|(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
(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).