Bill Text: FL S0662 | 2014 | Regular Session | Comm Sub

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-Comm_Sub.html

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       Florida Senate - 2014                              CS for SB 662
       
       
        
       By the Committees on Regulated Industries; and Health Policy
       
       
       
       
       
       580-02555-14                                           2014662c1
    1                        A bill to be entitled                      
    2         An act relating to nonresident sterile compounding
    3         permits; amending s. 465.003, F.S.; defining the terms
    4         “compounding” and “outsourcing facility”; amending s.
    5         465.0156, F.S.; conforming provisions to changes made
    6         by the act; expanding penalties to apply to injury to
    7         a nonhuman animal; deleting a requirement that the
    8         Board of Pharmacy refer regulatory issues affecting a
    9         nonresident pharmacy to the state where the pharmacy
   10         is located; creating s. 465.0158, F.S.; requiring
   11         registered nonresident pharmacies and outsourcing
   12         facilities to obtain a permit in order to ship, mail,
   13         deliver, or dispense compounded sterile products into
   14         this state; requiring submission of an application and
   15         a nonrefundable fee; specifying requirements;
   16         authorizing the board to deny, revoke, or suspend a
   17         permit, or impose a fine or reprimand for certain
   18         actions; providing dates by which certain nonresident
   19         pharmacies must obtain a permit; authorizing the board
   20         to adopt rules; amending s. 465.017, F.S.; authorizing
   21         the department to inspect nonresident pharmacies and
   22         nonresident sterile compounding permittees; requiring
   23         such pharmacies and permittees to pay for the costs of
   24         such inspections; providing an effective date.
   25          
   26  Be It Enacted by the Legislature of the State of Florida:
   27  
   28         Section 1. Subsections (18) and (19) are added to section
   29  465.003, Florida Statutes, to read:
   30         465.003 Definitions.—As used in this chapter, the term:
   31         (18) “Compounding” means a practice in which a licensed
   32  pharmacist or, in the case of an outsourcing facility, a person
   33  acting under the supervision of a licensed pharmacist, combines,
   34  mixes, or alters ingredients of a drug or product to create
   35  another drug or product.
   36         (19) “Outsourcing facility” means a single physical
   37  location registered as an outsourcing facility under the federal
   38  Drug Quality and Security Act, Pub. L. No. 113-54, at which
   39  sterile compounding of a product is conducted.
   40         Section 2. Subsections (4) and (5) of section 465.0156,
   41  Florida Statutes, are amended, present subsections (6) through
   42  (8) of that section are redesignated as subsections (7) through
   43  (9), respectively, and a new subsection (6) is added to that
   44  section, to read:
   45         465.0156 Registration of nonresident pharmacies.—
   46         (4) The board may deny, revoke, or suspend registration of,
   47  or fine or reprimand, a nonresident pharmacy for failure to
   48  comply with s. 465.0158, s. 465.017(2), or s. 465.025, or with
   49  any requirement of this section in accordance with the
   50  provisions of this chapter.
   51         (5) In addition to the prohibitions of subsection (4) the
   52  board may deny, revoke, or suspend registration of, or fine or
   53  reprimand, a nonresident pharmacy in accordance with the
   54  provisions of this chapter for conduct which causes or could
   55  cause serious bodily injury or serious psychological injury to a
   56  human or serious bodily injury to a nonhuman animal in resident
   57  of this state if the board has referred the matter to the
   58  regulatory or licensing agency in the state in which the
   59  pharmacy is located and the regulatory or licensing agency fails
   60  to investigate within 180 days of the referral.
   61         (6) A nonresident pharmacy is subject to s. 456.0635.
   62         Section 3. Section 465.0158, Florida Statutes, is created
   63  to read:
   64         465.0158 Nonresident sterile compounding permit.—
   65         (1) In order to ship, mail, deliver, or dispense, in any
   66  manner, a compounded sterile product into this state, a
