Current through Reg. 49, No. 38; September 20, 2024
(a) Notice to the department.
(1) When the source of distressed drugs is
the result of a natural disaster, accident, power failure, or other emergency,
the salvage establishment or salvage broker shall make contact with the
department within 24 hours after their initial awareness of the emergency and
prior to any removal of distressed drugs from the place at which it was located
when it became distressed.
(2) If
emergency removal of distressed drugs referenced in subsection (a)(1) of this
section is required, notice to the department shall be made as soon thereafter
as possible. It shall be the duty of the salvage establishment or salvage
broker to make contact with the department within 48 hours whenever distressed
drugs subject to the provisions of this subsection are obtained.
(3) Distressed drugs referenced in this
subsection shall not be moved out of the State of Texas without prior approval
of the department and the responsible state agency in the state to receive the
drugs. Concurrence shall also be obtained from the U.S. Food and Drug
Administration, or U.S. Department of Agriculture, Food Safety and Inspection
Service, prior to interstate movement.
(b) Protection of Salvageable and Salvaged
Drugs.
(1) All salvageable and salvaged drugs
stored by salvage establishments or salvage brokers shall be held at
appropriate temperatures and under appropriate conditions in accordance with
requirements, if any, in the labeling of such drugs.
(2) All salvageable and salvaged drugs, while
being stored or processed at a salvage establishment, salvage warehouse, or
during transportation, shall be protected from contamination.
(3) Poisonous and toxic materials shall be
identified and handled under such conditions as will not contaminate other
salvageable or salvaged drugs, or constitute a hazard to personnel.
(c) Segregation of drugs. All
salvageable drugs shall be promptly sorted and segregated from nonsalvageable
drugs to prevent further contamination of the distressed drugs to be salvaged
or offered for sale or distribution.
(d) Nonsalvageable drugs.
(1) Containers, including metal and glass
containers with press caps, screw caps, pull rings, or other types of openings
which have been in contact with nonpotable water, liquid foam, or other
deleterious substances, as a result of fire fighting efforts, flood, sewer
backups, or similar mishaps, shall be deemed unfit for sale or distribution,
i.e., nonsalvageable drugs as defined in §
229.573(17)
of this title (relating to Definitions).
(2) Nonsalvageable drugs shall be disposed of
as in §
229.579
of this title (relating to Sanitary Facilities and Controls).
(3) Distressed drugs which are deemed to be
nonsalvageable by a duly authorized agent of the Texas Department of Health
shall, at the request of the agent, be destroyed under the supervision of that
agent at the expense of the owner.
(e) Transporting of distressed drugs.
(1) Distressed drugs shall be moved from the
site of a fire, flood, sewer backup, wreck, or other cause as expeditiously as
possible after compliance with subsection (a) of this section so as not to
become putrid, rodent or insect defiled, or otherwise hazardous to public
health.
(2) All distressed and
salvageable drugs of a perishable nature shall be transported only in vehicles
provided with adequate refrigeration, if necessary, for product maintenance
prior to reconditioning.
(f) Handling of distressed articles other
than drugs. If distressed articles other than drugs are also salvaged, they
shall be handled separately so as to prevent contamination from poisonous and
toxic materials or other contaminants.
(g) Cross-contamination protection.
Sufficient precautions shall be taken to prevent cross-contamination among the
various types of drugs that are salvageable or salvaged.
(h) Salvageable drugs. All salvageable drugs
shall be reconditioned prior to sale or distribution except for such sale or
distribution to a person holding a valid license to engage in a salvage
operation.
(i) Reconditioned drugs.
All reconditioned drugs must be in compliance with the Texas Food, Drug, and
Cosmetic Act, Health and Safety Code, Chapter 431.
(j) Labeling. All salvaged drugs must be
labeled in accordance with the requirements of the Texas Food, Drug, and
Cosmetic Act, Health and Safety Code, Chapter 431; the Federal Food, Drug, and
Cosmetic Act,
21
U.S.C., §301 et seq. as amended; the
Fair Packaging and Labeling Act,
15 U.S.C.,
§1451 et seq. as amended; and the
federal regulations promulgated under those Acts.
(k) Salvage warehouses. A person may not use
a salvage warehouse to recondition drugs or sell to consumers.
