Both over-the-counter and ethical, or prescription-only, drug products manufactured in the United States and throughout most of the world must be made according to the Good Manufacturing Practices (GMPs), promulgated and enforced by the FDA. Each lot of active and inactive raw material, containers, and closures received in a plant is sampled and tested before it can be used in a pharmaceutical product. The products are made according to strictly written batch records. Qualified pharmacists measure, check, and recheck each step in the manufacturing. The batch is sampled, tested, and approved before it is released for shipment to drug wholesalers, hospitals, and pharmacies. All drug products carry an expiration date on the package label, which informs the user as to the product's duration of potency. Each drug manufacturer must register a list of each product it makes with the FDA. Every two years the FDA inspects the manufacturer for compliance with federal regulations.
Over-the-counter pharmaceuticals are sold in retail pharmacies and drug departments in a variety of retail establishments. These products include vitamins, cough and cold remedies, laxatives, analgesics, antiseptics, antacids, and contraceptives. Ethical pharmaceutical products are sold only on a prescription order from a physician or dentist and are dispensed by a pharmacist. The information concerning a product is provided to the physician and the pharmacist by the company's medical-service representative. Some of the prescription-only classes of drugs are antiinfectives, sedatives, ataractics, antispasmodics, cardiovascular drugs and antihypertensives, analgesics, and hormones.