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
Weight Loss Rankings Score
out of 10

About this pharmacy

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.

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].

Yes
Semaglutide
Compounded semaglutide produced
Yes
Tirzepatide
Compounded tirzepatide produced

States Licensed (0)

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 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.

See Top Semaglutide ProvidersAll Pharmacies
Sources & methodology — as of June 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.