[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: 21CFR203.32]
[Page 107]
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 D Samples
Sec. 203.32 Drug sample storage and handling requirements.
(a) Storage and handling conditions. Manufacturers, authorized
distributors of record, and their representatives shall store and handle
all drug samples under conditions that will maintain their stability,
integrity, and effectiveness and ensure that the drug samples are free
of contamination, deterioration, and adulteration.
(b) Compliance with compendial and labeling requirements.
Manufacturers, authorized distributors of record, and their
representatives can generally comply with this section by following the
compendial and labeling requirements for storage and handling of a
particular prescription drug in handling samples of that drug.
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