Historical Perspective
The food and drug program began over 100 years ago when the Republic of Hawaii adopted the Pure Food and Drug Law in 1898. The Bureau of Pure Food and Drugs was established to enforce the law. The initial law was broadened in 1941 when the Hawaii Food, Drug and Cosmetic Act was passed, and circa 1962, the Bureau of Pure Food and Drugs became the Food and Drug Branch. The branch became part of the Department of Health's Environmental Health Division, now known as the Environmental Health Services Division (EHSD).

Food and Drug is a statewide regulatory program with a large and diverse area of responsibility. It safeguards public health by ensuring that:

a. Food, drugs, cosmetics, medical devices, and related consumer products are safe and properly labeled; and

b. Poisonous household substances and prescription drugs are packaged in child-resistant containers when required.

The drugs that are regulated by the branch include over-the-counter, prescription, and generic drugs. Medical devices include a wide array of medical products that range from simple devices such as hearing aids and condoms, to sophisticated devices such as heart replacement valves, to controversial devices such as breast implants.

The Branch inspects establishments that manufacture, store, distribute and sell these products. In addition, the branch operates proactively and invests a considerable amount of time working with industry to prevent problems from developing; e.g., providing assistance through technical consultation and evaluations, reviewing operational processes and labels, along with other prevention techniques.

Organizational Structure
The Branch consists of the program manager, a prescription drug program specialist, a data management/training specialist, 3 inspection sections, and a clerical support section.
The data management/training specialist manages the branch’s data system and conducts the statewide training of branch personnel.
The prescription drug program specialist is responsible for ensuring that: all prescription drugs are safe and effective; drugs are dispensed according to valid prescriptions from authorized practitioners; drugs are dispensed with proper labeling to ensure use according to directions; and generic drugs are safe and therapeutically equivalent to brand name drugs.
The three inspectional sections consist of:

The Monitoring Section which implements the food sampling/monitoring program for pesticide residues and other chemical contaminants.

Compliance Section I which is responsible for implementing the food and drug inspection program on the neighbor islands and rural Oahu.

Compliance Section 2 which is responsible for implementing the food and drug inspection program in central Oahu.

Legal Authority
The food and drug program enforces the following chapters of the Hawaii Revised Statutes (HRS):

• Chapter 328, Food, Drugs and Cosmetics;
• Chapter 328C, Donated Drugs;
• Chapter 328D, Bottled Water;
• Chapter 328E, Intoxicating Compounds;
• Chapter 330, Sale of Poisons;
• Chapter 330C, Hawaii Poison Prevention Packaging Act; and parts of
• Chapter 321, Department of Health.
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  The program also enforces the following Hawaii Administrative Rules (HAR):
  
  
• HAR 11-12, Food Establishment Sanitation;
• HAR 11-29, Food and Food Products (numerous federal food rules have been adopted in this chapter);
• HAR 11-33, Hawaii Drug Formulary of Equivalent Drug Products;
• HAR 11-35, Shellfish Sanitation; and
• HAR 11-36, Sale of Prophylactics Through Vending Machines.