Bill Amendment: FL S0836 | 2014 | Regular Session
NOTE: For additional amemendments please see the Bill Drafting List
Bill Title: Medical Gas
Status: 2014-06-13 - Chapter No. 2014-89 [S0836 Detail]
Download: Florida-2014-S0836-Senate_Committee_Amendment_181392.html
Bill Title: Medical Gas
Status: 2014-06-13 - Chapter No. 2014-89 [S0836 Detail]
Download: Florida-2014-S0836-Senate_Committee_Amendment_181392.html
Florida Senate - 2014 COMMITTEE AMENDMENT
Bill No. CS for SB 836
Ì181392.Î181392
LEGISLATIVE ACTION
Senate . House
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1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 499.001, Florida Statutes, is amended to
6 read:
7 499.001 Florida Drug and Cosmetic Act; short title.
8 Sections 499.001-499.94 499.001-499.081 may be cited as the
9 “Florida Drug and Cosmetic Act.”
10 Section 2. Subsections (12) through (32) and subsections
11 (47) through (55) of section 499.003, Florida Statutes, are
12 renumbered as subsections (11) through (31) and subsections (46)
13 through (54), respectively, and present subsections (11), (43),
14 and (46) of that section are amended, to read:
15 499.003 Definitions of terms used in this part.—As used in
16 this part, the term:
17 (32)(11) “Compressed Medical gas” means any liquefied or
18 vaporized gas that is a prescription drug, whether it is alone
19 or in combination with other gases, and as defined in the
20 federal act.
21 (43) “Prescription drug” means a prescription, medicinal,
22 or legend drug, including, but not limited to, finished dosage
23 forms or active pharmaceutical ingredients subject to, defined
24 by, or described by s. 503(b) of the federal Food, Drug, and
25 Cosmetic act or s. 465.003(8), s. 499.007(13), or subsection
26 (32) (11), subsection (46), or subsection (52) (53), except that
27 an active pharmaceutical ingredient is a prescription drug only
28 if substantially all finished dosage forms in which it may be
29 lawfully dispensed or administered in this state are also
30 prescription drugs.
31 (46) “Prescription medical oxygen” means oxygen USP which
32 is a drug that can only be sold on the order or prescription of
33 a practitioner authorized by law to prescribe. The label of
34 prescription medical oxygen must comply with current labeling
35 requirements for oxygen under the Federal Food, Drug, and
36 Cosmetic Act.
37 Section 3. Subsection (1), paragraphs (a), (c), (g), (m),
38 (n), and (o) of subsection (2), and subsection (5) of section
39 499.01, Florida Statutes, are amended to read:
40 499.01 Permits.—
41 (1) Prior to operating, a permit is required for each
42 person and establishment that intends to operate as:
43 (a) A prescription drug manufacturer;
44 (b) A prescription drug repackager;
45 (c) A nonresident prescription drug manufacturer;
46 (d) A prescription drug wholesale distributor;
47 (e) An out-of-state prescription drug wholesale
48 distributor;
49 (f) A retail pharmacy drug wholesale distributor;
50 (g) A restricted prescription drug distributor;
51 (h) A complimentary drug distributor;
52 (i) A freight forwarder;
53 (j) A veterinary prescription drug retail establishment;
54 (k) A veterinary prescription drug wholesale distributor;
55 (l) A limited prescription drug veterinary wholesale
56 distributor;
57 (m) A medical oxygen retail establishment;
58 (n) A compressed medical gas wholesale distributor;
59 (o) A compressed medical gas manufacturer;
60 (m)(p) An over-the-counter drug manufacturer;
61 (n)(q) A device manufacturer;
62 (o)(r) A cosmetic manufacturer;
63 (p)(s) A third party logistics provider; or
64 (q)(t) A health care clinic establishment.
65 (2) The following permits are established:
66 (a) Prescription drug manufacturer permit.—A prescription
67 drug manufacturer permit is required for any person that is a
68 manufacturer of a prescription drug and that manufactures or
69 distributes such prescription drugs in this state.
70 1. A person that operates an establishment permitted as a
71 prescription drug manufacturer may engage in wholesale
72 distribution of prescription drugs manufactured at that
73 establishment and must comply with all of the provisions of this
74 part, except s. 499.01212, and the rules adopted under this
75 part, except s. 499.01212, which apply to a wholesale
76 distributor.
77 2. A prescription drug manufacturer must comply with all
78 appropriate state and federal good manufacturing practices.
79 3. A blood establishment, as defined in s. 381.06014,
80 operating in a manner consistent with the provisions of 21
81 C.F.R. parts 211 and 600-640, and manufacturing only the
82 prescription drugs described in s. 499.003(53)(d) s.
83 499.003(54)(d) is not required to be permitted as a prescription
84 drug manufacturer under this paragraph or to register products
85 under s. 499.015.
86 (c) Nonresident prescription drug manufacturer permit.—A
87 nonresident prescription drug manufacturer permit is required
88 for any person that is a manufacturer of prescription drugs,
89 unless permitted as a third party logistics provider, located
90 outside of this state or outside the United States and that
91 engages in the wholesale distribution in this state of such
92 prescription drugs. Each such manufacturer must be permitted by
93 the department and comply with all of the provisions required of
94 a wholesale distributor under this part, except s. 499.01212.
95 1. A person that distributes prescription drugs for which
96 the person is not the manufacturer must also obtain an out-of
97 state prescription drug wholesale distributor permit or third
98 party logistics provider permit pursuant to this section to
99 engage in the wholesale distribution of such prescription drugs.
100 This subparagraph does not apply to a manufacturer as defined in
101 s. 499.003(30)(e) s. 499.003(31)(e).
102 2. Any such person must comply with the licensing or
103 permitting requirements of the jurisdiction in which the
104 establishment is located and the federal act, and any product
105 wholesaled into this state must comply with this part. If a
106 person intends to import prescription drugs from a foreign
107 country into this state, the nonresident prescription drug
108 manufacturer must provide to the department a list identifying
109 each prescription drug it intends to import and document
110 approval by the United States Food and Drug Administration for
111 such importation.
112 (g) Restricted prescription drug distributor permit.—
113 1. A restricted prescription drug distributor permit is
114 required for:
115 a. Any person located in this state who engages in the
116 distribution of a prescription drug, which distribution is not
117 considered “wholesale distribution” under s. 499.003(53)(a) s.
118 499.003(54)(a).
119 b. Any person located in this state who engages in the
120 receipt or distribution of a prescription drug in this state for
121 the purpose of processing its return or its destruction if such
122 person is not the person initiating the return, the prescription
123 drug wholesale supplier of the person initiating the return, or
124 the manufacturer of the drug.
125 c. A blood establishment located in this state which
126 collects blood and blood components only from volunteer donors
127 as defined in s. 381.06014 or pursuant to an authorized
128 practitioner’s order for medical treatment or therapy and
129 engages in the wholesale distribution of a prescription drug not
130 described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
131 care entity. A mobile blood unit operated by a blood
132 establishment permitted under this sub-subparagraph is not
133 required to be separately permitted. The health care entity
134 receiving a prescription drug distributed under this sub
135 subparagraph must be licensed as a closed pharmacy or provide
136 health care services at that establishment. The blood
137 establishment must operate in accordance with s. 381.06014 and
138 may distribute only:
139 (I) Prescription drugs indicated for a bleeding or clotting
140 disorder or anemia;
141 (II) Blood-collection containers approved under s. 505 of
142 the federal act;
143 (III) Drugs that are blood derivatives, or a recombinant or
144 synthetic form of a blood derivative;
145 (IV) Prescription drugs that are identified in rules
146 adopted by the department and that are essential to services
147 performed or provided by blood establishments and authorized for
148 distribution by blood establishments under federal law; or
149 (V) To the extent authorized by federal law, drugs
150 necessary to collect blood or blood components from volunteer
151 blood donors; for blood establishment personnel to perform
152 therapeutic procedures under the direction and supervision of a
153 licensed physician; and to diagnose, treat, manage, and prevent
154 any reaction of a volunteer blood donor or a patient undergoing
155 a therapeutic procedure performed under the direction and
156 supervision of a licensed physician,
157
158 as long as all of the health care services provided by the blood
159 establishment are related to its activities as a registered
160 blood establishment or the health care services consist of
161 collecting, processing, storing, or administering human
162 hematopoietic stem cells or progenitor cells or performing
163 diagnostic testing of specimens if such specimens are tested
164 together with specimens undergoing routine donor testing. The
165 blood establishment may purchase and possess the drugs described
166 in this sub-subparagraph without a health care clinic
167 establishment permit.
168 2. Storage, handling, and recordkeeping of these
169 distributions by a person required to be permitted as a
170 restricted prescription drug distributor must be in accordance
171 with the requirements for wholesale distributors under s.
172 499.0121, but not those set forth in s. 499.01212 if the
173 distribution occurs pursuant to sub-subparagraph 1.a. or sub
174 subparagraph 1.b.
175 3. A person who applies for a permit as a restricted
176 prescription drug distributor, or for the renewal of such a
177 permit, must provide to the department the information required
178 under s. 499.012.
179 4. The department may adopt rules regarding the
180 distribution of prescription drugs by hospitals, health care
181 entities, charitable organizations, other persons not involved
182 in wholesale distribution, and blood establishments, which rules
183 are necessary for the protection of the public health, safety,
184 and welfare.
185 (m) Medical oxygen retail establishment permit.—A medical
186 oxygen retail establishment permit is required for any person
187 that sells medical oxygen to patients only. The sale must be
188 based on an order from a practitioner authorized by law to
189 prescribe. The term does not include a pharmacy licensed under
190 chapter 465.
191 1. A medical oxygen retail establishment may not possess,
192 purchase, sell, or trade any prescription drug other than
193 medical oxygen.
194 2. A medical oxygen retail establishment may refill medical
195 oxygen for an individual patient based on an order from a
196 practitioner authorized by law to prescribe. A medical oxygen
197 retail establishment that refills medical oxygen must comply
198 with all appropriate state and federal good manufacturing
199 practices.
