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FEDERAL · 21 CFR

Part 201 — Labeling

75 sections · Title 21: Food and Drugs

§ 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.
§ 201.50Statement of identity.
§ 201.51Declaration of net quantity of contents.
§ 201.55Statement of dosage.
§ 201.56Requirements on content and format of labeling for human prescription drug and biological products.
§ 201.57Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
§ 201.58Waiver of labeling requirements.
§ 201.60Principal display panel.
§ 201.61Statement of identity.
§ 201.62Declaration of net quantity of contents.
§ 201.63Pregnancy/breast-feeding warning.
§ 201.64Sodium labeling.
§ 201.66Format and content requirements for over-the-counter (OTC) drug product labeling.
§ 201.67Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
§ 201.70Calcium labeling.
§ 201.71Magnesium labeling.
§ 201.72Potassium labeling.
§ 201.80Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1).
§ 201.100Prescription drugs for human use.
§ 201.105Veterinary drugs.
§ 201.115New drugs or new animal drugs.
§ 201.116Drugs having commonly known directions.
§ 201.117Inactive ingredients.
§ 201.119In vitro diagnostic products.
§ 201.120Prescription chemicals and other prescription components.
§ 201.122Drugs for processing, repacking, or manufacturing.
§ 201.125Drugs for use in teaching, law enforcement, research, and analysis.
§ 201.127Drugs; expiration of exemptions.
§ 201.128Meaning of “intended uses”.
§ 201.129Drugs; exemption for radioactive drugs for research use.
§ 201.130Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
§ 201.150Drugs; processing, labeling, or repacking.
§ 201.161Medical gases.
§ 201.200Disclosure of drug efficacy study evaluations in labeling and advertising.
§ 201.300Notice to manufacturers, packers, and distributors of glandular preparations.
§ 201.301Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
§ 201.302Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
§ 201.303Labeling of drug preparations containing significant proportions of wintergreen oil.
§ 201.304Tannic acid and barium enema preparations.
§ 201.305Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
§ 201.306Potassium salt preparations intended for oral ingestion by man.
§ 201.307Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
§ 201.308Ipecac syrup; warnings and directions for use for over-the-counter sale.
§ 201.309Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
§ 201.310Phenindione; labeling of drug preparations intended for use by man.
§ 201.311§ 201.311 [Reserved]
§ 201.312Magnesium sulfate heptahydrate; label declaration on drug products.
§ 201.313Estradiol labeling.
§ 201.314Labeling of drug preparations containing salicylates.
§ 201.315Over-the-counter drugs for minor sore throats; suggested warning.
§ 201.316Drugs with thyroid hormone activity for human use; required warning.
§ 201.317Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
§ 201.319Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
§ 201.320Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
§ 201.323Aluminum in large and small volume parenterals used in total parenteral nutrition.
§ 201.325Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
§ 201.326Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
§ 201.327Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
§ 201.328Labeling of medical gas containers.