The Board proposes the rule amendment to update violations and 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 the rule amendment to update violations and penalties.

SUMMARY: Violations and penalties will be updated in the rule.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS 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, 465.016, 465.023 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: C. Erica White, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 Chapters 456, 465, 499, or 893 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 Chapters 456, 465, 499, 893 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 statutory provision of Chapter 465, F.S., or the rules promulgated thereunder. 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.

VIOLATION	PENALTY RANGE
	FIRST VIOLATION MINIMUM, INCLUDING FIRST TIME OR SINGLE COUNT VIOLATIONS	SECOND AND SUBSEQUENT 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 to $5,000 fine and Revocation.	$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.)	$5,000 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) to $5,000 fine and one (1) year suspension followed by one (1) year probation.	$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. (Sections 465.016(1)(d), (m), F.S.)	$250 fine, indefinite suspension with PRN review and board appearance to revocation.	One (1) year suspension followed by one (1) year probation, to 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 to $1,000 fine and one (1) year probation.	$1,000 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 obtain or renew permit or cease practice) to Revocation.	$10,000 fine, (penalty will require permittee to renew permit or cease practice), to Revocation, and referral to State Attorney’s Office for criminal prosecution.
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 to one (1) year suspension followed by 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 to Revocation.	$10,000 fine and Revocation.
e. Practicing pharmacy as an inactive licensee. (Section 465.015(2)(b), F.S.)	$500 fine per month Fine based on length of time in practice while inactive (maximum $6000) to $10,000 $500 fine and one (1) year suspension 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 to $5,000 fine and one (1) year probation.	$5,000 fine and one (1) year probation, to Revocation.
(II) Scheduled (controlled substances) legend drugs.	$5,000 fine to $10,000 fine and one (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 to $5,000 fine and one (1) year suspension.	$5,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation.
(II) Scheduled (controlled substances) legend drugs.	$5,000 fine and one (1) year probation to Revocation.	$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. (Section 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 (maximum $6,000) to one (1) year probation.	$7,500 fine and one (1) year suspension to Revocation 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 to $2,200 fine and one (1) year probation.	$2,500 fine, 12-hour Laws & Rules course or MPJE, and one (1) year probation to Revocation.
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 to $2,500 fine and one (1) year probation.	$2,500 fine, 12-hour Laws & Rules course or MPJE, and one (1) year probation to Revocation.
k. Failure to follow emergency prescription requirements. (Section 465.0275, F.S.)	$500 fine to $2,500 fine and one (1) year probation.	$2,500 1,000 fine and one (1) year probation to $5,000 fine and one (1) year suspension followed by 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 to $5,000 fine and one (1) year probation.	$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 to $1,000 fine and one (1) year probation.	$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 to $5,000 fine and one (1) year probation.	$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 and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$1,000 fine and one (1) year probation, to revocation.
(II) Failure to report.	$1,000 fine and one (1) year probation to one (1) year suspension.	$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 and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$1,000 fine and one (1) year probation, to revocation.
p. Violation of requirements for administration of vaccines and epinephrine auto injection. (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 to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
(II) Failure to maintain proper insurance.	$500 fine and suspension until insured to one (1) year probation.	$1,000 fine, suspension until insured, followed by one (1) year probation to revocation.
(III) Failure to maintain and make available patient records.	$500 fine to one (1) year probation.	$1,000 fine and one (1) year probation to revocation.
(IV) Uncertified administration of vaccine.	$5,000 fine and one (1) year suspension of immunization certification until certified to one (1) year suspension.	$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 to one (1) year probation.	$1,000 fine and one (1) year probation to revocation.
q. Failure to request photo or other verification of identity prior to dispensing a controlled substance to a person not known. (465.0155(2), F.S.	$500 fine and 12 hour Laws & Rules course or MPJE to one (1) year probation.	$1,000 fine and one (1) year probation, to revocation.
r.  Failure to inform customers of less expensive drug when cost sharing obligation to customer exceeds retail price. (465.0244(2), F.S.)	$500 fine and 12 hour Laws & Rules course or MPJE to one (1) year probation.	$1,000 fine to one (1) year suspension of dispensing rights.
2. Chapter 499, F.S.:
a. Adulteration or misbranding of a drug. (Sections 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.)	$1,000 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$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 adulterated or misbranded. (Section 499.005(3), F.S.)	$1,000 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$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 to one (1) year probation.	$2,500 fine and one (1) year probation, to revocation.
(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 to two (2) year suspension.	$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) to one (1) year probation.	$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 to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
d. Recordkeeping requirement. (Section 499.0121, F.S.); (Sections 499.005(18), (19), F.S.)	$500 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$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 to one (1) year probation.	$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. (Sections 893.04(1)(a), (b), (c), F.S.)	$1,500 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$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 and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$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 to one (1) year probation.	$2,500 fine and (1) year probation, to revocation.
