Controlled Substances: Registration

slides 1-18

which three entities are required to register w the DEA?

manufacturers

distributors

dispensers

the people who make drugs are called…

a. distributors

b. manufacturers

c. dispensers

b

wholesalers are deemed…

a. manufacturers

b. dispensers

c. distributors

c

pharmacies are considered…

a. manufacturers

b. dispensers

c. distributors

b

why are pharmacies considered dispensers by the DEA and not the individual pharmacists?

because the license/ registration is tied to the business/ location not the individual pharmacist

can a pharmacy be a manufacturer?

yes if they compound drugs in bulk or for resale

Which DEA form is required to register as a new pharmacy that can dispense controls?

224

form 224 is for ____ and is most used by _____

pharmacies

pharmacists

form 224 can also be used for…

practitioners

mid levels

hospital

teaching institution`

Form 225 is used by…

manufactuers, distributors, and or researchers

Form 225 could include pharmacists but…

they are not in a dispensing role

Form 225 could include a pharmacist that is NOT in a dispensing role, what does that mean?

they would be working in the industry, in research, or in drug distribution (they are not going to be dispensing)

form 363: purpose

separate DEA form needed for pharmacies/clinics that want to dispense FDA approved sched II controls for maint and detox treatment

classifies the business as a Narcotic Treatment program

DEA registration certificate includes…

DEA registration number

expiration date

business activity

drug schedules authorized

registered address

“not transferable”

DEA form 224 expires…

3 years after the last renewal on the last day of the month

the DEA mails a notification about expiring license ___ days before expiration date

60

the DEA emails a notification about expiring license ___ days before expiration date

20

how is renewal done for DEA form 224?

online baybee

who can sign the renewal form for DEA form 224?

registrant, designated person, someone with power of attorney

chain stores are defined by having ____ stores

more than 50

chain stores are requested to use the _____ when renewing lisences

chain renewal program

how should a business go about changing their address if they house controls?

they must get the new addy approved by DEA before the move

after DEA approval of move, a company is issued a new ____

DEA license

after the DEA approves the move and the company changes addresses, what must be kept until a completed renewal cycle?

the old and new DEA licenses

after the DEA approves the move and the company changes addresses, how long do the old and new DEA licenses have to be kept?

until a renewal cycle is complete

termination of registration requires that the companies return ____ and ____ to the DEA

DEA license and any 222 forms

if a pharmacy is sold or the ownership is changes, the registrant must notify the DEA at least ____ inadvance

14 days

if a pharmacy is sold or the ownership is changes, the registrant must notify the DEA, via…

registered or certified mail to the special agent in charge

if a pharmacy is sold or the ownership is changes, the registrant must notify the DEA. What must be included in this notification?

from both parties: the name, address, registration number and authorized business activity

if the business will change addresses

date the C-2s are transfered

DEA 222 form for each C2 medication transfered

the DEA can deny, suspend, or revoke registration from the license holder if they…

lied on the application

convicted of a felony involving a control

committed an act against public interest

is excluded from federal programs (medicaid or medicare)

when determining if the license holder is working in favor of the general public interest, what factors are considered?

recommendation from teh state licensing agency

experience with handling controls

conviction record

compliance with control laws

any other conduct that may threaten public health and safety

Chain pharmacies are exempt from renewing individual licenses if they have at least ____ stores

50

chain pharmacies with at least 50 stores, can do DEA form 224b, which allows for…

the chain to send a list of the renewed pharmacies to the DEA

the fee to be paid all at once

which form can chain pharmacies fill out so that the individual stores do not need to renew their licenses one by one?

DEA form 224b

who does not need to register with the DEA for handling controls?

warehouses

practitioner office that does not store controls

common delivery businesses like fedex

slide 16 idk how to put that in here

slide 16

which ppl are exempt from getting a DEA #/ registration

Military providers

Public Health Service Providers

Bureau of Prison Practitioners

Physicians in training

Law enforcement

Patient

why do federal government ppl not need DEA numbers?

bc they use service ID and branch/ agency name

why do physicians in training not need DEA #?

bc they use the hospital DEA number with added numbers at the end

regulated sellers of schedules listed chemical products do not need a DEA registration but they have to ______ for that exemption

self certify with the DEA

regulated sellers of schedules listed chemical products have to self certify with the DEA, what does that include?

training employees

notification to the DEA that they are compliant

pharmacies that sell bulk quantities must registered as a distributor, what form should be used for this?

form 225