Sec. 431.413. PEDIGREE CONTENTS.
(a) A pedigree must include all necessary identifying information concerning each sale in the product's chain of distribution from the manufacturer, through acquisition and sale by a wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the drug. At a minimum, the chain of distribution information must include:
(1) the name, address, telephone number, and, if available, the e-mail address of each person who owns the prescription drug and each wholesale distributor of the prescription drug;
(2) the name and address of each location from which the product was shipped, if different from the owner's name and address;
(3) the transaction dates; and
(4) certification that each recipient has authenticated the pedigree.
(b) The pedigree must include, at a minimum, the:
(1) name of the prescription drug;
(2) dosage form and strength of the prescription drug;
(3) size of the container;
(4) number of containers;
(5) lot number of the prescription drug; and
(6) name of the manufacturer of the finished dosage form.
(c) Each pedigree statement must be:
(1) maintained by the purchaser and the wholesale distributor for at least three years; and
(2) available for inspection and photocopying not later than the second business day after the date a request is submitted by the department or a peace officer in this state.
(d) The executive commissioner shall adopt rules to implement this section.
(e) Expired.
(e-1) If, after consulting with manufacturers, distributors, and pharmacies responsible for the sale and distribution of prescription drugs in this state, the department determines that electronic track and trace pedigree technology is universally available across the entire prescription pharmaceutical supply chain, the department shall establish a targeted implementation date for electronic track and trace pedigree technology. After the department has established a targeted implementation date, the department may revise the date. The targeted implementation date may not be earlier than July 1, 2010.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 12, eff. September 1, 2007.
Acts 2015, 84th Leg., R.S., Ch. 1 (S.B. 219), Sec. 3.1010, eff. April 2, 2015.
Section: Previous 431.407 431.408 431.409 431.4095 431.410 431.411 431.412 431.413 431.414 431.415 431.451 431.452 431.453 431.454 431.455 NextLast modified: September 28, 2016