[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR206.10]

[Page 100]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE--Table of Contents
 
Sec. 206.10  Code imprint required.

    (a) Unless exempted under Sec. 206.7, no drug product in solid oral 
dosage form may be introduced or delivered for introduction into 
interstate commerce unless it is clearly marked or imprinted with a code 
imprint that, in conjunction with the product's size, shape, and color, 
permits the unique identification of the drug product and the 
manufacturer or distributor of the product. Identification of the drug 
product requires identification of its active ingredients and its dosage 
strength. Inclusion of a letter or number in the imprint, while not 
required, is encouraged as a more effective means of identification than 
a symbol or logo by itself. Homeopathic drug products are required only 
to bear an imprint that identifies the manufacturer and their 
homeopathic nature.
    (b) A holder of an approved application who has, under Sec. 314.70 
(b)(2)(xi) or (b)(2)(xii) of this chapter, supplemented its application 
to provide for a new imprint is not required to bring its product into 
compliance with this section during the pendency of the agency's review. 
Once the review is complete, the drug product is subject to the 
requirements of the rule.
    (c) A solid oral dosage form drug product that does not meet the 
requirement for imprinting in paragraph (a) of this section and is not 
exempt from the requirement may be considered adulterated and misbranded 
and may be an unapproved new drug.
    (d) For purposes of this section, code imprint means any single 
letter or number or any combination of letters and numbers, including, 
e.g., words, company name, and National Drug Code, or a mark, symbol, 
logo, or monogram, or a combination of letters, numbers, and marks or 
symbols, assigned by a drug firm to a specific drug product.

[58 FR 47958, Sept. 13, 1993, as amended at 60 FR 19846, Apr. 21, 1995]