Meeting labeling requirements of various drug products

[Adam Fleming]

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act) are the laws that manufacturers of these products need to comply with in order to meet labeling requirements of these products. These laws are separately made for a number of products and their subcategories, such as drugs, cosmetics, cosmetics that are also drugs, and so on. In addition, the regulations set out by the EMA also need to be complied with by manufacturers of these products, if they plan to market to the EU markets.

One of the elementary requirements of the FDA is that the ingredients of the cosmetics must be declared prominently. By this definition, the prominence should be such that users should be able to see the declaration when they purchase and see the product. The FDA prescribes that the letters in the ingredient declaration should be not less than 1/16 of an inch in height. In cases where the total package surface available for labeling is less than 12 sq. inches, the height of the letters must be at least 1/32 of an inch.

Particular about the specifications

The FDA also requires that the ingredients must be declared in descending order of importance. Color additives must be declared too, but does not require an order of prominence. The active ingredients, as well as the additives, must be clearly declared. Labels should carry warnings when they carry ingredients that are likely to cause damage to some or another part of the body. Products such as aerosols, deodorant sprays used by females, and soaps and other cosmetics used by children have their own labeling requirements.

If all this is a snapshot of the only the prominent labeling requirements for just cosmetics, imagine the kind and variety of requirements that need to be met for all other related products such as medical devices, drugs, vitamin supplements and many others. And what about understanding the EMA’s requirements?

Knowledge of the labeling requirements of the products need not be intimidating, because this is the content of a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Learning session on labeling

The speaker at this webinar is Salma Michor, who is founder and CEO of Michor Consulting Schweiz GmbH, which serves such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. The full extent of Salma’s experience will come into play at this webinar. To register for this session and to benefit from the wealth of Salma’s experience, please register by logging on to Labeling Drug Products

This webinar will focus its attention on the ways by which to remain compliant with the labeling requirements of the various regulatory bodies vis-à-vis a number of products. Salma will explain the challenges associated with remaining compliant with the labeling requirements of products such as generics, prescription drugs, OTC drugs, medical devices, vitamin supplements, traditional herbal remedies, foods, cosmetics and biocides, and will suggest ways of dealing with them. She will focus in particular on the EU requirements for labeling of these products. Regulatory Affairs and labeling specialists will understand the intricate details of the labeling requirements for these products at this webinar.