DEA registration and controlled substance storage - lecture 2 Flashcards
DEA Registration
The Controlled Substance Act (CSA) established a closed system for the distribution of controlled substances.
This means if a person is engaged in certain activities involving controlled substances, they must obtain a DEA registration
Person, as used in legal prose, includes individuals, but also institutions, corporations, and similar groups
There are ten types of DEA federal registrations
Ten DEA Registration Types
Manufacturing
Distributing
Reverse distributing
***Dispensing or instructing (primary registration used by practitioners, pharmacies, hospitals, teaching institutions)
Research (C-I)
Research (C-II through C-V)
Narcotic treatment program (including compounder)
Importing
Exporting
Chemical analysis
Obtaining DEA Registration
Before engaging in an activity requiring registration, you must first obtain a registration:
- A separate registration is required for each place of business/practice location where controlled substances are held
There are different forms for everything in the DEA.
-DEA Form 224: application for dispensing or instructing registration (renewed every 3 years)
-DEA Form 225: application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration (Renewed annually)
Most registrations are renewed annually, but the dispensing or instructing registration is valid for 3 years
DEA Registration Schedules
Schedule I (1)
Schedule II narcotic (2)
Schedule II non-narcotic (2N)
Schedule III narcotic (3)
Schedule III non-narcotic (3N)
Schedule IV (4)
Schedule V (5)
DEA Registration Schedules
A person may only handle products for which they are registered. If you don’t check the box, you cannot perform any business related to that schedule!
A typical pharmacy would be registered for drug schedules 2, 2N, 3, 3N, 4 and 5
A dispensing or instructing registration is limited to schedules II-V
DEA Registrant Coincident Activities
Coincident activities are 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 (manufacturer has to distribute to warehouses or pharmacies)
There are often limitations on coincident activities. If these limits are exceeded, a new registration is required.
No Coincident Activities Allowed
Reverse Distributing
Exporting
Dispensing or Instructing Registration Coincident Activities
Essencially can do research, instructional activities, manufacturing, central fill ativities, and distributing as long as less than 5% of total dosage units distributed in that year
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 II-V in a proportion not exceeding 20% of the complete solution, compound or mixture
A retail pharmacy may perform central fill pharmacy activities
A pharmacy may distribute a controlled substance to another practitioner for the purpose of general dispensing, so long as that distribution does not exceed 5% of the total dosage units distributed and dispensed within the same year
DEA number
are utilized on all documentation required by the DEA.
All DEA Numbers are structured the same way:
Nine characters total
Two letters - First letter will corrospond with practice of provider (A,B,G, or F if provider is big 4) and (M if provider is midlevel) Second letter is usually first letter of providers last name or institution name (NOT ALWAYS
Seven numbers
AB1234563
DEA legitimacy check
This does not 100% tell us if the prescription is fraudulent (as people trying to make fact scripts might now this trick) but if the numbers dont add up it tells us 100% script is fake
Add up 1,3,4 number
Add up 2,4,6 number then x2
add the 2 equations above and the number should be the same as the last number in DEA code (if its double digets should be last number of double diget sum - if you get 42 the last number of DEA should be 2)
can use the CSA registration validation tool to check for fraudulent DEA numbers
DEA Registration Exemptions
An agent or employee of a person who is registered to engage in a particular activity is not required to obtain an individual registration
e.g. pharmacist, nurse, institutional pharmacy
Common or contract carriers and warehousemen, who possess a controlled substance in the usual course of business, are exempt
e.g. FedEx, USPS, Marken
The ultimate user who possesses a controlled substance lawfully is exempt
e.g. patient or caregiver
Institutional DEA Number Usage
This is reserved for individual practitioners who are agents or employees of a hospital/health system and do not have their own DEA number
To utilize an institutional DEA number, the practitioner must meet the following requirements:
The activity is done in the usual course of the individual’s professional practice
The jurisdiction in which the individual is practicing allows the action
The 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 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
Controlled Substance Security
The
Controlled Substance Act (CSA) states “Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.”
The registrant puts safety measures in place, and the DEA determines whether they are appropriate. The DEA considers:
-Activities conducted
-Type and form of controlled substances handled
-Quantity of controlled substances handled
-Storage system of controlled substances
C-II through C-V Storage
There is specific language surrounding the storage of controlled substances for practitioners:
“Controlled substances shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners can disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.”
Other CS Storage
C-I drugs must “be stored in a securely locked, substantially constructed cabinet”
A practitioner storing controlled substances in their office or clinic must store them in a locked cabinet
