[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.105]

[Page 178]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 250_SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS--Table of Contents
 
       Subpart B_New Drug or Prescription Status of Specific Drugs
 
Sec.  250.105  Gelsemium-containing preparations regarded as prescription drugs.

    It is the consensus of informed medical opinion that the margin of 
safety between the therapeutic and toxic concentration of gelsemium is 
narrow and it is difficult to predict the point at which the dose will 
be toxic. Very small doses may cause toxic symptoms. It is therefore the 
view of the Food and Drug Administration that gelsemium is not a proper 
ingredient in any product that is to be sold without prescription. 
Accordingly, any drug containing gelsemium will be regarded as 
misbranded under section 503(b)(4) of the Federal Food, Drug, and 
Cosmetic Act if its label fails to bear in a prominent and conspicuous 
fashion the statement ``Rx only.''

[40 FR 14033, Mar. 27, 1975, as amended at 67 FR 4906, Feb. 1, 2002]