Labeling Requirements for Over-the-Counter Drugsįormat and content requirements for over-the-counter (OTC) drug product labeling. Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). ![]() Requirements on content and format of labeling for human prescription drug and biological products. Labeling Requirements for Prescription Drugs and/or Insulin Labeling for systemic antibacterial drug products.Įxceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. ![]() Prescription drugs containing sulfites required warning statements. ![]() 6 in certain drugs for human use.ĭeclaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. Drugs name and place of business of manufacturer, packer, or distributor.ĭrugs and devices National Drug Code numbers.ĭrugs prominence of required label statements.ĭrugs Spanish-language version of certain required statements.ĭeclaration of presence of FD&C Yellow No.
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