Town & Country Compounding

Town & Country Compounds Both Non-sterile and Sterile Prescriptions

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.

Learn More: TCC Sterile Compounding Labs

Why Would a Sterile Compounded Prescription Be Needed by a Patient?

Certain drugs, combinations of drugs, concentration of the drugs, or specific dosage forms that the patient needs may not be commercially available at a traditional retail pharmacy.

Example 1

What if your child has a condition called myopia (nearsightedness), and your doctor has prescribed atropine eye drops at a 0.1% 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. 

Learn More: TCC Sterile Compounding Labs

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.

Low-Dose Atropine for Kids with Myopia >>

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.

Men’s Sexual Health >>

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.

Other Commonly Prescribed Sterile Prescriptions

Fortified Antimicrobial Eye Drops/Fortified Antibiotic Eye Drops

Eye drops are often needed at a higher strength than what is commercially available for certain conditions and, therefore, must be prepared by a compounding pharmacy.

Fortified Eye Drops
Preparation of aminoglycosides
Fortified tobramycin or fortified gentamycin 14 mg/ml (1.4%) Method: Take 2 ml from an injectable vial of intravenous (IV) tobramycin or gentamicin (40 mg/ml). Add the injected 2 ml to a 5-ml bottle of commercially available tobramycin or gentamycin eye drops (0.3%)
Shelf‑life: Refrigerate and shake well before instillation
Fortified amikacin 40 mg/ml Method: IV formulation can be used (80 mg/2 cc ampules)
Shelf‑life: Refrigerate and shake well before instillation
Preparation of cephalosporins
Fortified cefazolin eye drops: 50 mg/ml (5%) or fortified ceftazidime: 50 mg/ml (5%) Method: Add 9.2 ml of artificial tears to a vial of cefazolin 1 g (powder for injection) and dissolve. Take 5 ml of this solution and add it to 5 ml of artificial tears
Shelf‑life: Refrigerate and shake well before instillation
Topical vancomycin eye drops: 15 mg/ml, 25 mg/ml, or 50 mg/ml (5%) Method: To a 500 mg vial of vancomycin:

a) Add 33 ml of 0.9% sodium chloride for injection USP (no preservatives) or artificial tears to compound a solution of 15 mg/ml

b) Add 20 ml of 0.9% sodium chloride for injection USP (no preservatives) or artificial tears to compound a solution of 25 mg/ml

c) Add 10 ml of 0.9% sodium chloride for injection USP (no preservatives) or artificial tears to compound a solution of 50 mg/ml

Storage: Refrigerate and shake well before instillation
Topical linezolid 2 mg/ml (0.2%) Method: Can be used directly from parenteral linezolid available as 200 mg/100 ml (2 mg/ml) IV infusion
Topical colistin (0.19%) Indication: Multiple drug‑resistant Pseudomonas aeruginosa bacterial keratitis
Method: It is prepared from parenteral colistimethate sodium powder (Xylistin) 1 million IU/75 mg and added to 10 ml of distilled water to obtain 7.5 mg/ml (0.75%). 1 ml of the above solution is then added to 3 ml of distilled water to obtain 0.19% colistin drops
Topical imipenem–cilastatin eye drops (1%) Method: To parenteral imipenem (500 mg)–cilastatin(500 mg), add 10 ml sterile water to create a solution of strength 50 mg/ml. Take 1 ml of this solution and add 4 ml of sterile water to make topical imipenem 1% to obtain 1 mg/ml
Storage: In amber‑colored bottles
Preparation of antifungals
Topical amphotericin B (0.15%) Method: Add 10 ml of distilled or sterile water to parenteral 50 mg of amphotericin B powder for injection. Draw 3 ml of this and add to 7 ml of artificial tear eye drops
Shelf‑life: Refrigerate and shake well before instillation
Storage: should not be exposed to light. The drops should be inspected at each visit for any turbidity, which may indicate contamination or drug precipitation
Topical voriconazole eye drops (1%) Method: Voriconazole powder (200 mg) was reconstituted with 19 ml of water for injections in order to obtain 20ml of a 10-mg/ml voriconazole solution: Voriconazole eye drops (1%)
Storage: Refrigerate at 4°C and shake well before instillation
Others: Trimethoprim/sulfamethoxazole
16 mg/ml/80 mg/ml commercial preparation can be used

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.

More on Ketamine Infusion Therapy >>

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, FDA, 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 T&C, 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.

See our pharmacy labs >>

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 >>

535 E CRESCENT AVENUE
RAMSEY, NJ 07446

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Town & Country Compounding provides the most advanced formulations based on the most recent research and peer-reviewed guidelines.

We work with patients and their medical providers with finding the right customized treatment that works, when commercially made medications are not showing results. Medication is not one-size-fits-all.

Please contact our experts to learn more.

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