The Board proposes rule amendments to clarify language, to update existing penalties and to set forth additional violations and appropriate penalties.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-30.001Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances

PURPOSE AND EFFECT: The Board proposes rule amendments to clarify language, to update existing penalties and to set forth additional violations and appropriate penalties.

SUMMARY: The proposed rule amendments are necessary to clarify language, to update existing penalties, and to set forth additional violations and appropriate penalties in regard to disciplinary guidelines.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION:  The agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule.  A SERC has not been prepared by the agency.  The agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein:  During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature.  No person or interested party submitted additional information regarding the economic impact at that time. Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 456.072, 456.079, 465.005 FS.

LAW IMPLEMENTED: 456.072, 456.079 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 64B16-30.001 follows. See Florida Administrative Code for present text.)

 

64B16-30.001 Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances.

(1) The board sets forth below a range of disciplinary guidelines from which disciplinary penalties will be imposed upon licensees guilty of violating Chapter 465 or Section 828.055, F.S. The purpose of the disciplinary guidelines is to give notice to licensees of the range of penalties which will normally be imposed upon violations of particular provisions of Chapter 465 or Section 828.055, F.S. The term license means any permit, registration, certificate, or license, including a provisional license, issued by the Department. Penalty ranges are shown as minimum and maximum guidelines as well as for first time single count violations and for multiple or repeated violations of the same provision of Chapter 465, F.S., or the rules promulgated thereto. If an actual range of penalties is not provided, the listed penalty shall be the guideline penalty for the violation(s) unless aggravating or mitigating factors are shown. All penalties at the upper range of the sanctions set forth in the guidelines, e.g., suspension, revocation, etc., include lesser penalties, e.g., fine, continuing education, probation, or reprimand, which may be included in the final penalty at the board’s discretion. Probation may be subject to conditions, including restriction from practice in certain settings, restricting the licensee to working only under designated conditions or in certain settings, requiring continuing or remedial education, or any other restriction found to be necessary for the protection of the public health, safety, and welfare. In addition to any other discipline imposed under these guidelines, the board shall assess costs relating to the investigation and prosecution of the case.

(2) The following disciplinary guidelines shall be followed by the board in imposing disciplinary penalties upon licensees and permittees for violation of the below mentioned statutes and rules. For the purposes of this rule, the descriptions of the violations are abbreviated and the full statute or rule cited should be consulted to determine the prohibited conduct.

		PENALTY RANGE
VIOLATION		MINIMUM, INCLUDING FIRST TIME OR SINGLE COUNT VIOLATIONS		MAXIMUM, INCLUDING MULTIPLE OR REPEATED VIOLATIONS OF THE SAME PROVISION
(a) Obtaining a license or permit by misrepresentation, fraud, or error (Section 465.016(1)(a), F.S.) (Section 465.023(1)(a), F.S.)
1. By negligent misrepresentation on original application or renewal		$1,000 fine and 12 hour Laws and Rules course or MPJE and 3 hour ethics course		$5,000 fine and one (1) year suspension, to Revocation
2. By fraudulent misrepresentation on original application or renewal		$10,000 fine for each count and Revocation		$10,000 fine for each count and Revocation
3. By error of the Department or Board on original application or renewal		Revocation		Revocation
(b) Procuring or attempting to procure a license or permit for another person by false representation.  (Section 465.016(1)(b), F.S.) (Section 465.023(1)(b), F.S.)		$10,000 fine for each count and Revocation		$10,000 fine for each count and Revocation
(c) Permitting any unlicensed persons, including owner or operator of pharmacy, to practice pharmacy. (Section 465.016(1)(c), F.S.)		$2,500 fine and 12 hour Laws & Rules course or Multistate Pharmacy Jurisprudence Exam (MPJE)		$5,000 to $10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
(d) Being unfit or incompetent to practice pharmacy by reason of habitual intoxication, medicinal drug abuse, or physical or mental condition that threatens public safety. (Section 465.016(1)(d), (m), F.S.)		$250 fine, indefinite suspension with PRN review and board appearance		Revocation
(e) Violating laws governing the practice of pharmacy. (Section 465.016(1)(e), F.S.) (Section 465.023(1)(c), F.S.)
1. Chapter 465, F.S.:
a. Failure to supervise registered pharmacy technician. (Section 465.014, F.S.)		$250 fine and one (1) year probation and 12 hour Laws and Rules course or MPJE		$1000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
b. Operating a pharmacy that is not registered. (Section 465.015(1)(a), F.S.)		$500 fine per month to maximum of $5,000 (penalty will require permittee to renew permit or cease practice)		$10,000 fine (penalty will require permittee to renew permit or cease practice), to Revocation
c. Operating a pharmacy where an unlicensed, unregistered, or unsupervised person practices pharmacy. (Section 465.015(1)(b), F.S.)		$5,000 fine and one (1) year probation		$10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
d. Making a false or fraudulent statement to the board. (Section 465.015(2)(a), F.S.)		$10,000 fine		$10,000 fine and Revocation
e. Practicing pharmacy as an inactive licensee. (Section 465.015(2)(b), F.S.)		Fine based on length of time in practice while inactive; $500 fine per month		$10,000 fine and two (2) years suspension, to Revocation
f. Selling or dispensing drugs without a prescription. (Section 465.015(2)(c), F.S.)
(i) Non-scheduled legend drugs.		$1,500 fine		$5,000 fine and one (1) year probation, to Revocation
(ii) Scheduled (controlled substances) legend drugs.		$5,000 fine and (1) year probation		$10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
g. Selling samples or complimentary drugs. (Section 465.015(2)(d), F.S.)
(i) Non-scheduled legend drugs.		$1,500 fine and (1) year probation		$5,000 fine and one (1) year probation, to Revocation
(ii) Scheduled (controlled substances) legend drugs.		$5,000 fine and one (1) year probation		$10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation

