription drug wholesale distributor permit or third
184 party logistics provider permit pursuant to this section to
185 engage in the wholesale distribution of such prescription drugs.
186 This subparagraph does not apply to a manufacturer as defined in
187 s. 499.003(30)(e) s. 499.003(31)(e).
188 2. Any such person must comply with the licensing or
189 permitting requirements of the jurisdiction in which the
190 establishment is located and the federal act, and any product
191 wholesaled into this state must comply with this part. If a
192 person intends to import prescription drugs from a foreign
193 country into this state, the nonresident prescription drug
194 manufacturer must provide to the department a list identifying
195 each prescription drug it intends to import and document
196 approval by the United States Food and Drug Administration for
197 such importation.
198 (g) Restricted prescription drug distributor permit.—
199 1. A restricted prescription drug distributor permit is
200 required for:
201 a. Any person located in this state who engages in the
202 distribution of a prescription drug, which distribution is not
203 considered “wholesale distribution” under s. 499.003(53)(a) s.
204 499.003(54)(a).
205 b. Any person located in this state who engages in the
206 receipt or distribution of a prescription drug in this state for
207 the purpose of processing its return or its destruction if such
208 person is not the person initiating the return, the prescription
209 drug wholesale supplier of the person initiating the return, or
210 the manufacturer of the drug.
211 c. A blood establishment located in this state which
212 collects blood and blood components only from volunteer donors
213 as defined in s. 381.06014 or pursuant to an authorized
214 practitioner’s order for medical treatment or therapy and
215 engages in the wholesale distribution of a prescription drug not
216 described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
217 care entity. A mobile blood unit operated by a blood
218 establishment permitted under this sub-subparagraph is not
219 required to be separately permitted. The health care entity
220 receiving a prescription drug distributed under this sub
221 subparagraph must be licensed as a closed pharmacy or provide
222 health care services at that establishment. The blood
223 establishment must operate in accordance with s. 381.06014 and
224 may distribute only:
225 (I) Prescription drugs indicated for a bleeding or clotting
226 disorder or anemia;
227 (II) Blood-collection containers approved under s. 505 of
228 the federal act;
229 (III) Drugs that are blood derivatives, or a recombinant or
230 synthetic form of a blood derivative;
231 (IV) Prescription drugs that are identified in rules
232 adopted by the department and that are essential to services
233 performed or provided by blood establishments and authorized for
234 distribution by blood establishments under federal law; or
235 (V) To the extent authorized by federal law, drugs
236 necessary to collect blood or blood components from volunteer
237 blood donors; for blood establishment personnel to perform
238 therapeutic procedures under the direction and supervision of a
239 licensed physician; and to diagnose, treat, manage, and prevent
240 any reaction of a volunteer blood donor or a patient undergoing
241 a therapeutic procedure performed under the direction and
242 supervision of a licensed physician,
243
244 as long as all of the health care services provided by the blood
245 establishment are related to its activities as a registered
246 blood establishment or the health care services consist of
247 collecting, processing, storing, or administering human
248 hematopoietic stem cells or progenitor cells or performing
249 diagnostic testing of specimens if such specimens are tested
250 together with specimens undergoing routine donor testing. The
251 blood establishment may purchase and possess the drugs described
252 in this sub-subparagraph without a health care clinic
253 establishment permit.
254 2. Storage, handling, and recordkeeping of these
255 distributions by a person required to be permitted as a
256 restricted prescription drug distributor must be in accordance
257 with the requirements for wholesale distributors under s.
258 499.0121, but not those set forth in s. 499.01212 if the
259 distribution occurs pursuant to sub-subparagraph 1.a. or sub
260 subparagraph 1.b.
261 3. A person who applies for a permit as a restricted
262 prescription drug distributor, or for the renewal of such a
263 permit, must provide to the department the information required
264 under s. 499.012.
265 4. The department may adopt rules regarding the
266 distribution of prescription drugs by hospitals, health care
267 entities, charitable organizations, other persons not involved
268 in wholesale distribution, and blood establishments, which rules
269 are necessary for the protection of the public health, safety,
270 and welfare.
271 (m) Medical oxygen retail establishment permit.—A medical
272 oxygen retail establishment permit is required for any person
273 that sells medical oxygen to patients only. The sale must be
274 based on an order from a practitioner authorized by law to
275 prescribe. The term does not include a pharmacy licensed under
276 chapter 465.
277 1. A medical oxygen retail establishment may not possess,
278 purchase, sell, or trade any prescription drug other than
279 medical oxygen.
280 2. A medical oxygen retail establishment may refill medical
281 oxygen for an individual patient based on an order from a
282 practitioner authorized by law to prescribe. A medical oxygen
283 retail establishment that refills medical oxygen must comply
284 with all appropriate state and federal good manufacturing
285 practices.
286 3. A medical oxygen retail establishment must comply with
287 all of the wholesale distribution requirements of s. 499.0121.
288 4. Prescription medical oxygen sold by a medical oxygen
289 retail establishment pursuant to a practitioner’s order may not
290 be returned into the retail establishment’s inventory.
291 (n) Compressed medical gas wholesale distributor permit.—A
292 compressed medical gas wholesale distributor is a wholesale
293 distributor that is limited to the wholesale distribution of
294 compressed medical gases to other than the consumer or patient.
295 The compressed medical gas must be in the original sealed
296 container that was purchased by that wholesale distributor. A
297 compressed medical gas wholesale distributor may not possess or
298 engage in the wholesale distribution of any prescription drug
299 other than compressed medical gases. The department shall adopt
300 rules that govern the wholesale distribution of prescription
301 medical oxygen for emergency use. With respect to the emergency
302 use of prescription medical oxygen, those rules may not be
303 inconsistent with rules and regulations of federal agencies
304 unless the Legislature specifically directs otherwise.
305 (o) Compressed medical gas manufacturer permit.—A
306 compressed medical gas manufacturer permit is required for any
307 person that engages in the manufacture of compressed medical
308 gases or repackages compressed medical gases from one container
309 to another.
310 1. A compressed medical gas manufacturer may not
311 manufacture or possess any prescription drug other than
312 compressed medical gases.
313 2. A compressed medical gas manufacturer may engage in
314 wholesale distribution of compressed medical gases manufactured
315 at that establishment and must comply with all the provisions of
316 this part and the rules adopted under this part that apply to a
317 wholesale distributor.
318 3. A compressed medical gas manufacturer must comply with
319 all appropriate state and federal good manufacturing practices.
320 (5) A prescription drug repackager permit issued under this
321 part is not required for a restricted prescription drug
322 distributor permitholder that is a health care entity to
323 repackage prescription drugs in this state for its own use or
324 for distribution to hospitals or other health care entities in
325 the state for their own use, pursuant to s. 499.003(53)(a)3. s.
326 499.003(54)(a)3., if:
327 (a) The prescription drug distributor notifies the
328 department, in writing, of its intention to engage in
329 repackaging under this exemption, 30 days before engaging in the
330 repackaging of prescription drugs at the permitted
331 establishment;
332 (b) The prescription drug distributor is under common
333 control with the hospitals or other health care entities to
334 which the prescription drug distributor is distributing
335 prescription drugs. As used in this paragraph, “common control”
336 means the power to direct or cause the direction of the
337 management and policies of a person or an organization, whether
338 by ownership of stock, voting rights, contract, or otherwise;
339 (c) The prescription drug distributor repackages the
340 prescription drugs in accordance with current state and federal
341 good manufacturing practices; and
342 (d) The prescription drug distributor labels the
343 prescription drug it repackages in accordance with state and
344 federal laws and rules.
345
346 The prescription drug distributor is exempt from the product
347 registration requirements of s. 499.015 with regard to the
348 prescription drugs that it repackages and distributes under this
349 subsection.
350 Section 4. Paragraph (b) of subsection (2) of section
351 499.0121, Florida Statutes, is amended to read:
352 499.0121 Storage and handling of prescription drugs;
353 recordkeeping.—The department shall adopt rules to implement
354 this section as necessary to protect the public health, safety,
355 and welfare. Such rules shall include, but not be limited to,
356 requirements for the storage and handling of prescription drugs
357 and for the establishment and maintenance of prescription drug
358 distribution records.
359 (2) SECURITY.—
360 (b) An establishment that is used for wholesale drug
361 distribution must be equipped with:
362 1. An alarm system to detect entry after hours; however,
363 the department may exempt by rule establishments that only hold
364 a permit as prescription drug wholesale distributor-brokers and
365 establishments that only handle medical oxygen; and
366 2. A security system that will provide suitable protection
367 against theft and diversion. When appropriate, the security
368 system must provide protection against theft or diversion that
369 is facilitated or hidden by tampering with computers or
370 electronic records.
