2015 Survey Of Pharmacy Law Pdf

Front 1

First Florida Board Enactment year

Back 1

1889

Front 2

# of Florida Compliance Officers / Inspectors

Back 2

18

Front 3

Florida Board Fiscal Year dates

Back 3

July 1 - June 30

Front 4

# of Board Members?

Pharmacists? Public?

How do they reach office?

Back 4

9 members = 7 pharmacists + 2 public

--4 of the pharmacists must be practicing, all must have been practicing for >/= 4 yrs, serve for 4 yr term, and are limited to 2 full terms

--Public members serve 4 yr term, limited to 2 full terms

--at least 1 must be 60yoa or older

All are appointed by the governor of FL

Front 5

Exam requirements

Back 5

NAPLEX, MPJE

FL participates in NAPLEX score transfer program (valid for transfer for 1 yr)

Must graduate from accredited COP to take exams

Front 6

Pharmacy Practice Experience hour requirements

during school?

post-grad?

what year to be eligible?

college-supervised hours?

Back 6

during school practical hours: 2,080 hrs

post-grad practical hours: none

what year does in/externship credit begin: 1PD

college-supervised experience hours: varies

Front 7

licensure/registration requirements for. . .

training sites?

preceptors?

interns?

fee for interns?

intern licensure duration?

Back 7

training sites - NO registration

preceptors - NO registration

interns - YES licensure

interns - NO fees/renuals

interns - license NEVER EXPIRES

Front 8

Florida foreign pharmacist licensure requirements

(see FPGEC Application Bulletin at www.nabp.net for more info)

Back 8

pass NAPLEX and MPJE

2,080 hrs -- 500 of which must be in state

NO 'appearance before board'

FPGEC (Foreign Pharmacy Graduate Examination Committee from NABP) certification {loophole for Canadians '93-'04}

1~their school is checked to meet min length/content

2~document licensure/registration as pharmacist in other country

3~pass the FPGEE (foreign pharmacy graduate equivalency exam) and TOEFL (test of English as foreign language)

Front 9

Initial Pharmacist Licensure

agency?

age?

fee?

temporary license?

criminal history check?

Back 9

~agency - BoP (board of pharmacy)

~minimum age - 18yrs

~fee - $190

~temporary - yes, temporary military license may be issued to an eligible spouse of any active duty. must submit proof entitled to full license

~criminal check - no

Front 10

Pharmacist licensure transfer to LEAVE FL (?)

fee?

MPJE?

Special requirements?

Back 10

fee - $100

MPJE - YES

special requirements - contact board for special requirements; military pharmacists who have practiced in the last 6 mos are eligible for expedited licensure

Front 11

Pharmacist licensure transfer to COME TO FL (?)

board?

hearings per year?

temporary license?

Back 11

board - review/approval (no hearing)

hearings per year - 6

temporary license - YES; temporary military licenses may be issued to an eligible spouse of an active duty member of the armed forces and submit proof that entitled to full license

Front 12

Pharmacist License Renewal

schedule?

renewal fee?

expiration date?

notification date?

Back 12

schedule - biennial on ODD years

renewal fee - $205

expires - Sept 30th on ODD years

notified - 90-120 days prior to expiration

Front 13

Continuing Pharmacy Edu Requirements (CPE)

Back 13

30 hours every 2 years

~10 hrs from live program

~2 hrs on medication errors

~1 hr on AIDS/HIV prior to FIRST RENEWAL

(24 hrs of consultant/nuclear pharmacist coursework biennial for consultant/nuclear pharmacist license)

Front 14

1 CEU = ? contact hours

Back 14

1 CEU = 10 contact hours

(1 contact hour = 0.1 CEU)

Front 15

Discipline of Pharmacist Licenses

what agency disciplines licensees?

how many licenses ('13-'14) were. . .

suspended?

revoked?

reinstated?

Back 15

agency - Board of Pharmacy

suspended - 8

revoked - 23

reinstated - 2

Front 16

Techs

licensed?

registered?

certified?

registration fee?

renewal schedule?

training?

CPE?

exams?

BoP can deny, revoke, suspend, restrict?

