64B16-30.001: Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances
PURPOSE AND EFFECT: The Board proposes the rule amendment to update the guidelines, minor violations and citations.
SUMMARY: The guidelines, minor violations and citations will be updated.
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 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy/MQA, 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 practitioners guilty of violating Chapter 465, 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, F.S. The term license means any permit, registration, certificate, or license, including a provisional license, issued by the Department. The minimum penalty range is based upon a first time single count violation of each provision listed. The maximum penalty range is based upon multiple or repeated violations of the same provision of Chapter 465, F.S., or the rules promulgated thereto. All penalties at the upper range of the sanctions set forth in the guidelines, i.e., suspension, revocation, etc., include lesser penalties, i.e., fine, 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 for violation of the below mentioned statutes and rules:
|
PENALTY RANGE | |
VIOLATION |
MINIMUM |
MAXIMUM |
(a) Obtaining a license by misrepresentation fraud or error (Section 465.016(1)(a), F.S.) (Section 465.023(1)(a), F.S.) |
Revocation |
Revocation |
(b) Procuring a license through false representation (Section 465.016(1)(b), F.S.) (Section 465.023(1)(b), F.S.) |
Revocation |
Revocation |
(c) Permitting unlicensed persons to practice pharmacy (Section 465.016(1)(c), F.S.) |
$2,500 fine and 12 hours Laws & Rules course or Multistate Pharmacy Jurisprudence Exam (MPJE) |
Revocation |
(d) Being unfit or incompetent to practice pharmacy (Section 465.016(1)(d), (m), F.S.) |
$250 fine, indefinite suspension with PRN review and board appearance |
Revocation or, at the licensee’s discretion, voluntarily relinquishment with reinstatement under the terms and conditions approved by the board |
(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 pharmacy technician (Section 465.014, F.S.) |
$250 |
Revocation |
b. Operating a pharmacy without a permit (Section 465.015(1)(a), F.S.) |
$500 per month to maximum of $5,000 (penalty will require permittee to renew permit or cease practice) |
Revocation |
c. Operating a pharmacy where an unlicensed and unsupervised person practices pharmacy (Section 465.015(1)(b), F.S.) |
$5,000 fine and one (1) year probation |
Revocation |
d. Making a false or fraudulent statement to the board (Section 465.015(2)(a), F.S.) |
$5,000 fine |
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 |
Revocation |
f. Selling or dispensing drugs without a prescription (Section 465.015(2)(c), F.S.) |
|
|
(i) Non-scheduled legend drugs |
$1,500 fine |
Revocation |
(ii) Scheduled (controlled substances) legend drugs |
$5,000 fine and one (1) year probation |
Revocation |
g. Selling samples or complimentary drugs (Section 465.015(2)(d), F.S.) |
|
|
(i) Non-scheduled legend drugs |
$1,500 fine |
Revocation |
(ii) Scheduled (controlled Substances) legend drugs |
$5,000 fine and one (1) year probation |
Revocation |
h. Failure to notify the board of or not to have a prescription department manager or consultant pharmacist Sections 465.018, .019, .0193, .0196, or .0197, F.S.
|
|
|
(i) Failure to notify
|
Fine based on length of time prior to notifying board. $500 |
$7,500 |
(ii) Failure to have prescription department manager or consultant pharmacist of record |
Fine based on length of time prior to notifying board, $750 per month and one (1) year probation |
Revocation |
i. Failure to comply with required substitution of legend drug requirements (Section 465.025, F.S.) |
$500 fine and 12 hour Laws & Rules Course or MPJE. |
$2,500 fine |
j. Failure to follow negative formulary requirements (Section 465.025(6), F.S.) 64B16-27.500, F.A.C. |
$1000 fine and 12 hours Laws & Rules Course or MPJE
|
$2,500 fine 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 |
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.) 64B16-27.210, F.A.C. |
$500 fine |
$1,000 fine, one (1) year probation and suspension of right to dispense |
(ii) Dispensing drug not on the formulary (Section 465.186(2), F.S.) 64B16-27.220, F.A.C. 64B16-27.230, F.A.C. |
$1,500 fine |
Revocation |
n. Committing error or omission in performance of a specific function of prescription drug processing (Section 465.016(1)(t), F.S. 2. Chapter 499, F.S. |
$250 |
Revocation |
a. Adulteration of a drug (Section 499.005(2), (3), F.S.) (Section 499.006, F.S.) |
$1,000 fine |
Revocation |
b. Misbranding a drug (Section 499.005(2), (3), F.S.) (Section 499.007, F.S.) |
|
|
(i) Incomplete or inaccurate labeling (Section 499.007, F.S.) 64B16-28.108, F.A.C. |
$250 |
$2,500 fine and one (1) year probation |
(ii) Fraudulent misbranding of legend drugs (499.007, F.S.) |