   67  nonresident pharmacy registered under s. 465.0156, or an
   68  outsourcing facility, must hold a nonresident sterile
   69  compounding permit.
   70         (2) An application for a nonresident sterile compounding
   71  permit shall be submitted on a form furnished by the board. The
   72  board may require such information as it deems reasonably
   73  necessary to carry out the purposes of this section. The fee for
   74  an initial permit and biennial renewal of the permit shall be
   75  set by the board pursuant to s. 465.022(14).
   76         (3) An applicant must submit the following to the board to
   77  obtain an initial permit, or to the department to renew a
   78  permit:
   79         (a) Proof of registration as an outsourcing facility with
   80  the Secretary of the United States Department of Health and
   81  Human Services if the applicant is eligible for such
   82  registration pursuant to the federal Drug Quality and Security
   83  Act, Pub. L. No. 113-54.
   84         (b) Proof of registration as a nonresident pharmacy,
   85  pursuant to s. 465.0156, unless the applicant is an outsourcing
   86  facility and not a pharmacy, in which case the application must
   87  include proof of an active and unencumbered license, permit, or
   88  registration issued by the state, territory, or district in
   89  which the outsourcing facility is physically located which
   90  allows the outsourcing facility to engage in compounding and to
   91  ship, mail, deliver, or dispense a compounded sterile product
   92  into this state if required by the state, territory, or district
   93  in which the outsourcing facility is physically located.
   94         (c) Written attestation by an owner or officer of the
   95  applicant, and by the applicant’s prescription department
   96  manager or pharmacist in charge, that:
   97         1. The applicant has read and understands the laws and
   98  rules governing sterile compounding in this state.
   99         2. A compounded sterile product shipped, mailed, delivered,
  100  or dispensed into this state meets or exceeds this state’s
  101  standards for sterile compounding.
  102         3. A compounded sterile product shipped, mailed, delivered,
  103  or dispensed into this state must not have been, and may not be,
  104  compounded in violation of the laws and rules of the state in
  105  which the applicant is located.
  106         (d) The applicant’s existing policies and procedures for
  107  sterile compounding, which must comply with pharmaceutical
  108  standards in chapter 797 of the United States Pharmacopoeia and
  109  any standards for sterile compounding required by board rule or
  110  current good manufacturing practices for an outsourcing
  111  facility.
  112         (e) A current inspection report from an inspection
  113  conducted by the regulatory or licensing agency of the state,
  114  territory, or district in which the applicant is located. The
  115  inspection report must reflect compliance with this section. An
  116  inspection report is current if the inspection was conducted
  117  within 6 months before the date of submitting the application
  118  for the initial permit or within 1 year before the date of
  119  submitting an application for permit renewal. If the applicant
  120  is unable to submit a current inspection report conducted by the
  121  regulatory or licensing agency of the state, territory, or
  122  district in which the applicant is located due to acceptable
  123  circumstances, as established by rule, the department shall:
  124         1. Conduct, or contract with an entity approved by the
  125  board to conduct, an onsite inspection for which all costs shall
  126  be borne by the applicant;
  127         2. Accept a current and satisfactory inspection report, as
  128  determined by rule, from an entity approved by the board; or
  129         3. Accept a current inspection report from the United
  130  States Food and Drug Administration conducted pursuant to the
  131  federal Drug Quality and Security Act, Pub. L. No. 113-54.
  132         (4) A permittee may not ship, mail, deliver, or dispense a
  133  compounded sterile product into this state if the product was
  134  compounded in violation of the laws or rules of the state in
  135  which the permittee is located or does not meet or exceed this
  136  state’s sterile compounding standards.
  137         (5) In accordance with this chapter, the board may deny,
  138  revoke, or suspend the permit of, fine, or reprimand a permittee
  139  for:
