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In the medical industry, bar code labels and product labels are strictly controlled. As a distributor, you want to make sure you are in compliance with these regulations, or it could mean big trouble for your business.

The FDA puts the burden of bar code labels and product labels on manufacturers and distributors, rather than hospitals. They have no responsibility to do that. This article tells you what you need to know about bar coding your medical and pharmaceutical products.

According to the FDA, every medical or biological product must have a bar code with its National Drug Code number on it. The National Drug Code is also referred to as the NDC. Your product needs to have this number on it if it is a drug, pharmaceutical, biological product, or in some cases even things such as herbal remedies, suppositories and other common daily-use products.

Who Needs A Bar Code?

If you sell any kind of drug, whether prescription or over-the-counter, that is commonly used in hospitals, you are required to put a bar code on that product. This goes also for any kind of biological product. Even if you are simply a small distributor, repackager or re-labeler.

There is an exception – if you are a distributor who doesn’t do anything at all to the drug, you don’t need a bar code. This means simply repackaging the product requires a bar code. But, if it simply passes through your hands without you altering the product in any way, you don’t need your own bar code.

There are very few exemptions to this rule. You may think that a small product that contains only a tiny amount of actual pharmaceuticals may be alright without such stringent practices, but even the most common over the counter products should be labeled.

What Is “Commonly Used In Hospitals”?

Prescriptions drugs all must be bar coded. However, not all over the counter drugs need one. As stated above, only over the counter medications that are commonly used in hospitals are required to have a bar code. But, how do you determine if your product meets this criteria?

Of course, you know who is using your product. If your orders are going out to hospitals, you know you need one. But what about small clinics or nursing homes? The FDA has specific guidelines that determine what is or isn’t a hospital. Leave it up to them to decide that. In general, it is any institution that offers medical, treatment or diagnostic services, but this definition can also include nursing services as well. You can always check with the institution you are selling your products to, and ask them if they are technically considered a hospital. Their order paperwork will probably indicate this.

Once you know what you need, any adhesive label or product label company can print your bar codes for you. Once you’ve got the information sorted out, it’s just a matter of making the order and affixing the labels.