HAR 238 - Food Drugs and Cosmetics Flashcards
when prescribing to a pet, whos name goes on the prescription?
the owners (not the pets)
Hawaiian equivalent of “IC” - drugs
“same as”
Hawaiian equivalent of “IC” - biologics
“interchangeable with”
what to do when directions do not fit on label
“take according to written instructions” - must have written instructions for use, CANNOT have “take as directed” with no written instructions
how many refills is the default if provider does not dictate refill qty?
zero; would be otherwise misbranded if it is given refills when not authorized
what forms of signature are acceptable for provider signatures on erxs?
bitmap or graphic image of signature + oral code
digital signature
electronic signature
how many refills can be authorized if designated as PRN?
may be refilled up to 12 months from the written date
then may be refilled once in the next 3 month for no more than 30 days and can provide no medication for 15 months beyond the written date
what must appear on every prescription drug label?
“CAUTION: state/federal law prohibits dispensing without a prescription” or “Rx Only”
otherwise considered misbranded
requirements of condition on prescription
- offer to have it included
- inform of right to not have it included
- if not listed as part of directions, shall not be included on label
additional information needed beyond typical mass requirements of prescriptions
the format in which the rx was recieve (oral written erx)
MUST interchange occur?
no - it must be offered ot the pt (with cost savings) but brand may be requested by pt
Brand required
must be handwritten, checking a box is not appropriate or permitted
exceptions to interchange law?
- anti-epileptic drug unless provider and patient both approve interchange;
- pharmacy must notify provider w/in 2 business days if changed biologic unless its the same as previous refill
source for drug interchanges?
orange book
source for biologic interchanges?
purple book
