Reading 8, 9, 10 - Controlled Substances Flashcards
C-I definition
NO MEDICAL USE
High abuse potential
Psych and Physical dependence not defined
C-II Definition
High abuse potential
Severe psych and physical dependence
C-III definition
High psych dependence
moderate to low physical dependence
C-IV definition
Limited pysch and physical dependence
Maxium doses in 48 hours if C-V product contains opium
240 mL or 48 doses units
Maxium doses of C-V OTC products that are not opium
120 mL and 24 dosage units
Max amount of Sudafed someone can buy in a day?
3.6 grams
How can an OTC product controlled substance be sold legally?
ONLY by a pharmacist to a patient 18 years or older who shows their ID
—- must record name and address of purchaser, name and quantity, date, initials of pharmacist
The activities that do NOT have coincidence actitivities:
Reverse distributing
Narcotic treatment program
Exporting
What form should manufacturers fill out in order to manufacture controlled substances?
DEA Form 225
What form should narcotic treatment program fill out in order to manufacture controlled substances?
DEA From 363
What form should hospitals fill out in order to contain control substances?
DEA Form 224
What form should domestic chemical fill out in order to make controls?
DEA Form 510
What form should importers fill out in order to import controlled substances?
DEA Form 225
What form do you have to fill out in order to do research with controlled substances?
DEA Form 225
What is DEA registration based on?
Schedules of drugs handled
Activities engaged in
What DEA registration activities do practitioners and pharmacists need to apply under?
Dispenser
A DEA number starting with R indicates?
A distributor
What are the 3 exceptions to people obtaining DEA numbers to handle controlled substances?
- Pharmacists and Practitioners using their institutions DEA
- UPS and FedEx
- Patient or Law enforcement
If a practitioner is using the hospital DEA number as a surgeon, can she/he prescribe Norco after a hip replacement of their daughter?
NO, no prescribing to family or friends under DEA hospital number
If a OBGYN physician treats a patient for cervical pain, then tweaks their ADHD medications to give Adderall. Is this okay under hospital DEA number?
NO, needs to be under the course of their professional practice
If a practitioner hold controlled substances in their office, how must it be stored?
IN A LOCKED CABINET
What type of controlled substances HAVE to be locked away?
C-1
An employee application came in and they were convicted with a misdemeanor pertaining to controlled substances. Can you hire them without filling out a waiver?
Yes
How long should records of controlled substance inventory be kept>
2 years
What does a 2 file system look like?
C-II file
Everything else file (other schedules within non-controlled marked with red c in lower RIGHT corner)
What can you NOT store in a central recordkeeping place for controlled substances?
Executed DEA forms
Inventories
Prescriptions
How long must you wait for denial of a central recordkeeping from the DEA before assuming you are approved?
14 days
How do you order C-III medications?
Just like non-controlled substances
How do you order C-II medications?
DEA Form 222
Electronic Order form on CSOS
What information should be on a DEA 222 form?
Drug name
Strength
Package size
number of packages
may include NDC
supplier’s name and address
Sign and date by Registrant (plus POA if needed)
What is the ONLY way a purchaser can edit a DEA form?
By calling the manufacturer and canceling an item
What do manufactuers add to the DEA form once they receive it?
DEA number
NDC for each drug
Number of containers sent
the date
How long does a manufacturer have to fill a partial C-II order fill?
60 days from the order date
What is the major different between DEA Written Form 222 and Electronic order forms when it comes to manufacturers not able to fill the order?
With electronic order forms the manufacturers CANNOT endorse the order to another supplier
How often should a pharmacy update its controlled substance inventory?
Every two years (Biennial)
