64B18-14.009. Minor Violations; Notices of Compliance

(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. History–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.