Bill Text: FL S0836 | 2014 | Regular Session | Comm Sub
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Medical Gas
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2014-06-13 - Chapter No. 2014-89 [S0836 Detail]
Download: Florida-2014-S0836-Comm_Sub.html
Bill Title: Medical Gas
Spectrum: Slight Partisan Bill (? 2-1)
Status: (Passed) 2014-06-13 - Chapter No. 2014-89 [S0836 Detail]
Download: Florida-2014-S0836-Comm_Sub.html
Florida Senate - 2014 CS for SB 836
By the Committee on Regulated Industries; and Senator Bean
580-02206-14 2014836c1
1 A bill to be entitled
2 An act relating to medical gas; creating part III of
3 ch. 499, F.S., entitled “Medical Gas”; creating s.
4 499.81, F.S.; defining terms; creating s. 499.82,
5 F.S.; requiring a person or establishment located
6 inside or outside the state which intends to
7 distribute medical gas within or into this state to
8 obtain an applicable permit before operating; listing
9 the people or entities that are legally authorized to
10 receive medical gas; establishing categories of
11 permits and setting requirements for each; creating s.
12 499.821, F.S.; requiring the Department of Business
13 and Professional Regulation to establish the form and
14 content of an application; stating that an applicant
15 who is denied a permit has a right of review pursuant
16 to ch. 120, F.S.; authorizing the department to set
17 fees within certain parameters; creating s. 499.822,
18 F.S.; requiring a permit to expire 2 years after the
19 last day of the month in which the permit was issued;
20 providing requirements for the renewal of a permit;
21 requiring the department to adopt rules for the
22 renewal of permits; creating s. 499.823, F.S.;
23 authorizing the department to consider certain factors
24 in determining the eligibility of an applicant;
25 creating s. 499.824, F.S.; authorizing the department
26 to approve certain permitholder changes; authorizing
27 the department to revoke the permit of a person that
28 fails to comply with this section; creating s. 499.83,
29 F.S.; requiring an applicant for or a holder of a
30 permit as a wholesale distributor of medical gas or as
31 a medical oxygen retailer to designate a registered
32 agent; creating s. 499.84, F.S.; setting the minimum
33 requirements for the storage and handling of medical
34 gas; creating s. 499.85, F.S.; requiring a wholesale
35 distributor of medical gas to implement measures to
36 secure the location from unauthorized entry; setting
37 facility requirements for security purposes;
38 authorizing a vehicle used for on-call delivery of
39 oxygen USP and oxygen-related equipment to be parked
40 at a place of residence; requiring the department to
41 adopt rules governing the wholesale distribution of
42 prescription medical oxygen; creating s. 499.86, F.S.;
43 requiring a wholesale distributor of medical gases to
44 visually examine an immediate container upon receipt
45 for identity and to determine if the medical gas
46 container has been damaged or is otherwise unfit for
47 distribution; requiring a medical gas container that
48 is damaged or otherwise unfit for distribution to be
49 quarantined; requiring outgoing shipments to be
50 inspected; requiring wholesale distributors to review
51 certain records; creating s. 499.87, F.S.; authorizing
52 the return of medical gas that has left the control of
53 the wholesale distributor; requiring that medical gas
54 that is damaged, misbranded, or adulterated be
55 quarantined from other medical gases until it is
56 destroyed or returned to the manufacturer or wholesale
57 distributor from which it was acquired; creating s.
58 499.88, F.S.; requiring a wholesale distributor to
59 obtain certain information before the initial
60 acquisition of the medical gas; providing certain
61 exemptions; creating s. 499.89, F.S.; requiring a
62 wholesale distributor to establish and maintain
63 transactional records; providing a retention period
64 for certain records and requiring that the records be
65 available for inspection during that period; creating
66 s. 499.90, F.S.; requiring a wholesale distributor to
67 establish, maintain, and adhere to certain written
68 policies and procedures; creating s. 499.91, F.S.;
69 prohibiting certain acts; creating s. 499.92, F.S.;
70 establishing criminal penalties; authorizing property
71 or assets subject to forfeiture to be seized pursuant
72 to a warrant; creating s. 499.93, F.S.; authorizing
73 the department to require a facility that engages in
74 wholesale distribution to undergo an inspection;
75 authorizing the department to authorize a third party
76 to inspect wholesale distributors; creating s.
77 499.931, F.S.; providing that trade secret information
78 required to submitted pursuant to this part must be
79 maintained by the department; creating s. 499.94,
80 F.S.; requiring fees collected pursuant to this part
81 to be deposited into the Professional Regulation Trust
82 Fund; creating s. 499.95, F.S.; authorizing the
83 department for the purpose of initiating an
84 investigation or proceeding under this part to
85 administer oaths, take depositions, issue and serve
86 subpoenas, and compel attendance of witnesses and the
87 production of books, papers, documents or other
88 evidence; requiring an attorney to whom the department
89 reports a violation of this part to timely institute
90 proceedings in the court of competent jurisdiction;
91 exempting minor violations from reporting requirements
92 at the department’s discretion; providing that this
93 part is cumulative and does not repeal or affect the
94 power, duty, or authority of the department; amending
95 ss. 409.9201, 460.403, and 465.0265; conforming
96 provisions to changes made by the act; amending s.
97 499.001, F.S.; conforming a provision to changes made
98 by the act; amending s. 499.003, F.S.; conforming
99 terminology, deleting a definition, and defining the
100 term “medical gas”; amending ss. 499.01 and 499.0121,
101 F.S.; conforming provisions to changes made by the
102 act; amending s. 499.01211, F.S.; changing the
103 membership of the Drug Wholesale Distributor Advisory
104 Council; requiring the Compressed Gas Association to
105 appoint one person to the council; amending ss.
106 499.01212, 499.015, 499.024, 499.041, 499.05, 499.051,
107 499.066, 499.0661, and 499.067, F.S.; conforming
108 provisions to changes made by the act; providing an
109 effective date.
110
111 Be It Enacted by the Legislature of the State of Florida:
112
113 Section 1. Part III of chapter 499, Florida Statutes,
114 consisting of ss. 499.81-499.95, Florida Statutes, is created
115 and is entitled “Medical Gas.”
116 Section 2. Section 499.81, Florida Statutes, is created to
117 read:
118 499.81 Definitions.—As used in this part, the term:
119 (1) “Adulterated” with respect to medical gas means medical
120 gas that:
121 (a) Consists, in whole or in part, of impurities or
122 deleterious substances that exceed normal specifications;
123 (b) Has been produced, prepared, packed, or held under
124 conditions whereby the gas may have been contaminated, causing
125 it to be rendered injurious to health; or was manufactured,
126 processed, packed, or held using methods, facilities, or
127 controls that do not conform to or are not operated or
128 administered in conformity with current good manufacturing
129 practices;
130 (c) Has a container interior that is composed, in whole or
131 in part, of a poisonous or deleterious substance that may render
132 the container contents injurious to health; or
133 (d) Has a strength that differs from, or that is of a
134 quality or purity that fails to meet, the standards established
135 in the USP-NF, if the gas is purported to be, or is represented
136 as, medical gas as recognized in the USP-NF. Such a
137 determination as to strength, quality, or purity must be made in
138 accordance with the tests or methods of assay set forth in the
139 USP-NF or a validated equivalent, or, in the absence or
140 inadequacy of these tests or methods of assay, those prescribed
141 under the authority of the federal act shall be used. However, a
142 gas that is purported to be, or is represented as, medical gas
143 as recognized in the USP-NF but that differs in strength,
144 quality, or purity from the standards established in the USP-NF
145 may not be deemed adulterated for purposes of this paragraph if
146 the difference is plainly stated on its label.
147 (2) “Department” means the Department of Business and
148 Professional Regulation.
149 (3) “Distribute” or “distribution” means to sell or offer
150 to sell, deliver or offer to deliver, broker, give away, or
151 transfer medical gas, by passage of title or by physical
152 movement. The term does not include:
153 (a) Dispensing or administering medical gas;
154 (b) Delivering or offering to deliver medical gas by a
155 common carrier in its usual course of business; or
156 (c) A sales activity that takes place in an establishment
157 that is owned or controlled by a person or business entity
158 authorized to distribute medical gas within or into this state
159 or staffed by persons employed by such person, if the location
160 where the sales activity takes place does not physically store
161 or transport medical gas.
162 (4) “Emergency use oxygen” means oxygen USP that is
163 administered without a prescription for an emergency situation
164 concerning oxygen deficiency or resuscitation and that is in a
165 container labeled in accordance with FDA standards.
166 (5) “FDA” means the federal Food and Drug Administration.
167 (6) “Federal act” means the federal Food, Drug, and
168 Cosmetic Act, 21 U.S.C. ss. 301 et seq.
169 (7) “Health care entity” means a person, including an
170 organization business entity, which provides diagnostic,
171 medical, surgical, or dental treatment or rehabilitative care.
172 The term includes a home respiratory care provider or a person
173 or entity authorized to administer emergency use oxygen, but
174 does not include a retail pharmacy or wholesale distributor.
175 (8) “Immediate container” means a compressed gas cylinder
176 or liquid container that contains medical gas. The term does not
177 include a large-bulk liquid or high pressure container, such as
178 a storage tank, vehicle-mounted vessel, trailer, or railcar.
179 (9) “Intracompany transaction” means a transaction between
180 divisions, subsidiaries, parents, or affiliated or related
181 companies under the common ownership and control of a single
182 corporate entity.
183 (10) “Label” means a display of a written, printed, or
184 graphic matter upon an immediate container. The term does not
185 include the letters, numbers, or symbols stamped onto a
186 container as required by the United States Department of
187 Transportation.
188 (11) “Manufacturer” means a person or entity that
189 manufactures medical gas in bulk or that transfers the gas or
190 liquefied gas product from one container to another.
191 (12) “Medical gas” is defined in accordance with the
192 federal act and means a liquefied or vaporized gas that is a
193 prescription drug, regardless of whether it is alone or combined
194 with other gases.
195 (13) “Medical gas-related equipment” means a device used as
196 an accessory or component part to contain or control flow,
197 delivery, or pressure during the administration of medical gas,
198 such as liquid-oxygen base and portable units, pressure
199 regulators, flow meters, and oxygen concentrators.
200 (14) “Misbranded” means medical gas that has a label that
201 is false or misleading or a label that does not:
202 (a) Display the name and address of the manufacturer,
203 packer, or distributor;
204 (b) Provide an accurate statement of the quantity of active
205 ingredients or show an accurate monograph for the medical gas;
206 or
207 (c) In the case of mixtures of designated medical gases,
208 identify the component percentages of each designated medical
209 gas used to make the mixture.
210 (15) “Prescription medical oxygen” means oxygen USP, a drug
211 that may be sold only by the order or prescription of a licensed
212 practitioner authorized by law to prescribe.
213 (16) “USP-NF” or “USP” means the standards published in the
214 official book, “The United States Pharmacopeia and the National
215 Formulary.”
216 (17) “Wholesale distribution” means the distribution of
217 medical gas by a wholesale distributor of medical gas to a
218 person other than a consumer or patient. The term does not
219 include:
220 (a) The sale, purchase, or trade of a medical gas, an offer
221 to sell, purchase, or trade a prescription drug or device, or
222 the dispensing of medical gas pursuant to a prescription;
223 (b) The sale, purchase, or trade of a medical gas or an
224 offer to sell, purchase, or trade medical gas for an emergency
225 medical reason that includes, but is not limited to:
226 1. A transfer of a medical gas between wholesale
227 distributors or between a wholesale distributor and a retail
228 pharmacy or health care entity to alleviate a temporary shortage
229 of medical gas resulting from a delay in or an interruption of a
230 regular distribution schedule;
231 2. Sales to a licensed emergency medical service provider,
232 such as an ambulance company, a firefighting organization, or a
233 licensed practitioner authorized to prescribe medical gases;
234 3. Provision of minimal emergency supplies of medical gas
235 to a nursing home for use in an emergency or during the hours of
236 the day when necessary medical gas cannot be obtained; or
237 4. Transfers of medical gases to alleviate a temporary
238 shortage between retail pharmacies;
239 (c) An intracompany transaction;
240 (d) The sale, purchase, or trade of medical gas or an offer
241 to sell, purchase, or trade medical gas among hospitals,
242 pharmacies, or other health care entities that are under common
243 control;
244 (e) The sale, purchase, or trade of medical gas, or the
245 offer to sell, purchase, or trade medical gas by a charitable
246 organization that has been granted an exemption under s.
