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Orange Label Requirement

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A prescription container shall be identified as a controlled substance by either:
 (i) an orange label; 
 (ii)  a  label of  another color over which is superimposed an orange 
  transparent adhesive tape; or 
 (iii) an auxiliary orange label affixed to the front of such container 
  and bearing the  legend,  prominently  marked  or  printed  "Controlled Substance, Dangerous Unless Used As Directed"; 

(c)  Any label, transparency, or auxiliary label shall be applied in a  manner which would inhibit its removal. 

ARTICLE 33: NEW YORK STATE CONTROLLED SUBSTANCES ACT  
§3333



21CFR290.5 
Sec. 290.5 Drugs; statement of required warning.  
The label of any drug listed as a "controlled substance" in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

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