06-002825PL Department Of Health, Board Of Medicine vs. Peter N. Brawn, M.D. Status: Closed Recommended Order on Thursday, December 28, 2006.

Summary: Respondent violated the requirements imposed on him as a dispensing practitioner.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE )

)

Petitioner, )

)

vs. ) Case No. 06 - 2825PL

)

PETER N. BRAWN, M.D., )

)

Respondent. )

_________________________________)

RECOMMENDED ORDER

Pursuant to notice, a formal hearing w as held in this case

before Larry J. Sartin, an Administrative Law Judge of the

Divi sion of Administrative Hearings, on October 18, 2006 , by

video teleconference between Miami and Tallahassee, Florida .

APPEARANCES

For Petitioner: April Dawn M. Skilling

Warren J. Pea rson

Assistants General Counsel

Prosecution Services Unit

Office of General Counsel

Department of Health

4052 Bald Cypress Way, Bin - C65

Tallahassee, Florida 32399

For Respondent: Sean M. Ellsworth, Esquire

Ellsw orth Law Firm, P.A.

404 Washington Avenue, Suite 750

Miami Beach, Florida 33139

STATEMENT OF THE ISSUE

The issue in this case is whether Respondent, Peter N.

Brawn, M.D., committed violations of Chapter 458, Florida

Statutes (2001) , as alleged in an Administrative Complaint filed

by Petitioner, the Department of Health, on November 23, 2005,

in DOH Case Number 2002 - 12896 , as amended ; and, if so, what

disciplinary action should be taken against his license to

practice medicine in the State of Flo rida.

PRELIMINARY STATEMENT

On or about November 23, 2005, the Department of Health

filed an Administrative Complaint against Peter N. Brawn, M.D.,

an individual licensed to practice medicine in Florida, before

the Board of Medicine, in which it alleged th at Dr. Brawn had

committed violations of Section 458.331(1)(g), Florida Statutes

(2001). Dr. Brawn disputed the allega tions of fact contained in

the A dministrative C omplaint and requested a formal

administrative hearing pursuant to Section 120.569(2)(a),

Florida S tatutes (2005).

On August 4, 2006, the matter was filed with the Division

of Administrative Hearings with a request that an a dministrative

l aw j udge be assigned the case to conduct proceedings pursuant

to Section 120.57(1), Florida Statutes (2005) . The matter was

designated DOAH Case Number 06 - 2825PL and was assigned to the

undersigned.

The final hearing was scheduled by Notice of Hearing

entered August 17, 2006, for October 12, 2006. By Order

Granting Continuance and Re - scheduling Hearing, Petit ioner’s

R equest for an A lternative H earing D ate was granted , and the

final hearing was re - scheduled for October 18, 2006.

On October 5, 2006, Petitioner filed a Motion to Amend

Administrative Complaint in order to correct scrivener’s errors

as to specifi c statutory pr ovisions and rule numbers. The

motion was granted by Order on October 16, 2006.

On October 5, 2006, a Joint Stipulation was filed by the

parties. The Joint Stipulation contains, in relevant part,

stipulated facts. Those facts have been inc luded in this

Recommended Order.

The final hearing was held via video teleconference between

Miami and Tallahassee. Petitioner presented the testimony of

Jaiser Figuereo and Evelyn Garrido - Morgan, I nvestigators for ,

respectively, the Department of Health and the Agency for Health

Care Administration . Petitioner offered and had admitted

Exhibits 1, 3 through 13, and 15. A ruling was reserved on

Petitioner’s Exhibit 2, a certified copy of a Final O rder

entered in DOH Case Number 2002 - 15991 ( DOAH Case Numbe r 05 -

1640PL ) in which the Florida Board of Medicine disciplined Dr.

Brawn's license to pract ice medicine.

The parties were invited to address the admissibility of

Petitioner’s Exhibit 2 in their proposed recommended orders ,

which they did . After full cons ideration of the matter,

Peti ti oner’ s Exhibit 2 is hereby admitted . The question of

whether Dr. Brawn has previously been discipline d is an issue

that must be considered in deciding appropriate sanctions, if

the allegations of the Administrative Complaint , as amended, are

proved. See F la. Admin. Code R. 64B8 - 8.001(3). Such

disciplinary action does not constitute an alleged "violation"

which the case law cited by Dr. Brawn clearly contemplates must

be pled. Dr. Brawn is presumed to be aware of the rules

governing discipline of his license , and he was clearly aware of

his prior disciplinary history. There is, therefore, no

prejudice to Dr. Brawn by admitting Petitioner's Exhibit 2.

