[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.137]

[Page 127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                Subpart G--Packaging and Labeling Control
 
Sec. 211.137  Expiration dating.

    (a) To assure that a drug product meets applicable standards of 
identity, strength, quality, and purity at the time of use, it shall 
bear an expiration date determined by appropriate stability testing 
described in Sec. 211.166.
    (b) Expiration dates shall be related to any storage conditions 
stated on the labeling, as determined by stability studies described in 
Sec. 211.166.
    (c) If the drug product is to be reconstituted at the time of 
dispensing, its labeling shall bear expiration information for both the 
reconstituted and unreconstituted drug products.
    (d) Expiration dates shall appear on labeling in accordance with the 
requirements of Sec. 201.17 of this chapter.
    (e) Homeopathic drug products shall be exempt from the requirements 
of this section.
    (f) Allergenic extracts that are labeled ``No U.S. Standard of 
Potency'' are exempt from the requirements of this section.
    (g) New drug products for investigational use are exempt from the 
requirements of this section, provided that they meet appropriate 
standards or specifications as demonstrated by stability studies during 
their use in clinical investigations. Where new drug products for 
investigational use are to be reconstituted at the time of dispensing, 
their labeling shall bear expiration information for the reconstituted 
drug product.
    (h) Pending consideration of a proposed exemption, published in the 
Federal Register of September 29, 1978, the requirements in this section 
shall not be enforced for human OTC drug products if their labeling does 
not bear dosage limitations and they are stable for at least 3 years as 
supported by appropriate stability data.

[43 FR 45077, Sept. 29, 1978, as amended at 46 FR 56412, Nov. 17, 1981; 
60 FR 4091, Jan. 20, 1995]