The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1989 - Administrative law 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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Page 18
... responsibility to demonstrate that he can perform the method prop- erly through the use of positive and negative controls and recovery and re- producibility studies . ( Sec . 707 , 57 Stat . 500 ; 21 U.S.C. 377 ) [ 42 FR 15559 , Mar. 22 ...
... responsibility to demonstrate that he can perform the method prop- erly through the use of positive and negative controls and recovery and re- producibility studies . ( Sec . 707 , 57 Stat . 500 ; 21 U.S.C. 377 ) [ 42 FR 15559 , Mar. 22 ...
Page 52
... Responsible individual " includes those in positions of power or author- ity to detect , prevent , or correct viola- tions of the Federal Food , Drug , and Cosmetic Act . ( e ) [ Reserved ] ( f ) " Product " means an article sub- ject ...
... Responsible individual " includes those in positions of power or author- ity to detect , prevent , or correct viola- tions of the Federal Food , Drug , and Cosmetic Act . ( e ) [ Reserved ] ( f ) " Product " means an article sub- ject ...
Page 53
... responsibility for the manufac- ture and marketing of the product to be recalled . ( j ) " Market withdrawal " means a firm's removal or correction of a dis- tributed product which involves a minor violation that would not be sub- ject ...
... responsibility for the manufac- ture and marketing of the product to be recalled . ( j ) " Market withdrawal " means a firm's removal or correction of a dis- tributed product which involves a minor violation that would not be sub- ject ...
Page 54
... and distributors carry out their responsibility to protect the public health and well - being from products that present a risk of injury or gross deception or are otherwise de- fective . This 54 $ 7.40 21 CFR Ch . I ( 4-1-89 Edition )
... and distributors carry out their responsibility to protect the public health and well - being from products that present a risk of injury or gross deception or are otherwise de- fective . This 54 $ 7.40 21 CFR Ch . I ( 4-1-89 Edition )
Page 55
... responsible firms may ef- fectively discharge their recall respon- sibilities . These sections also recognize that ... responsibility for the manufacture and marketing of the product that is to be recalled . ( c ) Recall is generally ...
... responsible firms may ef- fectively discharge their recall respon- sibilities . These sections also recognize that ... responsibility for the manufacture and marketing of the product that is to be recalled . ( c ) Recall is generally ...
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Common terms and phrases
52 Stat Act Record System administrative record advisory committee agency amended 21 U.S.C. amended at 54 animal drug approval authorized available for public cation CBER CDER CDRH chapter chlorofluorocarbon Color additive mixtures coloring purposes Commissioner of Food conform contain copy Cosmetic Act D&C Red decision Deputy Direc determination diluents Director and Deputy Division Dockets Management Branch documents Drug Administration drug application Drug Evaluation employee environmental established Evaluation and Research Exemption from certification FD&C Federal Food FEDERAL REGISTER filed following officials food additive Food and Drug functions interested person issue label listed manufacturing practice matter medical devices meeting ment ministration notice Office of Compliance oral package Packaging and Labeling paragraph participant percent petition presiding officer Privacy Act Record procedures proceeding proposed public disclosure pursuant recall regulations regulatory request requirements sioner submission submitted Subpart tion tive
Popular passages
Page 167 - A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.
Page 217 - food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food...
Page 6 - label" means a display of written, printed, or graphic matter upon the immediate container of any article ; 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 on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (1) The...
Page 193 - Provided, however , that if any individual is denied any right, privilege, or benefit that he would otherwise be entitled "by Federal law, or for which he would otherwise be eligible, as a result of the maintenance of such material, such material shall be provided to such individual...
Page 220 - A statement that the study Involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental...
Page 220 - An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject...
Page 64 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 227 - Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members...
Page 54 - The application of a guaranty or undertaking referred to in section 303 (c) (2) of the Act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes...
Page 196 - September 27, 1975. (h) Rights of Legal Guardians. For the purposes of this section, the parent of any minor, or the legal guardian of any individual who has been declared to be incompetent due to physical or mental incapacity or age by a court of competent jurisdiction, may act on behalf of the individual.