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 to one (1) year suspension.	$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 to one (1) year suspension.	$5,000 fine and one (1) year suspension, to revocation.
f. Receiving controlled substances without an appropriate order form. (Section 893.06(1), F.S.)	$2,500 fine to one (1) year probation.	$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 to one (1) year suspension.	$5,000 fine and one (1) year suspension followed by one (1) year probation, to Revocation.
h. Failure to take a biennial inventory. (Sections 893.07(1)(a), (2), (3), (4), (5), F.S.)	$1,000 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$2,500 fine and one (1) year probation, to revocation.
i. Failure to maintain a complete and accurate record of controlled substances. (Sections 893.07(1)(b), (2), (3), (4), (5), F.S.)	$1,000 fine, 12-hour Laws & Rules course or MPJE to 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 to one (1) year suspension.	$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 to one (1) year suspension.	$5,000 fine and one (1) year suspension, to revocation.
l. Unlawful possession of controlled substance. (Section 893.13, F.S.)	$5,000 fine and two (2) years’ probation to one (1) year suspension.	$10,000 fine and one (1) year suspension followed by two (2) years’ probation, to revocation.
m. Failure to report information regarding dispensed controlled substances to the Prescription Drug Monitoring Program Controlled Substance Dispensing Information Electronic System.  (893.055(3), F.S.)	$250 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
n.  Failure to consult the Prescription Drug Monitoring Program Controlled Substance Dispensing Information Electronic System prior to dispensing a controlled substance.  (893.055(8), F.S.)	$250 fine and 12-hour Laws & Rules course or MPJE to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
o.  Failure to maintain confidentiality of information obtained from the Prescription Drug Monitoring Program Controlled Substance Dispensing Information Electronic System.  (893.0551(6), F.S.)
(I). Knowing violation.	$10,000 fine and one (1) year probation to one (1) year suspension.	$10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
(II). Negligent violation.	Reprimand to $500 fine and 12 hour Laws & Rules course or MPJE.	One (1) year probation and $1,000 fine to one (1) year suspension.
4. Violation of Federal Drug Abuse Act 21 U.S.C. 821 et seq. (Manufacture, Distribution, and Dispensing of Controlled Substances.)	$1,000 500 fine and one (1) year probation to one (1) year suspension.	$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, to revocation.	$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), F.S.)
1. Misdemeanor.	$1,000 fine to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
2. Felony.	$5,000 fine and one (1) year suspension followed by two (2) years’ probation, to revocation.	$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 to one (1) year probation.	$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)(j), F.S.)
1. Knowing violation.	$10,000 fine and one (1) year probation to one (1) year suspension.	$10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
2. Negligent violation.	Reprimand to $500 fine and 12 hour Laws & Rules course or MPJE.	One (1) year probation and $1,000 fine to one (1) year suspension.
(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, to $1,000 fine and one-year probation.	$1,000 fine and one (1) year probation to one (1) year suspension.
(j) Improperly placing returned drugs into the stock of a pharmacy. (Section 465.016(1)(l), F.S.)	$1,500 fine to $1,000 fine and one-year probation.	$3,000 fine and one (1) year probation to one (1) year suspension.
(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, to $1,000 fine and one-year probation.	One (1) year probation and $2,000 fine to one (1) year suspension
b. Sink and running water, sufficient space, refrigeration, sanitation, equipment. (Rule 64B16-28.102, F.A.C.)	Suspension until compliance.	$2,000 fine to 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 to 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 to one (1) year probation.	$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 to one (1) year probation.	$5,000 fine and two (2) years’ probation, to revocation.
f. No change.
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 to one (1) year probation.	$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 to one (1) year probation.	$5,000 fine and one (1) year probation, to revocation.
i. No change.
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 to one (1) year suspension.	$5,000 fine and one (1) year suspension followed by two (2) years’ probation, to revocation.
k. through t. No change.
(l) through (n) No change.
(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 to revocation.
(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 to revocation.
(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 to one (1) year suspension.	$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
(II) Knowingly.	Revocation.	Revocation.
(r) through (t) No change.
(u) Violating Section 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.)	$10,000 fine and one (1) year probation to one (1) year suspension.	Revocation, and a fine of $10,000.
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 to one (1) year suspension.	$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 to one (1) year probation 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 to one (1) year suspension.	$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)(e), F.S.) (Rules 64B16-26.103(1)(c), (4)(e), F.A.C.)	$500 fine and suspension until compliant.	$1,000 fine and suspension until compliant.
5.  through 9. No change.
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 and suspension until compliant.	$2,500 to $10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
b. No change.
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.)
a. Knowingly filing a false report or willful obstruction.	$10,000 fine and two (2) years’ probation to one (1) year suspension.	$10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
b. No change.
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 to one (1) year suspension.	$10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
13. No change.
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 to one (1) year suspension.	$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 to one (1) year suspension.	$5,000 to $10,000 fine and one (1) year suspension followed by two (2) years’ probation, to Revocation.
16. through 27. No change.
(v) No change.

(3) through (4) No change.

Rulemaking Authority 456.072, 456.079, 465.005 FS. Law Implemented 456.072, 456.079, 465.016, 465.023 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, 2-5-14, 1-10-17,                                              .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 6, 2018