Monograph Reform

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This proposed Safety Administrative Order (AO) is only for the single ingredient propylhexedrine.

Learn about CHPA's current slate of federal legislative priorities including OTC regulatory reform, dietary supplement regulation modernization, supply chain and product integrity, and more.

FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.

This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).

FDA Announcement of a proposed safety-based Administrative Order to update the pregnancy warning labeling for NSAID-containing drug products.

Explore consultants who can assist with communications, regulatory policy, strategy, operations, compliance, product development, and more.

Learn about the OTC review process, drug monographs, and time and extent applications.

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