371 Section 5. Subsections (1) and (2) of section 499.01211,
372 Florida Statutes, are amended to read:
373 499.01211 Drug Wholesale Distributor Advisory Council.—
374 (1) There is created the Drug Wholesale Distributor
375 Advisory Council within the department. The council shall meet
376 at least once each calendar quarter. Staff for the council shall
377 be provided by the department. The council shall consist of 12
378 11 members who shall serve without compensation. The council
379 shall elect a chairperson and a vice chairperson annually.
380 (2) The Secretary of Business and Professional Regulation
381 or his or her designee and the Secretary of Health Care
382 Administration or her or his designee shall be members of the
383 council. The Secretary of Business and Professional Regulation
384 shall appoint 10 nine additional members to the council who
385 shall be appointed to a term of 4 years each, as follows:
386 (a) Three different persons, each of whom is employed by a
387 different prescription drug wholesale distributor permitted
388 licensed under this part which operates nationally and is a
389 primary wholesale distributor, as defined in s. 499.003 s.
390 499.003(47).
391 (b) One person employed by a prescription drug wholesale
392 distributor permitted licensed under this part which is a
393 secondary wholesale distributor, as defined in s. 499.003 s.
394 499.003(52).
395 (c) One person employed by a retail pharmacy chain located
396 in this state.
397 (d) One person who is a member of the Board of Pharmacy and
398 is a pharmacist licensed under chapter 465.
399 (e) One person who is a physician licensed pursuant to
400 chapter 458 or chapter 459.
401 (f) One person who is an employee of a hospital licensed
402 pursuant to chapter 395 and is a pharmacist licensed pursuant to
403 chapter 465.
404 (g) One person who is an employee of a pharmaceutical
405 manufacturer.
406 (h) One person who is an employee of a permitted medical
407 gas manufacturer or medical gas wholesale distributor and who
408 has been recommended by the Compressed Gas Association.
409 Section 6. Paragraph (e) of subsection (1), paragraph (b)
410 of subsection (2), and paragraph (b) of subsection (3) of
411 section 499.041, Florida Statutes, are amended to read:
412 499.041 Schedule of fees for drug, device, and cosmetic
413 applications and permits, product registrations, and free-sale
414 certificates.—
415 (1) The department shall assess applicants requiring a
416 manufacturing permit an annual fee within the ranges established
417 in this section for the specific type of manufacturer.
418 (e) The fee for a compressed medical gas manufacturer
419 permit may not be less than $400 or more than $500 annually.
420 (2) The department shall assess an applicant that is
421 required to have a wholesaling permit an annual fee within the
422 ranges established in this section for the specific type of
423 wholesaling.
424 (b) The fee for a compressed medical gas wholesale
425 distributor permit may not be less than $200 or more than $300
426 annually.
427 (3) The department shall assess an applicant that is
428 required to have a retail establishment permit an annual fee
429 within the ranges established in this section for the specific
430 type of retail establishment.
431 (b) The fee for a medical oxygen retail establishment
432 permit may not be less than $200 or more than $300 annually.
433 Section 7. Section 499.05, Florida Statutes, is amended to
434 read:
435 499.05 Rules.—
436 (1) The department shall adopt rules to implement and
437 enforce this chapter part with respect to:
438 (a) The definition of terms used in this chapter part, and
439 used in the rules adopted under this chapter part, when the use
440 of the term is not its usual and ordinary meaning.
441 (b) Labeling requirements for drugs, devices, and
442 cosmetics.
443 (c) The establishment of fees authorized in this chapter
444 part.
445 (d) The identification of permits that require an initial
446 application and onsite inspection or other prerequisites for
447 permitting which demonstrate that the establishment and person
448 are in compliance with the requirements of this chapter part.
449 (e) The application processes and forms for product
450 registration.
451 (f) Procedures for requesting and issuing certificates of
452 free sale.
453 (g) Inspections and investigations conducted under s.
454 499.051 or s. 499.93, and the identification of information
455 claimed to be a trade secret and exempt from the public records
456 law as provided in s. 499.051(7).
457 (h) The establishment of a range of penalties, as provided
458 in s. 499.066; requirements for notifying persons of the
459 potential impact of a violation of this chapter part; and a
460 process for the uncontested settlement of alleged violations.
461 (i) Additional conditions that qualify as an emergency
462 medical reason under s. 499.003(53)(b)2. or s. 499.82 s.
463 499.003(54)(b)2.
464 (j) Procedures and forms relating to the pedigree paper
465 requirement of s. 499.01212.
466 (k) The protection of the public health, safety, and
467 welfare regarding good manufacturing practices that
468 manufacturers and repackagers must follow to ensure the safety
469 of the products.
470 (l) Information required from each retail establishment
471 pursuant to s. 499.012(3) or s. 499.83(2)(c), including
472 requirements for prescriptions or orders.
473 (m) The recordkeeping, storage, and handling with respect
474 to each of the distributions of prescription drugs specified in
475 s. 499.003(53)(a)-(d) or s. 499.82(14) s. 499.003(54)(a)-(d).
476 (n) Alternatives to compliance with s. 499.01212 for a
477 prescription drug in the inventory of a permitted prescription
478 drug wholesale distributor as of June 30, 2006, and the return
479 of a prescription drug purchased prior to July 1, 2006. The
480 department may specify time limits for such alternatives.
481 (o) Wholesale distributor reporting requirements of s.
482 499.0121(14).
483 (p) Wholesale distributor credentialing and distribution
484 requirements of s. 499.0121(15).
485 (2) With respect to products in interstate commerce, those
486 rules must not be inconsistent with rules and regulations of
487 federal agencies unless specifically otherwise directed by the
488 Legislature.
489 (3) The department shall adopt rules regulating
490 recordkeeping for and the storage, handling, and distribution of
491 medical devices and over-the-counter drugs to protect the public
492 from adulterated products.
493 Section 8. Subsections (1) through (4) of section 499.051,
494 Florida Statutes, are amended to read:
495 499.051 Inspections and investigations.—
496 (1) The agents of the department and of the Department of
497 Law Enforcement, after they present proper identification, may
498 inspect, monitor, and investigate any establishment permitted
499 pursuant to this chapter part during business hours for the
500 purpose of enforcing this chapter part, chapters 465, 501, and
501 893, and the rules of the department that protect the public
502 health, safety, and welfare.
503 (2) In addition to the authority set forth in subsection
504 (1), the department and any duly designated officer or employee
505 of the department may enter and inspect any other establishment
506 for the purpose of determining compliance with this chapter part
507 and rules adopted under this chapter part regarding any drug,
508 device, or cosmetic product.
509 (3) Any application for a permit or product registration or
510 for renewal of such permit or registration made pursuant to this
511 chapter part and rules adopted under this chapter part
512 constitutes permission for any entry or inspection of the
513 premises in order to verify compliance with this chapter part
514 and rules; to discover, investigate, and determine the existence
515 of compliance; or to elicit, receive, respond to, and resolve
516 complaints and violations.
517 (4) Any application for a permit made pursuant to s.
518 499.012 or s. 499.831 and rules adopted under those sections
519 that section constitutes permission for agents of the department
520 and the Department of Law Enforcement, after presenting proper
521 identification, to inspect, review, and copy any financial
522 document or record related to the manufacture, repackaging, or
523 distribution of a drug as is necessary to verify compliance with
524 this chapter part and the rules adopted by the department to
525 administer this chapter part, in order to discover, investigate,
526 and determine the existence of compliance, or to elicit,
527 receive, respond to, and resolve complaints and violations.
528 Section 9. Subsections (1) through (4) of section 499.066,
529 Florida Statutes, are amended to read:
530 499.066 Penalties; remedies.—In addition to other penalties
531 and other enforcement provisions:
532 (1) The department may institute such suits or other legal
533 proceedings as are required to enforce any provision of this
534 chapter part. If it appears that a person has violated any
535 provision of this chapter part for which criminal prosecution is
536 provided, the department may provide the appropriate state
537 attorney or other prosecuting agency having jurisdiction with
538 respect to such prosecution with the relevant information in the
539 department’s possession.
540 (2) If any person engaged in any activity covered by this
541 chapter part violates any provision of this chapter part, any
542 rule adopted under this chapter part, or a cease and desist
543 order as provided by this chapter part, the department may
544 obtain an injunction in the circuit court of the county in which
545 the violation occurred or in which the person resides or has its
546 principal place of business, and may apply in that court for
547 such temporary and permanent orders as the department considers
548 necessary to restrain the person from engaging in any such
549 activities until the person complies with this chapter part, the
550 rules adopted under this chapter part, and the orders of the
551 department authorized by this chapter part or to mandate
552 compliance with this chapter part, the rules adopted under this
553 chapter part, and any order or permit issued by the department
554 under this chapter part.
