<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER OLICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.252Enforcement and Penalties

(a) Inspection. To enforce these sections or the Texas Food, Drug, and Cosmetic Act, 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:

  (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 these sections or the Act.

(b) Receipt for samples. An authorized agent or health authority who makes an inspection of 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, shall give to 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 these sections or under the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act), or Federal Food, Drug, and Cosmetic Act (Federal Act), Chapter V, or a person who is in charge or custody of those records shall, 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 nonprescription drug in commerce or holding a nonprescription drug received in commerce shall, 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 these sections shall 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 laws and regulations adopted in §229.242 of this title (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, but not limited to: detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and/or administrative penalties. Administrative and civil penalties will be assessed using the Severity Levels contained in §229.251 of this title (relating to Minimum Standards for Licensure).


Source Note: The provisions of this §229.252 adopted to be effective February 1, 2007, 32 TexReg 315

Next Page Previous Page



Home TxReg TAC OM NewTac Public Footer Bar