Federal & Florida Pharmacy Law Review
Check out www.flrules.org
Section 1: Federal Food, Drug & Cosmetic Act & etc…
FEDERAL FOOD, DRUG & COSMETIC ACT & MAJOR AMENDMENTS
1.
Food, Drug & Cosmetic Act 1983
a.
Drugs proven SAFE
b.
Established FDA
c.
Specifies only 3 basic illegal acts; adulteration, misbranding, & the placing into
interstate commerce of an unapproved new drug
2.
Durham-Humphrey amendment 1951
a.
2 classes of drugs (Rx & OTC)
b.
Determines “Rx to OTC Switch” (ie: Prilosec, Rogaine, Claritin, etc.)
c.
Authorized verbal Rx & refills
3.
Kefauver-Harris amendment 1962
a.
Drugs safe & EFFECTIVE
b.
Established good manufacturing practices (cGMP)
c.
FDA jurisdiction over Rx drug advertising
4.
Medical Device amendment 1976
a.
Safe & effective medical devices
b.
FDA can regulate med devices
5.
Orphan Drug Act 1983
a.
Incentive to manufactures: drugs for rare dz (rare = < 200,000 people)
6.
Drug price competition & Patent Term Restoration Act 1984
a.
Easier for generic products to be rated “bioequivalent”
b.
Provided patent life extensions to brand under certain conditions
7.
Prescription drug marketing Act 1987 (PDMA)  samples
a.
State licensing of rx drug wholesalers
b.
Bans re-import of rx made in US
c.
Bans sale, trade, or purchase of samples
d.
Mandates storage, handling, & recordkeeping of samples
e.
Prohibits, w/certain exceptions, resale of rx drugs purchased by hospitals/facilities
8.
FDA modernization act 1997 (FDAMA)
a.
Major changes to FDCA
b.
From: “Caution: Federal law prohibits dispensing w/o a rx”; To: “rx only”
c.
Eliminated requirement that certain substances be labeled “Warning- may be habit
forming”
Prohibited acts under FDCA
1.
Adulteration:
a.
Contains filthy, putrid or decomposed substance
b.
Prepared/held under unsanitary conditions & possible contamination or injurious to
health
c.
Methods are not GMP
d.
Composed of any poisonous or deleterious substance
e.
Unsafe color additives
f.
If it purports to be a drug & its strength/quality/purity is different than what is on the
label
g.
Mixed/packed with any substance that reduces its strength or quality
2.
Misbranding:
a.
Labeling is false/misleading
b.
Rx drug & manufacturers labeling fails to contain:
i. Name & address manufacturer/packer/distributor
ii. Established name of drug
iii. Net quantity (wt, quantity, or dosage units)
iv. Weight of active ingredient per dosage unit
v. Federal legend - “Caution: Federal law prohibits dispensing w/o a “rx” OR
“Rx only.”
vi. If not PO, then specific routes of admin
vii. Special storage instructions, if appropriate
viii. Lot #
ix. Expiration date
x. Adequate info for use (PI – for health professional)
c.
OTC drug that fails to contain:
i. Statement of identity
ii. Name & address manufacturer/packer/distributor
iii. Net quantity
iv. Cautions & warnings needed to protect
v. Content & format of OTC product labeling in “Drug Facts” panel format:
1.
Active ingredient
2.
Purpose
3.
Use/indications
4.
Warnings
5.
Directions
6.
Other info
7.
Inactive ingredients (alphabetical)
8.
Questions? Optional w/phone #
d.
It is a drug liable to deterioration unless packaged/labeled accordingly
e.
Container is made, formed, or filled to be misleading
f.
Drug is exact imitation of another drug or offered for sale under the name of
another drug
g.
Dangerous to health when used in dosage or manner suggested in label
h.
Packaged of labeled in violation of the poison prevention act
ADVERTISING or promotion of rx drugs
1.
FDA regulates Rx
2.
FTC regulates OTCs
3.
Advertising of rx drug prices, considered reminder advertising. It is exempt from
regulations as long as it meets these requirements:
a.
Only purpose is to provide info on price (NOT on safety, efficacy, or indications)
b.
Contains the proprietary name of drug, if any; generic name, strength, dosage
form, price charged for specific quantity
c.
MAY include availability of professional services as long as not misleading
d.
Price stated MUST include all charges; mailing fees & delivery fees may be stated
separately
SPECIAL WARNING requirements
4.
FDC – Yellow # 5 (tartazine) & #6
a.
Must disclose presence & provide warning in “precautions” b/c poss. allergic rxn
5.
Aspartame
a.
Must disclose presence & provide warning in “precautions” for Phenylketonurics:
contains phenylalanine __mg per dosage unit
6.
Sulfites
a.
Rx drugs containing sulfites must contain allergy warning in “warnings” section
7.
Mineral Oil
a.
Warning to only be taken at HS & NOT used in infants unless directed by MD.
Label can NOT encourage use during pregnancy
8.
Wintergreen oil
a.
Any drug containing > 5% methyl salicylate (flavor) include warning: use other
than directed may be dangerous & drug should be kept out of reach of children
9.
Sodium Phosphates
a.
Limits amount in oral soln to <90mL per OTC container; requires specific warning
10. Isoproterenol inhalation preperations
a.
Requires warning not to exceed dose prescribed & to contact MD if difficulty
breathing persists
11. Ipecac Syrup:
a.
Statement in boxed & red letters: “For emergency use to cause vomiting in
poisoning. Before using, call physician, the poison prevention center, or hospital
emergency room immediately for advice.”
b.
Warning “Warning: keep out of reach of children. Do not use in unconscious
persons.”
c.
Dosage of med must appear (15mL (1 tsp) in individuals > 1y/o)
d.
May only be sold in 1 oz containers
12. Phenacetine (acetophenetidin)
a.
Warning: possible kidney damage (taken in large amounts/for long period of time)
13.
Salicylates:
a.
ASA & others: warnings about Reye’s syndrome
b.
Retail containers of 1¼ grain (81mg; pediatric) ASA cannot be sold in containers
holding > 36 tablets
14. Alcohol warning
a.
Internal analgesics & antipyretics including APAP, ASA, IBU, Naproxen,
Ketoprofen, ect – required to have warning for persons consuming > 3 bev/day &
to consult with MD before taking
FDA drug & devices recall classifications: (descending order of importance)
1.
Class 1 (BAD!): reasonable probability will cause serious AE or death
2.
Class 2: may cause temp/medically reversible AE or probability of serious AE is
remote
3.
Class 3: not likely to cause serious AE
Pt Package inserts: (MANDATORY)
1.
Supplied by manufacturer & written for lay person
2.
Required upon initial filling for certain products
3.
Hospitalized/institutionalized pts: provided at first admin & then q 30 days. Required
for:
a.
Oral contraceptives
b.
Estrogen products
c.
Progesterone products
4.
Failure to provide would be MISBRANDING
Medication Guides (voluntary)
5.
Similar to PPI
6.
FDA will require for drugs when:
a.
Pt labeling could prevent serious AE
b.
Product has serious risks relative to benefit
c.
Pt adherence to directions is crucial
7.
Med Guides written in standard format & for lay person
8.
Manufacturers  obtain FDA approval BEFORE distributing med guides.
9.
Meds Guides REQUIRED for:
a.
Epzicom (abacavir/lamivudine); Ziagen (abacavir); Trizivir
(abacavir/lamivudine/zidovudine)
b.
Soriatane (acitretin)
c.
Lotronex (alosteron HCL)
d.
Cordarone (amiodarone)
e.
Antidepressants in child/teen
f.
Strattera (amoxetine)
g.
Tracleer (bosentan)
h.
Palladone (hydromorphone HCL)
i.
Roferon-A (interferon alpha-2A); Rebif (interferion beta-1A); Infergen (interferon
alfacon-1); Avonex (interferon beta-1A)
j.
Accutane (isotrentinion)
k.
Relivid (lenolidamide)
l.
Lindane
m.
Lariam (mefloquine HCL)
n.
Mifepex (mifepristone)
o.
Viramune (nevirapine)
p.
NSAIDS
q.
Pegasys (peginterferion alfa-2A); PEG-intron (peginterferion alfa-2B)
r.
Elidel (pimecrolimus)
s.
Symlin (pramlitidine)
t.
Ribavirin (all brands)
u.
Servent (salmeterol)
v.
Advair (salmeterol/fluticasone)
w.
Emsam (selegeline)
x.
Xyrem (Na oxybate)
y.
Soltamox or Nolvadex (tamoxifen)
z.
Forteo (teriparatide)
aa. Protopic (tacrolimus)
1
Restricted distribution systems:
1.
Isotretinoin (Accutane) – iPLEDGE
a.
Only MD registered in iPLEDGE may prescribe.
i. Must agree to assume responsibility of preg counseling
ii. Must obtain & enter results into iPLEDGE BEFORE prescribing
b.
Only pts registered in iPLEDGE can be prescribed this drug
i. Must comply with: complete informed consent form; obtain counseling
about risks/requirements for safe drug use; comply with preg tests & use
of contraception
c.
Only pharmacies registered in iPLEDGE can dispense
i. Must attest to: knowing risks; training other Rphs, comply/seek all others
comply with program; obtain isotretinion from iPLEDGE registered
wholesalers; return unused product; not fill for any party other than
qualified pt
d.
To dispense – RPh must obtain authorization from iPLEDGE
(ipledgeprogram.com) via internet or telephone
2.
Lotronex (alosetron HCL)
a.
Indicated only for women w/severe diarrhea-predominate chronic (>6mo) IBS who
have failed every other therapy
b.
Prescribing program requires STICKER to be affixed to ALL rx for Lotronex
c.
Telephone, fax, or electronic rx NOT valid
d.
Rx dispensed in original retail pack (included med guide; package insert &
follow-up survey enrollment
3.
Clozaril (clozapine)
a.
Used for schizophrenia –monitoring for potentially fatal agranulocytosis
b.
Only dispensed by pharmacies registered w Clozaril National Registry
c.
May only dispense enough tablets until next blood test
4.
Thalomid (thalidomide)
a.
System for Thalidomide education & prescribing safety (STEPS) program requires
registration of all prescribers, pts, & RPhs
b.
Requires preg testing, informed consent, authorization, validation prior to
dispensing, compliance with measures to prevent pregnancy, education materials,
pt counseling, & required reporting of fetal exposure
c.
Rx limited to 28 days in blister packs w/safety info
d.
NO telephone rx or automatic refills
5.
Tikosyn (dofetilide)
a.
Tx of AF; only available in retail pharmacies in Tikosyn in Pharmacy System
(TIPS) program
b.
RPh must verify prescriber is qualified by checking database (tikosynlist.com) or
telephone prior to dispensing
c.
RPh must initial & date each rx & stamp with special TIPS stamp
6.
Tracleer (bosentan)
a.
Tx of pulmonary arterial HTN – needs monitor for liver tox
b.
Only available through designated pharmacies participating in Tracleer Access
Program (TAP)
7.
Xyrem (sodium oxybate or also known as GHB)
a.
Tx of narcolepsy – schedule III
b.
Available only through a single centralized pharmacy
National Drug Code (NDC) Number
1.
10 or 11 digit # that identifies particular drug by manufacturer, product, & package
a.
First 4-5 digits = manufacturer - LABELER
b.
Next 4 digits = specific drug - PRODUCT
c.
Last 2 digits = package size - PACKAGE
2.
FDA does NOT mandate that drug manufacturers place NDC codes on labels!!!
(Most manufacturers do though)
Compounding vs Manufacturing
1.
FDA issued compliance policy guide 1992
2.
FDA Modernization Act (FDAMA) 1997
a.
Compounding in pharmacy ≠ manufacturing
b.
