[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.105]

[Page 153]
 
                        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 ``Caution: Federal law prohibits dispensing 
without prescription.''

    Effective Date Note: At 67 FR 4906, Feb. 1, 2002, Sec. 250.105 was 
amended in the last sentence by removing the phrase `` `Caution: Federal 
law prohibits dispensing without prescription.' '' and by adding in its 
place the phrase `` `Rx only.' '', effective April 2, 2002.