A compounding pharmacy is a specialized type of pharmacy that creates customized medications tailored to meet the unique needs of individual patients. Unlike traditional pharmacies that dispense mass-produced drugs, compounding pharmacies mix ingredients in precise formulations as prescribed by doctors. This personalized approach allows for adjustments in dosage strength, routes of administration, alternative delivery methods, the removal of allergens or harmful additives, and improve patient convenience and compliance.
Compounded medications are particularly beneficial for patients requiring discontinued drugs or individuals who need specialized forms such as liquid, topical, or chewable medications. Compounding pharmacies work closely with doctors and pharmacists to help ensure that patients receive medications best suited to their medical conditions and personal preferences.
Types of Medications a Compounding Pharmacy Can Provide
Some common types of compounded medications:
- Customized Dosages: If a commercially available medication doesn’t come in the exact strength you need, compounding pharmacies can adjust the dosage to match your doctor’s prescription. This may be required for patients who are sensitive to certain medications and have a higher side effect profile for commercial strengths. Compounding would be a useful route to reduce side effects. Some FDA-approved meds were approved decades ago and have not been updated with the latest health data and protocols. In these scenarios, doctors can compound the correct dose and regime for patients.
- Changes to Route of Administration: Drug products can be formulated into oral solid dosage forms including tablets, capsules, and troches, oral liquid forms like solutions and suspensions, topical forms like gels, creams, and ointments, or other drug delivery systems. Compounded drug products can help address certain obstacles that different patient demographics commonly face such as difficulty swallowing or needing extended-release versions of their prescribed medication. Removing these barriers through formulation development and optimization attempts to remove potential, patient-specific obstacles and promotes medication compliance.
- Allergy-Friendly Medications: Many standard medications contain dyes, preservatives, lactose, gluten, or other ingredients that may cause adverse reactions. Compounding allows for the removal of these additives to create a safer option for sensitive patients, reducing the risk of allergic reactions and intolerances.
Pediatric and Veterinary Medications: Children and pets often require specially formulated medications with custom dosages and flavors to improve compliance. Flavored suspensions, chewable tablets, and transdermal gels can make it easier to administer medications to young patients and animals who may resist taking standard forms.
Are Compounded Medications Safe and Regulated?
One of the most common concerns about compounded medications is their safety. While compounded drugs are not FDA-approved in the same way as mass-produced pharmaceuticals, compounding pharmacies must follow strict guidelines to ensure safety and quality.
- Regulatory Oversight: Compounding pharmacies operate under the guidance of the FDA and state pharmacy boards and follow United States Pharmacopeia (USP) standards, including USP <795> for non-sterile compounding, USP <797> for sterile compounding, and USP <800> for hazardous drug handling. These regulations ensure that medications are prepared in a controlled environment and meet stringent safety standards.
- Expertise: Compounding pharmacy staffed by not only pharmacists but also PhD scientists who are experts in formulation development, analytical testing, and Current Good Manufacturing Practice (cGMP) operations to ensure a safe, high-quality drug product.
- Quality Control: Reputable compounding pharmacies conduct rigorous testing to confirm the identification (ID), potency, purity, impurities, and stability of their formulations. They also ensure that proper sterility and contamination controls are in place, minimizing risks associated with compounded medications.
Get Started with Vici Today
At Vici, we specialize in developing pharmaceutical quality, hard-to-formulate, custom compounded drug products and medications personalized to meet your treatment plan requirements. Whether you require alternative dosage forms, precise formulations, or allergen-free formulation options, our formulation development scientists, analytical chemists, and pharmacists are committed to providing safe, effective, and personalized solutions. Contact us today to learn more about our compounding and formulation capabilities.
