Bill Text: FL S0836 | 2014 | Regular Session | Introduced
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-Introduced.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-Introduced.html
Florida Senate - 2014 SB 836
By Senator Bean
4-00674-14 2014836__
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.; requiring the department to ensure
17 that information obtained during the application
18 process identified as trade secret is maintained and
19 remains confidential; authorizing the department to
20 set fees within certain parameters; creating s.
21 499.822, F.S.; requiring a permit to expire 2 years
22 after the last day of the month in which the permit
23 was issued; providing requirements for the renewal of
24 a permit; requiring the department to adopt rules for
25 the renewal of permits; creating s. 499.823, F.S.;
26 authorizing the department to consider certain factors
27 in determining the eligibility of an applicant;
28 creating s. 499.824, F.S.; authorizing the department
29 to approve certain permitholder changes; authorizing
30 the department to revoke the permit of a person that
31 fails to comply with this section; creating s. 499.83,
32 F.S.; requiring an applicant for or a holder of a
33 permit as a wholesale distributor of medical gas or as
34 a medical oxygen retailer to designate a registered
35 agent; creating s. 499.84, F.S.; setting the minimum
36 requirements for the storage and handling of medical
37 gas; creating s. 499.85, F.S.; requiring a wholesale
38 distributor of medical gas to implement measures to
39 secure the location from unauthorized entry; setting
40 facility requirements for security purposes;
41 authorizing a vehicle used for on-call delivery of
42 oxygen USP and oxygen-related equipment to be parked
43 at a place of residence; requiring the department to
44 adopt rules governing the wholesale distribution of
45 prescription medical oxygen; creating s. 499.86, F.S.;
46 requiring a wholesale distributor of medical gases to
47 visually examine an immediate container upon receipt
48 for identity and to determine if the medical gas
49 container has been damaged or is otherwise unfit for
50 distribution; requiring a medical gas container that
51 is damaged or otherwise unfit for distribution to be
52 quarantined; requiring outgoing shipments to be
53 inspected; requiring wholesale distributors to review
54 certain records; creating s. 499.87, F.S.; authorizing
55 the return of medical gas that has left the control of
56 the wholesale distributor; requiring that medical gas
57 that is damaged, misbranded, or adulterated be
58 quarantined from other medical gases until it is
59 destroyed or returned to the manufacturer or wholesale
60 distributor from which it was acquired; creating s.
61 499.88, F.S.; requiring a wholesale distributor to
62 obtain certain information before the initial
63 acquisition of the medical gas; providing certain
64 exemptions; creating s. 499.89, F.S.; requiring a
65 wholesale distributor to establish and maintain
66 transactional records; providing a retention period
67 for certain records and requiring that the records be
68 available for inspection during that period; creating
69 s. 499.90, F.S.; requiring a wholesale distributor to
70 establish, maintain, and adhere to certain written
71 policies and procedures; creating s. 499.91, F.S.;
72 prohibiting certain acts; creating s. 499.92, F.S.;
73 establishing criminal penalties; authorizing property
74 or assets subject to forfeiture to be seized pursuant
75 to a warrant; creating s. 499.93, F.S.; authorizing
76 the department to require a facility that engages in
77 wholesale distribution to undergo an inspection;
78 authorizing the department to authorize a third party
79 to inspect wholesale distributors; requiring the
80 department to ensure that information obtained during
81 the inspection process identified as trade secret is
82 maintained and remains confidential; creating s.
83 499.94, F.S.; requiring fees collected pursuant to
84 this part to be deposited into the Professional
85 Regulation Trust Fund; creating s. 499.95, F.S.;
86 authorizing the department for the purpose of
87 initiating an investigation or proceeding under this
88 part to administer oaths, take depositions, issue and
89 serve subpoenas, and compel attendance of witnesses
90 and the production of books, papers, documents or
91 other evidence; requiring an attorney to whom the
92 department reports a violation of this part to timely
93 institute proceedings in the court of competent
94 jurisdiction; exempting minor violations from
95 reporting requirements at the department’s discretion;
96 providing that this part is cumulative and does not
97 repeal or affect the power, duty, or authority of the
98 department; amending ss. 409.9201, 460.403, 465.0265;
99 conforming provisions to changes made by the act;
100 amending s. 499.001, F.S.; conforming a provision to
101 changes made by the act; amending s. 499.003, F.S.;
102 conforming terminology, deleting a definition, and
103 defining the term “medical gas”; amending ss. 499.01
104 and 499.0121, F.S.; conforming provisions to changes
105 made by the act; amending s. 499.01211, F.S.; changing
106 the membership of the Drug Wholesale Distributor
107 Advisory Council; requiring the Compressed Gas
108 Association to appoint one person to the council;
109 amending ss. 499.01212, 499.015, 499.024, 499.041,
110 499.05, 499.051, 499.066, 499.0661, and 499.067, F.S.;
111 conforming provisions to changes made by the act;
112 providing an effective date.
113
114 Be It Enacted by the Legislature of the State of Florida:
115
116 Section 1. Part III of chapter 499, Florida Statutes,
117 consisting of ss. 499.81-499.95, Florida Statutes, is created
118 and is entitled “Medical Gas.”
119 Section 2. Section 499.81, Florida Statutes, is created to
120 read:
121 499.81 Definitions.—As used in this part, the term:
122 (1) “Adulterated” with respect to medical gas means medical
123 gas that:
124 (a) Consists, in whole or in part, of impurities or
125 deleterious substances that exceed normal specifications;
126 (b) Has been produced, prepared, packed, or held under
127 conditions whereby the gas may have been contaminated, causing
128 it to be rendered injurious to health; or was manufactured,
129 processed, packed, or held using methods, facilities, or
130 controls that do not conform to or are not operated or
131 administered in conformity with current good manufacturing
132 practices;
133 (c) Has a container interior that is composed, in whole or
134 in part, of a poisonous or deleterious substance that may render
135 the container contents injurious to health; or
136 (d) Has a strength that differs from, or that is of a
137 quality or purity that fails to meet, the standards established
138 in the USP-NF, if the gas is purported to be, or is represented
139 as, medical gas as recognized in the USP-NF. Such a
140 determination as to strength, quality, or purity must be made in
141 accordance with the tests or methods of assay set forth in the
142 USP-NF or a validated equivalent, or, in the absence or
143 inadequacy of these tests or methods of assay, those prescribed
144 under the authority of the federal act shall be used. However, a
145 gas that is purported to be, or is represented as, medical gas
146 as recognized in the USP-NF but that differs in strength,
147 quality, or purity from the standards established in the USP-NF
148 may not be deemed adulterated for purposes of this paragraph if
149 the difference is plainly stated on its label.
150 (2) “Department” means the Department of Business and
151 Professional Regulation.
152 (3) “Distribute” or “distribution” means to sell or offer
153 to sell, deliver or offer to deliver, broker, give away, or
154 transfer medical gas, by passage of title or by physical
155 movement. The term does not include:
156 (a) Dispensing or administering medical gas;
157 (b) Delivering or offering to deliver medical gas by a
158 common carrier in its usual course of business; or
159 (c) A sales activity that takes place in an establishment
160 that is owned or controlled by a person or business entity
161 authorized to distribute medical gas within or into this state
162 or staffed by persons employed by such person, if the location
163 where the sales activity takes place does not physically store
164 or transport medical gas.
165 (4) “Emergency use oxygen” means oxygen USP that is
166 administered without a prescription for an emergency situation
167 concerning oxygen deficiency or resuscitation and that is in a
168 container labeled in accordance with FDA standards.
169 (5) “FDA” means the federal Food and Drug Administration.
170 (6) “Federal act” means the federal Food, Drug, and
171 Cosmetic Act, 21 U.S.C. ss. 301 et seq.
172 (7) “Health care entity” means a person, including an
173 organization business entity, which provides diagnostic,
174 medical, surgical, or dental treatment or rehabilitative care.
175 The term includes a home respiratory care provider or a person
176 or entity authorized to administer emergency use oxygen, but
177 does not include a retail pharmacy or wholesale distributor.
178 (8) “Immediate container” means a compressed gas cylinder
179 or liquid container that contains medical gas. The term does not
180 include a large-bulk liquid or high pressure container, such as
181 a storage tank, vehicle-mounted vessel, trailer, or railcar.
182 (9) “Intracompany transaction” means a transaction between
183 divisions, subsidiaries, parents, or affiliated or related
184 companies under the common ownership and control of a single
185 corporate entity.
186 (10) “Label” means a display of a written, printed, or
187 graphic matter upon an immediate container. The term does not
188 include the letters, numbers, or symbols stamped onto a
189 container as required by the United States Department of
190 Transportation.
191 (11) “Manufacturer” means a person or entity that
192 manufactures medical gas in bulk or that transfers the gas or
193 liquefied gas product from one container to another.
194 (12) “Medical gas” is defined in accordance with the
195 federal act and means a liquefied or vaporized gas that is a
196 prescription drug, regardless of whether it is alone or combined
197 with other gases.