247 501(c)(3) of the Internal Revenue Code to a nonprofit affiliate
248 of the organization, to the extent otherwise permitted by law;
249 (f) The purchase or other acquisition of medical gas by a
250 hospital or other similar health care entity that is a member of
251 a group purchasing organization, for the hospital’s or the
252 health care entity’s own use, from the group purchasing
253 organization or from another hospital or similar health care
254 entity that is a member of such organization;
255 (g) The return of residual medical gas that may be
256 reprocessed in accordance with the manufacturer’s procedures or
257 the return of recalled, expired, damaged, or otherwise
258 nonsalable medical gas, when returned by a hospital, health care
259 entity, pharmacy, or charitable institution to a wholesale
260 distributor;
261 (h) An activity that is exempt from the definition of the
262 term “wholesale distribution” as provided in s. 499.003; or
263 (i) A transaction that is excluded from the definition of
264 the term “wholesale distribution” under the federal act or
265 regulations implemented under the federal act related to medical
266 gas.
267 (18) “Wholesale distributor” means a person or entity
268 engaged in the wholesale distribution of medical gas within or
269 into this state, including, but not limited to, a manufacturer,
270 an own-label distributor, a private-label distributor, a
271 warehouse, including a manufacturers’ and distributors’
272 warehouse, and a wholesale medical gas warehouse.
273 Section 3. Section 499.82, Florida Statutes, is created to
274 read:
275 499.82 Permits.—
276 (1) A person or establishment, located inside or outside
277 the state, which intends to distribute medical gas within or
278 into this state must obtain the applicable permit before
279 operating.
280 (2) All of the following are legally authorized to receive
281 medical gas: permitted medical gas manufacturers or permitted
282 wholesale distributors, licensed pharmacies or health care
283 entities, people authorized to receive emergency use oxygen
284 without a prescription, locations with automated external
285 defibrillation machines where emergency use oxygen is intended
286 to be used with such machines, or companies that need medical
287 gas in the installation and refurbishment of piping and
288 equipment used to contain or administer medical gas.
289 (3) An applicant who is a natural person must be at least
290 18 years of age or an applicant must be managed, controlled, or
291 overseen, directly or indirectly, by a natural person who is at
292 least 18 years of age.
293 (4) An out-of-state wholesale distributor that provides
294 services in this state must be legally authorized as a wholesale
295 distributor in the state in which it resides or is incorporated.
296 (5) A wholesale distributor may not operate from a place of
297 residence, and a place of residence may not be granted a permit
298 or operate under this part, except for the on-call delivery of
299 home care oxygen by a home respiratory care technician.
300 (6) If wholesale distribution is conducted at more than one
301 location within this state or more than one location
302 distributing into this state, each location must be permitted by
303 the department.
304 (7) The following permits are established:
305 (a) Medical gas wholesale distributor permit.—A medical gas
306 wholesale distributor permit is required for wholesale
307 distribution within or into this state.
308 1. Such permit does not authorize distribution to a
309 consumer or patient.
310 2. The medical gas must be in the container that was
311 obtained by that wholesale distributor without further
312 manufacturing operations being performed.
313 3. A wholesale distributor may not possess or engage in the
314 wholesale distribution of any prescription drug other than
315 medical gas.
316 (b) Medical gas manufacturer permit.—A medical gas
317 manufacturer permit is required for a person who engages in the
318 manufacture of medical gas by physical air separation, chemical
319 action, purification, or filling containers using a liquid-to
320 liquid, liquid-to-gas, or gas-to-gas process and distributes
321 such medical gas within or into this state. A medical gas
322 manufacturer:
323 1. May not manufacture or possess a prescription drug other
324 than medical gas unless the appropriate permit is obtained.
325 2. May engage in the wholesale distribution of medical gas
326 that is manufactured at the permitted establishment without
327 obtaining a medical gas wholesale distributor permit, but shall
328 comply with this part and applicable rules.
329 3. Shall comply with all appropriate state and federal good
330 manufacturing practices.
331 (c) Medical oxygen retail establishment permit.—A medical
332 oxygen retail establishment permit is required for a person who
333 sells prescription medical oxygen directly to patients. Such
334 sales must be based upon an order or prescription from a
335 licensed practitioner authorized by law to prescribe. A pharmacy
336 licensed under chapter 465 is exempt from this paragraph. A
337 medical oxygen retail establishment:
338 1. May not possess, purchase, sell, or trade a prescription
339 drug other than medical oxygen unless other appropriate permits
340 are obtained.
341 2. May refill a prescription medical oxygen container for a
342 patient based on an order or prescription from a licensed
343 practitioner authorized by law to prescribe. A medical oxygen
344 retail establishment that refills prescription medical oxygen
345 shall comply with all appropriate state and federal good
346 manufacturing practices.
347 3. Shall comply with the storage and handling requirements
348 under s. 499.84.
349 4. May not receive back into its inventory any prescription
350 medical oxygen that it sold pursuant to a licensed
351 practitioner’s order.
352 Section 4. Section 499.821, Florida Statutes, is created to
353 read:
354 499.821 Permit application.—
355 (1) The department shall establish by rule the form and
356 content of an application to obtain a permit listed under s.
357 499.82.
358 (a) An application for a permit must be filed with the
359 department and must include the following information:
360 1. The trade or business names, including fictitious names,
361 currently and formerly used by the applicant, which may not be
362 identical to a name used by an unrelated wholesale distributor
363 authorized in this state to purchase medical gas.
364 2. The name or names of the owner and operator of the
365 permittee, if not the same person or entity. The application
366 must also include the following if the applicant is:
367 a. An individual: the applicant’s business address and date
368 of birth.
369 b. A sole proprietorship: the business address of the sole
370 proprietor and the name and federal employer identification
371 number of the business entity.
372 c. A partnership: the business address and date of birth of
373 each partner and the name and federal employer identification
374 number of the partnership.
375 d. A limited liability company: the business address and
376 title of each company officer, the name and federal employer
377 identification number of the limited liability company, and the
378 state of incorporation.
379 e. A corporation: the business address and title of each
380 corporate officer and director; the name, state of
381 incorporation, and federal employer identification number of the
382 corporation; and the name and business address of any parent
383 company.
384 3. A list of disciplinary actions pertinent to wholesale
385 distributors of prescription drugs or controlled substances by a
386 state or federal agency against the applicant seeking to
387 distribute into this state and against a principal, owner,
388 director, or officer.
389 4. An address and description of each facility or
390 warehouse, including a description of the security system for
391 any location used for medical gas storage or wholesale
392 distribution.
393 (b) The applicant shall attest in writing that the
394 information contained in the application is complete and
395 accurate, that the applicant has not been convicted of or
396 disciplined for a criminal or prohibited act, and that the
397 application contains complete disclosure of any past criminal
398 convictions or violations of state or federal law relating to
399 medical gases.
400 (2) An applicant that is denied a permit has the right to
401 review of the department’s decision pursuant to chapter 120.
402 (3) An applicant must submit a reasonable fee, to be
403 determined by the department, in order to obtain a permit. The
404 fee for a medical gas wholesale distributor permit may not be
405 less than $200 or more than $300 annually. The fee for a medical
406 gas manufacturer permit may not be less than $400 or more than
407 $500 annually. The fee for a medical oxygen retail establishment
408 permit may not be less than $200 or more than $300 annually.
409 Section 5. Section 499.822, Florida Statutes, is created to
410 read:
411 499.822 Expiration and renewal of a permit.—
412 (1) A permit issued under this part automatically expires 2
413 years after the last day of the month in which the permit was
414 originally issued unless the permit is suspended or revoked
415 before the automatic expiration date.
416 (2) A permit issued under this part may be renewed by
417 submitting an application for renewal on a form furnished by the
418 department and paying the appropriate fee. The application for
419 renewal must contain a statement by the applicant attesting that
420 the information is true and correct. If a renewal application
421 and renewal fee are submitted and postmarked after the
422 expiration date of the permit, the permit may be renewed only
423 upon payment of a late renewal delinquent fee of $100, plus the
424 required renewal fee, within 60 days after the expiration date.
425 (3) Failure to renew a permit in accordance with this
426 section precludes future renewal. If a permit has expired and
427 cannot be renewed, the person or establishment must submit an
428 application for a new permit, pay the applicable application
429 fee, the initial permit fee, and all applicable penalties, and
430 be issued a new permit by the department before engaging in an
431 activity that requires a permit under this part.
432 (4) The department shall adopt rules to administer this
433 section, including setting a reasonable fee for a renewal
434 application.
435 Section 6. Section 499.823, Florida Statutes, is created to
436 read:
437 499.823 Minimum qualifications.—The department may deny an
438 application for a permit or refuse to renew a permit based upon:
439 (1) Whether the applicant has violated, or has been
440 disciplined by a regulatory agency in any state for violating, a
441 federal, state, or local law relating to wholesale distribution;
442 (2) The applicant’s criminal convictions;
443 (3) The applicant’s past experience in manufacturing or
444 distributing medical gas;
445 (4) Any false or fraudulent material contained in an
446 application;
447 (5) Suspension, sanction, or revocation of a permit
448 currently or previously held by the applicant for violations of
449 a state or federal law relating to medical gas;
450 (6) Compliance with previously granted permit requirements;
451 (7) Compliance with the requirements to maintain or make
452 available to the department or permitting authority or to a
453 federal, state, or local law enforcement official records
454 required to be maintained by a wholesale distributor; and
455 (8) Any other factors or qualifications that the department
456 considers relevant to and consistent with public health and
457 safety.
458 Section 7. Section 499.824, Florida Statutes, is created to
459 read:
460 499.824 Permitholder changes.—
461 (1) A permit issued by the department is valid only for the
462 person or entity to which it is issued and is not subject to
463 sale, assignment, or other transfer, voluntarily or
464 involuntarily, and is not valid for an establishment other than
465 the establishment for which it was originally issued, except as
466 provided in this part. The department may approve the following
467 changes, and a person or entity may continue to operate in the
468 following manner:
469 (a) Change of location.—A person or entity permitted under
470 this part must notify the department 30 days before changing
471 location. The department shall set a change-of-location fee not
472 to exceed $100.
473 (b) Change in ownership.—If a majority of the ownership or
474 controlling interest of a permitted establishment is transferred
475 or assigned or if a lessee agrees to undertake or provide
476 services such that legal liability for operation of the
477 establishment will rest with the lessee, an application for a
478 new permit is required. The application for the new permit must
479 be submitted 30 days before the change of ownership. However, if
480 an applicant is a permitholder or is wholly owned by or wholly
481 owns a permitholder under this part, the application for the new
482 permit must be made by the date of the sale, transfer,
483 assignment, or lease. Between the date of the change of
484 ownership and the date of the application approval or denial by
485 the department, an applicant may distribute under the permit
486 number of the previous owner.
487 (c) Change of name.—A permitholder may change its name
488 without submitting a new permit application. However, the
489 permitholder must notify the department 30 days before changing
490 its name. The permitholder may continue to operate the
491 establishment while the notification is being processed.
492 (d) Closure.—If an establishment permitted under this part
493 closes, the owner must notify the department, in writing, before
494 the effective date of the closure and must:
495 1. Return the permit to the department; and
496 2. If the permittee is authorized to distribute medical
497 gas, indicate the disposition of such medical gas, including the
498 name, address, and inventory, and provide the name and address
499 of a person to contact regarding access to the records that are
500 required to be maintained under this part. Transfer of ownership
501 of medical gas may be made only to persons authorized to receive
502 medical gas pursuant to this part.
503 (e) Change in information.—Any change in information
504 required under this part, other than a change of information as
505 set forth in paragraphs (a)-(d), must be submitted to the
506 department within 30 days after such change.