555 (3) The department may impose an administrative fine, not
556 to exceed $5,000 per violation per day, for the violation of any
557 provision of this chapter part or rules adopted under this
558 chapter part. Each day a violation continues constitutes a
559 separate violation, and each separate violation is subject to a
560 separate fine. All amounts collected pursuant to this section
561 shall be deposited into the Professional Regulation Trust Fund
562 and are appropriated for the use of the department in
563 administering this chapter part. In determining the amount of
564 the fine to be levied for a violation, the department shall
565 consider:
566 (a) The severity of the violation;
567 (b) Any actions taken by the person to correct the
568 violation or to remedy complaints; and
569 (c) Any previous violations.
570 (4) The department shall deposit any rewards, fines, or
571 collections that are due the department and which derive from
572 joint enforcement activities with other state and federal
573 agencies which relate to this chapter part, chapter 893, or the
574 federal act, into the Professional Regulation Trust Fund. The
575 proceeds of those rewards, fines, and collections are
576 appropriated for the use of the department in administering this
577 chapter part.
578 Section 10. Paragraph (a) of subsection (1) and paragraph
579 (a) of subsection (2) of section 499.0661, Florida Statutes, are
580 amended to read:
581 499.0661 Cease and desist orders; removal of certain
582 persons.—
583 (1) CEASE AND DESIST ORDERS.—
584 (a) In addition to any authority otherwise provided in this
585 chapter, the department may issue and serve a complaint stating
586 charges upon a any permittee or upon an any affiliated party,
587 whenever the department has reasonable cause to believe that the
588 person or individual named therein is engaging in or has engaged
589 in conduct that is:
590 1. An act that demonstrates a lack of fitness or
591 trustworthiness to engage in the business authorized under the
592 permit issued pursuant to this chapter part, is hazardous to the
593 public health, or constitutes business operations that are a
594 detriment to the public health;
595 2. A violation of a any provision of this chapter part;
596 3. A violation of a any rule of the department;
597 4. A violation of an any order of the department; or
598 5. A breach of a any written agreement with the department.
599 (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
600 (a) The department may issue and serve a complaint stating
601 charges upon an any affiliated party and upon the permittee
602 involved whenever the department has reason to believe that an
603 affiliated party is engaging in or has engaged in conduct that
604 constitutes:
605 1. An act that demonstrates a lack of fitness or
606 trustworthiness to engage in the business authorized under the
607 permit issued pursuant to this chapter part, is hazardous to the
608 public health, or constitutes business operations that are a
609 detriment to the public health;
610 2. A willful violation of this chapter part; however, if
611 the violation constitutes a misdemeanor, a complaint may not be
612 served as provided in this section until the affiliated party is
613 notified in writing of the matter of the violation and has been
614 afforded a reasonable period of time, as set forth in the
615 notice, to correct the violation and has failed to do so;
616 3. A violation of a any other law involving fraud or moral
617 turpitude which constitutes a felony;
618 4. A willful violation of a any rule of the department;
619 5. A willful violation of an any order of the department;
620 or
621 6. A material misrepresentation of fact, made knowingly and
622 willfully or made with reckless disregard for the truth of the
623 matter.
624 Section 11. Section 499.067, Florida Statutes, is amended
625 to read:
626 499.067 Denial, suspension, or revocation of permit,
627 certification, or registration.—
628 (1)(a) The department may deny, suspend, or revoke a permit
629 if it finds that there has been a substantial failure to comply
630 with this chapter part or chapter 465, chapter 501, or chapter
631 893, the rules adopted under this part or those chapters, any
632 final order of the department, or applicable federal laws or
633 regulations or other state laws or rules governing drugs,
634 devices, or cosmetics.
635 (b) The department may deny an application for a permit or
636 certification, or suspend or revoke a permit or certification,
637 if the department finds that:
638 1. The applicant is not of good moral character or that it
639 would be a danger or not in the best interest of the public
640 health, safety, and welfare if the applicant were issued a
641 permit or certification.
642 2. The applicant has not met the requirements for the
643 permit or certification.
644 3. The applicant is not eligible for a permit or
645 certification for any of the reasons enumerated in s. 499.012.
646 4. The applicant, permittee, or person certified under s.
647 499.012(16) demonstrates any of the conditions enumerated in s.
648 499.012.
649 5. The applicant, permittee, or person certified under s.
650 499.012(16) has committed any violation of this chapter ss.
651 499.005-499.0054.
652 (2) The department may deny, suspend, or revoke any
653 registration required by the provisions of this chapter part for
654 the violation of any provision of this chapter part or of any
655 rules adopted under this chapter part.
656 (3) The department may revoke or suspend a permit:
657 (a) If the permit was obtained by misrepresentation or
658 fraud or through a mistake of the department;
659 (b) If the permit was procured, or attempted to be
660 procured, for any other person by making or causing to be made
661 any false representation; or
662 (c) If the permittee has violated any provision of this
663 chapter part or rules adopted under this chapter part.
664 (4) If a any permit issued under this chapter part is
665 revoked or suspended, the owner, manager, operator, or
666 proprietor of the establishment shall cease to operate as the
667 permit authorized, from the effective date of the suspension or
668 revocation until the person is again registered with the
669 department and possesses the required permit. If a permit is
670 revoked or suspended, the owner, manager, or proprietor shall
671 remove all signs and symbols that identify the operation as
672 premises permitted as a drug wholesaling establishment; drug,
673 device, or cosmetic manufacturing establishment; or retail
674 establishment. The department shall determine the length of time
675 for which the permit is to be suspended. If a permit is revoked,
676 the person that owns or operates the establishment may not apply
677 for a any permit under this chapter part for a period of 1 year
678 after the date of the revocation. A revocation of a permit may
679 be permanent if the department considers that to be in the best
680 interest of the public health.
681 (5) The department may deny, suspend, or revoke a permit
682 issued under this chapter part which authorizes the permittee to
683 purchase prescription drugs if an any owner, officer, employee,
684 or other person who participates in administering or operating
685 the establishment has been found guilty of a any violation of
686 this chapter part or chapter 465, chapter 501, or chapter 893,
687 any rules adopted under this part or those chapters, or any
688 federal or state drug law, regardless of whether the person has
689 been pardoned, had her or his civil rights restored, or had
690 adjudication withheld.
691 (6) The department shall deny, suspend, or revoke the
692 permit of a any person or establishment if the assignment, sale,
693 transfer, or lease of an establishment permitted under this
694 chapter part will avoid an administrative penalty, civil action,
695 or criminal prosecution.
696 (7) Notwithstanding s. 120.60(5), if a permittee fails to
697 comply with s. 499.012(6) or s. 499.833, as applicable, the
698 department may revoke the permit of the permittee and shall
699 provide notice of the intended agency action by posting a notice
700 at the department’s headquarters and by mailing a copy of the
701 notice of intended agency action by certified mail to the most
702 recent mailing address on record with the department and, if the
703 permittee is not a natural person, to the permittee’s registered
704 agent on file with the Department of State.
705 (8) The department may deny, suspend, or revoke a permit
706 under this part if it finds the permittee has not complied with
707 the credentialing requirements of s. 499.0121(15).
708 (9) The department may deny, suspend, or revoke a permit
709 under this part if it finds the permittee has not complied with
710 the reporting requirements of, or knowingly made a false
711 statement in a report required by, s. 499.0121(14).
712 Section 12. Part III of chapter 499, Florida Statutes,
713 consisting of ss. 499.81-499.94, Florida Statutes, is created
714 and entitled “Medical Gas.”
715 Section 13. Section 499.81, Florida Statutes, is created to
716 read:
717 499.81 Administration and enforcement.—
718 (1) This part is cumulative and shall be construed and
719 applied as being in addition to, and not in substitution for or
720 limiting any powers, duties, or authority of the department
721 under any other law of this state; except that, with respect to
722 the regulation of medical gas, this part controls over any
723 conflicting provisions.
724 (2) The department shall administer and enforce this part
725 to prevent fraud, adulteration, misbranding, or false
726 advertising in the manufacture and distribution of medical
727 gases.
728 (3) For the purpose of an investigation or proceeding
729 conducted by the department under this part, the department may
730 administer oaths, take depositions, subpoena witnesses, and
731 compel the production of books, papers, documents, or other
732 records. Challenges to, and enforcement of, subpoenas and orders
733 shall be handled as provided in s. 120.569.
734 (4) Each state attorney, county attorney, or municipal
735 attorney to whom the department or its designated agent reports
736 a violation of this part shall cause appropriate proceedings to
737 be instituted in the proper courts without delay and prosecuted
738 as required by law.
739 (5) This part does not require the department to report,
740 for the purpose of instituting proceedings under this part,
741 minor violations of this part when the department believes that
742 the public interest will be adequately served by a written
743 notice or warning.
