Guide to Labeling of Pharmaceutical Products

The Food and Drug Administration (FDA) governs the labeling of pharmaceutical products in the US. All pharmaceutical products must be labeled according to the FDA’s regulations and guidance. Labeling pharmaceutical products is a meticulous process; given the concerns surrounding consumer safety, even minor mistakes have grave and expensive consequences.

In fact, labeling mistakes account for more than 22% of all detentions in the United States.

The FDA defines ‘labeling’ as “all labels and other written, printed, or graphic matters (1) upon any articles or any of its containers or wrappers, or (2) accompanying such an article.” Labeling, therefore, includes not just the medication packet but the box and leaflet.

Common information on pharmaceutical labels includes batch numbers, control numbers, manufacturer titles, dosage recommendations, ingredients, and more.

This guide details the labeling of pharmaceutical products, explaining what the FDA regulations require, how manufacturers should format the labels, and what information to highlight.

The FDA’s requirements for the labeling of pharmaceutical products

Over-the-counter (OTC) pharmaceuticals

The FDA has been responsible for labeling over-the-counter (OTC) pharmaceuticals since the OTC Drug Review in 1972. The OTC category covers a wide range of medications: cough medicines, antihistamines, dandruff shampoos, anti-fungal products, sunscreens, and much more – these are considered established categories/subcategories of OTC pharmaceuticals.

An OTC monograph is created for each drug grouping, functioning as a rulebook for the categories. The monograph explains the standard conditions, uses, dosages, and active ingredients for each drug to allow for public consumption under the GRASE designation: “generally recognized as safe and effective.”

Monographs change depending on the grouping. However, FDA regulations require that all medical labels include:

• A list of active Ingredients
• A list of inactive ingredients
• General purposes
• Directions for use
• Applicable warnings
• Control numbers
• Expiration date

In addition, the FDA advises that warnings follow certain headings:

• “Do not use” refers to contraindications.
• “Ask a doctor before use if you have” refers to certain medical conditions requiring you to contact a medical professional.
• “Ask a doctor or pharmacist before use if you are” refers to potential adverse drug-drug or drug-food interactions.
• “Stop use and ask a doctor if” details signs of toxicity.
• “When using this product” covers potential side effects and drug interaction, e.g., “may cause drowsiness” or “avoid alcoholic drinks.”
• “Keep out of reach of children” is required for most drugs.

Prescription pharmaceuticals

Prescription medications contain two types of pharmaceutical labels: primary labels and packaging inserts.

Primary labels require:

• The established name of the drug
• Brand name of the drug
• The drug quantity measured in the appropriate dosing unit, e.g., volume, weight, and capsule number.
• The recommended dosage information.

Packaging inserts are far more comprehensive; FDA regulations require that all prescription medicine labels include:

• Boxed warning. Strong warnings, such as serious side effects or health risks, are detailed.
• Indications and usage. What conditions to use the medication for.
• Dosage and administration. The amount of the drug a patient should take and how to administer the drug.
• Dosage forms and strength. Details the drug’s physical form and the concentration of key ingredients.
• Contraindications. Details the physical conditions which may lead to the medication causing undesirable effects.
• Warnings and precautions, adverse reactions, and drug interactions. Details the risk associated with the drug, which conditions it may aggravate, and which drugs it can interact with.
• Controlled substance. Notes if the drug is a restricted or prohibited substance.
• Overdosage. Describes the potential adverse reactions from consuming more than the recommended dosage.
• Description and ingredients. Details the active compounds used in the drugs and includes all ingredients.
• Pharmacology and toxicology. Explains the medication’s actions and any diseases that result from long-term use.

In addition, prescription packaging inserts can also contain a clinical study summary, advice for drug storage, handling information, and patient counseling information.

Printing pharmaceutical labels

Given the stringent FDA rules and severe penalties for improper pharmaceutical labels, all information must be accurate, traceable, clear, and legible.

Indeed, the FDA also details the appropriate design for pharmaceutical labels, including:

• Font size and type
• Language (appropriate grammar, abbreviations, terms, etc.)
• Format
• Materials

There are multiple printer types to choose from when deciding the machine to code pharmaceutical packaging. Some of the most popular printer types include: CIJ (continuous inkjet), laser, TTO (thermal transfer) and TIJ (thermal inkjet).

AMI specializes in in thermal inkjet (TIJ) printers because of their accuracy, simplicity and reliability. Because the font on packaging or inserts is usually very small, high-resolution printing is necessary. TIJ printers range from 300 to 600 dots per inch (DPI) while ensuring legibility. But, TIJ may not be the best option for you and your organization and it’s important to consult with an AMI coding and marking expert to ensure you are getting the best value and most effective solution.

You want to make sure that your printer can be readily integrated with automated packaging lines, printing high-resolution, alphanumerics, product information, barcodes, and more onto either paper, plastic, or any other material.

Controlling label quality

All pharmaceutical labels must meet the FDA’s regulatory standards – there’s no room for mistakes. Using TIJ printers, you ensure there are no mistakes; and with proper precautions in the manufacturing process, e.g., clearing previous print jobs, you can prevent any printing errors.

Labels also need to withstand UV light, be resistant to water, and paper labels must have a strong adhesive strength.

Use best practices for pharmaceutical labeling 

Failing to follow the FDA’s guidelines properly results in fines, recalls, and other stringent penalties. Relying on a TIJ printer guarantees you can meet the FDA’s standards, preventing any regulatory oversight or consumer safety concerns.

Automated Marking offers handheld and inline thermal inkjet systems that maximize your capacity and efficiency without sacrificing clarity. By pulling information directly from other windows-based programs, our printers reduce the risk of human error from manually inputted data.

Contact our pharmaceutical labeling experts to talk about your printing and labeling options. No matter your pharmaceutical packaging materials or the label size, we can help boost the speed and accuracy of your label printing.