GLP Watchdog

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

Stonegate Pharmacy Review

Austin, Texas, established in 2007: Stonegate Pharmacy, a 503A compounder. Its GLP-1 medications, semaglutide and tirzepatide, are made as once-weekly subcutaneous injectables and as sublingual rapid-dissolving tablets. A 2019 inspection noted sterile-practice deviations, and an FDA State Referral Letter followed in 2020.

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503A
Location: Austin, TX
Website: Official site
States licensed: 5
6.0
★★★☆☆6.0/10

Our own score · methodology

GLP-1 Partners

None of these fill through Stonegate Pharmacy. They are compounded GLP-1 sellers we have an affiliate relationship with. Each carries the same score it would without one.

Some of the links on this page earn us money. If you sign up with a provider after following one, that provider may pay GLP Watchdog a commission. Learn more

Cash-pay pricing · HSA/FSA accepted · every partner checked by our editors

9.0

YourEra

Semaglutide at $99/month, well below the typical price

Starting price: $99/mo

Get started →Read review YourEra →
9.1

Collective

Flat any-dose pricing, if you can absorb a $199 annual membership on top

Starting price: $59/mo + membership

Get started →Read review Collective →
7.3

Found

People who want clinician visits billed to commercial insurance, with compounded medication in the plan price

Starting price: $179/mo

Get started →Read review Found →
9.3

Embody

A flat compounded tirzepatide or semaglutide price at every dose, from a seller that names its pharmacies

Starting price: $79/mo

Get started →Read review Embody →

Accreditations and Standards

Sterile compounding in this country runs on one rulebook, General Chapter <797> of the United States Pharmacopeia[4]. Depending on what is being made, the finished preparation is then tested for sterility under USP <71>[5] and for bacterial endotoxins under USP <85>[6]. Every pharmacy on this page owes those standards already. Which regulator oversees the pharmacy depends on its route, set out in our explainer on 503A and 503B compounding pharmacies. What follows is what this one has added on top.

Past the state pharmacy license, we could not verify any outside accreditation for this pharmacy.

What It Compounds

Whether any pharmacy may compound semaglutide or tirzepatide at all turns on where the reference product sits on the FDA Drug Shortage List. When a drug comes off that list the door closes, and it has closed before[7].

Semaglutide
Compounds semaglutide
Tirzepatide
Compounds tirzepatide

States Licensed (5)

TXCOFLAZNM

What Regulators Have on File

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.
2019-04-24
FDA warning-letter close-out and referral letter to the Texas State Board of Pharmacy issued for Stonegate Pharmacy LP (Austin, TX).

How GLP Watchdog Scored This Pharmacy

Accreditation held6/10
Standing with regulators5/10
States licensed1/10
GLP-1 compounding10/10
Years operating9/10

We research every score ourselves. The methodology page sets out how each part is weighted. To check any pharmacy yourself, follow the six public checks in our guide to verifying an online GLP-1 pharmacy, or run its name through the pharmacy legitimacy lookup.

Medium confidence · Last verified · How we check provider data

Frequently Asked Questions

Here is what we can and cannot confirm. Stonegate Pharmacy operates as a 503A compounding pharmacy out of Austin, TX, and has been open since 2007. Its authority to operate rests on a state board of pharmacy license and nothing further. Our records carry 2 documented regulatory action(s), listed further down this page.
Stonegate Pharmacy works out of Austin, TX. It holds licenses to ship into 5 US states.
Alongside its other compounded preparations, Stonegate Pharmacy makes compounded semaglutide and compounded tirzepatide. Being a 503A pharmacy, it compounds only against a prescription written for one named patient, with the state board of pharmacy watching.
Two things separate them: who inspects, and how much may be made at once. A 503B outsourcing facility registers with the FDA itself, works to current Good Manufacturing Practices (cGMP), submits to FDA inspection, and may make compounded medication in batches with no named patient attached. A 503A pharmacy cannot do that. It fills a prescription written for one patient, answers mainly to its state board of pharmacy, and works to the USP <797> standard for sterile compounding. Neither route produces an FDA-approved drug.

Glossary

The words sellers use, defined. Tap any term.

Where to fill semaglutideBack to the register
Sources & methodology — as of November 2026
  1. 1.FDA — Compounding and the 503A Pharmacy Framework— U.S. Food & Drug Administration.
  2. 2.FDA — 503B Outsourcing Facility Registration and Requirements— U.S. Food & Drug Administration.
  3. 3.PCAB — Pharmacy Compounding Accreditation Board Standards— Accreditation Commission for Health Care (ACHC) / PCAB.
  4. 4.USP General Chapter <797> — Pharmaceutical Compounding: Sterile Preparations— United States Pharmacopeia.
  5. 5.USP General Chapter <71> — Sterility Tests— United States Pharmacopeia.
  6. 6.USP General Chapter <85> — Bacterial Endotoxins Test— United States Pharmacopeia.
  7. 7.FDA — Drug Shortages Database (current shortage listings)— U.S. Food & Drug Administration.