200 3. A medical oxygen retail establishment must comply with
201 all of the wholesale distribution requirements of s. 499.0121.
202 4. Prescription medical oxygen sold by a medical oxygen
203 retail establishment pursuant to a practitioner’s order may not
204 be returned into the retail establishment’s inventory.
205 (n) Compressed medical gas wholesale distributor permit.—A
206 compressed medical gas wholesale distributor is a wholesale
207 distributor that is limited to the wholesale distribution of
208 compressed medical gases to other than the consumer or patient.
209 The compressed medical gas must be in the original sealed
210 container that was purchased by that wholesale distributor. A
211 compressed medical gas wholesale distributor may not possess or
212 engage in the wholesale distribution of any prescription drug
213 other than compressed medical gases. The department shall adopt
214 rules that govern the wholesale distribution of prescription
215 medical oxygen for emergency use. With respect to the emergency
216 use of prescription medical oxygen, those rules may not be
217 inconsistent with rules and regulations of federal agencies
218 unless the Legislature specifically directs otherwise.
219 (o) Compressed medical gas manufacturer permit.—A
220 compressed medical gas manufacturer permit is required for any
221 person that engages in the manufacture of compressed medical
222 gases or repackages compressed medical gases from one container
223 to another.
224 1. A compressed medical gas manufacturer may not
225 manufacture or possess any prescription drug other than
226 compressed medical gases.
227 2. A compressed medical gas manufacturer may engage in
228 wholesale distribution of compressed medical gases manufactured
229 at that establishment and must comply with all the provisions of
230 this part and the rules adopted under this part that apply to a
231 wholesale distributor.
232 3. A compressed medical gas manufacturer must comply with
233 all appropriate state and federal good manufacturing practices.
234 (5) A prescription drug repackager permit issued under this
235 part is not required for a restricted prescription drug
236 distributor permitholder that is a health care entity to
237 repackage prescription drugs in this state for its own use or
238 for distribution to hospitals or other health care entities in
239 the state for their own use, pursuant to s. 499.003(53)(a)3. s.
240 499.003(54)(a)3., if:
241 (a) The prescription drug distributor notifies the
242 department, in writing, of its intention to engage in
243 repackaging under this exemption, 30 days before engaging in the
244 repackaging of prescription drugs at the permitted
245 establishment;
246 (b) The prescription drug distributor is under common
247 control with the hospitals or other health care entities to
248 which the prescription drug distributor is distributing
249 prescription drugs. As used in this paragraph, “common control”
250 means the power to direct or cause the direction of the
251 management and policies of a person or an organization, whether
252 by ownership of stock, voting rights, contract, or otherwise;
253 (c) The prescription drug distributor repackages the
254 prescription drugs in accordance with current state and federal
255 good manufacturing practices; and
256 (d) The prescription drug distributor labels the
257 prescription drug it repackages in accordance with state and
258 federal laws and rules.
259
260 The prescription drug distributor is exempt from the product
261 registration requirements of s. 499.015 with regard to the
262 prescription drugs that it repackages and distributes under this
263 subsection.
264 Section 4. Paragraph (b) of subsection (2) of section
265 499.0121, Florida Statutes, is amended to read:
266 499.0121 Storage and handling of prescription drugs;
267 recordkeeping.—The department shall adopt rules to implement
268 this section as necessary to protect the public health, safety,
269 and welfare. Such rules shall include, but not be limited to,
270 requirements for the storage and handling of prescription drugs
271 and for the establishment and maintenance of prescription drug
272 distribution records.
273 (2) SECURITY.—
274 (b) An establishment that is used for wholesale drug
275 distribution must be equipped with:
276 1. An alarm system to detect entry after hours; however,
277 the department may exempt by rule establishments that only hold
278 a permit as prescription drug wholesale distributor-brokers. and
279 establishments that only handle medical oxygen; and
280 2. A security system that will provide suitable protection
281 against theft and diversion. When appropriate, the security
282 system must provide protection against theft or diversion that
283 is facilitated or hidden by tampering with computers or
284 electronic records.
285 Section 5. Subsections (1) and (2) of section 499.01211,
286 Florida Statutes, are amended to read:
287 499.01211 Drug Wholesale Distributor Advisory Council.—
288 (1) There is created the Drug Wholesale Distributor
289 Advisory Council within the department. The council shall meet
290 at least once each calendar quarter. Staff for the council shall
291 be provided by the department. The council shall consist of 12
292 11 members who shall serve without compensation. The council
293 shall elect a chairperson and a vice chairperson annually.
294 (2) The Secretary of Business and Professional Regulation
295 or his or her designee and the Secretary of Health Care
296 Administration or her or his designee shall be members of the
297 council. The Secretary of Business and Professional Regulation
298 shall appoint 10 nine additional members to the council who
299 shall be appointed to a term of 4 years each, as follows:
300 (a) Three different persons, each of whom is employed by a
301 different prescription drug wholesale distributor permitted
302 licensed under this part which operates nationally and is a
303 primary wholesale distributor, as defined in s. 499.003 s.
304 499.003(47).
305 (b) One person employed by a prescription drug wholesale
306 distributor permitted licensed under this part which is a
307 secondary wholesale distributor, as defined in s. 499.003 s.
308 499.003(52).
309 (c) One person employed by a retail pharmacy chain located
310 in this state.
311 (d) One person who is a member of the Board of Pharmacy and
312 is a pharmacist licensed under chapter 465.
313 (e) One person who is a physician licensed pursuant to
314 chapter 458 or chapter 459.
315 (f) One person who is an employee of a hospital licensed
316 pursuant to chapter 395 and is a pharmacist licensed pursuant to
317 chapter 465.
318 (g) One person who is an employee of a pharmaceutical
319 manufacturer.
320 (h) One person who is an employee of a permitted medical
321 gas manufacturer or medical gas wholesale distributor and who
322 has been recommended by the Compressed Gas Association.
323 Section 6. Paragraph (e) of subsection (1), paragraph (b)
324 of subsection (2), and paragraph (b) of subsection (3) of
325 section 499.041, Florida Statutes, are amended to read:
326 499.041 Schedule of fees for drug, device, and cosmetic
327 applications and permits, product registrations, and free-sale
328 certificates.—
329 (1) The department shall assess applicants requiring a
330 manufacturing permit an annual fee within the ranges established
331 in this section for the specific type of manufacturer.
332 (e) The fee for a compressed medical gas manufacturer
333 permit may not be less than $400 or more than $500 annually.
334 (2) The department shall assess an applicant that is
335 required to have a wholesaling permit an annual fee within the
336 ranges established in this section for the specific type of
337 wholesaling.
338 (b) The fee for a compressed medical gas wholesale
339 distributor permit may not be less than $200 or more than $300
340 annually.
341 (3) The department shall assess an applicant that is
342 required to have a retail establishment permit an annual fee
343 within the ranges established in this section for the specific
344 type of retail establishment.
345 (b) The fee for a medical oxygen retail establishment
346 permit may not be less than $200 or more than $300 annually.
347 Section 7. Section 499.05, Florida Statutes, is amended to
348 read:
349 499.05 Rules.—
350 (1) The department shall adopt rules to implement and
351 enforce this chapter part with respect to:
352 (a) The definition of terms used in this chapter part, and
353 used in the rules adopted under this chapter part, when the use
354 of the term is not its usual and ordinary meaning.
355 (b) Labeling requirements for drugs, devices, and
356 cosmetics.
357 (c) The establishment of fees authorized in this chapter
358 part.
359 (d) The identification of permits that require an initial
360 application and onsite inspection or other prerequisites for
361 permitting which demonstrate that the establishment and person
362 are in compliance with the requirements of this chapter part.
363 (e) The application processes and forms for product
364 registration.
365 (f) Procedures for requesting and issuing certificates of
366 free sale.
367 (g) Inspections and investigations conducted under s.
368 499.051 or s. 499.93 s. 499.051, and the identification of
369 information claimed to be a trade secret and exempt from the
370 public records law as provided in s. 499.051(7).
371 (h) The establishment of a range of penalties, as provided
372 in s. 499.066; requirements for notifying persons of the
373 potential impact of a violation of this chapter part; and a
374 process for the uncontested settlement of alleged violations.
375 (i) Additional conditions that qualify as an emergency
376 medical reason under s. 499.003(53)(b)2. or s. 499.82 s.
377 499.003(54)(b)2.
378 (j) Procedures and forms relating to the pedigree paper
379 requirement of s. 499.01212.
380 (k) The protection of the public health, safety, and
381 welfare regarding good manufacturing practices that
382 manufacturers and repackagers must follow to ensure the safety
383 of the products.
384 (l) Information required from each retail establishment
385 pursuant to s.499.012(3) or s 499.83(2)(c) s. 499.012(3),
386 including requirements for prescriptions or orders.
387 (m) The recordkeeping, storage, and handling with respect
388 to each of the distributions of prescription drugs specified in
389 s. 499.003(53)(a)-(d) or s. 499.82(14) s. 499.003(54)(a)-(d).
390 (n) Alternatives to compliance with s. 499.01212 for a
391 prescription drug in the inventory of a permitted prescription
392 drug wholesale distributor as of June 30, 2006, and the return
393 of a prescription drug purchased prior to July 1, 2006. The
394 department may specify time limits for such alternatives.
395 (o) Wholesale distributor reporting requirements of s.
396 499.0121(14).
397 (p) Wholesale distributor credentialing and distribution
398 requirements of s. 499.0121(15).
399 (2) With respect to products in interstate commerce, those
400 rules must not be inconsistent with rules and regulations of
401 federal agencies unless specifically otherwise directed by the
402 Legislature.
403 (3) The department shall adopt rules regulating
404 recordkeeping for and the storage, handling, and distribution of
405 medical devices and over-the-counter drugs to protect the public
406 from adulterated products.
