Lecture 10 - DEA Registration and Controlled Substance Storage Flashcards
What is a closed system for the distribution of controlled substances?
-A person must obtain a DEA registration if they want to engage in certain activities involving controlled substances
-Person, as used in legal prose, includes individuals but also institutions, corporations, and similar groups
-There are ten types of DEA federal registrations
What is the main DEA registration type?
Dispensing or instructing (primary registration used by practitioners, pharmacies, hospitals, teaching institutions)
What is a DEA form 224?
Application for dispensing or instructing registration
What is a DEA form 225?
Application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
How long is a dispensing or instructing registration valid?
3 years
What does an N after a schedule number indicate in DEA registration scheduling?
It means it is non-narcotic
What drug schedules would a typical pharmacy be registered for?
-2, 2N, 3, 3N, 4 and 5
-A dispensing or instructing registration is limited to schedules 2-5
-A person may only handle products for which they are registered. If you do not check the box, you cannot perform any business related to that schedule
What are coincident activities?
-Extra activities that a DEA registrant may engage in without obtaining a different registration
-Coincident activities are often required to allow the registrant to complete their primary registered function
-There are often limitations on coincident activities. If these limits are exceeded, a new registration is required
Which registration types do not permit coincident activities?
-Reverse distributing
-Exporting
What coincident activities may dispensing or instructing registrants perform?
-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 statute)
-A pharmacist may manufacture a product containing a narcotic controlled substance in schedule 2-4 in a proportion not exceeding 20% of the complete solution, compound or mixture
-A retail pharmacy may perform central fill pharmacy activities
What does the first letter represent in a DEA number?
Represents the type of registrant
What letter does a dispensing or instructing registration have in their DEA number?
A, B, F, or G
What letter does a mid-level practitioner have in their DEA number?
M
What does the second letter represent in a DEA number?
The registrants last name or the name of the business that initially registered
How is the last number of a DEA number decided?
-Add the first, third and fifth digits together
-Add the second, fourth, and sixth digits together and multiply that sum by 2
-Add the result from steps 1 and 2
-Determine if the right-most digit from step 3 matches the DEA numbers final digit
What are some exemptions of DEA registrations?
-An agent or employee of a person who is registered to engage in a particular activity is not required to obtain an individual registration
-Common or contract carriers and warehousemen who possess a controlled substance in the usual course of business are exempt
-The patient who possesses a controlled substance lawfully is exempt
What prescribers utilize a DEA number from an institution instead of their own DEA number?
Individual practitioners who are agents or employees of a hospital/health system and do not have their own DEA number
What requirements must a practitioner meet to utilize an institutional DEA number?
-The activity is done in the usual course of the individuals professional practice
-The jurisdiction in which the individual is practicing allows the action
-The jurisdiction 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 employment
-The institution applies a specific internal code to the DEA number for each practitioner authorized to practice
-The institution keeps a current list of internal codes for verification purposes
How does the DEA determine if certain safety measures are appropriate for guarding against theft and diversion?
-Activities conducted
-Type and form of controlled substances handled
-Quantity of controlled substances handled
-Storage system of controlled substances
