...it complies with all of the following conditions: (1) Such drug or device, because of its toxicity ` ;]= , l{ נͺ W )v w < Q <O}/ ֥ zP * ... %aR m e X Y r׽ M |1 F pdZ*̡ Ǜ is not generally recognized among experts qualified by scientific training and experience to evaluate...

...intended for use by man which .... (B) Because of its toxicity or other potentiality for harmful eft'' or the method of its use, or the collateral measures necessary to its is not safe for use except under the supervision of a practitioner by law to administer such a drug;...

...a 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...use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such...

...requirements are not necessary for the protection of the public health by reason of the drug's toxlclty or other potentiality for harmful effect, or the method...nec-essary to its use, and he finds that the drug 1 is safe and effective for use in self-medication as directed in proposed labeling 1 . A proposal...

...necessary for the protection of the public health by reason of the §310.103 §310.201 drug's toxlcity or other potentiality for harmful effect, or the method...measures necessary to its use, and he finds that the dru? is safe and effective for use in self-medication as directed in proposed labeling. A proposal...

...requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method...use, or the collateral measures necessary to its use. The exemption of a drug from the prescription-dispensing requirements of section 503 (b) (1) (C) of...

...Exemptions From Adequate Directions for Use § 801.109 Prescription devices. A device which, because of any potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such...

...(4) and (5) of this paragraph. (d) Exemption for prescription devices. A device which, because of any potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such...

...Exemptions From Adequate Directions for Use 6801.109 Prescription devices. A device which, 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 supervision of a practitioner licensed...

...restriction does not indicate safety concerns about its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use. (ii) The cumulative total number of dosage units (eg, tablets, capsules, ounces) sold for each dosage...