14-004511RU Shelley Kay Hill, R.N. vs. Department Of Health, Board Of Nursing Status: Closed Settled and/or Dismissed prior to entry of RO/FO on Tuesday, August 18, 2015.

Summary: A Board of Nursing statement that the injection of Botox is outside the scope of practice for registered nurses and does not constitute the administration of medication constitutes an unadopted rule in violation of section 120.54(1)(a), Florida Statutes.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

SHELLEY KAY HILL, R.N.,

Petitioner,

vs. Case No. 14 - 4511RU

DEPARTMENT OF HEALTH, BOARD OF

NURSING,

Respondent.

_______________________________/

FINAL ORDER

Pursuant to notice, a hearing was conducted in this case on

January 27, 2015, by video teleconference at sites in Orlando

and Tallahassee, Florida, b efore Administrative Law Judge

F. Scott Boyd of the Division of Administrative Hearings (DOAH) .

APPEARANCES

For Petitioner: Ge orge F. Indest III, E squire

Carole C. Schriefer, Esquire

Joanne Kenna, Esquire

The Health Law Firm

1101 Douglas Avenue

Altamonte Springs, Florida 32714

For Respondent : Lee Ann Gustafson , Esquire

Rachel W. Clark, Esquire

Department of Legal Affairs

The Capitol, Plaza Level 01

Tallahassee, Florida 32399

STATEMENT OF THE ISSU E

Whether the statement that " T he injection of Botox is not

within the scope of practice for registered nurses and does not

constitute the administration of med i cation , " ( " the Boto x

statement " ) constitutes an unadopted rule in violation of

section 120.54(1), Florida Statutes ( 2014 ) . 1/

PRELIMINARY STATEMENT

Petitioner , Shelley Kay Hill , a licensed r egistered n urse ,

filed t his unadopted rule challenge on September 24, 2014 .

Respondent , the Department of Health, Board of Nursing, filed a

Motion for Summary Final Order on October 7, 2014, which was

denied. The case was set for hearing on October 15, 2014.

Petitioner filed eight requests for official recognition,

which were not timely opposed by Respondent. All requests were

granted, with the exception of the fifth request, which was

granted in part and denied in part; and the seventh and eighth

requests, w hich were denied.

Petitioner served Respondent with 12 Requests for Admission

on October 17, 2014. A dditional and amended r equests were filed

on October 20, 2014, bringing the total to 23 Requests for

A dmission. Respondent timely provided r esponse s to th e original

12 requests on November 6, 2014. Respondent did not timely

respond to the additional amended r equests.

After continuance, the hearing was conducted on January 27,

2015. At hearing, the parties stipulated to several facts,

which were accepted and have been incorporated into the Findings

of Fact below. Petitioner offered 15 exhibits at hearing, but

14 of these were not accepted, as they were the cases and

materials already official ly recogni zed . 2/ A copy of the

Administrative Complaint was ac cepted into evidence as Exhibit

P - 8. Notwithstanding Respondent ' s failure to respond to

Petitioner ' s Amended Requests for Admission, Respondent disputed

some of these admissions at hearing. In the interest of hearing

the case on the merits, and because P etitioner failed to show

any prejudice, Respondent was permitted to withdraw the default

admissions and to deny some of the Amended Requests for

Admission at hearing. Respondent also moved for reconsideration

of the Orders granting official recognition be cause Respondent

did not receive timely notice under section 90.203(1) , Florida

Statutes . The motion was denied, as further discussed below.

Respondent offered no exhibits. Neither party offered any

witnesses.

T he one - volume T ranscript was filed on Febr uary 25 , 2015.

P roposed final orders were timely submitted by both parties and

were carefully considered.

FINDINGS OF FACT

The following facts are found, as stipulated, admitted, or

officially recognized (duplicates have been set forth only

once):

Sti pulated Facts

1 . Ms. Shelley Kay Hill is a registered nurse in the s tate

of Florida, license number RN 9317251.

2 . The D epartment of Health (DOH) is a state agency

charged with regulating the practice of nursing pursuant to

section 20.43, chapter 456, and chapter 464, Florida Statutes.

