Abstract

REGULATORY LABELLING REQUIREMENTS AND ITS COMPARISON IN USA AND CANADA

Krupa C. Thula*, Harita K. Odedra and Dr. Dilip G. Maheshwari

ABSTRACT

Labels are beneficial description of the products which is very useful for the consumers to distinguish the goods from others. Consequently, these are the unique identity of the product. Now a day, it becomes a habit of most of the population to see the product label before they go for purchase. An excellent design, description and posture also influence the buyers and consumers. This article describe about various regulatory requirements for different dosage forms with precautions in USA and Canada according to their code of regulations and comparison of labelling requirement in both countries. In the USA, The content & format requirements of labelling for human prescription drug & biological products comes under 21 CFR 201.56(d) & 201.57. In the Canada, Labelling of Pharmaceutical Drugs for Human Use replaces the Health Canada guidance document labelling of Drugs for Human Use. In 1989, this guidance document came into effect, was revised in 1991, Health Canada had remove it from circulation because most of its content was deemed to be out-of-date. The inner label affixed to an immediate container of the drug. The outer label includes any label affixed to the drug packaging, including a pouch, card, accordion label, or other construct.

Keywords: Study, Labelling, Requirements, USA, Canada and Comparison.