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.