[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: 21CFR203.38]
[Page 109]
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. 203.38 Sample lot or control numbers; labeling of sample units.
(a) Lot or control number required on drug sample labeling and
sample unit label. The manufacturer or authorized distributor of record
of a drug sample shall include on the label of the sample unit and on
the outside container or packaging of the sample unit, if any, an
identifying lot or control number that will permit the tracking of the
distribution of each drug sample unit.
(b) Records containing lot or control numbers required for all drug
samples distributed. A manufacturer or authorized distributor of record
shall maintain for all samples distributed records of drug sample
distribution containing lot or control numbers that are sufficient to
permit the tracking of sample units to the point of the licensed
practitioner.
(c) Labels of sample units. Each sample unit shall bear a label that
clearly denotes its status as a drug sample, e.g., ``sample,'' ``not for
sale,'' ``professional courtesy package.''
(1) A drug that is labeled as a drug sample is deemed to be a drug
sample within the meaning of the act.
(2) A drug product dosage unit that bears an imprint identifying the
dosage form as a drug sample is deemed to be a drug sample within the
meaning of the act.
(3) Notwithstanding paragraphs (c)(1) and (c)(2) of this section,
any article that is a drug sample as defined in section 503(c)(1) of the
act and Sec. 203.3(i) that fails to bear the label required in this
paragraph (c) is a drug sample.
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