Pharmaceutical Labeling Guide for FDA-Compliant Drug Labels

Small American pharmaceutical businesses are growing in number. Their services include drug research, consultancy, manufacturing, repackaging, distribution, etc. We have seen their profit potential at the height of the Coronavirus lockdowns, as both small and big companies increased their stock, racing to find the right vaccine or cure.

The pharmaceutical industry is highly regulated, much more so than the food and cosmetics businesses. One way to ensure medication safety is by proper labeling, a tricky and meticulous process. In this article, we present a simple guide to making FDA–compliant drug labels.

What Is a Drug, and What Products Require Pharmaceutical Labeling?

What Information Is Required on a Drug Label?

When Should You Use Barcodes on Pharmaceutical Labels?

How Can You Ensure the Legibility of Drug Labels?

What Is a Drug, and What Products Require Pharmaceutical Labeling?

The FDA defines a drug as a substance that qualifies under any of the following categories:

Recognized by an official drug formulary.
Used in the diagnosis, mitigation, cure, treatment or prevention of disease.
Can alter a body structure or function.
A component of a medication but not of a medical device.
Not a medical device but is used in healthcare.
Biological products, e. g. vaccines, tissues, recombinant proteins, etc., having any of the above features.

Meanwhile, a drug product is any product that contains a substance that can be classified as a drug.

From these legal definitions, we must be aware that not all drugs are sold in pharmacies. Some of them are marketed as common household items, such as anti-acne solutions, hand sanitizers, toiletries and many others. All of these products require FDA-compliant labels.

What Information Is Required on a Drug Label?

The pharmaceutical labeling guidelines are found in Title 21 of the Code of Federal Regulations Part 201 (21 CFR 201), and the FDA strictly enforces them. Any misstep can render a drug misbranded. The regulations are different for prescription and over-the-counter (OTC) drugs.

Below is an easy-to-understand walkthrough of the 21 CFR 201 guidelines.

1. Labeling Requirements for Prescription Drugs

Prescription drugs, including insulin, must have the information below.

On the primary product label:

Statement of identity—this is the drug’s established name, which is different from its brand name. It should be written prominently on the label.
Brand name—the trade name under which the product is being marketed.
Net quantity of contents—expressed in the appropriate measurement units, depending on the drug. For example, solids are measured by weight. Liquids are measured by volume. Insulin is measured by the number of dosing units. Those exempted from declaring their net quantities are physician samples and products in packages weighing 8 grams or lighter.
Statement of dosage—this refers to the recommended usual dosage of the drug. However, dosing depends on the drug and its applications. To explain the variations, manufacturers and distributors can say “See package insert for dosage information” on the packaging label and explain the rest in the insert.

Prescription drugs must also be accompanied by their full prescribing information, including their safe use and scientific evidence of safety and efficacy. These details may be written in the package insert. They must not be misleading and must be free of promotional language. They include the following:

Boxed warning—any strong warnings about the product. It alerts healthcare providers and consumers of the increased risk of serious side effects from using the drug.
Indications and usage—the conditions that the drug can treat, prevent, improve, etc.
Dosage and administration—dosing depends on the drug’s applications. For example, acutely ill diabetics may be given higher insulin doses than stable patients. “Administration” refers to the route by which the drug is given, e. g. by the mouth, applied on the skin, injected in the skin or blood vessels, etc.
Dosage forms and strengths—the physical form and drug concentration of the product.
Contraindications—physical conditions that can worsen upon drug intake. For example, warfarin can cause excessive bleeding in liver disease patients. Therefore, liver disease is a contraindication for warfarin intake.
Warnings and precautions—this section explains the risk of developing severe adverse reactions.
Adverse reactions—the drug’s unwanted side effects.
Drug interactions—the substances that can reduce or enhance the drug’s effects. For example, multiple antibiotics can be given to the same patient for their synergistic effects. Meanwhile, stomach acid-reducing drugs can lessen the absorption of some pH-sensitive medications.
Use in specific populations—explains the drug’s applications in certain groups, like children, pregnant women, the elderly, etc.
Drug abuse and dependence—this part explains the drug’s potential to cause abuse or dependence. Opiates like morphine and oxycodone must include this section.
Controlled substance—classifies the drug’s status under the Controlled Substances Act, i. e. if it is restricted or prohibited due to its abuse or dependence potential.
Overdosage—explains the drug’s physical effects when taken excessively, as well as the measures to take when such effects are observed.
Description—a summary of the product’s active ingredients and their actions in the body.
Ingredients—the product’s components, including active and inactive ones. Their proportions must be clearly stated.
Clinical pharmacology—explains specific technical information about the drug’s effects on the body.
Nonclinical toxicology—summarizes the evidence regarding the drug’s potential to cause cancer, infertility, birth defects and other serious side effects. The experiments here involve human and non-human tissue samples, not live persons.
Clinical studies—this segment summarizes the evidence supporting the drug’s safety and efficacy in humans.
References—this section cites relevant literature that supports the drug’s effects.
How supplied—storage and handling information.
Patient counseling information—summarizes the vital information that healthcare providers must explain to patients. Examples are ways to avoid adverse effects and what to do when toxicity signs are observed.

