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, 1990 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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acid administered amended Amount amoxicillin Amprolium animal drug animal feed antibiotic approved aqueous bacitracin bacterial Bambermycins batch for potency body weight cattle chapter chickens chloramphenicol chlortetracycline cloxacillin coccidiosis coli Commissioner daily dihydrostreptomycin dilute dosage forms dose Drug Administration edible tissues erythromycin Federal law restricts feed efficiency flavor Food and Drug g/ton gentamicin grams horses intended hydrochloride Indications ingredient injection labeling licensed veterinarian Limitations manufacture ment milk milligrams milligrams per pound milliliter mycin NAS/NRC neomycin novobiocin number of milligrams ointment oral oxytetracycline P.O. Box package paragraph PCB's percent polymyxin pound of body procaine penicillin Proceed as directed records Related tolerances Requirements for certification residues restricts this drug retort roxarsone sample scheduled process slaughter sodium Specifications Sponsor Standards of identity sterile streptomycin strongyles submitted Subpart sulfamethazine sulfate swine tablets tains Tests and methods tetracy tetracycline tion treat treatment trihydrate tylosin veterinarian
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Страница 92 - ... 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.
Страница 17 - 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 74 - 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 74 - ... for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Страница 92 - Its identity, strength, quality, and purity and 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 64 - 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 577 - ... 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 88 - 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 565 - 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 88 - ... 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...