E2 Lecture 2 Flashcards
10 Types of Registration
Manufacturing
Distributing
Reverse Distributing
Dispensing & Instructing –> pharmacy
Research (Schedule I)
Research (Schedule II-V)
Narcotic Treatment Program including compounder
Importing
Exporting
Chemical Analysis
DEA Form 224
retail pharmacy
hospital/clinic
practitioner
mid-level practitioner
teaching institution
DEA Form 225
manufacturer
distributor
researcher
analytical laboratory
importer
exporter
DEA Form 363
narcotic treatment programs
DEA Form 510
domestic chemical
How often are most registrations renewed?
annually
How often are dispensing & instructing registrations renewed?
every 3 years
What is a narcotic?
opioid or opioid containing
or
cocaine
Typical Registration for Pharmacy includes which drug classes?
2
2N
3
3N
4
5
A pharmacy can distribute up to 5% of the total amount of controlled substances dispensed, but after that, they must obtain a separate registration for distribution
A pharmacy can distribute up to 5% of the total amount of controlled substances dispensed, but after that, they must obtain a separate registration for distribution
Which two registrations do not allow coincident activities?
Reverse Distributing
Exporting
Coincident Activities for Dispensing & Instructing
May conduct research and instructional activities with substances for which registration was granted (mid-level practitioners may only conduct research to the extent authorized in state)
pharmacist may manufacture a product containing a NARCOTIC controlled substance in schedule II-V in proportion not exceeding 20% of the complete solution
pharmacy may distribute controlled substance to another practitioner for the purpose of general dispensing so long as distribution does not exceed 5% of total dosage units within same year
retail pharmacy may perform central fill pharmacy activities
DEA Number
AB1234567
9 characters (two letters + 7 numbers)
A, B, F, G
Big 4 Prescribers & Pharmacy
M
Mid-level practitioner
P, R
Distributor
How to check legitimacy of DEA number?
- Add the 1st, 3rd, and 5th digits together
- Add the 2nd, 4th, and 6th digits together & multiple by 2
- Add results from the steps above
- Determine if right most digit matches DEA final digit
DEA Registration Exemptions
- Agent or employee of a person who is registered to engage in a particular activity is not required to obtain an INDIVIDUAL registration
- pharmacist, nurse, institutional pharmacy - Common or contract carriers and warehouseman, who possess a controlled substance in the usual course of business
- UPS, FedEx, USPS - Ultimate user who possesses a controlled substance lawfully
- patient or caregiver
Institutional DEA Number Usage
- activity is done in the usual course of the individuals professional practice
- jurisdiction in which the individual is practicing allows the action
- institution has verified the individual may perform the action in the jurisdiction in which they are practicing
- the practitioner acts only within the scope of their employement
- institution applies a specific internal code to the DEA number for each practitioner authorized to practice
- institution keeps a current list of internal codes for verification purposes