Section H - Controlled Substances

Question 1

DEA 224 Form

Answer 1

Used for registering Pharmacies with the DEA

Question 2

DEA 225 Form

Answer 2

Used for registering Manufacturers, Distributors, Importers, Exporters, or Researchers with DEA

Question 3

DEA 363 Form

Answer 3

Used for registering Narcotic Treatment Programs with the DEA

Question 4

How long are DEA registrations valid for?

Answer 4

36 months

Question 5

When are registration renewal forms sent to registrants?

Answer 5

60 days before expiration date of the registration

Question 6

When must registrants notify DEA in writing if they have not received renewal forms?

Answer 6

If they haven’t received renewal forms within 45 days of their expiration date.

Question 7

Who does not need to have their own DEA registration?

Answer 7

• Warehouses used by registrants to store controlled substances.
• A practitioner’s office that prescribes controlled drugs, but they aren’t administered or dispensed
• Common carriers (ex freight delivery companies
• Office where controlled drugs are solicited, made, or supervised, but doesn’t contain them

Question 8

Why may the DEA deny registration of an Applicant?

Answer 8

• falsified info on application
• convicted of drug-related felony
• committed acts that would make registration inconsistent with public interest
• had state license suspended, revoked, or denied
• if applicant has been subject to mandatory exclusion from participation in Medicare or Medicaid

Question 9

Copy 1 of DEA 222 Color and Destination

Answer 9

Brown and goes to supplier

Question 10

Copy 2 of DEA 222 Color and Destination

Answer 10

Green, goes to supplier first, and then forwarded to DEA

Question 11

Copy 3 of DEA 222 Color and Destination

Answer 11

Blue and retained by the purchaser

Question 12

How long do order forms need to be retained?

Answer 12

2 years

Question 13

When my pharmacists compound controlled substances for “office use”

Answer 13

• compounded as an aqueous, oleaginous, solid dosage form
• doesn’t contain more than 20% controlled substance
• only distributed to practitioner authorized to dispense

Question 14

How long to paper or electronic controlled prescription records need to be kept

Answer 14

2 years

Question 15

When is FAxing of CII scripts acceptable?

Answer 15

• Home infusion pharmacies
• LTCF
• Hospice patients

Question 16

How long are CII scripts for patients in LTCF or terminally ill valid for?

Answer 16

60 days

Question 17

Amount of CV OTC that can be sold without a script containing opium

Answer 17

• 240mL

- 48 dosage units

Question 18

Amount of CV OTC that can be sold without a script that doesn’t contain opium

Answer 18

• 120mL

- 24 dosage units

Question 19

What info must a record book for dispensing CV OTC medications contain?

Answer 19

• name & address of each purchaser
• name & quantity of controlled substance purchased
• date of purchase
• name or initials of pharmacist who dispensed the substance

Question 20

DEA 41 Form

Answer 20

sent to DEA when reverse distributor destroys a controlled substance.

Question 21

DEA 106 Form

Answer 21

Report of Theft or Loss of Controlled Substances form