Florida Regulations 64B16-30.002: Minor Violations
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(1) The Board sets forth the following guidelines for use by Department investigators when a licensee is in noncompliance of an initial offense of a minor violation. The Board deems the following violations, depending upon severity, to be consistent with Florida Statutes § 456.073(3)
(a) Outdated pharmaceuticals – Fl. Admin. Code R. 64B16-28.110
(b) Failure to meet regulation of daily operating hours – Fl. Admin. Code R. 64B16-28.404
(c) Generic substitution sign not displayed – Florida Statutes § 465.025(7)
(d) Information required on controlled substance prescriptions: practitioner’s address, practitioner’s DEA registration number, patient’s address – Florida Statutes § 893.04
(e) Failure to have certified by dispensing pharmacists the daily hard-copy printout or daily log – paragraph 64B16-28.140(3)(c) or (e), F.A.C.
(f) Failure to have pharmacy minimally equipped i.e. references, compounding equipment, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida – Fl. Admin. Code R. 64B16-28.107
(g) Failure to properly identify pharmacy technicians – Fl. Admin. Code R. 64B16-27.410
(h) Results of P&E quality assurance program not documented or available for inspection – Fl. Admin. Code R. 64B16-28.820(3)(d)
(i) Improper storage of legend drugs – Fl. Admin. Code R. 64B16-28.120
(j) Improper documentation of destruction of controlled substances – rules 64B16-28.301, 64B16-28.303, F.A.C.
(k) Consultant pharmacist’s monthly reports not current or available for inspection – rule 64B16-28.501, subsection 64B16-28.702(2), F.A.C.
(l) Controlled substance prescription labels lack transfer crime warning labeling – Fl. Admin. Code R. 64B16-28.502(2)(c)
(m) Failure to maintain proof of licensure, display licenses/registrations or notices, or to properly identify pharmacy staff – Fl. Admin. Code R. 64B16-27.100
(n) Failure to have a continuously designated Prescription Department Manager or Consultant Pharamcist of Record, if the gap between designations is less than fifteen (15) business days – rules 64B16-27.450 and 64B16-28.501, F.A.C.
(2) The Department’s investigator may issue a Notice of Deficiencies when the above conditions occur and the requirements of Florida Statutes § 456.073(3), are met. In such cases licensees shall correct the violation and respond to the investigator on forms provided by the Department and with other evidence of compliance as may be necessary, within 30 days, to certify current compliance. Failure to do so shall subject the licensee to further proceedings.
Rulemaking Authority 456.073(3), 465.005 FS. Law Implemented 456.073(3) FS. History-New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002, Amended 12-9-98, 8-26-02, 11-7-17, 7-11-18.
Terms Used In Florida Regulations 64B16-30.002
- Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
(b) Failure to meet regulation of daily operating hours – Fl. Admin. Code R. 64B16-28.404
(c) Generic substitution sign not displayed – Florida Statutes § 465.025(7)
(d) Information required on controlled substance prescriptions: practitioner’s address, practitioner’s DEA registration number, patient’s address – Florida Statutes § 893.04
(e) Failure to have certified by dispensing pharmacists the daily hard-copy printout or daily log – paragraph 64B16-28.140(3)(c) or (e), F.A.C.
(f) Failure to have pharmacy minimally equipped i.e. references, compounding equipment, and a current copy of the laws and rules governing the practice of pharmacy in the State of Florida – Fl. Admin. Code R. 64B16-28.107
(g) Failure to properly identify pharmacy technicians – Fl. Admin. Code R. 64B16-27.410
(h) Results of P&E quality assurance program not documented or available for inspection – Fl. Admin. Code R. 64B16-28.820(3)(d)
(i) Improper storage of legend drugs – Fl. Admin. Code R. 64B16-28.120
(j) Improper documentation of destruction of controlled substances – rules 64B16-28.301, 64B16-28.303, F.A.C.
(k) Consultant pharmacist’s monthly reports not current or available for inspection – rule 64B16-28.501, subsection 64B16-28.702(2), F.A.C.
(l) Controlled substance prescription labels lack transfer crime warning labeling – Fl. Admin. Code R. 64B16-28.502(2)(c)
(m) Failure to maintain proof of licensure, display licenses/registrations or notices, or to properly identify pharmacy staff – Fl. Admin. Code R. 64B16-27.100
(n) Failure to have a continuously designated Prescription Department Manager or Consultant Pharamcist of Record, if the gap between designations is less than fifteen (15) business days – rules 64B16-27.450 and 64B16-28.501, F.A.C.
(2) The Department’s investigator may issue a Notice of Deficiencies when the above conditions occur and the requirements of Florida Statutes § 456.073(3), are met. In such cases licensees shall correct the violation and respond to the investigator on forms provided by the Department and with other evidence of compliance as may be necessary, within 30 days, to certify current compliance. Failure to do so shall subject the licensee to further proceedings.
Rulemaking Authority 456.073(3), 465.005 FS. Law Implemented 456.073(3) FS. History-New 11-12-90, Formerly 21S-17.002, 21S-30.002, 61F10-30.002, 59X-30.002, Amended 12-9-98, 8-26-02, 11-7-17, 7-11-18.