Florida Senate - 2012 CS for SB 1006
By the Committee on Health Regulation; and Senator Latvala
588-03799-12 20121006c1
1 A bill to be entitled
2 An act relating to health care; creating s. 383.146,
3 F.S.; providing definitions; providing requirements
4 for screening newborns for critical congenital heart
5 disease; providing an exception; requiring that the
6 physician, midwife, or other person attending the
7 newborn maintain a record if the screening has not
8 been performed and attach a written objection signed
9 by the parent or guardian; requiring appropriate
10 documentation of the screening completion in the
11 medical record; requiring that each hospital and each
12 licensed birth center designate a lead physician and a
13 licensed health care provider, respectively, to
14 provide programmatic oversight for the screening;
15 requiring that the screening for critical congenital
16 heart disease be conducted on all newborns in
17 hospitals and birth centers in this state; authorizing
18 the Department of Health to adopt rules to administer
19 the screening program; providing powers and duties of
20 the department; amending s. 499.003, F.S.; revising
21 the definitions of the terms “distribute” or
22 “distribution,” “drug,” “establishment,” “prescription
23 drug,” and “wholesale distribution”; amending s.
24 499.01, F.S.; deleting provisions relating to an
25 exemption from nonresident prescription drug
26 manufacturer permit requirements; deleting provisions
27 relating to an exemption from out-of-state
28 prescription drug wholesale distributor permit
29 requirements for intracompany sale or transfer of
30 prescription drugs; authorizing certain business
31 entities to pay for prescription drugs obtained by
32 practitioners licensed under ch. 466, F.S.; providing
33 an exemption from permit requirements for the
34 distribution into this state of prescription drug
35 active pharmaceutical ingredients for incorporation
36 into prescription drugs in finished dosage form;
37 requiring a distributor claiming such exemption to
38 maintain a valid license, permit, or registration in
39 the state from which the prescription drug was
40 distributed; requiring compliance with certain
41 recordkeeping requirements; exempting compliance with
42 pedigree paper requirements; providing an exemption
43 from permit requirements for distribution into this
44 state of limited quantities of a prescription drug
45 that has not been repackaged for research and
46 development or to a holder of a letter of exemption
47 issued by the Department of Business and Professional
48 Regulation for research, teaching, or testing;
49 granting the department authority to define the term
50 “limited quantities” by rule and limit therein the
51 number of transactions and amount of prescription
52 drugs distributed into the state; requiring a
53 distributor claiming such exemption to maintain a
54 valid license, permit, or registration in the state
55 from which the prescription drug was distributed;
56 requiring all purchasers and recipients of such
57 prescription drugs to ensure the products are not
58 resold or used on humans except in lawful clinical
59 trials and biostudies; requiring compliance with
60 certain recordkeeping requirements; exempting
61 compliance from pedigree paper requirements; providing
62 labeling requirements for active pharmaceutical
63 ingredients distributed within the state for teaching,
64 testing, research, and development; exempting from
65 out-of-state prescription drug wholesale distributor
66 permit requirements intracompany transactions or the
67 sale of prescription drugs from an out-of-state
68 distributor to a distributor in this state if both
69 distributors conduct wholesale distributions under the
70 same business name; requiring compliance with
71 recordkeeping and pedigree paper requirements;
72 allowing distributors and recipients of prescription
73 drugs claiming exemption from certain permitting
74 requirements to maintain on file their FDA
75 registration number, resident state distributor
76 license or permit number, and most recent resident
77 state or FDA inspection report; providing that persons
78 claiming such exemptions are subject to part I of ch.