Back 16

Techs

licensed - NO

registered - YES; after Board-approved training

certified - NO

fee - $100

renewal - biennial

training - YES; before registered

CPE - 20hrs / 2yrs

exam - NO

BoP revoke etc. - YES

Front 17

ratio of techs to pharmacist. . .

in ambulatory care?

in institutional care?

Back 17

ratio. . . upon approval of BoP (otherwise 1:1)

amb - 3:1

institutional care - 3:1

Front 18

hospital tech. . .

accept called-in Rx?

enter Rx into computer?

check other tech's work?

call physician for refill auth?

compound?

transfer orders?

Back 18

hospital tech. . .

accept called in Rx - NO

enter Rx into computer - YES

check other tech's work - NO

call physician for refill auth - YES

compound - YES

transfer orders - NO

Front 19

community tech. . .

accept call in Rx from physician?

enter Rx into computer?

check work of other techs?

call physician for refill auth?

compound?

transfer orders?

Back 19

community tech. . .

accept call in Rx - NO

enter Rx into computer - YES

check work of other techs - NO

call physician for refill auth - YES

compound - YES

transfer orders - NO

Front 20

Pharmacy licensure

# of license categories?

must non-resident pharmacy be licensed/registered?

must non-resident pharmacist be licensed?

separate sterile compound license pharmacies?

separate license registered with FDA as outsourcing compounding pharmacy?

pharmacy licensure/registration initial / renewal / schedule fee?

controlled substance license/fees?

state recognize VIPPS accreditation?

Back 20

Pharmacy licensure

~# of license categories - 17

~ must non-resident pharmacy be licensed/registered? - YES; if ship/mail/deliver/dispense/provide rx drugs or devices to state residents

~must non-resident pharmacist be licensed - NO

~sterile compound license pharmacy - YES

~separate license registered with FDA as outsourcing compounding pharmacy - YES

~pharmacy licensure/registration - $250 / $250 / 2yr

~controlled substance license/fees - none

~FL recognize VIPPS - NO

Front 21

VIPPS?

Back 21

Verified Internet Pharmacy Practice Sites

NABP sets criteria

Front 22

Pharmacy Classes (17 of them)

Back 22

Class I (nursing home - institutional)

Class II (hospital - institutional)

Class IIA

Modified Class IIB

Modified Class IIC

Community (+permit for schedule II&III)

Special Parenteral/Enteral

Special Parenteral/Enteral Extended Scope

Special Nonresident

Special Closed System

Special End Stage Renal Disease

Animal Shelter

Nuclear

Special Assisted Living Facility

Internet

Nonresident

Nonresident Sterile Compounding

Front 23

Wholesale Distributor Licensure

Licensed by whom?
Does BoP regulate rx/non-rx medical device distributors? are they licensed?

license out-of-state wholesalers?

license wholesalers of non-rx drugs?

does FL recognize VAWD (Verified-Accredited Wholesaler Distributors) accreditation?

Back 23

licensed by - Bureau of Drugs, Devices, and Cosmetics

BoP regulate; licensed - NO; NO

license out-of-state wholesalers - YES
license wholesalers of non-rx drugs - NO

VAWD recognized - NO

Front 24

Drug Control Regulations

Food, Drug, and Cosmetic Act?

Dangerous Drug Law?

Controlled Substances Act?

Precursor substances placed in controlled substance schedule?

Controlled substances of concern scheduled differently from Fed Controlled Substance Act?

Regulate OTC pseudoephedrine?

Regulate dispensing of Rx med devices?

Regulate dispensing of medical oxygen?

Back 24

Food, Drug, and Cosmetic Act - YES same as fed

Dangerous Drug Law - YES same as fed

Controlled Substances Act - YES same as fed

Precursors scheduled - NO

Differ from Fed Controlled Substance Act - NO

Regulate OTC pseudoephedrine - YES

Regulate Rx med devices - NO

Regulate medical oxygen - NO

Front 25

Drug Product Selection Laws

State drug formulary?

Two-line Rx format?

generic substitution permissive or mandatory?

How to prevent substitution?

cost savings pass-on?

patient consent?

designated non-substitutable drugs (narrow therapeutic index drugs)?

interchangeability requirements for biosimilars/biologics?