3 . Section 464.018(1)(h) provides that unprofessional

conduct as defined by B oard of Nursing rule constitutes gro unds

for disciplinary action.

4 . Florida Administrative Code Rule 64B9 - 8.005(13)

provides that unprofessional conduct includes practicing beyond

the scope of the licensee ' s license, educational preparation or

nursing experience.

5 . Ms. Hill is licensed p ursuant to c hapter 464 and is a

health care practitioner as defined in s ection 456.001(4).

6. Botox is a medication.

7 . It is within the scope of practice for registered

nurses in the s tate of Florida to administer medication.

8 . As of October 17, 2014, the Florida Board of Nursing

website located at http://floridasnursing.gov/general - faqs

states that a practical or registered nurse may not inject Botox

as it is not within the scope of practice for practical or

registered nurses.

9. As of October 17, 20 14, the Florida Board of Nursing

website located at http://floridasnursing.gov/general - faqs

states that Botox injection does not constitute the

administration of medication.

10 . Petitioner ' s Request s for Admission served on

Respondent DOH on October 17, 2 014, in this case include an

Exhibit " A " which is a printout of the " General FAQs " from the

Board of Nursing ' s website on October 17, 2014.

11 . The scope of practice for a registered nurse licensed

in the s tate of Florida includes the administration of

me dications.

12 . Injection is a form of administration of medication.

13 . Registered nurses are allowed to inject medications

within the scope of nursing practice in the state of Florida.

1 4 . As of October 17, 2014, the Florida Board of Nursing

website (located at http://floridasnursing.gov/general - faqs),

under the s ection " General FAQs, " states:

Can a practical or registered

nurse inject Botox?

The injection of Botox is not within the

s cop e of practice for practical or

registered nurses and does not constitute

the administration of medication.

1 5 . Petitioner ' s Amended Request s for Admission include

Exhibit RFA - 1 , served on Respondent DOH on October 20, 2014 ,

which is an accurate copy of a printout from the Florida Board

of Nursing ' s website ( h ttp://floridasnursing.gov/general - faqs)

under the Section " General FAQs, " as it existed on October 17,

2014.

1 6 . Proposed Exhibit P - 5, a copy of the proposed exhibit

attached to Petitioner ' s Amended Request s for Admission as " RFA -

1 " that was served on Respondent DOH on October 20, 2014 , is

authentic.

1 7 . Proposed Exhibit P - 5, the exhibit attached to the

Petitioner ' s Amended Request s for Admission as " RFA - 1 " that was

served on Respondent DOH on October 20, 2014 , is admissible.

1 8 . Injection is one of the methods of administration of a

medication.

19 . There has been no Florida Law Weekly notice regarding

rulemaking as it relates to the injection of Botox by nurses.

2 0 . The definition of " registered nurse, " as stated in

s ection 4 64.003(22), is as follows: "' Registered nurse ' means

any person licensed in this state to practice professional

nursing. "

2 1 . Botox is a drug.

2 2 . The Florida Department of Health and the Florida Board

of Nursing have disciplined registered nurses for administering

Botox by injection, as indicated in Final Order No. DOH 12 - 2134 -

S - MQA in Department of Health vs. Debra Ann Leckron, R.N. , DOH

Case No. 2012 - 01979, filed October 11, 2012 . (Order entered

Nov. 20, 2014).

2 3 . The Florida Department of Health and the Florida Board

of Nursing have disciplined registered nurses for administering

Botox by injection, as indicated in Final Order No. DOH 14 - 0617 -

S - MQA in Department of Health vs. Maritza Novas, R.N. , DOH Case

Nos. 2013 - 05848 and 2013 - 06561, filed April 18, 2014. (Order

entered Nov. 20, 2014).

24 . The Board of Nursing ' s statements regarding the

injection of Botox by nurses are statements of general

applicability to nurses.

Admissi ons

2 5 . There is no Florida Administrative Code r ule that

specifically prohibits the administration of Botox.

2 6 . The Florida Board of Nursing has made no declaratory

statements regarding the administration of Botox by nurses.

