| (a) Inspection. To enforce this subchapter or the 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:
(1) enter at reasonable times a place of business,
including a factory or warehouse, in which a nonprescription drug
is manufactured, packed, or held for introduction into commerce or
held after the introduction;
(2) enter a vehicle being used to transport or hold
a nonprescription drug in commerce; or
(3) 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.
(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 who is required to maintain records referenced
in this subchapter or under the Act, or Federal Food, Drug, and Cosmetic
Act (Federal Act), Chapter V, or a person who is 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 records for verification and copying.
(2) A person, including a carrier engaged in commerce,
or other person receiving a nonprescription drug in commerce or holding
a nonprescription 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 nonprescription
drug;
(B) the holding of any nonprescription drug after movement
in commerce; and
(C) the quantity, shipper, and consignee of any nonprescription
drug.
(d) Retention of records. Records required by this
subchapter must be maintained at the place of business or other location
that is reasonably accessible for a period of at least three years
following disposition of the nonprescription drug unless a greater
period of time is required by §229.242 of this subchapter (relating
to Applicable Laws and Regulations).
(e) Adulterated and misbranded nonprescription drug.
If the department identifies an adulterated or misbranded nonprescription
drug, the department may impose the applicable provisions of Subchapter
C of the Act, including detention, emergency order, recall, and administrative
penalties. Administrative penalties will be assessed using the Severity
Levels contained in §229.261 of this chapter (relating to Assessment
of 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.
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