The Board proposes the rule amendments in order to update guidelines, minor violations, and citations.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-30.001: Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances
64B16-30.003: Citations
PURPOSE AND EFFECT: The Board proposes the rule amendments in order to update guidelines, minor violations, and citations.
SUMMARY: Guidelines, minor violations and citations will be updated.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
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.
SPECIFIC AUTHORITY: 456.072, 456.073, 456.077, 456.079, 465.005 FS.
LAW IMPLEMENTED: 456.072, 456.077, 456.079 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

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, registation, certificate, or license, including a provioisional 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

VIOLATIONMINIMUMMAXIMUM

 

(a) Obtaining a license byRevocationRevocation

misrepresentation fraud or error

(Section 465.016(1)(a), F.S.)

(Section 465.023(1)(a), F.S.)

 

(b) Procuring a license throughRevocationRevocation

false representation

(Section 465.016(1)(b), F.S.)

(Section 465.023(1)(b), F.S.

 

(c) Permitting unlicensed persons$2,500 fine and 12 hours LawsRevocation $5,000 and one (1) year
to practice pharmacy& Rules course or Multistatesuspension

(Section 465.016(1)(c), F.S.)Pharmacy Jurisprudence Exam

(MPJE)

 

(d) Being unfit or incompetent to$250 fine, indefinite suspensionRevocation or, at the licensee’s

practice pharmacywith PRN review and boarddiscretion, voluntarily relinquishment

(Section 465.016(1)(d), (m), F.S.)appearancewith 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$250 1,500 fine and one (1) yearRevocation $5,000 and one (1) year
pharmacy technicianprobation and 12 hour Laws &suspension

(Section 465.014, F.S.)Rules Course or MPJE

 

b. Operating a pharmacy$500 per month to maximum ofRevocation (if no permit exists, refer
without a permit$5,000 (penalty will requireto State’s Attorney)

(Section 465.015(1)(a), F.S.)permittee to renew permit or

cease practice)

 

c. Operating a pharmacy where$5,000 fine and one (1) yearRevocation $5,000 and one (1) year

an unlicensed and unsupervisedprobationsuspension

person practices pharmacy

(Section 465.015(1)(b), F.S.)

 

d. Making a false or fraudulent$5,000 fineRevocation

statement to the board

(Section 465.015(2)(a), F.S.)

 

e. Practicing pharmacy as anFine based on length of time inRevocation or $5,000 maximum

inactive licenseepractice while inactive;(penalty will require license

(Section 465.015(2)(b), F.S.)$500 $200/monthto renew license or cease practice)

 

f. Selling or dispensing

drugs without a prescription

(Section 465.015(2)(c), F.S.)

(i) Non-scheduled legend drugs$1,500 fineRevocation $5,000 and one (1) year

suspension

(ii) Scheduled (controlled$5,000 fine and one (1) yearRevocation

substances) legend drugsprobation

 

g. Selling samples orSame as violation of 465.015(2)(c)

complimentary drugsF.S. (see sub-subparagraph

(Section 465.015(2)(d), F.S.)64B16-30.001, F.A.C.

(2)(e)1.f., F.A.C., above)

(i) Non-scheduled legend drugs$1,500 fineRevocation

(ii) Scheduled (controlled $5,000 fine and one (1) yearRevocation

Substances) legend drugsprobation

 

h. Failure to notify the board of

or not to have a prescription

department manager or

consultant pharmacist

(Section 465.022(4), F.S.)

(i) Failure to notifyFine based on length of time$7,500 $5,000 maximum (penalty

Section 465.018 F.S.prior to notifying board. $500requires notification or ceasing

$200 per monthpractice)

(ii) Failure to have prescriptionFine based on length of timeRevocation of permit

department manager or consultantprior to notifying board, $750

pharmacist of recordper month and one (1) year

probation $2,500 fine and one

(1) year probation

 

i. Failure to comply with required$500 fine and 12 hour Laws &$2,500 fine

substitution of legend drugRules Course or MPJE. $1,000

requirements (Section 465.025, F.S.)fine

 

j. Failure to follow negative$1000 fine and 12 hours Laws$2,500 fine and one (1) year probation

formulary requirements& Rules Course or MPJE

(Section 465.025(6), F.S.)Reprimand

64B16-27.500, F.A.C.

