Is Stonegate Pharmacy legit?

Stonegate Pharmacy is a 503A compounding pharmacy based in Austin, TX that has been operating since 2007. It operates under state board of pharmacy licensure. Note: our records show 1 documented regulatory action(s) — see the Regulatory Actions section below.

Where is Stonegate Pharmacy located?

Stonegate Pharmacy is headquartered in Austin, TX. The pharmacy is licensed to ship to 0 US states.

What does Stonegate Pharmacy produce?

Stonegate Pharmacy produces compounded semaglutide and compounded tirzepatide in addition to other compounded preparations. As a 503A pharmacy, it dispenses compounded medications in response to individual patient prescriptions under state board of pharmacy oversight.

What is the difference between 503A and 503B?

503A pharmacies prepare compounded medications for individual patients in response to specific prescriptions and are regulated primarily by state boards of pharmacy under USP sterile compounding standards. 503B outsourcing facilities register directly with the FDA, follow current Good Manufacturing Practices (cGMP), and can produce compounded medications in larger batches without patient-specific prescriptions. 503B facilities are subject to FDA inspection.

Compounding Pharmacy · Est. 2007 · Austin, TX · 503A

Stonegate Pharmacy Review

Stonegate Pharmacy is a 503A compounding pharmacy in Austin, Texas, established in 2007, that compounds GLP-1 medications including semaglutide and tirzepatide as once-weekly subcutaneous injectables and sublingual rapid-dissolving tablets. It received an FDA State Referral Letter in 2020 after a 2019 inspection noted sterile-practice deviations.

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503A

Location: Austin, TX

Website: www.stonegaterx.com

States licensed: 0

6.0

Weight Loss Rankings Score

out of 10

About this pharmacy

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.

We have not verified any third-party accreditations for this pharmacy beyond its state pharmacy license.

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].

Yes

Semaglutide

Compounded semaglutide produced

Yes

Tirzepatide

Compounded tirzepatide produced

States Licensed (0)

Regulatory Actions

2020-09-21

FDA State Referral Letter issued to Stonegate Pharmacy, LP (Austin, TX) following a July-Aug 2019 inspection that observed deviations from appropriate sterile practice standards that could lead to drug contamination.

Weight Loss Rankings Score Breakdown

Accreditation & Compliance6/10

Regulatory Standing5/10

State Coverage0/10

GLP-1 Production10/10

Track Record9/10

Scores are independently researched. See our methodology for details.

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

See Top Semaglutide Providers All Pharmacies

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.