Part 14

Question 1

Applicants seeking to register as manufacturers or outsourcing facilities SHALL provide proof of registraiton with ___ as a manufacturer or outsourcing facility

A. FDA
B. BOP
C. DEA

Answer 1

A. FDA

SHALL provide proof of registraiton with the FDA as a manufacturer or outsourcing facility to the BOP

Question 2

Prescription drugs and prescription devices that are damaged/outdated SHALL be ___ from other prescription drugs and prescription devices until destroyed or returned

Answer 2

SHALL be quarantined and physically separated from others

Question 3

Any prescription drug whose immediate or sealed outer or sealed secondary containers have been ___ SHALL be quarantined and physically separated from other prescription drugs and devices until either destroyed or returned.

Answer 3

Have been Opened or USED

Question 4

Manufacturers and wholesalers must keep records of which of the following?

A. The source of the prescription drugs and prescription devices
B. The address of the location from which the prescription drugs and prescription devices were shipped
C. The identity and quantity of the prescription drugs and prescription devices received and distributed or disposed of
D. The dates of receipt and distribution or other disposition of the prescription drugs and prescription devices.

Answer 4

A. The source of the prescription drugs and prescription devices
B. The address of the location from which the prescription drugs and prescription devices were shipped
C. The identity and quantity of the prescription drugs and prescription devices received and distributed or disposed of
D. The dates of receipt and distribution or other disposition of the prescription drugs and prescription devices.

Records must be available for 2 years

Question 5

Manufacturers and wholesalers inventories and records SHALL be available for inspection and photocopying by authorized officials for a period of ___ following disposition of the prescription drugs and prescription devices.

A. 1 year
B. 2 years
C. 5 years
D. 10 years

Answer 5

B. 2 years

Question 6

Manufacturers and wholesalers records kept at a central location apart from the inspection site and NOT electronically retrievable SHALL be made available for inspection within what time frame?

A. 24hr
B. 2 working days
C. 3 working days
D. 7 working days

Answer 6

B. 2 working days

Question 7

Manufacturers and wholesalers Shall permit the ___ officials to enter and inspect premises and delivery vehicles.

A. Board of pharmacy
B. Federal authorized law enforcement
C. State authorized law enforcement

Answer 7

A. Board of pharmacy
B. Federal authorized law enforcement
C. State authorized law enforcement

Question 8

Manufacturers and Wholesalers that handle CS SHALL register with

A. FDA
B. DEA
C. BOP
D. USP
E. NABP

Answer 8

B. DEA

C. BOP

Question 9

Any manufacturer/wholesaler who holds an active sterile compounding registration from the board of pharmacy and THAT HOLDS a license or registration from the FDA shall comply with

A. FDA Current Good Manufacturing practice in manufacturing, processing, packing, or hold of Drugs
B. FDA Current Good Manufacturing Practice for Finished Pharmaceuticals
C. DEA regulations relating to controlled substances 21 CFR
D. USP standards

Answer 9

A. FDA Current Good Manufacturing practice in manufacturing, processing, packing, or hold of Drugs
B. FDA Current Good Manufacturing Practice for Finished Pharmaceuticals
C. DEA regulations relating to controlled substances 21 CFR
D. USP standards –> 1140-07-02

Question 10

Any manufacturer/wholesaler who holds an active sterile compounding registration from the board of pharmacy and THAT DOES NOT hold a license or registration from the FDA shall comply with

A. FDA Current Good Manufacturing practice in manufacturing, processing, packing, or hold of Drugs
B. FDA Current Good Manufacturing Practice for Finished Pharmaceuticals
C. DEA regulations relating to controlled substances 21 CFR
D. USP standards

Answer 10

D. USP standards