h. Failure to notify the board of, or failure to have, a prescription department manager or a supervising, a responsible, or a consultant pharmacist. (Sections 465.018, .019, .0193, .0196, or .0197, F.S. and 465.022(10), (11), F.S.)
(i) Failure to notify. (Section 465.018, F.S.)		Fine based on length of time prior to notifying board. $500 per month		$7,500 maximum (penalty requires notification or ceasing practice)
(ii) Failure to have prescription department manager or a supervising, a responsible, or a consultant pharmacist of record.		Fine based on length of time practicing without designated pharmacist, $750 fine per month and one (1) year probation		$2,000 fine per month, to Revocation
i. Failure to comply with substitution of legend drug requirements. (Sections 465.025(2), (3), (4), F.S.)		$500 fine and 12 hour Laws & Rules course or MPJE		$2,500 fine, 12 hour Laws & Rules course or MPJE, and one (1) year probation
j. Failure to follow negative formulary requirements. (Section 465.025(6), F.S.) (Rule 64B16-27.500, F.A.C.)		$1,000 fine and 12 hour Laws & Rules course or MPJE		$2,500 fine, 12 hour Laws & Rules course or MPJE, and one (1) year probation
k. Failure to follow emergency prescription requirements. (Section 465.0275, F.S.)		$500 fine		$1,000 fine and one (1) year probation
l. Engage in prohibited rebate scheme. (Section 465.185, F.S.)		$1,500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine, 12 hour Laws & Rules course or MPJE, and one (1) year probation, to Revocation
m. Failure to comply with pharmacist dispensing requirements. (Section 465.186, F.S.)
(i) Failure to follow procedure, but dispense drug appearing on formulary. (Section 465.186(3), F.S.) (Rule 64B16-27.210, F.A.C.)		$500 fine		$1000 fine and one (1) year probation to suspension of right to dispense
(ii) Dispensing drug not on the formulary. (Section 465.186(2), F.S.) (Rules 64B16-27.220, .230, F.A.C.)		$1,500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation to $10,000 fine and Revocation
n. Failure to timely report fraudulent obtaining or attempted obtaining of controlled substances from a pharmacy. (Section 465.015(3), F.S.)
(i) Failure to timely report		$500 fine		$1,000 fine and one (1) year probation
(ii) Failure to report		$1,000 fine and one (1) year probation		$5,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
o. Violation of facsimile prescription requirements (Section 465.035, F.S.)		$500 fine		$1,000 fine and one (1) year probation
p. Violation of requirements for administration of vaccines and epinephrine autoinjection. (Section 465.189, F.S.) (Section 465.009(6)(a), F.S.)
(i) Failure to enter into a written protocol.		$2,500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation
(ii) Failure to maintain proper insurance.		$500 fine and suspension until insured		$1,000 fine, suspension until insured, followed by one (1) year probation
(iii) Failure to maintain and make available patient records.		$500 fine		$1,000 fine and one (1) year probation
(iv) Uncertified administration of vaccine.		$5,000 fine and suspension until certified		$7,500 fine and suspension until certified, followed by one (1) year probation, to Revocation
(v) Failure to submit copy of protocol or written agreement to the board.		$500 fine		$1,000 fine and one (1) year probation
2. Chapter 499, F.S.:
a. Adulteration or misbranding of a drug. (Section 499.005(2), (3), F.S.) (Section 499.006, F.S.) (Section 499.007, F.S.)
(i)  Adulteration of a drug. (Section 499.005(2) F.S.) (Section 499.006, F.S.)		$1000 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
(ii) Receipt or delivery of any drug that is altered or misbranded. (Section 499.005 (3), F.S.)		$1000 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation, to Revocation
(iii) Incomplete or inaccurate labeling. (Section 499.007, F.S.) (Rule 64B16-28.108, F.A.C.		$250 fine and 12 hour Laws & Rules course or MPJE		$2,500 fine and one (1) year probation
(iv) Fraudulent misbranding of legend drugs. (Section 499.007, F.S.)		$10,000 fine and one (1) year suspension followed by one (1) year probation		$10,000 fine and two (2) years suspension followed by two (2) years probation, to Revocation
b. Failure to obtain a permit or registration, or operating without a valid permit when it is required. (Section 499.005(22), F.S.		$500 fine per month to maximum of $5,000 (penalty will require permittee to renew permit or cease practice)		$10,000 fine (penalty will require permittee to renew permit or cease practice), to Revocation
c. Prescription drug pedigree violations. (Section 499.005(28), F.S.) (Section 499.0051, F.S.)		$500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation, to Revocation
d. Recordkeeping requirement. (Section 499.0121, F.S.) (Section 499.005(18), (19), F.S.)		$500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation, to Revocation
e. Storage of drugs. (Section 499.0121, F.S.)		$500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation, to Revocation
3. Chapter 893, F.S. (Controlled Substances):
a. Filling a written or oral prescription for controlled substances that does not meet the requirements of Chapter 893.F.S. (Section 893.04(1)(a), (b), (c), F.S.)		$1,500 fine		$5,000 fine and one (1) year probation, to Revocation
b. Failing to retain prescription records for two (2) years. (Section 893.04(1)(d), F.S.)		$1,000 fine		$5,000 fine and one (1) year probation, to Revocation
c. Failing to appropriately label. (Section 893.04(1)(e), F.S.)		$250 fine and 12 hour Laws & Rules course or MPJE		$2,500 fine and (1) year probation
d. Dispensing a Schedule II drug inappropriately with a non-written prescription. (Section 893.04(1)(f), F.S.)		$5,000 fine and one (1) year probation		$10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
e. Inappropriate refilling of Schedule III, IV, or V drugs. (Section 893.04(1)(g), F.S.) (Section 893.04(2)(e), F.S.)		$1,750 fine and one (1) year probation		$5,000 fine and one (1) year suspension
f. Receiving controlled substances without an appropriate order form. (Section 893.06(1), F.S.)		$2,500 fine		$5,000 fine and one (1) year probation, to Revocation
g. Possession of controlled substances outside the regular course of business, occupation, profession, employment, or duty. (Section 893.06(2), F.S.)		$2,500 fine and one (1) year probation		$5,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
h. Failure to take a biennial inventory. (Section 893.07(1)(a), (2), (3), (4), (5), F.S.)		$1,000 fine		$2,500 fine and one (1) year probation
i. Failure to maintain a complete and accurate record of controlled substances. (Section 893.07(1)(b), (2), (3), (4), (5), F.S.)		$1,000 fine and one (1) year probation		$5,000 fine and two (2) years probation, to Revocation
j. Dispensing Schedule V controlled substances in other than good faith. (Section 893.08(3)(b), F.S.)		$5,000 fine and one (1) year probation		$10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
k. Inappropriate selling of Schedule V controlled substance. (Section 893.08(3)(c), F.S.)		$1,500 fine and one (1) year probation		$5,000 fine and one (1) year suspension
l. Unlawful possession of controlled substance. (Section 893.13, F.S.)		$5,000 fine and two (2) years probation		$10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
4. Violation of Federal Drug Abuse Act 21 U.S.C. 821 et seq.  (Manufacture, Distribution, and Dispensing of Controlled Substances)		$500 fine and one (1) year probation		$2,000 fine up to $10,000 and one (1) year suspension followed by two (2) years probation, to Revocation
5. Violation of Food and Drug Act 21 U.S.C. 301 – 392.		$2,500 fine and one (1) year suspension		$7,500 fine and two (2) years suspension followed by two (2) years probation, to Revocation
(f) Criminal conviction related to Pharmacy. (Section 465.016(1)(f), F.S.) (Section 465.023(1)(d)
1. Misdemeanor.		$1,000 fine		$5,000 fine, one (1) year probation, to Revocation
2. Felony.		$5,000 fine and one (1) year suspension followed by two (2) years probation		$10,000 fine and two (2) years suspension followed by three (3) years probation, to Revocation
(g) Using in the compounding of a prescription, or furnishing upon prescription, an ingredient or article different in any manner from the ingredient or article prescribed, except as authorized in Section 465.019(6), F.S. or Section 465.025, F.S., (Section 465.016(1)(g), F.S.); or, compounding, dispensing or distributing legend drugs outside professional practice of pharmacy. (Section 465.016(1)(i), F.S.)		$250 fine without ingestion or harm, to $500 with ingestion, and complete approved CE course in the prevention of medication errors of no less than eight (8) hours		$500 fine without ingestion or harm, to $1,000 with ingestion, complete approved CE course in the prevention of medication errors of no less than eight (8) hours, and two (2) years probation, to Revocation
(h) Filing a false report or failing to file a report required by law. (Section 465.016(1)(i), F.S.)
1. Knowing violation.		$2,000 fine and one (1) year probation		$10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
2. Negligent violation.		Reprimand		One (1) year probation and $1,000 fine
(i) Failure to make prescription price information available. (Section 465.016(1)(k), F.S.)		$250 fine and 12 hour Laws & Rules course or MPJE		$1,000 fine and one (1) year probation
(j) Improperly placing returned drugs into the stock of a pharmacy. (Section 465.016(1)(l), F.S.)		$1,500 fine		$3,000 fine and one (1) year probation

