PQ Pharmacy

• Pharmacy Profile Name: PQ Pharmacy, LLC
• Website: pqpharmacy.com
• Address: 15215 Technology Drive, Brooksville, FL 34604
• President: Hale Dimetry
• Pharmacy Type: 503B FDA-registered outsourcing facility
• GLP-1 Products: Semaglutide, Tirzepatide (produced during shortage era)
• Licensed: All states except California and North Dakota
• Founded/Registered: 2020

About the Pharmacy

Located in Brooksville, Florida, PQ Pharmacy operates a 12,000 square-foot facility producing 503B sterile products to meet the needs of patients in medical practices, hospitals, and surgery centers nationwide. The pharmacy was established in 2020 and registered with the FDA as a 503B outsourcing facility in October 2020, placing it among the newer entrants to the high-volume compounding market.

PQ Pharmacy describes its operations as focused on stringent FDA guidelines, with every batch undergoing thorough testing for sterility, potency, and endotoxin levels before release. The pharmacy focuses on formulating products that address market shortages and caters to specific patient populations, aiming to collaborate with healthcare systems and providers.

GLP-1 Compounding

PQ Pharmacy compounded semaglutide and tirzepatide as essential copies during the FDA shortage period, supplying pharmacies and medical practices. PQ Pharmacy produced essential copy shortage products, with each product carrying its own dedicated NDC, shipped overnight and kept cold with a beyond-use date of six months from date of compounding.

Given the FDA Warning Letter issued in October 2025 (see Regulatory History below), the current status of GLP-1 production at PQ Pharmacy is uncertain as of March 2026. Patients and providers should verify directly whether PQ Pharmacy remains an active supplier and whether its sterility deficiencies have been corrected to FDA satisfaction.

Type of Pharmacy

PQ Pharmacy is a 503B FDA-registered outsourcing facility — the higher-scrutiny tier of compounding that requires cGMP compliance, FDA registration, regular inspections, semi-annual product reporting, and adverse event reporting. Its 503B designation means it can supply pharmacies and medical practices with bulk compounded sterile injectables without individual patient prescriptions.

Regulatory History:

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FDA Form 483 — October 2022: A 2022 inspection at PQ Pharmacy’s Brooksville facility issued a Form 483 citing failure to submit initial registration product reports to FDA, discrepancies in hold times for compounded ophthalmic solutions, an operator qualified only within limited parameters performing out-of-scope manufacturing, and deficiencies in the aseptic processing cleaning and disinfection program.

FDA Warning Letter — October 10, 2025: Following an inspection from March 25 to April 4, 2025, the FDA issued Warning Letter #715795 to PQ Pharmacy, LLC. The inspection found that drug products produced failed to meet the conditions of Section 503B, and that the investigator noted serious deficiencies in practices for producing drug products intended or expected to be sterile, which put patients at risk. Among the documented violations: an operator was observed resting their arms on the work surface of the hood during aseptic production — a direct contamination risk in a sterile manufacturing environment.

The FDA strongly recommended that PQ Pharmacy’s management undertake a comprehensive assessment of operations including facility design, procedures, personnel, processes, maintenance, materials, and systems — with particular focus on aseptic processing operations — and that a third-party consultant with relevant sterile drug manufacturing expertise assist in conducting this evaluation.

States Licensed In

PQ Pharmacy is licensed in all states except California and North Dakota.

Telehealth Providers They Work With

PQ Pharmacy operates as a wholesale B2B supplier to pharmacies and medical practices rather than directly to named telehealth platforms. No specific named consumer-facing telehealth platform partnerships were identified in public records. Its products reach patients through the pharmacies and practices that purchased from PQ Pharmacy wholesale.

Pricing from Reviews

Pricing for PQ Pharmacy’s 503B sterile products is published through pharmacy wholesale channels, with a 10% discount available for new account setups through at least one pharmacy cooperative network. Consumer-facing GLP-1 pricing is set by the downstream practices and pharmacies purchasing from PQ Pharmacy rather than appearing as retail pricing on PQ Pharmacy’s own channels.

Overall Reviews

PQ Pharmacy does not have a meaningful consumer-facing review profile, consistent with its B2B wholesale model. Providers and pharmacies that purchased from PQ Pharmacy during the shortage era received semaglutide and tirzepatide through an overnight cold-chain shipping program. The October 2025 FDA Warning Letter for serious sterility deficiencies — including the documented instance of an operator resting arms directly on an aseptic hood work surface — represents a significant quality concern for a 503B outsourcing facility whose core function is producing sterile injectables.