198 (13) “Medical gas-related equipment” means a device used as
199 an accessory or component part to contain or control flow,
200 delivery, or pressure during the administration of medical gas,
201 such as liquid-oxygen base and portable units, pressure
202 regulators, flow meters, and oxygen concentrators.
203 (14) “Misbranded” means medical gas that has a label that
204 is false or misleading or a label that does not:
205 (a) Display the name and address of the manufacturer,
206 packer, or distributor;
207 (b) Provide an accurate statement of the quantity of active
208 ingredients or show an accurate monograph for the medical gas;
209 or
210 (c) In the case of mixtures of designated medical gases,
211 identify the component percentages of each designated medical
212 gas used to make the mixture.
213 (15) “Prescription medical oxygen” means oxygen USP, a drug
214 that may be sold only by the order or prescription of a licensed
215 practitioner authorized by law to prescribe.
216 (16) “USP-NF” or “USP” means the standards published in the
217 official book, “The United States Pharmacopeia and the National
218 Formulary.”
219 (17) “Wholesale distribution” means the distribution of
220 medical gas by a wholesale distributor of medical gas to a
221 person other than a consumer or patient. The term does not
222 include:
223 (a) The sale, purchase, or trade of a medical gas, an offer
224 to sell, purchase, or trade a prescription drug or device, or
225 the dispensing of medical gas pursuant to a prescription;
226 (b) The sale, purchase, or trade of a medical gas or an
227 offer to sell, purchase, or trade medical gas for an emergency
228 medical reason that includes, but is not limited to:
229 1. A transfer of a medical gas between wholesale
230 distributors or between a wholesale distributor and a retail
231 pharmacy or health care entity to alleviate a temporary shortage
232 of medical gas resulting from a delay in or an interruption of a
233 regular distribution schedule;
234 2. Sales to a licensed emergency medical service provider,
235 such as an ambulance company, a firefighting organization, or a
236 licensed practitioner authorized to prescribe medical gases;
237 3. Provision of minimal emergency supplies of medical gas
238 to a nursing home for use in an emergency or during the hours of
239 the day when necessary medical gas cannot be obtained; or
240 4. Transfers of medical gases to alleviate a temporary
241 shortage between retail pharmacies;
242 (c) An intracompany transaction;
243 (d) The sale, purchase, or trade of medical gas or an offer
244 to sell, purchase, or trade medical gas among hospitals,
245 pharmacies, or other health care entities that are under common
246 control;
247 (e) The sale, purchase, or trade of medical gas, or the
248 offer to sell, purchase, or trade medical gas by a charitable
249 organization that has been granted an exemption under s.
250 501(c)(3) of the Internal Revenue Code to a nonprofit affiliate
251 of the organization, to the extent otherwise permitted by law;
252 (f) The purchase or other acquisition of medical gas by a
253 hospital or other similar health care entity that is a member of
254 a group purchasing organization, for the hospital’s or the
255 health care entity’s own use, from the group purchasing
256 organization or from another hospital or similar health care
257 entity that is a member of such organization;
258 (g) The return of residual medical gas that may be
259 reprocessed in accordance with the manufacturer’s procedures or
260 the return of recalled, expired, damaged, or otherwise
261 nonsalable medical gas, when returned by a hospital, health care
262 entity, pharmacy, or charitable institution to a wholesale
263 distributor;
264 (h) An activity that is exempt from the definition of the
265 term “wholesale distribution” as provided in s. 499.003; or
266 (i) A transaction that is excluded from the definition of
267 the term “wholesale distribution” under the federal act or
268 regulations implemented under the federal act related to medical
269 gas.
270 (18) “Wholesale distributor” means a person or entity
271 engaged in the wholesale distribution of medical gas within or
272 into this state, including, but not limited to, a manufacturer,
273 an own-label distributor, a private-label distributor, a
274 warehouse, including a manufacturers’ and distributors’
275 warehouse, and a wholesale medical gas warehouse.
276 Section 3. Section 499.82, Florida Statutes, is created to
277 read:
278 499.82 Permits.—
279 (1) A person or establishment, located inside or outside
280 the state, which intends to distribute medical gas within or
281 into this state must obtain the applicable permit before
282 operating.
283 (2) All of the following are legally authorized to receive
284 medical gas: permitted medical gas manufacturers or permitted
285 wholesale distributors, licensed pharmacies or health care
286 entities, people authorized to receive emergency use oxygen
287 without a prescription, locations with automated external
288 defibrillation machines where emergency use oxygen is intended
289 to be used with such machines, or companies that need medical
290 gas in the installation and refurbishment of piping and
291 equipment used to contain or administer medical gas.
292 (3) An applicant who is a natural person must be at least
293 18 years of age or an applicant must be managed, controlled, or
294 overseen, directly or indirectly, by a natural person who is at
295 least 18 years of age.
296 (4) An out-of-state wholesale distributor that provides
297 services in this state must be legally authorized as a wholesale
298 distributor in the state in which it resides or is incorporated.
299 (5) A wholesale distributor may not operate from a place of
300 residence, and a place of residence may not be granted a permit
301 or operate under this part, except for the on-call delivery of
302 home care oxygen by a home respiratory care technician.
303 (6) If wholesale distribution is conducted at more than one
304 location within this state or more than one location
305 distributing into this state, each location must be permitted by
306 the department.
307 (7) The following permits are established:
308 (a) Medical gas wholesale distributor permit.—A medical gas
309 wholesale distributor permit is required for wholesale
310 distribution within or into this state.
311 1. Such permit does not authorize distribution to a
312 consumer or patient.
313 2. The medical gas must be in the container that was
314 obtained by that wholesale distributor without further
315 manufacturing operations being performed.
316 3. A wholesale distributor may not possess or engage in the
317 wholesale distribution of any prescription drug other than
318 medical gas.
319 (b) Medical gas manufacturer permit.—A medical gas
320 manufacturer permit is required for a person who engages in the
321 manufacture of medical gas by physical air separation, chemical
322 action, purification, or filling containers using a liquid-to
323 liquid, liquid-to-gas, or gas-to-gas process and distributes
324 such medical gas within or into this state. A medical gas
325 manufacturer:
326 1. May not manufacture or possess a prescription drug other
327 than medical gas unless the appropriate permit is obtained.
328 2. May engage in the wholesale distribution of medical gas
329 that is manufactured at the permitted establishment without
330 obtaining a medical gas wholesale distributor permit, but shall
331 comply with this part and applicable rules.
332 3. Shall comply with all appropriate state and federal good
333 manufacturing practices.
334 (c) Medical oxygen retail establishment permit.—A medical
335 oxygen retail establishment permit is required for a person who
336 sells prescription medical oxygen directly to patients. Such
337 sales must be based upon an order or prescription from a
338 licensed practitioner authorized by law to prescribe. A pharmacy
339 licensed under chapter 465 is exempt from this paragraph. A
340 medical oxygen retail establishment:
341 1. May not possess, purchase, sell, or trade a prescription
342 drug other than medical oxygen unless other appropriate permits
343 are obtained.
344 2. May refill a prescription medical oxygen container for a
345 patient based on an order or prescription from a licensed
346 practitioner authorized by law to prescribe. A medical oxygen
347 retail establishment that refills prescription medical oxygen
348 shall comply with all appropriate state and federal good
349 manufacturing practices.
350 3. Shall comply with the storage and handling requirements
351 under s. 499.84.
352 4. May not receive back into its inventory any prescription
353 medical oxygen that it sold pursuant to a licensed
354 practitioner’s order.
355 Section 4. Section 499.821, Florida Statutes, is created to
356 read:
357 499.821 Permit application.—
358 (1) The department shall establish by rule the form and
359 content of an application to obtain a permit listed under s.
360 499.82.
361 (a) An application for a permit must be filed with the
362 department and must include the following information:
363 1. The trade or business names, including fictitious names,
364 currently and formerly used by the applicant, which may not be
365 identical to a name used by an unrelated wholesale distributor
366 authorized in this state to purchase medical gas.
367 2. The name or names of the owner and operator of the
368 permittee, if not the same person or entity. The application
369 must also include the following if the applicant is:
370 a. An individual: the applicant’s business address and date
371 of birth.
372 b. A sole proprietorship: the business address of the sole
373 proprietor and the name and federal employer identification
374 number of the business entity.
375 c. A partnership: the business address and date of birth of
376 each partner and the name and federal employer identification
377 number of the partnership.
378 d. A limited liability company: the business address and
379 title of each company officer, the name and federal employer
380 identification number of the limited liability company, and the
381 state of incorporation.
382 e. A corporation: the business address and title of each
383 corporate officer and director; the name, state of
384 incorporation, and federal employer identification number of the
385 corporation; and the name and business address of any parent
386 company.
387 3. A list of disciplinary actions pertinent to wholesale
388 distributors of prescription drugs or controlled substances by a
389 state or federal agency against the applicant seeking to
390 distribute into this state and against a principal, owner,
391 director, or officer.
392 4. An address and description of each facility or
393 warehouse, including a description of the security system for
394 any location used for medical gas storage or wholesale
395 distribution.