79 499, F.S., the Florida Drug and Cosmetic Act;
80 requiring persons claiming such exemptions to make all
81 records regarding prescription drug distribution
82 available to the department, upon request, within 48
83 hours; requiring submission of a report of mishandled
84 or adulterated prescription drugs within 14 days after
85 receipt of such drugs; authorizing the department to
86 adopt rules; providing that failure to comply with
87 requirements or rules governing such exemptions
88 constitutes unlawful purchase or receipt of a
89 prescription drug from a person not authorized to
90 distribute prescription drugs to that purchaser or
91 recipient; providing that knowing failure to comply
92 with such requirements constitutes unlawful sale,
93 distribution, purchase, trade, holding, or offering of
94 a drug; providing penalties; providing construction
95 with respect to federal and state laws relating to
96 controlled substances; providing that a prescription
97 drug repackager permit is not required for certain
98 restricted prescription drug distributor permitholders
99 that distribute prescription drugs to certain
100 hospitals or other health care entities; exempting
101 certain restricted prescription drug distributors from
102 product registration requirements; providing an
103 effective date.
104
105 Be It Enacted by the Legislature of the State of Florida:
106
107 Section 1. Section 383.146, Florida Statutes, is created to
108 read:
109 383.146 Newborn screening for critical congenital heart
110 disease.—
111 (1) DEFINITIONS.—As used in this section, the term:
112 (a) “Department” means the Department of Health.
113 (b) “Newborn” means an age range from birth through 29
114 days.
115 (c) “Screening” means measuring blood oxygen saturation
116 using pulse oximetry to determine whether a newborn needs
117 additional diagnostic evaluation for critical congenital heart
118 disease.
119 (2) REQUIREMENTS FOR SCREENING OF NEWBORNS; REFERRAL FOR
120 ONGOING SERVICES.—
121 (a) Each licensed hospital that provides maternity and
122 newborn care services shall ensure that, prior to discharge, all
123 newborns are screened for the detection of critical congenital
124 heart disease.
125 (b) Each licensed birth center that provides maternity and
126 newborn care services shall ensure that, prior to discharge, all
127 newborns are screened for the detection of critical congenital
128 heart disease.
129 (c) If the parent or legal guardian of the newborn objects
130 to the screening, the screening must not be completed,
131 notwithstanding any other provision of this section. In such
132 case, the physician, midwife, or other person who is attending
133 the newborn shall maintain a record that the screening has not
134 been performed and attach a written objection that must be
135 signed by the parent or guardian.
136 (d) For home births, the health care provider in attendance
137 is responsible for the screening.
138 (e) Appropriate documentation of the screening completion,
139 results, interpretation, and recommendations must be placed in
140 the medical record within 24 hours after completion of the
141 screening procedure.
142 (f) Each hospital shall formally designate a lead physician
143 who is responsible for programmatic oversight of newborn
144 congenital heart disease screening. Each licensed birth center
145 shall designate a licensed health care provider to provide such
146 programmatic oversight. Such physician or health care provider
147 shall ensure that the appropriate referrals are completed
148 following a positive screening test result.
149 (g) By October 1, 2012, screening for critical congenital
150 heart disease must be conducted on all newborns in hospitals and
151 birth centers in this state following birth admission.
152 (3) RULES.—After consultation with the Genetics and Newborn
153 Screening Advisory Council, the department shall adopt and
154 enforce rules requiring that every newborn in this state be
155 screened for critical congenital heart disease. The department
156 shall adopt such additional rules as are necessary for the
157 administration of this section, including rules providing
158 definitions of terms, rules relating to the methods used and
159 time or times for testing as accepted medical practice
160 indicates, rules relating to charging and collecting fees for
161 the administration of the newborn screening program required by
162 this section, rules for processing requests and releasing test
163 and screening results, and rules requiring mandatory reporting
164 of the results of tests and screenings for this condition to the
165 department.
166 (4) POWERS AND DUTIES OF THE DEPARTMENT.—The department
167 shall administer and provide services required pursuant to this
168 section and shall:
169 (a) Furnish to all physicians, county health departments,
170 perinatal centers, birth centers, and hospitals forms on which
171 the results of tests for critical congenital heart disease shall
172 be reported to the department.
173 (b) Have the authority to charge and collect fees
174 sufficient to administer the newborn screening program required
175 under this section.
