Pharmacist DEA manual Flashcards
DEA Form 224
224a
Register pharmacy that will dispense controlled substances
Note: form 223 is the certificate of registration
224a: renewal of registration
How often must pharmacy renew DEA registration
Every 3 years
No earlier than 60 days prior to expiration
Can renew within 1 calendar month of exp w/o having to submit for new DEA registration
DEA form 224b
Chain renewal form- for corporations with 50+ pharmacies
Controlled substance records required retention period
2 years
Transfer of business notification timeframe: DEA notification
14 days
Name, address, registration #, authorized business activity of each party, and the date of transfer
Inventory upon transfer of CS during transfer of business
Complete ON DAY OF TRANSFER final inventory for out of business and initial inventory for squiring business
No need to send to DEA
Note: accuracy of records is responsibility of transferor and maintenance of record is responsibility of transferee
Notification to DEA upon transfer of business
-14 days in advance
-name/address/registration # of transferor and transferee
-where business to be conducted at same or different address and what that adress is
-dare on which transfer of CS will occur
-note: will need final inventory will be done (keep on file but don’t send to DEA) and 222s or CSOS used to document transfer
Can you still use triplicate 222 order forms!
No! Now there is mandatory use of single sheet 222s
SORS and SUPPORT ACT
Note: Since the SUPPORT ACT, now ALL DEA registrants that distribute CS must report suspicious orders (via SORS)
SORS- suspicious order reporting system
Can you delivery a CS to another country?
-Not without proper authorization:
-would need to be registered with DEA as an exporter
-would need necessary permits or submitted necessary declarations for export
DEA form 107
Theft/loss of listed chemicals (chemicals to make CS)
Authorized collectors of controlled substances
-Manufacturers, distributors, reverse distributors, narcotic tx programs, hospitals/clinics w/ pharmacy, retail pharmacies, or retail/hospital @LTCF can register as authorized collectors
-must modify registration (no fee) to become authorized collector unless retail or hospital/clinic Can PARTNER w/ reverse distributor for mail back program (also no record keeping reqs for this!)
-pts can bring in CS to these collection sites for disposal (only lawful ultimate users, person on behalf of dead person, LTCF on behalf of pt can deposit)
-to cease collection must notify DEA in writing
-for retail and hospital and LTCF collection must take place inside the registered location.
-in retail the receptacle must be in immediate proximity of where CS are stored and where employee is present (can be seen from pharmacy counter)
-in hospital receptacle must be in area regularly monitored by employees and not where emergency care is provided
-at LTCF receptacle where monitored by employees
-in narcotic tx program receptacle locked in room w/ no other CS (only time small opening doesn’t need lock when not supervised)
-can collect CS and non-controls but NOT c1
-no counting/sorting/handling CS after placement in receptacle
-2 employees to change liner
Receptacles at LTFC
-Upon discontinuation disposal of CS is immediately but max 3 business days
-Only authorized retail pharmacy or hospital/clinical w/ on-site pharmacy can manage receptacles at LTCF
-liners managed by either 1 authorized collector employee plus 1 supervised (eg. Charge RN) lvl employee, OR two employees of authorized collector
-after liner removed can only store at LTFC for max 3 business days locked up
CS collection receptacle container reqs?
Liner reqs?
Container:
-securely faster to permanent structure
-locked
-small opening (stuff goes in but not out)
-sign: “only C2-5 and non-CS”
-small opening locked when not supervised (unless narcotic tx program)
Inner liner:
-water proof, tamper evident, tear resistant
-removable/sealable w/o emptying or touching contents
-opaque
-size clearly marked (eg. 10 gal)
-bears unique ID number so it can be tracked
-maintain records for liners including: date acquired and installed, ID#/size of unused liners and installed liners, address and collector registration# installed
at, name/sigs of 2 people installed it, all same info as above but for REMOVED liners, date sealed liners sent to storage or sent for destruction and ID# and names/sigs, for destruction need reverse distributor info
Central fill pharmacy stuff
-retail pharmacy also does central fill activities does not need a separate CS registration
-central and retail have corresponding responsibility to ensure rx is legit
-***retail can FAX CS (including C2) to central fill
Automatic dispensing systems at LTCF (ADS)
-Retail pharmacy can operate and ADS at a LTCF
-must have separate registration
-records of dispenses can be kept at retail location
-dispenses on a single dose basis at time of administration
-Drug is counted as pharmacy stock
Pt own control substance on the pt when brought to hospital
-Lock it up and store as pt belongings and send home with them or member of household……
-MEMBER OF HOUSEHOLD can dispose of in hospital collection receptacle if they have one (True also in DEA manual), or mail back program
-if abandoned **or if no authorized person to take control of CS* contact DEA field division office
Can you continue operating if DEA license is exp but your app has been submitted?
Yes if the renewal app was submitted prior to exp
This is not the same as if it’s expired already and you have 30 days to renew w/o needing new registration, in this case you cannot continue operations
When can PHARMACY be disciplined?
refusal to return or destroying lawful rx, privacy violations, discrimination, intimidating or harassing