Other details may be required aside from the above.

2. Labeling Requirements for Over-the-Counter Drugs

OTC medicines typically do not need prescriptions, although healthcare providers may include them in patients’ charts for symptomatic treatment. They have a low potential for abuse and are safe when taken in the recommended amounts. They do not have to have package inserts if their labels are big enough to contain all the required information.

The following details should be found on the principal display panels of OTC meds:

Statement of identity
Brand name, which may include the company logo
Net quantity of contents
Statement of dosage

Meanwhile, the following information must be written in the “Drug Facts” section:

Active ingredient—the established name of the main drug component.
Purpose—the drug category or categories that the product may fit into. For example, acetaminophen and ibuprofen are both classified as fever reducers and pain relievers.
Uses—the product’s specific indications.
Warnings—they include the drug’s contraindications and potential side effects, prefaced by the following phrases or statements:
“Do not use”—states the contraindications.
“Ask a doctor before use if you have”—patients with medical conditions must ask a doctor first if they have the conditions listed under this segment. For children’s OTC meds, the starting phrase should be “Ask a doctor before use if a child has…”
“Ask a doctor or pharmacist before use if you are”—states the potential drug-drug or drug-food interactions.
“When using this product”—states the product’s potential side effects and what activities to avoid while using it. For example, some whitening and anti-acne formulations may require patients to stay out of the sun during the treatment period.
“Stop use and ask a doctor if”—toxicity signs that the consumer should watch out for. The contact information of the manufacturer, distributor or FDA must likewise be included here.
Pregnancy or breastfeeding warning—pregnant and lactating mothers have increased sex hormones in their bodies. The bodily changes can render some drugs ineffective or prone to triggering unwanted side effects among mothers. Meanwhile, drugs that may not harm mothers can affect the children (fetuses, infants) that depend on them for nourishment.
Other required warnings—may include flammability, whether or not the product is for external use only and other precautions that do not fit in the above categories.
“Keep out of reach of children”—a precaution to include to help avoid the drug’s accidental ingestion or overdose in children.
Directions for use—instructions for the drug’s proper use, e. g. preparation, intake route, dosage, etc.
Other pertinent information—includes the following:
Content of the electrolytes sodium, calcium, magnesium, and potassium, which can alter brain, heart and other body functions if taken in excess.
The inclusion of phenylalanine or aspartame, which are fatal to phenylketonurics. Phenylalanine is an amino acid, while aspartame is an artificial sweetener with a chemical structure similar to phenylalanine.
The inclusion of tartrazine (FD&C Yellow No. 5), sulfites and other agents that can trigger allergies.
Inactive ingredients—substances that are not considered drugs, such as binders, softeners, etc.
“Questions?” or “Questions or comments?”—to be followed by the contact information and schedule of people that can answer questions about the product, including its side effects. The manufacturer or distributor’s contact information may be indicated in this section, printed in 6-point bold font. Side effects may be reported to the FDA via the hotline 1-800-FDA-1088.

Guidelines on capitalization, typeface, font size and other ways to make drug label information prominent are also included in 21 CFR 201.

Prescription drugs typically have their details in package inserts. They may use small fonts because of the huge amount of information that patients and healthcare providers need to know about these products. Meanwhile, most OTC meds have all the drug facts written on their primary or secondary packages, as labeling these drugs requires less information.

Learn More:

English is the primary language, so foreign labels must have English translations. Expiration dates must appear on the primary and secondary packaging.

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When Should You Use Barcodes on Pharmaceutical Labels?

