                                 CODE OF VIRGINIA

MISBRANDED DRUG OR DEVICE (§ 54.1-3462)

A drug or device shall be deemed to be misbranded:

1. If its labeling is false or misleading in any particular.

2. If its package does not bear a label containing the name and place of
business of the manufacturer, packer, or distributor. However, all prescription
drugs intended for human use and devices shall bear a label containing the name
and place of business of the manufacturer of the final dosage form of the drug
and, if different, the name and place of business of the packer or distributor
and an accurate statement of the quantity of the contents in terms of weight,
measure, or numerical count. Reasonable variations shall be permitted, and
exemptions for small packages shall be allowed in accordance with regulations of
the Board.

3. If any word, statement, or other information required by or under authority
of this chapter to appear on the label or labeling is not prominently placed
with such conspicuousness, as compared with other words, statements, designs or
devices, in the labeling, and in such terms as to render it likely to be read
and understood by the ordinary individual under customary conditions of purchase
and use.

4. If it is for use by man and contains any quantity of the narcotic or hypnotic
substances alpha-eucaine, barbituric acid, beta-eucaine, bromal, carbromal,
chloral, coca, cocaine, codeine, morphine, opium, paraldehyde, or sulfonmethane,
or any chemical derivative of such substances, which derivative, after
investigation has been found to be and designated as, habit forming, by
regulations issued by the Board under this chapter, unless its label bears the
name and quantity or proportion of such substance or derivative and in
juxtaposition therewith the statement &#8220;Warning &#8212; May Be Habit
Forming.&#8221;

5. If it is a drug, unless its label bears, to the exclusion of any other
nonproprietary name, except the applicable systematic chemical name or the
chemical formula, the established name of the drug, and in case it is fabricated
from two or more ingredients, the established name and quantity of each active
ingredient, including the kind and quantity or proportion of any alcohol, and
the established name and quantity or proportion of any bromides, ether,
chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine,
hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,
ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of
any such substances. However, the requirement for stating the quantity of the
active ingredients, other than the quantity of those specifically named in this
subdivision, shall apply only to prescription drugs. Any prescription drug shall
have the established name of the drug or ingredient printed on its label
prominently and in type at least half as large as that used for any proprietary
name or designation for such drug or ingredient. Exemptions may be allowed under
regulations of the Board.
			As used in this subdivision, the term &#8220;established name,&#8221; with
respect to a drug or ingredient, means the applicable official name designated
pursuant to &#xA7; 508 of the federal act, or if there is no such name and such
drug, or such ingredient, is an article recognized in an official compendium,
then the official title in such compendium or if neither exists, then the common
or usual name, if any, of such drug or of such ingredient. Whenever, an article
is recognized in the United States Pharmacopoeia National Formulary and in the
Homeopathic Pharmacopoeia under different official titles, the official title
used in the United States Pharmacopoeia National Formulary shall apply unless it
is labeled and offered for sale as a homeopathic drug, in which case the
official title used in the Homeopathic Pharmacopoeia shall apply.

6. Unless its labeling bears adequate directions for use and such adequate
warnings against use in those pathological conditions or by children where its
use may be dangerous to health, or against unsafe dosage or methods or duration
of administration or application, in such manner and form, as are necessary for
the protection of users. The Board shall promulgate regulations exempting such
drug or device from such requirements when these requirements are not necessary
to protect the public health and the articles are also exempted under
regulations issued under &#xA7; 502(f) of the federal act.

7. If it purports to be a drug the name of which is recognized in an official
compendium, unless it is packaged and labeled as prescribed. The method of
packing may be modified with the consent of the Board, or if consent is obtained
under the federal act. Whenever a drug is recognized in both the United States
Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United
States, it shall be subject to the requirements of the United States
Pharmacopoeia National Formulary with respect to packaging and labeling unless
it is labeled and offered for sale as a homeopathic drug, in which case it shall
be subject to the provisions of the Homeopathic Pharmacopoeia of the United
States and not to those of the United States Pharmacopoeia National Formulary.
However, in the event of inconsistency between the requirements of this
subdivision and those of subdivision 5 as to the name by which the drug or its
ingredients shall be designated, the requirements of subdivision 5 shall
prevail.

8. If it is dangerous to health when used in the dosage, or with the frequency
or duration prescribed, recommended, or suggested in the labeling or
advertising.

9. If it is, or purports to be, or is represented as a drug composed wholly or
partly of insulin, unless it is from a batch for which a certificate or release
has been issued pursuant to &#xA7; 506 of the federal act, and such certificate
or release is in effect with respect to such drug.

10. If it is, or purports to be, or is represented as a drug composed wholly or
partly of any kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative,
unless it is from a batch, for which a certificate or release has been issued
pursuant to &#xA7; 507 of the federal act, and such certificate or release is in
effect for such drug. This subdivision shall not apply to any drug or class of
drugs exempted by regulations promulgated under &#xA7; 507(c) or (d) of the
federal law.
			For the purpose of this subdivision the term &#8220;antibiotic drug&#8221;
means any drug intended for use by man containing any quantity of any chemical
substance which is produced by microorganisms and which has the capacity to
inhibit or destroy microorganisms in dilute solution, including, the chemically
synthesized equivalent of any such substance.

11. If it is a color additive, the intended use of which in or on drugs is for
coloring only, unless its packaging and labeling are in conformity with such
packaging and labeling requirements applicable to such color additive,
prescribed under the provisions of the federal act.

12. In the case of any prescription drug distributed or offered for sale in this
Commonwealth, unless the manufacturer, packer, or distributor includes in all
advertisements and other descriptive printed matter a true statement of (i) the
established name, as defined in this section, printed prominently and in type at
least half as large as that used for any trade or brand name, (ii) the formula
showing quantitatively each ingredient of such drug to the extent required for
labels under this section, and (iii) such other information in brief summary
relating to side effects, contraindications, and effectiveness as are required
in regulations issued under the federal act.

13. If a trademark, trade name or other identifying mark, imprint or device of
another or any likeness of the foregoing has been placed thereon or upon its
container with intent to defraud.
			Drugs and devices which are, in accordance with the practice of the trade, to
be processed, labeled or repacked in substantial quantities at establishments
other than those where originally processed or packed shall be exempt from any
labeling or packaging requirements of this chapter if such drugs and devices are
being delivered, manufactured, processed, labeled, repacked or otherwise held in
compliance with regulations issued by the Board.

HISTORY: Code 1950, § 54-463; 1958, c. 551; 1970, c. 650, § 54-524.93; 1976,
c. 644; 1988, c. 765.