Exam 2 Flashcards
1
Q
Why was the Controlled Substances Act enacted?
A
- Created new category of substances and drugs
- Used registration to control the distribution of controlled entities
Overall: reduce the diversion of controlled substances to illicit markets
2
Q
Factors to Determine Scheduling or Removal from Schedules
A
- Its actual or relative potential for abuse
- Scientific evidence of its pharmacologic effect, if known
- The state of current knowledge regarding the drug or other substance
- Its history and current pattern of abuse
- The scope, duration, and significance of abuse
- What, if any, risk there is to public health
- Its psychic or physiological dependence liability
- Whether the substance is an immediate precursor of a substance already controlled under this subchapter
3
Q
What can the Factors to Determine Scheduling or Removal from Schedules lead to
A
- Becomes scheduled when it was previously not
- Changes to a different schedule than it was previously in
- Is removed from the schedules entirely
- Remains in its current position (controlled/uncontrolled)
4
Q
Schedule I: Medical Use?
A
No
5
Q
Schedule I: Abuse Potential?
A
High
6
Q
Schedule I: Physiological Dependency?
A
Not defined
7
Q
Schedule I: Physical Dependency?
A
Not defined
8
Q
Schedule II: Medical Use?
A
Yes
9
Q
Schedule II: Abuse Potential?
A
High
10
Q
Schedule II: Psychological Dependency?
A
Severe
11
Q
Schedule II: Physical Dependency?
A
Severe
12
Q
Schedule III: Medical Use?
A
Yes
13
Q
Schedule III: Abuse Potential?
A
Lower than I or II
14
Q
Schedule II: Psychological Dependency?
A
High
15
Q
Schedule III: Physical Dependency?
A
Moderate to low
16
Q
Schedule IV: Medical Use?
A
Yes
17
Q
Schedule IV: Abuse Potential?
A
Lower than III
18
Q
Schedule IV: Psychological Dependency?
A
Limited
19
Q
Schedule IV: Physical Dependency?
A
Limited
20
Q
Schedule V: Medical Use?
A
Yes
21
Q
Schedule V: Abuse Potential?
A
Lower than IV
22
Q
Schedule V: Psychological Dependency?
A
Limited
23
Q
Schedule V: Physical Dependency?
A
Limited
24
Q
Schedule I examples
A
MDMA
marijuana
heroin
mescaline
25
Schedule II examples
```
Adderall
Cocaine
Fentanyl
Methadone
methamphetamine
Pentobarbital
```
26
Schedule III examples
anabolic steroids
buprenorphine
ketamine
27
schedule IV examples
```
alprazolam
chlordiazepoxide
phenobarbital
phentermine
tramadol
```
28
schedule V examples
lomotil
pregabalin
vimpat
robitussin
29
who determines the minimum schedule for a substance
federal government, but states may place them in a higher schedule
30
manufacturer labeling of controlled substances
- manufacturers must place a symbol indicating what schedule a controlled substance is in as a part of the drug's labeling.
- The symbol must be located on the label of the commercial container
- symbol or notation must be large enough to easily identify the product's schedule while on a pharmacy or warehouse shelf
31
which agency is tasked with enforcing controlled substance laws and regulations of the US
DEA
32
who fills out DEA form 224
- retail pharmacy
- hospital/clinic practitioner
- teaching institution
- mid level practitioner
33
who fills out DEA Form 225
- manufacturer
- distributor
- researcher
- analytical laboratory
- importer
- exporter
34
who fills out DEA form 363
narcotic treatment programs
35
who fills out DEA form 510
domestic chemical
36
registration renewal timing
In most cases, registrations must be renewed every years, however, the dispensing or instructing registration type if valid for 3 years
37
manufacturing coincident activities allowed
I-V: may distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered
II-V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfr. was issued
38
distributing coincident activities allowed
may acquire schedules II-V controlled substances from collectors for the purposes of destruction
39
Dispensing or instruction coincident activities allowed
May conduct research and instructional activities with those substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form 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.
40
research coincident activities allowed
```
A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in §1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or
registered or authorized to conduct chemical analysis with controlled substances.
```
May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempted from registration pursuant to §1301.24; and conduct instructional activities with controlled substances.
41
importing coincident activities allowed
may distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered
42
chemical analysis activities allowed
May manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to §1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct
instructional activities with controlled substances.
43
First big four practitioner DEA beginning letter
A,B,F or G
44
Mid-level practitioner DEA beginning letter
M
45
What is the second letter for DEA registration
first initial of the prescriber's last name or the last name they first applied for registration
46
How to verify the DEA number
1. Add the 1 , 3 , and 5 digits together,
ndth th
2. Add the 2 , 4 , and 6 digits together and multiply by 2,
3. Add the result from step 1 and step 2,
4. Determine if the right-most digit from step 3 matches the DEA number’s final digit (the
check digit).
47
Do pharmacists need a DEA number?
No, because registration requirements are waived for an agent or employee of a person registered to engage in a particular activity
48
Do common or contract carriers require a DEA
No since these companies usually don't know what's in a package they are carrying
49
Individual practitioners may dispense, administer, or prescribe controlled substances under an institutional DEA number as long as:
1. It is done in the usual course of their professional practice
2. They are permitted to administer, dispense, or prescribe by the jurisdiction in which they're practicing
3. The institution they're working for has verified they are permitted to dispense, administer, or prescribe drugs within the jurisdiction they're working
4. The practitioner is acting only within the scope of their employment in the institution
5. The institution authorizes the practitioner to administer, dispense, or prescribe under the hospital DEA number and uses a specific internal code to the DEA number for each practitioner authorized
6. The institution keeps a current list of internal codes and the practitioners they match for verification purposes
50
How to secure controlled substances in schedules II through V
dispense such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances
51
Do CIIs have to be locked up based on federal law
no
52
How to secure controlled substances during schedule I
stored in a securely locked, substantially constructed cabinet
53
How do practitioners store controlled substances
locked cabinet
54
what drugs do practitioners store in a safe or steel cabinet equivalent to a US Government Class V security container
thiafentanil
carfentanil
etorphine hcl
diprenorphine
55
Employee screening rule
Registrant is now allowed to employ anyone who has been convicted of a felony relating to controlled substances or who has had an application for registration with the DEA denied, registration, revoked, or has surrendered their DEA registration for cause
56
How long should records and inventories of controlled substances per federal law
kept for at least 2 years from the record or inventory date
57
What records and inventories of controlled substances need to be kept
a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of
58
what must be kept in a registered location and not in a central locations
DEA form 222
Inventories
Prescriptions
59
What must schedules III, IV, and V invoices contain
Date
| Labeled as controlled
60
What is the form to order schedule I or II drugs
DEA form 222
61
Who should order and execute DEA form 222
the individual who signed the most recent registration paperwork
If unavailable, POA
62
How many years do DEA 222s need to be kept?
2 years; however, state laws and insurance contracts may require forms to be kept for longer