396 (b) The applicant shall attest in writing that the
397 information contained in the application is complete and
398 accurate, that the applicant has not been convicted of or
399 disciplined for a criminal or prohibited act, and that the
400 application contains complete disclosure of any past criminal
401 convictions or violations of state or federal law relating to
402 medical gases.
403 (2) An applicant that is denied a permit has the right to
404 review of the department’s decision pursuant to chapter 120.
405 (3) Information submitted to the department by an applicant
406 for the purposes of this section which the applicant identifies
407 as trade secret information as defined under s. 812.081 shall be
408 maintained by the department and remain confidential and exempt
409 from s. 119.07(1) and s. 24(a), Art. I of the State Constitution
410 for as long as the information is retained by the department.
411 (4) An applicant must submit a reasonable fee, to be
412 determined by the department, in order to obtain a permit. The
413 fee for a medical gas wholesale distributor permit may not be
414 less than $200 or more than $300 annually. The fee for a medical
415 gas manufacturer permit may not be less than $400 or more than
416 $500 annually. The fee for a medical oxygen retail establishment
417 permit may not be less than $200 or more than $300 annually.
418 Section 5. Section 499.822, Florida Statutes, is created to
419 read:
420 499.822 Expiration and renewal of a permit.—
421 (1) A permit issued under this part automatically expires 2
422 years after the last day of the month in which the permit was
423 originally issued unless the permit is suspended or revoked
424 before the automatic expiration date.
425 (2) A permit issued under this part may be renewed by
426 submitting an application for renewal on a form furnished by the
427 department and paying the appropriate fee. The application for
428 renewal must contain a statement by the applicant attesting that
429 the information is true and correct. If a renewal application
430 and renewal fee are submitted and postmarked after the
431 expiration date of the permit, the permit may be renewed only
432 upon payment of a late renewal delinquent fee of $100, plus the
433 required renewal fee, within 60 days after the expiration date.
434 (3) Failure to renew a permit in accordance with this
435 section precludes future renewal. If a permit has expired and
436 cannot be renewed, the person or establishment must submit an
437 application for a new permit, pay the applicable application
438 fee, the initial permit fee, and all applicable penalties, and
439 be issued a new permit by the department before engaging in an
440 activity that requires a permit under this part.
441 (4) The department shall adopt rules to administer this
442 section, including setting a reasonable fee for a renewal
443 application.
444 Section 6. Section 499.823, Florida Statutes, is created to
445 read:
446 499.823 Minimum qualifications.—The department may deny an
447 application for a permit or refuse to renew a permit based upon:
448 (1) Whether the applicant has violated, or has been
449 disciplined by a regulatory agency in any state for violating, a
450 federal, state, or local law relating to wholesale distribution;
451 (2) The applicant’s criminal convictions;
452 (3) The applicant’s past experience in manufacturing or
453 distributing medical gas;
454 (4) Any false or fraudulent material contained in an
455 application;
456 (5) Suspension, sanction, or revocation of a permit
457 currently or previously held by the applicant for violations of
458 a state or federal law relating to medical gas;
459 (6) Compliance with previously granted permit requirements;
460 (7) Compliance with the requirements to maintain or make
461 available to the department or permitting authority or to a
462 federal, state, or local law enforcement official records
463 required to be maintained by a wholesale distributor; and
464 (8) Any other factors or qualifications that the department
465 considers relevant to and consistent with public health and
466 safety.
467 Section 7. Section 499.824, Florida Statutes, is created to
468 read:
469 499.824 Permitholder changes.—
470 (1) A permit issued by the department is valid only for the
471 person or entity to which it is issued and is not subject to
472 sale, assignment, or other transfer, voluntarily or
473 involuntarily, and is not valid for an establishment other than
474 the establishment for which it was originally issued, except as
475 provided in this part. The department may approve the following
476 changes, and a person or entity may continue to operate in the
477 following manner:
478 (a) Change of location.—A person or entity permitted under
479 this part must notify the department before making a change of
480 location. The department shall set a change-of-location fee not
481 to exceed $100.
482 (b) Change in ownership.—If a majority of the ownership or
483 controlling interest of a permitted establishment is transferred
484 or assigned or if a lessee agrees to undertake or provide
485 services such that legal liability for operation of the
486 establishment will rest with the lessee, an application for a
487 new permit is required. The application for the new permit must
488 be made before the change of ownership. However, if an applicant
489 is a permitholder or is wholly owned by or wholly owns a
490 permitholder under this part, the application for the new permit
491 must be made by the date of the sale, transfer, assignment, or
492 lease. Between the date of the change of ownership and the date
493 of the application approval or denial by the department, an
494 applicant may distribute under the permit number of the previous
495 owner.
496 (c) Change of name.—A permitholder may make a change of
497 name without submitting a new permit application. The
498 permitholder must notify the department before making a change
499 of name. The permitholder may continue to operate the
500 establishment while the notification is being processed.
501 (d) Closure.—If an establishment permitted under this part
502 closes, the owner must notify the department, in writing, before
503 the effective date of the closure and must:
504 1. Return the permit to the department; and
505 2. If the permittee is authorized to distribute medical
506 gas, indicate the disposition of such medical gas, including the
507 name, address, and inventory, and provide the name and address
508 of a person to contact regarding access to the records that are
509 required to be maintained under this part. Transfer of ownership
510 of medical gas may be made only to persons authorized to receive
511 medical gas pursuant to this part.
512 (2) Notwithstanding paragraph (1)(a), a permitholder in
513 good standing may change the type of permit issued by completing
514 a new application for the requested permit, paying the amount of
515 the difference in the permit fees, and meeting the applicable
516 permitting requirements for the new permit type. A refund may
517 not be issued if the fee for the new permit is less than the fee
518 that was paid for the original permit. The new permit expires on
519 the expiration date of the original permit being changed.
520 (3) The department may revoke a permit for failure to
521 comply with this section.
522 Section 8. Section 499.83 Florida Statutes, is created to
523 read:
524 499.83 Registered agent.—An applicant for or a holder of a
525 permit as a medical gas wholesale distributor or as a medical
526 oxygen retail establishment shall designate a registered agent
527 in this state for purposes of service of process. If an
528 applicant or a permitted wholesale distributor or medical oxygen
529 retailer fails to designate a registered agent, the Secretary of
530 State shall be deemed the true and lawful attorney of the
531 applicant or the permitted wholesale distributor or medical
532 oxygen retailer, and, in such case, the legal processes in any
533 action or proceeding against an applicant or permitted wholesale
534 distributor or medical oxygen retailer which grows out of or
535 arising from wholesale distribution or retail may be served upon
536 the Secretary of State. A copy of the service of process shall
537 be mailed to the applicant or the permitted wholesale
538 distributor or medical oxygen retailer by the department by
539 certified mail, return receipt requested, postage prepaid, at
540 the address of the applicant or the distributor or retailer as
541 designated on the application for a permit in this state.
542 Section 9. Section 499.84, Florida Statutes, is created to
543 read:
544 499.84 Minimum requirements for the storage and handling of
545 medical gas.—
546 (1) A facility that receives, stores, warehouses, handles,
547 holds, offers, markets, displays, or transports medical gas must
548 avoid any negative effect on the identity, strength, quality, or
549 purity of medical gas by:
550 (a) Being constructed in a way that ensures that medical
551 gas is maintained in accordance with its product labeling
552 recommendations or in compliance with official compendium
553 standards, such as the USP-NF;
554 (b) Being of a suitable size and construction that
555 facilitates cleaning, maintenance, and proper wholesale
556 distribution;
557 (c) Having an adequate storage area with appropriate
558 lighting, ventilation, space, equipment, and security
559 conditions;
560 (d) Having a quarantine area for the storage of medical gas
561 that is suspected of being misbranded, adulterated, or otherwise
562 unfit for distribution;
563 (e) Being maintained in an orderly condition;
564 (f) Being in a commercial location, except if a personal
565 dwelling location is used for the on-call delivery of oxygen USP
566 for home care use and the person providing on-call delivery is
567 employed by or acting under a written contract with a permittee;
568 (g) Providing for the secure storage of patient
569 information, if applicable, by restricting access and
570 implementing policies and procedures that protect the integrity
571 and confidentiality of patient information; and
572 (h) Providing and maintaining appropriate inventory
573 controls in order to detect and document any theft of nitrous
574 oxide.
575 (2) Medical gas must be stored under appropriate conditions
576 in accordance with the manufacturers’ recommendations on product
577 labeling and department rules or, in the absence of rules, in
578 accordance with applicable industry standards. Medical gas must
579 be packaged in accordance with official compendium standards,
580 such as the USP-NF.
581 Section 10. Section 499.85, Florida Statutes, is created to
582 read:
583 499.85 Security.—
584 (1) A facility that engages in wholesale distribution shall
585 implement measures to secure its facility from unauthorized
586 entry. Such measures must include the following:
587 (a) Access from outside the premises must be well
588 controlled and kept to a minimum.
589 (b) The outside perimeter of the premises must be well
590 lighted.
591 (c) Areas in which medical gas is held must be restricted
592 by a fence or other system that detects or deters entry after
593 hours and limits access only to authorized personnel.
