Senate Bill sb1372c4

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    Florida Senate - 2004      CS for CS for CS for CS for SB 1372

    By the Committees on Appropriations; Finance and Taxation;
    Criminal Justice; Health, Aging, and Long-Term Care; and
    Senator Saunders



    309-2514-04

  1                      A bill to be entitled

  2         An act relating to pharmacy; amending s.

  3         465.003, F.S.; defining the term "Internet

  4         pharmacy"; amending s. 465.0156, F.S.;

  5         exempting Internet pharmacies from registration

  6         requirements applicable to nonresident

  7         pharmacies; requiring the registered

  8         nonresident pharmacy and the pharmacist

  9         designated by that pharmacy to serve as the

10         prescription department manager or its

11         equivalent to be licensed in the state of

12         location; amending s. 465.016, F.S.; providing

13         for disciplinary action for dispensing a

14         medicinal drug when the pharmacist knows or has

15         reason to believe the prescription is not based

16         on a valid practitioner-patient relationship;

17         creating s. 465.0161, F.S.; prohibiting the

18         distribution of medicinal drugs by an Internet

19         pharmacy without a permit; providing penalties;

20         amending s. 465.0196, F.S., relating to special

21         pharmacy permits, to conform; creating s.

22         465.0197, F.S.; requiring Internet pharmacies

23         to be permitted and providing requirements

24         therefor; requiring the Internet pharmacy and

25         the pharmacist designated by that pharmacy to

26         serve as the prescription department manager or

27         its equivalent to be licensed in the state of

28         location; amending s. 465.023, F.S.; providing

29         an additional ground for which the Board of

30         Pharmacy may take action against a permitted

31         pharmacy; amending s. 465.0255, F.S.; revising

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 1         requirements for pharmacists to deliver

 2         specified disclosures to purchasers when

 3         dispensing a medicinal drug; amending s.

 4         465.026, F.S.; creating an exception to the

 5         requirements for filling or refilling a

 6         transferred prescription for a medicinal drug

 7         listed in Schedule II under ch. 893, F.S.;

 8         amending s. 499.0121, F.S.; providing

 9         recordkeeping requirements relating to the

10         storage and handling of prescription drugs

11         which certain affiliated groups must fulfill;

12         amending s. 895.02, F.S.; including violation

13         of s. 465.0161, F.S., in the definition of the

14         term "racketeering activity" for prosecution

15         under ch. 895, F.S.; providing an appropriation

16         and authorizing positions; providing an

17         effective date.

18  

19  Be It Enacted by the Legislature of the State of Florida:

20  

21         Section 1.  Paragraph (a) of subsection (11) of section

22  465.003, Florida Statutes, is amended to read:

23         465.003  Definitions.--As used in this chapter, the

24  term:

25         (11)(a)  "Pharmacy" includes a community pharmacy, an

26  institutional pharmacy, a nuclear pharmacy, and a special

27  pharmacy, and an Internet pharmacy.

28         1.  The term "community pharmacy" includes every

29  location where medicinal drugs are compounded, dispensed,

30  stored, or sold or where prescriptions are filled or dispensed

31  on an outpatient basis.

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 1         2.  The term "institutional pharmacy" includes every

 2  location in a hospital, clinic, nursing home, dispensary,

 3  sanitarium, extended care facility, or other facility,

 4  hereinafter referred to as "health care institutions," where

 5  medicinal drugs are compounded, dispensed, stored, or sold.

 6         3.  The term "nuclear pharmacy" includes every location

 7  where radioactive drugs and chemicals within the

 8  classification of medicinal drugs are compounded, dispensed,

 9  stored, or sold. The term "nuclear pharmacy" does not include

10  hospitals licensed under chapter 395 or the nuclear medicine

11  facilities of such hospitals.

12         4.  The term "special pharmacy" includes every location

13  where medicinal drugs are compounded, dispensed, stored, or

14  sold if such locations are not otherwise defined in this

15  subsection.

