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.
(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 the offering or contracting
for wholesale distribution; sale or transfer of a prescription drug
into, within, or out of Texas; and, who does not take title to or
physical possession of the prescription 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) Co-licensed product partner--One of two or more
parties having the right to engage in the manufacturing or marketing
of a prescription drug consistent with the United States Food and
Drug Administration's (FDA) regulations and guidance implementing
the Prescription Drug Marketing Act of 1987 (Pub. L. No. 100 - 293).
(7) Commissioner--Commissioner of the Texas Department
of State Health Services.
(8) Component--Any ingredient intended for use in the
manufacture of a drug product, including those that might not appear
in such drug product.
(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 that 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) Drop shipment--The sale of a prescription drug
to a wholesale distributor by the manufacturer of the prescription
drug, or by the manufacturer's co-licensed product partner, third-party
logistics provider, or exclusive distributor, in which:
(A) the wholesale distributor takes title but not physical
possession of the prescription drug;
(B) the wholesale distributor invoices the pharmacy,
pharmacy warehouse, or other person authorized by law to dispense
or administer the drug to a patient; and
(C) the pharmacy, pharmacy warehouse, or other authorized
person receives delivery of the prescription drug directly from the
manufacturer or the manufacturer's third-party logistics provider
or exclusive distributor.
(12) 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 Food, Drug, and Cosmetic
Act, §403(r) and 21 United States Code (USC) §301, et seq.,
and for which the claim is approved by the FDA, is not a drug solely
because the label or labeling contains such a claim.
(13) Emergency medical reasons--Includes transfers
of a prescription drug between a wholesale distributor or pharmacy
to alleviate a temporary shortage of a prescription drug arising from
delays in or interruption of regular distribution schedules; sales
to nearby emergency medical services, i.e., ambulance companies and
firefighting organizations in the same state or same marketing or
service area, or nearby licensed practitioners of drugs for use in
the treatment of acutely ill or injured persons; provision of minimal
emergency supplies of drugs to nearby nursing homes for use in emergencies
or during hours of the day when necessary drugs cannot be obtained;
and transfers of prescription drugs by a retail pharmacy to alleviate
a temporary shortage.
(14) Federal Act--Federal Food, Drug, and Cosmetic
Act, 21 USC, §301, et seq., as amended.
(15) 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.
(16) Inactive ingredient--Any component, other than
an active ingredient, including excipient, flavor, fragrance, and
color.
(17) 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.
(18) Manufacturer--A person who manufactures, prepares,
propagates, compounds, processes, packages, or repackages prescription
drugs, or a person who changes the container, wrapper, or labeling
of any prescription drug package. A person licensed or approved by
the FDA to engage in the manufacture of drugs or devices, consistent
with the federal agency's definition of manufacturer under the agency's
regulations and guidance implementing the Prescription Drug Marketing
Act of 1987 (Pub. L. No. 100 - 293). The term does not include a pharmacist
engaged in compounding done within the practice of pharmacy and pursuant
to a prescription drug order or initiative from a practitioner for
a patient or prepackaging done in accordance with Texas Occupations
Code §562.154.
(19) Manufacturer's exclusive distributor--A person
who holds a wholesale distributor license under this subchapter, who
contracts with a manufacturer to provide or coordinate warehousing,
distribution, or other services on behalf of the manufacturer, and
who takes title to, but does not have general responsibility to direct
the sale or disposition of, the manufacturer's prescription drug.
A manufacturer's exclusive distributor must be an authorized distributor
of record to be considered part of the normal distribution channel.
(20) Misbranded drug--Has the meaning specified in
the Act at §431.112.
(21) Nonprescription drug--Any drug that is not a prescription
drug, including the terms Over-the-Counter Drug and Non-legend Drug.
(22) Normal distribution channel--A chain of custody
for a prescription drug, either directly or by drop shipment, from
the manufacturer of the prescription drug, the manufacturer to the
manufacturer's co-licensed product partner, the manufacturer to the
manufacturer's third-party logistics provider, or the manufacturer
to the manufacturer's exclusive distributor, to:
(A) a pharmacy to:
(i) a patient; or
(ii) another designated person authorized by law to
dispense or administer the drug to a patient;
(B) an authorized distributor of record to:
(i) a pharmacy to a patient; or
(ii) another designated person authorized by law to
dispense or administer the drug to a patient;
(C) an authorized distributor of record to a wholesale
distributor licensed under this subchapter to another designated person
authorized by law to administer the drug to a patient;
(D) an authorized distributor of record to a pharmacy
warehouse to the pharmacy warehouse's intracompany pharmacy;
(E) a pharmacy warehouse to the pharmacy warehouse's
intracompany pharmacy or another designated person authorized by law
to dispense or administer the drug to a patient;
(F) a person authorized by law to prescribe a prescription
drug that by law may be administered only under the supervision of
the prescriber; or
Cont'd... |
