DEAform 224
renew every? - ANSWER 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 - ANSWER employees,
contract carrier, ultimate user
who has to obtain a registration as a chemical distributor? who is exempt?
what are the drugs listed here? - ANSWER -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 - ANSWER DEA chemical distributor registration
the attorney general can suspend or revoke DEA registration with what findings -
ANSWER 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 - ANSWER -transfer to customer, dispensing rx
-destruction
1
,-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? - ANSWER 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 - ANSWER 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 - ANSWER 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... - ANSWER in a locked cabinet or dispersed in
non-controlled stock to deter theft. electronic alarm recommended
2
,DEA from 106 - ANSWER 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 - ANSWER -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 - ANSWER no adulteration, no misbranding - didnt account for
efficacy or safety or ingredients
harrison narcotic act - ANSWER containers of narcs had to have tax stamps
-tracking of narcs started
food drug and cosmetic act 1938 - ANSWER -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 - ANSWER seperated Rx from OTC
-can Rx by oral or written
-can do refills
3
, -directions for use on OTC, information for use on Rx - transfered to product pt sheet
kefauver-harris ammendment 1962 *** - ANSWER -now you have to test for efficacy
-DESI (1938-1962 tested for efficacy) PT 1938 grandfathered.
-GMP started
-NDA started
controlled substance act 1970 - ANSWER DEA started and registrations
drugs put into schdules
poison prevent packaging act - ANSWER child proof or OTC tamper proof to prevent
poisonings
excep:SL,dr can state for 1 rx, pt can blanket statement (document)
orphan drug act - ANSWER tax relief to manufacture drugs for rare diseases
drug price competition act - ANSWER aka hatch waxman ammendment
-ANDA
-accelerated drug approval for generics - only test equivalency
prescription drug marketing act PDMA - ANSWER drug pedigrees
federal standards for storage, dist, recordkeeping or Rx drugs
"drug diversion act"
-bans re-importation
prescription drug user fee act (PDUFA) - ANSWER fees on manuf and prod to go to FDA
4
renew every? - ANSWER 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 - ANSWER employees,
contract carrier, ultimate user
who has to obtain a registration as a chemical distributor? who is exempt?
what are the drugs listed here? - ANSWER -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 - ANSWER DEA chemical distributor registration
the attorney general can suspend or revoke DEA registration with what findings -
ANSWER 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 - ANSWER -transfer to customer, dispensing rx
-destruction
1
,-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? - ANSWER 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 - ANSWER 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 - ANSWER 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... - ANSWER in a locked cabinet or dispersed in
non-controlled stock to deter theft. electronic alarm recommended
2
,DEA from 106 - ANSWER 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 - ANSWER -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 - ANSWER no adulteration, no misbranding - didnt account for
efficacy or safety or ingredients
harrison narcotic act - ANSWER containers of narcs had to have tax stamps
-tracking of narcs started
food drug and cosmetic act 1938 - ANSWER -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 - ANSWER seperated Rx from OTC
-can Rx by oral or written
-can do refills
3
, -directions for use on OTC, information for use on Rx - transfered to product pt sheet
kefauver-harris ammendment 1962 *** - ANSWER -now you have to test for efficacy
-DESI (1938-1962 tested for efficacy) PT 1938 grandfathered.
-GMP started
-NDA started
controlled substance act 1970 - ANSWER DEA started and registrations
drugs put into schdules
poison prevent packaging act - ANSWER child proof or OTC tamper proof to prevent
poisonings
excep:SL,dr can state for 1 rx, pt can blanket statement (document)
orphan drug act - ANSWER tax relief to manufacture drugs for rare diseases
drug price competition act - ANSWER aka hatch waxman ammendment
-ANDA
-accelerated drug approval for generics - only test equivalency
prescription drug marketing act PDMA - ANSWER drug pedigrees
federal standards for storage, dist, recordkeeping or Rx drugs
"drug diversion act"
-bans re-importation
prescription drug user fee act (PDUFA) - ANSWER fees on manuf and prod to go to FDA
4
