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Town and Country Sterile Compounding Labs

Sterile Compounded Prescriptions Made Available at T&C Pharmacy

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.

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.

This differs from Non-Sterile Compounding

Why would a sterile compounded prescription be needed by a patient?

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

What Are Some Sterile Prescriptions?

Examples of sterile compounded prescriptions made at Town & Country Compounding

*Click + to Explore

+ 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).

Learn More About Tri Mix or Quad Injections

*T&C has patient instructional videos for injections and devices pertaining to ED

+ Atropine Eye Drops (Low-Dose For Pediatric Patients)

The strength of eyedrops 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 

Sometimes a patient needs a compounded medication to be administered at the surgery center for a procedure. 
*These are compounded with a prescription for a specific patient

+ Autologous Serum Eye Drops

Autologous serum eyedrops are often requested when patients have not success with various treatments for chronic dry eyes. Their own serum is used to make their eyedrops.

Autologous Serum Eye Drops Chronic Severe Dry Eyes

 

How Autologous Serums Work

Conventional therapies for severe dry eyes fail to heal the epithelial cells, which are the cells on the top layer of the cornea. The dry epithelial cells sometimes fall off of the cornea easily. Autologous serum comes from the patient’s own blood serum and plasma (Source: clevelandclinic.org). 

The fluid contains epithelium-promoting growth factors  and becomes a good replacement for tears. 

 

Sjogren’s syndrome is an inflammatory condition in which the mucous membranes, especially in the nose and mouth become very dry. Sometimes you will see this in patients who have rheumatoid arthritis and lupus. 

 autologous serum eyedrops (ASED) are thought to contain various growth factors and nutrients from the serum that benefit the surface of the eye and may help with corneal epithelial defects. Serum contains albumin, vitamin A, and nerve and epidermal growth factors that may promote healthy growth and healing of the ocular surface. These nutrients are not in over-the-counter artificial tears preparations. 

They are sometimes used by doctors with patients with neuropathic eye pain, keratitis and may also be used before and after certain high-risk corneal transplants and SLET procedures, or for post-vitrectomy diabetics.

Read More:

+ Intravitreal Injections

Sometimes a patient needs a compounded medication to be administered at the surgery center for a procedure. 
*These are compounded with a prescription for a specific patient

 

The procedure allows medication to be administered in the space behind the eye called the vitreous cavity.  The procedure takes place in the in a clinic, surgery center or hospital, and any compounded medications that may be needed are prepared by our pharmacy with a prescription for each specific patient. 

Intravitreal injections are used for several types of conditions.

  • Age-related macular degeneration (AMD)
  • Diabetic retinopathy
  • Retinal vein occlusion 
  • endophthalmitis infection
    • Intravitreal antibiotics are needed to try and prevent loss of vision

Classes of drugs that are often used in intravitreal injections

  • Steroids
  • Antibiotics
  • Antifungals

See More: Intravitreal Injections

+ 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) and send them to the clinic for infusion. 

  • Vitamin C (ascorbic acid) infusion
  • Myers Cocktail 
  • Glutathione
  • Amino acids

Commonly requested injectables that are commercial available and/or compounded

  • EDTA 250 mg/ml
  • Glycerin 50%
  • Glycerin 72%
  • Glutathione 200 mg/ml
  • Methylcobalamin 10,000 mcg/ml
  • Nicotinamide Adenine Dinucleotide (NAD+) 50 mg/ml
  • Pantothenic acid 250mg/ml
  • Pyridoxine 100 mg/ml
  • Selenium 40 mcg/ml
  • Vitamin C 
  • Vitamin D3 50,000 IU/ml
  • Zinc chloride 10mg/ml

Amino Acids:

  • Arginine 50 mg/ml
  • Carnitine 50 mg/ml
  • Glycine 50 mg/ml
  • Taurine 50 mg/ml

+ Ketamine Infusions

Ketamine infusion clinics provide the infusion therapy to patients. Ketamine may be used as a part of 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. 

Read More:

+ 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 home care services. 

What to Expect: Targeted Drug Delivery >>

Common medications that go into an intrathecal pump for targeted drug delivery are:

  • Baclofen
  • Morphine
  • Clonidine
  • Bupivacaine
  • Hydromorphone
  • Prialt® (ziconotide)
  • Fentanyl

Video Resource: Targeted Drug Delivery with Medronic’s Synchro Med II pump

Targeted drug delivery utilizes an implanted, programmable pump to release specific doses of medication for pain or spasticity through a catheter directly into the spinal cord. 

