Please evaluate the labeling and formulation of your drug merchandise to ensure that they are formulated and labeled in accordance with the proposed rule above, or in any other case eligible for marketing in the United States under the FD&C Act. Such advertising, nevertheless, is subject to the risk that a final rule may require reformulation, relabeling, or FDA approval by way of the “new drug” procedures of part 505 of the FD&C Act 21 U.S.C. We have not carried out an entire formulation and labeling examination of all your products. Pending a final monograph/rule, FDA does not object to the advertising of products that meet both the formulation and labeling necessities described in the proposed rule. OTC drug products intended as are being evaluated under ongoing rulemaking for OTC Topical Drug Products as part of FDA’s OTC Drug Review.
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