What Information Should Be on Drug Labels?

The regulations are different for prescription and over-the-counter drugs.

Here is an easy-to-understand walkthrough of the guidelines.

Labeling requirements for prescription drugs

On the primary product label:

• Statement of identity
• Brand name
• Net quantity of contents
• Statement of dosage

Prescription drugs must be accompanied by complete prescribing information, which includes instructions for safe use as well as scientific evidence of safety and efficacy. These specifics could be included in the package insert. They must not be deceptive and contain promotional language.

Here are some examples:

• Boxed warning
• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in a specific population (explains the drug’s applications in certain groups, such as children, pregnant women, and the elderly)
• Drug abuse and dependence
• Controlled substance
• Overdosage
• Description
• Ingredients
• 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, which is found during experiments involving human and nonhuman tissue samples of dead persons)
• Clinical studies (summarizes the evidence supporting the drug’s safety and efficacy in humans)
• References (this section cites relevant literature that supports the drug’s effects)
• Storage and handling information
• Patient counseling information

Labeling requirements for over-the-counter medications

Over-the-counter (OTC) medications do not typically require a prescription, but they may be included in patients' charts for symptomatic treatment by healthcare providers. When taken in the recommended amounts, they have a low potential for abuse and are safe.

OTC drugs do not need package inserts if their labels are large enough to include all the necessary information.

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

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

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

• Active ingredient
• Purpose
• Uses
• Warnings
• Contraindications
• Other required warnings
• Directions for use
• Other pertinent information
• Inactive ingredients
• Questions or comments should be followed by the contact information and availability of people who can answer questions about the product, including its side effects. This section may include contact information for the manufacturer or distributor.

Package inserts for prescription drugs typically contain information about the drugs. Because there is so much information that patients and healthcare providers need to know about these products, they may use small fonts. However, because labeling these drugs requires less information, most OTC medications have all the drug facts written on their primary or secondary packaging.

The U.S. Food and Drug Administration (FDA) is the government agency in charge of setting dispensing guidelines, inspecting drugs, and conducting research for new drugs. Their approval determines whether a drug is available to consumers, and their recommendations cover most medications.

The Drug Enforcement Administration is the government agency in charge of enforcing the rules and guidelines that govern how prescription drugs are handled in the United States. This includes prescription guidelines and other dispensing issues, as well as standards for how drugs are monitored, inventoried, and moved.

The U.S. Drug Enforcement Administration (DEA) and FDA collaborate to develop and enact legislation on drug handling and, in this case, packaging and information. Certain information must be included on a prescription drug label.

The FDA requires prescription labeling to be printed with:

• Pharmacy information
• The doctor’s information
• Instructions
• Physical description of the drug
• Federal caution statement
• Dates
• Pharmacy prescription number
• Number of pills
• Number of times the drug can be reordered

The federal caution is a statement required by the DEA that is used to determine whether a drug is being used by the person for whom it was prescribed. The purpose of prescription drug warning labels is to deter abuse.

It is illegal to remove a warning label from a prescription drug package.

The U.S. Food and Drug Administration (FDA) clearance process for a novel medicine might take anywhere from five to twenty years.

Preclinical research (animal studies) is the first step, followed by the submission of an investigational new drug (IND) application to commence clinical studies testing efficacy and safety in humans, and the submission of a new drug application to seek regulatory approval (NDA).

Preclinical testing

• The toxicity, pharmacokinetics, and metabolism of the chemical are investigated at this phase of the study.
• Drug qualities, such as chemical composition, stability, and solubility, are determined.

Investigational New Drug (IND) application

• Following the completion of the preclinical research, the company submits an Investigational New Drug (IND) application.
• The document covers not only all known information about the substance (drug production parameters, chemical makeup, and behavior) but also the proposed plan for human trials.

Clinical trials

There are four phases:

1. Phase I: About 20 to 100 volunteers with the target illness condition are involved. This will take several months of specialized research to determine the safe and appropriate dosages of the new medicine. Approximately 70 percent of medications submitted for human trials will be approved.
2. Phase II: A few dozen to as many as 300 persons are involved. The goal of this phase of clinical research is to determine the efficacy of the proposed treatment as well as to compile a list of side effects that may occur because of its administration. This phase can last anywhere from a few months to two years. Only 33 percent of drugs will pass.
3. Phase III: A large-scale effort involving thousands of volunteers with the clinical condition that the drug is intended to treat. The goal here is to keep an eye on the drug's safety and efficacy.
4. Phase IV: Phase IV clinical trials (post-marketing surveillance) include thousands of people. It is mainly done to find the adverse event profile of the drug.

New Drug Application (NDA) application

The FDA review teams submit evaluation reports along with recommendations to the FDA's administrative arm, which approves or rejects the NDA.

Drug labeling

The FDA will examine a potential new drug's labeling and packaging to ensure that appropriate and accurate information is communicated to both healthcare personnel and regular customers.

Facility inspection

• An FDA team inspects the manufacturing facilities at the site where the drug will be manufactured.
• This is a standard procedure in the drug approval process.

After fulfilling these steps, the FDA approves the drug.