Mpje Concept (Correct Answers)
DEAform 224
renew every?Correct Answersnew pharmacy registration to dispense controlled substances (application for new registration) - pharmacy registration is renewed every 3 years (renewal registration form DEA form 224a - chain=224b) - registration kept onsite...
Mpje Concept (Correct Answers)
DEAform 224
renew every?Correct Answersnew pharmacy registration to dispense controlled
substances (application for new registration) - pharmacy registration is renewed every 3
years (renewal registration form DEA form 224a - chain=224b) - registration kept onsite
- issued by attorney gen.
3 exceptions for registration for dispensing controlled substancesCorrect
Answersemployees, contract carrier, ultimate user
who has to obtain a registration as a chemical distributor? who is exempt?
what are the drugs listed here?Correct Answers-wholesale distribution
-retail pharmacies registered for controlled substances and retail distributors who sales
are for personal use are below threshold quantities
-ephedrine,pseudoephedrine, phenylprolanolamine (PPA), and ephedrine combos (List
1 chemicals)
not to exceed 3.6g/day or 9g/month
DEA form 510Correct AnswersDEA chemical distributor registration
the attorney general can suspend or revoke DEA registration with what findingsCorrect
Answersfalsified application, felony conviction involving controlled substances or list 1
chemicals, license suspended,revoked or denied, excluded from medicare/medicaid, act
inconsistant with public interest
4 ways to get rid of controlled substances
records kept for how longCorrect Answers-transfer to customer, dispensing rx
-destruction
-transfer to another DEA registrant (dr,back to distributor or manufacturer)
-surrender to DEA/law enforcement
>2 years, readily available (5yrs UCSA)
how to transfer C2 substances to another DEA registrant, pharmacy, manuf?
C3-C5?
five percent rule?Correct Answersreceiving registrant must issue Form 222
(dr brings 222 form into the pharmacy) - also need if transfering ownership of pharmacy
w/ inventory- notify DEA of transfer 14 PT - keep records for 2 years
-just need documentation with drug name, dosage form, strength, quant, date and
name, address, DEA number of those involved
note:if transfering >5% of yearly sold controlled than need to register as a distributor!!!
(five percent rule)
DEA form 41Correct Answersform submitted to the special agent in charge (3 copies)
that list controlled substances desiring to dispose of - form needed to report disposal or
breakage/spillage
4 ways controlled substances can be destroyedCorrect Answersauth by special agent to
do one of the following
-transfer to person registered
-delivery to an agent
-destruction in presence of an agent
-another means determined by agent
(per UCSA:maintain records for 5 yrs)
,DEA states schedule 2,3,4,5 should be...Correct Answersin a locked cabinet or
dispersed in non-controlled stock to deter theft. electronic alarm recommended
DEA from 106Correct Answersreport of theft or significant loss of controlled substances
-notify local police and DEA w/in 1 day if determined than submit form
-do not use to report miscounts/adjustments/ breakage/spillage
-if lost in transit supplier reports, if pharmacy signs for it and than notices it was lost in
transit the pharmacy has to report
according to DEA how long must records be maintained for controlled substances?
what records must be maintained?
C2 noteCorrect Answers-2 years
-used and unused 222s (or elec equiv), power of attoney authorization, receipts and
invoices for C3-5, all inventory records or CSs, records of CSs distributed/dispensed,
form 106, form 41, records of transfers between pharmacies, dea registrations
certificate, self certification and log book for meth epidemic act
-C2 records must be maintained seperately
pure food and drug actCorrect Answersno adulteration, no misbranding - didnt account
for efficacy or safety or ingredients
harrison narcotic actCorrect Answerscontainers of narcs had to have tax stamps
-tracking of narcs started
food drug and cosmetic act 1938Correct Answers-saftey now tested before approved
(not efficacy yet)
-expanded definitions of adultered and misbranded - directions for use, warning
-extended to cosmetics
durham and humphrey ammendment 1951Correct Answersseperated Rx from OTC
-can Rx by oral or written
-can do refills
-directions for use on OTC, information for use on Rx - transfered to product pt sheet
kefauver-harris ammendment 1962 ***Correct Answers-now you have to test for
efficacy
-DESI (1938-1962 tested for efficacy) PT 1938 grandfathered.
