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HHSC requires drug companies to complete this form in accordance with §354.1921, Texas Administrative Code (Addition of Drugs to the Texas Drug Code Index). The form is used when a drug is new to the market or when an existing drug on the Texas Drug Code Index (TDCI), or formulary, has a new formulation or labeler changes. The TDCI is available online at https://www.txvendordrug.com/formulary.
When to Prepare
A drug must have the following to be considered for inclusion on the TDCI:
- A rebate agreement with the Centers for Medicare & Medicaid Services
- A listing on the Medicaid Drug Rebate Program website
- A listing on First Databank and Medi-Span
Drug companies with one or more of their products on the TDCI are responsible for using this form to announce changes pertaining to any of the information on this form no later than such revisions are scheduled to occur.
Drugs submitted on this form should include the National Drug Code of the company who is holding the drug forth as its own and has the company’s name on the label of the container sold to the pharmacy.
All drugs on the TDCI must bear the FDA-defined labeler code, with the exception of a licensed full-service drug wholesaler that is marketing the final sale to the provider.
- All fields in the “Drug Description”, “Pricing Information”, and “Certification” sections should be completed in their entirety. The fields in the “Contacts” section should be completed as applicable.
- The review process takes up to 90 days once the form is submitted to HHSC and considered complete. The HHSC Drug Addition Process (PDF) explains the timeline of how drugs are added to the TDCI.
- The form must be accompanied with FDA approval letter(s).
- Drug companies must also submit the following:
- Copy of package insert
- Copy of Certificate of Liability Insurance
- Material for p hysicians or file card, if available.
- Any of the following that apply:
- FDA new drug application approval letter
- FDA abbreviated new drug application approval letter
- FDA over-the-counter monograph
- Other applicable documents
VDP Formulary Management (MC-2250)
Texas Health and Human Services
4900 North Lamar Blvd.
Austin, TX 78751
- Email: firstname.lastname@example.org
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- Questions about this form should be directed to the Vendor Drug Program by email at email@example.com.