744 Section 14. Section 499.82, Florida Statutes, is created to
745 read:
746 499.82 Definitions.—As used in this part, the term:
747 (1) “Adulterated,” means a medical gas that:
748 (a) Consists, in whole or in part, of impurities or
749 deleterious substances exceeding normal specifications;
750 (b) Is produced, prepared, packed, or held under conditions
751 whereby the medical gas may have been contaminated causing it to
752 be rendered injurious to health; or if the methods used in, or
753 the facilities or controls used for, its manufacture,
754 processing, packing, or holding do not conform to or are not
755 operated or administered in conformity with current good
756 manufacturing practices to ensure that the medical gas meets the
757 requirements of this part as to safety and has the identity and
758 strength and meets the quality and purity characteristics that
759 the medical gas is represented to possess;
760 (c) Is held in a container with an interior that is
761 composed in whole or in part of a poisonous or deleterious
762 substance that may render the contents injurious to health; or
763 (d) Is represented as having a strength differing from, or
764 quality or purity falling below, the standard set forth in the
765 USP-NF. A medical gas defined in USP-NF may not be deemed to be
766 adulterated under this paragraph merely because it differs from
767 the standard of strength, quality, or purity set forth in the
768 USP-NF if its difference in strength, quality, or purity from
769 that standard is plainly stated on its label. The determination
770 as to strength, quality, or purity shall be made:
771 1. In accordance with the tests or methods of assay in the
772 USP-NF or its validated equivalent; or
773 2. In the absence or inadequacy of such tests or methods of
774 assay, in accordance with the tests or methods of assay
775 prescribed under the federal act.
776 (2) “Department” means the Department of Business and
777 Professional Regulation.
778 (3) “Distribute” or “distribution” means to sell; offer to
779 sell; deliver; offer to deliver; transfer by either the passage
780 of title, physical movement, or both; broker; or give away a
781 medical gas. The term does not include:
782 (a) The dispensing or administration of a medical gas;
783 (b) The delivery of, or an offer to deliver, a medical gas
784 by a common carrier in its usual course of business; or
785 (c) Sales activities taking place in a location owned,
786 controlled, or staffed by persons employed by a person or entity
787 permitted in this state to distribute a medical gas, if that
788 location is not used to physically store or move a medical gas.
789 (4) “Emergency medical reasons” include:
790 (a) Transfers between wholesale distributors or between a
791 wholesale distributor and a retail pharmacy or health care
792 entity to alleviate a temporary shortage of a medical gas
793 arising from a long-term delay or interruption of regular
794 distribution schedules.
795 (b) Sales, purchases, trades, transfers, or use of a
796 medical gas acquired by a medical director or licensed emergency
797 medical services provider for use by the emergency medical
798 services provider and its permitted transport and nontransport
799 vehicles in accordance with the provider’s license under part
800 III of chapter 401.
801 (c) The provision of emergency supplies of medical gases to
802 nursing homes during the hours of the day when necessary medical
803 gases cannot normally be obtained from the nursing home’s
804 regular distributors.
805 (d) The transfer of medical gases between retail pharmacies
806 to alleviate a temporary shortage.
807 (5) “Emergency use oxygen” means oxygen USP administered in
808 emergency situations without a prescription for oxygen
809 deficiency and resuscitation. The container must be labeled in
810 accordance with requirements of the United States Food and Drug
811 Administration.
812 (6) “Federal act” means the Federal Food, Drug, and
813 Cosmetic Act.
814 (7) “Medical gas” means a liquefied or vaporized gas that
815 is a prescription drug, whether alone or in combination with
816 other gases, and as defined in the federal act.
817 (8) “Medical gas-related equipment” means a device used as
818 a component part or accessory used to contain or control the
819 flow, delivery, or pressure during the administration of a
820 medical gas, such as liquid oxygen base and portable units,
821 pressure regulators and flow meters, and oxygen concentrators.
822 (9) “Misbranded” means having a label that is false or
823 misleading; a label without the name and address of the
824 manufacturer, packer, or distributor and without an accurate
825 statement of the quantities of active ingredients; or a label
826 without an accurate monograph for the medical gas, except in the
827 case of mixtures of designated medical gases where the label
828 identifies the component percentages of each designated medical
829 gas used to make the mixture.
830 (10) “Medical oxygen” means oxygen USP which must be
831 labeled in compliance with labeling requirements for oxygen
832 under the federal act.
833 (11) “Product labeling” means the labels and other written,
834 printed, or graphic matter upon an article, or the containers or
835 wrappers that accompany an article, except for letters, numbers,
836 and symbols stamped into the container as required by the
837 federal Department of Transportation.
838 (12) “USP” means the United States Pharmacopeia.
839 (13) “USP-NF” means the United States Pharmacopeia-National
840 Formulary.
841 (14) “Wholesale distribution” means the distribution of
842 medical gas to a person other than a consumer or patient.
843 Wholesale distribution of medical gases does not include:
844 (a) The sale, purchase, or trade of a medical gas; an offer
845 to sell, purchase, or trade a medical gas; or the dispensing of
846 a medical gas pursuant to a prescription;
847 (b) Activities exempt from the definition of wholesale
848 distribution in s. 499.003;
849 (c) The sale, purchase, or trade of a medical gas or an
850 offer to sell, purchase, or trade a medical gas for emergency
851 medical reasons; or
852 (d) Other transactions excluded from the definition of
853 wholesale distribution under the federal act or regulations
854 implemented under the federal act related to medical gas.
855 (15) “Wholesale distributor” means any person or entity
856 engaged in wholesale distribution of medical gas within or into
857 this state, including, but not limited to, manufacturers; own
858 label distributors; private-label distributors; warehouses,
859 including manufacturers’ and distributors’ warehouses; and
860 wholesale medical gas warehouses.
861 Section 15. Section 499.83, Florida Statutes, is created to
862 read:
863 499.83 Permits.—
864 (1) A person or entity that intends to distribute medical
865 gas within or into this state, unless exempted under this part,
866 must obtain the applicable permit before operating as:
867 (a) A medical gas wholesale distributor;
868 (b) A medical gas manufacturer; or
869 (c) A medical oxygen retail establishment.
870 (2) The following permits are established:
871 (a) Medical gas wholesale distributor permit.—A medical gas
872 wholesale distributor permit is required for wholesale
873 distribution, whether within or into this state. A medical gas
874 must remain in the original container obtained by the wholesale
875 distributor and the wholesale distributor may not engage in
876 further manufacturing operations unless it possesses a medical
877 gas manufacturer permit. A medical gas wholesale distributor may
878 not possess or engage in the wholesale distribution of a
879 prescription drug that is not a medical gas or distribute a
880 medical gas other than by wholesale distribution unless
881 otherwise authorized under this chapter.
882 (b) Medical gas manufacturer permit.—A medical gas
883 manufacturer permit is required for a person or entity located
884 in this state which engages in the manufacture of medical gases
885 by physical air separation, chemical action, purification, or
886 filling containers by a liquid-to-liquid, liquid-to-gas, or gas
887 to-gas process and distributes those medical gases within this
888 state.
889 1. A permitted medical gas manufacturer may not manufacture
890 or possess a prescription drug other than a medical gas, unless
891 otherwise authorized under this chapter.
892 2. A permitted medical gas manufacturer may not distribute
893 a medical gas without obtaining the applicable permit, except
894 that it may engage in wholesale distribution of medical gases
895 that it manufactured without obtaining a medical gas wholesale
896 distributor permit if it complies with this part and the rules
897 adopted under this part that apply to a wholesale distributor.
898 3. A permitted medical gas manufacturer shall comply with
899 all of the requirements applicable to a wholesale distributor
900 under this part and all appropriate state and federal good
901 manufacturing practices.
902 (c) Medical oxygen retail establishment permit.—A medical
903 oxygen retail establishment permit is required for an entity
904 that is located in the state and that sells or delivers medical
905 oxygen directly to patients in this state. The sale and delivery
906 must be based on a prescription or an order from a practitioner
907 authorized by law to prescribe. A pharmacy licensed under
908 chapter 465 does not require a permit as a medical oxygen retail
909 establishment.
910 1. A medical oxygen retail establishment may not possess,
911 purchase, sell, or trade a medical gas other than medical
912 oxygen, unless otherwise authorized under this chapter.
913 2. A medical oxygen retail establishment may fill and
914 deliver medical oxygen to an individual patient based on an
915 order from a practitioner authorized by law to prescribe. The
916 medical oxygen retail establishment must comply with all
917 appropriate state and federal good manufacturing practices.
918 Medical oxygen sold or delivered by a medical oxygen retail
919 establishment pursuant to an order from a practitioner may not
920 be returned into the retail establishment’s inventory.
921 3. A medical oxygen retail establishment shall comply with
922 all of the requirements applicable to a wholesale distributor
923 under this part, except for those requirements that pertain
924 solely to nitrous oxide.
