QUESTIONS AND ANSWERS GUARANTEE A+
✔✔Manu's packaging - ✔✔1) Meds must be in CRC
2) Bulk packaging to be repackaged by RPH doesnt have to be in special packaging
3) Unit packaging from manu must comply with CRC
✔✔Waiver for CRC - ✔✔Must document waivers, don't need to have sig, pt can say it
orally.
✔✔Prescription Drug Marketing Act - ✔✔1) Proper storage / handling of drugs.
2) Establish maintenance of records
3) Prohibits interstate commerce unless registered with shipping state
4) Bans reimportation of Rx Drugs (except same manu)
5) Bans sale/trade/purchase of samples.
6) Bans traffic in counterfeiting drug coupons
7) Prohibits resale of rx drugs by hospital for drugs purchased at special prices
8) Mandates storage/records of drug samples
9) MD's request for samples in writing
10) Criminal and civil penalties
✔✔Samples - ✔✔Only practitioners can receive. Pharmacies can receive if requested
by practitioner. Written request needed:
1) Name, add, professional designation, sig of MD
2) drug name, quantity, and manu
3) date.
***Manu's must keep ANNUAL inventory. Must keep records for THREE years.
✔✔Drug Recall - ✔✔-Remove products from market thats:
1) Misbranded. 2) Adulterated. 3) threaten consumer safety.
✔✔Recall classifications - ✔✔Class I: Cause serious adverse health
consequences/death.
Class 2: Cause temp or medically reverisble adverse health consquences.
Class 3: Not likely to cause adverse health probs
✔✔Package inserts? - ✔✔OC's, IU devices, estrogen containing products,
progestational drug products . In COMMUNITY pharmacy - need inserts EVERYTIME
product refilled. In INSTITUTION - req only on intial dispensing and Q 30 days.
✔✔OTC Labels - KNOW THIS - ✔✔1) Product name
2) Name and addy of manu or distributor
3) list of active or other ing (not amt?)
4) amt of contents (strength of ACTIVE ing)
5) adequate warnings
,6) adequate directions for use
✔✔CMEA - ✔✔3.6g daily limit //
9g monthly limit //
7.5g monthly limit if MAIL SERVICE //
Must maintain: product name, quantity, name and addy, date and time, must ask for
photo ID. Doesnt apply to 60mg or less.
✔✔Can prescriber dispense? - ✔✔Prescriber cannot charge pt for more than 72 hrs of
meds dispensed EXCEPT=======
Prescriber working in hospital / dispense at no charge / greater than 10 miles from
pharmacy / dispense in institutional clinic / licensed under Art 135 (vets) of this title /
dispense under medical emergency / dispense drug reconstituted by prescriber /
dispense allergic extracts // dispense drugs covered under oncology or AIDS protocol
✔✔All prescription blanks MUST CONTAIN - ✔✔1) ONE SIGNATURE LINE //
2) Statement under lien: rx will be filled generically unless prescriber writes daw in box
below //
3) that box
4) Words DISPENSE AS WRITTEN under box
5) profession
6) Imprinted name of prescriber
✔✔Substitution - ✔✔1) Rx written by brand name,
2) DAW box empty,
3) drug is therapeutically equivalent,
4) less expensive.
****If OOS, give brand at generic price.
***If emergency, give brand at regular price and record on back: date/hour/nature of
emergency.
✔✔Emergency - ✔✔1) Alleviate severe pain.
2) Threaten disability.
3) Take life if not treated.
✔✔Dosage forms not interchangeable - ✔✔EC tabs
CR products
Injectable susp
suppositories
different delivery systems for aerosol and nebulizer drugs
✔✔Orange book - ✔✔A_ = no bioeq problems//
B_= docuemented bioequivalence problems!! ///
BX = insufficient data ///
, O = oil solns // T = topical, C = tabs, caps, D = active ing and dose form, E = delayed
release oral, N = aerosol neb delivery system, R = suppository or enema, S = standard
deficiencies
✔✔RPH doesnt have to sub if: - ✔✔1) RPH dispense brand at generic price.
2) Medical emergencies when generic not available.
3) no equivalent exists.
✔✔Sub issues - ✔✔Pt can't request brand if DAW not written = RPH must calls MD to
get auth... NYS Generic sub law doesn't apply to RX's written and filled out of state or
vitamins. Applies to NURSING HOMES.
✔✔EPIC (Elderly pharmaceutical insurance coverage) - ✔✔-Changed lower half of rx
blank, prescriber not liable for poor prod, must inform PT that Rx is generic, and indicate
in order order - brand or generic? /////// Dispensing = cannot waive or reduce copay,
quantity limited to 30 days or 100 dosage units, must be filled in NYS. Claim higher fee,
must make emergency delivery at no cost to consumer!
✔✔EPIC Higher Fee - ✔✔24 hour emergency rx service, medical emergency delivery
service at no charge to patient (5 miles), pt drug profiles maintained for all pts, direct pt
consultation with every Rx.
✔✔NYS Medicaid Mandatory Generic Program - ✔✔Encourage prescribers to give A
rated generics. If want to give BRAND< must call 24 hour prior authorization call line
and answer questions for reason. MUST WRITE ON THE FACE OF RX:
1) Prior auth #
2) DAW in box
3) Words: Brand necessary or brand medically necessary in handwriting.
-------RPH must call number and validate. GOOD for 6 MONTHS.
✔✔Exempt products from mandatory Medicaid Program - ✔✔Coumadin // Gengraf,
sandimmune, neoral // clozaril, tegretol, dilantin, zarontin // lanoxin, levothyroxine
✔✔Poison - ✔✔Drug, chemical, or preparation likely to be DESTRUCTIVE to adult
human life in quantity of 60 GRAINS OR LESS....
Schedule A = arsenic, atropine, chloral hydrate, strychnine, hydrocyanic acid....
Schedule B = belladonna, ergot, digitalis, chloroform, mineral and oxalic acids
✔✔Poison label - ✔✔Name of article, word POISON, name and address of seller. ALL
IN RED!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!`
✔✔Poison Register - what required? - ✔✔1) Date of sale.
2) Name or address of purchaser.
3) Name and quantity of substance.
4) Purpose of purchase.