 

k. Failure to follow emergency$500 fine$1,000 fine and one (1) year probation

prescription requirements

(Section 465.0275, F.S.)

 

l. Engage in prohibited$1,500 fineRevocation $5,000 fine and one (1)

rebate schemeyear probation

(Section 465.185, F.S.)

 

m. Failure to comply with

pharmacist dispensing

requirements (Section 465.186, F.S.)

(i) Failure to follow procedure,$500 fine Reprimand$1,000 fine, one (1) year probation

but dispense drug appearing onand suspension of right to dispense

formulary (Section 465.186(3), F.S.)

64B16-27.210, F.A.C.

(ii) Dispensing drug not on the$1,500 fineRevocation Same as violation of

formulary 465.186(2), F.S.)465.015(2)(c), F.S. (see sub- (Section 64B16-27.220, F.A.C.                            subparagraph

64B16-27.230, F.A.C.64B16-30.001(2)(e)1.f., F.A.C.,

above)

 

2. Chapter 499, F.S.

a. Adulteration of a drug$1,000 fine $2,000 fine andRevocation

(Section 499.005(2), (3), F.S.)one (1) year probation

(Section 499.006, F.S.)

b. Misbranding a drug

(Section 499.005(2), (3), F.S.)

(Section 499.007, F.S.)

(i) Incomplete or inaccurate$250 $1,000 fine and 12 hour$2,500 fine and one (1) year

labeling (Section 499.007, F.S.)Laws & Rules Course or MPJEprobation

64B16-28.108, F.A.C.

(ii) Fraudulent misbranding of$2,500 fine and One (1) yearRevocation

legend drugs (499.007, F.S.)suspension

c. Prescriptions Drug Pedigree$500 fine and 12 hour LawsRevocation

& Rules Course or MPJE

d. Recordkeeping requirement$500 fine and 12 hour LawsRevocation

& Rules Course or MPJE

e. Storage of drugs$500 fine and 12 hour LawsRevocation

& Course or MPJE

3. Chapter 893, F.S.

(Controlled substances)

a. Filling a prescription for$1,500 fine$5,000 fine and one (1) probation

controlled substances that does

not meet the requirements of

Chapter 893, F.S.

a. Filling a prescription not$1,500 fine$5,000 fine and one (1) year

appropriately signedsuspension

(Section 893.04(1)(b), F.S.)

b. Filling an improper

prescription (other

64B16-30.001(2)(e)3., F.A.C.

above) (893.04(1)(b), (c), F.S.)

 

b.c. Failing to retain prescription$1,000 fineRevocation $2,500 fine and one (1)

records for two (2) yearsyear probation

(Section 893.04(1)(d), F.S.)

c.d. Failing to appropriately label$250 500 fine and 12 hour Laws$2,500 $1,000 fine and one (1) year

(Section 893.04(1)(e), F.S.)& Rules course or MPJEprobation

d.e. Dispensing a Schedule II$5,000 $2,500 fine and one (1)Revocation $5,000 fine and one (1)

drug inappropriately with ayear probationyear probation (for dispensing

non-written prescriptionwithout a prescription see sub-

(Section 893.04(1)(f), F.S.)subparagraph 64B16-30.001, F.A.C.