Pharmacy may NOT advertise compounding of any particular drug, class of drug,
or type of drug ***US Supreme court ruled in 2002 that entire compounding
provisions of FDAMA were invalidated
FDA 2002 Policy on Compounding:
1.
FDA defers to state authorities regarding the less significant violations of the act related
to pharmacy compounding of human drugs
2.
FDA will work with state if needed for investigations, ect
3.
If FDA gets suspicious that pharmacy is manufacturing  they need to consider
whether the pharmacy is engaging in the following acts considered manufacturing:
a.
Compounding drugs in anticipation of receiving rx (except in limited quantities in
relation to amounts of drugs compounded after receiving valid prescriptions)
b.
Compounding drugs removed/w/drawn from market for safety reasons
c.
Compounding from “bulk active ingredients” that are not components of FDA
approved drug w/out FDA investigational new drug application (IND)
d.
Receiving, storing, or using drug substances w/out first obtaining written
assurance from supplier that each lot made in FDA-registered facility
e.
Receiving, storing, or using drug components not meeting official compendia
requirements
f.
Using commercial scale manufacturing/testing equipment for compounding
g.
Compounding for 3rd parties or offering drugs for wholesale for resale
h.
Compounding drugs commercially available (essentially copies)
i.
Failing to operate w/in compliance to state law
Pregnancy Categories (ascending order of importance)
1.
Category A – Adequate, well-controlled clinical studies IN preg
a.
No evidence of risk in last two trimesters
2.
Category B – Adequate, well-controlled clinical studies NOT in preg - animal studies
showed no risk; OR animal studies show AE but human studies have not shown risk in 1st
trimester
a.
No evidence of risk in last two trimesters
3.
Category C – safety of drug not determined.
a.
Drug should NOT be used unless benefit > risk to fetus
4.
Category D – positive evidence of risk to fetus
a.
ONLY admin if benefits > > > risk to fetus
5.
Category X – indicate risk of damage caused by drug - outweighs ANY possible benefit
Poison Prevention Act***
1.
Administered by Consumer Product Safety Commission (CPSI)
2.
Requires child-resistant containers for rx & OTC
3.
Exemptions:
a.
Request of pt or MD
b.
Bulk containers not intended for household use
c.
Drugs distributed to institutionalized pts
d.
1 package size of OTC designed for elderly
e.
*Specific drugs*:
i. Oral contraceptives, conjugated estrogens & norethindrone acetate in
manufacturers package
ii. Medroxyprogesterone tablets
iii. SL nitroglycerin
iv. SL or chewable isosorbide dinitrate 10 mg or less
v. ASA or APAP in effervescent tablets or granules
vi. Potassium supplements in unit dose packaging
vii. Sodium fluoride (not more than 264mg per package)
viii. Anhydrous cholestyramine & colestipol packets
ix. Aerosol products
x. Erythromycin ethylsuccinate granules for oral suspension & oral
suspensions w/ < 8g erythromycin
xi. Erythromycin ethylsuccinate tablets in packages < 16g ery.
xii. Prednisone tablets (< 105 mg/package)
xiii. Methylprednisolone tablets (< 84 mg/package)
xiv. Mebendazole tablets (< 600 mg/package)
xv. Betamethasone tablets (< 12.6 mg/package)
xvi. Preparations in aerosol containers intended for inhalation
xvii. Pancrelipase preparations
xviii. Sucrose preparations in soln of glycerol & water
FDA ORANGE BOOK
1.
Official name: “Approved drug products w/therapeutic equivalence evaluations”
2.
Primary source for determining generic equivalency
3.
Uses 2 letter coding system w/1st letter being the key:
a.
A = pharmaceutically & therapeutically equivalent
b.
B = NOT pharmaceutically & therapeutically equivalent
4.
Products w/no known or suspected bioequivalence issues:
a.
AA – conventional dosage forms
b.
AN – solutions & powders for aerosolization
c.
AO – injectable oil soln
d.
AP – injectable aqueous soln
e.
AT – topical products
5.
AB rating  Products w/actual or potential bioequivalence problems, but for which
adequate scientific evidence has established bioequivalence
FDA classification system for New drugs
1.
Therapeutic Classification:
a.
Type P (Priority) – Drug represents major therapeutic gain b/c no other effective
drugs available for tx certain illness OR it has significant advantages to currently
marketed drugs (“Fast tracked”)
b.
Type S (Standard) – drug similar to others on market
2.
Chemical Classification:
a.
Type 1 – new molecular structure; must not be currently marketed in US
b.
Type 2 – new derivative of molecular structure already approved in US
c.
Type 3 – new formulation of drug already marketed in US
d.
Type 4 – new combo of two or more drugs
e.
Type 5 – drug manufactured by new company
f.
Type 6 – new therapeutic indication for already approved drug
2
FEDERAL & FLORIDA CSS ACT
Drug Classification
1.
Schedule I (C-I)
a.
High potential for abuse
b.
No currently accepted medical use in US
c.
Includes:
i. Opiates & derivatives such as heroin & dihyromorpine
ii. Hallucinogens such as marijuana, lysergic acid diethylamide (LSD),
peyote, mescaline
iii. Depressants such as methaqualone
2.
Schedule II (C-II) – high abuse, severe dependence
a.
High potential for abuse
b.
Has a currently accepted medical use (as do all the following schedules)
c.
Abuse may lead to severe physical or psychological dependence
d.
Includes:
i. Opium & other narcotics such as morphine, codeine, dihydrocodeine,
oxycodone, methadone, meperidine, hydromorphone, fentanyl, & cocaine
ii. Stimulants such as amphetamine, methamphetamine, phenmetrazine, &
methyphenidate
iii. Depressants such as pentobarbital, secobarbital, amobarbital,
glutehimide, & phencyclidine
3.
Schedule III (C-III) – less abuse, moderate or low dependence (high psych)
a.
Potential for abuse less than C-II
b.
Abuse may lead to moderate or low physical dependence or high psychological
dependence
c.
Includes:
i. Many narcotic C-II drugs but in combo with another ingredient such as
ASA/codeine, APAP/codeine, APAP/hydrocodone (Vicodin)
ii. Suppository forms of amobarbital, secobarbital, or pentobarbital
iii. Stimulants such as chlorphentermine, phendimetrazine, & benzphetamine
iv. Anabolic steroids
v. Ketamine
vi. Paregoric
d.
When mixed with other non-narcotic agents, cannot contain more than:
i. **1.8g codeine or dihydrocodeine per 100mL; or not > 90mg/dosage unit
ii. 300mg dihydrocodeine (hydrocodone) or ethylmorphine per 100mL, or not
> 15mg/dosage unit
iii. 500mg of opium per 100mL/100g, or not > 25mg/dosage unit
iv. 50mg morphine per 100mL/100g
4.
Schedule IV (C-IV) – low abuse, limited dependence
a.
Low potential for abuse relative to C-III
b.
Abuse may lead to limited physical or psychological dependence
c.
Includes:
i. Narcotics such as dextropropoxyphene & products w/not more than 1mg
difenoxin & not less than 25 mcg atropine sulfate/dosage unit
ii. Depressants such as alprazolam, chloral hydrate, diazepam, lorazepam,
Phenobarbital
iii. Stimulants such as diethylpropion & phentermine
iv. Others such as pentazocine & butorphanol
5.
Schedule V (C-V) – low abuse, limited dependence
a.
Low potential for abuse
b.
Abuse may lead to limited physical or psychological dependence
c.
Includes:
i. Anti-tussive products containing codeine (up to 240 mL OTC but must be
logged) & antidiarrheal products containing opium
d.
When mixed with other non-narcotic agents, cannot contain more than:
i. **200mg of codeine per 100mL/100g**
ii. 100mg dihydrocodeine, ethylmorphine, or opium per 100mL/100g
iii. 2.5mg diphenoxylate & not less than 25mg atropine/dosage unit
iv. 0.5mg difenoxin & not less than 25mg atropine/dosage unit
Scheduling of compounded CSs
1.
Must be compounded w/1 or more non-narcotic therapeutic ingredients
2.
Codeine
a.
C-V limit = 200 mg/100mL
b.
C-III limit = 1800 mg/100mL
3.
Opium
a.
C-V limit = 100 mg/100mL
b.
C-III limit = 500 mg/100mL
Registration
1.
General information
a.
Manufactures, distributes, or dispenses any CS = register with DEA
b.
Dispensers register q 3 year with DEA
c.
Separate registration for separate locations
d.
Application for registration – DEA form 224 for dispenser
2.
Exemptions
a.
An agent/employee of any registered manufacturer/distributor/dispenser if acting
in usual course of business (ex. RPh does not have to register – pharmacy does)
b.
Carrier/warehouse man or employee (such as UPS/FedEx)
c.
Ultimate user
3.
Practitioner’s use of hospital DEA #
a.
Interns, residents, staff physicians & mid-level practitioners who are agents of
hospital/institution may administer, dispense, or prescribe CS under the
registration of the hospital/institution
b.
Hospital must assign a specific internal code for each practitioner above
4.
Registration for military personnel
a.
Registration waived for military physicians (as long as in course of official duties)
b.
Military physicians must indicate branch of service & service identification #
instead of DEA # on prescriptions
5.
Activities requiring separate registrations
a.
Manufacturing (C-I – C-V)
b.
Distributing (C-I – C-V)
c.
Dispensing (C-II – C-V) – includes practitioners & pharmacies
d.
Conducting research (C-I) (C-II – C-V)
e.
Conducting narcotic treatment program (C-II – C-V)
f.
Conducting chemical analysis (C-I – C-V)
g.
Importing (C-I – C-V)
h.
Exporting (C-I – C-V)
6.
Verifying a DEA registration
a.
Step 1 – add 1st, 3rd, & 5th digit
b.
Step 2 – add 2nd, 4th, & 6th digit & multiply by 2
c.
Step 3 – add sum of steps 1 & 2 & the last digit of sum should = last DEA # digit
Transfer or temporary use of registration
1.
DEA does not generally permit a registration to be transferred but written requests should
be made to DEA headquarters
2.
When DC’ing CS activities or business, a pharmacy registrant may transfer the authority
to conduct CS activities to a new registrant  The section requires notifying the DEA in
person or by registered/certified mail, return receipt requested at least 14 days in
advance of the proposed transfer & meeting specific inventory requirements.
3.
If new owner has not yet obtained DEA registration, DEA does permit the new owner to
continue business of the pharmacy under the previous owners registration, provided
the following requirements are met:
1.
New owner must expeditiously apply for DEA & state license
2.
Previous owner provides power of attorney to new owner that provides for:
a.
Previous owner agrees to allow CS activities carried out under their DEA
registration
b.
Previous owner agree to allow new owner to carry out the CS activities
(such as ordering controls), as agent of previous owner
c.
Previous owner acknowledges they will be held accountable for any
violations
d.
Previous owner agrees that CS activities of pharmacy may be carried out
under their DEA & shall remain in effect for no more than 45 days after
purchase date
** FYI – transfer of DEA permit ONLY (max 45 days) in Florida… ≠ pharmacy permit from
state.. Must have NEW permit on 1st day pharmacy opens
3.
New owner must notify the appropriate local DEA office of the proposed use of the
previous owner’s DEA registration, & furnish copy of power of attorney
Ordering Schedule I or II CSs *** DEA form 222***
1.
Required for each sale/transfer for C-I & C-II
2.
Forms can only be ordered by registrants (i.e. have DEA#)
3.
Each form has 1 original & 2 copies
4.
Only 1 item ordered on each numbered line
5.
Orders for etorphine HCl & diprenorphine must contain only these substances
6.
The number of lines completed must be noted on the form
7.
Name & address of supplier from whom the CSs are being ordered must be entered
8.
Must be signed & dated by person authorized to sign application for registration
9.
