Current through Reg. 50, No. 187; September 24, 2024
(1) Section
456.073(3),
F.S., authorizes the Board, when enforcing rules and statutes, to permit the
Department to issue a notice of noncompliance for any initial offense which is
a minor violation as defined by Board rule. A minor violation under this
statute is defined as one which does not endanger public health, safety, or
welfare and does not demonstrate a serious inability to practice.
(2) Section
120.695, F.S., authorizes the
Board, when enforcing rules, to permit the Department to issue a notice of
noncompliance when there is a first time offense that is a minor violation as
defined by Board rule. A minor violation is defined as one in which there is no
economic or physical harm; no adverse effect to the public health, safety, or
welfare; and no significant threat of such harm.
(3) A notice of noncompliance in lieu of
other actions 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
violation under the other provisions of Section
456.073, F.S. There is only one
exception to the prohibition against use of a notice of noncompliance when
there is more than one violation. 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 subsection (4), paragraphs (k), (l), (m), and (n), if
there is not evidence of diversion.
(4) The Board hereby establishes the
following as minor violations which the Department may act upon by issuing
notices of noncompliance for an initial offense:
(a) Advertising violations encompassed by
Rule 64B18-14.004, F.A.C.;
(b) Patient records deficiencies encompassed
by Sections 456.057(1) and
461.013(1)(m),
F.S.;
(c) Failure to provide the
disclaimer required by Section
456.062, F.S.;
(d) 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.
(e)
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.
(f) Failure of a
certified x-ray assistant to notify the supervising podiatric physician(s) of
any changes to their certification status prior to continuing to perform the
duties of a certified podiatric x-ray assistant, contrary to Rule
64B18-24.003, F.A.C.
(g) For a practitioner who is not required to
register as a dispensing practitioner, failing to dispense drugs in the
manufacturer's labeled packaged 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.
(h) Failing to properly store medications
which require refrigeration, contrary to Rule
64B16-28.102(3),
F.A.C. Sink and Running Water, Sufficient Space, Refrigeration, Sanitation,
Equipment, effective 5-4-05, incorporated herein and available at
https://www.flrules.org/gateway/RuleNo.asp?title=GENERAL%20REQUIREMENTS%20-%20PERMITS&ID=64B16-28.102,
and
http://www.flrules.org/Gateway/reference.asp?No=Ref-11508.
(i) Failing to remove outdated medications
from stock, contrary to Rule
64B16-28.110, F.A.C., Outdated
Pharmaceuticals, effective 4-4-19, incorporated herein and available at
https://www.flrules.org/gateway/RuleNo.asp?title=GENERAL%20REQUIREMENTS%20-%20PERMITS&ID=64B16-28.110,
and
http://www.flrules.org/Gateway/reference.asp?No=Ref-11509.
(j) Failing to have proper labeling on all
stock medications, contrary to Section
499.007, F.S.
(k) Failing to post the generic drug sign,
contrary to Section 465.025(7),
F.S. This applies to dispensing practitioners only.
(l) 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.
(m) 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.
(n) 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.
(o) 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, Maintenance of Records and
Inventories, effective 9-9-14, incorporated herein and available at
https://www.govinfo.gov/content/pkg/CFR-2019-title21-vol9/pdf/CFR-2019-title21-vol9-sec1304-04.pdf,
and
http://www.flrules.org/Gateway/reference.asp?No=Ref-11507.
(p) Failing to dispense medication in a
childproof container, contrary to
16 C.F.R. §
1700.14(a)(10), Substances
Requiring Special Packaging, effective 8-7-73, incorporated herein and
available at
https://www.govinfo.gov/content/pkg/CFR-2019-title16-vol2/pdf/CFR-2019-title16-vo12-sec1700-14.pdf
and
http://www.flrules.org/Gateway/reference.asp?No=Ref-11506.
(5) Failure of the licensee to take action in
correcting the violation within 15 days after notice shall result in the
institution of regular disciplinary proceedings. Failure of the licensee to
comply with the notice of noncompliance within the time allowed or subsequent
violations of a same or similar offense shall result in the issuance of a
citation pursuant to Rule
64B18-14.010, F.A.C., or, if the
citation is declined or if there is no citation available for the specific
violation, shall result in the institution of the regular disciplinary process
set forth in Section 456.073,
F.S.
Rulemaking Authority 456.072(3), 456.073, 461.005 FS. Law
Implemented 120.695, 456.073 FS.
New 4-1-91, Formerly 21T-14.009, 61F12-14.009, Amended
2-25-96, 6-17-97, Formerly 59Z-14.009, Amended 8-8-99, 10-7-07,
2-17-20.
