02-004916RX John W. Sullivan, D.C., And Florida Chiropractors Physicians Association, Inc. vs. Department Of Health, Board Of Chiropractic Medicine Status: Closed DOAH Final Order on Thursday, October 9, 2003.

Summary: Rule prohibiting chiropractors from administering injectable vitamins not invalid exercise of delegated legislative authority; evidence established statutory definitions of "legend drugs" included injectable vitamins, making administration off-limits.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

JOHN W. SULLIVAN, D.C., and )

FLORIDA CHIROPRACTIC )

PHYSICIANS' ASSOCIATION, INC., )

)

Petitioners, )

)

vs. ) Case No. 02 - 4916RX

)

DEPARTMENT OF HEALTH, BOARD OF )

CHIROPRACTIC MEDICINE, )

)

Respondent. )

)

FINAL ORDER

Pursuant to notice, Lawrence P. Stevenson, Administrative

Law Judge, Division of Administrative Hearings, conducted a

formal hearing in the above - styled case on June 3 through 5,

2 003, in Tallahassee, Florida.

APPEARANCES

For Petitioners: Neil F. Garfield, Esquire

6840 Southwest 20th Street

Plantation, Florida 33317

For Respondent: Donna Erlich, Esquire

Board of Chiropractic Medicine

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1703

Robert P. Daniti, Esquire

Department of Healt h

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1703

STATEMENT OF THE ISSUE

Whether Rule 64B2 - 17.0025(4), Florida Administrative Code,

constitutes an invalid exercise of delegated legislative

authority.

PRELIMINARY STATEMENT

On December 30, 2002, Petitioners, John W. Sullivan, D.C.,

and Florida Chiropractic Physicians' Association, Inc.

("Petitioners"), filed a "Petition for Declaratory, Injunctive

and Supplemental Relief" at the Division of Administrativ e

Hearings ("DOAH"). On January 6, 2003, Respondent, Department

of Health, Board of Chiropractic Medicine (the "Board"), filed a

motion to dismiss on the ground that the petition requested

relief that DOAH could not grant. By Order dated January 16,

2003 , Judge Stephen F. Dean granted the motion to dismiss but

gave Petitioners until January 23, 2003, to amend their

petition.

On January 23, 2003, Petitioners filed an Amended Petition

for Determination of Invalidity of Rule 64B2 - 17.0025(4), Florida

Administ rative Code. After a lengthy discovery process, the

matter was set for final hearing on June 3 through 5, 2003. A

conflict in Judge Dean's schedule necessitated the reassignment

of the case to the undersigned.

At the hearing, Petitioners offered the test imony of

John W. Sullivan, D.C.; Roderic A. Lacy, D.C.; Paul J.

Yocom, D.C.; and Frederick D. Yost, D.C. Joseph L. Johnston,

D.C., and Drs. Lacy and Sullivan testified as rebuttal

witnesses. Pursuant to order, the parties exchanged and

submitted their ex hibits in binders. Petitioners had two

binders of proposed exhibits. From Book One, Petitioners'

Exhibits 17 and 30 were admitted into evidence. From Book Two,

Petitioners' Exhibits 1, 2, 4, 7, 8, 9, 12, 14, and 21 were

admitted into evidence.

Responde nt offered the testimony of Paul Lambert, Esquire,

general counsel to the Florida Chiropractic Association; William

Nevius, D.C.; Ronald J. Hoffman, D.C.; Jerry Hill, a licensed

pharmacist and bureau chief of Statewide Pharmaceutical Services

for the Depar tment of Health; and the videotaped deposition

testimony of William G. Nychis, acting director of the Division

of New Drugs and Labeling Compliance, Center for Drug Evaluation

and Research, Office of Compliance, in the Federal Food and Drug

Administration ("FDA"). Respondent's Exhibits 1 through 6, and

B, C, D, F, H, J - 1, K, L, M, and N were admitted into evidence.

Respondent's Exhibit N was the deposition testimony of

Everett A. Kelly, a pharmacist and former member of the Florida

House of Representative s. Respondent's Exhibit I, a vial of

injectable cyanocobalimin (Vitamin B - 12) and its packaging, was

inadvertently omitted and is hereby deemed admitted.

A four - volume Transcript of the hearing was filed at the

Division of Administrative Hearings on June 26, 2003. By

stipulation at the hearing, the parties agreed to file their

proposed final orders no later than July 25, 2003. Petitioners

filed their Proposed Final Order on July 23, 2003. Respondent's

Proposed Recommended Order was filed on July 25, 200 3. Both

parties' proposals have been given careful consideration in the

preparation of this Final Order.

Unless otherwise indicated, all statutory references in

this Final Order are to the 2003 version of the Florida Statutes

and all references to Rules a re to the current version of the

Florida Administrative Code.

FINDINGS OF FACT

Based on the oral and documentary evidence adduced at the

final hearing and the entire record in this proceeding, the

following findings of fact are made:

1. The Board is the state agency responsible for the

licensure and regulation of chiropractic medicine in the State

of Florida. Section 456.013 and Chapter 460.

2. Petitioner, John W. Sullivan, is a licensed Florida

chiropractic physician subject to regulation by the Boar d.

Petitioner, the Florida Chiropractic Physicians' Association,

Inc., is a Florida corporation organized as a trade association

to represent the interests of the Florida - licensed chiropractic

physicians who compose a large portion of its membership.

Dr. Sullivan is the president of the Florida Chiropractic

Physicians' Association. The Board does not contest the

standing of either Petitioner to initiate this proceeding.

3. Petitioners have challenged Rule 64B2 - 17.0025(4) as an

invalid exercise of delega ted legislative authority. The

challenged rule provides:

64B2 - 17.0025. Standard of Practice for

Phlebotomy, Physiotherapy, and the

Administration of Items for Which a

Prescription is not Required; Prohibition of

Prescribing or Administering Legend Drug s.

(1) Any chiropractic physician who in his

practice uses physiotherapy, phlebotomizes,

or administers items for which a

prescription is not required must have

acquired the competence to perform said

service, procedure, or treatment through

appropriat e education and/or training. Any

chiropractic physician who provides any

treatment or service for which he or she has

not been specifically educated or trained

shall be deemed to be performing

professional responsibilities which the

licensee knows or has reason to know he or

she is not competent to perform, and shall

be subject to discipline pursuant to Section

460.413(1)(t), Florida Statutes.

(2) For the purpose of Chapter

460.403(8)(c), [1] Florida Statutes, "items

for which a prescription is not requ ired"

include "proprietary drugs" such as patent

or over - the - counter drugs in their unbroken,

original package and which is not misbranded

under the provisions of Chapter 499.001 -

499.081, Florida Statutes.

(3) For the purpose of Chapter

460.403(8)(c), Florida Statutes, and this

rule "administration" is defined as the

administration of one dose of any

proprietary drug, and the recommendation and

direction of dosage levels for the patient's

needs. Administration shall not include

dispensing of repackage d proprietary drugs.

(4) All chiropractic physicians are

explicitly prohibited by Chapter 460.403,

Florida Statutes, from prescribing or

administering to any person any legend drug.

