OTC (Over-The-Counter) drugs are also called over-the-counter drugs, and the FDA has also recognized the term "over-the-counter drugs". There are currently nearly 400,000 drugs sold in the United States, of which more than 300,000 are OTC drugs. There are two main ways to obtain drugs in the United States: either prescription drugs based on a doctor's prescription, or consumers purchasing OTC drugs directly.

The increase in health care costs in the United States and the emergence of safer and more effective OTCs have encouraged patients to self-treat illnesses that in the past would have required professional medical treatment. This trend has resulted in increased access to formerly prescribed medicines as these partially prescribed medicines are now included in the over-the-counter range. These over-the-counter medicines provide consumers with a wider range of choices and opportunities.

The first major federal regulation enacted in the United States to regulate drugs was the Federal Food and Drug Act of 1906, but it was not until the passage of the Federal Food, Drug, and Cosmetic Regulations in 1938 that Legally limit the safety of drugs. Legislation for this new law had been under consideration since 1933. Just because people used this newly marketed dapsamide elixir mixed with the toxic solvent glycol, more than 100 people died, many of them children. This incident ultimately led to the formation of the statute. The Federal Food, Drug, and Cosmetic Act of 1938 requires that all new drug products placed on the market after 1938 be demonstrated to be safe for human use before marketing, under what is often referred to as the original provision. Marketed products are not subject to the terms of a New Drug Application (NDA). However, some currently sold OTC drugs, such as aspirin, are still affected by this provision. In addition, when the FDA reviews OTC drugs, it has reviewed the safety, effectiveness, and labeling of all OTC drugs, regardless of whether they are first sold. When is the date. Throughout the new drug application process in the United States, prescription drugs can be reclassified as OTC drugs and retain their new drug status. It can also directly approve new drug applications for OTC drugs (without reclassification), such as isoprofen 200 mg (a dose that has never been used in the prescription). When a new drug has been used by many patients for many years, it can be considered generally recognized as safe and effective. OTC drugs that pass FDA review can also obtain fully recognized status. When the review is completed, all OTC drugs that have not been approved as new drugs will be assigned to the OTC drug monograph (see "The meaning of OTC monograph" for details).

Before the FDA began reviewing OTC drugs in 1972, no unit under the FDA specifically dealt with OTC drugs currently on sale. Initially, DFDA officials helped advisory review groups review the ingredients, labels, and warnings of OTC drugs sold and released the resulting federal documents. In 1977, larger, more formal organizations were formed, including the OTC Drug Review Division of the Center for Drug Evaluation and Research (CDER). However, at that time, most issues related to new drugs (including reclassification and applications) were handled in one of the Center for Drug Evaluation and Research's new drugs divisions rather than by the OTC drug division.

The OTC Drug Evaluation Department was reorganized into the OTC Drug Evaluation Office in 1991. It complements the work of the New Drug Review Division, which handles new drug applications and prescription drug conversions. It includes a monograph reviewer, a medical reviewer and a pharmaceutical policy staff. They are designated to also raise OTC drug issues such as prescription-to-OTC drug transitions, new OTC drugs, international harmonization, and necessary monitoring of health care spending.

2. Since the last OTC drug advisory group was disbanded in 1981, there has been no dedicated advisory group to routinely examine OTC issues. OTC ingredients are sometimes reviewed by a standing prescription drug advisory panel.

In 1991, the FDA announced the establishment of the Over-the-counter Drugs Advisory Committee to review and evaluate the safety and effectiveness of OTC drugs, and to serve as a place for exchange of opinions when converting various prescription drugs to over-the-counter drugs.

A core committee of 10 people with extensive experience and expertise was established. The members are knowledgeable in internal medicine, obstetrics and gynecology, dermatology, epidemiology, pharmacy, clinical pharmacology, pediatrics and related professional fields. expert. When discussing a certain topic, the core committee can invite experts from other FDA committees who have expertise in this issue to participate in the discussion. For example, when considering topical formulations, several dermatology experts may be invited. The new committee also includes a consumer representative and a non-voting industry liaison. The first meeting was held in December 1992 to consider the pharmaceutical effects of alcohol in OTC products, and smaller doses were prescribed for drugs intended for oral administration.

In recent years, the U.S. Food and Drug Administration (FDA) has made new regulations on OTC drug labels in order to standardize the labels of OTC drugs sold in the U.S. market and reduce the abuse of OTC drugs. It is estimated that 170,000 patients are hospitalized each year due to OTC drug abuse, resulting in approximately $7.5 billion in wasted treatment costs. Researchers found that half of OTC abuse incidents could be avoided by regulating labeling to strengthen consumer guidance on taking medications. Regulation: The basic contents of all OTC drugs must appear on the label in order, and the text should be easy to understand. The drug-related contents that must appear on the label are: active ingredients; usage; precautions; medication instructions; adverse drug reactions and other information. The new regulations stipulate six different label types, which manufacturers can freely choose according to the shape and size of their products. The regulation will have a two-year trial period. The FDA will also implement a program aimed at strengthening consumers' common sense about taking OTC drugs, especially for children, special care needs, and the elderly. This work will be jointly undertaken by the Over-the-Counter Drug Industry Association and the National Drug Store Association***