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
