CONTROLLED‑SUBSTANCE ( C2-C5)

What are the 3 parts of an NDC?

 10 or 11 digits, Labeler → Product → Package.

 What agency enforces controlled‑substance laws?

DEA

 Schedule II definition?

 High abuse, medical use.

DEA Number

Format: 2 letters + 7 digits

Verification:

1. Add digits 1 + 3 + 5

2. Add digits 2 + 4 + 6

3. Multiply second sum × 2

4. Add the totals

5. Final digit = 7th digit

 Schedule II 

 No refills, no Transfer, Partial fills Only for LTCF or terminally ill 

Schedule III–V Max refills?

 5 refills

Schedule III–V Time limit?

 6 months

 Form DEA 224?

 Pharmacy registration.

 Form DEA 222?

 Order Schedule II drugs.

 CSOS?

 Electronic alternative to DEA 222.

Form DEA 41?

 Destruction of controlled substances.

 Form DEA 106?

 Report theft or significant loss.

 How often is the controlled‑substance inventory?

 Every 2 years (biennial).

 Schedule II inventory count?

 Exact.

 Schedule III–V inventory count?

 Estimate allowed but if Containers >1,000 units → exact count. 

 How long must controlled‑substance records be kept?

 Minimum 2 years.

 What are the pseudoephedrine limits under CMEA?

3.6 g/day, 9 g/30 days;

 What is a perpetual inventory?

 A continuously updated record of the quantity of Schedule II controlled substances on hand. 

 What is diversion?

 Unauthorized use, removal, or distribution of a controlled substance. 

 How must controlled substances be stored?

 Securely to prevent theft, unauthorized access, and diversion 

 Name common red flags in prescription of Control substains

• Altered quantities/strengths

• DEA number fails verification

• Out‑of‑state prescriber

• Hospital pad without doctor name

• Suspicious handwriting/ink

• Unusual prescribing patterns