407 Section 8. Subsections (1) through (4) of section 499.051,
408 Florida Statutes, are amended to read:
409 499.051 Inspections and investigations.—
410 (1) The agents of the department and of the Department of
411 Law Enforcement, after they present proper identification, may
412 inspect, monitor, and investigate any establishment permitted
413 pursuant to this chapter part during business hours for the
414 purpose of enforcing this chapter part, chapters 465, 501, and
415 893, and the rules of the department that protect the public
416 health, safety, and welfare.
417 (2) In addition to the authority set forth in subsection
418 (1), the department and any duly designated officer or employee
419 of the department may enter and inspect any other establishment
420 for the purpose of determining compliance with this chapter part
421 and rules adopted under this chapter part regarding any drug,
422 device, or cosmetic product.
423 (3) Any application for a permit or product registration or
424 for renewal of such permit or registration made pursuant to this
425 chapter part and rules adopted under this chapter part
426 constitutes permission for any entry or inspection of the
427 premises in order to verify compliance with this chapter part
428 and rules; to discover, investigate, and determine the existence
429 of compliance; or to elicit, receive, respond to, and resolve
430 complaints and violations.
431 (4) Any application for a permit made pursuant to s.
432 499.012 or s. 499.831 and rules adopted under those sections
433 that section constitutes permission for agents of the department
434 and the Department of Law Enforcement, after presenting proper
435 identification, to inspect, review, and copy any financial
436 document or record related to the manufacture, repackaging, or
437 distribution of a drug as is necessary to verify compliance with
438 this chapter part and the rules adopted by the department to
439 administer this chapter part, in order to discover, investigate,
440 and determine the existence of compliance, or to elicit,
441 receive, respond to, and resolve complaints and violations.
442 Section 9. Subsections (1) through (4) of section 499.066,
443 Florida Statutes, are amended to read:
444 499.066 Penalties; remedies.—In addition to other penalties
445 and other enforcement provisions:
446 (1) The department may institute such suits or other legal
447 proceedings as are required to enforce any provision of this
448 chapter part. If it appears that a person has violated any
449 provision of this chapter part for which criminal prosecution is
450 provided, the department may provide the appropriate state
451 attorney or other prosecuting agency having jurisdiction with
452 respect to such prosecution with the relevant information in the
453 department’s possession.
454 (2) If any person engaged in any activity covered by this
455 chapter part violates any provision of this chapter part, any
456 rule adopted under this chapter part, or a cease and desist
457 order as provided by this chapter part, the department may
458 obtain an injunction in the circuit court of the county in which
459 the violation occurred or in which the person resides or has its
460 principal place of business, and may apply in that court for
461 such temporary and permanent orders as the department considers
462 necessary to restrain the person from engaging in any such
463 activities until the person complies with this chapter part, the
464 rules adopted under this chapter part, and the orders of the
465 department authorized by this chapter part or to mandate
466 compliance with this chapter part, the rules adopted under this
467 chapter part, and any order or permit issued by the department
468 under this chapter part.
469 (3) The department may impose an administrative fine, not
470 to exceed $5,000 per violation per day, for the violation of any
471 provision of this chapter part or rules adopted under this
472 chapter part. Each day a violation continues constitutes a
473 separate violation, and each separate violation is subject to a
474 separate fine. All amounts collected pursuant to this section
475 shall be deposited into the Professional Regulation Trust Fund
476 and are appropriated for the use of the department in
477 administering this chapter part. In determining the amount of
478 the fine to be levied for a violation, the department shall
479 consider:
480 (a) The severity of the violation;
481 (b) Any actions taken by the person to correct the
482 violation or to remedy complaints; and
483 (c) Any previous violations.
484 (4) The department shall deposit any rewards, fines, or
485 collections that are due the department and which derive from
486 joint enforcement activities with other state and federal
487 agencies which relate to this chapter part, chapter 893, or the
488 federal act, into the Professional Regulation Trust Fund. The
489 proceeds of those rewards, fines, and collections are
490 appropriated for the use of the department in administering this
491 chapter part.
492 Section 10. Paragraph (a) of subsection (1) and paragraph
493 (a) of subsection (2) of section 499.0661, Florida Statutes, are
494 amended to read:
495 499.0661 Cease and desist orders; removal of certain
496 persons.—
497 (1) CEASE AND DESIST ORDERS.—
498 (a) In addition to any authority otherwise provided in this
499 chapter, the department may issue and serve a complaint stating
500 charges upon a any permittee or upon an any affiliated party,
501 whenever the department has reasonable cause to believe that the
502 person or individual named therein is engaging in or has engaged
503 in conduct that is:
504 1. An act that demonstrates a lack of fitness or
505 trustworthiness to engage in the business authorized under the
506 permit issued pursuant to this chapter part, is hazardous to the
507 public health, or constitutes business operations that are a
508 detriment to the public health;
509 2. A violation of a any provision of this chapter part;
510 3. A violation of a any rule of the department;
511 4. A violation of an any order of the department; or
512 5. A breach of a any written agreement with the department.
513 (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
514 (a) The department may issue and serve a complaint stating
515 charges upon an any affiliated party and upon the permittee
516 involved whenever the department has reason to believe that an
517 affiliated party is engaging in or has engaged in conduct that
518 constitutes:
519 1. An act that demonstrates a lack of fitness or
520 trustworthiness to engage in the business authorized under the
521 permit issued pursuant to this chapter part, is hazardous to the
522 public health, or constitutes business operations that are a
523 detriment to the public health;
524 2. A willful violation of this chapter part; however, if
525 the violation constitutes a misdemeanor, a complaint may not be
526 served as provided in this section until the affiliated party is
527 notified in writing of the matter of the violation and has been
528 afforded a reasonable period of time, as set forth in the
529 notice, to correct the violation and has failed to do so;
530 3. A violation of a any other law involving fraud or moral
531 turpitude which constitutes a felony;
532 4. A willful violation of a any rule of the department;
533 5. A willful violation of an any order of the department;
534 or
535 6. A material misrepresentation of fact, made knowingly and
536 willfully or made with reckless disregard for the truth of the
537 matter.
538 Section 11. Section 499.067, Florida Statutes, is amended
539 to read:
540 499.067 Denial, suspension, or revocation of permit,
541 certification, or registration.—
542 (1)(a) The department may deny, suspend, or revoke a permit
543 if it finds that there has been a substantial failure to comply
544 with this chapter part or chapter 465, chapter 501, or chapter
545 893, the rules adopted under this part or those chapters, any
546 final order of the department, or applicable federal laws or
547 regulations or other state laws or rules governing drugs,
548 devices, or cosmetics.
549 (b) The department may deny an application for a permit or
550 certification, or suspend or revoke a permit or certification,
551 if the department finds that:
552 1. The applicant is not of good moral character or that it
553 would be a danger or not in the best interest of the public
554 health, safety, and welfare if the applicant were issued a
555 permit or certification.
556 2. The applicant has not met the requirements for the
557 permit or certification.
558 3. The applicant is not eligible for a permit or
559 certification for any of the reasons enumerated in s. 499.012.
560 4. The applicant, permittee, or person certified under s.
561 499.012(16) demonstrates any of the conditions enumerated in s.
562 499.012.
563 5. The applicant, permittee, or person certified under s.
564 499.012(16) has committed any violation of this chapter ss.
565 499.005-499.0054.
566 (2) The department may deny, suspend, or revoke any
567 registration required by the provisions of this chapter part for
568 the violation of any provision of this chapter part or of any
569 rules adopted under this chapter part.
570 (3) The department may revoke or suspend a permit:
571 (a) If the permit was obtained by misrepresentation or
572 fraud or through a mistake of the department;
573 (b) If the permit was procured, or attempted to be
574 procured, for any other person by making or causing to be made
575 any false representation; or
576 (c) If the permittee has violated any provision of this
577 chapter part or rules adopted under this chapter part.
578 (4) If a any permit issued under this chapter part is
579 revoked or suspended, the owner, manager, operator, or
580 proprietor of the establishment shall cease to operate as the
581 permit authorized, from the effective date of the suspension or
582 revocation until the person is again registered with the
583 department and possesses the required permit. If a permit is
584 revoked or suspended, the owner, manager, or proprietor shall
585 remove all signs and symbols that identify the operation as
586 premises permitted as a drug wholesaling establishment; drug,
587 device, or cosmetic manufacturing establishment; or retail
588 establishment. The department shall determine the length of time
589 for which the permit is to be suspended. If a permit is revoked,
590 the person that owns or operates the establishment may not apply
591 for a any permit under this chapter part for a period of 1 year
592 after the date of the revocation. A revocation of a permit may
593 be permanent if the department considers that to be in the best
594 interest of the public health.
595 (5) The department may deny, suspend, or revoke a permit
596 issued under this part which authorizes the permittee to
597 purchase prescription drugs if an any owner, officer, employee,
598 or other person who participates in administering or operating
599 the establishment has been found guilty of a any violation of
600 this chapter part or chapter 465, chapter 501, or chapter 893,
601 any rules adopted under this part or those chapters, or any
602 federal or state drug law, regardless of whether the person has
603 been pardoned, had her or his civil rights restored, or had
604 adjudication withheld.
605 (6) The department shall deny, suspend, or revoke the
606 permit of a any person or establishment if the assignment, sale,
607 transfer, or lease of an establishment permitted under this
608 chapter part will avoid an administrative penalty, civil action,
609 or criminal prosecution.
610 (7) Notwithstanding s. 120.60(5), if a permittee fails to
611 comply with s. 499.012(6) or s. 499.833, as applicable, the
612 department may revoke the permit of the permittee and shall
613 provide notice of the intended agency action by posting a notice
614 at the department’s headquarters and by mailing a copy of the
615 notice of intended agency action by certified mail to the most
616 recent mailing address on record with the department and, if the
617 permittee is not a natural person, to the permittee’s registered
618 agent on file with the Department of State.
