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Compounded Pharmacy Services
July 20, 2005
Stan Wojta
National Director
800-994-6322 x668
New England Compounding Center
EXECUTIVE SUMMARY
NECC has been a leading compounding pharmacy in the New England region
and has earned a national reputation as a provider of high quality
compounded medications and excellent service to patients and prescribers.
These are the points that differentiate us from other compounders:
All of NECC’s compounding activities are performed in our State-ofthe–art laboratory. This laboratory contains the latest equipment,
including Class 10 Microsphere Environments, Electronic Analytical
Balances, and other equipment designed for our specialized
compounding practice.
NECC observes all aspects of USP Chapter 797 Guidelines for Aseptic
Compounding and specializes in compounding only.
NECC compounds each and every day. Our four registered pharmacists
are trained in the art of compounding.
All sterile compounding activities are performed by a Registered
Pharmacist, not a technician.
NECC is state licensed as a pharmacy nationwide, registered with the
DEA, and provides service to 49 out of 50 states.
NECC tests sterile compounded medications using an Independent
Laboratory, operated under the direction of a team of chemists and
microbiologists. This independent laboratory tests for Potency,
Sterility and Pyrogenicity.
Our professional team of Pharmacists and Technicians are a resource
to our customers. The proper care and nurturing of the Patient,
Physician, Pharmacist relationship is paramount and one of our
greatest strengths
New England Compounding Center
Company Confidential
06/28/2017
Page 1
SECTION II – FREQUENTLY ASKED QUESTIONS
1. Identify any accreditation your pharmacy has received or any certification of your
facilities.
A. 1.
We are licensed, regulated and inspected by the Massachusetts
Board of Pharmacy. www.state.ma.us/reg/boards/ph. They
regulate us as a “pharmacy with a central intravenous admixture
service” This is the strictest criteria for pharmacies in place
today.
Additionally, Massachusetts Board of Pharmacy inspections are
the basis for our being licensed in other states. Currently we are
state licensed as a pharmacy nationwide, registered with the
DEA, and provide service to 49 out of 50 states.
2. Provide the ratio of pharmacist to technicians in your compounding areas.
A. 2.
Four Licensed Pharmacists, Five Certified Technicians, One
Registered Technician.
3. Give a brief description of the safety measures in place to ensure accuracy of the
product. Including results of any laboratory confirmations.
A. 3.
New England Compounding Center maintains an organizationwide Continuous Quality Improvement Program, including ongoing Quality Assurance Meetings.
Samples from final product batch lots are sent to an independent
lab (Analytical Research Laboratories in Oklahoma City, OK. Tel:
405-271-1144) for sterility, endotoxin (pyrogenicity), and
potency testing.
Tested medication is quarantined and dispensed only after
sample has tested negative for endotoxin and microbial
contamination. Test results are provided with each order if
requested.
New England Compounding Center
Company Confidential
06/28/2017
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4. Describe the process to ensure the sterility of the products produced as well as any
testing processes you follow.
A. 4.
Formulations are sterilized by either filtration through a 0.22
micron filter or by autoclaving.
Sterile fluids and injectables are prepared in a Class 10
Microenvironment (barrier isolator), and our electronic
analytical balances ensure accurate weighing.
All sterile compounding activities are performed by a Registered
Pharmacist, not a technician.
5. Please indicate sources of bulk ingredients. Do they comply with USP or NF
specifications?
A. 5.
USP chemicals are obtained only from FDA registered Chemical
Distribution facilities.
6. Please describe methods, other than what is listed above, that are used to enable
compliance with USP 797 regulations.
A. 6.
An independent 3rd party pharmacy consultant inspects our
facility periodically to ensure we are observing all USP 797
requirements.
Class 10 microenvironments are validated every 6 months by
Scientific Air Analysis, Inc of Ashland, MA. Tel: 508-881-7100
All personnel are trained/validated by an outside agency,
Professional Compounding Centers of America (PCCA).
Each vial is labeled with a use-by-date appropriate to the
formulation.
Compounded preparations are packaged in containers meeting
USP standards. Container used depends on the physical and
chemical properties of the compounded preparation.
Product is dispensed by prescription only, for specific patients.
New England Compounding Center
Company Confidential
06/28/2017
Page 3
7. Describe the process in place to ensure compliance with HIPAA regulations.
A. 7.
Only Authorized pharmacy staff members have access to patient
names to process the prescription.
Faxed prescription orders go directly into our secured pharmacy
area.
Prescription processing is done using software accessible only to
authorized pharmacy staff. This software is completely separate
from our billing and customer service software programs.
All staff go through a rigorous HIPAA training program.
All staff members sign a contract promising to respect and
protect patient confidentiality.
Patient information is never transmitted over the internet.
Patient information is used only for treatment, payment, or
health care operations.
See Attachment B for supporting documentation.
8. State whether site-visits can be provided.
A. 8.
Site visits can be provided at your convenience.
New England Compounding Center
Company Confidential
06/28/2017
Page 4
SECTION III – SERVICES PROVIDED BY NECC
1. Detailed listing of how product can be obtained, prescription requirements etc.
A. 1.
Following completion of an Account Information Form (NECC
does not require a term contract) orders may be placed via our
dedicated, secure fax portal.
NECC compounds medications as a result of a practitioner’s
patient specific prescription drug order.
All prescriptions go directly to our Pharmacy. A registered
Pharmacist validates the prescription, performs calculations,
checks for drug compatibility and possible interactions and signs
off on the prescription.
Registered Pharmacists and/or certified pharmacy technicians
compound the medication.
A second Registered Pharmacist re-verifies all information and
prescriptions.
2. Description of method of how product will be delivered. Including steps taken to
prevent exposure to storage conditions outside of USP recommendations.
A. 2.
Medications are packaged in a taper/light resistant Mylar bag
and then packaged for overnight or second day delivery.
Medications are typically shipped overnight delivery via Federal
Express and are tracked door to door. Temperature sensitive
medications are shipped in approved environmentally controlled
packaging.
Each physician’s office is called by a New England Compounding
Center Customer Service Representative on the scheduled
delivery date to insure the medications arrived on-time and
intact.
3. Acceptable methods of payment
A. 3.
Acceptable methods of payment are Credit Card or Purchase
Order, net 30 days with approved credit application.
New England Compounding Center
Company Confidential
06/28/2017
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