Law Flashcards
how long do records need to be kept via Ohio law
3 years
how long do records need to be kept via FDA law
2 years
when is it legal to send a rx from computer to fax machine
rx operates within a closed system
computer to computer system is down
when does a pharmacist not have to disclose the price of a drug
schedule 2 drugs
How long does a pharmacy have to retrieve records to be reviewed
3 business days
At what point does a pharmacy need a wholesaler license
5% rule
- if a pharmacy buys $$$ worth of drug and sells 5% to someone other than their own patients they need a wholesaler license
- anything less than 5% is considered occasional sale
Define prescription drug
habit forming
unsafe for use except under the supervision of a practicioner
What will be the expiration date on a prescription
1 year from the dispensing date
or
manufacturer’s expiration date whichever is shorter
how long is a consult agreement effective for
2 years
who can participate in a consult agreement
ohio licensed pharmacists
ohio licensed physicians
no PAs
no APNs
how long do you have to notify the board if the pharmacists in a consult agreement is no longer authorized to prescribed controlled substances
5 days
once a pharmacist obtains a valid DEA registration to prescribe how many days to they have to notify the board
30 days
when does an OARRs report need checked when prescribinh
adding a controlled substance
adjusting a controlled substance
how often can a pharmacists provide an emergency prescription
once per prescription
or
once per year if it’s a 30 day supply
what is the amount of drug that can be given in an emergency prescription
72-hour, except C2
30-day if it’s a consistent drug
how many attempts do you have to pass the NAPLEX and MJPE
5
when must an intern notify the board and employer when they are no longer enrolled in a school of pharmacy
72 hours
after an intern is no longer enrolled when must they return their intern certificate to the board
10 days
intern and pharmacist license renewal date
september 15
how many days do you have to notify the board of a name change
30
how many days do you have to notify the board of a change of address
30
how many days do you have to notify the board of a change of employment
30
how many days do you have to notify the board for a change in responsible pharmacist
10
how many days in advance must you notify the board to discontinue business
30
what date do terminal distributers renew licenses
april 1
what date do wholesaler’s renew licenses
july 1
what date do laboratory terminal distributors renew licenses
april 1
what date must a rx be filled from issuance
6 months
max number of non-controlled substances that can be written on one rx
3
drugs encompassed by a category 1 license for terminal distributors
single dose injections of IV fluids
Drugs encompassed by a category 2 license for terminal distributors
any dangerous drug
+ category 1 drugs
Drugs encompassed by a category 3 license for terminal distributors
controlled substances
+ category 1 & 2 drugs
how many CE hours are required
40 hours every 2 years
how many hours are required of patient safety/medication errors
2 hours
When do CE hours need to be reported
sept 15 of the year they are due
how many CE hours of law are required
2 hours
how long can your license lapse before you have to retake the naplex and mjpe
3 years
how many days does a pharmacist have to notify the MD of interchangeable biological product is substituted
5 days
what does the orange book include
FDA generic bioequivalence
What does the purple book include
FDA list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
can you transfer a c2 escript if its never been filled
yes
What are the items required on an outpatient label (10)
name and address of dispenser directions full name of patient full name of prescriber date of dispensing cautions Rx number drug name and strength quantity state if compounded
What 2 items are required on a small container within a prescription
rx number
patient name
What items are required on an inpatient unit dose prescription (6)
name of drug route of administration if not oral strength lot number and expiration date manufacturer or repacker special storage conditions
requirements for IV bags inpatient (6)
patient name name and amount of solution name and amount of drug expiration date or BUD name and address of pharmacy cautionary statements
requirements for IV bags outpatient (11)
name and address of pharmacy and phone number full patient name full name of prescriber directions and route date of dispensing any cautions name and volume of solution name and amount of drug quantity of the drug dispensed expiration date storage condition
what 3 things are required on a label for a sample
name of prescriber
patient name
directions
what 3 things on a C2 prescription that cannot be changed
patient name
doctor
drug name
how long does a pharmacy have to get rid of an outdated drug
1 year
how long does a wholesaler have to get rid of an outdated drug
2 years
What is an adulterated drug
1) physical conditions of the drugs, environment in which they were manufactured, anything unsanitary or damaged
2) if a drug leaves teh pharmacy and is then re-dispensed
3) outdated drugs
What needs to be completed on the date of discontinuing business of a pharmacy
complete controlled substance inventory
if missing/stolen drugs are controlled what must the pharmacist do
notify DEA immediately
file form 106
within 1 business day
how many days does a pharmacy have to report a stolen controlled substance to the board
30 days
Can a patient donate drugs
no
a person donating an eligible drug may not have taken custody of the drug prior to the donation
can controlled substances be donated
no
What is the expiration date of a drug that can be donated
6 months or greater
who is eligible to receive donated drug
resident of ohio
no 3rd party reimbursement
or
patient of a nonprofit clinic
what age can a pharmacist give an immunization to without a prescription
13
what age can a pharmacist give an immunization to with a prescription
7
what age can a pharmacist give a flu shot
7
what two records does a pharmacist need to give immunizations
successful completion of immunization course
BLS
anabolic steroids are what schedule of drug
3
can a practicioner request the drug name be omitted from the label
yes
records dating back to how long must be immediately retrievable
12 months
how many days do you have to retrieve records for the past 36 months
3 days
what happens to refills once a physician dies
patient can have one more refill
correct temperature for refrigerated products
2-8 degrees celsius
how many minutes do you have to submit a medical marijuana sale to oarrs
5 minutes
do naltrexone prescriptions need submitted to OARRS
only ones that are indicated for treatment of alcohol dependence or prevention of relapse to opioid dependence
when does OARRS need checked
adds a new/different OARRS substances to therapy
OARRS has not been reviewed for 12 months
prescriber from outside area
patient from outside area
rph beleives pt got more than one md in past 3 months
pt showing s/sx of abuse
can you give an OARRS report copy to a MD?
