Chapter 6: Disciplinary Actions and Procedures, and Miscellaneous Laws and Rules

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. The period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed what timeframe?

1 year

*I. Disciplinary Actions and Procedures- H. Citations (Florida Statute $ 456.077 and Rule 64B16-30.003):* 1. Florida law requires each Board under the Department of Health to establish, by rule, a list of violations for which a citation may be issued. By law, how are these "Citation Violations" defined? 2. These citations may include what type of punishment? 3. Are citations considered disciplinary actions for the first offense? 4. What are 17 examples of these Citation Violations?

1. *Citation violations:* are those violations for which there is no substantial threat to the public health, safety, and welfare or no violation of standard of care involving injury to a patient. 2. A citation may include a penalty (fine) and payment of the costs of investigation. 3. No. A citation is NOT considered disciplinary action for the first offense. 4. Citation violations include: (1) Practicing pharmacy as an inactive licensee (2) Operating a pharmacy with an inactive permit (3) First-time failure to complete the required continuing education requirements during the biennial license period (4) Failure to timely pay a fine or costs incurred by a Board order (5) Failure to display any sign, license, or permit required by statute or rule (6) Failure to have any reference material required by statute or rule available (7) Failure to notify the Board of a change in prescription department manager or consultant pharmacist (8) Using, in the compounding of a prescription, or furnishing upon a prescription, any ingredient or article different in any manner from the ingredient or article prescribed or dispensing a medication with dosage form instructions different in any way than prescribed, provided that the medication was not used or ingested (9) Tendering a check payable to the Board of Pharmacy or Department of Health that is dishonored (10) Failure to comply with the educational course requirements for HIV/AIDS (11) Failure to correct minor violations (12) First-time failure to report controlled substance dispensing information to the PDMP (13) First-time failure to consult the PDMP prior to dispensing a controlled substance (14) Failure to request a photo or other verification of identity prior to dispensing a controlled substance to a person not known (15) Failure to inform customers of a less expensive drug when cost-sharing obligation to customer exceeds retail price (16) Failure to comply with pharmacist to registered pharmacy technician ratio for activities not involving sterile compounding with no injury to patient (17) Failure to remove from active stock and properly quarantine outdated prescription drugs.

II. Miscellaneous Laws and Rules- *A. Administration of Antipsychotic Medication by Injection (§ 465.1893):* 1. A pharmacist, at the direction of a licensed physician, may administer a long-acting antipsychotic medication approved is by the FDA by injection to a patient if the pharmacist satisfies what 3 requirements? 2. What is required for administration of injectable drugs by pharmacists? 3. A pharmacist seeking to administer a long-acting antipsychotic medication by injection must complete an ___-hour continuing education (CE) course that concerns the safe and effective administration of behavioral health and antipsychotic medications by injection, including, but not limited to, potential allergic reactions to such medications. 4. Can this course apply/count toward the required 30 hours of pharmacist continuing education (CE) for license renewal?

1. A pharmacist, at the direction of a licensed physician, may administer a long-acting antipsychotic medication approved is by the FDA by injection to a patient if the pharmacist: (1) Is authorized by and acting within the framework of an established protocol with the prescribing physician. (2) Practices at a facility that accommodates privacy for non-deltoid injections and conforms with state rules and regulations regarding the appropriate and safe disposal of medication and medical waste. (3) Has completed the course required below. 2. A separate prescription from a physician is required for each injection administered by a pharmacist. 3. *8-hour* continuing education (CE) course 4. Yes. They can

*II. Miscellaneous Laws and Rules- B. Dispensing Practitioner (§ 465.0276):* 1. A practitioner authorized by law to prescribe drugs may dispense such drugs to her or his patients in the regular course of her or his practice in compliance with this section. A practitioner who dispenses medicinal drugs for human consumption for a fee or remuneration of any kind, whether direct or indirect, must fulfill what 3 requirements? 2. A dispensing practitioner may not dispense a controlled substance listed in Schedule II or Schedule III. This restriction does not apply to what 7 scenarios?

