[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.533]

[Page 41]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.533  Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.

    (a) Atropine sulfate, belladonna alkaloids, and belladonna alkaloids 
as contained in Atropa belladonna and Datura stramonium have been 
present as ingredients in cough-cold drug products for use as an 
anticholinergic. Anticholinergic drugs have been marketed OTC in cough-
cold drug products to relieve excessive secretions of the nose and eyes, 
symptoms that are commonly associated with hay fever, allergy, rhinitis, 
and the common cold. Atropine sulfate for oral use as an anticholinergic 
is probably safe at dosages that have been used in marketed cough-cold 
products (0.2 to 0.3 milligram); however, there are inadequate data to 
establish general recognition of the effectiveness of this ingredient. 
The belladonna alkaloids, which contain atropine (d, dl hyoscyamine) and 
scopolamine (l- hyoscine), are probably safe for oral use at dosages 
that have been used in marketed cough-cold products (0.2 milligram) but 
there are inadequate data to establish general recognition of the 
effectiveness of these ingredients as an anticholinergic for cough-cold 
use. Belladonna alkaloids for inhalation use, as contained in Atropa 
belladonna and Datura stramonium, are neither safe nor effective as an 
OTC anticholinergic. There are inadequate safety and effectiveness data 
to establish general recognition of the safety and/or effectiveness or 
any of these ingredients, or any other ingredient, for OTC use as an 
anticholinergic in cough-cold drug products.
    (b) Any OTC cough-cold drug product that is labeled, represented, or 
promoted for use as an anticholinergic is regarded as a new drug within 
the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic 
Act, for which an approved new drug application under section 505 of the 
act and part 314 of this chapter is required for marketing. In the 
absence of an approved new drug application, such product is also 
misbranded under section 502 of the act.
    (c) Clinical investigations designed to obtain evidence that any 
cough-cold drug product labeled, represented, or promoted for OTC use as 
an anticholinergic is safe and effective for the purpose intended must 
comply with the requirements and procedures governing the use of 
investigational new drugs set forth in part 312 of this chapter.
    (d) After the effective date of the final regulation, any such OTC 
cough-cold drug product that is labeled, represented, or promoted for 
use as an anticholinergic may not be initially introduced or initially 
delivered for introduction into interstate commerce unless it is the 
subject of an approved new drug application.

[50 FR 46587, Nov. 8, 1985, as amended at 55 FR 11579, Mar. 29, 1990]