A legend drug is defined as a drug required

by federal or state law to be dispensed only

by prescription. For the purpose of this

rule, any form of injectable substance is

beyond the scope of practice for

chiropractors.

(5) Notwithstanding the prohibition

against prescribing and administering legend

drugs under Section 460.403 or 499.0122,

Florida Statutes, chiropractic physicians

may order, store, and administer, for

emergency purposes only at the chiropractic

physician's office or place of business,

prescription medical oxygen and may also

order, store, and administer the following

topical anesthetics in aerosol form:

(a) Any solution consisting of 25 percent

ethyl chloride and 75 percent

dichlorodifluoromethane.

(b) Any solution consisting of 15 percent

dichlorodifluoromethane and 85 percent

trichloromonofluoro methane.

However, this rule does not authorize a

chiropractic physician to prescribe medical

oxygen as defined in chapter 499.

Specific Authority 460.405 FS. Law

Implemented 460.403(8)(c), (f),

460.413(1)(t), FS. History -- New 10 - 17 - 90,

Formerly 21D - 17.0025, 61F2 - 17.0025,

59N - 17.0025, Amended 2 - 16 - 98.

(Emphasis added)

4. Section 460.405 cited as the specific authority for the

challenged rules, provides:

The Board of Chiropractic Medicine has

authority to adopt rules pursuant to

ss. 120.536(1 ) and 120.54 to implement the

provisions of this chapter conferring duties

upon it.

5. Section 460.403(9), paragraphs (c) and (f) of which are

cited as a law implemented by the challenged rule, provides:

(c)1. Chiropractic physicians may adjust,

manip ulate, or treat the human body by

manual, mechanical, electrical, or natural

methods; by the use of physical means or

physiotherapy, including light, heat, water,

or exercise; by the use of acupuncture; or

by the administration of foods, food

concentrates, food extracts, and items for

which a prescription is not required and may

apply first aid and hygiene, but

chiropractic physicians are expressly

prohibited from prescribing or administering

to any person any legend drug except as

authorized under subparag raph 2. , from

performing any surgery except as stated

herein, or from practicing obstetrics.

2. Notwithstanding the prohibition

against prescribing and administering legend

drugs under subparagraph 1., or s. 499.0122,

pursuant to board rule chiropracti c

physicians may order, store, and administer,

for emergency purposes only at the

chiropractic physician's office or place of

business, prescription medical oxygen and

may also order, store, and administer the

following topical anesthetics in aerosol

form:

a. Any solution consisting of 25 percent

ethylchloride and 75 percent

dichlorodifluoromethane.

b. Any solution consisting of 15 percent

dichlorodifluoromethane and 85 percent

trichloromonofluoromethane.

However, this paragraph does not authoriz e

a chiropractic physician to prescribe

medical oxygen as defined in chapter 499.

* * *

(f) Any chiropractic physician who has

complied with the provisions of this chapter

is authorized to analyze and diagnose

abnormal bodily functions and to ad just the

physical representative of the primary cause

of disease as is herein defined and

provided. As an incident to the care of the

sick, chiropractic physicians may advise and

instruct patients in all matters pertaining

to hygiene and sanitary measures as taught

and approved by recognized chiropractic

schools and colleges. A chiropractic

physician may not use acupuncture until

certified by the board. Certification shall

be granted to chiropractic physicians who

have satisfactorily completed the requir ed

coursework in acupuncture and after

successful passage of an appropriate

examination as administered by the

department. The required coursework shall

have been provided by a college or

university which is recognized by an

accrediting agency approved by the United

States Department of Education. [2] (Emphasis

added)

6. Section 460.413(1)(t), cited as a law implemented by

the challenged rule, provides:

(1) The following acts constitute grounds

for denial of a license or disciplinary

action, as specif ied in s. 456.072(2):

* * *

(t) Practicing or offering to practice

beyond the scope permitted by law or

accepting and performing professional

responsibilities which the licensee knows or

has reason to know that she or he is not

competent to perfor m.

7. At issue in this case is whether the relevant Florida

Statutes authorize chiropractic physicians to administer foods,

food supplements and nutrients to patients by way of injection.

If the statutes do authorize chiropractic physicians to

administe r these substances via injection, then the express

prohibition on the administration of " any form of injectable

substance" by chiropractic physicians contained in

Rule 64B2 - 17.0025(4) is without legislative authorization.

8. In 1923, the Florida Legis lature established the

"Florida State Board of Chiropractic Examiners" to oversee the

licensing and discipline of chiropractic physicians. The scope

of chiropractic practice was set forth as follows, in relevant

part:

Any Chiropractor who has complied wit h the

provisions of this Act may adjust by hand

the articulations of the spinal column, but

shall not prescribe or administer to any

person any medicine now or hereafter

included in materia medica . . . .

Chapter 9330, Section 12, Laws of Florida (1923).

(Emphasis added)

9. Section 12 of Chapter 9330, Laws of Florida, was

amended in 1941 to provide, in relevant part:

B. Any chiropractor who has complied with

the provisions of this Act may:

* * *

(2) Chiropractors may adjust, manipulate

or t reat the human body by manual,

mechanical, electrical or natural methods,

or by the use of physical means,

Physiotherapy (including light, heat, water

or exercise) or by the use of foods and food

concentrates, food extracts, and may apply

first aid and hyg iene, but chiropractors are

expressly prohibited from prescribing or

administering to any person any medicine or

drug included in Materia Medica . . . .

Chapter 20871, Section 1, Laws of Florida (1941).

(Emphasis added)

10. In 1957, the Florida Legislatu re amended the statute,

then numbered Section 460.11, Florida Statutes, to provide, in

relevant part:

(2) Any chiropractic physician who has

complied with the provisions of this chapter

may:

* * *

(b) Chiropractic physicians may adjust,

manip ulate, or treat the human body by

manual, mechanical, electrical or natural

methods, or by the use of physical means,

physiotherapy (including light, heat, water

or exercise) or by the oral administration

of foods and food concentrates, food

extracts , and may apply first aid and

hygiene, but chiropractic physicians are

expressly prohibited from prescribing or

administering to any person any medicine or

drug . . . .

Chapter 57 - 215, Section 3, Laws of Florida. (Emphasis added).

11. Aside from being renumb ered Section 460.03 by

Chapter 79 - 211, Section 1, Laws of Florida, the relevant

language of the statute remained essentially unchanged between

1957 and 1986. Chapter 86 - 285, Section 2, amended

Section 460.03(3), to provide:

(c) Chiropractic physicians may adjust,

manipulate, or treat the human body by

manual, mechanical, electrical, or natural

methods or by the use of physical means or

physiotherapy, including light, heat, water,

or exercise, or by the use of acupuncture,

or by the administration of foo ds, food

concentrates, food extracts, and proprietary

drugs , and may apply first aid and hygiene,

but chiropractic physicians are expressly

prohibited from prescribing or administering

to any person any legend drug . . . .

