food drug and cosmetics act
new drugs need to be proven safe
Durham Humprhey act?
prescription vs OTC drugs
Lantus and humalog need an RX?
Need an RX
what Ibuprofen dose does not require an RX? what one does?
200 mg does not
800 mg does
Kefauver Harris amendment
safe and efficacous
can pharmacies give out samples?
NO! unless owned by charitable organization
If a products strength is less than what is on the labeled? midbranded or adulterated?
BOTH
Adulteration
purity of the product
misbranding
something is wrong with the label
what is the usual dosing of ipecac syrup?
for emergency use only 1 tablespoon 15 ml
how old do you have to be to use ipecac syrup?
1 year
what med has risk of reyes syndrome?
Aspirin
Class 1 recall?
Death
Class 2 recall?
may cause temp adverse effects
Class 3 recall?
not likely to cause harm
FDA does not have legal authority to order a recall of a drug but they can seize products so most companies will comply
true
failure to provide a patient package insert equals what?
misbranding
what are patient package inserts for?
estrogen containing products.
if patient is in hospital how often do you have to give patient package insert?
first administartion and every 30 days thereafter
which drug uses the IPLEDGE program?
Accutane (Isotretinoin)
NDC drug code first 4-5 digits are what?
manufacture
NDC drug code 2nd 4 digits are what?
Specific drug
NDC drug code last 2 digits?
package
having NDC code does not mean FDA approval
true
compounding is regulated by?
state
Manufacturing is regulated by?
FDA
what is the orange book used for?
therapeutic equivalence. A is equivalent B is not
what is the purple book used for?
Biosimilar book
who can provide a request to get non child safety cap?
only the patient. prescriber can do it for 1 rx
OSHA
hazardous communicatoins standard
when an pharmacies disclose PHI?
payment
law enforcement agencies
state drug monitoring programs
boards of pharmacies
FDA
HITECH ACT adds what?
most be notified of a breach in their info within 60 calender days after the breach is discovered
Schedule 1 drugs
High potential for abuse no accepted medical use in USA
Methaqualone Schedule
Schedule 1
Marijuana Schedule
Schedule 1
Heroin Schedule
Schedule 1
Mescaline Schedule
Schedule 1
Peyote Schedule
Schedule 1
LSD Schedule
Schedule 1
Schedule 2 drugs
high abuse for potential have accepted medical use physical and psycological dependence
Hydrocodone Schedule
2
Morphine Schedule
2
Codeine Schedule
2
Dihydrocodeine Schedule
2
Methadone Schedule
2
Meperidine Schedule
2
Hydromorphone Schedule
2
Fentanyl Schedule
2
Cocaine Schedule
2
stimulants Schedule
2
Phenmetrazine Schedule
2
Pentobarbital Schedule
2
Secobarbital Schedule
2
amobarbital Schedule
2
Glutehimide Schedule
2
Phencyclidine Schedule
2
Schedule 3 controlled drugs
moderate or low physical depeendce byt high psychologicl dependence
Codeine combo products Schedule
3
suppository forms Schedule
3
Anabolic steroids Schedule
3
Ketamine Schedule
3
Paregoric Schedule
3
Chlorphentermine Schedule
3
Phendimetrazine Schedule
3
Schedule 4 drugs
Limited physical or psychological dependence
...
...
alprazolam Schedule
4
Phentermine Schedule
4
Carisoprodol Schedule
4
Tramadol Schedule
4
Butoprhanol Schedule
4
Chloral hydrate Schedule
4
not more than how man mg of difenoxin and not less than how many mcgs of atropine to be schedule 4
1 mg and 25 mcgs
schedule 5
limited physical or psychological dependence
codeine cough syrup Schedule
5
Pregabalin Schedule
5
mid level practitioners start with the letter what?
M
If MD precribes controlled substances at mutiple locations then what?
need to be registered with DEA at each site
if codeine or an opiate is mixed with water what schedule is it?
2
concnetration limit for codeine C5
200 mg / 100 ml
concnetration limit for codeine C3
1.8 g/100 ml 90 mg per dosage unit
dea 222 forms what colors?
BROWN GREEN BLUE
if the supplier does not have enough within how many days do they have to supply the balance?
Within 60 days
how much % of controlled substance sales to be registered as a distributor
as long as no more than 5% total quantity
within how long must report loss of a controlled substance to DEA?
within 1 business day
what dea form is for theft or loss of controlled drugs?
DEA 106
DEA 106
for lost or stolen controlled substances
what does the orange control sticker say?
Caution federal law prohibits the transfer of this drug to any person other than the patient for whom it was presribed
what meds need the orange control sticker? what is the exception?
Control 2-4.. if for a blinded clinical study
DEA form 41
for destruction of controlled substances
how many witnesses must there be when destroying controlled substances?
at least 2 witnesses
how often to complete controlled substance inventory?
every 2 years bieneally.. when drug is reclassified or when you first open for busniness
what records cannot be stored centrally? 3 of them
DEA order forms copy 3 of 222, Rxs, or inventories these must be kept at phaarmacy
who can prescirbe meds?
MD
Dentists
Podiatrists
Veterniarians
Optometric Glaucoma Specialists
what is the exception for partials fills for C2s?
if patient is termianlly ill.. must fill within 60 days
for schedule 3-5 can you partial fill?
yes as long as it does not exceepd quantity.. also 5 refills or 6 months
can retail pharmacies sell methadone 40 mg?
no! only for addiction
buprenorphine schedule?
3
subozone schedule?
3
how man grams of pseudophed in a day/ in a month
3 grams in a day or 9.6 grams in a week
less than how many mg of pseudophed do not need to sign log book?
less than 60 mg
which meds do not need a safety cap?
Oral contraceptives
Medroxyprogesterone
Sublingual nitro or isosorbide dinitrate of 10 mg or less
aspirin and acetaminophen in effervesecent granules
Cholestyramine and colestipol
prendisone not containing more than 105 mg
methylprednisolone not more than