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One of the main responsibilities of the Food and Drug Administration (FDA) is to regulate labeling standards for pharmaceutical, medical, nutraceutical and dietary products. We’ve compiled a list of guidelines to help you better understand pharmaceutical labels and healthcare product labels. Whether you’re labeling prescription drugs or medical devices – all pharmaceutical and healthcare products must be labeled correctly for consumer safety.
1. Labeling responsibility
According to the FDA, all labels printed for use in the pharmaceutical and healthcare industries need to be designed and implemented so that they can stay in place and be read in a variety of environments through distribution, storage, and use.
The label maker is responsible for ensuring that the print is legible and remains the same throughout the life of the product. Product manufacturers are responsible for complying with content and format requirements – click here for more information on FDA regulations.
2. Displaying product information
All types of labeling have content requirements for what information and claims can be made on a label. Each drug and medical device classification has its own requirements for what information should appear on the product. Several important points to include in a pharmaceutical or healthcare product label are:
=>> Official product name
=>> Active and inactive ingredients
=>> Drug Facts table
=>> Purpose and use
=>> Warnings
=>> Directions
=>> Allergic reactions
3. Label formatting for FDA approval
Your labels must be designed in the appropriate FDA format for your product classification, such as OTC drugs, oral contraceptives, combination products, etc. Click here for a list of label guidelines related to medications. Some things you should consider when designing a label for FDA approval:
Font size and type (must be legible)
Language (proper use of abbreviations, grammar, advertised claims, etc.)
Format (organization and presence of sections such as supplementary information, warnings, uses, etc.)
Materials (depending on the nature of the product)
4. Selecting approved components
Label materials for pharmaceuticals are not strictly regulated in packaging/containers touching the drug product. Your label materials can be made from standard white paper stock to holographic film to shrink sleeve labels, depending on what you want the label to do.
Multi-layer labels are often used because pharmaceutical and healthcare products need to share large amounts of information. For greater product safety, you should choose adhesives, coatings, and inks that are “low transfer” meaning little to no substance transfers from the material to the drug or device.
5. Controlling the quality of labels
Each label printed should be thoroughly inspected to ensure that the information is consistent and accurate. Industry standards must be met for safety and liability reasons, which is why it’s important to discuss their quality control process with your label manufacturer
Printing of multiple pharmaceutical labels: Products should be separated to avoid any mix-up or switch. Product segregation can be physical or spatial or accomplished by performing press runs at different times to avoid confusion. Ask your label manufacturer that the areas around the presses are completely cleared of previous print jobs – this provides less room for any printing errors.
Proper control of storage: An important consideration, when dealing with printed labels for use in the pharmaceutical industry proper storage control is required to prevent any mix-ups or switches. After running your labels and before issuing them for use, you should carefully test them to ensure they meet your specifications and FDA standards.
