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[2007 Index Page]

 

Title 21 - Food and Drugs

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

PART 201 - LABELING


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.
201-50 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.
201-60 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.
201-100 Prescription drugs for human 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.
201-150 Drugs; processing, labeling, or repacking.
201-161 Carbon dioxide and certain other gases.
201-200 Disclosure of drug efficacy study evaluations in labeling and advertising.
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.
201-312 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.
201-319 Water-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.
201-320 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.

 

 

 

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