The Transcript of the formal hearing was filed with the

Division of Admini strative Hearings on October 30, 2006. By

Notice of Filing of Transcript issued on October 31, 2006, the

parties were informed that the Transcript had been filed and

that they had until November 29, 2006, to file proposed

recommended orders. Both parties timely filed a Proposed

Recommended Order on November 29, 2006, and each has been fully

considered in rendering this Recommended Order.

All further references to Florida Statutes and the Florida

Administrative Code are to the 2001 versions unless otherwis e

noted.

FINDINGS OF FACT

A . The Parties .

1. Petitioner, the Department of Health (hereinafter

referred to as the "Department") is the agency of the State of

Florida charged with the responsibility for the investigation

and prosecution of complaints invo lving physicians licensed to

practice medicine in Florida. § 20.43 and Chs. 456 and 458,

Fla. Stat. (2006).

2. Respondent, Peter N. Brawn, M.D., is, and was at all

times material to this matter, a physician licensed to practice

medicine in Florida, havin g been issued license number ME 75202.

3. Dr. Brawn is board - certified in pathology.

4. Dr. Brawn's address at the times relevant to this

proceeding was 525 Caroline Street, Key West, Florida 33040.

B. Dr. Brawn's Status as a Dispensing Practitione r .

5. At the times relevant to this proceeding, Dr. Brawn was

registered with the Board of Medicine (hereinafter referred to

as the "Board"), as a "Dispensing Practitioner ."

6. Dr. Brawn had informed the Department on March 25,

2002, that he did not dispense medical drugs for a fee, but also

stated that he wished to remain on the dispensing practitioner

register. He, therefore, was registered as a d ispensing

p ractitioner at the times relevant.

7. T he Department is statutorily required to conduct

inspections at the offices of dispensing practitioner s for the

purpose of determining whether the practitioner is in compliance

with the statutes and rules applicable to his or her dispensing

practice.

C . The Events of April 15 - 16 , 2002 .

8. On or about April 15, 20 02, Jaiser Figuereo, an

investigator for the Department 's Investigation Services Unit,

traveled to Dr. Brawn's office to conduct an inspection of his

dispensing practice. Dr. Brawn had no prior notice of the

inspection.

9. Upon arriving at Dr. Brawn's pr emises , which were

located in a "typical Key West home," Investigator Figuereo

entered a n unlocked front gate and walked up the front porch to

the front door . Finding the front door open, Investigator

Figuereo entered the building where she found several ladies in

a room who appeared to be accessing the internet at computer

terminal s . She identified herself to the ladies and asked to

speak with Dr. Brawn. Shortly thereafter, a gentleman came

downstairs and indicated he was Dr. Brawn. Investigator

Figuer eo verified Dr. Brawn's identity with his driver's

license.

10. Investigator Figuereo, who was new to her position,

did not feel comfortable proceeding with the inspection alone

because of her concern that the office was being used to

dispense medications via the internet . Therefore, s he told Dr.

Brawn that she would return the following day to conduct the

office inspection .

11. After leaving the office, Investigator Figuereo

returned to the hotel where she was staying with other

investigators with whom she had traveled to Key West. Those

investigators were employees of the Agency for Health Care

Administration (hereinafter referred to as "AHCA") .

Investigator Figuereo explained what she had seen at Dr. Brawn's

office and requested assistance from fello w I nvestigators Evelyn

Garrido - Morgan, Jose Rodriguez, and Paul Randall.

12. On April 16, 2002, I n vestigators Figu ereo, Garrido -

Morgan, Rodriquez , and Randall drove to Dr. Brawn's office to

conduct the inspection , where they were met by Dr. Braw n.

13. As the inspection progressed, Investigator Figuereo,

among other things, complete d an AH C A Investigative Services

Inspection Form for Dispensing Practitioners (hereinafter

referred to as the "Inspection Form"). The I nspection F orm

list s 28 inquiries which i nvestigators are to make during the

inspection of a dispensing practitioner. The investigator is

supposed to make a determination of and note on the form whether

the 28 areas of inquiry are "satisfactory."