16         5.  The term "Internet pharmacy" includes locations not

17  otherwise licensed or issued a permit under this chapter,

18  within or outside this state, which use the Internet to

19  communicate with or obtain information from consumers in this

20  state and use such communication or information to fill or

21  refill prescriptions or to dispense, distribute, or otherwise

22  engage in the practice of pharmacy in this state. Any act

23  described in this definition constitutes the practice of

24  pharmacy as defined in subsection (13).

25         Section 2.  Subsections (7) and (8) are added to

26  section 465.0156, Florida Statutes, to read:

27         465.0156  Registration of nonresident pharmacies.--

28         (7)  This section does not apply to Internet pharmacies

29  required to be permitted under s. 465.0197.

30         (8)  Notwithstanding s. 465.003(10), for purposes of

31  this section, the registered pharmacy and the pharmacist

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 1  designated by the registered pharmacy as the prescription

 2  department manager or the equivalent must be licensed in the

 3  state of location in order to dispense into this state.

 4         Section 3.  Paragraph (s) is added to subsection (1) of

 5  section 465.016, Florida Statutes, to read:

 6         465.016  Disciplinary actions.--

 7         (1)  The following acts constitute grounds for denial

 8  of a license or disciplinary action, as specified in s.

 9  456.072(2):

10         (s)  Dispensing any medicinal drug based upon a

11  communication that purports to be a prescription as defined by

12  s. 465.003(14) or s. 893.02(20) when the pharmacist knows or

13  has reason to believe that the purported prescription is not

14  based upon a valid practitioner-patient relationship.

15         Section 4.  Section 465.0161, Florida Statutes, is

16  created to read:

17         465.0161  Distribution of medicinal drugs without a

18  permit.--An Internet pharmacy that distributes a medicinal

19  drug to any person in this state without being permitted as a

20  pharmacy under this chapter commits a felony of the second

21  degree, punishable as provided in s. 775.082, s. 775.083, or

22  s. 775.084.

23         Section 5.  Section 465.0196, Florida Statutes, is

24  amended to read:

25         465.0196  Special pharmacy permits.--Any person

26  desiring a permit to operate a special pharmacy which does not

27  fall within the definitions set forth in s. 465.003(11)(a)1.,

28  2., and 3. shall apply to the department for a special

29  pharmacy permit. If the board certifies that the application

30  complies with the applicable laws and rules of the board

31  governing the practice of the profession of pharmacy, the

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 1  department shall issue the permit. No permit shall be issued

 2  unless a licensed pharmacist is designated to undertake the

 3  professional supervision of the compounding and dispensing of

 4  all drugs dispensed by the pharmacy. The licensed pharmacist

 5  shall be responsible for maintaining all drug records and for

 6  providing for the security of the area in the facility in

 7  which the compounding, storing, and dispensing of medicinal

 8  drugs occurs. The permittee shall notify the department within

 9  10 days of any change of the licensed pharmacist responsible

10  for such duties. Every permittee that employs or otherwise

11  utilizes pharmacy technicians shall have a written policy and

12  procedures manual specifying those duties, tasks, and

13  functions which a pharmacy technician is allowed to perform.

14         Section 6.  Section 465.0197, Florida Statutes, is

15  created to read:

16         465.0197  Internet pharmacy permits.--

17         (1)  Any person desiring a permit to operate an

18  Internet pharmacy shall apply to the department for an

19  Internet pharmacy permit. If the board certifies that the

20  application complies with the applicable laws and rules of the

21  board governing the practice of the profession of pharmacy,

22  the department shall issue the permit. No permit shall be

23  issued unless a licensed pharmacist is designated as the

24  prescription department manager for dispensing medicinal drugs

25  to persons in this state. The licensed pharmacist shall be

26  responsible for maintaining all drug records and for providing

27  for the security of the area in the facility in which the

28  compounding, storing, and dispensing of medicinal drugs to

29  persons in this state occurs. The permittee shall notify the

30  department within 30 days of any change of the licensed

31  pharmacist responsible for such duties. Every permittee that

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 1  employs or otherwise utilizes pharmacy technicians shall have

 2  a written policy and procedures manual specifying those

 3  duties, tasks, and functions which a pharmacy technician is

 4  allowed to perform.

