This manual outlines ways in which a retail pharmacy company can develop a useful plan of action in the event it is faced with a recall. This manual will focus on the recall procedures that apply to products regulated by the Food and Drug Administration, especially prescription and over-the-counter drugs.
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- I. INTRODUCTION
- II. DEFINITIONS AND KEY CONCEPTS
- A. The Key Players
- B. What Is a “Recall”?
- C. What Is Not a “Recall”?
- E. The Law of Recalls
- F. Mandatory Recall Authority
- III. PREPARATION FOR A RECALL - GENERAL PRACTICE
- A. Contract Manufacturing and Recall Exposure
- B. Relationships with Suppliers
- 1. Set Standards/Specifications for Incoming Products
- 2. Obtain Guarantees from Your Suppliers
- 3. Inspect All Incoming Product
- C. Product Handling and Record Keeping
- D. Procedures for Handling Complaints and Inquiries
- IV. PREPARATION FOR A RECALL - RECALL PROCEDURES
- A. Retail Pharmacy Store - Corporate Headquarters
- 1. Designate a Recall Coordinator and a Recall Team
- 2. Establish a Recall Contact at Each Supplier
- 3. Create an Internal Communication Plan
- 4. Select a Reputable Outside Laboratory
- 5. Obtain Adequate Insurance Coverage
- B. Retail Pharmacy Store - Retail Store, Warehouse, and Distribution Center
- 1. Designate an In-store Recall Manager
- 2. Create an Internal Communication Plan
- V. CONDUCTING A RECALL - RECALL INITIATED BY YOUR SUPPLIER
- A. Receiving a Recall/Market Withdrawal Request
- B. Preparing to Implement the Recall
- C. Implementing the Recall
- VI. CONDUCTING A RECALL -RECALL OF PRIVATE LABEL PRODUCTS INITIATED BY YOUR COMPANY
- A. Investigating and Evaluating a Product Defect - Working with the Contract Manufacturer
- 1. Assembling the Recall Team
- 2. Gathering All the Facts
- 3. Conducting a Health Hazard Evaluation
- 4. Deciding Whether to Recall the Product
- B. Notifying Government Agencies
- C. Developing a Recall Plan
- D. Implementing a Recall
- VII. CONDUCTING A RECALL - WHEN THE GOVERNMENT IS INVOLVED
- A. Timing
- B. Testing
- C. Deciding Whether to Recall the Product
- D. Developing the Recall Plan
- E. Implementing the Recall - Recalling Firm
- F. Publicity
- VII. HANDLING THE PRESS AND PUBLIC RELATIONS
- A. How Consumers React to Risk
- B. Coordinating All Communications
- C. Shaping Your Message
- D. Issuing Press Releases
- E. Working With The News Media
- IX. HANDLING VISITS BY REGULATORY OFFICIALS
- A. Who May Visit
- B. What Records You Should Let Them See
- X. SPECIAL SITUATIONS
- A. Prescription Drugs and Devices
- B. Infant Formula Recalls
- C. Medical Device Recalls
- D. Consumer Product Safety Commission Recalls
- E. Controlled Substances Recalls
- F. USDA, Food Safety and Inspection Service Recalls
- G. Environmental Protection Agency Recalls
- XI. WRAPPING UP EXHIBITS
- A. Sample Recall Notice
- B. FDA Recall Policy
- C. FDA Model Press Release
- D. FDA Regulations For Infant Formula Recalls
- E. FDA Regulations For Medical Device Recalls
- F. CPSC Recall Handbook
- G. EPA Recall Authority
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