14. Dr. Brawn's personal office was accessible b y walking

around the front porch of the house to the left side of the

building. Sitting outside the door to his office was a

refrigerator, which Dr. Brawn identified as the one he used to

store medications which required refrigeration. The

refrigerator, which had no visible means of being locked, could

be accessed by anyone who entered the front gate and cl imbed the

stairs to the porch .

15. Investigators Figuereo and Garrido - Morgan found the

inside of the refrigerator to be dirty and observed a foul smel l

about it. The following was found inside the refrigerator: (1)

insulin , which requires refrigeration to rem a in safe and

effective for patient use ; (2) uncapped, unlabeled syringes

containing an unidentified clear liquid; (3) a vial, which was

leaking, c ontaining a brown substance which appeared to be blood

(this observation was not, however, proved) ; and ( 4 ) a substance

that was described as either " spoiled food " o r "fish or bait or

something."

16. When asked by Investigator Figuereo why he had stored

t he uncapped , unlabeled syringes in the refrigerator, Dr. Brawn

responded that he could not otherwise dispose of them because he

did not know where his " sharps container " was located.

17. Upon entering Dr. Brawn's office , the investigators

found it cramped in size , dusty , and messy. It did not appear

that the office was air - conditioned and the atmosphere was

described as "musty . " Medications were stored on Dr. Brawn's

desk, three shelves on the side of the office, and in a closet.

Dr. Brawn's office was the only place the investigators found on

the premises where non - refrigerated medications were being

stored.

18. The investigators observed that opened medicine

bottles containing pills were s cattered a mong boxes lying around

the office . U ncontained pill s were also found lying on a

counter and Dr. Brawn's desk . Open manufact urer - type medicine

containers were also found.

19. Investigators Figuereo and Garrido - Morgan also found

expired and unexpired medications stored mixed together in Dr.

Brawn's office .

20. The investigators found 19 boxes of expired "Baycol"

during their inspection of Dr. Brawn's office . Baycol is a

medication that was recalled by its manufacturer on August 8,

2001. The recall was supported by the Food and Drug

Administration in a pu blication bearing the same date. Because

of the recall, t he investigators confiscated the 19 boxes of

medication . Following the removal of the Baycol from Dr.

Brawn's office, the medication was transferred to the

Department's evidence custodian.

21. Inv estigator Garrido - Morgan gathered the remaining

expired medications found during the inspection and, while

accompanied by Dr. Brawn, proceeded to dispose of them do wn a

toilet within the office.

22. Of the 28 areas of inquiry on the Inspection Form

comple ted by Investigator Figuereo during the inspection of Dr.

Brawn's office, it was found that 15 of the 28 areas of inquiry

were not satisfactory. Petitioner's Exhibit 1. Relevant to the

charges of the Administrative Complaint, as amended, the

following ar eas of inquiry were determined to be unsatisfactory:

. . . .

3. Generic drug sign displayed.

{465.025(7), F.S.}{64B8 - 8.011(3)(b)10,

F.A.C.}

4. Stock medications appropriately labeled

for dispensing from a licensed

manufacturer. {499.007(2), F.S.}

. . . .

6. Outdated medications removed from

stock. {499.007(2), F.S.}{64B16 - 28.110,

F.A.C.}

7. Medications requiring refrigeration

appropriately stored. {64B16 - 28.104,

F.A.C.}

. . . .

16. Patient record contains medical history

required for counsel ing. {64B16 - 27.800,

F.A.C.}

17. Controlled substances securely

maintained and stored in a locked

cabinet. {21 CFR 1301.75}

. . . .

20. Controlled substance prescriptions

provide practitioner's name/address and

DEA number. {893.04(1)(c)2, F.S.}

. . . .

25. Controlled substance biennial inventory

conducted. {893.07(1)(a), F.S.}

23. Dr. Brawn did not display in a prominent, clear, and

unobstructed place at or near where prescriptions were being

dispersed by him , the notice required by Section 465.025 (7),

Florida Statutes.

24. Dr. Brawn's office contained medications which were

loose and, therefore, not properly labeled. The syringes stored

in the refrigerator lacked proper labels, required by Section

499.007(2), Florida Statutes.

25 . There were exp ired prescription medications (outdated)

stored, unqua rantined, in Dr. Brawn's office inconsistent with

Florida Administrative Code Rule 64B16 - 28.110.

26 . The medications stored within Dr. Brawn's refrigerator

were not properly stored. The refrigerator w as unlocked and

easily accessible and unsanitary.

27 . The only patient records maintained by Dr. Brawn, as

he admitted during the investigation, consisted of a copy of an

internet questionnaire completed by patients and submitted via

computer. The questi onnaire lacked information about a

patient's date of birth, age, gender, medical and drug history,

and new and refilled prescriptions received from Dr. Brawn's

office.

28. The evidence failed to prove that Dr. Brawn had any

controlled substances on the pr emises. The only direct

testimony on this issue was that of Ms. Figuereo who indicated

that she saw unsecured controlled substances. She did not,

however, indicate what controlled substances or how she

identified them, or where she saw the medications. Given this

lack of specificity and testimony that Dr. Brawn had indicated

he had no controlled substances, it is found that the Department

failed to prove there were any controlled substances found

during the inspection. It cannot, therefore, be found tha t Dr.

Brawn did not use a proper prescription form for controlled

substances. While the form provided to the investigators was

not adequate, the evidence failed to prove that Dr. Brawn used

that form to prescribe controlled substances.

29. Dr. Brawn admi tted that he did not have a biennial

inventory of controlled substances, stating that he was not

aware one was required.

30. At the conclusion of the inspection, Dr. Brawn signed

the Inspection Form which had been completed by Investigator

Figuereo.

31 . Dr. Brawn was told that the investigators would return

in 30 days to see if the deficiencies noted had been rectified.

Upon returning the Dr. Brawn's office, Ms. Figuereo was told

that Dr. Brawn was out of town.

CONCLUSIONS OF LAW

A . Jurisdiction .

32. T he Division of Administrative Hearings has

jurisdiction over the subject matter of this proceeding and of

the parties thereto pursuant to Sections 120.569, 120.57(1), and

456.073(5), Florida Statutes (2006).

B. The Charges of the Administrative Complaint .

33. Section 458.331(1), Florida Statutes, authorizes the

Board to impose penalties ranging from the issuance of a letter

of concern to revocation of a physician's license to practice

medicine in Florida if a physician commits one or more acts

specified t herein.

34. In its Administrative Complaint, as amended, the

Department has alleged that Dr. Brawn has violated Section

458.331(1)(g), Florida Statutes.

C . The Burden and Standard of Proof .

35. The Department seeks to impose penalties against

Responden t through the Administrative Complaint , as amended,

that include suspension or revocation of his license and/or the

imposition of an administrative fine. Therefore, the Department

has the burden of proving the specific allegations of fact that

support its charge that Dr. Brawn violated Sections

458.331(1)(g), Florida Statutes, by clear and convincing

evidence. See Department of Banking and Finance, Division of

Securities and Investor Protection v. Osborne Stern and Co. , 670

So. 2d 932 (Fla. 1996); Ferris v. Turlington , 510 So. 2d 292

(Fla. 1987); Pou v. Department of Insurance and Treasurer , 707

So. 2d 941 (Fla. 3d DCA 1998). See also Section 120.57(1)(j),

Florida Statutes (2006)("Findings of fact shall be based on a

preponderance of the evidence, except in penal or licensure

disciplinary proceedings or except as otherwise provided by

statute.").

36. What constitutes "clear and convincing" evidence was

described by the court in Evans Packing Co. v. Department of

Agriculture and Consumer Services , 550 So. 2d 112, 116 n.5 (Fla.

1st DCA 1989), as follows:

. . . [C]lear and convincing evidence

requires that the evidence must be found to

be credible; the facts to which the

witnesses testify must be distinctly

remembered; the evidence must be precise and

explici t and the witnesses must be lacking

in confusion as to the facts in issue. The

evidence must be of such weight that it

produces in the mind of the trier of fact

the firm belief or conviction, without

hesitancy, as to the truth of the

allegations sought to be established.

Slomowitz v. Walker , 429 So. 2d 797, 800

(Fla. 4th DCA 1983).

See also In re Graziano , 696 So. 2d 744 (Fla. 1997); In re

Davey , 645 So. 2d 398 (Fla. 1994); Walker v. Florida Department

of Business and Professional Regulation , 705 So. 2d 652 (Fla.

5th DCA 1998)(Sharp, J., dissenting).

D. Section 458.331(1)(g), Florida Statutes .

37. Section 458.331(g), Florida Statutes (2001), defines

the following disciplinable offense : "[f]ailing to perform any

statutory or legal obligation p laced upon a licensed physician . "

38. The specific "statutory or legal obligation" placed

upon Dr. Brawn which the Department has alleged in the

Administrative Complaint, as amended, he violated is Section

465.0276(2)(b), Florida Statutes, which provides :

(2) A practitioner who dispenses

medicinal drugs for human consumption for

fee or remuneration of any kind, whether

direct or indirect, must :

. . . .

(b) Comply with and be subject to all

laws and rules applicable to pharmacists and

pharmacies, including, but not limited to,

this chapter and chapters 499 and 893 and

all federal laws and federal regulations.

39. The specific laws and rules "applicable to pharmacists

and pharmacies" which the Department has alleged Dr. Brawn

failed to comply with are inclu ded in the Administrative

Complai nt, as amended, in paragraph 8. In particular, it is

alleged that Dr. Brawn:

a. failed to display a generic sign , as

required by Section 465.025(7), Florida

Statutes (2001), and Rule 64B8 -

8.011(3)(b)10, Florida Administrat ive

Code (he reinafter referred to as

"FAC");

b . failed to maintain an adequate

refrigerated storage facility , as

req uired by Rule 64B16 - 28.104, FAC;

c . failed to maintain a safe, clean and

sanitary prescription department, as

req uired by Rule 64B16 - 28.10 5, FAC;

d. failed to remove outdated medications

from stock , as required by Section

499.0121(5)(a)2., Florida Statutes

(20 01), and Rule 64B16 - 28.110, FAC;

e . failed to maintain appropriate

labeling, as required by Section

499.007(2), Florida Statutes (20 01),

and Rule 64B16 - 18.108, FAC;

f . failed to maintain patient records

containing medical history required for

counseling, as req uired by Rule 64B16 -

27.800, FAC;

g . failed to store controlled substances

in a locked cabinet as , required by 21

CFR 1301.75;

h . failed to include practitioner's name

and DEA number on prescriptions , as

required by Section 893.04(1)(c)2,

Florida Statutes (2001).

i . failed to conduct a biennial inventor y,

as required by Section 893.0 7(1),

Florida Statutes (2001).

4 0. The evidence clearly and convincingly proved that Dr.

Brawn violated Section 458.33 1(1)(g), Florida Statutes , by

failing to comply with some, but not all, of the statutory and

legal obligations placed upon him as a dispensing practitio ner.

41. In part icular, the Department proved that Dr. Brawn

violated Section 465.025(7), Florida Statutes . Section

465.025(7), Florida Statutes, provides the following:

Every community pharmacy shall display in a

prominent place that is in clear and

unobstructed view, a t or near the place

where prescriptions are dispensed, a sign in

block letters not less than 1 inch in height

which shall read: "CONSULT YOUR PHARMACIST

CONCERNING THE AVAILABILITY OF A LESS

EXPENSIVE GENERICALLY EQUIVALENT DRUG AND

THE REQUIREMENTS OF FL ORIDA LAW."

42. Dr. Brawn failed to post any generic drug sign in

compliance with Section 465.025(7), Florida Statutes.

43. The Department proved that Dr. Brawn violated Florida

Administrative Code Rule 64B16 - 28.104, which provides the

following:

There shall be provided in each pharmacy

adequate facilities for the proper storage

of pharmaceuticals which require

refrigeration, and such pharmaceuticals

shall be stored therein, and in such manner

as to preserve their therapeutic activity.

Dr. Brawn's unsec ured and unsanitary refrigerator failed to

comply with the requirement of this rule.

4 4 . The Department proved that Dr. Brawn violated Florida

Administrative Code Rule 64B16 - 28.105, which provides:

Any establishment which is issued a pharmacy

permit which shall be found guilty of

operating a prescription department under

unclean, unsanitary, overcrowded or

unhealthful conditions, which endanger the

safety or health of the public served by

such establishments shall be subject to

disciplinary action, includi ng revocation or

suspension of said permit, pursuant to the

provisions of Chapter 465. F.S.

Dr. Brawns' dispensing facilities, with unexpired and expired

medication stored together and stored outside their containers

clear ly violated this rule.

