FDA documented distributed Semaglutide 2.5 mg/mL injection with 79.876% potency and deemed it adulterated and misbranded.
Tirzepatide
FDA documented distributed Tirzepatide 10 mg/mL lots with 86.779% and 89.13% potency; first-party site also states patient-specific tirzepatide compounding.
Product evidence does not establish current availability.
Locations in the source record
221 Gale Lane, Kennett Square, PA 19348
Services named by sources
503A patient-specific compounding
Sterile and nonsterile compounding
Human and animal compounded medications
GLP-1 compounding
Regulatory compliance
503 pathway evidence
A pathway label describes which federal rules apply — it is not a quality claim.
Section 503A
Source-backed pathway evidence
FDA correspondence states that Boothwyn represented itself as a Pennsylvania-licensed pharmacy complying with section 503A; the 2026 FDA warning applies insanitary-condition requirements regardless of section 503A status.
Section 503B
Not conclusively established
not found in current fda registry check
Telehealth providers
No provider relationship is verified in the bound sources.
Clinic Scout links a provider only when an explicit source names the relationship.
FDA warning-letter/Form 483/current-503B and Pennsylvania state-action sources were checked. Two FDA warnings and the Pennsylvania penalty/probation were verified.
U.S. Food and Drug Administration · 2025-06-09
Warning Letter
FDA stated Boothwyn produced and distributed adulterated and misbranded animal drugs, compounded copies from bulk substances, dispensed quantities suggesting office stock, distributed products with out-of-specification endotoxin results, and had records FDA said were altered or false.
Status not stated
Pennsylvania State Board of Pharmacy / Department of State · 2025-10-21
Consent agreement, civil penalty and probation
Pennsylvania fined Boothwyn $1 million and placed its license on probation after finding large-scale GLP-1 compounding in uninspected facilities.
Status not stated
U.S. Food and Drug Administration · 2026-01-16
Warning Letter
FDA stated that sterile products were prepared under insanitary conditions and that distributed semaglutide, tirzepatide and other products differed from labeled strengths; the letter cites a voluntary recall and cessation of sterile GLP-1 production, followed by notice of intent to resume.
Boothwyn Pharmacy compounds tirzepatide only on a patient-specific prescription basis, and each order is prepared for the individual patient named on the prescription.
You distributed seven (7) batches of drugs with out-of-specification (OOS) bacterial endotoxin testing (BET) results ... Your PIC also created false records of investigations which did not occur.
Boothwyn Pharmacy ... began compounding popular injectable weight-loss drugs, known as GLP-1 medications, in early September 2024 ... producing over a thousand doses each day, in uninspected facilities. Department of State fines Boothwyn Pharmacy $1 million and places its license on probation.
Your Semaglutide 2.5mg/mL Injection was subpotent ... potency of 79.876% and your Tirzepatide 10mg/mL Injection was subpotent ... potency of 86.779% and ... 89.13%.
Updated as of 8/18/2026 ... This table lists the outsourcing facilities that have submitted registration information that has been determined to be complete by the data lock date for the latest weekly update of the table.
Related evidence records
Continue with records sharing source-backed directory tags.
These links are based only on shared GLP-1 relevance or 503-pathway tags; they do not assert affiliation or a dispensing relationship.
GLP Clinic Scout does not issue a blanket legitimacy verdict. This research record preserves 6 dated first-party or regulator citation(s), 3 regulatory/action record(s), and 4 explicitly unresolved field(s). Review the cited evidence and current license status before making a decision.
Weekly price watch
Know when GLP-1 prices move.
One useful comparison each week. No spam, no sold lists, and you can unsubscribe anytime.