1. A practitioner who dispenses medicinal drugs for human consumption for a fee or remuneration of any kind, whether direct or indirect, must: (1) Register with her or his professional licensing board as a dispensing practitioner and pay a fee at the time of such registration and upon each renewal of her or his license. (2) Comply with and be subject to all laws and rules applicable to pharmacists and pharmacies. (3) 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. 2. A dispensing practitioner may not dispense a controlled substance listed in Schedule II or Schedule III. This restriction does not apply to: (1) The dispensing of complimentary packages of medicinal drugs which are labeled as a drug sample or complimentary drug to a practitioner's own patients in the regular course of her or his practice without the payment of a fee or remuneration of any kind, whether direct or indirect. (2) The dispensing of controlled substances in the healthcare system of the Department of Corrections. (3) The dispensing of a controlled substance listed in Schedule II or Schedule Ill in connection with the performance of a surgical procedure under the following conditions: I. For a Schedule II opioid drug for the treatment of acute pain, the 3- or 7-day supply limits apply. See Chapter 2, Section IX II. For the treatment of pain other than acute pain, a practitioner must indicate "NON-ACUTE PAIN" on a prescription. III. For the treatment of pain related to a traumatic injury with an Injury Severity Score of 9 or greater, a practitioner must concurrently prescribe an emergency opioid antagonist. IV. For a controlled substance listed in Schedule III, the amount dispensed may not exceed a 14-day supply. (4) The dispensing of a controlled substance listed in Schedule II or Schedule III pursuant to an approved clinical trial. (5) The dispensing of methadone in a facility licensed under addiction is provided. § 397.427 where medication-assisted treatment for opiate addiction is provided. (6) The dispensing of a controlled substance listed in Schedule II or Schedule III to a patient of a hospice facility. (7) The dispensing of controlled substances listed in Schedule II or Schedule III which have been approved by the United States Food and Drug Administration (FDA) for the purpose of treating opiate addictions, including, but not limited to, buprenorphine and buprenorphine combination products, by an authorized practitioner authorized to the practitioner's own patients for the medication assisted treatment of opiate addiction.

*I. Disciplinary Actions and Procedures- F. Disciplinary Guidelines (Rule 64B16-30.001):* NOTE: This rule sets out a comprehensive list of the range of disciplinary penalties that will be imposed upon a licensee that is found guilty of specific violations. The Board can deviate from the guidelines upon a showing of aggravating or mitigating circumstances by clear and convincing evidence. 1. Aggravating circumstances serve to increase the penalty imposed. What are 4 examples of these aggravating circumstances? 2. Mitigating circumstances serve to decrease the penalty imposed. What are 6 examples of these mitigating circumstances? 3. All fines imposed by the Board must be paid within _____ days from the date of the final order unless that time limitation has been modified by the Board for good cause in order to prevent undue hardship.

1. Aggravating circumstances include: (1) History of previous violations of the practice act and rules (2) In the case of negligent acts, the magnitude and scope of damage or potential damage inflicted upon the patient or the public (3) Evidence of violation of professional practice acts in other jurisdictions where the licensee has been disciplined by the appropriate regulatory authority (4) Harm that occurred. 2. Mitigating circumstances include: (1) In the case of negligent acts, the minor nature of the damage or potential damage to the patient or the public (2) Lack of previous disciplinary history in Florida or any other jurisdiction (3) Restitution of any monetary damage suffered by the patient (4) The licensee's professional standing among his or her peers (5) Steps already taken by the licensee to ensure the non-occurrence of similar violations in the future (6) The degree of financial hardship incurred by the imposition of fines or suspension. 3. 90 days

*II. Miscellaneous Laws and Rules- C. Sale of Syringes and Needles:* Does Florida Law require a prescription to sell syringes or needles?

1. Florida law does not require a prescription to sell syringes or needles to a person 18 years of age or over. 2. A prescription is required for persons under 18 years of age.

*I. Disciplinary Actions and Procedures- D. Board Action on Pharmacy Permit Applicants (§ 465.022(5) and (6)):* The Department or Board shall deny an application for a pharmacy permit if the applicant or an affiliated person, partner, officer, director, or prescription department manager or consultant pharmacist of record of the applicant has committed what 10 violations?

