Security Control Questionnaire

To effectively evaluate security controls, researchers who conduct activities with controlled substances must complete this form. Security measures must be evaluated and implemented as required by CFR Food and Drug, Part 21, section 1301.71 to1301.75 to prevent theft and diversion. This form will assist the researcher in evaluating current security methods and assist in developing additional security controls if required.

Principal DEA Registration Holder: __________________________________

DEA Registration Number: ______________

Expiration: ______________

Laboratory Reviewed: ______________

1. Scheduled Substances Registered: (check highest authorized level only)

a. Schedule I (5 pts) _______

b. Schedule II (5 pts) _______

c. Schedule III(2 pts) _______

d. Schedule IV(2 pts) _______

e. Schedule V (1 pt) _______

2. Type and Form of Substance:

a. Bulk Liquids (5 pts) _______

b. Dosage Units (2 pts) _______

c. Usable Powders(5 pts) _______

d. Non- Usable Powders(1 pt) _______

3. Storage location of Substances:

a. Schedule I and/or II:

i. Vault (0 pts) _______

ii. Safe (0 pts) _______

iii. Secure enclosure (4 pts) _______

iv. Other location (5pts) _______

b. Schedule III, IV and/or V:

i. Vault (0 pts) _______

ii. Safe (0 pts) _______

iii. Secure enclosure (2 pts) _______

iv. Other location (5pts) _______

4. Key or Combination Control:

a. Less than 3 staff members have access (0 pts) _______
b. Less than 9 staff members have access (3 pts) _______
c. More than 9 staff members have access (5 pts) _______

5. Detection and Alarm Systems:

a. Schedule I and/or II:

b. Schedule III, IV and/or V:

i. Electronic security system (0 pts)_______
ii. Safe/vault alarm system (0 pts)_______
iii. Cipher locks/card access on laboratory doors (3 pts)_______
iv. No security additions (5 pts)_______

6. Are there established procedures for guests and visitors:

a. Yes (0 pts) _______
b. No (5 pts) _______

7. Are disposition records updated upon retrieval:

a. Yes (0 pts) _______
b. No (5 pts) _______

TOTAL SCORE _______

Scoring and Security Effectiveness:

If the security score is between 0-10, security measures are adequate. All individual item scores greater than 3 should be reviewed and evaluated for possible security breaches.

If the security score is between11-30, security measures may need to be increased. All individual item scores greater than 3 must be reviewed and evaluated for possible security breaches. The Department of Environmental Health and Safety is available to assist in review of laboratory security measures.

If the security score is between 31-50, security measures must be increased. All individual item scores greater than 3 must be reviewed and changes implemented. The Department of Environmental Health and Safety is available to assist in review and implementation of increased laboratory security measures.