(a) Inspection.
(1) To enforce this subchapter or the Texas Food, Drug,
and Cosmetic Act, Texas Health and Safety Code Chapter 431 (Act),
the commissioner, an authorized agent, or a health authority may,
on presenting appropriate credentials to the owner, operator, or agent
in charge of a place of business:
(A) enter at reasonable times a place of business,
including a factory or warehouse, in which a prescription drug is
manufactured, packed, or held for introduction into commerce or held
after the introduction;
(B) enter a vehicle being used to transport or hold
a prescription drug in commerce; or
(C) inspect at reasonable times, within reasonable
limits, and in a reasonable manner, the place of business or vehicle
and all equipment, finished and unfinished materials, containers,
and labeling of any item and obtain samples necessary for the enforcement
of this subchapter or the Act.
(2) The inspection of a place of business, including
a factory, warehouse, or consulting laboratory, in which a prescription
drug is manufactured, processed, packed, or held for introduction
into commerce extends to any place or thing, including a record, file,
paper, process, control, or facility, to determine whether the drug:
(A) is adulterated or misbranded;
(B) may not be manufactured, introduced into commerce,
sold, or offered for sale under the Act; or
(C) is otherwise in violation of this subchapter or
the Act.
(3) An inspection under paragraph (2) of this subsection
does not extend to:
(A) financial data;
(B) sales data other than shipment data;
(C) pricing data;
(D) personnel data other than data relating to the
qualifications of technical and professional personnel performing
functions under the Act;
(E) research data other than data:
(i) relating to new drugs and antibiotic drugs; and
(ii) subject to reporting and inspection under regulations
issued under §505(i) or (j) of the Federal Food, Drug, and Cosmetic
Act, 21 United States Code (USC) §301, et seq., as amended, (Federal
Act); or
(F) data relating to other drugs, in the case of a
new drug, subject to reporting or inspection under regulations issued
under §505(j) of the Federal Act.
(4) An inspection under paragraph (2) of this subsection
must be started and completed with reasonable promptness.
(b) Receipt for samples. An authorized agent or health
authority who inspects a place of business, including a factory or
warehouse, and obtains a sample during or on completion of the inspection
and before leaving the place of business, must give the owner, operator,
or the owner's or operator's agent a receipt describing the sample.
(c) Access to records.
(1) A person required to maintain records referenced
in this subchapter or under the Act or Chapter V of the Federal Act
or a person in charge or custody of those records must, at the request
of an authorized agent or health authority, permit the authorized
agent or health authority at all reasonable times, access to and to
copy and verify the records.
(2) A person, including a carrier engaged in commerce,
or other person receiving a prescription drug in commerce or holding
a prescription drug received in commerce must, at the request of an
authorized agent, permit the authorized agent at all reasonable times
to have access to and to copy and verify all records showing:
(A) the movement in commerce of any prescription drug;
(B) the holding of any prescription drug after movement
in commerce; and
(C) the quantity, shipper, and consignee of any prescription
drug.
(d) Retention of records. Records required by this
subchapter must be maintained at the place of business or other location
reasonably accessible for a period of at least three years following
disposition of the prescription drug unless a greater period of time
is required by §229.420 of this subchapter (relating to Applicable
Laws and Regulations).
(e) Adulterated or misbranded prescription drug. If
the department identifies an adulterated or misbranded prescription
drug, the department may impose the applicable enforcement provisions
of Subchapter C of the Act including detention, emergency order, recall,
and administrative penalties. The department may request the attorney
general or local law enforcement institute an action for criminal
penalties, collection of civil penalties, condemnation, destruction,
and injunction under the Act.
(f) Order to cease distribution.
(1) The commissioner must issue an order requiring
a person, including a manufacturer, distributor, or retailer of a
prescription drug, to immediately cease distribution of the drug if
the commissioner determines there is a reasonable probability:
(A) a wholesale distributor has:
(i) violated this subchapter or the Act; or
(ii) sold, distributed, transferred, manufactured,
repackaged, handled, or held a counterfeit prescription drug intended
for human use that could cause serious adverse health consequences
or death; and
(B) other procedures would result in unreasonable delay.
(2) An order under this subsection must provide the
person subject to the order an opportunity for an informal hearing
on the actions required by the order to be held not later than the
10th day after issuance of the order.
(3) If, after providing an opportunity for a hearing,
the commissioner determines inadequate grounds exist to support the
actions required by the order, the commissioner must vacate the order.
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