Fla. Admin. Code Ann. R. 64B8-8.011 - Notice of Noncompliance

Current through Reg. 47, No. 249; December 28, 2021

(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

Fla. Admin. Code Ann. R. 64B8-8.011

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, Amended by Florida Register Volume 44, Number 158, August 14, 2018 effective 8-28-18, Amended by Florida Register Volume 45, Number 230, November 26, 2019 effective 12-12-19.

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