[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: 21CFR203.23]

[Page 85]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 203--PRESCRIPTION DRUG MARKETING--Table of Contents
 
                      Subpart C--Sales Restrictions
 
Sec. 203.23  Returns.

    The return of a prescription drug purchased by a hospital or health 
care entity or acquired at a reduced price by or donated to a charitable 
institution is exempt from the prohibitions in Sec. 203.20, provided 
that:
    (a) The hospital, health care entity, or charitable institution 
documents the return by filling out a credit memo specifying:
    (1) The name and address of the hospital, health care entity, or 
charitable institution;
    (2) The name and address of the manufacturer or wholesale 
distributor from which it was acquired;
    (3) The product name and lot or control number;
    (4) The quantity returned; and
    (5) The date of the return.
    (b) The hospital, health care entity, or charitable institution 
forwards a copy of each credit memo to the manufacturer and retains a 
copy of each credit memo for its records;
    (c) Any drugs returned to a manufacturer or wholesale distributor 
are kept under proper conditions for storage, handling, and shipping, 
and written documentation showing that proper conditions were maintained 
is provided to the manufacturer or wholesale distributor to which the 
drugs are returned.

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