594 (2) A facility that engages in wholesale distribution must
595 have:
596 (a) A security system that provides protection against
597 theft and, if appropriate, theft that is enabled or obscured by
598 tampering with computers or electronic records.
599 (b) A security system that protects the integrity and
600 confidentiality of data and documents.
601 (3) If a wholesale distributor uses electronic distribution
602 records, he or she must employ, train, and document the training
603 of personnel for the proper use of the applicable technology and
604 equipment.
605 (4) A vehicle used for on-call delivery of oxygen USP and
606 oxygen-related equipment for home care use by a home care
607 provider may be parked at a place of residence. Such vehicle
608 while unattended must be locked and equipped with an audible
609 alarm.
610 (5) The department shall adopt rules that govern the
611 wholesale distribution of prescription medical oxygen for
612 emergency use by persons authorized to receive emergency use
613 oxygen. Unless the laws of this state specifically direct
614 otherwise, such rules must be consistent with federal rules and
615 regulations, including the labeling requirements of oxygen under
616 the federal act.
617 Section 11. Section 499.86, Florida Statutes, is created to
618 read:
619 499.86 Examination of materials.—
620 (1) A wholesale distributor must visually examine an
621 immediate container upon receipt from the manufacturer in order
622 to identify the medical gas and to determine if the container
623 has been damaged or is otherwise unfit for wholesale
624 distribution. Such examination must occur in a manner that would
625 reveal damage to the container which could suggest possible
626 adulteration or misbranding.
627 (2) A medical gas container that is damaged or otherwise
628 unfit pursuant to subsection (1) must be quarantined from the
629 rest of the stock of medical gas until it is determined that the
630 medical gas in question was not misbranded or adulterated.
631 (3) An outgoing shipment must be inspected for identity and
632 to ensure that medical gas containers that have been damaged in
633 storage or held under improper conditions are not delivered.
634 (4) A wholesale distributor must review records documenting
635 the acquisition of medical gas upon receipt for accuracy and
636 completeness.
637 Section 12. Section 499.87, Florida Statutes, is created to
638 read:
639 499.87 Returned, damaged, and outdated medical gas.—
640 (1) Medical gas that has left the control of a wholesale
641 distributor may be returned to the manufacturer or wholesale
642 distributor from which it was acquired.
643 (2) Unless medical gas is reprocessed by a manufacturer
644 employing proper and adequate controls to ensure the identity,
645 strength, quality, and purity of the reprocessed medical gas,
646 the gas may not be resold as a medical gas even if its integrity
647 was maintained.
648 (3) Medical gas that has been subjected to improper
649 conditions, such as a fire, accident, or natural disaster, may
650 not be salvaged or reprocessed.
651 (4) Medical gas, including its container, which is damaged,
652 misbranded, or adulterated must be quarantined from other
653 medical gases until it is destroyed or returned to the
654 manufacturer or wholesale distributor from which it was
655 acquired. External contamination to a medical gas container or
656 closure system which does not impact the integrity of the
657 medical gas is not considered damage or adulteration for
658 purposes of this subsection. If medical gas is adulterated or
659 misbranded or suspected of being adulterated or misbranded,
660 notice shall be provided to the manufacturer or wholesale
661 distributor from which the medical gas was acquired and to the
662 appropriate boards and federal regulatory bodies.
663 (5) A medical gas container that has been opened or used
664 but is not adulterated or misbranded is considered empty and
665 must be quarantined from nonempty medical gas containers and
666 returned to the manufacturer or wholesale distributor from which
667 it was acquired for destruction or reprocessing.
668 (6) Medical gas, its container, or its associated
669 documentation or labeling that is suspected of being used in
670 criminal activity must be retained until its disposition is
671 authorized by the department or an applicable law enforcement
672 agency.
673 Section 13. Section 499.88, Florida Statutes, is created to
674 read:
675 499.88 Due diligence.—
676 (1) A wholesale distributor shall obtain, before the
677 initial acquisition of medical gas, the following information
678 from the supplying wholesale distributor or manufacturer:
679 (a) If a manufacturer is distributing to a wholesale
680 distributor, evidence that the manufacturer is registered and
681 the medical gas is listed with the FDA;
682 (b) If a wholesale distributor is distributing to a
683 wholesale distributor, evidence that the wholesale distributor
684 supplying the medical gas is permitted to distribute medical gas
685 within or into the state;
686 (c) The name of the contact person for the supplying
687 manufacturer or wholesale distributor; and
688 (d) Certification that the manufacturer’s or wholesale
689 distributor’s policies and procedures comply with this part.
690 (2) A wholesale distributor is exempt from obtaining the
691 information from a manufacturer as required under subsection (1)
692 if the manufacturer is registered with the FDA in accordance
693 with s. 510 of the federal act and provides:
694 (a) Proof of such registration; and
695 (b) Proof of inspection within the past 3 years by the FDA
696 or other regulatory body or proof of conformance with industry
697 standards or guidelines as identified by the department.
698 (3) A manufacturer or wholesale distributor that
699 distributes to or acquires medical gas from another wholesale
700 distributor shall provide to or obtain from the distributing or
701 acquiring manufacturer or distributor the information required
702 by s. 499.89(1), as applicable.
703 Section 14. Section 499.89, Florida Statutes, is created to
704 read:
705 499.89 Recordkeeping.—
706 (1) A wholesale distributor shall establish and maintain a
707 record of transactions regarding the receipt and the
708 distribution, or other disposition, of medical gases. Such
709 records constitute an audit trail and must contain information
710 sufficient to perform a recall of medical gas in compliance with
711 21 C.F.R. s. 211.196 and 21 C.F.R. s. 820.160(b). Such records
712 must include all the following information, which need not
713 appear in the same document:
714 (a) The dates of receipt and wholesale distribution, or
715 other disposition, of the medical gas.
716 (b) The name, address, permit number, and permit expiration
717 date for the entity purchasing the medical gas from the
718 wholesale distributor.
719 (c) The name, address, permit number, and permit expiration
720 date for the entity receiving the medical gas from the wholesale
721 distributor, if different from the information required under
722 paragraph (b).
723 (d) Information sufficient to perform a recall of all
724 medical gas received or distributed.
725 (2) From the time of their creation, such records shall be
726 kept for 3 years for high pressure medical gas and for 1 year
727 for cryogenic or refrigerated liquid medical gas.
728 (3) During the retention period, such records shall be made
729 available for inspection and photocopying by an authorized
730 official of a state, federal, or local governmental agency. If
731 such records are kept at the inspection site or could be
732 immediately retrieved by electronic means, they shall be made
733 readily available for authorized inspection during the retention
734 period. Records kept at a central location apart from the
735 inspection site and not electronically retrievable shall be made
736 available for inspection within 2 business days of a request.
737 (4) A pedigree paper is not required for the wholesale
738 distribution of medical gas.
739 Section 15. Section 499.90, Florida Statutes, is created to
740 read:
741 499.90 Policies and procedures.—A wholesale distributor
742 shall establish, maintain, and adhere to written policies and
743 procedures for the receipt, security, storage, transport,
744 shipping, and wholesale distribution of medical gas and shall
745 establish, maintain, and adhere to procedures for maintaining
746 inventories; for identifying, recording, and reporting losses or
747 thefts; and for correcting all errors and inaccuracies in
748 inventories associated with nitrous oxide. A wholesale
749 distributor shall include in its written policies and procedures
750 the following:
751 (1) A procedure for handling recalls and withdrawals of
752 medical gas. Such procedure must deal with recalls and
753 withdrawals due to:
754 (a) Action initiated at the request of the FDA or any
755 federal, state, or local law enforcement or other government
756 agency, including the department; or
757 (b) Voluntary action by the manufacturer of medical gas to
758 remove defective or potentially defective medical gases from the
759 market.
760 (2) A procedure preparing for, protecting against, and
761 handling a crisis that affects the security or operation of a
762 facility in the event of a strike, fire, flood, or other natural
763 disaster or other situations of local, state, or national
764 emergency.
765 (3) A procedure for reporting criminal or suspected
766 criminal activity involving the inventory of nitrous oxide to
767 the department and to applicable law enforcement agencies within
768 3 business days after becoming aware of the criminal or
769 suspected criminal activity.
770 Section 16. Section 499.91, Florida Statutes, is created to
771 read:
772 499.91 Prohibited acts.—A person may not perform or cause
773 the performance of, or aid and abet in, any of the following
774 acts in this state:
775 (1) The manufacture, sale, or delivery, or the holding or
776 offering for sale, of medical gas that is adulterated,
777 misbranded, or has otherwise been rendered unfit for
778 distribution.
779 (2) The adulteration or misbranding of medical gas.
780 (3) The receipt of medical gas that is adulterated,
781 misbranded, stolen, or obtained by fraud or deceit or the
782 delivery or proffered delivery of such medical gas for pay or
783 otherwise.
784 (4) The alteration, mutilation, destruction, obliteration,
785 or removal of the whole or any part of the product labeling of
786 medical gas or the willful commission of any other act with
787 respect to medical gas that results in it being misbranded.
788 (5) The purchase or receipt of medical gas from a person
789 who is not authorized by permit to distribute wholesale medical
790 gas or who is exempted from permitting requirements to
791 distribute wholesale medical gas to such purchaser or recipient.