“Intrathecal drug delivery offers patients a way to experience pain relief using a fraction of an oral medication dose, which can help to minimize the uncomfortable and sometimes intolerable side effects (e.g., drowsiness, dizziness, nausea, vomiting and constipation) that often accompany pain medication taken orally.”
Source: ABOUT THE THERAPY TARGETED DRUG DELIVERY

Targeted drug delivery also can provide pain relief in patients who cannot achieve adequate analgesia even with high doses of oral opioid medications.

Read More: Journals of Neurosurgery:Surgical treatment of spasticity: intrathecal baclofen pump implantation under subarachnoid block

Testing of intrathecal injections at an independent analytical lab 

The intrathecal stock solutions have been tested by an independent analytical laboratory to establish that they have maintained their indicated potency and sterility over a 180-day period along with a USP method suitability testing.

Then, once compounded into single dose vials, the intrathecal stock solutions are quarantined, and samples are sent to an independent testing laboratory for the following tests prior to being released from quarantine for dispensing:

  • Potency testing
  • Sterility testing (USP 71)
  • Endotoxin testing (USP 85)

+ Elastomeric Infusion Pumps

An elastomeric pump is a disposable one-time use device for a continuous infusion, often used for medications such as:

  • Antibiotics
  • Chemotherapeutic agents
  • Anesthetics 
  • Analgesics

Uses of Elastomeric Pump & How Is It Used >>

Continuous Ambulatory Delivery Device– a CADD® pump is an infusion pump that you may see at the bedside at a hospital. 

It is a reusable medical device that can be programmed to deliver continuous infusion as well as bolus doses for pain management. The patient may be allowed to control when and how often they get a dose of their medication

This pump may be helpful in painful diseases such as pancreatitis, sickle cell anemia or may be used to help ease pain after surgery or ease suffering in end-of-life care (hospice).

Read More: Patient-Controlled Analgesia Pumps

+ Continuous Ambulatory Delivery Devices (CADD® pumps)

Continuous Ambulatory Delivery Device (CADD®) pump is an infusion pump that you may see at the bedside at a hospital. 

It is a reusable medical device that can be programmed to deliver continuous infusion as well as bolus doses for pain management. The patient may be allowed to control when and how often they get a dose of their medication

This pump may be helpful in painful diseases such as pancreatitis, sickle cell anemia or may be used to help ease pain after surgery or ease suffering in end-of-life care (hospice).

Learn More About Patient-Controlled Analgesia Pumps >>

+ Chemotherapy

Drugs used for chemotherapy (chemo) are also referred to as oncology drugs, antineoplastic drugs or cytotoxic drugs. This class of drugs is used in cancer patients but can also be used to treat other things
such as multiple sclerosis (MS), arthritis and others.
Source: CDC

Chemo drugs or other drugs needed during therapy may be sterile or nonsterile, and our labs are prepared to do either type. For example, a customized sterile eye drop, eye ointment or infusion may be
needed. We also provide sterile and non-sterile chemotherapeutic antineoplastic drugs for clinical trials.

Please contact us if you have a specific need or if you are a company in need of a clinical trial.

Contact Us >>    More About Clinical Trials >>

More on Cancer Clinical Trials

AMERICAN SOCIETY OF HEMATOLOGY

CLINICAL TRIAL SUPPORT CENTER

CLINICAL TRIALS INFORMATION FOR PATIENTS & CAREGIVERS

WHAT ARE CLINICAL TRIALS

+ Fortified Antibiotic Eye Drops

Eyedrops are often needed at a higher strength than what is commercially available for certain conditions and therefore, must be prepared by a compounding pharmacy. Often, the alternative to fortified ophthalmic drops is hospitalization and Intravenous infusions. It is important to get these eyedrops to the patient very quickly when needed!

