Fla. Admin. Code Ann. R. 64B8-8.011 - Notice of Noncompliance
(1) Pursuant to
Section 456.073(3),
F.S., the Department is authorized to provide a notice of noncompliance for an
initial offense of a minor violation if the board establishes by rule a list of
minor violations. A minor violation is one which does not endanger the public
health, safety, and welfare and which does not demonstrate a serious inability
to practice the profession. A notice of noncompliance in lieu of other action
is authorized only if the violation is not a repeat violation and only if there
is only one violation. If there are multiple violations, then the Department
may not issue a notice of noncompliance, but must prosecute the violations
under the other provisions of Section
456.073, F.S. There are only two
exceptions to the prohibition against use of a notice of noncompliance when
there is more than one violation. The first is that a notice of noncompliance
may be issued to a registered dispensing practitioner for a first time
violation of one or more of the violations listed in paragraph (3)(b),
subparagraphs 4., 5., 10., 11., 12., 13., and 14., if there is not evidence of
diversion. The second is that a notice of noncompliance may be issued to a
licensee for a first time violation of one or both of the violations listed in
paragraph (3)(c). Failure of a licensee to take action in correcting the
violation within 15 days after notice may result in the institution of regular
disciplinary proceedings.
(2) The
Department shall submit to the board a monthly report detailing the number of
notices given, the number of cases completed through receipt of a notarized
statement of compliance from the licensee, and the types of violations for
which notices of noncompliance have been issued. Notices of noncompliance shall
be considered by the probable cause panels when reviewing a licensee's
subsequent violations of a same or similar offense.
(3) The following violations are those for
which the board authorizes the Department to issue a notice of noncompliance.
(a) Advertising offenses specified herein.
1. Section
458.331(1)(d),
F.S., which provides for physician discipline when the physician is found
guilty of false, deceptive, or misleading advertising. The only type of false,
deceptive, or misleading advertising which would be resolved by a notice of
noncompliance would be advertising which is false, deceptive, or misleading
because it fails to list the name of the physician conspicuously in the
advertisement contrary to subsection
64B8-11.001(2),
F.A.C. This would also be a violation of Section
458.331(1)(nn),
F.S., which provides for physician discipline when a physician is found guilty
of, among other things, violating a rule of the board.
2. Section
458.331(1)(g),
F.S., which provides for physician discipline when the physician is found
guilty of failing to perform a statutory or legal obligation placed upon a
licensed physician. The specific statutory obligation related to advertising,
which, if not performed might merit the issuance of a notice of noncompliance,
would be a failure to perform the statutory obligation set forth in Section
456.062, F.S., provides that a
specific disclosure statement must appear in any advertisement for a free,
discounted fee, or reduced fee service, examination or treatment by a health
care practitioner licensed pursuant to Chapter 458, F.S.
(b) Failure to perform one of the following
statutory or legal obligations:
1. Section
382.008, F.S., which provides
that within 72 hours after receipt of a death or fetal death certificate from a
funeral director, the medical certification shall be completed, signed, and
made available to the funeral director by the physician in charge of the
decedent's care for the illness or condition which resulted in the death, or
the physician in attendance at the time of death or fetal death or immediately
before or after such death or fetal death, who shall certify over his signature
the cause of death to his best knowledge and belief.
2. Section
893.02, F.S., which provides
that a prescription order for a controlled substance shall not be issued on the
same prescription blank with another prescription order for a controlled
substance which is named or described in a different schedule, nor shall any
prescription order for a controlled substance be issued on the same
prescription blank as a prescription order for a medicinal drug, as defined in
Section 465.003(7),
F.S., which does not fall within the definition of a controlled substance as
defined in Chapter 893, F.S.
3.
Failing to maintain records relating to the receipt and disposition of
controlled substances, and the required biennial inventory, as provided for in
Section 893.07, F.S. This violation may
be resolved by a notice of noncompliance only if the whereabouts of the drugs
can be accounted for by other means and there is no evidence of
diversion.
4. Failing to, before
dispensing any drug, give the patient a written prescription and orally or in
writing advise the patient that the prescription may be filled in the
practitioner's office or at any pharmacy, in violation of Section
465.0276(2)(c),
F.S. This applies to dispensing practitioners only.
5. Dispensing medication without proper
labeling, contrary to the provisions of Section
893.05(2),
F.S., and Rule 64B16-28.108, F.A.C. This
applies to dispensing practitioners only.
