Source: https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=14&ch=280&rl=5
Timestamp: 2019-06-18 10:49:14
Document Index: 99305288

Matched Legal Cases: ['§280', '§309', '§309', '§280', '§351', '§351', '§280']

RULE §280.5 Prescription and Diagnostic Drugs for Therapeutic Optometry
(a) A therapeutic optometrist may administer and prescribe any drug authorized by Section 351.358(a) and (b)(1) of the Act.
<?Pub Caret -2> (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, Sections 562.008 and 563.002 of the Texas Occupations Code, and §309.3 of this title.
(c) All prescriptions shall contain the following information:
(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), shall contain the following:
(1) the name, address and telephone number of the therapeutic optometrist;
(2) the date of dispensing;
(4) the name and strength of the drug; and
(5) the directions for use.
(f) At least annually, the Texas Optometry Board shall provide to the Texas State Board of Pharmacy a list of the topical ocular pharmaceutical agents which may be prescribed by therapeutic optometrist.
(g) A therapeutic optometrist may administer and prescribe all:
(1) ophthalmic devices;
(2) over-the-counter oral medications; and
(3) appropriate topical pharmaceutical agents used for diagnosing and treating visual defects, abnormal conditions, and diseases of the human eye and adnexa, which are included in the following classifications or are combinations of agents in the classifications. No drug falling within one of the following categories may be used for the treatment of glaucoma in a manner that was not permitted by law on August 31, 1991:
(A) anti-allergy:
(i) antihistamine;
(ii) membrane stabilizer;
(B) anti-fungal:
(i) imidazoles;
(ii) polyenes;
(C) anti-infective:
(i) aminoglycoside;
(ii) anti-cell membrane;
(iii) anti-cell wall synthesis;
(iv) anti-DNA synthesis;
(v) anti-protein synthesis (excluding chloramphenicol);
(vi) anti-ACHase;
(vii) cephalosporin;
(viii) agents affecting intermediary metabolism;
(D) anti-inflammatory:
(i) nonsteroidal anti-inflammatory drug (NSAID);
(ii) steroid;
(E) antiseptic;
(F) chelating agent;
(G) chemical cautery;
(H) cycloplegic: parasympatholytic;
(I) hyperosmotic;
(J) miotic:
(i) anti-ACHase;
(ii) parasympathomimetic;
(K) mucolytic;
(L) mydriatic: sympathomimetic (Alpha 1 agonists only);
(M) vasoconstrictor: sympathomimetic (Alpha 1 agonists only)
(N) antivirals.
(h) The authority of an optometric glaucoma specialist to prescribe antiglaucoma drugs is defined in §280.10. The following are those drugs which are classified as antiglaucoma drugs and may not be used by a therapeutic optometrist in a manner that was not permitted by law on August 31, 1991:
(1) Pilocarpine 1%-10%
(2) Carbachol 0.75%-3%
(3) Carteolol
(4) Epinephrine 0.25%-2%
(5) Dipivefrin 0.1%
(6) Betaxolol 0.5%
(7) Levobunolol 0.5%
(8) Metipranolol 0.3%
(9) Timolol 0.25%-0.5%
(10) Physostigmine 0.25%-0.5%
(11) Demecarium 0.125%-0.25%
(12) Echothiophate 0.03%-0.25%
(13) Isoflurophate 0.25%
(i) This formulary specifically lists the types of drugs which may be prescribed by a therapeutic optometrist. Subject to the antiglaucoma limitations described in subsections (g) and (h) of this section, a therapeutic optometrist may possess and administer any topical ocular pharmaceutical agent which has a legitimate diagnostic or therapeutic use.
(j) 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) A therapeutic optometrist must obtain a registration number from the DPS for the principal office of practice. Application may be made for a separate registration for the practice of optometry at a satellite office but all requirements of this rule shall apply in all locations.
(3) 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.
(4) 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 and 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.
(5) Minimum security controls shall be established to include but not limited to:
(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,
(6) Failure of the therapeutic optometrist to maintain strict security and proper accountability of controlled substance 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