(Emphasis added)

The underscored language indicates two significant changes made

by the Legislature in 1986. First, the term "oral

administration" was changed simply to "administration," and

"proprietary drugs" were added to the list of items that

chiropractic physicians were allowed to administer. Second, the

items that chiropractic physicians were prohibited from

prescribing or administering was changed from "any medicine or

drug" to "any legend drug."

12. Chapter 86 - 285, Section 1, Laws of Florida, also added

the following language to Section 460.403(3)(f), Florida

Statutes (currently Section 460.403(9)(f)):

Any chiropractic physician licensed after

October 1, 1986, may not phlebotomize or use

physiotherapy or acupuncture or administer

proprietary drugs until certified by the

boar d to use any of such procedures.

Certification shall be granted to

chiropractic physicians licensed after

October 1, 1986, who have satisfactorily

completed the required coursework in the

procedure or procedures for which

certification is sought, and afte r

successful passage of an appropriate

examination as administered by the

department. The required coursework shall

have been provided by a college or

university which is recognized by an

accrediting agency approved by the United

States Department of Educ ation.

Chiropractic physicians licensed after

October 1, 1986, seeking certification in

one or more of the procedures for which

certification is required may elect to take

the certification examination at the time of

taking the initial licensing examinati on or

at any subsequent examination. Nothing

herein shall be construed to require

chiropractic physicians who have met all

requirements for licensure prior to the

effective date of this act to become

certified to phlebotomize or use

physiotherapy.

13. D r. Ronald J. Hoffman testified that he was a member

of the Board in 1986 and was directed by the Board's chairman to

create the syllabus for the certification course in proprietary

drugs required by the 1986 amendment to the statute, quoted

above. In conj unction with the National College of

Chiropractic, Dr. Hoffman designed a 72 - hour certification

course, including three to four hours of instruction relating to

injectable nutrients.

14. In Chapter 97 - 247, Section 1, Laws of Florida, the

term "propr ietary drugs" was deleted from the list of items that

chiropractic physicians may administer. In its place was

inserted the term "items for which a prescription is not

required," which is the current language of Section

460.403(9)(c), set forth in Finding of Fact 5, supra . Chapter

97 - 247 also deleted the requirement that a chiropractic

physician obtain certification to administer proprietary drugs.

15. Petitioners' challenge focuses on the language in

Rule 64B2 - 17.0025(4) stating that "any form of inje ctable

substance is beyond the scope of practice for chiropractors."

Petitioners contend that the statutory language permitting

chiropractic physicians to "administer" foods, food

concentrates, and food extracts (generally, vitamins and

nutrients) by its terms allows chiropractic physicians to inject

those substances into their patients. Petitioners admit that

between 1955 and 1986, the statute limited their practice to the

"oral administration" of the listed substances. However,

Petitioners also argue t hat the Legislature's changing the term

"oral administration" to "administration" in 1986, evinced a

clear intent to allow chiropractic physicians to administer

foods, food concentrates, and food extracts in any manner,

including by injection.

16. In his testimony, Dr. John Sullivan went even further,

arguing that the term "administer" can only mean "administer by

injection." His contention on this point was echoed by

Petitioners' witness Dr. Roderic Lacy. Another witness for

Petitioners, Dr. Paul Yocom , D.C., testified that

"administration" at least implies some action by the physician

and that a physician does not typically place a pill in the

patient's mouth.

17. Dr. Lacy testified that when the Legislature removed

the word "oral" from the statute i n 1986, "everybody was under

the impression they were going to be able to do injectable

nutrition" because the certification course in proprietary drugs

included a section on injectable nutrients. Dr. Lacy stated

that this impression changed when "practic ally nobody passed"

the certification examination and the issue of injecting

vitamins and nutrients "kind of faded away."

18. Petitioners contend that it is nonsensical that the

law would permit them to prescribe and administer foods, food

concentrates, and food extracts in an oral form, but not to

administer the same substances via subcutaneous injection.

19. Dr. Sullivan testified that vitamins are food, whether

taken orally or by injection. The body uses the vitamins in the

same way regardless of t he method by which the vitamins enter

the body. The same vitamin does not become a "drug" simply

because the means of administering it changes. Dr. Sullivan

pointed out that some people cannot metabolize certain vitamins

orally and must take them by inje ction.

20. Dr. Lacy testified that an inability to administer

vitamins and nutrients by injection restricts a chiropractic

physician's ability to treat patients. He noted that the

absorption rate when vitamins are taken orally is 10 to 20

percent, whe reas the absorption rate for injections is 100

percent. If a patient is deficient in a certain vitamin or

nutrient, the number of oral doses the patient would need to

address the deficiency could make the patient sick.

21. Dr. Lacy testified that he w as unaware of any instance

of a serious adverse reaction related to the injection of a

vitamin or nutrient. Dr. Lacy noted that "injectable" simply

means that the vitamin is in a sterile, water soluble solution,

and that the character of the vitamin itsel f is unchanged. Both

Dr. Sullivan and Dr. Lacy testified that because injectable

vitamins are water soluble, any excess amounts are eliminated

from the body via urination.

22. Petitioners attacked the term "legend drug" as a vague

and overbroad term in the Rule. Dr. Lacy testified that

"legend" simply means "label," and, therefore, that any drug

with a label on it could be termed a "legend drug." Given the

broad meaning of "legend," Dr. Lacy argued that there could be

"legend drugs," "legend vitamins," and even "legend foods,"

though no one questions the right of a chiropractic physician to

prescribe foods and vitamins.

23. Dr. Lacy testified that he contacted the Food and Drug

Administration to find out its definition of the term "legend

drug." He s tated that FDA informed him that it was a "slang

term" used interchangeably with the term "prescription drug" and

without a written definition.

24. Dr. Yocom testified that he spent "many hours" on the

internet in search of a definition of the term "lege nd drug."

He could not find that the term "existed per se ." He found

references to the term "legend drug," but always without

definition. Dr. Yocom testified that in his mind, "legend"

simply means "a description, a label."

25. Dr. Sullivan testified that "legend" does not mean

"prescription only." A "legend" on a label simply tells the

user what is in the product and how to use it. Dr. Sullivan

testified that such products as aspirin, Tylenol, Benadryl,

Excedrin P.M., and even oral vitamins are "leg end" products

because their labels contain instructions for their use.

26. In addition to their dispute with the Board's use of

the terms "administration" and "legend drug," Petitioners, by

their testimony, indicate that they have a different

understan ding of the term "prescription" than that employed by

the Board. Dr. Yocom testified that he "prescribes" hot packs,

cold packs, and exercise to his patients. Dr. Sullivan

"prescribes" certain diets to his weight loss patients.

27. This testimony dis regards the common understanding of

the term "prescription," i.e. , an order for medication, therapy,

or a therapeutic device given by a properly authorized person to

a person properly authorized to dispense or perform the order.

In the context of drugs, " prescription" carries a connotation

that the patient will receive a medication that the patient

could not lawfully procure without a physician's order. 3 While

it is literally true that a physician may "prescribe" such

things as cold packs, exercise, and d iets, the patient does not

require a physician's prescription to obtain them. Petitioners'

testimony on this point cannot be credited.