792 (6) The knowing and willful sale or transfer of medical gas
793 to a recipient who is not legally authorized to receive medical
794 gas, except for limited distributions of medical oxygen as
795 necessary to protect the health, safety, or welfare of a patient
796 in his or her home.
797 (7) The failure to maintain or provide records required
798 under this part and its implementing regulations.
799 (8) Providing the department or any of its representatives
800 or any state or federal official with false or fraudulent
801 records or making false or fraudulent statements regarding this
802 part and its implementing regulations.
803 (9) The wholesale distribution of medical gas that was:
804 (a) Purchased by a public or private hospital or other
805 health care entity, except for the physical distribution of such
806 medical gas to an authorized recipient at the direction of a
807 hospital or other health care entity;
808 (b) Donated or supplied at a reduced price to a charitable
809 organization; or
810 (c) Stolen or obtained by fraud or deceit.
811 (10) The failure to obtain a permit or operating without a
812 valid permit when a permit is required.
813 (11) The obtaining of or attempt to obtain medical gas by
814 fraud, deceit, or misrepresentation or engaging in
815 misrepresentation or fraud in the distribution of medical gas.
816 (12) Except for oxygen USP in emergency situations, the
817 distribution of medical gas to a patient without an order or
818 prescription from a licensed practitioner authorized by law to
819 prescribe.
820 (13) The distribution of medical gas that was previously
821 dispensed by a pharmacy or a licensed practitioner authorized by
822 law to prescribe.
823 (14) The distribution of medical gas or medical gas-related
824 equipment to a patient, unless the patient has been provided
825 with the appropriate information and counseling on the use,
826 storage, and disposal of medical gas.
827 (15) The failure to report an act prohibited under this
828 part and its implementing regulations.
829 (16) The failure to exercise due diligence as provided in
830 s. 499.88.
831 Section 17. Section 499.92, Florida Statutes, is created to
832 read:
833 499.92 Criminal acts.—
834 (1) A person commits a felony of the third degree,
835 punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
836 if he or she:
837 (a) With intent to defraud or deceive adulterates or
838 misbrands medical gas.
839 (b) Engages in the wholesale distribution of, and knowingly
840 purchases or receives, medical gas from a person not legally
841 authorized to distribute medical gas.
842 (c) Engages in the wholesale distribution of, and knowingly
843 sells, barters, brokers, or transfers, medical gas to a person
844 not legally authorized to purchase medical gas in the
845 jurisdiction in which the person receives the medical gas.
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
873 the manufacture or wholesale distribution of medical gas to
874 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 (5) The department shall ensure that information obtained
896 during the inspection process which is identified by the
897 establishment being inspected as a trade secret, as defined in
898 s. 812.081, is maintained by the department and remains
899 confidential and exempt from s. 119.07(1) and s. 24(a), Art. I
900 of the State Constitution for as long as the information is
901 retained by the department.
902 Section 19. 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 20. 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 21. 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 22. 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 23. 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).
1327
1328 The value of individual items of the legend drugs or goods or
1329 services involved in distinct transactions committed during a
1330 single scheme or course of conduct, whether involving a single
1331 person or several persons, may be aggregated when determining
1332 the punishment for the offense.
1333 Section 24. Paragraph (c) of subsection (9) of section
1334 460.403, Florida Statutes, is amended to read:
1335 460.403 Definitions.—As used in this chapter, the term:
1336 (9)
1337 (c)1. Chiropractic physicians may adjust, manipulate, or
1338 treat the human body by manual, mechanical, electrical, or
1339 natural methods; by the use of physical means or physiotherapy,
1340 including light, heat, water, or exercise; by the use of
1341 acupuncture; or by the administration of foods, food
1342 concentrates, food extracts, and items for which a prescription
1343 is not required and may apply first aid and hygiene, but
1344 chiropractic physicians are expressly prohibited from
1345 prescribing or administering to any person any legend drug
1346 except as authorized under subparagraph 2., from performing any
1347 surgery except as stated herein, or from practicing obstetrics.
1348 2. Notwithstanding the prohibition against prescribing and
1349 administering legend drugs under subparagraph 1. or s.
1350 499.82(7)(c) s. 499.01(2)(m), pursuant to board rule
1351 chiropractic physicians may order, store, and administer, for
1352 emergency purposes only at the chiropractic physician’s office
1353 or place of business, prescription medical oxygen and may also
1354 order, store, and administer the following topical anesthetics
1355 in aerosol form:
1356 a. Any solution consisting of 25 percent ethylchloride and
1357 75 percent dichlorodifluoromethane.
1358 b. Any solution consisting of 15 percent
1359 dichlorodifluoromethane and 85 percent
1360 trichloromonofluoromethane.
1361
1362 However, this paragraph does not authorize a chiropractic
1363 physician to prescribe medical oxygen as defined in chapter 499.
1364 Section 25. Subsection (3) of section 465.0265, Florida
1365 Statutes, is amended to read:
1366 465.0265 Centralized prescription filling.—
1367 (3) The filling, delivery, and return of a prescription by
1368 one pharmacy for another pursuant to this section may shall not
1369 be construed as the filling of a transferred prescription as
1370 described set forth in s. 465.026 or as a wholesale distribution
1371 as defined set forth in s. 499.003 s. 499.003(54).
1372 Section 26. Subsection (1), paragraphs (a), (c), (g), (m),
1373 (n), and (o) of subsection (2), and subsection (5) of section
1374 499.01, Florida Statutes, are amended to read:
1375 499.01 Permits.—
1376 (1) Before Prior to operating, a permit is required for
1377 each person and establishment that intends to operate as:
1378 (a) A prescription drug manufacturer;
1379 (b) A prescription drug repackager;
1380 (c) A nonresident prescription drug manufacturer;
1381 (d) A prescription drug wholesale distributor;
1382 (e) An out-of-state prescription drug wholesale
1383 distributor;
1384 (f) A retail pharmacy drug wholesale distributor;
1385 (g) A restricted prescription drug distributor;
1386 (h) A complimentary drug distributor;
1387 (i) A freight forwarder;
1388 (j) A veterinary prescription drug retail establishment;
1389 (k) A veterinary prescription drug wholesale distributor;
1390 (l) A limited prescription drug veterinary wholesale
1391 distributor;
1392 (m) A medical oxygen retail establishment;
1393 (n) A compressed medical gas wholesale distributor;
1394 (o) A compressed medical gas manufacturer;
1395 (m)(p) An over-the-counter drug manufacturer;
1396 (n)(q) A device manufacturer;
1397 (o)(r) A cosmetic manufacturer;
1398 (p)(s) A third party logistics provider; or
1399 (q)(t) A health care clinic establishment.
1400 (2) The following permits are established:
1401 (a) Prescription drug manufacturer permit.—A prescription
1402 drug manufacturer permit is required for any person that is a
1403 manufacturer of a prescription drug and that manufactures or
1404 distributes such prescription drugs in this state.
1405 1. A person that operates an establishment permitted as a
1406 prescription drug manufacturer may engage in wholesale
1407 distribution of prescription drugs manufactured at that
1408 establishment and must comply with all of the provisions of this
1409 part, except s. 499.01212, and the rules adopted under this
1410 part, except s. 499.01212, which apply to a wholesale
1411 distributor.
1412 2. A prescription drug manufacturer must comply with all
1413 appropriate state and federal good manufacturing practices.
1414 3. A blood establishment, as defined in s. 381.06014,
1415 operating in a manner consistent with the provisions of 21
1416 C.F.R. parts 211 and 600-640, and manufacturing only the
1417 prescription drugs described in s. 499.003(53)(d) s.
1418 499.003(54)(d) is not required to be permitted as a prescription
1419 drug manufacturer under this paragraph or to register products
1420 under s. 499.015.
1421 (c) Nonresident prescription drug manufacturer permit.—A
1422 nonresident prescription drug manufacturer permit is required
1423 for any person that is a manufacturer of prescription drugs,
1424 unless permitted as a third party logistics provider, located
1425 outside of this state or outside the United States and that
1426 engages in the wholesale distribution in this state of such
1427 prescription drugs. Each such manufacturer must be permitted by
1428 the department and comply with all of the provisions required of
1429 a wholesale distributor under this part, except s. 499.01212.
1430 1. A person that distributes prescription drugs for which
1431 the person is not the manufacturer must also obtain an out-of
1432 state prescription drug wholesale distributor permit or third
1433 party logistics provider permit pursuant to this section to
1434 engage in the wholesale distribution of such prescription drugs.
1435 This subparagraph does not apply to a manufacturer as defined in
1436 s. 499.003(30)(e) s. 499.003(31)(e).
1437 2. Any such person must comply with the licensing or
1438 permitting requirements of the jurisdiction in which the
1439 establishment is located and the federal act, and any product
1440 wholesaled into this state must comply with this part. If a
1441 person intends to import prescription drugs from a foreign
1442 country into this state, the nonresident prescription drug
1443 manufacturer must provide to the department a list identifying
1444 each prescription drug it intends to import and document
1445 approval by the United States Food and Drug Administration for
1446 such importation.
