Pharmacy evidence record · researched 2026-08-20
BPI Labs, LLC
FDA's 2025 Form 483 lists multiple semaglutide injection strengths.
FDA's 2025 and 2026 Form 483s list tirzepatide products; the 2026 observation states tirzepatide bulk substance could not be used under section 503B.
Product evidence does not establish current availability.
Regulatory compliance
A pathway label describes which federal rules apply — it is not a quality claim.
Section 503A
not supported
Section 503B
FDA's compounding-action index and Form 483 identify BPI as an outsourcing facility/503B facility, but an exact current weekly-registry row was not recovered.
Telehealth providers
Clinic Scout links a provider only when an explicit source names the relationship.
Regulatory history
FDA compounding-action/Form 483/current-503B and Florida license/action sources were checked. The Florida record showed no discipline or public complaint.
U.S. Food and Drug Administration · 2021-04-30
U.S. Food and Drug Administration · 2021-09-01
The FDA action index lists the letter; its substantive terms were not recovered.
issuedU.S. Food and Drug Administration · 2025-02-21
FDA cited missing section 503B label information on semaglutide, tirzepatide and other products.
Status not statedU.S. Food and Drug Administration · 2025-07-28
The FDA action index lists the letter; its substantive terms were not recovered.
issuedU.S. Food and Drug Administration · 2026-04-17
FDA cited use of tirzepatide bulk substance that could not be used under section 503B and quality-unit procedure deficiencies.
Status not statedNo Clinic Scout patient reviews are published for this pharmacy. Submissions go through manual moderation before anything appears here.
What this record verifies for you
Each line traces to a citation in the source list below — read the exact captured wording before relying on it.
No superiority claim is made for review volume, ratings, or patient sentiment.
BPI Labs, LLC, Largo, FL - 503B Facility - 483 Issued 04/17/2026 - FMD-145 Letter Issued 07/28/2025 - 483 Issued 02/21/2025 - FMD-145 Letter Issued 09/01/2021 - 483 Issued 04/30/2021
Examples ... include ... Semaglutide Injection 1mg/mL ... Semaglutide Injection,30mg/6mL ... Tirzepatide Injection,30mg/3mL ... Tirzepatide Injection,60mg/3mL
Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B ... Specifically, Your facility compounded human drug products using tirzepatide bulk drug substance.
License Number: PH32473 License Status: Clear/Active ... Administrative complaints or disciplinary actions: Discipline on File No Public Complaint No
Founded in 2012 as a subsidiary of Belcher Pharmaceuticals, BPI Labs has grown into a premier manufacturer of high-quality injectable pharmaceuticals. Headquartered in Largo, FL
GLP Clinic Scout does not issue a blanket legitimacy verdict. This research record preserves 5 dated first-party or regulator citation(s), 5 regulatory/action record(s), and 4 explicitly unresolved field(s). Review the cited evidence and current license status before making a decision.
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