507 (2) Notwithstanding paragraph (1)(a), a permitholder in
508 good standing may change the type of permit issued by completing
509 a new application for the requested permit, paying the amount of
510 the difference in the permit fees, and meeting the applicable
511 permitting requirements for the new permit type. A refund may
512 not be issued if the fee for the new permit is less than the fee
513 that was paid for the original permit. The new permit expires on
514 the expiration date of the original permit being changed.
515 (3) The department may revoke a permit for failure to
516 comply with this section.
517 Section 8. Section 499.83 Florida Statutes, is created to
518 read:
519 499.83 Registered agent.—An applicant for or a holder of a
520 permit as a medical gas wholesale distributor or as a medical
521 oxygen retail establishment shall designate a registered agent
522 in this state for purposes of service of process. If an
523 applicant or a permitted wholesale distributor or medical oxygen
524 retailer fails to designate a registered agent, the Secretary of
525 State shall be deemed the true and lawful attorney of the
526 applicant or the permitted wholesale distributor or medical
527 oxygen retailer, and, in such case, the legal processes in any
528 action or proceeding against an applicant or permitted wholesale
529 distributor or medical oxygen retailer which grows out of or
530 arising from wholesale distribution or retail may be served upon
531 the Secretary of State. A copy of the service of process shall
532 be mailed to the applicant or the permitted wholesale
533 distributor or medical oxygen retailer by the department by
534 certified mail, return receipt requested, postage prepaid, at
535 the address of the applicant or the distributor or retailer as
536 designated on the application for a permit in this state.
537 Section 9. Section 499.84, Florida Statutes, is created to
538 read:
539 499.84 Minimum requirements for the storage and handling of
540 medical gas.—
541 (1) A facility that receives, stores, warehouses, handles,
542 holds, offers, markets, displays, or transports medical gas must
543 avoid any negative effect on the identity, strength, quality, or
544 purity of medical gas by:
545 (a) Being constructed in a way that ensures that medical
546 gas is maintained in accordance with its product labeling
547 recommendations or in compliance with official compendium
548 standards, such as the USP-NF;
549 (b) Being of a suitable size and construction that
550 facilitates cleaning, maintenance, and proper wholesale
551 distribution;
552 (c) Having an adequate storage area with appropriate
553 lighting, ventilation, space, equipment, and security
554 conditions;
555 (d) Having a quarantine area for the storage of medical gas
556 that is suspected of being misbranded, adulterated, or otherwise
557 unfit for distribution;
558 (e) Being maintained in an orderly condition;
559 (f) Being in a commercial location, except if a personal
560 dwelling location is used for the on-call delivery of oxygen USP
561 for home care use and the person providing on-call delivery is
562 employed by or acting under a written contract with a permittee;
563 (g) Providing for the secure storage of patient
564 information, if applicable, by restricting access and
565 implementing policies and procedures that protect the integrity
566 and confidentiality of patient information; and
567 (h) Providing and maintaining appropriate inventory
568 controls in order to detect and document any theft of nitrous
569 oxide.
570 (2) Medical gas must be stored under appropriate conditions
571 in accordance with the manufacturers’ recommendations on product
572 labeling and department rules or, in the absence of rules, in
573 accordance with applicable industry standards. Medical gas must
574 be packaged in accordance with official compendium standards,
575 such as the USP-NF.
576 Section 10. Section 499.85, Florida Statutes, is created to
577 read:
578 499.85 Security.—
579 (1) A facility that engages in wholesale distribution shall
580 implement measures to secure its facility from unauthorized
581 entry. Such measures must include the following:
582 (a) Access from outside the premises must be well
583 controlled and kept to a minimum.
584 (b) The outside perimeter of the premises must be well
585 lighted.
586 (c) Areas in which medical gas is held must be restricted
587 by a fence or other system that detects or deters entry after
588 hours and limits access only to authorized personnel.
589 (2) A facility that engages in wholesale distribution must
590 have:
591 (a) A security system that provides protection against
592 theft and, if appropriate, theft that is enabled or obscured by
593 tampering with computers or electronic records.
594 (b) A security system that protects the integrity and
595 confidentiality of data and documents.
596 (3) If a wholesale distributor uses electronic distribution
597 records, he or she must employ, train, and document the training
598 of personnel for the proper use of the applicable technology and
599 equipment.
600 (4) A vehicle used for on-call delivery of oxygen USP and
601 oxygen-related equipment for home care use by a home care
602 provider may be parked at a place of residence. Such vehicle
603 while unattended must be locked and equipped with an audible
604 alarm.
605 (5) The department shall adopt rules that govern the
606 wholesale distribution of prescription medical oxygen for
607 emergency use by persons authorized to receive emergency use
608 oxygen. Unless the laws of this state specifically direct
609 otherwise, such rules must be consistent with federal rules and
610 regulations, including the labeling requirements of oxygen under
611 the federal act.
612 Section 11. Section 499.86, Florida Statutes, is created to
613 read:
614 499.86 Examination of materials.—
615 (1) A wholesale distributor must visually examine an
616 immediate container upon receipt from the manufacturer in order
617 to identify the medical gas and to determine if the container
618 has been damaged or is otherwise unfit for wholesale
619 distribution. Such examination must occur in a manner that would
620 reveal damage to the container which could suggest possible
621 adulteration or misbranding.
622 (2) A medical gas container that is damaged or otherwise
623 unfit pursuant to subsection (1) must be quarantined from the
624 rest of the stock of medical gas until it is determined that the
625 medical gas in question was not misbranded or adulterated.
626 (3) An outgoing shipment must be inspected for identity and
627 to ensure that medical gas containers that have been damaged in
628 storage or held under improper conditions are not delivered.
629 (4) A wholesale distributor must review records documenting
630 the acquisition of medical gas upon receipt for accuracy and
631 completeness.
632 Section 12. Section 499.87, Florida Statutes, is created to
633 read:
634 499.87 Returned, damaged, and outdated medical gas.—
635 (1) Medical gas that has left the control of a wholesale
636 distributor may be returned to the manufacturer or wholesale
637 distributor from which it was acquired.
638 (2) Unless medical gas is reprocessed by a manufacturer
639 employing proper and adequate controls to ensure the identity,
640 strength, quality, and purity of the reprocessed medical gas,
641 the gas may not be resold as a medical gas even if its integrity
642 was maintained.
643 (3) Medical gas that has been subjected to improper
644 conditions, such as a fire, accident, or natural disaster, may
645 not be salvaged or reprocessed.
646 (4) Medical gas, including its container, which is damaged,
647 misbranded, or adulterated must be quarantined from other
648 medical gases until it is destroyed or returned to the
649 manufacturer or wholesale distributor from which it was
650 acquired. External contamination to a medical gas container or
651 closure system which does not impact the integrity of the
652 medical gas is not considered damage or adulteration for
653 purposes of this subsection. If medical gas is adulterated or
654 misbranded or suspected of being adulterated or misbranded,
655 notice shall be provided to the manufacturer or wholesale
656 distributor from which the medical gas was acquired and to the
657 appropriate boards and federal regulatory bodies.
658 (5) A medical gas container that has been opened or used
659 but is not adulterated or misbranded is considered empty and
660 must be quarantined from nonempty medical gas containers and
661 returned to the manufacturer or wholesale distributor from which
662 it was acquired for destruction or reprocessing.
663 (6) Medical gas, its container, or its associated
664 documentation or labeling that is suspected of being used in
665 criminal activity must be retained until its disposition is
666 authorized by the department or an applicable law enforcement
667 agency.
668 Section 13. Section 499.88, Florida Statutes, is created to
669 read:
670 499.88 Due diligence.—
671 (1) A wholesale distributor shall obtain, before the
672 initial acquisition of medical gas, the following information
673 from the supplying wholesale distributor or manufacturer:
674 (a) If a manufacturer is distributing to a wholesale
675 distributor, evidence that the manufacturer is registered and
676 the medical gas is listed with the FDA;
677 (b) If a wholesale distributor is distributing to a
678 wholesale distributor, evidence that the wholesale distributor
679 supplying the medical gas is permitted to distribute medical gas
680 within or into the state;
681 (c) The name of the contact person for the supplying
682 manufacturer or wholesale distributor; and
683 (d) Certification that the manufacturer’s or wholesale
684 distributor’s policies and procedures comply with this part.
685 (2) A wholesale distributor is exempt from obtaining the
686 information from a manufacturer as required under subsection (1)
687 if the manufacturer is registered with the FDA in accordance
688 with s. 510 of the federal act and provides:
689 (a) Proof of such registration; and
690 (b) Proof of inspection within the past 3 years by the FDA
691 or other regulatory body or proof of conformance with industry
692 standards or guidelines as identified by the department.
693 (3) A manufacturer or wholesale distributor that
694 distributes to or acquires medical gas from another wholesale
695 distributor shall provide to or obtain from the distributing or
696 acquiring manufacturer or distributor the information required
697 by s. 499.89(1), as applicable.
698 Section 14. Section 499.89, Florida Statutes, is created to
699 read:
700 499.89 Recordkeeping.—
701 (1) A wholesale distributor shall establish and maintain a
702 record of transactions regarding the receipt and the
703 distribution, or other disposition, of medical gases. Such
704 records constitute an audit trail and must contain information
705 sufficient to perform a recall of medical gas in compliance with
706 21 C.F.R. s. 211.196 and 21 C.F.R. s. 820.160(b). Such records
707 must include all the following information, which need not
708 appear in the same document:
709 (a) The dates of receipt and wholesale distribution, or
710 other disposition, of the medical gas.
711 (b) The name, address, permit number, and permit expiration
712 date for the entity purchasing the medical gas from the
713 wholesale distributor.
714 (c) The name, address, permit number, and permit expiration
715 date for the entity receiving the medical gas from the wholesale
716 distributor, if different from the information required under
717 paragraph (b).
718 (d) Information sufficient to perform a recall of all
719 medical gas received or distributed.
720 (2) From the time of their creation, such records shall be
721 kept for 3 years for high pressure medical gas and for 1 year
722 for cryogenic or refrigerated liquid medical gas.
723 (3) During the retention period, such records shall be made
724 available for inspection and photocopying by an authorized
725 official of a state, federal, or local governmental agency. If
726 such records are kept at the inspection site or could be
727 immediately retrieved by electronic means, they shall be made
728 readily available for authorized inspection during the retention
729 period. Records kept at a central location apart from the
730 inspection site and not electronically retrievable shall be made
731 available for inspection within 2 business days of a request.
732 (4) A pedigree paper is not required for the wholesale
733 distribution of medical gas.
734 Section 15. Section 499.90, Florida Statutes, is created to
735 read:
736 499.90 Policies and procedures.—A wholesale distributor
737 shall establish, maintain, and adhere to written policies and
738 procedures for the receipt, security, storage, transport,
739 shipping, and wholesale distribution of medical gas and shall
740 establish, maintain, and adhere to procedures for maintaining
741 inventories; for identifying, recording, and reporting losses or
742 thefts; and for correcting all errors and inaccuracies in
743 inventories associated with nitrous oxide. A wholesale
744 distributor shall include in its written policies and procedures
745 the following:
746 (1) A procedure for handling recalls and withdrawals of
747 medical gas. Such procedure must deal with recalls and
748 withdrawals due to:
749 (a) Action initiated at the request of the FDA or any
750 federal, state, or local law enforcement or other government
751 agency, including the department; or
752 (b) Voluntary action by the manufacturer of medical gas to
753 remove defective or potentially defective medical gases from the
754 market.
755 (2) A procedure preparing for, protecting against, and
756 handling a crisis that affects the security or operation of a
757 facility in the event of a strike, fire, flood, or other natural
758 disaster or other situations of local, state, or national
759 emergency.
760 (3) A procedure for reporting criminal or suspected
761 criminal activity involving the inventory of nitrous oxide to
762 the department and to applicable law enforcement agencies within
763 3 business days after becoming aware of the criminal or
764 suspected criminal activity.
765 Section 16. Section 499.91, Florida Statutes, is created to
766 read:
767 499.91 Prohibited acts.—A person may not perform or cause
768 the performance of, or aid and abet in, any of the following
769 acts in this state:
770 (1) The manufacture, sale, or delivery, or the holding or
771 offering for sale, of medical gas that is adulterated,
772 misbranded, or has otherwise been rendered unfit for
773 distribution.