1447 (g) Restricted prescription drug distributor permit.—
1448 1. A restricted prescription drug distributor permit is
1449 required for:
1450 a. Any person located in this state who engages in the
1451 distribution of a prescription drug, which distribution is not
1452 considered “wholesale distribution” under s. 499.003(53)(a) s.
1453 499.003(54)(a).
1454 b. Any person located in this state who engages in the
1455 receipt or distribution of a prescription drug in this state for
1456 the purpose of processing its return or its destruction if such
1457 person is not the person initiating the return, the prescription
1458 drug wholesale supplier of the person initiating the return, or
1459 the manufacturer of the drug.
1460 c. A blood establishment located in this state which
1461 collects blood and blood components only from volunteer donors
1462 as defined in s. 381.06014 or pursuant to an authorized
1463 practitioner’s order for medical treatment or therapy and
1464 engages in the wholesale distribution of a prescription drug not
1465 described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
1466 care entity. A mobile blood unit operated by a blood
1467 establishment permitted under this sub-subparagraph is not
1468 required to be separately permitted. The health care entity
1469 receiving a prescription drug distributed under this sub
1470 subparagraph must be licensed as a closed pharmacy or provide
1471 health care services at that establishment. The blood
1472 establishment must operate in accordance with s. 381.06014 and
1473 may distribute only:
1474 (I) Prescription drugs indicated for a bleeding or clotting
1475 disorder or anemia;
1476 (II) Blood-collection containers approved under s. 505 of
1477 the federal act;
1478 (III) Drugs that are blood derivatives, or a recombinant or
1479 synthetic form of a blood derivative;
1480 (IV) Prescription drugs that are identified in rules
1481 adopted by the department and that are essential to services
1482 performed or provided by blood establishments and authorized for
1483 distribution by blood establishments under federal law; or
1484 (V) To the extent authorized by federal law, drugs
1485 necessary to collect blood or blood components from volunteer
1486 blood donors; for blood establishment personnel to perform
1487 therapeutic procedures under the direction and supervision of a
1488 licensed physician; and to diagnose, treat, manage, and prevent
1489 any reaction of a volunteer blood donor or a patient undergoing
1490 a therapeutic procedure performed under the direction and
1491 supervision of a licensed physician,
1492
1493 as long as all of the health care services provided by the blood
1494 establishment are related to its activities as a registered
1495 blood establishment or the health care services consist of
1496 collecting, processing, storing, or administering human
1497 hematopoietic stem cells or progenitor cells or performing
1498 diagnostic testing of specimens if such specimens are tested
1499 together with specimens undergoing routine donor testing. The
1500 blood establishment may purchase and possess the drugs described
1501 in this sub-subparagraph without a health care clinic
1502 establishment permit.
1503 2. Storage, handling, and recordkeeping of these
1504 distributions by a person required to be permitted as a
1505 restricted prescription drug distributor must be in accordance
1506 with the requirements for wholesale distributors under s.
1507 499.0121, but not those described set forth in s. 499.01212 if
1508 the distribution occurs pursuant to sub-subparagraph 1.a. or
1509 sub-subparagraph 1.b.
1510 3. A person who applies for a permit as a restricted
1511 prescription drug distributor, or for the renewal of such a
1512 permit, must provide to the department the information required
1513 under s. 499.012.
1514 4. The department may adopt rules regarding the
1515 distribution of prescription drugs by hospitals, health care
1516 entities, charitable organizations, other persons not involved
1517 in wholesale distribution, and blood establishments, which rules
1518 are necessary for the protection of the public health, safety,
1519 and welfare.
1520 (m) Medical oxygen retail establishment permit.—A medical
1521 oxygen retail establishment permit is required for any person
1522 that sells medical oxygen to patients only. The sale must be
1523 based on an order from a practitioner authorized by law to
1524 prescribe. The term does not include a pharmacy licensed under
1525 chapter 465.
1526 1. A medical oxygen retail establishment may not possess,
1527 purchase, sell, or trade any prescription drug other than
1528 medical oxygen.
1529 2. A medical oxygen retail establishment may refill medical
1530 oxygen for an individual patient based on an order from a
1531 practitioner authorized by law to prescribe. A medical oxygen
1532 retail establishment that refills medical oxygen must comply
1533 with all appropriate state and federal good manufacturing
1534 practices.
1535 3. A medical oxygen retail establishment must comply with
1536 all of the wholesale distribution requirements of s. 499.0121.
1537 4. Prescription medical oxygen sold by a medical oxygen
1538 retail establishment pursuant to a practitioner’s order may not
1539 be returned into the retail establishment’s inventory.
1540 (n) Compressed medical gas wholesale distributor permit.—A
1541 compressed medical gas wholesale distributor is a wholesale
1542 distributor that is limited to the wholesale distribution of
1543 compressed medical gases to other than the consumer or patient.
1544 The compressed medical gas must be in the original sealed
1545 container that was purchased by that wholesale distributor. A
1546 compressed medical gas wholesale distributor may not possess or
1547 engage in the wholesale distribution of any prescription drug
1548 other than compressed medical gases. The department shall adopt
1549 rules that govern the wholesale distribution of prescription
1550 medical oxygen for emergency use. With respect to the emergency
1551 use of prescription medical oxygen, those rules may not be
1552 inconsistent with rules and regulations of federal agencies
1553 unless the Legislature specifically directs otherwise.
1554 (o) Compressed medical gas manufacturer permit.—A
1555 compressed medical gas manufacturer permit is required for any
1556 person that engages in the manufacture of compressed medical
1557 gases or repackages compressed medical gases from one container
1558 to another.
1559 1. A compressed medical gas manufacturer may not
1560 manufacture or possess any prescription drug other than
1561 compressed medical gases.
1562 2. A compressed medical gas manufacturer may engage in
1563 wholesale distribution of compressed medical gases manufactured
1564 at that establishment and must comply with all the provisions of
1565 this part and the rules adopted under this part that apply to a
1566 wholesale distributor.
1567 3. A compressed medical gas manufacturer must comply with
1568 all appropriate state and federal good manufacturing practices.
1569 (5) A prescription drug repackager permit issued under this
1570 part is not required for a restricted prescription drug
1571 distributor permitholder that is a health care entity to
1572 repackage prescription drugs in this state for its own use or
1573 for distribution to hospitals or other health care entities in
1574 the state for their own use, pursuant to s. 499.003(53)(a)3. s.
1575 499.003(54)(a)3., if:
1576 (a) The prescription drug distributor notifies the
1577 department, in writing, of its intention to engage in
1578 repackaging under this exemption, 30 days before engaging in the
1579 repackaging of prescription drugs at the permitted
1580 establishment;
1581 (b) The prescription drug distributor is under common
1582 control with the hospitals or other health care entities to
1583 which the prescription drug distributor is distributing
1584 prescription drugs. As used in this paragraph, “common control”
1585 means the power to direct or cause the direction of the
1586 management and policies of a person or an organization, whether
1587 by ownership of stock, voting rights, contract, or otherwise;
1588 (c) The prescription drug distributor repackages the
1589 prescription drugs in accordance with current state and federal
1590 good manufacturing practices; and
1591 (d) The prescription drug distributor labels the
1592 prescription drug it repackages in accordance with state and
1593 federal laws and rules.
1594
1595 The prescription drug distributor is exempt from the product
1596 registration requirements of s. 499.015 with regard to the
1597 prescription drugs that it repackages and distributes under this
1598 subsection.
1599 Section 27. Paragraph (b) of subsection (2) of section
1600 499.0121, Florida Statutes, is amended to read:
1601 499.0121 Storage and handling of prescription drugs;
1602 recordkeeping.—The department shall adopt rules to implement
1603 this section as necessary to protect the public health, safety,
1604 and welfare. Such rules shall include, but not be limited to,
1605 requirements for the storage and handling of prescription drugs
1606 and for the establishment and maintenance of prescription drug
1607 distribution records.
1608 (2) SECURITY.—
1609 (b) An establishment that is used for wholesale drug
1610 distribution must be equipped with:
1611 1. An alarm system to detect entry after hours; however,
1612 the department may exempt by rule establishments that only hold
1613 a permit as prescription drug wholesale distributor-brokers and
1614 establishments that only handle medical oxygen; and
1615 2. A security system that will provide suitable protection
1616 against theft and diversion. When appropriate, the security
1617 system must provide protection against theft or diversion that
1618 is facilitated or hidden by tampering with computers or
1619 electronic records.
1620 Section 28. Section 499.01211, Florida Statutes, is amended
1621 to read:
1622 499.01211 Drug Wholesale Distributor Advisory Council.—
1623 (1) There is created the Drug Wholesale Distributor
1624 Advisory Council within the department. The council shall meet
1625 at least once each calendar quarter. Staff for the council shall
1626 be provided by the department. The council shall consist of 12
1627 11 members who shall serve without compensation. The council
1628 shall elect a chairperson and a vice chairperson annually.
