NECC New England Compounding Center::Maryland Lawyers Handling Fungal Meningitis Lawsuits::Facts about NECC
If you received a steroid injection and are now suffering from fungal meningitis, call our office to seek compensation from the drug maker NECC - 410-288-2900.
Call the office at 410-288-2900 to speak with attorney G. Randolph Rice, Jr., for immediate help if you have been diagnosed with fungal meningitis and received a steroid injection.
What did NECC offer to medical providers?
Medications that are:
- No Longer Manufactured
- Persistently Backordered, because of Production Shortages
- Not Commercially Available in the Dosage Form the Patient Needs (e.g., preservative-free)
What type of Interventional Pain Management medications did NECC offer?
Steroids (Preservative-Free): Methylprednisolone Acetate, Triamcinolone Acetonide,
Betamethasone Repository, Betamethasone Sodium Phosphate "Particulate-Free", Dexamethasone Sodium Phosphate "Particulate-Free"
Intrathecal Pump Refills: Baclofen, Morphine, Hydromorphone, Clonidine, Bupivacaine, Fentanyl, Sufentanil, Meperidine Custom Combinations
Neurolytic Agent: Phenol 6-10% / Glycerol
"Racz" Procedure: "Hypertonic" Saline 10%, Hyaluronidase 1500u
How did NECC claim their medications were formulated?
- USP 797 Compliant
- All CSPs are compounded for your patients by pharmacists and technicians extensively trained in aseptic compounding
- Medications are prepared in a Class 10 Microenvironment (barrier isolator)
- Medications are comprised of USP quality ingredients
How did NECC claim they prepared the medications they sold?
"What is Compounding
Because every patient is different and has different needs, customized medications are a vital part of quality medical care.
Compounding is the art and science of combining, mixing, or altering pure, active ingredients to create customized medications for an individual patient in response to a licensed practitioner’s prescription.
Compounding: The Need
The basis of the profession of pharmacy has always been the "Triad," the patient-physician-pharmacist relationship. Through this relationship, patient needs are determined and decisions are made about treatment regimens that may include a compounded medication, including but not limited to:
Medications that are Not Commercially Available
Manufacturers have limited product lines due to a variety of economic and chemical restrictions. Therefore, there are limited chemical forms, dosage forms, strengths, flavors and packaging that are available for the physician to prescribe and the pharmacist to dispense. A compounding pharmacy allows the physician to prescribe a custom-tailored medication that is not available commercially.
Medications that are Not Stable
Some pharmaceutical preparations have a limited shelf-life due to chemical instabilities and therefore can’t be mass-produced by pharmaceutical manufacturers. These “short-shelf life” formulations can be compounded by pharmacists who have the ability to produce smaller lots more frequently ensuring stability for the intended patients. Physicians who utilize the services of a compounding pharmacy can prescribe the most appropriate medications for their patients.
Altered Commercially Available Medications
A patient may be allergic to a preservative or dye in a manufactured product. Some patients have difficulty swallowing a capsule and require a troche or lozenge. Many pediatric patients are non-compliant because their medications are bitter, but become compliant when the medication is flavored to their liking. All of these problems can be addressed by a compounding pharmacy. Compounding pharmacists can prepare dye-free or preservative-free dosage form and change the look and taste of a dosage form. This allows physicians to prescribe a commercially available medication in a different dosage form to meet a specific patient need and ensure patient compliance."
How did NECC describe their facility?
"NECC 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.
NECC 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).
NECC 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."
What types of medications did NECC provide for Ophthalmology and Retina Surgeons?
"Pre-Cataract" Dilation Drops (Preservative-Free): (T) Tropicamide,
#1) T -C-PE 1%-1%-2.5%
#2) T -C-PE 1%-1%-10%
#3) T -C-PE-K 1%-1%-2.5%-0.5%
#4) T -C-PE-K 1%-1%-10%-0.5%
Avastin-"Unit-dose Syringe": 1.25mg-0.05ml
light-resistant mylar bag
Triamcinolone Acetonide: 40mg/ml (PF), 1ml vial
Frozen/Unit-Dose Antibiotics: Vancomycin 10mg/ml, 1ml vial
Ceftazidime 22.5mg/ml, 1ml vial
What types of medications did NECC provide for Aesthetics?
Mesotherapy/ Lipolysis: Phosphatidylcholine, PPC-Premix, Collagenase, L-Carnitine, Hyaluronidase
Chemical Peels: Glycolic Acid, Salicylic Acid, Trichloracetic Acid, Lactic Acid, Jessner’s Solution, TCA/SA, Retinoic Acid Solution
Triple Anesthetic Cream: 20%-6%-4% (30g or 60g), 20%-8%-8%
Bleaching Creams: Hydroquinone, Retinoic Acid, Kojic Acid
Sclerotherapy: Hypertonic Saline, Glycerin, Dextose/Sodium Chloride
Was NECC Licensed?
NECC claims "NECC is licensed and may legally dispense prescription medications in all 50 states"
Where is NECC located?
NECC (New England Compounding Center)
697 Waverly Street
Framingham, MA 01702
What Speciality Medications did NECC provide for hospitals?
Pain Management: P/F Steroids, Intrathecal Pump Refills, Phenol Inj. / Ethanol Inj., Hypertonic Saline
Radiology/ Nuclear Medicine: Talc (sterile), Sulphan Blue
Surgery: Irrigation Solutions (provided individually and in combinations of Bacitracin, Polymyxin & Neomycin)
Ophthalmology: "Pre-Cataract" Dilation Drop Combos, Avastin™ (Unit Dose)
Emergency: LET Gel/Solution
Miscellaneous: Alum Irrigation Solution, Methacholine Kits, Glutaraldehyde, Hydroxyprogesterone Caproate 250mg/ml inj. (10ml or 1ml)
What should I do if I have be diagnosed with fungal meningitis in Maryland?
Contact us as soon as possible to begin the legal claim process and ensure you protect your legal rights. We here to help and manage the legal process so you can concentrate on healing. Contact the office at 410-288-2900 for immediate help.