Patient Safety & Transparency
Myth: Compounded medications are just counterfeit or knock-off versions of commercially available drugs.
Fact: Compounded medications are not counterfeit or knock-offs. They are custom-made medications prepared by licensed pharmacists to meet the unique needs of individual patients. These treatments are created based on a healthcare provider’s prescription and are often used when commercially available options are unsuitable, such as for patients with allergies, dosage form requirements, or unique medical conditions.
Myth: The quality of compounded medications is unpredictable.
Fact: The quality of compounded medications is maintained through rigorous standards and best practices. Pharmacies that specialize in compounding follow guidelines from the United States Pharmacopeia (USP), which sets standards for the quality, purity, strength, and consistency of compounded medications.
Myth: Compounding pharmacies cannot create essential copies of commercially available drugs
Fact: Compounded medications are not counterfeit or knock-offs. They are custom-made medications prepared by licensed pharmacists to meet the unique needs of individual patients. These treatments are created based on a healthcare provider’s prescription and are often used when commercially available options are unsuitable, such as for patients with allergies, dosage form requirements, or unique medical conditions.
Myth: Compounded medications are less safe than commercially manufactured medications.
Fact: When properly compounded by a licensed pharmacist in a clean and controlled environment, compounded medications can be as safe as commercially manufactured ones. Pharmacists follow stringent guidelines and best practices to ensure the safety and efficacy of compounded medications. In fact, large-scale compounding facilities and outsourcing pharmacies regulated under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must follow GMPs which include: Facility Design and Maintenance: Proper facility layout to prevent cross-contamination, with dedicated clean rooms, controlled environments, and regular maintenance.
Personnel Qualifications and Training: Staff must be adequately trained in sterile and non-sterile compounding, with ongoing education and assessments to ensure compliance with procedures.
Standard Operating Procedures (SOPs): Detailed written procedures for all compounding processes, equipment use, and testing methods.
Quality Assurance and Control: Implementation of a quality management system that includes batch testing, in-process controls, and monitoring to ensure the final product meets specified standards.
Raw Material Control: Proper sourcing, testing, and storage of active pharmaceutical ingredients (APIs) and excipients to confirm identity, potency, and purity.
Sterile Compounding Standards: Special considerations for sterile preparations, such as aseptic techniques, microbial testing, and environmental monitoring.
Documentation and Record-Keeping: Accurate, comprehensive records of all compounding activities, including batch records, testing data, and deviations.
Labeling and Packaging: Clear and compliant labeling of compounded products, including dosage, ingredients, expiration date, and storage instructions.
Myth: It is impossible to know what ingredients are in compounded treatments.
Fact: Bulk quantities of compounded medications, as well as bulk medications produced by pharmaceutical manufacturers, must be accompanied by a valid certificate of analysis (CoA). CoAs are documents that verify the quality and composition of the product and ensures it meets required standards and specifications for safety and efficacy before being dispensed to patients. CoAs include important details like:
Product Identification: Name and batch/lot number of the compounded product.
Ingredients and Concentrations: Details about the active ingredients and their exact concentrations.
Testing Results: Analytical results for various quality control tests, such as potency, purity, sterility (for sterile products), and absence of contaminants.
Expiration Date: Stability data supporting the product’s shelf life.
Myth: Compounded treatments are unsafe because they’re not FDA-approved
Fact: While compounded medications are not FDA-approved like mass-produced drugs, they are made in licensed and regulated pharmacies that must follow strict safety and quality standards. Compounding pharmacies are regulated by state boards of pharmacy, and those producing larger-scale or sterile products are subject to FDA oversight. Properly compounded medications are prepared following Good Manufacturing Practices (GMPs) and are tailored to be safe and effective for the patient’s specific needs.
Myth: Compounded medications are more dangerous than commercially available drugs.
Fact: Compounding is a long-standing practice that addresses specific patient needs not met by off-the-shelf medications. Pharmacists use high-quality ingredients, adhere to precise formulations, and follow rigorous procedures to ensure the safety, potency, and efficacy of the compounded treatment.