619 (8) The department may deny, suspend, or revoke a permit
620 under this part if it finds the permittee has not complied with
621 the credentialing requirements of s. 499.0121(15).
622 (9) The department may deny, suspend, or revoke a permit
623 under this part if it finds the permittee has not complied with
624 the reporting requirements of, or knowingly made a false
625 statement in a report required by, s. 499.0121(14).
626 Section 12. Part III of chapter 499, Florida Statutes,
627 consisting of ss. 499.81-499.94, Florida Statutes, is created
628 and entitled “Medical Gas.”
629 Section 13. Section 499.81, Florida Statutes, is created to
630 read:
631 499.81 Administration and enforcement.—
632 (1) This part is cumulative and shall be construed and
633 applied as being in addition to, and not in substitution for or
634 limiting any powers, duties, or authority of the department
635 under any other law of this state; except that, with respect to
636 the regulation of medical gas, this part controls over any
637 conflicting provisions.
638 (2) The department shall administer and enforce this part
639 to prevent fraud, adulteration, misbranding, or false
640 advertising in the manufacture and distribution of medical
641 gases.
642 (3) For the purpose of an investigation or proceeding
643 conducted by the department under this part, the department may
644 administer oaths, take depositions, subpoena witnesses, and
645 compel the production of books, papers, documents, or other
646 records. Challenges to, and enforcement of, subpoenas and orders
647 shall be handled as provided in s. 120.569.
648 (4) Each state attorney, county attorney, or municipal
649 attorney to whom the department or its designated agent reports
650 a violation of this part shall cause appropriate proceedings to
651 be instituted in the proper courts without delay and prosecuted
652 as required by law.
653 (5) This part does not require the department to report,
654 for the purpose of instituting proceedings under this part,
655 minor violations of this part when the department believes that
656 the public interest will be adequately served by a written
657 notice or warning.
658 Section 14. Section 499.82, Florida Statutes, is created to
659 read:
660 499.82 Definitions.—As used in this part, the term:
661 (1) “Adulterated,” means a medical gas that:
662 (a) Consists, in whole or in part, of impurities or
663 deleterious substances exceeding normal specifications;
664 (b) Is produced, prepared, packed, or held under conditions
665 whereby the medical gas may have been contaminated causing it to
666 be rendered injurious to health; or if the methods used in, or
667 the facilities or controls used for, its manufacture,
668 processing, packing, or holding do not conform to or are not
669 operated or administered in conformity with current good
670 manufacturing practices to ensure that the medical gas meets the
671 requirements of this part as to safety and has the identity and
672 strength and meets the quality and purity characteristics that
673 the medical gas is represented to possess;
674 (c) Is held in a container with an interior that is
675 composed in whole or in part of a poisonous or deleterious
676 substance that may render the contents injurious to health; or
677 (d) Is represented as having a strength differing from, or
678 quality or purity falling below, the standard set forth in the
679 USP-NF. A medical gas defined in USP-NF may not be deemed to be
680 adulterated under this paragraph merely because it differs from
681 the standard of strength, quality, or purity set forth in the
682 USP-NF if its difference in strength, quality, or purity from
683 that standard is plainly stated on its label. The determination
684 as to strength, quality, or purity shall be made:
685 1. In accordance with the tests or methods of assay in the
686 USP-NF or its validated equivalent; or
687 2. In the absence or inadequacy of such tests or methods of
688 assay, in accordance with the tests or methods of assay
689 prescribed under the federal act.
690 (2) “Department” means the Department of Business and
691 Professional Regulation.
692 (3) “Distribute” or “distribution” means to sell; offer to
693 sell; deliver; offer to deliver; transfer by either the passage
694 of title, physical movement, or both; broker; or give away a
695 medical gas. The term does not include:
696 (a) The dispensing or administration of a medical gas;
697 (b) The delivery of, or an offer to deliver, a medical gas
698 by a common carrier in its usual course of business; or
699 (c) Sales activities taking place in a location owned,
700 controlled, or staffed by persons employed by a person or entity
701 permitted in this state to distribute a medical gas, if that
702 location is not used to physically store or move a medical gas.
703 (4) “Emergency medical reasons” include:
704 (a) Transfers between wholesale distributors or between a
705 wholesale distributor and a retail pharmacy or health care
706 entity to alleviate a temporary shortage of a medical gas
707 arising from a long-term delay or interruption of regular
708 distribution schedules.
709 (b) Sales or transfers to licensed emergency medical
710 services in this state, including ambulance companies and
711 firefighting organizations.
712 (c) The provision of emergency supplies of medical gases to
713 nursing homes during the hours of the day when necessary medical
714 gases cannot normally be obtained from the nursing home’s
715 regular distributors.
716 (d) The transfer of medical gases between retail pharmacies
717 to alleviate a temporary shortage.
718 (5) “Emergency use oxygen” means oxygen USP administered in
719 emergency situations without a prescription for oxygen
720 deficiency and resuscitation. The container must be labeled in
721 accordance with requirements of the United States Food and Drug
722 Administration.
723 (6) “Federal act” means the Federal Food, Drug, and
724 Cosmetic Act.
725 (7) “Medical gas” means a liquefied or vaporized gas that
726 is a prescription drug, whether alone or in combination with
727 other gases, and as defined in the federal act.
728 (8) “Medical gas-related equipment” means a device used as
729 a component part or accessory used to contain or control the
730 flow, delivery, or pressure during the administration of a
731 medical gas, such as liquid oxygen base and portable units,
732 pressure regulators and flow meters, and oxygen concentrators.
733 (9) “Misbranded” means having a label that is false or
734 misleading; a label without the name and address of the
735 manufacturer, repackager, or distributor and without an accurate
736 statement of the quantities of active ingredients; or a label
737 without an accurate monograph for the medical gas, except in the
738 case of mixtures of designated medical gases where the label
739 identifies the component percentages of each designated medical
740 gas used to make the mixture.
741 (10) “Medical oxygen” means oxygen USP which must be
742 labeled in compliance with labeling requirements for oxygen
743 under the federal act.
744 (11) “Product labeling” means the labels and other written,
745 printed, or graphic matter upon an article, or the containers or
746 wrappers that accompany an article, except for letters, numbers,
747 and symbols stamped into the container as required by the
748 federal Department of Transportation.
749 (12) “USP” means United States Pharmacopeial Convention.
750 (13) “USP-NF” means United States Pharmacopeia-National
751 Formulary.
752 (14) “Wholesale distribution” means the distribution of
753 medical gas to a person other than a consumer or patient.
754 Wholesale distribution of medical gases does not include:
755 (a) The sale, purchase, or trade of a medical gas; an offer
756 to sell, purchase, or trade a medical gas; or the dispensing of
757 a medical gas pursuant to a prescription;
758 (b) Activities exempt from the definition of wholesale
759 distribution in s. 499.003; or
760 (c) Other transactions excluded from the definition of
761 wholesale distribution under the federal act or regulations
762 implemented under the federal act related to medical gas.
763 (15) “Wholesale distributor” means any person or entity
764 engaged in wholesale distribution of medical gas within or into
765 this state, including, but not limited to, manufacturers; own
766 label distributors; private-label distributors; warehouses,
767 including manufacturers’ and distributors’ warehouses; and
768 wholesale medical gas warehouses.
769 Section 15. Section 499.83, Florida Statutes, is created to
770 read:
771 499.83 Permits.—
772 (1) A person or entity that intends to distribute medical
773 gas within or into this state, unless exempted under this part,
774 must obtain the applicable permit before operating as:
775 (a) A medical gas wholesale distributor;
776 (b) A medical gas manufacturer; or
777 (c) A medical oxygen retail establishment.
778 (2) The following permits are established:
779 (a) Medical gas wholesale distributor permit.—A medical gas
780 wholesale distributor permit is required for wholesale
781 distribution, whether within or into this state. A medical gas
782 must remain in the original container obtained by the wholesale
783 distributor and the wholesale distributor may not engage in
784 further manufacturing operations unless it possesses a medical
785 gas manufacturer permit. A medical gas wholesale distributor may
786 not possess or engage in the wholesale distribution of a
787 prescription drug that is not a medical gas or distribute a
788 medical gas other than by wholesale distribution unless
789 otherwise authorized.
790 (b) Medical gas manufacturer permit.—A medical gas
791 manufacturer permit is required for a person or entity located
792 in this state which engages in the manufacture of medical gases
793 by physical air separation, chemical action, purification, or
794 filling containers by a liquid-to-liquid, liquid-to-gas, or gas
795 to-gas process and distributes those medical gases within this
796 state.
797 1. A permitted medical gas manufacturer may not manufacture
798 or possess a prescription drug other than a medical gas, unless
799 otherwise authorized.
800 2. A permitted medical gas manufacturer may not distribute
801 a medical gas without obtaining the applicable permit, except
802 that it may engage in wholesale distribution of medical gases
803 that it manufactured without obtaining a medical gas wholesale
804 distributor permit if it complies with this part and the rules
805 adopted under this part that apply to a wholesale distributor.
806 3. A permitted medical gas manufacturer shall comply with
807 all of the requirements applicable to a wholesale distributor
808 under this part and all appropriate state and federal good
809 manufacturing practices.
810 (c) Medical oxygen retail establishment permit.—A medical
811 oxygen retail establishment permit is required for an entity
812 that is located in the state and that dispenses medical oxygen
813 directly to patients in this state. The sale and delivery must
814 be based on an order from a practitioner authorized by law to
815 prescribe. A pharmacy licensed under chapter 465 does not
816 require a permit as a medical oxygen retail establishment.
817 1. A medical oxygen retail establishment may not possess,
818 purchase, sell, or trade a medical gas other than medical
819 oxygen, unless otherwise authorized.
820 2. A medical oxygen retail establishment may fill and
821 deliver medical oxygen to an individual patient based on an
822 order from a practitioner authorized by law to prescribe. The
823 medical oxygen retail establishment must comply with all
824 appropriate state and federal good manufacturing practices.
825 Medical oxygen sold or delivered by a medical oxygen retail
826 establishment pursuant to an order from a practitioner may not
827 be returned into the retail establishment’s inventory.
828 3. A medical oxygen retail establishment shall comply with
829 all of the requirements applicable to a wholesale distributor
830 under this part, except for those requirements that pertain
831 solely to nitrous oxide.
832 (3) An out-of-state wholesale distributor that engages in
833 wholesale distribution into this state must be legally
834 authorized to engage in the wholesale distribution of medical
835 gases as a wholesale distributor in the state in which it
836 resides or is incorporated and provide proof of registration as
837 set forth in s. 499.93(3), if required.
838 (4) A wholesale distributor may not operate from a place of
839 residence, and a place of residence may not be granted a permit
840 or operate under this part, except for the on-call delivery of
841 home care oxygen for wholesale distributors that also maintain a
842 medical oxygen retail establishment permit.
843 (5) If wholesale distribution is conducted at more than one
844 location within this state or more than one location
845 distributing into this state, each location must be permitted by
846 the department.
847 Section 16. Section 499.831, Florida Statutes, is created
848 to read:
849 499.831 Permit application.—
850 (1) The department shall adopt rules to establish the form
851 and content of the application to obtain a permit and to renew a
852 permit listed under this part.
853 (2) An applicant must be at least 18 years of age or be
854 managed, controlled, or overseen, directly or indirectly, by a
855 natural person who is at least 18 years of age.
856 (3) An application for a permit must be filed with the
857 department and must include all of the following information:
858 (a) The trade or business name of the applicant, including
859 a fictitious name, which may not be identical to a name used by
860 an unrelated entity permitted in this state to dispense or
861 distribute medical gas.
862 (b) The name or names of the owner and operator of the
863 applicant, if not the same person or entity. The application
864 must also include:
865 1. If the applicant is an individual, the applicant’s name,
866 business address, and date of birth.
867 2. If the applicant is a sole proprietorship, the business
868 address of the sole proprietor and the name and federal employer
869 identification number of the business entity.
870 3. If the applicant is a partnership, the name, business
871 address, date of birth of each partner, the name of the
872 partnership, and the partnership’s federal employer
873 identification number.
874 4. If the applicant is a limited liability company, the
875 name, business address, and title of each company officer, the
876 name of the limited liability company and federal employer
877 identification number, and the name of the state in which the
878 limited liability company was organized.
879 5. If the applicant is a corporation, the name, business
880 address, and title of each corporate officer and director, the
881 corporate names, the state of incorporation, the federal
882 employer identification number, and, if applicable, the name and
883 business address of the parent company.
884 (c) A list of disciplinary actions pertinent to wholesale
885 distributors, manufacturers, and retailers of prescription drugs
886 or controlled substances by a state or federal agency against
887 the applicant seeking to distribute into this state and any such
888 disciplinary actions against such applicant’s principals,
889 owners, directors, or officers.
890 (d) A complete disclosure of all of the applicant’s past
891 felony convictions.
892 (e) An address and description of each facility and
893 warehouse, including all locations used for medical gas storage
894 or wholesale distribution including a description of each
895 facility’s security system.
896 (4) An applicant shall attest in writing that the
897 information contained in its application is complete and
898 accurate.
899 (5) An applicant must submit a reasonable fee, to be
900 determined by the department, in order to obtain a permit.
901 (a) The fee for a medical gas wholesale distributor permit
902 may not be less than $200 or more than $300 annually.
903 (b) The fee for a medical gas manufacturer permit may not
904 be less than $400 or more than $500 annually.
905 (c) The fee for a medical oxygen retail establishment
906 permit may not be less than $200 or more than $300 annually.
907 (6) Upon approval of the application by the department and
908 payment of the required fee, the department shall issue a permit
909 to the applicant pursuant to the rules adopted under this part.
910 Section 17. Section 499.832, Florida Statutes, is created
911 to read:
912 499.832 Expiration and renewal of a permit.—
913 (1) A permit issued under this part automatically expires 2
914 years after the last day of the month in which the permit was
915 originally issued.
916 (2) A permit issued under this part may be renewed by
917 submitting an application for renewal on a form furnished by the
918 department and paying the appropriate fee. The application for
919 renewal must contain a statement by the applicant attesting that
920 the information is true and correct. Upon approval of a renewal
921 application by the department and payment of the required
922 renewal fee, the department shall renew a permit issued under
923 this part pursuant to the rules adopted under this part.
924 (3) A renewal application may be accepted up to 60 days
925 after the expiration date of the permit if, along with the
926 permit renewal fee, the applicant submits an additional renewal
927 delinquent fee of $100. A permit that expired more than 60 days
928 before a renewal application was submitted or postmarked may not
929 be renewed.
930 (4) Failure to renew a permit in accordance with this
931 section precludes future renewal. If a permit has expired and
932 cannot be renewed, the person, entity, or establishment holding
933 the permit must cease all permit related activities. In order to
934 engage in activities that require a permit the person, entity,
935 or establishment must submit an application for a new permit,
936 pay the applicable application fee, the initial permit fee, and
937 all applicable penalties, and be issued a new permit by the
938 department before engaging in an activity that requires a permit
939 under this part.
940 (5) The department shall adopt rules to administer this
941 section, including setting a reasonable fee for a renewal
942 application.
943 Section 18. Section 499.833, Florida Statutes, is created
944 to read:
945 499.833 Permitholder changes.—
946 (1) A permit issued under this part is valid only for the
947 person or entity to which it is issued and is not subject to
948 sale, assignment, or other transfer, voluntarily or
949 involuntarily.
950 (2) A permit issued under this part is not valid for an
951 establishment other than the establishment for which it was
952 originally issued.
953 (3) The department may approve the following permit
954 changes:
955 (a) Change of location.—A person or entity permitted under
956 this part must notify and receive approval from the department
957 before changing location. The department shall set a change-of
958 location fee not to exceed $100.
959 (b) Change in ownership.—If a majority of the ownership or
960 controlling interest of a permitted establishment is transferred
961 or assigned or if a lessee agrees to undertake or provide
962 services such that legal liability for operation of the
963 establishment will rest with the lessee, an application for a
964 new permit is required. Such application must be submitted and
965 approved by the department before the change of ownership takes
966 place. However, if a permitted wholesale distributor or
967 manufacturer is changing ownership and the new owner has held
968 another permit that allows the wholesale distribution of medical
969 gas under this chapter for the preceding 18 months without
970 having been found in violation of the provisions of this chapter
971 relating to medical gases, then the new owner may operate under
972 the permit of the acquired entity if the new owner submits the
973 application for a new permit by the first business day after
974 ownership is transferred or assigned. A new owner operating
975 under the original permit is responsible for compliance with all
976 laws and regulations governing medical gas. If the application
977 is denied, the new owner shall immediately cease operation at
978 the establishment until a permit is issued to the new owner.
979 (c) Change of name.—A permitholder may make a change of
980 business name without submitting a new permit application.
981 However, the permitholder must notify the department before
982 making the name change.
983 (d) Closure.—If an establishment permitted under this part
984 closes, the owner must notify the department, in writing, before
985 the effective date of the closure and must:
986 1. Return the permit to the department; and
987 2. Indicate the disposition of any medical gas authorized
988 to be distributed or dispensed under the permit, including the
989 name, address, and inventory, and provide the name and address
990 of a person to contact regarding access to the records that are
991 required to be maintained under this part. Transfer of ownership
992 of medical gas may be made only to persons authorized to receive
993 medical gas pursuant to this part.
994 (e) Change in information.—Any change in the information
995 required under this part, other than the changes in paragraphs
996 (a)-(d), shall be submitted to the department within 30 days
997 after such change occurs.
998 (4) A permitholder in good standing may change the type of
999 permit issued by completing a new application for the requested
1000 permit, meeting the applicable permitting requirements for the
1001 new permit type, and paying any difference between the permit
1002 fees. A refund may not be issued if the fee for the new permit
1003 is less than the fee that was paid for the original permit. The
1004 new permit retains the expiration date of the original permit.
1005 Section 19. Section 499.834, Florida Statutes, is created
1006 to read:
1007 499.834 Minimum qualifications.—The department shall
1008 consider all of the following factors in determining eligibility
1009 for, and renewal of, a permit for a person or entity under this
1010 part:
1011 (1) A finding by the department that the applicant has
1012 violated or been disciplined by a regulatory agency in any state
1013 for violating a federal, state, or local law relating to
1014 prescription drugs.
1015 (2) Felony convictions of the applicant under a federal,
1016 state, or local law.
1017 (3) The applicant’s past experience in the manufacture,
1018 retail, or distribution of medical gases.
1019 (4) False or fraudulent material provided by the applicant
1020 in an application made in connection with the manufacturing,
1021 retailing, or distribution of prescription drugs.
1022 (5) Any suspension, sanction, or revocation by a federal,
1023 state, or local government against a license or permit currently
1024 or previously held by the applicant or its owners for violations
1025 of a federal, state, or local law regarding prescription drugs.
1026 (6) Compliance with previously granted licenses or permits.
1027 (7) Compliance with the requirements that distributors or
1028 retailers of medical gases maintain records and make records
1029 available to the department licensing authority or federal,
1030 state, or local law enforcement officials.
1031 (8) Other factors or qualifications the department
1032 considers relevant to and consistent with the public health and
1033 safety.
1034 Section 20. Section 499.84, Florida Statutes, is created to
1035 read:
1036 499.84 Minimum requirements for the storage and handling of
1037 medical gases.—
1038 (1) A facility where a medical gas is received, stored,
1039 warehoused, handled, held, offered, marketed, displayed, or
1040 transported, to avoid any negative effect on the identity,
1041 strength, quality, or purity of the medical gas, must:
1042 (a) Be of suitable construction to ensure that medical
1043 gases are maintained in accordance with the product labeling of
1044 the medical gas or in compliance with the USP-NF;
1045 (b) Be of suitable size and construction to facilitate
1046 cleaning, maintenance, and proper permitted operations;
1047 (c) Have adequate storage areas with appropriate lighting,
1048 ventilation, space, equipment, and security conditions.
