American Custom Technologies is often requested to produce topical patches which are a combination of already FDA-monographed OTC drugs and new ingredients.
**We would be delighted to produce your OTC drugs in compliance with FDA monograph regulations.**
We will not produce products which we know are likely to be subject to FDA compliance actions – including recalls and fines. We cannot do so in good conscience. We know that other manufacturers do so – but we pride ourselves in the quality of our work, and we are, as an FDA registered facility, subject to FDA audits.
We asked an FDA representative directly about this and were told:
Please be aware that one of the factors that are considered when reviewing a product to determine whether it is a drug is by the intended use, an example of this is ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.
Though the product may not be labeled specifically stating a certain use, this product would appear to be a drug product and must comply with FDA drug regulations.
The manufacture or marketing of unapproved drugs in the U.S. is subject to FDA compliance actions.
Some of our most commonly requested FDA monographed OTC drugs are: Menthol, Capsaicin, Wintergreen (aka Methyl Salicitate), Lidocaine, and Camphor. We are an FDA registered facility, and we would be happy to manufacture products which are in compliance with the current FDA monograph regulations.
Here is a helpful link from the FDA about OTC drugs, and what they are – and are not: https://www.accessdata.fda.gov/scripts/cder/training/OTC/topic2/topic2/da_01_02_0030.htm
We recommend that our customers who are interested in producing products combining already monographed drugs and other active ingredients begin the process of a New Drug Application – including investing in experienced legal representation.