176 Section 2. Subsections (17), (19), (20), and (43), and
177 paragraph (a) of subsection (54) of section 499.003, Florida
178 Statutes, are amended to read:
179 499.003 Definitions of terms used in this part.—As used in
180 this part, the term:
181 (17) “Distribute” or “distribution” means to sell; offer to
182 sell; give away; transfer, whether by passage of title, physical
183 movement, or both; deliver; or offer to deliver. The term does
184 not mean to administer or dispense and does not include the
185 billing and invoicing activities that commonly follow a
186 wholesale distribution transaction.
187 (19) “Drug” means an article that is:
188 (a) Recognized in the current edition of the United States
189 Pharmacopoeia and National Formulary, official Homeopathic
190 Pharmacopoeia of the United States, or any supplement to any of
191 those publications;
192 (b) Intended for use in the diagnosis, cure, mitigation,
193 treatment, therapy, or prevention of disease in humans or other
194 animals;
195 (c) Intended to affect the structure or any function of the
196 body of humans or other animals; or
197 (d) Intended for use as a component of any article
198 specified in paragraph (a), paragraph (b), or paragraph (c), and
199 includes active pharmaceutical ingredients, but does not include
200 devices or their components, parts, or accessories. For purposes
201 of this paragraph, an “active pharmaceutical ingredient”
202 includes any substance or mixture of substances intended,
203 represented, or labeled for use in drug manufacturing that
204 furnishes or is intended to furnish, in a finished dosage form,
205 any pharmacological activity or other direct effect in the
206 diagnosis, cure, mitigation, treatment, therapy, or prevention
207 of disease in humans or other animals, or to affect the
208 structure or any function of the body of humans or other
209 animals.
210 (20) “Establishment” means a place of business which is at
211 one general physical location and may extend to one or more
212 contiguous suites, units, floors, or buildings operated and
213 controlled exclusively by entities under common operation and
214 control. Where multiple buildings are under common exclusive
215 ownership, operation, and control, an intervening thoroughfare
216 does not affect the contiguous nature of the buildings. For
217 purposes of permitting, each suite, unit, floor, or building
218 must be identified in the most recent permit application.
219 (43) “Prescription drug” means a prescription, medicinal,
220 or legend drug, including, but not limited to, finished dosage
221 forms or active pharmaceutical ingredients subject to, defined
222 by, or described by s. 503(b) of the Federal Food, Drug, and
223 Cosmetic Act or s. 465.003(8), s. 499.007(13), or subsection
224 (11), subsection (46), or subsection (53), except that an active
225 pharmaceutical ingredient is a prescription drug only if
226 substantially all finished dosage forms in which it may be
227 lawfully dispensed or administered in this state are also
228 prescription drugs.
229 (54) “Wholesale distribution” means distribution of
230 prescription drugs to persons other than a consumer or patient,
231 but does not include:
232 (a) Any of the following activities, which is not a
233 violation of s. 499.005(21) if such activity is conducted in
234 accordance with s. 499.01(2)(g):
235 1. The purchase or other acquisition by a hospital or other
236 health care entity that is a member of a group purchasing
237 organization of a prescription drug for its own use from the
238 group purchasing organization or from other hospitals or health
239 care entities that are members of that organization.
240 2. The sale, purchase, or trade of a prescription drug or
241 an offer to sell, purchase, or trade a prescription drug by a
242 charitable organization described in s. 501(c)(3) of the
243 Internal Revenue Code of 1986, as amended and revised, to a
244 nonprofit affiliate of the organization to the extent otherwise
245 permitted by law.
246 3. The sale, purchase, or trade of a prescription drug or
247 an offer to sell, purchase, or trade a prescription drug among
248 hospitals or other health care entities that are under common
249 control. For purposes of this subparagraph, “common control”
250 means the power to direct or cause the direction of the
251 management and policies of a person or an organization, whether
252 by ownership of stock, by voting rights, by contract, or
253 otherwise.
