[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.23]
[Page 104]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
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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