Pharm Law Exam 2 Lecture 2 Flashcards
Who needs to obtain DEA registration? How many types of DEA federal registration are there?
If a person engaged in certain activities involving controlled substances, they must obtain a DEA registration.
Person could be individual or institution/corporation.
There are 10 types of DEA federal registrations
Name a DEA registration type that we need to know for exam
Dispensing or instructing (used by practitioners, pharmacies, hospitals, teaching institutions)
What is required if there are multiple locations that hold controlled substances for a single corporation
A separate regsitration is required for each place of business/practice location where controlled substances are held.
What is the DEA form 224 used for
Application for dispensing or instructing registration
What is DEA form 225 used for
Application for manufacturer, distributor, reverse distributor, researcher, analytical laboratory, importer or exporter registration
How long are DEA registrations valid for before renewal? What is an exception
Most registrations are renewed annually, but the dispensing or instructing registration s valid for 3 yrs.
What two scheduled drugs have narcotic and non narcotic vairances?
Schedule II and Schedule III
Schedule II narcotic (2)
Schedule II Non narcotic (2N)
Schedule III narcotic (3)
Schedule III Non narotic (3N)
What is considered a narcotic?
Something derived from either opiate or cocaine
WHat drug schedules would a typical pharmacy be registered for?
2, 2N, 3, 3N, 4 and 5
What is a dispensing or instructing registration limited to?
schedules II-V
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
They are extra activities that a DEA registrant may engage in without obtaining a different registration
What registration types do not permit coincident activities
Reverse distributing
NArcotic treatment program (including compounder)
Exporting
When are coincident activities permitted?
Dispensing or instructing registration
What are the coincident activities that dispensing or registrants may 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 II-V in a proportion not exceeding 20% of the complete solution, compound or mixture
-A retail pharmacy may perform central fill pharmacy activities
Out of the following DEA registrants, all are allowed to perform some type of coincident activities EXCEPT
Distributing
Chemical analysis
Importing
Exporting
Exporting
What are DEA numbers structured as
9 characters
Two letters
Seven numbers
How do we check DEA numbers potential legitimacy? Do we legally have to do it?
Not expressly written in law, but is still important
Check CSA validation tool to confrim
What does the 1st letter of the DEA number represent? What are they for different providers
1st letter represents type of registrant
- dispensing or instructing registration types have DEA numbers that start with A, B, F or G (Big 4 [prescribers)
- Mid level practitioners have DEA numbers with M
What does the 2nd letter represent in DEA number
The registrants last name or the name of the business that initially registered (names change so it will not always match the prescriber or company name
How are the DEA numbers numbers sequenced?
Add 1st, 3rd and 5th digit together and put it to the side
Add 2nd, 4th and 6th digit together and multiply by two
Add the result of step 1 and 2. The seventh digit of the DEA number should match the last digit of the calculation
WHat are some notable expemtions to DE registrations
An agent or employee of a person who is registered to engage in a particular activity os not required to obtain an individual registration (pharmacist, nurse, institutional pharmacy)
Common contact carriers and warehouse men who possess a controlled substance (UPS, FedEx)
The user of the controlled substance (patient/ caregiver)
To utilize an institutional DEA number, the practitioner must meet which 6 criteria
- activity is done in usual course of 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 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
What does the CSA (controlled substance act) state about controlled substance security
Registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances
What are 4 things the DEA takes into account regarding controlled substance security
-Activities conducted
- Type and form of controlled substance handled
- Quantity of controlled substance handled
- Storage system of controlled substance
