This blog is for informational purposes only. All drug labels should follow current FDA regulations. Label Tech Inc. is not an authority on FDA regulations. For FDA regulations click here.
A recent poll reveals that 60 percent of people using prescription drugs have made errors in taking medications. An estimated 100,000 people in the US die every year because of medication errors. These deaths are preventable and better pharmaceutical labels may be one of the best methods of prevention. The quality of the labeling is extremely important to the patient's perception of the quality of the product and may have profound implications for his or her safe use of the medication and compliance with the prescribed regimen.
This blog will examine some of the requirements for drug labels.
The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. The FDA divides that responsibility into two phases: pre-approval (pre-market) and post-approval (post-market). New drug labels must be submitted in the pre-approval stage of FDA testing.
Drug labeling refers to all of the printed information that accompanies a drug, including the label, the wrapping and the package insert. The FDA regulation that is required to appear on a drug label depends upon the regulatory classification of the drug. Prescription (Rx) finished drugs have very different (and much more comprehensive) drug label requirements than active pharmaceutical ingredients (APIs). Similarly, there are very different requirements for over the counter drug labels than for homeopathic or prescription (Rx) drug labels.
The FDA requires that drug labeling be balanced and not misleading. The label must be scientifically accurate and provide clear instruction to health care practitioners for prescription drugs and to consumers for over the counter drugs. Labeling regulations require that the statement of ingredients include all ingredients, in descending order of predominance in the drug. These ingredients must also be identified by their established name.
In evaluating prescription drug labels, the FDA looks at the overall usefulness of the information that accompanies the drug. The name of the medicine along with any critical warnings must be given top billing. The label must describe the uses of the medicine along with the conditions under which the medicine should not be used. The consumer must be given directions for the contraindications, for example, "Talk to your health care professional before taking this medication if any of these apply to you."
Under FDA regulations, the label must describe foods, drugs and activities that the patient should avoid while taking the medication, along with any related precautions. The drug manufacturer must spell out the symptoms of any adverse reactions to the drug. The FDA requires the manufacturer to collect this information. If the patient faces any risk of drug tolerance or dependency while taking the drug, the label must contain a warning.
The label must also contain clear instructions for the correct use of the medication, including dosage and the required procedure in the event of a missed dose. This description should cover any special instructions, such as taking the medicine with food or water. In addition, the label should spell out storage instructions and general instructions, such as discussing questions with a health professional, because the label is not intended to be all-inclusive. The label should warn of the danger of giving the drug to someone other than the patient.
Drug labels also detail another serious safety issue: potentially dangerous side effects that can occur if a drug is taken concurrently with another medication. These so-called interactions are noted in the highlights section of the label. Less important and less frequent risks are also listed farther down on the label.
When designing a drug label, be sure to consult the FDA for current drug labeling requirements.