Labels Used by Pharmaceutical Companies

The manufacture and distribution of licensed pharmaceuticals is an area which requires strict quality controls, as well as a high degree of supervision. Drug labeling requirements are put in place to ensure the proper handling and distribution of controlled substances. These processes provide a means for tracking and transferring of accurate information between companies, agencies and consumers.

Identification

• The need to control how drugs are manufactured and marketed has brought about some pretty tight legislation regarding how prescription labels appear. Drug shipments made by pharmaceutical companies are required to follow strict packaging and labeling guidelines. Regulations and policies are put in place by the U.S. Food & Drug Administration and other agencies to inform and protect the consumer, as well as prevent the manufacture of counterfeit drugs and illegal trafficking. These requirements also work to prevent medical errors within the many levels of the health care system.

FDA Labeling Regulations

• The Prescription Drug and Marketing Act of 2006 requires pharmaceutical companies to include certain types of information on prescription labels. Information required includes dosage instructions, drug name, dosage amounts and possible side effects. In addition, inserts containing drug information and instructions for use are also required within the packaging materials. These procedures are put in place to regulate distribution channels, as well as drug safety and effectiveness. Information contained on the label also restricts how drug shipments can be marketed within the health care system.

Standards

• In order to meet federal regulatory requirements, pharmaceutical companies employ a number of procedures within the manufacturing and packaging of controlled substances. These procedures determine how labels and materials are inspected and tracked within the manufacturing process. Inspection processes include multiple checkpoints wherein inspectors are required to validate and sign-off on each item. Prior to shipping, each item receives its own final inspection to verify all inspection levels have signed off, and to ensure package labeling and contents meet regulatory standards.

Marketing

• When marketing newly approved drugs, government regulations require pharmaceutical companies to label their items according to a specified format. This format is designed to provide access of needed information by health care practitioners. In addition, any marketing messages must be directed according to the information that appears on the label in regards to drug purpose and use. This mandate was put in place to prevent pharmaceutical companies from exploiting the health care industry through false representation of product use.

Considerations

• The FDA enacted the Food Drug & Cosmetic Act in 1951. This legislation requires different labeling guidelines for different classifications of drugs. As a result, prescription medications have stricter labeling requirements than over-the-counter, or OTC drugs. This has resulted in higher costs for pharmaceutical companies to meet the labeling requirements for prescription medications. These requirements address the need to be able to track, regulate and contain controlled substances within the consumer market.