1. Has obtained a permit by misrepresentation or fraud 2. Has attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false representation. 3. Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy. 4. Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to healthcare fraud. 5. Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under Chapter 409, Chapter 817, or Chapter 893, or a similar felony offense committed in another state or jurisdiction, since July 1, 2009. 6. Has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under 21 U.S.C. ss. 801-970 or 42 U.S.C. ss. 1395-1396 since July 1, 2009. 7. Has been terminated for cause from the Florida Medicaid program unless the applicant has been in good standing with the Florida Medicaid program for the *most recent 5-year period.* 8. Has been terminated for cause, pursuant to the appeals procedures established by the state, from any other state Medicaid program, unless the applicant has been in good standing with a state Medicaid program for the *most recent 5-year period* and the *termination occurred at least 20 years before the date of the application*. 9. Is currently listed on the United States Department of Health and Human Services Office of Inspector General's List of Excluded Individuals and Entities. 10. Has dispensed any medicinal drug based upon a communication that purports to be a prescription as defined when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including history and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by Board rule under Chapter 458, Chapter 459, Chapter 461, Chapter 463, Chapter 464, or Chapter 466. NOTE: The Department or Board may deny an application for a pharmacy permit if the applicant or an affiliated person, partner, officer, director, or prescription department manager or consultant pharmacist of record of the applicant has violated or failed to comply with any provision of this chapter; Chapter 499, the Florida Drug and Cosmetic Act; Chapter 893; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; or any rules or regulations promulgated thereunder unless the violation or noncompliance is technical.

*I. Disciplinary Actions and Procedures- G. Minor Violations (Rule 64B16-30.002 and Florida Statute § 456.073(3)):* 1. Florida law requires each Board under the Department of Health to establish, by rule, a list of violations that are considered minor violations for an initial offense. For these minor violations which do not endanger the public health, safety, and welfare and which do not demonstrate a serious inability to practice the profession, the Board may issue what? 2. 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 what timeframe if these notices are issued? 3. What are 14 examples of minor violations? 4. Are these notices considered disciplinary action?

1. Notice of Noncompliance NOTE: The Board of Pharmacy rule calls them Notice of Deficiencies. 2. The Department's investigator may issue a Notice of Deficiencies when the conditions below occur. 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. 3. Minor Violations include: (1) Outdated pharmaceuticals (Rule 64B16-28.110) (2) Failure to meet regulation of daily operating hours (Rule 64B16-28.404) (3) Generic substitution sign not displayed (§ 465.025(7)) (4) Information required on controlled substance prescriptions: practitioner's address, practitioner's DEA registration number, patient's address (FLCSA § 893.04) (5) Failure by dispensing pharmacists to have certified the daily hard-copy printout or daily log (Rule 64B16-28.140(3)(c) or (e)) (6) 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 (Rule 64B16-28.107); (7) Failure to properly identify pharmacy technicians (Rule 64B16-27.410) (8) Results of P&E quality assurance program not documented or available for inspection (Rule 64B16 28.820(3)(d)) (9) Improper storage of legend drugs (Rule 64B16-28.120) (10) Improper documentation of destruction of controlled substances (Rules 64B16-28.301 and 64 B16-28.303) (11) Consultant pharmacist's monthly reports not current or available for inspection (Rules 64B16-28.501 and 64B16-28.702(2)) (12) Controlled substance prescription labels lack transfer crime warning labeling (Rule 64B16-28.502(2) (c)) (13) Failure to maintain proof of licensure, display licenses/ registrations or notices, or to properly identify pharmacy staff (Rule 64B16-27.100); and (14) Failure to have a continuously designated Prescription Department Manager or Consultant Pharmacist of Record, if the gap between designations is less than 15 business days (Rules 64B16-27,450 and 64B16-28.501). 4. No. A Notice of Deficiencies is not considered disciplinary action.

*I. Disciplinary Actions and Procedures- A. Authority to Inspect (§ 465.017):* 1. Duly authorized agents and employees of the department *may inspect in a lawful manner at all 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, manufactured, packed, packaged, made, stored, sold, offered for sale, exposed for sale, or kept for sale for what 3 purposes? 2. Duly authorized agents and employees of the department may inspect a registered nonresident pharmacy or a registered nonresident sterile compounding permittee. Who has to cover the costs of such inspections?