1049 (d) Have a quarantined area for storage of medical gases
1050 that are suspected of being misbranded, adulterated, or
1051 otherwise unfit for distribution;
1052 (e) Be maintained in an orderly condition;
1053 (f) Be located in a commercial location and not in a
1054 personal dwelling or residence location, except that a personal
1055 dwelling location used for on-call delivery of oxygen USP for
1056 homecare use if the person providing on-call delivery is
1057 employed by or acting under a written contract with an entity
1058 that holds a medical oxygen retailer permit;
1059 (g) Provide for the secure and confidential storage of
1060 patient information, if applicable, with restricted access and
1061 policies and procedures to protect the integrity and
1062 confidentiality of patient information; and
1063 (h) Provide and maintain appropriate inventory controls to
1064 detect and document any theft of nitrous oxide.
1065 (2) Medical gas shall be stored under appropriate
1066 conditions in accordance with the manufacturer’s recommendations
1067 on product labeling and department rules or, in the absence of
1068 rules, in accordance with applicable industry standards.
1069 (3) Medical gas shall be packaged in accordance with
1070 official compendium standards, such as the USP-NF.
1071 Section 21. Section 499.85, Florida Statutes, is created to
1072 read:
1073 499.85 Security.—
1074 (1) A permitholder that has a facility used for the
1075 distribution or retailing of medical gases shall protect such
1076 gases from unauthorized access by implementing all of the
1077 following security measures:
1078 (a) Keeping access from outside the premises well
1079 controlled and to a minimum.
1080 (b) Ensuring the outside perimeter of the premises is well
1081 lit.
1082 (c) Limiting access into areas where medical gases are held
1083 to authorized personnel.
1084 (d) Equipping all facilities with a fence or other system
1085 to detect or deter entry after hours.
1086 (2) A facility used for distributing or retailing medical
1087 gases shall be equipped with a system that provides suitable
1088 protection against theft, including if appropriate, protection
1089 against theft of computers or electronic records and the
1090 protection of the integrity and confidentiality of data and
1091 documents.
1092 (3) A facility used for wholesale distribution of medical
1093 gases shall be equipped with inventory management and control
1094 systems that protect against, detect, and document any instances
1095 of theft of nitrous oxide.
1096 (4) If a wholesale distributor uses electronic distribution
1097 records, the wholesale distributor shall employ, train, and
1098 document the training of personnel in the proper use of such
1099 technology and equipment.
1100 (5) Vehicles used for on-call delivery of oxygen USP and
1101 oxygen-related equipment for home care use by home care
1102 providers may be parked at a place of residence and must be
1103 locked and equipped with an audible alarm when not attended.
1104 (6) The department shall adopt rules that govern the
1105 distribution of medical oxygen for emergency use by persons
1106 authorized to receive emergency use oxygen. Unless the laws of
1107 this state specifically direct otherwise, such rules must be
1108 consistent with federal regulations, including the labeling
1109 requirements of oxygen under the federal act.
1110 Section 22. Section 499.86, Florida Statutes, is created to
1111 read:
1112 499.86 Examination of materials.—
1113 (1) A wholesale distributor must visually examine a medical
1114 gas container upon receipt from the manufacturer in order to
1115 identify the medical gas stored within and to determine if the
1116 container has been damaged or is otherwise unfit for
1117 distribution. Such examination must occur in a manner that would
1118 reveal damage to the container which could suggest possible
1119 adulteration or misbranding.
1120 (2) A medical gas container that is found to be damaged or
1121 otherwise unfit pursuant to subsection (1) must be quarantined
1122 from the stock of medical gas until a determination is made that
1123 the medical gas in question is not misbranded or adulterated.
1124 (3) An outgoing shipment must be inspected to identify the
1125 medical gases in the shipment to ensure that medical gas
1126 containers that have been damaged in storage or held under
1127 improper conditions are not distributed or dispensed.
1128 (4) A wholesale distributor must review records documenting
1129 the acquisition of medical gas upon receipt for accuracy and
1130 completeness.
1131 Section 23. Section 499.87, Florida Statutes, is created to
1132 read:
1133 499.87 Returned, damaged, and outdated medical gas.—
1134 (1) A medical gas that has left the control of the
1135 wholesale distributor may be returned to the wholesale
1136 distributor or manufacturer from which it was acquired, but may
1137 not be resold as a medical gas unless it is reprocessed by a
1138 manufacturer using proper and adequate controls to ensure the
1139 identity, strength, quality, and purity of the reprocessed
1140 medical gas.
1141 (2) A medical gas that has been subjected to improper
1142 conditions, such as a fire, accident, or natural disaster, may
1143 not be salvaged or reprocessed.
1144 (3) A medical gas, including its container, which is
1145 damaged, misbranded, or adulterated must be quarantined from
1146 other medical gases until it is destroyed or returned to the
1147 manufacturer or wholesale distributor from which it was
1148 acquired. External contamination of a medical gas container or
1149 closure system which does not impact the integrity of the
1150 medical gas is not considered damaged or adulterated for
1151 purposes of this subsection. If a medical gas is adulterated or
1152 misbranded or suspected of being adulterated or misbranded,
1153 notice shall be provided to the manufacturer or wholesale
1154 distributor from which the medical gas was acquired and to the
1155 appropriate boards and federal regulatory bodies.
1156 (4) A medical gas container that has been opened or used
1157 but is not adulterated or misbranded is considered empty and
1158 must be quarantined from nonempty medical gas containers and
1159 returned to the manufacturer or wholesale distributor from which
1160 it was acquired for destruction or reprocessing.
1161 (5) A medical gas, its container, or its associated
1162 documentation or labeling that is suspected of being used in
1163 criminal activity must be retained until its disposition is
1164 authorized by the department or an applicable law enforcement
1165 agency.
1166 Section 24. Section 499.88, Florida Statutes, is created to
1167 read:
1168 499.88 Due diligence.—
1169 (1) A wholesale distributor shall obtain, before the
1170 initial acquisition of medical gas, the following information
1171 from the supplying wholesale distributor or manufacturer:
1172 (a) If a manufacturer is distributing to a wholesale
1173 distributor, evidence that the manufacturer is registered and
1174 the medical gas is listed with the United States Food and Drug
1175 Administration;
1176 (b) If a wholesale distributor is distributing to a
1177 wholesale distributor, evidence that the wholesale distributor
1178 supplying the medical gas is legally authorized to distribute
1179 medical gas within or into the state;
1180 (c) The name of the responsible facility contact person for
1181 the supplying manufacturer or wholesale distributor; and
1182 (d) Certification that the manufacturer’s or wholesale
1183 distributor’s policies and procedures comply with this part.
1184 (2) A wholesale distributor is exempt from obtaining the
1185 information from a manufacturer, as required under subsection
1186 (1), if the manufacturer is registered with the United States
1187 Food and Drug Administration in accordance with s. 510 of the
1188 federal act and the manufacturer provides:
1189 (a) Proof of such registration; and
1190 (b) Proof of inspection by the United States Food and Drug
1191 Administration or other regulatory body within the past 3 years
1192 demonstrating substantial compliance with current good
1193 manufacturing practices applicable to medical gases.
1194 (3) A manufacturer or wholesale distributor that
1195 distributes to or acquires medical gas from another wholesale
1196 distributor shall provide to or obtain from the distributing or
1197 acquiring manufacturer or distributor the information required
1198 by s. 499.89(1), as applicable.
1199 Section 25. Section 499.89, Florida Statutes, is created to
1200 read:
1201 499.89 Recordkeeping.—
1202 (1) A permitholder under this part shall establish and
1203 maintain a record of transactions regarding the receipt and the
1204 distribution, or other disposition, of medical gases, as
1205 applicable. Such records constitute an audit trail and must
1206 contain information sufficient to perform a recall of medical
1207 gas in compliance with 21 C.F.R. s. 211.196 and 21 C.F.R. s.
1208 820.160(b). Such records must include all of the following
1209 information, which may be kept in two separate documents one
1210 related to the distribution of medical gas and the other related
1211 to the receipt of medical gas:
1212 (a) The dates of receipt and distribution or other
1213 disposition of the medical gas.
1214 (b) The name, address, license or permit number and its
1215 expiration date for the person or entity purchasing the medical
1216 gas from the wholesale distributor.
1217 (c) The name, address, license or permit number and its
1218 expiration date for the person or entity receiving the medical
1219 gas, if different from the information required under paragraph
1220 (b).
1221 (d) Information sufficient to perform a recall of all
1222 medical gas received, distributed, or dispensed.
1223 (2) Such records shall be made available for inspection and
1224 copying by an authorized official of any federal, state, or
1225 local governmental agency for a period of:
1226 (a) Three years following the distribution date of high
1227 pressure medical gases.
1228 (b) Two years following the distribution date for cryogenic
1229 or refrigerated liquid medical gases.
1230 (3) Records kept at the inspection site or that can be
1231 immediately retrieved by computer or other electronic means
1232 shall be readily available for authorized inspection during the
1233 retention period. Records kept at a central location apart from
1234 the inspection site and not electronically retrievable shall be
1235 made available for inspection within 2 working days of a request
1236 by an authorized official of any state or federal governmental
1237 agency charged with enforcement of these rules.
1238 (4) A pedigree paper is not required for distributing or
1239 dispensing medical gas.
1240 (5) A wholesale distributor shall maintain records
1241 sufficient to aid in the mandatory reporting of any theft,
1242 suspected theft, or other significant loss of nitrous oxide to
1243 the department and other appropriate law enforcement agencies.
