...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...

...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 * *...

...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...

...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...

...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 of...or the collateral measures 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...

...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 of...use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed...

...drug be restricted to sale by prescription only if the drug — "(B) because of its toxicity or other potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use, has been determined by the Administrator, on the basis of opinions generally 1'eld among experts qualified...

...drug be restricted to sale by prescription only if the drug — "(B) because of its toxicity or other potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use, has been determined by the Administrator, on the basis of opinions generally held among experts qualified...

...of the patient. If the drug is intended for use by man and — "(1) because of its toxicity or other potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use, it is not generally recognized among experts qualified by scientific training and experience to evaluate...

...drug can be dispensed on a prescription if such a drug or device, because of its toxicity or other potentiality for harmful effect, or the method of...use, or the collateral measures necessary to its use, if not generally recognized among experts qualified by scientific training and experience to evaluate...