254 4. The sale, purchase, trade, or other transfer of a
255 prescription drug from or for any federal, state, or local
256 government agency or any entity eligible to purchase
257 prescription drugs at public health services prices pursuant to
258 Pub. L. No. 102-585, s. 602 to a contract provider or its
259 subcontractor for eligible patients of the agency or entity
260 under the following conditions:
261 a. The agency or entity must obtain written authorization
262 for the sale, purchase, trade, or other transfer of a
263 prescription drug under this subparagraph from the State Surgeon
264 General or his or her designee.
265 b. The contract provider or subcontractor must be
266 authorized by law to administer or dispense prescription drugs.
267 c. In the case of a subcontractor, the agency or entity
268 must be a party to and execute the subcontract.
269 d. A contract provider or subcontractor must maintain
270 separate and apart from other prescription drug inventory any
271 prescription drugs of the agency or entity in its possession.
272 d.e. The contract provider and subcontractor must maintain
273 and produce immediately for inspection all records of movement
274 or transfer of all the prescription drugs belonging to the
275 agency or entity, including, but not limited to, the records of
276 receipt and disposition of prescription drugs. Each contractor
277 and subcontractor dispensing or administering these drugs must
278 maintain and produce records documenting the dispensing or
279 administration. Records that are required to be maintained
280 include, but are not limited to, a perpetual inventory itemizing
281 drugs received and drugs dispensed by prescription number or
282 administered by patient identifier, which must be submitted to
283 the agency or entity quarterly.
284 e.f. The contract provider or subcontractor may administer
285 or dispense the prescription drugs only to the eligible patients
286 of the agency or entity or must return the prescription drugs
287 for or to the agency or entity. The contract provider or
288 subcontractor must require proof from each person seeking to
289 fill a prescription or obtain treatment that the person is an
290 eligible patient of the agency or entity and must, at a minimum,
291 maintain a copy of this proof as part of the records of the
292 contractor or subcontractor required under sub-subparagraph d
293 sub-subparagraph e.
294 f.g. In addition to the departmental inspection authority
295 set forth in s. 499.051, the establishment of the contract
296 provider and subcontractor and all records pertaining to
297 prescription drugs subject to this subparagraph shall be subject
298 to inspection by the agency or entity. All records relating to
299 prescription drugs of a manufacturer under this subparagraph
300 shall be subject to audit by the manufacturer of those drugs,
301 without identifying individual patient information.
302 Section 3. Paragraphs (c), (e), and (t) of subsection (2)
303 of section 499.01, Florida Statutes, are amended, and
304 subsections (3) and (4) are added to that section, to read:
305 499.01 Permits.—
306 (2) The following permits are established:
307 (c) Nonresident prescription drug manufacturer permit.—A
308 nonresident prescription drug manufacturer permit is required
309 for any person that is a manufacturer of prescription drugs,
310 unless permitted as a third party logistics provider, located
311 outside of this state or outside the United States and that
312 engages in the wholesale distribution in this state of such
313 prescription drugs. Each such manufacturer must be permitted by
314 the department and comply with all of the provisions required of
315 a wholesale distributor under this part, except s. 499.01212.
316 1. A person that distributes prescription drugs for which
317 the person is not the manufacturer must also obtain an out-of
318 state prescription drug wholesale distributor permit or third
319 party logistics provider permit pursuant to this section to
320 engage in the wholesale distribution of such prescription drugs.
321 This subparagraph does not apply to a manufacturer as defined in
322 s. 499.003(31)(e).
323 2. Any such person must comply with the licensing or
324 permitting requirements of the jurisdiction in which the
325 establishment is located and the federal act, and any product
326 wholesaled into this state must comply with this part. If a
327 person intends to import prescription drugs from a foreign
328 country into this state, the nonresident prescription drug
329 manufacturer must provide to the department a list identifying
330 each prescription drug it intends to import and document
331 approval by the United States Food and Drug Administration for
332 such importation.