1. Purposes: (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 (3) Securing such other evidence as may be needed for prosecution under this chapter. 2. They are covered by the pharmacy or permittee.

*I. Disciplinary Actions and Procedures- E. Disciplinary Action (§ 465.023):* 1. The Department or the Board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under § 465.022(3), has committed what 8 violations? 2. 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. What are the details of such suspensions or revocations?

1. The Department or the Board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under § 465.022(3), has: (1) Obtained a permit by misrepresentation or fraud or through an error of the Department or the Board (2) Attempted to procure, or has procured, a permit for any other person by making, or causing to be made, any false or representation (3) Violated any of the requirements of this chapter (465) or any of the rules of the Board of Pharmacy; of Chapter 499, known as the "Florida Drug and Cosmetic Act"; of 21 U.S.C. ss. 301-392, known as the "Federal Food, Drug, and Cosmetic Act; of 21 U.S.C. ss. 821 et seq. known as the "Comprehensive Drug Abuse Prevention and Control Act; or of Chapter 893 (4) Been convicted or found guilty, regardless of adjudication, of a felony or any other crime involving moral turpitude in any of the courts of this state, of any other state, or of the United States (5) Been convicted or disciplined by a regulatory agency of the Federal Government or a regulatory agency of another state for any offense that would constitute a violation of this chapter (6) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy NOTE: All healthcare licensees, including pharmacists, must report to their respective Board any conviction or pleas of nolo contendere to any crime in writing within 30 days. See § 456.072(1)(X) (7) Been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to healthcare fraud (8) Dispensed any medicinal drug based upon a communication that purports to be a prescription when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship that includes a documented patient evaluation, including history and a physical examination adequate to establish the diagnosis for which any drug is prescribed and any other requirement established by Board rule under Chapter 458, Chapter 459, Chapter 461, Chapter 463, Chapter 464, or Chapter 466. 2. 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. (1) In the event of such revocation or suspension, the owner, manager, or proprietor shall remove from the premises all signs and symbols identifying the premises as a pharmacy. (2) The period of such suspension shall be prescribed by the Board of Pharmacy, but in no case shall it exceed 1 year. (3) In the event that the permit is revoked, the person owning or operating the establishment shall not be entitled to make application for a permit to operate a pharmacy for a period of 1 year from the date of such revocation. (4) 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 disposition shall be subject to continuing supervision and approval by the Board of Pharmacy.

*I. Disciplinary Actions and Procedures- I. Overview of Disciplinary Procedure:* 1. Complaints against pharmacies, pharmacists, registered pharmacy technicians, and registered pharmacy interns made to the Board of Pharmacy are investigated by whom? 2. What if the complaint is NOT considered a minor violation or one that can be resolved with a citation? 3. The Department will notify the subject of the complaint and provide the subject an opportunity to submit a response. After a thorough investigation, what happens next? 4. The Department then makes a final recommendation to a whom on the complaint? Within what timeframe of its receipt is this final recommendation made? 5. This group that makes the final recommendation is composed of whom? 6. How do they come to a final decision? 7. If probable cause is found, a complaint is filed and the subject has ___ days to respond. 8. What are the subject(s) of these complaints options once notified?

1. The Medical Quality Assurance (MQA) Division of the Florida Department of Health 2. If the complaint is not considered a minor violation or one that can be resolved with a citation, *formal disciplinary action may be taken.* 3. The complaint is forwarded to the prosecution services unit where an attorney reviews the file and recommends either dismissal or the filing of an administrative complaint. 4. The Department then makes a final recommendation to a *Probable Cause Panel* on the complaint *within 6 months of its receipt.* 5. The Probable Cause Panel is composed of *at least two Board members*. NOTE: The Probable Cause Panel is given a copy of the Department's complete investigative file, any expert opinions obtained by the Department, and the subject's response to the complaint, if one was submitted. 6. The Probable Cause Panel determines whether a complaint should be closed or an administrative complaint filed. A decision to either find probable cause on a complaint or to dismiss it must be made by a majority vote of the Probable Cause Panel. 7. 21 days 8. The subject of a complaint may request a formal administrative hearing before an Administrative Law Judge or an informal hearing before the Board. Regardless of the type of hearing requested, a complaint can also be settled through a consent decree or stipulation which is submitted to the Board for approval. NOTE: Any Board member who participated on the Probable Cause Panel for a complaint may not vote on the final disciplinary decision for that complaint.

