Tex. Health & Safety Code § 431.405 · Subchapter N. WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS
QUALIFICATIONS FOR LICENSE.
Text — Current through the 89th 2nd Called Legislative Session, 2025
(a) The department may not issue a wholesale distributor license to an applicant without considering the minimum federal information and related qualification requirements published in federal regulations at 21 C.F.R. Part 205, including:
(1) factors in reviewing the qualifications of persons who engage in wholesale distribution, 21 C.F.R. Section 205.6;
(2) appropriate education and experience for personnel employed in wholesale distribution, 21 C.F.R. Section 205.7; and
(3) the storage and handling of prescription drugs and the establishment and maintenance of prescription drug distribution records, 21 C.F.R. Section 205.50.
(b) In addition to meeting the minimum federal requirements as provided by Subsection (a), to qualify for the issuance or renewal of a wholesale distributor license under this subchapter, the designated representative of an applicant or license holder must:
(1) be at least 21 years of age;
(2) have been employed full-time for at least three years by a pharmacy or a wholesale distributor in a capacity related to the dispensing or distributing of prescription drugs, including recordkeeping for the dispensing or distributing of prescription drugs;
(3) be employed by the applicant full-time in a managerial-level position;
(4) be actively involved in and aware of the actual daily operation of the wholesale distributor;
(5) be physically present at the applicant's place of business during regular business hours, except when the absence of the designated representative is authorized, including sick leave and vacation leave;
(6) serve as a designated representative for only one applicant at any one time, except in a circumstance, as the department determines reasonable, in which more than one licensed wholesale distributor is colocated in the same place of business and the wholesale distributors are members of an affiliated group, as defined by Section 1504, Internal Revenue Code of 1986;
(7) not have been convicted of a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or the distribution of controlled substances; and
(8) not have been convicted of a felony under a federal, state, or local law.
Notes and commentary — not statutory text
History
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. 7, eff. September 1, 2007.
Source of truth
- Edition
- Current through the 89th 2nd Called Legislative Session, 2025
- Official file
- https://statutes.capitol.texas.gov/Docs/HS/htm/HS.431.htm
- Text hash
- sha256 5861d4bde80b14783104cbb855101b649e739bcaec1b8bf1eaffc8c4765df248
- Composed by
- compose_tx.py 2026-10-05: the Legislative Council's chapter files read in document order; verify_tx.py's independent reading (lxml DOM walk) agrees character for character
Cited by 3 provisions
Provisions in this library whose text cites Tex. Health & Safety Code § 431.405. Each shows the citation as that text prints it.
Health and Safety Code
- Tex. Health & Safety Code § 431.4031EXEMPTION FROM CERTAIN PROVISIONS FOR CERTAIN WHOLESALE DISTRIBUTORS.Printed as Sections 431.405(b), 431.407, 431.412, and 431.413
- Tex. Health & Safety Code § 431.4045INSPECTION REQUIRED.Printed as Section 431.405
- Tex. Health & Safety Code § 431.414REFUSAL TO LICENSE; SUSPENSION OR REVOCATION OF LICENSE.Printed as Section 431.405
Procedural information only. Not legal advice and not a substitute for the advice of an attorney. Confirm the current text with the official publisher before relying on it.