Section 229.584 - Enforcement and Penalties(a) General license actions. The department may deny, suspend, or revoke the license of an applicant or licensee who fails to comply with any of the following: (1) failure to comply with the Act or these sections;(2) falsification of information provided in an application for a license;(3) refuses to allow the department to conduct an inspection or collect samples;(4) interferes with the department in the performance of its duties;(5) removes or disposes of a detained drugs in violation of the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, § 431.021; or(6) fails to inform the department of any salvage warehouse(s) at the time of an inspection or when requested by the department.(b) Emergency license suspensions. (1) The department may suspend a license without notice when there is an imminent threat to the health or safety of the public.(2) If an emergency suspension order is issued without a hearing, the department, not later than the 30th day after the date on which the emergency order was issued, shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be held under departmental formal hearing rules governed by §§ 1.21, 1.23, 1.25 and 1.27 of this title (relating to Formal Hearing Procedures).(c) Hearings. (1) Any hearings for the denial, suspension, or revocation of a license are governed by §§ 1.21, 1.23, 1.25 and 1.27 of this title.(2) Within 20 days after the postmark date of the department's written notice of proposed denial, suspension, or revocation, the applicant or licensee may request a hearing in writing from the department. If the applicant or licensee does not request a hearing during the required time period, then the applicant or licensee is deemed to have waived his/her right to a hearing.(d) Reinstatement of license. (1) A person whose application for a license has been denied or whose license has been placed under an emergency suspension may request a reinspection for the purpose of granting or reinstating a license not later than the 30th day after the denial or emergency suspension. Not later than the tenth day after the receipt of a written request from the applicant or licensee, the department shall make a reinspection.(2) As regards a nonemergency suspension or a revocation, the licensee may request at any time, an inspection for reinstating the license or for issuing a new license.(3) If, after inspection, the department determines that the applicant or licensee meets the requirements of the Act or these sections, the department shall reinstate the license or issue a new license, as appropriate.(4) Reinspection fee. Except as provided for in §229.576(c) of of this title (relating to Licensing Fees), a salvage establishment or salvage broker who requests reinstatement of a license that has been denied, suspended, or revoked pursuant to this section shall pay a nonrefundable inspection fee of $600.(e) Emergency order. (1) General. The commissioner or the commissioner's designee may issue an emergency order, either mandatory or prohibitory, concerning the sale or distribution of distressed drugs in the department's jurisdiction if the commissioner or the commissioner's designee determines that:(A) the sale or distribution of those drugs creates or poses an immediate and serious threat to human life or health; and(B) other procedures available to the department to remedy or prevent the threat will result in unreasonable delay.(2) Absence of notice and hearing. The commissioner or the commissioner's designee may issue the emergency order without notice and hearing if the commissioner or the commissioner's designee determines it is necessary under the circumstances.(3) Hearings. If an emergency order is issued without a hearing, the department shall determine a time and place for a hearing at which the emergency order will be affirmed, modified, or set aside. The hearing shall be governed by §§ 1.21, 1.23, 1.25 and 1.27 of this title.(f) Administrative penalty. If a person violates these sections, or an order adopted or license issued under the Act, the commissioner may assess an administrative penalty against the person. (1) The penalty may not exceed $25,000 for each violation. Each day a violation continues is a separate violation.(2) In determining the amount of the penalty, the commissioner shall consider the following criteria: (A) the person's previous violations;(B) the seriousness of the violation;(C) any hazard to the health and safety of the public;(D) the person's demonstrated good faith; and(E) other matters as justice may require.(3) Violations subject to this subsection shall be categorized into severity levels as determined in § 229.261 of this title (relating to Assessment of Administrative Penalties).(4) Hearings, appeals from, and judicial review of final administrative decisions under this subsection shall be conducted according to the contested case provisions of the Government Code, Chapter 2001, and §§ 1.21, 1.23, 1.25, and 1.27 of this title.(5) An administrative penalty may be assessed only after a person charged with a violation is given an opportunity for a hearing.(6) If a hearing is held, the commissioner shall make findings of fact and shall issue a written decision regarding the occurrence of the violation and the amount of the penalty.(7) If the person charged with the violation does not request a hearing, the commissioner may assess a penalty after determining that a violation has occurred and the amount of the penalty.(8) After making a determination under this subsection that a penalty is to be assessed, the commissioner shall issue an order requiring that the person pay the penalty.(9) The commissioner may consolidate a hearing held under this subsection with another proceeding.(10) Not later than the 30th day after the date of issuance of an order finding that a violation has occurred, the commissioner shall inform the person against whom the order is issued of the amount of the penalty.25 Tex. Admin. Code § 229.584
The provisions of this §229.584 adopted to be effective December 17, 2002, 27 TexReg 11751; amended to be effective January 1, 2005, 29 TexReg 11984