Sec. 431.415. ORDER TO CEASE DISTRIBUTION. (a) The department 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 department determines there is a reasonable probability that:
(1) a wholesale distributor has:
(A) violated this subchapter;
(B) falsified a pedigree; or
(C) 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
(2) other procedures would result in unreasonable delay.
(b) An order under Subsection (a) 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.
(c) If, after providing an opportunity for a hearing, the department determines that inadequate grounds exist to support the actions required by the order, the commissioner shall vacate the order.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1012, eff. April 2, 2015.
Structure Texas Statutes
Title 6 - Food, Drugs, Alcohol, and Hazardous Substances
Subtitle A - Food and Drug Health Regulations
Chapter 431 - Texas Food, Drug, and Cosmetic Act
Subchapter N. Wholesale Distributors of Prescription Drugs
Section 431.4011. Ongoing Relationship
Section 431.4012. Applicability of Subchapter
Section 431.402. License Required
Section 431.403. Exemption From Licensing
Section 431.4031. Exemption From Certain Provisions for Certain Wholesale Distributors
Section 431.404. License Application
Section 431.4045. Inspection Required
Section 431.405. Qualifications for License
Section 431.406. Effect of Operation in Other Jurisdictions; Reports
Section 431.407. Criminal History Record Information
Section 431.4095. Renewal Notification; Change or Renewal
Section 431.410. Change of Location of Place of Business
Section 431.411. Minimum Restrictions on Transactions
Section 431.412. Pedigree Required
Section 431.413. Pedigree Contents
Section 431.414. Refusal to License; Suspension or Revocation of License
Section 431.415. Order to Cease Distribution