Sterile Compounding vs Non-Sterile Compounding
Nowadays, pharmaceutical compounding is becoming a clique as it continues to grow in demand and availability. Popularly, its benefits and compounding capabilities are essential, particularly for patients with patient-specific and customized medications.
What is compounding?
In compounding, pharmaceutical companies designed and formulated their compounded prescriptions for patients with specific unique needs. As in most cases, these compounds are for patients who cannot tolerate the commercially-available drug, whether intolerance to ingredients or a dosage issue. In this practice licensed pharmacist works closely with both physician and patient to ensure the right formulation dosage and standards are met.
How safe is compounding?
Compounding is a safe medical practice that has long been practiced in the pharmaceutical industry, as far as back sixty years ago. However, these formulated compounded drugs are not commercially available since each individual is unique from the other. For those patients who wish to avail the benefits of compounding, they should talk with their medical practitioner or pharmacist.
What is sterile compounding?
Sterile compounding is a method of creating a customized medication in a virus and bacteria-free environment to prevent contamination and ensure the safety of the patient.
Typically, the compounded medications are given through infusion, injection, or application to the eye. Administering the compounded medications involves high risks of causing infection, but with sterile compounding techniques, the risk of infection is reduced.
The pharmacies that offer this kind of service are called compounding pharmacies and their services include highly-trained and specialized staff, with state-of-the-art equipment, and practices quality assurance programs that adhere to standard policies and procedures.
What Procedures and Techniques are Applied?
- 1. Using proper personal protective equipment (PPE):
- hair coverings
- gloves7
- masks
- goggles
- 2. Wearing a hood against infectious microorganisms from entering a work area.
- 3. Sterilizing the equipment or autoclaving.
- 4. Deactivating surfaces such as with an oxidizing material, cleaning with germicidal material, and disinfecting using alcohol.
What is Non-Sterile Compounding?
Non-sterile compounding is also a process of customized medication but the environment is not completely free from viruses and bacteria. Usually, the compounded medications are applied either by:
- orally (capsules, suspensions, solutions, sugar-free/dye-free/lactose-free formulations)
- topically (creams/gels/transdermal gels)
- sublingual (troches/solutions)
- suppository (rectal/vaginal)
In non-sterile compounding, the risk of causing an infection is very low and there is no need for compounding the medications using sterile techniques.
What is a Sterile Compounding License, with USP 797 Standards?
A sterile compounding license having USP 797 standards is a credential for a compounding pharmacy that has met the USP 797 standards, or the pharmaceutical compounding sterile preparation standards. These USP 797 standard pharmacies are equipped with sterile preparations ensuring the patient’s medical needs, guaranteeing safe and quality environmental measures are met.
With Whom Do USP 797 Standards Apply?
The USP 797 Standards that prepare compounded sterile preparations apply to:
1. Institutions or places
- pharmacies
- hospitals
- healthcare institutions
- patient treatment clinics
- physicians' practice facilities
- other facilities
2. Disciplines/Professions
- Pharmacy technicians
- Physicians
- Pharmacists
- Nurses
What are the Advantages of Sterile Compounding?
1. Easy to use medications.
A highly trained compounding pharmacist can customize a certain medication in which the patients find hard to take or administer, particularly patients such as:
- young children
- elderly patients
- and even pets
2. Able to use alternative dosages or forms.
Patients who want to change their medication in a different dosage form can get through compounding pharmacies like large medication pills to a good-flavored liquid form. In addition, some medications can also be compounded into a topical form like a gel or a cream, for easy skin application.
3. Able to re-create discontinued medications.
There are times when certain big manufacturing companies stop producing certain drugs, making it hard for other patients to continue their medications. An expert compounding pharmacist can re-create the discontinued medications with pharmaceutical-based ingredients making sure the patients get the care they need.
4. Options for allergy-friendly medication.
A professional compounding pharmacy can custom-build a formulated medication offering patients an allergy-free or sensitive-free dosage. Also, patients with a high intolerance to gluten, alcohol, lactose, or dyes can get most from the benefits of compounded medications.
5. One-of-a-kind pharmacy services.
A compounding pharmacy can help identify a patient’s needs including its side effects and other related concerns to their compounded medications. Unlike ordinary pharmacies, compounding clinics can create a unique treatment plan for patients and be able to offer treatments for unusual or resistant maladies that traditional medicines cannot.
What is Potency Testing Program?
Potency testing programs or also known as quantitative tests is a process of measuring the concentration of the active drug or pharmaceutical ingredient. This testing is important to make sure the concentration matches its target amount and provides the right benefits for compounding pharmacies.
Fort Myers, Florida’s Leading Compounding Pharmacy
When it comes to compounding medications, nothing is more important than giving patients critical medication needs. Since 1991, Myerlee Pharmacy has been providing high-quality, affordable, and patient-specific medications to customers in Fort Myers, Florida, and the surrounding areas around Lee County.
Our unique compounded drug formulations of medication, either sterile or non-sterile compounding, is the best, effective and safest medication we give to our customers. We have the experience and expertise in compounding sterile products that you can rely on.
Myerlee Pharmacy has established itself in Lee County as a well-respected leader in the pharmaceutical compounding industry. Our on-site sterile compounding pharmacy is the only pharmacy in Lee County with a sterile license from the State Board of Pharmacy and is equipped with an ISO Class 7 Clean Room that meets USP 797 guidelines.
Sterile and Non-Sterile Compounding Pharmacy
Learn more about sterile and non-sterile compounding and other services with Myerlee Pharmacy at 239-482-3022, or message us online today!
