In the United States, production and sale of OTC products are regulated by the Food and Drug Administration (FDA): this Agency requires that manufacturing and control of OTCs comply with cGMP practices (Current Good Manufacturing Practice). Products that are not classified as drugs in the EU might be considered as OTCs in the US according to their real use and other characteristics.

Certain cosmetic products can be considered OTC products when they are characterized by:

• claims that can lead to think that the product is a drug even though it is marketed as a cosmetic item
• active principles that can lead to think that the product is a drug due to its therapeutic use.

Some examples

• Sun screen products
• Sun filters
• Skin care
• Makeup (with indications on sun protection)
• Deodorants (antiperspirants)
• Anti-dandruff
• Anti-ageing

OTC products must be manufactured and controlled according to cGMP requisites for pharmaceuticals intended for human consumption. We can offer the following support:

• Cleaning validation
• Development and validation of methods
• Microbiological and chemical and physical quality control
• Challenge test
• Stability studies
• Photostability studies
• Sample storage
• Tests on USP and OTC monographies
• Regulatory consultancy and support