[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.26]

[Page 6]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec. 500.26  Timed-release dosage form drugs.

    (a) Drugs are being offered in dosage forms that are designed to 
release the active ingredients over a prolonged period of time. There is 
a possibility of unsafe overdosage or ineffective dosage if such 
products are improperly made and the active ingredients are released at 
one time, over too short or too long a period of time, or not released 
at all. Drugs marketed in this form, which are referred to by such terms 
as timed-release, controlled-release, prolonged-release, sustained-
release, or delayed-release drugs, are regarded as new animal drugs 
within the meaning of section 201(v) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) Timed-release dosage form animal drugs that are introduced into 
interstate commerce are deemed to be adulterated within the meaning of 
section 501(a)(5) of the act and subject to regulatory action unless 
such animal drug is the subject of an approved new animal drug 
application as required by paragraph (a) of this section.
    (c) The fact that the labeling of this kind of drug may claim 
delayed, prolonged, controlled, or sustained-release of all or only some 
of the active ingredients does not affect the new animal drug status of 
such articles. A new animal drug application is required in any such 
case.
    (d) New animal drug applications for timed-release dosage form 
animal drugs must contain, among other things, data to demonstrate 
safety and effectiveness by establishing that the article is 
manufactured using procedures and controls to ensure release of the 
total dosage at a safe and effective rate. Data submitted in the new 
animal drug application must demonstrate that the formulation of the 
drug and the procedures used in its manufacture will ensure release of 
the active ingredient(s) of the drug at a safe and effective rate and 
that these release characteristics will be maintained until the 
expiration date of the drug. When the drug is intended for use in food-
producing animals, data submitted must also demonstrate that, with 
respect to possible residues of the drug, food derived from treated 
animals is safe for consumption.

[42 FR 8635, Feb. 11, 1977, as amended at 60 FR 38480, July 27, 1995]