$2,500 fine and One (1) year suspension |
Revocation |
c. Prescriptions Drug Pedigree |
$500 fine and 12 hour Laws & Rules Course or MPJE |
Revocation |
d. Recordkeeping requirement |
$500 fine and 12 hour Laws& Rules Course or MPJE |
Revocation |
e. Storage of drugs |
$500 fine and 12 hour Laws & Course or MPJE |
Revocation |
3. Chapter 893, F.S. (Controlled substances) |
|
|
a. Filling a prescription for controlled substances that does not meet the requirements of Chapter 893, F.S. |
$1,500 |
$5,000 fine and one (1) probation |
|
|
|
|
|
|
b. (Section 893.04(1)(d), F.S.) |
$1,000 fine |
Revocation |
c. (Section 893.04(1)(e), F.S.) |
$250 |
$2,500 |
d. (Section 893.04(1)(f), F.S.) |
$5,000 |
Revocation |
e. (Section 893.04(1)(g), F.S.) |
$1,750 fine and one (1) year probation |
One (1) year suspension |
f. (Section 893.06(1), F.S.) |
$2,500 |
Revocation |
g. |
$2,500 fine and one (1) year probation |
Revocation |
h. (893.07(1)(a), (2), (3), (4), (5), F.S.) |
$1000 fine |
$2,500 fine and one (1) year probation |
i. (893.07(1)(b), (2), (3), (4), (5), F.S.) |
$1,000 fine and one (1) year probation |
Revocation |
j. (Section 893.08(3)(b), F.S.) |
$5,000 |
Revocation |
k. (Section 893.08(3)(c), F.S.) |
$1,500 fine and one (1) year probation |
One (1) year suspension |
l. (Section 893.13, F.S.) |
$5,000 |
Revocation |
4. Violation of Federal Drug Abuse Act 21 U. S. C. 821 et seq. |
$500 |
Revocation |
(f) Criminal conviction related to pharmacy (Section 465.016(1)(f), F.S.) (Section 465.023(1)(d), F.S.) |
|
|
(i) Misdemeanor |
$1,000 fine |
Revocation |
(ii) Felony: |
One (1) year suspension, two (2) years probation & $5,000 fine |
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 465.019(6), F.S., or 465.025, F.S., or compounding, dispensing or distributing legend drugs outside professional practice of pharmacy (465.016(1)(g), F.S.) (465.016(1)(i), F.S.) |
$250 fine and complete approved CE course in the prevention of medication errors of no less than eight (8) hours |
Revocation |
(h) Filing a false report or failing to file a report required by law |
|
|
1. Knowing violation |
$2,000 fine and one (1) year probation |
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. 64B16-28.101 to 64B16-28.1035 64B16-27.100
64B16-28.109 64B16-27.103
64B16-27.104 64B16-26.400 64B16-26.2032 64B16-28.1081 64B16-26.301 64B16-28.114 64B16-27.105 64B16-27.211 64B16-28.113 64B16-28.2021 64B16-28.603
|
$500 |
One (1) year probation and $2,000 fine |
b. 64B16-28.102 |
Suspension until compliance |
Revocation |
c. 64B16-27.101(counterfeit drugs) |
$1,000 fine for dispensing |
Revocation |
d. 64B16-28.110 (outdated pharmaceuticals) |
$500 fine for possession $1,000 fine for dispensing |
Revocation |
e. 64B16-28.301, 64B16-28.303 (destruction of controlled substances) |
$500 fine and 12 hour laws and rules or MPJE |
Revocation |
f. 64B16-26.300 (Serving as consultant pharmacist without being licensed as a consultant pharmacist) |
$500 per month up to |
Revocation |
g. 64B16-28.140 |
$1,000 fine |
Revocation |
h. 64B16-28.120 (Location of legend drugs) |
$1,000 fine |
Revocation |
i. Tendering a check payable to the Board of Pharmacy or to the Department of Health that is dishonored by the institution upon which it is drawn
|
$500 and 12 hours Laws and Rules or MJPE |
$1000 fine plus payment of the check within 30 days |
j. |
$500 per month up to $5000 fine (fine based upon the length of time the person is practicing without being licensed as a nuclear pharmacist) |
Revocation |
k. |
One (1) year probation and $1,000 fine |
Revocation |
l. |
$1,500 |
Revocation |
m. Failure to complete the required continuing education during the biennial licensure period. |
|
|
1. Failure to complete less than ten (10) hours |
$500 |
$1,500 |
2. Failure to complete ten (10) or more hours In addition, licensees shall take two 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. |
$1,000 |
$2,500 |
n. Failure to maintain program requirements for certification, training, or continuing education programs or providers. |
$500 |
Revocation |
o. Failure to retain continuing education records |
$250 |
$1,500 |
p. Failure to practice in accordance with established practice standards |
|
|
1. Pharmacist |
$500 |
Revocation |
2. Pharmacy Technician |
$250 |
Revocation |
3. Pharmacy Intern |
$250 |
Revocation |
4. Permittee |
$500 |
Revocation |
q. Failure to have current policies and procedures |
$500 |
Revocation |
r. Failure to have or maintain standards for an automated fill system in a community pharmacy |
$500 and 12 hours Laws & Rules MJPE |
Revocation |
s. Failure to have or maintain standards for an institutional, special, or central fill pharmacy |
$500 and 12 hour Laws & Rules or MJPE |
Revocation |
t. Failure to maintain standards for animal control shelters. |
$500 |
Revocation |
2. Violation of orders of Board or Department |
