Okla. Stat. tit. 63, § 63-1-1409

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 of any prescription drug or device and the packer or

distributor; and the name and place of business of the manufacturer,

packer or distributor of any nonprescription drug or device.

Manufacturer, as used herein, shall mean the person or firm which

has mixed, tableted, encapsulated or otherwise prepared the drug in

the form in which it is offered for sale to pharmacies.

(2) an accurate statement of the quantity of the

contents in terms of weight, measure or numerical count; provided

that under this clause reasonable variations shall be permitted, and

exemptions as to small packages shall be established, by regulations

prescribed by the State Board of Health.

(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,

betaeucaine, 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 State Commissioner of Health, after

investigation, found to be, and by regulations under this article

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, quantity and proportion of any alcohol, and also

including, whether active or not, the name and quantity or

proportion of any bromides, ether, chloroform, acetanilid,

acetphenetidin, antipyrine, atropine, hyoscine, hyoscyamine, arsenic

Oklahoma Statutes - Title 63. Public Health and Safety Page 613

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 this clause 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 requirements.
safe 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 requirements.

(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 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 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) if it has been found by the Commissioner to be a drug

liable to deterioration, unless it is packaged in such form and

manner, and its label bears a statement of such precautions, as the

Board shall by regulations require as necessary for the protection

of public health. No such regulation shall be established for any

drug recognized in an official compendium until the Commissioner

shall have informed the appropriate body charged with the revision

of such compendium of the need for such packaging or labeling

requirements and such body shall have failed within a reasonable

time to prescribe such requirement.

(i) if it is a drug and its container is so made, formed, or

filled as to be misleading; if it is an imitation of another drug;

or if it is offered for sale under the name of another drug.

(j) 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.

(k) if it is a drug intended for use by man which:

(1) is a habit-forming drug to which paragraph (d)

of this section applies; or

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(2) because of its toxicity or other potentiality

for harmful effect, or the method of use, or the collateral measures

necessary to its use, is not safe for use except under the

supervision of a physician, dentist or veterinarian; or

(3) is limited by an effective application under

Section 505 of the Federal Act to use under professional supervision

by a physician, dentist or veterinarian, unless it is dispensed

only:

(i) upon a written prescription of a physician,

dentist or veterinarian, or

(ii) upon the oral prescription of a physician,

dentist or veterinarian which is reduced promptly to writing and

filed by the pharmacist, or

(iii) by refilling any such written or oral

prescription if such refilling is authorized by the prescriber

either in the original prescription or by oral order which is

promptly reduced to writing and filed by the pharmacist; provided,

that any drug dispensed by filling or refilling a written or oral

prescription of a physician, dentist, or veterinarian shall be

exempt from the requirements of this section, except paragraphs (a)

and (i), if the drug bears a label containing the name and address

of the dispenser, the serial number and date of the prescription or

its filling, the name of the prescriber, and, if stated in the

prescription, the name of the patient, and the directions for use

and cautionary statements, if any, contained in such prescription.

This exemption shall not apply to any drug dispensed in the course

of the conduct of a business of dispensing drugs, pursuant to

diagnosis by mail.
the serial number and date of the prescription or

its filling, the name of the prescriber, and, if stated in the

prescription, the name of the patient, and the directions for use

and cautionary statements, if any, contained in such prescription.

This exemption shall not apply to any drug dispensed in the course

of the conduct of a business of dispensing drugs, pursuant to

diagnosis by mail.

(1) if the packaging, name or appearance of a prescription

drug product is deceptively similar to or would cause unnecessary

confusion with competitive, chemically-similar drug products which

have a previously established or substantial position in the

marketplace.