 | 1972 - 488 pages
...which the drug is to be dispensed; Provided, however, That the information required by subdivisions (i) and (ii) of this subparagraph is not required on the...use" 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...use" 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...use" 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....use" 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... | |
 | 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,...use" 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... | |
 | 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... | |
 | 1991 - 620 pages
...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... | |
 | 2000 - 736 pages
...because of any potentiality for harmful effect, or the method of its use, or the collateral measure« necessary to its use is not safe except under the...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: (l)(i) In the possession... | |
 | 1966 - 690 pages
...required by subdivisions (i) and (ii) of this subparagraph is not required on the so-called remrader-piece labeling which calls attention to the name of the...use" 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... | |
| |
... (d) Exemption for prescription devices. A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed... 