$2,500 fine and one (1) year probation |
Revocation |
(l) License disciplined by another jurisdiction (Section 465.016(1)(h), F.S.) |
Same penalty as imposed in other jurisdiction or as closely as possible to penalties set forth in Florida Statutes |
|
(m) Failure to comply with the Board’s rule on patient counseling (64B16-27.800, 64B16-27.810, 64B16-27.820) |
$750 fine |
$2,500 fine and one year probation |
(n) Violation 465.018 by and through 456.016 and 465.023, F.S. |
Penalty as closely as possible to those set forth in the Disciplinary Guidelines |
|
(o) Violating 456.072, F.S. |
|
|
1. Making misleading, deceptive, or fraudulent representations in or related to the practice of the licensee’s profession. |
$1,500 |
Revocation |
2. Intentionally violating any rule adopted by the Board or the Department |
$2,500 |
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. |
|
|
(i) Misdemeanor |
$1,000 fine |
Revocation |
(ii) Felony |
$3,000 fine and one (1) year probation |
Revocation |
4. Failing to comply with the educational course requirements for human immunodeficiency virus and acquired immune deficiency syndrome, or medical errors |
$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 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. |
Same penalty as imposed in other jurisdiction or as closely as possible to penalties for similar violation |
|
6. Having been found liable in a civil proceeding for knowingly filing a false report or complaint with the Department against another licensee. |
$3,000 fine |
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 |
Revocation or denial of license application |
|
8. Except as provided in Section 456.016, 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. |
$500 fine and one (1) year probation |
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 |
$2,000 fine |
Revocation |
10. Failing to perform any statutory or legal obligation placed upon the licensee |
$2,000 fine |
Revocation |
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. |
$2,500 |
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. |
$10,000 fine and two (2) years probation |
Revocation |
13. Exercising influence on the patient or client for the purpose of financial gain or the licensee or a third party |
$3,000 fine and two (2) years probation |
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. |
$2,000 fine and two (2) years probation |
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. |
$2,000 fine and two (2) years probation |
Revocation |
16. Violating any provision of this part, 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 |
$1,000 fine |
Revocation |
17. Improperly interfering with an investigation or inspection authorized by statute, or with any disciplinary proceeding |
$2,500 fine and two (2) years probation |
Revocation |
18. Failing to report to the Board in writing within 30 days after the licensee has been convicted or found guilty or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. |
$1,000 fine |
Revocation |
19. Testing positive for any drug, as defined in Section 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. |
$1,500 |
Revocation |
20. 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 |
21. Being convicted of, or entering a plea of guilty or nolo contendere to any misdemeanor or felony, regardless of adjudication, under 18 USC s. 669, ss. 285-287, s. 371, s. 1001, s. 1035, s. 1341, s. 1343, s. 1347, s. 1349, or s. 1518, or 42 USC ss. 1320a-7b, relating to the Medicaid program. (456.072(1)(ii), F.S.) |
Revocation and a fine of $10,000, or in the case of application for licensure, denial of license. |
|
22. Failing to remit the sum owed to the state for overpayment from the Medicaid program pursuant to a final order, judgment, or settlement. (456.072(1)(jj), F.S.) |
From a letter of concern to probation, and a fine of $500 to $5,000. |
From a reprimand to revocation, and a fine of $2,500 to $5,000. |
(23) Being terminated from the state Medicaid program, or any other state Medicaid program, or the federal Medicare program. (456.072(1)(kk), F.S.) |
From a letter of concern to suspension, and a fine of $1,000 to $5,000. |
From a reprimand to revocation, and a fine of $5,000 to $10,000. |
(24) Being convicted of, or entering into a plea of guilty or nolo contendere to any misdemeanor or felony, regardless of adjudication, which relates to health care fraud. (456.072(1)(ll), F.S.) |
Revocation and a fine of $10,000, or in the case of application for licensure, denial of license. |
|
(3) No change.
(4) All fines imposed by the Board shall be paid within a period of ninety (90) thirty (30) days from the date of the final ordered entered by the Board. This time limitation may be modified by the Board for good cause shown in order to prevent undue hardship.
Rulemaking Specific 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,________.