Official ly Recognized Facts

2 7 . On October 24, 2014, t he official website of the

Florida Board of Nursing, on its " General FAQs " (Frequently

Asked Questions) web page, contain ed the following question and

answer:

Can a practical or registered nurse

inject Botox?

The injection of B otox is not within the

scope of practice for practical or

registered nurses and does not constitute

the administration of medication.

2 8 . On October 24, 2014, t he official website of the

Florida Board of Nursing, on its Search Results web page, when

the term " Botox " was searched, yield ed the following results:

Can a practical or registered nurse

inject Botox?

The injection of Botox is not within the

scope of pra ctice for practical or

registered nurses and does not constitute

the administration of medication.

29 . On October 28, 2014, t he official website of the

Florida Board of Nursing, in its " Help Center " web page,

contain ed the following question and answer:

Help Center/Can a practical or registered

nurse inject Botox?

The injection of Botox is not within the

scope of practice for practical or

registered nurses and does not constitute

the administration of medication.

3 0 . Botox is a pproved by the U.S. Food and Drug

Administration (FDA).

Ultimate Facts

31 . The Botox statement constitutes a rule within the

definition of section 120.52(16).

32 . The Botox statement, or a substantially similar

statement , ha s not been adopted as a rule under chapter 120

procedur es .

33 . The Board of Nursing did not show that it is not

practicable or feasible to adopt the Botox statement as a rule.

C ONCLUSIONS OF LAW

Standin g and Jurisdiction

3 4 . In administrative proceedings, standing is a matter of

subject matter jurisdiction. Abbott Labs. v. Mylan Pharms.,

Inc. , 15 So. 3d 642, 651 n.2 (Fla. 1st DCA 2009). Section

120.56(4) provides that " [a]ny person substantially affected by

an agency stat ement may seek an administrative determination

that the statement violates s. 120.54(1)(a). "

3 5 . In order to establish standing, a challenger must show

an immediate " injury in fact " within the protected " zone of

interest . " See, e.g. , Fla. Medical Ass ' n, Inc. v. Dep ' t of

Prof ' l Reg. , 426 So. 2d 1112, 1114 (Fla. 1st DCA 1983).

3 6 . Respondent d id not contest Petitioner ' s standing to

challenge the Botox statement. Petitioner is a registered nurse

and so is bound by the scope of practice established for

registered nurses . The Botox statement declares that certain

activity is not within the scope of practice of a registered

nurse. Petitioner has standing to challenge the Botox statement

as an unadopted rule . See Ward v. Bd. of Trs. of the Int. Imp.

Trus t Fund , 651 So. 2d 1236, 1237 (Fla. 4th DCA 1995)(standing

is recognized where rule directly regulates the challenger ' s

occupational field).

3 7 . Respondent argues, however, based on United Wisconsin

Life Insurance Co. v. Department of Insurance , 831 So. 2d 239

(Fla. 1st DCA 2002), that because an A dministrative C omplaint

ha s been filed against Petitioner, s he has a remedy through h er

defenses in th at case , and the unadopted rule challenge here is

an impermissible collateral attack .

3 8 . Respondent reads United Wisconsin too broadly. While

the unadopted rule challenge in that case was brought against a

statement of charges in an administrative complaint , the basis

for the court ' s opinion was more narrow . Specifically, the

United Wisconsin court first fou nd no showing that th e charges --

directed only to United Wisconsin and alleging facial violation

of statutory provisions -- were in any way statements of " general

applicability. " The court specifically noted that the issues

raised by the administrative complaint arose for the first and

only time as a result of United Wisconsin ' s actions. The court

then went on to state that , " on the present facts , " the

unadopted rule challenge also constituted a collateral

challenge.

39 . While Petitioner here does ch allenge the Botox

statement appearing in the Administrative Complaint against her ,

she also challenges the same and similar statement s as they

appear on Respondent ' s website . The Botox statement by its own

terms is applicable to both practical and registe red nurses. In

fact, the parties stipulated that the Botox statement was a

statement of general applicability to nurses. Were United

Wisconsin to be read so broadly as to preclude an unadopted rule

challenge to such generally applicable statements just because

administrative charges have also been filed, th e provisions of

section 120.56(4) would be eviscerated , and the unique

legislative policy goals 3 / of that statutory section would n ot be

achieved . Petitioner has standing and her unadopted rule

challe nge should not be dismissed under the doctrine of United

Wisconsin .