  140         (a) Failure to comply with this section;
  141         (b) A violation listed under s. 456.0635, s. 456.065, or s.
  142  456.072, except s. 456.072(1)(s) or (1)(u);
  143         (c) A violation under s. 465.0156(5); or
  144         (d) A violation listed under s. 465.016.
  145         (6) A nonresident pharmacy registered under s. 465.0156
  146  which ships, mails, delivers, or dispenses a compounded sterile
  147  product into this state may continue to do so if the product
  148  meets or exceeds the standards for sterile compounding in this
  149  state, the product is not compounded in violation of any law or
  150  rule of the state where the pharmacy is located, and the
  151  pharmacy applies for and is issued a permit under this section
  152  on or before February 28, 2015.
  153         (7) An applicant registering on or after October 1, 2014,
  154  as a nonresident pharmacy under s. 465.0156 may not ship, mail,
  155  deliver, or dispense a compounded sterile product into this
  156  state until the applicant is registered as a nonresident
  157  pharmacy and is issued a permit under this section.
  158         (8) The board shall adopt rules as necessary to administer
  159  this section, including rules for:
  160         (a) Submitting an application for the permit required by
  161  this section.
  162         (b) Determining how, when, and under what circumstances an
  163  inspection of a nonresident sterile compounding permittee must
  164  be conducted.
  165         (c) Evaluating and approving entities from which a
  166  satisfactory inspection report will be accepted in lieu of an
  167  onsite inspection by the department or an inspection by the
  168  licensing or regulatory agency of the state, territory, or
  169  district where the applicant is located.
  170         Section 4. Section 465.017, Florida Statutes, is amended to
  171  read:
  172         465.017 Authority to inspect; disposal.—
  173         (1) Duly authorized agents and employees of the department
  174  may shall have the power to inspect in a lawful manner at all
  175  reasonable hours any pharmacy, hospital, clinic, wholesale
  176  establishment, manufacturer, physician’s office, or any other
  177  place in the state in which drugs and medical supplies are
  178  compounded, manufactured, packed, packaged, made, stored, sold,
  179  offered for sale, exposed for sale, or kept for sale for the
  180  purpose of:
  181         (a) Determining if any provision of the provisions of this
  182  chapter or any rule adopted promulgated under its authority is
  183  being violated;
  184         (b) Securing samples or specimens of any drug or medical
  185  supply after paying or offering to pay for such sample or
  186  specimen; or
  187         (c) Securing such other evidence as may be needed for
  188  prosecution under this chapter.
  189         (2) Duly authorized agents and employees of the department
  190  may inspect a nonresident pharmacy registered under s. 465.0156
  191  or a nonresident sterile compounding permittee under s. 465.0158
  192  pursuant to this section. The costs of such inspections shall be
  193  borne by such pharmacy or permittee.
  194         (3)(2)(a) Except as permitted by this chapter, and chapters
  195  406, 409, 456, 499, and 893, records maintained in a pharmacy
  196  relating to the filling of prescriptions and the dispensing of
  197  medicinal drugs may shall not be furnished only to any person
  198  other than to the patient for whom the drugs were dispensed, or
  199  her or his legal representative, or to the department pursuant
  200  to existing law, or, if in the event that the patient is
  201  incapacitated or unable to request such said records, her or his
  202  spouse except upon the written authorization of such patient.
  203         (a) Such records may be furnished in any civil or criminal
  204  proceeding, upon the issuance of a subpoena from a court of
  205  competent jurisdiction and proper notice to the patient or her
  206  or his legal representative by the party seeking such records.
  207         (b) The board shall adopt rules establishing to establish
  208  practice guidelines for pharmacies to dispose of records
  209  maintained in a pharmacy relating to the filling of
  210  prescriptions and the dispensing of medicinal drugs. Such rules
  211  must shall be consistent with the duty to preserve the
  212  confidentiality of such records in accordance with applicable
  213  state and federal law.
  214         Section 5. This act shall take effect October 1, 2014.