Compounding is the art and science of creating personalized medications tailored to meet the unique needs of individual patients. Unlike mass-produced medications, compounded medications are prepared by our specially trained pharmacists who mix ingredients to the exact strength and dosage form required by the patient and prescribed by their doctor. This process allows for customization in various aspects, including flavor, dosage, and form (such as capsules, creams, gels, or liquids).
Why Choose compounding?
At Mills Compounding Pharmacy, we specialize in both sterile and non-sterile compounding, providing personalized medications tailored to meet the unique needs of each patient.
Compounded medications can provide solutions when:
Commercial Medications are Unavailable
Shortages or discontinuations of commercially available drugs can leave patients without essential medications. Compounding provides an alternative source.
Allergies and Sensitivities
Patients with allergies or sensitivities to dyes, preservatives, or other additives can receive medications free from these ingredients.
Unique Dosage Requirements
Pediatric, geriatric, or animal patients often require doses that are not commercially available.
Alternative Dosage Forms
Compounded medications can be prepared in forms that are easier for patients to take, such as flavored liquids, transdermal gels, or suppositories.
Sterile vs. Non-Sterile Compounding:
Understanding the Difference
- Sterile Compounding
Sterile compounding involves the preparation of medications in an environment free from bacteria, viruses, and other microorganisms. This type of compounding is used for medications that are to be administered via injection or application to areas of the body that are highly susceptible to infection, such as the eyes.
- Non-Sterile Compounding
Non-sterile compounding involves the preparation of medications that are not required to be sterile. These medications are typically administered via routes that do not require sterility, such as oral, topical, or rectal.
WHat is sterile compounding?
Sterile compounding involves the preparation of medications in an environment free from bacteria, viruses, and other microorganisms. This type of compounding is used for medications that are to be administered via injection or application to areas of the body that are highly susceptible to infection, such as the eyes.
Common Sterile Compounded Medications:
Injectables
Medications that are administered directly into the bloodstream, muscles, or under the skin.
Key Features of Sterile Compounding:
Controlled Environment
Sterile compounding is performed in a cleanroom or a laminar airflow hood, where air quality and surfaces are strictly controlled to prevent contamination.
Stringent Protocols
The process follows rigorous protocols to ensure sterility, including the use of sterile equipment, personal protective equipment (PPE), and aseptic techniques.
Regulatory Standards
Adheres to USP <797> guidelines, which set the standards for sterile compounding practices.
WHat is non-sterile compounding?
Non-sterile compounding involves the preparation of medications that are not required to be sterile. These medications are typically administered via routes that do not require sterility, such as oral, topical, or rectal.
Common Non-Sterile Compounded Medications:
Liquid solutions, suspensions and emulsions
Topical creams, ointments, and gels
Applied to the skin for localized treatment.
Transdermal gels, lotions, creams and ointments
Applied to the skin for systemic treatment.
Capsules and tablets
Sprays and Foams
Lozenges, troches, and gummies
Suppositories
Administered rectally or vaginally
Animal-friendly treats
Key Features of Non-Sterile Compounding:
Flexible Formulations
Allows for a wide range of formulations, including changes in dosage strength, flavor, and form.
Customized Medications
Ideal for patients with allergies or sensitivities to certain ingredients or those who need specific dosage adjustments.
Regulatory Standards
Adheres to USP <795> guidelines, which set the standards for non-sterile compounding practices.
Rules and Regulations
Around Compounding
Compounding pharmacies operate under strict guidelines to ensure the safety and efficacy of compounded medications. In the United States, these regulations are governed by various agencies, including:
State Board of Pharmacy
Each state has its own board that regulates pharmacy practice, including compounding.
Food and Drug Administration (FDA)
While the FDA does not directly regulate compounded medications, it does oversee the bulk drug substances that can be used in compounding and enforces laws to prevent the manufacturing of compounded drugs that are essentially copies of FDA-approved drugs.
U.S. Pharmacopeia (USP)
USP sets standards for the quality, purity, strength, and consistency of compounded medications. Key chapters include USP <795> for non-sterile compounding and USP <797> for sterile compounding.
Quality Guidelines for Compounding
Ensuring the highest quality of compounded medications involves adherence to rigorous standards:
Ingredient Quality
Only high-quality, pharmaceutical-grade ingredients are used in compounding. Ingredients must be sourced from FDA-registered suppliers.
Sterile and Non-Sterile Compounding
For medications that must be sterile (such as eye drops or injectables), compounding is done in a controlled, clean environment to prevent contamination. Non-sterile compounding follows stringent hygiene and preparation protocols.
Training and Certification
Pharmacists and pharmacy technicians involved in compounding must undergo specialized training and certification to ensure they are knowledgeable about compounding techniques and safety practices.
Equipment and Facilities
Compounding pharmacies must use state-of-the-art, innovative equipment and maintain facilities that meet or exceed regulatory standards.
Testing and Verification
Compounded medications undergo rigorous testing for potency, purity, and stability. Regular quality checks and third-party testing help ensure that each medication meets the required specifications.
Commitment to Excellence
Mills Compounding Pharmacy is dedicated to providing personalized care and high-quality medications tailored to the unique needs of our patients. We adhere to all regulatory guidelines and quality standards, ensuring the safety and effectiveness of every compounded medication we prepare. We have voluntarily achieved PCAB Accreditation for both non-sterile and sterile compounding.
If you have any questions about compounding or need a customized medication, please contact us. Our experienced pharmacists are here to discuss your needs and provide you with the best possible solutions. Your health and well-being are our top priorities, and we are committed to delivering the highest standard of care.