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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter C - Drugs: General |
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Part 201 - Labeling |
| Subpart A - General Labeling Provisions |
| § 201.1 - Drugs; name and place of business of manufacturer, packer, or distributor. |
| § 201.2 - Drugs and devices; National Drug Code numbers. |
| § 201.5 - Drugs; adequate directions for use. |
| § 201.6 - Drugs; misleading statements. |
| § 201.10 - Drugs; statement of ingredients. |
| § 201.15 - Drugs; prominence of required label statements. |
| § 201.16 - Drugs; Spanish-language version of certain required statements. |
| § 201.17 - Drugs; location of expiration date. |
| § 201.18 - Drugs; significance of control numbers. |
| § 201.19 - Drugs; use of term “infant”. |
| § 201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use. |
| § 201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use. |
| § 201.22 - Prescription drugs containing sulfites; required warning statements. |
| § 201.23 - Required pediatric studies. |
| § 201.24 - Labeling for systemic antibacterial drug products. |
| § 201.25 - Bar code label requirements. |
| § 201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile. |
| Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin |
| § 201.50 - Statement of identity. |
| § 201.51 - Declaration of net quantity of contents. |
| § 201.55 - Statement of dosage. |
| § 201.56 - Requirements on content and format of labeling for human prescription drug and biological products. |
| § 201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1). |
| § 201.58 - Waiver of labeling requirements. |
| § 201.59 - Effective date of 201.56, 201.57, 201.100(d)(3), and 201.100(e). |
| Subpart C - Labeling Requirements for Over-the-Counter Drugs |
| § 201.60 - Principal display panel. |
| § 201.61 - Statement of identity. |
| § 201.62 - Declaration of net quantity of contents. |
| § 201.63 - Pregnancy/breast-feeding warning. |
| § 201.64 - Sodium labeling. |
| § 201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling. |
| § 201.70 - Calcium labeling. |
| § 201.71 - Magnesium labeling. |
| § 201.72 - Potassium labeling. |
| § 201.80 - Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1). |
| Subpart D - Exemptions From Adequate Directions for Use |
| § 201.100 - Prescription drugs for human use. |
| § 201.105 - Veterinary drugs. |
| § 201.115 - New drugs or new animal drugs. |
| § 201.116 - Drugs having commonly known directions. |
| § 201.117 - Inactive ingredients. |
| § 201.119 - In vitro diagnostic products. |
| § 201.120 - Prescription chemicals and other prescription components. |
| § 201.122 - Drugs for processing, repacking, or manufacturing. |
| § 201.125 - Drugs for use in teaching, law enforcement, research, and analysis. |
| § 201.127 - Drugs; expiration of exemptions. |
| § 201.128 - Meaning of “intended uses”. |
| § 201.129 - Drugs; exemption for radioactive drugs for research use. |
| Subpart E - Other Exemptions |
| § 201.150 - Drugs; processing, labeling, or repacking. |
| § 201.161 - Medical gases. |
| Subpart F - Labeling Claims for Drugs in Drug Efficacy Study |
| § 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising. |
| Subpart G - Specific Labeling Requirements for Specific Drug Products |
| § 201.300 - Notice to manufacturers, packers, and distributors of glandular preparations. |
| § 201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations. |
| § 201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil. |
| § 201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil. |
| § 201.304 - Tannic acid and barium enema preparations. |
| § 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings. |
| § 201.306 - Potassium salt preparations intended for oral ingestion by man. |
| § 201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale. |
| § 201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale. |
| § 201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement. |
| § 201.310 - Phenindione; labeling of drug preparations intended for use by man. |
| § 201.311 - [Reserved] |
| § 201.312 - Magnesium sulfate heptahydrate; label declaration on drug products. |
| § 201.313 - Estradiol labeling. |
| § 201.314 - Labeling of drug preparations containing salicylates. |
| § 201.315 - Over-the-counter drugs for minor sore throats; suggested warning. |
| § 201.316 - Drugs with thyroid hormone activity for human use; required warning. |
| § 201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning. |
| § 201.320 - Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances. |
| § 201.322 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required alcohol warning. |
| § 201.323 - Aluminum in large and small volume parenterals used in total parenteral nutrition. |
| § 201.325 - Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information. |
| § 201.326 - Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling. |
| § 201.327 - Over-the-counter sunscreen drug products; required labeling based on effectiveness testing. |
| § 201.328 - Labeling of medical gas containers. |
| Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA |