Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

PART 201--LABELING

TEXT PDF201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
TEXT PDF201.2 Drugs and devices; National Drug Code numbers.
TEXT PDF201.5 Drugs; adequate directions for use.
TEXT PDF201.6 Drugs; misleading statements.
TEXT PDF201.10 Drugs; statement of ingredients.
TEXT PDF201.15 Drugs; prominence of required label statements.
TEXT PDF201.16 Drugs; Spanish-language version of certain required statements.
TEXT PDF201.17 Drugs; location of expiration date.
TEXT PDF201.18 Drugs; significance of control numbers.
TEXT PDF201.19 Drugs; use of term ``infant''.
TEXT PDF201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
TEXT PDF201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
TEXT PDF201.22 Prescription drugs containing sulfites; required warning statements.
TEXT PDF201.23 Required pediatric studies.
TEXT PDF201.24 Labeling for systemic antibacterial drug products.
TEXT PDF201.25 Bar code label requirements.
TEXT PDF201.50 Statement of identity.
TEXT PDF201.51 Declaration of net quantity of contents.
TEXT PDF201.55 Statement of dosage.
TEXT PDF201.56 General requirements on content and format of labeling for human prescription drugs.
TEXT PDF201.57 Specific requirements on content and format of labeling for human prescription drugs.
TEXT PDF201.58 Requests for waiver of requirement for adequate and well-controlled studies to substantiate certain labeling statements.
TEXT PDF201.59 Effective date of 201.56, 201.57, 201.100(d)(3), and 201.100(e).
TEXT PDF201.60 Principal display panel.
TEXT PDF201.61 Statement of identity.
TEXT PDF201.62 Declaration of net quantity of contents.
TEXT PDF201.63 Pregnancy/breast-feeding warning.
TEXT PDF201.64 Sodium labeling.
TEXT PDF201.64 Sodium labeling.
TEXT PDF201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
TEXT PDF201.70 Calcium labeling.
TEXT PDF201.71 Magnesium labeling.
TEXT PDF201.72 Potassium labeling.
TEXT PDF201.100 Prescription drugs for human use.
TEXT PDF201.105 Veterinary drugs.
TEXT PDF201.115 New drugs or new animal drugs.
TEXT PDF201.116 Drugs having commonly known directions.
TEXT PDF201.117 Inactive ingredients.
TEXT PDF201.119 In vitro diagnostic products.
TEXT PDF201.120 Prescription chemicals and other prescription components.
TEXT PDF201.122 Drugs for processing, repacking, or manufacturing.
TEXT PDF201.125 Drugs for use in teaching, law enforcement, research, and analysis.
TEXT PDF201.127 Drugs; expiration of exemptions.
TEXT PDF201.128 Meaning of ``intended uses''.
TEXT PDF201.129 Drugs; exemption for radioactive drugs for research use.
TEXT PDF201.150 Drugs; processing, labeling, or repacking.
TEXT PDF201.161 Carbon dioxide and certain other gases.
TEXT PDF201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.
TEXT PDF201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
TEXT PDF201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
TEXT PDF201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
TEXT PDF201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
TEXT PDF201.304 Tannic acid and barium enema preparations.
TEXT PDF201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
TEXT PDF201.306 Potassium salt preparations intended for oral ingestion by man.
TEXT PDF201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
TEXT PDF201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
TEXT PDF201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
TEXT PDF201.310 Phenindione; labeling of drug preparations intended for use by man.
TEXT PDF201.312 Magnesium sulfate hepta&chyph;hy&chyph;drate; label declaration on drug products.
TEXT PDF201.313 Estradiol labeling.
TEXT PDF201.314 Labeling of drug preparations containing salicylates.
TEXT PDF201.315 Over-the-counter drugs for minor sore throats; suggested warning.
TEXT PDF201.316 Drugs with thyroid hormone activity for human use; required warning.
TEXT PDF201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
TEXT PDF201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carb&chyph;oxymethyl&chyph;cellu&chyph;lose sodium, carrageenan, chondrus, gluco&chyph;man&chyph;nan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), poly&chyph;carbo&chyph;phil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
TEXT PDF201.320 Warning statements for drug products containing or manufactured with chloro&chyph;fluoro&chyph;carbons or other ozone-depleting substances.
TEXT PDF201.322 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required alcohol warning.
TEXT PDF201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.

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