GFPL - purple book Flashcards
Pure food and drug act
1906
no misbranded/adulterated interstate lines
= did not require ingredient list
= did not regulate cosmetics/devices
food drug and cosmetic act
1938
proven to be safe with directions
warnings about habit forming
yes cosmetics/devices
Durham-humphrey amendment
1951
legend vs otc
“caution federal law prohibits dispensing without rx”
Kefauver-harris ammendment
1962 safe + effective infomred consent research reporting ADr GMP
who is responsible for drug advertising?
OTC: FTC
RX: FDA
what qualifies for the orphan drug act
<200,000 pts
hatch-waxman
aka: drug price competition and patent-term restoration
only prove bioequivalance + ANDA
new drugs awarded 5 extra years
prescription drug marketing act
1987
bans re=import
ban sale of samples
standards for storage
FDA modernization act
1997
- pharmacies can compund, not subject to GMP
- Caution label replaced with “rx only”
- habit warning removed
- may share some unapproved uses
tiers of copays for MED D drugs
T1: least expensive generic
T2: preferred brand
T3: non-preferred brand
T4: rare, high cost
provisions of medicare D
- any willing provider clause
- cannot require mail - order
- must be advised of losest cost generic
med d requires inclusion of all drugs in what drug classes?
anticonvulsants antidepressants antineoplastics antipsychotics antiretrovirals immunosuppressants
which drug classes are gnerally not allowed under part d?
barbs benzos weight loss/gain hair growth fertility vitamins outpt that require monitoring
enrollment period for part d
3 months before and after birthday (7 months)
what must medicare target for MTM?
quarterly targeting
- 2-3 chronic diseases
- many meds (2-8)
- predicted to cost more than a threshold
what are the 7 core diseases to be targeted by med D and how many must they target?
must target at least 4 of the following: htn HF DM dyslipidemia respiratory dx bone dx mental health
how long can the FDA sit on an IND?
30 days
what ingredients do not need to be included on lists for drugs?
flavors, fragrances
can simply say cherry flavor or peppermint aroma
also inert gases for stability
what meds require special warnings?
FDC yellow no 5 (tartrazine) - allergies aspartame - phenylalanine \_\_mg/unit sulfites - allergies mineral oils - HS, no infants/pregnant wintergreen oil >5% - no children NaPhos - max 90ml otc isoproternol - breathing ipecac - 30 oz bottles acetophentidin - kidney salicylates - reyes
can pharmacies ever have samples?
no - only in a health facility if storing for a provider
who has record keeping requirements for samples?
mfrs and distributors - 3 year record of sample orders
when are barcodes on drug products required?
on all drug products supplied to hospitals
most serious drug recall
Class I: serious adverse consequences
Class II: temporary/reversible effects
Class III: unlikely to to cause any health consequenses
how much of a supply can compounders ship out of state?
max 5%
expiration dates for compounded rxs
non-aquesous: 25% of commercial products or 6 months
aqueous solutions: 14 days at cold temperature
all others max of 30 days
low risk sterile products
transfer from a vile or amplue with a needle and syringe
TPN using commercial sterile solutions
sterile soutions into elastomeric devices
high risk stile products
Cat I:
- pooling sterile drugs for subsequent transfers
- complex compounding involving multiple aseptic processes ( TMP via comounding devices)
- multi day use in a pump
Cat II: DANGER ZONE
- non-sterile drug substances
- open systems