1244 Section 26. Section 499.90, Florida Statutes, is created to
1245 read:
1246 499.90 Policies and procedures.—A wholesale distributor
1247 shall establish, maintain, and adhere to written policies and
1248 procedures for the receipt, security, storage, transport,
1249 shipping, and distribution of medical gases and shall establish,
1250 maintain, and adhere to procedures for maintaining inventories;
1251 for identifying, recording, and reporting losses or thefts; and
1252 for correcting all errors and inaccuracies in inventories
1253 associated with nitrous oxide. A wholesale distributor shall
1254 include in its written policies and procedures the following:
1255 (1) A procedure for handling recalls and withdrawals of
1256 medical gas. Such procedure must deal with recalls and
1257 withdrawals due to:
1258 (a) Action initiated at the request of the United States
1259 Food and Drug Administration or any federal, state, or local law
1260 enforcement or other government agency, including the
1261 department; or
1262 (b) Voluntary action by a manufacturer of medical gases to
1263 remove defective or potentially defective medical gases from the
1264 market.
1265 (2) A procedure that includes preparation for, protection
1266 against, and responding to a crisis that affects the security or
1267 operation of a facility that stores medical gases in the event
1268 of a strike; a fire, flood, or other natural disaster; or other
1269 local, state, or national emergency.
1270 (3) A procedure for reporting criminal or suspected
1271 criminal activity involving the inventory of nitrous oxide to
1272 the department and to applicable law enforcement agencies within
1273 3 business days after becoming aware of the criminal or
1274 suspected criminal activity.
1275 Section 27. Section 499.91, Florida Statutes, is created to
1276 read:
1277 499.91 Prohibited acts.—A person may not perform or cause
1278 the performance of, or aid and abet in, any of the following
1279 acts in this state:
1280 (1) The manufacture, sale, or delivery, or the holding or
1281 offering for sale, of a medical gas that is adulterated,
1282 misbranded, or is otherwise unfit for distribution.
1283 (2) The adulteration or misbranding of a medical gas.
1284 (3) The receipt of a medical gas that is adulterated,
1285 misbranded, stolen, or obtained by fraud or deceit, or the
1286 delivery or proffered delivery of such medical gas for pay or
1287 otherwise.
1288 (4) The alteration, mutilation, destruction, obliteration,
1289 or removal of all or any part of the product labeling of a
1290 medical gas, or the willful commission of any other act with
1291 respect to a medical gas that results in it being misbranded.
1292 (5) The purchase or receipt of a medical gas from a person
1293 not authorized to distribute or dispense medical gas or who is
1294 not exempted from permitting requirements to wholesale
1295 distribute medical gas to such purchaser or recipient.
1296 (6) The knowing and willful sale or transfer of a medical
1297 gas to a recipient who is not legally authorized to receive a
1298 medical gas, except that a violation does not exist if a
1299 permitted wholesale distributor provides oxygen to a permitted
1300 medical oxygen retail establishment that is out of compliance
1301 with the notice of location change requirements of s. 499.834,
1302 provided that the wholesale distributor with knowledge of the
1303 violation notifies the department of the transaction by the next
1304 business day.
1305 (7) The failure to maintain or provide records required
1306 under this part and the rules adopted under this part.
1307 (8) Providing the department or any of its representatives
1308 or any state or federal official with false or fraudulent
1309 records or making false or fraudulent statements regarding this
1310 part or the rules adopted under this part.
1311 (9) The distribution of a medical gas that was:
1312 (a) Purchased by a public or private hospital or other
1313 health care entity, except for the physical distribution of such
1314 medical gas to an authorized recipient at the direction of a
1315 hospital or other health care entity;
1316 (b) Donated or supplied at a reduced price to a charitable
1317 organization; or
1318 (c) Stolen or obtained by fraud or deceit.
1319 (10) The failure to obtain a license or permit or operating
1320 without a valid license or permit, if one is required.
1321 (11) The obtaining of, or attempt to obtain, a medical gas
1322 by fraud, deceit, or misrepresentation or engaging in
1323 misrepresentation or fraud in the distribution of a medical gas.
1324 (12) Except for emergency use oxygen, the distribution of a
1325 medical gas to a patient without a prescription from a
1326 practitioner authorized by law to prescribe a medical gas.
1327 (13) The distribution or dispensing of a medical gas that
1328 was previously dispensed by a pharmacy or a practitioner
1329 authorized by law to prescribe.
1330 (14) The distribution or dispensing of a medical gas or
1331 medical gas-related equipment to a patient, unless the patient
1332 has been provided with the appropriate information and
1333 counseling on the use, storage, and disposal the medical gas.
1334 (15) Failure to report an act prohibited under this part or
1335 the rules adopted under this part.
1336 (16) Failure to exercise due diligence as provided in s.
1337 499.88.
1338 Section 28. Section 499.92, Florida Statutes, is created to
1339 read:
1340 499.92 Criminal acts.—
1341 (1) A person commits a felony of the third degree,
1342 punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
1343 if he or she:
1344 (a) Adulterates or misbrands a medical gas with intent to
1345 defraud or deceive;
1346 (b) Knowingly purchases or receives a medical gas from a
1347 person not legally authorized to distribute or dispense medical
1348 gas;
1349 (c) Knowingly engages in the wholesale distribution of, or
1350 sells, barters, brokers, or transfers, a medical gas to a person
1351 not legally authorized to purchase or receive medical gas in the
1352 jurisdiction in which the person receives the medical gas. A
1353 permitted wholesale distributor that, at its location, provides
1354 oxygen to a permitted medical oxygen retail establishment that
1355 is out of compliance with only the change of location notice
1356 requirement under s. 499.834, does not commit a violation of
1357 this subsection if the wholesale distributor notifies the
1358 department of the transaction no later than the next business
1359 day; or
1360 (d) Knowingly falsely creates a label for a medical gas or
1361 knowingly falsely misrepresents a factual matter contained in a
1362 label for a medical gas.
1363 (2) A person found guilty of an offense under this section,
1364 under the authority of the court convicting and sentencing the
1365 person, shall be ordered to forfeit to the state any real or
1366 personal property:
1367 (a) Used or intended to be used to commit, to facilitate,
1368 or to promote the commission of such offense; and
1369 (b) Constituting, derived from, or traceable to the gross
1370 proceeds that the defendant obtained directly or indirectly as a
1371 result of the offense.
1372 (3) Property or assets subject to forfeiture under
1373 subsection (2) may be seized pursuant to a warrant obtained in
1374 the same manner as a search warrant or as otherwise authorized
1375 by law, and held until the case against a defendant is
1376 adjudicated. Monies ordered forfeited, or proceeds from the sale
1377 of other assets ordered forfeited, shall be equitably divided
1378 between the department and other agencies involved in the
1379 investigation and prosecution that led to the conviction. Other
1380 property ordered forfeited after conviction of a defendant may,
1381 at the discretion of the investigating agencies, be placed into
1382 official use by the department or the agencies involved in the
1383 investigation and prosecution that led to the conviction.
1384 Section 29. Section 499.93, Florida Statutes, is created to
1385 read:
1386 499.93 Inspections.—
1387 (1) The department may require a facility that engages in
1388 the manufacture, retail sale, or wholesale distribution of
1389 medical gas to undergo an inspection in accordance with a
1390 schedule to be determined by the department, including
1391 inspections for initial permitting, permit renewal, and a
1392 permitholder’s change of location. The department may recognize
1393 a third party to inspect wholesale distributors in this state or
1394 other states pursuant to a schedule to be determined by the
1395 department.
1396 (2) The department may recognize another state’s
1397 inspections of a manufacturer or wholesale distributor located
1398 in that state if such state’s laws are deemed to be
1399 substantially equivalent to the laws of this state by the
1400 department.
1401 (3) A manufacturing facility of medical gases is exempt
1402 from inspection by the department if:
1403 (a) The manufacturing facility is currently registered with
1404 the United States Food and Drug Administration under s. 510 of
1405 the federal act and can provide proof of registration, such as a
1406 copy of the Internet verification page; and
1407 (b) The manufacturing facility can provide proof of
1408 inspection by the Food and Drug Administration, or if the
1409 facility is located in another state, inspection by the Food and
1410 Drug Administration or other governmental entity charged with
1411 regulation of good manufacturing practices related to medical
1412 gases in that state within the past 3 years, which demonstrates
1413 substantial compliance with current good manufacturing practices
1414 applicable to medical gases.
1415 (4) A permitholder under this part shall exhibit or have
1416 readily available its state permits and its most recent
1417 inspection report administered by the department.
1418 Section 30. Section 499.931, Florida Statutes, is created
1419 to read:
1420 499.931 Trade secret information.—Information required to
1421 be submitted under this part which is a trade secret as defined
1422 in s. 812.081(1)(c) and designated as a trade secret by an
1423 applicant or permitholder must be maintained as required under
1424 s. 499.051.
1425 Section 31. Section 499.94, Florida Statutes, is created to
1426 read:
1427 499.94 Fees.—A fee collected for a permit under this part
1428 shall be deposited into the Professional Regulation Trust Fund.
1429 Moneys collected under this part shall be used for administering
1430 this part. The department shall maintain a separate account in
1431 the trust fund for the Drugs, Devices, and Cosmetics program.
1432 Section 32. Paragraph (a) of subsection (1) of section
1433 409.9201, Florida Statutes, is amended to read:
1434 409.9201 Medicaid fraud.—
1435 (1) As used in this section, the term:
1436 (a) “Prescription drug” means any drug, including, but not
1437 limited to, finished dosage forms or active ingredients that are
1438 subject to, defined in by, or described in by s. 503(b) of the
1439 Federal Food, Drug, and Cosmetic Act or in by s. 465.003(8), s.
1440 499.003(52), s. 499.003(46) or (53) or s. 499.007(13), or s.
1441 499.82(10).
1442
1443 The value of individual items of the legend drugs or goods or
1444 services involved in distinct transactions committed during a
1445 single scheme or course of conduct, whether involving a single
1446 person or several persons, may be aggregated when determining
1447 the punishment for the offense.
