Pure Food and Drug Act

FDA requires the following information on all OTC labels

Active ingredient Uses Warnings Inactive ingredients Purpose Directions Other Information

The FDA has the power to.....?

Approve or deny new drug applications to ensure conformity to standards, approve experimental use of new drugs on humans, and to ensure that all approved drugs are safe and effective.

Adulterate

Changing the physical condition of a drug or device, if the strength or quality differs from the one stated on the label.

Prescription

Drug order, or instructions provided by a medical practitioner that authorizes that the patient to be provided with medication

Over-The-Counter (OTC)

Drug that doesn't need a prescription to dispense. Advil and tylenol are examples. Most people can buy OTC drugs.

Legend drugs

Drugs that need a prescription to dispense and only a licensed practitioner can prescribe or dispense them. Other than doctors, professionals allowed to prescribe drugs differ from state to state. SBP of each state dictates laws regarding legend drugs.

Durham-Humphrey Amendment of 1951

Established a set criteria for classifying prescription and nonprescription drugs and specified which medication could be refilled without a prescription. This amendment could also prohibit dispensing legend drugs without a prescription.

in addition the FDA requires the label to include

Expiration date. when applicable lot or batch code (manufacturer info to help identify the product) name and address of manufacturer, pack or distributer net quantity of contents (how much of the product is in each package) what to do if an overdose occurs

Other Information

How to store the product properly and required information about certain ingredients, such as the amount of calcium, potassium, or sodium the product contains.

Misbrand

Incorrect representation of the drug made by the manufacturer, may have false or misleading labels, or may be missing warnings or have not very good directions.

Food, Drug, and Cosmetic Act (FDCA) of 1938

Made the Food and Drug Administration (FDA)

Food and Drug Administration (FDA)

Made to ensure foods are pure and safe to eat; drugs and medical devices are safe and effective; cosmetics don't cause harm. This version of the act required pharmacy manufacturers to file new drug applications which could be approved or denied.

Purpose

Product action or category; such as antihistamine, antacid, or cough suppressant.

Pure Food and Drug Act of 1906

Prohibited the manufacture, sale, or transportation of misbranded foods and drugs. In 1912 congress modified the act to ban false statements about healing powers of drugs, it also attached the Sherley Amendment , which required and regulated drug labeling.

Directions

Specific age categories, how often and how long, how much to take and when.

inactive Ingredients

Substances such as colors or flavors.

Uses

Symptoms or diseases the product will treat or prevent.

Active Ingredient

Therapeutic substance in a product; the amount of active ingredient per unit.

Warnings

When to not use the product; conditions that may require advice from a doctor before use; possible side effects; when to stop taking product and talk to a doctor, EXAMPLES: if pregnant or breastfeeding seek guidance from a healthcare professional; out of reach from children

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects