Label Requirements for Human Drug Products

About 1.5 million preventable drug errors occur every year in the U.S., according to a white paper presented to the American College of Physicians Foundation in 2007. Americans take a growing number of both prescription and over-the-counter (OTC) drug products today. The average number of prescription medications the average adult takes is seven to 10. Elderly Americans take from 19 to 27 different human drug products.



Drug label requirements are of great concern because as many as half the adults in the U.S. have limited health literacy skills and the differences in wording and styles of labels on human drug products can be difficult for many to understand. The FDA has been working to make drug labels more uniform and understandable.

FDA Regulations for Prescription Medication Labels

• There are as many as 50 different drug label types, based on state regulations.

  The Food and Drug Administration (FDA) requires that all prescription drug labels contain the name of the drug, the name and address of the pharmacy dispensing the drug, and the serial or lot number for that batch of medication.

  Additional label requirements include the doctor's name, the patient's name and instructions for use.

Insert Labeling Requirements

• Additonal information must be provided other than what is on the container label.

  The FDA also requires that prescription drugs come with informational inserts or added paperwork that includes a summary of the scientific evidence supporting the medicine's use as a human drug product, the conditions it is used for and the contraindications for use (when it should not be used).

  Dosages, strength and the expiration date must be listed. Side effects, interactions with other drugs, dependency information, and storage and handling must be included on prescription human drug products.

  The drug must come with a list of ingredients and certain ingredients must bear additional warnings, such as medications that include certain food dyes, aspartame and sulfites.

OTC Label Requirements

• Over-the-counter drugs also have labeling requirements.

  Over-the-counter )OTC) human drug products also have label requirements. They must have detailed usage and warning information, an ingredient list and state the purpose of the products. The directions for different ages and populations must be on the label as well as information about storage and specific ingredients, such as the amount of sodium it may contain.

  OTC drug labels also contain the expiration date, the batch or lot number, the name and address of the manufacturer, and overdose information.