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, 1984 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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52 Stat 90 Stat accessories amended ance standards antibodies antigens application blood Cardiopulmonary bypass catheter cell chapter Class II perform Class III premar Classification clude Commissioner complaint files components consist of antigens controls determine device intended device is exempt device that consists diagnostic diathermy Drug Administration electrical electrode electronic product emission equipment Federal fetal fluid Food and Drug hearing aid hemodialysis hemoglobin heparin human Immunoglobulin immunological test system implanted intended for medical intraocular lens investigational study ket approval labeling laser product lens manufacturing practice means medical device medical purposes ment monitor pacemaker package panel paragraph patient person platelet practice regulation premarket notification procedures pressure procedures in Subpart protein quirements concerning records radiation reagents are devices requirements respect to complaint Secs Sept serological reagents serum specific spect sponsor statement sterile submitted Subpart tion tissue transducer tube type of device ultrasonic uterus
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345. lappuse - Milk is the whole, fresh, clean, lacteal secretion obtained by the complete milking of one or more healthy cows, properly fed and kept, excluding that obtained within 15 days before and 5 days after calving, or such longer period as may be necessary to render the milk practically colostrum free.
13. lappuse - 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 of label...
17. lappuse - ... shall be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fractions of the pound...
14. lappuse - principal display panel" means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for retail sale.
13. lappuse - All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the...
51. lappuse - label" means a display of written, printed, or graphic matter upon the immediate container of any substance; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears...
18. 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 frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
83. lappuse - The risks to the subject are so outweighed by the sum of the benefits to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks...
19. lappuse - If a shipment or delivery, or any part thereof, of a drug or device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such...
285. lappuse - The cost of such supervision shall include, but not be restricted to, the following: (a) Travel expenses of the supervising officer. (b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law. (c) Services of the supervising officer, to be calculated at a flat...