Applications and Forms - Drug Manufacturers and Distributors

For assistance with licensing, call 512-834-6727.

Drug Manufacturers and Distributors Program Update
11/19/2021

EFFECTIVE IMMEDIATELY

All applications with fees are to be sent to this address:

Department of State Health Services 
Cash Receipts Branch – MC 2003
PO Box 149347
Austin, TX 78714-9347

Drug Manufacturers

Nonprescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13006) (PDF, 151KB)
• Minor Amendment Change - Name, Address (EF23-13007) (PDF, 151KB)

Prescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13008) (PDF, 253KB)
• Minor Amendment Change - Name, Address (EF23-13009) (PDF, 235KB)
• Prescription Drugs - Additional Documentation Required With Renewal (PDF, 175KB)

Drug Distributors

Nonprescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13002) (PDF, 226KB)
• Minor Amendment Change - Name, Address (EF23-13003) (PDF, 225KB)

Prescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13004) (PDF, 261KB)
• Minor Amendment Change - Name, Address (EF23-13005) (PDF, 261KB)
• Prescription Drugs - Additional Documentation Required With Renewal (PDF, 175KB)

Out of State Nonprescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13014) (PDF, 256KB)
• Minor Amendment Change - Name, Address (EF23-13015) (PDF, 251KB)

Out of State Prescription Drugs License Applications

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13016) (PDF, 289KB)
• Minor Amendment Change - Name, Address (EF23-12999) (PDF, 257KB)
• Prescription Drugs - Additional Documentation Required With Renewal (PDF, 175KB)

Multiple Products

Nonprescription Drugs-Food-Devices

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13010) (PDF, 223KB)
• Minor Amendment Change - Name, Address (EF23-13011) (PDF, 224KB)

Compressed Medical Gases-Nonprescription Drugs-Food-Devices

• Initial, Renewal or Change of Ownership - Including Legal Entity (EF23-13012) (PDF, 231KB)
• Minor Amendment Change - Name, Address (EF23-13013) (PDF, 224KB)