The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1963 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.0 percent 85 percent acetate acid added amended application bacitracin bear the statement calcium calcium chloride chapter cheese chloride Chlortetracycline colby cheese color concentration contains not less corn sirup Cosmetic D&C Red definition and standard dihydrostreptomycin dilute dosage dried extract Federal Food flask flavoring food additive food packaging food-handling equipment fruit glucose sirup glycol grams gredients hydrochloride juice July label shall bear label statement less than 85 ment methyl milligrams milliliter mixture Moisture neomycin number of milligrams number of units optional ingredients oysters packing paperboard phosphate buffer polymyxin potassium potency prepared Proceed as directed process cheese quantity represented to contain rubber and rubber rubber products salt sample sirup skim milk sodium solids solution sorbic acid spice standard of identity statement of optional streptomycin subparagraph substance sugar sulfate tetracycline tion titanium trichloride titration tolerances for residues units per milliliter
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49. lappuse - That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
19. lappuse - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and fre-quency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented...
496. lappuse - He shall also specify in his order the time within which objection to the authenticity of such documents must be made to comply with paragraph (d) of this section. (c) Documentary evidence not submitted in advance in accordance with the requirements of paragraphs (a) and (b) of this section shall not be received in evidence in the absence of a clear showing that the offering party had good cause for his failure to produce the evidence sooner. (d) The authenticity of all documents submitted in advance...
25. lappuse - The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling.
515. lappuse - Caution — If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.
6. lappuse - The existence of a difference of opinion, among experts qualified by scientific training and experience, as to the truth of a representation made or suggested in the labeling is a fact (among other facts) the failure to reveal which may render the labeling misleading, if there Is a material weight of opinion contrary to such representation.
24. lappuse - An exemption of a shipment or other delivery of a drug or device under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such subparagraph.
492. lappuse - It is understood that when this application is approved, the labeling and advertising for the drug will prescribe, recommend, or suggest its use only under the conditions stated in the labeling which Is part of this application; and if the article Is a prescription drug, it is understood that any labeling which furnishes or purports to furnish information for use or which prescribes, recommends, or suggests a dosage for use of the drug will...
322. lappuse - The date used for computing the 90-day limit for the purposes of section 409(c) (2) of the act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to submit the sample. If the information or sample Is requested a reasonable time in advance of the 180 days, but Is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice. (k...
320. lappuse - English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation Is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified. If the petitioner does not himself perform...