Commitment to QualityProviding quality medication for all.

Here’s something we think everyone deserves to know: before any medication leaves our facility, it’s been tested, reviewed, and signed off by our Quality team. Every batch. No exceptions. Empower Pharmacy is a PCAB-accredited 503A compounding pharmacy, and Empower Pharma is an FDA-registered 503B outsourcing facility operating under current Good Manufacturing Practice (cGMP) standards — the same framework required of pharmaceutical manufacturers. That’s not a small thing, and we don’t treat it like one.

Accreditations and certifications

We carry accreditations and certifications that hold us to rigorous, independently verified standards. Here’s what they actually mean:

Accredited Compounding Pharmacy

PCAB Accredited — 503A Compounding Pharmacy

503A Compounding Pharmacy

PCAB accreditation through the Accreditation Commission for Health Care (ACHC) is voluntary — we pursue it because it validates that our compounding practices meet the highest standards for sterile and non-sterile preparations, aligned with USP requirements. Nobody made us get it. We got it because it matters.

LegitScript Certified

LegitScript certification means an independent third party — one with no stake in the pharmacy industry — has verified that we comply with applicable pharmacy laws and regulations. For patients and providers, it’s one more outside set of eyes confirming that we are who we say we are.

FDA Registered 503B Facility

FDA Registered — 503B Outsourcing Facility

503B Outsourcing Facility

Our 503B outsourcing facility is registered with the U.S. Food and Drug Administration and operates under current Good Manufacturing Practice (cGMP) regulations. That’s the same quality framework required of pharmaceutical manufacturers — a bar most compounding pharmacies never have to meet.

CERTIFICATE OF CONFORMANCE

Testosterone Cypionate 200 mg/mL (5 mL) Injection

CERTIFICATE OF CONFORMANCE

NAD+ Aqueous 100 mg/mL (10 mL) Injection

CERTIFICATE OF CONFORMANCE

Glutathione Preservative Free 200 mg/mL (30 mL) Injection

QUALITY CULTURE

When Shaun Noorian founded Empower in 2009, he made a decision that still shapes how we operate: quality is not a cost center. It’s the foundation everything else is built on.

That means our facilities were engineered for cleanroom-grade manufacturing from day one — not converted retail space or a pharmacy that grew into manufacturing. It means our Quality Unit has full authority to hold or reject any batch, full stop, with no override from production or commercial pressure. It means every deviation gets investigated, every corrective action gets tracked to closure, and no batch ships until Quality says it ships.

We’re proud of that. And we think you should know about it.

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Empower Pharmacy 2021 Group Photo

End-to-end Quality ProcessQuality at Every Step

The following describes the quality process at our FDA-registered 503B outsourcing facility, which operates under current Good Manufacturing Practice (cGMP) regulations.

Quality at Empower is not a department. It is a system that governs every step from raw material procurement to finished product release.

Supplier Qualification

We don’t buy ingredients from just anyone. Every raw material we use comes from a qualified, approved supplier - one our Quality team has evaluated before a single ingredient ever enters our facility. Formal specifications are set for every material, and nothing gets purchased outside that approved framework.

We maintain an Approved Supplier List with ongoing oversight, and anything that doesn’t meet our specifications gets rejected and segregated before it can go further.

Incoming Material Testing

When materials arrive, they go straight into quarantine. Our Quality Control team tests each incoming material against its specifications. Anything intended for sterile products undergoes bacterial endotoxin and microbial limits testing. Nothing moves to production until testing is complete and Quality gives the green light.

Once cleared, materials are stored in temperature-controlled environments that are continuously monitored and temperature-mapped to protect their stability.

Production Controls

Production starts with batch records issued by our Quality Unit — not by whoever happens to be on the floor that day. Quality staff are present throughout, verifying every raw material for accuracy and purity before it enters the process. Multiple in-process checks confirm product quality at each stage, and our production processes are formally validated to demonstrate they consistently deliver.

Environmental Monitoring

Our cleanroom environments don’t just get cleaned — they get continuously monitored. We track particle counts, viable air sampling, surface monitoring, and personnel monitoring throughout production. Material, product, process, and personnel flows are designed to minimize contamination risk. When monitoring data shows an excursion from established limits, we investigate and act.

Finished Product Testing

Once a batch is complete, it is tested against product specifications before anyone signs off on it. For sterile products, that means:

  • Appearance: Visual evaluation against established specifications.
  • Assay (Potency): Quantitative analysis confirming the active ingredient meets its labeled strength.
  • pH: Verification that the formulation falls within its validated range.
  • Subvisible Particulates: Testing to confirm particulate matter meets USP and cGMP acceptance criteria.
  • Endotoxins: Bacterial endotoxin testing to ensure patient safety for injectable products.
  • Sterility: Microbiological testing to confirm the absence of viable microorganisms.

Every batch also goes through 100% visual inspection by qualified personnel, followed by Acceptance Quality Limit (AQL) sampling. A batch is released only after all testing passes and the Quality Unit completes its review.

Batch Release & Certificate of Conformance

Before any batch is released, it goes through a comprehensive documentation and review process. Batch records are issued by the Quality Unit before production begins and reviewed by both manufacturing leadership and Quality when it’s done. Critical process parameters, in-process results, equipment calibration, raw material quality, and environmental monitoring data are all verified. Any nonconformance must be fully investigated and resolved — no shortcuts.

Every batch gets a Certificate of Conformance, generated by Quality Control and approved by Quality Assurance. It’s full traceability and accountability, documented, for every product that leaves our facility.

Quality Management System

Our quality infrastructure is built on a comprehensive Quality Management System aligned with FDA's six-system inspection model. This system governs every function that touches product quality:

Document control and record retention:

Every procedure is current, reviewed, and accessible.

Change management:

The impact of any process, equipment, or material change is evaluated before implementation.

Risk management:

Structured methodologies identify, assess, and mitigate quality risks.

Investigation and CAPA:

Corrective and Preventive Action processes drive root cause analysis and systemic improvement when deviations occur.

Customer complaint management:

Every concern is documented, investigated, and resolved.

Annual Product Reviews and Quality Management Reviews:

Leadership receives data-driven oversight of quality performance.

Our Quality Unit operates with full authority over production decisions, including the power to hold or reject any batch that does not meet specifications.

Metal Manufacturing Canisters

Scale & InfrastructureBuilt for Pharmaceutical-Grade Quality

We’ve invested more than $55 million in purpose-built compounding and manufacturing facilities, designed and managed by our own in-house team of pharmaceutical engineers. This isn’t a pharmacy that outgrew its space. It’s infrastructure that was built for pharmaceutical-grade manufacturing from the start.

Every piece of production equipment goes through formal qualification before it touches a product: Installation Qualification (IQ) to verify correct setup, Operational Qualification (OQ) to confirm it runs within spec, and Performance Qualification (PQ) to prove it delivers consistent results under real production conditions. Same framework, same rigor as pharmaceutical manufacturers.

Our operations are supported by a digitized Quality Management System that tracks deviations, manages corrective actions, and gives us real-time quality oversight across every function.

The investment shows. And so does the output.

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