4 0 . The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this

proceeding. § 120.56(4) , Fla. Stat.

Burden and Standard of Proof

4 1 . The burden is on Petitioner to show that the

Botox statement constitutes a rule within the meaning of

section 120.52 (16) and that Respondent has not adopted it under

applicable rulemaking procedure s . § 120.56(4)(a) , Fla. Stat .

If Petitioner succeeds , the burden then shift s to Respondent to

prove that rulemaking is not feasible or practicable.

§ 120.56(4)(b) , Fla. Stat.

4 2 . The standard of proof is by a preponderance of the

evidence. § 120.56(1)(e) , Fla. Stat .

Official Recognition

4 3 . Although Respondent did not timely respond to any of

Petitioner ' s several r equests for o fficial r ecognition,

Respondent belatedly asserted at hearing that these requests did

not technically comply with section 90.203(1), Florida Statutes,

because timely written not ice was not given to Respondent and

filed in this proceeding .

4 4 . A technical failure to comply with section 90.203(1)

notice provisions is not fatal to a motion to take judicial

notice, as long as there has been reasonable notice and an

opportunity to be heard. Scripps Research Inst., Inc. v.

Scripps Research Inst. , 916 So. 2d 988, 990 (Fla. 4th DCA

2005)(court may take judicial notice of a matter on its own

motion or may excuse the failure of a party requesting judicial

notice to comply with written n otice provisions).

4 5 . In Rogers v. State , 413 So. 2d 1270, 1271 (Fla. 1st

DCA 1982), it was held that a criminal defendant was not

prejudiced by lack of sufficient notice even though the

administrative rule he was charged with violating had been

judicially noticed only three days before his trial, because the

court found he had been furnished the text of the rule by the

information three months earlier. Similarly i n this rule

challenge case, the text of the statements on Respondent ' s

website w ere set forth in the original Petition filed by

Petitioner on September 24, 2014, and a printout of the website

page was attached as an exhibit.

4 6 . In any event , Respondent c an hardly claim to need an

extended period of time to verify whether or not information

appears on its own website. The only other item officially

recognized in this proceeding that was not also a matter of

stipulation was the fact that Botox has been ap proved by the

U.S. Food and Drug Administration . 4 / Respondent was given seven

days to respond to each of th ese requests for official

recognition . This was ample time to determine the accuracy of

all of these statements .

4 7 . At hearing, when asked what prejudice Respondent had

suffered by the granting of official recognition, none was

alleged, other than that " the rules of evidence are not being

followed. " Respondent demonstrated no prejudice. Official

recognition was app ropriate.

Definition of " Rule "

4 8 . Section 120.52(16), in relevant part, defines the term

" rule " as follows:

" Rule " means each agency statement of

general applicability that implements,

interprets, or prescribes law or policy or

describes the procedure or practice

requirements of an agency and includes any

form which imposes any requirement or

solicits any informatio n not specifically

required by statute or by an existing rule.

This definition contains several overlapping elements.

Agency Statement

49 . A petition challenging a statement as an unadopted

rule must include the text of the statement or a description of

it. A statement may be in any form, and does not need to be in

writing. Dep ' t of H igh . Saf. & Motor Veh. v. Schluter , 705 So.

2d 81, 84 (Fla. 1st DCA 1997). Petitioner sufficiently

identified the text of the Botox statement in her petition.

5 0 . T he statement must be shown to be an " agency "

statement , that is, an expression of the agency as an

institution , not merely the position of an e mployee acting on

h er own . It must be properly attributable to the agency head or

some duly - authorized delegate. Id. at 87 (Benton, J.,

concurring and dissenting) . T he parties stipulated that the

Botox statement appears in several places on the Board of

Nursing website . There has been no contention that it is not

attributable to the Board.