Purchaser may authorize other individuals to execute forms by creating power of attorney
10. Forms that are not complete, legible, properly prepared or signed will not be accepted
11. Forms that show any alteration, erasure or changes will not be accepted
12. Purchaser submits Original copy 1 & copy 2 of the form to the supplier & retains Copy 3.
13. Supplier records on Copy 1 & 2 the number of containers supplied & date shipped
14. If order cannot be filled in its entirety, supplier may fill the order in part & supply the
balance w/in 60 days
15. Supplier retains Copy 1 & fwds Copy 2 to DEA
16. Purchaser records on Copy 3 the number of containers received & date.
17. If a completed order form is lost/stolen, purchaser must be prepare another 222 form in
triplicate along with a statement containing the serial number & date of lost form & stating
that the goods covered by the first order were not received because the form was lost.
3
Storage & Records
1.
Storage (not mandatory)
a.
May store controls in secure cabinet that is locked
b.
May store controls by dispersal throughout the non-controlled stock to deter theft
c.
May not store all CSs on one unsecured shelf
2.
Inventories
a.
Initial inventory on day open for business
b.
Newly scheduled drugs must be inventoried on the day scheduled
c.
Biennial (every 2 years) – must be maintained in the pharmacy for 2 years
d.
Counts
i. Exact count for all scheduled IIs
ii. Estimated count for schedule IIIs – unless container contains > 1000 units
3.
Records
a.
Receipt of CSs
i. C-II – copy 3 of DEA 222
ii. C-III – C-V – suppliers invoice
b.
Disbursement of CSs
i. Prescription files – storage options
1.
3 files
a.
File 1 = C-II
b.
File 2 = C-III-V
c.
File 3 = nonscheduled
2.
2 files
a.
File 1 = C-II
b.
File 2 = CIII-V & nonscheduled – with CS prescriptions
stamped with a red “C” not less than 1 inch in height in lower
RIGHT corner
3.
2 files
a.
File 1 = C-II-V with C-III, IV, V stamped with red “C”
b.
File 2 = non scheduled
c.
If pharmacy maintains a data processing system for
prescriptions that permits identification of RX & retrieval, the
requirement of the red “C” is waived.
ii. Transfers to another registrant
1.
C-II  DEA 222 form & Copy 1 serves as record of transfer
2.
C-III – C-V  evidenced by a commercial invoice
3.
5% rule – does not exist anymore in FL! Must obtain a Retail
Pharmacy Wholesaler’s Permit
iii. Destruction
1.
Transfer to authorized reverse distributor – requires form 222 for CII or invoice for C-III-V
2.
Once yearly destruction
a.
Retail pharmacies can request permission to destroy CS
once per calendar year
b.
Use DEA form 41 (Registrants Inventory of Drugs
Surrendered) listing drugs to be destroyed, & a letter stating
date & method of destruction, & at least 2 witnesses (MD,
RPh, PA, nurse, cop)
c.
Form 41 & letter must be received by nearest DEA office
at least 2 weeks prior to proposed date – 14 DAYS
d.
DEA will notify registrant in writing of decision
e.
Once destroyed, signed copies of DEA Form 41 must be
forwarded to DEA
3.
Blanket Authorizations for destruction (needles, syringes,
injectables)
a.
Issued on a limited basis to hospitals, clinics, or others
b.
DEA Form 41 must be used to inventory drugs destroyed
iv. Lost or theft of CSs
1.
Notify DEA & local police immediately upon discovery
2.
Complete DEA Form 106 (Theft of loss of CSs)
c.
Central Recordkeeping
i. A registrant wishing to maintain shipping & financial records at a central
location other than registered location must notify the nearest DEA office
ii. Unless registrant is notified by the DEA that the permission to keep the
central records is denied, the registrant may begin maintaining central
records 14 days after notifying the DEA
iii. Central records shall not included executed DEA order forms, rxs, or
inventories. These must be kept at the pharmacy
Dispensing CSs Prescriptions
1.
General
a.
Must be issued for a legitimate medical purpose by a practitioner acting in the
usual course of sound professional practice
b.
Corresponding responsibility doctrine – the practitioner is responsible for the
proper prescribing & dispensing of CSs. YET, the corresponding responsibility
rests with the RPh who dispenses the rx
c.
A prescription for “office use” is not valid.
2.
Schedule II Prescriptions
a.
General
i. C-II require written rx signed by practitioner (or electronic w/
necessary security requirements)
ii. C-II cannot be refilled
iii. No time limit under federal law as to when a C-II rx must be filled after
being signed. In Florida, it is 1 year.
b.
Faxed Prescriptions – NOT valid for C-II except for:
i. C-II narcotic for pt undergoing home infusion/IV pain therapy
ii. C-II CS for pts in long term care facilities (LTCF)
iii. C-II narcotic for pt in hospice care
c.
Emergency Dispensing
i. Emergency situation: practitioner may phone/fax a C-II under certain cond:
1.
Emergency means:
a.
Immediate admin is necessary
b.
No alternative tx is available
c.
Not possible for prescriber to provide a written rx
2.
Qt prescribed & dispensed must be limited to 72 hour supply
3.
Rx order must immediately be reduced to writing by RPh & contain
all info except practitioner’s signature
4.
If prescriber is not known to RPh, RPh must make reasonable
effort to determine phone authorization came from valid practitioner
5.
W/in 7 days, the prescribing practitioner must furnish the RPh a
written, signed rx for the CS prescribed (if mailed, it must be
postmarked w/in 7days). The prescription should be marked
“Authorization for Emergency Dispensing”
d.
Partial dispensing (New – 2007)
i. RPh may partially dispense C-II if they are unable to supply the full quantity
provided the RPh notes the quantity supplied on the FRONT of the rx
ii. The remaining portion must be dispensed w/in 72 hours.
iii. Exception for “terminally ill” & LTCF pts:
1.
Partial fills are allowed as many times as needed as long as all
records of partial fillings are recorded/maintained in computer
2.
All partial fills must be completed w/in 60 days from issue date
iv. Sec. 1306.12 – Refilling rx; issuance of multiple prescriptions
1.
C-II refills prohibited
2.
A practitioner may issue multiple prescriptions (3 separate rx w/30
day supply on each) authorizing the pt to receive a total of up to 90
day supply of a C-II as long as:
a.
Each rx for a legit medical purpose
b.
Practitioner provides written instructions on each rx
indicating earliest date of filling each prescription
c.
Practitioner concludes that providing the rxs does not create
risk of diversion or abuse
d.
Must be permissible under state laws
3.
Nothing above shall be construed as mandating or encourageing
individual practitioners to issue multiple RX or to see their pts only
once q 90 days.
3.
Schedule III – V prescriptions
a.
May be filled from written, verbal, or faxed, or electronic prescriptions
b.
May be refilled as indicated on rx up to 5 times or 6 months from date issued
c.
Transfers:
i. Refills may be transferred ONCE
ii. If pharmacies share an electronic, real-time, online database of rx, they
may transfer up to the max # of refills permitted by law & prescriber
authorization
4.
a.
b.
5.
Dispensing can only be done by a pharmacist
Cannot sell more than:
i. 8oz (240mL) or 48 dosage units of any CS containing opium
ii. 120 mg Codiene (60 mg dihydrocodiene, 30 mg ethyl morphine)
iii. 4oz (120mL) or 24 dosage units of any other CS
c.
Cannot sell to the same person w/in 48 hours
d.
Purchaser has to be at least 18 years old
e.
Identification is required if person is not known to pharmacist
f.
RPh must maintain a bound record book containing:
i. Name & address of purchaser
ii. Name & quantity of CS dispensed
iii. The date of purchase
iv. Name or initials of RPh who did the dispensing
Prescribing & dispensing of certain narcotic drugs
a.
Methadone can only be dispensed as treatment for pain (confirm this if new rx)
b.
Methadone or any other drugs CANNOT be dispensed for the maintenance or
detoxification of addicts unless provided by a registered narcotic treatment center
c.
Office-based treatment of opiate dependence
i. Drug addiction treatment act (2000) allows tx of opiate dependence from
physicians office. Law allows “special” physicians to prescribe certain
narcotic C-III-V drugs to treat opiate dependence
ii. Physicians who have qualified to prescribe under this act can be identified
by the letter “X” which appears as a prefix in their DEA registration
iii. First two drugs under act: Subutex (buprenorphine) & Suboxone
(buprenorphine/naloxone). Both C-III
Florida CSs Act – Florida Statute Chapter 893 (456, 465, 499, 893 are all Florida statutes.. law
written by legislature & deferred to board of pharmacy to write “rules” that are much more
comprehensive & detailed)
6.
893.04 - Pharmacist & Practitioner
a.
Oral rx must be promptly reduced to writing by RPh
b.
Written rx must be dated & signed by practitioner on date issued
i. CIII-V: call MD if no date & re-write as verbal order – don’t just fill in blank
ii. C-II: give rx back to pt to take to MD
c.
Required on prescription:
i. Pt full name & address
ii. Practitioner full name, address, & DEA #
iii. If for animal, species of animal
iv. Name of CS prescribed, strength, quantity, & directions
v. Number of the prescription as recorded in pharmacies prescription files
vi. Initials of the dispensing pharmacists & date filled
d.
Prescription records must be maintained for 2 years
e.
Required information on the prescription label:
i. Pharmacy name & address
ii. Date filled
iii. Prescription number
iv. Prescriber name
v. Pt name
vi. Directions for use
vii. Warning that it is a crime to transfer the CS to any person other than the pt
for whom it is prescribed
f.
Prescription for C-II drug may be filled only upon a written rx except in an
emergency situation
g.
No prescriptions in C III-V may be refilled more than 5 times w/in 6 months
h.
RPh may dispense emergency refill of up to 72 hour supply of a CS except for a
C-II
7.
893.07 Records – inventory, etc. same as federal law
Review: DEA Forms
a.
Form 222: C-II ordering, destroying (by reverse distributor), & transferring
b.
Form 41: controls destroying (q year at retail & injections at hospital)
c.
Form 106: controls lost or stolen
OTC sales of schedule V drugs
4
FLORIDA PHARMACY LAWS & REGULATIONS
Prescriptive Authority
1.
Practitioners (chapter they are licensed under)
a.
Physician – chapter 458
b.
Dentist – chapter 466
c.
Veterinarian – chapter 474
d.
Osteopathic physician – chapter 459
e.
Naturopath – chapter 461
f.
Out-of-state practitioners – rx valid but only if for tx of a chronic condition
2.
Physician assistants & advanced nurse practitioners
a.
Physician assistants – limited formulary, cannot prescribe CSs, antipsychotics,
general anesthetics, radiographic contrast materials, & all parenteral preparations
other than insulin & epinephrine
b.
Advanced practice nurses – may initiate orders under protocol
3.
Certified optometrists – may prescribe (& administer) topical ocular pharmaceutical
agents on formulary below:
a.
Cyclopegics & mydriatics – atropine sulfate <1%, phenylephrine HCL > 2.5%,
cyclopentalate HCL >2%
b.
Local anesthetics – any
c.
Diagnostic products – any
d.
Ophthalmic decongestants/antihistamines – any
e.
Antibacterial – any except chloramphenicol
f.
NSAIDs – any
g.
Anti-glaucoma agents – any except cholinesterase inhibitors
h.
Miscellaneous – any other topical ocular agent except antifungals
465.002 – Legislative findings; INTENT
1.
“Sole legislative purpose for the chapter is to ensure pharmacists practicing in FL & every
pharmacy meet minimum requirements for safe practice”
2.
Chapter on “general practice of pharmacy”
465.003 – DEFINITIONS
1.
Consultant pharmacist – RPh that is licensed as consultant RPh (Fl is only state
w/separate license for consultants)
2.
