| (a) A therapeutic optometrist may administer and prescribe
any drug authorized by Section 351.358 of the Act.
(b) To prohibit substitution of a generically equivalent
drug product on a written prescription drug order, a therapeutic optometrist
must write across the face of the written prescription, in the therapeutic
optometrist's own handwriting, "brand necessary" or "brand
medically necessary." If the therapeutic optometrist does not
clearly indicate "brand necessary" or "brand medically
necessary," the pharmacist may substitute a generically equivalent
drug product in compliance with the Texas Pharmacy Act, (Tex. Occ.
Code Sections 562.008 and 562.009), and §309.3 of this title
(relating to Substitution Requirements).
(c) All prescriptions shall contain the following information:
(1) the date of issuance;
(2) the name and address of the patient for whom the
drug is prescribed;
(3) the name, strength, and quantity of the drug, medicine,
or device prescribed;
(4) the direction for use of the drug, medicine, or
device prescribed;
(5) the name and address of the therapeutic optometrist;
(6) the manually written signature of the prescribing
therapeutic optometrist; or an electronic signature provided that
the prescription is electronically signed by the practitioner using
a system which electronically replicates the practitioner's manual
signature on the written prescription, and provided:
(A) that security features of the system require the
practitioner to authorize each use; and
(B) the prescription is printed on paper that is designed
to prevent unauthorized copying of a completed prescription and to
prevent the erasure or modification of information written on the
prescription by the prescribing practitioner; and
(7) the license number of the prescribing therapeutic
optometrist including the therapeutic designation.
(d) The prescribing therapeutic optometrist issuing
verbal or electronic prescription drug orders to a pharmacist shall
furnish the same information required for a written prescription,
except for the written signature. If the therapeutic optometrist does
not clearly indicate "brand necessary" or "brand medically
necessary" when communicating the prescription to the pharmacist,
the pharmacist may substitute a generically equivalent drug product
in compliance with the Texas Pharmacy Act and §309.3 of this
title (related to Substitution Requirements).
(e) A therapeutic optometrist may charge a reasonable
fee for drugs administered within the optometric office, but a therapeutic
optometrist shall not charge for any drugs supplied to the patient
as take-home medication. Any drug supplied by a therapeutic optometrist
other than an over-the counter drug shall be labeled in compliance
with the following information in compliance with the Texas Dangerous
Drug Act (Health and Safety Code, Chapter 483), and it shall contain
the following:
(1) the name, address, and telephone number of the
therapeutic optometrist;
(2) the date of dispensing;
(3) the name of the patient;
(4) the name and strength of the drug; and
(5) the directions for use.
(f) A therapeutic optometrist may administer and prescribe
all:
(1) ophthalmic devices;
(2) over-the-counter medications including oral and
other treatments; and
(3) appropriate prescription topical pharmaceutical
agents used for diagnosing and treating visual defects, abnormal conditions,
and diseases of the human eye and adnexa.
(g) The authority of an optometric glaucoma specialist
to prescribe antiglaucoma drugs is defined by Section 351.3581 of
the Act.
(h) A therapeutic optometrist may possess and administer
cocaine eye drops for diagnostic purpose. The cocaine eye drops must
be no greater than 10 percent solution in prepackaged liquid form.
(1) A therapeutic optometrist must observe all requirements
of the Texas Controlled Substances Act, the Health and Safety Code,
Chapter 481, and all requirements of the Texas Department of Public
Safety (DPS) Drug Rules in making application and maintaining renewal
of a United States Drug Enforcement Administration (DEA) registration
number for possession of the cocaine eye drops, a Schedule II controlled
substance.
(2) The therapeutic optometrist must use the required
DEA form for the purchase of the cocaine eye drops and shall maintain
a complete and accurate record of purchases (to include samples received
from pharmaceutical manufacturer representatives) and administration
of controlled substances. The maximum amount to be purchased and maintained
in an office of practice shall be no more than two vials, one opened
and one in inventory.
(3) The recordkeeping listed in this section shall
be subject to inspection at all times by the Texas Department of Public
Safety, the U.S. Drug Enforcement Administration, and the Texas Optometry
Board. Any officer or employee of the governmental agencies shall
have the right to inspect and copy records, reports, and other documents
and inspect security controls, inventory, and premises where such
cocaine eye drops are possessed or administered.
(4) Minimum security controls shall be established
to include but not limited to:
(A) establishing adequate security to prevent unauthorized
access and diversion of the controlled substance;
(B) during the course of business activities, not allowing
any individual access to the storage area for controlled substances
except those authorized by the therapeutic optometrist;
(C) storing the controlled substance in a securely
locked, substantially constructed cabinet or security cabinet which
shall meet the requirements under the DPS Drug Rules; or
(D) not employ in any manner an individual that would
have access to controlled substances who has had a federal or state
application for controlled substances denied or revoked, or have been
convicted of a felony offense under any state or federal law relating
to controlled substances or been convicted of any other felony, or
have been a licensee of a health regulatory agency whose license has
been revoked, canceled, or suspended.
(5) Failure of the therapeutic optometrist to maintain
strict security and proper accountability of controlled substances
shall be deemed to be a violation of the Act, §351.501 and §351.551.
|
| Source Note: The provisions of this §280.5 adopted to be effective September 2, 1991, 16 TexReg 4454; amended to be effective January 8, 1992, 16 TexReg 7742; amended to be effective January 19, 1993, 18 TexReg 119; amended to be effective February 22, 1996, 21 TexReg 1093; amended to be effective July 8, 1996, 21 TexReg 5976; amended to be effective October 14, 1999, 24 TexReg 8749; amended to be effective August 3, 2000, 25 TexReg 7173; amended to be effective December 25, 2002, 27 TexReg 11919; amended to be effective June 26, 2003, 28 TexReg 4635; amended to be effective November 27, 2012, 37 TexReg 9362; amended to be effective May 22, 2023, 48 TexReg 2575;amended to be effective September 16, 2024, 49 TexReg 7326 |
