 | 1965 - 1520 pages
...new-drug application or required as a condition for its certification or exemption from certification ; and (ii) The same information concerning the ingredients...cannot be prepared, shall be exempt from section 502 (f)(l) of the act if all the following conditions are met: (1) The device is: (1) (a) In the possession... | |
 | 1972 - 488 pages
...the labeling are consistent with and not contrary to such approved or permitted labeling; and (il) The same Information concerning the ingredients of...cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the followine conditions are met: (1) The device is: (I) (a) In the possession... | |
 | 1967 - 406 pages
...drug Is to be dispensed; Provided, however, That the information required by subdivisions (i) and (11) of this subparagraph is not required on the so-called...cannot be prepared, shall be exempt from section 502 (f)(l) of the act if all the following conditions are met: (1) The device is: (1) (a) In the possession... | |
 | 1971 - 748 pages
...by subdivisions (i) and (il) of this subparagraph is not required on the so-called reminder- piece labeling which calls attention to the name of the...cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the following conditions are met: (1) The device is: (i) (a) In the possession... | |
 | 1963 - 1124 pages
...cartons, bearing information for use of the drug also bears the date of the is§1.106 §1.106 suance or the date of the latest revision of such labeling....cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the following conditions are met: (1) The device is: (1) (a) In the possession... | |
 | 1964 - 1242 pages
...the drug also bears the date of the Issuance or the date of the latest revision of such labeling. (8) A prescription drug intended for both human and veterinary...cannot be prepared, shall be exempt from section 502 (f) (1) of the act if all the following conditions are met: (I) The device is: (1) (a) In the possession... | |
 | 1974 - 258 pages
...dru? also beers the date of the Issuance or the date of the latest revision of such labeling. (в) A prescription drug Intended for both human and veterinary...use" cannot be prepared, shall be exempt from section 509 <f)(l) of the act if all the following conditions are met: (1) The device Is: (I) (a) In the possession... | |
 | 1956 - 1164 pages
...scientific literature widely disseminated among veterinarians licensed by law to administer such drug. (d) Exemption for prescription devices. A device which,...cannot be prepared, shall be exempt from section 502 (f) (1) of the act If all the following conditions are met : (1) The device is in the possession of... | |
 | 1977 - 334 pages
...shall not be unreasonably large. Subpart D — Exemptions From Adequate Directions for Use § 801.109 Prescription devices. A device which, because of any...cannot be prepared, shall be exempt from section 502 (f)(l) of the act if all the following conditions are met: (a) The device is: (1Xi) In the possession... | |
 | 2001 - 756 pages
...part 82. [61 FR 20101. May 3, 1996] Subpart D— Exemptions From Adequate Directions for Use §801.109 Prescription devices. A device which, because of any...use" cannot be prepared, shall be exempt from section 502(f)(l) of the act if all the following conditions are met: (a) The device is: (lnii In the possession... | |
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A prescription drug intended for both human and veterinary use shall comply with paragraph (b) of this section and subparagraphs (4) and (5) of this paragraph. (d) Exemption for prescription devices. A device which, because of any potentiality for harmful... 
