Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter O - LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS-INCLUDING GOOD MANUFACTURING PRACTICES
Section 229.252 - Enforcement and Penalties

Universal Citation: 25 TX Admin Code ยง 229.252

Current through Reg. 49, No. 38; September 20, 2024

(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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