EXAM 2 Federal Controlled Substance Law Pt2 Flashcards
What has the manufacturer of a scheduled drug have to put on the label?
C symbol with the schedule number
C-II, C-III, C-IV, C-V
How does the Controlled Substance Act mainly try to prevent the diversion of scheduled drugs?
Registration of anyone who is involved in moving these drugs-> closed system
-so they either have a DEA number or a prescription
What does anyone who possesses a scheduled drug has to be?
-A registrant
-a patient with a valid prescription or exempt from registration
Who are included in individuals who are exempt from being a registrant or a prescription holder for a controlled substance?
-pharmacists (the pharmacy is registered)
-truck drivers
-plant employees
-others in the manufacturing /distribution line
What are the 10 types of federal registration?
- Manufacturing (C-I to C-V)
- Distribution (C-I to C-V)
-> distributer may need registration for reverse distribution in case they receive drugs that are sent back - Reverse distribution (C-I to C-V) – accepting drugs for destruction
- Dispensing or instructing – pharmacies and physicians, others
- Research (C-I)
- Research (C-II to C-V)
- Narcotic Treatment Programs (C-II to C-V), like methadone clinics
- Importing (C-I to C-V)
- Exporting (C-I to C-V)
- Chemical Analysis (C-I to C-V) - Research
What do the first two letters in the DEA number mean?
the first letter denotes the level of practitioner
-A, B, C = practitioner (hospital, pharmacies)
-M = mid-level practitioner (authorized nurses, physician assistant)
second letter denotes the first letter of practitioner’s last name or the first letter of the company name
(the letter may not match up since people get married or companies get bought up)
Digits in the DEA number
AH 342554__
3 + 2 + 5 = 10
(4 + 5 + 4) * 2 = 26
10 + 26 = 36 –> take 6 as the last digit
-> AH 3425546
Who is considered a practitioner according to 21 USC § 802?
US Code
-physician
-dentist
-veterinarian
-scientific investigator
-pharmacy (not a pharmacist)
-hospital
-or other person licensed, registered, or otherwise permitted by the US to practice or do research with controlled substances
the definitions may vary - the ones on the Code of Federal Regulations matter the most bc that’s where the DEA has control
Who is considered a Dispenser according to the US Code 21 USC § 802?
US Code -> Federal
A practitioner (pharmacy) who delivers a controlled substance to an ultimate user or a research subject
Who is considered a Dispenser according to the Code of Federal Regulations, 21 CFR 1300.01?
-individual practitioner
-institutional practitioner
-pharmacy or pharmacist who dispenses a controlled substance
Where in the law is a pharmacist actually defined as someone who can dispense controlled substances?
in the Code of Regulations
21 CFR 1300.01
What is the period in which a dispenser must re-register with the DEA?
every 3 years
A dispenser is allowed to distribute controlled substances without being registered as a distributor. T/F?
True.
can do some limited distribution without
being registered as a distributor
the main focus of a dispenser: is delivering controlled substances to ultimate users
What does the term distributor mean?
means a person who so delivers a controlled substance or a listed (other than administering or dispensing)
When is a dispenser allowed to distribute controlled substances?
-distribution to another registered practitioner
-it must be recorded
-C-I or C-II requires DEA “order form”
-the total number of dosage units of all controlled
substances distributed do not exceed 5%
