(a) HHSC maintains a closed formulary (HHSC Psychiatric Drug Formulary) that lists drugs approved by the PEFC for use by service system components and their contractors.     
      (b) A drug is not available for general use by service system components or their contractors unless it is approved by the PEFC. Drugs not listed in the HHSC Psychiatric Drug Formulary or Interim Formulary Update may not be used except under the limited circumstances described in §306.359 of this subchapter (relating to Prescribing Non-formulary Drugs).     
      (c) The use of formulary drugs in unusual clinical situations or the use of unusual drug combinations must be accompanied by written justification in the individual's medical record. Additional clinical consultation in these situations should occur as deemed necessary by the prescribing practitioner.     
      (d) Reserve drugs may be prescribed for use outside the guidelines described in the formulary if the prescription is justified in the individual's medical record and reviewed in audits of reserve drug use conducted by the service system component as clinically indicated.     
      (e) Drug research conducted at an HHSC facility is governed by 25 TAC Chapter 414, Subchapter P (relating to Research in TDMHMR Facilities). Local authorities conducting drug research must comply with all applicable state and federal laws, rules, and regulations, including 45 CFR Part 46, as required by §301.325 of this title (relating to Rights and Protection).     
     Source Note:        The provisions of this §306.354 adopted to be effective February 24, 2021, 46 TexReg 1246