Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64B18 - Board of Podiatric Medicine › Chapter 64B18-14 - DISCIPLINARY MATTERS › Section 64B18-14.009 - Minor Violations; Notices of Compliance

Current through Reg. 50, No. 138; July 16, 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
.