no they must request their own
but you can talk to them about it and show them they just can’t keep it
can an IPPE or an APPE be an OARRS delegate of the pharmacy
no, they must be a paid internship
what is ohio’s MED threshold
80
what is USP 797
sterile products compounding chapter
What is USP 795
non-sterile products compounding chapter
any USP # under what is federally enforceable
1000
is it ok to bulk compound products and sell to other pharmacies
no it is illegal
when can a pharmacist compound a commercially available product
drug shortage
pt needs med made without certain item
pt needs a different dosage form
what is them max that a prescriber can have on hand of a compounded drug
72 hour supply limit
when can pharmacies compound for physicians use in office
treat emergency situations
unanticipated procedures for which a time delay would negatively affect patient outcomes
diagnostic purposes
what is the max MDs can have for in office use of a compounded topical product
60 grams or 60 mL
and only one container at a time
BUD for low risk compounds
48 hours at room temp
14 days when refrigerated
45 days frozen solid state
BUD for medium risk compounds
30 hours room temp
9 days when refrigerated
45 days frozen solid states
BUD for high risk compounds
24 hours room temp
3 days when refrigerated
45 days when frozen solid states
what 2 unique things are on a label for a compounded product
for direct patient administration only
not for resale
what is the days supply a vet can supply to a patient of a compounded product
7 days
Define charitable pharmacies
has terminal distributors’ license
is exempt from federal taxation
is not a hospital
how much continuing education does a registered pharmacy technician need
10 hours total every 2 years
2 hours in pharmacy law
2 hours in medication safety
how many pharmacy technician trainees can a pharmacist supervise at one time
3
what must be done prior to prescribing opioids to minors
get informed consent
when does a MD not need informed consent when prescribing opioids to a minor
emergency
treatment for surgery
in a hospital
how long does a pharmacy have to notify the board if they start dispensing naloxone
30 days
what must a pharmacy have in order to provide lab testing or POC testing
certification through CLIA
how long does a pharmacist have to notify a MD that they gave a long term injectable drug
7 days
for an injectable drug (Not vaccine) is the pharmacy where it is dispensed also where the patient is required to get the inejection
No
how many days from the written date do you have to fill an opioid prescription
14 days
what is the max number of days an opioid Rx can be filled for
90 days
can you change the date on an opioid prescription
yes after calling the doctor
what is the supply limit a MD can prescribe opioids for acute pain
7 days
what is the supply limit a MD can prescribe opioids for acute pain for a minor
5 days
if an opioid is partially filled how long does a patient have to fill the rest of the prescription
30 days
what form is needed to order C2 drugs
DEA form 222
how many refills are allowed for C3s and C4s
5 refills or 6 months
what is the limit on selling a C5 as OTC when it was previously written as an RX
cannot sell if it was written as an rx in the past 6 months
What is DEA form 222
C2 ordering
What is DEA form 224
original registration for DEA license
What is DEA form 225
license to manufacture controlled substances
What is DEA form 224a
DEA re-registration form
What is DEA form 41
disposal of controlled substances
What is DEA form 106
theft or loss of controlled substances
how long does a pharmacy have to complete an annual inventory of controlled substances
13 months since previous inventory
When does a C 3,4,5 need to be estimated versus exact
<1000 can be estimated
>1000 must be exact
when a non-controlled substance becomes a controlled substance how long does the pharmacy have to do an inventory
10 days
what are reasons a pharmacy can partially fill a C2 and how long do they have to fill it
in a LTC, terminally ill = 6 months
requested = 30 days
what is the max number of pt a MD can treat how many pt with buprenorphine the first year and then years after
30 first year
100 after that
what is the max number of days a MD can write a rx for weight reduction
30 days
what is required on label of OTC drugs
name of product name and address of manufacturer net contents name and amount of all active ingredients name of any habit-forming drug included cautions and warnings directions
what is a class 1 drug recall
will cause either serious AE or death
what is a class 2 drug recall
may cause temporary or medically reversible AE on health or where the probability of serious AE is remote
What is a class 3 drug recall
exposure is not likely to cause AE
max PSE allowed to be sold per day
3.6g
max PSE allowed to be sold per month
9 g
what is the 1906 pure food and drug act
prohibited the interstate commerce of adulterated foods and drugs
what is the 1911 shirley amendments
prohibited false and misleading claims for drug products
what is the 1938 federal food, drug, and cosmetic act
scientific proof of safety before a drug could be marketed
what is the 1951 durham-humphrey amendment
created two classes of products prescription and over the counter
what is the 1962 harris-kefauver amendments
scientific proof of efficacy
what is the 1983 orphan drug act
gave economic tax incentives for pharmaceutical manufacturers to develop drugs for rare diseases
what is the 1984 drug price competition patent restoration act
created the ANDA for generic drugs (prove bioequivalence) and restored some of patent life for the time a drug sat at the FDA waiting approval
What is the prescription drug marketing act of 1984
regulated samples
cannot re-import drugs from other countries
regulates who hospitals can sell to
what is the 1994 dietary supplement health and education act
made herbals officially dietary supplements
for immunizations what is the pharmacist to intern ratio
6:1