(k) Violating a rule or order of the Board or Department. (Section 465.016(1)(n), F.S.)
1. Rules of Board of Pharmacy.
a. Rules 64B16-28.101 to 64B16-28.1035, F.A.C. Rule 64B16-27.100, F.A.C. Rule 64B16-28.109, F.A.C. Rule 64B16-27.103, F.A.C. Rule 64B16-27.104, F.A.C. Rule 64B16-26.400, F.A.C. Rule 64B16-26.2032 F.A.C. Rule 64B16-28.1081, F.A.C. Rule 64B16-27.105, F.A.C. Rule 64B16-27.211, F.A.C. Rule 64B16-28.113, F.A.C. Rule 64B16-28.2021, F.A.C. Rule 64B16-28.603, F.A.C.		$500 fine and 12 hour Laws & Rules course or MPJE		One (1) year probation and $2,000 fine
b. Sink and running water, sufficient space, refrigeration, sanitation, equipment. (Rule 64B16-28.102, F.A.C.)		Suspension until compliance		$2,000 fine and Revocation
c. Knowingly purchase, sell, possess, or distribute counterfeit drugs. (Rule 64B16-27.101, F.A.C.)		$5,000 fine, one (1) year suspension followed by one (1) year probation to Revocation		$10,000 fine and Revocation
d. Failure to remove outdated pharmaceuticals, or dispensing of same. (Rule 64B16-28.110, F.A.C.)		$500 fine for possession, $1,000 fine for dispensing		$2,500 - $5,000 fine and two (2) years probation, to Revocation
e. Violation of destruction of controlled substances. (Rules 64B16-28.301, and .303 F.A.C.)		$500 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and two (2) years probation, to Revocation
f. Serving as consultant pharmacist without being licensed as a consultant pharmacist. (Rule 64B16-26.300, F.A.C.)		$500 per month up to $5,000 fine (fine based upon the length of time the person is serving as a consultant without being licensed as a consultant pharmacist)		$7,500 fine and one (1) year suspension followed by two (2) years probation, to Revocation
g. Violation of requirements for records maintained in a data processing system. (Rule 64B16-28.140, F.A.C.)		$1,000 fine and 12 hour Laws & Rules course or MPJE plus 8 hours CE course in record keeping		$5,000 fine and two (2) years probation, to Revocation
h. Failure to properly store legend drugs. (Rule 64B16-28.120, F.A.C.)		$1,000 fine and 12 hour Laws & Rules course or MPJE		$5,000 fine and one (1) year probation, to Revocation
i. Practicing nuclear pharmacy without being licensed as a nuclear pharmacist. (Rule 64B16-26.303, F.A.C.)		$500 per month up to $5,000 fine (fine based upon the length of time the person is practicing without being licensed as a nuclear pharmacist)		$10,000 fine and one (1) year suspension, to Revocation
j. Failure to follow technical requirements for nuclear pharmacy. (Rules 64B16-28.901 and .902, F.A.C.)		One (1) year probation and $1,000 fine, to $2,500 fine and six (6) months suspension followed by one (1) year probation		$5,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
k. Failure to properly transfer prescription files and medicinal drugs when closing pharmacy. (Rules 64B16-28.202 and .203, F.A.C.)		Revocation		Revocation
l. Failure to complete the required continuing education during the biennial licensure period. (Rule 64B16-26.103, F.A.C.)
(i) Failure to complete less than ten (10) hours.		$500 fine and suspension until completed		$1,500 fine and suspension until completed
(ii) Failure to complete ten (10) or more hours.		$1,000 fine. In addition, licensees shall take two (2) additional hours of continuing education for each of the continuing education deficiencies.  Said hours shall not count for continuing education renewal requirements for the next biennium.		$2,500 fine and suspension until deficiency and penalty units are completed. In addition, licensees shall take two (2) additional hours of continuing education for each of the continuing education deficiencies.  Said hours shall not count for continuing education renewal requirements for the next biennium.
m. Failure to retain continuing education records. (Rule 64B16-26.603, F.A.C.)		$250 fine		$1,500 fine and suspension of license until undocumented courses are completed and documentation is submitted to the Department.