925 (3) An out-of-state wholesale distributor that engages in
926 wholesale distribution into this state must be legally
927 authorized to engage in the wholesale distribution of medical
928 gases as a wholesale distributor in the state in which it
929 resides and provide proof of registration as set forth in s.
930 499.93(3), if required.
931 (4) A wholesale distributor may not operate from a place of
932 residence, and a place of residence may not be granted a permit
933 or operate under this part, except for the on-call delivery of
934 home care oxygen for wholesale distributors that also maintain a
935 medical oxygen retail establishment permit.
936 (5) If wholesale distribution is conducted at more than one
937 location within this state or more than one location
938 distributing into this state, each location must be permitted by
939 the department.
940 Section 16. Section 499.831, Florida Statutes, is created
941 to read:
942 499.831 Permit application.—
943 (1) The department shall adopt rules to establish the form
944 and content of the application to obtain a permit and to renew a
945 permit listed under this part.
946 (2) An applicant must be at least 18 years of age or be
947 managed, controlled, or overseen, directly or indirectly, by a
948 natural person who is at least 18 years of age.
949 (3) An application for a permit must be filed with the
950 department and must include all of the following information:
951 (a) The trade or business name of the applicant, including
952 current and former fictitious names, which may not be identical
953 to a name used by an unrelated entity permitted in this state to
954 dispense or distribute medical gas.
955 (b) The name or names of the owner and operator of the
956 applicant, if not the same person or entity. The application
957 must also include:
958 1. If the applicant is an individual, the applicant’s name,
959 business address, and date of birth.
960 2. If the applicant is a sole proprietorship, the business
961 address of the sole proprietor and the name and federal employer
962 identification number of the business entity.
963 3. If the applicant is a partnership, the name, business
964 address, date of birth of each partner, the name of the
965 partnership, and the partnership’s federal employer
966 identification number.
967 4. If the applicant is a limited liability company, the
968 name, business address, and title of each company officer, the
969 name of the limited liability company and federal employer
970 identification number, and the name of the state in which the
971 limited liability company was organized.
972 5. If the applicant is a corporation, the name, business
973 address, and title of each corporate officer and director, the
974 corporate names, the state of incorporation, the federal
975 employer identification number, and, if applicable, the name and
976 business address of the parent company.
977 (c) A list of disciplinary actions pertinent to wholesale
978 distributors, manufacturers, and retailers of prescription drugs
979 or controlled substances by a state or federal agency against
980 the applicant seeking to distribute into this state and any such
981 disciplinary actions against such applicant’s principals,
982 owners, directors, or officers.
983 (d) A complete disclosure of all of the applicant’s past
984 felony convictions.
985 (e) An address and description of each facility and
986 warehouse, including all locations used for medical gas storage
987 or wholesale distribution including a description of each
988 facility’s security system.
989 (4) An applicant shall attest in writing that the
990 information contained in its application is complete and
991 accurate.
992 (5) An applicant must submit a reasonable fee, to be
993 determined by the department, in order to obtain a permit.
994 (a) The fee for a medical gas wholesale distributor permit
995 may not be less than $200 or more than $300 annually.
996 (b) The fee for a medical gas manufacturer permit may not
997 be less than $400 or more than $500 annually.
998 (c) The fee for a medical oxygen retail establishment
999 permit may not be less than $200 or more than $300 annually.
1000 (6) Upon approval of the application by the department and
1001 payment of the required fee, the department shall issue a permit
1002 to the applicant pursuant to the rules adopted under this part.
1003 Section 17. Section 499.832, Florida Statutes, is created
1004 to read:
1005 499.832 Expiration and renewal of a permit.—
1006 (1) A permit issued under this part automatically expires 2
1007 years after the last day of the month in which the permit was
1008 originally issued.
1009 (2) A permit issued under this part may be renewed by
1010 submitting an application for renewal on a form furnished by the
1011 department and paying the appropriate fee. The application for
1012 renewal must contain a statement by the applicant attesting that
1013 the information is true and correct. Upon approval of a renewal
1014 application by the department and payment of the required
1015 renewal fee, the department shall renew a permit issued under
1016 this part pursuant to the rules adopted under this part.
1017 (3) A renewal application may be accepted up to 60 days
1018 after the expiration date of the permit if, along with the
1019 permit renewal fee, the applicant submits an additional renewal
1020 delinquent fee of $100. A permit that expired more than 60 days
1021 before a renewal application was submitted or postmarked may not
1022 be renewed.
1023 (4) Failure to renew a permit in accordance with this
1024 section precludes future renewal. If a permit has expired and
1025 cannot be renewed, the person, entity, or establishment holding
1026 the permit must cease all permit related activities. In order to
1027 engage in such activities, the person, entity, or establishment
1028 must submit an application for a new permit, pay the applicable
1029 application fee, the initial permit fee, and all applicable
1030 penalties, and be issued a new permit by the department before
1031 engaging in an activity that requires a permit under this part.
1032 (5) The department shall adopt rules to administer this
1033 section, including setting a reasonable fee for a renewal
1034 application.
1035 Section 18. Section 499.833, Florida Statutes, is created
1036 to read:
1037 499.833 Permitholder changes.—
1038 (1) A permit issued under this part is valid only for the
1039 person or entity to which it is issued and is not subject to
1040 sale, assignment, or other transfer, voluntarily or
1041 involuntarily.
1042 (2) A permit issued under this part is not valid for an
1043 establishment other than the establishment for which it was
1044 originally issued.
1045 (3) The department may approve the following permit
1046 changes:
1047 (a) Change of location.—A person or entity permitted under
1048 this part must notify and receive approval from the department
1049 before changing location. The department shall set a change-of
1050 location fee not to exceed $100.
1051 (b) Change in ownership.—If a majority of the ownership or
1052 controlling interest of a permitted establishment is transferred
1053 or assigned or if a lessee agrees to undertake or provide
1054 services such that legal liability for operation of the
1055 establishment will rest with the lessee, an application for a
1056 new permit is required. Such application must be submitted and
1057 approved by the department before the change of ownership takes
1058 place. However, if a permitted wholesale distributor or
1059 manufacturer is changing ownership and the new owner has held
1060 another permit that allows the wholesale distribution of medical
1061 gas under this chapter for the preceding 18 months without
1062 having been found in violation of the provisions of this chapter
1063 relating to medical gases, then the new owner may operate under
1064 the permit of the acquired entity if the new owner submits the
1065 application for a new permit by the first business day after
1066 ownership is transferred or assigned. A new owner operating
1067 under the original permit is responsible for compliance with all
1068 laws and regulations governing medical gas. If the application
1069 is denied, the new owner shall immediately cease operation at
1070 the establishment until a permit is issued to the new owner.
1071 (c) Change of name.—A permitholder may make a change of
1072 business name without submitting a new permit application.
1073 However, the permitholder must notify the department before
1074 making the name change.
1075 (d) Closure.—If an establishment permitted under this part
1076 closes, the owner must notify the department, in writing, before
1077 the effective date of the closure and must:
1078 1. Return the permit to the department; and
1079 2. Indicate the disposition of any medical gas authorized
1080 to be distributed or dispensed under the permit, including the
1081 name, address, and inventory, and provide the name and address
1082 of a person to contact regarding access to the records that are
1083 required to be maintained under this part. Transfer of ownership
1084 of medical gas may be made only to persons authorized to receive
1085 medical gas pursuant to this part.
1086 (e) Change in information.—Any change in the information
1087 required under this part, other than the changes in paragraphs
1088 (a)-(d), shall be submitted to the department within 30 days
1089 after such change occurs.
1090 (4) A permitholder in good standing may change the type of
1091 permit issued by completing a new application for the requested
1092 permit, meeting the applicable permitting requirements for the
1093 new permit type, and paying any difference between the permit
1094 fees. A refund may not be issued if the fee for the new permit
1095 is less than the fee that was paid for the original permit. The
1096 new permit retains the expiration date of the original permit.
1097 Section 19. Section 499.834, Florida Statutes, is created
1098 to read:
1099 499.834 Minimum qualifications.—The department shall
1100 consider all of the following factors in determining eligibility
1101 for, and renewal of, a permit for a person or entity under this
1102 part:
1103 (1) A finding by the department that the applicant has
1104 violated or been disciplined by a regulatory agency in any state
1105 for violating a federal, state, or local law relating to
1106 prescription drugs.
1107 (2) Felony convictions of the applicant under a federal,
1108 state, or local law.
1109 (3) The applicant’s past experience in the manufacture,
1110 retail, or distribution of medical gases.
1111 (4) False or fraudulent material provided by the applicant
1112 in an application made in connection with the manufacturing,
1113 retailing, or distribution of prescription drugs.
