[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR211.170]

[Page 131-132]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS--Table of Contents
 
                     Subpart I--Laboratory Controls
 
Sec. 211.170  Reserve samples.

    (a) An appropriately identified reserve sample that is 
representative of each lot in each shipment of each active ingredient 
shall be retained. The reserve sample consists of at least twice the 
quantity necessary for all tests required to determine whether the 
active ingredient meets its established specifications, except for 
sterility and pyrogen testing. The retention time is as follows:
    (1) For an active ingredient in a drug product other than those 
described in paragraphs (a) (2) and (3) of this section, the reserve 
sample shall be retained for 1 year after the expiration date of the 
last lot of the drug product containing the active ingredient.
    (2) For an active ingredient in a radioactive drug product, except 
for nonradioactive reagent kits, the reserve sample shall be retained 
for:
    (i) Three months after the expiration date of the last lot of the 
drug product containing the active ingredient if the expiration dating 
period of the drug product is 30 days or less; or
    (ii) Six months after the expiration date of the last lot of the 
drug product containing the active ingredient if the expiration dating 
period of the drug product is more than 30 days.
    (3) For an active ingredient in an OTC drug product that is exempt 
from bearing an expiration date under Sec. 211.137, the reserve sample 
shall be retained for 3 years after distribution of the last lot of the 
drug product containing the active ingredient.
    (b) An appropriately identified reserve sample that is 
representative of each lot or batch of drug product shall be retained 
and stored under conditions

[[Page 132]]

consistent with product labeling. The reserve sample shall be stored in 
the same immediate container-closure system in which the drug product is 
marketed or in one that has essentially the same characteristics. The 
reserve sample consists of at least twice the quantity necessary to 
perform all the required tests, except those for sterility and pyrogens. 
Except for those for drug products described in paragraph (b)(2) of this 
section, reserve samples from representative sample lots or batches 
selected by acceptable statistical procedures shall be examined visually 
at least once a year for evidence of deterioration unless visual 
examination would affect the integrity of the reserve sample. Any 
evidence of reserve sample deterioration shall be investigated in 
accordance with Sec. 211.192. The results of the examination shall be 
recorded and maintained with other stability data on the drug product. 
Reserve samples of compressed medical gases need not be retained. The 
retention time is as follows:
    (1) For a drug product other than those described in paragraphs (b) 
(2) and (3) of this section, the reserve sample shall be retained for 1 
year after the expiration date of the drug product.
    (2) For a radioactive drug product, except for nonradioactive 
reagent kits, the reserve sample shall be retained for:
    (i) Three months after the expiration date of the drug product if 
the expiration dating period of the drug product is 30 days or less; or
    (ii) Six months after the expiration date of the drug product if the 
expiration dating period of the drug product is more than 30 days.
    (3) For an OTC drug product that is exempt for bearing an expiration 
date under Sec. 211.137, the reserve sample must be retained for 3 years 
after the lot or batch of drug product is distributed.

[48 FR 13025, Mar. 29, 1983, as amended at 60 FR 4091, Jan. 20, 1995]