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RULE §280.5Prescription and Diagnostic Drugs for Therapeutic Optometry

(a) A therapeutic optometrist may administer and prescribe any drug authorized by Section 351.358 of the Texas Optometry 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.

(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; and

  (3) appropriate topical or oral 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 Texas Optometry 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,

    (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 Texas Optometry 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

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