-GMP started
-NDA started
controlled substance act 1970Correct AnswersDEA started and registrations
drugs put into schdules
poison prevent packaging actCorrect Answerschild proof or OTC tamper proof to
prevent poisonings
excep:SL,dr can state for 1 rx, pt can blanket statement (document)
orphan drug actCorrect Answerstax relief to manufacture drugs for rare diseases
drug price competition actCorrect Answersaka hatch waxman ammendment
-ANDA
-accelerated drug approval for generics - only test equivalency
prescription drug marketing act PDMACorrect Answersdrug pedigrees
federal standards for storage, dist, recordkeeping or Rx drugs
"drug diversion act"
-bans re-importation
,prescription drug user fee act (PDUFA)Correct Answersfees on manuf and prod to go to
FDA
nutrional labeling education act NLEACorrect Answersprevented disease prevention
claims in food labels - dietary supplements upset
dietary supplement and health education act (DSHEA)Correct AnswersDS no longer
food - not subject to testing by FDA
-4 things can state: moa,how it affects the body, how it benefits a deficiency, general
well being
-can not claim to help disease - but can have marketing in store as long as not manuf or
store made
-label must state has not been tested
-FDA can now pull unsafe products - manuf has to submit ADRs
best pharmaceutical for children actCorrect Answersvoluntary incentive - increase
patent length if test on kids
pediatric research equity actCorrect Answersfda can now req pediatric testing
drugCorrect Answersrecognized by USP, or NF or other - used to
treat,cure,prevent,diagnose a disease - affects structure of the body
new drugCorrect Answersnot safe for condition stated or as labeling states
prescription drugCorrect Answershabit forming or could could toxicity or harmful affect
to public - limited by approved application
- not safe for use unless under the care of a dr
OTC drugCorrect Answerssafe and effective for use, must comply to GMP, must have
adequate directions for use - written in layperson terms
NDACorrect Answersnew drug application - needed before marketing
ANDACorrect Answersabbreviated new drug app - needed before marketing of a
generic
adulteratedCorrect Answersprepared,packaged or held in unsanitary
not following GMP
conatiner leeches poison or deleterious
unsafe color added
varies from official compendia
otc drug not in tamper-resistant
misbrandedCorrect Answerslabel is false/misleading
label does not state name place of manuf
wrong quantity
info not prominent or missing something
generic not less than 1/2 size of brand
not following compendia standards
drug package is misleading or imitative
insulin or aB not batch certified
which FDA recall is the most seriousCorrect Answersclass 1 recall - reasonable
probability use will cause serious adverse health conseq or death
drug development stagesCorrect Answersanimal, IND (to ship), phase 1 (small,healthy
to determine preferred admin route and safe dosage), phase 2 (larger w/ event to test
efficacy), phase 3 (larger, multicenter, strict criteria safety and efficacy, risk vs benefit),
NDA, phase 4 (post marketing), ANDA (for generic or new indic)
, OBRA 90Correct Answersomnibus budget recon. act 1990
indirect way for federal gov. to regulate pharmacy - cut costs
3 components
1-rebate programs. drugs provided to state medicaid programs at "best price" or diff
between AMP and best price rebate (340B)
2-demonstration projects - showed cost savings based on DURs
3-DURs (retrospective,educational,prospective)
HIPAACorrect Answershealth ins portability and accountability act
congress madated
-electronic standards to simplify transfers
-development of privacy standards for electronic data (privacy rule) pertaining to
protected health info (PHI - indiv. indentifiable health info)
-entities must get pt consent to use PHI for treatment, payment.
-newly modified (HITECH act) which reqs pts be notified if breach (refill reminders ok
per hipaa)
medicareCorrect Answers>65 or certain disabilites
part A: financing for hospital
part B: like regular ins, monthly charge
part D: voluntary Rx coverage, monthly fee, deductible and dounut hole (2251-5100),
also allows for MTM
medicaidCorrect Answershealth care to certain classes of indigents
reimbursements are controversial
federal est MAC (max allowable cost)
CMS (centers for medicare/medicaid services) est federal upper limit (FUL)
if not one of their FUL agents than reimbursement based on est acquisition cost (EAC)
+ disp fee or usual charge
controverial!
medicare/medicaid fraud and abuse actCorrect Answersantikickback provision and
prohibts false statements to get payment
-felony, 25,000, 5 yrs in prison and may be excluded from billing CMS, and may loose
license
USP chapter 795Correct Answerspharmaceutical compounding - non-sterile
-compounder is capable and qualified
-pure,quality ingredients
-process steps validated and finished product reproducible (standard operating
procedures SOPs to help reduce error)
-environment approp
-BUD determined and labeled
-documented
-definitions: preparation (form),official substance, active ingred, added substances
-quality, quantity, calculations, measurements confirmed
-measurements accurate w/in 10% (tolerance)
-pt counseling on use, storage and BUD
USP chapter 797Correct Answerspharmaceutical compounding - sterile (usually inj)
compounded sterile products (CSPs)
-prevent contamination, be consistant
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