Americans expect and deserve consistent healthcare product labeling, no matter what state they buy or use the items in. It is in every citizen's best interest for the federal government to retain authority over safety labeling standards. Centralized regulation removes variability and guarantees the reliability of health data listed on consumer product packaging from coast to coast.
The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.
This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).
FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.
The following information on botanical ingredients should be included in either a bulk botanical raw material specification sheet (for business-to-business transactions) or finished product labeling (when selling directly to consumers).
To address the growing need for more information on dietary supplements available in the market, the Office of Dietary Supplements at the National Institutes of Health has developed the Dietary Supplement Label Database. This valuable resource compiles comprehensive information obtained from the labels of dietary supplement products sold in the United States.
Under a voluntary program which began in November 2007, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines.
As a direct result of the PROTECT initiative, CHPA developed a voluntary guideline for industry suggesting ways to standardize volumetric measures in dosing directions and dosing devices for oral pediatric liquid drug products.