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Retail Pharmacy Recall Manual

Published by: Food Institute Information and Research Center

Published: Oct. 1, 2008 - 100 Pages


Table of Contents



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

Abstract

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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