CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 4]

[CITE: 21CFR250.105]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C - DRUGS: GENERAL

PART 250 -- SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

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]