774 (2) The adulteration or misbranding of medical gas.
775 (3) The receipt of medical gas that is adulterated,
776 misbranded, stolen, or obtained by fraud or deceit or the
777 delivery or proffered delivery of such medical gas for pay or
778 otherwise.
779 (4) The alteration, mutilation, destruction, obliteration,
780 or removal of the whole or any part of the product labeling of
781 medical gas or the willful commission of any other act with
782 respect to medical gas that results in it being misbranded.
783 (5) The purchase or receipt of medical gas from a person
784 who is not authorized by permit to distribute wholesale medical
785 gas or who is exempted from permitting requirements to
786 distribute wholesale medical gas to such purchaser or recipient.
787 (6) The knowing and willful sale or transfer of medical gas
788 to a recipient who is not legally authorized to receive medical
789 gas, except that a violation does not exist as to a distributor
790 that provides oxygen to a permitted medical oxygen retail
791 establishment if the distributor is out of compliance with only
792 the change of location notice requirement under s. 499.824.
793 (7) The failure to maintain or provide records required
794 under this part and its implementing regulations.
795 (8) Providing the department or any of its representatives
796 or any state or federal official with false or fraudulent
797 records or making false or fraudulent statements regarding this
798 part and its implementing regulations.
799 (9) The wholesale distribution of medical gas that was:
800 (a) Purchased by a public or private hospital or other
801 health care entity, except for the physical distribution of such
802 medical gas to an authorized recipient at the direction of a
803 hospital or other health care entity;
804 (b) Donated or supplied at a reduced price to a charitable
805 organization; or
806 (c) Stolen or obtained by fraud or deceit.
807 (10) The failure to obtain a permit or operating without a
808 valid permit when a permit is required.
809 (11) The obtaining of or attempt to obtain medical gas by
810 fraud, deceit, or misrepresentation or engaging in
811 misrepresentation or fraud in the distribution of medical gas.
812 (12) Except for oxygen USP in emergency situations, the
813 distribution of medical gas to a patient without an order or
814 prescription from a licensed practitioner authorized by law to
815 prescribe.
816 (13) The distribution of medical gas that was previously
817 dispensed by a pharmacy or a licensed practitioner authorized by
818 law to prescribe.
819 (14) The distribution of medical gas or medical gas-related
820 equipment to a patient, unless the patient has been provided
821 with the appropriate information and counseling on the use,
822 storage, and disposal of medical gas.
823 (15) The failure to report an act prohibited under this
824 part and its implementing regulations.
825 (16) The failure to exercise due diligence as provided in
826 s. 499.88.
827 Section 17. Section 499.92, Florida Statutes, is created to
828 read:
829 499.92 Criminal acts.—
830 (1) A person commits a felony of the third degree,
831 punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
832 if he or she:
833 (a) With intent to defraud or deceive adulterates or
834 misbrands medical gas.
835 (b) Engages in the wholesale distribution of, and knowingly
836 purchases or receives, medical gas from a person not legally
837 authorized to distribute medical gas.
838 (c) Engages in the wholesale distribution of, and knowingly
839 sells, barters, brokers, or transfers, medical gas to a person
840 not legally authorized to purchase medical gas in the
841 jurisdiction in which the person receives the medical gas,
842 except that a violation does not exist as to a distributor that
843 provides oxygen to a permitted medical oxygen retail
844 establishment if the distributor is out of compliance with only
845 the change of location notice requirement under s. 499.824.
846 (d) Knowingly, falsely creates a label for medical gas or
847 knowingly, falsely represents a factual matter contained in a
848 label for medical gas.
849 (2) A court that has authority over a person who violates
850 this section and that convicts such person shall order him or
851 her to forfeit to the state real or personal property or assets:
852 (a) Used or intended to be used to commit, facilitate, or
853 promote the commission of such violation; and
854 (b) Constituting, derived from, or traceable to the gross
855 proceeds that the defendant obtained as a result of the
856 violation.
857 (3) Property or assets subject to forfeiture under
858 subsection (2) may be seized pursuant to a warrant obtained in
859 the same manner as a search warrant or as otherwise authorized
860 by law and held until the case against the defendant is
861 adjudicated. Moneys ordered to be forfeited or proceeds from the
862 sale of assets ordered to be forfeited shall be equitably
863 divided between the department and agencies involved in the
864 investigation and prosecution that led to the conviction. Other
865 property ordered to be forfeited after conviction of a defendant
866 may, at the discretion of the investigating agencies, be placed
867 into official use by the department or the agencies involved in
868 the investigation and prosecution.
869 Section 18. Section 499.93, Florida Statutes, is created to
870 read:
871 499.93 Inspections.—
872 (1) The department may require a facility that engages in the
873 manufacture, retail sale, or wholesale distribution of medical
874 gas to undergo an inspection in accordance with a schedule to be
875 determined by the department.
876 (2) The department may recognize other state inspections of
877 a manufacturer or wholesale distributor in another state if such
878 state’s laws are deemed to be substantially equivalent to the
879 laws of this state.
880 (3) A manufacturing facility is exempt from inspection by
881 the department if the facility:
882 (a) Is currently registered with the FDA in accordance with
883 s. 510 of the federal act and can provide proof of such
884 registration, such as a copy of the online verification page;
885 and
886 (b) Can provide proof of inspection within the past 3 years
887 by the FDA or, if the facility is located in another state, by
888 another governmental entity charged with regulation of good
889 manufacturing practices related to medical gas.
890 (4) A wholesale distributor must exhibit or have readily
891 available its state permits and its most recent inspection
892 report administered by the department. The department may
893 authorize a third party to inspect wholesale distributors who
894 distribute within or into this state.
895 Section 19. Section 499.931, Florida Statutes, is created
896 to read:
897 499.931 Trade secret information.—Information required to
898 be submitted under this part which is a trade secret as defined
899 in s. 812.081(1)(c) and designated as a trade secret by an
900 applicant or permit holder must be maintained as required under
901 s. 499.051.
902 Section 20. Section 499.94, Florida Statutes, is created to
903 read:
904 499.94 Fees.—A fee collected for a permit under this part
905 shall be deposited into the Professional Regulation Trust Fund.
906 Moneys collected under this part shall be used for administering
907 this part. The department shall maintain a separate account in
908 the trust fund for the Drugs, Devices, and Cosmetics program.
909 Section 21. Section 499.95, Florida Statues, is created to
910 read:
911 499.95 Enforcement and construction of this part.—
912 (1) For the purpose of initiating an investigation or
913 proceeding under this part, the department may administer oaths,
914 take depositions, issue and serve subpoenas, and compel the
915 attendance of witnesses and the production of books, papers,
916 documents, or other evidence. Challenges to, and enforcement of,
917 a subpoena and an order shall be conducted in accordance with s.
918 120.569.
919 (2) A state, county, or municipal attorney to whom the
920 department or its designated agent reports a violation of this
921 part shall timely institute proceedings in the court of
922 competent jurisdiction and shall prosecute in the manner
923 required by law.
924 (3) The department is not required to report minor
925 violations to a state, county, or municipal attorney if the
926 department determines that the public interest is best served by
927 issuance of a written notice or warning to the violator.
928 (4) This part is cumulative and does not repeal or affect
929 the power, duty, or authority of the department. However,
930 relating to the regulation of medical gas, if this part
931 conflicts with other law, this part controls.
932 Section 22. Section 499.001, Florida Statutes, is amended
933 to read:
934 499.001 Florida Drug and Cosmetic Act; short title.
935 Sections 499.001-499.95 499.001-499.081 may be cited as the
936 “Florida Drug and Cosmetic Act.”
937 Section 23. Present subsections (11) through (32) and (46)
938 through (55) of section 499.003, Florida Statutes, are amended,
939 and a new subsection (32) is added to that section, to read:
940 499.003 Definitions of terms used in this part.—As used in
941 this part, the term:
942 (11) “Compressed medical gas” means any liquefied or
943 vaporized gas that is a prescription drug, whether it is alone
944 or in combination with other gases.
945 (11)(12) “Contraband prescription drug” means any
946 adulterated drug, as defined in s. 499.006, any counterfeit
947 drug, as defined in this section, and also means any
948 prescription drug for which a pedigree paper does not exist, or
949 for which the pedigree paper in existence has been forged,
950 counterfeited, falsely created, or contains any altered, false,
951 or misrepresented matter.
952 (12)(13) “Cosmetic” means an article, with the exception of
953 soap, that is:
954 (a) Intended to be rubbed, poured, sprinkled, or sprayed
955 on; introduced into; or otherwise applied to the human body or
956 any part thereof for cleansing, beautifying, promoting
957 attractiveness, or altering the appearance; or
958 (b) Intended for use as a component of any such article.
959 (13)(14) “Counterfeit drug,” “counterfeit device,” or
960 “counterfeit cosmetic” means a drug, device, or cosmetic which,
961 or the container, seal, or labeling of which, without
962 authorization, bears the trademark, trade name, or other
963 identifying mark, imprint, or device, or any likeness thereof,
964 of a drug, device, or cosmetic manufacturer, processor, packer,
965 or distributor other than the person that in fact manufactured,
966 processed, packed, or distributed that drug, device, or cosmetic
967 and which thereby falsely purports or is represented to be the
968 product of, or to have been packed or distributed by, that other
969 drug, device, or cosmetic manufacturer, processor, packer, or
970 distributor.
971 (14)(15) “Department” means the Department of Business and
972 Professional Regulation.
973 (15)(16) “Device” means any instrument, apparatus,
974 implement, machine, contrivance, implant, in vitro reagent, or
975 other similar or related article, including its components,
976 parts, or accessories, which is:
977 (a) Recognized in the current edition of the United States
978 Pharmacopoeia and National Formulary, or any supplement
979 thereof;,
980 (b) Intended for use in the diagnosis, cure, mitigation,
981 treatment, therapy, or prevention of disease in humans or other
982 animals;, or
983 (c) Intended to affect the structure or any function of the
984 body of humans or other animals,
985
986 and that does not achieve any of its principal intended purposes
987 through chemical action within or on the body of humans or other
988 animals and which is not dependent upon being metabolized for
989 the achievement of any of its principal intended purposes.
990 (16)(17) “Distribute” or “distribution” means to sell;
991 offer to sell; give away; transfer, whether by passage of title,
992 physical movement, or both; deliver; or offer to deliver. The
993 term does not mean to administer or dispense and does not
994 include the billing and invoicing activities that commonly
995 follow a wholesale distribution transaction.
996 (17)(18) “Drop shipment” means the sale of a prescription
997 drug from a manufacturer to a wholesale distributor, where the
998 wholesale distributor takes title to, but not possession of, the
999 prescription drug, and the manufacturer of the prescription drug
1000 ships the prescription drug directly to a chain pharmacy
1001 warehouse or a person authorized by law to purchase prescription
1002 drugs for the purpose of administering or dispensing the drug,
1003 as defined in s. 465.003.
1004 (18)(19) “Drug” means an article that is:
1005 (a) Recognized in the current edition of the United States
1006 Pharmacopoeia and National Formulary, official Homeopathic
1007 Pharmacopoeia of the United States, or any supplement to any of
1008 those publications;
1009 (b) Intended for use in the diagnosis, cure, mitigation,
1010 treatment, therapy, or prevention of disease in humans or other
1011 animals;
1012 (c) Intended to affect the structure or any function of the
1013 body of humans or other animals; or
1014 (d) Intended for use as a component of any article
1015 specified in paragraph (a), paragraph (b), or paragraph (c), and
1016 includes active pharmaceutical ingredients, but does not include
1017 devices or their nondrug components, parts, or accessories. For
1018 purposes of this paragraph, an “active pharmaceutical
1019 ingredient” includes any substance or mixture of substances
1020 intended, represented, or labeled for use in drug manufacturing
1021 that furnishes or is intended to furnish, in a finished dosage
1022 form, any pharmacological activity or other direct effect in the
1023 diagnosis, cure, mitigation, treatment, therapy, or prevention
1024 of disease in humans or other animals, or to affect the
1025 structure or any function of the body of humans or other
1026 animals.
