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Executive Summary

ESTROGEN PATIENT PACKAGE INSERTS MUST ACCOMPANY PRODUCT throughout distribution channels, FDA said in a final rule on estrogen PPIs published in the May 4 Federal Register. The agency currently requires that PPIs accompany estrogen products through trade channels, but had proposed relaxing that requirement in an Oct. 9, 1987 notice. FDA is retaining the distribution requirement, the final rule explains, because the agency "agrees [with comments] that the proposed change in distribution requirements may increase the likelihood that some patients may not receive the patient package insert." The agency "also agrees that discontinuing the requirement that the patient package insert be included in or with each dispensed package will increase the likelihood that patients will not receive the required information," FDA added. Like the proposed rule, the final document relaxes the PPI labeling requirements by identifying the type, but not specifics, of information that must be included. Under the rule, manufacturers must include statements about the benefits, proper use, contraindications and risks of estrogen therapy. The PPI should also include information on how a patient may reduce the risks of estrogen use as well as include identifying information (i.e., name of drug and name and address of manufacturer). In a same day Federal Register notice, FDA announced that it is revoking its guideline texts for professional and patient labeling of estrogen products. In place of the labeling guidelines, FDA will provide "informal labeling guidance texts to assist persons in meeting labeling requirements." The agency explained that it "has decided to issue informal guidance texts rather than guidelines to enable manufacturers and others to receive the most current information available to the agency in the most timely manner possible." The guidances, FDA noted, are "informal documents...[that] do not bind or otherwise obligate the agency or a person referring to them."

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