Controlled Substances Act

Question 1

How much medicine can a person have on them if they leave the country?

Answer 1

50 units TOTAL

Question 2

In the case of significant loss or theft, which form must be filled out?

Answer 2

Form 106 within 1 day

Question 3

How much time is allowed for a pharmacy to pull records from a central location?

Answer 3

2 days

Question 4

How often is inventory required by law?

Answer 4

Twice a year

Question 5

When is inventory mandated?

Answer 5

When something is introduced onto the market as a controlled substance, not when changing schedules.

Question 6

Form 222 Copy 1

Answer 6

Supplier

Question 7

Form 222 Copy 2

Answer 7

DEA (sent by supplier)

Question 8

Form 222 Copy 3

Answer 8

Pharmacy

Question 9

How do you verify a DEA number?

Answer 9

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

Question 10

With an emergency C2 prescription, how many days does the prescriber have to get the script to the pharmacy?

Answer 10

7 days

Question 11

When can you emergency supply a C2 greater than 72 hours and for how long maximum?

Answer 11

If patient terminally ill or in LTCF (documented on script) and for 60 days.

Question 12

What three hard copy items must be kept in the pharmacy?

Answer 12

Prescriptions, bi-annual inventory records, and Form 222s

Question 13

If supplier must partial quantity to the pharmacy, how long do they have before the Form 222 is void?

Answer 13

Form 222’s are valid for 60 days

Question 14

What happens to C2s if a pharmacy closes?

Answer 14

They can be returned to the DEA using a Form 222

Question 15

How much codeine can you get OTC in some states?

Answer 15

120cc or 48 dosage units within 48 hours

ZERO IN PA

Question 16

Which classes does the DEA require a prescription for?

Answer 16

C1 and C2. BUT. The FDA requires a prescription for C3-5 except for codeine. BUT some states still require script for codeine.

Question 17

What’s a form 41?

Answer 17

If you want to get rid of controlled substances (return or destroy) other than C2

Question 18

What’s a Form 104

Answer 18

Voluntarily giving of controlled substances (closing a pharmacy)

Question 19

Form 363?

Answer 19

Register as narcotic treatment program

Question 20

Form 224

Answer 20

Register as new pharmacy, hospital, clinic, teaching institution, or practitioner

Question 21

Form 225

Answer 21

Register as new manufacturer, wholesaler, distributor, importer/exporter, or researcher

Question 22

Who is involved in the closed controlled substances closed system?

Answer 22

Manufacturer –> distributor –> Prescriber –> dispenser –> patient –> Manufacturer

Question 23

Who can write for controlled substances?

Answer 23

Physicians, podiatrists, dentists, vets, NP and PA

Question 24

Category 1

Answer 24

Manufacturers

Question 25

Category 2

Answer 25

Distributors

Question 26

Category 3

Answer 26

Reverse Distributors

Question 27

Category 4

Answer 27

Dispenser (prescriber/pharmacy)

Question 28

Category 7

Answer 28

Narcotic Treatment Program

Question 29

Which is controlled, fioricet or fiorinal?

Answer 29

Fiorinal is schedule III

Question 30

Explain what you would do in this scenario: Pt presents rx for 60 of percocet. You only have 34.

Answer 30

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

Question 31

How many refills can each schedule have?

Answer 31

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)

Question 32

What are the places that don’t need a separate DEA registration number for each location?

Answer 32

1. Warehouse of a registrant
2. Office of a registrant or prescriber
3. Freight forwarding facility

Question 33

How long does someone have to reregister for their DEA number after it expires?

Answer 33

60 days

Bulk manufacturers - 120 days

Question 34

How long are DEA numbers valid for different entities?

Answer 34

Dispensing/instructing - 3 years

Everyone else - 1 year

Question 35

How many patients can one practitioner treat in an NTP?

Answer 35

≤30, but after 1 year of telling govt this is what you’re doing, you can ask to treat up to 100 patients

Question 36

When prescriber applies for X number, how many days does the secretary of HHS have to approve/deny?

Answer 36

45 days and if DEA hears nothing after 45 days, then the practitioner is good to go

Question 37

How do you get more 222 forms?

Answer 37

Request Form 222a or it’ll automatically be sent 30 days after the last shipment of 7 or 14.

Question 38

How long do copies of Form 222s need to be kept for inspection?

Answer 38

2 years

Question 39

In partial filling an rx for a terminally ill patient or in LTCF, how many days do you have to partial fill the rx?

Answer 39

60 days

Question 40

What is something that Rite Aid realized in the past few months about controlled rx?

Answer 40

Need to have the full address of the patient on the rx

Question 41

What are 3 things an electronic rx needs to be able to do to transmit controlled substances?

Answer 41

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

Question 42

What are the three options for a 2 factor authentication of a e-rx?

Answer 42

1. Something only MD knows (password)
2. Something only MD is (fingerprint)
3. Hard token (key or badge or whatever)

Question 43

How much sudafed can a pharmacy sell someone in a day?

Answer 43

3.6g per calendar DAY

Question 44

How much sudafed can a mobile retailer/mail order sell in 30 days?

Answer 44

7.5g per 30 days

Question 45

How much sudafed can a retail pharmacy sell someone in 30 days?

Answer 45

9g per 30 days