Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 201: Labeling

Section No. Description
Section 201.1 Drugs and devices; National Drug Code numbers
Section 201.2 Drugs; adequate directions for use
Section 201.5 Drugs; misleading statements
Section 201.6 Drugs; statement of ingredients
Section 201.10 Drugs; prominence of required label statements
Section 201.15 Drugs; Spanish-language version of certain required statements
Section 201.16 Drugs; location of expiration date
Section 201.17 Drugs; significance of control numbers
Section 201.18 Drugs; use of term ``infant''
Section 201.19 Declaration of presence of FD&C; Yellow No
Section 201.20 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use
Section 201.21 Prescription drugs containing sulfites; required warning statements
Section 201.22 Required pediatric studies
Section 201.23 Labeling for systemic antibacterial drug products
Section 201.24 Bar code label requirements
Section 201.25 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile
Section 201.26 Statement of identity
Section 201.50 Declaration of net quantity of contents
Section 201.51 Statement of dosage
Section 201.55 Requirements on content and format of labeling for human prescription drug and biological products
Section 201.56 Specific requirements on content and format of labeling for human prescription drug and biological products described in
Section 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described
Section 201.57 Waiver of labeling requirements
Section 201.58 Principal display panel
Section 201.60 Statement of identity
Section 201.61 Declaration of net quantity of contents
Section 201.62 Pregnancy/breast-feeding warning
Section 201.63 Sodium labeling
Section 201.64 Format and content requirements for over-the-counter (OTC) drug product labeling
Section 201.66 Calcium labeling
Section 201.70 Magnesium labeling
Section 201.71 Potassium labeling
Section 201.72 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not
Section 201.80 Prescription drugs for human use
Section 201.100 Veterinary drugs
Section 201.105 New drugs or new animal drugs
Section 201.115 Drugs having commonly known directions
Section 201.116 Inactive ingredients
Section 201.117 In vitro diagnostic products
Section 201.119 Prescription chemicals and other prescription components
Section 201.120 Drugs for processing, repacking, or manufacturing
Section 201.122 Drugs for use in teaching, law enforcement, research, and analysis
Section 201.125 Drugs; expiration of exemptions
Section 201.127 Meaning of ``intended uses''
Section 201.128 Drugs; exemption for radioactive drugs for research use
Section 201.129 Drugs; processing, labeling, or repacking
Section 201.150 Carbon dioxide and certain other gases
Section 201.161 Disclosure of drug efficacy study evaluations in labeling and advertising
Section 201.200 Notice to manufacturers, packers, and distributors of glandular preparations
Section 201.300 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations
Section 201.301 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil
Section 201.302 Labeling of drug preparations containing significant proportions of wintergreen oil
Section 201.303 Tannic acid and barium enema preparations
Section 201.304 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings
Section 201.305 Potassium salt preparations intended for oral ingestion by man
Section 201.306 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale
Section 201.307 Ipecac syrup; warnings and directions for use for over-the-counter sale
Section 201.308 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement
Section 201.309 Phenindione; labeling of drug preparations intended for use by man
Section 201.310 Magnesium sulfate heptahydrate; label declaration on drug products
Section 201.312 Estradiol labeling
Section 201.313 Labeling of drug preparations containing salicylates
Section 201.314 Over-the-counter drugs for minor sore throats; suggested warning
Section 201.315 Drugs with thyroid hormone activity for human use; required warning
Section 201.316 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning
Section 201.317 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium
Section 201.319 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting
Section 201.320 Aluminum in large and small volume parenterals used in total parenteral nutrition
Section 201.323 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required
Section 201.325 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and
Section 201.326 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing
Section 201.327 Prescription-drug advertisements