4 5 . The D epartment proved that Dr. Brawn violated Section

499.0121(5)(a)2., Florida Statutes, which provides that

"[p]rescription drugs must b e examined at least every 12 months,

and drugs for which the expiration date has passed must be

removed and quarantined ," a nd Florida Administrative Code Rule

64B16 - 28.110, which provides the following:

Persons qualified to do so shall examine the

stock of the prescription department of each

pharmacy at a minimum interval of four

months, and shall remove all deteriorated

pharm aceuticals, or pharmaceuticals which

bear upon the container an expiration date

which date has been reached, and under no

circumstances will pharmaceuticals or

devices which bear upon the container an

expiration date which has been reached be

sold or dispe nsed to the public.

Dr. Brawn failed to segregate expired medications from unexpired

ones in violation of the foregoing rule as alleged in the

Administrative Compl aint, as amended, in violation of both the

statute and the rule.

46 . The Department proved that Dr. Brawn had in his

possession drugs which are considered "misbranded" pursuant to

Section 499.007(2), Florida Statutes . Section 499.007(2),

Florida Statutes, provides that "[a] drug or device is

misbranded" :

(2) Unless, if in package for m, it be ars

a label containing:

(a) The name and place of business of the

manufacturer or distributor; in addition,

for a medicinal drug, as defined in s.

499.003 , the label must contain the name and

place of business of the manufacturer of the

finished dosage form of the drug. For the

purpose of this paragraph, the finished

dosage form of a medicinal drug is that form

of the d rug which is, or is intended to be,

dispensed or administered to the patient and

requires no further manufacturing or

processing other than packaging,

re constitution, and labeling; and

(b) An accurate statement of the quantity

of the contents in terms of weight, measure,

or numerical count; however, under this

section, reasonable variations are

permitted, and the department shall

establish by rule exemptions for small

packages .

The "misbranded" drugs found during the inspection were in

violation of the requirements for labeling established in

Florida Administrative Code Rule 64B16 - 28.108. The Department,

therefore, proved that Dr. Brawn violated the rule.

47 . The Department proved that Dr. Brawn violated Florida

Administrative Code Rule 64B16 - 27.800, which provides, in part,

the following:

(1) A patient record system shall be

maintained by all pharmacies for patients to

whom new or refill prescriptions are

dispensed. The patient record system shall

provide for the immediate retrieval of

information necessary for the dispensing

pharmacist to identify previously dispensed

drugs at the time a new or refill

prescription is presented for dispensing.

The pharmacist shall ensure that a

reasonable effort is made to obtain, record

and maintain the following information:

(a) Full name of the patient for whom the

drug is intended;

(b) Address and telephone number of the

patient;

(c) Patient’s age or date of birth;

(d) Patient’s gender;

(e) A list of all new and refill

prescriptions obtained by t he patient at the

pharmacy maintaining the patient record

during the two years immediately preceding

the most recent entry showing the name of

the drug or device, prescription number,

name and strength of the drug, the quantity

and date received, and the n ame of the

prescriber; and

(f) Pharmacist comments relevant to the

individual’s drug therapy, including any

other information peculiar to the specific

patient or drug.

(2) The pharmacist shall ensure that a

reasonable effort is made to obtain from t he

patient or the patient’s agent and shall

record any known allergies, drug reactions,

idiosyncrasies, and chronic conditions or

disease states of the patient and the

identity of any other drugs, including over -

the - counter drugs, or devices currently

bein g used by the patient which may relate

to prospective d r ug review. The pharmacist

shall record any related information

indicated by a licensed health care

practitioner.

Dr. Brawn's "medical records" failed to c omply with the

foregoing rule.

48. The evid ence failed to prove clearly and convincingly

that Dr. Brawn violated 21 CFR 1301.75 by failing to store

controlled substances in a locked cabinet or that he violated

Section 893.041(1)(c)2, Florida Statutes, by failing to include

information required on p rescriptions for controlled substances.

49. Finally, the Department proved clearly and

convincingly that Dr. Brawn, by failing to conduct a biennial

inventory, violated Section 893.07(1)(a), Florida Statutes:

Every person who engages in the

manufacture, compounding, mixing,

cultivating, growing, or by any other

process producing or preparing, or in the

dispensing, importation, or, as a

wholesaler, distribution, of controlled

substances shall:

(a) On January 1, 1974, or as soon

thereafter as any perso n first engages in

such activity, and every second year

thereafter, make a complete and accurate

record of all stocks of controlled

substances on hand. The inventory may be

prepared on the regular physical inventory

date which is nearest to, and does not vary

by more than 6 months from, the biennial

date that would otherwise apply. As

additional substances are designated for

control under this chapter, they shall be

inventoried as provided for in this

subsection.