 5         (2)  An Internet pharmacy must obtain a permit under

 6  this section to sell medicinal drugs to persons in this state.

 7         (3)  An Internet pharmacy shall provide pharmacy

 8  services at a high level of protection and competence and

 9  shall disclose to the board the following specific

10  information:

11         (a)  That it maintains at all times a valid, unexpired

12  license, permit, or registration to operate the pharmacy in

13  compliance with the laws of the state in which the dispensing

14  facility is located and from which the medicinal drugs shall

15  be dispensed.

16         (b)  The location, names, and titles of all principal

17  corporate officers and the pharmacist who serves as the

18  prescription department manager for dispensing medicinal drugs

19  to persons in this state. This disclosure shall be made within

20  30 days after any change of location, principal corporate

21  officer, or pharmacist serving as the prescription department

22  manager for dispensing medicinal drugs to persons in this

23  state.

24         (c)  That it complies with all lawful directions and

25  requests for information from the regulatory or licensing

26  agency of all states in which it is licensed as well as with

27  all requests for information made by the board pursuant to

28  this section. It shall respond directly to all communications

29  from the board concerning emergency circumstances arising from

30  errors in the dispensing of medicinal drugs to persons in this

31  state.

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 1         (d)  That it maintains its records of medicinal drugs

 2  dispensed to patients in this state so that the records are

 3  readily retrievable from the other business records of the

 4  pharmacy and from the records of other medicinal drugs

 5  dispensed.

 6         (e)  That during its regular hours of operation but not

 7  less than 6 days per week, for a minimum of 40 hours per week,

 8  a toll-free telephone service shall be provided to facilitate

 9  communication between patients in this state and a pharmacist

10  at the pharmacy who has access to the patient's records. This

11  toll-free number must be disclosed on the label affixed to

12  each container of dispensed medicinal drugs.

13         (4)  Notwithstanding s. 465.003(10), for purposes of

14  this section, the Internet pharmacy and the pharmacist

15  designated by the Internet pharmacy as the prescription

16  department manager or the equivalent must be licensed in the

17  state of location in order to dispense into this state.

18         Section 7.  Subsection (1) of section 465.023, Florida

19  Statutes, is amended to read:

20         465.023  Pharmacy permittee; disciplinary action.--

21         (1)  The department or the board may revoke or suspend

22  the permit of any pharmacy permittee, and may fine, place on

23  probation, or otherwise discipline any pharmacy permittee who

24  has:

25         (a)  Obtained a permit by misrepresentation or fraud or

26  through an error of the department or the board;

27         (b)  Attempted to procure, or has procured, a permit

28  for any other person by making, or causing to be made, any

29  false representation;

30         (c)  Violated any of the requirements of this chapter

31  or any of the rules of the Board of Pharmacy; of chapter 499,

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 1  known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss.

 2  301-392, known as the "Federal Food, Drug, and Cosmetic Act";

 3  of 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug

 4  Abuse Prevention and Control Act; or of chapter 893; or

 5         (d)  Been convicted or found guilty, regardless of

 6  adjudication, of a felony or any other crime involving moral

 7  turpitude in any of the courts of this state, of any other

 8  state, or of the United States; or.

 9         (e)  Dispensed any medicinal drug based upon a

10  communication that purports to be a prescription as defined by

11  s. 465.003(14) or s. 893.02(20) when the pharmacist knows or

12  has reason to believe that the purported prescription is not

13  based upon a valid practitioner-patient relationship that

14  includes a documented patient evaluation, including history

15  and a physical examination adequate to establish the diagnosis

16  for which any drug is prescribed and any other requirement

17  established by board rule under chapter 458, chapter 459,

18  chapter 461, chapter 463, chapter 464, or chapter 466.

19         Section 8.  Section 465.0255, Florida Statutes, is

20  amended to read:

21         465.0255  Expiration date of medicinal drugs; display;

22  related use and storage instructions.--

23         (1)  The manufacturer, repackager, or other distributor

24  of any medicinal drug shall display the expiration date of

25  each drug in a readable fashion on the container and on its

26  packaging. The term "readable" means conspicuous and bold.

27         (2)  Each pharmacist for a community pharmacy

28  dispensing medicinal drugs and each practitioner dispensing

29  medicinal drugs on an outpatient basis shall display on the

30  outside of the container of each medicinal drug dispensed, or

31  in other written form delivered to the purchaser:,

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 1         (a)  The expiration date when provided by the

 2  manufacturer, repackager, or other distributor of the drug; or

 3  and

 4         (b)  An earlier beyond-use date for expiration, which

 5  may be up to 1 year after the date of dispensing.

 6  

 7  The dispensing pharmacist or practitioner must provide

 8  information concerning the expiration date to the purchaser

 9  upon request and must provide appropriate instructions

10  regarding the proper use and storage of the drug.

11         (3)  Nothing in This section does not shall impose

12  liability on the dispensing pharmacist or practitioner for

13  damages related to, or caused by, a medicinal drug that loses

14  its effectiveness prior to the expiration date displayed by

15  the dispensing pharmacist or practitioner.

16         (4)(3)  The provisions of this section are intended to

17  notify the patient receiving a medicinal drug of the

18  information required by this section, and the dispensing

19  pharmacist or practitioner shall not be liable for the

20  patient's failure to heed such notice or to follow the

21  instructions for storage.

22         Section 9.  Subsection (7) is added to section 465.026,

23  Florida Statutes, to read:

24         465.026  Filling of certain prescriptions.--Nothing

25  contained in this chapter shall be construed to prohibit a

26  pharmacist licensed in this state from filling or refilling a

27  valid prescription which is on file in a pharmacy located in

28  this state or in another state and has been transferred from

29  one pharmacy to another by any means, including any electronic

30  means, under the following conditions:

31  

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 1         (7)  A community pharmacy licensed under this chapter

 2  which only receives and transfers prescriptions for dispensing

 3  by another pharmacy may transfer a prescription for a

 4  medicinal drug listed in Schedule II under chapter 893. The

 5  pharmacy receiving the prescription may ship, mail, or deliver

 6  into this state, in any manner, the dispensed Schedule II

 7  medicinal drug under the following conditions:

 8         (a)  The pharmacy receiving and dispensing the

 9  transferred prescription maintains at all times a valid,

10  unexpired license, permit, or registration to operate the

11  pharmacy in compliance with the laws of the state in which the

12  pharmacy is located and from which the medicinal drugs are

13  dispensed;

14         (b)  The community pharmacy and the receiving pharmacy

15  are owned and operated by the same person and share a

16  centralized database; and

17         (c)  The community pharmacy assures its compliance with

18  federal laws and subsections (1)-(5).

19         Section 10.  Paragraph (h) is added to subsection (6)

20  of section 499.0121, Florida Statutes, to read:

21         499.0121  Storage and handling of prescription drugs;

22  recordkeeping.--The department shall adopt rules to implement

23  this section as necessary to protect the public health,

24  safety, and welfare.  Such rules shall include, but not be

25  limited to, requirements for the storage and handling of

26  prescription drugs and for the establishment and maintenance

27  of prescription drug distribution records.

28         (6)  RECORDKEEPING.--The department shall adopt rules

29  that require keeping such records of prescription drugs as are

30  necessary for the protection of the public health.

31  

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 1         (h)1.  This paragraph applies only to an affiliated

 2  group, as defined by s. 1504 of the Internal Revenue Code of

 3  1986, as amended, which is composed of chain drug entities,

 4  including at least 50 retail pharmacies, warehouses, or

 5  repackagers, which are members of the same affiliated group,

 6  if the affiliated group:

 7         a.  Discloses to the department the names of all its

 8  members; and

 9         b.  Agrees in writing to provide records on

10  prescription drug purchases by members of the affiliated group

11  not later than 48 hours after the department requests such

12  records, regardless of the location where the records are

13  stored.

