Labelling of medicines
FDA bar codes
DATES: Effective Date: This rule is
effective on April 26, 2004.
Compliance Dates: Drug products that receive approval on or
the rule's effective date must comply with the bar code requirement
within 60 days after the drug's approval date. Drug products that
received approval before the final rule's effective date must comply
with the bar code requirement within 2 years after the final rule's
effective date. Specific information on how the rule will be
implemented can be found in section II.I of this document.
1. The authority citation for 21 CFR Part 201 continues to
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
2. Section 201.25 is added to read as follows:
Sec. 201.25 Bar code label requirements.
(a) Who is subject to these bar code requirements?
repackers, relabelers, and private label distributors of a human
prescription drug product or an OTC drug product that is regulated
under the Federal Food, Drug, and Cosmetic Act or the Public Health
Service Act are subject to the bar code requirements in this section
unless they are exempt from the registration and drug listing
requirements in section 510 of the act.
(b) What drugs are subject to these bar code requirements?
following drug products are subject to the bar code label requirements:
Prescription drug products (excluding samples), biological products,
and over-the-counter drug products that are dispensed under an order
and are commonly used in hospitals. For purposes of this section, an
over-the-counter drug product is ``commonly used in hospitals'' if it
is packaged for institutional use, labeled for institutional use, or
marketed, promoted, or sold to hospitals.
(c) What does the bar code look like, and where does the bar
(1) Each drug product described in paragraph (b) in this
must have a bar code that contains, at a minimum, the appropriate
National Drug Code (NDC) number in a linear bar code that meets Uniform
Code Council (UCC/EAN) standards. Additionally, the bar code must:
(i) Be surrounded by sufficient blank space so that the bar
can be scanned correctly; and
(ii) Remain intact under normal conditions of use.
(2) The bar code must appear on the drug's label as defined
section 201(k) of the act.