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OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional. 

Similarly, cosmetic products can be considered as OTCs. Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic. Likewise, certain active ingredients can cause a product to be considered a drug owing to their therapeutic use.
OTC products compliant with the OTC drug monograph may be marketed without prior FDA approval.
For example, in the U.S., antidandruff shampoos and sunscreen products  are considered to be OTCs.
OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.

Mérieux NutriSciences can help with cGMP compliance in relation to the following:

  • Method development and validation
  • Quality control
  • Stability testing

For more in-depth information on the analytic services that Mérieux NutriSciences can provide for OTC drugs and cosmetics, please refer to the Pharmaceuticals section. 

 

All our Tests and Services

 Full range of scientific tests to support your safety evaluations.

Clinical evaluations in order to demonstrate the efficacy of your product.

Wide range of chemical and physical analyses of cosmetic products in accordance with ICH guidelines.

Characterization and quantification of microorganisms in final cosmetic and personal care products, in intermediate products and for the control of manufacturing environments. We conduct tests to assess the efficiency of antimicrobial preservation agents, as well as sterility and bioburden tests.

Stability and Period After Opening (PAO)

To ensure that your products meet quality standards when stored under proper conditions, a safety and stability assessment is required. Mérieux NutriSciences provides a full complement of customizable analytical methods in order to respond to customer requirements on a case-by-case basis. 

Stability and Period After Opening (PAO)
OTC Cosmetics

OTC (over-the-counter) medicines are safe and effective drugs used by the general public without prior recourse to a healthcare professional. OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption. 

Mérieux NutriSciences can help with cGMP compliance in relation to the following:

  • Method development and validation
  • Quality control
  • Stability testing
OTC Cosmetics
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