1448 Section 33. Paragraph (c) of subsection (9) of section
1449 460.403, Florida Statutes, is amended to read:
1450 460.403 Definitions.—As used in this chapter, the term:
1451 (9)
1452 (c)1. Chiropractic physicians may adjust, manipulate, or
1453 treat the human body by manual, mechanical, electrical, or
1454 natural methods; by the use of physical means or physiotherapy,
1455 including light, heat, water, or exercise; by the use of
1456 acupuncture; or by the administration of foods, food
1457 concentrates, food extracts, and items for which a prescription
1458 is not required and may apply first aid and hygiene, but
1459 chiropractic physicians are expressly prohibited from
1460 prescribing or administering to any person any legend drug
1461 except as authorized under subparagraph 2., from performing any
1462 surgery except as stated herein, or from practicing obstetrics.
1463 2. Notwithstanding the prohibition against prescribing and
1464 administering legend drugs under subparagraph 1. or s.
1465 499.83(2)(c) s. 499.01(2)(m), pursuant to board rule
1466 chiropractic physicians may order, store, and administer, for
1467 emergency purposes only at the chiropractic physician’s office
1468 or place of business, prescription medical oxygen and may also
1469 order, store, and administer the following topical anesthetics
1470 in aerosol form:
1471 a. Any solution consisting of 25 percent ethylchloride and
1472 75 percent dichlorodifluoromethane.
1473 b. Any solution consisting of 15 percent
1474 dichlorodifluoromethane and 85 percent
1475 trichloromonofluoromethane.
1476
1477 However, this paragraph does not authorize a chiropractic
1478 physician to prescribe medical oxygen as defined in chapter 499.
1479 Section 34. Subsection (3) of section 465.0265, Florida
1480 Statutes, is amended to read:
1481 465.0265 Centralized prescription filling.—
1482 (3) The filling, delivery, and return of a prescription by
1483 one pharmacy for another pursuant to this section shall not be
1484 construed as the filling of a transferred prescription as
1485 described set forth in s. 465.026 or as a wholesale distribution
1486 as defined set forth in s. 499.003 s. 499.003(54).
1487 Section 35. Paragraph (b) of subsection (2) of section
1488 499.01212, Florida Statutes, is amended to read:
1489 499.01212 Pedigree paper.—
1490 (2) FORMAT.—A pedigree paper must contain the following
1491 information:
1492 (b) For all other wholesale distributions of prescription
1493 drugs:
1494 1. The quantity, dosage form, and strength of the
1495 prescription drugs.
1496 2. The lot numbers of the prescription drugs.
1497 3. The name and address of each owner of the prescription
1498 drug and his or her signature.
1499 4. Shipping information, including the name and address of
1500 each person certifying delivery or receipt of the prescription
1501 drug.
1502 5. An invoice number, a shipping document number, or
1503 another number uniquely identifying the transaction.
1504 6. A certification that the recipient wholesale distributor
1505 has authenticated the pedigree papers.
1506 7. The unique serialization of the prescription drug, if
1507 the manufacturer or repackager has uniquely serialized the
1508 individual prescription drug unit.
1509 8. The name, address, telephone number, and, if available,
1510 e-mail contact information of each wholesale distributor
1511 involved in the chain of the prescription drug’s custody.
1512
1513 When an affiliated group member obtains title to a prescription
1514 drug before distributing the prescription drug as the
1515 manufacturer as defined in s. 499.003(30)(e) under s.
1516 499.003(31)(e), information regarding the distribution between
1517 those affiliated group members may be omitted from a pedigree
1518 paper required under this paragraph for subsequent distributions
1519 of that prescription drug.
1520 Section 36. Paragraph (a) of subsection (1) and subsection
1521 (3) of section 499.015, Florida Statutes, are amended to read:
1522 499.015 Registration of drugs, devices, and cosmetics;
1523 issuance of certificates of free sale.—
1524 (1)(a) Except for those persons exempted from the
1525 definition of manufacturer in s. 499.003 s. 499.003(31), any
1526 person who manufactures, packages, repackages, labels, or
1527 relabels a drug, device, or cosmetic in this state must register
1528 such drug, device, or cosmetic biennially with the department;
1529 pay a fee in accordance with the fee schedule provided by s.
1530 499.041; and comply with this section. The registrant must list
1531 each separate and distinct drug, device, or cosmetic at the time
1532 of registration.
1533 (3) Except for those persons exempted from the definition
1534 of manufacturer in s. 499.003 s. 499.003(31), a person may not
1535 sell any product that he or she has failed to register in
1536 conformity with this section. Such failure to register subjects
1537 such drug, device, or cosmetic product to seizure and
1538 condemnation as provided in s. 499.062, and subjects such person
1539 to the penalties and remedies provided in this part.
1540 Section 37. Subsection (3) of section 499.024, Florida
1541 Statutes, is amended to read:
1542 499.024 Drug product classification.—The department shall
1543 adopt rules to classify drug products intended for use by humans
1544 which the United States Food and Drug Administration has not
1545 classified in the federal act or the Code of Federal
1546 Regulations.
1547 (3) Any product that falls under the definition of drug in
1548 s. 499.003 s. 499.003(19) may be classified under the authority
1549 of this section. This section does not subject portable
1550 emergency oxygen inhalators to classification; however, this
1551 section does not exempt any person from ss. 499.01 and 499.015.
1552 Section 38. This act shall take effect October 1, 2014.
1553
1554 ================= T I T L E A M E N D M E N T ================
1555 And the title is amended as follows:
1556 Delete everything before the enacting clause
1557 and insert:
1558 A bill to be entitled
1559 An act relating to medical gas; amending s. 499.001,
1560 F.S.; conforming provisions to changes made by this
1561 act; amending s. 499.003, F.S.; revising terms;
1562 amending ss. 499.01 and 499.0121, F.S.; conforming
1563 provisions to changes made by this act; amending s.
1564 499.01211, F.S.; adding a member of to the Drug
1565 Wholesale Distributor Advisory Council; authorizing
1566 the Compressed Gas Association to recommend one person
1567 to the council for appointment; amending ss. 499.041,
1568 499.05, 499.051, 499.066, 499.0661, and 499.067, F.S.;
1569 conforming provisions to changes made by this act;
1570 creating part III of ch. 499, F.S., entitled “Medical
1571 Gas”; creating s. 499.81, F.S.; providing for the
1572 administration and enforcement of this part; creating
1573 s. 499.82, F.S.; defining terms; creating s. 499.83,
1574 F.S.; requiring a person or entity that intends to
1575 distribute medical gas within or into this state to
1576 obtain an applicable permit before operating;
1577 establishing categories of permits and setting
1578 requirements for each; creating s. 499.831, F.S.;
1579 requiring the Department of Business and Professional
1580 Regulation to establish the form and content of an
1581 application; authorizing the department to set fees
1582 within certain parameters; creating s. 499.832, F.S.;
1583 providing that a permit expires 2 years after the last
1584 day of the month in which the permit was originally
1585 issued; providing requirements for the renewal of a
1586 permit; requiring the department to adopt rules for
1587 the renewal of permits; creating s. 499.833, F.S.;
1588 authorizing the department to approve certain
1589 permitholder changes; creating s. 499.834, F.S.;
1590 authorizing the department to consider certain factors
1591 in determining the eligibility of an applicant;
1592 creating s. 499.84, F.S.; setting the minimum
1593 requirements for the storage and handling of medical
1594 gas; creating s. 499.85, F.S.; setting facility
1595 requirements for security purposes; authorizing a
1596 vehicle used for on-call delivery of oxygen USP and
1597 oxygen-related equipment to be parked at a place of
1598 residence; requiring the department to adopt rules
1599 governing the distribution of medical oxygen; creating
1600 s. 499.86, F.S.; requiring a wholesale distributor of
1601 medical gases to visually examine a medical gas
1602 container upon receipt in order to identify the
1603 medical gas stored within and to determine if the
1604 container has been damaged or is otherwise unfit for
1605 distribution; requiring a medical gas container that
1606 is damaged or otherwise unfit for distribution to be
1607 quarantined; requiring outgoing shipments of medical
1608 gas to be inspected; requiring wholesale distributors
1609 to review certain records; creating s. 499.87, F.S.;
1610 authorizing the return of medical gas that has left
1611 the control of a wholesale distributor; requiring that
1612 medical gas that is damaged, misbranded, or
1613 adulterated be quarantined from other medical gases
1614 until it is destroyed or returned to the manufacturer
1615 or wholesale distributor from which it was acquired;
1616 creating s. 499.88, F.S.; requiring a wholesale
1617 distributor to obtain certain information before the
1618 initial acquisition of a medical gas; providing
1619 certain exemptions; creating s. 499.89, F.S.;
1620 requiring a permitholder under this part to establish
1621 and maintain transactional records; providing a
1622 retention period for certain records and requiring
1623 that such records be available for inspection during
1624 that period; creating s. 499.90, F.S.; requiring a
1625 wholesale distributor to establish, maintain, and
1626 adhere to certain written policies and procedures;
1627 creating s. 499.91, F.S.; prohibiting certain acts;
1628 creating s. 499.92, F.S.; establishing criminal
1629 penalties; authorizing property or assets subject to
1630 forfeiture to be seized pursuant to a warrant;
1631 creating s. 499.93, F.S.; authorizing the department
1632 to require a facility that engages in in the
1633 manufacture, retail sale, or wholesale distribution of
1634 medical to undergo an inspection; authorizing the
1635 department to authorize a third party to inspect such
1636 facilities; creating s. 499.931, F.S.; providing that
1637 trade secret information required to be submitted
1638 pursuant to this part must be maintained by the
1639 department; creating s. 499.94, F.S.; requiring fees
1640 collected pursuant to this part to be deposited into
1641 the Professional Regulation Trust Fund; amending ss.
1642 409.9201, 460.403, 465.0265, 499.01212, 499.015, and
1643 499.024, F.S.; conforming cross references; providing
1644 an effective date.
