Dr. C's MPJE: Ch.6 Disciplinary Actions and Procedures, and miscellaneous laws and rules

Duly authorized agents and employees of the department may inspect in a lawful manner at al reasonable hours any pharmacy, hospital, clinic, wholesale establishment, manufacturer, physician's office, or any other place in the state in which drugs and medical supplies are compounded, man- ufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for the purpose of:

(1) Determining if any provision of this chapter or any rule adopted under its authority is being violated; (2) Securing samples or specimens of any drug or medical supply after paying or offering to pay for such sample or specimen; or (3) Securing such other evidence as may be needed for prosecution under this chapter.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Failing to notify the Board in writing within ____ days of the commencement or cessation of practice when such commencement or cessation of practice was a result of a pending or completed disciplinary action or investigation in another jurisdiction.

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Grounds for Denial of a License or Disciplinary Action (§ 465.016) Being unfit or incompetent to practice pharmacy by reason of:

A. Habitual intoxication; b. Misuse or abuse of any controlled substance; C. Abnormal physical or mental condition which threatens the public safety.

If a pharmacy permit is revoked or suspended, the owner, manager, or proprietor shall cease to operate the establishment as a pharmacy as of the effective date of such suspension or revocation.

A. In the event of such revocation or suspension, theowner, manager, or proprietor shall remove from the premises al signs and symbols identifying the premises as a pharmacy, b. The period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed 1 year. c. In the event that the permit is revoked, the person owning or operating the establishment shall not beentitled to make application for a permit to operate a pharmacy for aperiod of 1year from the date of such revocation. d. Upon the effective date of such revocation, the permittee shall advise the Board of Pharmacy of the disposition of the medicinal drugs located on the premises. Such dis- position shall be subject to continuing supervision and approval by the Board of Pharmacy.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Compounding, dispensing, or distributing legend drugs or ___ other than in the course of the profes- sional practice of pharmacy.

CS

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Being unable to practice pharmacy with reasonable skill and safety by reason of illness, use of drugs, narcotics, chemicals, or any other type of material or as a result of any mental or physical condition.

Despite these provisions, many cases of impairment due to alco hol, drugs, or mental or physical issues do not result indiscipline. Florida has an impaired practitionerprogram called theProfessionals Resource Network (PRN). A pharmacist with animpairment who voluntarily enters Into a contract for treatment with PRN will not be referred t o the Board for discipline as long as they acknowledge theimpairment and successfully complete the program. The Board may also refer pharmacists to the PRN program fi they receive a complaint regarding impairment under certal circumstances. For more Information, see www.fipm.org

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Using, in the compounding or dispensing of a prescrip- tion, an ingredient or article ___ in any matter from the ingredient or article prescribed (except as authorized for generic substitution or a formulary system).

Different

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Making or filing a report or record known to be ___, intentionally or negligently failing to file a report or record required by state or federal law, or willfully impeding or obstructing such filing or inducing another person to do so.

False

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Violating the FFDCA or FCSA

Federal Food, Drug, and Cosmetic Act or Fed- eral Controlled Substances Act.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Violating a rule of the Board or Department or violating an order previously entered in a disciplinary ____.

Hearing

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Having been disciplined by a regulatory authority in another state for any offense that would be a violation of the ___ act.

Pharmacy

Grounds for Denial of a License or Disciplinary Action (§ 465.016) ____ or attempting to _____ license for another person.

Procuring

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Committing an error or omission during theperformance of aspecific function ofprescription drug processing, which includes, for purposes of this paragraph:

Receiving, interpreting, or clarifying a prescription. b. Entering prescription data into the pharmacy's record. c. Verifying or validating a prescription. d. Performing pharmaceutical calculations. e. Performing prospective drug review as defined by the Board. Obtaining refill and substitution authorizations. g. Interpreting or acting on clinical data. h. Performing therapeutic interventions. .i Providing drug information concerning a patient's prescription. j. Providing patient counseling.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Failing to make prescription fee or price information readily available upon ______.

Request

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Placing in the stock of any pharmacy any part of a prescrip- tion that has been returned by a patient (exception for __.).

Unit-dose medication in hospitals, nursing homes, etc

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Using or releasing apatient's records except as __

authorized.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Failing to report to the Department a physician who the pharmacist knows has violated the grounds for disciplinary action set out in the law under which that person is licensed and who provides healthcare services in a facility licensed under Chapter 395 (hospitals and otherlicensed facilities) or aHealth Maintenance Organization (HMO) in which the pharmacist also provides service. However, a person who the licensee knows is unable to practice medicine or osteopathic medicine with reasonable skill and safety to patients by rea- son of illness or use of alcohol, drugs, narcotics, chemicals, or any other type of material, or as a result of a mental or physical condition, may be reported to a consultant operating an____ rather than to the Department.

impaired practitioner (PRN) program While this rule only discusses reporting of impaired physicians that work in the same facilities as a pharmacist, it is recommended that a pharmacist refer any impaired coworker to the Florida Professionals Recovery Net- work (PRN).

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Obtaining license by ____ or _____ through an error of the Board or Department.

misrepresentation or fraud

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Having been convicted or found guilty, regardless of adjudication, of a crime which directly relates to the ability to ___. A plea of nolo contendere (no contest) constitutes a conviction for purposes of this section

practice pharmacy.

Duly authorized agents and employees of the department may inspect a registered nonresident pharmacy or a registered nonresident sterile compounding permittee. The costs of such inspections shall be borne by ?

such pharmacy or permittee.

Grounds for Denial of a License or Disciplinary Action (§ 465.016) Permitting person not licensed as a pharmacist in this state or not registered as an intern in this state, or a registered intern who is not acting under the direct and immediate supervision of a licensed pharmacist ___ in a pharmacy owned or operated by such pharmacist or in a pharmacy where such pharmacist is employed or on duty.

to fill, compound, or dispense any prescription