28. The Board's position is that Rule 64B2 - 17.0025 was

adopted in 1990 precisely because many chiropractors were

c onfused about the effect of the 1986 legislation. Paul

Lambert, the general counsel for the Florida Chiropractic

Association, testified that, at the time the legislation passed,

he believed that chiropractic physicians were authorized to

administer inject able vitamins and that he drafted a legal

opinion in support of that position in 1989. Testimony at the

hearing established that many chiropractors, including some

members of the Board, shared Mr. Lambert's opinion. The Board's

position is that the Rule, defining the terms "administration"

and "legend drug," was necessary to dispel this misconception.

29. Dr. Hoffman testified that, after he prepared the

certification course, he researched the question of whether

Vitamin B - 12, the most commonly used inj ectable vitamin, was a

legend drug. He concluded that it was. Dr. Hoffman testified

that this fact appeared to be common knowledge among pharmacists

but that chiropractors seemed unaware of it. He stated that he

likely would not have included instructio n on injectable

vitamins in the certification course had he known injectable

vitamins were considered legend drugs.

30. As a result of his research, Dr. Hoffman became a firm

proponent of a rule to disallow the use of injectable vitamins

by chiropractic physicians. Dr. Hoffman testified that he

helped draft the language of the Rule and helped to promulgate

it as a member of the Board in 1990.

31. The Rule defines "legend drug" as " a drug required by

federal or state law to be dispensed only by prescrip tion." As

noted above, Petitioners challenged this definitional conflation

of the terms "legend drug" and "prescription drug." The

Department responded that every "federal or state law" relevant

to the medical professions and to the profession of pharmac y

treats the terms as equivalent and that the Rule simply

clarified that the 1986 legislation intended "legend drug" to

carry this common meaning.

32. This issue is significant, if not dispositive, of this

case, because the Board introduced persuasive e vidence that the

FDA considers all injectable drugs, including injectable

vitamins and nutrients, to be "legend" or "prescription" drugs.

William Nychis, acting director of the FDA's Division of New

Drugs and Labeling Compliance, testified that insulin is the

only item intended for parenteral administration that the FDA

does not classify as a drug.

33. Mr. Nychis began his analysis by referencing the

definition of "drug" found in Section 201(g) of the Federal

Food, Drug, and Cosmetic Act, codified at 21 U.S.C.

Section 321(g)(1):

The term "drug" means (A) articles

recognized in the official United States

Pharmacopoeia, official Homoeopathic

Pharmacopoeia of the United States, or

official National Formulary, or any

supplement to any of them; and (B) artic les

intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of

disease in man or other animals; and

(C) articles (other than food) intended to

affect the structure or any function of the

body of man or other animals; and

(D) articles intended for use as a component

of any article specified in clause (A), (B),

or (C). A food or dietary supplement for

which a claim, subject to sections

343(r)(1)(B) and 343(r)(3) of this title or

sections 343(r)(1)(B) and 343(r)(5)(D) of

this title, is m ade in accordance with the

requirements of section 343(r) of this title

is not a drug solely because the label or

the labeling contains such a claim. A food,

dietary ingredient, or dietary supplement

for which a truthful and not misleading

statement is ma de in accordance with section

343(r)(6) of this title is not a drug under

clause (C) solely because the label or the

labeling contains such a statement.

34. Mr. Nychis testified that "legend drug" and

"prescription drug" are considered synonymous terms by the FDA.

He stated that a legend drug is one for which adequate

directions for use by the lay person cannot be written, and

which therefore must carry the "Rx" or “prescription only”

legend. In contrast, a "proprietary" or over - the - counter drug

is on e that can bear adequate directions for use by the lay

person. The classification of drugs is performed on a case - by -

case basis.

35. Prescription drugs are articles that because of their

toxicity or other potential for adverse effect, or because of

thei r method of use, or because of the collateral measures

necessary for their use, are not safe for use except under the

supervision of a practitioner authorized by state law to

administer such a drug. Prescription drugs are not available to

the consumer exc ept through an authorized practitioner.

36. Mr. Nychis testified that any item, except insulin,

administered by injection is classified by the FDA as a

prescription drug. Products that are intended to be injected,

because of the collateral measure nece ssary for their use, are

not considered safe except under the supervision of a

practitioner authorized by law to administer and prescribe such

drugs. Mr. Nychis emphasized that it is up to the states to

determine who is a practitioner authorized by law to prescribe

and administer prescription drugs and that the FDA takes no

position as to the propriety of allowing chiropractic physicians

to prescribe or administer injectable vitamins.

37. Mr. Nychis testified that as early as 1945, the FDA,

in what is ca lled trade correspondence, first began to classify

injectable vitamins and nutrients as prescription drugs. In

1951, the definition was clearly set forth in Section 503(b)(1)

of the Food, Drug and Cosmetic Act, codified at 21 U.S.C.

Section 353(b)(1) and set out in full in the Conclusions of Law

below. For at least 50 years, the FDA has not classified an

injectable vitamin or nutrient as anything other than a

prescription or legend drug. Mr. Nychis testified that even

injectable water is classified as a drug.

38. Legend drugs or prescription drugs are identified as

"Rx" in the FDA publication, "Approved Drug Products with

Therapeutic Equivalence Evaluations," also known as "The Orange

Book." Large numbers of injectable vitamins and nutrients are

listed as "Rx" in the Orange Book. Some fat - soluble vitamin

tablets and injections are also listed as "Rx" or prescription.

Even "soy bean oil" (vitamin E) can be found listed in the

Orange Book as a prescription drug in its injectable form.

39. Appendix C t o the Orange Book lists 43 "routes of

administration" for drug products, demonstrating that

"injection" is not necessarily an equivalent term to

"administration," as contended by Dr. Sullivan. In any event,

the use of the term "administration" of food pro ducts in Section

460.403(9)(c) must be read in conjunction with the statute's

prohibition on "administering" legend drugs. Once it is

established that injectable vitamins are legend drugs, then it

follows that "administration" of food products, whatever i t

might include, cannot include the method of injection.

40. Jerry Hill has been a pharmacist for more than 30

years and is the bureau chief of statewide pharmaceutical

services for the Florida Department of Health, responsible for

the licensure of drug w holesale facilities and manufacturing

facilities. Mr. Hill testified that the term "legend drug" has

been in use for at least as long as he has been a pharmacist.

The "legend" on these products is the notice that federal or

state law prohibits dispensing them without a prescription or

the "Rx only" notice. Mr. Hill testified that the statutes

enforced by his agency treat "legend drug," "prescription drug,"

and "medicinal drug" as interchangeable terms. He cited, as an

example Section 499.003(25), which provides:

"Legend drug," "prescription drug," or

"medicinal drug" means any drug, including,

but not limited to, finished dosage forms,

or active ingredients subject to, defined

by, or described by s. 503(b) of the Federal

Food, Drug, and Cosmetic Act or

s . 465.003(8), s. 499.007(12), or

s. 499.0122 (1)(b) or (c).

