N.Y. Education Law § 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.