Question

1. Describe labeling requirements for Rx, OTC, and dietary supplements.

Answer 1

Drug labeling contains information on genomic biomarkers that describes and provides guidance on drug exposure and clinical response variability, mechanisms of drug action, polymorphic drug target, genotype based dosing, disposition pathways, risk for adverse events, precautions, drug- drug interactions, contraindications and nutritional mangement.   

Labeling requirements for over the counter(OTC) devices:

a) Principal display panel is that portion of the label which is intended to be displayed.presented, shown, or examined under customary conditions for retail sales.

b) Statement of Identity: It lists the common name of the device followed by a statement of its principal intended action.

c) Net quantity of contents statement: This is mentiond in terms of weight, measure, placement and count.

Labeling requirements for dietary supplements:

It includes descriptive name of the product stating that it is a " dietary supplement", the name and place of business of the manufacturer, a list of ingredients and the net contents of the product. It contains nutrition labeling in the form of a " supplement facts" panel which identifies the dietary ingredients contained in the product.