14         2.  Each warehouse within the affiliated group must

15  comply with all applicable federal and state drug wholesale

16  permit requirements and must purchase, receive, hold, and

17  distribute prescription drugs only to a retail pharmacy or

18  warehouse within the affiliated group. Such a warehouse is

19  exempt from providing a pedigree paper in accordance with

20  paragraphs (d) and (e) to its affiliated group member

21  warehouse, provided that:

22         a.  Any affiliated group member that purchases or

23  receives a prescription drug from outside the affiliated group

24  must receive a pedigree paper if the prescription drug is

25  distributed in or into this state and a pedigree paper is

26  required under this section and must authenticate the

27  documentation as required in subsection (4), regardless of

28  whether the affiliated group member is directly subject to

29  regulation under this chapter; and

30         b.  The affiliated group makes available to the

31  department on request all records related to the purchase or

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 1  acquisition of prescription drugs by members of the affiliated

 2  group, regardless of the location where the records are

 3  stored, if the prescription drugs were distributed in or into

 4  this state.

 5         3.  If a repackager repackages prescription drugs

 6  solely for distribution to its affiliated group members for

 7  the exclusive distribution to and among retail pharmacies that

 8  are members of the affiliated group to which the repackager is

 9  a member:

10         a.  The repackager must:

11         (I)  In lieu of the written statement required by

12  paragraph (d) or paragraph (e), for all repackaged

13  prescription drugs distributed in or into this state, state in

14  writing under oath with each distribution of a repackaged

15  prescription drug to an affiliated group member warehouse or

16  repackager: "All repackaged prescription drugs are purchased

17  by the affiliated group directly from the manufacturer or from

18  a prescription drug wholesaler that purchased the prescription

19  drugs directly from the manufacturer.";

20         (II)  Purchase all prescription drugs it repackages:

21         (A)  Directly from the manufacturer; or

22         (B)  From a prescription drug wholesaler that purchased

23  the prescription drugs directly from the manufacturer; and

24         (III)  Maintain records in accordance with this section

25  to document that it purchased the prescription drugs directly

26  from the manufacturer or that its prescription drug wholesale

27  supplier purchased the prescription drugs directly from the

28  manufacturer.

29         b.  All members of the affiliated group must provide to

30  agents of the department on request records of purchases by

31  all members of the affiliated group of prescription drugs that

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 1  have been repackaged, regardless of the location where the

 2  records are stored or where the repackager is located.

 3         4.  This paragraph expires July 1, 2006.

 4         Section 11.  Paragraph (a) of subsection (1) of section

 5  895.02, Florida Statutes, is amended to read:

 6         895.02  Definitions.--As used in ss. 895.01-895.08, the

 7  term:

 8         (1)  "Racketeering activity" means to commit, to

 9  attempt to commit, to conspire to commit, or to solicit,

10  coerce, or intimidate another person to commit:

11         (a)  Any crime which is chargeable by indictment or

12  information under the following provisions of the Florida

13  Statutes:

14         1.  Section 210.18, relating to evasion of payment of

15  cigarette taxes.

16         2.  Section 403.727(3)(b), relating to environmental

17  control.

18         3.4.  Section 409.920, relating to Medicaid provider

19  fraud.

20         4.3.  Section 414.39, relating to public assistance

21  fraud.

22         5.  Section 440.105 or s. 440.106, relating to workers'

23  compensation.

24         6.  Section 465.0161, relating to distribution of

25  medicinal drugs without a permit as an Internet pharmacy.

26         7.6.  Sections 499.0051, 499.0052, 499.0053, 499.0054,

27  and 499.0691, relating to crimes involving contraband and

28  adulterated drugs.

29         8.7.  Part IV of chapter 501, relating to

30  telemarketing.

31  

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 1         9.8.  Chapter 517, relating to sale of securities and

 2  investor protection.