1027 (19)(20) “Establishment” means a place of business which is
1028 at one general physical location and may extend to one or more
1029 contiguous suites, units, floors, or buildings operated and
1030 controlled exclusively by entities under common operation and
1031 control. Where multiple buildings are under common exclusive
1032 ownership, operation, and control, an intervening thoroughfare
1033 does not affect the contiguous nature of the buildings. For
1034 purposes of permitting, each suite, unit, floor, or building
1035 must be identified in the most recent permit application.
1036 (20)(21) “Federal act” means the Federal Food, Drug, and
1037 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
1038 (21)(22) “Freight forwarder” means a person who receives
1039 prescription drugs which are owned by another person and
1040 designated by that person for export, and exports those
1041 prescription drugs.
1042 (22)(23) “Health care entity” means a closed pharmacy or
1043 any person, organization, or business entity that provides
1044 diagnostic, medical, surgical, or dental treatment or care, or
1045 chronic or rehabilitative care, but does not include any
1046 wholesale distributor or retail pharmacy licensed under state
1047 law to deal in prescription drugs. However, a blood
1048 establishment is a health care entity that may engage in the
1049 wholesale distribution of prescription drugs under s.
1050 499.01(2)(g)1.c.
1051 (23)(24) “Health care facility” means a health care
1052 facility licensed under chapter 395.
1053 (24)(25) “Hospice” means a corporation licensed under part
1054 IV of chapter 400.
1055 (25)(26) “Hospital” means a facility as defined in s.
1056 395.002 and licensed under chapter 395.
1057 (26)(27) “Immediate container” does not include package
1058 liners.
1059 (27)(28) “Label” means a display of written, printed, or
1060 graphic matter upon the immediate container of any drug, device,
1061 or cosmetic. A requirement made by or under authority of this
1062 part or rules adopted under this part that any word, statement,
1063 or other information appear on the label is not complied with
1064 unless such word, statement, or other information also appears
1065 on the outside container or wrapper, if any, of the retail
1066 package of such drug, device, or cosmetic or is easily legible
1067 through the outside container or wrapper.
1068 (28)(29) “Labeling” means all labels and other written,
1069 printed, or graphic matters:
1070 (a) Upon a drug, device, or cosmetic, or any of its
1071 containers or wrappers; or
1072 (b) Accompanying or related to such drug, device, or
1073 cosmetic.
1074 (29)(30) “Manufacture” means the preparation, deriving,
1075 compounding, propagation, processing, producing, or fabrication
1076 of any drug, device, or cosmetic.
1077 (30)(31) “Manufacturer” means:
1078 (a) A person who prepares, derives, manufactures, or
1079 produces a drug, device, or cosmetic;
1080 (b) The holder or holders of a New Drug Application (NDA),
1081 an Abbreviated New Drug Application (ANDA), a Biologics License
1082 Application (BLA), or a New Animal Drug Application (NADA),
1083 provided such application has become effective or is otherwise
1084 approved consistent with s. 499.023;
1085 (c) A private label distributor for whom the private label
1086 distributor’s prescription drugs are originally manufactured and
1087 labeled for the distributor and have not been repackaged;
1088 (d) A person registered under the federal act as a
1089 manufacturer of a prescription drug, who is described in
1090 paragraph (a), paragraph (b), or paragraph (c), who has entered
1091 into a written agreement with another prescription drug
1092 manufacturer that authorizes either manufacturer to distribute
1093 the prescription drug identified in the agreement as the
1094 manufacturer of that drug consistent with the federal act and
1095 its implementing regulations;
1096 (e) A member of an affiliated group that includes, but is
1097 not limited to, persons described in paragraph (a), paragraph
1098 (b), paragraph (c), or paragraph (d), which member distributes
1099 prescription drugs, whether or not obtaining title to the drugs,
1100 only for the manufacturer of the drugs who is also a member of
1101 the affiliated group. As used in this paragraph, the term
1102 “affiliated group” means an affiliated group as defined in s.
1103 1504 of the Internal Revenue Code of 1986, as amended. The
1104 manufacturer must disclose the names of all of its affiliated
1105 group members to the department; or
1106 (f) A person permitted as a third party logistics provider,
1107 only while providing warehousing, distribution, or other
1108 logistics services on behalf of a person described in paragraph
1109 (a), paragraph (b), paragraph (c), paragraph (d), or paragraph
1110 (e).
1111
1112 The term does not include a pharmacy that is operating in
1113 compliance with pharmacy practice standards as defined in
1114 chapter 465 and rules adopted under that chapter.
1115 (31)(32) “Medical convenience kit” means packages or units
1116 that contain combination products as defined in 21 C.F.R. s.
1117 3.2(e)(2).
1118 (32) “Medical gas” is defined in accordance with the
1119 federal act and means a liquefied or vaporized gas that is a
1120 prescription drug, regardless of whether it is alone or combined
1121 with other gases.
1122 (46) “Prescription medical oxygen” means oxygen USP which
1123 is a drug that can only be sold on the order or prescription of
1124 a practitioner authorized by law to prescribe. The label of
1125 prescription medical oxygen must comply with current labeling
1126 requirements for oxygen under the Federal Food, Drug, and
1127 Cosmetic Act.
1128 (47) “Primary wholesale distributor” means any wholesale
1129 distributor that:
1130 (a) Purchased 90 percent or more of the total dollar volume
1131 of its purchases of prescription drugs directly from
1132 manufacturers in the previous year; and
1133 (b)1. Directly purchased prescription drugs from not fewer
1134 than 50 different prescription drug manufacturers in the
1135 previous year; or
1136 2. Has, or the affiliated group, as defined in s. 1504 of
1137 the Internal Revenue Code, of which the wholesale distributor is
1138 a member has, not fewer than 250 employees.
1139 (c) For purposes of this subsection, “directly from
1140 manufacturers” means:
1141 1. Purchases made by the wholesale distributor directly
1142 from the manufacturer of prescription drugs; and
1143 2. Transfers from a member of an affiliated group, as
1144 defined in s. 1504 of the Internal Revenue Code, of which the
1145 wholesale distributor is a member, if:
1146 a. The affiliated group purchases 90 percent or more of the
1147 total dollar volume of its purchases of prescription drugs from
1148 the manufacturer in the previous year; and
1149 b. The wholesale distributor discloses to the department
1150 the names of all members of the affiliated group of which the
1151 wholesale distributor is a member and the affiliated group
1152 agrees in writing to provide records on prescription drug
1153 purchases by the members of the affiliated group not later than
1154 48 hours after the department requests access to such records,
1155 regardless of the location where the records are stored.
1156 (47)(48) “Proprietary drug,” or “OTC drug,” means a patent
1157 or over-the-counter drug in its unbroken, original package,
1158 which drug is sold to the public by, or under the authority of,
1159 the manufacturer or primary distributor thereof, is not
1160 misbranded under the provisions of this part, and can be
1161 purchased without a prescription.
1162 (48)(49) “Repackage” includes repacking or otherwise
1163 changing the container, wrapper, or labeling to further the
1164 distribution of the drug, device, or cosmetic.
1165 (49)(50) “Repackager” means a person who repackages. The
1166 term excludes pharmacies that are operating in compliance with
1167 pharmacy practice standards as defined in chapter 465 and rules
1168 adopted under that chapter.
1169 (50)(51) “Retail pharmacy” means a community pharmacy
1170 licensed under chapter 465 that purchases prescription drugs at
1171 fair market prices and provides prescription services to the
1172 public.
1173 (51)(52) “Secondary wholesale distributor” means a
1174 wholesale distributor that is not a primary wholesale
1175 distributor.
1176 (52)(53) “Veterinary prescription drug” means a
1177 prescription drug intended solely for veterinary use. The label
1178 of the drug must bear the statement, “Caution: Federal law
1179 restricts this drug to sale by or on the order of a licensed
1180 veterinarian.”
1181 (53)(54) “Wholesale distribution” means distribution of
1182 prescription drugs to persons other than a consumer or patient,
1183 but does not include:
1184 (a) Any of the following activities, which is not a
1185 violation of s. 499.005(21) if such activity is conducted in
1186 accordance with s. 499.01(2)(g):
1187 1. The purchase or other acquisition by a hospital or other
1188 health care entity that is a member of a group purchasing
1189 organization of a prescription drug for its own use from the
1190 group purchasing organization or from other hospitals or health
1191 care entities that are members of that organization.
1192 2. The sale, purchase, or trade of a prescription drug or
1193 an offer to sell, purchase, or trade a prescription drug by a
1194 charitable organization described in s. 501(c)(3) of the
1195 Internal Revenue Code of 1986, as amended and revised, to a
1196 nonprofit affiliate of the organization to the extent otherwise
1197 permitted by law.
1198 3. The sale, purchase, or trade of a prescription drug or
1199 an offer to sell, purchase, or trade a prescription drug among
1200 hospitals or other health care entities that are under common
1201 control. For purposes of this subparagraph, “common control”
1202 means the power to direct or cause the direction of the
1203 management and policies of a person or an organization, whether
1204 by ownership of stock, by voting rights, by contract, or
1205 otherwise.
1206 4. The sale, purchase, trade, or other transfer of a
1207 prescription drug from or for any federal, state, or local
1208 government agency or any entity eligible to purchase
1209 prescription drugs at public health services prices pursuant to
1210 Pub. L. No. 102-585, s. 602 to a contract provider or its
1211 subcontractor for eligible patients of the agency or entity
1212 under the following conditions:
1213 a. The agency or entity must obtain written authorization
1214 for the sale, purchase, trade, or other transfer of a
1215 prescription drug under this subparagraph from the Secretary of
1216 Business and Professional Regulation or his or her designee.
1217 b. The contract provider or subcontractor must be
1218 authorized by law to administer or dispense prescription drugs.
1219 c. In the case of a subcontractor, the agency or entity
1220 must be a party to and execute the subcontract.
1221 d. The contract provider and subcontractor must maintain
1222 and produce immediately for inspection all records of movement
1223 or transfer of all the prescription drugs belonging to the
1224 agency or entity, including, but not limited to, the records of
1225 receipt and disposition of prescription drugs. Each contractor
1226 and subcontractor dispensing or administering these drugs must
1227 maintain and produce records documenting the dispensing or
1228 administration. Records that are required to be maintained
1229 include, but are not limited to, a perpetual inventory itemizing
1230 drugs received and drugs dispensed by prescription number or
1231 administered by patient identifier, which must be submitted to
1232 the agency or entity quarterly.
1233 e. The contract provider or subcontractor may administer or
1234 dispense the prescription drugs only to the eligible patients of
1235 the agency or entity or must return the prescription drugs for
1236 or to the agency or entity. The contract provider or
1237 subcontractor must require proof from each person seeking to
1238 fill a prescription or obtain treatment that the person is an
1239 eligible patient of the agency or entity and must, at a minimum,
1240 maintain a copy of this proof as part of the records of the
1241 contractor or subcontractor required under sub-subparagraph d.
1242 f. In addition to the departmental inspection authority
1243 described set forth in s. 499.051, the establishment of the
1244 contract provider and subcontractor and all records pertaining
1245 to prescription drugs subject to this subparagraph shall be
1246 subject to inspection by the agency or entity. All records
1247 relating to prescription drugs of a manufacturer under this
1248 subparagraph shall be subject to audit by the manufacturer of
1249 those drugs, without identifying individual patient information.
1250 (b) Any of the following activities, which is not a
1251 violation of s. 499.005(21) if such activity is conducted in
1252 accordance with rules established by the department:
1253 1. The sale, purchase, or trade of a prescription drug
1254 among federal, state, or local government health care entities
1255 that are under common control and are authorized to purchase
1256 such prescription drug.
1257 2. The sale, purchase, or trade of a prescription drug or
1258 an offer to sell, purchase, or trade a prescription drug for
1259 emergency medical reasons. For purposes of this subparagraph,
1260 the term “emergency medical reasons” includes transfers of
1261 prescription drugs by a retail pharmacy to another retail
1262 pharmacy to alleviate a temporary shortage.
1263 3. The transfer of a prescription drug acquired by a
1264 medical director on behalf of a licensed emergency medical
1265 services provider to that emergency medical services provider
1266 and its transport vehicles for use in accordance with the
1267 provider’s license under chapter 401.
