Bill Text: FL S0662 | 2014 | Regular Session | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Nonresident Sterile Compounding Permits

Spectrum: Committee Bill

Status: (Introduced - Dead) 2014-04-29 - Laid on Table, companion bill(s) passed, see CS/HB 7077 (Ch. 2014-148) [S0662 Detail]

Download: Florida-2014-S0662-Introduced.html

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       Florida Senate - 2014                                     SB 662
       
       
        
       By the Committee on Health Policy
       
       
       
       
       
       588-01081-14                                           2014662__
    1                        A bill to be entitled                      
    2         An act relating to nonresident pharmacies; amending s.
    3         465.0156, F.S.; conforming provisions to changes made
    4         by the act; deleting a requirement that the Board of
    5         Pharmacy refer regulatory issues affecting a
    6         nonresident pharmacy to the state where the pharmacy
    7         is located; creating s. 465.0158, F.S.; requiring
    8         registered nonresident pharmacies to obtain a permit
    9         in order to ship, mail, deliver, or dispense
   10         compounded sterile products into this state; requiring
   11         submission of an application and a nonrefundable fee;
   12         specifying requirements; requiring the Department of
   13         Health to inform permittees of any law or rule
   14         changes; authorizing the board to deny, revoke, or
   15         suspend a permit for certain actions; providing dates
   16         by which certain registered and unregistered
   17         nonresident pharmacies must obtain a permit;
   18         authorizing the Board of Pharmacy to adopt rules;
   19         providing for future repeal; amending s. 465.017,
   20         F.S.; authorizing the department to inspect registered
   21         nonresident pharmacies; requiring nonresident
   22         pharmacies to pay for the costs of such inspections;
   23         providing an effective date.
   24          
   25  Be It Enacted by the Legislature of the State of Florida:
   26  
   27         Section 1. Subsections (4) and (5) of section 465.0156,
   28  Florida Statutes, are amended to read:
   29         465.0156 Registration of nonresident pharmacies.—
   30         (4) The board may deny, revoke, or suspend registration of,
   31  or fine or reprimand, a nonresident pharmacy for failure to
   32  comply with s. 465.025, s. 465.0158, or with any requirement of
   33  this section in accordance with the provisions of this chapter.
   34         (5) In addition to the prohibitions of subsection (4), the
   35  board may deny, revoke, or suspend registration of, or fine or
   36  reprimand, a nonresident pharmacy in accordance with the
   37  provisions of this chapter for conduct that which causes or
   38  could cause serious bodily injury or serious psychological
   39  injury to a human or animal in resident of this state if the
   40  board has referred the matter to the regulatory or licensing
   41  agency in the state in which the pharmacy is located and the
   42  regulatory or licensing agency fails to investigate within 180
   43  days of the referral.
   44         Section 2. Section 465.0158, Florida Statutes, is created
   45  to read:
   46         465.0158 Nonresident pharmacy compounded sterile products
   47  permit.—A nonresident pharmacy registered under s. 465.0156 must
   48  also hold a compounded sterile products permit issued under this
   49  section in order to ship, mail, deliver, or dispense, in any
   50  manner, a compounded sterile product into this state.
   51         (1) Application for a permit shall be submitted on a form
   52  furnished by the board, together with a nonrefundable permit fee
   53  as provided under s. 465.022(14). The board may require such
   54  information as it deems reasonably necessary to carry out the
   55  purposes of this section, including information pertaining to
   56  registration as an outsourcing facility with the Secretary of
   57  the United States Department of Health and Human Services.
   58         (2) As a condition of initial permitting and permit
   59  renewal, the owners, officers, and prescription department
   60  manager or pharmacist in charge of the nonresident pharmacy must
   61  attest in writing that they have read and understand the laws
   62  and rules governing sterile compounding in this state and that
   63  any compounded sterile product shipped, mailed, delivered, or
   64  dispensed into this state will meet or exceed this state’s
   65  standards for sterile compounding.
   66         (a) The department shall notify all compounded sterile
   67  products permittees when state laws or rules affecting the
   68  standards for sterile compounding in this state are adopted or
   69  revised, along with the effective date of the law or rule.
   70         (b) If the department fails to notify a permittee of a
   71  change in state laws or rules, or the permittee does not receive
   72  notification of applicable rules, the permittee remains legally
