Sterile and Non-Sterile Compounded Prescriptions Explained
Compounding pharmacists can prepare both non-sterile and sterile compounded prescriptions.
Non-sterile means that the medications are used in or on parts of the body where sterility is not essential, such as on the skin or in the mouth.
Sterile medications must be sterile when introduced into the body. Sterile medications may be in the form of ophthalmic drops (eye drops), infusions, injections (IV intravenous, IM intramuscular, SQ subcutaneous), or irrigations containing medications to be used inside the eyes, lungs, veins, spine, muscle, or bladder.
Many pharmacies do not do sterile compounding due to rigorous regulations and financial investment along with expertise required for preparing drugs in a sterile environment. At Town & Country, we do both sterile and non-sterile.
What Is a Sterile Compounding Pharmacy?
A sterile compounding pharmacy is one in which pharmacists and certified technicians prepare specialized medications in an environment that is free from bacteria, viruses, fungi and any other organisms that could cause infection.
Why Would a Sterile Compounded Prescription Be Needed by a Patient?
Example 1
What if your child has a condition called myopia (nearsightedness), and your doctor has prescribed atropine eye drops at a 0.01% concentration. You go to your local retail pharmacy to get the medication filled, and they tell you that the eye drops do not come in the strength you need. The drops are only available here. You will need a sterile compounding pharmacy to provide the prescription with the strength your child needs.
Example 2
What if you have had prostate cancer and your doctor prescribed an injection called tri-mix or quad-mix. Your local retail pharmacy has never heard of it.You will need a sterile compounding pharmacy. Learn more >>
Example 3
You have dry eyes and have tried multiple prescriptions that have not worked for you. Maybe you have been diagnosed with Sjogren’s syndrome, which is an inflammatory condition where mucous membranes, especially in the nose and mouth become very dry. Sometimes, you will see this in patients who have rheumatoid arthritis and lupus. Your doctor has prescribed your own serum to be used for your eye drops. What? Your local retail pharmacy has no idea what this is?You need a compounding pharmacy to help you through this process of trying autologous serum eye drops (ASED).
See: Thicker than Water: Autologous Serum and A Report by the American Academy of Ophthalmology
Town & Country Compounding’s State of the Art Compounding Labs
Town & Country Compounding has expanded and we are now in our state-of-the-art compounding facility in Ramsey, NJ and we ship to multiple states.
We compound the highest quality sterile and non-sterile medications in our new state-of-the-art laboratories. We are fully compliant with all aspects as a sterile and non-sterile 503A compounding pharmacy.
Our sterile suite is made up of 5 different rooms in which we only prepare sterile products.
The quality and standards of our labs are the same standards that Pharma uses even though we are much smaller than a huge drug manufacturer. In fact, we work with pharma, universities, and physician groups for early-phase drug development or clinical trials.
Some Prescriptions That Are Compounded in Our Sterile Lab:
Atropine Eye Drops (Lower-Strength for Pediatric Patients)
The strength of eye drops needed for children with myopia is not commercially available. A compounding pharmacist can use the higher-strength commercial product and dilute it for the pediatric patient. This is done only in a sterile compounding lab.
Tri-mix, Bi-mix, Quad-mix Injections
Injections that are commonly prescribed for male patients who have had prostate surgery or for males who have not had success with typical therapies for erectile dysfunction (ED).
TCC has patient instructional videos for injections and devices pertaining to ED.
Autologous Serum Eye Drops (ASED)
Autologous serum eye drops are often requested when patients have not had success with various treatments for chronic dry eyes. Their own serum is used to make their eye drops.
IV Infusions for Nutritional Therapy
*These are compounded with a prescription for a specific patient
Many times, there are commercially available injectable products that need to be mixed together into an IV infusion. We can prepare them for the individual patient with a prescription.
- Vitamin C (ascorbic acid) infusion
- Myers’ Cocktail
- Glutathione
- Amino acids
Ketamine Infusions (IV Ketamine)
Ketamine infusion clinics provide infusion therapy to patients. Ketamine may be used as part of a program for managing psychiatric disorders such as major depressive disorder, treatment-resistant depression, post-traumatic stress disorder, anxiety and acute suicidal thinking, and also chronic pain management.
Intrathecal Injections for Pain Pumps (for Targeted Drug Delivery)
We compound various medications for patients who have intrathecal pumps used for chronic pain or spasticity. We can fill orders for intrathecal medications for patients who get their intrathecal pumps refilled either at their doctor’s offices or at home through homecare services. We also compound medications for elastomeric infusion pumps and CADD pumps.
Inspections, Accreditations, and Compliance with Regulations
Town & Country Compounding has been inspected by the NJ State Board of Pharmacy and National Association of Boards of Pharmacy (NABP) in addition to accreditation inspections. We are also accredited by ACHC for sterile compounding, non-sterile compounding, nursing, and home infusion.
Town & Country Compounding is Compliant with USP 800, USP 797, and 795
In order to be compliant with the NJ State Board of Pharmacy and NABP, pharmacies are required to be compliant with USP 800 regulations along with USP 797 for sterile operations and USP 795 for non-sterile compounding.
At Town & Country Compounding, we have spent the last 2 years preparing and building out our new pharmacy, and investing over a million dollars in becoming compliant with all of the new regulations.
USP 797 (sterile) and USP 795 (non-sterile) and USP 800 compliance are required by compounding pharmacies in New Jersey.
Any pharmacy that ships prescriptions to patients in New Jersey must also be compliant with these guidelines.
USP 800 Adds Significant Safety Standards.
Facility Upgrades Needed to Protect Employees from Hazardous Drugs >>