41. As did Mr. Nychis, Mr. Hill testified that drugs are

classified not merely by their substance, but by their intended

use and method of administration as well. Thus, he contradicted

the Peti tioners' testimony that a vitamin is considered "food"

regardless of its method of administration. Mr. Hill noted that

in its oral dosage form, Vitamin B - 12 may be classified as a

dietary supplement. If the label indicates some use to treat a

medical con dition, Vitamin B - 12 may be classified as an over -

the - counter medication. In its injectable form, Vitamin B - 12 is

a legend drug, available only by prescription.

42. Mr. Hill also agreed with Mr. Nychis that, except for

insulin, all dosage forms in whic h the route of administration

is injectable are classified as prescription drugs. Mr. Hill

stated that no injectable products may be purchased from a

Florida pharmacy without a prescription. He testified that it

would be his duty to seize any injectable Vitamin B - 12 that he

found in the possession of a chiropractic physician and to

prosecute the chiropractic physician for unlawful possession of

a prescription drug.

43. Everett A. Kelly has been a licensed pharmacist in

Florida since 1961 and served in th e Florida House of

Representatives for 22 years. Mr. Kelly confirmed Mr. Hill's

testimony that the term "legend drug" is synonymous with the

term "prescription drug." The referenced "legend" is the

identification that the item is "Rx only" or may be disp ensed

only by prescription. Mr. Kelly testified that Florida defers

to the FDA's classifications of substances as "drugs." On this

point, both Mr. Hill and Mr. Kelly noted that federal law allows

the states to make their drug laws more restrictive than t he

federal laws, but does not allow the states to enact less

restrictive laws. Mr. Hill cited the example of ephedrine

hydrochloride, which the FDA classifies as an over - the - counter

drug, but for which Florida requires a prescription.

44. Mr. Kelly also confirmed the testimony of Mr. Nychis

and Mr. Hill that all injectable items, except insulin, are

legend drugs. Mr. Kelly explained that insulin is excepted

because diabetics must use it daily for their entire lives, and

that the diagnosing physician's in itial prescription is

considered sufficient for the patient to receive insulin in

perpetuity. Mr. Kelly stated that, aside from insulin, every

other injectable product, including water for injection, is a

legend drug.

45. The testimony of Mr. Hill, Mr. N ychis, and Mr. Kelly

as to the meaning of the term "legend drug" is credited insofar

as it represents their understanding of the common usage in

their respective professions, based upon federal and state

statutory definitions. The contrary testimony of Pe titioners'

witnesses as to the meaning of "legend drug" cannot be credited.

These chiropractic physicians were essentially offering a

layman's view of the term derived from internet searches, phone

calls to unidentified FDA employees, and a self - serving

d isregard of the fact that "legend drug" is defined in state and

federal statutes.

46. In summary, the testimony established that when the

1986 legislation became law, many chiropractors focused on the

change of "oral administration" to "administration" an d

concluded that they were now free to administer injectable

vitamins and nutrients to their patients. Even some members of

the Board shared this belief, as evidenced by the inclusion of

instruction regarding injectable nutrients in the certification

cour se for proprietary drugs. However, closer examination of

the issue and consultation with professionals in other health

fields led the Board to an understanding that the term "legend

drug" includes any injectable substance, even vitamins and

nutrients that may be considered foods or over - the - counter drugs

in their oral form. This understanding, and the need to make

all chiropractic physicians aware of the true state of the law,

led the Board to adopt Rule 64B2 - 17.0025 in 1990.

47. Petitioners raised sever al other issues that merit

brief discussion. Petitioners attempted to offer evidence of

legislative intent regarding the 1986 legislation by way of

statements by Dennis Jones, the state representative who

sponsored the relevant amendments. The Board atte mpted to

counter this evidence with testimony by Mr. Kelly, who was also

in the state House of Representatives in 1986. The undersigned

declined to accept any of this testimony, finding that an

individual legislator's statements cannot form the basis for a

finding of legislative intent. See State v. Patterson , 694

So. 2d 55, 58 n.3 (Fla. 5th DCA 1997), and cases cited therein

(testimony of individual legislators as to what they intended to

accomplish is of doubtful worth in determining legislative

intent and may not even be admissible).

48. Petitioners argued that certain members of the Florida

Chiropractic Physicians' Association, having completed the

certification course and passed the examination in the late

1980's, continue to hold certification in th e administration of

proprietary drugs, including injectable vitamins. As noted

above, the Legislature in 1997 removed the statutory authority

for the Board to grant certification to chiropractic physicians

in proprietary drugs. In fact, the current statu tory scheme

permits any chiropractic physician to administer "items for

which a prescription is not required," rendering the old

certification program meaningless. Further, the evidence at the

hearing established that the certifications in proprietary dru gs

could not have certified their holders to administer injectable

vitamins, which are legend drugs that no chiropractic physician

can be authorized to administer under the relevant statutes.

49. Petitioners offered the 1987, 1989, and 1990 editions

of t he "Florida Health Care Atlas" as evidence that the 1986

legislation authorized chiropractic physicians to administer

injectable vitamins. Each of the cited editions of the Atlas

does, in fact, state that "chiropractors may now . . .

administer proprietar y drugs and injectable vitamins upon

certification . . . ." However, the Board pointed out that the

Atlas was a publication of the Department of Health and

Rehabilitative Services, not the Board of Chiropractic Medicine

or its parent agency at the time, t he Department of Professional

Regulation. The Board disavowed the inaccurate information in

the Atlas, which was in any event a reference guide lacking the

legal effect of a statute or rule.

50. Finally, Petitioners offered documentation that the

Boa rd in 2000 approved a 50 - hour continuing education course

that included a three hour section on "injectable nutrients."

However, the notice of Board approval included an italicized

notice that the three - hour section on injectable nutrients would

not be ac cepted. Subsequently, in January 2001, the Board

approved a three - hour course in injectable nutrients for

continuing education credit but required the presentation to

include a disclaimer that all or portions of the material

presented constituted practice outside the scope of the

profession.

CONCLUSIONS OF LAW

51. The Division of Administrative Hearings has

jurisdiction over the parties and the subject matter of this

proceeding according to Section 120.56(1) and (3).

52. Section 120.56, provides in per tinent part:

1) GENERAL PROCEDURES FOR CHALLENGING THE

VALIDITY OF A RULE OR A PROPOSED RULE. --

(a) Any person substantially affected by

a rule or a proposed rule may seek an

administrative determination of the

invalidity of the rule on the ground that

the rule is an invalid exercise of delegated

legislative authority.

(b) The petition seeking an

administrative determination must state with

particularity the provisions alleged to be

invalid with sufficient explanation of the

facts or grounds for the alleged invalidity

and facts sufficient to show that the person

challenging a rule is substantially affected

by it, or that the person challenging a

proposed rule would be substantially

affected by it.

* * *

(3) CHALLENGING EXISTING RULES; SPECIAL

PROVISIONS. --

(a) A substantially affected person may

seek an administrative determination of the

invalidity of an existing rule at any time

during the existence of the rule.

53. Petitioner John W. Sullivan and those members of the

Florida Chiropractic Physicians' Association, who are Florida

licensed chiropractic physicians, are affected persons with

standing to challenge the validity of Rule 64B2 - 17.0025(4). See

Florida Board of Medicine v. Florida Academy of Cosmetic

Surgery, Inc. , 808 S o. 2d 243, 250 - 251 (Fla. 1st DCA 2002).