II. Miscellaneous Laws and Rules- *D. Standards of Practice for Orthotics and Pedorthics (§ 465.1901 and Rule 64B16-27.850):* FOOT STUFF 1. Although the Florida Department of Health licenses practitioners of orthotics and pedorthics under FS 468.803, the FPA specifically exempts pharmacists from those provisions. What does this mean? 2. The pharmacist's professional responsibilities include in these scenarios include what 7 responsibilities? 3. What does the Infectious Disease Elimination Act (IDEA) that was passed into law in Florida in 2019 and allow?

1. This means that a pharmacist may, pursuant to written prescription, participate in the evaluation treatment formulation, measuring, designing, fabricating, assembling, fitting, adjusting, servicing, or providing initial training to accomplish the fitting of an orthosis or pedorthic device. NOTE: If a patient is under the care of a licensed occupational therapist or physical therapist, the pharmacist must consult with the therapist if the therapist has requested consultation. 2. The pharmacist's professional responsibilities include: (1) Ongoing consultation with the prescribing physician (2) Orthotic and/or pedorthic evaluation of the patient (3) Identification and documentation of precautions, special problems, or contraindications (4) Development, implementation of, and periodic review of a treatment plan (5) Collaboration with other members of the healthcare team (6) Advising the patient of the nature of the purpose and nature of the services to be rendered and the techniques for use and care of the devices. (7) Determination of the appropriateness of proper fit and function of the devices 3. The Infectious Disease Elimination Act (IDEA) allows counties to set up needle and syringe exchange programs

*I. Disciplinary Actions and Procedures- B. Grounds for Denial of a License or Disciplinary Action (§ 465.016):* 10. What action regarding prescription returns are grounds for the denial of licensure or disciplinary action? Are there exceptions to this? 11. Being unable to practice pharmacy with reasonable skill and safety for what 3 reasons are grounds for the denial of licensure or disciplinary action? Are there exceptions? 12. Violating a rule of the Board or Department or violating an order previously entered in a disciplinary hearing is also grounds for denial or licensure or disciplinary action. What are the rules for reporting other healthcare professionals when known violations or an inability to practice has occurred? 13. When it is a result of a *pending or completed disciplinary action or investigation in another jurisdiction*, the commencement or cessation of practice is grounds for denial or licensure or disciplinary action, if one fails to notify the Board in writing within what timeframe? 14. What about patients PHI (Protected Health Information)? 15. Dispensing any medicinal drug is grounds for denial of licensure or disciplinary action if the pharmacist knows or suspects that what is not present/established? 16. Committing an error or omission during the performance of a specific function of prescription drug processing, is grounds for denial of licensure or disciplinary action. What are 10 examples of these types of errors?