333 3. A nonresident prescription drug manufacturer permit is
334 not required for a manufacturer to distribute a prescription
335 drug active pharmaceutical ingredient that it manufactures to a
336 prescription drug manufacturer permitted in this state in
337 limited quantities intended for research and development and not
338 for resale, or human use other than lawful clinical trials and
339 biostudies authorized and regulated by federal law. A
340 manufacturer claiming to be exempt from the permit requirements
341 of this subparagraph and the prescription drug manufacturer
342 purchasing and receiving the active pharmaceutical ingredient
343 shall comply with the recordkeeping requirements of s.
344 499.0121(6), but not the requirements of s. 499.01212. The
345 prescription drug manufacturer purchasing and receiving the
346 active pharmaceutical ingredient shall maintain on file a record
347 of the FDA registration number; the out-of-state license,
348 permit, or registration number; and, if available, a copy of the
349 most current FDA inspection report, for all manufacturers from
350 whom they purchase active pharmaceutical ingredients under this
351 section. The department shall specify by rule the allowable
352 number of transactions within a given period of time and the
353 amount of active pharmaceutical ingredients that qualify as
354 limited quantities for purposes of this exemption. The failure
355 to comply with the requirements of this subparagraph, or rules
356 adopted by the department to administer this subparagraph, for
357 the purchase of prescription drug active pharmaceutical
358 ingredients is a violation of s. 499.005(14).
359 (e) Out-of-state prescription drug wholesale distributor
360 permit.—An out-of-state prescription drug wholesale distributor
361 is a wholesale distributor located outside this state which
362 engages in the wholesale distribution of prescription drugs into
363 this state and which must be permitted by the department and
364 comply with all the provisions required of a wholesale
365 distributor under this part. An out-of-state prescription drug
366 wholesale distributor that applies to the department for a new
367 permit or the renewal of a permit must submit a bond of
368 $100,000, or other equivalent means of security acceptable to
369 the department, such as an irrevocable letter of credit or a
370 deposit in a trust account or financial institution, payable to
371 the Florida Drug, Device, and Cosmetic Trust Fund. The purpose
372 of the bond is to secure payment of any administrative penalties
373 imposed by the department and any fees and costs incurred by the
374 department regarding that permit which are authorized under
375 state law and which the permittee fails to pay 30 days after the
376 fine or costs become final. The department may make a claim
377 against such bond or security until 1 year after the permittee’s
378 license ceases to be valid or until 60 days after any
379 administrative or legal proceeding authorized in this part which
380 involves the permittee is concluded, including any appeal,
381 whichever occurs later.
382 1. The out-of-state prescription drug wholesale distributor
383 must maintain at all times a license or permit to engage in the
384 wholesale distribution of prescription drugs in compliance with
385 laws of the state in which it is a resident.
386 2. An out-of-state prescription drug wholesale distributor
387 permit is not required for an intracompany sale or transfer of a
388 prescription drug from an out-of-state establishment that is
389 duly licensed as a prescription drug wholesale distributor, in
390 its state of residence, to a licensed prescription drug
391 wholesale distributor in this state, if both wholesale
392 distributors conduct wholesale distributions of prescription
393 drugs under the same business name. The recordkeeping
394 requirements of ss. 499.0121(6) and 499.01212 must be followed
395 for this transaction.
396 (t) Health care clinic establishment permit.—Effective
397 January 1, 2009, a health care clinic establishment permit is
398 required for the purchase of a prescription drug by a place of
399 business at one general physical location that provides health
400 care or veterinary services, which is owned and operated by a
401 business entity that has been issued a federal employer tax
402 identification number. For the purpose of this paragraph, the
403 term “qualifying practitioner” means a licensed health care
404 practitioner defined in s. 456.001, or a veterinarian licensed
405 under chapter 474, who is authorized under the appropriate
406 practice act to prescribe and administer a prescription drug.