 3         10.9.  Section 550.235, s. 550.3551, or s. 550.3605,

 4  relating to dogracing and horseracing.

 5         11.10.  Chapter 550, relating to jai alai frontons.

 6         12.11.  Chapter 552, relating to the manufacture,

 7  distribution, and use of explosives.

 8         13.12.  Chapter 560, relating to money transmitters, if

 9  the violation is punishable as a felony.

10         14.13.  Chapter 562, relating to beverage law

11  enforcement.

12         15.14.  Section 624.401, relating to transacting

13  insurance without a certificate of authority, s.

14  624.437(4)(c)1., relating to operating an unauthorized

15  multiple-employer welfare arrangement, or s. 626.902(1)(b),

16  relating to representing or aiding an unauthorized insurer.

17         16.15.  Section 655.50, relating to reports of currency

18  transactions, when such violation is punishable as a felony.

19         17.16.  Chapter 687, relating to interest and usurious

20  practices.

21         18.17.  Section 721.08, s. 721.09, or s. 721.13,

22  relating to real estate timeshare plans.

23         19.18.  Chapter 782, relating to homicide.

24         20.19.  Chapter 784, relating to assault and battery.

25         21.20.  Chapter 787, relating to kidnapping.

26         22.21.  Chapter 790, relating to weapons and firearms.

27         23.22.  Section 796.03, s. 796.04, s. 796.05, or s.

28  796.07, relating to prostitution.

29         24.23.  Chapter 806, relating to arson.

30         25.24.  Section 810.02(2)(c), relating to specified

31  burglary of a dwelling or structure.

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 1         26.25.  Chapter 812, relating to theft, robbery, and

 2  related crimes.

 3         27.26.  Chapter 815, relating to computer-related

 4  crimes.

 5         28.27.  Chapter 817, relating to fraudulent practices,

 6  false pretenses, fraud generally, and credit card crimes.

 7         29.28.  Chapter 825, relating to abuse, neglect, or

 8  exploitation of an elderly person or disabled adult.

 9         30.29.  Section 827.071, relating to commercial sexual

10  exploitation of children.

11         31.30.  Chapter 831, relating to forgery and

12  counterfeiting.

13         32.31.  Chapter 832, relating to issuance of worthless

14  checks and drafts.

15         33.32.  Section 836.05, relating to extortion.

16         34.33.  Chapter 837, relating to perjury.

17         35.34.  Chapter 838, relating to bribery and misuse of

18  public office.

19         36.35.  Chapter 843, relating to obstruction of

20  justice.

21         37.36.  Section 847.011, s. 847.012, s. 847.013, s.

22  847.06, or s. 847.07, relating to obscene literature and

23  profanity.

24         38.37.  Section 849.09, s. 849.14, s. 849.15, s.

25  849.23, or s. 849.25, relating to gambling.

26         39.38.  Chapter 874, relating to criminal street gangs.

27         40.39.  Chapter 893, relating to drug abuse prevention

28  and control.

29         41.40.  Chapter 896, relating to offenses related to

30  financial transactions.

31  

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 1         42.41.  Sections 914.22 and 914.23, relating to

 2  tampering with a witness, victim, or informant, and

 3  retaliation against a witness, victim, or informant.

 4         43.42.  Sections 918.12 and 918.13, relating to

 5  tampering with jurors and evidence.

 6         Section 12.  The sum of $590,051 is appropriated from

 7  the Medical Quality Assurance Trust Fund to the Department of

 8  Health, and nine full-time equivalent positions are

 9  authorized, for the 2004-2005 fiscal year for the purpose of

10  implementing this act.

11         Section 13.  This act shall take effect July 1, 2004.

12  

13          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
14                   CS for CS for CS for SB 1372

15                                 

16  Clarifies the current language in the bill related to record
    keeping procedures by drug wholesalers.
17  

18  

19  

20  

21  

22  

23  

24  

25  

26  

27  

28  

29  

30  

31  

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