Compounding Pharmacy · , · 503A
SmartPharmaRX Review
SmartPharmaRX is a 503A licensed compounding pharmacy compounding sterile preparations in accordance with USP 797 (with USP 795 / 800 alignment) and cGMP-aligned protocols. Compounds GLP-1 therapies including tirzepatide and semaglutide, with each preparation tested for sterility, potency, endotoxin, and stability before release. Specific state license footprint is described as 'select states' but not enumerated on the public site.
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About this pharmacy
SmartPharmaRX is a 503A licensed compounding pharmacy compounding sterile preparations in accordance with USP 797 (with USP 795 / 800 alignment) and cGMP-aligned protocols. Compounds GLP-1 therapies including tirzepatide and semaglutide, with each preparation tested for sterility, potency, endotoxin, and stability before release. Specific state license footprint is described as 'select states' but not enumerated on the public site.
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 2026-05-23 via pharmacy-directory-cross-state-audit-2026-05-23 · 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 May 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.