(1) A
drug or device is deemed to be misbranded:
(a) If its labeling is false or misleading in any particular;
(b) If its labeling or packaging fails to conform with the requirements of
section 25-5-419;
(c) If in package form, unless it bears a label containing:
(I) The name and place of business of the manufacturer, packer, or
distributor; and
(II) An accurate statement of the quantity of the contents in terms of weight,
measure, or numerical count, which statement shall be separately and accurately
stated in a uniform location upon the principal display panel of the label, except as
exempted by section 25-5-402 (4)(c); but, as to such terms of quantity, reasonable
variations shall be permitted, and exemptions as to small packages shall be
established, by regulation prescribed by the department or issued under the federal
act;
(d) If any word, statement, or other information required by or under
authority of this part 4 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;
(e) (I) If it is a drug, unless:
(A) Its label bears, to the exclusion of any other nonproprietary name (except
the applicable systematic chemical name or the chemical formula), the established
name, as defined in subparagraph (II) of this paragraph (e), of the drug, if such there
be; 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 bromides, ether, chloroform, acetanilid, acetophenetidin, 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; except that the requirement for stating
the quantity of the active ingredients, other than the quantity of those specifically
named in this sub-subparagraph (A), shall apply only to prescription drugs; and
(B) For any prescription drug, the established name of such drug or
ingredient, as the case may be, on such label (and on any labeling on which a name
for such drug or ingredient is used) is printed prominently and in type at least half
as large as that used thereon for any proprietary name or designation for such drug
or ingredient. To the extent that compliance with the requirements of this sub-subparagraph (B) and sub-subparagraph (A) of this subparagraph (I) as to
fabricated drugs is impracticable, exemptions shall be established by regulations
promulgated by the department or under the federal act.
(II) As used in this paragraph (e), the term established name, with respect
to a drug or ingredient thereof, means:
(A) The applicable official name designated pursuant to the federal act; or
(B) If there is no such name and such drug or such ingredient is an article
recognized in an official compendium, then the official title thereof in such
compendium; or
(C) If neither sub-subparagraph (A) nor sub-subparagraph (B) of this
subparagraph (II) applies, then the common or usual name, if any, of such drug or of
such ingredient;
(D) Where sub-subparagraph (B) of this subparagraph (II) applies to an article
recognized in the United States pharmacopoeia and in the homeopathic
pharmacopoeia under different official titles, the official title used in the United
States pharmacopoeia 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.
(f) 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; but, where any requirement as to such adequate directions for
use, as applied to any drug or device, is not necessary for the protection of the
public health, the department shall promulgate regulations exempting such drug or
device from such requirement, and articles exempted under regulations issued
under the federal act shall also be exempt;
(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; but the
method of packing may be modified with the consent of the department or if
consent is obtained under the federal act. 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. In the event of inconsistency between the
requirements of this paragraph (g) and those of paragraph (e) of this subsection (1)
as to the name by which the drug or its ingredients are designated, the
requirements of paragraph (e) of this subsection (1) shall prevail.
(h) If it is found by the department or under the federal act 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 regulations issued by the department
or under the federal act 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 department has informed the appropriate body charged with
the revision of such compendium of the need for such packaging or labeling
requirements and such body has failed within a reasonable time to prescribe such
requirements.
(i) (I) If it is a drug and its container is so made, formed, or filled as to be
misleading; or
(II) If it is an imitation of another drug; or
(III) 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 its labeling represents it to have any effect in albuminuria, appendicitis,
arteriosclerosis, arthritis, baldness, blood poison, bone disease, Bright's disease,
cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas,
gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles,
meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis
(infantile paralysis), prostate gland disorders, pyelitis, rheumatism, scarlet fever,
sexual impotence, sexually transmitted infection, sinus infection, smallpox,
tuberculosis, tumors, typhoid, or uremia, and shall also be deemed to be false;
except that no labeling in violation of paragraphs (a) and (b) of this subsection (1)
shall be deemed to be false under this paragraph (k) if it is disseminated only to
members of the medical, dental, chiropractic, or veterinary professions or is
disseminated only for the purpose of public health education by persons not
commercially interested, directly or indirectly, in the sale of such drugs or devices;
but, if the department determines that an advance in medical science has made any
type of self-medication safe as to any of the diseases named in this paragraph (k),
the department shall by regulation authorize the labeling of drugs having curative
or therapeutic effect for such disease, subject to such conditions and restrictions
as the department may deem necessary in the interests of public health; except
that this paragraph (k) shall not be construed as indicating that self-medication for
any disease is safe or efficacious;
(l) If it is for human use and contains any quantity of the narcotic or hypnotic
substance alpha eucaine, barbituric acid, betaeucaine, bromal, carbromal, chloral,
coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or
sulphonmethane, or any chemical derivative of the substance, which derivative,
after investigation, has been found to be and designated as habit-forming by rules
issued by the department or pursuant to the federal act, unless its label bears the
name and quantity or proportion of the substance or derivative and in juxtaposition
therewith the statement Warning - May be habit-forming;
(m) If it is, or purports to be, or is represented as a drug composed wholly or
partly of insulin, unless:
(I) It is from a batch with respect to which a certificate or release has been
issued pursuant to the federal act; and
(II) Such certificate or release is in effect with respect to such drug;
(n) 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 thereof, unless:
(I) It is from a batch with respect to which a certificate or release has been
issued pursuant to the federal act; and
(II) Such certificate or release is in effect with respect to such drug; but this
subparagraph (II) shall not apply to any drug or class of drugs exempted by
regulations promulgated under the federal act. For the purpose of this paragraph
(n), antibiotic drug 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).
(o) If it is a color additive, the intended use of which in or on drugs is for the
purpose of 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 section 25-5-413 (2) or of the federal act;
(p) In the case of any prescription drug distributed or offered for sale in this
state, unless the manufacturer, packer, or distributor thereof includes, in all
advertisements and other descriptive printed matter issued or caused to be issued
by the manufacturer, packer, or distributor with respect to that drug, a true
statement of:
(I) The established name, as defined in paragraph (e)(II) of this subsection (1),
printed prominently and in type at least half as large as that used for any trade or
brand name thereof;
(II) The formula showing quantitatively each ingredient of such drug to the
extent required for labels under the federal act; and
(III) Such other information in brief summary relating to side effects,
contraindications, and effectiveness as shall be required in regulations issued
under the federal act;
(q) 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.
(2) A drug sold on a prescription given by a member of the medical, dental, or
veterinary profession (except a drug sold in the course of the conduct of a business
of selling drugs pursuant to diagnosis by mail) shall be exempt from the
requirements of this section if such member of the medical, dental, or veterinary
profession is authorized by law to administer such drug or if such drug bears a label
containing the name and place of business of the seller, the serial number and date
of such prescription, the name of such member of the medical, dental, or veterinary
profession, and, if stated in the prescription, the name of the patient, the directions
for use, and any cautionary statements contained in such prescription.
(3) Drugs and devices which, in accordance with the practice of the trade,
are 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 part 4 if such drugs
and devices are being delivered, manufactured, processed, labeled, repacked, or
otherwise held in compliance with regulations issued by the department or under
the federal act.