CGMP

• All drugs distributed in the United States must be manufactured in accordance with standards called good manufacturing practices (GMP), and the FDA inspects manufacturing facilities before a drug can be approved.
  
  

FDA Regulation

• The Food and Drug Administration has industry-specific guidelines for everything from food packaging to appropriate procedures for testing of new drugs. These guidelines are available at the FDA website. If a company does not follow the FDA guidelines or fails to pass inspection, the product can still be released to the public; the FDA cannot stop the product from being released.
  
  

FDA Recall

• If the failure to meet cGMPs results in the distribution of a defective drug, the FDA will request the company to voluntarily recall the product. This is usually sufficient, but if a company refuses to recall a drug, the FDA can warn the public and, if it is not then recalled, could seize the drugs that are on the market.