Dispense – transfer of possession of medicinal drug by RPh to ultimate consumer
a.
Pharmacists shall: interpret/assess the rx for potential AE, interactions, & dosage
regimen; provide counseling on proper drug usage (oral or written)
b.
Sales transaction/delivery ≠ dispensing
c.
Administration ≠ dispensing
3.
Medicinal drugs or “drugs” – commonly known as “prescription” or “legend”
4.
Patent or proprietary preparation – medicine in its unbroken, original package which is
sold to the public by manufacturer/distributor that is not misbranded under FDCA
5.
Pharmacy –
a.
Community pharmacy
b.
Institutional pharmacy
c.
Nuclear pharmacy – does not include hospitals licensed under chapter 395
d.
Special pharmacy
e.
Internet pharmacy – locations not otherwise licensed of issued a permit under this
chapter w/in or outside this state which uses internet
f.
Pharmacy department shall be considered closed whenever a Florida licensed
pharmacist is not present & on duty. This shall not be construed to not allow
pharmacist to not leave pharmacy for “normal” pharmacy stuff
6.
Practice of the profession of pharmacy – compounding, dispensing, & consulting & also
doing “other pharmaceutical services” such as monitoring pt drug therapy, assisting in
medication management, review pt drug therapy, & consulting with pt prescriber
7.
Prescription – includes written or transmitted by any means of communication (including
oral). The term “prescription” also includes a pharmacists order for a product selected
from the formulary created pursuant to 465.186. Rx can be retained in written form or
electronic, provided it can be produced upon lawful request.
465.004 BOARD OF PHARMACY –
1.
9 members
a.
7 pharmacists & 2 consumer/public members
2.
Pharmacists Members
a.
Residents of FL & engaged in practice of pharmacy for at least 4 years (does not
specify that they have to be practicing while on board but they usually are)
i. 1 community pharmacist
ii. 1 modified/class II institutional pharmacy
3.
Consumer/public members
a.
Never been licensed as a pharmacist
b.
No connection with practice of pharmacy, drug manufacturer or wholesaler
Licensure of Pharmacists
465.007 – Licensure by examination
1.
Basic requirements
a.
Complete form/pay fee
b.
At least 18 years old
c.
Have a pharmacy degree; or graduated from outside US school & passes TOEFL,
TSE, & FPGEE & have 2080 hours supervised work activity program (64B1626.205.
d.
Complete internship program that shall not exceed 2080 hrs.
2.
Rule 64B16-26.1001 – Exam & application fees
a.
Licensure by examination - $100
b.
Licensure by endorsement - $100
c.
CE provider - $150
d.
CE course approval - $50
3.
Rule 64B16-26.1002 – Initial license fees
a.
Pharmacist - $195
b.
Consultant pharmacist - $55
c.
Nuclear pharmacist - $55
4.
Rule 64B16-26.1003 – Active license renewal
5.
Rule 64B16-26.1004 – Inactive license election; renewal, fees
a.
At time of renewal, to place the license on inactive status by submitting a written
request with the board for inactive status & submitting the inactive status renewal
fee of $245 plus a $5 unlicensed activity fee
b.
At the time of license renewal to change the inactive status license to active
status, provided the licensee meets the CE requirements for each biennium the
license was on inactive status, submits the reactivation fee of $70, & the current
active renewal fee set forth above
6.
Rule 64B16-26.1005 – RETIRED LICENSE election; renewal, fees
a.
License can be put on retired status
b.
If inactive for < 5 yrs, the licensee must pass MPJE
c.
If inactive for > 5 yrs, the licensee must pass the NAPLEX & MPJE
7.
Rule 64B16-26.1021 – DELINQUENT LICENSE reversion; reinstatement; fees
a.
An active or inactive license that is not renewed by midnight of the expiration date
of the license shall automatically revert to delinquent status
8.
Rule 64B16-26.100 Examination requirements
a.
NAPLEX
b.
MPJE – Florida version
c.
Must obtain scaled score of 75 on both NAPLEX/MPJE
9.
Rule 64B16-26.203 – Licensure by examination
a.
All applicants shall complete Medication Errors course (at least 2 hours)
b.
Applicants must submit proof of completion of internship program of at least 1500
hours & 2080 hours for all other programs
c.
All requirements must be met w/in 1 yr of receipt of application or have to reapply
d.
Successful exam scores may be use upon reapplication only if completed w/in 3
years of reapplication
10. Rule 64B16-26.2031 – Licensure by examination; foreign pharmacy graduates
a.
Graduate of a 4 year undergraduate pharmacy program outside US & completed
internship approved by board
b.
Passed foreign pharmacy grad equivalency exam
c.
Demonstrate proficiency in the use of English (Toefl) w/score >500 for
pencil/paper or 173 in computer version (this might be higher now as it was
updated)
d.
Demonstrate they can speak English (TSE) w/score at least 200 or 45 on
recalibrated
e.
Complete at least 2080 h supervised work w/in Florida
11.
12.
Rule 64B16-26.2032 – Licensure by Examination; internship requirements
465.0075 – Licensure by endorsement; manner of application – endorsement, rule
64B16-26.204 F.A.C.
a.
Must meet age, internship, & education requirements in 465.007
b.
Must submit proof that one of the following requirements has been met:
i. Licensed & practicing in another jurisdiction for at least 2 of the
immediately preceding 5 yrs. If they meet this requirement, proof of 30
hours CE obtained in last 2 years preceding the application
ii. Successful completion of an internship meeting requirements of section
465.0075(1)(c), w/in 2 preceding years
c.
Must submit proof of completion of the following:
i. Course of 2 hours on Med errors no earlier than 12 mos prior to application
d.
Applicants qualifying under the education requirements (foreign grads) must
complete the requirements for rule 64B16-26.205 prior to exam
e.
All requirements for licensure by endorsement must be met w/in 1 yr of the receipt
of application
f.
Applicants must receive a passing score on the license exam no more than 12
years prior to application
g.
Applicants applying shall cause the NABP or other similar organization to issue a
Transfer of pharmaceutical licensure certificate showing: exam date, results,
states of licensure, disciplinary actions, & licensure status
h.
Applicants deemed qualified for licensure by endorsement shall only be required
to complete MPJE for Florida. Passing scores on this exam may be use upon
reapplication only if exam taking w/in 3 years of reapplication
465.008 – Renewal of License – must submit renewal application, pay fee & comply with CE
requirements. Licenses renewed q 2 yrs. Persons licensed for 50 years or more are exempt from
payment of renewal or delinquent fee & is given a lifetime license
1.
Rule 64B16-26.102 – inactive license renewal
a.
If a license is not renewed automatically it becomes delinquent
b.
Licensees may request to be placed on inactive status at time of renewal but must
still pay renewal fee. May become active again by meeting CE requirements
465.009 – continuing professional pharmaceutical education (CE) – requires completion of
board approved CE prior to renewal of license, allows board to adopt rules & make exceptions
for emergencies & hardships
1.
Rule 64B16-26.103
a.
Requires 30 hours of board approved CE w/in the 24 months period prior to the
expiration date of the license
b.
Initial renew – no CE required if renewal is w/in 1 year of initial license; if more
than 1 year then need 15 CE hours
c.
Need two contact hours of Med errors (Rule 64B16-26.6011)
d.
May obtain 5 hours of CE in subject matter of risk management by attending one
full day of a board meeting at which disciplinary hearings are conducted (No CE if
attending due to board requirement)
e.
Board of pharmacy member may obtain 5 hours CE in “risk management” by
serving on a probable cause panel
f.
A volunteer expert witness providing expert witness opinions for cases being
reviewed by the department shall receive 5 hours CE in “risk management”
2.
Rule 64B16- 26.1012 – approved CE provider renewal fees
3.
Rule 64B16-26.104 – Exemption for members of armed forces – spouse included
4.
Rule 64B16-26.600 – Tripartite CE committee
a.
Comprised of equal representation from BoP, each college/school pharmacy in
state, & practicing pharmacists
b.
Has authority to approve CE providers & approval of courses submitted by
providers
c.
Two year terms
5.
Rule 64B16- 26.601 – standard for approval of CE courses
6.
Rule 64B16-26.603 – reporting CE requirements – must report CE compliance with
renewal. Records of CE must be kept for 2 years after renewal period for audit purposes.
7.
Rule 64B16-26.606 – number of required hours – 30 hours required & at least 10 hours
from live seminars, video conference, or interactive computer
465.0125 – Consultant pharmacist license; application, renewal, fees, responsibilities, rules
5
1.
2.
3.
4.
5.
6.
7.
Consultant RPh responsible for maintaining all drug records required by law & for
establishing drug-handling procedures for the safe handling & storage of drug.
a.
May be responsible for ordering & evaluating any laboratory or clinical testing
b.
RPh must have completed additional training & demonstrate additional
qualifications
Consultant RPh/PharmD may be responsible for ordering/evaluating lab/clinical testing
for pts under care of licensed home health agency, when needed
a.
In order for the consultant/PharmD to qualify & accept this authority, they must
receive 3 hours of CE relating to lab/clinical testing
Rule 64B16-26.300 – Consultant pharmacist licensure
a.
Hold RPh license which is active & in good standing
b.
Completed approved consultant RPh course of no fewer than 12 hours sponsored
by a COP w/in FL & approved by FL BOP tripartite CE committee, pass test
c.
Consultant RPh must then complete period of assessment & eval w/preceptor w/in
1 year of completion of course set forth above:
i. Completed in no more than 3 consecutive months
ii. Shall include at least 40 hours training, 60% on-site at institution that
holds a pharmacy permit
Rule 64B16-26.301– subject matter for consultant RPh training program
a.
Laws, regulations, policies, procedures, record keeping, reports, P&T committee,
ID committee, etc
Rule 64B16-26.302 – subject matter for consultant RPh recertification program
a.
A License Renewal Continuing Education Program must consist of at least 12
self-contained hrs of training in subjects specified w/a block of at least 3 hrs in
any subject category. Duplicated courses are not acceptable.
i. Drug Therapy – Disease State ii. Administrative Responsibilities.
ii. Consultant Pharmacist Facility Responsibilities
Rule 64B16-26.320 CE – ordering & evaluation of laboratory tests
a.
Consultant RPH/Pharm Ds who wish to order & evaluate laboratory tests under
465.0125 must complete an initial CE course of 3 hours & a recertification course
of 1 hour every biennium
b.
The 3 hour certification course & 1 hour recert course may be applied to the 24 hr
consultant RPh requirement or the 30 hr general CE requirement but not both
- limited to nursing home facilities & home health agencies (unless there’s a
prescriber care plan)
**FYI info: RPh needs 30 CE’s; consultant needs 24 CEs – total of 54 CEs q 2 yrs
a.
8 3 hour programs q 2 years to keep consultant license (or 2 weekend retreats)
Pharmacy Interns & Pharmacy Technicians
465.013 Registration of pharmacy interns
1.
Rule 64B16-26.400 – pharmacy INTERNS, registration, employment
a.
Pharmacist interns in the state must be registered
b.
Must be enrolled in internship program at COP or have graduated & not yet
licensed
c.
No intern can perform acts relating to the filling, compounding, or dispensing of
medical drugs unless done under direct & immediate supervision of Fl RPh.
2.
Rule 64B16-26.401 – Requirements for an internship program sufficient to qualify for
licensure by exam
a.
No licensed RPh may supervise > 1 intern at any one time
b.
Program must be 1500 hrs if reviewed & authorized by board or 2080 hr otherwise
c.
RPh preceptor requirements: current license (not revoked, suspended, on
probation, subject to unpaid fine, or undergoing disciplinary proceedings) &
engaged in practice at least 2 years.
d.
Hrs worked > 50 h/wk prior to graduation or 60h/wk after graduation do not count
465.014 – Pharmacy Technicians
1.