The conditions that may require fortified eyedrops:

  • Resistant microbial keratitis This diagnosis is considered an emergency situation. The infection can progress rapidly and can progress quickly and can cause permanent damage that decreases vision.  Around 30,000 cases of microbial keratitis occur annually in the U.S.
    Read more:
    Common Eye Infections
    The Pharmacist’s Role in Managing Microbial Keratitis
  • Corneal ulcers
  • Bacterial infections on the ocular surface

Fortified eye drops

“Timely intervention will help treat the most resistant microbial keratitis and prevent the need for surgical intervention”

Tobramycin Fortified Ophthalmic Solution
  • We can compound strengths 13 mg/mL-15 mg/mL (BUD = 14 days)
  • Refrigeration Required

Vancomycin Fortified Ophthalmic Solution
  • We can compound strengths 12.5 mg/mL, 14 mg/mL, 25 mg/mL, 50 mg/mL (BUD = 14 days)
  • Refrigeration Required

Other anti-microbial ophthalmic medications:
  • Amikacin (2.5%)
  • Cefazolin (50 mg/mL)
  • Ceftazidime (5%)
  • Chlorhexidine Digluconate (0.02% – 1%)
  • Polyhexamethylene Biguanide (PHMB) (0.02%)
  • Voriconazole (0.1 – 1%)

Additional ophthalmic medications we commonly compound:
  • Acetylcysteine (5%, 10%)
  • Albumin (4%, 5%)
  • Atropine (0.01%, 0.02%, 0.025%, 0.1%, 0.125%)
  • Cyclosporin MCT (0.1%-0.5%, 1%, 2%)
  • Dexamethasone (0.01%, 0.1%)
  • Edetate Disodium (EDTA) (1%, 2%, 3%)
  • Glycerin (50%)
  • Mitomycin (0.02% – 0.04%)
  • Prednisolone (1%)
  • Timolol (0.5%)

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 will ship to multiple states.

Inspected by the NABP/NJ State Board of Pharmacy

Advanced Laboratories

We compound the highest quality sterile and non-sterile medications in our new state-of-the art laboratories.

USP 800, 797, and 795 Compliant

Our profession has adopted new rules and regulations from the State Board of Pharmacy and the USP (United States Pharmacopeia). We are USP 800 compliant with all aspects as a sterile and non-sterile 503A compounding pharmacy. (See below for more on the regulations)

Town & Country Sterile Lab Suite

The sterile lab suite at Town & Country Compounding has multiple labs (ISO certified rooms) where injectable medications, intravenous (IV) solutions, ophthalmic eyedrops, intravitreal injections, intrathecal infusions for targeted drug delivery, and other sterile medications are prepared.

The labs (ISO certified rooms) are separated depending on the types of drugs that are compounded in each, positive pressure rooms for non-hazardous sterile medication and negative pressure rooms for hazardous sterile medication.

*Pictured: John Herr, RPh., in front of T&C Sterile Lab

Our sterile suite is made up of 5 different rooms in which we only prepare sterile products. There is special anti-microbial epoxy flooring that is resistant to bacterial and fungal growth.  We utilize a Plascore® pharmaceutical grade wall and ceiling system constructed of welded steel and aluminum panels which provide antimicrobial surfaces and are chemically welded together.

Learn more: Modular Cleanroom Systems

  • USP 797 (ISO 7 certified positive pressure buffer room) (non-hazardous drugs)
  • USP 797 ISO 8 positive pressure ante room
  • USP 797/800 (ISO 7 certified negative pressure Buffer room) (hazardous drugs)
  • USP 797/800 (ISO 7 certified negative pressure ante room (hazardous drugs)
  • ISO 8 certified positive pressure hand scrubbing and gowning room

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, physician groups for early phase drug development or clinical trials.

Sterile Products for Clinical Trials

We work with Pharma companies, Health systems, and universities and to create sterile and non-sterile medications for clinical trials and drug development.

For example, we work on the development of IND and NDA medications, as well as new delivery vehicles for existing drugs. We also have HD (hazardous drug) labs equipped to compound chemotherapy drugs and other drugs considered hazardous by NIOSH

TCC Clinical Trials

Premium Standards in Sterile Preparations

There are many specific rules, procedures, techniques and regulations that must be considered when compounding sterile preparations. Safety, quality and accuracy are all of the utmost importance; from the drugs and concentrations that are used, to the pharmacists or certified technicians who are compounding and the environment they are made in.

“Safety, quality and accuracy are all of the utmost importance.”

It takes much expertise and investment along with educational commitment to be a sterile compounding pharmacy, as shown in the ASHP Guidelines on Compounding Sterile Preparations.

