When a drug product recall occurs, the recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. Over the past few years, there has been an increasing trend in the number of prescribed and over-the-counter drug recalls. When a recall occurs, it is critical for a distributor to follow a specific recall strategy to avoid any errors, ensure accuracy and timeliness of returns, and avoid costly losses due to loss of inventory or fines from process errors.

As a drug distributor, pharmacies and medical offices absorb some of the impact from the recall, even though the recall likely has nothing to do with the distributors process. Recalls disrupt the entire distribution process impacting customers and causing potential brand reputational damage.  This can include a decrease in customer satisfaction affecting sales, testing customer relationships, and disrupting supply chains.

What Precautions Can Be Put in Place For Drug Recalls?

Distributors must develop a drug recall plan before a drug recall has been initiated. Drug recall programs can be applied at the retail level or at the manufacturer level. Reverse distribution of each of these may vary, and it is important to work with your reverse distributor to understand what options are available.

Additionally, the FDA may require a drug recall to occur if a new finding of a product emerges, or if the FDA finds the benefits of a product no longer outweigh the risks – in which case a drug withdrawal would occur.

In either case, establishing a solid reverse distribution process with a reputable partner will allow the returns to be handled and recorded properly.

Follow these important steps to manage a drug product recall:

1. Keep a record of the product recall.
2. Record the quantity being recalled during your packaging process.
3. Follow proper packaging and return procedures.
4. File the product recall records for future reference. Some pharmacies keep the recall notice up to three years. Check your state for additional requirements.

At National Pharmaceutical Returns, we work with our distribution partners to ensure a solid reverse distribution process is in place in case of a drug recall. We are Drug Distributor Accredited by the National Association of Boards of Pharmacy (BABP) to specialize in helping our customers through any return process. Staying current with processes and procedures saves our customers time and money. To ensure you have a proper pharmaceutical returns process in place, give us a call at 800-252-7727.