Packaging appeal becomes much less important than patient protection when labeling pharmaceutical products. Barcodes are necessary because they help enhance the package’s protective features. They have the following roles:

1. Drug Barcodes Prove that a Drug Product Satisfies FDA Regulations

The FDA assigns a National Drug Code (NDC) number and barcode to each approved prescription drug, OTC medication and insulin product. All prescription drug and insulin product labels must have them. Meanwhile, OTC meds, e. g. acetaminophen and ibuprofen, are required to display them only when they are used in medical facilities.

Manufacturers, repackers, relabelers and private label distributors are responsible for the NDC’s inclusion in labels. Business owners who do nothing to the drug itself are not.

The NDC has a 1D barcode that represents a 10-digit numeric string. It has the following segments:

The labeler code, which identifies the medication’s manufacturer or distributor. It has 4-5 characters.
The product code, which encodes the product. It is 3-4 digits long.
The package code, which represents the trade package size and type. It is 1-2 digits long.

NDC codes can be written in three configurations: 4-4-2, 5-4-1 and 5-3-2. In the FDA’s pharmaceutical database, an asterisk may be added between digits to ensure the NDC codes’ uniqueness.

Hospital drugs must have the NDC on the primary and secondary packaging. The codes help avoid medication errors by letting healthcare providers know if they are giving their patients the right drugs.

2. Drug Barcodes Help Improve Health Data Recording

Manufacturers can use additional barcodes to ensure quality and thoroughness in health data recording. Lot numbers and expiration dates may be included in these barcodes. Such information can help prevent adverse events, thus protecting patients.

3. Drug Barcodes Make Drugs Traceable

From time to time, health authorities may check pharmacies for contaminated or adulterated products. In such cases, serialization can help improve their traceability. Contaminated batches can be chemically analyzed to identify all potential hazards. The FDA can also recall them and investigate if there is a need to stop all future productions.

4. Drug Barcodes Help Prevent Counterfeiting

Cargo thieves often steal pharmaceuticals to sell them in the black or gray market. Once stolen, their packets may be tampered with, and the drugs subsequently replaced by ineffective fakes. Manufacturers can assign random codes to their drug products to stop counterfeiting.

For non-NDC barcodes, the FDA allows the use of 1D or 2D barcoding systems.

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Zebra Compatible Labels 2″ x 1″

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How Can You Ensure the Legibility of Drug Labels?

Ensuring drug label legibility helps you protect consumers and avoid regulatory problems. You can do the following to make certain that your labels clearly explain your drug’s effects and uses:

Follow the FDA’s guidelines in enhancing the prominence of drug label information.
Use labels that can withstand chemical exposure, moisture, UV light and many other environmental factors. BOPP stickers, thermal transfer paper labels and laminated sheet labels can endure these elements and are, therefore, suitable for drug labeling. Use freezer stickers if the product needs cold storage.
Store your labels in a safe place until you’re ready to use them.
Use a printing technology that produces fade-resistant prints. If custom-made labels are out of the question, consider using thermal transfer printers.
The FDA does not have specific rules about printing barcodes. However, it requires the ciphers to remain scannable at all times. You may check out our barcode-printing guide to help you create quality drug barcode labels.
Avoid placing barcodes in perforated or embossed areas to keep them machine-readable at all times.

With these tips, you should be printing FDA-compliant pharmaceutical labels in no time.

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Dymo LabelWriter 4XL

Brother QL 820 NWB

Conclusion

In summary, the FDA sets strict labeling requirements for the pharmaceutical industry. Small business owners’ compliance protects their reputation and consumers’ welfare.

Pharmacies are not the only places that sell drug products, as other retail establishments have them, too. However, prescription and OTC meds require more substantial label information, including drug effects, uses, safety, contraindications, scientific evidence of efficacy, etc. Additionally, they need barcodes to help enhance the labels’ ability to protect consumers from the harms of medication errors.

Lastly, small business owners must ensure the completeness and legibility of their pharmaceutical labels. Our simple guide here can provide a quick check of their drug stickers for information thoroughness and readability.

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Tags: Label Guide

Melodie

A Simple Guide to Making FDA-Compliant Drug Labels

What Is a Drug, and What Products Require Pharmaceutical Labeling?

What Information Is Required on a Drug Label?

When Should You Use Barcodes on Pharmaceutical Labels?

How Can You Ensure the Legibility of Drug Labels?

What Is a Drug, and What Products Require Pharmaceutical Labeling?

What Information Is Required on a Drug Label?

1.

Labeling Requirements for Prescription Drugs

2.