Back 25

state drug formulary - NO pharmacy-by-pharmacy develops list of drug products

two-line rx format - NO

generic substitution - mandatory

prevent substitution - MD must indicate on rx

cost savings pass-on - full savings must be passed on to consumer

patient consent for substitution - YES

non-substitutables - YES

interchangeability requirements for biosimilars/biologics - NO; only if approved by FDA

Front 26

Prescription Requirements

accept non-control from out-of-state prescriber?

accept control from out-of-state provider?

Rx for syringe/needle?

syringe/needle sale only in pharmacy?

time limit on rx refills?

schedule V otc?

control rx monitoring program?

mandatory rx monitoring program?

allow preprinted rx for non-controls?

require expiration on vial in community?

how long maintain rx record?

Rx pad formatting requirements?

Back 26

accept non-control from out-of-state prescriber - YES; some restrictions

accept control from out-of-state provider - YES; some restrictions

Rx for syringe/needle - NO; cannot sell to minor (unless lawful need)

syringe/needle sale only in pharmacy - NO

time limit on rx refills - 1 yr from written; no refill for Sch.II; III/IV/V 5x in 6mos

schedule V otc - YES

control rx monitoring program - YES

mandatory rx monitoring program - NO

preprinted rx for non-control - YES but not MD's signature

require expiration on vial - YES

maintain rx record - 2 yrs

rx pad formatting - NO

Front 27

Faxed Rx

regulated faxing of rx?

controlled substance faxed rx?

Internal security code required?

transmission marked "faxed copy"?

Prescriber info required?

signature of prescriber's transmitting agent?

non-fading record (legibility time)?

disposition of original rx?

Back 27

regulated faxing of rx - YES

controls faxed - YES III-V, limited II

internal security code required - NO

transmission marked "faxed copy" - NO

prescriber info required - YES

signature of prescriber's transmitting agent - NO

non-fading requirement - NO

disposition of original rx - cannot be filled until fax from prescriber reaches pharmacy (cannot accept fax handed to pharmacy by patient)

Front 28

Electronic rx transmission

in-state prescriber computer to pharmacy computer allowed?

out-of-state prescriber computer to pharmacy computer allowed?

transfer between in-state pharmacy computers?

transfer between out-of-state pharmacy computers?

electronic prescribing of controls?

Back 28

in-state prescriber to pharmacy - YES
out-of-state prescriber to pharmacy - YES

transfer between in-state pharmacies - YES
transfer between out-of-state pharmacies - YES

e-prescribing controls - " -- " (no comment for FL)

Front 29

Patient counseling requirements

for medicaid pts?

for all other pts?

for new rx?

for refills?

face-to-face by pharmacist?

are pt profiles mandated?

Back 29

medicaid pt - must OFFER to counsel

all other pts - must OFFER to counsel

new rx - must OFFER to counsel

refills - must OFFER to counsel

face-to-face - YES if pt/agent is in pharmacy, otherwise written offer to counsel with phone #

pt profiles mandated - YES

Front 30

Prescribing authority

PA (physician assistant)?

ARNP (advanced registered nurse practitioner)?

CNS (clinical nurse specialist)?

nurse midwife?

midwife?

NP (nurse practitioner)?

OB/GYN Nurse Practitioner?

Pediatric Nurse Practitioner?

Psychiatric Nurse Practitioner?

CRNA (certified registered nurse anesthetist)?

Dr. of homeopathy (within course of practice)?

optometrist?

EMT paramedic (emergency medical tech)?

naturopathic doctor?

Back 30

PA - dependent, limited formulary

ARNP - dependent; may initiate orders under protocol

CNS - NO

nurse midwife - NO

midwife - NO

nurse practitioner - NO

OB/GYN nurse practitioner - NO

pediatric nurse practitioner - NO

psychiatric nurse practitioner - NO

CRNA - dependent, limited prescribing authority

Dr. of homeopathy - Not licensed

optometrist - independent limited authority within specified formulary for the profession

EMT paramedic - NO

naturopathic doctor - independent unlimited authority (cannot obtain new licenses)

Front 31

Dispensing authority

MD?