54. As the moving party asserting the affirmative by

attacking the validity of an existing agency rule, Petitioners

in this case retain the burden of proof throughout the entire

proceeding. Espinoza v. Department of Business and Professional

Regulation , 739 So. 2d. 1250, 1251 (Fla. 3d DCA 1999); Balino v.

Department of Health and Rehabilitative Services , 348 So. 2d 349

(Fla. 1st DCA 1977); Section 120.56(3).

55. The party attacking an existing rule has the burden to

prove that the Rule constitutes an invalid exercise of delegated

legislative authority. Cortes v. State Board of Regents , 655

So. 2d 132 (Fla. 1st DCA 1995). The standard of proof is a

preponderance of the evidence. See Section 120.56(3).

56. An Administrative Law Judge may invalidate an existing

Rule only if it is an invalid exercise of delegated legislative

authority. See Section 120.56(1)(a) and (3)(a).

57. Section 120.52(8) defines "invalid exercise of

delegated legislative authority" to me an:

[A]ction which goes beyond the powers,

functions, and duties delegated by the

Legislature. A proposed or existing rule is

an invalid exercise of delegated legislative

authority if any one of the following

applies:

(a) The agency has materially f ailed to

follow the applicable rulemaking procedures

or requirements set forth in this chapter;

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(3)(a)1.;

(c) The rule enlarges, modifies, or

c ontravenes the specific provisions of law

implemented, citation to which is required

by s. 120.54(3)(a)1.;

(d) The rule is vague, fails to establish

adequate standards for agency decisions, or

vests unbridled discretion in the agency;

(e) The rule is arbitrary or capricious.

A rule is arbitrary if it is not supported

by logic or the necessary facts; a rule is

capricious if it is adopted without thought

or reason or is irrational; or ;

(f) The rule imposes regulatory costs on

the regulated perso n, county, or city which

could be reduced by the adoption of less

costly alternatives that substantially

accomplish the statutory objectives.

A grant of rulemaking authority is

necessary but not sufficient to allow an

agency to adopt a rule; a specific law to be

implemented is also required. An agency may

adopt only rules that implement or interpret

the specific powers and duties granted by

the enabling statute. No agency shall have

authority to adopt a rule only because it is

reasonably related to th e purpose of the

enabling legislation and is not arbitrary

and capricious or is within the agency's

class of powers and duties, nor shall an

agency have the authority to implement

statutory provisions setting forth general

legislative intent or policy. St atutory

language granting rulemaking authority or

generally describing the powers and

functions of an agency shall be construed to

extend no further than implementing or

interpreting the specific powers and duties

conferred by the same statute.

58. Peti tioners' challenge to Rule 64B2 - 17.0025(4) is

based on paragraphs (b), (c), (d), and (e) of Section 120.52(8). 4

At the hearing, Petitioners abandoned their challenge to the

Rule based on paragraph (a) of Section 120.52(8).

59. Petitioners also alleged in the Amended Petition that

the Rule violates "the powers set forth in the Florida

Constitution delegating legislative powers solely to the Florida

Legislature." The alleged constitutional deficiencies are not

analyzed in this Final Order because it is well - settled that an

Administrative Law Judge cannot declare an existing Rule

unconstitutional. See Department of Administration v. Division

of Administrative Hearings , 326 So. 2d 187, 189 (Fla. 1st DCA

1976).

60. Petitioners challenge Rule 64B2 - 17.0025(4), which

provides:

All chiropractic physicians are explicitly

prohibited by Chapter 460.403, Florida

Statutes, from prescribing or administering

to any person any legend drug. A legend

drug is defined as a drug required by

federal or state law to be dispen sed only by

prescription. For the purpose of this rule,

any form of injectable substance is beyond

the scope of practice for chiropractors.

61. The Board's grant of rulemaking authority is found at

Section 460.405, which provides:

The Board of Chiropra ctic Medicine has

authority to adopt rules pursuant to

ss. 120.536(1) and 120.54 to implement the

provisions of this chapter conferring duties

upon it.

62. The Board is charged with regulating the practice of

chiropractic medicine. Section 460.403(9), t he statute pursuant

to which the Board promulgated Rule 64B2 - 17.0025(4), consists of

the very definition of the practice of chiropractic medicine.

The Board clearly possesses the authority to adopt rules

implementing the statute defining the practice of c hiropractic,

provided those rules do not deviate from the statutory

definitions.

63. Petitioners challenge the definition of "legend drug"

provided in the Rule. They must concede that Section 460.403(9)

prohibits chiropractic physicians from "prescribing or

administering to any person any legend drug," except for certain

named items not relevant to this case. However, Petitioners

contend that the statute does not define "legend drug," and

argue that the definition set forth in the Rule is in derogation

o f the statute. This argument is premised on the claim that

since 1986, the statute has allowed chiropractic physicians to

administer vitamins and nutrients via injection but that the

Rule impermissibly prohibits such administration.

64. Through testimon y, Petitioners attempted to create the

impression that the term "legend drug" is something of a

mystery, a "slang term" with a murky past and no precise meaning

that is here employed by the Board to circumvent the intent of

the statute.

65. In response, the Board noted two definitions of the

term found in the Florida Statutes. Chapter 465 regulates the

practice of pharmacy. Section 465.003(8) provides:

"Medicinal drugs" or "drugs" means those

substances or preparations commonly known as

"prescription" or "legend" drugs which are

required by federal or state law to be

dispensed only on a prescription, but shall

not include patents or proprietary

preparations as hereafter defined.

66. Chapter 499 is the "Florida Drug and Cosmetic Act."

Section 499.003 sets forth the definitions of terms employed in

the Florida Drug and Cosmetic Act, and includes:

(25) "Legend drug," "prescription drug," or

"medicinal drug" means any drug, including,

but not limited to, finished dosage forms,

or active ingredients subjec t to, defined

by, or described by s. 503(b) of the Federal

Food, Drug, and Cosmetic Act or

s. 465.003(8), s. 499.007(12), or

s. 499.0122(1)(b) or (c).

67. The first of the laws cited in Section 499.003(25) is

Section 503(b) of the Federal Food, Drug, and Cosmetic Act,

which is codified at 21 U.S.C. Section 353(b), and provides:

(b) Prescription by physician; exemption

from labeling and prescription requirements;

misbranded drugs; compliance with narcotic

and marihuana laws

(1) A drug intended for use by man

which --

(A) because of its toxicity or other

potentiality for harmful effect, or the

method of its use, or the collateral

measures necessary to its use, is not safe

for use except under the supervision of a

practitioner licensed by law to administer

such drug; or

(B) is limited by an approved application

under section 355 of this title to use under

the professional supervision of a

practitioner licensed by law to administer

such drug; shall be dispensed only (i) upon

a written prescript ion of a practitioner

licensed by law to administer such drug, or

(ii) upon an oral prescription of such

practitioner which is reduced promptly to

writing and filed by the pharmacist, or

(iii) by refilling any such written or oral

prescription if such refi lling is authorized

by the prescriber either in the original

prescription or by oral order which is

reduced promptly to writing and filed by the

pharmacist. The act of dispensing a drug

contrary to the provisions of this paragraph

shall be deemed to be an act which results

in the drug being misbranded while held for

sale.

