 | 1939 - 1522 lapas
...complies with all of the following conditions: (1) Such drug or device, because of its toxicity or other potentiality for harmful effect or the method of its...the collateral measures necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate its... | |
 | United States. Food and Drug Administration - 1959 - 1068 lapas
...dispensing of a drug without the prescription of a physician, when because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed bj law to administer such drug * *... | |
 | United States - 1977 - 1276 lapas
...habit-forming drug to which section 352(d) of this title applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of...collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or... | |
 | 1991 - 620 lapas
...area measure, the declaration shall be expressed both in terms of square 21 CFR Ch. I (4-1-91 Edition) inches and, if applicable ( 1 square foot or more),...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... | |
 | 1988 - 590 lapas
...be recognized. Variations from stated quantity of contents shall not be unreasonably large. Subport D Exemptions From Adequate Directions for Use...use" cannot be prepared, shall be exempt from section 502(f)(1) of the act if all the following conditions are met: (a) The device is: (1) (i) In the possession... | |
 | 1996 - 700 lapas
...Variations from stated quantity of contents shall not be unreasonably large. Subport D Exemptions From 1 Adequate Directions for Use (801.109 Prescription...use" cannot be prepared, shall be exempt from section 502(0(1) of the act if all the following conditions are met: (a) The device is: (l)(i) In the possession... | |
 | 1974 - 258 lapas
...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...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... | |
 | 2000 - 736 lapas
...part 82. [61 FR 20101. May 3, 1996] Subpart D Exemptions From Adequate Directions for Use 6801.109 Prescription devices. A device which, because of any...effect, or the method of its use, or the collateral measure« necessary to its use is not safe except under the supervision of a practitioner licensed... | |
 | United States. Congress. House. Interstate and foreign commerce - 1951 - 246 lapas
...and 3 should be reversed, whereby the basic one is last) will read: because of its toxicity or other potentiality for harmful effect or the method of its...the collateral measures necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate its... | |
| |
Subpart D Exemptions From Adequate Directions for Use § 801.109 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... 
