Drug Quality and Security Act Update

Description

Get up to speed on federal and state regulation of compounding and how the Compounding Quality Act—part of the Drug Quality and Security Act—has been implemented.  Learn how these regulatory activities affect your practice.

Pharmacist Learning Objectives

At the completion of this knowledge-based activity, pharmacists and technicians will be able to: 

  1. Describe the regulatory issues facing 503A compounders.
  2. Discuss the regulatory issues facing 503B outsourcing facilities
  3. Describe the types of FDA inspections of compounding facilities 
  4. Explain the impact of federal and state level policies have had on 503A and 503B compounders

Technician Learning Objectives

At the completion of this knowledge-based activity, pharmacists and technicians will be able to: 

  1. Describe the regulatory issues facing 503A compounders.
  2. Discuss the regulatory issues facing 503B outsourcing facilities
  3. Describe the types of FDA inspections of compounding facilities 
  4. Explain the impact of federal and state level policies have had on 503A and 503B compounders
 
 
 
Speakers:
Julie
Julie Dohm,
Agency Lead on Compounding
FDA
 
Rachael
Rachael Pontikes,
 
Learning Level: Level 2
Track: Pharmacy Law and Regulations
Session Time Slot(s): 
Date: 
Sunday, March 18
Time: 
1:00 PM - 3:00 PM
Room: 
Music City Center - Room 104C-D
ACPE Pharmacist: 0202-0000-18-016-L03-P
CEUs Pharmacist: 0.2
ACPE Pharmacy Technician: 0202-0000-18-016-L03-T
CEUs Pharmacy Technician: 0.2
Activity Type:
Knowledge-based