Controlled Substances Act Flashcards
How much medicine can a person have on them if they leave the country?
50 units TOTAL
In the case of significant loss or theft, which form must be filled out?
Form 106 within 1 day
How much time is allowed for a pharmacy to pull records from a central location?
2 days
How often is inventory required by law?
Twice a year
When is inventory mandated?
When something is introduced onto the market as a controlled substance, not when changing schedules.
Form 222 Copy 1
Supplier
Form 222 Copy 2
DEA (sent by supplier)
Form 222 Copy 3
Pharmacy
How do you verify a DEA number?
1: Add 1, 3, and 5
2: Add 2, 5, and 6
3: Multiply step 2 by 2
4: Add Step 1 and Step 2
5. Last digit of Step 4 = Last digit of DEA number
With an emergency C2 prescription, how many days does the prescriber have to get the script to the pharmacy?
7 days
When can you emergency supply a C2 greater than 72 hours and for how long maximum?
If patient terminally ill or in LTCF (documented on script) and for 60 days.
What three hard copy items must be kept in the pharmacy?
Prescriptions, bi-annual inventory records, and Form 222s
If supplier must partial quantity to the pharmacy, how long do they have before the Form 222 is void?
Form 222’s are valid for 60 days
What happens to C2s if a pharmacy closes?
They can be returned to the DEA using a Form 222
How much codeine can you get OTC in some states?
120cc or 48 dosage units within 48 hours
ZERO IN PA
Which classes does the DEA require a prescription for?
C1 and C2. BUT. The FDA requires a prescription for C3-5 except for codeine. BUT some states still require script for codeine.
What’s a form 41?
If you want to get rid of controlled substances (return or destroy) other than C2
What’s a Form 104
Voluntarily giving of controlled substances (closing a pharmacy)
Form 363?
Register as narcotic treatment program
Form 224
Register as new pharmacy, hospital, clinic, teaching institution, or practitioner
Form 225
Register as new manufacturer, wholesaler, distributor, importer/exporter, or researcher
Who is involved in the closed controlled substances closed system?
Manufacturer –> distributor –> Prescriber –> dispenser –> patient –> Manufacturer
Who can write for controlled substances?
Physicians, podiatrists, dentists, vets, NP and PA
Category 1
Manufacturers
Category 2
Distributors
Category 3
Reverse Distributors
Category 4
Dispenser (prescriber/pharmacy)
Category 7
Narcotic Treatment Program
Which is controlled, fioricet or fiorinal?
Fiorinal is schedule III
Explain what you would do in this scenario: Pt presents rx for 60 of percocet. You only have 34.
Give the patient the 34, IF you know that a shipment of the rest will be coming in the next 3 days. You only have 72 hours to fill the remainder and if it doesn’t come in, then they need a new rx
How many refills can each schedule have?
CII: none
CIII-IV: 5 or for 6 months, whichever is fewer
CV: as many as you want (BUT in PA - same as C3 and C4)
What are the places that don’t need a separate DEA registration number for each location?
- Warehouse of a registrant
- Office of a registrant or prescriber
- Freight forwarding facility
How long does someone have to reregister for their DEA number after it expires?
60 days
Bulk manufacturers - 120 days
How long are DEA numbers valid for different entities?
Dispensing/instructing - 3 years
Everyone else - 1 year
How many patients can one practitioner treat in an NTP?
≤30, but after 1 year of telling govt this is what you’re doing, you can ask to treat up to 100 patients
When prescriber applies for X number, how many days does the secretary of HHS have to approve/deny?
45 days and if DEA hears nothing after 45 days, then the practitioner is good to go
How do you get more 222 forms?
Request Form 222a or it’ll automatically be sent 30 days after the last shipment of 7 or 14.
How long do copies of Form 222s need to be kept for inspection?
2 years
In partial filling an rx for a terminally ill patient or in LTCF, how many days do you have to partial fill the rx?
60 days
What is something that Rite Aid realized in the past few months about controlled rx?
Need to have the full address of the patient on the rx
What are 3 things an electronic rx needs to be able to do to transmit controlled substances?
Authentication - 3rd party must be able to verify sender’s identity was properly verified
Nonrepudiation - 3rd party must be able to identify origin of rx
Message integrity - 3rd party must be able to verify that no alteration was made to rx at any point in transmission or after receiving
What are the three options for a 2 factor authentication of a e-rx?
- Something only MD knows (password)
- Something only MD is (fingerprint)
- Hard token (key or badge or whatever)
How much sudafed can a pharmacy sell someone in a day?
3.6g per calendar DAY
How much sudafed can a mobile retailer/mail order sell in 30 days?
7.5g per 30 days
How much sudafed can a retail pharmacy sell someone in 30 days?
9g per 30 days