Rule 64B16-27.410 – Pharmacy TECHNICIAN 1:1 ratio (automatic approval for this)
a.
Unless approved by BoP, RPh may not supervise more than 1 tech
b.
Must be under direct & immediate supervision
c.
Pharmacy Techs must wear identification badge identifying them as techs
d.
Tasks technicians may perform:
i. Prepacking
ii. Assisting in prep of rx (typing label & computer entry)
iii. Issuing supplies & other products from hospital pharmacy to other places in
hospital
iv. Initiating refill requests (any change must be confirmed by RPh)
v. Initiating communication to prescriber to obtain clarification on dates,
prescribers name, brand/generic preference, or DEA/license #
2.
Rule 64B16-27.420 – Pharmacy technician 2:1 or 3:1 ratio (must apply for)
a.
Rx department manager or consultant RPh must submit request & receive
approval from the BOP for a 2:1 or 3:1
b.
Community pharmacies serving nursing homes, community or special pharmacies
providing parental &/or enteral services, institutional pharmacies, & nuclear
pharmacies may allow a technician to:
i. Reconstitute bulk parenteral/enteral preps to be stored for dispensing at
later date
ii. Refill unit does mobile transport systems
iii. Distribute bulk medicinal drugs, appliances & other health care products to
other departments
c.
Rule 64B16-27.430 – responsibility of RPh
i. RPh has professional & personal responsibility for any delegated act
performed by licensed interns & pharmacy technicians
ii. You violate this rule when selling wrong rx to wrong pt
d.
Rule 64B16-27.440 – policies & procedures
i. Any pharmacy using pharmacy technicians must have written policies &
procedures regarding # positions & their utilization, including the specific
score of technician responsibilities
Pharmacy Permits & Registration
465.018 – COMMUNITY pharmacies, permits
1.
Must have Rx dept manager & notify board w/in 10 days of change of manager
2.
Obligated to be open 40 hr/wk & 5 days/week
465.019 – INSTITUTIONAL pharmacies
1.
Class I (nursing homes) –
a.
All meds administered from individual rx containers to individual pts
b.
Meds are NOT dispensed on the premises, except that nursing homes may
purchase medical oxygen for admin to residents.
c.
No medicinal drugs may be dispensed in a class I institutional pharmacy
2.
Class II (hospitals)
a.
Institutional pharmacies that employ a RPh shall provide dispensing & consulting
services on the premises ONLY to pts of institution
b.
In declaration of emergency by governor, it may provide dispensing & consulting
services to individuals who are not pts of the institution
3.
Modified Class II (Rule 64B16-28.702)–
a.
Pharmacies in short-term, primary care treatment centers that meet all the
requirements for a class II permit, except space & equipment requirements
4.
Medicinal drugs shall be dispensed in an institutional pharmacy to outpatients only when
that institution has secured a community pharmacy permit from BOP or DOH.
a.
An individual licensed to prescribe in this state may dispense up to a 24 hr supply
to any pt of the ER of a hospital that operates a Class II pharmacy, provided that
physician determines drug is warranted & that community pharmacy services are
not readily accessible to pt
b.
Such dispensing must be in accordance w/procedures of hospital
c.
If the use of the drug is to exceed 24 hours, the prescriber must dispense the 24
hours supply & also a prescription for the drug for pt to fill later
5.
All institutional pharmacies shall be under the professional supervision of a consultant
pharmacist & the compounding/dispensing of medicinal drugs shall only be done by a
licensed pharmacist. If technicians are employed, they need to have written policies &
procedures of the tasks they are allowed to perform.
6.
In a Class II pharmacy, a formulary is NOT mandatory. Yet, if they decide to use one,
they need to establish policies/procedures in accordance with American Hospital
Association & American Society of Hospital Pharmacists
465.0196 – SPECIAL pharmacy permits
1.
Rule 64B16-28.800 – General
a.
Special pharmacies are pharmacies providing miscellaneous specialized services
b.
All pharmacies must have policy/procedures manual w/types of services provided
2.
Rule 64B16-28.810 – special – limited community permit –
a.
Used by class II (hospital) pharmacies when dispensing to employees, medical
staff, & their dependents, pts of the ER, & pts of hospital not to exceed 3 days
supply
3.
Rule 64B16-28.820 – sterile products & special parenteral/enteral compounding
4.
Rule 64B16-28.830 – closed system pharmacy
a.
Dispenses to facilities where rx are individually prepared for the ultimate consumer
including nursing homes, jails, ALFs, or other custodial care facilities
b.
Must have 24 hour on-call service
5.
Rule 64B16-28.850 – ESRD – provides dialysis products & supplies to persons with CKF
for self administration at persons home or specified address
6.
Rule 64B16-28.860 – Special – parenteral/enteral extended scope
a.
Used by Class II to compound & dispense to pt specific parenteral/enteral drugs
7.
Rule 64B16-28.870 – Special – ALF
a.
Optional license for ALFs using drugs in unit dose packaging.
b.
Drugs may NOT be dispensed on premises.
c.
Allows medicinal drugs (not CSs) to be returned to the dispensing pharmacy
under Rule 64B16-28.118
465.0197 – INTERNET pharmacy permits
1.
Must have rx dept manager (not required to be FL licensed)
a.
FYI: allow 30 days to notify of change in rx dept manager to BoP
2.
Must obtain permit to sell drugs to person in the state
3.
Must show that it is properly licensed in the state where located
4.
Must have toll-free telephone number
5.
465.0161 – makes it a second degree felony for an internet pharmacy to distribute a
medicinal drug w/out a permit
465.0156 – Registration of NONRESIDENT pharmacies
1.
Rule 64B16-28.840 – special – non-resident –
a.
A pharmacy located outside the state delivering a dispensed medicinal drug in any
manner into this state
2.
Pharmacy & the RPh designated as the rx dept manager must be licensed in the state
where located (not necessarily Florida)
3.
Required toll-free telephone number
Disciplinary Actions & Inspections
465.016 – Disciplinary actions – Grounds for discipline – pharmacists
1.
Obtaining license by misrepresentation or fraud
2.
Procuring or attempting to procure a license for another person
3.
Permitting person not licensed as RPh or intern, or allowing intern not acting under direct
supervision to fill, compound, or dispense & rx
4.
Being unfit/incompetent to practice pharmacy b/c:
a.
Habitual intoxication
b.
Misuse/abuse of any CS
c.
Abnormal physical or mental condition which threatens the public safety
5.
Violating the FDCA or Federal CS act
6.
Having been convicted or found guilty, regardless of adjudication of a crime which directly
relates to the ability to practice pharmacy. A plea of nolo contender (no contest)
constitutes a conviction
7.
Dispensing or compounding using an ingredient/article different in any matter from the
ingredient/article prescribed (except as authorized for generic subs/formulary)
8.
Having been disciplined by a regulatory authority in another state
9.
Compounding, dispensing, or distributing legend drugs/controls other than in the course
of the professional practice of pharmacy
10. Making or filing a report or record known to be false, intentionally or negligently failing to
file a report of record required by state/federal law. Or obstructing/impeding someone
else from doing so.
11. Failing to make prescription fee or price information readily available upon request
12. Placing in the stock of any pharmacy any part of a rx that has been dispensed (exception
for unit dose meds in hospital, nursing homes, etc.)
13. Being unable to practice pharmacy w/reasonable skill & safety by reason of illness, use of
drugs, narcotics, or chemicals or anything else
6
14.
Violating a rule of the BOP/DoH or violating an order previously entered in a disciplinary
hearing
15. Failing to report to the DoH a physician who the RPh knows has violated the grounds for
disciplinary action
16. Failing to notify the BoP in writing w/in 20 days of commencement/cessation of practice
when commencement/cessation was a result of a pending or completed disciplinary
action or investigation in another jurisdiction
17. Using or releasing a pts records except as authorized
18. Violating any provision of chapter 465 or 456 & any rules adopted pursuant thereto
19. *** Dispensing any medicinal drug based upon a communication that purports to be a rx
as defined by 465.003(14) or 893.02(20) when the RPh knows or has reason to believe
that the purported rx is not based upon a valid practitioner-pt relationship***
465.023 – Disciplinary action – permits
465.017 – authority to inspect
465.015 – Violations & penalties
1.
It is unlawful for any person to own, operate, maintain, open, establish, conduct, or have
charge of a pharmacy which is not registered under this chapter & in which a licensed
RPh does not fill, compound, or dispenses any rxs
2.
It is unlawful for any persons:
a.
To make false/fraudulent statement in any application, affidavit, or statement
present to the board
b.
To fill, compound, or dispense rx if not a RPh or intern
c.
To sell or dispense drugs w/out rx
d.
To sell samples or complimentary packages of drug products
3.
It is unlawful for:
a.
Any person other than a RPh licensed in FL to use the title “pharmacist”/“druggist”
or otherwise lead public to believe they’re engaged in the practice of pharmacy
b.
Any person other than the owner of a pharmacy registered in FL to display a sign
that leads people to think that the person is engaged in the practice of pharmacy
c.
Any person/firm/corp. that is not a licensed or registered pharmacy in this state to:
i. Use in a trade name, sign, letter, or advertisement any term including
“drug,” “pharmacy,” “prescription drugs”, “Rx”, or “apothecary” which
implies that person, etc is licensed of registered to practice pharmacy
ii. Hold him/herself to others as a person/firm/corp licensed/registered in FL
Miscellaneous Statutory Provisions
465.024 – PROMOTING SALE OF CERTAIN DRUGS PROHIBITED
1.
No RPh, owner, or employee of a retail drug establishment shall use any communication
media to promote or advertise the use or sale of any CS appearing in any schedule in
chapter 893 (including anabolic steroids & narcotics)
465.0255 – EXPIRATION DATE of medicinal drugs
1.
RPh in community pharmacy must place on label or in other written information delivered
to purchaser the expiration date provided by manufacturer OR an earlier beyond used
date up to one year after date of dispensing
2.
Rule 64B16-28.402 – the expiration date must be in the following format “discard after
(date).” Not required when dispensed in unit dose packing that has an expiration date.
465.0235 – Automated pharmacy systems used by long-term care facilities, hospices or
state correctional institutions
1.
Rule 64B16-28.607 – rules have been developed but not yet adopted
465.025 – SUBSTITUTION of Drugs
1.
RPh must substitute a generic equivalent unless requested otherwise by the purchaser if
drug is on the pharmacy’s positive formulary.
a.
Prescriber may prohibit substitution by writing “Medically necessary” in their own
handwriting, or if a verbal rx by expressly indicating to the RPh that substitution is
prohibited.
b.
Rule 64B16-27.520 – Positive drug formulary – required list of generic & brand
name drug products that will be substituted by each community pharmacy
c.
Rule 64B16-27.510- Identification of manufacturer – each formulary shall include
the name of the manufacture of the generic drug
2.
RPh notify the pt of substitution, the amount of price difference, & the pt right to refuse
substitution. RPh must pass on full amount of savings to pt.
a.
Rule 64B16-27.530 – duty of RPh to inform regarding drug substitution
i. Info on substitution must be communicated (in any way) at a meaningful
time to allow the pt to make an informed choice regarding substitution.
3.
Negative Formulary –
a.
Board of pharmacy & medicine (BOP/M) shall develop a formulary of drugs that
demonstrate significant biological or therapeutic inequivalence which may NOT
be substituted
i. Rule 64B16-27.500 – Negative drug formulary
1.
Digitoxin
2.
Conjugated Estrogens
3.
Dicumarol
4.
Chlorpromazine (solid oral dosage form)
5.
Theophylline (controlled release)
6.
