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, 1981 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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accordance acid administered amended Amount ampicillin Amprolium animal drug animal feed antibiotic application aqueous Arsanilic acid bacitracin bacterial body weight buffer cattle chapter chloramphenicol chlortetracycline cloxacillin coccidiosis Conditions dihydrostreptomycin dosage forms dose erythromycin facturing or feeding Federal law restricts feed containing feed efficiency feeding practice follows food additive Food and Drug g/ton grams grams per pound horses hydrochloride immediate container Indications ingredient injection labeling licensed veterinarian Limitations manu ment milligrams milligrams per pound milliliter monensin mycin neomycin novobiocin ointment oral Oxytetracycline P.O. Box package paragraph percent phosphate polymyxin potassium pound of body premix procaine penicillin Proceed as directed promotion and feed recognized as safe Related tolerances Requirements for certification residues restricts this drug retort revised roxarsone sample sodium solution Specifications Sponsor Standards of identity Stat sterile streptomycin Subpart substance sulfate swine tablets tains Tests and methods tetracycline tion treatment tylosin veterinarian
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Страница 73 - ... 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.
Страница 129 - ... were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug...
Страница 65 - Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture, processing, or packing thereof in any locality, be injurious to health...
Страница 14 - If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.
Страница 548 - ... may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use> . and...
Страница 17 - Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English. (2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon In the foreign language. (3) If...
Страница 125 - 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...
Страница 125 - ... to determine whether such drug is safe for use under such conditions. In making this determination the Commissioner shall consider, among other relevant factors: (i) The probable consumption of such drug and of any substance formed in or on food because of the use of such drug; (ii) The cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substances; (iii) Safety factors which, in the opinion of experts qualified by scientific training...
Страница 534 - Where a petition is received for the issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a food additive in such definition and standard of identity, the provisions of the regulations in this part shall apply with respect to the information that must be submitted with respect to the food additive. Since section 409 (b) (5) of the act requires...
Страница 128 - ... 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.