5 1 . Respondent notes that an agency statement explaining

how an existing rule of general applicability will be applied in

a particular set of facts is not itself a r ule. Respondent

correctly asserts that it has a duty to enforce the statutory

scope of nursing practice and that a n agency is not forced to

adopt a rule for " every possible variation on a theme. "

Respondent notes that t his level of detail is left for the

adjudication process , citing E nvironmental Trust v. Department

of Environmental Protection , 714 So. 2d 493, 498 (Fla. 1 st DCA

1998).

5 2 . However, the evidence and argument in this case has

not identified any statute or existing rule of general

applicab ility that could be enforce d to prohibit the injection

of Botox. In fact, t he " practice of professional nursing " is

defined in section 464.003(20) as:

The performance of those acts requiring

substantial specialized knowledge, judgment,

and nursing skill based upon applied

principles of psychological, biological,

physical, and social s ciences which shall

include, but not be limited to:

(a) The observation, assessment, nursing

diagnosis, planning, intervention, and

evaluation of care; health teaching and

counseling of the ill, injured, or infirm;

and the promotion of wellness, maintenance

of health, and prevention of illness of

others.

(b) The administration of medications and

treatments as prescribed or authorized by a

duly licensed practitioner authori zed by the

laws of this state to prescribe such

medications and treatments.

(c) The supervision and teaching of other

personnel in the theory and performance of

any of the acts described in this

subsection.

A professional nurse is responsible and

accoun table for making decisions that are

based upon the individual ' s educational

preparation and experience in nursing.

(Emphasis added.)

5 3 . The parties stipulated that Botox is a medication,

that injection is one of the methods of administration of a

medica tion, and that registered nurses are allowed to inject

medications within the scope of nursing practice in the state of

Florida. T hus , the Botox statement is not just a simple

application of statutory language to a particular set of facts.

In fact, the b lanket statement prohibiting the injection of

Botox, at least superficially , 5/ seems to be completely contrary

to the expressed statutory policy. Cf. St. Francis Hosp., Inc.

v. Dep ' t of HRS , 553 So. 2d 1351 , 1354 (Fla. 1st DCA

1989) (statement which expands upon statutory policy or gives it

an interpretation not readily apparent from its literal reading

re presents agency policy .) The Botox statement is , therefore , a

statement of Board policy.

General Applicability

5 4 . The requirement that a statement must be one of

general applicability has several facets. It involves first the

field of operation of the statement. Dep ' t of Com merce v.

Matthews Corp. , 358 So. 2d 256 (Fla. 1st DCA 1978)(w age rate s

applicable to public works contracts held not to be rules

because they applied only to the construction of a particular

public building and did not establish wages elsewhere in the

state into the future ) . The Botox statement by its own terms is

applicabl e to all practical and registered nurses in the state ,

now and into the future for an indefinite period.

5 5 . The concept of general applicability also involves the

force and effect of the statement itself . An agency statement

that requires compliance, creates or adversely affects rights,

or otherwise has the direct and consistent effect of law is a

rule. State Bd. of Admin. v. Huberty , 46 So. 3d 1144, 1147

(Fla. 1st DCA 2010). The Botox statement requires compliance by

nurses, expressly restricts the ability of nurses to perform

certain tasks, and has the direct effect of law. The evidence

showed no other provision of the Florida Statutes or Florida

Administrative Code which has the effect of prohibiting the

injection of Botox. It was stipulated that nurses have been

disciplined for actions inconsistent with the Botox statement.

5 6 . An agency statement must also be consistently

applicable. In Department of Highway Safety and Motor Vehicles

v. Schluter , 705 So. 2d 81, 82 (Fla. 1st DCA 1997), the cour t

found three of the challenged policies not to be generally

applicable because an employee ' s supervisor was not required to

apply them, and therefore they could not be considered to have

the " direct and consistent effect of law. " See also Coventry

First, LLC, v. Office of Ins . Reg . , 38 So. 3d 200, 20 5 (Fla. 1st

DCA 2010) (examination manual provided to examiners of the Office

of Insurance Regulation not generally applicable because

examiners had discretion not to follow it). Practical and

registered nurses do not have the discretion to choose t o follow

or not follow the Botox statement .

I mplements, I nterprets, or P rescribes

5 7 . The Botox statement goes beyond the general statutory

provisions of chapter 464 to establish an exp ress blanket

prohibition against the injection of Botox. It prescribes

policy. The Botox statement meets the definition of a rule

under section 120.52(16).