Pancrelipase (oral dosage form)
465.0251 (2001) requires BOP/M to remove any generic drug from the negative formulary list if
every commercially marketed product equivalent of that drug is “A” rated in the FDA Orange
Book
465.026 – Filling of certain prescriptions – TRANSFERS
1.
RPh may refill a rx on file in a pharmacy in FL of another state that has been transferred
by any means, including electronically.
2.
Requirements prior to transfer, the RPh must:
a.
Advise pt that rx on file at the other pharmacy must be cancelled
b.
Determine that the rx is valid & may be filled or refilled
c.
Notify RPh/pharmacy where rx is on file that rx must be cancelled
d.
Record in writing or electronically the rx info:
i. Name of the pharmacy transferred from
ii. Rx number
iii. Name of drug
iv. Original amount dispensed
v. Date of the original dispensing
vi. Number of remaining authorized refills
e.
Obtain consent of the prescriber when RPh deems it necessary
3.
Requirements when receiving transfer request, the RPh must:
a.
Transfer the info required above to the RPh
b.
Record on the rx or electronically:
i. The requesting pharmacy
ii. Name of the pharmacist
iii. Date of the request
c.
Cancel the prescription (either electronically or by writing “Void” on rx)
4.
If transferred rx is not dispensed w/in a reasonable time, the RPh shall notify the
transferring pharmacy which serves to revalidate the cancelled prescription
5.
Electronic transfers of prescriptions are permitted regardless of whether the transferor or
transferee pharmacy is open for business
6.
see Rule 64B16-27.105 Transfer of prescriptions
465.0275 EMERGENCY PRESCRIPTION REFILL –
1.
If pt requests refill & RPh is unable to obtain refill authorization, the RPh may dispense a
one-time emergency refill of up to a 72-hour supply of prescribed medication.
2.
This is w/the exception of those areas or counties included in a emergency order or
proclamation of a state emergency declared by the Governor, in which the executive
order may authorize the pharmacist to dispense up to a 30-day supply, providing that:
a.
Rx is not for a C-II
b.
Med is essential for the maintenance of life or to the continuation of therapy in a
chronic condition
c.
In RPh professional judgment, the interruption of therapy might reasonably
produce undesirable health consequences or cause physical/mental discomfort
d.
The dispensing RPh creates a written order containing all of the prescription
information required by chapter 465, 499, & 893 & signs that order
e.
Dispensing RPh notifies prescriber of the emergency dispensing w/in a
reasonable time after dispensing
465.0276 – Dispensing practitioner
1.
A person may not dispense drugs unless licensed as a RPh except that a practitioner
who can prescribe drugs can dispense drugs to their pts under this section.
2.
A practitioner who dispenses for fee or remuneration must:
a.
Register w/their board as dispensing practitioner & pay registration fee
b.
Comply with laws applicable to pharmacies & RPhs
c.
Before dispensing, give pt a written prescription that pt may have filled at
practitioner’s office or at any pharmacy
3.
Dispensing practitioners are subject to inspection just like a pharmacy
4.
Dispensing of drugs by a practitioner in violation of this section shall subject license to
suspension or revocation
5.
Does not apply to dispensing of sample drugs w/out fee
465.035 – FAX prescriptions FROM PT
1.
RPh may fill rx from fax order sent by the pt but may not sell the rx until they have the
original written rx
2.
Rule 64B16-28.130 – Transmission of Prescriptions
a.
RPh may accept rx transmitted by any means of communication w/approval of pt
b.
RPh may not knowingly participate in a system that restricts the pts choice of
pharmacy
c.
RPh may not provide remuneration to the prescriber for rx referred to pharmacy
465.185 – Rebates prohibited
1.
It is unlawful for any person to pay/receive any commission (etc) or engage in any splitfee arrangement in any form with any physician, organization, agency, person, etc, either
directly or indirectly, for pts referred to a pharmacy registered under this chapter.
2.
Rule 64B16-27.1042 – rebates prohibited; violations defined – provides detailed
examples of prohibited acts such as providing supplies or equipment including
465.0265 – CENTRALIZED prescription filling
computers, faxes, etc. to a facility
1.
A pharmacy may perform centralized rx filling for another pharmacy if they have the same 3.
Rule 64B16-27.104(3) - No pharmacist or pharmacy, or employee or agent thereof, shall
owner or have a contract with the other pharmacy
enter into or engage in any agreement or arrangement with any physician or other
2.
Each pharmacy must have a policy/procedures manual that includes the following:
practitioner or nursing home or extended care facility for the payment or acceptance of
a.
Description of how each pharmacy will comply with federal/state laws
compensation in any form or type for the recommending of the professional services of
b.
Procedure for maintaining appropriate records to identify the RPh responsible for
either; or enter into a rebate or percentage rental agreement of any kind, whereby in any
dispensing the rx & counseling the pt
way a pt’s free choice of a pharmacist or pharmacy is or may be limited.
c.
Procedures for tracking the rx during each stage of filling & dispensing
d.
Procedure for identifying on the rx all pharmacies involved in filling/dispensing rx
e.
Policies/procedures for maintaining confidentiality/integrity of pt info
f.
Procedures for quality assurance program
3.
Rule 64B16-28.450 – ***Centralized Prescription Filing***
a.
Receiving pharmacy is the pharmacy that initially receives rx
b.
Supplier pharmacy is the pharmacy that fills the rx for receiving pharmacy
c.
A pharmacy that acts only as a supplier pharmacy & notifies the BOP, is exempt
from requirements for pt counseling area (Rule 64B16-28.1035), signage (Rule
64B16-28.109(1)), & operating hours (Rule 64B16-28.404).
d.
The supplying pharmacy & receiving pharmacy shall be identified on the label.
The receiving pharmacy is identified by name & address. The supplying pharmacy
may be identified by a code available at the receiving pharmacy.
e.
Rule 64B16-28.451 – pharmacy common database
f.
Rule 64B16-28.605 – Class II institutional pharmacies – automated distribution
g.
Rule 64B16-28.607 – automated pharmacy systems – long-term care, hospice, &
prison
7
465.186 PHARMACISTS ORDER for medicinal drugs (RPh’s “prescribing” ability)
1.
Provides for committee to develop formulary that a RPh may order/prescribe & dispense.
Drugs must fall under one of the following categories:
a.
Drug whose active ingredient is approved for OTC
b.
Drug recommended by FDA for transfer to OTC status pending approval
c.
Drug containing antihistamine or decongestant as single active ingredient/combo
d.
Fluoride in any strength
e.
Lindane in any strength
f.
OTC approved for reimbursement by FL Medicaid program
g.
Any topical anti-infective excluding eye/ear anti-infectives
2.
Drugs on formulary may only be dispensed by RPh ordering the drug & shall not be
refilled, nor shall another drug be ordered for the same condition unless consistent with
the dispensing procedures
3.
Drug provided must be labeled
4.
RPh providing services shall be eligible for reimbursement by 3rd party plans when
provided by contract
5.
Rule 64B16-27.700 Purpose & effect
6.
Rule 64B16-27.210 General terms & conditions to be followed by a RPh when ordering &
dispensing approved medical drugs:
a.
May not order injectable drugs
b.
May not order drugs for pregnant/nursing mothers
c.
Quantity cannot exceed a 34 day supply or standard course of treatment. Pts shall
be advised that they should seek advice of an appropriate health care provider is
their present condition/symptom/complaint does not improve upon completion of
drug regimen.
d.
Directions for use shall not exceed the manufacturers recommended dosage
e.
May only perform service in a Florida permitted pharmacy
f.
RPh must create rx
g.
RPh must maintain pt profile, separate from rx order & shall date & initial all profile
entries. Such profiles shall be maintained for 2 years.
h.
List of required info to be in pt profile: medical hx, CC, drug ordered, etc.
Rule 64B16-27.220 – MEDICINAL DRUGS WHICH MAY BE ORDERED BY PHARMACISTS:
Oral analgesics for mild/mod pain

Magnesium salicylate/phenyltoloxamine citrate

Acetylsalicylic acid (zero order release, long acting)

Choline salicylate & magnesium salicylate

Naproxen, naproxen sodium, & IBU for minor pain & menstrual cramps for pt w/no hx of
PUD (limited to 6 day supply)
Urinary analgesics – phenazopyridine (no more than 2 day supply)
Otic analgesics – antipyrene 5.4%, benzocaine 1.4%, glycerin
Anti-nausea preparations

meclizine up to 25mg except for pt taking CNS depressant

Scopolamine not exceeding 1.5mg per dermal patch
Antihistamines & decongestants.

Antihistamines.
o
Diphenhydramine.
o
Carbinoxamine.
o
Pyrilamine.
o
Dexchlorpheniramine.
o
Brompheniramine.

Decongestants
o
Phenylephrine.
o
Azatadine.
Topical antifungal/antibacterials.

Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20g).

Haloprogin 1%.

Clotrimazole topical cream & lotion.

Erythromycin topical.
Topical anti-inflammatory - hydrocortisone not exceeding 2.5%.
Otic antifungal/antibacterial - Acetic acid 2% in aluminum acetate soln (ears only)
Keratolytics - Salicylic acid 16.7% & lactic acid 16.7% to be applied to warts, except for pts
under two (2) years of age
Vitamins with fluoride. (Not including vitamins w/folic acid in excess of 0.9 mg.)
Medicinal drug shampoos containing Lindane (no more than 4oz)
Ophthalmics - Naphazoline 0.1% ophthalmic solution
Histamine H2 antagonists - Cimetidinel; Famotidine; Ranitidine HC1
Acne products - Benzoyl Peroxide
Topical Antiviral - Acyclovir ointment & Penciclovir.
Pharmacy Practice – Rules Chapter 27
Rule 64B16-27.100 – display of wall certificate & renewal certificates
1.
The current license of each RPh shall be displayed in a place in or near the prescription
department, & in such manner that it can be easily read by patrons. RPh employed in
secondary practice sites shall present a valid wallet license as evidence of licensure.
2.
No RPh shall display their license in any pharmacy where they are not employed.
3.
RPh/intern must be clearly identified by an identification badge or monogrammed smock
showing their name & if they are a pharmacist or an intern.
Rule 64B16-27.101 – Counterfeit drugs
Rule 64B16-27.103 – oral prescriptions & copies
1.
Only a RPh or intern may accept an oral rx or provide a copy or read a rx to a person
Rule 64B16-27.104 – Conduct governing registered RPh & pharmacy permitees
1.
Advertising – may advertise medicinal drugs but not controls
2.
RPh or employee shall not maintain a location other than a pharmacy from which to
solicit, accept or dispense rx
3.
RPh or pharmacy may not have an arrangement or agreement w/a practitioner or nursing
home for any payment of compensation for recommending professional services or any
type of rebate
4.
May not knowingly place in stock any rx that has been compounded for or dispensed to a
customer other than as permitted (unit dose returns for nursing home pts)
5.
RPh may not serve as rx dept manager of more than one pharmacy, yet board can grant
exceptions
Rule 64B16-27.700 – definition of compounding
1.
Compounding includes:
a.
Preparation of drugs or devices in anticipation of rx based on routine, regularly
observed prescribing patterns
b.
Preparation pursuant to rx of drugs or devices which are not commercially
available
c.
Preparation of commercially available products from bulk when prescribing
practitioner has prescribed compounded product on a per pt basis & the pt has
been made aware that the compounded product will be prepared by RPh.
d.
The reconstitution of commercially available products pursuant to the
manufacturers guidelines is permissible w/out notice to the practitioner
2.
Preparation of drugs or devices for sale or transfer to pharmacies, practitioners, or
entities for purposes of dispensing or distribution is NOT compounding. Exception for pt
specific compounded rx provided to another pharmacy under centralized rx dispensing
rules
OBRA ’90 – Pt records, DUR, & counseling
1.
