22 Tex. Admin. Code § 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.
Notes
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