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mpje exam with comprehensive questions and well elaborated correct answers graded A+

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mpje exam with comprehensive questions and well elaborated correct answers graded A+

Institution
Nebraska MPJE
Course
Nebraska MPJE

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mpje exam with comprehensive
questions and well elaborated correct
answers graded A+
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,DEAform 224

renew every? - correct ans:new 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 substances - correct ans:employees, contract
carrier, ultimate user



who has to obtain a registration as a chemical distributor? who is exempt?

what are the drugs listed here? - correct ans:-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 510 - correct ans:DEA chemical distributor registration



the attorney general can suspend or revoke DEA registration with what findings - correct ans:falsified
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 long - correct ans:-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 ans:receiving 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 41 - correct ans:form 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 destroyed - correct ans:auth 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 ans:in a locked cabinet or dispersed in non-controlled
stock to deter theft. electronic alarm recommended



DEA from 106 - correct ans:report 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 note - correct ans:-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 act - correct ans:no adulteration, no misbranding - didnt account for efficacy or
safety or ingredients



harrison narcotic act - correct ans:containers of narcs had to have tax stamps

-tracking of narcs started



food drug and cosmetic act 1938 - correct ans:-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 1951 - correct ans:seperated 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 ans:-now you have to test for efficacy

-DESI (1938-1962 tested for efficacy) PT 1938 grandfathered.

-GMP started

-NDA started



controlled substance act 1970 - correct ans:DEA started and registrations

drugs put into schdules



poison prevent packaging act - correct ans:child proof or OTC tamper proof to prevent poisonings

excep:SL,dr can state for 1 rx, pt can blanket statement (document)

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Institution
Nebraska MPJE
Course
Nebraska MPJE

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Written in
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