22 Tex. Admin. Code § 315.3

Current through Reg. 49, No. 43; October 25, 2024
Section 315.3 - Prescriptions
(a) Schedule II Prescriptions.
(1) Except as provided by subsection (e) of this section, a practitioner, as defined in §481.002(39)(A) of the TCSA, must issue a written prescription for a Schedule II controlled substance only on an official Texas prescription form or through an electronic prescription that meets all requirements of the TCSA. This subsection also applies to a prescription issued in an emergency situation.
(2) A practitioner who issues a written prescription for any quantity of a Schedule II controlled substance must complete an official prescription form.
(3) Except as provided by subsection (f) of this section, a practitioner may issue multiple written prescriptions authorizing a patient to receive up to a 90-day supply of a Schedule II controlled substance provided:
(A) each prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
(B) the practitioner provides written instructions on each prescription, other than the first prescription if the practitioner intends for that prescription to be filled immediately, indicating the earliest date on which a pharmacy may dispense each prescription; and
(C) the practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse.
(4) A schedule II prescription must be dispensed no later than 30 days after the date of issuance or, if the prescription is part of a multiple set of prescriptions, issued on the same day, no later than 30 days after the earliest date on which a pharmacy may dispense the prescription as indicated on each prescription.
(5) A person dispensing a Schedule II controlled substance prescription shall provide written notice on the safe disposal of controlled substance prescription drugs that includes information on locations at which Schedule II controlled substance prescription drugs are accepted for safe disposal. In lieu of listing those locations, the notice may alternatively provide the address of an Internet website specified by the board that provides a searchable database of locations at which Schedule II controlled substance prescription drugs are accepted for safe disposal. The written notice may be provided to the patient in an electronic format, such as by e-mail, if the patient or patient's agent requests the notice in an electronic format and the request is documented. Such written notice is not required if:
(A) the Schedule II controlled substance prescription drug is dispensed at a pharmacy or other location that:
(i) is authorized to take back those drugs for safe disposal; and
(ii) regularly accepts those drugs for safe disposal; or
(B) the dispenser provides to the person to whom the Schedule II controlled substance prescription drug is dispensed, at the time of dispensation and at no cost to the person:
(i) a mail-in pouch for surrendering unused controlled substance prescription drugs; or
(ii) chemicals to render any unused drugs unusable or non-retrievable.
(b) Schedules III through V Prescriptions.
(1) A practitioner, as defined in §§481.002(39)(A), (C), (D) of the TCSA, may use prescription forms and order forms through individual sources. A practitioner may issue, or allow to be issued by a person under the practitioner's direction or supervision, a Schedule III through V controlled substance on a prescription form for a valid medical purpose and in the course of medical practice.
(2) Except as provided in subsection (f) of this section, Schedule III through V prescriptions may be refilled up to five times within six months after date of issuance.
(c) Electronic prescribing.
(1) A practitioner is permitted to issue and to dispense an electronic controlled substance prescription only in accordance with the requirements of the Code of Federal Regulations, Title 21, Part 1311.
(2) Effective January 1, 2021, a prescription for a controlled substance is not required to be issued electronically and may be issued in writing if the prescription is issued:
(A) in circumstances in which electronic prescribing is not available due to temporary technological or electronic failure;
(B) by a practitioner to be dispensed by a pharmacy located outside this state; or
(C) in any other circumstance described in §481.0755(a) of the TCSA.
(3) A prescriber may apply for a waiver from the electronic prescribing requirement by:
(A) submitting a waiver request form to the agency that issued the license, certification, or registration to the prescriber, including any information requested on the form; and
(B) demonstrating circumstances necessitating a waiver from the requirement, including:
(i) economic hardship, as determined by the agency that issued the license, registration, or certification to the prescriber on a prescriber/by prescriber basis, taking into account factors including:
(I) any special situational factors affecting either the cost of compliance or ability to comply;
(II) the likely impact of compliance on profitability or viability; and
(III) the availability of measures that would mitigate the economic impact of compliance;
(ii) technological limitations not reasonably within the control of the prescriber; or
(iii) other exceptional circumstances demonstrated by the prescriber.
(C) A waiver may be issued to a prescriber for a period of one year as specified in Chapter 481 of the Texas Controlled Substances Act. A prescriber may reapply for a subsequent waiver not earlier than the 30th day before the date the waiver expires if the circumstances that necessitated the waiver continue.
(d) Controlled substance prescriptions may not be postdated.
(e) Advanced practice registered nurses or physician assistants may only use the official prescription forms issued with their name, address, phone number, and DEA numbers, and the delegating physician's name and DEA number.
(f) Opioids for the treatment of acute pain.
(1) For the treatment of acute pain, as defined in §481.07636 of the TCSA, a practitioner may not:
(A) issue a prescription for an opioid in an amount that exceeds a 10-day supply; or
(B) provide for a refill of the opioid prescription.
(2) Paragraph (1) of this subsection does not apply to a prescription for an opioid approved by the U.S. Food and Drug Administration for the treatment of substance addiction that is issued by a practitioner for the treatment of substance addiction.
(3) A dispenser is not subject to criminal, civil, or administrative penalties for dispensing or refusing to dispense a controlled substance under a prescription that exceed the limits provided by paragraph (1) of this subsection.

22 Tex. Admin. Code § 315.3

Adopted by Texas Register, Volume 41, Number 10, March 4, 2016, TexReg 1690, eff. 3/10/2016; Amended by Texas Register, Volume 42, Number 22, June 2, 2017, TexReg 2931, eff. 6/11/2017; Amended by Texas Register, Volume 44, Number 49, December 6, 2019, TexReg 7547, eff. 12/9/2019; Amended by Texas Register, Volume 45, Number 09, February 28, 2020, TexReg 1434, eff. 3/5/2020; Amended by Texas Register, Volume 45, Number 50, December 11, 2020, TexReg 8866, eff. 12/10/2020; Amended by Texas Register, Volume 46, Number 23, June 4, 2021, TexReg 3521, eff. 6/9/2021