...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...

...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;...

...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...

...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. The exemption of a drug from the prescription-dispensing requirements of section 503 (b) (1) (C) of...

...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...

...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...

...not indicate safety concerns about the condition's toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use. (2) The condition must have been marketed OTC for a minimum of 5 continuous years in the same country...

...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...