10. Placing in the stock of any pharmacy any part of a prescription that has been returned by a patient (exception for unit-dose medication in hospitals, nursing homes, etc.). 11. Being unable to practice pharmacy with reasonable skill and safety due to: (1) Illness (2) Use of drugs, narcotics, chemicals, or any other type of material (3) As a result of any mental or physical condition. STUDY TIP/EXCEPTIONS: Despite these provisions, many cases of impairment due to alcohol, drugs, or mental or physical issues do not result in discipline. Florida has an impaired practitioner program called the Professionals Resource Network (PRN). A pharmacist with an impairment who voluntarily enters into a contract for treatment with PRN *will not be referred to the Board for discipline as long as they acknowledge the impairment and successfully complete the program*. The Board may also refer pharmacists to the PRN program if they receive a complaint regarding impairment under certain circumstances. For more information, see www.flprn.org 12. 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 other licensed facilities) or an 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 reason 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 impaired practitioner (PRN) program rather than to the Department. STUDY TIP: 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 co-worker to the Florida Professionals Recovery Network (PRN). 13. Within 20 days 14. Using or releasing a patient's records except as authorized. NOTE: Violating any provision of Chapter 456 or 465 and any rules adopted pursuant thereto is also grounds for denial of licensure or disciplinary action. 15. Dispensing any medicinal drug based upon a communication that purports to be a prescription when the pharmacist knows or has reason to believe that the purported prescription is not based upon a *valid practitioner-patient relationship*. 16. Error(s) or omission(s) during the performance of a specific function of prescription drug processing includes: (1) Receiving, interpreting, or clarifying a prescription (2) Entering prescription data into the pharmacy's record (3) Verifying or validating a prescription (4) Performing pharmaceutical calculations (5) Performing prospective drug review as defined by the Board (6) Obtaining refill and substitution authorizations (7) Interpreting or acting on clinical data (8) Performing therapeutic interventions (9) Providing drug information concerning a patient's prescription (10) Providing patient counseling

II. Miscellaneous Laws and Rules- *B. Dispensing Practitioner (§ 465.0276):* 3. A practitioner who confines her or his activities to the dispensing of complimentary packages of medicinal drugs to the practitioner's own patients in the regular course of her or his practice, without the payment of a fee or remuneration of any kind, whether direct or indirect, and who herself or himself dispenses such drugs is not required to register as a dispensing practitioner. The practitioner must dispense such drugs in the manufacturer's labeled package with the practitioner's name, patient's name, and date dispensed, or, if such drugs are not dispensed in the manufacturer's labeled package, they must be dispensed in a container which bears what 5 required pieces of information? 4. Does this law prohibit a licensed veterinarian from administering a compounded drug to a patient or dispensing a compounded drug to the patient's owner or caretaker.

3. A practitioner who confines her or his activities to the dispensing of complimentary packages of medicinal drugs to the practitioner's own patients in the regular course of her or his practice, without the payment of a fee or remuneration of any kind, whether direct or indirect, and who herself or himself dispenses such drugs is not required to register as a dispensing practitioner. The practitioner must dispense such drugs in the manufacturer's labeled package with the practitioner's name, patient's name, and date dispensed, or, if such drugs are not dispensed in the manufacturer's labeled pack-age, they must be dispensed in a container which bears the following information: (1) Practitioner's name (2) Patient's name (3) Date dispensed (4) Name and strength of drug (5) Directions for use. 4. No. This law does not prohibit a licensed veterinarian from administering a compounded drug to a patient or dispensing a compounded drug to the patient's owner or caretaker.

See § 456.072(1)(X): All healthcare licensees, including pharmacists, must report to their respective Board any conviction or pleas of nolo contendere to any crime in writing within what timeframe?

In writing within 30 days

*I. Disciplinary Actions and Procedures- C. Other Violations (§ 465.015):* Read Slide about other Violations

NOTE: Some of these violations are criminal violations and are applicable to any person (not just pharmacists or pharmacy technicians) while other ones are specific to pharmacists or pharmacy technicians. 1. It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have charge of, either alone or with another person or persons, a pharmacy: (1) Which is not registered under the provisions of this chapter. (2) In which a person not licensed as a pharmacist in this state or not registered as an intern in this state, or in which an intern who is not acting under the direct and immediate personal supervision of a licensed pharmacist fills, compounds, or dispenses any prescription or dispenses medicinal drugs. 2. It is unlawful for any person: (1) To make a false or fraudulent statement, either for herself or himself or for another person, in any application, affidavit, or statement presented to the Board or in any proceeding before the Board. (2) To fill, compound, or dispense prescriptions or to dispense medicinal drugs if such person does not hold an active license as a pharmacist in this state, is not registered as an intern in this state, or is an intern not acting under the direct and immediate personal supervision of a licensed pharmacist. (3) To sell or dispense medicinal drugs without first being furnished with a prescription. (4) To sell samples or complimentary packages of drug products. 3. It is unlawful for any person other than a pharmacist licensed under this chapter to use the title "pharmacist" or "druggist" or otherwise lead the public to believe that she or he is engaged in the practice of pharmacy. 4. It is unlawful for any person other than an owner of a pharmacy registered under this chapter to display any sign or to take any other action that would lead the public to believe that such person is engaged in the business of compounding, dispensing, or retailing any medicinal drugs. This paragraph shall not preclude a person not licensed as a pharmacist from owning a pharmacy. 5. It is unlawful for a person, firm, or corporation that is not licensed or registered under this chapter to: (1) Use in a trade name, sign, letter, or advertisement any term, including "drug," "pharmacy," " prescription drugs," "Rx," or "apothecary," which implies that the person, firm, or corporation is licensed or registered to practice pharmacy in this state. (2) Hold himself or herself out to others as a person, firm, or corporation licensed or registered to practice pharmacy in this state. 6. It is unlawful for a person who is not registered as a pharmacy technician under this chapter, or who is not otherwise exempt from the requirement to register as a pharmacy technician, to perform the functions of a registered pharmacy technician, or hold himself or herself out to others as a person who is registered to perform the functions of a registered pharmacy technician in this state.