1114 (5) Any suspension, sanction, or revocation by a federal,
1115 state, or local government against a license or permit currently
1116 or previously held by the applicant or its owners for violations
1117 of a federal, state, or local law regarding prescription drugs.
1118 (6) Compliance with previously granted licenses or permits.
1119 (7) Compliance with the requirements that distributors or
1120 retailers of medical gases maintain records and make records
1121 available to the department licensing authority or federal,
1122 state, or local law enforcement officials.
1123 (8) Other factors or qualifications the department has
1124 established in rule that are relevant to and consistent with the
1125 public health and safety.
1126 Section 20. Section 499.84, Florida Statutes, is created to
1127 read:
1128 499.84 Minimum requirements for the storage and handling of
1129 medical gases.—
1130 (1) A facility where a medical gas is received, stored,
1131 warehoused, handled, held, offered, marketed, displayed, or
1132 transported, to avoid any negative effect on the identity,
1133 strength, quality, or purity of the medical gas, must:
1134 (a) Be of suitable construction to ensure that medical
1135 gases are maintained in accordance with the product labeling of
1136 the medical gas or in compliance with the USP-NF;
1137 (b) Be of suitable size and construction to facilitate
1138 cleaning, maintenance, and proper permitted operations;
1139 (c) Have adequate storage areas with appropriate lighting,
1140 ventilation, space, equipment, and security conditions;
1141 (d) Have a quarantined area for storage of medical gases
1142 that are suspected of being misbranded, adulterated, or
1143 otherwise unfit for distribution;
1144 (e) Be maintained in an orderly condition;
1145 (f) Be located in a commercial location and not in a
1146 personal dwelling or residence location, except that a personal
1147 dwelling location used for on-call delivery of oxygen USP for
1148 homecare use if the person providing on-call delivery is
1149 employed by or acting under a written contract with an entity
1150 that holds a medical oxygen retailer permit;
1151 (g) Provide for the secure and confidential storage of
1152 patient information, if applicable, with restricted access and
1153 policies and procedures to protect the integrity and
1154 confidentiality of patient information; and
1155 (h) Provide and maintain appropriate inventory controls to
1156 detect and document any theft of nitrous oxide.
1157 (2) Medical gas shall be stored under appropriate
1158 conditions in accordance with the manufacturer’s recommendations
1159 on product labeling and department rules or, in the absence of
1160 rules, in accordance with applicable industry standards.
1161 (3) Medical gas shall be packaged in accordance with
1162 official compendium standards, such as the USP-NF.
1163 Section 21. Section 499.85, Florida Statutes, is created to
1164 read:
1165 499.85 Security.—
1166 (1) A permitholder that has a facility used for the
1167 distribution or retailing of medical gases shall protect such
1168 gases from unauthorized access by implementing all of the
1169 following security measures:
1170 (a) Keeping access from outside the premises well
1171 controlled and to a minimum.
1172 (b) Ensuring the outside perimeter of the premises is well
1173 lit.
1174 (c) Limiting access into areas where medical gases are held
1175 to authorized personnel.
1176 (d) Equipping all facilities with a fence or other system
1177 to detect or deter entry after hours.
1178 (2) A facility used for distributing or retailing medical
1179 gases shall be equipped with a system that provides suitable
1180 protection against theft, including if appropriate, protection
1181 against theft of computers or electronic records and the
1182 protection of the integrity and confidentiality of data and
1183 documents.
1184 (3) A facility used for wholesale distribution of medical
1185 gases shall be equipped with inventory management and control
1186 systems that protect against, detect, and document any instances
1187 of theft of nitrous oxide.
1188 (4) If a wholesale distributor uses electronic distribution
1189 records, the wholesale distributor shall employ, train, and
1190 document the training of personnel in the proper use of such
1191 technology and equipment.
1192 (5) Vehicles used for on-call delivery of oxygen USP and
1193 oxygen-related equipment for home care use by home care
1194 providers may be parked at a place of residence and must be
1195 locked and equipped with an audible alarm when not attended.
1196 (6) The department shall adopt rules that govern the
1197 distribution of medical oxygen for emergency use by persons
1198 authorized to receive emergency use oxygen. Unless the laws of
1199 this state specifically direct otherwise, such rules must be
1200 consistent with federal regulations, including the labeling
1201 requirements of oxygen under the federal act. Such rules may not
1202 be inconsistent with part III of chapter 401 or rules adopted
1203 thereunder.
1204 Section 22. Section 499.86, Florida Statutes, is created to
1205 read:
1206 499.86 Examination of materials.—
1207 (1) A wholesale distributor must visually examine a medical
1208 gas container upon receipt from the manufacturer in order to
1209 identify the medical gas stored within and to determine if the
1210 container has been damaged or is otherwise unfit for
1211 distribution. Such examination must occur in a manner that would
1212 reveal damage to the container which could suggest possible
1213 adulteration or misbranding.
1214 (2) A medical gas container that is found to be damaged or
1215 otherwise unfit pursuant to subsection (1) must be quarantined
1216 from the stock of medical gas until a determination is made that
1217 the medical gas in question is not misbranded or adulterated.
1218 (3) An outgoing shipment must be inspected to identify the
1219 medical gases in the shipment to ensure that medical gas
1220 containers that have been damaged in storage or held under
1221 improper conditions are not distributed or dispensed.
1222 (4) A wholesale distributor must review records documenting
1223 the acquisition of medical gas upon receipt for accuracy and
1224 completeness.
1225 Section 23. Section 499.87, Florida Statutes, is created to
1226 read:
1227 499.87 Returned, damaged, and outdated medical gas.—
1228 (1) A medical gas that has left the control of the
1229 wholesale distributor may be returned to the wholesale
1230 distributor or manufacturer from which it was acquired, but may
1231 not be resold as a medical gas unless it is reprocessed by a
1232 manufacturer using proper and adequate controls to ensure the
1233 identity, strength, quality, and purity of the reprocessed
1234 medical gas.
1235 (2) A medical gas that has been subjected to improper
1236 conditions, such as a fire, accident, or natural disaster, may
1237 not be salvaged or reprocessed.
1238 (3) A medical gas, including its container, which is
1239 damaged, misbranded, or adulterated must be quarantined from
1240 other medical gases until it is destroyed or returned to the
1241 manufacturer or wholesale distributor from which it was
1242 acquired. External contamination of a medical gas container or
1243 closure system which does not impact the integrity of the
1244 medical gas is not considered damaged or adulterated for
1245 purposes of this subsection. If a medical gas is adulterated or
1246 misbranded or suspected of being adulterated or misbranded,
1247 notice shall be provided to the manufacturer or wholesale
1248 distributor from which the medical gas was acquired and to the
1249 appropriate boards and federal regulatory bodies.
1250 (4) A medical gas container that has been opened or used
1251 but is not adulterated or misbranded is considered empty and
1252 must be quarantined from nonempty medical gas containers and
1253 returned to the manufacturer or wholesale distributor from which
1254 it was acquired for destruction or reprocessing.
1255 (5) A medical gas, its container, or its associated
1256 documentation or labeling that is suspected of being used in
1257 criminal activity must be retained until its disposition is
1258 authorized by the department or an applicable law enforcement
1259 agency.
1260 Section 24. Section 499.88, Florida Statutes, is created to
1261 read:
1262 499.88 Due diligence.—
1263 (1) A wholesale distributor shall obtain, before the
1264 initial acquisition of medical gas, the following information
1265 from the supplying wholesale distributor or manufacturer:
1266 (a) If a manufacturer is distributing to a wholesale
1267 distributor, evidence that the manufacturer is registered and
1268 the medical gas is listed with the United States Food and Drug
1269 Administration;
1270 (b) If a wholesale distributor is distributing to a
1271 wholesale distributor, evidence that the wholesale distributor
1272 supplying the medical gas is legally authorized to distribute
1273 medical gas within or into the state;
1274 (c) The name of the responsible facility contact person for
1275 the supplying manufacturer or wholesale distributor; and
1276 (d) Certification that the manufacturer’s or wholesale
1277 distributor’s policies and procedures comply with this part.
1278 (2) A wholesale distributor is exempt from obtaining the
1279 information from a manufacturer, as required under subsection
1280 (1), if the manufacturer is registered with the United States
1281 Food and Drug Administration in accordance with s. 510 of the
1282 federal act and the manufacturer provides:
1283 (a) Proof of such registration; and
1284 (b) Proof of inspection by the United States Food and Drug
1285 Administration or other regulatory body within the past 3 years
1286 demonstrating substantial compliance with current good
1287 manufacturing practices applicable to medical gases.
1288 (3) A manufacturer or wholesale distributor that
1289 distributes to or acquires medical gas from another wholesale
1290 distributor shall provide to or obtain from the distributing or
1291 acquiring manufacturer or distributor the information required
1292 by s. 499.89(1), as applicable.