1268 4. The revocation of a sale or the return of a prescription
1269 drug to the person’s prescription drug wholesale supplier.
1270 5. The donation of a prescription drug by a health care
1271 entity to a charitable organization that has been granted an
1272 exemption under s. 501(c)(3) of the Internal Revenue Code of
1273 1986, as amended, and that is authorized to possess prescription
1274 drugs.
1275 6. The transfer of a prescription drug by a person
1276 authorized to purchase or receive prescription drugs to a person
1277 licensed or permitted to handle reverse distributions or
1278 destruction under the laws of the jurisdiction in which the
1279 person handling the reverse distribution or destruction receives
1280 the drug.
1281 7. The transfer of a prescription drug by a hospital or
1282 other health care entity to a person licensed under this part to
1283 repackage prescription drugs for the purpose of repackaging the
1284 prescription drug for use by that hospital, or other health care
1285 entity and other health care entities that are under common
1286 control, if ownership of the prescription drugs remains with the
1287 hospital or other health care entity at all times. In addition
1288 to the recordkeeping requirements of s. 499.0121(6), the
1289 hospital or health care entity that transfers prescription drugs
1290 pursuant to this subparagraph must reconcile all drugs
1291 transferred and returned and resolve any discrepancies in a
1292 timely manner.
1293 (c) The distribution of prescription drug samples by
1294 manufacturers’ representatives or distributors’ representatives
1295 conducted in accordance with s. 499.028.
1296 (d) The sale, purchase, or trade of blood and blood
1297 components intended for transfusion. As used in this paragraph,
1298 the term “blood” means whole blood collected from a single donor
1299 and processed for transfusion or further manufacturing, and the
1300 term “blood components” means that part of the blood separated
1301 by physical or mechanical means.
1302 (e) The lawful dispensing of a prescription drug in
1303 accordance with chapter 465.
1304 (f) The sale, purchase, or trade of a prescription drug
1305 between pharmacies as a result of a sale, transfer, merger, or
1306 consolidation of all or part of the business of the pharmacies
1307 from or with another pharmacy, whether accomplished as a
1308 purchase and sale of stock or of business assets.
1309 (54)(55) “Wholesale distributor” means any person engaged
1310 in wholesale distribution of prescription drugs in or into this
1311 state, including, but not limited to, manufacturers;
1312 repackagers; own-label distributors; jobbers; private-label
1313 distributors; brokers; warehouses, including manufacturers’ and
1314 distributors’ warehouses, chain drug warehouses, and wholesale
1315 drug warehouses; independent wholesale drug traders; exporters;
1316 retail pharmacies; and the agents thereof that conduct wholesale
1317 distributions.
1318 Section 24. Paragraph (a) of subsection (1) of section
1319 409.9201, Florida Statutes, is amended to read:
1320 409.9201 Medicaid fraud.—
1321 (1) As used in this section, the term:
1322 (a) “Prescription drug” means any drug, including, but not
1323 limited to, finished dosage forms or active ingredients that are
1324 subject to, defined in by, or described in by s. 503(b) of the
1325 Federal Food, Drug, and Cosmetic Act or in by s. 465.003(8), s.
1326 499.003(52), s. 499.003(46) or (53) or s. 499.007(13), or s.
1327 499.81(15).
1328
1329 The value of individual items of the legend drugs or goods or
1330 services involved in distinct transactions committed during a
1331 single scheme or course of conduct, whether involving a single
1332 person or several persons, may be aggregated when determining
1333 the punishment for the offense.
1334 Section 25. Paragraph (c) of subsection (9) of section
1335 460.403, Florida Statutes, is amended to read:
1336 460.403 Definitions.—As used in this chapter, the term:
1337 (9)
1338 (c)1. Chiropractic physicians may adjust, manipulate, or
1339 treat the human body by manual, mechanical, electrical, or
1340 natural methods; by the use of physical means or physiotherapy,
1341 including light, heat, water, or exercise; by the use of
1342 acupuncture; or by the administration of foods, food
1343 concentrates, food extracts, and items for which a prescription
1344 is not required and may apply first aid and hygiene, but
1345 chiropractic physicians are expressly prohibited from
1346 prescribing or administering to any person any legend drug
1347 except as authorized under subparagraph 2., from performing any
1348 surgery except as stated herein, or from practicing obstetrics.
1349 2. Notwithstanding the prohibition against prescribing and
1350 administering legend drugs under subparagraph 1. or s.
1351 499.82(7)(c) s. 499.01(2)(m), pursuant to board rule
1352 chiropractic physicians may order, store, and administer, for
1353 emergency purposes only at the chiropractic physician’s office
1354 or place of business, prescription medical oxygen and may also
1355 order, store, and administer the following topical anesthetics
1356 in aerosol form:
1357 a. Any solution consisting of 25 percent ethylchloride and
1358 75 percent dichlorodifluoromethane.
1359 b. Any solution consisting of 15 percent
1360 dichlorodifluoromethane and 85 percent
1361 trichloromonofluoromethane.
1362
1363 However, this paragraph does not authorize a chiropractic
1364 physician to prescribe medical oxygen as defined in chapter 499.
1365 Section 26. Subsection (3) of section 465.0265, Florida
1366 Statutes, is amended to read:
1367 465.0265 Centralized prescription filling.—
1368 (3) The filling, delivery, and return of a prescription by
1369 one pharmacy for another pursuant to this section may shall not
1370 be construed as the filling of a transferred prescription as
1371 described set forth in s. 465.026 or as a wholesale distribution
1372 as defined set forth in s. 499.003 s. 499.003(54).
1373 Section 27. Subsection (1), paragraphs (a), (c), (g), (m),
1374 (n), and (o) of subsection (2), and subsection (5) of section
1375 499.01, Florida Statutes, are amended to read:
1376 499.01 Permits.—
1377 (1) Before Prior to operating, a permit is required for
1378 each person and establishment that intends to operate as:
1379 (a) A prescription drug manufacturer;
1380 (b) A prescription drug repackager;
1381 (c) A nonresident prescription drug manufacturer;
1382 (d) A prescription drug wholesale distributor;
1383 (e) An out-of-state prescription drug wholesale
1384 distributor;
1385 (f) A retail pharmacy drug wholesale distributor;
1386 (g) A restricted prescription drug distributor;
1387 (h) A complimentary drug distributor;
1388 (i) A freight forwarder;
1389 (j) A veterinary prescription drug retail establishment;
1390 (k) A veterinary prescription drug wholesale distributor;
1391 (l) A limited prescription drug veterinary wholesale
1392 distributor;
1393 (m) A medical oxygen retail establishment;
1394 (n) A compressed medical gas wholesale distributor;
1395 (o) A compressed medical gas manufacturer;
1396 (m)(p) An over-the-counter drug manufacturer;
1397 (n)(q) A device manufacturer;
1398 (o)(r) A cosmetic manufacturer;
1399 (p)(s) A third party logistics provider; or
1400 (q)(t) A health care clinic establishment.
1401 (2) The following permits are established:
1402 (a) Prescription drug manufacturer permit.—A prescription
1403 drug manufacturer permit is required for any person that is a
1404 manufacturer of a prescription drug and that manufactures or
1405 distributes such prescription drugs in this state.
1406 1. A person that operates an establishment permitted as a
1407 prescription drug manufacturer may engage in wholesale
1408 distribution of prescription drugs manufactured at that
1409 establishment and must comply with all of the provisions of this
1410 part, except s. 499.01212, and the rules adopted under this
1411 part, except s. 499.01212, which apply to a wholesale
1412 distributor.
1413 2. A prescription drug manufacturer must comply with all
1414 appropriate state and federal good manufacturing practices.
1415 3. A blood establishment, as defined in s. 381.06014,
1416 operating in a manner consistent with the provisions of 21
1417 C.F.R. parts 211 and 600-640, and manufacturing only the
1418 prescription drugs described in s. 499.003(53)(d) s.
1419 499.003(54)(d) is not required to be permitted as a prescription
1420 drug manufacturer under this paragraph or to register products
1421 under s. 499.015.
1422 (c) Nonresident prescription drug manufacturer permit.—A
1423 nonresident prescription drug manufacturer permit is required
1424 for any person that is a manufacturer of prescription drugs,
1425 unless permitted as a third party logistics provider, located
1426 outside of this state or outside the United States and that
1427 engages in the wholesale distribution in this state of such
1428 prescription drugs. Each such manufacturer must be permitted by
1429 the department and comply with all of the provisions required of
1430 a wholesale distributor under this part, except s. 499.01212.
1431 1. A person that distributes prescription drugs for which
1432 the person is not the manufacturer must also obtain an out-of
1433 state prescription drug wholesale distributor permit or third
1434 party logistics provider permit pursuant to this section to
1435 engage in the wholesale distribution of such prescription drugs.
1436 This subparagraph does not apply to a manufacturer as defined in
1437 s. 499.003(30)(e) s. 499.003(31)(e).
1438 2. Any such person must comply with the licensing or
1439 permitting requirements of the jurisdiction in which the
1440 establishment is located and the federal act, and any product
1441 wholesaled into this state must comply with this part. If a
1442 person intends to import prescription drugs from a foreign
1443 country into this state, the nonresident prescription drug
1444 manufacturer must provide to the department a list identifying
1445 each prescription drug it intends to import and document
1446 approval by the United States Food and Drug Administration for
1447 such importation.
1448 (g) Restricted prescription drug distributor permit.—
1449 1. A restricted prescription drug distributor permit is
1450 required for:
1451 a. Any person located in this state who engages in the
1452 distribution of a prescription drug, which distribution is not
1453 considered “wholesale distribution” under s. 499.003(53)(a) s.
1454 499.003(54)(a).
1455 b. Any person located in this state who engages in the
1456 receipt or distribution of a prescription drug in this state for
1457 the purpose of processing its return or its destruction if such
1458 person is not the person initiating the return, the prescription
1459 drug wholesale supplier of the person initiating the return, or
1460 the manufacturer of the drug.
1461 c. A blood establishment located in this state which
1462 collects blood and blood components only from volunteer donors
1463 as defined in s. 381.06014 or pursuant to an authorized
1464 practitioner’s order for medical treatment or therapy and
1465 engages in the wholesale distribution of a prescription drug not
1466 described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
1467 care entity. A mobile blood unit operated by a blood
1468 establishment permitted under this sub-subparagraph is not
1469 required to be separately permitted. The health care entity
1470 receiving a prescription drug distributed under this sub
1471 subparagraph must be licensed as a closed pharmacy or provide
1472 health care services at that establishment. The blood
1473 establishment must operate in accordance with s. 381.06014 and
1474 may distribute only:
1475 (I) Prescription drugs indicated for a bleeding or clotting
1476 disorder or anemia;
1477 (II) Blood-collection containers approved under s. 505 of
1478 the federal act;
1479 (III) Drugs that are blood derivatives, or a recombinant or
1480 synthetic form of a blood derivative;
1481 (IV) Prescription drugs that are identified in rules
1482 adopted by the department and that are essential to services
1483 performed or provided by blood establishments and authorized for
1484 distribution by blood establishments under federal law; or
1485 (V) To the extent authorized by federal law, drugs
1486 necessary to collect blood or blood components from volunteer
1487 blood donors; for blood establishment personnel to perform
1488 therapeutic procedures under the direction and supervision of a
1489 licensed physician; and to diagnose, treat, manage, and prevent
1490 any reaction of a volunteer blood donor or a patient undergoing
1491 a therapeutic procedure performed under the direction and
1492 supervision of a licensed physician,
1493
1494 as long as all of the health care services provided by the blood
1495 establishment are related to its activities as a registered
1496 blood establishment or the health care services consist of
1497 collecting, processing, storing, or administering human
1498 hematopoietic stem cells or progenitor cells or performing
1499 diagnostic testing of specimens if such specimens are tested
1500 together with specimens undergoing routine donor testing. The
1501 blood establishment may purchase and possess the drugs described
1502 in this sub-subparagraph without a health care clinic
1503 establishment permit.
1504 2. Storage, handling, and recordkeeping of these
1505 distributions by a person required to be permitted as a
1506 restricted prescription drug distributor must be in accordance
1507 with the requirements for wholesale distributors under s.
