CS D

Question 1

Distribution of free samples:

• Who is allowed

Answer 1

Only licensees

• licensed by the department for research, instructional activities or chemical analysis.

Question 2

Who can receive samples of CS?

Answer 2

• Patients who can not afford the CS (Patient Assistance Program)
• Patient specific
• Not for general advertisement

Question 3

Controlled Substances: Safety/ Loss or Theft:

• FDA requirement for safety
• Who to report to if theft/ loss occurs?
• How to report?
• How soon
• Do you still have to report if recovered?

Answer 3

The Federal Controlled Substance Act requires that the DEA establish a “closed system” of control of all manufacturing, distribution and dispensing of all controlled substances.

The registrant shall notify the DEA Field Division Office

• In writing
• Any theft or significant loss of any controlled substance
• Within one business day of the discovery

BNE

• The licensee shall promptly notify the department of any theft or loss of any controlled substance.
• Such theft or loss shall be reported on forms furnished by the department.

The theft or loss must be reported regardless:

• Whether or not the controlled substances are recovered
• Whether or not the responsible parties are identified and action taken against them

Question 4

What is a significant loss?

How do you determine?

Answer 4

1. The actual quantity of controlled substances lost in relation to the type of business
2. The specific controlled substances lost
3. Can it be associated with access to those controlled substances by specific individuals?
4. Is the loss attributed to unique activities that may take place?
5. Is there a pattern of losses over a specific time period?
6. Are specific controlled substances more likely to be diverted?
7. Local trends