Lec 8 USP, Inspections, Equivalency Flashcards
(22 cards)
USP <795>
a. nonsterile compounding
b. sterile compounding
c. hazardous substances
a. nonsterile compounding
USP <797>
a. nonsterile compounding
b. sterile compounding
c. hazardous substances
b. sterile compounding
USP <800>
a. nonsterile compounding
b. sterile compounding
c. hazardous substances
c. hazardous substances
T or F: USP <797> requires beyond-use-dates (BUDs) to be assigned to nonsterile products
F
(USP <795> not <797>)
which of the following does NOT apply as hazardous?
a. carcinogenic
b. teratogenic
c. reproductive toxicity
d. antibiotics
e. organ toxicity
f. genetotoxicity
g. new drugs that mimic existing hazardous drugs
d. antibiotics
if an expiration date is listed as January 2029, what day of the month will it expire?
last day of the month (Jan 31st)
T or F: a BUD is usually later than the expiration date
F (cannot be later than expiration)
T or F: the BUD for a compounded product should never be later than 1 year from dispensing the product
T
repackaged products must meet all provisions of the _____
a. FDA
b. FDCA
c. FTC
d. DEA
b. FDCA
(federal food, drug, and cosmetic act)
T or F: taking a drug out of a stock bottle and placing into a prescription bottle for dispensing meets the criteria for repackaging
F
BUD of no more than six months or the expiration date, whichever is sooner
a. non-aqueous formulation
b. water-containing oral formulations
c. water containing topical, mucosal, and semisolid formulations
a. non-aqueous formulation
BUD of no more than 14 days or the expiration date, whichever is sooner
a. non-aqueous formulation
b. water-containing oral formulations
c. water containing topical, mucosal, and semisolid formulations
b. water-containing oral formulations
BUD of no more than 30 days or the product expiration date, whichever is sooner
a. non-aqueous formulation
b. water-containing oral formulations
c. water containing topical, mucosal, and semisolid formulations
c. water containing topical, mucosal, and semisolid formulations
BUD of non-aqueous formulation compound
a. no more than 14 days
b. no more than 30 days
c. no more than 6 months
c. no more than 6 months
BUD of water-containing oral formulations compound
a. no more than 14 days
b. no more than 30 days
c. no more than 6 months
a. no more than 14 days
BUD of water-containing topical, mucosal, and semisolid formulations
a. no more than 14 days
b. no more than 30 days
c. no more than 6 months
b. no more than 30 days
T or F: FDA inspectors may request entry to a pharmacy by showing a notice of inspection and their credentials
T
which of the following is FALSE about DEA Notice of Inspection (NOI)?
a. You have the right to require the DEA to get an administrative inspection warrant (AIW)
b. You may withdraw your consent to inspection at any time
c. Administrative inspection warrants (AIW) can be served at any time, search warrants can only be served during regular hours
d. You have the right to refuse an inspection, at which point they will get an AIW
c. Administrative inspection warrants (AIW) can be served at any time, search warrants can only be served during regular hours
(it is the other way around)
T or F: the BoP needs a warrant to do an inspection
F
(in almost every state you cannot say no to these inspections)
therapeutic equivalency
a. orange book
b. purple book
a. orange book
provides interchangeable biological product information
a. orange book
b. purple book
b. purple book
which of the following is FALSE about the therapeutic equivalence (TE) code?
a. First letter indicates the relevant therapeutic equivalence code
b. Second letter indicates the dosage form
c. Drugs with a three-character code are considered therapeutically equivalent only to other drugs with the same three-character code
d. The first letter B represents therapeutic equivalence
d. The first letter B represents therapeutic equivalence
(the letter A represents therapeutic equivalence)
