Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1986 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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82 Stat acid administered orally Amount amoxicillin Amprolium animal drug antibiotic application aqueous bacitracin batch for potency body weight capsules cattle caused chapter chickens chloramphenicol chlortetracycline cloxacillin coli data as specified diethylcarbamazine dihydrostreptomycin dilute dogs and cats dose equivalent Federal law restricts follows Food and Drug g/ton gentamicin grams heartworm hydrochloride immediate container include effectiveness data Indications injection labeling licensed veterinarian Limitations ment milk milligrams per pound milliliter mycin NAS/NRC need not include neomycin ointment oxytetracycline P.O. Box package paragraph percent piperazine polymyxin pound of body powder Proceed as directed Related tolerances Requests for certification Requirements for certification residues restricts this drug retort roundworms scheduled process slaughter sodium Specifications spectinomycin Sponsor Standards of identity sterile stock solution streptomycin strongyles Subpart sulfamethazine sulfate swine tablets tains tests and assays Tests and methods tetracy tetracycline tion treat treatment trihydrate tylosin weight per day zeranol
Populāri fragmenti
95. lappuse - ... evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.
55. lappuse - The composition of which Is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
11. lappuse - ... (j) and (k) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking,...
91. lappuse - ... substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and...
91. lappuse - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling...
13. lappuse - ... units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart (see examples in paragraphs (m) (3) and (4) of this section).
55. lappuse - ... if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2...
5. lappuse - ... (3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or Information; (4) Insufficiency of label space (for the prominent placing of such word. statement, or Information) resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency...
95. lappuse - Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved...
525. lappuse - Except where evidence is submitted which justifies use of a different safety factor, a safety factor in applying animal experimentation data to man of 100 to 1, will be used; that is, a food additive for use by man will not be granted a tolerance that will exceed Viooth of the maximum amount demonstrated to be without harm to experimental animals.