407 1. An establishment must provide, as part of the
408 application required under s. 499.012, designation of a
409 qualifying practitioner who will be responsible for complying
410 with all legal and regulatory requirements related to the
411 purchase, recordkeeping, storage, and handling of the
412 prescription drugs. In addition, the designated qualifying
413 practitioner shall be the practitioner whose name, establishment
414 address, and license number is used on all distribution
415 documents for prescription drugs purchased or returned by the
416 health care clinic establishment. Upon initial appointment of a
417 qualifying practitioner, the qualifying practitioner and the
418 health care clinic establishment shall notify the department on
419 a form furnished by the department within 10 days after such
420 employment. In addition, the qualifying practitioner and health
421 care clinic establishment shall notify the department within 10
422 days after any subsequent change.
423 2. The health care clinic establishment must employ a
424 qualifying practitioner at each establishment.
425 3. In addition to the remedies and penalties provided in
426 this part, a violation of this chapter by the health care clinic
427 establishment or qualifying practitioner constitutes grounds for
428 discipline of the qualifying practitioner by the appropriate
429 regulatory board.
430 4. The purchase of prescription drugs by the health care
431 clinic establishment is prohibited during any period of time
432 when the establishment does not comply with this paragraph.
433 5. A health care clinic establishment permit is not a
434 pharmacy permit or otherwise subject to chapter 465. A health
435 care clinic establishment that meets the criteria of a modified
436 Class II institutional pharmacy under s. 465.019 is not eligible
437 to be permitted under this paragraph.
438 6. This paragraph does not apply to the purchase of a
439 prescription drug by a licensed practitioner under his or her
440 license. A professional corporation or limited liability company
441 composed of dentists and operating as authorized in s. 466.0285
442 may pay for prescription drugs obtained by a practitioner
443 licensed under chapter 466, and the licensed practitioner is
444 deemed the purchaser and owner of the prescription drugs.
445 (3)(a) A permit issued under this part is not required to
446 distribute a prescription drug active pharmaceutical ingredient
447 from an establishment located in the United States to an
448 establishment located in this state permitted as a prescription
449 drug manufacturer under this part for use by the recipient in
450 preparing, deriving, processing, producing, or fabricating a
451 prescription drug finished dosage form at the establishment in
452 this state where the product is received under an approved and
453 otherwise valid New Drug Approval Application, Abbreviated New
454 Drug Application, New Animal Drug Application, or Therapeutic
455 Biologic Application, provided that the application, active
456 pharmaceutical ingredient, or finished dosage form has not been
457 withdrawn or removed from the market in this country for public
458 health reasons.
459 1. Any distributor claiming exemption from permitting
460 requirements pursuant to this paragraph shall maintain a
461 license, permit, or registration to engage in the wholesale
462 distribution of prescription drugs under the laws of the state
463 from which the product is distributed.
464 2. Any distributor claiming exemption from permitting
465 requirements pursuant to this paragraph and the prescription
466 drug manufacturer purchasing and receiving the active
467 pharmaceutical ingredient shall comply with the recordkeeping
468 requirements of s. 499.0121(6), but not the requirements of s.
469 499.01212.
470 (b) A permit issued under this part is not required to
471 distribute limited quantities of a prescription drug that has
472 not been repackaged from an establishment located in the United
473 States to an establishment located in this state permitted as a
474 prescription drug manufacturer under this part for research and
475 development or to a holder of a letter of exemption issued by
476 the department under s. 499.03(4) for research, teaching, or
477 testing. The department shall define the term “limited
478 quantities” by rule and may include the allowable number of
479 transactions within a given period of time and the amounts of
480 prescription drugs distributed into the state for purposes of
481 this exemption.
482 1. Any distributor claiming exemption from permitting
483 requirements pursuant to this paragraph shall maintain a
484 license, permit, or registration to engage in the wholesale
485 distribution of prescription drugs under the laws of the state
486 from which the product is distributed.
487 2. All purchasers and recipients of any prescription drugs
488 distributed pursuant to this paragraph shall ensure that the
489 products are not resold or used, directly or indirectly, on
490 humans except in lawful clinical trials and biostudies
491 authorized and regulated by federal law.
492 3. Any distributor claiming exemption from permitting
493 requirements pursuant to this paragraph, and the purchaser and
494 recipient of the prescription drug, shall comply with the
495 recordkeeping requirements of s. 499.0121(6), but not the
496 requirements of s. 499.01212.
