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
States licensed: 0
6.0
★★★☆☆3/5

Editorial score · methodology

Top-Rated GLP-1 Partners

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No insurance needed · HSA/FSA eligible · vetted by our editors

8.1

RxSpan MD

Physician-led, pharmacy-transparent compounded GLP-1 with brand-name options

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8.0

Strut Health

Oral-lozenge compounded GLP-1 access

Starting price: $99/mo

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7.8

Yucca Health

Mainstream telehealth GLP-1 access

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7.7

TrimRx

Best overall value

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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].

Semaglutide
Compounded semaglutide produced
Tirzepatide
Compounded tirzepatide produced

States Licensed

Stonegate Pharmacy has not published a state-by-state licensure list. Verify licensure for your state directly with your state board of pharmacy before filling a prescription here.

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

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.
Stonegate Pharmacy is headquartered in Austin, TX. The pharmacy is licensed to ship to 0 US states.
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.
503A pharmacies prepare compounded medications for individual patients in response to specific prescriptions and are regulated primarily by state boards of pharmacy under USP <797> 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.

Key terms, explained

New to GLP-1s? Tap any term for a quick, plain-English definition.

Sources & methodology — as of September 2026
  1. 1.FDA — Compounding and the 503A Pharmacy FrameworkU.S. Food & Drug Administration.
  2. 2.FDA — 503B Outsourcing Facility Registration and RequirementsU.S. Food & Drug Administration.
  3. 3.PCAB — Pharmacy Compounding Accreditation Board StandardsAccreditation Commission for Health Care (ACHC) / PCAB.
  4. 4.USP General Chapter <797> — Pharmaceutical Compounding: Sterile PreparationsUnited States Pharmacopeia.
  5. 5.USP General Chapter <71> — Sterility TestsUnited States Pharmacopeia.
  6. 6.USP General Chapter <85> — Bacterial Endotoxins TestUnited States Pharmacopeia.
  7. 7.FDA — Drug Shortages Database (current shortage listings)U.S. Food & Drug Administration.