[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: 21CFR201.25]
[Page 19-20]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart A General Labeling Provisions
Sec. 201.25 Bar code label requirements.
(a) Who is subject to these bar code requirements? Manufacturers,
repackers, relabelers, and private label distributors of a human
prescription drug product or an over-the-counter (OTC) drug product that
is regulated under the Federal Food, Drug, and Cosmetic Act or the
Public Health Service Act are subject to these bar code requirements
unless they are exempt from the registration and drug listing
requirements in section 510 of the Federal Food, Drug, and Cosmetic Act.
(b) What drugs are subject to these bar code requirements? The
following drug products are subject to the bar code label requirements:
(1) Prescription drug products, however:
(i) The bar code requirement does not apply to the following
entities:
(A) Prescription drug samples;
(B) Allergenic extracts;
(C) Intrauterine contraceptive devices regulated as drugs;
(D) Medical gases;
(E) Radiopharmaceuticals; and
(F) Low-density polyethylene form fill and seal containers that are
not packaged with an overwrap.
(ii) The bar code requirement does not apply to prescription drugs
sold by a manufacturer, repacker, relabeler, or private label
distributor directly to patients, but versions of the same drug product
that are sold to or used in hospitals are subject to the bar code
requirements.
(2) Biological products; and
(3) OTC drug products that are dispensed pursuant to an order and
are commonly used in hospitals. For purposes of this section, an OTC
drug product is ``commonly used in hospitals'' if it is packaged for
hospital use, labeled for hospital use (or uses similar terms), or
marketed, promoted, or sold to hospitals.
(c) What does the bar code look like? Where does the bar code go?
(1) Each drug product described in paragraph (b) of this section must
have a bar code that contains, at a minimum, the appropriate National
Drug Code (NDC) number in a linear bar code that meets European Article
Number/Uniform Code Council (EAN.UCC) or Health Industry Business
Communications Council (HIBCC) standards. Additionally, the bar code
must:
(i) Be surrounded by sufficient blank space so that the bar code 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 by
section 201(k) of the Federal Food, Drug, and Cosmetic Act.
(d) Can a drug be exempted from the bar code requirement? (1) On our
own initiative, or in response to a written request from a manufacturer,
repacker, relabeler or private label distributor, we may exempt a drug
product from the bar code label requirements set forth in this section.
The exemption request must document why:
(i) compliance with the bar code requirement would adversely affect
the safety, effectiveness, purity or potency of the drug or not be
technologically feasible, and the concerns underlying the request could
not reasonably be addressed by measures such as package redesign or use
of overwraps; or
(ii) an alternative regulatory program or method of product use
renders the bar code unnecessary for patient safety.
(2) Requests for an exemption should be sent to the Office of New
Drugs (HFD-020), Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville,
[[Page 20]]
MD 20857 (requests involving a drug product) or to the Office of
Compliance and Biologics Quality (HFM-600), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852 (requests involving a biological product).
[69 FR 9170, Feb. 26, 2004]
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