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Title 21 - Title 21
Part 201 - LABELING
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Description
DRUGS: GENERAL - LABELING
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66 sections
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§201.1 - Drugs; name and place of business of manufacturer, packer, or distributor.
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§201.10 - Drugs; statement of ingredients.
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§201.100 - Prescription drugs for human use.
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§201.105 - Veterinary drugs.
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§201.115 - New drugs or new animal drugs.
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§201.116 - Drugs having commonly known directions.
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§201.117 - Inactive ingredients.
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§201.119 - In vitro diagnostic products.
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§201.120 - Prescription chemicals and other prescription components.
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§201.122 - Drugs for processing, repacking, or manufacturing.
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§201.125 - Drugs for use in teaching, law enforcement, research, and analysis.
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§201.127 - Drugs; expiration of exemptions.
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§201.128 - Meaning of “intended uses”.
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§201.129 - Drugs; exemption for radioactive drugs for research use.
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§201.15 - Drugs; prominence of required label statements.
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§201.150 - Drugs; processing, labeling, or repacking.
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§201.16 - Drugs; Spanish-language version of certain required statements.
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§201.161 - Medical gases.
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§201.17 - Drugs; location of expiration date.
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§201.18 - Drugs; significance of control numbers.
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§201.19 - Drugs; use of term “infant”.
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§201.2 - Drugs and devices; National Drug Code numbers.
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§201.20 - Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
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§201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.
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§201.21 - Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
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§201.22 - Prescription drugs containing sulfites; required warning statements.
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§201.23 - Required pediatric studies.
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§201.24 - Labeling for systemic antibacterial drug products.
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§201.25 - Bar code label requirements.
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§201.26 - Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
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§201.300 - Notice to manufacturers, packers, and distributors of glandular preparations.
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§201.301 - Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
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§201.302 - Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
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§201.303 - Labeling of drug preparations containing significant proportions of wintergreen oil.
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§201.304 - Tannic acid and barium enema preparations.
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§201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
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§201.306 - Potassium salt preparations intended for oral ingestion by man.
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§201.307 - Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
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§201.308 - Ipecac syrup; warnings and directions for use for over-the-counter sale.
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§201.309 - Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
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§201.310 - Phenindione; labeling of drug preparations intended for use by man.
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§201.311 - Unknown
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§201.312 - Magnesium sulfate heptahy-drate; label declaration on drug products.
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§201.313 - Estradiol labeling.
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§201.314 - Labeling of drug preparations containing salicylates.
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§201.315 - Over-the-counter drugs for minor sore throats; suggested warning.
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§201.316 - Drugs with thyroid hormone activity for human use; required warning.
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§201.317 - Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
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§201.5 - Drugs; adequate directions for use.
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§201.50 - Statement of identity.
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§201.51 - Declaration of net quantity of contents.
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§201.55 - Statement of dosage.
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§201.56 - Requirements on content and format of labeling for human prescription drug and biological products.
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§201.57 - Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
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§201.58 - Waiver of labeling requirements.
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§201.6 - Drugs; misleading statements.
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§201.60 - Principal display panel.
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§201.61 - Statement of identity.
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§201.62 - Declaration of net quantity of contents.
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§201.63 - Pregnancy/breast-feeding warning.
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§201.64 - Sodium labeling.
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§201.66 - Format and content requirements for over-the-counter (OTC) drug product labeling.
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§201.70 - Calcium labeling.
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§201.71 - Magnesium labeling.
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§201.72 - Potassium labeling.
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§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).
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