[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.6]

[Page 8-9]
 
                        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 A--General Provisions
 
Sec. 310.6  Applicability of ``new drug'' or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for 
          hearing to identical, related, and similar drug products.

    (a) The Food and Drug Administration's conclusions on the 
effectiveness of drugs are currently being published in the Federal 
Register as Drug Efficacy Study Implementation (DESI) Notices and as 
Notices of Opportunity for Hearing. The specific products listed in 
these notices include only those that were introduced into the market 
through the new drug procedures from 1938-62 and were submitted for 
review by the National Academy of Sciences-National Research Council 
(NAS-NRC), Drug Efficacy Study Group. Many products which are identical 
to, related to, or similar to the products listed in these notices have 
been marketed under different names or by different firms during this 
same period or since 1962 without going through the new drug procedures 
or the Academy review. Even though these products are not listed in the 
notices, they are covered by the new drug applications reviewed and thus 
are subject to these notices. All persons with an interest in a product 
that is identical, related, or similar to a drug listed in a drug 
efficacy notice or a notice of opportunity for a hearing will be given 
the same opportunity as the applicant to submit data and information, to 
request a hearing, and to participate in any hearing. It is not feasible 
for the Food and Drug Administration to list all products which are 
covered by an NDA and thus subject to each notice. However, it is 
essential that the findings and conclusions that a drug product is a 
``new drug'' or that there is a lack of evidence to show that a drug 
product is safe or effective be applied to all identical, related, and 
similar drug products to which they are reasonably applicable. Any 
product not in compliance with an applicable drug efficacy notice is in 
violation of section 505 (new drugs) and/or section 502 (misbranding) of 
the act.
    (b)(1) An identical, related, or similar drug includes other brands, 
potencies, dosage forms, salts, and esters of the same drug moiety as 
well as of any drug moiety related in chemical structure or known 
pharmacological properties.
    (2) Where experts qualified by scientific training and experience to 
evaluate the safety and effectiveness of drugs would conclude that the 
findings and conclusions, stated in a drug efficacy notice or notice of 
opportunity for hearing, that a drug product is a ``new drug'' or that 
there is a lack of evidence to show that a drug product is safe or 
effective are applicable to an identical, related, or similar drug 
product, such product is affected by the notice. A combination drug 
product containing a drug that is identical, related, or similar to a 
drug named in a notice may also be subject to the findings and 
conclusions in a notice that a drug product is a ``new drug'' or that 
there is a lack of evidence to show that a drug product is safe or 
effective.
    (3) Any person may request an opinion on the applicability of such a 
notice to a specific product by writing to the Food and Drug 
Administration at the address shown in paragraph (e) of this section.
    (c) Manufacturers and distributors of drugs should review their 
products as drug efficacy notices are published and assure that 
identical, related, or similar products comply with all applicable 
provisions of the notices.
    (d) The published notices and summary lists of the conclusions are 
of particular interest to drug purchasing agents. These agents should 
take particular care to assure that the same purchasing policy applies 
to drug products that are identical, related, or similar to those named 
in the drug efficacy notices. The Food and Drug Administration applies 
the same regulatory policy to all such products. In many instances a 
determination can readily be made as to the applicability of a drug 
efficacy notice by an individual who is knowledgeable about drugs and 
their indications for use.

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Where the relationships are more subtle and not readily recognized, the 
purchasing agent may request an opinion by writing to the Food and Drug 
Administration at the address shown in paragraph (e) of this section.
    (e) Interested parties may submit to the Food and Drug 
Administration, Center for Drug Evaluation and Research, Office of 
Compliance, HFD-300, 5600 Fishers Lane, Rockville, MD 20857, the names 
of drug products, and of their manufacturers or distributors, that 
should be the subject of the same purchasing and regulatory policies as 
those reviewed by the Drug Efficacy Study Group. Appropriate action, 
including referral to purchasing officials of various government 
agencies, will be taken.
    (f) This regulation does not apply to OTC drugs identical, similar, 
or related to a drug in the Drug Efficacy Study unless there has been or 
is notification in the Federal Register that a drug will not be subject 
to an OTC panel review pursuant to Secs. 330.10, 330.11, and 330.5 of 
this chapter.

[39 FR 11680, Mar. 29, 1974, as amended at 48 FR 2755, Jan. 21, 1983; 50 
FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990]