 | 1965 - 1520 pagini
...advertised or represented; and if the article is subject to section 505 or 507 of the act, the labeling providing such information is substantially the same...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 pagini
...the labeling are consistent with and not contrary to such approved or permitted labeling; and (il) The same Information concerning the ingredients of...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 of a person (or his agents... | |
 | 1971 - 748 pagini
...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...of the act if all the following conditions are met: (1) The device is: (i) (a) In the possession of a person (or his agents or employees) regularly and... | |
 | 1967 - 406 pagini
...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... | |
 | 1963 - 1124 pagini
...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....of the act if all the following conditions are met: (1) The device is: (1) (a) In the possession of a person (or his agents or employees) regularly and... | |
 | 1974 - 258 pagini
...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 pagini
...scientific literature widely disseminated among veterinarians licensed by law to administer such drug. (d) Exemption for prescription devices. A device which,...of the act If all the following conditions are met : (1) The device is in the possession of a person (or his agents or employees) regularly and lawfully... | |
 | 1977 - 334 pagini
...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 pagini
...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... | |
 | 1991 - 620 pagini
...shall not be unreasonably large. Subpart D — Exemptions From Adequate Directions for Use § 801.109 Prescription devices. A device which, because of any...device, and hence for which "adequate directions for useo cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions... | |
| |
... recommendations for use of the drug. (5) All labeling, except labels and cartons, bearing information for use of the drug also bears the date of the issuance or the date of the latest revision of such labeling. (6) A prescription drug intended for... 