1629 (2) The Secretary of Business and Professional Regulation
1630 or his or her designee and the Secretary of Health Care
1631 Administration or her or his designee shall be members of the
1632 council. The Secretary of Business and Professional Regulation
1633 shall appoint nine additional members to the council who shall
1634 be appointed to a term of 4 years each, as follows:
1635 (a) Three different persons each of whom is employed by a
1636 different prescription drug wholesale distributor licensed under
1637 this part which operates nationally and is a primary wholesale
1638 distributor, as defined in s. 499.003 s. 499.003(47).
1639 (b) One person employed by a prescription drug wholesale
1640 distributor licensed under this part which is a secondary
1641 wholesale distributor, as defined in s. 499.003 s. 499.003(52).
1642 (c) One person employed by a retail pharmacy chain located
1643 in this state.
1644 (d) One person who is a member of the Board of Pharmacy and
1645 is a pharmacist licensed under chapter 465.
1646 (e) One person who is a physician licensed pursuant to
1647 chapter 458 or chapter 459.
1648 (f) One person who is an employee of a hospital licensed
1649 pursuant to chapter 395 and is a pharmacist licensed pursuant to
1650 chapter 465.
1651 (g) One person who is an employee of a pharmaceutical
1652 manufacturer.
1653 (3) The Compressed Gas Association shall appoint one person
1654 to the council who is an employee of a permitted medical gas
1655 wholesale distributor or manufacturer.
1656 (4)(3) The council shall review this part and the rules
1657 adopted to administer this part annually, provide input to the
1658 department regarding all proposed rules to administer this part,
1659 make recommendations to the department to improve the protection
1660 of the prescription drugs and public health, make
1661 recommendations to improve coordination with other states’
1662 regulatory agencies and the federal government concerning the
1663 wholesale distribution of drugs, and make recommendations to
1664 minimize the impact of regulation of the wholesale distribution
1665 industry while ensuring protection of the public health.
1666 Section 29. Paragraph (b) of subsection (2) of section
1667 499.01212, Florida Statutes, is amended to read:
1668 499.01212 Pedigree paper.—
1669 (2) FORMAT.—A pedigree paper must contain the following
1670 information:
1671 (b) For all other wholesale distributions of prescription
1672 drugs:
1673 1. The quantity, dosage form, and strength of the
1674 prescription drugs.
1675 2. The lot numbers of the prescription drugs.
1676 3. The name and address of each owner of the prescription
1677 drug and his or her signature.
1678 4. Shipping information, including the name and address of
1679 each person certifying delivery or receipt of the prescription
1680 drug.
1681 5. An invoice number, a shipping document number, or
1682 another number uniquely identifying the transaction.
1683 6. A certification that the recipient wholesale distributor
1684 has authenticated the pedigree papers.
1685 7. The unique serialization of the prescription drug, if
1686 the manufacturer or repackager has uniquely serialized the
1687 individual prescription drug unit.
1688 8. The name, address, telephone number, and, if available,
1689 e-mail contact information of each wholesale distributor
1690 involved in the chain of the prescription drug’s custody.
1691
1692 When an affiliated group member obtains title to a prescription
1693 drug before distributing the prescription drug as the
1694 manufacturer as defined in s. 499.003(30)(e) under s.
1695 499.003(31)(e), information regarding the distribution between
1696 those affiliated group members may be omitted from a pedigree
1697 paper required under this paragraph for subsequent distributions
1698 of that prescription drug.
1699 Section 30. Paragraph (a) of subsection (1) and subsection
1700 (3) of section 499.015, Florida Statutes, are amended to read:
1701 499.015 Registration of drugs, devices, and cosmetics;
1702 issuance of certificates of free sale.—
1703 (1)(a) Except for those persons exempted from the
1704 definition of manufacturer in s. 499.003 s. 499.003(31), any
1705 person who manufactures, packages, repackages, labels, or
1706 relabels a drug, device, or cosmetic in this state must register
1707 such drug, device, or cosmetic biennially with the department;
1708 pay a fee in accordance with the fee schedule provided by s.
1709 499.041; and comply with this section. The registrant must list
1710 each separate and distinct drug, device, or cosmetic at the time
1711 of registration.
1712 (3) Except for those persons exempted from the definition
1713 of manufacturer in s. 499.003 s. 499.003(31), a person may not
1714 sell any product that he or she has failed to register in
1715 conformity with this section. Such failure to register subjects
1716 such drug, device, or cosmetic product to seizure and
1717 condemnation as provided in s. 499.062, and subjects such person
1718 to the penalties and remedies provided in this part.
1719 Section 31. Subsection (3) of section 499.024, Florida
1720 Statutes, is amended to read:
1721 499.024 Drug product classification.—The department shall
1722 adopt rules to classify drug products intended for use by humans
1723 which the United States Food and Drug Administration has not
1724 classified in the federal act or the Code of Federal
1725 Regulations.
1726 (3) Any product that falls under the definition of drug in
1727 s. 499.003 s. 499.003(19) may be classified under the authority
1728 of this section. This section does not subject portable
1729 emergency oxygen inhalators to classification; however, this
1730 section does not exempt any person from ss. 499.01 and 499.015.
1731 Section 32. Paragraph (e) of subsection (1), paragraph (b)
1732 of subsection (2), and paragraph (b) of subsection (3) of
1733 section 499.041, Florida Statutes, are amended to read:
1734 499.041 Schedule of fees for drug, device, and cosmetic
1735 applications and permits, product registrations, and free-sale
1736 certificates.—
1737 (1) The department shall assess applicants requiring a
1738 manufacturing permit an annual fee within the ranges established
1739 in this section for the specific type of manufacturer.
1740 (e) The fee for a compressed medical gas manufacturer
1741 permit may not be less than $400 or more than $500 annually.
1742 (2) The department shall assess an applicant that is
1743 required to have a wholesaling permit an annual fee within the
1744 ranges established in this section for the specific type of
1745 wholesaling.
1746 (b) The fee for a compressed medical gas wholesale
1747 distributor permit may not be less than $200 or more than $300
1748 annually.
1749 (3) The department shall assess an applicant that is
1750 required to have a retail establishment permit an annual fee
1751 within the ranges established in this section for the specific
1752 type of retail establishment.
1753 (b) The fee for a medical oxygen retail establishment
1754 permit may not be less than $200 or more than $300 annually.
1755 Section 33. Paragraphs (i) and (m) of subsection (1) of
1756 section 499.05, Florida Statutes, are amended to read:
1757 499.05 Rules.—
1758 (1) The department shall adopt rules to implement and
1759 enforce this chapter part with respect to:
1760 (i) Additional conditions that qualify as an emergency
1761 medical reason under s. 499.003(53)(b)2. s. 499.003(54)(b)2.
1762 (m) The recordkeeping, storage, and handling with respect
1763 to each of the distributions of prescription drugs specified in
1764 s. 499.003(53)(a)-(d) s. 499.003(54)(a)-(d).
1765 Section 34. Subsections (1) through (4) of section 499.051,
1766 Florida Statutes, are amended to read:
1767 499.051 Inspections and investigations.—
1768 (1) The agents of the department and of the Department of
1769 Law Enforcement, after they present proper identification, may
1770 inspect, monitor, and investigate any establishment permitted
1771 pursuant to this chapter part during business hours for the
1772 purpose of enforcing this chapter part, chapters 465, 501, and
1773 893, and the rules of the department that protect the public
1774 health, safety, and welfare.
1775 (2) In addition to the authority set forth in subsection
1776 (1), the department and any duly designated officer or employee
1777 of the department may enter and inspect any other establishment
1778 for the purpose of determining compliance with this part and
1779 rules adopted under this chapter part regarding any drug,
1780 device, or cosmetic product.
1781 (3) Any application for a permit or product registration or
1782 for renewal of such permit or registration made pursuant to this
1783 chapter part and rules adopted under this chapter part
1784 constitutes permission for any entry or inspection of the
1785 premises in order to verify compliance with this chapter part
1786 and rules; to discover, investigate, and determine the existence
1787 of compliance; or to elicit, receive, respond to, and resolve
1788 complaints and violations.
1789 (4) Any application for a permit made pursuant to s.
1790 499.012 or s. 499.821 and rules adopted under those sections
1791 that section constitutes permission for agents of the department
1792 and the Department of Law Enforcement, after presenting proper
1793 identification, to inspect, review, and copy any financial
1794 document or record related to the manufacture, repackaging, or
1795 distribution of a drug as is necessary to verify compliance with
1796 this chapter part and the rules adopted by the department to
1797 administer this chapter part, in order to discover, investigate,
1798 and determine the existence of compliance, or to elicit,
1799 receive, respond to, and resolve complaints and violations.
1800 Section 35. Section 499.066, Florida Statutes, is amended
1801 to read:
1802 499.066 Penalties; remedies.—In addition to other penalties
1803 and other enforcement provisions:
1804 (1) The department may institute such suits or other legal
1805 proceedings as are required to enforce any provision of this
1806 chapter part. If it appears that a person has violated any
1807 provision of this chapter part for which criminal prosecution is
1808 provided, the department may provide the appropriate state
1809 attorney or other prosecuting agency having jurisdiction with
1810 respect to such prosecution with the relevant information in the
1811 department’s possession.
