Compounding Pharmacy · Southlake, TX · 503B
FarmaKeio Outsourcing Review
FarmaKeio Outsourcing is the FDA-registered 503B arm of the FarmaKeio Pharmacy Network, a Texas-based custom compounding operation that produces sterile formulations including semaglutide and tirzepatide combinations. FarmaKeio is licensed in 49 states plus Puerto Rico and the U.S. Virgin Islands and is a lead plaintiff, alongside the Outsourcing Facilities Association, in litigation challenging the FDA's removal of tirzepatide from the drug shortage list.
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About this pharmacy
FarmaKeio Outsourcing is the FDA-registered 503B arm of the FarmaKeio Pharmacy Network, a Texas-based custom compounding operation that produces sterile formulations including semaglutide and tirzepatide combinations. FarmaKeio is licensed in 49 states plus Puerto Rico and the U.S. Virgin Islands and is a lead plaintiff, alongside the Outsourcing Facilities Association, in litigation challenging the FDA's removal of tirzepatide from the drug shortage list.
Certifications & Compliance
All sterile compounding pharmacies in the United States are required to follow United States Pharmacopeia General Chapter <797> sterile compounding standards[4], with finished preparations evaluated against USP <71> sterility testing[5] and USP <85> bacterial endotoxin testing[6] as appropriate for the product type.
Drugs Produced
Compounding pharmacies' ability to produce semaglutide or tirzepatide depends on the FDA Drug Shortage List status for each reference product; compounding eligibility can change when a drug moves on or off the shortage list[7].
States Licensed (0)
Regulatory Actions
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Medium confidence · Last verified 2026-06-04 via manual · How we verify provider data
Frequently Asked Questions
Glossary references
Key terms in this article, linked to their canonical definitions.
- Semaglutide · Drugs and brands
- Tirzepatide · Drugs and brands
- Compounded GLP-1 · Pharmacy and drug forms
- 503A pharmacy · Pharmacy and drug forms
- 503B outsourcing facility · Pharmacy and drug forms
- PCAB accreditation · Pharmacy and drug forms
- Off-label use · Insurance and regulatory
- FDA Drug Shortage List · Insurance and regulatory
Sources & methodology — as of June 2026
- 1.FDA — Compounding and the 503A Pharmacy Framework— U.S. Food & Drug Administration.
- 2.FDA — 503B Outsourcing Facility Registration and Requirements— U.S. Food & Drug Administration.
- 3.PCAB — Pharmacy Compounding Accreditation Board Standards— Accreditation Commission for Health Care (ACHC) / PCAB.
- 4.USP General Chapter <797> — Pharmaceutical Compounding: Sterile Preparations— United States Pharmacopeia.
- 5.USP General Chapter <71> — Sterility Tests— United States Pharmacopeia.
- 6.USP General Chapter <85> — Bacterial Endotoxins Test— United States Pharmacopeia.
- 7.FDA — Drug Shortages Database (current shortage listings)— U.S. Food & Drug Administration.