497 4. The immediate package or container of any active
498 pharmaceutical ingredient distributed into the state which is
499 intended for teaching, testing, research, and development shall
500 bear a label prominently displaying the statement: “Caution:
501 Research, Teaching, or Testing Only – Not for Manufacturing,
502 Compounding, or Resale.”
503 (c) An out-of-state prescription drug wholesale distributor
504 permit is not required for an intracompany sale or transfer of a
505 prescription drug from an out-of-state establishment that is
506 duly licensed as a prescription drug wholesale distributor in
507 its state of residence to a licensed prescription drug wholesale
508 distributor in this state, if both wholesale distributors
509 conduct wholesale distributions of prescription drugs under the
510 same business name. The recordkeeping requirements of ss.
511 499.0121(6) and 499.01212 must be followed for such
512 transactions.
513 (d) Persons receiving prescription drugs from a source
514 claimed to be exempt from permitting requirements under this
515 subsection shall maintain on file:
516 1. A record of the FDA establishment registration number,
517 if any;
518 2. The resident state prescription drug wholesale
519 distribution license, permit, or registration number; and
520 3. A copy of the most recent resident state or FDA
521 inspection report, for all distributors and establishments whom
522 they purchase or receive prescription drugs under this
523 subsection.
524 (e) All persons claiming exemption from permitting
525 requirements pursuant to this subsection who engage in the
526 distribution of prescription drugs within or into the state are
527 subject to this part, including ss. 499.005 and 499.0051, and
528 shall make available, within 48 hours, to the department on
529 request all records related to any prescription drugs
530 distributed under this subsection, including those records
531 described in s. 499.051(4), regardless of the location where the
532 records are stored.
533 (f) A person purchasing and receiving a prescription drug
534 from a person claimed to be exempt from licensing requirements
535 pursuant to this subsection shall report to the department in
536 writing within 14 days after receiving any product that is
537 misbranded or adulterated or that fails to meet minimum
538 standards set forth in the official compendium or state or
539 federal good manufacturing practices for identity, purity,
540 potency, or sterility, regardless of whether the product is
541 thereafter rehabilitated, quarantined, returned, or destroyed.
542 (g) The department may adopt rules to administer this
543 subsection which are necessary for the protection of the public
544 health, safety, and welfare. Failure to comply with the
545 requirements of this subsection, or rules adopted by the
546 department to administer this subsection, is a violation of s.
547 499.005(14), and a knowing failure is a violation of s.
548 499.0051(4).
549 (h) This subsection does not relieve any person from any
550 requirement prescribed by law with respect to controlled
551 substances as defined in the applicable federal and state laws.
552 (4) A prescription drug repackager permit issued under this
553 part is not required for a restricted prescription drug
554 distributor permitholder that is a health care entity that
555 repackages prescription drugs in this state for its own use or
556 distributes prescription drugs to a hospital or other health
557 care entity in the state for its own use pursuant to s.
558 499.003(54)(a)3. if the restricted prescription drug
559 distributor:
560 (a) Notifies the department in writing of its intention to
561 engage in repackaging under this exemption 30 days before
562 actually engaging in the repackaging of prescription drugs at
563 the permitted establishment;
564 (b) Is under common control with the hospital or other
565 health care entity to which the restricted prescription drug
566 distributor distributes prescription drugs. For purposes of this
567 paragraph, the term “common control” means the power to direct
568 or cause the direction of the management and policies of a
569 person or an organization, whether by ownership of stock, by
570 voting rights, by contract, or otherwise;
571 (c) Repackages the prescription drugs in accordance with
572 federal and state current good manufacturing practices; and
573 (d) Labels the prescription drugs in accordance with state
574 and federal laws and rules.
575
576 The restricted prescription drug distributor is exempt from the
577 product registration requirements of s. 499.015 with regard to
578 the prescription drugs that it repackages and distributes under
579 this subsection.
580 Section 4. This act shall take effect July 1, 2012.