(2)(e)1.f., F.A.C., above)

e.f. Inappropriate refilling of$1,750 fine and one (1) yearOne (1) year suspension

Schedule III, IV, or V drugsprobation

(Section 893.04(1)(g), F.S.)

f.g. Receiving controlled$2,500 $1,500 fineRevocation $5,000 fine and one (1)

substances without an appropriateyear probation

order form (Section 893.06(1), F.S.)

g.h. Unlawful possession of$2,500 fine and one (1) yearRevocation

controlled substancesprobation

(893.06(2), F.S.)

h.i. Failure to take a biennial$1000 fine$2,500 fine and one (1) year

inventoryprobation

(893.07(1)(a), (2), (3), (4), (5), F.S.)

i.j. Failure to maintain a complete$1,000 fine and one (1) yearRevocation

and accurate record of controlledprobation

substances

(893.07(1)(b), (2), (3), (4), (5), F.S.)

j.k. Dispensing controlled substance$5,000 $2,500 fine and one (1)Revocation

in other than good faithyear probation

(Section 893.08(3)(b), F.S.)

k.l. Inappropriate selling of$1,500 fine and one (1) yearOne (1) year suspension

Schedule V controlled substanceprobation

(Section 893.08(3)(c), F.S.)

l.m. Unlawful possession of$5,000 $2,500 fine and two (2)Revocation

controlled substanceone (1) years probation

(Section 893.13, F.S.)

4. Violation of Federal Drug$500 $1,000 fine and one (1)Revocation $5,000 fine and one (1)

Abuse Act 21 U. S. C. 821 et seq.year probationyear suspension

 

(f) Criminal conviction related toMisdemeanor: $1,000 fine$5,000 fine, one (1) year suspension

pharmacyand two (2) years probation

(Section 465.016(1)(f), F.S.)

(Section 465.023(1)(d), F.S.)

(i) Misdemeanor$1,000 fineRevocation

(ii) Felony:One (1) year suspension, two (2)Revocation

years probation & $5,000 fine

(g) Using in the compounding of a$250 fine and completeRevocation

prescription, or furnishing uponapproved CE course in the

prescription, an ingredient or articleprevention of medication errors

different in any manner from theof no less than eight (8) hours

ingredient or article prescribed,$1,000 fine and one (1) year

except as authorized inprobation

Section 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.)

 

(h) Filing a false report or failing

to file a report required by law

1. Knowing violation$2,000 fine and one (1) yearRevocation

probation

2. Negligent violationReprimandOne (1) year probation and $1,000

fine

 

(i) Failure to make prescription$250 fine and 12 hour Laws &$1,000 fine and one (1) year

price information availableRules Course or MPJEprobation

information availableLetter of guidance

(Section 465.016(1)(k), F.S.)

(j) Improperly placing returned$1,500 fine$3,000 fine and one (1) year

drugs into the stock of a pharmacyprobation

(Section 465.016(1)(l), F.S.)

 

(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$500 $1,000 fine and 12 hourOne (1) year probation and $2,000

64B16-28.104Laws & Rules or MPJEfine

64B16-27.100

64B16-28.106

64B16-28.107

64B16-28.109

64B16-27.103

64B16-28.111

64B16-27.104

64B16-26.400

64B16-26.401

64B16-28.404

64B16-26.301

64B16-28.114

64B16-27.105

b. 64B16-28.105 (sanitation)Suspension until complianceRevocation

c. 64B16-27.101 (counterfeit drugs)$1,000 fineRevocation Same as penalty

for adulterated drugs

(see subparagraph

64B16-30.001(2)(e)2., F.A.C.)

d. 64B16-28.110 (outdated$500 fine for possessionRevocation One (1) year probation

pharmaceuticals)$1,000 fine for dispensingand $2,000 fine (if drugs dispensed,

one (1) year suspension)

e. 64B16-28.112 (violations)Same as underlying statutory or rule

violation

f. 64B16-26.300 (Serving as$500 per month up to a $5,000Revocation One (1) year suspension

consultant pharmacist withoutfine maximum (fine based uponof pharmacist license

being licensed as a consultantthe length of time the person is

pharmacist)serving as a consultant without

being licensed as a consultant

pharmacist

g. 64B16-28.140 and 64B16-28.150$1,000 fineRevocation $5,000 fine and two (2)

(Data processing systems)(2) years probation

 

h. 64B16-28.120 (Location of$1,000 fineRevocation $5,000 fine and two (2)

legend drugs) years probation

 

i. 64B16-28.900, 64B16-28.901,

64B16-28.902 (Nuclear pharmacy)

