General Labeling Provisions | Midpage

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Code of Federal Regulations

Subpart A

General Labeling Provisions

201.1Drugs; name and place of business of manufacturer, packer, or distributor.201.2Drugs and devices; National Drug Code numbers.201.5Drugs; adequate directions for use.201.6Drugs; misleading statements.201.10Drugs; statement of ingredients.201.15Drugs; prominence of required label statements.201.16Drugs; Spanish-language version of certain required statements.201.17Drugs; location of expiration date.201.18Drugs; significance of control numbers.201.19Drugs; use of term “infant”.201.20Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.201.21Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.201.22Prescription drugs containing sulfites; required warning statements.201.23Required pediatric studies.201.24Labeling for systemic antibacterial drug products.201.25Bar code label requirements.201.26Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.