n. Failure to practice in accordance with established practice standards. (Rules 64B16-27.1001 and .104, F.A.C.)
(i) Pharmacist		$500 to $1,000 fine and 12 hour Laws & Rules course or MPJE to one (1) year probation		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
(ii) Pharmacy Intern		$250 to $500 fine and 12 hour Laws & Rules course or MPJE		$1000 to $5,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
(iii) Permittee		$500 to $1,000 fine and 12 hour Laws & Rules course or MPJE to one (1) year probation		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
o. Failure to have or maintain current policies and procedures for automated pharmacy system or central fill pharmacy. (Rules 64B16-28.141 and.450, F.A.C.)		$500 to $1000 fine and 12 hour Laws & Rules course or MPJE		$2,500 to $5,000 fine and suspension of license/permit until current policies and procedures are in place, to Revocation
p. Failure to have or maintain standards for an institutional pharmacy. (Rules 64B16-28.602, .6021, .605, .606, .702, F.A.C.)		$500 fine and 12 hour Laws & Rules course or MJPE		$2,500 to $5,000 fine and suspension of license until policies and procedures are in place, to Revocation
q. Failure to have or maintain standards for a special pharmacy. (Rules 64B16-28.800, .810, .820, .840, .850, .860, .870, F.A.C.)		$500 fine and 12 hour Laws & Rules course or MJPE		$2,500 to $5,000 fine and suspension of license until policies and procedures are in place, to Revocation
r. Failure to maintain standards for animal control shelters. (Rule Chapter 64B16-29, F.A.C.)		$500 fine and 12 hour Laws & Rules course or MJPE		$2,500 to $5,000 fine and suspension of license until policies and procedures are in place, to Revocation
s. Failure to comply with Board’s rule on patient counseling. (Rules 64B16-27.800, .810, .820, F.A.C.)		$250 fine without ingestion or harm, to $500 with ingestion, and complete approved CE course in the prevention of medication errors of no less than eight (8) hours		$500 fine without ingestion or harm, to $1,000 with ingestion, complete approved CE course in the prevention of medication errors of no less than eight (8) hours, and two (2) years probation, to Revocation

