Do you know how your sterile compounded medicines are made?
Standards and regulations for making compounded medications vary from state to state. New Jersey is known to have some of the most stringent compounding regulations in the country.
Town & Country Compounding 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.
- 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
Let us show you how we make ours.
Take a tour of our high-tech sterile compounding labs.
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.
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 Compounding Standards
Town & Country Compounding Is Compliant and goes beyond the requirements of USP 795, USP 797, and USP 800 Guidelines
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.
Common Sterile Medications
Sterile eye medications
Town & Country Compounding are trusted by ophthalmologists to address several conditions of the eye.
*Click examples below to expand/collapse
Other sterile medications
Tri-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).
*Town & Country has patient instructional videos for injections and devices pertaining to ED.
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.
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)
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
- 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
Compounded Myers’ Cocktail IV Infusions
Prescribers who practice in the areas of functional, integrative, longevity, and anti-aging medicine often prescribe customized Myers’ Cocktail Infusions for their patients to receive in a relaxing setting in their office.
Due to the high demand for these wellness infusions, prescribers should ensure they team up with an accredited and dependable sterile compounding pharmacy.
What is a Myers' Cocktail IV (Myers' Cocktail Infusion)?
A Myers’ Cocktail IV is a customized infusion given to the patient in an office setting. It is a type of intravenous (IV) nutrient therapy that contains a combination of vitamin C, B vitamins, magnesium, and calcium. The nutrients in the IV cocktail can help support overall wellness, immune function, mood, energy, and athletic recovery and help reduce overall inflammation in the body.
Practitioners that prescribe Myers’ Cocktails for their patients often customize the IV bag with various antioxidants in addition to vitamin “boosters,” depending on the patient’s symptoms or nutrient deficiencies. Glutathione is commonly given separately immediately after the infusion.’
Who may benefit from a Myers' Cocktail IV Infusion?
Those who need to rejuvenate, rehydrate, recover, or replenish vitamins and nutrients for various reasons.
Trimix & Bimix
Trimix is an injectable three-drug prescribed medication used for erectile dysfunction. The active ingredients in the mixture are usually alprostadil, papaverine, and phentolamine. Quad-mix adds one extra drug, atropine.
- We help patients get results.
- Quality products made right.
- Education to help make the process as "normal" as possible
More About Tri-Mix & Bi-Mix Injections
Trimix is an injectable three-drug prescribed medication. The active ingredients in the mixture are usually alprostadil, papaverine, and phentolamine. Quad-mix adds one extra drug, atropine.
Dr. Phillip S. Kim, MD
President, Pennsylvania Pain Society Center for Interventional Pain & Spine
Town & Country Compounding makes customized medication at the highest level.
Their high-tech labs, expertise, and rigorous compounding protocols give me confidence that my patients are getting the best quality compounds.
Sterile laboratories for clinical trials
Premium Standards in Sterile Preparations
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.
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.
Sterile Compounding Resource Center