Compliance in the Pharmaceutical Industry

The pharmaceutical industry is heavily regulated by state and federal laws. The U.S. Food and Drug Administration also provides guidelines to the pharmaceutical industry pertaining to manufacturing and labeling requirements. Pharmaceutical companies, researchers and pharmacists are expected to adhere to the compliance standards established in their industry.

Function

• The Office of Inspector General, of the U.S. Department of Health and Human Services, instituted a compliance program for the pharmaceutical industry. The program is designed to set standards and expectations for how pharmaceutical companies develop, manufacture and market their drugs.

Purpose

• Compliance regulations are developed to ensure and enhance the safety of consumers who use pharmaceutical products. Accordingly, pharmacy compliance standards are in place for areas such as laboratory contamination control, quality testing control, clinical trials and research, ingredients, and labeling.

Effects

• Having pharmaceutical compliance standards in place decreases the amount of medication recalls, as well as reduces the number of reported adverse medication reactions. It also minimizes the potential for unethical practices.

Warning

• Without compliance programs, pharmaceutical companies would not have any regulations to abide by in terms of the ingredients they use in their products or how they choose to label their medication bottles.