 

(i) Practicing nuclear pharmacy$500 per month up to $5000 fineRevocation of pharmacist’s license or

without being licensed as a(fine based upon the length ofpermit

nuclear pharmacyisttime the person is practicing

(Section 64B16-28.903, F.A.C.)without being licensed as a

nuclear pharmacist) $1,000

fine and one (1) year probation

 

(ii) Failure to follow technicalOne (1) year probation andRevocation of license of practice

requirements (64B16-28.901 and$1,000 finenuclear pharmacy

64B16-28.902, F.A.C.)

j. 64B16-28.202 and 64B16-28.203$1,500Revocation of permit

(transfer of prescription files and

drugs)

2. Violation of orders of Board or$2,500 fine and one (1) yearRevocation

Departmentprobation

 

(l) License disciplined by anotherSame penalty as imposed in

jurisdictionother jurisdiction or as closely

(Section 465.016(1)(h), F.S.)as possible to penalties set forth

in Florida Statutes

 

(m) Failure to comply with Board’s$750 fine$2,500 fine and, one year probation

rule on patient counseling

(64B16-27.800, 64B16-27.810,

64B16-27.820, F.A.C.)

 

(n) Violation 465.018 by andPenalty as closely as possiblePenalty as closely as possible to those

through 465.016 and 465.023to those set forth in theset forth in the Disciplinary

Disciplinary GuidelinesGuidelines

 

(o) Violating 456.072, F.S.

1. Making misleading, deceptive, or$1,500 $2,500 fine and one (1)Revocation $5,000 fine and one (1)

fraudulent representations in oryear probationyear suspension

related to the practice of the

licensee’s profession.

2. Intentionally violating any rule$2,500 $1,500 fine and two (2)Revocation $2,500 fine and one (1)

adopted by the Board or theone (1) years probationyear probation

Department, as appropriate.

3. Being convicted or found guiltyMisdemeanor: $1,000 fine$5,000 fine and one (1) year

of, or entering a plea of guilty orFelony: $3,000 fine and one (1)suspension

nolo contendere to, regardless ofyear probation

adjudication, a crime in any

jurisdiction which relates to the

practice of, or the ability to practice,

a licensee’s profession.

(i) Misdemeanor$1000 fineRevocation

(ii) Felony$3000 fine and one (1) year

probation.Revocation

4. Failing to comply with the$500 fine$1,000 fine

educational course requirements

for human immunodeficiency virus

and acquired immune deficiency

syndrome, or medical errors.

5. Having a license or the authoritySame penalty as imposed inSame penalty as imposed in other

to practice the regulated professionother jurisdiction or as closelyjursidiction or as closely as possible

revoked, suspended, or otherwiseas possible to penalties forto penalties for similar violation

acted against, including the denial ofsimilar violation

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.

6. Having been found liable in a$3,000 fineRevocation $5,000 fine and six (6)

civil proceeding for knowinglymonth suspension

filing a false report or complaint

with the Department against

another licensee.

7. Attempting to obtain, obtaining,Revocation or denial of license

or renewing a license to practice aapplication

profession by bribery, by fraudulent

misrepresentation, or through an

error of the Department or the

Board.

8. Except as provided in Section$500 fine and one (1) yearRevocation $1,000 fine and two (2)

465.016, F.S., failing to report to theprobationyears probation

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.

9. Aiding, assisting, procuring,$2,000 fineRevocation $5,000 fine and one (1)

employing, or advising any year suspension

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.

10. Failing to perform any statutory$2,000 fineRevocation $5,000 fine and one (1)

or legal obligation placed upon ayear probation

licensee.

11. Making or filing a report which$2,500 $3,000 fine and two (2)Revocation $5,000 fine and one (1)

the licensee knows to be false,years probationyear suspension

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.

12. Making deceptive, untrue, or$10,000 fine and two (2) yearsRevocation $10,000 fine and one (1)

fraudulent representations in orprobationyear suspension

related to the practice of a

profession or employing a trick or

a scheme in or related to the

practice of a profession.

