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Our Pharmacy Facility:
- Was designed and constructed as a “compounding-only” lab to provide an ideal environment for our staff to produce only the highest quality compounded medications.
- Is USP Chapter 797/795 compliant.
- Utilizes only state of the art compounding equipment.
- Contains Class-10 barrier isolators within a Class-1000 clean room.
Our Highly Trained Pharmacists:
- Are licensed and regulated by the Massachusetts Board of Registration in Pharmacy.
- Have completed American Council on Pharmaceutical Education-accredited aseptic training courses.
- Follow national standards of practice for sterile product preparation as set forth by professional associations such as the American Society of Health-System Pharmacists (ASHP) and the United States Pharmacopeia (USP).
- Are members of the International Academy of Compounding Pharmacists (IACP) and the Massachusetts Pharmacists Association (MPhA).
Our Quality Control System Overview:
- Chemicals are obtained only from FDA registered chemical distributors.
- Samples from final product batch lots are sent to an independent FDA registered analytical lab for sterility, endotoxin (pyrogen) testing, quantitative analysis (potency) and extended stability testing.
- Tested medications are quarantined and dispensed only after the sample has tested negative for endotoxin and microbial contamination.
- The Quality Assurance Team (QAT), made up of employees from all departments within NECC, meets regularly to review all quality related items.
- All aseptic compounding actions are performed in compliance with NECC’s Standard Operating Procedures (SOPs). These SOPs have been “mapped” against USP 797 “Pharmaceutical Compounding – sterile preparations” to ensure that all USP 797 requirements are observed.