t. Standards of practice for compounding CSPs. (Rules 64B16-27.700 and .797, F.A.C.)
(i) No harm		$500 fine, 12 hour Laws & Rules course, and course governing sterile compounds, to $2,000 fine and one (1) year probation		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
(ii) Harm		$2,000 fine, one (1) year probation, and 12 hour Laws & Rules course, to Revocation		Revocation
2. Violation of orders of the Board or Department.		$2,500 fine and one (1) year probation, to suspension until compliance with order		$5,000 fine and one (1) year probation, to suspension until compliance with order, to Revocation
(l) License disciplined by another jurisdiction for an offense that would constitute a violation of this chapter. (Section 465.016(1)(h), F.S.) (Section 465.023(1)(e), F.S.)		Same penalty as imposed in other jurisdiction or as closely as possible to penalties set forth in Florida Statutes		Same penalty as imposed in other jurisdiction or as closely as possible to penalties set forth in Florida Statutes to $10,000 fine and Revocation
(m) Failing to report to the Department any Chapter 458 or 459 licensee violation. (Section 465.016(1)(o), F.S.)		$500 fine and 12 hour Laws & Rules course or MJPE		$1,500 fine and 12 hour Laws & Rules course or MJPE
(n) Abandoning or allowing permit to become null and void after notice of disciplinary proceedings. (Section 465.018(3), F.S.)		Revocation		Revocation
(o) Failing to notify the Board of commencement or cessation of practice due to discipline in another jurisdiction. (Section 465.016(1)(p), F.S.)		$500 fine and 12 hour Laws & Rules course or MJPE		$2,000 fine and two (2) years probation
(p) Using or releasing patient records improperly. (Section 465.016(1)(q), F.S.)		$1,000 fine and 12 hour Laws & Rules course or MJPE		$2,500 fine and one (1) year probation

