[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.100]

[Page 9]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 310_NEW DRUGS--Table of Contents
 
         Subpart B_Specific Administrative Rulings and Decisions
 
Sec. 310.100  New drug status opinions; statement of policy.


    (a) Over the years since 1938 the Food and Drug Administration has 
given informal advice to inquirers as to the new drug status of 
preparations. These drugs have sometimes been identified only by general 
statements of composition. Generally, such informal opinions were 
incorporated in letters that did not explicitly relate all of the 
necessary conditions and qualifications such as the quantitative formula 
for the drug and the conditions under which it was prescribed, 
recommended, or suggested. This has contributed to misunderstanding and 
misinterpretation of such opinions.
    (b) These informal opinions that an article is ``not a new drug'' or 
``no longer a new drug'' require reexamination under the Kefauver-Harris 
Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval 
of a new drug application is withdrawn under provisions of section 
505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally 
recognized as safe may become a ``new drug'' within the meaning of 
section 201(p) of said act as amended by the Kefauver-Harris Act on 
October 10, 1962. This is of special importance by reason of proposed 
actions to withdraw approval of new drug applications for lack of 
substantial evidence of effectiveness as a result of reports of the 
National Academy of Sciences--National Research Council on its review of 
drug effectiveness; for example, see the notice published in the Federal 
Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et 
al.
    (c) Any marketed drug is a ``new drug'' if any labeling change made 
after October 9, 1962, recommends or suggests new conditions of use 
under which the drug is not generally recognized as safe and effective 
by qualified experts. Undisclosed or unreported side effects as well as 
the emergence of new knowledge presenting questions with respect to the 
safety or effectiveness of a drug may result in its becoming a ``new 
drug'' even though it was previously considered ``not a new drug.'' Any 
previously given informal advice that an article is ``not a new drug'' 
does not apply to such an article if it has been changed in formulation, 
manufacture control, or labeling in a way that may significantly affect 
the safety of the drug.
    (d) For these reasons, all opinions previously given by the Food and 
Drug Administration to the effect that an article is ``not a new drug'' 
or is ``no longer a new drug'' are hereby revoked. This does not mean 
that all articles that were the subjects of such prior opinions will be 
regarded as new drugs. The prior opinions will be replaced by opinions 
of the Food and Drug Administration that are qualified and current on 
when an article is ``not a new drug,'' as set forth in this subchapter.

[39 FR 11680, Mar. 29, 1974]