AND SOLUTIONS SCORED A+
✔✔FDA modernization Ave of 1997 - ✔✔1) fast track NDAs
2) compounding clarifications( states regulate)
3) changed long legend to "Rx only"
4) removed habit forming wording
5) encouraged NDAs for new uses
6) six months patent protection for peds studies
✔✔Exp date for non aqueous liquid or solid dosage compound - ✔✔25% of time
remaining on commercial product or 6 months- whichever is less
✔✔Exp date on aqueous compound - ✔✔14 days
✔✔Exp date on compounded meds that don't fit the two main categories - ✔✔Duration
of therapy- not to exceed 30 days.
✔✔Makeup of the pharmacy examining board - ✔✔7 members with staggered 4 year
terms. 5 pharmacists and 2 public members
✔✔What constitutes the "active practice of pharmacy" - ✔✔2000 hours in past 12
months, or 2000 hours with no less than 500 hours in each 3 of the 4 past 12 month
periods
✔✔Requirements of a remote dispensing site technician - ✔✔Yes, as long as it is
dispensed to the same patient
✔✔Can a pharmacy repackage a cs Rx? - ✔✔No! Under no circumstances can a
pharmacy take cs from a non dea registrant
✔✔Can you take an Rx via an answering machine? - ✔✔Yes, if you know the providers
voice
✔✔Requirements of a remote dispensing site technician - ✔✔1) 18 or older
2) high school grad or equivalent
3)1500 hours of tech work within past 3 years or completed approved tech training
program
✔✔When can a c2 be taken by fax? - ✔✔1) direct administration by injection routes
2)ltcf patient
3) hospice patient
✔✔Do warehouses need a DEA number? - ✔✔No.
, ✔✔How long is a 222 good for if partially filled? - ✔✔60 days following the date on the
order form.
✔✔What volume of OTC c5 can you sell in a 48 hour period? - ✔✔227 g of opium or
113 g of any other c5
✔✔Maximum quantity of pseudoephedrine that can be purchased? - ✔✔7.5 grams per
30 days.
✔✔Cutoff for codeine as c3? - ✔✔Not more than 1.8 grams per 100 ml/grams or 90mg
per dosage unit with something else
✔✔What schedule is straight codeine? - ✔✔C2
✔✔Cutoff for ethylmorphine as a c3? - ✔✔Not more than 300 mg per 100 ml/grams. Not
more than 15mg per dosage unit- both combined with something else
✔✔Cutoff for opium as a c3? - ✔✔Not more than 500 mg per 100ml/grams or 25 mg per
dosage unit combined with something else
✔✔Cutoff for morphine as a c3? - ✔✔Not more than 50 mg of morphine per 100
ml/grams combined with something else.
✔✔Schedule of buprenorphine? - ✔✔C3
✔✔Schedule of anabolic steroids? - ✔✔C3
✔✔Schedule of benzodiazepines? - ✔✔C4
✔✔Schedule of ephedrine? - ✔✔C4
✔✔Requirements for diphenoxin/ atropine fit schedule 3? - ✔✔Not more than 1mg of d-
oxin with not less than 25 mcg of atropine per dosage unit
✔✔Schedule of butorphenol? - ✔✔4
✔✔Schedule of pentazocine? - ✔✔4
✔✔Requirements for codeine to be a c5? - ✔✔Not more than 200 mg per 100ml/grams
✔✔Requirements of opium to be a c5? - ✔✔Not more than 100mg of opium per
100ml/grams.