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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER WLICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES
RULE §229.430Enforcement and Penalties

(a) Inspection.

  (1) To enforce this subchapter 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:

    (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, in order 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 may 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 Act; or

    (F) data relating to other drugs that, in the case of a new drug, would be subject to reporting or inspection under regulations issued under §505(j) of the Federal Act.

  (4) An inspection under paragraph (2) of this subsection shall be started and completed with reasonable promptness.

(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 this subchapter or under the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or Chapter V of the Federal Food, Drug, and Cosmetic Act (Federal Act) 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 prescription drug in commerce or holding a prescription 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 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 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 prescription drug unless a greater period of time is required by laws and regulations adopted in §229.420 of this title (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, but not limited to: detention, emergency order, recall, condemnation, destruction, injunction, civil penalties, criminal penalties, and/or administrative penalties.

(f) Order to cease distribution.

  (1) The commissioner shall 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 that:

    (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 with an opportunity for an informal hearing on the actions required by the order to be held not later than the 10th day after the date of issuance of the order.

  (3) If, after providing an opportunity for a hearing, the commissioner determines that inadequate grounds exist to support the actions required by the order, the commissioner shall vacate the order.


Source Note: The provisions of this §229.430 adopted to be effective February 1, 2007, 32 TexReg 315; amended to be effective December 9, 2010, 35 TexReg 10755

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