New York Laws
Article 137 - Pharmacy
6815 - Adulterating, Misbranding and Substituting.

§ 6815. Adulterating, misbranding and substituting. 1. Adultered
drugs. A drug or device shall be deemed to be adulterated:

a. (1) If it consists in whole or in part of any filthy, putrid, or
decomposed substance; or (2) if it has been prepared, packed, or held
under insanitary conditions whereby it may have been contaminated with
filth, or whereby it may have been rendered injurious to health; or (3)
if it is a drug and its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the contents
injurious to health; or (4) if it is a drug and it bears or contains,
for purposes of coloring only, a coal-tar color other than one from a
batch that has been certified in accordance with regulations provided in
this article.

b. If it purports to be, or is represented as, a drug the name of
which is recognized in an official compendium, and its strength differs
from, or its quality or purity falls below, the standard set forth in
such compendium. Such determination as to strength, quality or purity
shall be made in accordance with the tests or methods of assay set forth
in such compendium, or, in the absence or inadequacy of such tests or
methods of assay, then in accordance with tests or methods of assay
prescribed by regulations of the board of pharmacy as promulgated under
this article. Deviations from the official assays may be made in the
quantities of samples and reagents employed, provided they are in
proportion to the quantities stated in the official compendium. No drug
defined in an official compendium shall be deemed to be adulterated
under this paragraph because (1) it exceeds the standard of strength
therefor set forth in such compendium, if such difference is plainly
stated on its label; or (2) it falls below the standard of strength,
quality, or purity therefor set forth in such compendium if such
difference is plainly stated on its label, except that this clause shall
apply only to such drugs, or classes of drugs, as are specified in regu-
lations which the board shall promulgate when, as applied to any drug,
or class of drugs, the prohibition of such difference is not necessary
for the protection of the public health. Whenever a drug is recognized
in both the United States pharmacopoeia and the homeopathic
pharmacopoeia of the United States, it shall be subject to the
requirements of the United States pharmacopoeia 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.

c. If it is not subject to the provisions of paragraph b of this
subdivision and its strength differs from, or its purity or quality
falls below, that which it purports or is represented to possess.

d. If it is a drug and any substance has been (1) mixed or packed
therewith so as to reduce its quality or strength or (2) substituted
wholly or in part therefor.

e. If it is sold under or by a name not recognized in or according to
a formula not given in the United States pharmacopoeia or the national
formulary but that is found in some other standard work on pharmacology
recognized by the board, and it differs in strength, quality or purity
from the strength, quality or purity required, or the formula prescribed
in, the standard work.

2. Misbranded and substituted drugs and devices. A drug or device
shall be deemed to be misbranded:

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

b. If in package form, unless it bears a label containing (1) the name
and place of business of the manufacturer, packer, or distributor; and
(2) an accurate statement of the quantity of the contents in terms of
weight, measure, or numerical count: Provided, that under clause (2) of

this paragraph the board may establish reasonable variations as to
quantity and exemptions as to small packages.

c. If any word, statement, or other information required by or under
authority of this article to appear on the label or labeling is not
prominently placed thereon 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.

d. If it is for use by man and contains any quantity of the narcotic
or hypnotic substance alpha eucaine, barbituric acid, beta eucaine,
bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin,
marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane; or
any chemical derivative of such substance, which derivative has been by
the secretary, after investigation, found to be, and by regulations
under this article, or by regulations promulgated by the board,
designated as, habit forming; unless its label bears the name and
quantity, or proportion, of such substance or derivative and in
juxtaposition therewith the statement "Warning--May be habit forming."

e. If it is a drug and is not designated solely by a name recognized
in an official compendium unless its label bears (1) the common or usual
name of the drug, if such there be; and (2) in case it is fabricated
from two or more ingredients, the common or usual name of each active
ingredient, including the kind and quantity by percentage or amount of
any alcohol, and also including, whether active or not, the 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, contained therein: Provided, that, to the extent
that compliance with the requirements of clause (2) of this paragraph is
impracticable, exemptions shall be established by regulations
promulgated by the board.

f. Unless its labeling bears (1) adequate directions for use; and (2)
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: Provided,
that, where any requirement of clause (1) of this paragraph, as applied
to any drug or device, is not necessary for the protection of the public
health, the board shall promulgate regulations exempting such drug or
device from such requirement.

g. 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
therein: Provided, that, the method of packing may be modified with the
consent of the secretary in accordance with regulations promulgated by
the board. Whenever a drug is recognized in both the United States
pharmacopoeia and the homeopathic pharmacopoeia of the United States, it
shall be subject to the requirements of the United States pharmacopoeia
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.

h. (1) If it is a drug and its container is so made, formed or filled
as to be misleading; (2) if it is an imitation of another drug; (3) if
it is offered for sale under the name of another drug; or (4) if it
bears a copy, counterfeit, or colorable imitation of the trademark,
label, container or identifying name or design of another drug.

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

j. Except as required by article thirty-three of the public health
law, the labeling provisions of this article shall not apply to the
compounding and dispensing of drugs on the written prescription of a
physician, a dentist, a podiatrist or a veterinarian, which prescription
when filled shall be kept on file for at least five years by the
pharmacist or druggist. Such drug shall bear a label containing the name
and place of business of the dispenser, the serial number and date of
the prescription, directions for use as may be stated in the
prescription, name and address of the patient and the name of the
physician or other practitioner authorized by law to issue the
prescription. In addition, such label shall contain the proprietary or
brand name of the drug and, if applicable, the strength of the contents,
unless the person issuing the prescription explicitly states on the
prescription, in his own handwriting, that the name of the drug and the
strength thereof should not appear on the label.