13. Exercising influence on the$3,000 fine and two (2) yearsRevocation $5,000 fine and one (1)

patient or client for the purpose ofprobationyear suspension

financial gain of the licensee or a

third party.

14. Practicing or offering to practice$2,000 fine and two (2) yearsRevocation $5,000 fine and one (1)

beyond the scope permitted by lawprobationyear suspension

or accepting and performing

professional responsibilities the

licensee knows, or has reason to

know, the licensee is not competent

to perform.

15. Delegating or contracting for the$2,000 fine and two (2) yearsRevocation $5,000 fine and one (1)

performance of professionalprobationyear suspension

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.

16. Violating any provision of this$1,000 fineRevocation $5,000 fine and two (2)

part, the applicable professionalyears probation

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.

17. Improperly interfering with an$2,500 fine and two (2) yearsRevocation $5,000 fine and one (1)

investigation or inspectionprobationyear suspension

authorized by statute, or with any

disciplinary proceeding.

18. Failing to report to the board in$1,000 fineRevocation $2,500 fine and one (1)

writing within 30 days after theyear probation

licensee has been convicted or

found guilty or entered a plea of

nolo contendere to, regardless of

adjudication, a crime in any

jurisdiction.

19. Testing positive for any drug, as$1,500 $2,500 fine PRNRevocation $5,000 fine and one (1)

defined in Section 112.0455, F.S.,evaluation and two (2) yearsyear suspension

on any confirmed preemploymentprobation or compliance with

or employer ordered drug screeningPRN contract

when the practitioner does not have

a lawful prescription and legitimate

medical reason for using such drug.

20. Being terminated from or failingSuspension until successfulRevocation

to successfully complete an impairedcompletion or receipt of written

practitioners treatment programconfirmation of compliance

(Section 456.072(1)(hh), F.S.)with ongoing treatment and a

fine of up to $1,000.

 

(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,________.

 

64B16-30.003 Citations.

(1) through (2) No change.

(3) The following violations with accompanying fines may be disposed of by citation:

(a) through (g) No change.

(h) Using in the compounding of a prescription,$250 fine, Completion of an approved CE course in the
or furnishing upon prescription, an ingredient orprevention of medication errors or no less than 8 hours
article prescription, an ingredient or article

ingredient or article prescribed, except as authorized

in Section 465.019(6) or 465.025, F.S.; or dispensing

a medication with dosage instructions different in any

way than prescribed, provided that the medication was

not used or ingested.

1. No allegation of harm or ill effects is present;

2. The licensee has no prior disciplinary history; and

3. The event did not result in or pose a significant threat to the health and safety of the patient or the public.

The penalty shall be a letter of concern, payment of costs, and completion of an approved continuing education course in the prevention of medication dispensing errors, of no less than eight (8) hours.

(i) Tendering a check payable to the Board of$100 fine plus payment of the check within 30 days.
Pharmacy or to the Department of Health that is
dishonored by the Institution upon which it is drawn.

(j) Failing to comply with the Educational course$500
requirements for Human immunodeficiency virus and

Acquired immune deficiency syndrome (HIV/AIDS),

or medical errors

(k) Failure to correct Minor violation as listed in$250
Rule 64B16-30.002, F.A.C.

(4) No change.

(5) The procedures described herein apply only for an initial offense of the alleged violation. Subsequent violation(s) of the same rule or statute shall require the procedures of Section 456.073, F.S., to be applied. In addition, should an initial offense for which a citation could be issued occur in conjunction with violations not described herein, then the procedures of Section 456.073 455.225, F.S., shall apply.

Rulemaking Specific Authority 456.073, 456.077, 465.005 FS. Law Implemented 456.077 FS. History–New 12-22-91, Formerly 21S-30.003, 61F10-30.003, 59X-30.003, Amended 4-3-00, 1-2-02, 8-26-02, 1-12-03,_________.

 

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: September 10, 2009

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: August 28, 2009