(a) Applying to have a drug added to the HHSC Psychiatric Drug Formulary.
  (1) Any member of the PEFC, any service system component practitioner, or any contract practitioner may apply to have a drug added to the HHSC Psychiatric Drug Formulary by completing the New Drug Application form found in the HHSC Psychiatric Drug Formulary on the HHSC Psychiatric Formulary website.
  (2) Include the following with the New Drug Application form:
    (A) published articles in biomedical literature that substantiate the efficacy and safety of the proposed drug;
    (B) information on the advantages of the proposed drug compared with similar formulary drugs;
    (C) a list of formulary drugs that the proposed drug would replace or supplement; and
    (D) cost effectiveness data.
(b) Submitting the application.
  (1) An HHSC facility practitioner or HHSC facility contract practitioner shall submit the application to the facility's pharmacy and therapeutics committee for approval. If the committee approves the application, the committee forwards the application to the PEFC.
  (2) A non-facility service system component practitioner or non-facility service system component contract practitioner shall submit the application to the component's clinical/medical director or designee who determines if the application is appropriate and complete, and if so, shall forward the application to the PEFC.
  (3) A member of the PEFC shall submit the application directly to the PEFC.
(c) Considering the application. The PEFC considers the drug application and shall:
  (1) approve the proposed drug's inclusion and, if appropriate, approve audit criteria and recommend dosage guidelines;
  (2) approve the proposed drug on a trial basis for a specified period of time;
  (3) approve the proposed drug as a reserve drug, with guidelines;
  (4) postpone the decision until a later meeting; or
  (5) deny the proposed drug's inclusion.

Source Note: The provisions of this §306.357 adopted to be effective February 24, 2021, 46 TexReg 1246