(q) Knowingly, or with reason to believe, dispensing based on purported prescription where patient-prescriber relationship is invalid. (Section 465.016(1)(s), F.S.) (Section 465.023(1)(h), F.S.)
(i) Reason to believe		$2,000 fine, 12 hour Laws & Rules course or MJPE, and one (1) year probation		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
(ii) Knowingly		Revocation		Revocation
(r) Committing an error or omission during prescription drug processing. (Section 465.016(1)(t), F.S.)		$250 fine without ingestion or harm, to $500 with ingestion, and complete approved CE course in the prevention of medication errors of no less than eight (8) hours		$500 fine without ingestion or harm, to $1,000 with ingestion, complete approved CE course in the prevention of medication errors of no less than eight (8) hours, and two (2) years probation, to Revocation
(s) Guilty of a felony involving moral turpitude. (Section 465.023(1)(d), F.S.)		$1,000 fine and 12 hour Laws & Rules course or MJPE		$5,000 fine and one (1) year probation, to Revocation
(t) Guilty of a crime related to health care fraud. (Section 465.023(1)(g), F.S.)		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license
(u) Violating 456.072, F.S. (Section 465.016(1)(r), F.S.)
1. Making misleading, deceptive, or fraudulent representation in or related to the practice of the licensee’s profession. (Section 456.072(1)(a), F.S.)		$1,500 fine and one (1) year probation		Revocation
2. Intentionally violating any rule adopted by the Board or the Department. (Section 456.072(1)(b), F.S.)		$2,500 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation

3. Being convicted or found guilty of, or entering 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, a licensee’s profession. (Section 456.072(1)(c), F.S.)
a. Misdemeanor		$1,000 fine and suspension until compliant		$2,500 fine and suspension until compliant, followed by one (1) year probation, to Revocation
b. Felony		$3,000 fine and one (1) year probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
4. Failing to comply with the educational course requirements for human immunodeficiency virus and acquired immune deficiency syndrome, or medical errors. (Section 456.072(1)(a), F.S.) (Rules 64B16-26.103(1)(c), (4)(e), F.A.C.)		$500 fine		$1,000 fine
5. Having a license or the authority to practice the regulated profession revoked, suspended, or otherwise acted against, including the denial of licensure, by the licensing authority of any jurisdiction, including its agencies or subdivisions, for a violation that would constitute a violation under Florida law. The licensing authority’s acceptance of a relinquishment of licensure, stipulation, consent order, or other settlement, offered in response to or in anticipation of the filing of charges against the license, shall be construed as action against the license. (Section 456.072(1)(f), F.S.)		Same penalty as imposed in other jurisdiction or as closely as possible to penalties for similar violation		Same penalty as imposed in other jurisdiction or as closely as possible to penalties for similar violation, to $10,000 fine and Revocation
6. Having been found liable in a civil proceeding for knowingly filing a false report or complaint with the Department against another licensee. (Section 456.072(1)(g), F.S.)		$3,000 fine		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation

7. Attempting to obtain, obtaining, or renewing a license to practice a profession by bribery, by fraudulent misrepresentation, or through an error of the Department or the Board. (Section 456.072(1)(h), F.S.)		$10,000 fine and Revocation or denial of license application		$10,000 fine and Revocation or denial of license application
8. Except as provided in Section 465.016, F.S., failing to report to the Department any person who the licensee knows is in violation of this part, the chapter regulating the alleged violator, or the rules of the Department or the Board. (Section 456.072(1)(i), F.S.)		$500 fine and 12 hour Laws & Rules course or MJPE		$1,500 fine and 12 hours Laws & Rules or MJPE, to one (1) year suspension or Revocation
9. Aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice a profession contrary to this part, the chapter regulating the profession, or the rules of the Department or the Board. (Section 456.072(1)(j), F.S.)		$2,000 fine and 12 hour Laws & Rules course or MJPE, to one (1) year probation		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
10. Failing to perform any statutory or legal obligation placed upon a licensee, including failure to repay student loans or perform scholarship service obligations. (Section 456.072(1)(k), F.S.)
a. Generally		$2,000 fine		$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
b. Student loans or scholarship service		The minimum disciplinary action imposed shall be a suspension of the license until new payment terms are agreed upon or the scholarship obligation is resumed, followed by probation for the duration of the student loan or remaining scholarship obligation period, and a fine equal to 10 percent of the defaulted loan amount		Suspension of the license until new payment terms are agreed upon or the scholarship obligation is resumed, followed by probation for the duration of the student loan or remaining scholarship obligation period, and a fine equal to 10 percent of the defaulted loan amount, to Revocation with a minimum total fine of $10,000