These procedures and techniques include:

  • Personal protective equipment (PPE), such as gowns,  gloves, goggles, masks booties, and hair coverings is worn
  • Compounding is done in a Primary Engineering Control (laminar flow hood, biological safety cabinet) that prevents infectious microorganisms from entering a work area
  • Compounding surfaces must be deactivated, cleaned with a germicidal and sporicidal cleaners, and disinfected multiple times daily with sterile 70% isopropyl alcohol.

Get Compounded Medications Delivered

We Can Ship to Patients in the States Where We Are Licensed or Deliver Locally

tcc-logo-white-new-location

Experts in sterile pharmacy compounding prescriptions for patients in:

New Jersey
New York
Connecticut
Delaware
Florida
Kentucky

Maryland
Ohio
Pennsylvania
Rhode Island
Massachusetts

Contact Us

Central Fill Agreement with Other Pharmacies 

Business opportunity to solicit sterile business from non-sterile pharmacies.

Town & Country Compounding can contract with other pharmacies in New Jersey to compound sterile prescriptions for their patients through a legal contract called a central fill agreement

This allows us to legally compound sterile prescriptions for your patients on your pharmacy’s behalf, instead of you referring the patient over to our pharmacy.  Within the contract, Town & Country Compounding’s duty is to compound the sterile preparation, and the dispensing pharmacy’s duty is to dispense the medication and counsel the patient.  This allows more opportunities for you to be able to serve your current patients’ sterile compounding needs. If you are a pharmacy in NJ and are interested in learning more, contact us for more information

Expand Your Pharmacy Services

Accreditations, Inspections and Compliance with Regulations

STERILE COMPOUNDING RESOURCE CENTER

National Home Infusion Association
OVERSIGHT OF STERILE COMPOUNDING

Oversight for sterile compounding practice falls primarily to the states and is typically governed by the individual state’s board of pharmacy, however the Food and Drug Administration (FDA) also maintains authority to inspect pharmacies for insanitary conditions. In some states, the Board of Medicine (or similar entity) regulates sterile compounding that occurs in physician offices. Most pharmacies maintain active accreditation from an agency that performs rigorous inspections for compliance with state laws and internal policies. Majority of state laws and accreditation standards are based on the principles outlined in the U.S. Pharmacopeial Chapter <797> Pharmaceutical Compounding – Sterile Preparations.

Town & Country Compounding is compliant with USP 800, USP 797 and 795

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.

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. 

USP 797

USP 797 (sterile) compliance is required by compounding pharmacies in New Jersey

Note: any pharmacy that ships prescriptions to patients in New Jersey must also be compliant with these guidelines.

Learn More About USP 797 >>

USP 795

USP 795 (non-sterile) compliance is required by compounding pharmacies in New Jersey

Note: any pharmacy that ships prescriptions to patients in New Jersey must also be compliant with these guidelines.

Learn More About USP 795 >>

USP 800

USP 800 Compliance is required by compounding pharmacies in New Jersey

 Note: any pharmacy that ships prescriptions to patients in New Jersey must also be compliant with these guidelines.

Learn More About USP 800 >>

Why is USP 800 is Important?

Facility Upgrades Needed to Protect Employees from Hazardous Drugs

 

If a pharmacy didn’t upgrade their lab to be compliant with USP 800, they can no longer compound things such as 

Progesterone
Estrogen
Testosterone
Chemotherapy

 

USP 800 Adds Significant Safety Standards >>

Cleanroom Certification 

We go above and beyond the USP 797 requirements

We are required by NJ and our accreditation organization to have a company come in and certify our cleanrooms twice yearly.

In addition to what is required, we also contract our own independent CETA (controlled environment testing association) professional to do additional surface and active air sampling more often than is required.  We also perform additional fingertip testing of personnel beyond the minimum requirement of USP 797.

Wireless monitoring systems throughout the pharmacy

We have installed wireless sensors from Monnit® not only our sterile suite of rooms, but also in our entire facility

Wireless sensors continuously monitor such things as:

  1. Temperature of all rooms, refrigerators, freezers and incubators
  2. Humidity levels of all rooms
  3. Pressure differential between our different ISO classified cleanrooms
  4. Pressure differential between our USP 800 non sterile compounding lab and our USP 795 compounding lab
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New Jersey & NYC’s Expert Compounding Pharmacy