1293 Section 25. Section 499.89, Florida Statutes, is created to
1294 read:
1295 499.89 Recordkeeping.—
1296 (1) A permitholder under this part shall establish and
1297 maintain a record of transactions regarding the receipt and the
1298 distribution, or other disposition, of medical gases, as
1299 applicable. Such records constitute an audit trail and must
1300 contain information sufficient to perform a recall of medical
1301 gas in compliance with 21 C.F.R. s. 211.196 and 21 C.F.R. s.
1302 820.160(b). Such records must include all of the following
1303 information, which may be kept in two separate documents one
1304 related to the distribution of medical gas and the other related
1305 to the receipt of medical gas:
1306 (a) The dates of receipt and distribution or other
1307 disposition of the medical gas.
1308 (b) The name, address, license or permit number and its
1309 expiration date for the person or entity purchasing the medical
1310 gas from the wholesale distributor.
1311 (c) The name, address, license or permit number and its
1312 expiration date for the person or entity receiving the medical
1313 gas, if different from the information required under paragraph
1314 (b).
1315 (d) Information sufficient to perform a recall of all
1316 medical gas received, distributed, or dispensed.
1317 (2) Such records shall be made available for inspection and
1318 copying by an authorized official of any federal, state, or
1319 local governmental agency for a period of:
1320 (a) Three years following the distribution date of high
1321 pressure medical gases.
1322 (b) Two years following the distribution date for cryogenic
1323 or refrigerated liquid medical gases.
1324 (3) Records kept at the inspection site or that can be
1325 immediately retrieved by computer or other electronic means
1326 shall be readily available for authorized inspection during the
1327 retention period. Records kept at a central location apart from
1328 the inspection site and not electronically retrievable shall be
1329 made available for inspection within 2 working days of a request
1330 by an authorized official of any state or federal governmental
1331 agency charged with enforcement of these rules.
1332 (4) A pedigree paper is not required for distributing or
1333 dispensing medical gas.
1334 (5) A wholesale distributor shall maintain records
1335 sufficient to aid in the mandatory reporting of any theft,
1336 suspected theft, or other significant loss of nitrous oxide to
1337 the department and other appropriate law enforcement agencies.
1338 Section 26. Section 499.90, Florida Statutes, is created to
1339 read:
1340 499.90 Policies and procedures.—A wholesale distributor
1341 shall establish, maintain, and adhere to written policies and
1342 procedures for the receipt, security, storage, transport,
1343 shipping, and distribution of medical gases and shall establish,
1344 maintain, and adhere to procedures for maintaining inventories;
1345 for identifying, recording, and reporting losses or thefts; and
1346 for correcting all errors and inaccuracies in inventories
1347 associated with nitrous oxide. A wholesale distributor shall
1348 include in its written policies and procedures all of the
1349 following:
1350 (1) A procedure for handling recalls and withdrawals of
1351 medical gas. Such procedure must deal with recalls and
1352 withdrawals due to:
1353 (a) Action initiated at the request of the United States
1354 Food and Drug Administration or any federal, state, or local law
1355 enforcement or other government agency, including the
1356 department; or
1357 (b) Voluntary action by a manufacturer of medical gases to
1358 remove defective or potentially defective medical gases from the
1359 market.
1360 (2) A procedure that includes preparation for, protection
1361 against, and responding to a crisis that affects the security or
1362 operation of a facility that stores medical gases in the event
1363 of a strike; a fire, flood, or other natural disaster; or other
1364 local, state, or national emergency.
1365 (3) A procedure for reporting criminal or suspected
1366 criminal activity involving the inventory of nitrous oxide to
1367 the department and to applicable law enforcement agencies within
1368 3 business days after becoming aware of the criminal or
1369 suspected criminal activity.
1370 Section 27. Section 499.91, Florida Statutes, is created to
1371 read:
1372 499.91 Prohibited acts.—A person may not perform or cause
1373 the performance of, or aid and abet in, any of the following
1374 acts:
1375 (1) The manufacture, sale, or delivery, or the holding or
1376 offering for sale, of a medical gas that is adulterated,
1377 misbranded, or is otherwise unfit for distribution.
1378 (2) The adulteration or misbranding of a medical gas.
1379 (3) The receipt of a medical gas that is adulterated,
1380 misbranded, stolen, or obtained by fraud or deceit, and the
1381 delivery or proffered delivery of such medical gas for pay or
1382 otherwise.
1383 (4) The alteration, mutilation, destruction, obliteration,
1384 or removal of all or any part of the product labeling of a
1385 medical gas, or the willful commission of any other act with
1386 respect to a medical gas that results in it being misbranded.
1387 (5) The purchase or receipt of a medical gas from a person
1388 not authorized to distribute or dispense medical gas or who is
1389 not exempted from permitting requirements to wholesale
1390 distribute medical gas to such purchaser or recipient.
1391 (6) The knowing and willful sale or transfer of a medical
1392 gas to a recipient who is not legally authorized to receive a
1393 medical gas, except that a violation does not exist if a
1394 permitted wholesale distributor provides oxygen to a permitted
1395 medical oxygen retail establishment that is out of compliance
1396 with the notice of location change requirements of s. 499.834,
1397 provided that the wholesale distributor with knowledge of the
1398 violation notifies the department of the transaction by the next
1399 business day.
1400 (7) The failure to maintain or provide records required
1401 under this part and the rules adopted under this part.
1402 (8) Providing the department or any of its representatives
1403 or any state or federal official with false or fraudulent
1404 records or making false or fraudulent statements regarding this
1405 part or the rules adopted under this part.
1406 (9) The distribution of a medical gas that was:
1407 (a) Purchased by a public or private hospital or other
1408 health care entity, except for the physical distribution of such
1409 medical gas to an authorized recipient at the direction of a
1410 hospital or other health care entity;
1411 (b) Donated or supplied at a reduced price to a charitable
1412 organization; or
1413 (c) Stolen or obtained by fraud or deceit.
1414 (10) The failure to obtain a license or permit or operating
1415 without a valid license or permit, if one is required.
1416 (11) The obtaining of, or attempt to obtain, a medical gas
1417 by fraud, deceit, or misrepresentation or engaging in
1418 misrepresentation or fraud in the distribution of a medical gas.
1419 (12) Except for emergency use oxygen, the distribution of a
1420 medical gas to a patient without a prescription from a
1421 practitioner authorized by law to prescribe a medical gas.
1422 (13) The distribution or dispensing of a medical gas that
1423 was previously dispensed by a pharmacy or a practitioner
1424 authorized by law to prescribe.
1425 (14) The distribution or dispensing of a medical gas or
1426 medical gas-related equipment to a patient, unless the patient
1427 has been provided with the appropriate information and
1428 counseling on the use, storage, and disposal of the medical gas.
1429 (15) Failure to report an act prohibited under this part or
1430 the rules adopted under this part.
1431 (16) Failure to exercise due diligence as provided in s.
1432 499.88.
1433 Section 28. Section 499.92, Florida Statutes, is created to
1434 read:
1435 499.92 Criminal acts.—
1436 (1) A person commits a felony of the third degree,
1437 punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
1438 if he or she:
1439 (a) Adulterates or misbrands a medical gas with intent to
1440 defraud or deceive;
1441 (b) Knowingly purchases or receives a medical gas from a
1442 person not legally authorized to distribute or dispense medical
1443 gas;
1444 (c) Knowingly engages in the wholesale distribution of, or
1445 sells, barters, brokers, or transfers, a medical gas to a person
1446 not legally authorized to purchase or receive medical gas in the
1447 jurisdiction in which the person receives the medical gas. A
1448 permitted wholesale distributor that provides oxygen to a
1449 permitted medical oxygen retail establishment that is out of
1450 compliance with only the change of location notice requirement
1451 under s. 499.834, does not commit a violation of this paragraph
1452 if the wholesale distributor notifies the department of the
1453 transaction no later than the next business day; or
1454 (d) Knowingly falsely creates a label for a medical gas or
1455 knowingly misrepresents a factual matter contained in a label
1456 for a medical gas.
1457 (2) A person found guilty of an offense under this section,
1458 under the authority of the court convicting and sentencing the
1459 person, shall be ordered to forfeit to the state any real or
1460 personal property:
1461 (a) Used or intended to be used to commit, to facilitate,
1462 or to promote the commission of such offense; and
1463 (b) Constituting, derived from, or traceable to the gross
1464 proceeds that the defendant obtained directly or indirectly as a
1465 result of the offense.
1466 (3) Property or assets subject to forfeiture under
1467 subsection (2) may be seized pursuant to a warrant obtained in
1468 the same manner as a search warrant or as otherwise authorized
1469 by law, and held until the case against a defendant is
1470 adjudicated. Monies ordered forfeited, or proceeds from the sale
1471 of other assets ordered forfeited, shall be equitably divided
1472 between the department and other agencies involved in the
1473 investigation and prosecution that led to the conviction. Other
1474 property ordered forfeited after conviction of a defendant may,
1475 at the discretion of the investigating agencies, be placed into
1476 official use by the department or the agencies involved in the
1477 investigation and prosecution that led to the conviction.
