[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR203.38]

[Page 95]
 
                        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.