6. For a physician who is not required to
register as a dispensing practitioner, failing to dispense drugs in the
manufacturer's labeled package with the practitioner's name, patient's name,
and the date dispensed or, if such drugs are not dispensed in the
manufacturer's labeled package, failing to dispense the medication in a
container which bears the following information: practitioner's name; patient's
name; date dispensed; name and strength of the drug; and directions for use,
contrary to Section 465.0276, F.S.
7. Failing to properly store medications
which require refrigeration, contrary to Rule 64B16-28.104, F.A.C.
8. Failing to remove outdated medications
from stock, contrary to Rule
64B16-28.110, F.A.C.
9. Failing to have proper labeling on all
stock medications, contrary to Section
499.007(2),
F.S.
10. Failing to post the
generic drug sign, contrary to Section
465.025(7),
F.S. This applies to dispensing practitioners only.
11. Failing to initial and date all
controlled substances dispensed and all refills thereof, contrary to Section
893.04(1)(c)6., F.S. This applies to dispensing practitioners only.
12. Filling controlled substance
prescriptions which do not have the patient's address on them, contrary to
Section 893.04(1)(c)1., F.S. This applies to dispensing practitioners
only.
13. Filling controlled
substance prescriptions which do not have the practitioner's DEA number on
them, contrary to Section 893.04(1)(c)2., F.S. This applies to dispensing
practitioners only.
14. Using a
computer system, but failing to maintain a daily hard copy printout of
controlled substances initialed and dated by the practitioner and failing to
assure that the computer information is readily retrievable, contrary to
subsection 64B16-28.119(5), F.A.C. This applies to dispensing practitioners
only.
15. Failing to maintain
records relating to controlled substances in a readily retrievable form,
contrary to Section 893.07(4),
F.S., and 21 C.F.R.
1304.04.
16. Failing to dispense medication in a
childproof container, contrary to 16 C.F.R. 1700.14a(10).
17. First occurance of failing to comply with
the provisions of Sections
381.026 and
381.0261, F.S., to provide
patients with information about their patient rights and how to file a patient
complaint.
18. First occurrence of
failing to comply with the provisions of Section
456.0575, F.S., to notify the
patient or an individual identified pursuant to Section
765.401(1),
F.S., in person about adverse incidents that result in serious harm to the
patient, for the practitioner(s) who was not responsible for the adverse
incident.
19. Failure to comply
with the provisions of Section
456.44(7)(c),
F.S., to inform the patient of nonopioid alternatives for the treatment of
pain, to discuss the advantages and disadvantages of the use of nonopioid
alternatives, to provide the Department's educational pamphlet, or to document
the nonopioid alternatives in the patient's record.
(c) Violating any of the following provisions
of Chapter 458, F.S., as prohibited by Section
458.331(1)(nn),
F.S.:
1. Section
458.327, F.S., which provides
for criminal penalties for the practice of medicine without an active license.
A notice of noncompliance would be issued for this violation only if the
subject of the investigation met the following criteria: the subject must be
the holder of a license to practice medicine at all time material to the
matter; that license is otherwise in good standing; and that license must be
renewed and placed in an active status within 90 days of becoming delinquent.
If the license was delinquent for more than 90 days and the individual
continued to practice, then the matter would proceed under the other provisions
of Section 456.073, F.S.
2. Failing to notify the board of a change of
practice location, contrary to Section
458.319(5),
F.S.
(d) Violation of the
following medical director clinic responsibilities, as set forth in subsections
456.0375(2) and
(3), F.S.:
1. Failure to file or renew clinic
registration form.
2. Failure to
display clinic registration certificate.
3. Failure to post signs identifying
medical/clinical director in a conspicuous location.
4. Failure to ensure compliance with adverse
incident reporting requirements.
(e) Failure to complete the requirement for
instruction on domestic violence in the appropriate biennium as required by
Section 456.031, F.S. A notice of
noncompliance would be issued for this violation only if the licensee completed
the domestic violence course, but completion of said course was not during the
appropriate biennial renewal period.
(f) Failing to submit documentation to the
Department within 14 days of issuing a certification as required under Section
381.986(4)(b),
F.S.
Notes
Rulemaking Authority 456.073(3), 458.309 FS. Law Implemented 456.073(3), 456.0575 FS.
New 11-15-90, Formerly 21M-20.011, 61F6-20.011, 59R-8.011, Amended 1-27-00, 1-8-02, 1-12-03, 6-7-04, 8-26-09, 8-28-18, 12-12-19.
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