1478 Section 29. Section 499.93, Florida Statutes, is created to
1479 read:
1480 499.93 Inspections.—
1481 (1) The department may require a facility that engages in
1482 the manufacture, retail sale, or wholesale distribution of
1483 medical gas to undergo an inspection in accordance with a
1484 schedule to be determined by the department, including
1485 inspections for initial permitting, permit renewal, and a
1486 permitholder’s change of location. The department may recognize
1487 a third party to inspect wholesale distributors in this state or
1488 other states pursuant to a schedule to be determined by the
1489 department.
1490 (2) The department may recognize another state’s
1491 inspections of a manufacturer or wholesale distributor located
1492 in that state if such state’s laws are deemed to be
1493 substantially equivalent to the laws of this state by the
1494 department.
1495 (3) A manufacturing facility of medical gases is exempt
1496 from routine inspection by the department if:
1497 (a) The manufacturing facility is currently registered with
1498 the United States Food and Drug Administration under s. 510 of
1499 the federal act and can provide proof of registration, such as a
1500 copy of the Internet verification page; and
1501 (b) The manufacturing facility can provide proof of
1502 inspection by the Food and Drug Administration, or if the
1503 facility is located in another state, inspection by the Food and
1504 Drug Administration or other governmental entity charged with
1505 regulation of good manufacturing practices related to medical
1506 gases in that state within the past 3 years, which demonstrates
1507 substantial compliance with current good manufacturing practices
1508 applicable to medical gases.
1509 (4) A permitholder under this part shall exhibit or have
1510 readily available its state permits and its most recent
1511 inspection report administered by the department.
1512 Section 30. Section 499.931, Florida Statutes, is created
1513 to read:
1514 499.931 Trade secret information.—Information required to
1515 be submitted under this part which is a trade secret as defined
1516 in s. 812.081(1)(c) and designated as a trade secret by an
1517 applicant or permitholder must be maintained as required under
1518 s. 499.051.
1519 Section 31. Section 499.94, Florida Statutes, is created to
1520 read:
1521 499.94 Fees.—A fee collected for a permit under this part
1522 shall be deposited into the Professional Regulation Trust Fund.
1523 Moneys collected under this part shall be used for administering
1524 this part. The department shall maintain a separate account in
1525 the trust fund for the Drugs, Devices, and Cosmetics program.
1526 Section 32. Paragraph (a) of subsection (1) of section
1527 409.9201, Florida Statutes, is amended to read:
1528 409.9201 Medicaid fraud.—
1529 (1) As used in this section, the term:
1530 (a) “Prescription drug” means any drug, including, but not
1531 limited to, finished dosage forms or active ingredients that are
1532 subject to, defined in by, or described in by s. 503(b) of the
1533 Federal Food, Drug, and Cosmetic Act or in by s. 465.003(8), s.
1534 499.003(52), s. 499.003(46) or (53) or s. 499.007(13), or s.
1535 499.82(10).
1536
1537 The value of individual items of the legend drugs or goods or
1538 services involved in distinct transactions committed during a
1539 single scheme or course of conduct, whether involving a single
1540 person or several persons, may be aggregated when determining
1541 the punishment for the offense.
1542 Section 33. Paragraph (c) of subsection (9) of section
1543 460.403, Florida Statutes, is amended to read:
1544 460.403 Definitions.—As used in this chapter, the term:
1545 (9)
1546 (c)1. Chiropractic physicians may adjust, manipulate, or
1547 treat the human body by manual, mechanical, electrical, or
1548 natural methods; by the use of physical means or physiotherapy,
1549 including light, heat, water, or exercise; by the use of
1550 acupuncture; or by the administration of foods, food
1551 concentrates, food extracts, and items for which a prescription
1552 is not required and may apply first aid and hygiene, but
1553 chiropractic physicians are expressly prohibited from
1554 prescribing or administering to any person any legend drug
1555 except as authorized under subparagraph 2., from performing any
1556 surgery except as stated herein, or from practicing obstetrics.
1557 2. Notwithstanding the prohibition against prescribing and
1558 administering legend drugs under subparagraph 1. or s.
1559 499.83(2)(c) s. 499.01(2)(m), pursuant to board rule
1560 chiropractic physicians may order, store, and administer, for
1561 emergency purposes only at the chiropractic physician’s office
1562 or place of business, prescription medical oxygen and may also
1563 order, store, and administer the following topical anesthetics
1564 in aerosol form:
1565 a. Any solution consisting of 25 percent ethylchloride and
1566 75 percent dichlorodifluoromethane.
1567 b. Any solution consisting of 15 percent
1568 dichlorodifluoromethane and 85 percent
1569 trichloromonofluoromethane.
1570
1571 However, this paragraph does not authorize a chiropractic
1572 physician to prescribe medical oxygen as defined in chapter 499.
1573 Section 34. Subsection (3) of section 465.0265, Florida
1574 Statutes, is amended to read:
1575 465.0265 Centralized prescription filling.—
1576 (3) The filling, delivery, and return of a prescription by
1577 one pharmacy for another pursuant to this section shall not be
1578 construed as the filling of a transferred prescription as
1579 described set forth in s. 465.026 or as a wholesale distribution
1580 as defined set forth in s. 499.003 s. 499.003(54).
1581 Section 35. Paragraph (b) of subsection (2) of section
1582 499.01212, Florida Statutes, is amended to read:
1583 499.01212 Pedigree paper.—
1584 (2) FORMAT.—A pedigree paper must contain the following
1585 information:
1586 (b) For all other wholesale distributions of prescription
1587 drugs:
1588 1. The quantity, dosage form, and strength of the
1589 prescription drugs.
1590 2. The lot numbers of the prescription drugs.
1591 3. The name and address of each owner of the prescription
1592 drug and his or her signature.
1593 4. Shipping information, including the name and address of
1594 each person certifying delivery or receipt of the prescription
1595 drug.
1596 5. An invoice number, a shipping document number, or
1597 another number uniquely identifying the transaction.
1598 6. A certification that the recipient wholesale distributor
1599 has authenticated the pedigree papers.
1600 7. The unique serialization of the prescription drug, if
1601 the manufacturer or repackager has uniquely serialized the
1602 individual prescription drug unit.
1603 8. The name, address, telephone number, and, if available,
1604 e-mail contact information of each wholesale distributor
1605 involved in the chain of the prescription drug’s custody.
1606
1607 When an affiliated group member obtains title to a prescription
1608 drug before distributing the prescription drug as the
1609 manufacturer as defined in s. 499.003(30)(e) under s.
1610 499.003(31)(e), information regarding the distribution between
1611 those affiliated group members may be omitted from a pedigree
1612 paper required under this paragraph for subsequent distributions
1613 of that prescription drug.
1614 Section 36. Paragraph (a) of subsection (1) and subsection
1615 (3) of section 499.015, Florida Statutes, are amended to read:
1616 499.015 Registration of drugs, devices, and cosmetics;
1617 issuance of certificates of free sale.—
1618 (1)(a) Except for those persons exempted from the
1619 definition of manufacturer in s. 499.003 s. 499.003(31), any
1620 person who manufactures, packages, repackages, labels, or
1621 relabels a drug, device, or cosmetic in this state must register
1622 such drug, device, or cosmetic biennially with the department;
1623 pay a fee in accordance with the fee schedule provided by s.
1624 499.041; and comply with this section. The registrant must list
1625 each separate and distinct drug, device, or cosmetic at the time
1626 of registration.
1627 (3) Except for those persons exempted from the definition
1628 of manufacturer in s. 499.003 s. 499.003(31), a person may not
1629 sell any product that he or she has failed to register in
1630 conformity with this section. Such failure to register subjects
1631 such drug, device, or cosmetic product to seizure and
1632 condemnation as provided in s. 499.062, and subjects such person
1633 to the penalties and remedies provided in this part.
1634 Section 37. Subsection (3) of section 499.024, Florida
1635 Statutes, is amended to read:
1636 499.024 Drug product classification.—The department shall
1637 adopt rules to classify drug products intended for use by humans
1638 which the United States Food and Drug Administration has not
1639 classified in the federal act or the Code of Federal
1640 Regulations.
1641 (3) Any product that falls under the definition of drug in
1642 s. 499.003 s. 499.003(19) may be classified under the authority
1643 of this section. This section does not subject portable
1644 emergency oxygen inhalators to classification; however, this
1645 section does not exempt any person from ss. 499.01 and 499.015.
1646 Section 38. This act shall take effect October 1, 2014.