Rule 64B16-27.800 – requirement for PT RECORD
a.
Must provide for immediate retrieval of info to identify previously dispensed drugs.
b.
RPh must ensure that a effort is made to obtain, record, & maintain:
i. Name, address, telephone of pt
ii. Age or date of birth
iii. Pt gender
iv. List of new & refill rx obtained by pt at pharmacy during last 2 yrs
**Rule 64B16-27.300 – Standards of practice: CONTINUOUS QUALITY IMPROVEMENT (CQI) PROGRAM
v. Pharmacy comments relevant to pt drug therapy
1.
CQI – system of standards & procedures to identify & evaluate quality related events &
c.
RPh shall ensure that effort made to obtain any known allergies, drug reactions,
improve pt care
idiosyncrasies, & chronic conditions/dz states
2.
“Quality related event” – inappropriate dispensing or administration of a prescribed med
d.
Pt record shall be maintained for not less than 2 years from date of last entry
a.
A variation from prescribers rx order including: incorrect drug, drug strength,
2.
Rule 64B16-27.810 – Prospective DRUG USE REVIEW
dosage form, or pt, inadequate/incorrect packaging, labeling/directions
a.
RPh shall review pt record & each new/refill rx presented for dispensing in order to
b.
A failure to identify & manage over/under-utilization, therapeutic duplication, drugpromote therapeutic appropriateness by identifying:
disease contraindications, drug-drug interactions, incorrect drug dosage or
i. Over/under-utilization
duration or treatment, drug allergy interactions, or clinical abuse/misuse
ii. Therapeutic duplication
3.
Requirements
iii.
Drug-dz contraindications
a.
Each pharmacy shall maintain a CQI program that must be described in the
iv. Drug-drug interactions
pharmacy’s policy & procedure manual. It must contain meeting times (see
v. Incorrect drug dosage or duration of treatment
below), a planned process to record, measure & assess & improve the quality of
vi. Drug allergy interactions
pt care, documentation of all quality related events
vii. Clinical abuse/misuse
b.
CQI committee reviews quality related events at least q 3 months
b.
Upon recognizing any of the above, RPh shall take steps to avoid or resolve the
c.
Records maintained as a component of a pharmacy CQI program are confidential
potential problem
(section 766.101 FL statutes – medical review committees – immunity from
3.
Rule 64B16-27.820 – PT COUNSELING (see also Rule 64B16-28.1035)
liability). Records are considered peer review documents & are not subject to
a.
Requires verbal & written offer to counsel for new & refill rx
discovery in civil litigation or administrative actions.
b.
If delievered rx, offer shall be in writing & shall provide toll-free telephone #
d.
** As long as you record your error as a QRE & use it as a CQI, it won’t go as a
c.
If pt does not refuse counseling, RPh shall review pt record & counsel pt
violation against you & you cannot be criminally charged w/a crime/violation**
d.
Possible elements of counseling (all are up to the RPh)
i. Name & description of drug
Rule 64B16-27.400 – Practice of pharmacy
ii. Dosage form, dose, route, duration of therapy
1.
Only a licensed pharmacist can do the following:
iii. Intended use of drug & expected action
a.
Supervision & responsibility of CS inventory
iv. Special directions & precautions
b.
Interpreting & identifying prescription contents
v. Common SE, AE, DI, or CI & action required if they occur
c.
Consult w/MD regarding interpretation of a rx & data in pt profile
vi. Techniques for self monitoring therapy
d.
Engage in professional communication w/other health care professionals
vii. Proper storage
e.
Advising or consulting with a pt
viii. Rx refill info
f.
Certifying the finished rx & making the final check of a completed rx
ix. Action to take in event of missed dose
2.
RPh shall be directly & immediately available to the pt or pt’s agent for consultation &
x. RPh comments relevant to drug therapy
shall not dispense to a 3rd party. No rx shall be deemed properly dispensed unless RPh is
e.
Counseling is NOT required for inpatients of a hospital or institution
personally available
f.
Counseling is NOT required when pt/pt agent refuses such consultation
3.
Meal breaks- RPh may take a meal break, not to exceed 30 min in length, during which
the pharmacy department is not considered closed
Rule 64B16-27.830 – DRUG THERAPY MANAGEMENT
a.
Must post sign w/meal break times
1.
Allows RPh to provide drug therapy management services in compliance with orders in a
b.
Activities of techs during RPh meal breaks are still under direct supervision of RPh
“prescriber care plan” written by physician
2.
“Prescriber care plan” is individualized assessment of pt & orders for drugs, lab tests, &
Rule 64B16-27.615 – possession of sample medicinal drugs (also Rule 64B16-27.620)
other services intended to be executed by a RPh.
1.
Pharmacies may not be in the possession of samples unless ones RPh can prescribe
3.
May only be provided under the auspices of a pharmacy permit that provides a
2.
Institutional pharmacies may possess samples upon written request of the practitioner
transferable pt care record, pharmaceutical care area & CQI program
3.
Community pharmacies that are pharmacies of health care entities may possess samples
upon written request of practitioner
8
Rule 64B16-27.831 – Standards of practice for the dispensing of CS for pain tx
4.
A RPh who questions the legitimacy of a CS rx should insist on a picture identification of
the pt for whom drug is prescribed & RPh should photocopy identification or document it
on the back of the rx. The RPh should also verify the rx with the prescriber.
5.
If unable to verify rx w/prescriber & RPh believes it is a valid rx, the RPh may dispense a
partial quantity not to exceed a 72 hour supply. Once rx is verified, RPh may dispense
the balance w/in 72 hours of the partial filling.
6.
Requires every pharmacy permit holder to maintain a computerized record of control
prescriptions being dispensed. A hard copy printout summary of the last 60 days shall be
made available upon request w/in 72 hours.
7.
A RPh that believes a prescriber of CSs is involved in diversion of CSs SHALL report
such prescriber to the department of health.
General Requirements for Permits – Rules Chapter 28
1.
Rule 64B16-28.101 – prescription area accessible to inspection
a.
Authorized agents & employees of the DoH or others authorized by law shall have
right to inspect invoices, shipping tickets, or any other document pertaining to the
transfer of drugs or drug preparations, from or to all pharmacies & a reasonable
amount of time shall be allowed for said information to be made available
2.
Rule 64B16-28.102 – Sink & running water
a.
Sufficient space, refrigeration, sanitation, equipment, including but not limited to
pharmacy reference compendium in print or electronic form; …..
3.
Rule 64B16-28.103 – sufficient space in rx department (64B16-28.102)
a.
Subjective opinion of inspectors
4.
Rule 64B16-28.1035 – Pt consultation area
a.
Area suitable for private consultation which may consist of a designated counter
space
b.
Area shall be designated with a sign bearing “Pt consultation area” or similar
words
5.
Rule 64B16-28.104 - Refrigeration (64B16-28.102)
6.
Rule 64B16-28.105 - Sanitation (64B16-28.102)
7.
Rule 64B16-28.106 - Right to inspect invoices (Rule 64B16-28.101)
8.
Rule 64B16-28.107 – pharmacy equipment
a.
Current pharmacy reference compendium (book or electronic) such as USP/NF,
USPDI, Remingtons, Facts & comparisons… & a copy of Fl pharmacy law & rules
9.
Rule 64B16-26.1022 – permit fees
a.
Initial - $250
b.
Renewal (q 2 yrs) - $250
c.
Change - $100
d.
Delinquent - $100
10. ***Rule 64B16-28.108 labels & labeling – all permits***
a.
Provides for use of unit dose dispensing system provided certain requirements are
met
b.
The unit dose system must:
i. Indicate name of resident/pt & rx # or other identifying means, directions,
prescriber name
ii. If system uses a MAR (med. Admin. Record), it must be attached to or kept
on or in the unit dose system when delivering or administering drugs to pts
iii. Pharmacies serving nursing homes must also include name of the
dispensing pharmacy
c.
MAR requirements – MAR labeling must be prepared & reviewed by RPh, in Class
II, there shall be a quality assurance review of MAR’s by a RPh not < q 30 days
d.
A unit dose system must provide for method of separation & identification of drugs
for individual residents. If supply of med > 48 hours, drugs must be separated by
the name of pt & category
e.
Customized pt medication packages – allows use to rx containers for the
dispensing of multiple drugs in a single container following USP guidelines
(requires name, strength, qt of each drug as well as expiration date not > 60 days
from date of packaging)
11. 64B16-28.109 – Prescription Department closed
a.
A rx dept is considered closed whenever the establishment is open & a
pharmacist is not present & on duty. Must place a sign with bold letters not less
than 2” high stating “Prescription Department Closed.”
b.
A RPh may leave rx dept for “pharmacist” stuff & it does not have to close
c.
When rx dept closed, it shall be separated from the remained of the establishment
by a partition or other means of enclosure to prevent access & shall be securely
locked. Only a RPh shall have means to gain access to the rx dept & no other
person than a RPh may enter department when it is closed.
12.
13.
14.
15.
16.
17.
18.
19.
64B16-28.110 – outdated pharmaceuticals – stock of rx dept shall be examined at a
minimum of q 4 months & all deteriorated or expired drugs shall be removed.
64B16-28.113 – permits – single entity, single location
a.
A contiguous area under the control of the permit holder
b.
An area not > ½ mile from central location of permit
c.
Applied to big complexes such as hospital pharmacies
64B16-28.120 – all permits – storage of legend drugs; prepackaging
a.
All medicinal drugs are stored w/in the confines of rx department pursuant to the
pharmacies permit (community, class I, class II)
64B16-24.141 – allows for automated pharmacy systems in community pharmacies
a.
Must have policy/procedures, electronic info readily retrievable, & ability to comply
with product recalls
64B16-28.301 – destruction of CSs Class I pharmacies (LTC)
a.
Dispensed but not used by the pt shall not be returned to the pharmacy
b.
Shall be securely stored until destroyed
c.
Completed document containing name, quantity, drug strength, dosage form, pt
name, rx number, nursing home name at time of destruction, witnessed & signed
64B16-28.303 – destruction of CSs all permittees (excluding nursing homes)
a.
Method I
i. Complete DEA Form 41, witnessed & signed (RPh, DEA inspector, DOH
inspector, or health & rehabilitative services inspector)
ii. Prior DEA approval is NOT required BUT copy of DEA Form 41 must be
mailed to DEA immediately after destruction
b.
Method II
i. Request for destruction, DEA form 41 & a letter w/proposed date of
destruction, method of destruction send at least 2 wks prior to DEA
ii. Signed by: RPh & police officer
iii. Drugs may not be destroyed before DEA grants approval
c.
Method III
i. Controls shipped to reverse distributor for destruction in conformity with
federal guidelines
64B16-28.402 – labels & labeling – community permits
a.
Non-CSs:
i. Name & address pharmacy
ii. Name of prescriber
iii. Name of pt
iv. Date of filling
v. Prescription number
vi. Directions for use
vii. Name of drug (unless prescriber requests it to be w/held)
viii. Expiration date provided by manufacturer (RPh may choose earlier one)
1.
Info may be delivered to purchaser in other written form (other than
label)
2.
Must be in following format “discard after (date)”
b.
CSs:
i. Same as above plus:
1.
The # of the rx as recorded in rx files of the pharmacy in which it
was filled
2.
Clear, concise warning that it is a crime to transfer CSs to any
person other than the pt for whom it was prescribed
64B16-28.404 – Daily operating Hours – community pharmacies
a.
Must be open for minimum 40 hours per week & 5 days/week
b.
Exceptions provided for listed holidays, notice must be provided w/a sign
Record keeping
1.
Rule 64B16-28.140 – Community, special limited community, special closed systems,
special P&E, & nuclear permits
a.
All original rx shall be retained for not < 2 years from date of last filling.
b.