   73  obligated to meet or exceed this state’s standards with respect
   74  to any compounded sterile product shipped, mailed, delivered, or
   75  dispensed into this state. The board may provide an exception to
   76  this requirement by rule if the sterile compounding laws and
   77  rules of the state in which the nonresident pharmacy is located
   78  directly conflict with a board rule for sterile compounding in
   79  this state but provide a comparable standard of product safety
   80  and integrity.
   81         (3) A nonresident pharmacy may not ship, mail, deliver, or
   82  dispense any compounded sterile product into this state which:
   83         (a) Was compounded in violation of the laws and rules of
   84  the state in which the nonresident pharmacy is located; or
   85         (b) Does not meet or exceed this state’s sterile
   86  compounding standards as provided in subsection (2).
   87         (4) To the extent feasible, biennial permit renewal shall
   88  be timed to coincide with nonresident pharmacies’ registration
   89  renewal under s. 465.0156.
   90         (5) In accordance with this chapter, the board may deny,
   91  revoke, or suspend the permit of, or fine or reprimand, a
   92  nonresident pharmacy for:
   93         (a) Failure to comply with the requirements of this
   94  section; or
   95         (b) Conduct that causes or could cause serious bodily
   96  injury or serious psychological injury to a human or animal in
   97  this state.
   98         (6) A registered nonresident pharmacy that is currently
   99  shipping, mailing, delivering, or dispensing compounded sterile
  100  products into this state may continue to do so if such products
  101  meet or exceed the standards for sterile compounding in this
  102  state and the pharmacy is issued a nonresident pharmacy
  103  compounded sterile products permit on or before January 31,
  104  2015.
  105         (7) A nonresident pharmacy seeking registration in this
  106  state under s. 465.0156 on or after July 1, 2014, may not ship,
  107  mail, deliver, or dispense a compounded sterile product into
  108  this state until it has received the sterile compounded products
  109  permit required under this section.
  110         (8) The board shall adopt rules necessary to administer
  111  this section.
  112         (9) This section is repealed October 1, 2018, unless
  113  reenacted by the Legislature.
  114         Section 3. Section 465.017, Florida Statutes, is amended to
  115  read:
  116         465.017 Authority to inspect; disposal.—
  117         (1) Duly authorized agents and employees of the department
  118  may shall have the power to inspect in a lawful manner at all
  119  reasonable hours any pharmacy, including a nonresident pharmacy
  120  registered under s. 465.0156, and any, hospital, clinic,
  121  wholesale establishment, manufacturer, physician’s office, or
  122  any other place in the state in which drugs and medical supplies
  123  are manufactured, packed, packaged, made, stored, sold, offered
  124  for sale, exposed for sale, or kept for sale for the purpose of:
  125         (a) Determining if any provision of the provisions of this
  126  chapter or any rule adopted promulgated under its authority is
  127  being violated;
  128         (b) Securing samples or specimens of any drug or medical
  129  supply after paying or offering to pay for such sample or
  130  specimen; or
  131         (c) Securing such other evidence as may be needed for
  132  prosecution under this chapter.
  133         (2) The cost for inspecting a nonresident pharmacy shall be
  134  reimbursed by the pharmacy. The cost to the pharmacy is limited
  135  to the actual costs incurred by the department.
  136         (3)(2)(a) Except as permitted by this chapter, and chapters
  137  406, 409, 456, 499, and 893 or upon the written authorization of
  138  the patient, records maintained in a pharmacy relating to the
  139  filling of prescriptions and the dispensing of medicinal drugs
  140  may shall not be furnished only to any person other than to the
  141  patient for whom the drugs were dispensed, or her or his legal
  142  representative, or to the department pursuant to existing law,
  143  or if, in the event that the patient is incapacitated or unable
  144  to request such said records, her or his spouse except upon the
  145  written authorization of such patient.
  146         (a) Such records may be furnished in any civil or criminal
  147  proceeding, upon the issuance of a subpoena from a court of
  148  competent jurisdiction and proper notice to the patient or her
  149  or his legal representative by the party seeking such records.
  150         (b) The board shall adopt rules establishing to establish
  151  practice guidelines for pharmacies to dispose of records
  152  maintained in a pharmacy relating to the filling of
  153  prescriptions and the dispensing of medicinal drugs. Such rules
  154  must shall be consistent with the duty to preserve the
  155  confidentiality of such records in accordance with applicable
  156  state and federal law.
  157         Section 4. This act shall take effect July 1, 2014.