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, 1983 - Administrative law Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
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Page 5
... unless oth- erwise noted . SOURCE : 42 FR 15553 , Mar. 22 , 1977 , unless otherwise noted . Subpart A - General Provisions § 1.1 General . ( a ) The provisions of regulations promulgated under the Federal Food , Drug , and Cosmetic Act ...
... unless oth- erwise noted . SOURCE : 42 FR 15553 , Mar. 22 , 1977 , unless otherwise noted . Subpart A - General Provisions § 1.1 General . ( a ) The provisions of regulations promulgated under the Federal Food , Drug , and Cosmetic Act ...
Page 6
... unless such word , statement , or infor- mation also appears on the outer con- tainer or wrapper of the retail package of the article , or , as stated in para- graph ( e ) of this section , such infor- mation is easily legible by virtue ...
... unless such word , statement , or infor- mation also appears on the outer con- tainer or wrapper of the retail package of the article , or , as stated in para- graph ( e ) of this section , such infor- mation is easily legible by virtue ...
Page 14
... unless the new owner has ex- ecuted a bond and obtained a new au- thorization . Any authorization grant- ed under this section shall supersede and nullify any previously granted au- thorization with respect to the article . § 1.97 Bonds ...
... unless the new owner has ex- ecuted a bond and obtained a new au- thorization . Any authorization grant- ed under this section shall supersede and nullify any previously granted au- thorization with respect to the article . § 1.97 Bonds ...
Page 15
... unless the district director is in full agreement with the action . § 1.99 Costs chargeable in connection with relabeling and reconditioning inadmis- sible imports . The cost of supervising the relabel- ing or other action in connection ...
... unless the district director is in full agreement with the action . § 1.99 Costs chargeable in connection with relabeling and reconditioning inadmis- sible imports . The cost of supervising the relabel- ing or other action in connection ...
Page 16
... unless otherwise noted . Subpart A - General Provisions § 2.5 Imminent health . hazard to the public ( a ) Within the meaning of the Fed- eral Food , Drug , and Cosmetic Act an imminent hazard to the public health is considered to exist ...
... unless otherwise noted . Subpart A - General Provisions § 2.5 Imminent health . hazard to the public ( a ) Within the meaning of the Fed- eral Food , Drug , and Cosmetic Act an imminent hazard to the public health is considered to exist ...
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Common terms and phrases
0.2 percent 52 Stat 74 Stat acid Act Record System action Added administrative record advisory committee agency amounts consistent approval available for public batches thereof Bureau cations chapter color additive D&C Color additive mixtures coloring foods coloring purposes conform in identity contain D&C Green D&C Orange D&C Red D&C Yellow Data and information diluents Director and Deputy Dockets Management Branch Drug Administration drug application Effective date confirmed employee Exemption from certification externally applied drugs FD&C Federal Food FEDERAL REGISTER filed food additive Food and Drug hearing Identity and specifications institutional review board issue Lead as Pb listed manufacturing practice medical devices ment metics million mixtures for coloring mixtures prepared therefrom notice paragraph participant petition presiding officer procedures public disclosure public health pursuant recall regulations request restrictions revised safely standards of identity submitted Subpart thereof are exempt tion tive
Popular passages
Page 158 - 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 199 - 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 303 - HALDOL tablets contain FD&C Yellow No 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals, especially in those who have...
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 202 - 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; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research...
Page 148 - For the purposes of sections 205 and 207 of this title, the term "official responsibility" means the direct administrative or operating authority, whether intermediate or final, and either exercisable alone or with others, and either personally or through subordinates, to approve, disapprove, or otherwise direct Government action.
Page 186 - 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 303 - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.
Page 59 - advisory committee" means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof...
Page 211 - IRB records. (a) An institution, or where appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the...