1508 499.0121, but not those described set forth in s. 499.01212 if
1509 the distribution occurs pursuant to sub-subparagraph 1.a. or
1510 sub-subparagraph 1.b.
1511 3. A person who applies for a permit as a restricted
1512 prescription drug distributor, or for the renewal of such a
1513 permit, must provide to the department the information required
1514 under s. 499.012.
1515 4. The department may adopt rules regarding the
1516 distribution of prescription drugs by hospitals, health care
1517 entities, charitable organizations, other persons not involved
1518 in wholesale distribution, and blood establishments, which rules
1519 are necessary for the protection of the public health, safety,
1520 and welfare.
1521 (m) Medical oxygen retail establishment permit.—A medical
1522 oxygen retail establishment permit is required for any person
1523 that sells medical oxygen to patients only. The sale must be
1524 based on an order from a practitioner authorized by law to
1525 prescribe. The term does not include a pharmacy licensed under
1526 chapter 465.
1527 1. A medical oxygen retail establishment may not possess,
1528 purchase, sell, or trade any prescription drug other than
1529 medical oxygen.
1530 2. A medical oxygen retail establishment may refill medical
1531 oxygen for an individual patient based on an order from a
1532 practitioner authorized by law to prescribe. A medical oxygen
1533 retail establishment that refills medical oxygen must comply
1534 with all appropriate state and federal good manufacturing
1535 practices.
1536 3. A medical oxygen retail establishment must comply with
1537 all of the wholesale distribution requirements of s. 499.0121.
1538 4. Prescription medical oxygen sold by a medical oxygen
1539 retail establishment pursuant to a practitioner’s order may not
1540 be returned into the retail establishment’s inventory.
1541 (n) Compressed medical gas wholesale distributor permit.—A
1542 compressed medical gas wholesale distributor is a wholesale
1543 distributor that is limited to the wholesale distribution of
1544 compressed medical gases to other than the consumer or patient.
1545 The compressed medical gas must be in the original sealed
1546 container that was purchased by that wholesale distributor. A
1547 compressed medical gas wholesale distributor may not possess or
1548 engage in the wholesale distribution of any prescription drug
1549 other than compressed medical gases. The department shall adopt
1550 rules that govern the wholesale distribution of prescription
1551 medical oxygen for emergency use. With respect to the emergency
1552 use of prescription medical oxygen, those rules may not be
1553 inconsistent with rules and regulations of federal agencies
1554 unless the Legislature specifically directs otherwise.
1555 (o) Compressed medical gas manufacturer permit.—A
1556 compressed medical gas manufacturer permit is required for any
1557 person that engages in the manufacture of compressed medical
1558 gases or repackages compressed medical gases from one container
1559 to another.
1560 1. A compressed medical gas manufacturer may not
1561 manufacture or possess any prescription drug other than
1562 compressed medical gases.
1563 2. A compressed medical gas manufacturer may engage in
1564 wholesale distribution of compressed medical gases manufactured
1565 at that establishment and must comply with all the provisions of
1566 this part and the rules adopted under this part that apply to a
1567 wholesale distributor.
1568 3. A compressed medical gas manufacturer must comply with
1569 all appropriate state and federal good manufacturing practices.
1570 (5) A prescription drug repackager permit issued under this
1571 part is not required for a restricted prescription drug
1572 distributor permitholder that is a health care entity to
1573 repackage prescription drugs in this state for its own use or
1574 for distribution to hospitals or other health care entities in
1575 the state for their own use, pursuant to s. 499.003(53)(a)3. s.
1576 499.003(54)(a)3., if:
1577 (a) The prescription drug distributor notifies the
1578 department, in writing, of its intention to engage in
1579 repackaging under this exemption, 30 days before engaging in the
1580 repackaging of prescription drugs at the permitted
1581 establishment;
1582 (b) The prescription drug distributor is under common
1583 control with the hospitals or other health care entities to
1584 which the prescription drug distributor is distributing
1585 prescription drugs. As used in this paragraph, “common control”
1586 means the power to direct or cause the direction of the
1587 management and policies of a person or an organization, whether
1588 by ownership of stock, voting rights, contract, or otherwise;
1589 (c) The prescription drug distributor repackages the
1590 prescription drugs in accordance with current state and federal
1591 good manufacturing practices; and
1592 (d) The prescription drug distributor labels the
1593 prescription drug it repackages in accordance with state and
1594 federal laws and rules.
1595
1596 The prescription drug distributor is exempt from the product
1597 registration requirements of s. 499.015 with regard to the
1598 prescription drugs that it repackages and distributes under this
1599 subsection.
1600 Section 28. Paragraph (b) of subsection (2) of section
1601 499.0121, Florida Statutes, is amended to read:
1602 499.0121 Storage and handling of prescription drugs;
1603 recordkeeping.—The department shall adopt rules to implement
1604 this section as necessary to protect the public health, safety,
1605 and welfare. Such rules shall include, but not be limited to,
1606 requirements for the storage and handling of prescription drugs
1607 and for the establishment and maintenance of prescription drug
1608 distribution records.
1609 (2) SECURITY.—
1610 (b) An establishment that is used for wholesale drug
1611 distribution must be equipped with:
1612 1. An alarm system to detect entry after hours; however,
1613 the department may exempt by rule establishments that only hold
1614 a permit as prescription drug wholesale distributor-brokers and
1615 establishments that only handle medical oxygen; and
1616 2. A security system that will provide suitable protection
1617 against theft and diversion. When appropriate, the security
1618 system must provide protection against theft or diversion that
1619 is facilitated or hidden by tampering with computers or
1620 electronic records.
1621 Section 29. Section 499.01211, Florida Statutes, is amended
1622 to read:
1623 499.01211 Drug Wholesale Distributor Advisory Council.—
1624 (1) There is created the Drug Wholesale Distributor
1625 Advisory Council within the department. The council shall meet
1626 at least once each calendar quarter. Staff for the council shall
1627 be provided by the department. The council shall consist of 12
1628 11 members who shall serve without compensation. The council
1629 shall elect a chairperson and a vice chairperson annually.
1630 (2) The Secretary of Business and Professional Regulation
1631 or his or her designee and the Secretary of Health Care
1632 Administration or her or his designee shall be members of the
1633 council. The Secretary of Business and Professional Regulation
1634 shall appoint nine additional members to the council who shall
1635 be appointed to a term of 4 years each, as follows:
1636 (a) Three different persons each of whom is employed by a
1637 different prescription drug wholesale distributor licensed under
1638 this part which operates nationally and is a primary wholesale
1639 distributor, as defined in s. 499.003 s. 499.003(47).
1640 (b) One person employed by a prescription drug wholesale
1641 distributor licensed under this part which is a secondary
1642 wholesale distributor, as defined in s. 499.003 s. 499.003(52).
1643 (c) One person employed by a retail pharmacy chain located
1644 in this state.
1645 (d) One person who is a member of the Board of Pharmacy and
1646 is a pharmacist licensed under chapter 465.
1647 (e) One person who is a physician licensed pursuant to
1648 chapter 458 or chapter 459.
1649 (f) One person who is an employee of a hospital licensed
1650 pursuant to chapter 395 and is a pharmacist licensed pursuant to
1651 chapter 465.
1652 (g) One person who is an employee of a pharmaceutical
1653 manufacturer.
1654 (3) The Compressed Gas Association shall appoint one person
1655 to the council who is an employee of a permitted medical gas
1656 wholesale distributor or manufacturer.
1657 (4)(3) The council shall review this part and the rules
1658 adopted to administer this part annually, provide input to the
1659 department regarding all proposed rules to administer this part,
1660 make recommendations to the department to improve the protection
1661 of the prescription drugs and public health, make
1662 recommendations to improve coordination with other states’
1663 regulatory agencies and the federal government concerning the
1664 wholesale distribution of drugs, and make recommendations to
1665 minimize the impact of regulation of the wholesale distribution
1666 industry while ensuring protection of the public health.
1667 Section 30. Paragraph (b) of subsection (2) of section
1668 499.01212, Florida Statutes, is amended to read:
1669 499.01212 Pedigree paper.—
1670 (2) FORMAT.—A pedigree paper must contain the following
1671 information:
1672 (b) For all other wholesale distributions of prescription
1673 drugs:
1674 1. The quantity, dosage form, and strength of the
1675 prescription drugs.
1676 2. The lot numbers of the prescription drugs.
1677 3. The name and address of each owner of the prescription
1678 drug and his or her signature.
1679 4. Shipping information, including the name and address of
1680 each person certifying delivery or receipt of the prescription
1681 drug.
1682 5. An invoice number, a shipping document number, or
1683 another number uniquely identifying the transaction.
1684 6. A certification that the recipient wholesale distributor
1685 has authenticated the pedigree papers.
1686 7. The unique serialization of the prescription drug, if
1687 the manufacturer or repackager has uniquely serialized the
1688 individual prescription drug unit.
1689 8. The name, address, telephone number, and, if available,
1690 e-mail contact information of each wholesale distributor
1691 involved in the chain of the prescription drug’s custody.
1692
1693 When an affiliated group member obtains title to a prescription
1694 drug before distributing the prescription drug as the
1695 manufacturer as defined in s. 499.003(30)(e) under s.
1696 499.003(31)(e), information regarding the distribution between
1697 those affiliated group members may be omitted from a pedigree
1698 paper required under this paragraph for subsequent distributions
1699 of that prescription drug.
1700 Section 31. Paragraph (a) of subsection (1) and subsection
1701 (3) of section 499.015, Florida Statutes, are amended to read:
1702 499.015 Registration of drugs, devices, and cosmetics;
1703 issuance of certificates of free sale.—
1704 (1)(a) Except for those persons exempted from the
1705 definition of manufacturer in s. 499.003 s. 499.003(31), any
1706 person who manufactures, packages, repackages, labels, or
1707 relabels a drug, device, or cosmetic in this state must register
1708 such drug, device, or cosmetic biennially with the department;
1709 pay a fee in accordance with the fee schedule provided by s.
1710 499.041; and comply with this section. The registrant must list
1711 each separate and distinct drug, device, or cosmetic at the time
1712 of registration.
1713 (3) Except for those persons exempted from the definition
1714 of manufacturer in s. 499.003 s. 499.003(31), a person may not
1715 sell any product that he or she has failed to register in
1716 conformity with this section. Such failure to register subjects
1717 such drug, device, or cosmetic product to seizure and
1718 condemnation as provided in s. 499.062, and subjects such person
1719 to the penalties and remedies provided in this part.
1720 Section 32. Subsection (3) of section 499.024, Florida
1721 Statutes, is amended to read:
1722 499.024 Drug product classification.—The department shall
1723 adopt rules to classify drug products intended for use by humans
1724 which the United States Food and Drug Administration has not
1725 classified in the federal act or the Code of Federal
1726 Regulations.
1727 (3) Any product that falls under the definition of drug in
1728 s. 499.003 s. 499.003(19) may be classified under the authority
1729 of this section. This section does not subject portable
1730 emergency oxygen inhalators to classification; however, this
1731 section does not exempt any person from ss. 499.01 and 499.015.
1732 Section 33. Paragraph (e) of subsection (1), paragraph (b)
1733 of subsection (2), and paragraph (b) of subsection (3) of
1734 section 499.041, Florida Statutes, are amended to read:
1735 499.041 Schedule of fees for drug, device, and cosmetic
1736 applications and permits, product registrations, and free-sale
1737 certificates.—
1738 (1) The department shall assess applicants requiring a
1739 manufacturing permit an annual fee within the ranges established
1740 in this section for the specific type of manufacturer.
1741 (e) The fee for a compressed medical gas manufacturer
1742 permit may not be less than $400 or more than $500 annually.
1743 (2) The department shall assess an applicant that is
1744 required to have a wholesaling permit an annual fee within the
1745 ranges established in this section for the specific type of
1746 wholesaling.
1747 (b) The fee for a compressed medical gas wholesale
1748 distributor permit may not be less than $200 or more than $300
1749 annually.
1750 (3) The department shall assess an applicant that is
1751 required to have a retail establishment permit an annual fee
1752 within the ranges established in this section for the specific
1753 type of retail establishment.
