Other Flashcards
sterility/pyrogen testing for high risk CSPs necessary if
- batches >25 identical individual single dose packages
- mult dose vials for admin to mult pts
- product exposed longer than 12 hrs at refrigerator temps
- product exposed to temp >refrigerator longer than 6 hrs
Exempt parties from PDMP
- licensed/cert hospitals
- PDO within hospital that dispenses CS pursuant to chart orders or dispenses no more than 24 hr supply
- certified EMS
- PDO with waiver from board
specialized prescription drug outlet
outlet located within LCTF which is owned and operated by a managing PDO located w/in CO
LCTF w/ SPDO closes - how soon must notify board
7 days (by managing PDO’s pharmacist)
drugs acceptable for use by limited license for the capture of wildlife or animals (17)
acepromazine, ketamine, xylazine, tiletamine and zolazepam, sodium pentobarbital, butorphanol, azaperone, medetomidine, midazolam, haloperidol, nalbuphine, atipazmezole, tolazoline, naltrexone, doxapram, yohimbe, diphenhydramine
registration posting in other outlet
licenses, registrations, last inspection by board, approved protocols, consultant pharmacist reports, other
how long does consultant pharmacist have to provide protocols to board upon request
30 days
quarterly inspections and visits needed for which other outlets
jails, county health departments, schools (K-12), hospitals, family planning clinics, hospices, medical clinics, ambulatory surgical centers
interim designated consultant pharmacist
notify board in 10 days;
designee can be consultant pharmacist for no more than 90 days (if > 90days, app for new consultant should be submitted w/in 30days following 90 day period)
unlawful possession of any qty of what drugs is a level 4 drug felony?
ketamine, cathinones, flunitrazepam, or C-I/C-II
unlawful possession of any qty of what drugs is a level 1 drug misdemeanor?
CIII-V (except flunitrazepam, ketamine)
MMJ card produced by
CO dept of public health and environment
possession limits MMJ
2 oz usable, 6 plants (< 3 mature)
MMJ approved conditions
cachexia/wasting, cancer, chronic pain, epilepsy/sz, glaucoma, HIV/AIDS, MS, nausea
MMJ for pts < 21 y/o
approval from 2 MDs
amendment for approval of recreational MJ
64
limitations recreational MJ
must be >= 21 y/o; 1oz, 6 plants
changes pharmacist CAN make to C-II Rx after consult prescriber
dosage form, strength, qty, directions, issue date
CANNOT change on C-II
pt name, CS prescribed, signature of prescriber
C-II multiple Rxs
CO: 1 prescription can be written for ANY days supply
what is last digit in DEA number AU123456_
3
1+3+5=9
(2+4+6) x 2=24
9+24=33
CS prescriptions must contain
date/signed by prescriber on date issued
pts name and address (not DOB)
practitioners name, address, DEA
drug name, strength, dosage form, qty, directions, refills auth
partial fill od C-II
72 hrs
partial fill of C-II for LTCF
60 days
when an start dispensing CS
14 days after DEA receives notification of request
partial order fills of CS from supplier
60 days
copies of DEA 222 go to
1-supplier, 2-DEA, 3-retained
ryan height act
online pharmacy must have modified DEA registration
exceptions for prescribing opioids for addiction outside of DATA
- 3 days tx admin by prescriber while arranging for tx
- hospitalized pts (for condition other than addiction)
maintenance opioid treatment
> 21 days
OTC label must have
drug name and pharm category, name and address of manuf/distributor, qty of package contents, cautions/warnings, drug fact panel, directions (dose, freq, duration, admin, onset, route, preparation)
drug recall classes
I-serious, II-temporary harm, III-not likely to cause AE
drug price competition and patent term restoration act
ANDA - approved generics bioequivalent
Patent life for new brand drugs: 5 years exclusive marketing after approval
prescription drug marketing act
- states must license wholesale distributors
- bans sale, trade, purchase of samples
- prohibits community pharamcies from receiving samples
medical device act (& classes)
I-minor potential impact
II-moderate
III-major (requires premarket approval)
poison prevention packaging act
child-resistant containers cannot reuse
CR for all Rx drugs
OTCs that require it: ASA, Fe, APAP, IBU, lidocaine, naproxen, Benadryl, loperamide
(exception if labeled appropriately - not CR, for households w.o children)
child resistant def
85% of children < 5 cannot open w/in 5 mins
90% adults can open and close w/in 5 mins
federal alcohol regulations
AFT form 11 for dealers stamp
don’t need for 190-proof ethyl alcohol
hospitals have special AFT permit for tax-free EtOH
DEA Form 224
new retail pharmacy registration
five percent rule
cannot distribute to another pharmacy >5% of all CS dispensed by pharmacy throughout yr
how old to buy sudafed in CO
18
form 224a
renewal of registration - pharmacy, hospital, clinic, teaching institution, prescriber, midlevel
DEA form 225
manufacturer, importer, exporter, distributor, reverse distributor, researcher, canine handler, analytical lab
DEA form 363
Narcotic treatment clinics