(2) Any drug dispensed by filling or

refilling a written or oral prescription of

a practitioner licensed by law to administer

such drug shall be exempt from the

requirements of sectio n 352 of this title,

except paragraphs (a), (i)(2) and (3), (k),

and (l), and the packaging requirements of

paragraphs (g), (h), and (p), if the drug

bears a label containing the name and

address of the dispenser, the serial number

and date of the prescrip tion or of its

filling, the name of the prescriber, and, if

stated in the prescription, the name of the

patient, and the directions for use and

cautionary statements, if any, contained in

such prescription. This exemption shall not

apply to any drug dispe nsed in the course of

the conduct of a business of dispensing

drugs pursuant to diagnosis by mail, or to a

drug dispensed in violation of paragraph (1)

of this subsection.

(3) The Secretary may by regulation

remove drugs subject to section 355 of this

title from the requirements of paragraph (1)

of this subsection when such requirements

are not necessary for the protection of the

public health.

(4)(A) A drug that is subject to

paragraph (1) shall be deemed to be

misbranded if at any time prior to

di spensing the label of the drug fails to

bear, at a minimum, the symbol "Rx only."

(B) A drug to which paragraph (1) does

not apply shall be deemed to be misbranded

if at any time prior to dispensing the label

of the drug bears the symbol described in

s ubparagraph (A).

(5) Nothing in this subsection shall be

construed to relieve any person from any

requirement prescribed by or under authority

of law with respect to drugs now included or

which may hereafter be included within the

classifications stat ed in sections 4721,

6001, and 6151 of Title 26, or to marihuana

as defined in section 4761 of Title 26.

68. 21 U.S.C. Section 353(b) fully supports the testimony

of Mr. Nychis as to the FDA's methods of defining items as

"drugs," not merely based on the ir substance, but on their

methods of use and/or collateral measures necessary to their

use.

69. The second law cited in Section 499.003(25), Florida

Statutes, is Section 499.007, which provides:

A drug or device is misbranded:

* * *

(12) If it is a drug intended for use by

humans which is a habit - forming drug or

which, because of its toxicity or other

potentiality for harmful effect, or the

method of its use, or the collateral

measures necessary to its use, is not safe

for use except under th e supervision of a

practitioner licensed by law to administer

such drugs; or which is limited by an

effective application under s. 505 of the

federal act to use under the professional

supervision of a practitioner licensed by

law to prescribe such drug, un less it is

dispensed only:

(a) Upon the written prescription of a

practitioner licensed by law to prescribe

such drug;

(b) Upon an oral prescription of such

practitioner, which is reduced promptly to

writing and filled by the pharmacist; or

(c ) By refilling any such written or oral

prescription, if such refilling is

authorized by the prescriber either in the

original prescription or by oral order which

is reduced promptly to writing and filled by

the pharmacist.

This subsection does not re lieve any

person from any requirement prescribed by

law with respect to controlled substances as

defined in the applicable federal and state

laws.

70. The third law cited in Section 499.003(25) is Section

499.0122(1)(b) and (c), which provides:

(1) As used in this section, the term:

* * *

(b) "Prescription medical oxygen" means

oxygen USP that is a compressed medical gas

and which can only be sold on the order or

prescription of a practitioner authorized by

law to prescribe. The label of p rescription

medical oxygen must comply with current

labeling requirements for oxygen under the

Federal Food, Drug, and Cosmetic Act.

(c) "Veterinary legend drug" means a

legend drug intended solely for veterinary

use. The label of the drug must bear t he

statement, "Caution: Federal law restricts

this drug to use by or on the order of a

licensed veterinarian."

71. The term "legend drug" also appears in the practice

act for physicians, which contains the following, in Section

458.331:

(1) The follo wing acts constitute grounds

for denial of a license or disciplinary

action, as specified in s. 456.072(2):

* * *

(q) Prescribing, dispensing,

administering, mixing, or otherwise

preparing a legend drug, including any

controlled substance, other than in the

course of the physician's professional

practice. For the purposes of this

paragraph, it shall be legally presumed that

prescribing, dispensing, administering,

mixing, or otherwise preparing legend drugs,

including all controlled substances,

i nappropriately or in excessive or

inappropriate quantities is not in the best

interest of the patient and is not in the

course of the physician's professional

practice, without regard to his or her

intent.

72. Virtually identical grounds for denial of a license or

disciplinary action in relation to "legend drugs" are found in

the statutes governing osteopaths, podiatrists, naturopaths,

pharmacists, dentists, and veterinarians. See respectively

Sections 459.015(1)(t), 461.013(1)(o), 462.14(1)(q),

465.016( 1)(i), 466.028(1)(p), and 474.214(1)(ff). None of these

disciplinary statutes sets forth a separate definition of the

term "legend drug."

73. The fact that Section 460.403(9) lacks a separate

definition for the term "legend drug" does not empower the B oard

to ignore the definitions set forth in other sections of the

Florida Statutes. At the time the 1986 legislation was passed,

the term "legend drug" was employed in Chapter 465 and in the

various professional licensure statutes cited above and was

exp licitly defined in Chapter 499. 5 The Legislature must be

presumed to have been aware of these uses and definitions when

it employed the term "legend drug" in Chapter 86 - 285, Laws of

Florida, and to have intended the Board to make reference to

them in impl ementing the legislation.

74. To adopt Petitioners' view of the term, the Board

would have to ignore the multifarious provisions of the Florida

Statutes defining and using the term "legend drug" and further

ignore the federal statutes and the authori tative pronouncements

of the FDA as to the classification of injectable vitamins and

nutrients as legend drugs. The Board's imprimatur would place

chiropractic physicians in jeopardy of prosecution for

possessing and dispensing prescription drugs without statutory

authority to do so.

75. The mere deletion of the word "oral" from the statute

in the 1986 legislation cannot be considered in isolation. The

same 1986 legislation changed the items that chiropractic

physicians were prohibited from prescribing or administering

from "any medicine or drug" to "any legend drug." In

Chapter 96 - 296, Section 1, Laws of Florida, the Legislature

enacted specific exceptions to the legend drug prohibition,

relating to medical oxygen and certain topical anesthetics. The

evidence presented at the hearing overwhelmingly demonstrated

that injectable vitamins are legend drugs and are not listed in

the exceptions to the legend drug prohibition.

76. Section 460.403(9), considered in pari materia with

the sections of the Flo rida Statutes that reference its meaning

and the meaning of related items in conjunction with federal

law, clearly prohibits chiropractic physicians from

administering injectable vitamins and nutrients to their

patients. The challenged rule merely makes e xplicit the

prohibition that the statute implicitly states.

77. This case is clearly analogous to Board of Podiatric

Medicine v. Florida Medical Association , 779 So. 2d 658 (Fla.

