| (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.
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| Source Note: The provisions of this §315.3 adopted to be effective March 10, 2016, 41 TexReg 1690; amended to be effective June 11, 2017, 42 TexReg 2931; amended to be effective December 9, 2019, 44 TexReg 7547; amended to be effective March 5, 2020, 45 TexReg 1434; amended to be effective December 10, 2020, 45 TexReg 8866; amended to be effective June 9, 2021, 46 TexReg 3521 |
