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Over the Counter Drug Monographs and Cosmetics – Part 1

We’ve looked at the definitions of cosmetics, drugs, and cosmetic drugsFDA-monographs in the past, and listed cosmetics that have FDA monographs.  So, we thought we’d give more background on monographs and what they mean for cosmetic formulators.

Historical background

Before the Federal Drug Administration (FDA) existed most drugs were available without prescription. Unscrupulous individuals could bottle anything and sell it as a miracle cure. In 1938 the Food, Drug, and Cosmetic (FD&C) Act gave the FDA authority to issue regulations and was amended to clarify the difference between over-the-counter (OTC) and prescription drugs. OTC drugs are thought to be generally safe and effective (GRAS) and can be sold without prescription.

The Monograph Process

The monograph process has three phases each requiring publication in the Federal Registrar (FR), the official publication of the United States government which contains t contains government agency rules, proposed rules, and public notices. The first phase is a review by advisory panels. The panels determine whether or not fit GRAS criteria and are safe for self-use. The panel also reviews claims and recommends labeling. The findings of the panel are published in the Federal Registrar as an advanced notice of rule making (ANPR) which is followed by a period of time is allotted for public comment.

The panel classifies ingredients into three categories:

Category I – Generally safe and effective for claimed therapeutic indication

Category II – Not generally recognized as safe and effective or unacceptable indications

Category III – Insufficient data to permit final classification

Phase two is an assessment by the FDA including the panel review from phase one along with public comments and inclusion of any new data that has become available. The agency then publishes its conclusions in the FR as a tentative final monograph (TFM). Again, there is a period of time set aside for additional comments and data to be submitted from the public.

The final phase is publication of the monograph. After the monograph is published, products containing active ingredients not included in the monograph require a new drug application or a time and extent application which requires that the ingredient have demonstrated safe use in markets outside the US for at least 5 years. While monographs can be updated, it’s often a very long process. There are currently 8 ingredients that have been waiting for approval for the sunscreen monograph, some since 2002.

In part 2 we will look at the parts of an OTC monograph.

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