Exam 2 lecture 10 Flashcards
DEA registration
CSA established a closed system for distribution of controls
- If a person is engaged in certain activities involving controls, they must obtain a DEA registration
- Person, as used in legal prose, includes individuals, but also institutions, corporations, and similar groups
- There are 10 types of DEA federal regulations
DEA registration types
manufacturing
distributing
reverse distributing - take product and destroying
dispensing or instructing (primary registration used by practitioners, pharmacies, hospitals, teaching institutions)
research (C-1)
Research (C-2 through C-5)
Narcotic treatment program
importing
exporting
chemical analysis
Obtaining DEA registration
Must first obtain a registration:
A separate registration is required for each place of business/practice location where controlled substances are held
Forms required for DEA: DEA Form 224 and 225
Most registrations are renewed annually, but the dispensing or instructing registration is valid for 3 YEARS
DEA Form 224
application for dispensing or instructing registration
DEA Form 225
application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer, or exporter registration
What is a narcotic?
Opiate containing/derived drugs
Cocaine
DEA registration schedules labeling
Schedule 1 (1)
Schedule 2 narcotic (2)
Schedule 2 non-narcotic (2N)
Schedule 3 narcotic (3)
Schedule 3 non-narcotic (3N)
Schedule 4 (4)
Schedule 5 (5)
DEA registration schedules
A typical pharmacy would be registered for drug schedules: 2, 2N, 3, 3N, 4, and 5
A dispensing/instructing registration is limited to schedules 2-4
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
DEA registrant coincident activities
Coincident activities are:
extra activities that a DEA registrant may engage in without obtaining a different registration
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
No Coincident Activities Allowed
the following registration types do not permit coincident activities:
reverse distributing
exporting
Dispensing or Instructing Registration Coincident Activities
may perform the following activities:
- May conduct research and instructional activities with substances for which registration was granted (mid-level practitioners may only conduct research to 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
DEA Registration Numbers
All DEA numbers are structured the same way:
9 characters
2 letters
7 numbers
DEA Registration Number Legitimacy
Not written in law, but it is important for all pharmacy practitioners to be able to very a DEA number’s legitimacy
DEA number – Letters
First letter:
Dispensing/intstructing registration types have DEA numbers that start with A, B, F, G
Mid-level practitioners have DEA numbers that start with M
Big four prescribers start with A, B, G, F
Second letter:
Represents registrants last name, or the name of the business that initially registered.
Names can change, so this will not always match the prescriber or company name
DEA numbers – Numbers
- add 1st, 3rd, and 5th digits together
- add 2nd, 4th, and 6th digits and multiply that sum by 2
- add steps 1 and 2
- determine if right most digit from step 3 matches the DEA final digit
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 (pharmacist, nurse, institutional pharmacy)
Common or contract carriers and warehousemen, who possess a controlled substance in the usual course of business are exempt (FedEx, USPS, Marken)
Ultimate user who possesses a controlled substance is lawfully exempt (patient/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
Institutional DEA number usage requirements
- 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 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
CSA states “Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances”
Registrants puts safety measures and the DEA determines if they are appropriate:
- Activities conducted
- Type and form of controlled substances handled
- Quantity of controlled substances handled
- Storage system of controlled substances
C2 - C5 storage
Controlled substances shall be stored in a securely locked, substantially constructed cabinet.
Pharmacies and institutional practitioners can disperse substances throughout a stock of non-controlled substances in such a manner to obstruct theft or diversion of controls
Other control storage
C1 drugs must be stored in a securely locked, substantially constructed cabinet
A practitioner storing controls in their office or clinic must store them in a locked cabinet
What controls are stored in a safe or steel cabinet equivalent to US Government Class 5 security container?
thifentianil
carentanil
etorphine
hydrochloride
diprenorphine
