Pharmaceutical Labeling: Understanding Requirements & Guidelines
Pharmaceutical labeling requirements are stricter than those for other products in the United States. In fact, these drug products require extra steps administered by the Food and Drug Administration to ensure consumers get the right information.
So, how do you make sure your process for the labeling of pharmaceutical products meets these standards while also keeping your customers safe? Let’s take a closer look!
Which Products Require Pharmaceutical Labeling?
Pharmaceutical labels are required on any retail item containing a drug. This includes products such as over-the-counter medications and prescription drugs (but also many other products you wouldn’t commonly consider).
Anti-cavity toothpaste, rubbing alcohol, sunscreen, sunscreen-containing cosmetics and hand sanitizer are just a handful of thousands of products that also fall into the pharmaceutical labeling requirement! So, it’s important to understand what ingredients your product contains in order to make sure you stay compliant with all regulatory requirements.
What Should I Look For When Selecting Pharma Labels?
The label must remain in place on the container and be legible across its lifespan, including distribution, storage and use. The printing on the label must also be legible across this lifespan.
(This means you need to use labels that have strong adhesive strength and are resistant to water and UV light.)
What Information is Required for the Label?
Until 18 years ago, there was no clear guideline on the placement and legibility of information for drug product packaging, which made it easy for users to miss important information, including dosages, warnings and side effects.
The FDA found this as a major problem, especially for older people (who account for about 30% of over-the-counter drug sales), and in 2002, label requirements were established with only minor updates occurring since then. These regulations helped to standardize label format and statement language, making pharmaceutical packaging and product information easier to read and understand.
To meet today’s FDA regulations, labeling information on drugs must include the following in this order:
– Product Name
– Drug Facts Table
– Active Ingredients
– Purpose and Use
– Warnings
– Directions
– Allergic Reactions
– Inactive Ingredients
All drug products must be registered with the FDA, have a National Drug Code (NDC), and have that three-section NDC code printed on the front of the label. (You can read more about the NDC here.)
Breaking Down the Drug Facts Table
To clarify drug information, the FDA requires that all pharmaceutical product labels include a “Drug Facts” table. This table is modeled after the “Nutrition Facts” label found on food containers and contains several pieces of standard information:
- Active Ingredients – The drugs and their amount per dosage.
- Uses – What medicine is intended to treat.
- Warnings – This section is divided into several statements.
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- The “Do Not Use” statement covers warnings for medicine that shouldn’t be used unless prescribed by a doctor, or shouldn’t be used by some consumers if they have a specific illness or symptom.
- The “Ask a Doctor” or “Ask a Doctor or Pharmacist” statement advises consumers on when they should talk to a medical professional before continuing the use of the drug.
- “When Using This Product” covers side effects and drug interactions. Common statements include “May Cause Drowsiness” and “Avoid Alcoholic Drinks.”
- “Stop and Ask a Doctor If” covers side effects and signs of toxicity to watch out for. Likewise “Stop Using If” is used for side effects that indicate the consumer should stop use immediately.
- “Keep Out of Reach of Children” must be used on most drugs. However, a few products are generally exempt, like makeup that contains sunscreen.
- Directions – How to take the medicine.
- Other Information – This covers important information that doesn’t fit in the previous categories. Tamper protection techniques should be listed on this section of the label. This lets the consumer know the steps you’re taking to protect the container. For example, if you use a heat shrink seal over the cap, it won’t be obvious that it’s missing. This is also the area to list storage instructions.
- Inactive ingredients – Everything in the product that isn’t medicine.
Getting the Correct Pharmaceutical Labeling on the Correct Container
Mixing up labels on foods and other products is a problem, but mixing up pharmaceutical labels can be lethal. Drug manufacturers have to take extra steps to keep product labeling runs separated through production and application.
Separation is often achieved by doing print runs for different products on separate dates or using separate machines and storage areas along the supply chain. (It’s important to have the printing area completely cleared of previous products before printing.)
Once the labels are ready to use, pharmaceutical companies must store these labels in a controlled environment, with rolls removed only when the product type and label can be cross-verified to ensure product safety.
Preventing Drug Counterfeiting with Labeling
Counterfeiting is a major issue facing the pharmaceutical industry, for both manufacturers and law enforcement.
Instead of standard serial numbers, pharmaceutical manufacturers are turning to randomized tracking numbers and barcodes to make it more difficult for counterfeiters to duplicate labels. Other strategies to clearly identify product quality, like hidden images and tamper-proof labels, also make it harder 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
The FDA gives manufacturers the option of a “Questions?” or “Questions or Comments?” section at the end of their drug facts labels. This section tells the user how to contact the manufacturer if they have questions about the drug and can help prevent issues with missing or misunderstood information on the container.
Common Packaging Concerns with Pharmaceuticals
Packaging materials (such as boxes and package inserts) are often thrown out shortly after the consumer opens the product, so they can’t be relied on to get drug information to the end-user.
Most small labels limit the amount of information you can place on it, but with high-quality printing, you can squeeze a little bit more information onto small print areas.
In these instances, multi-layer or “expanded content” labels, which have a folded layer, are often used to maximize the space and ensure all information is included. Multi-layer labels increase the total surface area of the label without increasing its overall dimension, allowing consumers to peel back and unfold the label to see all of the drug’s required information.
Traceability for Prescription Products
An additional requirement to consider is the ability to trace prescription products throughout the supply chain (part of the 2013 Drug Supply Security Act). Ensuring that your labeling machine can also place serialization and traceability information on products should always be a focus.
When selecting a drug labeling solution, look for low migration adhesives. These glues won’t transfer to the medicine or the container, where they may interact with the drug and hinder the product quality.
What Kind of Machine Do I Need to Apply Pharmaceutical Labels?
Pharmaceutical labeling needs vary depending on the type and size of your operation, as well as the types of containers and protection measures used.
Looking to add anti-counterfeiting measures? The 3600pa Series Label Printer Applicator can generate over a dozen barcode formats for label printing, as well as offering several printing and graphics options. It also supports RS 232, parallel, Ethernet, USB and wireless connections, so it’s easy to connect to the rest of your production system. This lets you send randomized, trackable information to be printed on each label.
Do your products need a final inspection before labeling? Are you making short product runs? With our tabletop wrap labeler, your QC staff can load vials and round containers manually after inspection.
Looking for the ultimate in cleanliness and flexibility? Our Front/Back/Wrap system handles a variety of labeling tasks and container sizes. It can be configured in numerous ways, including left and right-hand setups. It can also be built with a stainless steel frame, eliminating the need for paint and the chance of contamination from paint chipping off the machine. Like the 3600pa, it can also be used with a print engine to add custom label information.
Need to Find a Better Labeling Solution? We Can Help.
In the pharmaceutical industry, it’s important to ensure customer and patient safety with clear, concise drug information labels. Following the GMP (Good Manufacturing Practice) and regulations set forth by the U.S. Food and Drug Administration, alongside our recommended best practices, our labeling applicators can further increase confidence in your product’s safety.
Whether you just want to speed up your labeling process, or you need to create a new, custom labeling system that complies with these legal requirements, contact CTM Labeling Systems.
We have local distributors who can tailor a labeling system to fit your label requirements and your production system.
