Exam 2 Flashcards
What was the purpose of the Comprehensive Drug Abuse Control and Prevention Act (Controlled Substances Act (CSA))?
- control and enforcement of controlled substances
- importation and exportation of vontrolled substances
- established a “closed” system for manufacturing, distributing, and dispensing of controlled substances
What federal agency is respondsible for enforcing controlled substance laws and regulations?
Drug Enforcement Administration (DEA)
Define: Narcotic
opium, opium derivative, opioid
Schedule II substances abuse may lead to ______ psychological and ________ physical dependance.
severe, severe
Schedule III substances abuse may lead to ______ psychological and ________ physical dependance.
high, moderate-low
If a manufacture does not include the controlled substance label, the packaging is ________.
misbranded
What drugs must be behind the counter or in locked cabinets?
scheduled listed chemical products (SLCPS)
What drugs are schedule listed chemical products (SLCPS)?
- phenylephrine
- ephrine
- phenylproponolamine
Who must register with the DEA?
any entity that handles controlled substances
What is the DEA form filed by pharmacies that dispense controlled substances?
DEA Form 224
How often do DEA registrations for pharmacies that dispense controlled substances renew their registration?
3 years
What are the types of DEA registration?
- manufacturing
- distributing
- reverse distributing
- dispensing or instructing
- research (I)
- research (II-V)
- narcotic treatment program
- importing
- exporting
- chemical analysis
Who needs a dispensing registration through the DEA?
- practitioners
- hospitals/clinic
- retail pharmacies
- central fill pharmacies
- teaching institutions
What is the DEA renewal form for pharmacies?
224a or 224b (chain pharmacies with 50 or more registrations)
Who is exempt from DEA registration?
- agents or employees of a person registered (pharmacists)
- common or contact carrier, warehouse workers, or employees
- users (patients)
- some armed service members, Public Health Service, Bureua of Prisons, other law enforcement officers
What is included in a valid DEA number?
- starts with A, B, F, or M if mid-level practioner
- 2 letter is first letter of last name
- add number 1, 3, 5
- add 2, 4, 6 and multiply by 2
- add together
- tenth place of math matches final digit od DEA number
What form is filed to order schedule II substances?
DEA form 222
paper forms (books of 7 or 14) or electronic system
What is the use of DEA form 222?
all pharmacy non-prescription transfers nof C-II medications
How long must DEA form 22 be kept on file?
2 years
How often should inventory for controlled substances be taken in pharmacies?
initially, then every 2 years (biennial), and with newly controlled substances
What information on controlled substances must be recorded?
- name of drug
- dosage form
- strength
- number of loose units (record as numbers)
- number of full containers
Which schedule drugs require exact counts?
- C-II
- C-III - C-V if the original container contained more than 1000 units
What records are required to be kept in reguards to controlled substances?
- controlled substances dispensed
- reports of theft or significant loss (DEA form 106)
- controlled substances destroyed (DEA form 41)
- DEA registration certification
- logbook for pseudoephedrine products
- executed DEA 222 forms
- reciepts or invoices for CIII-V
- power of attorney authorization to sign forms
- inventory records
- control substances distributed
Explain how control substance records must be kept:
C-II must be kept separately and C-III-C-V must be kept in such a way that information if readily retrievable (2-file or 3-file) red C if paper or electronic