1st DCA 2001), in which the Board of Podiatric Medicine had

proposed a rule defining the terms "human leg" and "surgical

treatment," as those terms were used in what is now Section

461.003(5). The cited statute defines the term "practice of

podiatric medicine" but does not further define the terms "human

leg" and "surgical treat ment," although it employs those terms

in the definition of the practice. The Administrative Law

Judge's Final Order had declared the proposed rule an invalid

exercise of delegated legislative authority. In reversing the

final order, the court wrote:

S everal experts in various disciplines

testified at the rule challenge hearing, and

documentary materials were also presented.

This evidence indicates that references to

the human leg may have multiple meanings

within the anatomic, medical, and podiatric

fields. While a limited meaning is

sometimes ascribed to the leg as referring

to that portion of the lower limb between

the knee and the ankle, a broader meaning is

also ascribed whereby the term refers to the

entire limb so as to encompass the lower leg

below the knee and the upper leg above the

knee. The administrative law judge accorded

the statutory terminology only the more

limited meaning, and reasoned that the

challenged rule therefore expanded the scope

of podiatric practice which was

legislativel y established under section

416.003(3). However, this ignores the

evidence as to a broader meaning which is

consistent with the definition in the

proposed rule, and the statute does not

suggest that a more limited meaning would

pertain. In light of the b road discretion

and deference which is accorded an agency in

the interpretation of a statute which it

administers, Public Employees Relations

Commission v. Dade County Police Benevolent

Association , 467 So. 2d 987 (Fla. 1985), and

because such an interpret ation should be

upheld when it is within the range of

permissible interpretations, Board of

Trustees of Internal Improvement Trust Fund

v. Levy , 656 So. 2d 1359 (Fla. 1st DCA

1995), the judge should not have rejected

the Board's definition of the term "hum an

leg" as used in section 461.003(3), and as

provided in rule 64B18 - 23.001. This

definition does not enlarge, modify, or

contravene the statute, and is neither

arbitrary nor capricious, and is fully

supported by competent substantial evidence

so as to be a proper exercise of the Board's

delegated legislative authority.

Id. at 660.

78. In the instant case, the evidence established that the

Board's definition of "legend drug" is well within the range of

permissible interpretations; does not enlarge, mo dify, or

contravene the statute; is neither arbitrary nor capricious; and

is fully supported by competent substantial evidence so as to be

a proper exercise of the Board's delegated legislative

authority.

79. Petitioners offered a great deal of testimony,

irrelevant to this case, to the effect that it is perfectly safe

for chiropractic physicians to administer injectable vitamins

and nutrients, that few if any patients have ever had an adverse

reaction to a Vitamin B - 12 injection. These arguments should b e

made to the Florida Legislature, which has the authority to

amend the statute to expand the scope of practice for

chiropractic physicians.

80. Petitioners have not met their burden of proof. They

have failed to demonstrate that Rule 64B2 - 17.0025(4) is an

invalid exercise of delegated legislative authority.

ORDER

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is

ORDERED that the Amended Petition is dismissed.

DONE AND ORDERED this 9th day of October, 2003, in

Tallahassee, Leon Co unty, Florida.

S

___________________________________

LAWRENCE P. STEVENSON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Administrative Hearings

this 9th day of October, 2003.

ENDNOTES

1/ Since the text of the Rule was last published in 1998,

Section 460.403(8)(c) has been renumbered as Section

460.403(9)(c). See Chapter 99 - 397, Section 105, Laws of

Florida.

2/ The inclusion of paragraph (f) appears to be a holdover from

the time when that paragraph included a certification procedure

for proprietary drugs, as will be further discussed below.

3/ Section 465.003 sets forth the definitions relevant to the

statutes regulating the practice of pharmacy. Subsection (14)

provides:

"Prescription" includes any order for drugs

or medicinal supplies written or transmitted

by any means of communication by a duly

licensed practitioner authorized by the laws

of the state to prescribe such drugs or

medicinal supplies and intended to be

dispensed by a pharmacist. The term also

includes an orally transmitted order by the

lawfully designated agent of such

pra ctitioner. The term also includes an

order written or transmitted by a

practitioner licensed to practice in a

jurisdiction other than this state, but only

if the pharmacist called upon to dispense

such order determines, in the exercise of

her or his profe ssional judgment, that the

order is valid and necessary for the

treatment of a chronic or recurrent illness.

The term "prescription" also includes a

pharmacist's order for a product selected

from the formulary created pursuant to

s. 465.186. Prescription s may be retained

in written form or the pharmacist may cause

them to be recorded in a data processing

system, provided that such order can be

produced in printed form upon lawful

request.

4/ The amended petition also claimed that the Rule was not

suppor ted by competent substantial evidence, as required by

Section 120.52(8)(f). However, Section 120.52(8)(f) was

repealed by Chapter 2003 - 94, Section 1, Laws of Florida,

effective June 4, 2003.

5/ Section 465.003(7), Florida Statutes (1985), provided

langu age identical to that in current Section 465.003(8), i.e.,

"Medicinal drugs" or "drugs" means those

substances or preparations commonly known as

"prescription" or "legend" drugs which are

required by federal or state law to be

dispensed only on a prescrip tion, but shall

not include patents or proprietary

preparations as hereafter defined.

See also Sections 458.331(1)(q), 459.015(1)(q), 461.013(1)(p),

462.14(1)(q), 465.016(1)(i), and 466.028(1)(q), Florida Statutes

(1985), all employing the term "legend dr ug."

Section 499.003(15), Florida Statutes (1985), provided:

"Legend drug" means any drug which can be

dispensed only by the prescription of a

licensed practitioner and which drug on its

label must bear either the words:

(a) "Caution: Federal Law Prohi bits

Dispensing Without Prescription";

(b) "Caution: Florida Law Prohibits

Dispensing Without Prescription"; or

(c) "Caution: Federal Law Restricts This

Drug to be Dispensed by or on the Order of a

Licensed Veterinarian."

Chapter 92 - 69, Section 3, Law s of Florida, deleted the quoted

definition and substituted the definition of "legend drug" found

in current Section 499.003(25).

COPIES FURNISHED :

Donna Erlich, Esquire

Robert P. Daniti, Esquire

Department of Health

4052 Bald Cypress Way, Bin A02

Talla hassee, Florida 32399 - 1703

Neil F. Garfield, Esquire

6840 Southwest 20th Street

Plantation, Florida 33317

Scott Boyd

Acting Executive Director/General Counsel

Joint Administrative Procedures Committee

120 Holland Building

Tallahassee, Florida 32399 - 13 00

Liz Cloud, Chief

Bureau of Administrative Code

The Elliott Building, Room 201

Tallahassee, Florida 32399 - 0250

William W. Large, General Counsel

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT T O JUDICIAL REVIEW

A party who is adversely affected by 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 commen ced by

filing the original Notice of Appeal with the agency clerk of

the Division of Administrative Hearings and a copy, accompanied

by filing fees prescribed by law, with the District Court of

Appeal, First District, or with the District Court of Appeal i n

the Appellate District where the party resides. The Notice of

Appeal must be filed within 30 days of rendition of the order to

be reviewed.