Impetus for Change and Standards of Practice for Compounding: A New Era 
Sponsored by Medisca, Inc.

Saturday, October 18, 2014, 10:30 am - 12:00 pm
Austin Convention Center
Location: 16A, Level 4
Continuing Education Credits: 1.5 (0.15 Contact Hours)
ACPE #: 207-000-14-236-L04-P

The Application-based activity explores the changes, current and forthcoming, to the practice of compounding. The implications surrounding H.R. 3204, Drug Quality and Security Act, and subsequent guidance documents for Pharmacy Compounding of Human Drug Products under Section 503A and Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B, of the Federal Food, Drug and Cosmetic Act are outlined. Subsequent changes to standards of practice as expressed in the United States Pharmacopeia and the National Institute for Occupational Safety and Health are revealed. Changes in legislation and standards of practice pave the way for new beginnings and opportunities. A positive outlook and newly realized philosophy and fundamental business practice infrastructure is presented. A unique framework for a comprehensive compounding-related quality management system now becomes a necessary framework for a compounding practice of the future. An overview of this framework is presented and rounds out this Application-based Activity.

Pharmacist Learning Objectives:

  1. Analyze the implications of H.R. 3204, Drug Quality and Security Act, and 503A and 503B of the FD&C Act.

  2. Contrast similarities and differences in standards of practice requirements under 503A and 503B of the FD&C Act.

  3. Summarize the health and safety requirements under NIOSH and the proposed USP Chapter <800>.

  4. Recognize a unique framework for a comprehensive compounding-related Quality First Management System.

  5. Illustrate new opportunities under a revised business practice infrastructure for pharmacy compounding.

  6. Construct the benefits of establishing a compounding practice infrastructure based on Quality, Risk and Validation Management.

  7. List new and innovative opportunities for the small and large compounding practice.

Speaker: Mark Badria, Pharm B. BSc. Hon. Pharm., Southern California Compounding Pharmacy, San Diego, California

Activity Type: Application-based
Audience: Pharmacists