May use electronic imaging record keeping system as long as it maintains an
exact image of the rx including reverse side if necessary
c.
Computer system must be backed up at least weekly
d.
Computer system must be able to produce an audit trail of drug usage for previous
2 yrs
e.
If pharmacy changes computer system, records must be transferred to new
system or printed out & saved as hard copy
f.
Rx dept manager must report loss of significant information w/in 10 days
g.
Daily hard copy/audit trail
i. Computer system must have capability of producing a daily hard copy
printout of all prescriptions filled or refilled containing the following
information:
1.
Prescription number
2.
Pt name
3.
Prescribers name
4.
Name & strength of product dispensed (manufacturer if generic)
5.
Quantity dispensed
6.
Initials or identification of dispensing RPh
7.
If not readily available: pt address, prescribers address, prescribers
DEA, quantity prescribed, date of issuance, total # refills dispensed
to date
ii. Daily hard copy must be produced w/in 72 hours of date drugs dispensed
iii. Each individual RPh who dispenses or refills rx shall verify that the data is
correct by dating & signing (no initials) the daily hard copy w/in 7 days
iv. In lieu of daily hard copy, RPh may maintain a log book in which each
individual RPh signs a statement each day attesting that the information
entered into the computer is correct
v. Computer system must be able to print a hard copy on demand or w/in 48
hrs
h.
Compounding records w/specific information must be maintained for each
batch/sub-batch of a compounded product
2.
64B16-28.150 – institutional & animal shelter permits – similar record keeping
requirements but are provided 7 days to provide requested forms (instead of 48 hours)
9
Institutional Class I Rules (Nursing home)
1.
Rule 64B16-28.501 – consultant RPh of record – must notify board w/in 10 days of a
change
2.
Rule 64B16-28.502 – Labels & labeling of medicinal drugs (nursing homes)
3.
Rule 64B16-28.503 (also for Modified Class IIB) starter dose prescriptions rule
a.
Allows a pharmacy serving a nursing home to contract w/local pharmacy near the
nursing home to provide a “starter dose” of a rx until the pharmacy can
dispense/deliver the order
Institutional Class II Rules (hospital)
1.
Rule 64B16-28.602 – dispensing
a.
Except for emergencies, drugs administered to a pt in hospital shall only be taken
from the original container or from a container that has been prepared by the RPh
2.
Rule 64B16-28.6021 – ED dispensing
a.
Physician in ER may dispense up to a 24 h supply
3.
Rule 64B16-28.603 – operating hours –
a.
Must be open for a sufficient number of hours required to provide adequate
pharmacy services to pt
4.
Rule 64B16-28.604 – Security –
a.
Pharmacy dept is considered closed when no RPh on duty.
b.
*Exception – nurse in charge may access the pharmacy to remove single doses of
drugs based on a valid physician order
5.
Rule 64B16-28.605 – Class II pharmacies – automated distribution & packaging
a.
The consultant pharmacist of record shall be responsible for:
i. Maintaining a record of each transaction or operation;
ii. Controlling access to the system;
iii. Maintaining policies & procedures for;
1.
Operation of the automated medication system;
2.
Training personnel who use the automated medication system;
3.
Maintaining pt services whenever the medication system is not
operating
4.
Defining a procedure for a pharmacist to grant or deny access to the
medication in the system.
iv. Security of the system;
v. Assuring that system protects pt confidentiality;
vi. Establishing a comprehensive Quality Assurance program;
vii. Establishing a procedure for stocking/restocking the medication system
viii. Ensuring compliance with all requirements for packaging & labeling.
b.
RPh shall perform prospective drug use review & approve each medication order
prior to administration of a medication except an override medication, a low risk
override medication or a physician controlled medication.
c.
RPh shall perform retrospective drug use review for an override medication.
d.
Multidisciplinary Committee for Decentralized Automated Medication Systems
shall:
i. Include at least one pharmacist;
ii. Establish the criteria & process for determining which medication qualifies
as an override medication or a low risk override medication
iii. Develop policies/procedures regarding the decentralized automated med
system
iv. Have its decisions reviewed & approved by the consultant pharmacist of
record.
e.
Stocking or Restocking of a Decentralized Automated Medication System.
i. RPh shall conduct a daily audit of medications placed or to be placed into
system
ii. A bar code verification, electronic verification, or similar verification process
shall be utilized to assure correct selection of medication
f.
Quality Assurance Program. The program shall provide for:
i. Review of override & low risk override medication utilization;
ii. Investigation of a medication error related to the automated medication
system;
iii. Review of a discrepancy or transaction reports & identify patterns of
inappropriate use or access;
iv. Review of the operation of the system;
g.
Record Keeping.
i. The following records shall be maintained for at least 60 days:
1.
Daily audits of stocking or restocking; for the output of centralized
automated medication system, if applicable
2.
6.
7.
Transaction records for all non-controlled medications or devices
distributed by the automated medication system.
ii. The following records shall be maintained for at least two (2) years:
1.
Any report or analysis generated as part of the quality assurance
program;
2.
Transaction records from the automated medication system for all
CSs dispensed or distributed.
Rule 64B16-28.606 – Remote medication order processing –
a.
Allows hospital pharmacy to have orders reviewed, approves, & entered into
computer by a RPh at another location (home, another pharmacy)
Rule 64B16-28.607 – Automated pharmacy system – long-term care, hospice, prison
a.
A provider pharmacy may provide pharmacy services to a long term care facility or
hospice licensed under Chapter 400, F.S., or a state correctional institution
operated under Chapter 944, F.S., through the use of an automated pharmacy
system.
Rule 64B16-28.702 – modified class II pharmacies
Rule 64B16-28.810 – special pharmacy – limited community permit
Destruction of Drugs
1.
Rule 64B16-28.301 – Class I
a.
CSs shall not be returned to the pharmacy & must be securely stored at the
nursing home until destroyed
b.
Record required with witness of consultant RPh, director of nursing, & nursing
home administrator must be made when destroyed
2.
Rule 64B16-28.303 – all other permits
a.
DEA form 41 signed by RPh of record, DEA inspector or DoH inspector
i. Does not require prior approval of DEA
b.
DEA form 41 signed by RPh of record, one other RPh, & a law enforcement officer
i. Requires prior approval from DEA at least 2 wks prior to planned
destruction
c.
Ship drugs to a reverse distributor w/appropriate documentation
OTHER RANDOM INFO:
1.
Weight loss medications in Florida
a.
BMI > 30 or >27 w/1 comorbidity factor
b.
Or measurable body fat content ≥ 25% of IBW (males) or ≥ 30% IBW (females)
Nuclear pharmacy rules
c.
Initial orders have to be written
1.
Rule 64B16-26.303 – Nuclear pharmacists licensure
d.
Refills can be verbally authorized
2.
Rule 64B16-26.303 – subject matter for nuclear pharmacists license renewal CE
2.
DSHEA
programs
3.
Plan B
3.
Rule 64B16-28.900 – Definitions – Nuclear pharmacy
a.
17 y/o F – call MD or send to clinic
a.
“Nuclear pharmacy” – one that provides radiopharmaceutical services
b.
18 w/o M - YES
b.
“Nuclear RPh” – RPh that has met training qualifications & licensed by BoP
4.
Who can inspect pharmacy files? DoH, HHS, child services, cop
c.
“Radiopharmaceutical service” – shall include, but not limited to, the procurement, 5.
Rx for pt must have species but does not have to have the name of the animal
storage, preparation, labeling, quality assurance testing, distribution, record
6.
Returning C-II to manufacturer
keeping & disposal of radiopharmaceuticals
a.
DEA 222 – send green copy to local DEA office, retain brown copy for records,
d.
“Radiopharmaceutical” any substance defined as a drug that exhibits spontaneous
you do not have to send DEA 222 with shipment
disintegration of unstable nuclei w/the emission of nuclear particles or photons &
7.
Fax for C-II:
includes any dug which is intended to be made radioactive. Includes
a.
To be compounded for direct admin by Iv, IM, parenteral, SC, IS
nonradioactive reagent kits & nuclide generators but does not include drug such
b.
LTCF
as carbon-containing compounds or potassium containing salts
c.
Hospice
e.
“Radiopharmaceutical quality assurance” – performance of appropriate chemical, 8.
C-II partial fills:
biological, & physical tests on radiopharmaceuticals & the interpretation of the
a.
Document on face of written rx how many pt received & remaining has to be
resulting data
dispensed w/in 72 hours – if not call MD b/c remaining is no good
f.
“Authentication of product history” – identifying the purchasing source, ultimate
b.
If pt is “terminally ill” or “LTCF pt” – can administer partials based on doses
fate, & intermediate handling of any component of a radiopharmaceutical or other
i. Must be documented each time filled & quantity needs to be documented
drug
ii. It expires & can not exceed 60 days supply
4.
Rule 64B16-28.901 – General requirements
9.
What RPh can change on C-II after talking with prescriber:
5.
Rule 64B16-28.902 - minimum requirements
a.
Pt info (except name)
6.
Rule 64B16-28.903 – Training Qualifications for nuclear pharmacists
b.
Drug strength, quantity, & directions for use & dosage form
a.
200 hrs of didactic training
c.
Must document time, date, signature
b.
500 hrs of radiopharmaceutical internship
d.
CANNOT change pt name or drug
7.
Continuing Education
10. Methamphetamine control act:
a.
Additional 24 hrs CE on nuclear pharmacy required
a.
Pseudoephedrine or phenylpropanolamine sales
b.
Cannot apply these house to 30 general CE requirements
b.
Keep records for two years
c.
Combat methamphetamine epidemic act 2005
Closing a Pharmacy & Change of Ownership
i. Scheduled listed chemical products
1.
Rule 64B16-28.1135 – Change of ownership
ii. Non-liquid must be unit dose or blister pack
a.
Pharmacy permit is NOT transferable. Upon pharmacy sale, new application must
iii. Limits: 3.6 g/day sales limit & 9g/30day purchase limit
be filed
iv. If dose >60mg, purchaser needs ID & to sign (not required if < 60mg)
b.
Change in ownership requires that new records be started & old records closed
11. Need to be unit dosed if: products containing 250 mg or more of elemental iron in a
2.
Rule 64B16-28.201 – closing pharmacy - definitions
concentration of 0.025%
3.
Rule 64B16-28.202 – closing of a pharmacy, transfer of rx files
12. ARNPs/Pas – cannot prescribe controls in Florida
a.
Notify board in writing of the effective date of closure & where rx will be transferred 13. Fioricet is a legend drug (rx non-controlled) while Fiorinal is a C-III
b.
On day of closure the former permittee must physically transfer the rx files to
14. Prescriber who can prescribe for methadone, subutex or suboxone for ADDICTION must
another pharmacy, affix a sign at the front entrance advising public of new location
have DEA that starts with a X
of rx files
a.
A regular prescriber may write a methadone rx for an addiction pt for a 1 day
4.
Rule 64B16-28.2021 – change of ownership
supply per fill with a max of 3 days while pt seeks tx program
5.
Rule 64B16-28.203 – transfer of medicinal drugs, change of ownership, closing of
15. Prescriber can NOT post-date a C-II rx – they must give 3 separate rx’s w/correct date &
pharmacy
then “do not fill until…” on the other 2 rxs. This is only for a 3 month supply, NEVER more
a.
Must provide transfer information to the board
16. To verify your license for employment prior to receiving it: call, fax, or check online?
b.
Must complete an inventory of all CSs
17. Only drug samples that can be prescribed by a RPh may be kept at a pharmacy
c.
Transfers of C-II drugs must be done w/a DEA 222 form
18. Unclaimed RX – may be returned to stock & reused for up to 1 year from date of filling.
Any rx reaching the products actual expiration date prior to 1 year or any product subject
to recall shall not be used.
8.
9.
10