E. The Appropriate Penalty .

50. In det ermining the appropriate punitive action to

recommend to the Board in this case, it is necessary to consult

the Board's "disciplinary guidelines," which impose restrictions

and limitations on the exercise of the Board's disciplinary

authority under Section 458.331, Florida Statutes. See Parrot

Heads, Inc. v. Department of Business and Professional

Regulation , 741 So. 2d 1231 (Fla. 5th DCA 1999).

51. The Board's guidelines are set out in Florida

Administrative Code Rule 64B8 - 8.001 (2), which provides , in

pe rtinent p art, that the penalty guideline for a violation of

Section 458.331(1)(g), Florida Statutes, ranges from a letter of

concern to revocation, and an administrative fine from $1,000.00

to $10,000.00.

52. Florida Administrative Code Rule 64B8 - 8.001(3)

provides that, in applying the penalty guidelines, the following

aggravating and mitigating circumstances are to be taken into

account:

(3) Aggravating and Mitigating

Circumstances. Based upon consideration of

aggravating and mitigating factors presen t

in an individual case, the Board may deviate

from the penalties recommended above. The

Board shall consider as aggravating or

mitigating factors the following:

(a) Exposure of patient or public to

injury or potential injury, physical or

otherwise: n one, slight, severe, or death;

(b) Legal status at the time of the

offense: no restraints, or legal

constraints;

(c) The number of counts or separate

offenses established;

(d) The number of times the same offense

or offenses have previously bee n committed

by the licensee or applicant;

(e) The disciplinary history of the

applicant or licensee in any jurisdiction

and the length of practice;

(f) Pecuniary benefit or self - again

inuring to the applicant or licensee;

(g) The involvement in any violation of

Section 458.331, Florida Statutes, of the

provision of controlled substances for

trade, barter or sale, by a licensee. In

such cases, the Board will deviate from the

penalties recommended above and impose

suspension or revocation of lice nsure;

(h) Any other relevant mitigating

factors.

53. In its Proposed Recommended Order, the Department has

requested that it be recommended that Dr. Brawn's license be

reprimanded , that he be required to pay an administrative fine

of $ 5,000.00 , and that he be required to attend continuing

education classes as determined by the Board . Dr. Brawn as

suggested that the penalty, if any, be limited to a Letter of

Concern and an administrative fine of $1,000.00.

54. Having carefully considered the facts o f this matter

in light of the provisions of Florida Administrative Code Rule

6 4B 8 - 8.001, it is concluded that the Department's proposed

penalty, with a reduction of $1,000.00 in the amount of the fine

due to the failure to prove Dr. Brawn violated 21 CFR 1 301.75

and Section 893.041(1)(c)2 . , Florida Statutes, is reasonable.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that a final order be entered by the Board of

Medicine finding that Peter M. Brawn, M.D., has violated Section

458.331(g), Florida Statutes (2001), as described in this

Recommended Order , issuing a reprimand of Dr. Brawn's license to

practice medicine, requiring that he pay an a dministrative fine

of $4,000.00, and requiring that he attend appro priate

continuing education classes in number and of a nature

determined by the Board.

DONE AND ENTERED this 2 8 th day of December , 2006, in

Tallahassee, Leon County, Florida.

S

________________________ ___________

LARRY J. SARTIN

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 o f the

Division of Administrative Hearings

t his 2 8 th day of December , 2006.

COPIES FURNISHED:

April Dawn M. Skilling

Warren James Pearson

Assistant s General Counsel

Prosecution Services Unit

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Shawn M. Ellsworth, Esquire

Ellsworth Law Firm, P.A.

404 Washington Avenue, Suite 750

Miami Beach, Florida 33139

Larry McPherson, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

R. S. Power, Agency Clerk

Department of Health

4052 Bald Cypress Way, Bin A02

Tallahassee, Florida 32399 - 1701

Timothy M. Cerio, General Counsel

Department of Health

4052 Bald Cypress Way, Bi n A02

Tallahassee, Florida 32399 - 1701

Dr. M. Rony François, Secretary

Department of Health

4052 Bald Cypress Way, Bin A00

Tallahassee, Florida 32399 - 1701

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions wit hin

15 days from the date of this recommended order. Any exceptions

to this recommended order should be filed with the agency that

will issue the final order in these cases.