11. Making or filing a report which the licensee knows to be false, intentionally or negligently failing to file a report or record required by state or federal law, or willfully impeding or obstructing another person to do so. Such reports or records shall include only those that are signed in the capacity of a licensee. (Section 456.072(1)(l), F.S.)		$2,500 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
12. Making deceptive, untrue, or fraudulent representations in or related to the practice of a profession or employing a trick or a scheme in or related to the practice of a profession. (Section 456.072(1)(m), F.S.)		$10,000 fine and two (2) years probation		$10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
13. Exercising influence on the patient or client for the purpose of financial gain of the licensee or a third party. (Section 456.072(1)(n), F.S.)		$3,000 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
14. Practicing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities the licensee knows, or has reason to know, the licensee is not competent to perform. (Section 456.072(1)(o), F.S.)		$2,000 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
15. Delegating or contracting for the performance of professional responsibilities by a person when the licensee delegating or contracting for performance of such responsibilities knows, or has reason to know, such person is not qualified by training, experience, and authorization when required to perform them. (Section 456.072(1)(p), F.S.)		$2,000 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation

16. Violating any provision of Chapter 456, the applicable professional practice act, a rule of the Department or the Board, or a lawful order of the Department or the Board, or failing to comply with a lawfully issued subpoena of the Department. (Section 456.072(1)(dd), F.S.) (Section 456.072(1)(q), F.S.)		$1,000 fine and 12 hour Laws & Rules course or MPJE, to one (1) year probation		$5,000 to $10,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation
17. Improperly interfering with an investigation or inspection authorized by statute, or with any disciplinary proceeding. (Section 456.072(1)(r), F.S.)		$2,500 fine and two (2) years probation		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
18. Engaging or attempting to engage in sexual misconduct as defined and prohibited in s. 456.063(1). (Section 456.072(1)(v), F.S.)		$10,000 fine and Revocation		$10,000 fine and Revocation
19. Being unable to practice with reasonable skill and safety by reason of illness or use of alcohol, drugs, narcotics, chemicals, or as a result of any mental or physical condition (board has authority to issue order to compel examination). (Section 456.072(1)(z), F.S.)		$500 fine, suspension until safe to practice with reasonable skill and safety, and appearance before the board		$2,500 fine and Revocation
20. Failing to report to the Board, or the Department if there is no Board, in writing within 30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. (Section 456.072(1)(x), F.S.)		$1,000 fine		$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
21. Testing positive for any drug, as defined in s. 112.0455, F.S., on any confirmed preemployment or employer ordered drug screening when the practitioner does not have a lawful prescription and legitimate medical reason for using such drug. (Section 456.072(1)(aa), F.S.)		$500 fine, suspension until safe to practice with reasonable skill and safety and appearance before the board		$2,500 fine and Revocation
22. Being terminated from, or failing to successfully complete, an impaired practitioners treatment program. (Section 456.072(1)(hh), F.S.)		Suspension until successful completion or receipt of written confirmation of compliance with ongoing treatment and a fine of up to $1,000		Revocation
23. Being convicted of, or entering a plea of guilty or nolo contendere to, any misdemeanor or felony, regardless of adjudication, under 18 U.S.C. s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518, or 42 U.S.C. ss. 1320a-7b, relating to the Medicaid program. (Section 456.072(1)(ii), F.S.)		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license
24. Failing to remit the sum owed to the state for overpayment from the Medicaid program pursuant to a final order, judgment, or settlement. (Section 456.072(1)(jj), F.S.)		$500 to $5,000 fine and one (1) year probation		$2,500 to $5,000 fine and suspension until amount owed is remitted, followed by two (2) years probation, to Revocation
25. Being terminated from the state Medicaid program pursuant to s. 409.913, any other state Medicaid program, or the federal Medicare program, as a result of fraud and abuse unless eligibility to participate in the program from which the practitioner was terminated has been restored. (Section 456.072(1)(kk), F.S.)		$10,000 fine and one (1) year probation, to one (1) year suspension followed by one (1) year probation		$10,000 fine and two (2) years suspension followed by two (2) years probation, to Revocation
26. Being convicted of, or entering a plea of guilty or nolo contendere to, any misdemeanor or felony, regardless of adjudication, a crime in any jurisdiction which relates to health care fraud. (Section 456.072(1)(ll), F.S.)		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license		Revocation and a fine of $10,000, or in the case of application for licensure, denial of license
(v) Violation of Section 828.055, F.S. by a permitted county or municipal animal control agency or humane society
1. Using drugs for animal euthanasia for an improper use. (Section 828.055(3)(a), F.S.)		Reprimand and a fine of $250		$500 fine and one (1) year suspension followed by one (1) year probation, to Revocation
2. Failing to take reasonable precautions against misuse, theft, loss, or diversion. (Section 828.055(3)(b), F.S.)		Reprimand and a fine of $250		$500 fine and one (1) year suspension followed by one (1) year probation, to Revocation
3. Failing to detect or to report a significant loss, theft, or inventory shortage of drugs. (Section 828.055(3)(c), F.S.)		Reprimand, $500 fine, and one (1) year probation		$1,000 fine and one (1) year suspension followed by two (2) years probation, to Revocation
4. Failing to follow the rules of the Board regarding proper storage and handling of drugs. (Section 828.055(3)(d), F.S.)		Reprimand and a fine of $250		$500 fine and one (1) year suspension followed by one (1) year probation, to Revocation
5. Violating any provision of Section 828.055, Chapter 465, Chapter 499, F.S., or any rule adopted under those chapters. (Section 828.055(3)(e), F.S.)		Reprimand and a fine of $250		$500 fine and one (1) year suspension followed by one (1) year probation, to Revocation