1754 (b) The fee for a medical oxygen retail establishment
1755 permit may not be less than $200 or more than $300 annually.
1756 Section 34. Paragraphs (i) and (m) of subsection (1) of
1757 section 499.05, Florida Statutes, are amended to read:
1758 499.05 Rules.—
1759 (1) The department shall adopt rules to implement and
1760 enforce this chapter part with respect to:
1761 (i) Additional conditions that qualify as an emergency
1762 medical reason under s. 499.003(53)(b)2. s. 499.003(54)(b)2.
1763 (m) The recordkeeping, storage, and handling with respect
1764 to each of the distributions of prescription drugs specified in
1765 s. 499.003(53)(a)-(d) s. 499.003(54)(a)-(d).
1766 Section 35. Subsections (1) through (4) of section 499.051,
1767 Florida Statutes, are amended to read:
1768 499.051 Inspections and investigations.—
1769 (1) The agents of the department and of the Department of
1770 Law Enforcement, after they present proper identification, may
1771 inspect, monitor, and investigate any establishment permitted
1772 pursuant to this chapter part during business hours for the
1773 purpose of enforcing this chapter part, chapters 465, 501, and
1774 893, and the rules of the department that protect the public
1775 health, safety, and welfare.
1776 (2) In addition to the authority set forth in subsection
1777 (1), the department and any duly designated officer or employee
1778 of the department may enter and inspect any other establishment
1779 for the purpose of determining compliance with this part and
1780 rules adopted under this chapter part regarding any drug,
1781 device, or cosmetic product.
1782 (3) Any application for a permit or product registration or
1783 for renewal of such permit or registration made pursuant to this
1784 chapter part and rules adopted under this chapter part
1785 constitutes permission for any entry or inspection of the
1786 premises in order to verify compliance with this chapter part
1787 and rules; to discover, investigate, and determine the existence
1788 of compliance; or to elicit, receive, respond to, and resolve
1789 complaints and violations.
1790 (4) Any application for a permit made pursuant to s.
1791 499.012 or s. 499.821 and rules adopted under those sections
1792 that section constitutes permission for agents of the department
1793 and the Department of Law Enforcement, after presenting proper
1794 identification, to inspect, review, and copy any financial
1795 document or record related to the manufacture, repackaging, or
1796 distribution of a drug as is necessary to verify compliance with
1797 this chapter part and the rules adopted by the department to
1798 administer this chapter part, in order to discover, investigate,
1799 and determine the existence of compliance, or to elicit,
1800 receive, respond to, and resolve complaints and violations.
1801 Section 36. Section 499.066, Florida Statutes, is amended
1802 to read:
1803 499.066 Penalties; remedies.—In addition to other penalties
1804 and other enforcement provisions:
1805 (1) The department may institute such suits or other legal
1806 proceedings as are required to enforce any provision of this
1807 chapter part. If it appears that a person has violated any
1808 provision of this chapter part for which criminal prosecution is
1809 provided, the department may provide the appropriate state
1810 attorney or other prosecuting agency having jurisdiction with
1811 respect to such prosecution with the relevant information in the
1812 department’s possession.
1813 (2) If any person engaged in any activity covered by this
1814 chapter part violates any provision of this chapter part, any
1815 rule adopted under this chapter part, or a cease and desist
1816 order as provided by this chapter part, the department may
1817 obtain an injunction in the circuit court of the county in which
1818 the violation occurred or in which the person resides or has its
1819 principal place of business, and may apply in that court for
1820 such temporary and permanent orders as the department considers
1821 necessary to restrain the person from engaging in any such
1822 activities until the person complies with this chapter part, the
1823 rules adopted under this chapter part, and the orders of the
1824 department authorized by this chapter part or to mandate
1825 compliance with this chapter part, the rules adopted under this
1826 chapter part, and any order or permit issued by the department
1827 under this chapter part.
1828 (3) The department may impose an administrative fine, not
1829 to exceed $5,000 per violation per day, for the violation of any
1830 provision of this chapter part or rules adopted under this
1831 chapter part. Each day a violation continues constitutes a
1832 separate violation, and each separate violation is subject to a
1833 separate fine. All amounts collected pursuant to this section
1834 shall be deposited into the Professional Regulation Trust Fund
1835 and are appropriated for the use of the department in
1836 administering this chapter part. In determining the amount of
1837 the fine to be levied for a violation, the department shall
1838 consider:
1839 (a) The severity of the violation;
1840 (b) Any actions taken by the person to correct the
1841 violation or to remedy complaints; and
1842 (c) Any previous violations.
1843 (4) The department shall deposit any rewards, fines, or
1844 collections that are due the department and which derive from
1845 joint enforcement activities with other state and federal
1846 agencies which relate to this chapter part, chapter 893, or the
1847 federal act, into the Professional Regulation Trust Fund. The
1848 proceeds of those rewards, fines, and collections are
1849 appropriated for the use of the department in administering this
1850 chapter part.
1851 (5) The department may issue an emergency order immediately
1852 suspending or revoking a permit if it determines that any
1853 condition in the establishment presents a danger to the public
1854 health, safety, and welfare.
1855 (6) The department may issue an emergency order to
1856 immediately remove from commerce and public access any drug,
1857 device, or cosmetic, if the department determines that the drug,
1858 device, or cosmetic presents a clear and present danger to the
1859 public health, safety, and welfare.
1860 (7) Resignation or termination of an affiliated party does
1861 not affect the department’s jurisdiction or discretion to
1862 proceed with action to suspend or revoke a permit or to impose
1863 other penalties or enforcement actions authorized by law.
1864 Section 37. Paragraph (a) of subsection (1) and paragraph
1865 (a) of subsection (2) of section 499.0661, Florida Statutes, are
1866 amended to read:
1867 499.0661 Cease and desist orders; removal of certain
1868 persons.—
1869 (1) CEASE AND DESIST ORDERS.—
1870 (a) In addition to any authority otherwise provided in this
1871 chapter, the department may issue and serve a complaint stating
1872 charges upon any permittee or upon any affiliated party,
1873 whenever the department has reasonable cause to believe that the
1874 person or individual named therein is engaging in or has engaged
1875 in conduct that is:
1876 1. An act that demonstrates a lack of fitness or
1877 trustworthiness to engage in the business authorized under the
1878 permit issued pursuant to this chapter part, is hazardous to the
1879 public health, or constitutes business operations that are a
1880 detriment to the public health;
1881 2. A violation of any provision of this chapter part;
1882 3. A violation of any rule of the department;
1883 4. A violation of any order of the department; or
1884 5. A breach of any written agreement with the department.
1885 (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
1886 (a) The department may issue and serve a complaint stating
1887 charges upon any affiliated party and upon the permittee
1888 involved whenever the department has reason to believe that an
1889 affiliated party is engaging in or has engaged in conduct that
1890 constitutes:
1891 1. An act that demonstrates a lack of fitness or
1892 trustworthiness to engage in the business authorized under the
1893 permit issued pursuant to this chapter part, is hazardous to the
1894 public health, or constitutes business operations that are a
1895 detriment to the public health;
1896 2. A willful violation of this chapter part; however, if
1897 the violation constitutes a misdemeanor, a complaint may not be
1898 served as provided in this section until the affiliated party is
1899 notified in writing of the matter of the violation and has been
1900 afforded a reasonable period of time, as set forth in the
1901 notice, to correct the violation and has failed to do so;
1902 3. A violation of any other law involving fraud or moral
1903 turpitude which constitutes a felony;
1904 4. A willful violation of any rule of the department;
1905 5. A willful violation of any order of the department; or
1906 6. A material misrepresentation of fact, made knowingly and
1907 willfully or made with reckless disregard for the truth of the
1908 matter.
1909 Section 38. Section 499.067, Florida Statutes, is amended
1910 to read:
1911 499.067 Denial, suspension, or revocation of permit,
1912 certification, or registration.—
1913 (1)(a) The department may deny, suspend, or revoke a permit
1914 if it finds that there has been a substantial failure to comply
1915 with this chapter part or chapter 465, chapter 501, or chapter
1916 893, the rules adopted under this chapter part or those
1917 chapters, any final order of the department, or applicable
1918 federal laws or regulations or other state laws or rules
1919 governing drugs, devices, or cosmetics.
1920 (b) The department may deny an application for a permit or
1921 certification, or suspend or revoke a permit or certification,
1922 if the department finds that:
1923 1. The applicant is not of good moral character or that it
1924 would be a danger or not in the best interest of the public
1925 health, safety, and welfare if the applicant were issued a
1926 permit or certification.
1927 2. The applicant has not met the requirements for the
1928 permit or certification.
1929 3. The applicant is not eligible for a permit or
1930 certification for any of the reasons enumerated in s. 499.012.
1931 4. The applicant, permittee, or person certified under s.
1932 499.012(16) demonstrates any of the conditions enumerated in s.
1933 499.012.
1934 5. The applicant, permittee, or person certified under s.
1935 499.012(16) has committed any violation of ss. 499.005-499.0054.
1936 (2) The department may deny, suspend, or revoke any
1937 registration required by the provisions of this chapter part for
1938 the violation of any provision of this chapter part or of any
1939 rules adopted under this chapter part.
1940 (3) The department may revoke or suspend a permit:
1941 (a) If the permit was obtained by misrepresentation or
1942 fraud or through a mistake of the department;
1943 (b) If the permit was procured, or attempted to be
1944 procured, for any other person by making or causing to be made
1945 any false representation; or
1946 (c) If the permittee has violated any provision of this
1947 chapter part or rules adopted under this chapter part.
1948 (4) If any permit issued under this chapter part is revoked
1949 or suspended, the owner, manager, operator, or proprietor of the
1950 establishment shall cease to operate as the permit authorized,
1951 from the effective date of the suspension or revocation until
1952 the person is again registered with the department and possesses
1953 the required permit. If a permit is revoked or suspended, the
1954 owner, manager, or proprietor shall remove all signs and symbols
1955 that identify the operation as premises permitted as a drug
1956 wholesaling establishment; drug, device, or cosmetic
1957 manufacturing establishment; or retail establishment. The
1958 department shall determine the length of time for which the
1959 permit is to be suspended. If a permit is revoked, the person
1960 that owns or operates the establishment may not apply for any
1961 permit under this chapter part for a period of 1 year after the
1962 date of the revocation. A revocation of a permit may be
1963 permanent if the department considers that to be in the best
1964 interest of the public health.
1965 (5) The department may deny, suspend, or revoke a permit
1966 issued under this chapter part which authorizes the permittee to
1967 purchase prescription drugs if any owner, officer, employee, or
1968 other person who participates in administering or operating the
1969 establishment has been found guilty of any violation of this
1970 chapter part or chapter 465, chapter 501, or chapter 893, any
1971 rules adopted under this chapter part or those chapters, or any
1972 federal or state drug law, regardless of whether the person has
1973 been pardoned, had her or his civil rights restored, or had
1974 adjudication withheld.
1975 (6) The department shall deny, suspend, or revoke the
1976 permit of any person or establishment if the assignment, sale,
1977 transfer, or lease of an establishment permitted under this
1978 chapter part will avoid an administrative penalty, civil action,
1979 or criminal prosecution.
1980 (7) Notwithstanding s. 120.60(5), if a permittee fails to
1981 comply with s. 499.012(6) or s. 499.83, as applicable, the
1982 department may revoke the permit of the permittee and shall
1983 provide notice of the intended agency action by posting a notice
1984 at the department’s headquarters and by mailing a copy of the
1985 notice of intended agency action by certified mail to the most
1986 recent mailing address on record with the department and, if the
1987 permittee is not a natural person, to the permittee’s registered
1988 agent on file with the Department of State.
1989 (8) The department may deny, suspend, or revoke a permit
1990 under this part if it finds the permittee has not complied with
1991 the credentialing requirements of s. 499.0121(15).
1992 (9) The department may deny, suspend, or revoke a permit
1993 under this part if it finds the permittee has not complied with
1994 the reporting requirements of, or knowingly made a false
1995 statement in a report required by, s. 499.0121(14).
1996 Section 39. This act shall take effect October 1, 2014.