Dr. of osteopathic medicine?

dentist?

podiatrist?

veterinarian?

Dr. of homeopathy?

PA?

ARNP?

CNS?

nurse midwife?

midwife?

NP?

OB/GYN Nurse Practitioner?

Pediatric Nurse Practitioner?

Psychiatric Nurse Practitioner?

Optometrist?

naturopathic Dr.?

Back 31

MD - YES (but not Sch.II / III)

Dr. of osteopathic medicine - YES (but not Sch.II / III)

dentist - YES
podiatrist - YES
veterinarian - YES

Dr. of homeopathy - NO, not licensed in FL

PA - YES, per formulary and as delegated by dispensing physician

ARNP - YES

CNS - NO

nurse midwife - NO

midwife - NO

NP - NO

OB/GYN NP - NO

pediatric NP - NO

psychiatric NP - NO

Optometrist - may dispense free of charge to pt

naturopathic Dr. - YES

Front 32

Possession of non-controlled legend drugs

MD?

Dr. of osteopathic medicine?

dentist?

podiatrist?

veterinarian?

Dr. of homeopathy?

PA?

ARNP?

CNS?

nurse midwife?

midwife?

NP?

OB/GYN NP?

Pediatric NP?

Psychiatric NP?

Optometrist?

naturopathic Dr.?

Pharmacist?

Back 32

MD - YES

Dr. of osteopathic medicine - YES

dentist - YES

podiatrist - YES

veterinarian - YES

Dr. of homeopathy - NO

PA - YES

ARNP - YES

CNS - NO

nurse midwife - NO

midwife - NO

NP - NO

OB/GYN NP - NO

Pediatric NP - NO

Psychiatric NP - NO

Optometrist - YES, only drugs related to diagnosis or tx of eye and adjacent structures

naturopathic Dr. - YES

Pharmacist - YES, in the course of professional practice

Front 33

Possession of controlled substances

MD?

Dr. of osteopathic medicine?

dentist?

podiatrist?

veterinarian?

Dr. of homeopathy?

PA?

ARNP?

CNS?

nurse midwife?

midwife?

NP?

OB/GYN NP?

Pediatric NP?

Psychiatric NP?

Optometrist?

naturopathic Dr.?

Pharmacist?

Back 33

MD - YES

Dr. of osteopathic medicine - YES

dentist - YES

podiatrist - YES

veterinarian - YES

Dr. of homeopathy - NO

PA - NO

ARNP - NO

CNS - NO

nurse midwife - NO

midwife - NO

NP - NO

OB/GYN NP - NO

Pediatric NP - NO

Psychiatric NP - NO

Optometrist - NO

naturopathic Dr. - YES

Pharmacist - YES via pharmacy as DEA registrant

Front 34

Miscellaneous state pharmacy laws

Does BoP allow centralized rx filling?

Collaborative practice agreements and/or protocol to allow pharmacists to initiate, modify, and/or D/C pt tx?

MTM outside of pharmacy setting?

pharmacist administer drugs?

administer immunizations?

May a prescriber own a pharmacy?

FL have "freedom of choice" legislation?

can pharmacy maintain electronic reference materials?

Does BoP require pharmacies to have continuous quality improvement program?

Does BoP have regulations aimed at relieving pharmacist workload?

Does BoP have regulatory oversight of pharmacy benefit managers?

FL have drug repository/donation program?

FL permit return and reuse meds?

FL have laws on disposal of meds?

Back 34

centralized rx filling - YES

collaborative practice agreement to manage tx - YES with restrictions

MTM outside of pharmacy setting - NO

administer drugs - NO

administer immunizations - YES if certified by BoP as immunizer

prescriber-owned pharmacy - YES

"freedom of choice" - NO

electronic references - YES

continuous quality improvement - YES

reduce pharmacist workload - YES meal break provisions

oversight of PBM - NO

drug repository/donation program - YES

return and reuse meds - NO

laws for disposal of meds - YES

Front 35

Does BoP require compliance with USP 797 sterile preparations compounding?

Back 35

USP 797 - YES the BoP has rules that include some USP 797