The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1993 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.–5. rezultāts no 92.
5. lappuse
... prepared from or with a virus or agent actually or po- tentially infectious , without regard to the degree of virulence or toxicogeni- city of the specific strain used . ( ii ) To a therapeutic serum , if com- posed of whole blood or ...
... prepared from or with a virus or agent actually or po- tentially infectious , without regard to the degree of virulence or toxicogeni- city of the specific strain used . ( ii ) To a therapeutic serum , if com- posed of whole blood or ...
6. lappuse
... prepared from or with the aid of a biological product . ( k ) Proper name , as applied to a product , means the name designated in the license for use upon each pack- age of the product . ( 1 ) Dating period means the period beyond ...
... prepared from or with the aid of a biological product . ( k ) Proper name , as applied to a product , means the name designated in the license for use upon each pack- age of the product . ( 1 ) Dating period means the period beyond ...
8. lappuse
... prepared prior to use for sterile operations . Re- frigerators , incubators and warm rooms shall be maintained at tempera- tures within applicable ranges and shall be free of extraneous material which might affect the safety of the ...
... prepared prior to use for sterile operations . Re- frigerators , incubators and warm rooms shall be maintained at tempera- tures within applicable ranges and shall be free of extraneous material which might affect the safety of the ...
11. lappuse
... safety and potency , except Whole Blood , Cryoprecipitated AHF , Plate- lets , Red Blood Cells , Plasma , and Source Plasma and Allergenic Prod- ucts prepared to a physician's 11 Food and Drug Administration , HHS § 600.13.
... safety and potency , except Whole Blood , Cryoprecipitated AHF , Plate- lets , Red Blood Cells , Plasma , and Source Plasma and Allergenic Prod- ucts prepared to a physician's 11 Food and Drug Administration , HHS § 600.13.
12. lappuse
... prepared to a physician's pre- scription . Samples so retained shall be selected at random from either final container material , or from bulk and final containers , provided they include at least one final container as a final package ...
... prepared to a physician's pre- scription . Samples so retained shall be selected at random from either final container material , or from bulk and final containers , provided they include at least one final container as a final package ...
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Bieži izmantoti vārdi un frāzes
8800 Rockville Pike amended at 49 animals antibody antigen applicable Authority citation biological product Biologics Evaluation Blood Group cell cultures Center for Biologics chapter collection cosmetic product Cryoprecipitated date of manufacture Department dilution Director donor dose Drug Administration establishment Evaluation and Research Federal Food final product Food and Drug Globulin guinea pigs hepatitis B surface human Immune ingredient injection inoculated introductory text least manufac measles virus ment metic mice milliliter monkeys monovalent virus pool mumps virus nomenclature change Office package label panel paragraph percent plasmapheresis Platelets Poliovirus Poliovirus Vaccine Potency test prepared prescribed procedures processing prod proper name reagents Red Blood Cells Reference requirements Rockville Pike rubella virus safety Schick Test serum source material Source Plasma statement sterile strain Subpart surface antigen tainer temperature tion tissue culture ture U.S. Standard unit Virus Vaccine Live volume Whole Blood
Populāri fragmenti
6. lappuse - State or possession, any virus, therapeutic serum, toxin, antitoxin, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man...
18. lappuse - Jan. 25, 1977] § 601.25 Review procedures to determine , ,that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use. For purposes of reviewing biological products that have been licensed prior to July 1, 1972, to determine that they are safe and effective and not misbranded, the following regulations shall apply. Prior administrative action...
22. lappuse - Mar. 26, 1990] § 601.26 Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
191. lappuse - The statement of the place of business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP Code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP Code shall appear either on the label or the labeling (including invoice).
192. lappuse - The declaration shall appear as a distinct item on the principal display panel, shall be separated (by at least a space equal to the height of the lettering used In the declaration) from other printed label information appearing above or below the declaration and (by at least a space equal to twice the width of the letter "N...
189. lappuse - Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon removal from such processing, labeling, or repacking establishment.
30. lappuse - ... could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system. (b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.
192. lappuse - ... under pressure, the declaration shall state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is included in the net quantity declaration.
21. lappuse - Investigations may be corroborated by partially controlled or uncontrolled studies, documented clinical studies by qualified experts, and reports of significant human experience during marketing. Isolated case reports, random experience, and reports lacking the details which permit scientific evaluation will not be considered.
97. lappuse - Type 3 virus. (d) Labeling. In addition to the items required by other applicable labeling provisions of this part, the final container label shall bear a statement indicating that liquid vaccine may not be used for more than 7 days after opening the container. Labeling may include a statement indicating that for frozen vaccine a maximum of 10 freeze-thaw cycles is permissible provided the total cumulative duration of thaw does not exceed 24 hours, and provided the temperature does not exceed 8°...