1812 (2) If any person engaged in any activity covered by this
1813 chapter part violates any provision of this chapter part, any
1814 rule adopted under this chapter part, or a cease and desist
1815 order as provided by this chapter part, the department may
1816 obtain an injunction in the circuit court of the county in which
1817 the violation occurred or in which the person resides or has its
1818 principal place of business, and may apply in that court for
1819 such temporary and permanent orders as the department considers
1820 necessary to restrain the person from engaging in any such
1821 activities until the person complies with this chapter part, the
1822 rules adopted under this chapter part, and the orders of the
1823 department authorized by this chapter part or to mandate
1824 compliance with this chapter part, the rules adopted under this
1825 chapter part, and any order or permit issued by the department
1826 under this chapter part.
1827 (3) The department may impose an administrative fine, not
1828 to exceed $5,000 per violation per day, for the violation of any
1829 provision of this chapter part or rules adopted under this
1830 chapter part. Each day a violation continues constitutes a
1831 separate violation, and each separate violation is subject to a
1832 separate fine. All amounts collected pursuant to this section
1833 shall be deposited into the Professional Regulation Trust Fund
1834 and are appropriated for the use of the department in
1835 administering this chapter part. In determining the amount of
1836 the fine to be levied for a violation, the department shall
1837 consider:
1838 (a) The severity of the violation;
1839 (b) Any actions taken by the person to correct the
1840 violation or to remedy complaints; and
1841 (c) Any previous violations.
1842 (4) The department shall deposit any rewards, fines, or
1843 collections that are due the department and which derive from
1844 joint enforcement activities with other state and federal
1845 agencies which relate to this chapter part, chapter 893, or the
1846 federal act, into the Professional Regulation Trust Fund. The
1847 proceeds of those rewards, fines, and collections are
1848 appropriated for the use of the department in administering this
1849 chapter part.
1850 (5) The department may issue an emergency order immediately
1851 suspending or revoking a permit if it determines that any
1852 condition in the establishment presents a danger to the public
1853 health, safety, and welfare.
1854 (6) The department may issue an emergency order to
1855 immediately remove from commerce and public access any drug,
1856 device, or cosmetic, if the department determines that the drug,
1857 device, or cosmetic presents a clear and present danger to the
1858 public health, safety, and welfare.
1859 (7) Resignation or termination of an affiliated party does
1860 not affect the department’s jurisdiction or discretion to
1861 proceed with action to suspend or revoke a permit or to impose
1862 other penalties or enforcement actions authorized by law.
1863 Section 36. Paragraph (a) of subsection (1) and paragraph
1864 (a) of subsection (2) of section 499.0661, Florida Statutes, are
1865 amended to read:
1866 499.0661 Cease and desist orders; removal of certain
1867 persons.—
1868 (1) CEASE AND DESIST ORDERS.—
1869 (a) In addition to any authority otherwise provided in this
1870 chapter, the department may issue and serve a complaint stating
1871 charges upon any permittee or upon any affiliated party,
1872 whenever the department has reasonable cause to believe that the
1873 person or individual named therein is engaging in or has engaged
1874 in conduct that is:
1875 1. An act that demonstrates a lack of fitness or
1876 trustworthiness to engage in the business authorized under the
1877 permit issued pursuant to this chapter part, is hazardous to the
1878 public health, or constitutes business operations that are a
1879 detriment to the public health;
1880 2. A violation of any provision of this chapter part;
1881 3. A violation of any rule of the department;
1882 4. A violation of any order of the department; or
1883 5. A breach of any written agreement with the department.
1884 (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
1885 (a) The department may issue and serve a complaint stating
1886 charges upon any affiliated party and upon the permittee
1887 involved whenever the department has reason to believe that an
1888 affiliated party is engaging in or has engaged in conduct that
1889 constitutes:
1890 1. An act that demonstrates a lack of fitness or
1891 trustworthiness to engage in the business authorized under the
1892 permit issued pursuant to this chapter part, is hazardous to the
1893 public health, or constitutes business operations that are a
1894 detriment to the public health;
1895 2. A willful violation of this chapter part; however, if
1896 the violation constitutes a misdemeanor, a complaint may not be
1897 served as provided in this section until the affiliated party is
1898 notified in writing of the matter of the violation and has been
1899 afforded a reasonable period of time, as set forth in the
1900 notice, to correct the violation and has failed to do so;
1901 3. A violation of any other law involving fraud or moral
1902 turpitude which constitutes a felony;
1903 4. A willful violation of any rule of the department;
1904 5. A willful violation of any order of the department; or
1905 6. A material misrepresentation of fact, made knowingly and
1906 willfully or made with reckless disregard for the truth of the
1907 matter.
1908 Section 37. Section 499.067, Florida Statutes, is amended
1909 to read:
1910 499.067 Denial, suspension, or revocation of permit,
1911 certification, or registration.—
1912 (1)(a) The department may deny, suspend, or revoke a permit
1913 if it finds that there has been a substantial failure to comply
1914 with this chapter part or chapter 465, chapter 501, or chapter
1915 893, the rules adopted under this chapter part or those
1916 chapters, any final order of the department, or applicable
1917 federal laws or regulations or other state laws or rules
1918 governing drugs, devices, or cosmetics.
1919 (b) The department may deny an application for a permit or
1920 certification, or suspend or revoke a permit or certification,
1921 if the department finds that:
1922 1. The applicant is not of good moral character or that it
1923 would be a danger or not in the best interest of the public
1924 health, safety, and welfare if the applicant were issued a
1925 permit or certification.
1926 2. The applicant has not met the requirements for the
1927 permit or certification.
1928 3. The applicant is not eligible for a permit or
1929 certification for any of the reasons enumerated in s. 499.012.
1930 4. The applicant, permittee, or person certified under s.
1931 499.012(16) demonstrates any of the conditions enumerated in s.
1932 499.012.
1933 5. The applicant, permittee, or person certified under s.
1934 499.012(16) has committed any violation of ss. 499.005-499.0054.
1935 (2) The department may deny, suspend, or revoke any
1936 registration required by the provisions of this chapter part for
1937 the violation of any provision of this chapter part or of any
1938 rules adopted under this chapter part.
1939 (3) The department may revoke or suspend a permit:
1940 (a) If the permit was obtained by misrepresentation or
1941 fraud or through a mistake of the department;
1942 (b) If the permit was procured, or attempted to be
1943 procured, for any other person by making or causing to be made
1944 any false representation; or
1945 (c) If the permittee has violated any provision of this
1946 chapter part or rules adopted under this chapter part.
1947 (4) If any permit issued under this chapter part is revoked
1948 or suspended, the owner, manager, operator, or proprietor of the
1949 establishment shall cease to operate as the permit authorized,
1950 from the effective date of the suspension or revocation until
1951 the person is again registered with the department and possesses
1952 the required permit. If a permit is revoked or suspended, the
1953 owner, manager, or proprietor shall remove all signs and symbols
1954 that identify the operation as premises permitted as a drug
1955 wholesaling establishment; drug, device, or cosmetic
1956 manufacturing establishment; or retail establishment. The
1957 department shall determine the length of time for which the
1958 permit is to be suspended. If a permit is revoked, the person
1959 that owns or operates the establishment may not apply for any
1960 permit under this chapter part for a period of 1 year after the
1961 date of the revocation. A revocation of a permit may be
1962 permanent if the department considers that to be in the best
1963 interest of the public health.
1964 (5) The department may deny, suspend, or revoke a permit
1965 issued under this chapter part which authorizes the permittee to
1966 purchase prescription drugs if any owner, officer, employee, or
1967 other person who participates in administering or operating the
1968 establishment has been found guilty of any violation of this
1969 chapter part or chapter 465, chapter 501, or chapter 893, any
1970 rules adopted under this chapter part or those chapters, or any
1971 federal or state drug law, regardless of whether the person has
1972 been pardoned, had her or his civil rights restored, or had
1973 adjudication withheld.
1974 (6) The department shall deny, suspend, or revoke the
1975 permit of any person or establishment if the assignment, sale,
1976 transfer, or lease of an establishment permitted under this
1977 chapter part will avoid an administrative penalty, civil action,
1978 or criminal prosecution.
1979 (7) Notwithstanding s. 120.60(5), if a permittee fails to
1980 comply with s. 499.012(6) or s. 499.83, as applicable, the
1981 department may revoke the permit of the permittee and shall
1982 provide notice of the intended agency action by posting a notice
1983 at the department’s headquarters and by mailing a copy of the
1984 notice of intended agency action by certified mail to the most
1985 recent mailing address on record with the department and, if the
1986 permittee is not a natural person, to the permittee’s registered
1987 agent on file with the Department of State.
1988 (8) The department may deny, suspend, or revoke a permit
1989 under this part if it finds the permittee has not complied with
1990 the credentialing requirements of s. 499.0121(15).
1991 (9) The department may deny, suspend, or revoke a permit
1992 under this part if it finds the permittee has not complied with
1993 the reporting requirements of, or knowingly made a false
1994 statement in a report required by, s. 499.0121(14).
1995 Section 38. This act shall take effect October 1, 2014.
1996