Rule Not Adopted

5 8 . As stipulated, there is no rule in the Florida

Administrative Code that specifically prohibits the

administration of Botox. The Botox statement specifically does

so. The Botox statement has not been adopted under the

procedures of section 120.54. Pet itioner alleged that Florida

Administrative Code Rule 64B9 - 8.005 was the specific rule that

should have been amended, though she was not required to

identify any specific rule. In response, Respondent contend s

that it c annot adopt the Botox statement as p art of rule

64B9 - 8.005, because it has no authority to define nursing scope

of practice. This argument is discussed as an " affirmative

defense " that rulemaking is not feasible or practicable.

Feasible and Practicable

59 . R ulemaking is not a matter of agency discretion .

Section 120.54(1)(a) requires that statements meeting the

definition of a rule be formally adopted as soon as feasible and

practicable. The burden is upon Respondent to show that

rulemaking is not feasible or practicable under secti on

120.54(1)(a) .

6 0 . The scope of nursing practice set forth in section

464.003(2) was quoted above. Section 456.003(6 ) provides:

Unless expressly and specifically granted in

statute, the duties conferred on the boards

do not include the enlargement,

modification, or contravention of the lawful

scope of practice of the profession

regulated by the boards. This subsection

shall not pr ohibit the boards, or the

department when there is no board, from

taking disciplinary action or issuing a

declaratory statement.

6 1 . Respondent notes that, based upon these statutes, it

has been determined in Florida Medical Association, Inc. v.

Department of Health, Board of Nursing , Case No. 12 - 1545RP (Fla.

DOAH Nov. 2, 2012), aff ' d 132 So. 3d 225 (Fla. 1 st DCA 2014),

that the Board of Nursing has no authority to promulgate

standards or scope of practice.

6 2 . Contrary to Respondent ' s argument , however, it does

not follow that because the Board of Nursing cannot adopt a rule

establishing scope of practice, it is therefore free to craft

and apply an unadopted rule which has the same effect .

6 3 . Rulemaking is a delegated legislative function , no t an

inherent executive one . Whiley v. Scott , 79 So. 3d 702, 710

(Fla. 2011)(agency promulgating a rule acts in place of the

legislature; rulemaking is a legislative function). A n agency

without a statutory grant of power to issue rules cannot

dispense with that fundamental requirement by the simple

expedient of avoiding the rulemaking procedures of section

120.54. The definition of a rule under section 120.52(16) is a

broad, functional one, which includes not only rules that have

been adopted following prescribed statutory procedures , but

rules that have not been, which are thus defined as " unadopted

rules " in section 120.52(20) . The Board of Nursing , without

statutory rulemaking authority to establish the scope of nursing

practice, cannot issue a rule of either variety . T he

Administrative Procedure Act does not restrict any organic

agency authority to adopt rules, rather, it and other statutes

grant agencies legislative authority to adopt them .

6 4 . Lack of authority to adopt a rule does not render it

" not feasib le " or " not practicab le " to adopt the rule as these

terms are defined in section 120.54(1)(a). Respondent has not

met the burden of show ing that rulemaking is not feasible or

practica b l e .

6 5 . The Botox statement violat es section 120.54(1)(a).

Attorneys ' Fees

6 6 . Petitioner requested attorneys ' fees and costs.

S ection 120.595(4)(a) provides that if an administrative law

judge determines that all or part of any agency statement

violates section 120.54(1)(a), a n order shal l be entered against

the agency for reasonable costs and reasonable attorney ' s fees,

unless the agency demonstrates that the statement is required by

the Federal Government to implement or retain a delegated or

approved program or to meet a condition to re ceipt of federal

funds.

FINAL ORDER

Upon consideration of the above F indings of F act and

C onclusions of L aw, it is

ORDERED that :

1. The statement that " [t] he injection of Botox is not

within the scope of practice for registered nurses and does not

constitute the administration of medication , " meets the

definition of a rule . It has not been adopted pursuant to

rulemaking procedures, in violation of section 120.54(1)(a),

Florida Statutes . Sec tion 120.56(4)(d) provides that the

Department of Health, Board of Nursing, must immediately

discontinue all reliance upon that statement , or any

substantially - similar statement , as a basis for agency action.

