Federal Compliance Summit On-Demand

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1. Which of the following "allows trademark holders to work with law enforcement on searches, seizures, and discover actions"? *

A. The Lawhorn Act
B. The Lanham Act
C. The Dangerous Doses Act
D. The Safe Medicines Act

2. What date was the DSCSA enacted? *

A. July 11th, 2009
B. September 18th, 2015
C. November 27, 2013
D. February 3rd, 2018

3. Which of the following are NOT required to be serialized? *

4. What year was the first general chapter of USP 797 released? *

A. 1994
B. 2001
C. 2004
D. 2009

5. The intent of the USP 797 is to serve as the minimum standards for the preparation of compounded sterile preparations (CSPs) for human and animal drugs. *

A. True
B. False

6. The use of technologies, techniques, materials, and procedures other than those described in USP 795 are not prohibited as long as they are inferior to those described herein and validated for the intended purpose. *

A. True
B. False

7. Category 1 CSPs are assigned a BUD of less than or equal to _____ hours at controlled room temperature or less than or equal to _____ hours if refrigerated. *

A. 12 hours, 24 hours
B. 6 hours, 12 hours
C. 24 hours, 48 hours
D. 2 hours, 8 hours

8. Category 2 CSPs may be assigned a BUD of >12 hours at controlled room temperature or >24 hours if refrigerated. *

A. True
B. False

9. Category 3 CSPs may be assigned a BUD longer than established for Category 2 CSPs, up to 180 days. *

A. True
B. False

10. In the revised Chapter of USP 797, all personnel qualifications for Category 1 and 2 CSPs must be completed: *

A. Every 3 months
B. Every 6 months
C. Every 12 months
D. Every 18 months

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