Our Approach to Quality & Safety

At Boothwyn Pharmacy, patient safety is the foundation of everything. From sterile compounding in our cleanrooms to the moment a medication reaches your door, every step of our process is guided by rigorous quality standards, advanced technology, and a culture of accountability.

We understand that patients trust us with their health. That trust demands uncompromising commitment to quality, precision, and compliance.

Built on the Highest Standards

Boothwyn Pharmacy operates under the nationally recognized United States Pharmacopeia (USP) Chapter <797> guidelines. These regulations establish strict protocols for maintaining sterile conditions, preventing contamination, and ensuring the strength, quality, and purity of every compounded medication.

Beyond USP <797> compliance, Boothwyn holds PCAB accreditation from the Accreditation Commission for Health Care (ACHC), underscoring its commitment to the high standards in sterile compounding.  These designations reflect ongoing, independent verification that our facilities, processes, and quality systems meet — and often exceed — federal and state standards.

Advanced Facilities and Environmental Controls

Boothwyn’s state-of-the-art compounding suites are designed to minimize risk and maintain sterility:

  • ISO-Classified Cleanrooms: Each sterile preparation is produced in an environment certified to ISO 5 or better conditions.

  • HEPA-Filtered Airflow Systems: Air is continuously filtered to remove particulates and microorganisms. Our HEPA filters are continuously changed and serviced.

  • Pressure-Controlled Zones: Positive and negative pressure differentials are used to protect both products and staff, ensuring cross-contamination cannot occur.

  • Routine Environmental Monitoring: Air and surface samples are regularly tested to verify cleanliness and aseptic techniques by third party vendors.

  • Third-Party Validation: As per the frequency specified in USP <797>,  all cleanrooms undergo independent certification and validation at least twice per year.

Safe Compounding Practices

Safety in compounding is not just about facilities — it’s about people and process. Every compounded medication follows a controlled, traceable workflow:

  1. Ingredient Verification: Boothwyn sources all active and inactive ingredients from FDA-registered suppliers and independently verifies each for identity, purity, and potency.

  2. Aseptic Technique: Trained pharmacists and technicians use sterile gloves, gowns, and equipment, working inside laminar airflow hoods to prevent contamination.

  3. Batch Documentation: Every step — from weighing and mixing to labeling and release — is recorded in a digital batch record system.

  4. Independent Testing: All GLP-1 Sterile compounded medications are tested for sterility, endotoxins, and potency by certified third-party laboratories before release.

  5. Final Pharmacist Review: No medication leaves our facility without verification by a licensed pharmacist for accuracy, dose, and quality.

Continuous Quality Assurance

Boothwyn’s Quality Assurance (QA) Department oversees all production and compliance programs. This team conducts ongoing audits, reviews environmental data, and leads regular staff training in aseptic technique and regulatory updates.

Our QA team also maintains a Corrective and Preventive Action (CAPA) system to ensure that any deviation, no matter how minor, is documented, analyzed, and fully resolved.

Every improvement we make — from upgraded HVAC systems to digital batch records — reflects our belief that safety is a living process, not a one-time achievement.

Transparency and Accountability

We believe that patients and providers deserve transparency into the quality of their medication.That’s why Boothwyn offers:

  • Accessible GLP-1 Test Results: Sterility, potency, and endotoxin test reports are available through our online patient portal.

  • Regulatory Readiness: Our facility is always inspection-ready for unannounced visits by NABP and state boards of pharmacy.

  • Open Communication: Our pharmacists are available to provide patient counseling pertaining to an individual's medicine, preparations and testing data.

Our Promise

Boothwyn Pharmacy’s mission is simple: to deliver compounded medications that meet the highest possible standard of safety, quality, and integrity.