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The information provided on the inner label (also called the container label) and outer label (on the packaging) should be legible and legible and should contain content approved by the NRA.
At a minimum, key information should be printed on the inner label and additional information should be provided on the outer label (for example, the carton) and/or the product leaflet.
Appropriateness of labels for low and ultra-low storage temperatures should be verified, if applicable. The label should remain properly attached to the container under various storage conditions during the shelf-life of the product. The label and its adhesive shall not adversely affect product quality due to leaching, migration and/or other means.
Which products require pharmaceutical labeling?
Retail items containing a drug require pharmaceutical labeling. This includes products like over-the-counter drugs and prescription drugs (but many other products you might not normally consider).
Anti-cavity toothpaste, rubbing alcohol, sunscreen, cosmetics containing sunscreen, and hand sanitizer are just a few of the thousands of products that fall under pharmaceutical labeling requirements! Therefore, it is important to understand what ingredients are in your product to ensure you comply with all regulatory requirements.
What should I look for when choosing a pharma label?
The label must remain in place on the container and be legible throughout its life, including distribution, storage and use. The print on the label must also be legible throughout this lifetime.
What information is required for the label?
Until 18 years ago, there were no clear guidelines for placement and legibility of information on drug product packaging, making it easy for users to miss important information including dosage, warnings and side effects.
The FDA saw this as a major problem, especially for the elderly (who account for about 30% of over-the-counter drug sales), and in 2002, the labeling requirement was established with only minor updates since then. These regulations helped standardize label format and statement language, making pharmaceutical packaging and product information easier to read and understand.
Getting the right pharmaceutical labeling on the right container
Mixing food and other product labels is a problem, but mixing pharmaceutical labels can be deadly. Drug manufacturers must take additional steps to separate product labeling by manufacturing and application.
Separation is often achieved by making print runs for different products on separate dates or using separate machines and storage areas along the supply chain. (It is important to completely clear the print area of previous products before printing.)
Once the labels are ready for use, pharmaceutical companies must store these labels in a controlled environment, removing the rolls only when the product type and label can be cross-verified to ensure product safety.
Prevention of drug counterfeiting with labels
Counterfeit is a major problem facing the pharmaceutical industry, both for manufacturers and law enforcement.
Instead of standard serial numbers, pharmaceutical manufacturers are turning to random tracking numbers and barcodes to make counterfeit labels more difficult to counterfeit. Other techniques to clearly identify product quality, such as hidden images and tamper-proof labels, also make it difficult for counterfeiters to duplicate or reuse labels.
If you use a print-and-apply machine for labeling, you can add unique information to each container as it passes through your labeling line.
Best Practices for Labeling of Pharmaceutical Products
FDA manufacturers have a “Question?” Gives the option or “Questions or Comments?” section at the end of their Drug Facts label. This section tells the user how to contact the manufacturer if they have questions about the drug and can help prevent problems with missing or misunderstood information on the container.
Common packaging concerns with pharmaceuticals
Packaging materials (such as boxes and package inserts) are often discarded after the consumer has opened the product, so they cannot be relied upon to convey drug information to the end user.
Most small labels limit the amount of information you can put on them, but with high-quality printing, you can squeeze more information into a smaller print area.
In these instances, multi-layer or “expanded content” labels, which have a folded layer, are often used to maximize space and ensure that all information is included. Multi-layer labels increase the total surface area of the label without increasing its overall dimensions, allowing consumers to peel and unfold the label to see all the necessary drug information.
