The following words and terms, when used in this subchapter,
have the following meanings, unless the context clearly indicates
otherwise.
(1) Act--The Texas Food, Drug, and Cosmetic Act, Texas
Health and Safety Code Chapter 431.
(2) Adulterated drug--Has the meaning specified in
the Act at §431.111.
(3) Authorized agent--An employee of the department
who is designated by the commissioner to enforce the provisions of
the Act.
(4) Broker--A person engaged in offering or contracting
for wholesale distribution sale or transfer of a nonprescription drug
into, within, or out of Texas and who does not take title to or physical
possession of the nonprescription drug.
(5) Change of ownership--A sole proprietor who transfers
all or part of the facility's ownership to another person or persons;
the removal, addition, or substitution of a person or persons as a
partner in a facility owned by a partnership; a corporate sale, transfer,
reorganization, or merger of the corporation which owns the facility
if sale, transfer, reorganization, or merger causes a change in the
facility's ownership to another person or persons; or if any other
type of association, the removal, addition, or substitution of a person
or persons as a principal of such association.
(6) Commissioner--Commissioner of the Texas Department
of State Health Services.
(7) Component--Any ingredient intended for use in the
manufacture of a drug product, including those that may not appear
in such drug product.
(8) Cosmetic--Articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwise applied to
the human body or any part of the human body for cleaning, beautifying,
promoting attractiveness, or altering the appearance, and articles
intended for use as a component of those articles. The term does not
include soap.
(9) Department--The Texas Department of State Health
Services.
(10) Device--An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory:
(A) recognized in the official United States Pharmacopoeia
National Formulary or any supplement to it;
(B) intended for use in the diagnosis of disease or
other conditions, or in the cure, mitigation, treatment, or prevention
of disease in humans or other animals; or
(C) intended to affect the structure or any function
of the body of humans or other animals and does not achieve any of
its principal intended purposes through chemical action within or
on the body of humans or other animals and is not dependent on metabolization
for the achievement of any of its principal intended purposes.
(11) Drug--Articles recognized in the official United
States Pharmacopoeia National Formulary, or any supplement to it;
articles designated or intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals; articles,
other than food, intended to affect the structure or any function
of the body of humans or other animals; and articles intended for
use as a component of any such article. The term does not include
devices or their components, parts, or accessories. A food for which
a claim is made in accordance with the Federal Act, §403(r),
21 USC §343, and for which the claim is approved by the United
States Food and Drug Administration (FDA) is not a drug solely because
the label or labeling contains such a claim.
(12) Federal Act--Federal Food, Drug, and Cosmetic
Act, 21 USC §301, et seq., as amended.
(13) Flea market--A location at which booths or similar
spaces are rented or otherwise made available temporarily to two or
more persons and at which the persons offer tangible personal property
for sale.
(14) Inactive ingredient--Any component other than
an active ingredient, including any excipient, flavor, fragrance,
and color.
(15) Labeling--All labels and other written, printed,
or graphic matter:
(A) upon any drug or any of its containers or wrappers;
or
(B) accompanying such drug.
(16) Manufacturer--A person who manufactures, prepares,
propagates, compounds, processes, packages, or repackages nonprescription
drugs, or a person who changes the container, wrapper, or labeling
of any nonprescription drug package.
(17) Misbranded drug--Has the meaning specified in
the Act at §431.112.
(18) Nonprescription drug--Any drug that is not a prescription
drug, including the terms Over-the-Counter Drug and Non-legend Drug.
(19) Nonprescription drug product--A finished dosage
form, for example, tablet, capsule, solution, etc., containing an
active nonprescription ingredient. The term also includes a finished
dosage form that does not contain an active ingredient but is intended
to be used as a placebo. Any nonprescription drug product that is
also a cosmetic or device or component thereof is also subject to
the applicable requirements of the Federal Act, Chapters V and VI,
and Subchapters E and F; and Subchapter D of this chapter (relating
to Regulation of Cosmetics) and Subchapter X of this chapter (relating
to Licensing of Device Distributors and Manufacturers).
(20) Over-the-Counter (OTC) drugs--Drugs that are safe
and effective for use by the general public without seeking treatment
by a health professional.
(21) Person--An individual, corporation, business trust,
estate, trust, partnership, association, or any other public or private
legal entity.
(22) Place of business--Each location at which a nonprescription
drug for wholesale distribution is located.
(23) Prescription drug--Any drug (including any biological
product, except for blood and blood components intended for transfusion
or biological products that are also medical devices) required by
federal law (including federal regulation) to be dispensed only by
a prescription, including finished dosage forms and bulk drug substances
subject to the Federal Act at §503(b).
(24) Wholesale distribution--Distribution to a person
other than a consumer or patient, including distribution to any person
by a manufacturer, repackager, own label distributor, broker, jobber,
warehouse, or wholesaler. This term does not include:
(A) intracompany sales of nonprescription drugs, which
means transactions or transfers of nonprescription drugs between a
division, subsidiary, parent, or affiliated or related company under
common ownership and control or any transaction or transfer between
co-license holders of a co-licensed product;
(B) the distribution of nonprescription drug samples
by a representative of a manufacturer or wholesale drug distributor;
(C) the delivery of, or offer to deliver, a nonprescription
drug by a common carrier solely in the common carrier's usual course
of business of transporting nonprescription drugs, if the common carrier
does not store, warehouse, or take legal ownership of the nonprescription
drug; and
(D) the sale or transfer from a purchaser, other than
a consumer, seller, or warehouser, of expired, damaged, returned,
or recalled nonprescription drugs to the original manufacturer or
to a reverse logistics provider.
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