Compounding Pharmacy · Exton, PA · 503B

ProRx Review

ProRx is an FDA-registered 503B outsourcing facility in Exton, Pennsylvania that compounded sterile semaglutide and tirzepatide injections at scale during the GLP-1 shortage. It has been the subject of two FDA warning letters (March 2025 and April 2026) and voluntary recalls totaling more than 50,000 vials of compounded GLP-1 products for lack of sterility assurance.

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503BFDA Registered 503B
Location: Exton, PA
States licensed: 0
4.5
★★☆☆☆2.3/5

Editorial score · methodology

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Not sourced from ProRx — these are our highest-scored vetted telehealth partners for compounded GLP-1s, if you'd rather start with a provider we've walked through end to end.

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

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7.1

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6.9

DudeMeds

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8.1

Oak

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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.

FDA Registered 503B
Registered directly with the FDA as a 503B outsourcing facility. Subject to FDA inspection and required to follow cGMP standards.

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

ProRx 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

2025-03-04
FDA Warning Letter (MARCS-CMS 696742) issued to ProRx, LLC citing cGMP violations, sterility deficiencies, non-registered ingredient sources, and inadequate labeling on compounded drugs including Semaglutide 5mg/2ml and Tirzepatide 60mg/3ml.
2025-10-15
Voluntary recall of nearly 40,000 vials of compounded tirzepatide and semaglutide injection due to lack of sterility assurance, on top of a prior recall of over 15,000 vials for the same reason.
2026-04-07
FDA Warning Letter (MARCS-CMS 723704) issued to ProRx LLC for producing tirzepatide that was ineligible for compounding (not in shortage since 2024, never on the 503B bulks list), plus unsanitary sterile production conditions, labeling, and adverse-event-reporting violations.

Weight Loss Rankings Score Breakdown

Accreditation & Compliance6/10
Regulatory Standing5/10
State Coverage0/10
GLP-1 Production10/10
Track Record5/10

Scores are independently researched. See our methodology for details.

High confidence · Last verified June 2026 · How we verify provider data

Frequently Asked Questions

ProRx is a 503B compounding pharmacy based in Exton, PA. It operates under state board of pharmacy licensure. Note: our records show 3 documented regulatory action(s) — see the Regulatory Actions section below.
ProRx is headquartered in Exton, PA. The pharmacy is licensed to ship to 0 US states.
ProRx produces compounded semaglutide and compounded tirzepatide in addition to other compounded preparations. As a 503B pharmacy, it can batch-produce sterile compounds under FDA cGMP standards.
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

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Sources & methodology — as of October 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.