1. (a) The advanced practice registered nurse with a valid prescription authorization number:

   1. (1) shall sign prescription drug orders for only those drugs that are:

      1. (A) authorized by Protocols or other written authorization for medical aspects of patient care; and
      2. (B) prescribed for patient populations within the accepted scope of professional practice for the advanced practice registered nurse's license; and
   2. (2) shall comply with the requirements for adequate physician supervision published in the rules of the Texas Medical Board relating to Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice Nurses as well as other applicable laws.

2. (b) Protocols or other written authorization shall be defined in a manner that promotes the exercise of professional judgement by the advanced practice registered nurse commensurate with the education and experience of that person.

   1. (1) A protocol or other written authorization:

      1. (A) is not required to describe the exact steps that the advanced practice registered nurse must take with respect to each specific condition, disease, or symptom; and
      2. (B) may state types or categories of medications that may be prescribed or contain the types or categories of medications that may not be prescribed.

   2. (2) Protocols or other written authorization shall be:

      1. (A) written, agreed upon and signed by the advanced practice registered nurse and the physician;
      2. (B) reviewed and signed at least annually; and
      3. (C) maintained in the practice setting of the advanced practice registered nurse.

3. (c) Prescription Information: The format and essential elements of the prescription shall comply with the requirements of the Texas State Board of Pharmacy. The following information must be provided on each prescription:

   1. (1) the patient's name and address;
   2. (2) the name, strength, and quantity of the drug to be dispensed;
   3. (3) directions to the patient regarding taking of the drug and the dosage;
   4. (4) the intended use of the drug, if appropriate;
   5. (5) the name, address, telephone number, and, if the prescription is for a controlled substance, the United States Drug Enforcement Administration number of the delegating physician;
   6. (6) address and telephone number of the site at which the prescription drug order was carried out or signed;
   7. (7) the date of issuance;
   8. (8) the number of refills permitted; and
   9. (9) the name, prescription authorization number, original signature, and, if the prescription is for a controlled substance, the Texas Department of Public Safety and United States Drug Enforcement Administration numbers of the advanced practice registered nurse signing or co-signing the prescription drug order.
4. (d) Generic Substitution. The advanced practice registered nurse shall authorize or prevent generic substitution on a prescription in compliance with the current rules of the Texas State Board of Pharmacy relating to Generic Substitution.
5. (e) An advanced practice registered nurse may prescribe medications for sexually transmitted diseases for partners of an established patient, if the advanced practice registered nurse assesses the patient and determines that the patient may have been infected with a sexually transmitted disease. Nothing in this subsection shall be construed to require the advanced practice registered nurse to issue prescriptions for partners of patients.

6. (f) Advanced practice registered nurses may prescribe only those medications that are FDA approved unless done through protocol registration in a United States Institutional Review Board or Expanded Access authorized clinical trial. "Off label" use, or prescription of FDA-approved medications for uses other than that indicated by the FDA, is permitted when such practices are:

   1. (1) within the current standard of care for treatment of the disease or condition; and
   2. (2) supported by evidence-based research.

Source Note:The provisions of this §222.4 adopted to be effective November 26, 2003, 28 TexReg 10502; amended to be effective February 14, 2010, 35 TexReg 866.