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To be included in the OTC Drug Review a product’s formulation and labeling must have existed in the marketplace in the United States on or before December 4, 1975, or be the subject of a final agency determination under 21 CFR 330.14. Pending a final monograph/rule, the Agency does not object to the marketing of products that meet both the formulation and labeling requirements described in the proposed rule. Such marketing, however, is subject to the risk that a final rule may require reformulation and/or relabeling or FDA approval through the “new drug” procedures of Section 505 of the FD&C Act (21 U.S.C. § 355).
We reiterate that silane quaternary ammonium chloride is not proposed as an active ingredient in the proposed rules/Tentative Final Monographs for topical antimicrobials. Nor does it appear to be otherwise included under the OTC Drug Review. Therefore, no topical antimicrobial product that includes silane quaternary ammonium chloride as an active ingredient is marketable under the OTC Drug Review even if the product includes an antimicrobial active ingredient that is covered under the OTC Drug Review.
We further note that according to 21 CFR 201.66(b)(2), an “active ingredient” means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.
This communication does not constitute a written advisory opinion under 21 CFR 10.85, but rather is an informal communication under 21 CFR 10.85(k) which represents the best judgement of the employee providing it. This information does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the Agency to the views expressed.
It is the responsibility of firms that manufacture drug products to comply with all requirements of federal law and FDA regulations, and to ensure that its drug products are safe and effective and do not violate the provisions of the Federal Food, Drug, and Cosmetic Act.