(3) The board shall be entitled to deviate from the above-mentioned guidelines upon a showing of aggravating or mitigating circumstances by clear and convincing evidence presented to the board prior to the imposition of a final penalty. The fact that an Administrative Law Judge of the Division of Administrative Hearings may or may not have been aware of the below-mentioned aggravating or mitigating circumstances prior to a recommendation of penalty in a Recommended Order shall not obviate the duty of the board to consider aggravating and mitigating circumstances brought to its attention prior to the issuance of a Final Order.

(a) Aggravating circumstances; circumstances which may justify deviating from the above set forth disciplinary guidelines and cause the enhancement of a penalty beyond the maximum level of discipline in the guidelines shall include but not be limited to the following:

1. History of previous violations of the practice act and the rules promulgated thereto.

2. In the case of negligent acts, the magnitude and scope of the damage or potential damage inflicted upon the patient or the general public by the licensee’s misfeasance.

3. Evidence of violation of professional practice acts in other jurisdictions wherein the licensee has been disciplined by the appropriate regulatory authority.

4. Harm occurred.

(b) Mitigating circumstances; circumstances which may justify deviating from the above set forth disciplinary guidelines and cause the lessening of a penalty beyond the minimum level of discipline in the guidelines shall include but not be limited to the following:

1. In cases of negligent acts, the minor nature of the damage or potential damage to the patient’s or the public’s health, safety, and welfare resulting from the licensee’s misfeasance.

2. Lack of previous disciplinary history in this or any other jurisdiction wherein the licensee practices his profession.

3. Restitution of any monetary damage suffered by the patient.

4. The licensee’s professional standing among his peers.

5. Steps already taken by the licensee to insure the non-occurrence of similar violations in the future, including continuing education.

6. The degree of financial hardship incurred by a licensee as a result of the imposition of fines or the suspension of his practice.

(4) All fines imposed by the Board shall be paid within a period of ninety (90) days from the date of the final order entered by the Board. This time limitation may be modified by the Board for good cause shown in order to prevent undue hardship.

Rulemaking Authority 456.072, 456.079, 465.005 FS. Law Implemented 456.072, 456.079 FS. History–New 3-1-87, Amended 5-11-88, Formerly 21S-17.001, 21S-30.001, 61F10-30.001, Amended 6-26-95, 1-30-96, Formerly 59X-30.001, Amended 12-3-97, 11-15-98, 5-3-00, 1-2-02, 11-29-06, 9-26-12, 2-14-13,__________.

 

 

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 14, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 6, 2013