Guidelines for Labeling Pharmaceutical and Healthcare Products

According to the FDA, all labels printed for use in the pharmaceutical and healthcare industry must be designed and applied so that the labels remain in place - and can easily be read no matter the conditions of distribution, storage, and use. Labels printed for pharmaceutical, medical, and healthcare industries can range from vitamin labels to over-the-counter medicine labels to prescription medicine labels. For safety the labels must meet Consolidated Label’s strict list of quality requirements, but also the regulatory requirements set forth by the Food and Drug Administration.

It is the label manufacturer’s responsibility to make sure that label print is legible and will remain that way throughout the product’s life span. Label integrity is important for all printed labels, but is imperative for pharmaceutical and healthcare products.

Ordering Labels

When you order your labels, we’ll prepare a proof and sample so you can verify the accuracy. Before we can print the labels, the samples must be thoroughly inspected, proofread, and approved. You’ll need to verify that the proof conforms to your specifications.

Printing Labels

After you’ve thoroughly reviewed and approved the samples, your labels are placed into production. Consolidated Label maintains documentation of proofreading and acceptance activities in a history record to prove that inspection was actually performed.

If you’re printing multiple pharmaceutical labels, the products should be separated according to the degree necessary to prevent any mix-ups or switches. Product separation can be physical or spatial, or can be completed by performing press runs at different times to avoid confusion. To avoid a labeling mix-up Consolidated Label maintains tight production controls. If the only labels being run are dissimilar products the production controls can be slightly less stringent. Before printing a new medical label, the areas around the presses are completely cleared from previous print jobs. This provides less room for any printing errors. Proper control of storage is also necessary in preventing any mix-ups or switches when dealing with labels printed for use in the pharmaceutical industry.

Label Inspection

After your labels have run and before they are issued for use, you must carefully examine them to ensure the labels comply with your specifications. Your examination must include any control numbers and expiration dates used on the labels. A written record of this issuance check must be created, including the name and date of the person performing the examination.

Every label printed at Consolidated Label is inspected thoroughly, and labels printed for the medical and pharmaceutical industry are handled with extreme care. Industry standards that must be met for safety reasons, and we take great pride in our process quality. This is accomplished through strict multiple inspections, and extreme care in processing, printing, storing and shipping these labels to you.

Consolidated Label has 20 years of experience printing high quality labels and we’re a leader in medical and pharmaceutical labels.

If you’re interested in ordering pharmaceutical or medical labels, you can get a no obligation, instant online label quote. Or, if you have a high-volume order feel free to contact one of our Label Consultants.