2 . Jurisdiction is retained for the purpose of

considering the award of attorneys ' fees and costs to

Petitioner for h er successful challenge under section

120.56(4). If the parties are unable to resolve the issue , a

written request for hearing on attorneys ' fees and costs shall

be file d with the Division of Administrative Hearings. Any

such request for hearing must be filed no later than 60 days

after the date of this Final Order.

DONE AND ORDERED this 10 th day of March, 2015, in

Tallahassee, Leon County, Florida.

S

F. SCOTT BOYD

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 10 th day of March, 2015.

ENDNOTES

1/ All references to statutes and rules are to the versions in

effect at the time of the challenge, except as otherwise

indicated.

2/ See Amos v. Moseley , 74 Fla. 555, 564, 77 So. 619, 622

(1917)(things of which a court takes judicial notice require no

proof).

3/ Unadopted rule challenges serve to enforce the rulemaking

requirements of chapter 120, an important public interest

distinct from that of a single respondent charged in an

administrative complaint. As stated in McDonald v. Department

of Banking and Finance , 346 So. 2d 569, 580 (Fla. 1st DCA 1977):

The APA does not in terms require agencies

to make rules of their policy statements of

general applicability, nor does it

explicitly invalidate action taken to

effectuate policy statements of that

character which have not been legitimated by

the rulemaking process. But that is the

necessary effect of the APA if the

prescribed rulemaking pro cedures are not to

be atrophied by nonuse.

The requirement to adopt rules was subsequently codified.

§ 120.535, Fla. Stat. (1991). The attorneys ' fees provisions of

section 120.595(4) encourage affected parties to undertake this

" private attorney general " function, and so encourage agencies

to engage in rulemaking when appropriate.

4/ The fact that Botox has been given FDA approval was

ultimately not found relevant to this case.

5/ The issue of whether or not the Botox statement substantively

contra venes a statutory provision is not at issue in this

120.56(4) proceeding, and its apparent contravention of the

statutory language is considered solely for purposes of

determining whether the statement constitutes a " rule. "

COPIES FURNISHED:

Lee Ann Gu stafson, Esquire

Rachel W. Clark, Esquire

Office of the Attorney General

Administrative Law Bureau

The Capitol, Plaza Level 01

Tallahassee, Florida 32399

(eServed)

George F. Indest, III, Esquire

Carole C. Schriefer, Esquire

Joanne Kenna, Esquire

The Health Law Firm

1101 Douglas Avenue

Altamonte Springs, Florida 32714

(eServed)

John H. Armstrong, M.D., F.A.C.S.

State Surgeon General

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399 - 1701

(eServed)

Jennifer A. Tschetter , General Counsel

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399 - 1701

(eServed)

Joe Baker, Jr., Executive Director

Department of Health

Board of Nursing

4052 Bald Cypress Way , Bin C02

Tallahassee, Florida 32399

(eServed)

Ann - Lynn Denker, Ph.D, ARNP Chair

Department of Health

Board of Nursing

4052 Bald Cypress Way

Tallahassee, Florida 32399

Ernest Reddick, Chief

Alexandra Nam

Department of State

R.A. Gray Building

500 South Bronough Street

Tallahassee, Florida 32399 - 0250

(eServed)

Ken Plante, Coordinator

Joint Administrative Procedures Committee

Room 680, Pepper Building

111 West Madison Street

Tallahassee, Florida 32399 - 1400

(eServed)

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected b y this Final Order is

entitled to judicial review pursuant to section 120.68, Florida

Statutes. Review proceedings are governed by the Florida Rules

of Appellate Procedure. Such proceedings are commenced by

filing the original notice of administrative ap peal with the

agency clerk of the Division of Administrative Hearings within

30 days of rendition of the order to be reviewed, and a copy of

the notice, accompanied by any filing fees prescribed by law,

with the clerk of the District Court of Appeal in the appellate

district where the agency maintains its headquarters or where a

party resides or as otherwise provided by law.