*I. Disciplinary Actions and Procedures- B. Grounds for Denial of a License or Disciplinary Action (§ 465.016):* 1. What 3 actions regarding licensing are grounds for denial or disciplinary action? 2. Being unfit or incompetent to practice pharmacy for what 3 possible reasons is grounds for denial or disciplinary action? 3. Violating what act(s) is/are grounds for denial or disciplinary action? 4. What specific type of conviction or guilty finding is grounds for denial or disciplinary action?

NOTE: The grounds of discipline listed below are from the Pharmacy Act, but pharmacists are also subject to some of the grounds for discipline applicable to all healthcare practitioners under the Florida Department of Health. See Florida statute § 456.072. 1. Punishable actions regarding licensing: (1) Obtaining license by misrepresentation or fraud or through an error of the Board or Department. (2) Procuring or attempting to procure a license for another person. (3) Permitting person not licensed as a pharmacist in this state or not registered as an intern in this state, or permitting a registered intern who is not acting under the direct and immediate supervision of a licensed pharmacist to fill, compound, or dispense any prescription in a pharmacy owned or operated by such pharmacist or in a pharmacy where such pharmacist is employed or on duty. 2. Being unfit or incompetent to practice pharmacy by reason of: (1) Habitual intoxication (2) Misuse or abuse of any controlled substance (3) Abnormal physical or mental condition which threatens the public safety. 3. Violating the federal Food, Drug and Cosmetic Act or Federal Controlled Substances Act (FDCA). 4. Having been convicted or found guilty, regardless of adjudication, of a crime which directly relates to the ability to practice pharmacy. A plea of nolo contendere (no contest) constitutes a conviction for purposes of this section.

*I. Disciplinary Actions and Procedures- B. Grounds for Denial of a License or Disciplinary Action (§ 465.016):* 5. What action regarding the use of specific ingredients and articles in compounding are grounds for denial or disciplinary action? 6. Can you be denied licensure or receive disciplinary action for being disciplined in another state? 7. When is the action(s) of compounding, dispensing, and distributing drugs grounds for denial of licensure or disciplinary action? 8. What action(s) regarding reporting/reporting/records is grounds for denial of licensure or disciplinary action? 9. What action regarding prescription fees or prices are grounds for the denial of licensure or disciplinary action?

NOTE: The grounds of discipline listed below are from the Pharmacy Act, but pharmacists are also subject to some of the grounds for discipline applicable to all healthcare practitioners under the Florida Department of Health. See Florida statute § 456.072. 5. Using, in the compounding or dispensing of a prescription, an ingredient or article different in any matter from the ingredient or article prescribed (except as authorized for generic substitution or a formulary system). 6. Yes. Having been disciplined by a regulatory authority in another state for any offense that would be a violation of the pharmacy act. 7. Compounding, dispensing, or distributing legend drugs or controlled substances other than in the course of the professional practice of pharmacy. 8. Making or filing a report or record known to be false, 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. 9. Failing to make prescription fee or price information readily available upon request.