Notice of Change/Withdrawal

DEPARTMENT OF HEALTH
Board of Pharmacy
RULE NO.: RULE TITLE:
64B16-30.001: Disciplinary Guidelines; Range of Penalties; Aggravating and Mitigating Circumstances
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 38 No. 4, January 27, 2012 issue of the Florida Administrative Weekly.

The change is in response to written comments submitted by the staff of the Joint Administrative Procedures Committee. The changes are as follows:

1. Subsection (2) shall now read as follows:

(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. For the purposes of this rule, the descriptions of the violations are abbreviated and the full statue or rule cited should be consulted to determine the prohibited conduct.

 

PENALTY RANGE

 

VIOLATION

MINIMUM

MAXIMUM

 

2. (2)(a) shall now read as follows:

(a) Obtaining a license by misrepresentation, fraud or error.

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

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

Revocation

$10,000 fine for each count and Revocation

Revocation

$10,000 fine for each count and Revocation

 

3. (2)(b) shall now read as follows:

(b) Procuring a license 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

 

4. (2)(e) shall now read as follows:

(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.

 

 

 

5. (2)(e)1.a. shall now read as follows:

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

Revocation

 

6. (2)(e)1.b. shall now read as follows:

b. Operating a pharmacy that is not registered

(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

 

7. (2)(e)1.d. shall now read as follows:

d. Making a false or fraudulent statement to the board

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

$10,000 fine for each count

$10,000 fine for each count and Revocation

 

8. (2)(e)1.h. shall now read as follows:

h. Failure to notify the board of or not to have a prescription department manager or consultant pharmacist

(Section 465.019, .0193, .0196, .0197, or 465.022(10)(11), F.S.

 

 

(i) Failure to notify

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 consultant pharmacist of record

Fine based on length of time prior to notifying board, $750 per month and one (1) year probation

Revocation

 

9. (2)(e)1.i. shall now read as follows:

i. Failure to comply with required substitution of legend drug requirements

(Section 465.025(2)(3) and (4), F.S.

$500 fine and 12 hour Laws & Rules Course or MPJE

$2,500 fine

 

10. (2)(e)3.a. shall now read as follows:

a. Filling a prescription for controlled substances that does not meet the requirements of Chapter 893, F.S.

$1500 fine

$5,000 fine and one (1) year probation

 

11. (2)(e)n. shall be removed from the rule in its entirety.

12. (2)(k)1.i. shall be removed from the rule in its entirety.

13. (2)(k)1.i.(i) shall be renumbered as (2)(k)1.i.

14. (2)(k)1.i.(ii) shall be renumbered as (2)(k)1.j.

15. (2)(k)1.j. shall be renumbered as (2)(k)1.k.

16. (2)(k)1.m. shall be renumbered as (2)(k)1.l. and shall now read as follows:

l. Failure to complete the required continuing education during the biennial licensure period. Rule 64B16-26.103, F.A.C.

 

 

 

17. (2)(k)1.m.1. shall be renumbered as (2)(k)1.l.1. and shall now read as follows:

1. Failure to complete less than ten (10) hours

$500

$1,500

 

18. (2)(k)l.m.2. shall be renumbered as (2)(k)1.l.2. and shall now read as follows:

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

 

19. (2)(k)1.n. shall be renumbered as (2)(k)1.m. and shall now read as follows:

m. Failure to maintain program requirements for certification, training, or continuing education programs or providers. Rule 64B16-26.601, F.A.C.

$500

Revocation

 

20. (2)(k)1.o. shall be renumbered as (2)(k)1.n. and shall now read as follows:

n. Failure to retain continuing education records. Rule 64B16-26.603, F.A.C.

$250

$1,500

 

21. (2)(k)1.p. shall be renumbered as (2)(k)1.o. and shall now read as follows:

o. Failure to practice in accordance with established practice standards. Rules 64B16-27.1001, .104, F.A.C.

 

 

 

22. (2)(k)1.o.2. shall be deleted in its entirety and (2)(k)1.o.1. through 3. shall now read as follows:

1. Pharmacist

$500

Revocation

2. Pharmacy Intern

$250

Revocation

3. Permittee

$500

Revocation

 

23. (2)(k)1.q. shall be renumbered as (2)(k)1.p. and shall now read as follows:

p. Failure to have current policies and procedures. Rules 64B16-28.141, .450, F.A.C.

$500

Revocation

 

24. (2)(k)1.r. shall be renumbered as (2)(k)1.q. and shall now read as follows:

q. Failure to have or maintain standards for an automated pharmacy system in a community pharmacy. Rule 64B16-28.141, F.A.C.

$500 and 12 hours Laws & Rules or MJPE

Revocation

 

25. (2)(k)1.s. shall be renumbered as (2)(k)1.r. and shall now read as follows:

r. Failure to have or maintain standards for a central fill pharmacy. Rule 64B16-28.450, F.A.C.

$500 and 12 hours Laws & Rules or MJPE

Revocation

 

26. (2)(k)1.s. shall now read as follows:

s. Failure to have or maintain standards for an institutional pharmacy. Rules 64B16-28.602, .6021, .605, .606, .702, F.A.C.

$500 and 12 hour Laws & Rules or MJPE

 

 

27. (2)(k)1.t. and shall now read as follows:

t. Failure to maintain or have standards for a special pharmacy Rules 64B16-28.800, .810, .820, .840, .850, .860, .870, F.A.C.

$500 and 12 hour Laws & Rules or MJPE

 

 

28. (2)(k)1.t. shall be renumbered as (2)(k)1.u. and shall now read as follows:

t. Failure to maintain standards for animal control shelters

$500

Revocation

 

29. (2)(n) shall now read as follows:

(n) Abandoning or allowing permit to become null and void after notice of disciplinary proceedings. Section 465.018(3), F.S.

Revocation

Revocation

 

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