Demonstrably Difficult to Compound Drug Products

8/21/01


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Table of Contents

Demonstrably Difficult to Compound Drug Products

Section 503A(b)(3)(A)

Factors

1. Drug Delivery System

2. Drug Formulation and Consistency

3. Bioavailability

4. Complexity of Compounding

5. Facilities and Equipment

6. Training

7. Testing and Quality Assurance

Factors

Approach

Approach

Approach

Preliminary Findings

Preliminary Findings

Preliminary Findings

Additional Products

PPT Slide

Author: CDER User